PCI Biotech Holding ASA
Prospectus in connection with
A fully underwritten Rights Issue of 10,000,000 New Shares, each with a par value of NOK 3
The listing of up to 10,000,000 Subscription Rights for trading on Oslo Axess under the ticker
symbol "PCIB T"
The listing of 10,000,000 New Shares offered in the Rights Issue on Oslo Axess
Subscription Price:
NOK 7
Trading period for the subscription rights:
From and including 14 December 2016 to 16:30 (CET) on 5 January 2017
Subscription Period:
From and including 14 December 2016 to 16:30 (CET) on 5 January 2017
Important notice:
SUBSCRIPTION RIGHTS NOT USED TO SUBSCRIBE FOR NEW SHARES BEFORE THE END OF THE SUBSCRIPTION PERIOD WILL
LAPSE WITHOUT COMPENSATION TO THE HOLDER, AND CONSEQUENTLY BE OF NO VALUE. TO ENSURE THAT THE
SUBSCRIPTION RIGHTS RECEIVED DO NOT BECOME VOID AND WITHOUT VALUE, THE HOLDER MUST NO LATER THAN 5
JANUARY 2017 AT 16:30 (CET) EITHER EXERCISE THE SUBSCRIPTION RIGHTS AND SUBSCRIBE FOR NEW SHARES OR SELL THE
SUBSCRIPTION RIGHTS.
Manager
13 December 2016
PCI Biotech Holding ASA - Prospectus
IMPORTANT INFORMATION
This prospectus (the "Prospectus") has been prepared in order to provide information regarding PCI Biotech Holding
ASA ("PCI Biotech", "PCI Biotech Holding" or the "Company") and its business in connection with (i) the fully
underwritten rights issue (the "Rights Issue") of 10,000,000 new shares in the Company, (the "New Shares"), (ii) the
listing of up to 10,000,000 subscription rights (the "Subscription Rights") issuable to shareholders who are
registered in the Company's shareholder register as at 12 December 2016 (the Company's shareholders as at the end
of the date of the general meeting held on 8 December 2016 resolving the Rights Issue as evidenced in the VPS in
accordance with normal T+2 settlement) (the "Record Date"), and (iii) the listing of the New Shares on Oslo Axess.
For the definitions of terms used throughout this Prospectus, see Section 16 "Definitions and Glossary of Terms" of
this Prospectus which also applies to the front-page of this Prospectus.
This Prospectus has been prepared to comply with the Norwegian Securities Trading Act of 29 June 2007 No 75 (the
"Securities Trading Act") and related secondary legislation including EC Commission Regulation EC/809/2004. This
Prospectus has been prepared solely in the English language. The Prospectus has been reviewed and approved by
the Financial Supervisory Authority of Norway (Nw. Finanstilsynet) (the “Norwegian FSA”) on 13 December 2016 in
accordance with Sections 7-7 and 7-8, cf. Section 7-2 of the Norwegian Securities Trading Act. The Norwegian FSA
has not controlled or approved the accuracy or completeness of the information contained in this Prospectus. The
Norwegian FSA’s control and approval relate solely to the fact that the Company has included descriptions in
accordance with pre-defined checklists of requirements, hereunder checklists III and XXV. Moreover, the Norwegian
FSA has not made any form of control or approval relating to corporate law matters described in or otherwise
covered by this Prospectus. This Prospectus is valid for a period of 12 months from the date of approval by the
Norwegian FSA.
The Company has furnished the information in this Prospectus. Fondsfinans AS (the "Manager") have been engaged
as manager for the Rights Issue.
All inquiries relating to this Prospectus should be directed to the Company or the Manager. No other person has
been authorised to give any information about or make any representation on behalf of the Company in connection
with the Rights Issue or the listing of the New Shares and, if given or made, such information or representation must
not be relied upon as having been authorised by the Company, the Manager or by any of the affiliates, advisors or
selling agents of any of the foregoing. Neither the delivery, distribution or publication of this Prospectus nor any sale
of New Shares made hereunder or the listing of any New Shares shall under any circumstances create any
implication that there has been no change in the Company's affairs or that the information set forth herein is correct
as of any date subsequent to the date hereof.
The information in this Prospectus is as of the date hereof and is subject to change, completion and amendment
without notice. Any new material information, material mistake, or inaccuracy that might have an effect on the
assessment of the Company's shares (the "Shares") arising after the date of publication of this Prospectus and
before the New Shares are listed on Oslo Axess, will be published and announced as a supplement to this Prospectus
in accordance with Section 7-15 of the Securities Trading Act. Announcements relating to the matters described in
this Prospectus will be considered to have been made once they have been received by Oslo Axess and distributed
through its information system.
An investment in the Company involves inherent risks. Potential investors should carefully consider the risk factors
set out in Section 2 in addition to the other information contained herein before making an investment decision. An
investment in the Company is suitable only for investors who understand the risk factors associated with this type of
investment and who can afford a loss of all or part of their investment. The contents of this Prospectus are not to be
construed as legal, business, financial or tax advice. Each reader of this Prospectus should consult its own legal
advisor, business advisor, financial advisor or tax advisor as to legal, business, financial and tax advice. If you are in
any doubt about the contents of this Prospectus you should consult your stockbroker, bank manager, lawyer,
accountant or other professional advisor.
This Prospectus is subject to Norwegian law, and any dispute arising in respect of this Prospectus is subject to the
exclusive jurisdiction of the Norwegian courts with Oslo District Court as legal venue.
The distribution of this Prospectus may be restricted by law in certain jurisdictions. This Prospectus may not be
used for the purpose of, and does not constitute, an offer to sell or issue, or a solicitation of an offer to buy or
subscribe for, any securities in any jurisdictions in any circumstances in which such offer or solicitation is not
lawful or authorised. The Company and the Manager require persons in possession of this Prospectus to inform
themselves about and to observe such restrictions.
2
PCI Biotech Holding ASA - Prospectus
The New Shares and the Subscription Rights have not been and will not be registered under the US Securities Act
of 1933, as amended (the "US Securities Act") or any state securities laws, and may not be offered or sold within
the United States. Furthermore, the New Shares and the Subscription Rights may not be offered or sold in or into
any other jurisdictions where the offering and sale of the New Shares and the Subscription Rights is restricted by
law.
3
PCI Biotech Holding ASA - Prospectus
TABLE OF CONTENTS
1.
SUMMARY ..................................................................................................................................................... 5
2.
RISK FACTORS .............................................................................................................................................. 13
3.
RESPONSIBILITY FOR THE PROSPECTUS ....................................................................................................... 19
4.
CAUTIONARY NOTE ..................................................................................................................................... 20
5.
THE RIGHTS ISSUE ........................................................................................................................................ 21
6.
PRESENTATION OF THE COMPANY .............................................................................................................. 32
7.
MARKET OVERVIEW .................................................................................................................................... 64
8.
BOARD OF DIRECTORS, MANAGEMENT, EMPLOYEES AND CORPORATE GOVERNANCE ............................... 72
9.
CAPITALISATION AND INDEBTEDNESS ......................................................................................................... 80
10. FINANCIAL INFORMATION ........................................................................................................................... 82
11. SHARES AND SHARE CAPITAL....................................................................................................................... 87
12. CERTAIN ASPECTS OF NORWEGIAN COMPANY AND SECURITIES LAW ......................................................... 90
13. TAXATION .................................................................................................................................................... 98
14. SELLING AND TRANSFER RESTRICTIONS ..................................................................................................... 101
15. ADDITIONAL INFORMATION ...................................................................................................................... 102
16. DEFINITIONS AND GLOSSARY..................................................................................................................... 103
APPENDIX 1: SUBSCRIPTION FORM.................................................................................................................... 107
4
PCI Biotech Holding ASA - Prospectus
1.
SUMMARY
Summaries are made up of disclosure requirements known as "Elements". These elements are numbered in
Sections A – E (A.1 – E.7) below. This summary contains all the Elements required to be included in a summary
for this type of securities and issuer. Because some Elements are not required to be addressed, there may be
gaps in the numbering sequence of the Elements. Even though an Element may be required to be inserted in the
summary because of the type of securities and Issuer, it is possible that no relevant information can be given
regarding the Element. In this case a short description of the Element is included in the summary with the
mention of "not applicable".
Section A – Introduction and warnings
A.1
Warning
This summary should be read as an introduction to the Prospectus.
Any decision to invest in the New Shares should be based on
consideration of the Prospectus as a whole by the investor.
Where a claim relating to the information contained in the Prospectus is
brought before a court, the plaintiff investor might, under the national
legislation in its Member State, have to bear the costs of translating the
Prospectus before the legal proceedings are initiated.
Civil liability attaches only to those persons who have tabled the
summary including any translation thereof, but only if the summary is
misleading, inaccurate or inconsistent when read together with the
other parts of the Prospectus or it does not provide, when read together
with the other parts of the Prospectus, key information in order to aid
investors when considering whether to invest in such securities.
A.2
Consent to the use of the
prospectus by financial
intermediaries
Not applicable. No consent is granted by the Company to the use of the
Prospectus for subsequent resale or final placement of the Shares.
Section B – Issuer
B.1
Legal and commercial
name
The Company's legal name is PCI Biotech Holding ASA and is also
sometimes referred commercially to as PCI Biotech.
B.2
Domicile and legal form,
legislation and country of
incorporation
The Company's registered name is PCI Biotech Holding ASA. The
Company is organised as a public limited liability company under
Norwegian law, in accordance with the Norwegian Public Limited
Liability Companies Act, and is registered with the Norwegian Register of
Business Enterprises with registration number 991 036 393. The
Company's registered office is Ullernchausséen 64, 0379 Oslo, Norway.
B.3
Current operations,
principal activities and
markets
PCI Biotech is an oncology-focused company developing innovative
products for cancer treatment. The products are based on PCI Biotech’s
patented technology, photochemical internalisation ("PCI"). The PCI
technology can enhance the effect of anticancer drugs by targeted, lightdirected drug delivery into cancer cells, and can also be used as a
platform that may both potentiate the effect of vaccines and enable
macromolecules to reach intracellular targets.
B.4a
Significant recent trends
affecting the Company
and the industry in which
it operates
There have been no significant changes in the financial or trading
position of the Group since 31 December 2015. There is no information
of any known trends, uncertainties, demands, commitments or events
that are reasonably likely to have a material effect on the issuer's
prospects for the current financial year.
5
PCI Biotech Holding ASA - Prospectus
B.5
Description of the Group
The Company has one wholly owned subsidiary, PCI Biotech AS, which is
a Norwegian Private Limited Liability Company. In addition, PCI Biotech
AS has established an Icelandic branch, PCI Biotech Utibu.
B.6
Interests in the Company
and voting rights
Shareholders owning 5% or more of the Shares have an interest in the
Company's share capital which is notifiable pursuant to the Norwegian
Securities Trading Act. The following shareholders owned more than 5%
of the Shares on the date of this Prospectus:
-
B.7
Selected historical key
financial information
Fondsavanse AS holds 1,500,000 Shares which corresponds to
approx. 10.1% of the Company.
Radiumhospitalets Forskningsstiftelse holds 1,159,853 Shares which
corresponds to approx. 7.8% of the Company.
MP Pensjon PK holds 916,531 Shares which corresponds to approx.
6.2% of the Company.
The following consolidated financial information has been derived from
the Company's audited consolidated annual financial statements for the
years ended 31 December 2015 and 2014, as well as the unaudited
consolidated interim financial statements for the three and nine month
periods ended 30 September 2016, prepared in accordance with IFRS.
Condensed consolidated income statement (2015 and 2014 figures are based on the audited annual
accounts, interim 2015 and 2016 figures are based on unaudited interim accounts)
(NOK thousands)
Three
Three months
Full year
months
Nine months
Nine months
ended 30
ended 30
ended 30
ended 30
September
September
Full year September 2016
September 2015
2016
2015
(unaudited)
(unaudited)
(unaudited)
(unaudited)
10,467
7,297
Other income ..............................................................................
7,249
7,144
2 333
2 415
Research and development .........................................................
38,844
39,341
30,847
28,761
11 014
11 049
General and administrative ..........................................................
4,252
4,428
2,526
2,473
853
782
Operating costs ..........................................................................
43,096
43,769
33,373
31,234
11 867
11 831
Operating results........................................................................
(32,629)
(36,472)
(26,124)
(24,090)
(9 535)
(9 416)
Financial income ..........................................................................
867
812
546
674
259
219
Financial costs ..............................................................................
160
180
4
127
-
99
707
632
Net financial result .....................................................................
542
546
259
120
Ordinary profit before taxes .....................................................
(31,922)
(35,840)
(25,582)
(23,544)
(9 276)
(9 296)
Tax on ordinary result ..................................................................
-
-
-
-
-
Net profit/(loss) ...........................................................................
(31,922)
(35,840)
(25,582)
(23,544)
(9 276)
(9 296)
2015
2014
6
PCI Biotech Holding ASA - Prospectus
Condensed consolidated statement of financial position (2014 and 2015 figures are based on the audited
annual accounts, interim 2015 and 2016 figures are based on unaudited interim accounts)
(NOK thousands)
31.12 2015
31.12 2014
30.09 2016
30.09.2015
(unaudited)
(unaudited)
Operating assets……………………………………………….
10
14
6
11
Short term receivables…………………………………………
7,139
4,614
9,811
7,643
Cash & cash equivalents…………….............................
49,249
15,754
20,663
53,897
Total assets…………………………………………………….
56,398
20,382
30,480
61,551
Paid in capital……………………………………………………
165,379
99,911
165,379
165,379
Other reserves…………………………………………………
(121,094)
(90,796)
(145,764)
(113,040)
Total equity……………………………………………………
44,284
9,114
19,615
52,339
Trade debtors…………………………………………………..
3,371
2,586
3,991
2,517
Other short term debt…………………………………….
8,742
8,681
6,874
6,695
Total liabilities………………………………………………
12,114
11,269
10,865
9,212
Total equity and liabilities………………………................
56,398
20,382
30,480
61,551
Condensed consolidated statement of cash flows (2014 and 2015 figures are based on the audited annual
accounts, interim 2015 and 2016 figures are based on unaudited interim accounts)
(NOK thousands)
Three
Three
Nine months
Nine months
months
months
ended 30
ended 30
ended
ended
Full year
Full year
Sep 2015
Sep 2016
30
30 Sep
2014
2015
(unaudited)
(unaudited)
Sep2015
2016
(35,840)
(31,922)
(23,544)
(25,582)
(9,296)
(9,276)
4
4
3
3
1
1
Share options…………………...
1,558
1,624
1 301
912
308
203
Net financials…………
(812)
(867)
(546)
(542)
(120)
(259)
Changes in working capital
3,417
(1,680)
(5,086)
(3,920)
(431)
(1,293)
(31,674)
(32,841)
(27,872)
(29,128)
(9,538)
(10,624)
812
867
546
542
120
259
(30,862)
(31,974)
(27,326)
(28,586)
(9,419)
(10,365)
-
65,469
65,469
-
-
-
-
65,469
65,469
-
-
-
(30,862)
33,495
38,143
(28,586)
(9,419)
(10,365)
46,595
15,754
15,754
49,249
63,316
31,028
15,754
49,249
53,897
20,663
53,897
20,663
Cash flow from operating activities
Ordinary profit before taxes……
Depreciation, amortisation and write
offs
Cash flow from operating activities
Net financials received………
Net cash flow from operating
activities
Net proceeds from share issues
Net cash flow from financing
activities
Net change in cash during the period
Cash and cash equivalents at the
beginning of the period
Cash and cash equivalents at the
end of the period
B.8
B.9
Selected key pro forma
financial information
Profit forecast or estimate
Not applicable. There is no pro forma financial information.
Not applicable. No profit forecast or estimate is made.
7
PCI Biotech Holding ASA - Prospectus
B.10
Audit report qualifications
Not applicable. There are no qualifications in the audit reports.
B.11
Working capital
The Company is of the opinion that the working capital available to the
Group, including the NOK 70 million fully underwritten syndicate, is
sufficient for its requirements, and for the next 12 months following the
date of this Prospectus.
Section C – Securities
C.1
Type and class of
securities admitted to
trading and identification
number
The Company has one class of shares in issue. The New Shares offered in
the Rights Issue will in all respect be equal to the existing Shares of the
Company, once the New Shares have been issued and registered with
the Norwegian Register of Business Enterprises and the VPS. The
Company's Shares are registered in VPS under ISIN NO 0010405640.
C.2
Currency
NOK.
C.3
Number of shares and per
value
At the date of this Prospectus, the Company's share capital is
NOK 44,701,170 consisting of 14,900,390 ordinary shares with a par
value of NOK 3 each. All the existing Shares are validly issued and fully
paid.
The Company is offering, and applying for the listing of, 10,000,000 New
Shares in connection with the Rights Issue.
C.4
Right attaching to the
securities
The New Shares will in all respect be equal to the existing Shares of the
Company once the New Shares have been issued and registered with the
Norwegian Register of Business Enterprises and the VPS. The Shares are
equal in all respects and there are no different voting rights or classes of
shares. Each Share carries one vote at the Company's general meeting.
C.5
Restrictions on
transferability
Not applicable. The Shares of the Company are freely transferable;
however, restrictions may apply by virtue of different jurisdiction's
securities laws and regulations.
C.6
Admission to trading
The Company's existing Shares are listed on Oslo Axess.
The Company expects commencement of trading in the New Shares on
Oslo Axess on or about 16 January 2017. The Company has not applied
for admission to trading of the Shares on any other stock exchange or
regulated market.
C.7
Dividend policy
PCI Biotech has paid no dividends to date. The Company's policy, being a
growth company, is not to pay dividends for the time being.
Section D – Risks
D.1
Key risks specific to the
Company or its industry
-
-
-
The Company is in an early stage of development and the
Company's clinical studies may not prove to be successful.
Unsuccessful clinical studies may result in the relevant product not
being commercialised.
There may be risks related to obtaining regulatory approvals which
are required for commercialisation of the Company's product.
Failure to obtain the necessary regulatory approvals may result in
the relevant product not being commercialised in certain
jurisdictions or at all.
The financial success of the Company requires obtaining acceptable
8
PCI Biotech Holding ASA - Prospectus
-
-
-
-
-
-
-
-
prices and reimbursements. There can be no guarantee that the
Company's drugs will obtain the selling prices or reimbursement
levels foreseen by the Company. If actual prices and reimbursement
levels granted to the Company's products happen to be lower than
anticipated it would likely have a negative impact on its products'
profitability and/or marketability.
The success, competitive position and future revenues will depend
in part on the Company's ability to protect intellectual property and
know-how. This will require the Company to obtain and maintain
patent protection for its products, methods, processes and other
technologies, to preserve trade secrets, to prevent third parties
from infringing on proprietary rights and to operate without
infringing the proprietary rights of third parties. Failure to do so
may result in competitors selling the Company's products, that the
Company's is prohibited from selling its products and costly
processes to defend intellectual property rights.
The Company is exposed to competition and operates in a highly
competitive industry. The biotechnology and pharmaceutical
industries are highly competitive with many large players and
subject to rapid and substantial technological change.
Developments by others may render the product candidates or
technologies obsolete or non-competitive.
The Company cannot be certain that it will be able to enter into
satisfactory agreements with third-party suppliers or
manufacturers. The Company's failure to enter into agreements
with such suppliers or manufacturers on reasonable terms, if at all,
could have a material and adverse effect on the business, financial
condition and results of operations.
The Company's business strategy is to commercialise its technology
partly through collaborative agreements with pharmaceutical or
biotechnology companies. The Company cannot give any assurance
that such agreements will be obtained on acceptable terms, nor
that the Company will be able to enter into any such agreements at
all.
The proceeds of the Rights Issue may not fund the Company until a
commercial stage has been reached.
The Company faces an inherent business risk of liability claims in the
event that the use or misuse of the compounds results in personal
injury or death.
The Company is highly dependent upon having a highly qualified
senior management and scientific team. The loss of a key employee
might impede the achievement of the scientific development and
commercial objectives.
The Company has not yet generated revenues from the sale of any
commercial pharmaceutical products, and does not expect to
generate such revenues in the near future. The Company expects to
continue to incur substantial operating losses until and if such time
as licensing revenues and/or product sales generate sufficient
revenues to fund continuing operations.
The Company's results will be exposed to exchange rate risks.
There is a risk that pricing of the kind experienced to date will
become difficult to achieve. Once approval is obtained for a product
there is no certainty that the Company or its licensees will achieve
commercial success since several factors will determine this,
including clinical performance of the product, approved indication,
competitive environment, pricing and reimbursement. There is no
guarantee that after regulatory approval reimbursement authorities
will agree to cover the cost of the product. Delays in reimbursement
9
PCI Biotech Holding ASA - Prospectus
-
-
-
-
D.3
Key risks specific to the
securities
-
-
-
or its denial will limit adoption of the product in the market.
The Company may face competition from low-cost generic
products. Loss of market exclusivity and the introduction of a
generic version of the same or a similar medicine typically results in
a significant and sharp reduction in net sales for the relevant
product, given that generic manufacturers typically offer their
versions of the same medicine at sharply lower prices.
The Company's international operations could be affected by
changes in intellectual property legal protections and remedies,
trade regulations and procedures and actions affecting approval,
production, pricing, reimbursement and marketing of products, as
well as by unstable governments and legal systems and intergovernmental disputes.
An increase in negative public sentiment or increase in public
scrutiny or pressure from a nation could lead, among other things,
to changes in legislation, to changes in the demand for the
products, additional pricing pressures with respect to the products,
or increased efforts to undercut intellectual property protections.
The Company is registered for value added tax (VAT) until the end
of 2016 and is dependent on an approval from the tax authorities
(Skatt Øst) for extension of advance registration for VAT for future
periods.
The Company is listed on a regulated market place with inherent
liquidity risk in the Company's shares and the Subscription Rights.
The price of the Shares and the Subscription Rights may fluctuate
significantly.
Future issuances of Shares or other securities in the Company may
dilute the holdings of shareholders and could materially affect the
price of the Shares.
Investors in the United States may have difficulty enforcing any
judgement obtained in the United States against the Company or its
directors or executive officers in Norway.
The transfer of the Shares may be subject to restrictions on
transferability and resale in certain jurisdictions.
Shareholders outside of Norway are subject to exchange rate risk.
Investors may not be able to exercise their voting rights for Shares
registered on nominee account.
If the Rights Issue fails, the Subscription Rights will no longer be of
value.
Section E – Offer
E.1
Net proceeds and
estimated expenses
The gross proceeds to the Company for the New Shares will be
NOK 70,000,000.
The total costs and expenses in relation to the Rights Issue and the listing
of the Subscription Rights and the New Shares are estimated to be
approximately NOK 3.6 million, in addition to an underwriting fee equal
to 2% of the aggregate amount underwritten by the Underwriters. The
costs and expenses will be paid by the Company.
E.2a
Reasons for the Rights
Issue and use of proceeds
The proceeds from the Share Issue are expected to secure the
Company’s funding needs, mainly to enable the Company to reach
regulatory clarity on requirements for a pivotal Phase II with fimaCHEM,
complete the fimaVACC Phase I study, and further pursue partnership
opportunities. Depending on inter alia potential partnering agreements
10
PCI Biotech Holding ASA - Prospectus
E.3
Terms and conditions of
the Rights Issue
and initiated projects the proceeds are expected to fund the Company to
mid 2018 or longer. The Company emphasises that the net proceeds
from the Rights Issue are not sufficient to fund completion of the
planned phase II part of the bile duct cancer study.
The Share Issue comprises an offer of 10,000,000 New Shares, with a par
value of NOK 3, each at a subscription price of NOK 7 per share.
Shareholders who are registered in the Company’s shareholder register
on 12 December 2016 (the Company’s shareholders as at the end of the
date of the general meeting, on 8 December 2016), as evidenced in the
VPS in accordance with normal T+2 settlement) will be granted tradable
subscription rights.
In order to secure the Company sufficient subscriptions in the Rights
Issue, the Company, together with the Manager, has established an
underwriting consortium consisting of existing shareholders and certain
external investors.
The Subscription Period for the Rights Issue commences on 14 December
2016 and expires at 16:30 (CET) on 5 January 2017 and may not be
closed prior to this date or extended.
The Subscription Rights will be issued and registered in the VPS under
ISIN NO 0010780745, and will be listed for trading on Oslo Axess under
the ticker symbol “PCIB T” from 14 December 2016 to 16:30 (CET) on 5
January 2017. The Subscription Rights will be delivered free of charge
and the recipient will not be debited any charges.
The allocation of New Shares will be made by the board of directors of
the Company by applying the following criteria:
I.
Allocation will be made to subscribers on the basis of granted
and acquired Subscription Rights which have been validly
exercised during the Subscription Period.
II.
If not all Subscription Rights are exercised, subscribers who
have exercised Subscription Rights and oversubscribed will be
allocated additional shares proportionally based on the number
of Subscription Rights exercised by each such subscriber. To the
extent that proportional allocation is not possible, the Company
will determine the allocation by the drawing lots.
III.
Shares not allocated pursuant to sub-items (I) and (II) will be
allocated to subscribers who have not exercised Subscription
Rights. Allocation will be sought made proportionally based on
the respective subscription amounts, provided, however, that
allocations may be rounded down to the nearest 100 shares.
IV.
Shares not allocated pursuant to sub-items (I), (II) and (III)
above, will be subscribed by, and allocated to, the Underwriters
(as defined in Section 5.18) in accordance with the underwriting
commitments of the respective Underwriters.
No distinction will be made between allocated and acquired/purchased
Subscription Rights.
The allocation of New Shares will take place after the expiry of the
Subscription Period on or about 10 January 2017 and notifications of
allocation will be issued by post on or about 10 January 2017.
11
PCI Biotech Holding ASA - Prospectus
The payment for the allocated New Shares falls due on 16 January 2017.
The Rights Issue is fully underwritten by MP Pensjon PK, Storebrand
Vekst, Bergen Kommunale Pensjonskasse, Radiumhospitalets
Forskningsstiftelse, Myna AS, Altitude Capital AS, Lucellum AS, Vicama
AS, LGJ Invest AS, Vinterstua AS, RUL AS, Falck Frås AS, Arne Loen AS,
Odd Roar Gresslien, Vanguard Invest AS, Hans Peter Bøhn, Lars
Viksmoen, Catilina Invest AS, Kristian Falnes AS, Chrem Capital AS, Dirk T
Bakker, Sven Edvin Florelius and Erryco Invest AS. Pursuant to the
underwriting agreements, the Underwriters shall receive an
underwriting fee equal to 2% of the aggregate amount underwritten by
the Underwriters.
E.4
Material and conflicting
interests
The Manager and/or its affiliates are currently providing, and may
provide in the future, investment and commercial banking services to
the Company and its affiliates in the ordinary course of business, for
which they may receive and may continue to receive customary fees and
commissions. The Manager does not intend to disclose the extent of any
such investments or transactions otherwise than in accordance with any
legal or regulatory obligation to do so.
Beyond the abovementioned, the Company is not aware of any interest
of any natural or legal persons involved in the Rights Issue.
E.5
Selling Shareholders and
lock-up agreements
In connection with their underwriting, the Underwriters have
undertaken lock-up obligations until the conclusion of the general
meeting that addresses the Rights Issue.
E.6
Dilution resulting from
the Rights Issue
The dilutive effect following the Rights Issue assuming full subscription
represents a dilution of 40.16 %.
E.7
Estimated expenses
charged to investor
Not applicable. The expenses related to the Rights Issue will be paid by
the Company.
12
PCI Biotech Holding ASA - Prospectus
2.
RISK FACTORS
General
Investing in Shares in the Company involves a high degree of risk. An investor considering an investment in the
Shares should consider carefully the following risk factors, being the principal known risks and uncertainties faced
by the Company as of the date hereof that the Company believes are the material risks relevant to an investment in
the Shares, as well as the other information contained in this Prospectus. Should any of the following risks occur, it
could have a material adverse effect on the Company’s business, prospects, results of operations, cash flows and
financial position, and the price of the Shares may decline, causing investors to lose all or part of their invested
capital.
It is not possible to quantify the significance to the Company of each individual risk factor, as each of the risk factors
mentioned below may materialise to a greater or lesser degree. The order in which the individual risks are
presented below is not intended to provide an indication of the likelihood of their occurrence nor of the severity or
significance of individual risks.
An investment in the Shares is suitable only for investors who understand the risk factors associated with this type
of investment and who can afford a loss of all or part of their investment.
Risk relating to the Company and its business
2.2.1
The Company is in an early stage of development and the Company's clinical studies may not prove to
be successful
The development of pharmaceuticals involves significant risk, and failure may occur at any stage during
development and after marketing approvals have been received, due to safety or clinical efficacy issues. Drug
development involves moving drug candidates through research and extensive testing of activity and side
effects in preclinical models before authorisation is given for further testing in humans in the clinical stage. The
clinical stage is divided into three consecutive phases (I, II and III) with the aim to elucidate the safety and
efficacy of a drug candidate before an application for marketing authorisation can be filed with the health
authorities. Each individual development step is associated with the risk of failure, hence an early stage drug
candidate carries a considerable higher risk of failure than a later stage candidate. Moreover, the
commencement and completion of clinical trials may be delayed by several factors, including but not limited to
unforeseen safety issues, issues related to determination of dose, lack of effectiveness during clinical trials,
slower than expected patient recruiting, inability to monitor patients adequately during or after treatment,
inability or unwillingness of medical investigators to follow the proposed clinical protocols and termination of
licence agreements necessary to complete trials.
2.2.2
Obtaining regulatory approvals is required for commercialisation of the Company's products
The Company will need approvals from the U.S. Food and Drug Administration (FDA) to market in the US and
from the European Medicines Agency (EMEA) to market in Europe, as well as equivalent regulatory authorities
in other foreign jurisdictions to commercialise in those regions. It cannot be assured that the Company will
receive such regulatory approvals necessary to commercialise the final products. Regulatory approvals may be
denied, delayed or limited for a number of reasons, as different regulatory authorities around the world have
different requirements for approving pharmaceuticals. The authorities have wide discretion in their drug
approval process and may request further testing before approval or post marketing. Delays in obtaining
regulatory approvals may delay commercialisation and the ability to generate revenues from product
candidates, impose extra cost on the Company, diminish competitive advantages and, after product approval,
safety or efficacy issues may emerge during post-marketing surveillance which may result in withdrawal or
restriction of the product approval. The Company's future earnings are likely to be largely dependent on the
timely approval of Amphinex for various indications. No assurances can be given with respect to obtaining such
approvals or the timing thereof.
2.2.3
The financial success of the Company requires obtaining acceptable price and reimbursement
In most markets, drug prices and reimbursement levels are regulated or influenced by authorities, other
healthcare providers, insurance companies or health maintenance organisations. Furthermore, the overall
healthcare costs to society have increased considerably over the last decades and governments all over the
world are striving to control them. There can be no guarantee that the Company's drugs will obtain the selling
13
PCI Biotech Holding ASA - Prospectus
prices or reimbursement levels foreseen by the Company. If actual prices and reimbursement levels granted to
the Company's products happen to be lower than anticipated it would likely have a negative impact on its
products' profitability and/or marketability.
2.2.4
The success, competitive position and future revenues will depend in part on the Company's ability to
protect intellectual property and know-how
This will require the Company to obtain and maintain patent protection for its products, methods, processes
and other technologies, to preserve trade secrets, to prevent third parties from infringing on proprietary rights
and to operate without infringing the proprietary rights of third parties. To date, the Company holds certain
exclusive patent rights in major markets, however, the Company cannot predict the degree and range of
protection any patents will afford against competitors and competing technologies, including whether third
parties will find ways to invalidate or otherwise circumvent the patents, if and when additional patents will be
issued, whether or not others will obtain patents claiming aspects similar to those covered by the Company's
patents and patents applications, whether the Company will need to initiate litigation or administrative
proceedings, or whether such litigation or proceedings are initiated by third parties against the Company
which may be costly or whether third parties will claim that the Company's technology infringes upon their
rights.
2.2.5
The Company operates in a highly competitive industry
The biotechnology and pharmaceutical industries are highly competitive with many large players and subject
to rapid and substantial technological change. Developments by others may render the product candidates or
technologies obsolete or non-competitive. The Company's drug candidates may not gain the market
acceptance required to be profitable even if they successfully complete initial and final clinical trials and
receive approval for sale by the relevant regulatory authorities. Many of the Company's competitors and
potential competitors have substantially greater capital resources, research and development resources,
regulatory and operational experience, manufacturing and marketing experience and production facilities. If
the Company fails to ultimately commercialise products or product candidates and/or achieve or maintain
profitability, an investment in the Shares could ultimately result in a significant or total loss of the investment.
2.2.6
The Company relies, and will continue to rely, upon third-parties for clinical trials and manufacturing
The Company cannot be certain that it will be able to enter into satisfactory agreements with third-party
suppliers or manufacturers. The Company's failure to enter into agreements with such suppliers or
manufacturers on reasonable terms, if at all, could have a material and adverse effect on the business,
financial condition and results of operations. The Company has quality and audit procedures in place to assure
the quality and reliability of third-party suppliers of research. All research results are, however, dependent on
the integrity of third-party researchers and compliance with established quality systems. Fraud or misconduct
by researchers may lead to the communication of misleading results. The Company needs to ensure that the
manufacturing process complies with applicable regulations and manufacturing practices as well as the
Company's own high quality standards. Any product/product candidate, however, will require technically
complex manufacturing processes or require a supply of highly specialised raw materials. As a result of these
factors, the production of any product/product candidate may be disrupted from time to time. The Company
may also not be able to rapidly alter production volumes to respond to changes in future commercial sale or
demand of a product. Poor manufacturing performance of third party manufacturers, a disruption in the
supply or the Company's failure to accurately predict the demand for any future commercial sale of a product
could have a significant adverse effect on the Company's business, financial condition or results of operations.
In addition, because the Company's products are intended to promote the health of patients, any supply
disruption could lead to allegations that the public health has been endangered and could subject the
Company to lawsuits.
2.2.7
The Company may not be able to develop new product candidates
The Company's future success will depend to a large extent upon the Company's ability to develop its lead
product candidate Amphinex. The Company may not have the ability to invent, explore and develop product
candidates that are of value to the medical market. Furthermore, the Company depends upon independent
investigators and collaborators, such as universities and medical institutions, to do the practical part of the
chemical, pharmaceutical, analytical, preclinical and clinical research and development. These collaborators
are not employees of the Company and the amount or timing of the resources they devote to the programs
cannot be fully controlled by the Company.
14
PCI Biotech Holding ASA - Prospectus
2.2.8
The Company may not be able to enter into partner agreements
The Company's business strategy is to commercialise its technology partly through collaborative agreements
with pharmaceutical or biotechnology companies. The Company cannot give any assurance that such
agreements will be obtained on acceptable terms, nor that the Company will be able to enter into any such
agreements at all. Furthermore, should such agreements be executed, there can be no assurance that the
agreements are not terminated by the other party.
2.2.9
The proceeds of the Rights Issue may not fund the Company until a commercial stage has been
reached
The Company funds, and intends to continue to fund, the research and development of the product and
product candidates to the stage where a license agreement can be obtained, profitability is attained or the
development is discontinued. There can be no assurance that the proceeds from the Rights Issue will be
sufficient for the Company to complete such research and development of any products or product
candidates. Consequently, the Company may seek to raise capital through equity and debt financings or from
other sources, collaborative arrangements or strategic alliances. However, the Company may prove unable to
raise such additional capital on commercially acceptable terms, if at all. If the Company is unable to generate
adequate funds from operations or from additional sources, then the business, results of operations and
financial condition may be materially and adversely affected.
2.2.10 The Company faces an inherent business risk of liability claims in the event that the use or misuse of
the compounds results in personal injury or death
The Company has not experienced any clinical trial liability claims to date, but it may experience such claims in
the future. The Company currently maintains clinical trial liability insurance for each trial in each country. The
insurance policy may not be sufficient to cover claims that may be made against the Company. Clinical trial
liability insurance may not be available in the future on acceptable terms, if at all. Any claims against the
Company, regardless of their merit, could materially and adversely affect its financial condition, because
litigation related to these claims would strain the financial resources in addition to consuming the time and
attention of the management.
2.2.11 The Company is reliant on key personnel and the ability to attract new, qualified personnel
The Company is highly dependent upon having a highly qualified senior management and scientific team. The
loss of a key employee might impede the achievement of the scientific development and commercial
objectives. Competition for key personnel with the experience that is required is intense and is expected to
continue to increase. There is no assurance that the Company will be able to retain key personnel, nor can
assurances be given that the Company will be able to recruit new key personnel in the future. In addition, the
Company relies on members of the board of directors, study investigators, an independent data monitoring
board and consultants to assist it in formulating the research and development strategy. All of the members of
the board of directors, study investigators, independent data monitoring board and all of the consultants are
otherwise employed and each such member or consultant may have commitments to other entities that may
limit their availability to the Company.
2.2.12 Most of the Company's expenses have since inception been related to research and development and
accordingly, the Company has accumulated substantial net losses and expects such losses to continue
as it continues product and clinical development and with the aim to obtain regulatory marketing
authorisation of products derived from its technology
The Company has not yet generated revenues from the sale of any commercial pharmaceutical products, and
does not expect to generate such revenues in the near future. The Company expects to continue to incur
substantial operating losses until and if such time as licensing revenues and/or product sales generate
sufficient revenues to fund continuing operations. The Company may never be able to generate any revenues
from the sale of any commercial pharmaceutical products or any further revenues from the licensing of its
product candidates or attain profitability. The Company has never paid dividend to its Shareholders and does
not anticipate paying any dividends in the foreseeable future.
15
PCI Biotech Holding ASA - Prospectus
2.2.13 The Company's results will be exposed to exchange rate risks
The value of non-Norwegian currency denominated revenues and costs will be affected by changes in currency
exchange rates or exchange control regulations. The vast majority of the Company's future revenues are
expected to be in USD and EUR while the major part of the Company's costs is in NOK, EUR, GBP and USD.
2.2.14 The Company is exposed to commercial risk
The market for cancer products has to date shown itself to be relatively unconcerned about therapy costs.
However, healthcare budgets worldwide are under severe stress. There is a risk that pricing of the kind
experienced to date will become difficult to achieve. Once approval is obtained for a product there is no
certainty that the Company or its licensees will achieve commercial success since several factors will
determine this, including clinical performance of the product, approved indication, competitive environment,
pricing and reimbursement. There is no guarantee that after regulatory approval reimbursement authorities
will agree to cover the cost of the product. Delays in reimbursement or its denial will limit adoption of the
product in the market.
2.2.15 The Company may face competition from low-cost generic products
In the long term the Company expects to face competition from lower-cost generic products. The Company's
product candidate is or is expected to be protected by patent rights that are expected to provide the Company
with exclusive marketing rights in various countries. However, patent rights are of varying strengths and
durations. Loss of market exclusivity and the introduction of a generic version of the same or a similar
medicine typically results in a significant and sharp reduction in net sales for the relevant product, given that
generic manufacturers typically offer their versions of the same medicine at sharply lower prices.
2.2.16 The Company is exposed to risks related to changes in regulatory environment
The Company's international operations could be affected by changes in intellectual property legal protections
and remedies, trade regulations and procedures and actions affecting approval, production, pricing,
reimbursement and marketing of products, as well as by unstable governments and legal systems and intergovernmental disputes. Any of these changes could adversely affect the Company's business.
2.2.17 The Company's results may be affected by changes in public sentiment
The pharmaceutical industry is under the close scrutiny of the public, governments and the media. In addition,
there is significant pressure on the industry from certain nations to make the products available to their
population at drastically lower costs. Any increase in such negative public sentiment or increase in public
scrutiny or pressure from such nations could lead, among other things, to changes in legislation, to changes in
the demand for the products, additional pricing pressures with respect to the products, or increased efforts to
undercut intellectual property protections. Such changes could adversely affect the Company's business,
financial condition or results of operations.
2.2.18 The Company's business involves use of chemicals and is thus exposed to environmental risks
The Company believes that its safety procedures for handling and disposing of such materials comply with the
state-of-art standards, however, there will always be a risk of accidental contamination or injury. If liable for an
accident, or if it suffers an extended facility shutdown, the Company could incur significant costs, damages or
penalties that could have a material adverse effect on its business, financial condition and results of
operations.
2.2.19 The Company is advanced registered for value added tax (VAT) until the end of 2016
The Company is advanced registered for value added tax (VAT) until the end of 2016 and is dependent on
approval from the tax authorities (Skatt Øst) for extension of the advance VAT registration for future periods. If
the Company is not accepted for advanced registration beyond 2016 it will have an impact on the future cash
burn and/or spending.
16
PCI Biotech Holding ASA - Prospectus
Risk factors relating to the Shares and the Subscription Rights
2.3.1
The Company is listed on a regulated market place with inherent liquidity risk in the Company's shares
and subscription rights
Historically, there has been a limited liquidity in the Company's shares. Currently, no research analysts are
following the Company. It cannot be guaranteed that a seller of shares in the Company and/or the Subscription
Rights will be able to find sufficient buyers of such shares and/or Subscription Rights at acceptable terms or at
all.
2.3.2
The price of the Shares and the Subscription Rights may fluctuate significantly
The trading price of the Shares and the Subscription Rights could fluctuate significantly in response to a
number of factors beyond the Company's control, including variations in operating results, adverse business
developments, announcements by competitors of new products or product candidates, significant contracts,
acquisitions or strategic relationships, publicity about the Company, its products or its competitors, lawsuits
against the Company, unforeseen liabilities, changes to the regulatory environment in which the Company
operates or general market conditions. Changes in the market's valuation of the Company may occur without
regard to the operating performance of the Company. The price of the Company's Shares and/or the
Subscription Rights may therefore fluctuate based upon factors that have little or nothing to do with the
Company, and these fluctuations may materially affect the price of its Shares and/or the Subscription Rights.
2.3.3
Future issuances of Shares or other securities in the Company may dilute the holdings of shareholders
and could materially affect the price of the Shares
It is likely that the Company may in the future decide to offer additional Shares or other securities in order to
finance clinical trials, operational investments, in connection with unanticipated liabilities or expenses or for
any other purposes. Any such additional offering could reduce the proportionate ownership and voting
interests of holders of Shares, as well as the earnings per Share of the Company and any offering by the
Company could have a material adverse effect on the market price of the Shares. The Company has
implemented an employee incentive program through the issuance of share options. The Company expects to
issue additional share options under the employee incentive program and the exercise of existing and new
share options may lead to dilution of the current shareholders.
2.3.4
Investors in the United States may have difficulty enforcing any judgment obtained in the United
States against the Company or its directors or executive officers in Norway
The Company is incorporated under the laws of the Kingdom of Norway, and all of its current directors and
executive officers reside outside the United States. Furthermore, most of the Company's assets and most of
the assets of the Company's directors and executive officers are located outside the United States. As a result,
investors in the United States may be unable to effect service of process on the Company or its directors and
executive officers or enforce judgements obtained in the United States courts against the Company or such
persons in the United States, including judgements predicated upon the civil liability provisions of the federal
securities laws of the United States. The Company has been advised by its Norwegian legal counsel that the
United States and Norway do not currently have a treaty providing for reciprocal recognition and enforcement
of judgments (other than arbitral awards) in civil and commercial matters.
2.3.5
The transfer of the Shares may be subject to restrictions on transferability and resale in certain
jurisdictions
The Shares have not been registered under the US Securities Act or any US state securities laws or any other
jurisdiction outside of Norway and are not expected to be registered in the future. As such, the Shares may not
be offered or sold except pursuant to an exemption from the registration requirements of the US Securities
Act and applicable securities laws. In addition, there can be no assurances that shareholders residing or
domiciled in the United States will be able to participate in future capital increases or rights offerings.
2.3.6
Shareholders outside of Norway are subject to exchange rate risk
The Shares are priced in NOK, and any future payments of dividends on the Shares are expected to be
denominated in NOK. Accordingly, any investor outside Norway is subject to adverse movements in the NOK
against their local currency, as the foreign currency equivalent of any dividends paid on the Shares or price
received in connection with any sale of the Shares could be materially adversely affected.
17
PCI Biotech Holding ASA - Prospectus
2.3.7
Investors may not be able to exercise their voting rights for Shares registered in a nominee account
Beneficial owners of the Shares that are registered in a nominee account (such as through brokers, dealers or
other third parties) may not be able to vote for such Shares unless their ownership is re-registered in their
names with the VPS prior to the Company's general meetings. The Company cannot guarantee that beneficial
owners of the Shares will receive the notice of a general meeting in time to instruct their nominees to either
effectuate a re-registration of their Shares or otherwise vote for their Shares in the manner desired by such
beneficial owners.
2.3.8
If the Rights Issue fails, the Subscription Rights will no longer be of value.
The Rights Issue is fully underwritten as further described in the Prospectus. However, if an Underwriter (as
defined in Section 5.18) or any subscriber in the Rights Issue default on their subscription and/or payment
obligation for New Shares, the Company may be unable to complete the Rights Issue as contemplated or at all.
If the Rights Issue is not completed (for any reason), all Subscription Rights including exercised Subscription
Rights will be of no value, and subscriptions and allocations of New Shares that have been made will be
disregarded and any subscription payments made will be returned without interest or any other
compensation. If the Rights Issue is not completed, investors will not receive any refund or compensation with
respect to Subscription Rights purchased in the market.
18
PCI Biotech Holding ASA - Prospectus
4.
CAUTIONARY NOTE
Forward-looking statements
This Prospectus includes "forward-looking" statements, including, without limitation, projections and
expectations regarding the Group's future financial position, business strategy, plans and objectives.
"Forward-looking" statements are statements concerning possible circumstances and/or events to occur in the
future, consequently, there is an inherent uncertainty tied to any such statement. All forward-looking
statements included in the Prospectus are based on information available to the Company, and views and
assessments of the Company, as at the date of this Prospectus. Except as required by the applicable stock
exchange rules or applicable law, the Company does not intend, and expressly disclaims any obligation or
undertaking, to publicly update, correct or revise any of the information included in this Prospectus, including
forward-looking information and statements, whether to reflect changes in the Company's expectations with
regard thereto or as a result of new information, future events, changes in conditions or circumstances or
otherwise on which any statement in this Prospectus is based.
When used in this document, the words "anticipate", "believe", "estimate", "expect", "seek to" "may", "plan"
and similar expressions, as they relate to the Company, its subsidiary or its management, are intended to
identify forward-looking statements. The Company can give no assurance as to the correctness of such
forward-looking statements and investors are cautioned that any forward-looking statements are not
guarantees of future performance. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors, which may cause the actual results, performance or achievements of the
Company and its subsidiaries, or, as the case may be, the industry, to materially differ from any future results,
performance or achievements expressed or implied by such forward-looking statements. Such forward-looking
statements are based on numerous assumptions regarding the Group's present and future business strategies
and the environment in which the Company and its subsidiary operate.
Factors that could cause the Company's actual results, performance or achievements to materially differ from
those in the forward-looking statements include but are not limited to, the competitive nature of the markets
in which the Company operates, technological developments, government regulations, changes in economic
conditions or political events. These forward-looking statements reflect only the Company's views and
assessment as at the date of this Prospectus. Factors that could cause the Company's actual results,
performance or achievements to materially differ from those in the forward-looking statements include, but
are not limited to, those described in Section 2 "Risk factors" and elsewhere in the Prospectus.
Given the aforementioned uncertainties, prospective investors are cautioned not to place undue reliance on
any of these forward-looking statements. Forward-looking statements are included in sections 1, 5, 6, 7, 8, 11
and 14.
Information sourced from third parties
The information in this Prospectus that has been sourced from third parties has been accurately reproduced
and as far as the Company is aware and able to ascertain from information published by that third party, no
facts have been omitted which would render the reproduced information inaccurate or misleading. The source
of third party information is identified where used.
20
PCI Biotech Holding ASA - Prospectus
5.
THE RIGHTS ISSUE
The purpose of the Rights Issue and use of proceeds
The Company had inter alia in its Q2 2016 report publicly disclosed that it has been in a process of evaluating
the Company's capital needs and financing alternatives, and updated the market on the process through a
stock exchange announcement on the 27th October 2016. Further, the Company had disclosed to the market
that at the prevailing cost levels the Company is financed into the first half of 2017. In order to secure that the
Company's business may continue also after the first half of 2017, the Company's board of directors resolved
to propose to the general meeting the fully underwritten Rights Issue with gross proceeds of NOK 70,000,000.
The extraordinary general meeting in the Company held on 8 December 2016 (the "EGM") approved the Rights
Issue.
The proceeds from the Rights Issue are expected to secure the Company’s funding needs, mainly to enable the
Company to reach regulatory clarity on requirements for marketing authorisation of fimaCHEM, complete the
fimaVACC Phase I study, and further pursue partnership opportunities. Depending on inter alia potential
partnering agreements and initiated projects the proceeds are expected to fund the Company to mid-2018 or
longer. The Company emphasise that the net proceeds from the Rights Issue is not sufficient to fund
completion of the planned phase II part of the bile duct cancer study. The Company’s main future funding
sources are revenue related to any partnering agreements, governmental grants and equity issues. The capital
market is used as a source of liquidity when this is appropriate and conditions in this market are competitive.
The Company also assesses other funding sources.
Overview of use of proceeds:
The additional proceeds will be allocated to each programme depending on the outcome of the regulatory
interactions for the fimaCHEM programme and the fimaVACC phase I results. Both inflection points are expected
during first half of 2017.
Overview of the Rights issue
The Rights Issue comprises an offer of 10,000,000 new shares, with a par value per share of NOK 3, each at a
subscription price of NOK 7 per share. The subscription price for the Rights Issue was set based on a bookbuilding process when establishing the underwriting consortium (as described in section 5.18 below).
Shareholders who are registered in the Company’s shareholder register on 12 December 2016 (the record date
showing the Company’s shareholders as at the end of the date of the EGM as evidenced in the VPS in
accordance with normal T+2 settlement) will be granted tradable subscription rights.
In order to secure the Company sufficient subscriptions in the Rights Issue, the Company, together with the
Manager, has established an underwriting consortium consisting of existing shareholders and certain external
investors. Please see section 5.18 for more details on the underwriting.
21
PCI Biotech Holding ASA - Prospectus
Resolution regarding the Rights Issue
The following resolution to increase the Company’s share capital in connection with the Rights Issue was
passed by the EGM:
"The Company’s share capital is increased pursuant to the Norwegian Public Limited Liability Companies Act
section 10-1 on the following conditions:
1.
The share capital is increased by NOK 30,000,000 by issuance of 10,000,000 shares, each with a par
value of NOK 3.
2.
The subscription price is NOK 7 per share.
3.
Shareholders who are registered in the Company’s shareholder register on 12 December 2016 (the
Company’s shareholders as at the end of the date of the general meeting as evidenced in the VPS in
accordance with normal T+2 settlement) will be issued subscription rights based on their pro rata
holdings of shares in the Company, in accordance with the Norwegian Public Limited Companies Act
section 10-4. The subscription rights shall be freely transferable and be listed on Oslo Axess during the
subscription period as described under item 7 below. Each share gives approximately 0.6711
subscription rights. The number of subscription rights issued to each shareholder will be rounded down
to the nearest whole subscription right. Each subscription right will give the right to subscribe for one
new share (provided the holder of said subscription right is eligible to subscribe for shares, cf. item 4
below). Oversubscription and subscription without subscription rights is permitted.
4.
The shares may not be subscribed by shareholders (or other persons) who, in the Company’s view, are
resident in a jurisdiction where such offering of shares would be unlawful or (for jurisdictions other
than Norway) would require any prospectus, registration or similar action. The Company (or a person
authorised by the Company) shall have the right (but no obligation) to sell subscription rights issued to
any such shareholder, against transfer of the net proceeds from such sale to the shareholder.
5.
A prospectus, which shall be approved by the Financial Supervisory Authority of Norway in accordance
with Chapter 7 of the Norwegian Securities Trading Act, shall be prepared in connection with the
Rigths Issue (the "Prospectus"). Unless the board of directors determines otherwise, the Prospectus
shall not be registered with or approved by any authorities outside Norway.
6.
Allocation of the new shares shall be made by the board of directors. The following allocation criteria
shall apply:
7.
a.
Allocation will be made to subscribers on the basis of granted and acquired subscription rights
which have been validly exercised during the subscription period.
b.
If not all subscription rights are exercised, subscribers who have exercised subscription rights
and oversubscribed will be allocated additional shares proportionally based on the number of
subscription rights exercised by each such subscriber. To the extent that proportional
allocation is not possible, the Company will determine the allocation by the drawing lots.
c.
Shares not allocated pursuant to sub-items (a) and (b) will be allocated to subscribers who
have not exercised subscription rights. Allocation will be sought made proportionally based on
the respective subscription amounts, provided, however, that allocations may be rounded
down to the nearest 100 shares.
d.
Shares not allocated pursuant to sub-items (a), (b) and (c) above will be subscribed by, and
allocated to, the underwriters in accordance with the underwriting commitments of the
respective underwriters.
The subscription period shall commence on 14 December 2016 and end on 5 January 2017 at 16:30
hours (CET). If the Prospectus is not approved by the Financial Supervisory Authority of Norway in time
for the subscription period to commence on 14 December 2016, the subscription period shall
commence on the second trading day on Oslo Axess after such approval has been obtained and the
22
PCI Biotech Holding ASA - Prospectus
expiry date shall be extended with a corresponding number of days as the postponement of the
commencement of the subscription period (and end at 16:30 hours (CET) on the last day of the
subscription period). In no event shall the subscription period end later than 28 February 2017. Shares
not subscribed for at the expiry of the subscription period, which thus will be allocated to the
underwriters, shall be subscribed for by the Manager, for and on behalf of the underwriters, within
three trading days after the expiry of the subscription period.
8.
Subscription shall be made by signing and returning the subscription form to be attached the
Prospectus.
9.
The due date for payment for the new shares is 16 January 2017, or the fifth trading day on Oslo Axess
after the expiry of the subscription period if the subscription period is postponed in accordance with
sub-item 7 above. Each subscriber with a Norwegian bank account must by completion of the
subscription form, grant Fondsfinans a one-time power of attorney to debit a stated bank account for
the subscription amount corresponding to the number of allocated shares. The debit will take place on
or around the due date for payment. For subscribers without a Norwegian bank account, payment
shall be made pursuant to the instructions in the subscription form attached the Prospectus.
10.
The new shares will entitle dividends from the registration of the share capital increase in the
Norwegian Register of Business Enterprises. The shares will in all other respects be equal to the issued
shares of the Company from the registration of the share capital increase in the Norwegian Register of
Business Enterprises.
11.
The estimated amount of expenses related to the share capital increase (in addition to the
underwriting commission mentioned in section 13) below is approximately NOK 3,600,000.
12.
With effect from the registration of the share capital increase with the Norwegian Register of Business
Enterprises, section 4 of the articles of association is amended to reflect the share capital and total
number of shares after the share capital increase.
13.
The shares are underwritten by an underwriting consortium consisting of existing shareholders and
new investors. As underwriting commission, the underwriters; MP Pensjon PK, Storebrand Vekst,
Bergen Kommunale Pensjonskasse, Radiumhospitalets Forskningsstiftelse, Myna AS, Altitude Capital
AS, Lucellum AS, Vicama AS, LGJ Invest AS, Vinterstua AS, RUL AS, Falck Frås AS, Arne Loen AS, Odd
Roar Gresslien, Vanguard Invest AS, Hans Peter Bøhn, Lars Viksmoen, Catilina Invest AS, Kristian Falnes
AS, Chrem Capital AS, Dirk T Bakker, Sven Edvin Florelius and Erryco Invest AS shall in total receive an
amount equal to 2% of the total underwriting amount.
Record Date
Shareholders who are registered in the Company’s shareholder register on 12 December 2016 (the Company’s
shareholders as at the end of the date of the EGM on 8 December 2016 as evidenced in the VPS in accordance
with normal T+2 settlement), will receive tradable Subscription Rights.
Provided that the delivery of traded Shares was made with ordinary T+2 settlement in the VPS, Shares that
were acquired until and including 8 December 2016 will give the right to receive Subscription Rights, whereas
Shares that were acquired from and including 9 December 2016 will not give the right to receive Subscription
Rights.
The Subscription Period
The Subscription Period for the Rights Issue commences on 14 December 2016 and expires at 16:30 (CET) on 5
January 2017 and may not be closed prior to this date or extended.
Subscription Price
The Subscription Price in the Rights Issue is NOK 7 per New Share. No expenses or taxes are charged to the
subscribers in the Rights Issue by the Company or the Manager.
23
PCI Biotech Holding ASA - Prospectus
Subscription Rights
In accordance with the resolution passed by the EGM, Shareholders will be allocated Subscription Rights in
proportion to their registered shareholding in the Company as at the Record Date. The Company will issue
approximately 0.6711 Subscription Rights per each Share registered as held by each Shareholder as at the
Record Date. The number of Subscription Rights issued to each Shareholder will be rounded down to the
nearest whole number of Subscription Right.
Each Subscription Right gives the holder the right to subscribe for and be allocated one new Share, provided
that the holder is not an Ineligible Person as defined in Section 5.23 below. Oversubscription and subscription
without Subscription Rights is permitted.
The Subscription Rights will be issued and registered in the VPS under ISIN NO 0010780745, and will be listed
for trading on Oslo Axess under the ticker symbol “PCIB T” from 14 December 2016 to 16:30 (CET) on 5 January
2017. The Subscription Rights will be delivered free of charge and the recipient will not be debited any
charges.
The Subscription Rights will be freely transferable subject to any relevant selling restrictions as further
described in Section 5.23.
The Subscription Rights may be used to subscribe for New Shares in the Rights Issue or be sold before the end
of the Subscription Period. Subscription Rights acquired during the Subscription Period carry the same right to
subscription and allocation of New Shares in the Rights Issue as originally granted Subscription Rights.
Subscription Rights not used to subscribe for New Shares or sold before the expiry of the Subscription Period
will lapse without compensation to the holder, and consequently be of no value.
Subscription Rights of Shareholders who are Ineligible Persons will initially be credited to such Shareholders’
VPS accounts. Such credit specifically does not constitute an offer to Ineligible Persons to subscribe for New
Shares. To the extent that any Shareholders are Ineligible Persons, their Subscription Rights may, upon
instruction from the Company, be sold by the Manager and credited to the accounts of the relevant
Shareholders, net of costs and expenses, if they have a value exceeding the costs involved in selling the
Subscription Rights and there is a market for acquiring such Subscription Rights. There can be no assurance
that the Company and/or the Manager will sell any Subscription Rights or, in the event that such sale is carried
out, be able to sell any Subscription Rights at a profit.
The subscription procedure
The subscription offices for subscriptions in the Rights Issue are as follows:
Fondsfinans AS
Haakon VII's gate 2
P:O. Box 1782 Vika
NO-0122 Oslo
Norway
Fax: +47 23 11 30 04
Email: [email protected]
The Subscription Forms must be received by the Manager prior to the expiry of the Subscription Period.
Neither the Company nor the Manager may be held responsible for delays in the mail system or for
Subscription Forms forwarded by e-mail or facsimile that are not received in time by the Manager. It is not
sufficient for the Subscription Form to be postmarked within the deadline.
Multiple subscriptions (i.e. subscriptions on more than one Subscription Form) within the Subscription Period
are permitted. Please note, however, that two separate Subscription Forms submitted by the same subscriber
with the same number of New Shares subscribed for on both Subscription Forms will only be counted once
unless otherwise is explicitly stated on one of the Subscription Forms. In the case of multiple subscriptions
24
PCI Biotech Holding ASA - Prospectus
through the VPS online subscription system or subscriptions made both on a Subscription Form and through
the VPS online subscription system, all subscriptions will be counted.
Norwegian residents with a Norwegian identification number (Norwegian: “personnummer”) may subscribe
for New Shares by following the link www.beringerfinance.com/deals/#filter=.ongoing, which will redirect the
subscriber to the VPS online subscription system. In order to use the online subscription system, the subscriber
must have, or obtain, a VPS account number. Neither the Manager nor the Company assume any responsibility
for failure to subscribe or inability to subscribe for New Shares due to technical or internet problems.
The Manager may at its sole discretion refuse any improperly completed, delivered or executed Subscription
Forms or any subscription that may be unlawful.
The subscription for New Shares is irrevocable and may not be withdrawn, cancelled or modified once it has
been received by the Manager.
Allocation of New Shares
The allocation of New Shares will be made by the board of directors of the Company by applying the following
criteria:
I.
Allocation will be made to subscribers on the basis of granted and acquired Subscription Rights which
have been validly exercised during the Subscription Period.
II.
If not all Subscription Rights are exercised, subscribers who have exercised Subscription Rights and
oversubscribed will be allocated additional shares proportionally based on the number of Subscription
Rights exercised by each such subscriber. To the extent that proportional allocation is not possible,
the Company will determine the allocation by the drawing lots.
III.
Shares not allocated pursuant to sub-items (I) and (II) will be allocated to subscribers who have not
exercised Subscription Rights. Allocation will be sought made proportionally based on the respective
subscription amounts, provided, however, that allocations may be rounded down to the nearest 100
shares.
IV.
Shares not allocated pursuant to sub-items (I), (II) and (III) above, will be subscribed by, and allocated
to, the Underwriters in accordance with the underwriting commitments of the respective
Underwriters.
No distinction will be made between allocated and acquired/purchased Subscription Rights.
The Company reserves the right to reject or reduce allocation of New Shares based on subscriptions not
covered by subscription rights.
The allocation of New Shares will take place after the expiry of the Subscription Period on or about 10 January
2017 and notifications of allocation will be issued by post on or about 10 January 2017. The board of directors
reserves the right to round off, regulate or in another way reject or reduce any subscription not covered by
Subscription Rights.
The Company will publish the result of the Rights Issue on or about 10 January 2017 through the information
system of Oslo Børs at www.newsweb.no under the ticker "PCIB".
Payment for the allocated New Shares
The payment for the allocated New Shares falls due on 16 January 2017 (the “Payment Date”).
Subscribers who have a Norwegian bank account
Subscribers who have a Norwegian bank account must, and will by signing the Subscription Form, provide
Fondsfinans AS, the Manager, with a one-time irrevocable authorisation to debit a specified bank account with
a Norwegian bank for the amount payable for the New Shares which are allocated to the subscriber.
25
PCI Biotech Holding ASA - Prospectus
The specified bank account is expected to be debited on or about the Payment Date. Fondsfinans AS is only
authorised to debit such account once, but reserve the right to make up to three debit attempts, and the
authorisation will be valid for up to seven working days after the Payment Date.
The subscriber furthermore authorises Fondsfinans AS to obtain confirmation from the subscriber’s bank that
the subscriber has the right to dispose over the specified account and that there are sufficient funds in the
account to cover the payment.
If there are insufficient funds in a subscriber’s bank account or if it for other reasons is impossible to debit such
bank account when a debit attempt is made pursuant to the authorisation from the subscriber, the
subscriber’s obligation to pay for the New Shares will be deemed overdue.
Payment by direct debiting is a service that banks in Norway provide in cooperation. In the relationship
between the subscriber and the subscriber’s bank, the standard terms and conditions for “Payment by Direct
Debiting – Securities Trading”, which are set out on page 2 of the Subscription Form, will apply, provided,
however, that subscribers who subscribe for an amount of NOK 5 million or more must ensure that payment
for the New Shares with cleared funds is made on or before 16:30 hours (CET) on 16 January 2017 and should
contact the Manager in this respect .
Subscribers who do not have a Norwegian bank account
Subscribers who do not have a Norwegian bank account must ensure that payment with cleared funds for the
New Shares allocated to them is made on or before the Payment Date.
Prior to any such payment being made, the subscriber must contact Fondsfinans AS at +47 23 11 30 00 for
further details and instructions.
Overdue payments
Overdue payments will be charged with interest at the applicable rate under the Norwegian Act on Interest on
Overdue Payment of 17 December 1976 No. 100; 8.5% per annum as at the date of this Prospectus. The
Company and the Manager reserve the right to have the Manager pre-fund the payment on behalf of
subscribers who have not made payment for the New Shares within the Payment Date. Irrespective of such
pre-funding (if any), if the subscriber fails to comply with the terms of payment or should payments not be
made when due, the subscriber will remain liable for payment of the New Shares allocated to it and the New
Shares allocated to such subscriber will not be delivered to the subscriber. In such case the Company and the
Manager reserve the right to, at any time and at the risk and cost of the subscriber, re-allot, cancel or reduce
the subscription and the allocation of the allocated New Shares, or, if payment has not been received by the
third day after the Payment Date, without further notice sell, assume ownership to or otherwise dispose of the
allocated New Shares in accordance with applicable law. If New Shares are sold on behalf of the subscriber,
such sale will be for the subscriber’s account and risk and the subscriber will be liable for any loss, costs,
charges and expenses suffered or incurred by the Company and/or the Manager as a result of, or in connection
with, such sales. The Company and/or the Manager may enforce payment for any amounts outstanding in
accordance with applicable law.
Financial intermediaries
All persons or entities holding Shares or Subscription Rights through financial intermediaries (i.e., brokers,
custodians and nominees) should read this Section 5.12. All questions concerning the timeliness, validity and
form of instructions to a financial intermediary in relation to the receipt and exercise of Subscription Rights
should be determined by the financial intermediary in accordance with its usual customer relations procedure
or as it otherwise notifies each beneficial shareholder.
Neither the Company nor the Manager are liable for any action or failure to act by a financial intermediary
through which Shares are held.
Subscription Rights
If a shareholder holds Shares registered through a financial intermediary on the Record Date, the financial
intermediary will customarily give the shareholder details of the aggregate number of Subscription Rights to
which it will be entitled. The relevant financial intermediary will customarily supply each shareholder with this
26
PCI Biotech Holding ASA - Prospectus
information in accordance with its usual customer relations procedures. Shareholders holding Shares through
a financial intermediary should contact the financial intermediary if they have received no information with
respect to the Rights Issue.
Shareholders who hold their Shares through a financial intermediary and who are Ineligible Persons will not be
entitled to exercise their Subscription Rights.
Subscription Period
The time by which notification of exercise instructions for subscription of New Shares must validly be given to
a financial intermediary may be earlier than the expiry of the Subscription Period. Such deadline will depend
on the financial intermediary. Shareholders who hold their Shares through a financial intermediary should
contact their financial intermediary if they are in any doubt with respect to the deadline.
Subscription
Any shareholder who is not an Ineligible Person (as defined in the below Section 5.23) and who holds its
Subscription Rights through a financial intermediary and wishes to exercise its Subscription Rights, should
instruct its financial intermediary in accordance with the instructions received from such financial
intermediary. The financial intermediary will be responsible for collecting exercise instructions from the
Shareholders and for informing the Manager of their exercise instructions.
Method of payment
Any shareholder who holds its Subscription Rights through a financial intermediary should pay the Subscription
Price for the New Shares that are allocated to it in accordance with the instructions received from the financial
intermediary. The financial intermediary must pay the Subscription Price in accordance with the instructions in
the Prospectus. Payment by the financial intermediary for the New Shares must be made no later than the
Payment Date. Accordingly, financial intermediaries may require payment to be provided to them prior to the
Payment Date.
Delivery and trading of the New Shares
The Company expects to register the share capital increase pursuant to the Rights Issue in the Norwegian
Register of Business Enterprises on or about 19 January 2017 (and no later than 6 April 2017), provided that
full payment for the allocated shares has been received by the Company. As soon as practically possible
thereafter, the allocated and paid New Shares will be transferred to the subscribers’ VPS accounts. The final
deadline for registration of the share capital increase pertaining to the Rights Issue with the Norwegian
Register of Business Enterprises, and hence for the subsequent delivery of the New Shares, is, pursuant to the
Norwegian Public Limited Companies Act, three months from the expiry of the Subscription Period, i.e. on 6
April 2017.
The New Shares may not be traded before registration of the share capital increase with the Norwegian
Register of Business Enterprises and delivery of the New Shares to the subscribers VPS-accounts. The first day
of trading on Oslo Axess is expected to be on or about 20 January 2017. The New Shares will not be sought or
admitted to trading on any other regulated market than Oslo Axess.
The rights conferred by the New Shares
The New Shares will in all respects carry full shareholder rights equal to the existing ordinary Shares of the
Company from the date the share capital increase is registered in the Norwegian Register of Business
Enterprises. From the same time, the holders of the New Shares will be entitled to dividend that may be
declared. The New Shares are issued electronically in registered form in accordance with the Norwegian Public
Limited Companies Act. The New Shares are freely transferable according to Norwegian law and the
Company’s Articles of Association. Certain lock-up restrictions are in place, as described in Section 5.18. For a
description of rights attaching to Shares in the Company, see Section 11 “Shares and share capital” of this
Prospectus. Pursuant to the Norwegian Public Limited Companies Act, all shareholders have equal rights to the
Company’s profits, in the event of liquidation and to receive dividend, unless all shareholders approve
otherwise.
27
PCI Biotech Holding ASA - Prospectus
Publication of information in respect to the Rights Issue
In addition to press releases on the Company’s website www.PCIBiotech.no, the Company intends to use Oslo
Børs' information system at www.newsweb.no to publish information with respect to the Rights Issue. The
Company will publish the result of the Rights Issue on or about 10 January 2017.
VPS registration
The Company’s Shares are registered in VPS, the Norwegian Central Securities Depository. The Shares’
securities number is ISIN NO 0010405640. The Company’s VPS registrar is Nordea Bank Norge ASA, Issuer
Services, P.O. box 1166 Sentrum, NO-0107 Oslo, Norway.
Like the existing Shares of the Company, the New Shares issued in the Rights Issue will be listed on Oslo Axess
under the ticker symbol "PCIB".
Share capital following the Rights Issue
As at the date of this Prospectus, the Company’s share capital is NOK 44,701,170 divided into 14,900,390
shares, each with a nominal value of NOK 3. The Company’s share capital is fully paid up and issued in
accordance with Norwegian Law.
The share capital following the Rights Issue will be increased from NOK 44,701,170 to NOK 74,701,170 divided
into 24,900,390 Shares, each with a nominal value of NOK 3. The New Shares will be issued in accordance with
the resolution passed at the EGM cf. Section 5.3. Please see Section 11 “Shares and share capital” for a further
description of the Company’s share capital.
The Underwriting and lock-up obligations for the Underwriters
On 17 November 2016, the Company entered into an underwriting agreement with each of the entities and
individuals listed in the table below (the “Underwriters”), who collectively underwrite the subscription of the
New Shares to be offered in the Rights Issue for NOK 70,000,000. If fewer than 10,000,000 New Shares are
subscribed for by the end of the Subscription Period, the Underwriters will be allocated the remaining New
Shares so that the full Rights Issue is subscribed for. The table below shows the subscription amount that each
of the Underwriters has undertaken to underwrite:
Underwriter
Address
MP Pensjon PK
Storebrand Vekst
Lakkegata 23, Postboks 665 Sentrum, 0106 Oslo
c/o Storebrand Asset Management AS, Professor
Kohts vei 9, Postboks 484, 1327 Lysaker
Olav Kyrres gate 22, 6. etg., Postboks 860 Sentrum,
5807 Bergen
Ullernchausséen 64, 0379 Oslo
c/o Ketil Knudsen, Diakonveien 7, 0370 Oslo
Olav Selvaags plass 5, 0252 Oslo
c/o Axera Business Management AS, Postboks 1955
Vika, 0125 Oslo
Skogholtveien 23B, 1178 Oslo
Månesigden 2, 1337 Sandvika
Dronning Mauds gate 1, Postboks 1404 Vika, 0115
Oslo
Hedrumveien 2199, 3282 Kvelde
c/o Line Loen, Borgenveien 35, 0370 Oslo
c/o Helge Kaland, Søreidneset 25, 5251 Søreidgrend
Båtstøjordet 119, Postboks 540, 1328 Høvik
Postboks 109, 4792 Lillesand
Ulriksdal 35, 5009 Bergen
Hoffsjef Løvenskioldsvei 36, 0382 Oslo
Bergen Kommunale Pensjonskasse
Radiumhospitalets Forskningsstiftelse
Myna AS
Altitude Capital AS
Lucellum AS
Vicama AS
LGJ Invest AS
Vinterstua AS
RUL AS
Falck Frås AS
Arne Loen AS
Odd Roar Gresslien
Vanguard Invest AS
Hans Peter Bøhn
28
NOK
underwritten
13,600,000
10,000,000
6,000,000
5,000,000
5,000,000
5,000,000
3,500,000
3,500,000
2,000,000
2,000,000
2,000,000
2,000,000
1,500,000
1,000,000
1,000,000
1,000,000
PCI Biotech Holding ASA - Prospectus
Lars Viksmoen
Catilina Invest AS
Kristian Falnes AS
Chrem Capital AS
Dirk T Bakker
Sven Edvin Florelius
Erryco Invest AS
Sum
Torget 5, Stocken, SE-474 92 Ellös, Sweden
c/o Roy Myklebust, Sørkedalsveien 258D, 0754 Oslo
Nerliveien 1, 4020 Stavanger
Dronning Mauds gate 1,
v/Gill-Johannes, Postboks 1404 Vika, 0115 Oslo
Gamle Ringeriksvei 17, 3406 Tranby
Enerveien 2C, 1450 Nesoddtangen
Steinåsen 19, 7049 Trondheim
1,000,000
1,000,000
1,000,000
1,000,000
800,000
600,000
500,000
70,000,000
Pursuant to the underwriting agreements, the Underwriters shall receive an underwriting fee equal to 2% of
the aggregate amount underwritten by the Underwriters.
In connection with their underwriting, the Underwriters have undertaken lock-up obligations until the
conclusion of the general meeting that addresses the Rights Issue.
The Company has not entered into any stabilisation agreements, market making agreements or similar
agreements for the trading of its Shares on Oslo Axess.
Proceeds and costs
The transaction costs of the Company related to the Rights Issue are estimated at approximately NOK 3.6
million, and accordingly the net proceeds of the Rights Issue will be approximately NOK 66.4 million. In
addition, the Company will pay an underwriting fee as described in Section 5.18.
No expenses or taxes are charged to the subscribers in the Rights Issue by the Company or the Manager.
Dilution
The dilutive effect following the Rights Issue assuming full subscription is 40.16%.
Jurisdiction and governing law
This Prospectus, the Subscription Form and the terms and conditions of the Rights Issue shall be governed by
and construed in accordance with, and the New Shares will be issued pursuant to, Norwegian law. Any dispute
arising out of, or in connection with, this Prospectus or the Rights Issue shall be subject to the exclusive
jurisdiction of Oslo District Court.
Interest of natural and legal persons involved in the Rights Issue
The Manager or its affiliates have provided from time to time, and will provide in the future, investment and
commercial banking services to the Company and its affiliates in the ordinary course of business, for which
they may have received and may continue to receive customary fees and commissions. The Manager, their
employees and any affiliates may currently own Shares in the Company. Further, in connection with the Rights
Issue, the Manager, their employees and any affiliate acting as an investor for its own account may receive
Subscription Rights (if they are shareholders) and may exercise their right to take up such Subscription Rights
and acquire New Shares, and, in that capacity, may retain, purchase or sell New Shares and any other
securities issued by the Company or other investments for their own account and may offer or sell such
securities (or other investments) otherwise than in connection with the Rights Issue. The Manager does not
intend to disclose the extent of any such investments or transactions otherwise than in accordance with any
legal or regulatory obligation to do so. The Manager will receive a variable commission, based on a percentage
of the gross proceeds, in connection with the Rights Issue and, as such, have an interest in the Rights Issue.
Except for the above, the Company is not aware of any natural or legal person having an interest in the Rights
Issue which is material in the context of the Rights Issue.
29
PCI Biotech Holding ASA - Prospectus
Selling and transfer restrictions
The distribution of this Prospectus and the offering and sale of the New Shares and the Subscription Rights
offered hereby may in certain jurisdictions be restricted by law. Persons in possession of this Prospectus are
required to inform themselves about and to observe any such restrictions and should consult their
professional advisers as to whether they require any governmental or other consent or need to observe any
other formalities to enable them to apply for or purchase New Shares.
This Prospectus may not be used for, or in connection with, and does not constitute, any offer to sell, or an
invitation to purchase, any of the New Shares or the Subscription Rights to any person who, in the Company’s
view, are resident in a jurisdiction where such offering of New Shares or granting of Subscription Rights would
be unlawful or (for jurisdictions other than Norway) would require any prospectus, registration or similar
action (“Ineligible Persons”).
No one has taken any action that would permit a public offering of the New Shares to occur outside of Norway.
Furthermore, the restrictions and limitations listed and described herein are not exhaustive, and other
restrictions and limitations in relation to the Prospectus and/or the Rights Issue that are not known or
identified by the Company and the Manager at the date of this Prospectus may apply in various jurisdictions as
they relate to the Prospectus and the Rights Issue. Please see Section 14 "Selling and Transfer Restrictions" for
further information.
Notwithstanding any other provision of this Prospectus, the Company and the Manager reserve the right to
permit investors to apply for New Shares if the Company and the Manager, in their absolute discretion, is
satisfied that the transaction in question will not constitute a breach of applicable laws and regulations. In any
such case, the Company and the Manager do not accept any liability for any actions that such investor takes or
for any consequences that it may suffer as a result of the Company and the Manager accepting the investor’s
application for New Shares.
Mandatory anti-money laundering procedures
The Rights Issue is subject to the Norwegian Money Laundering Act No. 11 of March 6, 2009 and the
Norwegian Money Laundering Regulations No. 302 of March 13, 2009 (collectively the “Anti-Money
Laundering Legislation”).
Subscribers who are not registered as existing customers of the Manager must verify their identity to the
Manager in accordance with requirements of the Anti-Money Laundering Legislation, unless an exemption is
available. Subscribers who have designated an existing Norwegian bank account and an existing VPS account
on the Subscription Form are exempted, unless verification of identity is requested by the Manager.
Subscribers who have not completed the required verification of identity prior to the expiry of the Subscription
Period will not be allocated New Shares.
Furthermore, participation in the Rights Issue is conditional upon the subscriber holding a VPS account. The
VPS account number must be stated in the Subscription Form. VPS accounts can be established with
authorised VPS registrars, who can be Norwegian banks, authorised securities brokers in Norway and
Norwegian branches of credit institutions established within the EEA. Establishment of a VPS account requires
verification of identity to the VPS registrar in accordance with the Anti-Money Laundering Legislation.
However, non-Norwegian investors may use nominee VPS accounts registered in the name of a nominee. The
nominee must be authorised by the Financial Supervisory Authority of Norway.
Participation of major existing shareholders and members of the Company’s management,
supervisory and administrative bodies in the Rights Issue
The Company is not aware of whether any major shareholders of the Company or members of the Company’s
management, supervisory or administrative bodies intend to subscribe for New Shares in the Rights Issue, or
whether any person intends to subscribe for more than 5% of the Rights Issue. Some members of the
Company’s management, supervisory or administrative bodies hold Shares in the Company as indicated in
Section 8 “Board of Directors, Management, Employees and Corporate governance” and will as existing
shareholders be granted Subscription Rights in respect of such Shares. Certain shareholders of the Company
are Underwriters and as such may subscribe for shares in accordance to their underwriting commitment. Hans
30
PCI Biotech Holding ASA - Prospectus
Peter Bøhn, Chairman of the Board of the Company, and Lars Viksmoen, member of the Board, have both
entered into underwriting agreement and have each separately underwritten NOK 1.0 million of the Rights
Issue.
No current members of the Board or Management (directly or through close associates) have participated in
share issues in the Company over the last 12 months.
31
PCI Biotech Holding ASA - Prospectus
6.
PRESENTATION OF THE COMPANY
Overview
PCI Biotech Holding ASA was incorporated on 12 March 2007. The Company is a public limited liability
company under the Norwegian Public Limited Liability Companies Act, registered with the Norwegian Register
of Business Enterprises with registration no. 991 036 393. The Company's registered office is Ullernchausséen
64, 0379 Oslo, Norway, telephone +47 67 11 54 00. The Company's website is www.pcibiotech.com. The
Company is often commercially referred to as "PCI Biotech".
PCI Biotech is an oncology-focused company developing innovative products for cancer treatment. The
products are based on PCI Biotech’s patented technology, photochemical internalisation ("PCI"). The PCI
technology can enhance the effect of anticancer drugs by targeted, light-directed drug delivery into cancer
cells, and can also be used as a platform that may both potentiate the effect of vaccines and enable
macromolecules to reach intracellular targets.
There are several industry specific abbreviations and terms used in this chapter, please see chapter 16 for
definitions and glossary.
Historical background and development
The table below provides an overview of key events in the history of the Company since 2007:
Year
2007
2008
2009
2010
2011
2012
2013
2014
2015
Event
Incorporated in Oslo, Norway
Listed at Oslo Axess following a spinoff of PCI Biotech AS from Photocure ASA and raised
NOK 60 million
1. Enabling PCI technology platform and start of the first clinical study
2. PCI Biotech-led consortium awarded EUR 1.1 million from the EU Eurostars Programme for
further development of PCI for delivery of siRNA
1. First preliminary clinical results indicating strong tumour response for localised cancer
treatment
2. Underwritten Rights Offering of NOK 90 million
1. Phase I study completed, demonstrating that Amphinex induced PCI of bleomycin is well
tolerated, and exhibiting early signs of promising efficacy
2. Selection of recurrent head & neck cancer as first clinical indication
3. Thorough trial design discussions with key opinion leaders and expert groups
4. Awarded NOK 10.8 million from The Research Council of Norway to further develop PCI for use
in local treatment of cancer
1. Initiated the ENHANCE study, a Phase II study with Amphinex induced PCI of bleomycin in
recurrent inoperable head & neck cancer
2. Selection of locally advanced inoperable bile duct cancer as second clinical indication
3. Regulatory pathway for Amphinex in head & neck cancer in EU clarified
4. Pre-clinical program in vaccination initiated
5. CE marking as a medical device for the PCI 652nm laser and PCI Biotech approved as
manufacturer and distributor of the laser
1. Redesigned the Phase II study in head & neck cancer to optimise intra-tumour illumination
2. Amphinex induced PCI of gemcitabine Phase I/II study on bile duct cancer ready to start
3. Promising pre-clinical vaccination results and IP generation – focus on vaccination amplified
4. Initiated discussions with the FDA on the head & neck cancer program
1. First patient treated in the Phase I/II study in inoperable bile duct cancer
2. Treatment evaluation of the first two intra-tumour optimisation groups in the Phase II study in
head & neck cancer completed
3. Safety evaluation of the first treatment cohort in the Phase I/II study for patients with
inoperable bile duct cancer completed
4. Awarded NOK 12.5 million from The Research Council of Norway to further development of PCI
for use in vaccination
1. Underwritten Rights Offering of NOK 70 million
2. Successful Investigational New Drug application (IND) review for the Amphinex ENHANCE study
32
PCI Biotech Holding ASA - Prospectus
3.
4.
5.
6.
2016
7.
1.
2.
3.
4.
5.
6.
7.
Safety evaluation of the second and third dose cohorts in the Phase I/II study for patients with
inoperable bile duct cancer completed
Initiated preclinical research collaboration in siRNA therapeutics (fimaNAC)
Received a positive international search report and written opinion regarding a patent
application, on the use of PCI Biotech’s proprietary technology photochemical internalisation
(PCI) in vaccination and immunotherapy
Strategic refocusing, with termination of the ENHANCE study for head & neck cancer due to
commercial and strategic reasons
Initiated preclinical research collaboration with a top-10 large pharma company (fimaNAC)
Phase I of the bile duct cancer study completed with promising early signs of efficacy
Initiated the first preclinical research collaboration in the field of vaccines (fimaVACC)
Preclinical research collaboration agreement with top-10 large pharma company extended
The results of the first-in-man Phase I study of Amphinex published in Lancet Oncology
Orphan drug designation of fimaporfin for treatment of cholangiocarcinoma granted in EU
Initiated preclinical research collaboration with BioNTech AG
Initiated a Phase I study in healthy volunteers for the fimaVACC technology
Legal structure
The Group consists of the parent company PCI Biotech Holding ASA, the wholly owned subsidiary PCI Biotech
AS and the Icelandic branch PCI Biotech Utibu.
Description of the companies in the Group
6.4.1
PCI Biotech Holding ASA
PCI Biotech Holding ASA is the parent company in the Group. The parent company has no employees. The
Group operations are managed through the fully owned subsidiary PCI Biotech AS which has a management
service agreement with the parent company, including services like management, finance and investor relation
functions for the Group.
6.4.2
PCI Biotech AS
The fully owned subsidiary PCI Biotech AS was incorporated in 2000. All operations within the Group are
managed through PCI Biotech AS and the company has eleven employees. The subsidiary has a research
collaboration agreement with the Radium Hospital Research Foundation and PCI Biotech AS has the rights to
obtain the intellectual property from the research collaboration. The company has several other international
research collaborators.
6.4.3
PCI Biotech Utibu
PCI Biotech Utibu is a dormant Icelandic branch of PCI Biotech AS.
Business description
6.5.1
Introduction
PCI Biotech is a cancer focused biopharmaceutical company headquartered in Norway and listed on the Oslo
Axess market place on the Oslo Stock Exchange. The Company is developing therapeutic products based on its
proprietary photochemical internalisation (PCI) technology, which induces light-triggered endosomal release
and may be used to unlock the true potential of a wide array of therapeutic modalities. Recent advancements
in cancer therapy imply a large potential to significantly improve the prognosis for millions of patients, not
least owing to the development of new classes of drugs, such as immunotherapeutics.
Both chemotherapies and several novel classes of drugs (e.g. many immunotherapeutics) need access to the
inside of their human target cells, e.g. tumour cells or immune cells, in order to be effective. Unfortunately,
many of these substances are by nature encapsulated in so-called endosomes as they enter the target cell.
Once inside the cell, most of the active compound may hence be trapped in the endosomes and therefore
unable to exert its therapeutic effect. Pharmaceutical companies around the world struggle to find effective
methods to release drugs that are entrapped in this way, and are actively searching for technologies that
33
PCI Biotech Holding ASA - Prospectus
provide adequate drug release inside the target cells, in order to exploit the full therapeutic and commercial
potential of their products.
PCI Biotech’s patented investigational drug fimaporfin is able to unlock the intracellular capsules (endosomes)
where the active compounds are entrapped. Hence, fimaporfin has the ability to unlock the true potential of
new promising classes of cancer therapy, such as certain immunotherapeutics, RNA therapeutics , as well as
established chemotherapies.
PCI Biotech has strategically built a multi-layered intellectual property with a composition of matter patent
pertaining to fimaporfin at the core and additional patent coverage more specific to the three programmes.
The first broad patent expired in 2015, which means that the field is open to entry by other players. However,
the Company’s know how and extensive patent estate surrounding the product and use areas of the PCI
technology provides significant entry barriers for competitors in most of the interesting business areas. In
addition, market exclusivity may be achieved with potential orphan designations for PCI Biotech’s product
candidate, fimaporfin, for the bile duct cancer program, as well as other niche indications. Please see section
6.15 Patents for further details.
6.5.2
The PCI technology platform
Photochemical Internalisation (PCI) is a proprietary technology for light-directed intracellular drug delivery by
triggered endosomal release, which may also be used to significantly enhance the immunological response to
vaccines. Many drugs must reach targets inside the cells to have an effect, but for various reasons, such as the
size of the drug or different drug resistance mechanisms, many types of drugs struggle to reach such targets.
PCI is developed to unlock the full potential of such drugs by enabling the drug molecules to reach their
intracellular targets in sufficient quantities to induce the desired therapeutic effect. Thus, by employing the PCI
technology, therapeutic modalities with a limited effect can be potentiated into effective cancer therapies. The
PCI technology can be used with several existing drugs, as well as new emerging therapies and vaccines.
The PCI technology was developed for enhancing and targeting the effect of the drugs by illumination of a
well-defined area of the body, following the administration of PCI Biotech’s proprietary photosensitising
compound and the active drug. The photosensitising compound is designed in a way that it will attach to the
cellular membrane of the target cells and during uptake of therapeutic drug molecules by the endocytosis
process, the photosensitiser becomes incorporated in the membrane of the endosomes and where the drug
molecules are entrapped. Following illumination with light at a wavelength that activates the photosensitiser,
the integrity of the endosomal membrane is disturbed and the drug is released into the cytosol (the liquid
matrix inside the cell) where it can reach its target of action. Since the drug enhancing effect of PCI occurs only
where light is applied, PCI is a localised targeted therapy.
Figure – Conceptual illustration of the PCI technology
1
2
3
STEP 1:
• TPCS2a (S) and the active molecule (D) are injected into the body and
carried by the blood stream to the cell
1
2
3
3
4
STEP 2:
• TPCS2a (S) and the active molecule (D) are taken up by the cell, but D
is unable to reach the target (T), as it is encapsulated in an endosome
• S is washed away from
1 the cell membrane, but2trapped in endosomes
• Light activates TPCS2a (S) in the membrane of the endosome
• The membrane integrity is affected and the active molecule released
2
3
S
The PCI component
- Light sensitive
component
- Amphinex - TPCS2a
STEP 3:
1
The active molecule
- Anticancer agent, e.g.
bleomycin,
gemcitabine
- Oligonucleotide, e.g.
siRNA
- Protein, e.g. antibodydrug conjugate
- Peptide: e.g. antigen
4
STEP 4:
• The active molecule (D) can now bind to its target (T) and initiate the
therapeutic response
34
The target
- Target for the active
molecule
- E.g. DNA, mRNA,
enzyme, microtubuli
4
4
PCI Biotech Holding ASA - Prospectus
The PCI technology platform consists of two elements: a proprietary small molecule photosensitiser (called
fimaporfin) and a light source. Although being a photochemical technology, PCI is very different from
traditional photodynamic therapy (PDT). While the aim of PDT is to kill the cells by the photochemical
reactions, the aim of PCI is to introduce drug molecules or macromolecules into the cytosol of the target cells.
It is this drug or macromolecule that gives the biological effect in a PCI treatment, and the intended biological
effect may range from cell killing (fimaCHEM), through gene silencing (fimaNAC) to enhanced antigen
presentation (fimaVACC). Needless to say, in the two latter approaches the target cells will not be killed, but PCI
is employed to give the cells new properties by modifying the intracellular trafficking of drugs/antigens.
For different applications, fimaporfin will be formulated differently and used at different doses e.g.
intravenous injection in localised cancer treatment versus minute amounts administered into the skin in the
vaccination setting. The light source may also be different for different applications. Red laser light is used in
localised cancer treatment to achieve good tissue penetration, while a simple blue led light may be used in
vaccination, as deep light penetration is not needed to reach antigen presenting cells (APC’s) at the site of
vaccination. fimaCHEM and fimaVACC are consequently very different products, although the same basic
mechanism of targeted endosomal release is applied.
In the field of immunology the PCI technology, fimaVACC, is applied to enhance the immunological responses of
vaccines. The fimaVACC technology aims for effective induction of CTLs (Cytotoxic T Lymphocytes; also called
CD8+ T-cells), which is key to realising the large potential of therapeutic cancer vaccination, something that has
been difficult to achieve with today’s vaccination technologies. PCI Biotech’s fimaVACC technology may provide
a solution to this challenge, thus substantially improving the ability of vaccines to trigger the immune system
to fight both cancers and infectious diseases. Induction of CTLs is typically mediated through so-called MHC
Class I antigen presentation by antigen presenting cells (APCs). PCI-mediated CTL-induction works by
effectively re-localising endocytosed antigens from endosomes to the cytosol in APCs, thereby making the
antigens accessible for the MHC Class I presentation machinery.
6.5.3
Business areas
Recent advancements in cancer therapy are expected to significantly improve the prognosis for millions of
patients, not least owing to the development of new classes of drugs, such as immunotherapeutics. The
potential of fimaporfin to improve the efficacy of anti-cancer agents has been convincingly shown in wellestablished preclinical models as well as in clinical trials, with the first clinical results being published in the
prestigious journal Lancet Oncology1. Based on these positive findings, PCI Biotech is now developing three
parallel programmes.
In the fimaCHEM program PCI Biotech aims at improving the efficacy of well-established chemotherapies. Based
on findings from two successful phase I studies in cancer patients, a phase II clinical trial is about to be initiated
in inoperable extrahepatic bile duct cancer, a rare, but fatal disease with no cure. Newly diagnosed patients
have received a single treatment before starting chemotherapy. The fimaCHEM treatment regimen consists of
an intravenous injection of fimaporfin, followed four days later by an intravenous infusion of gemcitabine and
a laser light application in the bile duct administered through an endoscope. PCI Biotech has recently obtained
orphan drug designation for this disease in EU, meaning that regulatory authorities may expedite the market
approval process, and that a market exclusivity period can be secured under the Orphan drug legislation. Bile
duct cancer is characterised by a remarkable resistance to common chemotherapy, and there is a high need
for new drug classes or alternative treatment methods. The most studied and used drug in bile duct cancer
treatment is gemcitabine, which is one of the drugs significantly enhanced by the PCI technology in preclinical
studies. Light access for PCI treatment is easy through endoscopic methods used routinely in these patients.
fimaVACC is a new vaccination technology with favourable features for therapeutic cancer vaccines; an
immunotherapeutic modality in need of improved efficacy. The pharmaceutical industry has long recognised
the potential of therapeutic cancer vaccination, i.e. vaccines that treat cancer by inducing or strengthening an
immune response towards cancerous cells. There has been a renewed focus on such vaccines over the past
few years, and FDA approved the first therapeutic cancer vaccine in 2010. There are however still important
unsolved issues and several companies have recently reported failed clinical studies. Effective induction of
1
Sultan et al (2016) Lancet Oncology DOI: http://dx.doi.org/10.1016/S1470-2045(16)30224-8
35
PCI Biotech Holding ASA - Prospectus
cytotoxic immune responses is key to realising the large potential of therapeutic cancer vaccination, but
vaccines often fail to generate the required responses. One of the most important reasons for this is probably
insufficient delivery of vaccine antigens to the appropriate processing machinery in so-called antigen
presenting cells, cells in the immune system that are the key for triggering an efficient cellular immune
response. The fimaVACC technology may solve this issue by effectively enhancing appropriate delivery of
vaccine antigens to the target antigen presenting cells.. In addition to the use in therapeutic vaccination for
cancer, fimaVACC has the potential to be used for both therapeutic and prophylactic vaccination also for
several other important diseases.
A clinical proof-of-concept trial with fimaVACC in healthy volunteers was initiated in September 2016. PCI
Biotech has also initiated a research collaboration with a therapeutic cancer vaccine company to explore the
potential of fimaVACC with a cancer vaccination technology in clinical development.
The Company has been awarded NOK 12.5 million in a BIA grant from The Research Council of Norway for
2014-2017 and the main focus of the project is to verify and further develop the fimaVACC technology for use
in therapeutic vaccines against cancer. The project also includes use of the technology in vaccination against
certain types of viral and bacterial infections.
PCI Biotech’s nucleic acid therapeutics program (fimaNAC) aims at improving the efficacy of novel nucleic acid
based therapies. The PCI delivery technology addresses a main hurdle in the development of nucleic acid
based therapies: sufficient release of the encapsulated therapeutics inside the targeted cells. Nucleic acid
therapeutics are widely acknowledged to have a large potential as therapeutic agents, and numerous clinical
trials with gene and oligonucleotide therapy are underway. The commercial exploitation of most such drugs
has been hampered by the lack of technologies for efficient delivery of the therapeutic molecules to their
targets inside cells2.
6.5.4
Research collaborations with commercial entities
PCI Biotech has five preclinical research collaborations entered into in 2015 and 2016, one within the fimaVACC
programme and four within the fimaNAC programme.
In January 2016, PCI Biotech announced the initiation of a preclinical research collaboration with the
Norwegian privately held pharmaceutical company, Ultimovacs AS, developing novel immunotherapy against
cancer. The purpose of the collaboration is to utilise the companies' complementary scientific platforms to
explore potential synergies. The partnership is governed by a preclinical research collaboration agreement. In
brief, the preclinical research collaboration will evaluate technology compatibility and synergy based on
preclinical in vivo studies. The companies will evaluate results achieved from this research collaboration and
then explore the potential for a further partnership for PCI Biotech’s fimaVACC programme.
PCI Biotech has four research collaborations within nucleic acid therapeutics (fimaNAC). A collaboration with
an undisclosed top-10 pharma company, with the aim to evaluate the synergistic effects of both parties'
technology platforms, to determine whether PCI Biotech's fimaNAC technology has the potential to enhance
the therapeutic effect of the partner's nucleic acid therapeutic compounds. The preclinical research agreement
covers evaluation of technology compatibility and synergy based on in vitro studies. The pharma company is
one of the global leaders in nucleic acid therapeutics and is responsible for funding and conducting the
research. The companies will evaluate the data generated in this research collaboration and explore the
potential for a further partnership based on this outcome. The original evaluation period spanned over 9
months, but an extension to end of 2016 was signed in May 2016, and it may be further extended. The
purpose of the extended research period is to further investigate optimisation of technological synergies.
The second collaborative research agreement for the fimaNAC programme is with RXi Pharmaceuticals, signed
in April 2015, with the aim to explore potential synergies between the companies’ complementary fimaNAC
technology and siRNA platform. RXi Pharmaceuticals (NASDAQ: RXII), is an American biotechnology company
focused on discovering and developing innovative therapeutics that address high unmet medical needs
primarily in the area of dermatology and ophthalmology. The pre-clinical research collaboration will evaluate
technology compatibility based on in vitro and in vivo studies. The costs related to the research collaboration
2
Dong et al. PNAS, 2014
36
PCI Biotech Holding ASA - Prospectus
will be covered by each company separately. The companies will evaluate results achieved from this research
collaboration and then explore the potential for a closer collaboration.
The third collaborative research agreement for the fimaNAC program is with BioNTech AG, signed in
September 2016. BioNTech AG is a fully integrated biotechnology company developing individualised cancer
immunotherapies and is an immunotherapy leader with bench-to-market capabilities, developing truly
personalised, well tolerated and potent treatments for cancer and other diseases. Established by clinicians
and scientists, the group is pioneering disruptive technologies ranging from individualised mRNA based
medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel antibody
checkpoint immunomodulators. BioNTech's clinical programmes are supported by an in-house molecular
diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE
and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held, with
Strüngmann Family Office as a majority shareholder, having closed the largest initial financing in the European
biopharma sector's history. The preclinical research collaboration will evaluate technology compatibility and
synergy based on in vivo studies performed by the University of Zurich. The companies will evaluate results
achieved from this research collaboration and then explore the potential for a further partnership. PCI
Biotech has already a collaboration agreement with the University of Zurich and the research is funded
through the existing agreement.
The fourth and most recently collaborative research agreement for the fimaNAC programme is with eTheRNA
immunotherapies NV (“eTheRNA”), and was signed in December 2016. The aim for the collaboration is to
evaluate technology compatibility and synergy based on in vivo studies. eTheRNA was founded in January 2013
as a spin-off of the Vrije Universiteit Brussel (VUB) Laboratory for Molecular and Cellular Therapy (LMCT)
headed by Prof K. Thielemans. eTheRNA immunotherapies (Belgium) is a pioneer in the development of
mRNA-based immunotherapies for different cancers and certain infectious diseases. eTheRNA is focusing on
therapies that prepare and activate the immune system by programming dendritic cells (DC) with synthetic
mRNA. For this purpose, eTheRNA continues to develop its proprietary TriMix platform comprising three
mRNA molecules that jointly have a boost effect on the activation and maturation of dendritic cells, leading to
potent population of both helper T-cells and cytotoxic T-cells. Encouraged by the impressive complete
response rate (>20%) of the combination therapy including TriMix-DC (the ex-vivo autologous version) and
ipilimumab in patients with pre-treated advanced melanoma (Neyns et al, 2016 - Journal Clinical Oncology),
the company is committed to establish its TriMix technology as the gold standard in the wider area of oncoimmunotherapy - both as a monotherapy product in adjuvant settings and in combination with checkpoint
inhibitors or other targeted therapies. eTheRNA has made significant preclinical progress in developing TriMix
not merely as an ex vivo product, but also as an in vivo formulation that can be made available ‘off the shelf’.
eTheRNA is initiating phase I/II clinical studies with an in vivo injectable TriMix product in melanoma and triple
negative breast cancer. As of 2017, eTheRNA immunotherapies will operate a state-of-the-art GMP-approved
manufacturing unit. The partnership is governed by a preclinical research collaboration agreement. The
companies will evaluate results achieved from this research collaboration and then explore the potential for a
further partnership.
PCI Biotech's business strategy is to commercialise its technology partly through collaborative commercial
agreements with pharmaceutical or biotechnology companies. The Company cannot give any assurance that
any of the above collaborative research agreements will lead to commercial agreements with the above
entities, nor that such agreements will be obtained on acceptable terms, nor that the Company will be able to
enter into any such agreements at all.
Value proposition
The main value propositions for the PCI Biotech Holding business model is to exploit the full potential of the
novel PCI technology within three main business areas:
37
PCI Biotech Holding ASA - Prospectus

fimaCHEM - Enhancement of existing therapeutics for localised treatment of cancer, for indications
with a clear unmet medical need; phase II ready opportunity in an orphan cancer indication,
cholangiocarcinoma (bile duct cancer).

fimaVACC - Novel mechanism of action of the PCI technology to be used as a CTL induction technology
for therapeutic and prophylactic vaccination with potential value creation in both cancer and
infectious diseases; phase I in healthy volunteers initiated.

fimaNAC - Novel delivery technology for pharmaceutical and biotechnology companies looking to
overcome the challenge of introducing nucleic acid therapeutics into cells; preclinical programme.
PCI Biotech’s value proposition for fimaCHEM is based on its photosensitiser drug delivery system
(photosensitiser platform); a system with potential to enhance both generic and patented drugs’ therapeutic
profiles in terms of efficacy and safety. Utilising this platform, PCI Biotech aims to provide solutions based on
the in-house developed fimaporfin (Amphinex®) photosensitiser and marketed cancer drugs. PCI Biotech
intends to capture value from concluding deals with pharmaceutical and biotechnology companies that allow
for the use of fimaporfin in combination with anticancer drugs. The photosensitiser will be used in
combination with the anticancer drugs, either as a separate product for use in combination with anticancer
drugs or as a combination pack.
The second value proposition, fimaVACC, will be realised by utilising the PCI technology as a CTL induction
mechanism for therapeutic and prophylactic vaccination, both within the field of cancer and infectious
diseases. When applied more specifically to the growing field of cancer immunotherapy, fimaVACC is used to
enhance the important cytotoxic effect of therapeutic cancer vaccines.
The third value proposition, fimaNAC, is based on the use of the PCI technology for intracellular delivery of
nucleic acid therapeutics. PCI Biotech intends to build value by positioning itself as a RNA therapeutics delivery
company and complete a series of partnering agreements with leading pharmaceutical and biotechnology
companies in the field.
PCI Biotech received in January 2012 CE marking as a medical device for its PCI 652nm laser. PCI Biotech is
approved as manufacturer and distributor of the laser. The approvals have been issued by the Notified Body
NEMKO, Norway. There may be future opportunities to develop commercial offers around devises related to
some of the PCI applications, although this is generally not an area of focus.
6.6.1
Competitive strengths
PCI Biotech believes that it has a number of competitive strengths that will enable it to successfully
commercialise its technology in the market place. These strengths include:

A technology with promising data for a wide range of modalities: The technology represents
multiple shots on goal. The current three fima programmes represent an opportunity to address
unmet needs in the field of cancer in three independent ways: immuno-oncology, RNA therapeutics,
and chemotherapy.

Clinical validation of the fimaCHEM program: two phase I studies completed, establishing proof of
concept for the PCI technology and showing a very good safety profile and promising early signs of
efficacy.

Clinical asset ready for out-licensing: the bile duct cancer programme (fimaCHEM) is a phase II-ready
asset that could attract interest from prospective partners looking for clinical stage assets in orphan
cancer indications.

Ongoing research collaborations: several research collaborations are ongoing and demonstrate
external validation of our innovative approaches in immuno-oncology and RNA therapeutics. We are
working towards building additional relationships with leading biotech and pharmaceutical companies
in this field, as well as progressing the existing collaborations to the next stage.
38
PCI Biotech Holding ASA - Prospectus

Strong intellectual property position: PCI Biotech has built a solid multi-layered patent estate to
protect its three fima programmes. Within the field of immunotherapy, PCI has built a solid IP position
securing protection to 2034-2035 within this field.

Experienced management team and board of directors: a strong executive management team and
board of directors with relevant biotech pharmaceutical drug development and commercial and
international experience. The highly experienced and competent organisation enables PCI Biotech
with accelerated development and efficient execution.

Cost efficient fimaporfin production: fimaporfin, our lead photosensitiser, is easy to produce and
handle, providing for simple logistics and low cost of goods.

Orphan Drug Designation: the fimaCHEM programme is currently focused on bile duct cancer, a rare
disease, and was recently granted Orphan Drug Designation in EU. An Orphan Drug Designation can
result in a number of advantages for PCI Biotech, including faster time to market, lower registration
fees, extended market exclusivity and premium pricing.
6.6.2
Revenue generation
PCI Biotech’s primary strategy is not to bring products to the global market on its own, but through various
kinds of licensing agreements with pharma and biotech companies:

Licensing agreements – an agreement involving the licensing of one of the three programs fimaCHEM,
fimaVACC or fimaNAC.
For products in clinical development, pharmaceutical companies typically prefer to wait for
compelling clinical data before in-licensing the products, even if this means paying a higher price to
gain access to the technology. This means that license deals will typically take place on the basis of at
least results from clinical Proof of Concept.
In the field of using the PCI technology for fimaNAC license deals may take place at a pre-clinical stage.
In general pre-clinical deals tend to be of lower value than deals based on clinical data.
Design of the pre-clinical and clinical Proof of Concept studies will be essential to support a successful
licensing strategy. At least some of the value in a license deal will be determined by the level of
exclusivity that the licensee receives. PCI Biotech considers these elements when selecting
compounds and indications for its pre-clinical and clinical Proof of Concept studies.

Research agreements – covers various kinds of agreements like feasibility studies, research
collaboration, strategic co-development etc. all with the intention of evaluating the PCI technology in
combination with a licensee’s own compounds or research programs. Research agreements may
include an option to license as part of the original deal terms. Research agreements are favoured by
pharmaceutical companies in situations where technologies are novel, there is insufficient clinical
evidence to proceed straight to a license deal, or where the licensee is unsure how best to use the
technology. Research agreements may provide PCI Biotech with access to molecules or vaccine
compounds that it may not otherwise be able to work with.

Grants – have been and will continue to be an important funding resource for R&D activities within
PCI Biotech. Grants are in the financial statement recognised as Other Revenue. PCI Biotech has been
awarded a grant from The Norwegian Research Council (program for user-managed innovation arena
(BIA)) of NOK 12.5 million in total for the period from July 2014 to June 2017. Other revenue also
contains resources received through the SkatteFUNN arrangement, a Norwegian tax incentive
scheme. PCI Biotech has two approved projects covering all its major R&D activities, supported by
SkatteFUNN from 2014-2019.
Goals
According to existing plans, PCI Biotech seeks to achieve the following by end of 2017:
 Become established as a successful cancer focused company on the Oslo Stock Exchange (Axess)
39
PCI Biotech Holding ASA - Prospectus






Positioned itself in the second generation cancer immunotherapy regimen, by successful completion
of a clinical proof of concept study for fimaVACC and further value creation for the fimaVACC asset
Granted orphan drug designation and opened an Investigational New Drug (IND) in the US for
fimaCHEM
Completed regulatory interactions with European and US authorities, to determine the fastest way to
market for fimaCHEM
Secured financing and/or a licencing deal and/or a collaborative partnership for further development
of the fimaCHEM asset
Progressed the existing research collaborations within fimaVACC and fimaNAC into a phase where the
potential for further partnerships is actively explored and determined
Enter into further research and/or strategic collaborations and/or licensing agreement(s) to facilitate
further development and use of the PCI technology for fimaVACC and fimaNAC
Customers
PCI Biotech is in clinical phase with its lead drug candidate fimaporfin, but no products have been
commercialised at this stage.
For the fimaCHEM program PCI Biotech will in addition to treating the various payer groups in the different
geographic markets as customers, e.g. US Government, US commercial payers (employer-based insurance),
and European social security systems in the various EU countries, focus marketing efforts towards the
community based, hospital based, and tertiary centre based prescribing surgeons and oncologists.
Patients with cancer in the bile duct are referred to a local hospital by their primary-care physician, in order to
start the process of diagnosing the disease more accurately. Bile duct cancer patients typically present with
jaundice and abdominal pain, and the disease is often in an advanced stage. The diagnostic workup includes
blood tests, ultrasound and cross sectional imaging (CT, MRI) and endoscopic examination of the bile duct is
often necessary to conclude on the primary cause of the poor biliary drainage. Alternative diagnoses include
cholangitis and benign causes of biliary stricture. If cancer is suspected at a local hospital, the patient is
referred to central/regional hospitals for further examinations. Here more blood tests and imaging
examinations will be performed, and a biopsy is also part of the workup to confirm cancer. If the patient has
cancer, it is important to define the exact location of the cancer in the biliary tree, as well as the spread to
lymph-nodes and adjacent/other organs. Both oncologists, radiologists, gastroenterologists and surgeons are
involved in the diagnostic process.
Within the field of fimaVACC and fimaNAC PCI Biotech aims to license the PCI technology to biotech and pharma
companies as an important enabling/enhancement technology for the partner’s compound and/or technology.
For the fimaVACC programme there is with the current intellectual property also an opportunity to develop inhouse vaccine candidates, following the same route of development as the fimaCHEM program.
Competition
Competition for the current fimaCHEM program in bile duct cancer is presented under section 6.9.1 to
6.9.1.5.1. Section 6.9.2 presents the competitive landscape for fimaVACC and section 6.9.3 for fimaNAC.
6.9.1
Types of cancer therapies and fimaCHEM’s positions in the competitive landscape for bile duct cancer
The cancer therapy (oncology) market is a broad market, and the optimal treatment depends on the type and
state of the cancer, as well as the patient’s overall physical condition. A patient’s treatment plan may consist
of one or many different treatments, all depending on the situation. Some cancer patients suffer from extreme
pain and want to increase their life quality for the remaining part of their lives, while for others being cured is
the target. Among the most common treatments are: surgery, chemotherapy, targeted therapy, radiation
therapy, immunotherapy and photodynamic therapy.
6.9.1.1. Surgery
Surgery is used to both diagnose and to treat cancer. During surgery, it is possible to remove the entire cancer
tissue or parts of cancer tissues for analysis to clarify the stage of cancer, and evaluate what measures can be
40
PCI Biotech Holding ASA - Prospectus
taken in order to treat the patient. In some cases, surgery can cure the patient from cancer, given that the
cancer has not spread to vital parts of the body3.
6.9.1.1.1. fimaCHEM’s position in the competitive landscape of surgery for bile duct cancer
For bile duct cancer patients there is currently no approved medicinal therapy. Resection through surgery is
the only treatment with curative potential, but only approximately 30% of the patients are operable and 5year survival is less than 5%4. PCI Biotech’s local treatment method has first-line treatment of inoperable
patients as the immediate target, which means that advancements in surgical procedures could potentially
somewhat reduce the number of patients available for fimaCHEM treatment. If successful in inoperable
patients, treatment with fimaCHEM could potentially lead to restaging of inoperable patients to become
available for surgery with curative intent. Furthermore, a majority of the surgically treated patients relapse
within 5 years and a potential upside of fimaCHEM could be as an alternative to surgery in selected patients,
with potential quality of life and health economic benefits.
6.9.1.2. Chemotherapy and targeted therapy
Chemotherapy and targeted agent therapy are systemic cancer treatments that involve the use of cytotoxic
and cytostatic drugs. This type of treatment may consist of one drug or a combination of different drugs, and
the drugs are administered either intravenously or orally. Patients may experience systemic adverse effects
from many of these therapies that may severely reduce their quality of life5.
6.9.1.2.1. fimaCHEM’s position in the competitive landscape of chemotherapy and targeted therapy for bile
duct cancer
Bile duct cancer has remarkable resistance to chemotherapy and there is currently no approved oncology
therapeutics. Nevertheless, the cytotoxic drugs gemcitabine and cisplatin, together with stenting of the bile
duct are becoming standard treatment in inoperable patients6. This chemotherapy is a not a direct competitor
to the PCI treatment in bile duct cancer, as the activity is relatively poor and fimaCHEM is positioned as an addon to this treatment regimen. The very low five-year survival rate for bile duct cancer indicates that here is no
potential cure for inoperable patients today. The pipeline for investigational new drugs within bile duct cancer
is weak and there are currently no competing marketable treatment alternatives. The competitive advantages
for fimaCHEM is potentially great efficacy due to local chemotherapy boost of gemcitabine, which has shown
activity in bile duct cancer. Like chemo- and targeted therapy, the fimaCHEM treatment is expected to be
repeatable. In addition fimaCHEM treatment is easily positioned in the current treatment regimen, since the
light treatment is done through endoscopic methods performed routinely in these patients.
6.9.1.3. Radiation therapy
Radiation therapy is a cancer treatment that involves the use of different types of high-energy external beam
radiation to irradiate and destroy cancer cells. Radiation therapy can be used as part of a treatment plan or as
monotherapy for cancer patients. It is a local treatment that targets only the tumour and the surrounding
healthy tissue7.
6.9.1.3.1. fimaCHEM’s position in the competitive landscape of radiation therapy for bile duct cancer
Radiation therapy is a direct competitor to PCI treatment in inoperable bile duct cancer. Approaches to
radiotherapy include external beam irradiation delivered either by conventional approaches or with conformal
treatment planning techniques, stereotactic radiotherapy and brachytherapy with iridium-192. There is
currently no evidence to support the routine use of external beam radiotherapy and chemo radiation for
unresectable disease. Experience with newer and more precise radiotherapy techniques, such as stereotactic
radiotherapy is limited and no randomised trial has compared this to conventional radiotherapy. Furthermore,
the possibility of higher rates of long-term toxicity has tempered the enthusiasm for these newer radiotherapy
3
http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/surgery/surgery-treatment-toc
4
Prochayakul, J Gastro int Dig Syst, 2014 and Shaib El-seraq Semm Liver Dis, 2014
5
http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Chemotherapy.aspx
6
Valle et al N Engl J Med 2010;362:1273-81
7
http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Radiotherapy/Radiotherapy .aspx
41
PCI Biotech Holding ASA - Prospectus
techniques. The potential value of brachytherapy is unproven and it has so far not been shown to be superior
to standard chemotherapy, chemoradiation or stenting alone8.
6.9.1.4. Immunotherapy
Doctors and scientists have for a long time anticipated that the immune system can be used to fight cancer,
and in recent years several new and effective immunotherapies have reached the market. Immunotherapy is a
form of therapy designed to actively exploit a patient’s own immune system to combat the cancer. The
immune system can be utilised in several ways, but the most common is either to increase or “boost” the
immune system to stimulate it to recognise the cancer cells as foreign bodies that are to be removed, or to
inhibit signals that down-regulate immune responses to tumours. This is normally achieved by giving the
patients antibodies, vaccines or non-specific cancer immunotherapies and adjuvants. Immunotherapy is now
an important form of treatment in the fight against many types of cancer9.
6.9.1.4.1. fimaCHEM’s position in the competitive landscape of immunotherapy for bile duct cancer
The bile duct cancer pipeline is generally very weak and there is currently no immunotherapy agents that are
approved or in advanced development (phase II or III)10. Few companies are focusing their strategy on
developing assets specifically for cholangiocarcinoma, but rather cholangiocarcinoma is one of numerous
cancers being pursued in large screening studies that include various solid tumors. That is the case of a few
large pharmaceutical companies pursuing large solid tumor phase I or phase II trials with small molecule kinase
inhibitors or immunotherapies, but in these cases cholangiocarcinoma is part of the life cycle management of
these products rather than a strategic intent in the field. In addition, PCI Biotech is focusing on perihilar
cholangiocarcinoma, thus companies with programs in distal or intrahepatic cholangiocarcinoma are not
considered direct competitors due to the different location and nature of the lesions
6.9.1.5. Photodynamic therapy (PDT)
PDT uses laser, or other light sources, combined with a light-sensitive drug (sometimes called a
photosensitising agent) to destroy cancer cells. A photosensitising agent is a drug that makes cells more
sensitive to light. The drug is attracted to the cancer cells. It does not become active until it is exposed to a
particular type of light. When the light is directed at the area of the cancer, the drug is activated and the
cancer cells are destroyed. PDT can be used to treat some cancers or conditions that may develop into a
cancer if not treated (pre-cancerous conditions). It is used when the affected area, or the cancer, is on or near
the lining of internal organs.
6.9.1.5.1. fimaCHEM’s position in the competitive landscape of PDT for bile duct cancer
PDT is a potential competitor within bile duct cancer, but the PDT therapy has historic lack of innovation and a
weak pipeline within the indication. An old PDT product is currently in Phase III development for bile duct
cancer in the US and selected European countries11. The anticipated benefits with PCI compared to PDT are
efficacy, improved tumour selectivity and benign functional outcome.
6.9.2
The competitive landscape for PCI Biotech’s fimaVACC technology
Therapeutic cancer vaccination is a growing field with a substantial development pipeline and high expected
market growth12. Several late stage failures due to poor efficacy have however highlighted the need for
improved vaccination technologies with increased immune responses13. fimaVACC is a novel Cytotoxic T-Cell
(CTL) induction technology with an innovative mode of action through CTL induction by enhanced MHC class I
antigen presentation in dendritic cells and macrophages. CTL induction is a key factor for the efficacy of
therapeutic vaccines. PCI Biotech has compelling pre-clinical data showing significant immune-potentiating
effects, which in addition works in strong synergy with other state-of-the-art vaccine technologies in clinical
development, and translates into therapeutic effect in disease models.
8
Khan et al (2012) Guidelines for the diagnosis and treatment of cholangiocarcinoma. Gut 61:1657-69; Kopek et al (2010) Stereotactic
body radiotherapy for unresectable cholangiocarcinoma. Radiother Oncol 94:47-52)
9
http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/immunotherapy/immunotherapy-what-is-immunotherapy
10
Bile Duct Cancer (Cholangiocarcinoma) – Pipeline Review, H1 2016. Research & Markets and www.clinicaltrials.gov
11
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS). www.clinicaltrials.gov
12
Therapeutic cancer vaccines market to 2019. GBI Research 2013
13
Cancer vaccine therapies: Failures and future opportunities. MD Becker Partners 2010
42
PCI Biotech Holding ASA - Prospectus
The most successful immunotherapeutic approach so far is with the so-called checkpoint inhibitors (CPI),
which works by inhibiting signals that down-regulate immune responses to tumours. Several CPI products have
reached the market based on excellent responses in some cancers, particularly melanoma. However, while the
effect is very good in selected patients, response rates across disease populations have generally been low14.
This may partly be due to poor inherent anti-tumour immune activation in the non-responding patients, and
combining immune activation with an effective vaccination approach such as fimaVACC with CPI’s could
potentially enhance the response rates significantly.
The active ingredient in fimaVACC (fimaporfin; TPCS2a) has been clinically documented at systemic dose levels
far above those contemplated for local injection in vaccination. The active ingredient is in addition stable, cost
effective and has broad applicability. All these attributes makes the fimaVACC technology a potential future
important player in the fight against cancer with immunotherapy.
In addition to the use in therapeutic vaccination for cancer, fimaVACC has the potential to be used for both
therapeutic and prophylactic vaccination also for several other important diseases. E.g., fimaVACC is very well
suited for therapeutic vaccination for the treatment of chronic viral diseases (e.g. Hepatitis B and C), and
possibly also for therapeutic vaccination for tuberculosis. Furthermore, the fimaVACC technology also has a
clear potential to contribute to the development of new prophylactic vaccines for important infectious
diseases lacking effective vaccines. Prominent examples are malaria and tuberculosis, but there are also many
other potential target disease for fimaVACC based prophylactic vaccination.
There are many other companies developing different technologies for enhancing the effect of cancer
vaccines. Among such technologies are new immunostimulatory agents (e.g. vaccine adjuvants, cytokines,
immunostimulatory antibodies), new particle-based vaccine delivery technologies (e.g. nanotechnologies,
microparticles) and technologies for direct delivery of vaccines into the target cells through the skin, e.g.
electroporation, laser illumination and microneedles. In addition, there is rapid development in the
immunotherapy area as a whole, something that may lead to technologies that may diminish the need for
therapeutic cancer vaccine. All these developments represent potential competition to the fimaVACC
technology. However, given fimaVACC’s patented mode of action, i.e. triggered endosomal release of antigens,
there is also ample opportunities for synergy between fimaVACC and other emerging technologies, something
that has already been demonstrated with many vaccine adjuvants, cytokines and particle-based vaccination
technologies.
6.9.3
The competitive landscape for PCI Biotech’s fimaNAC technology
PCI Biotech’s nucleic acid therapeutics program (fimaNAC) aims at improving the efficacy of novel nucleic acid
based therapies. Although there are now several nucleic acid therapeutics in late stage clinical development,
the enormous potential of this therapeutic area is still to a large degree unexploited. The most important
reason for this is that except for the liver delivery of nucleic acids to target tissues in the body has proven
notoriously difficult. The fimaNAC delivery technology addresses a main hurdle in the nucleic acid delivery
process: sufficient release of encapsulated nucleic acids inside the targeted cells. There is intense research
activities in this area both among competing companies and in academia, thus there are many potential
competing technologies to fimaNAC. Many companies are developing so-called lipid nanoparticles (LNPs) that
have significantly improved the delivery of larger nucleic acids such as mRNA. This represent serious
competition to the fimaNAC technology, but even the best of these LNPs are still rather inefficient in
endosomal escape, leaving a clear potential for further improvement by fimaNAC. There is also significant
progress in the development of so-called self-delivered nucleic acid, i.e. chemically modified nucleic acid that
can be delivered without a delivery vehicle. This strategy has been very successful for delivery of
oligonucleotides to the liver with many product candidates in clinical trials with promising results (e.g. by
Alnylam Pharmaceuticals and Ionis Pharmaceuticals), but for other tissues this technology is still inefficient and
the delivery problem is much more difficult to solve than for the liver. fimaNAC has shown very good effects
with different kinds of chemically modified oligonucleotides, and thus combining fimaNAC with existing and
future technologies in this area has a very interesting potential.
14
Mahoney KM, et al. Oncology (Williston Park). 2014;28 Suppl 3:39-48
43
PCI Biotech Holding ASA - Prospectus
Status and plans for the three development programs
6.10.1 fimaCHEM
The fimaCHEM program aims to fulfil unmet needs by local enhancement of approved chemotherapies. The
lead project – local enhancement of gemcitabine in bile duct cancer – is in clinical development in Europe with
Amphinex®, the intravenous formulation of fimaporfin. Fimaporfin has been granted Orphan Designation in EU
for this indication, which provides 10 years market exclusivity for the product upon approval and several other
incentives, including formal Protocol Assistance and reduced filing and review fees with the EMA.
Treatment evaluation of the fourth dose cohort (3 patients) in the phase Ib/II bile duct cancer study of
Amphinex was completed in January 2016. There were no safety concerns at any of these dose levels. Safety is
the primary objective of the phase Ib part of the study. A Cohort Review Committee (CRC) of clinical experts
and company representatives evaluates the results and provides recommendation for the continuation of the
study, after completion of each dose cohorts. The CRC recommended progression of the study into Phase II at
the completion of dose cohort 4. This recommendation was not based on safety findings, but on early
promising signs of efficacy in the previous dose cohort (both partial and complete responses), combined with
experience from earlier clinical studies with fimaporfin (Amphinex®).
Additional patients have been enrolled in the fourth dose cohort in 2016, to gain further experience with the
treatment at this dose level before start of Phase II. The Phase II part of the study will be modified to draw on
the experiences gained from the Phase Ib part, as well as recommendations from the investigators and PCI
Biotech’s Scientific Advisory Committee.
Final six months radiology results from the expanded cohort four became available during Q3 2016. The cohort
was expanded from three to six patients to gain further clinical data in anticipation of Phase II start. The last
patient was treated in March 2016.
Response Evaluation Criteria in Solid Tumors (RECIST) are rules defining when cancer patients are classified as
improving, staying the same, or worsening during treatment in a clinical study. The criteria define four
different outcomes based on total detectable tumor volume; Progressive Disease (PD) when there is more
than 20% increase; Stable Disease (SD) when there is less than 20% growth and less than 30% shrinkage;
Partial Response (PR), when there is more than 30% shrinkage; and Complete response (CR) when there is no
longer any radiologically detectable tumor present. The six months RECIST results in the two highest dose
cohorts (Cohort III and IV) suggest a significant effect on response rates by the treatment.
Table - RECIST classification of patients at 6 months by local hospital evaluation
RECIST*
PD
SD
PR
CR
Cohort IV***
1
2
1
1
1
NA**
2
Cohort III
1
Cohort II
1
2
1
1
Cohort I
1
* Response Evaluation Criteria In Solid Tumours (see text above for explanation of PD, SD, PR and CR)
** Not measurable / Not radiologically evaluable
*** Cohort IV expanded; Four radiologically evaluable patients at 6 months
A centralised radiological endpoint evaluation is an expected requirement by regulatory authorities for pivotal
clinical studies. The radiological images from Cohort III and IV were therefore submitted for centralised
evaluation, performed by two experts in RECIST classification. The centralised evaluation confirmed the high
response rates in Cohort III and IV.
44
PCI Biotech Holding ASA - Prospectus
Table - RECIST classification of patients in Cohort III and IV at 6 months – local versus central evaluation
RECIST
PD
SD
PR
CR
NA
Local
1
1
3
2
2
Central
2
1
2
2
2
The Company has, based on these promising results, initiated processes to assess the fastest way to market for
fimaCHEM in this life-threatening orphan indication without approved treatments. The strategy for the phase II
part of the bile duct cancer study will be settled after completion of regulatory interactions with European and
US authorities on the regulatory requirements for marketing authorisation for fimaCHEM in bile duct cancer.
The Phase I results have also furnished increased external interest that will be assessed in relation to various
financing and partnering alternatives.
Further hospitals in selected European countries will be added in preparation for Phase II. Eleven sites are
currently open. The Company also aims to expand the study to USA by opening an IND and seek orphan drug
designation by the FDA. Clearance by the FDA to include patients in the USA, through an IND, is an important
step for the phase II study. An IND acknowledges PCI Biotech’s data on file and may enable the Company to
accelerate development of the bile duct cancer programme through expansion in the USA. An orphan drug
designation may be of importance for a potential market approval process, and a market exclusivity period in
the USA can be secured under the Orphan drug legislation.
6.10.2 fimaVACC
The fimaVACC program aims to enhance the cellular immune responses important for therapeutic effect of
vaccines. This proprietary vaccination technology has entered towards clinical Phase I and has currently one
active research collaboration
PCI Biotech will expedite clinical validation of the fimaVACC technology through a healthy volunteer Phase I
study that commenced Q3 2016. Final study data will be available in first half of 2017. PCI Biotech has selected
Covance as strategic partner for this study, which will be performed in up to 80 healthy volunteers in the UK.
The aim is to validate safety and provide clinical translation of the impressive preclinical results. The study may
also provide important knowhow with regard to the optimal treatment regimen with fimaVACC.
The Company is actively working on business development activities to enter into new value-creating
collaborations, in addition to the active research collaboration with Ultimovacs. Another important valuecreating step for the fimaVACC programme is a successful clinical validation. Pre-clinical data has convincingly
demonstrated that the fimaVACC technology not only provides effective cytotoxic T-cell induction, but can also
elicit strong enhancement of all other important immune responses. In 2015 PCI Biotech received a positive
international search report and written opinion regarding a patent application, on the use of PCI Biotech’s
proprietary technology photochemical internalisation (PCI) in vaccination and immunotherapy. A granted
patent would provide PCI Biotech with the opportunity to establish patent-protected internal development
products for the fimaVACC asset.
6.10.3 fimaNAC
The fimaNAC programme provides intracellular delivery technology for nucleic acid therapeutics, which
represents one of the main hurdles for the commercialisation of this pharmaceutical class of products. It is a
preclinical stage opportunistic programme with four active research collaborations, one with a top-tier big
pharma company.
The Company will focus on active research collaborations to explore potential synergies and based on the
preclinical data transform the collaborations into commercial agreements. The Company will continue to
pursue the current opportunistic approach for this programme.
45
PCI Biotech Holding ASA - Prospectus
Strategy
PCI Biotech's strategy is to create value by effectively progressing development of the various business areas
towards commercialisation. The commercialisation of products is intended primarily through agreements with
external partners. For fimaCHEM the Company's goal is to establish partnerships based on results from the
clinical phase I or phase II. A future phase II and/or III part needed for marketing authorisation may be
performed in cooperation with or by other players within the field of oncology. The possibility of entering into
partnerships depends on the quality of the results and the nature of the regulatory path. Within the
immunotherapeutic fimaVACC programme PCI Biotech’s strategy is to use clinical proof of concept data from
the initiated phase I study to enter into various agreements. In parallel, the Company will explore the
possibility to expand the fimaVACC asset through further clinical development. For nucleic acid therapeutics,
fimaNAC, PCI Biotech's strategy is an opportunistic approach utilising preclinical results to enter into various
agreements for further development.
Business model
PCI Biotech’s human capital strategy is to focus on the core competencies required to support a development
and licensing based strategy and business model. Other capabilities, such as study conduct, patent filing and
maintenance, and manufacturing will be outsourced. This arrangement is set to ensure that PCI Biotech has
the core competence in-house to design and manage the execution of the activities considered necessary by
the management to achieve the short term and long term goals. This arrangement also allows PCI Biotech to
manage its business with a small core team, while other functions are supplied by external vendors to achieve
cost flexibility and access to relevant expertise when needed.
Figure - The business model of PCI Biotech
PCI Biotech intends to access all other capability that it requires through third party vendors. Competences
that are expected to be supplied by external vendors include: pre-clinical development; study conduct; patent
filing and maintenance; manufacturing; regulatory affairs; drug safety; and development of light sources.
Research activities will be conducted through existing partners, e.g. the Radium Hospital in Oslo, contract
research organisations or other third parties.
46
PCI Biotech Holding ASA - Prospectus
Pipeline and indicative key milestones
PCI Biotech has built a pipeline of attractive development opportunities based on the PCI technology. The
technology is progressed in three different development programmes, each addressing a distinct high-unmet
medical need application.
Figure - pipeline
Current status of PCI Biotech’s research and development, and strategy going forward for the three
development programmes based on the PCI technology.
Figure – Status and strategy going forward
47
PCI Biotech Holding ASA - Prospectus
Indicative key milestones in the development of fimaCHEM , fimaVACC and fimaNAC.
Figure - Indicative key milestones in the development of fimaCHEM , fimaVACC and fimaNAC.
*IND - Investigational New Drug
Research and development
6.14.1 General description of traditional drug development
The traditional research and development process to develop a new drug is a long and expensive process. It
may be divided into four phases with sub stages as depicted below.
Figure: Overview over the four stages of pharmaceutical development.
Research and screening stage
(2-10 years)
Clinical stage
(6-11 years)
Preclinical stage
(1-3 years)
•
•
Large scale screening
•
Efficacy studies
•
Novel prinicples studies
•
Toxicity studies
Phase I: First studies in
humans with focus on
safety and dosage
studies (1-3 years)
•
Phase II: Disease area
patients and efficacy
studies (2-3 years)
•
PhaseIII: Large scale
human trials and efficacy
studies (3-4 years)
Marketing stage
•
Approval of marketing
•
Indications studied and
approved
•
Pharmaeconomical
studies
6.14.1.1.Research and screening
The research and screening stage is normally a long process where novel principles and a vast selection of
compounds are studied and tested. A large number of chemical compounds are usually studied for a single
candidate that reaches the clinical phases. First patent application filing normally takes place during this phase.
6.14.1.2.The preclinical phase
In the preclinical phase the best drug candidates or technologies are evaluated in depth with focus on efficacy,
mechanism of action and toxicology. Toxicology studies are required by the regulatory authorities in order to
obtain a permission to start clinical studies. Preclinical data on absorption, distribution, metabolism and
excretion (ADME studies) should be established during early phases of clinical development. Particularly for a
combination use with drugs and technologies, a series of preclinical combination studies may be required
before one is allowed to enter the clinic. These typically include finding the right dose in combination, finding
the order of administration (which one first) and finding a suitable dose regimen (daily, weekly, infusion time
etc).
48
PCI Biotech Holding ASA - Prospectus
6.14.1.3.The clinical phase
Clinical studies represent the human trial phase for unapproved drugs and technologies involving drugs. At this
stage an investigational compound is administered to humans and is evaluated for its safety and effectiveness
in treating a specific disease. The clinical trials normally consist of three consecutive phases (I-III).
 Phase I studies are designed to determine the appropriate dose to be given and the safety of the drug
in humans, i.e. the actions and the side effects associated with increasing doses. They are generally
carried out in healthy volunteer subjects, except for cancer products, which are normally done in
patients. Phase I includes pharmacokinetic studies, where the absorption, distribution, metabolism
and elimination of the drug is studied. This stage may last for 1-3 years.
 Phase II represents the early controlled clinical studies to obtain preliminary data on the effectiveness
of the drug for a particular indication in patients with the disease. The common short-term side
effects and risks associated with the drugs or technologies involving drugs are determined. These
studies are typically conducted in a small testing set involving up to several hundred people for the
drug or combination of drugs to be tested on. The phase may typically last for 2-3 years.
 In Phase III extensive trials are executed in order to gather the necessary information about
effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
These studies must provide an adequate basis for extrapolating the results to the general population
and transmitting that information in the physician labelling. Phase III studies generally include several
hundred to several thousand people. This stage may endure for 3-4 years.
During the whole preclinical and clinical stage proper drug supplies must be secured. It includes making or
sourcing the actual drug substance, developing an appropriate formulation for administration of the drug or
technology involving drug components into humans and the chemical and pharmaceutical analyses needed to
finish the development and qualification of material for preclinical and clinical supplies. The process of
developing an industrially applicable process normally is a lengthy and expensive affair involving as many risk
elements as the preclinical and clinical development.
If the clinical phase trials are successful necessary approvals must be obtained and pharmaco-economical
studies will be conducted in order to make the grounds for a suitable market approach and follow-up activities
such as monitoring the use, effects and safety of the drugs or technologies involving drug components.
Regulatory approvals may be withdrawn if negative side-effects are proven.
6.14.1.4.The marketing phase
The post-clinical phase, or the marketing phase, includes market analysis, establishment of market strategies
and entering the market with the approved drugs. It also incorporates the activities of getting the products
approved for the market and continuous market surveillance and monitoring of performance, side-effects,
new development potential and competing products. The after-launch activities are important as negative
side-effects that are not uncovered during the clinical and pre-clinical phases may be discovered and
prevented. Also, approvals may be withdrawn due to significant mal-performance of a product.
There are a number of market surveillance and business intelligence data providers that publish reports and
statistics regarding how other companies and the industry in general is doing regarding key success
parameters. Some of these data are publicly available for free, but most are published in reports for purchase.
Available key figures and parameters include:
 Epidemiology
 Market values
 Price of products on the market
 Average probability of success for each development stage
 Competitor performance
6.14.1.5.Orphan designation
Health authorities in the major markets can also grant certain drugs orphan designation, if the drug treats a
disease that only affects a small number of people. This is a way of stimulating research and development of
drugs for less common diseases. An orphan drug designation can increase a firm’s profitability because it can
charge higher prices per treatment as well as pay lower fees to authorities. In addition orphan drug
designation can grant exclusivity in a market for up to ten years.
49
PCI Biotech Holding ASA - Prospectus
A medicinal product designated as an orphan drug is one that has been developed specifically to treat a rare
medical condition, the condition itself being referred to as “orphan disease”. It may be defined as drugs that
are not developed by the pharmaceutical industry for economic reasons, but which respond to public health
need. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public
policy in many countries and has resulted in medical breakthroughs that may not have otherwise been
achieved due to the economics of drug research and development.15 Sponsors who obtain orphan designation
for a medicine in a region (e.g. EU) benefit from a number of incentives, including protocol assistance and
market exclusivity for up to 10 years once the medicine is on the market, as well as various fee reductions. 16
6.14.1.6.Generic drugs
New innovative drugs normally enjoy high margins during the patent protection period, in order for the
company to recoup the associated high research and development costs. Drug patents give twenty years
protection, but they are applied for before clinical trials begin, so the effective patent life tends to be between
seven and twelve years. A generic drug is a drug without patent protection on the active ingredient which
enters the market after the patent protection has expired. It must contain the same active ingredients as the
original formulation and it is in most cases considered bioequivalent to the patented drug with respect to
pharmacokinetic and pharmacodynamic properties. Generic drugs are therefore assumed to be identical in
dose, strength, route of administration, safety, efficacy, and intended use, and the documentation
requirements are limited to showing that the generic drug has the same active ingredient with the same
bioavailability, follow the same quality manufacturing standards, and have similar labelling.
6.14.1.7.Drug development in cancer
There are several features about drug development in cancer, which potentially makes it quicker and less
expensive than in other disease areas.
 Phase I studies are carried out in actual patients and hence early evidence of effectiveness can be
obtained.
 Pivotal Phase II studies can be sufficient for marketing approval. Since cancer generally is a life
threatening disease and no cures are available, new drugs may be approved for marketing based only
on extended Phase II studies.
 The regulatory authorities may give an oncology drug orphan designation if the disease affects a small
cancer population to encourage companies to focus on niche diseases. This designation includes
company benefits that may improve profitability if the company decides to develop the drug. Such
benefits can include accelerated approvals, lower fees to authorities, market exclusivity for a certain
period of time (up to 10 years) and high price per treatment.
 Accelerated development and approvals are instruments that the authorities may apply to expedite
the development, evaluation, and marketing of new therapies intended to treat people with lifethreatening and severely-debilitating illnesses, especially where no satisfactory alternatives exist.
 Licensing activity is higher within oncology than in other therapeutic areas.
6.14.2 Drug development in PCI Biotech
The goals for the Company assume a defined level of activity to support the commercialisation of products
based on the PCI technology. This activity may be grouped into five categories: clinical; pre-clinical; Chemistry,
Manufacturing, and Control (CMC) and equipment; Patents; and Other costs. Clinical refers to the phase I/II
study in bile duct cancer on Amphinex in combination with cytotoxic agents and the phase I study with
fimaVACC. Pre-clinical refers mainly to the activities needed to test fimaporfin for safety, and other compounds
for compatibility with the PCI technology and demonstration of potential therapeutic benefit when compared
with existing therapies or potential therapies in development. Previous pre-clinical work suggests that the PCI
technology may have potential to enhance the effect of as many as 20% of relevant cancer drugs for localised
cancer treatment. Pre-clinical work within the field of fimaNAC is mainly aimed at supporting the on-going
research collaborations with other companies. The main focus of pre-clinical efficacy activities is within the
field of cancer immune therapy for utilising the fimaVACC technology. CMC and equipment constitutes the part
15
Sharma et al, J Pharm Bioallied Sci, 2010
16
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp and
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm364750.h
tm
50
PCI Biotech Holding ASA - Prospectus
of pharmaceutical development that deals with the nature of the drug substance and drug product, the
manner in which both are made, and the manner by which the manufacturing process is shown to be in
control. Equipment relates mainly to the laser and other tools necessary for the bile duct and fimaVACC
programs. Patents relate to work to improve fimaporfin and extend its patent life and to widen and prolong
the patent protection in the fimaVACC and fimaNAC areas. Items that not naturally fit into one of these four
categories are classified as other costs. These five categories of activity represent key cost centres for PCI
Biotech.
Key areas in the drug development process of PCI Biotech are commented below:
 Pre-clinical leadership - The foundations of the pre-clinical competence are the selection of
compounds for testing with fimaporfin and any future photosensitiser, design of in vitro and in vivo
screening (in particular selection of appropriate animal models), continued experimental research
into and development of fimaprofin, and research into and development of new photosensitisers. In
addition the main focus is on pre-clinical work to support the fimaVACC technology opportunity.
 Clinical leadership - Good clinical data is essential to support the licensing program of combination
products with chemotherapies. The foundation of this competence is the ability to design robust
Proof of Concept studies and have these executed rapidly and cost effectively. The design of
appropriate safety studies for Amphinex and future photosensitisers is also important.
 IP strategy - Development and maintenance of a good IP portfolio around the PCI technology is
regarded by the management to be critical to a success for PCI Biotech Holding. The Company needs
to have the competence to plan for and implement a robust IP portfolio.
 Regulatory strategy - Familiarity with photochemical-based products is expected to be essential for
the success of PCI Biotech. Regulatory strategy is a core competence, as it is likely that PCI Biotech will
need to offer licensees support with the regulatory filing of products ‘incorporating’ the PCI
technology since this expertise may not be present in the licensee companies. Demonstrating that it
has the right regulatory competence may be important in winning the licensing deals that PCI Biotech
wants.
 Business development - PCI Biotech’s strategy is founded on licensing. Business development is
therefore crucial to the success of the strategy. In addition to winning licensing deals, business
development can bring important intelligence to PCI Biotech.
PCI Biotech’s development strategy is to perform Phase I/II and II studies in cancer patients to obtain early
evidence of clinical effectiveness of PCI with different commercially interesting combination products based on
generic drugs for localised cancer treatment. These data is planned to be used to achieve licensing deals where
in most instances the main clinical documentation will be performed by the licensees. The accumulated preclinical and clinical data will also be used to attract interest from companies with new innovative therapies,
either on the market or in the pipeline, for collaboration and licensing agreements using the PCI technology to
enhance the effect and value of their therapies.
6.14.2.1.Research and development partners
6.14.2.1.1. Introduction
PCI Biotech operates its research and development activities based on collaborations with several outstanding
academic institutions globally and a number of third party contract research organisations (CROs). This
approach gives the Company access to world-leading research, whilst allowing it to manage development costs
prudently and perform the work rapidly. The Company has a number of research projects with several
institutions.
PCI Biotech makes extensive use of CROs in pre-clinical, clinical and regulatory projects. The CROs are carefully
screened and selected for each project. Project management is always handled by PCI Biotech’s core team of
highly skilled professionals. The task of coordinating a network of small and large CROs as well as several
freelance experts is a core competency in PCI Biotech, and a key factor for the Company's success.
Commercial research and development partners are presented under section 6.5.4.
51
PCI Biotech Holding ASA - Prospectus
6.14.2.1.2. Norwegian Radium Hospital Research Foundation, Norway
The Company has a long-standing research relationship with the Norwegian Radium Hospital Research
Foundation (RF). PCI Biotech Holding’s early patents were all filed by the RF and later transferred to PCI
Biotech. Under the terms of research agreements with RF from 2002 and 2007 and later amendments, the
Company supports the RF with research and development funding, and gets access to research facilities and
personnel at the Radium Hospital and an option on certain conditions to acquire new technologies developed
by the RF.
Thus, PCI Biotech has a right of first refusal to purchase from the RF, in whole or in part, any new technology
within the field of Photochemical Internalisation. If PCI Biotech is not interested in purchasing such technology
at the terms offered, RF can offer the technology to a third party. An offer to a third party cannot be at terms
more favorable to the acquirer than those offered to PCI Biotech, and PCI Biotech has the right to perform an
independent assessment of any agreement entered into between RF and a third party, to ensure that RF has
offered no more favourable terms to the third party than those previously rejected by PCI Biotech. If the terms
are found more favourable, PCI Biotech may request that the agreement between RF and the third party is to
be cancelled.
6.14.2.1.3. Other international collaborators
PCI Biotech also has several other international research collaboration partners:





University Hospital Zürich, Switzerland
The Norwegian Radium Hospital, Oslo, Norway
Eidgenössische Technische Hochschule (ETH) Zürich, Switzerland
University of Iceland, Faculty of Pharmaceutical Sciences
University College London, UK
In addition PCI Biotech has research collaboration partners in the ongoing clinical trial. The most important
collaborators include:

University Hospital Aintree, Liverpool, United Kingdom

Universitätsklinikum Essen, Germany

Charitè Comprehensive Cancer Center, Berlin, Germany

Ludwig-Maximillians University, Munich, Germany

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt, Germany

Universitätsklinikum Lepzig, Germany
6.14.2.2.
fimaCHEM (Amphinex® ) in combination with bleomycin
PCI Biotech’s lead candidate is the photosensitiser Amphinex. A Phase I study of Amphinex in combination with
the cytotoxic agent bleomycin in cancer patients, and an extension to this study, have been completed at
University College Hospital in London. A total of 22 patients were treated in these studies, with the majority
being head & neck cancer. A strong response to treatment was seen in all patients and Amphinex seemed to
be well tolerated17.
Summary of Study Design: Amphinex Phase I
Cancer type
Cutaneous and subcutaneous malignancies
Phase
I
Photosensitiser
Amphinex (active ingredient: fimaporfin)
Drug
Bleomycin (single dose)
Light source
Red laser, 652 nm
17
Sultan et al (2016) Lancet Oncology DOI: http://dx.doi.org/10.1016/S1470-2045(16)30224-8
52
PCI Biotech Holding ASA - Prospectus
Fixed variables
Bleomycin and light dose
Variables
Amphinex dose
Purpose of study
Assess safety and tolerance of Amphinex
Patient
description
Patients with cutaneous and/or subcutaneous tumours. Majority of patients had
Squamous cell carcinoma of the head & neck
Patient sample
size
Treatment
modality
22 patients treated across 5 dose groups
Surface illumination
Key findings from Phase 1
The primary objective of this dose escalation study was to assess the maximum tolerated dose of the new
component Amphinex when used in combination with bleomycin. Secondary objectives included
determination of the anti-tumour response of the treatment, as well as pharmacokinetics of the active
ingredient in Amphinex.
A total of 19 patients (mean age 60.6 years) were enrolled in the study. Four patients received 0.25 mg/kg
Amphinex-based PCI of bleomycin, nine patients received 0.5 mg/kg, three patients received 1.0 mg/kg and
three patients received 1.5 mg/kg. Nine patients (47%) were male and 17 patients (90%) were Caucasian.
Eighteen patients (95%) reported a total of 95 adverse events (AEs). The most common AEs were nausea and
pain. Four patients died: two patients due to respiratory failure, one patient due to pneumonia and
progression of underlying disease, and one patient was last seen 10 days after study treatment and died
approximately two and a half months after dosing. No death was considered related to study treatment. Ten
patients (53%) experienced a total of 15 serious adverse events (SAEs), including the four patients who died.
Six of the SAEs in five patients were considered treatment-related (definition of relationship: unlikely, possible,
and probable).
The primary objective of the study, dose limiting toxicity (DLT), was reached at the fourth dose (1.5 mg/kg)
level by the appearance of skin photosensitivity and significant ulceration of normal tissue in the treated areas.
The maximum tolerated dose (MTD) for Amphinex-based PCI with bleomycin had consequently been reached
at 1.0 mg/kg. After the MTD was defined six additional patients were treated at the selected dose of 0.5
mg/kg. In this cohort two patients experienced severe toxicities corresponding to the definition of a DLT one of
which was also a serious adverse event.
Tumour response evaluations were available for 16 patients at Day 28 and for 11 patients at Last Visit. The Last
Visit evaluations of the 11 patients were confirmed according to RECIST criteria, that is, the tumour response
was confirmed a minimum of four weeks after the Day 28 visit. The remaining patients were either withdrawn
or were evaluated within the four-week confirmation period. At Day 28, 11/16 patients (69%) had a Complete
Response of the target tumour to treatment, two patients (13%) had a Partial Response, two patients (13%)
had Stable Disease and one patient (6%) had Progressive Disease. At Last Visit, 5/11 patients (45%) had a
Complete Response, and two patients (18%) each had Partial Response, Stable Disease, and Progressive
Disease.
The maximum level of TPCS2a, the active ingredient in Amphinex, occurred 30 minutes after administration and
decreased towards zero. There was an almost linear relationship between dose and mean maximum
concentration, but with some tapering off with higher doses. There was little difference between dose groups
in the mean elimination rates. Mean elimination half-life (based on the last four measurements) ranged from
15 to 22 days.
In conclusion, Amphinex-based PCI of bleomycin was well tolerated under conditions of analgesia and
anaesthesia, and no unexpected safety concerns were raised. The MTD of Amphinex based PCI of bleomycin
was determined to be 1.0 mg/kg. There were early promising signs of efficacy of Amphinex-based PCI of
bleomycin.
53
PCI Biotech Holding ASA - Prospectus
6.14.2.3.
Phase II study in head and neck cancer
A Phase II study in head and neck cancer patients called the “ENHANCE“ study was in 2012 initiated on the
basis of the promising signs of efficacy in Phase I. This study was terminated 2Q 2015, based on both strategic
and clinical considerations. A review of the relevant market segment suggested a diminishing opportunity for
Amphinex induced treatment with bleomycin in recurrent head and neck cancer, not least due to expected
increased competition based on very positive reports on the effect of emerging immunotherapies in this
specific patient population. In addition, optimising the light dose for bleomycin-induced tumour ablation by
interstitial illumination turned out to be more complicated than anticipated.
6.14.2.4.Bile duct cancer
The bile duct drains bile from the liver into the small intestine. Bile duct cancer is a relatively rare cancer with
an annual incidence of 1-2 cases per 100,000 in the Western world. The incidence rate has been rising
worldwide over the past several decades. Surgery is the only potential curative treatment, but surgery is
possible only in a small fraction of the patients (10-35%). Overall survival at five years is dismal at less than 5%.
Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to loco-regional effects of the disease are
the most important causes of death181920.
6.14.2.4.1. Current treatment
Currently, surgery is the only curative option for these patients; yet the majority of the tumours are inoperable
at presentation. Inoperable patients are treated with stenting to try to keep the bile duct open and with
chemotherapy. The combination of gemcitabine and cisplatin has shown promising results and has become
standard treatment in some regions, but there is still a need for better treatments to increase overall survival
and quality of life.
6.14.2.4.2. fimaCHEM in the treatment of bile duct cancer
Bile duct cancer has been chosen as a good target disease for fimaChem as there is a clear medical need for a
better local treatment, access with light is easy by using already established treatment procedures and one of
the most used cytotoxic agents, gemcitabine, is one of the drugs that is significantly enhanced by fimaChem in
preclinical studies.
6.14.2.4.3. fimaCHEM (Amphinex) in combination with gemcitabine
A Proof of Concept (Phase I/II) study for the use of PCI in patients with inoperable bile duct cancer was
initiated in January 2014. In this indication Amphinex will be used in combination with the generic cytotoxic
agent gemcitabine.
Phase I/II study in patients with inoperable bile duct cancer (Cholangiocarcinoma)
The Proof of Concept study is an open-label, multi-centre Phase I/II study in up to 45 patients to assess the
safety and efficacy of Amphinex induced PCI of gemcitabine, followed by systemic cisplatin/gemcitabine, in
patients with inoperable bile duct cancer. The study consists of a dose escalation/phase I part to assess the
tolerance of local bile duct treatment and a randomised double-arm phase II part. In phase II patients will be
randomised to either a control arm (stenting alone followed by gemcitabine/cisplatin chemotherapy) or the
PCI arm (stenting followed by Amphinex induced PCI treatment of gemcitabine followed by
gemcitabine/cisplatin chemotherapy). The randomisation ratio for this study is 2.5:1 in favour of the PCI arm.
The Phase I primary objective is to determine a tolerable dose for local bile duct treatment with Amphinex
induced PCI of gemcitabine, while the Phase II primary objective is to assess efficacy in terms of progression
free survival.
18
Khan et al. Lancet 2005
19
Bragazzi et al Transl. Gastro intest cancer, 2012
20
Ghafoori et al. Int J Radiation Oncology Biol Phys, 2011
54
PCI Biotech Holding ASA - Prospectus
Summary of Study Design: Amphinex Phase I/II (Bile duct cancer)
Cancer type
Bile duct cancer (Cholangiocarcinoma)
Phase
I/II
Photosensitiser
Amphinex (active ingredient: TPCS2a)
Drug enhanced
Gemcitabine (single dose)
Light source
Red laser 652 nm
Fixed variables
Gemcitabine PCI dose and systemic cisplatin/gemcitabine dosing regimen
Variables
Amphinex and/or light dose
Purpose of
study
Open-label, multi-centre study to assess the safety and efficacy of a single treatment of
Amphinex induced PCI of gemcitabine, followed by systemic cisplatin/ gemcitabine. All
patients are stented. Phase I to find light and Amphinex dose. Phase II randomised to
compare PCI vs. stenting alone
Patient
description
Treatment
modality
Patient sample
size
Primary
endpoint:
Locally advanced inoperable bile duct cancer
Intraluminal illumination
Up to 45 patients
Progression free survival
Current status and plans
The first patient was included in January 2014 at Aintree University Hospital in Liverpool, UK, and the
treatment evaluation of the last dose cohort, cohort number four (three patients) was completed in January
2016. Cohort number four was thereafter expanded with additional patients and the last patient was treated
in March 2016. No safety concerns were observed at this dose level. The strategy for the phase II part of the
study is currently under review, see section 6.10.1 for further details.
6.14.2.5.
Cancer Immunotherapy - fimaVACC
Immunotherapy is a very promising and rapidly evolving modality for cancer treatment, with important
products already on the market and an extensive development pipeline, especially in the areas of checkpoint
inhibitors and therapeutic vaccines.
As compared to more conventional cancer therapeutic modalities immunotherapy has several important
advantages (i) it can attack cancer systemically, virtually seeking up cancer cells anywhere in the body; (ii) it is
specific for the cancer cells, leading to much less “collateral” damage than conventional cancer therapies, and
hence less severe side effects; (iii) the action is durable, potentially offering life-long cure and protection for
the patient; (iv) it can in principle be used on all types of cancer.
55
PCI Biotech Holding ASA - Prospectus
In most forms of cancer immunotherapy induction of so-called Cytotoxic T Lymphocytes (CTLs) is a key
component, since these cells are the immune system’s most important means for killing abnormal cells in the
body (e.g. cancer or virus-infected cells). Unfortunately induction of CTLs has been difficult to achieve with
today’s vaccination technologies. The fimaVACC technology can provide a solution to this problem, potentially
strongly enhancing the effect of many of the cancer immunotherapies that are on the market or under
development. The effect of the fimaVACC CTL induction technology will be especially important for therapeutic
cancer vaccination, but fimaVACC may also have important enhancing effects in various forms of combination
cancer immunotherapy, a modality that is expected to be the key for realising the full potential of cancer
immunotherapy.
Induction of CTLs is typically mediated through MHC Class I antigen presentation by antigen presenting cells
(APCs), typically requiring the presence of the antigen in the cytosol of the APC. The fimaVACC technology can
re-localise endocytosed vaccine antigens from endosomes to the cytosol in APCs, thereby making the antigens
accessible for the MHC Class I presentation machinery, significantly enhancing MHC Class I antigen
presentation by APCs.
Figure – Antigen presenting cells with MHC Class I presentation of the vaccine antigen
Antigen
fimaVACC mechanism of action on the cellular (A) and endosomal (B) level. Many types of antigens are taken up into
antigen presenting cell by endocytosis and the antigens will then be entrapped in endosomes inside the cell. For proper
MHC class I presentation it is essential that the antigens get access to the cell cytosol where the first phases of the MHC
Class I presentation pathway is located. In the fimaVACC technology the fimaporfin photosensitiser and illumination is
used to achieve release of antigens from the endosomes into the cytosol. This leads to strongly increased MHC Class I
presentation and induction of a CTL immune response.
In animal studies the fimaVACC technology has been used with different types of model vaccines for
assessment of the CTL immune response in vaccinated animals. In these studies the fimaporfin photosensitiser
has been mixed with the vaccine and the mixture has been injected into skin of mice, followed by illumination
of the injection site.
56
PCI Biotech Holding ASA - Prospectus
Figure – Conceptual illustration of the PCI technology used for fimaVACC
Figure – Conceptual illustration of the PCI technology used for fimaVACC
A: Animals with a melanoma tumour are vaccinated with a vaccine containing tumour antigen and fimaporfin.
B: Fimaporfin and the antigen are taken up into endosomes in antigen presenting cells.
C: Upon illumination the antigen is release from the endosome in the antigen presenting cell so that the antigen will be
localised in the cytosol of the cell.
D: In the cytosol the antigen will encounter the MHC Class I antigen presentation machinery. This leads to presentation
of the antigen on MHC Class I molecules on the surface of the antigen presenting cell; and induces a cytotoxic T-cells
(CTLs; CD8+ T- cells) immune response.
E: Analysis of blood samples from the vaccinated animal shows that fimaVACC has induced a very strong increase in the
number of antigen-specific cytotoxic T-cells; from close to 0% in animals not treated with fimaVACC (not shown) to
about 40 % in the fimaVACC treated animals (red circle).
F: The antigen-specific cytotoxic T-cells (red staining) will recognise the antigen in the tumour cell and will migrate into
the tumour.
G: The antigen-specific cytotoxic T-cells will kill the antigen-producing tumour cells, leading to eradication of the
tumour.
The results of these animal studies show that the use of the fimaVACC technology substantially increased the
amount of antigen-specific CTLs, and that fimaVACC can give strong synergistic effects with other state-of-art
vaccine technologies. Thus these studies indicate that fimaVACC could be used for enhancing the effect of many
different vaccines and immune therapies being developed for cancer treatment. Based on these promising
results PCI Biotech has filed several new patent applications in the vaccination area, and PCI Biotech has also
been awarded NOK 12.5 million in a BIA grant from The Research Council of Norway for the period 2014-2017
for developing PCI vaccination further. The preclinical proof-of-principle results have been published in
renowned scientific journals21.
6.14.2.5.1. Clinical validation of the fimaVACC program
PCI Biotech has initiated a healthy volunteer study as this is the fastest way forward for clinical validation of
the fimaVACC technology. The study started in Q3 2016 and is anticipated to be completed in 1H 2017. The
study is performed by a CRO in UK and up to 80 healthy volunteers will be enrolled. The primary aim of the
21
Waeckerle-Men et al, Eur J Pharm Biopharm, 2013; Håkerud et al, J Control Release, 2014, Håkerud et al, J control Release 2015
57
PCI Biotech Holding ASA - Prospectus
first in man study is to validate safety, and a secondary aim is to document the translation of the impressive
preclinical results into humans. PCI Biotech also foresees to gain useful knowledge for optimal treatment
regimen with fimaVACC.
Summary of Study Design: Phase I Study of Fimaporfin-induced PCI for Vaccination in Healthy Volunteers
Study Title
An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess
Safety, Tolerability, and Immune Response of Fimaporfin-induced
Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy
Male/Female Subjects.
Brief Summary
Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech
AS for use in novel Photochemical Internalisation (PCI) technology. PCI
technology is designed to enhance the effects of other drugs in a site-specific,
light-directed manner and is used to re-localise endocytosed molecules from
endosomes to cytosol. This research study is evaluating the use of the PCI
Technology in combination with adjuvant and vaccine antigens for safety and
induction of immune responses.
Study Objective
 Part A: To determine the Safety, Tolerability, and Immune Response when
PCI (fimaporfin and light) is given alone and in combination with an Adjuvant
in Healthy Subjects. Find Fimaporfin dose for the main part of the study.
 Part B: To Assess Safety, Tolerability, and Immune Response when
Antigen/Adjuvant is given alone and in combination with PCI (fimaporfin and
light).
 Part C: To Assess different time intervals between dosing of fimaporfin,
adjuvant/antigens and light application.
Primary Endpoints
 Safety Endpoints: Adverse events, Laboratory safety evaluations, Vital sign
assessments, Local tolerance (pain, erythema, oedema, induration and
ulceration) and Pain (during light application).
 Immunological Endpoints: Induction of vaccine-specific immune responses.
 Exploratory endpoints (optional): possible biomarker research aimed at a
more comprehensive exploration of the immune response, circulating
cytokines, and induction/increase in HPV-specific antibodies.
Study Design
Open-label, Phase I/Proof of Principle, Dose Escalation, Sequential-group Study
in 3 parts:
 Part A: Run-in Part for selection of fimaporfin starting dose in the main study
 Part B: Main Study Part testing different light dose and/or fimaporfin dose
groups (36 subjects) followed by an optional expansion group (12 subjects).
Control group will not receive Photosensitiser and light (PCI).
 Part C: Optional part to further optimise the dose regimen in the study by
changing time interval between drug administration and light application.
Study Population
Healthy volunteers, Male/Females 18-55 years
Up to 80 subjects
Interventions
Photosensitiser/Drug: Fimaporfin (active ingredient: TPCS2a)
Adjuvant: Hiltonol (Poly-ICLC)
Vaccine antigens:
- KLH (Keyhole Limpet Haemocyanin)
- HPV peptides (Human Papilloma Virus E7, 2 peptides)
Hiltonol, KLH and HPV doses are fixed throughout the whole study.
Fimaporfin, Hiltonol, KLH and HPV will be administered as intradermal
injections.
Light source
Red laser 652 nm.
Light will be applied to injection sites approximately 24 hours after injection of
study drugs. Optional part will assess timing between dosing and light
application.
58
PCI Biotech Holding ASA - Prospectus
6.14.2.6. Nucleic acid therapeutics- fimaNAC
Nucleic acid therapeutics are widely acknowledged to have a large potential as therapeutic agents, and
numerous clinical trials with gene, protein and oligonucleotide therapies have been or are being performed.
Most types of nucleic acids have their molecular targets inside the target cells, but the molecules are, by
factors of their size and charge, notoriously difficult to deliver in large enough payloads inside a cell to give an
effective therapeutic response. Nucleic acids are in most cells taken up by endocytosis, but are then trapped in
endosomes, constituting a barrier severely limiting the therapeutic effect that can be achieved. Thus, nucleic
acids are very good candidates for enhancement by an endosomal release technology like fimaNAC, and
preclinical experiments have shown that fimaNAC can give a substantial improvement in the effect of very
important classes of nucleic acids such as oligonucleotides (e.g. siRNA and mRNA). Regarding current research
activities, no major resources are allocated to further development of the fimaNAC asset, except activities
related to the ongoing research collaborations.
Patents
PCI Biotech takes advantage of a global network of academic institutions and third party contract research
organisations to give the Company access to high quality research at an affordable cost. It is inherent in this
research strategy to seek to patent innovative ideas developed in co-operation with such collaborators,
covering e.g. new variants of compounds or new areas of use, with the aim of prolonging and extending PCI
Biotech’s patent protection over what is offered through already approved patents. PCI Biotech is dependent
on solid patent protection for the commercialisation of the PCI technology, and will also seek prolongation of
the term of existing patents where possible.
PCI Biotech performs surveillance of scientific literature and newly published patent applications to keep up to
date within the field of PCI. Patents or patent applications that turn out to be of low commercial interest will
be abandoned. Since these already have been published they will represent prior art for other competitors
who might wish to file patents in the area. Patents are only filed in markets of economic significance. An
overview of PCI Biotech’s patent portfolio is shown below.
59
PCI Biotech Holding ASA - Prospectus
Platform and business area patents: Granted and Pending
No
Patent title
Priority
Brief patent description
date
1 Sulfonated Chlorins as
30.08.2001 The photosensitiser TPCS2a (fimaporfin) and similar
Photosensitiser
compounds. Pharmaceutically acceptable salts. Use
in photochemical internalisation and photodynamic
therapy
2 Chitosan-photosensitiser
15.05.2012 Chitosans as photosensitiser carrier and uptake
conjugates
enhancer
3 Soluble photosensitisers
14.08.2009 Soluble photosensitisers for the use in PCI. Covers
the fimaporin salt form used in current clinical
studies, and some similar substances.
4 Photochemical
29.11.2000 Methods of PCI in which the transfer molecule is
Internalisation for Virusattached to a viral carrier
Mediated Molecule
Delivery into the Cytosol
5 TKI-PCI
30.06.2008 The use of PCI for transfer of kinase inhibitors into
cells
6 siRNA-PCI
11.07.2006 The use of PCI for transfer of siRNA molecules into
cells
7 Method of expressing
15.03.1999 Use of the PCI method to achieve cell surface
antigens on the surface of
presentation of antigens, e.g. for vaccination
antigen presenting cells by
photochemical
internalisation
8 fimaVACC in combination
28.08.2013 Covers the use of the PCI technology in combination
with TLR agonists
with a very important group of immune enhancing
substances (Toll-like receptor agonists) and may
give PCI Biotech broad protection for the use of the
PCI technology with many of the therapeutic cancer
vaccines that are under development.,
9 Vaccination light device
28.08.2013 Various light devices for the use in fimaVACC
10 fimaVACC for
11.04.2014 Use of PCI for immunotherapy of melanoma
immunotherapy of
melanoma
11 fimaVACC in combination
28.08.2014 Use of PCI in combination with immuno-stimulating
with immune-stimulating
cytokines
cytokines
Expiry
2022
2025
(USA)
2033
2030
2021
2029
2027
2020
2034
2034
2035
2035
The patents and patent applications are owned directly or indirectly by PCI Biotech, following execution in
2001, 2002 and 2007 and later amendments of assignment agreements with Photocure ASA and the
Norwegian Radium Hospital Research Foundation respectively. While assignment agreements have been duly
executed, the former owners are still registered as such in some patent registries.
Patent no. 1 covering the photosensitiser fimaporfin (TPCS2a) the active pharmaceutical ingredient in
Amphinex, and the compound used in fimaCHEM, fimaVACC and fimaNAC was filed in 2001, and has been
granted in all important areas. Composition of matter patents covering actual products are commonly the
most important type of patents in the pharmaceutical industry. Accordingly, patent no. 1 is currently
considered the most important patent for PCI Biotech, as it is a composition of matter patent on the lead drug
candidate fimaporfin. PCI Biotech has in addition to this central composition of matter patent also a range of
patents and patent applications providing further coverage of certain applications and use areas (see below).
Patent application no. 2 covers several chitosan-photosensitiser conjugates with many possible uses with the
PCI technology. The application covers composition-of-matter and various use areas for these substances. The
patent application has not yet been granted in any important territory.
60
PCI Biotech Holding ASA - Prospectus
Patent application no. 3 covers the use of some water-soluble photosensitisers for PCI. The patent is granted in
many important territories and is still under examination in some territories. The patent covers different salt
forms of fimaporfin, among these the substance used today in fimaCHEM, fimaVACC and fimaNAC.
Patent application no. 4 coves the use of the PCI technology for some types of virus-mediated gene delivery,
and may be especially important in some areas of vaccination.
Patent application no. 5 concerns the use of the PCI technology for transfer of kinase inhibitors into cells. The
patent is granted in the US, pending in Europa (EPO) and Canada.
Patent applications no. 6 concerns the use of PCI siRNA, and is granted in many important markets. The patent
applications cover the use of PCI with siRNA in combination with various forms of carriers
Patent no. 7 covers the use of PCI in vaccination in general, and is granted in all important markets.
Patent applications 8-11 concern various aspects of the use of PCI in vaccination (fimaVACC). These applications
will give PCI Biotech the opportunity to obtain further patent protection for the use of the PCI technology in
vaccination, supplementing the already granted and pending patents within this area. The term of any granted
patents resulting from these applications would last at least until August 2034. For the fimaVACC program PCI
Biotech received in March 2015 a positive international search report and written opinion regarding a patent
application, on the use of PCI Biotech’s proprietary technology photochemical internalisation (PCI) in a very
important area of vaccination and immunotherapy (patent application 8). The patent application covers the
use of the PCI technology in combination with a very important group of immune enhancing substances and
may give PCI Biotech broad protection for the use of the PCI technology with many of the therapeutic cancer
vaccines that are under development until 2034-2035. Other fimaVACC patent applications concerns the use of
PCI in combination with immuno-stimulating cytokines (patent application no. 11), use of PCI for
immunotherapy of melanoma (patent application no. 10) and various light devices for the use in fimaVacc
(patent application no. 9). Successful long-term commercial exploitation of the fimaVacc asset is dependent on
patents 8-11.
For the bile duct cancer study under PCI Biotech’s fimaCHEM program the relevant patent coverage expire in
2022 (EU) and 2025 (US) with possibilities for up to five more years extension. Bile duct cancer is a rare disease
and with a potential orphan designation for PCI Biotech’s product candidate, fimaporfin, market exclusivity can
be secured for 7 years in US and 10 years in EU. Orphan designation in EU has been granted for fimaporfin in
bile duct cancer and is in application process for the USA. The Company is consequently not expected to be
dependent on the patent for market protection after approval of fimaporfin in this indication.
In addition to the patents and patent applications outlined in the above table, PCI Biotech has also filed several
as yet undisclosed patent applications.
There are no licenses, industrial, commercial or financial contracts or new manufacturing processes which is
material to the Company’s business or profitability and on which the Company is dependent.
61
PCI Biotech Holding ASA - Prospectus
Recent key publications in peer reviewed journals
Program
fimaCHEM
Publication
Disulfonated tetraphenyl chlorin
(TPCS2a)-induced photochemical
internalisation of bleomycin in
patients with solid malignancies: A
first-in-man phase I dose
escalation clinical trial.
Høgset et al.
Lancet Oncology, (2016)
fimaCHEM
Photochemical internalisation for
solid malignancies
Steen Madsen
Comment. Lancet Oncology, (2016)
fimaVACC
Cytosolic Delivery of Liposomal
Vaccines by Means of the
Concomitant Photosensitisation of
Phagosomes.
Hjálmsdóttir et al. Mol.
Pharmaceutics, (2016)
Photosensitiser and Light Pave the
Way for Cytosolic Targeting and
Generation of Cytosolic CD8 T Cells
Using PLGA Vaccine Particles.
Cristina Bruno et al. The Journal of
Immunology, 195 (2015) 166–173.
fimaVACC
Brief summary
In this clinical phase I study PCI
Biotech's proprietary
photosensitiser fimaporfin was
given at escalating doses in
combination with the cytotoxic
drug bleomycin to 22 patients with
advanced and recurrent cancer.
The treatment was found safe and
tolerable, and significant antitumour effect were seen at all
dose levels in this patient
population with aggressive
cutaneous and sub-cutaneous
tumours
The results of this phase 1 clinical
study are intriguing because they
suggest that photochemical
internalisation might have a role in
the treatment of early lesions and
palliation of advanced disease.
Demonstrating that the fimaVACC
technology can be applied to
particulate vaccines, such as
liposomes, significantly improving
cross-priming of CD8+ T-cells
PLGA (poly(lactide-co-glycolide)
microparticles) loaded with an
antigen and the fimaVACC
technology proved to be effective
for stimulation of CD8+ T-cells.
fimaVACC
Photosensitisation facilitates crosspriming of adjuvant-free protein
vaccines and stimulation of
tumour-suppressing CD8 T cells.
Monika Håkerud et al. Journal of
Controlled Release 198 (2015) 10–
17
The fimaVACC technology enables
access of a protein vaccine to MHC
class-I-restricted antigen
presentation, with strong CD8+ Tcell responses preventing tumour
growth in a melanoma model.
fimaVACC
Intradermal photosensitisation
facilitates stimulation of MHC
class-I
restricted CD8 T-cell responses of
co-administered antigen.
Monika Håkerud et al. Journal of
Controlled Release 174 (2014)
143–150
The fimaVACC technology
represents a potent tool for
delivery of antigens to cytosol for
stimulation of cytotoxic CD8+ Tcell responses after intradermal
vaccination.
fimaVACC
Photochemical targeting of
The first study to describe
62
PCI Biotech Holding ASA - Prospectus
fimaNAC
antigens to the cytosol for
stimulation of MHC class-Irestricted T-cell responses.
Waeckerle-Men et al. Eur J of
Pharmaceutics &
Biopharmaceutics 85 (2013) 34–41
fimaVACC-mediated immunisation
in vitro. The results revealed the
feasibility of this novel technology
in autologous vaccination for
stimulation of CD8+ T-cell
responses.
Light-induced gene expression
using messenger RNA
molecules.Bøe S et al.
Oligonucleotides 20:1-6 (2010)
Study to developed a site-specific
delivery strategy for mRNA
molecules through the use of
fimaNAC. The main benefit of the
strategy proposed is the possibility
for protein production from the
delivered mRNA in a way that is
controllable in a time- and sitespecific manner.
Litigation and disputes
The Company provides the following information regarding the registration process of the trademark
'Amphinex' as word mark in the EU. Application for registration filed from PCI in 2012 led to the confirmation
of the international registration by WIPO in February 2013 and publishing in GIM 5/2013.
Opposition was filed on behalf of Novartis in November 2013, on the grounds of likelihood of confusion with
an existing trademark. Novartis holds a national trademark registration for FINEX in the Czech Republic. The
EU registration of Amphinex was temporarily refused due to the opposition. An agreement has been reached
with Novartis. The trademark registration in the EU is completed.
Except for the above, neither the Company nor its subsidiary are, or have been during the course of the
preceding twelve months, involved in any legal, governmental or arbitration proceedings which may have, or
have had in the recent past, significant effects on the Company's and/or its subsidiary's financial position or
profitability, and the Company is not aware of any such proceedings which are pending or threatened.
Related party transactions
PCI Biotech Holding is relying on services provided by third parties, included related parties, as a result of its
organisational set-up. PCI Biotech Holding considers that its business relationship with Radiumhospitalets
Forskningsstiftelse regarding general research and development represents related party transactions. The
following table shows the magnitude of such transactions (all figures in NOK 1,000).
Purchase of services
The Norwegian Radium Hospital
Research Foundation
Theresa Comiskey Olsen
2016
Q3
2015
Q3
675
NA
886
NA
2016
YTD
2 203
NA
2015
YTD
2 543
17*
2015
FY
3 488
17*
* Comiskey Olsen ended her term as board member in May 2015 and transactions up to that date are disclosed.
Per Q3 2016, PCI Biotech had NOK 675 thousand in short term liability to The Norwegian Radium Hospital
Research Foundation.
More information on related party transactions are found in the annual report for 2015 in note 19, in the
annual report for 2014 in note 19 and in note 6 in the Q3 2016 report.
There has been has been no related party transactions after 30 September 2016 to the date of this Prospectus
other than NOK 563 thousands to Radiumhospitalets Forskningsstiftelse.
63
PCI Biotech Holding ASA - Prospectus
7.
MARKET OVERVIEW
PCI Biotech Holding is targeting the oncology market in three powerful ways; by developing PCI-based
anticancer therapeutics for certain cancer indications (fimaCHEM), by advancing its concept of CTL-induction for
the strengthening of immune responses in the field of immune-oncology (fimaVACC) and for the delivery of
nucleic acid therapeutics (fimaNAC). It should however not be excluded that the technology could have
potential uses in other therapeutic areas.
Oncology
7.1.1
Cancer market overview
The cancer market is large and fast growing. It is the third largest pharmaceutical market, following the
cardiovascular and central nervous system (CNS) therapy areas. There were 14.1 million new cancer cases in
2012, and the incidence rate has been increasing steadily in several regions in the world over the last decades.
In the US alone the estimated number of new cancer cases were 1.6 million in 2012, and it is estimated that
0.62 million Americans died from cancer that year22.
Figures 3 Cancer incidents and mortality (Source: WHO Globocan 2012)
The global spending on oncology drugs was around USD 91bn in 2013, and it has grown between 4% to 7%
annually in the recent years. Generally, global oncology has grown at a much higher pace than global
pharmacy in the last decade.
22
Source: GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.
64
PCI Biotech Holding ASA - Prospectus
Oncology drug sales by region23
Global oncology market dynamics 2003-2013
BRIC
5%
Other
13%
USA
39%
Japan
14%
EU/EEA
30%
Figure: Global oncology spending in USbn (2003-2013). Source: IMS MIDAS, Dec 2013.
Figure: Global oncology drug sales (top 100 companies).
As measured by the top 100 oncology companies in 2012, Europe and the US accounts for nearly 70% of the
global market.
There is a general understanding that the prices currently paid for innovative effective cancer treatments are
considered high and that the willingness to pay for effective new cancer therapies has led to increased prices
of cancer medicines over the last years.
7.1.2
Traditional cancer treatment (chemotherapy)
Chemotherapy is a systematic cancer treatment that involves the use of cytotoxic drugs, and is often used as
an adjuvant treatment given in addition to surgery or radiation therapy in order to kill any remaining cancer
cells or control the tumour growth. This kind of treatment may consist of one drug or a combination of drugs,
administered either intravenously or orally. Cancer drugs are normally categorised into the following four
groups: antineoplastics, immunostimulants, immunosuppressants and cytostatic hormone therapies. In the
table below these four main drug classes are described briefly:
Drug Class
Comments
Leading therapies
Antineoplastic
(cytotoxics)
 Function by hindering mitosis or cell division in cell cycle
 Are used in all stages of cancer treatment
 The target class for PCI Biotech




Taxotere
Gemzar
Cisplatin
Doxorubicin
Immunostimulant
 Alters the body’s defenses and cancer cells to boost, direct and restore the body’s
ability to fight cancer
 May replace cells damaged by treatment/cancer or may exert direct effect on cancer




Neulasta
Leucomax
Neupogen
Copaxone
Immunosuppressant
 Used to suppress cancers associated with the immune system, e.g. lymphoma
 MabThera
 Rituximab
 Used to treat hormonally-sensitive cancers




Cytostatic hormone
therapies
Lupron
Arimidex
Casodex
Tamoxifen
Major classes of cancer drugs.
The PCI technology has shown in an exhaustive in vitro screening that it may work well with a wide array of
antineoplastics or cytotoxics drugs. fimaCHEM, PCI technology’s application to the field of chemotherapeutics,
represents a strategic opportunity for PCI Biotech because of market dynamics specific to this field:
23
Source: Pharmaceutical & Biotech Sales Analysis by Country, Top Drugs, Top Regions, EvaluatePharma, May 2014.
65
PCI Biotech Holding ASA - Prospectus


Oncology is a large and growing market;
There is a continuing need for improved cancer therapies;

There is a growing use of combination therapy with multiple marketed products;


Blockbuster products that are coming off patent will require life-cycle management activity; and
There are generic versions of well-characterised products available for inclusion in Proof of Concept
studies.
In addition to these external factors, PCI Biotech has generated positive in vitro efficacy data of approximately
20% of relevant marketed oncology molecules in a screening system. Preliminary data also suggests that the
PCI technology may be able to improve response in drug resistant cancer cells, although this observation
requires further investigation.
More specifically, following a successful preclinical program with fimaCHEM, PCI Biotech has identified one
cancer for which fimaCHEM is now under clinical investigation: bile duct cancer. This programme is ready to
enter clinical phase 2 after having completed a safety study showing a good safety profile as well as promising
preliminary signs of efficacy. This cancer has been selected based on a number of criteria, including exciting
preclinical data, medical need of improved localised treatment, low experimental therapy risk, poor present
therapeutic treatment, as well as a low level of innovative research for this disease.
7.1.3
Bile duct cancer
Bile duct cancer (Cholangiocarcinoma) is a cancer that affects the cell lining of the bile duct. It is a rare disease
with an incidence rate of 1-2 per 100,000 in the western world, indicating a total patient population of close to
15,000 per year. The incidence rates are increasing worldwide. Overall survival at 5 years is dismal at less than
10%.
Bile duct cancer represents a patient population with a high unmet medical need. Most patients die of
unrelieved biliary obstruction. Resection is today the only potential cure but only possible in 10-35% of the
incidents24. The cancer shows remarkable resistance to chemotherapy. Gemcitabine + cisplatin is the most
effective chemotherapy combination and has become a standard treatment for bile duct cancer patients in
several regions25.
The immediate target for PCI Biotech is inoperable patients with perihilar disease. Across Europe and USA
approximately 3,000 are assumed to be eligible for PCI treatment. Possible upsides to the targeted patient
population include perihilar patients with more extensive metastatic spread, as well as distal bile duct disease.
Bile duct cancer is an orphan indication with a range of development and market incentives. The orphan
market has shown promising signs of growth. In 2012 orphan drug sales increased 7.1% to USD 83 billion from
the previous year. That compares with a 2.1% decline in overall prescription drug sales (excluding generics),
which fell to USD 645 billion in the same period. The worldwide orphan drug market is estimated to grow USD
127 billion by 2018, at a compound annual growth rate double that of the overall prescription drug
pharmaceutical market.26 The combination of lack of approved medical treatment options and bile duct
cancer being an orphan indication implies an attractive price potential for new products entering this market.
Bile duct cancer is an attractive indication for PCI Biotech. There is a potential for obtaining a significant
majority share of the identified eligible market due to the anticipated benefits, such as no competing
marketable treatment alternatives, greater efficacy due to local chemotherapy boosts and easy light access
through established standard procedures.
24
Ghafoori et al, Int J Radiation Oncology Biol Phys, 2011
25
Valle et al, N Engl J Med, 2010
26
Orphan Drug Report 2013, EvaluatePharma
66
PCI Biotech Holding ASA - Prospectus
Cancer immunotherapy
7.2.1
Cancer immunotherapy and market trends
In the past few years, the pharmaceutical industry has made great progress in understanding the role of the
immune system in cancer, leading to the development of the field of immunotherapy. In a nutshell,
immunotherapy utilises the body’s own immune system to fight cancer, which is a radically different approach
to treating cancer than chemotherapy.
The objective of cancer immunotherapy is to generate an immune response to eliminate or slow the growth of
tumour cells by stimulating and training the immune system to recognise cancer cells and attack those cells
more effectively. The armamentarium of the field of cancer immunotherapy includes many different
therapeutic approaches including antibody-based treatments, cell-based therapies, and therapeutic vaccines.
Immunotherapy has during the last years become an important weapon in the arsenal to fight many types of
cancers and is set to become one of the fastest growing and most promising biotech segments today. The
percentage of immunotherapy addressable cancers is expected to dramatically increase in the next few years,
thanks in part to combination strategies.
A recent Citi Research report indicates that the immunotherapy market will experience considerable growth
over the next decade, increasing from USD 1.1 billion in 2012 to an estimated USD 35 billion in 2023, or a 29%
annualised growth. A different source predicts the cancer immunotherapy market to reach USB 13.3 billion in
202327.
27
The Cancer Immunotherapy Market Will Capture Major-Market Sales of Over $13 Billion In 2023 and Will be Dominated by Immune
Checkpoint Inhibitors. Decision Resource Group (June, 2015)
67
PCI Biotech Holding ASA - Prospectus
Figure - Global immuno-oncology market28
7.2.2
Therapeutic vaccines overview
The objective of a therapeutic vaccine is to treat an existing cancer using the body’s natural defences. Whereas
in a traditional anti-infectious vaccine, the main component of the vaccine is a disease antigen, in the case of a
cancer vaccine the main component can be a peptide or protein found on the surface of tumour cells. By
vaccinating with such tumour-specific antigens, the body’s natural defences can be trained to recognise and
destroy cancers cells. To date only one vaccine has been commercialised (Provenge/Dendreon) and this
emerging and promising field has not delivered to the expectations of physicians and patients alike. One of the
major reasons for this has been the insufficient activation of immune cells called T-cells by the vaccines. T-cells
recognise mutated proteins on the surface of tumours and this triggers the T-cell to attack and kill the cancer
cells. Great strides have been made recently in the understanding of the cellular machinery of immune cells
that makes it possible now to develop technologies to tackle this issue. PCI Biotech’s fimaVACC is such a
technology, which in preclinical models has shown to greatly increase the activation of T-cells. According to
Bioseeker Group, 233 companies plus partners are today developing 275 cancer vaccine drugs in 600
development projects in cancer across 161 different targets. The top five indications are breast, colorectal,
lung, prostate and melanoma.
7.2.3
Cancer immunotherapy and fimaVACC
As mentioned above, a fundamental challenge for most existing therapeutic vaccine approaches is to produce
a strong and relevant immune response (T-cell activation). A potent induction of Cytotoxic T-cells is considered
paramount for successful therapeutic vaccination.
fimaVACC is an endosomal escape technology that may realise the true benefit of innovative therapeutic
vaccines by modifying the intracellular machinery of immune cells in such a way that antigens are more
efficiently delivered to the pathways that provide MHC class I presentation and induction of antigen specific
cytotoxic T-cells. The innovative and well characterised mode of action of fimaVACC can be applied to a wide
range of cancer vaccine technologies and provide PCI Biotech with a strategic opportunity to enter the field of
cancer immunotherapy at a time where the understanding of cancer biology and the potential of modulating
the immune response to fight cancer is growing at a rapid pace.
7.2.4
Market potential
From a market perspective, fimaVACC can be developed with a wide array of vaccine technologies, from
peptide to protein antigens. In terms of type of vaccination, fimaVACC is also a versatile technology that can be
used in multiple settings including, intradermal, intranodal, and intratumoural. Preclinical research has shown
that it could also be developed in conjunction with ex vivo vaccination. Another very promising way forward in
the development of fimaVACC is to combine this vaccination technology with other cancer immunotherapy
28
Citi Research, 2013
68
PCI Biotech Holding ASA - Prospectus
modalities such as checkpoint inhibitors (CPIs). Cancer cells often utilise immune checkpoint molecules to
suppress and evade an immune attack. T-cells. CPIs block these molecules produced by cancer cells, or the
receptor on T-cells that respond to them. The result is to remove the blinders that prevented T-cells from
recognising the cells as cancerous and leading an immune assault on the cancer cells.
There is a strong scientific rationale for combining CPIs with the fimaVACC technology: fimaVACC increases the
number of CD8+ T-cells induced by cancer vaccines while the CPIs prevent the tumour from evading the
immune response. This potentially powerful combination could be summarised with a car analogy where the
immune system is the engine, the vaccine is the fuel, the CPIs release the breaks, and fimaVACC is the
turbocharger.
PCI Biotech’s strategy is to develop fimaVACC with either peptide or protein vaccines, and explore the potential
of combination with checkpoint inhibitors. Ultimately, it is expected that the growth of the fimaVACC market
will track the growth in the use of CPIs with vaccines. A total of 18 vaccines are currently in early clinical
development in combination with CPIs in various cancer indications29.
Figure - Number of clinical trials with combinations of vaccines and CPI’s in various cancers
From a technology perspective, fimaVACC’S components have several advantages, including:

Safety – fimaporfin has already been tested at high intravenous dose levels in clinical studies

Stability – fimaporfin can be autoclaved and is stable at room temperature, also in solution

Innovative and well characterised mode of action - fimaporfin provides T-cells-induction by MHC class
I antigen presentation in dendritic cells and macrophages

Cost effective manufacturing – simple and cost-effective synthesis of fimaporfin

Broad applicability – can be used in combination with peptide and protein antigens as well as
particulate antigen formulations; prophylactic and therapeutic vaccination; in vivo or ex vivo.

An innovative, inexpensive, and disposable light activation device has been patented specifically for
use with the fimaVACC application.
69
PCI Biotech Holding ASA - Prospectus
Given the recent understanding of cancer biology and the lessons learned from early cancer vaccine
development, the timing is ideal for PCI Biotech to rollout fimaVACC and participate in the growing cancer
immunotherapy market. It is anticipated that a significant number of the cancer vaccines in development
could use fimaVACC to boost their activation of T-cells and increase their efficacy.
Nucleic acid therapeutics
RNA-based therapeutic modalities, which includes both therapeutics and vaccines, is a new class of medicines
with great potential for the treatment of cancer, with 35% of all programmes being developed in oncology
indications. This new area of cancer research holds great promise as demonstrated by early-phase clinical trials
as well as significant investment by the drug development community, the level of M&A activity and market
research showing that DNA and RNA therapeutics are growing at 12% CAGR, and expected to reach $1.2 billion
by 202030.
Table - Characteristics of RNA therapeutics by type31
7.3.1
RNA-based therapeutics
RNAi works by silencing or turning off gene expression. There are two types of RNA that are central to RNAi
technology: small interfering RNA or siRNA and micro RNA, and both must be delivered into cells effectively to
generate the effect. siRNA triggers mRNA degradation, while micro RNA (miRNA) inhibits translation by acting
as a guide strand for the RNA-induced silencing complex (RISC) to its mRNA target. While siRNA silencing
requires an exact match to its target mRNA, miRNA can function through imperfect base-pairing32.
7.3.2
RNA-based vaccines
The direct vaccination with mRNA molecules that encode a target antigen induces an immune response after
uptake by antigen-presenting cells. mRNA vaccination can be pursued by both intradermal and intra-tumour
injection; in the latter case the tumour is used as a factory producing the therapeutic protein medicine that
will destroy it.
7.3.3
The need for a good delivery system
One of the main challenges of RNA therapeutics is the ability to be transported into target areas on a cellular
level. The success of therapeutic use of RNA therapeutics relies on the development of safe and efficacious
29
Internal analysis by PCI Biotech based on information from www.clinicaltrials.gov
RNA-Based Therapeutics and Vaccines. Genetic Bioengineering and Biotechnology News, September 2015
31 RNA-Based Therapeutics and Vaccines. Genetic Bioengineering and Biotechnology News, September 2015
32 RNA-Based Therapeutics and Vaccines. Genetic Bioengineering and Biotechnology News, September 2015
30
70
PCI Biotech Holding ASA - Prospectus
delivery systems that introduce RNA therapeutics into target cells. PCI Biotech’s fimaNAc drug delivery
technology has the potential to address this issue.
7.3.4
Market potential
Research on RNA therapeutics was first initiated in 2002-2005, and in that past decade RNAi-focused biotech
companies saw great financial volatility due to perceived difficulties as moving the field forward which was
mostly due to the difficulties of cellular delivery of the RNA molecules. Recently however, new technologies
have been introduced and new companies have emerged while at the same time a link has been established
between immuno-oncology and RNA therapeutics development in oncology, leading to an increase in
investment and deals in the field. Although, as of today there are still no approved therapies, technologies
aimed at improving the delivery of these molecules will play a critical role in the future success of this market.
fimaNAc is well positioned to capture a significant part of the RNA Therapeutics delivery market as
demonstrated by the partnering activities of PCI Biotech in this field. Research firm Allied Market Research
forecasts that RNA-based therapies will generate revenues amounting to USD 1.2bn by 2020, and that
oncology will become the largest segment of the RNA-based treatments33. PCI Biotech’s fimaNAc strategy is
two-pronged: collaborate with biotech or pharmaceutical companies having difficulties with their clinical stage
RNA-based product in a rescue-type scenario and develop long-term relationship with companies developing
early stage innovative RNA-based technology.
33
Market research firm: RNA-based drugs to exceed $1B in sales by 2020. Source: http://www.fiercedrugdelivery.com/story/marketresearch-firm-rna-based-drugs-exceed-1-billion-sales-2020/2014-09-11
71
PCI Biotech Holding ASA - Prospectus
8.
BOARD OF DIRECTORS, MANAGEMENT, EMPLOYEES AND CORPORATE GOVERNANCE
Board of Directors
8.1.1
Overview
In accordance with Norwegian law, the Board of Directors is responsible for the overall and strategic
management of the Company and for ensuring that the Company's operations are organised and controlled in
a satisfactory manner. The Articles of Association provide that the board of directors shall consist of minimum
three and maximum seven members.
The names, positions, current term of office and shareholding in the Company of the Directors as at the date
of this Prospectus are set out in the table below:
Name
Hans Peter Bøhn
Kjetil Taskén
Hilde Hermansen Steineger
Christina Herder
Lars Viksmoen
Position
Chairman
Director
Director
Director
Director
Current term of office
Since 2015
Since 2008
Since 2014
Since 2015
Since 2016
Shareholding
50,000
5,000
-
All members of the Board have been elected for a term of one year.
The Company's registered office, Ullernchausséen 64, 0379 Oslo, Norway, serves as the business address for
the members of the board of directors in relation to their directorships of the Company.
8.1.2
Brief biographies of the Directors
Hans Peter Bøhn (born 1955), Chairman
Dr. Bøhn is a Norwegian citizen with a medical degree. He started his pharmaceutical industry career as
medical adviser in Nycomed Imaging. Over the ensuing 12 years he gained broad experience from
management positions in the pharmaceutical industry within drug safety, international marketing and
operations and clinical research as well as gaining a post-graduate Diploma of Pharmaceutical Medicine. After
the years in the industry he joined Fondsfinans as a financial analyst covering the life science sector. From
2012 he has been manager of the non-profit “Svanhild og Arne Musts Fond for Medisinsk Forskning” as well as
serving as an independent adviser to among others the Research Council of Norway, the Norwegian Cancer
Society, Innovation Norway, Oslo Cancer Cluster as well as a number of biotech start-up companies. He has
been a Board member of PCI Biotech Holding ASA since 2015.
Current directorships and management position .....................................................................


CEO, Svanhild og Arne Musts Fond for Medisinsk
Forskning
Board member of SpinChip AS
Previous directorships and management positions
in the last five years ................................................................................................................
 Analyst covering the life science sector, Fondsfinans
AS
Kjetil Taskén (born 1965), Director
Dr. Taskén holds an M.D and a Ph.D degree from University of Oslo (UiO) and is authorised to practice as a
physician in Norway. Dr. Taskén is Professor of Medicine at UiO since 2001. He is also Director of the
Biotechnology Centre of Oslo, UiO, and of Centre for Molecular Medicine Norway, Nordic EMBL Partnership,
UiO. He was co-founder and Board member of Lauras AS, where he also was VP R&D for almost 10 years. Dr.
Taskén has previously served as Board member of Biomedical Innovation AS and siRNAsense AS. He has been a
Board member of PCI Biotech Holding ASA since 2008.
72
PCI Biotech Holding ASA - Prospectus
Current directorships and management position .....................................................................


Director of the Biotechnology Centre of Oslo, UiO
Director of the Centre for Molecular Medicine
Norway, Nordic EMBL Partnership, UiO

Chairman of Kjetil Tasken AS
Previous directorships and management positions
in the last five years ................................................................................................................
 Board member of Lauras Immuno AS
 Board member of ChemLex AS
 Board member of Lauras AS
 Board member of Bio-Medisinsk Innovasjon AS
 Board member of SiRNAsense AS
 Vice President R&D / CSO of Lauras AS
Hilde Hermansen Steineger (born 1966), Director
Dr. Steineger holds a PhD in Medical Biochemistry from the University of Oslo, Norway. She previously served
as Strategic Innovation Management Nutrition & Health in BASF, and previously served as Head of Innovation
Management of Pronova BioPharma AS/ BASF. Dr. Steineger has held positions as VP IR & Communications at
Pronova BioPharma, as Senior Associate with Neomed Management, and as equity analyst at Kreditkassen
(now part of Nordea Markets) based in Oslo and Copenhagen. She has also worked as an independent advisor
focusing on start-ups in Life Science/Health Care. Dr. Steineger is currently a Board member at Strongbridge
Biopharma plc and Nordic Nanovector ASA. She has been a Board member of PCI Biotech Holding ASA since
May 2014.
Current directorships and management position .....................................................................




CEO of Jecurion Therapeutics AS
Board member of Nordic Nanovector ASA
Board member of Strongbridge Biopharma plc,
US
CEO and Deputy board member of Maxfield AS
Previous directorships and management positions
in the last five years ................................................................................................................

Board member of Afiew AS

Board member of Weifa Holding AS

Board member of Weifa AS

Board member of Inven2 AS

Board member of Algeta ASA

Board member of Clavis Pharma ASA

Deputy head of Maxfield AS

Head of Strategic Innovation Management,
Nutrition & Health BASF, Germany

Head of Innovation Management, Pronova
NioPharma/BASF

Vice President Business Development, Pronova
BioPharma
Christina Herder (born 1961), Director
Dr. Herder is the CEO of Modus Therapeutics AB, a Swedish drug development company, since 2014. She has
over 20 years of experience from the life science industry, both from the areas of drug development as well as
business development. Previous positions include Sobi, where she built up the portfolio management function
and worked with Corporate Development. She holds a PhD from Royal Institute of Technology in Stockholm,
73
PCI Biotech Holding ASA - Prospectus
Sweden, and an MBA from Stockholm University. Dr. Herder has previously served as board member of
Akinion Pharmaceuticals AB. She has been a Board member of PCI Biotech Holding ASA since 2015.
Current directorships and management position .....................................................................



CEO Modus Therapeutics AB, Sweden
CEO Modus Therapeutics Holding AB
Deputy board member Herder Consulting
AB
Previous directorships and management positions
in the last five years ................................................................................................................
 Board member of Akinion Pharmaceuticals AB,
Sweden
 Director, Corporate development, Sobi AB, Sweden
Lars Viksmoen (born 1949), Director
Dr. Viksmoen is Norwegian citizen and medical doctor from University of Oslo, Norway. After 10 years as
surgeon he started his professional life in the pharma industry at the Norwegian subsidiary of Merck & Co. Inc.
in 1990. During the last 25 years he has gained a broad international experience through several international
management and executive roles within the pharma, biotech as well as medtech industry. His main
responsibilities and capabilities have been within commercialisation of innovation, i.e. managing and leading
commercial focused business unites and organisations. In addition he has over the last close to 10 years broad
experience leading listed companies. His last position has been as President and CEO of GN ReSound AS,
Denmark, the fourth largest hearing-aid manufacturer worldwide, listed in Denmark. Currently, he works part
time as special strategic advisor at GN Store Nord A/S.
Current directorships and management position .....................................................................
 Board member Veloxis A/S, Denmark
Previous directorships and management positions
in the last five years ................................................................................................................
 CEO, Biotech Pharmacon ASA
 CEO, GN ReSound AS, Denmark
8.1.3
Remuneration
The Board of Directors received the following in remuneration in 2015. Information extracted from the annual
report for the year ended 31 December 2015 (figures in NOK 1 000):
Board of Directors
Erling Øverland (Chairman of the Board, stepped down May 2016)
Kjetil Taskén
Theresa Comiskey Olsen (left in May 2015)
Kjell Göran Stenberg (left in May 2015)
Hilde Hermansen Steineger
Hans Peter Bøhn (joined May 2015)
Christina Herder (joined May 2015)
Lars Viksmoen (joined May 2016)
Sum
*Please see section 6.16 Related parties' transactions for further information.
74
Director's fee
235
143
143
143
143
807
Other
17*
17
Total
235
143
160
143
143
824
PCI Biotech Holding ASA - Prospectus
Management
8.2.1
Overview
The names of the members of Management as at the date of this Prospectus, and their respective positions
and shareholdings in the Company, are presented in the table below:
Name
Position
Shares
Options
Per Walday
Chief Executive Officer (CEO)
44 019
25 000
Ronny Skuggedal
Chief Financial Officer (CFO)
15 000
66 000
Anders Høgset
Chief Scientific Officer (CSO)
47 977
17 000
Kristin Eivindvik
Project Director, (PD)
13 235
24 500
Gaël L’Hévéder
Chief Business Development Officer (CBDO)
10 000
91 000
The Company's registered office, Ullernchausséen 64, 0379 Oslo, Norway, serves as the business address for
the members of Management.
8.2.2
Brief biographies of the members of Management
Per Walday, Chief Executive Officer (born 1960)
Dr. Walday joined PCI Biotech Holding as CEO in the second quarter of 2008. Dr. Walday formerly had the
position as Global Head of Project Management at GE Healthcare with responsibility for project management
of all pharmaceutical product development. He holds a Ph. D. in physiology from the University of Oslo and has
had former manager positions in Nycomed Imaging/Amersham Health developing mainstream diagnostic
drugs found in the market today. Dr. Walday has a broad international network and is experienced with
business development and approvals of new products in the international scene of the pharmaceutical
industry.
Current directorships and management position .....................................................................

None other than PCI Biotech AS
Previous directorships and management positions
in the last five years ................................................................................................................

None
Description of options currently held by Per Walday
Expiry date
Exercise price
2017 - Q3
27.38
2020 - Q3
5.21
Total number of options
No of options
16 000
9 000
25 000
Allocation date
August 2012
November 2015
As measured from the date of issuance, 1/3 of the options can be exercised after 1 year (none earlier), an
additional 1/3 of the options can be exercised after 2 years, and the last 1/3 options can be exercised after 3
years.
Ronny Skuggedal, Chief Financial Officer (born 1976)
Mr. Skuggedal joined PCI Biotech in October 2013 as CFO with responsibility for finance, accounting and
investor relations, and with a key role in business development. He holds a Master of Science in Economics and
Business Administration from the Norwegian School of Economics (NHH) and a Master in Professional
Accountancy from BI Norwegian Business School. He is a State Authorised Public Accountant in Norway. Before
joining PCI Biotech, he was a Director at PwC within Assurance and he has twelve years of experience from
auditing and advisory services.
75
PCI Biotech Holding ASA - Prospectus
Current directorships and management position .....................................................................

None other than PCI Biotech AS
Previous directorships and management positions
in the last five years ................................................................................................................

None
Description of options currently held by Ronny Skuggedal
Expiry date
Exercise price
2018 - Q3
13.78
2020 – Q3
12.53
2020 – Q3
5.21
Total number of options
No of options
40 000
20 000
6 000
66 000
Allocation date
October 2013
April 2015
November 2015
As measured from the date of issuance, 1/3 of the options can be exercised after 1 year (none earlier), an
additional 1/3 of the options can be exercised after 2 years, and the last 1/3 options can be exercised after 3
years.
Anders Høgset, Chief Scientific Officer (born 1954)
Anders Høgset began in PCI Biotech in April 2001 as CSO. From 2004 he also was deputy CEO until the second
quarter of 2008, when he entered the CSO position again. He holds a Ph. D. in biochemistry from the
University of Oslo. Before working at PCI Biotech Dr. Høgset spent four years as a Senior Scientist at
Radiumhospitalet developing the PCI technology. From 1989 to 1997 Dr. Høgset was working as a Senior
Scientist and Project Manager at Nycomed (now GE Healthcare).
Current directorships and management position .....................................................................

None other than PCI Biotech AS
Previous directorships and management positions
in the last five years ................................................................................................................

None
Description of options currently held by Anders Høgset
Expiry date
Exercise price
2017 – Q3
27.38
2020 – Q3
5.21
Total number of options
No of options
11 000
6 000
17 000
Allocation date
August 2012
November 2015
Gaël L’Hévéder, Chief Business Development Officer (born 1968)
Mr. L’Hévéder joined PCI Biotech as CBDO in April 2013, bringing a combination of business development,
strategy, and business intelligence skills as well as an extensive global network. He holds a Master of Science in
Bioorganic Chemistry from Université Louis Pasteur, Strasbourg, France. Mr. L’Hévéder has more than 20 years
of international pharmaceutical and biotech experience acquired in the US and Europe. Following his MSc, Mr.
L’Hévéder joined the research team of Pharmacopeia, a biotech start-up developing a unique combinatorial
chemistry technology and then Sanofi-Aventis where he worked in various functions including research,
regulatory affairs and business intelligence. Subsequently, he joined Baxter in Switzerland to set-up the
business support function for the EU office and then Roche as Director of Partnering where he participated in
multiple clinical-stage licensing deals.
Current directorships and management position .....................................................................

None other than PCI Biotech AS
Previous directorships and management positions
in the last five years ................................................................................................................

Ciliatech Therapeutics AG
76
PCI Biotech Holding ASA - Prospectus
Description of options currently held by Gaël L’Hévéder
Expiry date
Exercise price
2018 - Q3
14.52
2020 – Q3
12.53
2020 – Q3
5.21
Total number of options
No of options
70 000
15 000
6 000
91 000
Allocation date
May 2013
April 2015
November 2015
Kristin Eivindvik, Project Director (born 1961)
Kristin Eivindvik joined PCI Biotech in March 2009 as Project Director. She has a Master of Science in Pharmacy
from the University of Oslo. Ms. Eivindvik formerly held the position as VP Business Operations, in Alertis
Medical AS, a Norwegian medical device company. She has extensive development- and manufacturing
experience from scientific-, management- and global project director positions within GE Healthcare (formerly
Nycomed Imaging/Amersham Health).
Current directorships and management position .....................................................................

None other than PCI Biotech AS
Previous directorships and management positions
in the last five years ................................................................................................................

None
Description of options currently held by Kristin Eivindvik
Expiry date
Exercise price
2017 – Q3
27.38
2020 – Q3
12.53
2020 – Q3
5.21
Total number of options
8.2.3
No of options
11 000
6 000
7 500
24 500
Allocation date
August 2012
April 2015
November 2015
Remuneration and benefits
The Management received the following in remuneration and benefits in 2015. Figures extracted from the
annual report for the year ended 31 December 2015 (figures in NOK 1 000):
Management
Per Walday, CEO
Ronny Skuggedal, CFO
Anders Høgset, CSO
Gaël L’Hévéder, CBDO
Kristin Eivindvik
Sum
Salary
1 545
1 006
959
1 477
939
5 925
Bonus
Other Benefits
93
65
83
50
22
313
Pension cost
404*
18
308*
4
306*
1 042
88
71
76
102
82
419
Total
2 129
1 160
1 426
1 633
1 349
7 697
*Including realisation of employee scheme options in 2015
8.2.4
Bonus program
The Management are entitled to receive bonus payments dependent on the Company's financial results,
progress in research and development and accomplishment of objectives or goals. The Chief Executive Officer
is entitled to a bonus payment of up to 25% of the yearly ordinary salary. The other member of the
Management is entitled to a bonus payment of up to 15% of the yearly ordinary salary.
Share option plan
The company has an employee option incentive program. The options are annulled immediately upon
termination of employment. The options are subject to restrictions on exercise. As measured from the date of
issuance, 1/3 of the options can be exercised after 1 year (none earlier), an additional 1/3 of the options can
77
PCI Biotech Holding ASA - Prospectus
be exercised after 2 years, and the last 1/3 options can be exercised after 3 years. No members of the board
have been granted any options. The current employee options outstanding are the following:
Current employee options (not including options held by the Management)
Allocation date
Expiry date
Exercise price
August 2012
2017 - Q3
27.38
May 2013
2018 - Q3
14.52
April 2015
2020 - Q3
12.53
November 2015
2020 - Q3
5.21
Total number of employee options (not incl. the Management)
No of options
48 500
15 000
32 500
75 500
171 500
Benefits upon termination
No employee, including any member of Management, has entered into employment agreements which
provide for any special benefits upon termination of employment, except for the Chief Executive Officer, Per
Walday. Mr. Walday's employment agreement includes a notice period of 6 months, and he is entitled to
receive salary for an additional 6 months if he is forcibly discharged from his position.
No member of the Board has or will have service contracts with the Company or any of its subsidiaries
providing for benefits upon termination of employment.
Pension and retirement benefits
For the year ended 31 December 2015, the costs of pensions for members of Management were NOK 0.4
million. The Company has no pension or retirement benefits for its Directors.
For more information regarding pension and retirement benefits, see note 5 and 19 to the annual financial
statements for the year ended 31 December 2015, incorporated by reference hereto as the Company's annual
accounts.
Loans and guarantees
Other than this, the Company has not granted any loans, guarantees or other commitments to any of its
Directors or to any member of Management.
Nomination committee
Section 6 of the Company's Articles of Association provides for a nomination committee composed of
minimum two members who are elected by the general meeting. The nomination committee is responsible for
nominating the members of the board of directors. The nomination committee of the Company comprises the
following members, each having been elected for a term expiring at the ordinary general meeting of the
Company in 2017: Kjetil Hestdal (Chairman), Erik Must and Anders Tuv.
Audit committee and remuneration committee
The Board of Directors constitutes both the audit committee and the remuneration committee. The primary
purpose of the remuneration committee is to facilitate the decision making of the Board of Directors in
matters relating to the remuneration of the executive management of the Group, reviewing recruitment
policies, career planning and management development plans, and prepare matters relating to other material
employment issues in respect of the executive management. The primary purposes of the audit committee
are: (i) to facilitate the decision making of the Board of Directors in discharging its duties relating to the
safeguarding of assets; (ii) the operation of adequate system and internal controls; control processes and the
preparation of accurate financial reporting and statements in compliance with applicable legal requirements,
corporate governance and accounting standards; and (iii)to provide support on handling the risk profile and
risk management of the Company.
78
PCI Biotech Holding ASA - Prospectus
Conflicts of Interests, etc.
None of the directors or members of management have during the last five years preceding the date of this
Prospectus:

any convictions in relation to indictable offences or convictions in relation to fraudulent offences;

received any official public incrimination and/or sanctions by any statutory or regulatory authorities
(including designated professional bodies) or ever been disqualified by a court from acting as a
member of the administrative, management or supervisory bodies of a company or from acting in the
management or conduct of the affairs of any company; or

been declared bankrupt or been associated with any bankruptcy, receivership or liquidation in his/her
capacity as a founder, director or senior manager of a company or partner of a limited partnership.
There are no potential conflicts of interest between the private interests or other duties of any of the
members of the management or the board of directors and their respective duties towards the Company.
There are no family relationships between members of the Board and members of the Management.
Employees
At the date of this Prospectus, the Company had a total of 11 employees. The average number of full-time
employees in 2015, 2014, 2013 and 2012 was 11 employees, 12 employees, 11 employees and 10 employees,
respectively.
Corporate governance
The Company has adopted and implemented a corporate governance regime which complies with the
Norwegian Code of Practice for Corporate Governance dated 30 October 2014 (the "Corporate Governance
Code"), with the exceptions stated in the annual report for the year ended 31 December 2015, see items 1.2,6,
9 and 11.
Dividend policy
PCI Biotech has paid no dividends to date. The Company's policy, being a growth company, is not to pay
dividends for the time being.
Scientific Advisory Committee
The Company established in 2015 a scientific advisory committee, which has unique competence and
experience in oncology, immunotherapy, clinical development and the PCI technology,. The clinical advisory
board consists of following members:




Professor Kristian Berg, Inventor of the PCI technology
Professor Jan Vermorken, Emeritus Professor of Oncology.
Professor Andrew Hughes, Strategy director of the experimental cancer medicine team at The Christie, UK
Professor Christoph Huber, Emeritus Professor of Medicine.
The responsibilities of the members of the scientific advisory committee include the critical review of the
Company’s clinical plans and results and advising the Management and the Board of Directors.
79
PCI Biotech Holding ASA - Prospectus
9.
CAPITALISATION AND INDEBTEDNESS
Capitalisation
The tables below should be read in conjunction with the information included elsewhere in this Prospectus,
including Section 10 "Financial information" and the annual financial statements and interim financial
statements incorporated hereto by reference, please see Section 15.3.
The following table sets forth information about the Group's unaudited consolidated capitalisation as at 30
September 2016. There has been no material change since 30 September 2016.
Below is an overview of the Group's unaudited capitalisation and liabilities as of 30 September 2016.
(NOK thousands)
30.09.2016
Total Current debt .............................................................................................................................................
10,865
Guaranteed ..........................................................................................................................................................
0.0
Secured ...............................................................................................................................................................
0.0
Unguaranteed/unsecured ...................................................................................................................................
10,865
Total Non-Current debt (excluding current portion of long-term debt) .....................................................
0.0
Guaranteed ..........................................................................................................................................................
0.0
Secured ...............................................................................................................................................................
0.0
Unguaranteed/unsecured ...................................................................................................................................
0.0
Shareholder's equity .........................................................................................................................................
19.615
Share capital.........................................................................
44,701
Legal reserve ........................................................................
120,678
Other reserves
(145,764)
Total ....................................................................................................................................................................
30,480
Indebtedness
The following table sets forth information about the Group's unaudited net indebtedness as at 30 September
2016.
Below is an overview of the Group's unaudited indebtedness as of 30 September 2016. There has been no
material change in the Group’s unaudited net indebtedness since 30 September 2016.
(NOK thousands)
30.09.2016
A. Cash ................................................................................................................................................................
20,663
B. Cash equivalents ............................................................................................................................................
0.0
C. Trading securities ...........................................................................................................................................
0.0
D. Liquidity (A) + (B) + (C) ................................................................................................................................
20,663
E. Current financial receivable ........................................................................................................................
9,811
F. Current bank debt ...........................................................................................................................................
0.0
G. Current portion of non-current debt ...............................................................................................................
0.0
H. Other current financial debt ............................................................................................................................
10,865
I. Current financial debt (F) + (G) + (H) ..............................................................................................................
10,865
J. Net current financial indebtedness (I) – (E) – (D)......................................................................................
(19,609)
K. Non-current bank loans ..................................................................................................................................
0.0
L. Bonds issued ...................................................................................................................................................
0.0
80
PCI Biotech Holding ASA - Prospectus
M. Other non-current loans .................................................................................................................................
0.0
N. Non-current financial indebtedness (K) + (L) + (M) ................................................................................
0.0
O. Net financial indebtedness (J) + (N) ..........................................................................................................
(19,609)
Working capital statement
The Company is of the opinion that the working capital available to the Group, including the NOK 70 million
fully underwritten syndicate, is sufficient for its requirements, and for the next 12 months following the date
of this Prospectus. The Company emphasises that the net proceeds from the Rights Issue is not sufficient to
fund completion of the planned phase II part of the bile duct cancer study. The Company’s main future
funding sources are revenue related to any partnering agreements, governmental grants and equity issues.
The capital market is used as a source of liquidity when this is appropriate and conditions in this market are
competitive. The Company also assesses other funding sources.
81
PCI Biotech Holding ASA - Prospectus
10.
FINANCIAL INFORMATION
Introduction
The tables set out in this Section 10 present selected financial information derived from the Group's audited
consolidated annual financial statements for the years ended 31 December 2015 and 2014 (incorporated
hereto by reference, please see Section 15.3) and the unaudited condensed consolidated interim financial
statements for the nine month period ended 30 September 2016 (incorporated hereto by reference, please
see Section 15.3.). The annual financial statements and the interim financial statements have been prepared in
accordance with IFRS, as adopted by the EU.
The Company's auditor is Ernst & Young AS, Dronning Eufemias gate 6, 0191 Oslo, Norway. Ernst & Young AS
and its auditors are members of the Norwegian Institute of Public Accountants (Den Norske Revisorforening).
Ernst & Young AS has been the Company's auditor since 2007. The annual financial statements have been
audited by Ernst & Young AS, and the auditor's reports are included together with the annual financial
statements in Appendix B. Ernst & Young AS has not audited, reviewed or produced any report on any other
information provided in this Prospectus.
The amounts from the financial information are presented in NOK, rounded to the nearest thousand, unless
otherwise stated. As a result of rounding adjustments, the figures in one or more rows or columns included in
the financial information may not add up to the total of that row or column.
The selected financial information presented herein should be read in connection with the annual financial
statements and interim financial statements and are incorporated hereto by reference, please see Section
15.3.
Summary of accounting principles
For information regarding accounting policies and the use of estimates and judgments, please refer to the
accounting principles in the annual financial statements for the year ended 31 December 2015, incorporated
hereto by reference, please see Section 15.3.
Condensed consolidated income statement
The Group's audited consolidated income statement for the years ended 31 December 2015 and 2014 and
from the unaudited condensed consolidated interim income statement for the three and nine month periods
ended 30 September in 2016 and 2015 are incorporated by reference in section 15.3.
Condensed consolidated income statement (2015 and 2014 figures are based on the audited annual
accounts, interim 2015 and 2016 figures are based on unaudited interim accounts)
(NOK thousands)
Three
Three months
Full year
2015
months
Nine months
Nine months
ended 30
ended 30
ended 30
ended 30
September
September
Full year September 2016
September 2015
2016
2015
(unaudited)
(unaudited)
(unaudited)
2014
(unaudited)
Other income ...............................................................................
10,467
7,297
7,249
7,144
2 333
2 415
38,844
39,341
Research and development..........................................................
30,847
28,761
11 014
11 049
General and administrative ...........................................................
4,252
4,428
2,526
2,473
853
782
Operating costs ...........................................................................
43,096
43,769
33,373
31,234
11 867
11 831
(32,629)
(36,472)
Operating results ........................................................................
(26,124)
(24,090)
(9 535)
(9 416)
867
812
Financial income ...........................................................................
546
674
259
219
Financial costs ..............................................................................
160
180
4
127
-
99
Net financial result ......................................................................
707
632
542
546
259
120
82
PCI Biotech Holding ASA - Prospectus
Ordinary profit before taxes ......................................................
(31,922)
(35,840)
(25,582)
(23,544)
(9 276)
(9 296)
Tax on ordinary result ...................................................................
-
-
-
-
-
Net profit/(loss)............................................................................
(31,922)
(35,840)
(25,582)
(23,544)
(9 276)
(9 296)
Condensed consolidated statement of comprehensive income
The table below sets out selected data from the Group's audited consolidated statement of comprehensive
income for the years ended 31 December 2015 and 2014 and from the unaudited consolidated interim
statement of comprehensive income for the three and nine month periods ended 30 September in 2016 and
2015.
(NOK thousands)
Nine
Nine Three months Three months
months ended
months ended
ended 30
ended 30
30 September
30 September
September
September
Full year
Full year
2015
2016
2015
2016
2014
2015
(unaudited)
(unaudited)
(unaudited)
(unaudited)
Net profit/(loss)............................................................................
(35,840)
(31,922)
(23,544)
(25,582)
(9,296)
(9,276)
Other comprehensive income.......................................................
-
-
-
-
-
Total other comprehensive
income, net of tax ........................................................................
-
-
-
-
-
Total comprehensive income, net
of tax ............................................................................................
(35,840)
(31,922)
(23,544)
(25,582)
(9,296)
(9,276)
(23,544)
(25,582)
(9,296)
(9,276)
Total comprehensive income for
the period ...................................................................................
(35,840)
(31,922)
Condensed consolidated statement of financial position
The table below sets out selected data from the Group's audited consolidated statement of financial position
as at 31 December 2015 and 2014 and from the unaudited condensed consolidated interim statement of
financial position for the nine month period ended 30 September in 2016.
(NOK thousands)
31.12.2014
30.09 2016
30.09.2015
31.12.2015
(unaudited)
(unaudited)
11
Fixed assets ................................................................................
14
10
6
Total fixed and intangible assets ................................................
14
10
6
11
Short term receivables ................................................................
4,614
7,139
9,811
7,643
Cash & cash equivalents ............................................................
15,754
49,249
20,663
53,897
Total current assets .....................................................................
20,368
56,389
30,474
61,540
Total assets ................................................................................
20,382
56,399
30,480
61,551
Paid in capital ..............................................................................
99,911
165,379
165,379
165,379
Other reserves ............................................................................. (90,796)
(121,094)
(145,764)
(113,040)
Total equity ................................................................................
9,114
44,284
19,615
52,339
Trade debtors ..............................................................................
2,586
3,371
3,991
2,517
Other short term debt ..................................................................
8,681
8,744
6,874
6,695
Total liabilities............................................................................
11,269
12,115
10,865
9,212
Total equity and liabilities
20,382
56,399
30,480
61,551
Condensed consolidated statement of cash flows
The table below sets out selected data from the Group's audited consolidated statements of cash flows for the
years ended 31 December 2015 and 2014 and from the unaudited condensed consolidated interim statement
of cash flows for the three and nine month periods ended 30 September in 2016 and 2015.
83
PCI Biotech Holding ASA - Prospectus
(NOK thousands)
Three
Three
Nine months
Nine months
months
months
ended 30
ended 30
ended 30
ended 30
September
September
September
September
Full year
Full year
2015
2016
2015
2016
2014
2015
(unaudited)
(unaudited)
(unaudited)
(unaudited)
(23,544)
(25,582)
(9,296)
(9,276)
offs .....................................................................................................
4
4
3
3
1
1
Share options ....................................................................................
1,558
1,624
1,301
912
308
203
Net financials .....................................................................................
(812)
(867)
(546)
(542)
(120)
(259)
Changes in working capital ...............................................................
3,417
(1,680)
(5,086)
(3,920)
(431)
(1,293)
(27,872)
(29,128)
(9,538)
(10,624)
546
542
120
259
(27,326)
(28,586)
(9,419)
(10,365)
-
-
Cash flow from operating activities
Ordinary profit before taxes ..............................................................
(35,840)
(31,922)
Depreciation, amortisation and write
Cash flow from operating activities
(31,674)
(32,841)
Net financials received ......................................................................
812
867
Net cash flow from operating
activities
(30,862)
(31,974)
65,469
Net proceeds from share issues .......................................................
65,469
Net cash flow from financing
activities
-
65,469
65,469
-
-
-
(30,862)
33,495
38,143
(28,586)
(9,419)
(10,365)
15,754
49,249
63,316
31,028
53,897
20,663
53,897
20,663
Net change in cash during the
period
Cash and cash equivalents at the
beginning of the period......................................................................
46,595
15,754
Cash and cash equivalents at the
end of the period
15,754
49,249
Condensed consolidated statement of changes in equity
The table below sets out selected data from the Group's audited consolidated statements of changes in equity
for the years ended 31 December 2015 and 2014 and for the unaudited nine month period ended 30
September 2016.
(NOK thousands)
Share
Total
Equity as of 31.12.2013
Other
capital
Share premium paid in capital
losses
23,179
76,732
0
Share option scheme ...........................................................
1,558
-
-
1,558
-
Comprehensive income for the period ................................
(35,840)
-
-
-
(35,840)
Allocation
-
-
-
(1,558)
1,558
9,114
Equity as of 31.12.2014
43,396
Uncovered
(56,515)
23,179
76,732
0
(90,796)
Capital increase ....................................................................
65,468
21,522
43,946
-
-
Share option scheme ...........................................................
1,624
-
-
1,624
-
Comprehensive income for the period ................................
(31,922)
-
-
-
(31,922)
Allocation ..............................................................................
-
-
-
(1,624)
1,624
44,701
120,678
-
(121,094)
Share option scheme ...........................................................
912
-
-
912
-
Comprehensive income in the period ..................................
(25,582)
-
-
-
(25,582)
Equity as of 31.12.2015
44,284
84
PCI Biotech Holding ASA - Prospectus
Equity as of 30.09.2016 (unaudited)
19,615
44,701
120,678
912
(146,676)
Research and development (R&D) costs
10.8.1 Historical R&D costs
The Company is currently working with activities for all of its three main programmes; fimaCHEM, fimaVACC and
fimaNAC. Historically the R&D costs are primarily related to the clinical development of fimaporfin (Amphinex)
in combination with cancer drugs for localised cancer treatment (fimaCHEM), and pre-clinical work within the
field of vaccines (fimaVACC), based on the Company's patented PCI technology. More specifically, the Company
is currently investing in a fimaCHEM clinical phase I/II study in bile duct cancer, which constitutes 100% of the
costs of Clinical studies in 2014-2015, and approximately 60% in 2016. The remaining 40% in 2016 relates to
the initiation of a fimaVACC phase I study. Within the field of vaccines the Company has been investing in a preclinical program with the aim to support translation of the fimaVACC programme into man and strengthen
products and intellectual property rights. The historical annual costs of Pre-clinical studies in 2014-2016 relates
primarily to fimaVACC (80-90%), with significantly less investments in fimaNAC (10-15%) and fimaCHEM (0-10%).
The activities within Chemistry, Manufactory and Control (CMC) and equipment costs primarily relate to the CE
marked laser and the product candidate fimaporfin (Amphinex). The R&D activities are financed by public
grants and equity. Patent costs in 2014, 2015 and 2016 relates mainly to the establishment of a new patent
portfolio within the field of vaccines (fimaVACC) and maintenance and examination of the general patent
portfolio in relevant territories. The table below states R&D costs for 2014 and 2015 that are audited figures.
Figures for the nine month period ended 30.09.2016 and for the period 01.10.2016 – 30.11.2016 are
unaudited.
01.01 - 30.09 2016
01.10.2016 – 30.11.2016
2015
(unaudited)
(unaudited)*
R&D - Clinical studies ...................................................................
19,267
17,808
16,648
4,733
10,745
R&D - Pre-clinical studies.............................................................
11,876
7,768
533
R&D - CMC and equipment .........................................................
5,396
4,941
3,422
650
R&D - Patents ...............................................................................
3,933
…. 4,220
3,009
329
-
-
-
38,844
30,847
6,245
(NOK thousands)
2014
R&D - Other costs.........................................................................
Total
39,341
*Based on unaudited, preliminary and estimated figures for 01.10.2016-30.11.2016.
There have been no significant investments after 30 September 2016 and up to the date of this Prospectus.
10.8.2 Future R&D costs
The Company is planning to allocate the current resources available and the net proceeds from the Rights
Issue primarily to R&D activities. More specifically, the Company will use the net proceeds from the Rights
Issue to reach regulatory clarity on requirements for marketing authorisation of fimaCHEM, complete the
fimaVACC Phase I study. For the fimaNAC programme R&D activities are limited to retaining intellectual
property rights and limited costs related to the research collaborations.
The Company is dependent on proceeds from the Rights Issue to pursue the planned allocation of resources
for R&D activities, please see section 6.7 Goals for further information regarding the planned allocation, hence
use of proceeds from the Rights Issue. The Company emphasises that the net proceeds from the Rights Issue is
not sufficient to fund the phase II part of the bile duct cancer study, please see section 6.12 Indicative key
milestones. The Company is dependent on partnering or additional funding, before potentially moving into
phase II parts of the current bile duct cancer study. A major part of the R&D activities are performed abroad
and the related costs are sensitive to potential changes in the foreign currency exchange rates. The Company
has not as of the date of this Prospectus committed to any major future investments.
Capital resources
The Company's primary source of liquidity has historically been cash flow from public grants and from financial
activities, i.e. net proceeds from share issues. As of 31 December 2015, the Company had cash and cash
85
PCI Biotech Holding ASA - Prospectus
equivalents of NOK 49.2 million and per 30 September 2016 NOK 20.7 million. As of the date of this
Prospectus, the Company had cash and cash equivalents of approximately NOK 16.8 million.
Receivables mainly consist of accrued, but not received public grants and tax incentive scheme (SkatteFUNN).
Receivable balances are monitored on an ongoing basis with the result that the Company's exposure to bad
debts is not significant. The Company has transactional currency exposure arising from purchases in currencies
other than the functional currency (NOK). The Company has not implemented any hedging strategy to reduce
currency risk.
The Company has no interest bearing debt.
10.9.1 Cash flow
The following presents a discussion and analysis of the Company's cash flow for the years ended 31 December
2014 and 2015, and the three and nine month periods ending 30 September 2016, (with comparison to
corresponding interim periods in 2015). The following analysis should be read in connection with, and is
qualified in its entirety by reference to, the full year financial statements and the interim financial statements
incorporated into this prospectus by reference.
The Company’s cash flow from operating activities is mainly impacted by the level of R&D activities in the
period.
The Company had a cash flow from operating activities in 2015 of NOK -32.8 million, compared to NOK -31.7
million in 2014. Net cash flow from operating activities for the three month period ended 30 September 2016
was NOK -10.4 million, compared to NOK -9.4 million for the corresponding period of 2015. For the nine month
period ended 30 September 2016 net cash flow from operating activities was NOK -28.6 million, compared to
NOK -27.3 million for the corresponding period of 2015. Net change in cash and cash equivalents in 2015 was
NOK 33.5 million, compared to NOK -30.9 million in 2014. The positive net change in cash and cash equivalents
in 2015 was impacted by net proceeds from a rights issue of NOK 65.5 million completed in February 2015.
Cash per 31.12.2015 were NOK 49.2 million.
In the three months period ended 30 September 2016 the Company had a net change in cash and cash
equivalents of NOK -10.4 million, compared to NOK -9.4 million in the corresponding period for 2015. In the
nine months period ended 30 September 2016 the Company had a net change in cash and cash equivalents of
NOK -28.6 million, compared to NOK 38.1 in the corresponding period of 2015. The figures for 2015 are
impacted by net proceeds of NOK 65.5 million from a share issue completed in February 2015. Cash and cash
equivalents per 30 September 2016 were NOK 20.7 million, compared to NOK 53.9 million per 30 September
2015.
10.9.2 Restrictions on the use of capital resources
There are no restrictions on the Company's use of its capital resources that have materially affected, or could
materially affect, directly or indirectly, the Company’s operations.
Significant changes
There have been no significant changes in the financial or trading position of the Group since 31 December
2015. There is no information of any known trends, uncertainties, demands, commitments or events that are
reasonably likely to have a material effect on the issuer's prospects for the current financial year.
86
PCI Biotech Holding ASA - Prospectus
11.
SHARES AND SHARE CAPITAL
The following is a summary of certain corporate information and material information relating to the Shares
and share capital of the Company and certain other shareholder matters, including summaries of certain
provisions of the Company's Articles of Association. The summary does not purport to be complete and is
qualified in its entirety by the Company's Articles of Association.
Current share capital
At the date of this Prospectus, the Company's share capital is NOK 44,701,170 consisting of 14,900,390
ordinary shares with a par value of NOK 3 each. All the existing Shares are validly issued in accordance with
Norwegian law and fully paid. The Shares are electronically registered in the VPS with ISIN NO 0010405640.
The Company’s VPS registrar is Nordea Bank Norge ASA, Issuer Services, P.O. box 1166 Sentrum, NO-0107
Oslo, Norway.
Share capital history
The table below summarises the development in the Company's share capital for periods covered by the
historical financial information incorporated hereto by reference, please see Section 15.3 and up to the date of
this Prospectus.
Date of
registration
Type of change
Change in issued
share capital
(NOK)
Subscription price
per Share
(NOK)
Par value per
Share
(NOK)
No. of issued
Shares after
change
Total issued
share capital
after change
(NOK)
01.01.2012
Start of period
-
-
3
7,666,390
22,999,170
29.07.2013
Capital increase
180,000
6.47
3
7,726,390
23,179,170
11.02.2015
Capital increase
21,000,000
10.00
3
14,726,390
44,179,170
28.04.2015
Capital increase
522,000
4.78
3
14,900,390
44,701,170
End of period
-
-
3
14,900,390
44,701,170
Admission to trading
The Shares currently issued are listed on Oslo Axess. The Company has not applied for admission to trading of
the Shares on any other stock exchange or regulated market.
Shareholders
As at 13 December 2016, the Company has the following ten largest shareholders, holding in aggregate 43.4%
of the issued and outstanding Shares:
Name
1
2
3
4
5
6
7
8
9
10
FONDSAVANSE AS
RADIUMHOSPITALETS FORSKNINGSSTIFTELSE
MP PENSJON PK
VICAMA AS
PHOTOCURE ASA
MYNA AS
GRESSLIEN, ODD ROAR
NORDNETT LIVSFORSIKRING
SYVERTSEN, SVEIN ERIK
LGJ INVEST AS
Number of Shares
Percentage (%)
1,500,000
1,159,853
916,531
743,288
563,179
453,000
320,000
300,242
258,050
250,487
10.1
7.8
6.2
4.9
3.8
3.0
2.2
2.0
1.7
1.7
There are no differences in voting rights between the shareholders. Each Share carries the right to one vote at
the general meeting of shareholders.
Shareholders owning 5% or more of the Shares have an interest in the Company's share capital which is
notifiable pursuant to the Norwegian Securities Trading Act. The table above shows the ownership percentage
87
PCI Biotech Holding ASA - Prospectus
held by such notifiable shareholders. See Section 12.10 "Disclosure obligations" for a description of the
disclosure obligations under the Norwegian Securities Trading Act.
To the best of the Company’s knowledge and belief, no shareholder, or group of shareholders, control the
Company, directly or indirectly. The Company is not aware of any arrangements the operation of which may at
a subsequent date result in a change of control of the Company.
Board of directors authorisations
At the annual general meeting held 19th May 2016 the board of directors was authorised to increase the share
capital by issuance of shares in connection with the Company's incentive scheme for employees by up to
NOK 2,235,000 by issuing 745,000 numbers of shares at par value of NOK 3. The authorisation may only be
used to issue shares against cash contribution to employees who are granted options under the Company's
incentive scheme. The authorisation is valid until the annual general meeting 2017, however no later than 30th
June 2017 and may be used for one or more capital increases until the maximum amount of NOK 2,235,000 is
reached.
Treasury shares
Neither the Company nor its subsidiary holds any Shares at the date of this Prospectus.
Shareholder rights
Norwegian law permits a Norwegian public limited liability company to issue different types of shares (e.g.
several classes of shares). In such case, a company's articles of association must specify the different rights,
preferences and privileges of the classes of shares and the total par value of each class of shares. The
Company's Articles of Association provide for a single class of shares with equal rights.
The Articles of Association
11.8.1 The Articles of Association
The Company's Articles of Association as at the date of this Prospectus are incorporated hereto by reference,
please see Section 15.3. The following is a summary of certain provisions of the Articles of Association.
Objective of the Company
Pursuant to article 3 of the Company's Articles of Association, the Company's objective is (non-official office
translation):
"The company's business activities shall include cancer treatment and drug delivery based on the PCI
technology and other related activities, including participation in other companies with similar activities
through equity, loan or by issue of guarantees"
Registered office
The Company's registered office is in Oslo municipality.
Share capital and par value
The Company's current share capital is NOK 44,701,170 divided into 14,900,390 Shares, each with a par value
of NOK 3.
Board of Directors
The Board of Directors shall consist of minimum three and maximum seven members as designated by the
general meeting.
Restrictions on transfer of Shares
The Articles of Association do not provide for any right of first refusal for the Company's shareholders or any
other restrictions on the transfer of Shares. Share transfers are not subject to approval by the Board of
Directors.
88
PCI Biotech Holding ASA - Prospectus
General meetings
Documents relating to matters to be treated on the general meeting can be made available on the Company's
website. This includes documents that pursuant to law shall be included in or appended to the notice of the
general meeting. If documents are made available this way, requirements by law of sending to shareholders
does not apply. Shareholders may require to receive the documents to be treated on the general meeting.
Nomination committee
The Company shall have a nomination committee consisting of minimum two members to be elected by the
general meeting. The nomination committee shall prepare the election of members to the Board of Directors.
Please see Section 8.7 "Nomination committee".
The Articles of Association of the Company does not contain any provisions stricter than is required by law in
relation to changing the capital of holders of the Shares.
89
PCI Biotech Holding ASA - Prospectus
12.
CERTAIN ASPECTS OF NORWEGIAN COMPANY AND SECURITIES LAW
Introduction
This section includes certain aspects of Norwegian legislation relating to shareholding in a Norwegian public
limited liability company, with its shares listed on Oslo Børs, but is however not a full or complete description
of the matters described herein. The following summary does not purport to be a comprehensive description
of all the legal considerations that may be relevant to a decision to purchase, own or dispose of Shares.
The Company is a Norwegian public limited company and is as such subject to, inter alia, Norwegian company
and securities law, including the Norwegian Public Limited Companies Act and the Norwegian Securities
Trading Act with regard to disclosure of inside information and ongoing disclosure requirements, market
abuse, mandatory take-overs, squeeze-out, etc.
Voting rights
Each share in the Company (other than the treasury shares) gives the holder the right to cast one vote at
general meetings of shareholders. There are no limitations under Norwegian law on the rights of non-residents
or foreign owners to hold or vote the Shares.
As a general rule, resolutions that shareholders are entitled to make pursuant to the Norwegian Public Limited
Companies Act or the Company’s Articles of Association require a simple majority of the votes cast. In the case
of election of directors to the Board of Directors, the persons who obtain the most votes cast are deemed
elected to fill the positions up for election. However, as required under Norwegian law, certain decisions,
including resolutions to waive preferential rights in connection with any share issue, to approve a merger or
de-merger, to amend the Company’s Articles of Association or to authorise an increase or reduction in the
share capital, must receive the approval of at least two-thirds of the aggregate number of votes cast as well as
at least two-thirds of the share capital represented at a shareholders’ meeting.
Norwegian law further requires that certain decisions which have the effect of substantially altering the rights
and preferences of any Shares or class of Shares receive the approval of the holders of such Shares or class of
shares as well as the majority required for amendments to the Company’s Articles of Association. Decisions
that (i) would reduce any shareholder’s right in respect of dividend payments or other rights to the assets of
the Company or (ii) restrict the transferability of the shares require a majority vote of at least 90% of the share
capital represented at the general meeting in question as well as the majority required for amendments to the
Company’s Articles of Association. Certain types of changes in the rights of shareholders require the consent of
all shareholders affected thereby as well as the majority required for amendments to the Company’s Articles
of Association.
In general, in order to be entitled to vote, a shareholder must be registered as the beneficial owner of Shares
in the share register kept by the VPS. Beneficial owners of Shares that are registered in the name of a nominee
are generally not entitled to vote under Norwegian law, nor are any persons who are designated in the register
as holding such Shares as nominees. Readers should note that there are varying opinions as to the
interpretation of Norwegian law in respect of the right to vote nominee-registered Shares. For example, Oslo
Børs has held that in its opinion “nominee-shareholders” may vote in general meetings if they actually prove
their shareholding prior to the general meeting.
General meetings of shareholders
Through the general meeting, the Company’s shareholders exercise the supreme authority in the Company,
subject to the limitations provided under the Norwegian Public Limited Companies Act.
All shareholders in the Company are entitled to attend and vote at general meetings, either in person or by
proxy. See “Voting rights” (above) with regard to certain restrictions on voting right applying for nomineeregistered Shares, etc.
General meetings are convened by the Company’s Board. In a public limited liability company a notice of a
90
PCI Biotech Holding ASA - Prospectus
general meeting shall be sent at the latest two weeks before the date of the meeting, however, in a company
whose shares are listed on a regulated market (such as PCI Biotech), the notice period is three weeks. In
addition, the Board shall call an extraordinary general meeting whenever so demanded in writing by the
auditor or shareholders representing at least 5% of the share capital, in order to deal with a specific subject.
The extraordinary general meeting must be held within one month from the date of the demand. The notice
shall include a proposal for an agenda for the meeting. A shareholder is entitled to submit proposals to be
discussed at general meetings provided such proposals are submitted in writing to the Board in such good time
that it can be entered on the agenda of the meeting.
The annual general meeting shall be called by the Board such that it can be held within six months from the
end of each financial year. The annual general meeting shall deal with and decide on the adoption of the
annual financial statement and annual report, the question of declaring dividend and such other matters as
may be set out in the notice calling the meeting.
Additional issuances and preferential rights
All issuances of Shares by the Company, including bonus issues, require an amendment to the Articles of
Association, which requires the same vote as other amendments to the Articles of Association. Furthermore,
under Norwegian law, the Company’s shareholders have a preferential right to subscribe for issues of new
Shares by the Company. The preferential rights to subscribe in an issue may be waived by a resolution in a
general meeting by the same vote required to approve amendments to the Articles of Association. A waiver of
the shareholders’ preferential rights in respect of bonus issues requires the approval of all outstanding Shares,
irrespective of class.
Under Norwegian law, bonus issues may be distributed, subject to shareholder approval, by transfer from the
Company’s free equity or from its share premium reserve. Such bonus issues may be affected either by issuing
Shares or by increasing the par value of the Shares outstanding.
Dividends
Dividends may be paid in cash or in some instances in kind. Pursuant to the Norwegian Public Limited
Companies Act, a public limited liability company may only distribute dividends to the extent it will have net
assets covering the company’s share capital and other restricted equity after the distribution has been made.
The calculation shall be made on the basis of the balance sheet in the Company’s last approved financial
statements, provided, however, that it is the registered share capital on the time of decision that applies.
Further, extraordinary dividend payments may be resolved based upon an interim balance sheet not older
than 6 months.
In the amount that may be distributed, a deduction shall be made for (i) the aggregate nominal value of
treasury shares held by the company, (ii) credit and collateral pursuant to Sections 8-7 and 8-10 of the
Norwegian Public Limited Companies Act, with the exception of credit and collateral repaid or settled prior to
the time of decision or credit which is settled by a netting in the dividend and (iii) other dispositions after the
balance day which pursuant to law shall lie within the scope of the funds that the Company may use to
distribute dividend. Even if all other requirements are fulfilled, the Company may only distribute dividend to
the extent that it after the distribution has a sound equity and liquidity.
Distribution of dividends is resolved by a majority vote at the general meeting of the shareholders of the
Company, and on the basis of a proposal from the Board of Directors. The general meeting cannot distribute a
larger amount than what is proposed or accepted by the Board of Directors. The general meeting can also
provide the Board of Directors with an authorisation to resolve an extraordinary dividend payment. Such
authorisation is however limited in time to the next ordinary General Meeting.
According to the Norwegian Public Limited Companies Act, there is no time limit after which entitlement to
dividends lapses. Under the Norwegian Limitations Act, the general period of limitation is three years from the
date on which an obligation is due. The payment date may not be set later than six months from the resolution
to distribute dividends. Further, there are no dividend restrictions or specific procedures for non – Norwegian
resident shareholders in the Norwegian Public Limited Companies Act.
Under Norwegian foreign exchange controls currently in effect, transfers of capital to and from Norway are not
91
PCI Biotech Holding ASA - Prospectus
subject to prior government approval except for the physical transfer of payments in currency, which is
restricted to licensed banks. Consequently, a non-Norwegian resident may receive dividend payments without
Norwegian exchange control consent if such payment is made only through a licensed bank.
Any potential future payments of dividends on the Shares will be denominated in NOK, and will be paid to the
shareholders through the VPS. Payment to investors registered in the VPS whose address is outside Norway
will be conducted by the Company’s registrar based on information received from the VPS. Investors
registered in the VPS with an address outside Norway who have not supplied VPS with their bank account
details or who do not have valid bank account number will receive a letter from the Company’s VPS registrar,
which needs to be returned before the dividend payment can take place.
Rights on liquidation
Under Norwegian law, a company may be liquidated by a resolution in a general meeting of the Company
passed by a two thirds majority of the aggregate votes cast as well as two thirds of the aggregate share capital
represented at such meeting. The Shares rank pari passu in the event of a return on capital by the Company
upon a liquidation or otherwise.
Competition filing connected to concentrations
The Competition Act requires that concentrations (mergers, acquisitions, etc.) wherein the undertakings
concerned have a combined annual turnover in Norway exceeding NOK 1 billion, shall be notified to the
Norwegian Competition Authority (Konkurransetilsynet) (hereinafter “NCA”) by way of a notification. If,
however, only one of the undertakings concerned has an annual turnover in Norway exceeding NOK 100
million, notification is not required. The NCA may, however, order the submission of a notification even below
these thresholds. The deadline to order such submission is the earlier of three (3) months from: (i) a final
agreement is entered into or (ii) when control is acquired.
A notification shall contain detailed information on the concentration. The requirements are similar to that of
the Commission’s form CO.
All notifications are published on the NCA’s website. Such publication includes information on the names and
enterprise registration numbers of the undertakings concerned, on the concentration, and on affected
markets.
Transactions requiring notifications are prohibited from being implemented (consummated) before they have
been notified to and reviewed by the NCA. There is no deadline for notifying concentrations to the NCA,
provided that the parties have not started to implement the concentration.
Trading and settlement
Official trading on Oslo Børs takes place between 09:00 hours (CET) and 16.20 hours (CET) each trading day,
with pre-trade period between 08:15 hours (CET) and 09:00 hours (CET), closing auction from 16:20 hours
(CET) to 16:30 hours (CET). Reporting of after exchange trades can be done until 17:30 hours (CET).
The settlement period for trading on Oslo Børs is two trading days (T+2).
SIX Securities Service has a license from the Financial Supervisory Authority to act as a central clearing service,
and has from 18 June 2010 offered clearing and counterparty services for equity trading on Oslo Børs.
Investment services in Norway may only be provided by Norwegian investment firms holding a license under
the Norwegian Securities Trading Act, branches of investment firms from an EEA member state or investment
firms from outside the EEA that have been licensed to operate in Norway. Investment firms in an EEA member
state may also provide cross-border investment services into Norway.
It is possible for investment firms to undertake market-making activities in shares listed in Norway if they have
92
PCI Biotech Holding ASA - Prospectus
a license to this effect under the Norwegian Securities Trading Act, or in the case of investment firms in an EEA
member state, a license to carry out market-making activities in their home jurisdiction. Such market-making
activities will be governed by the regulations of the Norwegian Securities Trading Act relating to brokers’
trading for their own account. However, such market-making activities do not as such require notification to
the Financial Supervisory Authority or Oslo Børs except for the general obligation of investment firms that are
members of the Oslo Børs to report all trades in stock exchange listed securities.
Information, control and surveillance
Under Norwegian law, Oslo Børs is required to perform a number of surveillance and control functions. The
Surveillance and Corporate Control unit of Oslo Børs monitors all market activity on a continuous basis. Market
surveillance systems are largely automated, promptly warning department personnel of abnormal market
developments.
The Norwegian FSA controls the issuance of securities in both the equity and bond markets in Norway and
evaluates whether the issuance documentation contains the required information and whether it would
otherwise be unlawful to carry out the issuance.
Under Norwegian law, a company that is listed on a Norwegian regulated market, or has applied for listing on
such market, must promptly release any inside information directly concerning the company (i.e. precise
information about financial instruments, the issuer thereof or other matters which are likely to have a
significant effect on the price of the relevant financial instruments or related financial instruments, and which
are not publicly available or commonly known in the market). A company may, however, delay the release of
such information in order not to prejudice its legitimate interests, provided that it is able to ensure the
confidentiality of the information and that the delayed release would not be likely to mislead the public. Oslo
Børs may levy fines on companies violating these requirements.
Disclosure obligations
If a person’s, entity’s or consolidated group’s proportion of the total issued shares and/or rights to shares in a
company listed on a regulated market in Norway (with Norway as its home state, which will be the case for the
Company) reaches, exceeds or falls below the respective thresholds of 5%, 10%, 15%, 20%, 25%, 1/3, 50%, 2/3
or 90% of the share capital or the voting rights of that company, the person, entity or group in question has an
obligation under the Norwegian Securities Trading Act to notify Oslo Børs and the issuer immediately. The
same applies if the disclosure thresholds are passed due to other circumstances, such as a change in the
company’s share capital.
As of the date of this Prospectus34 and based on the table set out in Section 10.8, the following registered
shareholders have holdings in excess of the statutory thresholds for disclosure requirements. In case of
nominee shareholders, the disclosure requirement applies to the beneficial owner of the Shares.
No.of Shares:
1,500,000
1,159,853
916,531
Percentage:
10.1 %
7.8 %
6.2 %
Name:
FONDSAVANSE AS
RADIUMHOSPITALETS FORSKNINGSSTIFTELSE
MP PENSJON PK
Shares held or acquired or disposed of by close associates, as defined in Section 2-5 of the Securities Trading
Act, are regarded as equivalent to the acquirer’s or disposer’s own Shares.
Other than the foregoing and primary insiders’ mandatory obligation to disclose trades, the Board is not aware
of any person having an interest in the Company’s share capital or voting rights that must be disclosed under
Norwegian law.
34
The information is based on VPS data as of 13 December 2016.
93
PCI Biotech Holding ASA - Prospectus
Notification and Publication Requirements
The Company provides its shareholders, Oslo Børs and the market as a whole with timely and accurate
information. Notices are published through Oslo Børs’ information system and on the Company’s web site,
www.pcibiotech.no.
Reports to Shareholders
The Company publishes annual and interim reports that include financial statements for the Group in
accordance with IFRS.
The VPS and transfer of Shares
The Company’s principal share register is operated through the VPS under the securities identification code
ISIN NO 0010405640. The Company’s registrar is Nordea Bank Norge ASA, Issuer Services, P.O. Box 1166
Sentrum, NO-0107 Oslo, Norway.
The VPS is the Norwegian paperless centralised securities register. It is an electronic book-keeping system in
which the ownership of, and all transactions relating to, Norwegian listed shares must be recorded. The VPS
and Oslo Børs are both wholly-owned by Oslo Børs VPS Holding ASA.
All transactions relating to securities registered with the VPS are made through computerised book entries. No
physical share certificates are, or may be, issued. The VPS confirms each entry by sending a transcript to the
registered shareholder irrespective of any beneficial ownership. To give effect to such entries, the individual
shareholder must establish a share account with a Norwegian account agent. Norwegian banks, Norges Bank
(being, Norway’s central bank), authorised securities brokers in Norway and Norwegian branches of credit
institutions established within the EEA are allowed to act as account agents.
As a matter of Norwegian law, the entry of a transaction in the VPS is prima facie evidence in determining the
legal rights of parties as against the issuing company or any third party claiming an interest in the given
security. A transferee or assignee of shares may not exercise the rights of a shareholder with respect to such
shares unless such transferee or assignee has registered such shareholding or has reported and shown
evidence of such share acquisition, and the acquisition is not prevented by law, the relevant company’s bylaws or otherwise.
The VPS is liable for any loss suffered as a result of faulty registration or an amendment to, or deletion of,
rights in respect of registered securities unless the error is caused by matters outside the VPS’ control which
the VPS could not reasonably be expected to avoid or overcome the consequences of. Damages payable by the
VPS may, however, be reduced in the event of contributory negligence by the aggrieved party.
The VPS must provide information to the Financial Supervisory Authority on an ongoing basis, as well as any
information that the Financial Supervisory Authority requests. Further, Norwegian tax authorities may require
certain information from the VPS regarding any individual’s holdings of securities, including information about
dividends and interest payments.
Shareholder register – Norwegian law
Under Norwegian law, shares are registered in the name of the beneficial owner of the shares. As a general
rule, there are no arrangements for nominee registration and Norwegian shareholders are not allowed to
register their shares in VPS through a nominee. However, foreign shareholders may register their shares in the
VPS in the name of a nominee (bank or other nominee) approved by the Financial Supervisory Authority. An
approved and registered nominee has a duty to provide information on demand about beneficial shareholders
to the company and to the Norwegian authorities. In case of registration by nominees, the registration in the
VPS must show that the registered owner is a nominee. A registered nominee has the right to receive
dividends and other distributions, but cannot vote in general meetings on behalf of the beneficial owners.
94
PCI Biotech Holding ASA - Prospectus
Foreign investment in shares listed in Norway
Foreign investors may trade shares listed on Oslo Børs through any broker that is a member of Oslo Børs,
whether Norwegian or foreign.
Insider trading
According to Norwegian law, subscription for, purchase, sale or exchange of financial instruments that are
listed, or subject to the application for listing, on a Norwegian regulated market, or incitement to such
dispositions, must not be undertaken by anyone who has inside information, as defined in Section 3-2 of the
Norwegian Securities Trading Act. The same applies to the entry into, purchase, sale or exchange of options or
futures/forward contracts or equivalent rights whose value is connected to such financial instruments or
incitement to such dispositions.
Mandatory offer requirement
The Norwegian Securities Trading Act requires any person, entity or consolidated group that becomes the
owner of shares representing more than one-third of the voting rights of a Norwegian company listed on a
Norwegian regulated market to, within four weeks, make an unconditional general offer for the purchase of
the remaining shares in that company. A mandatory offer obligation may also be triggered where a party
acquires the right to become the owner of shares that, together with the party’s own shareholding, represent
more than one-third of the voting rights in the company and Oslo Børs decides that this is regarded as an
effective acquisition of the shares in question. The mandatory offer obligation ceases to apply if the person,
entity or consolidated group sells the portion of the shares that exceeds the relevant threshold within four
weeks of the date on which the mandatory offer obligation was triggered.
When a mandatory offer obligation is triggered, the person subject to the obligation is required to immediately
notify Oslo Børs and the company in question accordingly. The notification is required to state whether an
offer will be made to acquire the remaining shares in the company or whether a sale will take place. As a rule,
a notification to the effect that an offer will be made cannot be retracted. The offer and the offer document
required are subject to approval by Oslo Børs before the offer is submitted to the shareholders or made public.
The offer price per share must be at least as high as the highest price paid or agreed by the offeror for the
shares in the six-month period prior to the date the threshold was exceeded. If the acquirer acquires or agrees
to acquire additional shares at a higher price prior to the expiration of the mandatory offer period, the
acquirer is obliged to restate its offer at such higher price. A mandatory offer must be in cash or contain a cash
alternative at least equivalent to any other consideration offered.
In case of failure to make a mandatory offer or to sell the portion of the shares that exceeds the relevant
threshold within four weeks, Oslo Børs may force the acquirer to sell the shares exceeding the threshold by
public auction. Moreover, a shareholder who fails to make an offer may not, as long as the mandatory offer
obligation remains in force, exercise rights in the company, such as voting in a general meeting, without the
consent of a majority of the remaining shareholders. The shareholder may, however, exercise his/her/its rights
to dividends and pre-emption rights in the event of a share capital increase. If the shareholder neglects
his/her/its duty to make a mandatory offer, Oslo Børs may impose a cumulative daily fine that runs until the
circumstance has been rectified.
Any person, entity or consolidated group that owns shares representing more than one-third of the votes in a
Norwegian company listed on a Norwegian regulated market is obliged to make an offer to purchase the
remaining shares of the company (repeated offer obligation) if the person, entity or consolidated group
through acquisition becomes the owner of shares representing 40%, or more of the votes in the company. The
same applies correspondingly if the person, entity or consolidated group through acquisition becomes the
owner of shares representing 50% or more of the votes in the company. The mandatory offer obligation ceases
to apply if the person, entity or consolidated group sells the portion of the shares which exceeds the relevant
threshold within four weeks of the date on which the mandatory offer obligation was triggered.
Any person, entity or consolidated group that has passed any of the above mentioned thresholds in such a way
95
PCI Biotech Holding ASA - Prospectus
as not to trigger the mandatory bid obligation, and has therefore not previously made an offer for the
remaining shares in the company in accordance with the mandatory offer rules is, as a main rule, obliged to
make a mandatory offer in the event of a subsequent acquisition of shares in the company.
Compulsory acquisition
Pursuant to the Norwegian Public Limited Companies Act and the Norwegian Securities Trading Act, a
shareholder who, directly or through subsidiaries, acquires shares representing 90% or more of the total
number of issued shares in a Norwegian public limited liability company, as well as 90% or more of the total
voting rights, has a right, and each remaining minority shareholder of the company has a right to require such
majority shareholder, to effect a compulsory acquisition for cash of the shares not already owned by such
majority shareholder. Through such compulsory acquisition the majority shareholder becomes the owner of
the remaining shares with immediate effect.
If a shareholder acquires shares representing more than 90% of the total number of issued shares, as well as
more than 90% of the total voting rights, through a voluntary offer in accordance with the Securities Trading
Act, a compulsory acquisition can, subject to the following conditions, be carried out without such shareholder
being obliged to make a mandatory offer: (i) the compulsory acquisition is commenced no later than four
weeks after the acquisition of shares through the voluntary offer, (ii) the price offered per share is equal to or
higher than what the offer price would have been in a mandatory offer, and (iii) the settlement is guaranteed
by a financial institution authorised to provide such guarantees in Norway.
A majority shareholder who effects a compulsory acquisition is required to offer the minority shareholders a
specific price per share, the determination of which is at the discretion of the majority shareholder. However,
where the offeror, after making a mandatory or voluntary offer, has acquired more than 90% of the voting
shares of a company and a corresponding proportion of the votes that can be cast at the general meeting, and
the offeror pursuant to Section 4-25 of the Norwegian Public Limited Companies Act completes a compulsory
acquisition of the remaining shares within three months after the expiry of the offer period, it follows from the
Norwegian Securities Trading Act that the redemption price shall be determined on the basis of the offer price
for the mandatory/voluntary offer unless specific reasons indicate another price.
Should any minority shareholder not accept the offered price, such minority shareholder may, within a
specified deadline of not less than two months, request that the price be set by a Norwegian court. The cost of
such court procedure will, as a general rule, be the responsibility of the majority shareholder, and the relevant
court will have full discretion in determining the consideration to be paid to the minority shareholder as a
result of the compulsory acquisition.
Absent a request for a Norwegian court to set the price or any other objection to the price being offered, the
minority shareholders would be deemed to have accepted the offered price after the expiry of the specified
deadline.
Foreign exchange controls
There are currently no foreign exchange control restrictions in Norway that would potentially restrict the
payment of dividends to a shareholder outside Norway, and there are currently no restrictions that would
affect the right of shareholders of a company that has its shares registered with the VPS who are not residents
in Norway to dispose of their shares and receive the proceeds from a disposal outside Norway. There is no
maximum transferable amount either to or from Norway, although transferring banks are required to submit
reports on foreign currency exchange transactions into and out of Norway into a central data register
maintained by the Norwegian customs and excise authorities. The Norwegian police, tax authorities, customs
and excise authorities, the National Insurance Administration and the Financial Supervisory Authority have
electronic access to the data in this register.
Restrictions on sale and transfer
No action has been taken or will be taken in any jurisdiction by the Company that would permit the possession
96
PCI Biotech Holding ASA - Prospectus
or distribution of any documents relating to the New Shares, including but not limited to this Prospectus, in
any country or jurisdiction where specific action for that purpose is required. In particular, the New Shares and
this Prospectus neither have nor will be registered under the U.S. Securities Act of 1933, as amended, or under
any other state securities laws.
97
PCI Biotech Holding ASA - Prospectus
13.
TAXATION
General
The statements herein regarding taxation are, unless otherwise stated, based on the laws in force in Norway as
of the date of this Prospectus, and are subject to any changes in law occurring after such date. Such changes
could be made on a retrospective basis. Tax rates indicated below are applicable for the income year 2016.
The following summary does not purport to be a comprehensive description of all the tax considerations that
may be relevant to a decision to acquire, own or dispose of the shares. Furthermore, the summary only
focuses on the shareholder categories explicitly mentioned below (individual shareholders and limited liability
companies). Shareholders are advised to consult their own tax advisors concerning the overall tax
consequences of their ownership of shares. In particular, this document does not include any information with
respect to U.S. taxation. Prospective investors who may be subject to tax in the United States are urged to
consult their tax adviser regarding the U.S. federal, state, local and other tax consequence of owning and
disposing of shares in PCI Biotech.
Norwegian Shareholders
Taxation of dividends – Individual shareholders
Dividends distributed to Norwegian individual shareholders are taxable as general income. The taxable
dividend, less a calculated tax-free allowance, is grossed up to 115 %, which amount is taxed at the general
income tax rate of 25% (resulting in an effective tax rate of 28.75%). The tax-free allowance shall be calculated
on a share by share basis, and the allowance for each share will be equal to the cost price of the share,
multiplied by a risk free interest rate. Any part of the calculated allowance one year exceeding the dividend
distributed on the share will the following years be deducted from taxable dividend income and also included
in the basis for calculating the allowance.
Taxation of dividends – Corporate shareholders (Limited liability companies)
Dividends distributed to a shareholder which is a limited liability company resident in Norway for tax purposes
(“Norwegian corporate shareholders”) and holding more than 90% of the shares and votes in the distributing
company are fully exempt from taxation. To other corporate shareholders 3% of the dividends shall be subject
to general income tax at the 25% rate.
Taxation on realisation of shares – Individual shareholders
Sale, redemption or other disposal of shares is considered a realisation for Norwegian tax purposes. A capital
gain or loss generated by a Norwegian individual shareholder through a disposal of shares is taxable or tax
deductible in Norway. Such capital gain or loss is included in or deducted from the basis for computation of
general income in the year of disposal. The gain is subject to tax and the loss is tax deductible irrespective of
the duration of the ownership and the number of shares disposed of.
The capital gain is calculated on the consideration received less the cost price of the share and transactional
expenses. The taxable gain, less a calculated tax-free allowance, is grossed up to 115 %, which amount is taxed
at the general income tax rate of 25% (resulting in an effective tax rate of 28.75 %). The allowance for each
share is equal to the total of allowance amounts calculated for this share for previous years (ref. “Taxation of
dividends – Individual shareholders” above), which exceeded dividends distributed on this share. The
calculated allowance may only be deducted in order to reduce a taxable gain calculated upon the realisation of
the share, and may not be deducted in order to produce or increase a loss for tax purposes.
If the shareholder owns shares acquired at different points in time, the shares that were acquired first will be
regarded as the first to be disposed of, on a first-in first-out basis.
Taxation on realisation of shares – Corporate shareholders (Limited liability companies)
Norwegian corporate shareholders are not taxable for capital gains related to realisation of shares in a
Norwegian company, and losses related to such realisation are not tax deductible.
Taxation related to independent subscription rights – Individual shareholders
A Norwegian individual shareholder’s subscription for independent subscription rights is not subject to taxation in
98
PCI Biotech Holding ASA - Prospectus
Norway. Costs related to the subscription for independent subscription rights will be added to the cost price of the
independent subscription right.
Exercise of independent subscription rights is not taxable; the cost price of the subscription right shall be added to
the tax base of the shares acquired.
A capital gain or loss generated by a Norwegian individual shareholder through a sale of independent subscription
rights is taxable or tax deductible in Norway. Such capital gain or loss is generally included in or deducted from the
basis for computation of general income in the year of disposal. The general income is taxable at the rate of 25%.
However, please note that the gains related to independent subscription rights granted to employees as a
consequence of their employment will be included in the basis for calculating their salary payments. Such salary
payments are subject to taxation at a marginal tax rate of 46.9%. In addition, the employer will be obligated to pay
social security contributions at a rate normally of 14.1%.
Taxation related to independent subscription rights – Corporate shareholders
A Norwegian corporate shareholder’s subscription for independent subscription rights is not subject to taxation in
Norway. Costs related to the subscription for independent subscription rights will be added to the cost price of the
independent subscription rights.
Norwegian corporate shareholders are generally exempt from tax on capital gains upon the sale or other
realisation of independent subscription rights to shares in a Norwegian company, and losses are not tax deductible.
Net wealth tax
The value of shares is included in the basis for the computation of wealth tax imposed on Norwegian individual
shareholders. The marginal wealth tax rate is 0.85 % of the value assessed. The value for assessment purposes for
shares on Oslo Børs is 100% of the listed value as of 1 January in the year of assessment. Norwegian corporate
shareholders are not subject to net wealth tax.
Non-Resident Shareholders
This section summarises Norwegian tax rules relevant to shareholders who are not resident in Norway for tax
purposes (“Non-resident shareholders”). Non-resident shareholders’ tax liabilities in their home country or
other countries will depend on applicable tax rules in the relevant country.
Taxation of dividends
Dividends distributed to shareholders who are individuals not resident in Norway for tax purposes (“Nonresident individual shareholders”), are as a general rule subject to withholding tax at a rate of 25%. The
withholding tax rate of 25% is normally reduced through tax treaties between Norway and the country in
which the shareholder is resident. The withholding obligation lies with the company distributing the dividends.
The above generally applies also to shareholders who are limited liability companies not resident in Norway for
tax purposes (“Non-resident corporate shareholders”). However, dividends distributed to Non-resident
corporate shareholders resident within the EEA for tax purposes are exempt from Norwegian withholding tax,
provided the shareholder genuinely is established and conducts business activity in the relevant jurisdiction.
Non-resident individual shareholders resident within the EEA area are subject to ordinary withholding tax, but
entitled to apply for a partial refund of the withholding tax, equal to a calculated allowance similar to the
calculated allowance used by Norwegian individual shareholders, ref above.
Nominee registered shares will be subject to withholding tax at a rate of 25% unless the nominee has obtained
approval from the Tax Directorate for the dividend to be subject to a lower withholding tax rate. To obtain
such approval the nominee is committed to file a summary to the tax authority including all beneficial owners
that are subject to lower withholding tax. Non-resident shareholders that have suffered a higher withholding
tax than set out by an applicable tax treaty or the Norwegian Tax Act may apply to the Norwegian tax
authorities for a refund of the excess withholding tax deducted.
If a Non-resident shareholder is carrying on business activities in Norway, and the shares are effectively
99
PCI Biotech Holding ASA - Prospectus
connected with such activities, the shareholder will be subject to the same taxation as Norwegian
shareholders, as described above.
Taxation on realisation of shares or independent subscription rights
Realisation of shares or independent subscription rights by a Non-resident individual or corporate shareholder
will not be subject to taxation in Norway unless the Non-resident shareholder is holding the shares or warrants
in connection with the conduct of a trade or business in Norway, in which case the tax treatment is as
described for Norwegian shareholders.
Net wealth tax
Shareholders not resident in Norway for tax purposes are not subject to Norwegian net wealth tax. Foreign
individual shareholders can however be taxable if the shareholding is effectively connected to the conduct of
trade or business in Norway.
Duties on the Transfer of Shares
No stamp or similar duties are currently imposed in Norway on the transfer of shares whether on acquisition
or disposal.
100
PCI Biotech Holding ASA - Prospectus
14.
SELLING AND TRANSFER RESTRICTIONS
As a consequence of the following restrictions, prospective investors are advised to consult legal counsel prior
to making any offer, resale, pledge or other transfer of the New Shares and the Subscription Rights offered
hereby.
Other than in Norway, the Company is not taking any action to permit an offering of the New Shares and the
Subscription Rights in any jurisdiction. Receipt of this Prospectus will not constitute an offer in those
jurisdictions in which it would be illegal to make an offer and, in those circumstances, this Prospectus is for
information only and should not be copied or redistributed. Except as otherwise disclosed in this Prospectus, if
an investor receives a copy of this Prospectus in any jurisdiction other than Norway, the investor may not treat
this Prospectus as constituting an invitation or offer to it, nor should the investor in any event deal in the New
Shares and the Subscription Rights, unless, in the relevant jurisdiction, such an invitation or offer could lawfully
be made to that investor, or the New Shares and the Subscription Rights could lawfully be dealt in without
contravention of any unfulfilled registration or other legal requirements. Accordingly, if an investor receives a
copy of this Prospectus, the investor should not distribute or send the same, or transfer Shares, to any person
or in or into any jurisdiction where to do so would or might contravene local securities laws or regulations.
None of the Company or the Manager, or any of their respective representatives or advisers, are making any
representation to any offeree or purchaser of the New Shares regarding the legality of an investment in the
New Shares by such offeree or purchaser under the laws applicable to such offeree or purchaser. Each investor
should consult with his or her own advisors as to the legal, tax, business, financial and related aspects of a
purchase of the New Shares.
The Rights Issue, New Shares and the Subscription Rights have not been and will not be registered under the US
Securities Act of 1933, as amended (the "US Securities Act") or any state securities laws, and may not be offered or
sold within the United States. Furthermore, the New Shares and the Subscription Rights may not be offered or sold
in or into any other jurisdictions where the offering and sale of the New Shares and the Subscription Rights is
restricted by law.
101
PCI Biotech Holding ASA - Prospectus
15.
ADDITIONAL INFORMATION
Advisors
Fondsfinans AS (Haakon VII's gate 2, NO-0161 Oslo, Norway) is acting as manager for the Rights Issue.
Advokatfirmaet Ræder DA (Henrik Ibsensgate 100, 0230 Oslo, Norway) is acting as Norwegian legal counsel to
the Company.
Documents on display
Copies of the following documents will be available for inspection at the Company's offices at Ullernchausséen
64, 0379 Oslo, Norway, during normal business hours from Monday to Friday each week (except public
holidays) for a period of twelve months from the date of this Prospectus.

The Company's Articles of Association and Certificate of Incorporation.

The Group's audited consolidated annual financial statements for the years ended 31 December 2015
and 2014.

The Group's unaudited condensed interim consolidated financial statements for the nine month
period ended 30 September 2016.
There are no reports, letters, evaluations or statements prepared by an expert at the Company’s request,
which is referred to in the Prospectus.
Documents incorporated by reference
The information incorporated by reference to this Prospectus should be read in connection with the cross
reference list as set out in the table below. The following documents have been incorporated hereto by
reference:
Section
in
Prospectus
Disclosure
Reference document and link
Page (P) in
requirements
reference
of
document
the
Prospectus
Section 10
Audited
historical
The Annual Accounts for the year ended 31 December 2015:
http://pcibiotech.no/wp-content/uploads/2015/03/2015-PCIB-
financial
Annual-Report.pdf
P 20 – P 48
information
The Annual Accounts for the year ended 31 December 2014:
P 13 – P 34
http://pcibiotech.no/wp-content/uploads/2014/01/PCIB-ASA-AnnualReport-2014.pdf
Section 10
Auditor's
report
Auditor's report for the year ended 31 December 2015:
http://pcibiotech.no/wp-content/uploads/2015/03/2015-PCIBAnnual-Report.pdf
Auditor's report for the year ended 31 December 2014:
P 49 – P 50
P 40 - 41
http://pcibiotech.no/wp-content/uploads/2014/01/PCIB-ASA-AnnualReport-2014.pdf
Section 10
Section 11.8
Unaudited
condensed
Interim
financial
statement
Articles
of
association
Condensed interim financial statement for the nine month period
ended 30 September 2016
http://pcibiotech.no/wp-content/uploads/2016/11/PCI-Biotech-Q32016-Report.pdf
PCI Biotech's article of association
http://pcibiotech.no/articles-of-association/
102
P 7 – P 11
PCI Biotech Holding ASA - Prospectus
16.
DEFINITIONS AND GLOSSARY
The following definitions and glossary apply in this Prospectus unless otherwise dictated by the context,
including the foregoing pages of this Prospectus.
ADC
Antibody Drug Conjugate
ADME
Administration, Distribution, Metabolism and Excretion
AE
Adverse Event
Antigen
Any structural substance which can induce a humoral or cellular adaptive
immune response in the body
Antigen presenting cell
Any of various immune cells that take up and process an antigen into a form
that when displayed at the cell surface in combination with a molecule of the
major histocompatibility complex is recognised by and serves to activate an
immune response
Antineoplastics
Drugs that inhibit or prevent the growth or development of cancer
Articles of Association
The articles of association of the Company
APC
Antigen Presenting Cell
Bleomycin
A chemotherapeutic used in cancer
Board
The board of directors of the Company
CCA
Cholangiocarcinoma (another term for bile duct cancer)
CE-mark
A mandatory conformity marking for certain products sold within the European
Economic Area (EEA) since 1985
Cetuximab
A biological therapeutic (monoclonal antibody) used in cancer
Chemotherapeutic
Chemical agents used in the treatment or control of disease (as cancer) or
mental illness
Cholangiocarcinoma
Bile duct cancer
CHMP
Committee for Human Medicinal Products (in the European Medicines Agency)
Cisplatin
A chemotherapeutic used in cancer
CMC
Chemistry, Manufacturing and Control
CNS
Central Nervous System
Company, PCI Biotech
Holding or PCI Biotech
PCI Biotech Holding ASA
Corporate
Code
The Norwegian Code of Practice for Corporate Governance dated 30 October
2014
Governance
CRO
Contract Research Organisation
CT
Computed Tomography (a radiologic imaging that uses computer processing to
generate an image of tissue density in slices through the patient's body)
103
PCI Biotech Holding ASA - Prospectus
CTL
Cytotoxic T Lymphocyte
Cytosol
The liquid found inside cells
Cytotoxic T lymphocyte
A T lymphocyte (a type of white blood cell) that kills cancer cells, cells that are
infected (particularly with viruses), or cells that are damaged in other ways (are
also known as cytotoxic T cell, T-killer cell, cytolytic T cell, CD8+ T-cell or killer T
cell)
DLT
Dose Limiting Toxicity
Docetaxel
A chemotherapeutic used in cancer
DRC
Dose Review Committee
EEA
The European Economic Area
EGM
The Company's extraordinary general meeting held 6 January 2015
EMA
European Medicines Agency
Endocytic vesicle
A membrane-bounded compartment inside cells, formed through endocytosis
(= endosome)
Endocytosis
An energy-using process that cells use to internalise molecules (such as
proteins) by engulfing them, whereby they get located in endosomes
Endoscopic
Typically refers to methods for looking inside the body for medical reasons
using an endoscope, an instrument used to examine the interior of a hollow
organ or cavity of the body
Endosome
A membrane-bounded compartment inside cells, formed through endocytosis
(= endocytic vesicle)
Endosomal
Referring to endosomes
FDA
Food and Drug Administration (in the USA)
FSMA
The Financial Services and Markets Act 2000
Gemcitabine
A chemotherapeutic used in cancer
GIM
Gazette of International Marks (magazine published by WIPO)
Group
The Company and its subsidiary
HNC
Head and Neck Cancer
HPV
Human Papilloma Virus
IFRS
International Financial Reporting Standards as adopted by the European Union
IND
Investigational New Drug (in the USA)
Ineligible Persons
Any person who, in the Company’s view, are resident in a jurisdiction where
such offering of New Shares or granting of Subscription Rights would be
unlawful or (for jurisdictions other than Norway) would require any prospectus,
registration or similar action
104
PCI Biotech Holding ASA - Prospectus
Immunotoxin
A human-made protein that consists of a targeting portion linked to a toxin
In vitro
Studies performed with cells or biological molecules studied outside their
normal biological context; for example proteins are examined in solution, or
cells in artificial culture medium
In vivo
Studies in which the effects of various biological entities are tested on whole,
living organisms usually animals
Listing
The listing of the New Shares on Oslo Axess
Manager
Fondsfinans AS
MHC I/II
Major Histocompatibility Complex class I / class II
MRI
Magnetic Resonance Imaging
MTD
Maximum Tolerated Dose
New Shares
The 10,000,000 new shares to be issued in the Rights Offering
NOK
Norwegian Kroner, the lawful currency of Norway
Norwegian FSA
The Financial Supervisory Authority of Norway (Finanstilsynet)
NRH
Norwegian Radium Hospital
NTNU
Norwegian University of Technology and Science
Nucleic acid
Large biomolecules, essential for all known forms of life; includes DNA
(deoxyribonucleic acid) and RNA (ribonucleic acid), which are made from
monomers known as nucleotides
OHIM
Office for Harmonisation in the Internal Market
Oligonucleotides
A nucleic acid polymer consisting of a small number of nucleotides (e.g. an
oligodeoxynucleotide or oligoribonucleotide)
Oncology
The branch of medical science dealing with tumors
Oslo Axess
A Norwegian regulated market operated by Oslo Børs
Oslo Børs
Oslo Børs ASA or, as the context may require, Oslo Børs, a Norwegian regulated
stock exchange operated by Oslo Børs ASA
PCI
Photochemical Internalisation
PDT
Photodynamic Therapy
PET-CT
Positron Emission Tomography combined with CT
Photochemical
Referring to chemical reactions initiated by the absorption of energy in the
form of light
Photosensitiser
A molecular or atomic species that initiates a photochemical reaction
Prophylactic
A medication or a treatment designed and used to prevent a disease from
occurring
105
PCI Biotech Holding ASA - Prospectus
Prospectus
This Prospectus dated 13 December 2016
QIBs
Qualified institutional buyers, as defined in Rule 144A under the U.S. Securities
Act
RECIST
Response Evaluation Criteria In Solid Tumors
Record Date
12 December 2016 (consequently, the Company’s shareholders as at the end of
the date of the EGM as evidenced in the VPS in accordance with normal T+2
settlement will receive subscription rights)
Relevant Member State
Each Member State of the European Economic Area which has implemented
the EU Prospectus Directive
RF
Radium Hospital Research Foundation
Rights Issue
The fully underwritten rights issue of 10,000,000 New Shares resolved at the
EGM
RNA
Ribonucleic Acid
RNAi
RNA interference
RR-HF
Rikshospitalet-Radiumhospitalet Helseforetak
R&D
Research and Development
SAE
Serious Adverse Event
Shares
The ordinary shares of the Company
siRNA
Small interfering RNA, sometimes known as short interfering RNA or silencing
RNA, is a class of double-stranded RNA molecules, 20-25 base pairs in length
Subscription Form
The subscription form attached as Appendice A to this Prospectus
Subscription Period
The subscription period for the Rights Issue which will take place from and
including 14 December 2016 to 16:30 (CET) on 5 January 2017
Subscription Rights
the Subscription Rights issued in the Rights Issue
Therapeutic
A medication or a treatment designed and used to treat a disease
TPCS2a
Di meso-tetraphenyl chlorin disulphonate (active ingredient in Amphinex)
USD
United States Dollar
U.S. Securities Act
The United States Securities Act of 1933, as amended
VPS
The Norwegian Central Securities Depository (Verdipapirsentralen)
WIPO
World Intellectual Property Organisation
106
APPENDIX 1: SUBSCRIPTION FORM
PCI Biotech Holding ASA
RIGHTS ISSUE
SUBSCRIPTION FORM
Securities no. ISIN NO 0010405640.
General information: The terms and conditions of the Rights Issue by PCI Biotech Holding ASA (the “Company”) are set out in the
prospectus dated 13 December 2016 (the “Prospectus”). Terms defined in the Prospectus shall have the same meaning in this
Subscription Form. The notice of, and minutes from, the Extraordinary General Meeting (with appendices), the Company’s by-laws
and annual accounts and annual reports for the last two years are available at the Company’s office address at Ullernchausséen 64,
0379 Oslo, Norway at www.pcibiotech.no. All announcements referred to in this Subscription Form will be made through Oslo Børs’
information system under the Company’s ticker “PCIB”.
Subscription procedures: The subscription period is from 09:00 hours (CET) on 14 December 2016 to 16:30 hours (CET) on 5
January 2017 (the “Subscription Period”). Correctly completed Subscription Forms must be received by the Manager before the
end of the Subscription Period at the following address: Fondsfinans AS, Haakon VII's gate 2, P.O. Box 1782 Vika, NO-0122 Oslo,
Norway, E-mail: [email protected], Fax: +47 23 11 30 04 (the “Subscription Office”). The subscriber is responsible for the
correctness of the information filled in on the Subscription Form. Subscription Forms that are incomplete or incorrectly completed,
or that are received after the end of the Subscription Period, and any subscription that may be unlawful, may be disregarded, at
the discretion of the Manager on behalf of the Company. Subscribers who are residents of Norway with a Norwegian personal
identification number may also subscribe for New Shares through the VPS online subscription system by following the link on
the following website: www.beringerfinance.com/deals/#filter=.ongoing. Subscriptions made through the VPS online subscription
system must be duly registered before the expiry of the Subscription Period. Neither the Company nor the Manager may be held
responsible for postal delays, unavailable fax lines, internet lines or servers or other logistical or technical problems that may result
in subscriptions not being received in time or at all by the Subscription Offices. Subscriptions are irrevocable and binding upon
receipt and cannot be withdrawn, cancelled or modified by the subscriber after having been received by an Subscription Office, or
in the case of subscriptions through the VPS online subscription system, upon registration of the subscription.
Subscription Price: The Subscription Price in the Rights Issue is NOK 7 per New Share.
Subscription Rights: Registered holders of the Company’s shares (the “Existing Shareholders”) as appearing in the VPS as at 12
December 2016 (the “Record Date”) will be granted Subscription Rights giving a preferential right to subscribe for, and be
allocated, the New Shares. Each Existing Shareholder will be granted 0.6711 Subscription Rights per 1 existing share registered with
the respective Existing Shareholder on the Record Date. The number of Subscription Rights issued to each Existing Shareholder will
be rounded down to the nearest whole Subscription Right. Each Subscription Right will, subject to applicable securities laws, give
the right to subscribe for and be allocated one New Share in the Rights Issue. Over-subscription and subscription without
Subscription Rights is permitted. Subscription Rights not used to subscribe for New Shares or not sold before the end of the
Subscription Period will lapse without compensation to the holder, and, consequently, will be of no value from that point in
time.
Allocation of New Shares: The New Shares will be allocated to the subscribers based on the allocation criteria set out in the
Prospectus. The Company reserves the right to reject or reduce any subscription for New Shares not covered by Subscription
Rights. The Company will not allocate fractional New Shares. Allocation of fewer New Shares than subscribed for does not impact
on the subscriber’s obligation to pay for the New Shares allocated. Notification of allocated New Shares and the corresponding
subscription amount to be paid by each subscriber is expected to be distributed in a letter from Fondsfinans AS on or about 10
January 2017. Subscribers who have access to investor services through an institution that operates the subscriber’s VPS account
should be able to see how many New Shares they have been allocated from 12:00 hours (CET) on or about 11 January 2017.
Payment: In completing this Subscription Form, or registering a subscription through the VPS online subscription system,
subscribers authorise Fondsfinans AS to debit the subscriber’s Norwegian bank account for the total subscription amount payable
for the New Shares allocated to the subscriber. Accounts will be debited on or about 16 January 2017 (the “Payment Date”), and
there must be sufficient funds in the stated bank account from and including the date falling 2 banking days prior to the Payment
Date. Subscribers who do not have a Norwegian bank account must ensure that payment for the allocated New Shares is made on
or before the Payment Date. Details and instructions can be obtained by contacting Fondsfinans AS, telephone +47 23 11 30 00.
Fondsfinans AS is only authorized to debit each account once, but reserves the right (but has no obligation) to make up to three
debit attempts for a period of up to seven working days after the Payment Date if there are insufficient funds on the account on
the Payment Date. Should any subscriber have insufficient funds in his or her account, should payment be delayed for any reason, if
it is not possible to debit the account or if payments for any other reasons are not made when due, overdue interest will accrue
and other terms will apply as set out under the heading “Overdue and missing payments” below. Payment by direct debiting is only
available for subscribers who are allocated New Shares for an amount below NOK 5 million and who have a Norwegian bank
account. Subscribers that do not have a Norwegian bank account and subscribers who subscribe for an amount exceeding NOK 5
million must contact the Manager for payment instructions.
A-1
SUBSCRIPTION
DETAILS OF THE SUBSCRIPTION
Subscriber’s VPS account:
Number
of Number
of
New
Shares (For broker: consecutive no.):
Subscription Rights:
subscribed
(incl. over-subscription):
SUBSCRIPTION RIGHT’S SECURITIES NUMBER: ISIN NO
0010780745
Subscription Price per Subscription amount to be paid:
New Share:
NOK
NOK 7
IRREVOCABLE AUTHORIZATION TO DEBIT ACCOUNT (MUST BE COMPLETED BY SUBSCRIBERS WITH A NORWEGIAN BANK ACCOUNT)
Norwegian bank account to be debited for the payment for New
Shares allocated (number of New Shares allocated x NOK 7).
(Norwegian bank account no.)
I/we hereby irrevocably (i) subscribe for the number of New Shares specified above subject to the terms and conditions set out in
this Subscription Form and in the Prospectus, (ii) authorize and instruct Fondsfinans AS (or someone appointed by Fondsfinans AS) to
take all actions required to transfer such New Shares allocated to me/us to the VPS Registrar and ensure delivery of the beneficial
interests to such New Shares to me/us in the VPS, on my/our behalf, (iii) authorize Fondsfinans AS to debit my/our bank account as
set out in this Subscription Form for the amount payable for the New Shares allotted to me/us, and (iv) confirm and warrant to have
read the Prospectus and that I/we are eligible to subscribe for New Shares under the terms set forth therein.
Place and date
must be dated in the Subscription Period.
Binding signature
The subscriber must have legal capacity. When signed on
behalf of a company or pursuant to an authorization,
documentation in the form of a company certificate or
power of attorney must be enclosed.
INFORMATION ON THE SUBSCRIBER – ALL FIELDS MUST BE COMPLETED
First name
Surname/company
Street address
Post code/district/
country
Personal ID number/
organization number
Nationality
E-mail address
Daytime telephone
number
ADDITIONAL GUIDELINES FOR THE SUBSCRIBER
Regulatory issues: In accordance with the Markets in Financial Instruments Directive (“MiFID”) of the European Union, Norwegian law
imposes requirements in relation to business investments. In this respect, the Manager must categorize all new clients in one of three
categories: eligible counterparties, professional clients and non-professional clients. All subscribers in the Rights Issue who are not
existing clients of the Manager will be categorized as non-professional clients. Subscribers can, by written request to the Manager, ask
to be categorized as a professional client if the subscriber fulfils the applicable requirements of the Norwegian Securities Trading Act.
For further information about the categorization, the subscriber may contact Fondsfinans AS (Fondsfinans AS, Haakon VII’s gate 2,
P.O. Box 1782 Vika, NO-0122 Oslo, Norway or [email protected]). The subscriber represents that he/she/it is capable of
evaluating the merits and risks of a decision to invest in the Company by subscribing for New Shares, and is able to bear the
economic risk, and to withstand a complete loss, of an investment in the New Shares.
Selling Restrictions: The attention of persons who wish to subscribe for New Shares is drawn to Section 14 “Selling and transfer
restrictions” of the Prospectus. The Company is not taking any action to permit a public offering of the Subscription Rights or the New
Shares (pursuant to the exercise of the Subscription Rights or otherwise) in any jurisdiction other than Norway. Receipt of the
Prospectus will not constitute an offer in those jurisdictions in which it would be illegal to make an offer and, in those circumstances,
the Prospectus is for information only and should not be copied or redistributed. Persons outside Norway should consult their
professional advisors as to whether they require any governmental or other consent or need to observe any other formalities to
enable them to subscribe for New Shares. It is the responsibility of any person wishing to subscribe for New Shares under the Rights
Issue to satisfy himself as to the full observance of the laws of any relevant jurisdiction in connection therewith, including obtaining
any governmental or other consent which may be required, the compliance with other necessary formalities and the payment of any
108
issue, transfer or other taxes due in such territories. The Subscription Rights and New Shares have not been registered, and will not be
registered, under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered, sold, taken
up, exercised, resold, delivered or transferred, directly or indirectly, within the United States. The Subscription Rights and New Shares
have not been and will not be registered under the applicable securities laws of Australia, Canada or Japan and may not be offered,
sold, taken up, exercised, resold, delivered or transferred, directly or indirectly, in or into Australia, Canada or Japan. This Subscription
Form does not constitute an offer to sell or a solicitation of an offer to buy New Shares in any jurisdiction in which such offer or
solicitation is unlawful. A notification of exercise of Subscription Rights and subscription for New Shares in contravention of the above
restrictions may be deemed to be invalid. By subscribing for the New Shares, persons effecting subscriptions will be deemed to have
represented to the Company that they, and the persons on whose behalf they are subscribing for the New Shares, have complied with
the above selling restrictions.
Execution Only: The Manager will treat the Subscription Form as an execution-only instruction. The Manager is not required to
determine whether an investment in the New Shares is appropriate or not for the subscriber. Hence, the subscriber will not benefit
from the protection of the relevant conduct of business rules in accordance with the Norwegian Securities Trading Act.
Information exchange: The subscriber acknowledges that, under the Norwegian Securities Trading Act and the Norwegian
Commercial Banks Act and foreign legislation applicable to the Manager there is a duty of secrecy between the different units of the
Manager as well as between the Manager and the other entities in the Manager’s groups. This may entail that other employees of the
Manager or the Manager’s groups may have information that may be relevant to the subscriber and to the assessment of the New
Shares, but which the Manager will not have access to in their capacity as Manager for the Offering.
Information barriers: The Manager is a securities firm that offers a broad range of investment services. In order to ensure that
assignments undertaken in the Manager’s corporate finance departments are kept confidential, the Manager’s other activities,
including analysis and stock broking, are separated from the Manager’s corporate finance departments by information walls.
Consequently, the subscriber acknowledges that the Manager’s analysis and stock broking activity may conflict with the subscriber’s
interests with regard to transactions in the Shares, including the New Shares.
VPS account and mandatory anti-money laundering procedures: The Right Issue is subject to the Norwegian Money Laundering Act
of 6 March 2009 No. 11 and the Norwegian Money Laundering Regulations of 13 March 2009 No. 302 (collectively, the “Anti-Money
Laundering Legislation”). Subscribers who are not registered as existing customers of the Manager must verify their identity to the
Manager in accordance with requirements of the Anti-Money Laundering Legislation, unless an exemption is available. Subscribers
who have designated an existing Norwegian bank account and an existing VPS account on the Subscription Form are exempted, unless
verification of identity is requested by the Manager. Subscribers who have not completed the required verification of identity prior to
the expiry of the Subscription Period will not be allocated New Shares. Participation in the Rights Issue is conditional upon the
subscriber holding a VPS account. The VPS account number must be stated in the subscription form. VPS accounts can be established
with authorized VPS registrars, who can be Norwegian banks, authorized securities brokers in Norway and Norwegian branches of
credit institutions established within the EEA. Establishment of a VPS account requires verification of identity to the VPS registrar in
accordance with the Anti-Money Laundering Legislation. However, non-Norwegian investors may use nominee VPS accounts
registered in the name of a nominee. The nominee must be authorized by the Financial Supervisory Authority of Norway.
Terms and conditions for payment by direct debiting - securities trading: Payment by direct debiting is a service the banks in Norway
provide in cooperation. In the relationship between the payer and the payer’s bank the following standard terms and conditions
apply:
a)
The service “Payment by direct debiting – securities trading” is supplemented by the account agreement
between the payer and the payer’s bank, in particular Section C of the account agreement, General terms
and conditions for deposit and payment instructions.
b)
Costs related to the use of “Payment by direct debiting – securities trading” appear from the bank’s
prevailing price list, account information and/or information given in another appropriate manner. The bank
will charge the indicated account for costs incurred.
c)
The authorization for direct debiting is signed by the payer and delivered to the beneficiary. The beneficiary
will deliver the instructions to its bank that in turn will charge the payer’s bank account.
d)
In case of withdrawal of the authorization for direct debiting the payer shall address this issue with the
beneficiary. Pursuant to the Norwegian Financial Contracts Act the payer’s bank shall assist if the payer
withdraws a payment instruction that has not been completed. Such withdrawal may be regarded as a
breach of the agreement between the payer and the beneficiary.
109
e)
The payer cannot authorize payment of a higher amount than the funds available on the payer’s account at
the time of payment. The payer’s bank will normally perform a verification of available funds prior to the
account being charged. If the account has been charged with an amount higher than the funds available, the
difference shall immediately be covered by the payer.
f)
The payer’s account will be charged on the indicated date of payment. If the date of payment has not been
indicated in the authorization for direct debiting, the account will be charged as soon as possible after the
beneficiary has delivered the instructions to its bank. The charge will not, however, take place after the
authorization has expired as indicated above. Payment will normally be credited the beneficiary’s account
between one and three working days after the indicated date of payment/delivery.
g)
If the payer’s account is wrongfully charged after direct debiting, the payer’s right to repayment of the
charged amount will be governed by the account agreement and the Norwegian Financial Contracts Act.
Overdue and missing payments: Overdue payments will be charged with interest at the applicable rate under the Norwegian Act on
Interest on Overdue Payment of 17 December 1976 No. 100; 8.5% per annum as of the date of the Prospectus. If the subscriber fails
to comply with the terms of payment or should payments not be made when due, the subscriber will remain liable for payment of the
New Shares allocated to it and the New Shares allocated to such subscriber will not be delivered to the subscriber. In such case the
Company and Fondsfinans AS reserve the right to, at any time and at the risk and cost of the subscriber, re-allot, cancel or reduce the
subscription and the allocation of the allocated New Shares, or, if payment has not been received by the third day after the Payment
Date, without further notice sell, assume ownership to or otherwise dispose of the allocated New Shares in accordance with
applicable law. If New Shares are sold on behalf of the subscriber, such sale will be for the subscriber’s account and risk and the
subscriber will be liable for any loss, costs, charges and expenses suffered or incurred by the Company and/or Fondsfinans AS as a
result of, or in connection with, such sales. The Company and/or Fondsfinans AS may enforce payment for any amounts outstanding
in accordance with applicable law.
110
Intentionally left blank
111
PCI Biotech Holding ASA
Ullernchausséen 64
0379 Oslo
Norway
Manager
Fondsfinans AS
Haakon VII's gate 2
P:O. Box 1782 Vika
NO-0122 Oslo
Norway
Phone: +47 23 11 30 04
Fax: +47 23 11 30 03
www.fondsfinans.no
Norwegian legal counsel to the Company
Advokatfirmaet Ræder DA
Henrik Ibsens gate 100
P.O. Box 2944 Solli
0230 Oslo
Norway
www.raeder.no
112