Company Update
May 12, 2017
Aimmune Therapeutics (AIMT)
Aimmune Enrolls First Patient into RAMSES Phase III Study
On May 11th, Aimmune Therapeutics (NasdaqGS: AIMT) announced dosing of the first
patient enrolled into the RAMSES Phase III study. The RAMSES trial is designed to evaluate
AR101, Aimmune’s proprietary desensitization therapy for individuals with peanut allergies, in
a real-world setting. Importantly, the trial does not require a double-blind, placebo controlled
food challenge (DBPCFC) to confirm a patient’s peanut allergy. This is consistent with
the way in which physicians diagnose and treat peanut allergies and eliminates the safety
concerns associated with DBPCFC. Aimmune expects that data from the RAMSES study
will strengthen a potential BLA filing for AR101, which would likely include data from the
PALISADE, RAMSES, and first cohort of ARC004 studies.
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RAMSES Trial Expected to Provide Real-World Data. In the PALISADE and Phase
II AR101 studies, DBPCFCs were used to quantify the gain in peanut protein tolerance
achieved through AR101. In contrast to these studies, the RAMSES trial will not require
a DBPCFC evaluation of peanut sensitivity for trial entry. Trial entry for RAMSES will be
based on medical history, skin prick reactivity, and the presence of certain immunological
markers. This trial design expands access to AR101 through removal of an obstacle to entry
for some peanut-allergic patients.
Safety concerns may make DBPCFCs unrealistic for real-world clinical practice, and
prescription of AR101 is expected to occur in the absence of this process. Furthermore, the
immune provocation inherent in DBPCFCs can sensitize the immune system, priming any
potential reaction to the next incidence of peanut exposure. This may make some patients
more sensitive to up-dosing after the DBPCFC is conducted, biasing the tolerability profile.
With Aimmune having already demonstrated a strong efficacy profile for AR101 with a
DBPCFC in Phase II studies, removal of this obstacle in RAMSES allows investigators to
focus on AR101’s safety profile and compatibility with clinical practice.
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Regulatory Filing for AR101 Expected in 2018. Aimmune expects to report topline
results from the PALISADE Phase III study around year-end 2017, which would
allow regulatory filings in the US and Europe in late 2018 if the data are positive. A
Biologics Licensing Application (BLA) filing for AR101 would likely include data from
the PALISADE and RAMSES studies as well the first cohort of the ARC004 trial, which
is a rollover study from PALISADE that is exploring a variety of dosing intervals. In
total, Aimmune’s submission is expected to include a safety database of approximately
600 patients. The Company’s Market Authorization Application (MAA) submission would
likely also include data from the ARTEMIS Phase III study, which is testing a higher efficacy
endpoint of tolerating 2,043 mg at 3 months of maintenance.
Analysts
David Sherman, Ph.D. (AC)
(212) 915-2570
[email protected]
Market Data
Price
Market Cap (M)
EV (M)
Shares Outstanding (M)
Fully Diluted Shares (M)
Avg Daily Vol
52-week Range:
Cash (M)
Net Cash/Share
Annualized Cash Burn (M)
Years of Cash Left
Debt (M)
Short Interest (M)
Short Interest (% of Float)
$19.87
$999
$740
50.3
57.2
314,719
$9.77 - $27.31
$259.3
$5.16
$90.0
~3.0
$0.0
4.20
13.2%
Financials
FY Dec
EPS
Q1
Q2
Q3
Q4
FY
2015A
(0.81)A
(1.60)A
(0.36)A
(0.39)A
(1.88)A
2016A
(0.37)A
(0.43)A
(0.53)A
(0.55)A
(1.89)A
2017A
(0.52)A
NA
NA
NA
NA
Expected Upcoming Milestones
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■
■
■
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Mid-2017 – Completion of up-dosing portion of PALISADE Phase III study.
Mid-2017 – Initiation of ARTEMIS Phase III study in Europe.
YE 2017 – Topline results from PALISADE Phase III study.
2018 – Launch ARC005 pediatric study.
Late 2018 – Potential submission of BLA and MAA filings.
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For analyst certification and disclosures please see page 3
May 12, 2017
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RAMSES Phase III Trial Design. This randomized, double-blind, placebo controlled Phase III trial is testing the safety and
tolerability of AR101 in children between the ages of 4 and 17 who have a severe peanut allergy. Participants are enrolled based on
medical history, skin-prick reactivity, and immunological markers, which more closely mirrors clinical practice than the use of a doubleblind, placebo-controlled food challenge (DBPCFC). This study will monitor approximately 440 US enrollees for treatment-emergent
adverse events during and after the initial six-month dosing period. RAMSES will also include an analysis of patient quality of life
using multiple validated patient-reported outcome measures. This trial is expected to bolster the safety database for AR101 and provide
proof of concept for incorporation of OIT into clinical practice.
Financial Results for the First Quarter of 2017. On May 8th, Aimmune announced financial results for the first quarter of 2017.
Research and development expenses for the quarter were $17.4 million, compared with $10.0 million for the first quarter of 2016.
This increase was largely driven by increased spending on clinical trials and contract manufacturing, as well as additional personnel.
Aimmune reported general and administrative expenses of $8.9 million, reflecting an increase from $5.7 million in the same period in
2016. The Company announced a net loss for the first quarter of $25.9 million, or $0.52 per share, compared with a net $15.5 million,
or $0.37 per share, loss in the same period in 2016. As of March 31st, Aimmune had cash and cash equivalents of $259.3 million.
Risk to Invesment
An investment in Aimmune Therapeutics is considered to be a high-risk investment. Aimmune is a development stage company with no
FDA-approved drugs in its portfolio. The Company does not currently generate profit and may not do so in the future. The company
may not receive FDA approval for its allergy desensitization treatments despite significant time, positive clinical trial data and financial
investments. Regulatory approval does not guarantee that the treatment will penetrate the market, and sales may not meet the expectations
of investors. Furthermore, unknown competitors may emerge and Aimmune may be unable to obtain sufficient capital to fund ongoing
operations.
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May 12, 2017
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analyst(s) in this report.
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