Aimmune Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Provides Recent Operational Highlights
FDAdecision on AR101 BLA filing acceptance expected by end of March
- Submission of AR101 marketing application in
Europeon track for mid-2019
- Initiation of AR201 phase 2 trial in egg allergy on track for mid-2019
- Company began 2019 with approximately
$340 millionin cash and investments and potential access to an additional $130 million
- Webcast and conference call today at
5:00 p.m. ET
“Last year was one of exceptional progress for Aimmune on multiple fronts as we advance AR101 to potentially be the first approved treatment for peanut allergy,” said Jayson Dallas, M.D., President and CEO of Aimmune. “In addition, we are on track to apply for European marketing approval of AR101 and initiate a phase 2 trial of AR201 for egg allergy, both in the middle of the year. We began 2019 in a strong financial position to commercialize AR101 and advance our pipeline programs. Our priority now is ensuring launch preparedness and continuing to collaborate with the allergy community and regulatory authorities to bring AR101 to the children, teens, and families affected by peanut allergy.”
- Biologics License Application (BLA) for AR101 submitted. On
December 21, 2018, Aimmune submitted a BLA for AR101 to the U.S. Food and Drug Administration( FDA) for the treatment of peanut allergy in children and adolescents ages 4-17 years. Following the reopening of the U.S. government in January 2019, the FDAinitiated review of the BLA for AR101. Aimmune expects that the FDAwill determine whether the BLA is acceptable for filing by the end of March 2019. Aimmune is currently engaged in discussions with the FDAregarding the review timeline for the BLA for AR101 in consideration of multiple factors, including: the agency’s initial determination that AR101 is exempt from PDUFA; AR101’s Breakthrough Therapy designation; and the apparent lack of precedent for the FDAreviewing a BLA for a PDUFA-exempt product candidate that has Breakthrough Therapy designation. If the Breakthrough Therapy designation for AR101 does not result in an expedited review of the BLA for AR101, the BLA will likely be reviewed under a 12-month target review period applicable to PDUFA-exempt applications, as measured from the January 2019start date.
- POSEIDON trial initiated. In
December 2018, Aimmune initiated its phase 3 POSEIDON trial to explore the efficacy and safety of AR101 in young peanut-allergic children, ages 1-3.
- PALISADE results published in NEJM. In
November 2018, the New England Journal of Medicine(NEJM) published the results of Aimmune’s landmark phase 3 PALISADE trial, the largest and most rigorously conducted oral immunotherapy trial for the treatment of peanut allergy and the only successful phase 3 trial for the treatment of peanut allergy ever conducted.
- AR101 with adjunctive dupilumab trial initiated. In
October 2018, a phase 2 trial of AR101 with adjunctive dupilumab was initiated in peanut-allergic patients. Regeneron is the trial’s sponsor, and Aimmune is supplying AR101 clinical trial material.
- Data presented at AAAAI. Aimmunepresented nine
abstracts at the
American Academy of Allergy, Asthma and Immunology (AAAAI) 2019 Annual Meeting. Notably, new data show that AR101 treatment reduced accidental exposures to peanut requiring medication and increased the amount of peanut tolerated with additional time on the AR101 300 mg daily dose.
- Phase 2 program on track. Aimmune’s Investigational New Drug
(IND) application for AR201 has been cleared by the
FDAand the company expects to begin a phase 2 trial in mid-2019.
- Strengthened balance sheet. In
November 2018, Nestlé Health Science made an additional $98 millionequity investment in Aimmune. In January 2019, Aimmune announced it had entered into a loan agreement with KKR, a leading global investment firm, for up to $170 millionto fund AR101 commercialization and pipeline development.
- Board of Directors expanded. In
November 2018, Aimmune announced the appointment of Brett Haumann, M.B.B.Ch., M.B.A., to its Board of Directors. Dr. Haumann brings extensive biotech and pharmaceutical leadership experience, including more than 20 years of development and discovery work in allergy and pulmonary medicines.
- Chief Commercial Officer appointed. In
January 2019, Aimmune named Andrew Oxtoby, a proven pharmaceutical leader, as the company’s first Chief Commercial Officer. Mr. Oxtoby joins Aimmune with deep, global experience with successful product launches, commercialization and strategic planning. In this role, Mr. Oxtoby’s immediate focus is the potential U.S. launch of AR101.
|1Q 19||Potential acceptance of AR101 BLA for review by the U.S. FDA|
|1H 19||ARTEMIS data on AR101 available|
|Mid 19||Initiate phase 2 clinical trial of AR201 in egg allergy|
|Mid 19||Submit Marketing Authorization Application for AR101 to the European Medicines Agency|
Fourth Quarter Financial Results
For the quarter and year ended
On a per share basis, net loss for the quarter and year ended
Research and development expenses for the quarter and year ended
General and administrative expenses for the quarter and year ended
Cash, cash equivalents, and investments totaled
In connection with this announcement,
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s expectations regarding the potential
benefits of AR101; Aimmune’s expectations regarding the potential
commercial launch of AR101, including the timing of a potential
acceptance and applicable review period of the BLA for AR101; Aimmune’s
expectations regarding the planned timing and filing for marketing
approval of AR101 in
This press release concerns AR101, a product candidate that is under clinical investigation, and AR201, a product candidate that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the FDA or the European Medicines Agency (EMA). AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
|AIMMUNE THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||107,511||$||73,487|
|Prepaid expenses and other current assets||8,687||6,681|
|Total current assets||312,619||189,111|
|Property and equipment, net||26,328||17,205|
|Prepaid expenses and other assets||608||618|
|Liabilities and Stockholders’ Equity|
|Total liabilities and stockholders’ equity||$||339,555||$||206,934|
(1)Derived from the audited financial statements, included in
the Company's Annual Report on Form 10-K for the year ended
|AIMMUNE THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Research and development(1)||$||33,029||$||28,654||$||133,420||$||89,325|
|General and administrative(1)||25,404||12,986||81,921||43,949|
|Total operating expenses||58,433||41,640||215,341||133,274|
|Loss from operations||(58,433||)||(41,640||)||(215,341||)||(133,274||)|
|Interest income, net||1,417||530||4,650||2,005|
|Loss before provision for income taxes||(57,016||)||(41,110||)||(210,691||)||(131,269||)|
|(Benefit) Provision for income taxes||(18||)||56||61||56|
|Net loss per share, basic and diluted||$||(0.95||)||$||(0.81||)||$||(3.67||)||$||(2.61||)|
|Shares used in computing net loss per basic and diluted share||59,780||50,839||57,403||50,401|
|(1)Includes employee stock-based compensation expense of:|
|Research and development||$||2,569||$||1,595||$||9,945||$||5,077|
|General and administrative||5,500||3,253||22,787||11,642|
|Total stock-based compensation expense||$||8,069||$||4,848||$||32,732||$||16,719|