News Releases
“We are well on track to introduce AR101 as potentially the first-ever approved treatment for peanut allergy, a significant milestone for our Company, the allergist community, and the millions of people who live with the daily risk of serious reactions to accidental peanut exposure,” said
Dr. Dallas added: “We also continue to advance efforts toward submitting a marketing authorization application for AR101 to the
AR101 Highlights
- Biologics License Application (BLA) for AR101 was accepted for review by the
U.S. Food and Drug Administration (FDA ). InMarch 2019 , theFDA accepted for review the BLA for AR101 for the treatment of peanut allergy in children and adolescents ages 4 to 17, which Aimmune had submitted to the agency inDecember 2018 . TheFDA informed Aimmune that the BLA will be reviewed under a 12-month target review period, as measured from theJanuary 2019 start date. Review of the BLA may therefore take until lateJanuary 2020 . TheFDA expects to convene an advisory committee meeting to discuss the application. - Positive phase 3 ARTEMIS topline data announced; submission of marketing authorization application (MAA) to
European Medicines Agency (EMA) on track. InMarch 2019 , the Company announced that the phase 3 ARTEMIS European clinical trial of AR101 for the treatment of peanut allergy in children and adolescents ages 4 to 17 met its primary efficacy endpoint. Topline data showed the proportion of AR101-treated patients who tolerated a 1,000-mg dose of peanut protein (2,043 mg cumulative) in a blinded exit challenge after approximately nine months of AR101 treatment was significantly higher (p<0.00001) than in the placebo group. The median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit. The trial also greatly exceeded a 15% lower-bound of the 95% confidence interval (CI) of the difference between treatment arms for the primary endpoint. The safety profile and completion rate observed in ARTEMIS were consistent with results seen in previous AR101 clinical trials, and no cases of anaphylaxis or eosinophilic esophagitis (EoE) were observed. Aimmune intends to submit a MAA for AR101 to the EMA in mid-2019. Aimmune also plans to present full results of the ARTEMIS trial in an oral presentation at theEuropean Academy of Allergy and Clinical Immunology (EAACI) Congress onJune 2, 2019 .
POSEIDON trial and AR101 with adjunctive dupilumab trials ongoing. In
AR201 Highlights
- Phase 2 trial initiation on track for mid-2019. Aimmune’s Investigational New Drug (IND) application for AR201 was cleared by the
FDA , as previously announced, and the Company remains on track to begin a phase 2 trial in egg allergy in mid-2019.
Upcoming Milestones |
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Mid 2019 | Initiate phase 2 clinical trial of AR201 in egg allergy | ||
Mid 2019 | Submit Marketing Authorization Application for AR101 to the European Medicines Agency | ||
Second Half of 2019 | Potential FDA Advisory Committee meeting to review AR101 BLA | ||
Jan 2020 | Potential FDA approval of AR101 for the treatment of peanut allergy in children and adolescents ages 4 to 17 | ||
Q1 2020 | Potential U.S. commercial launch of AR101 | ||
First Quarter Financial Results
For the quarter ended
On a per share basis, net loss for the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Cash, cash equivalents, and investments totaled
Conference Call
In connection with this announcement,
About
Forward-Looking Statements
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 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 | |||||||||
(In thousands) | |||||||||
March 31, | |||||||||
2019 |
December 31, |
||||||||
Assets | |||||||||
Cash and cash equivalents | $ | 81,058 | $ | 107,511 | |||||
Short-term investments | 202,113 | 196,421 | |||||||
Prepaid expenses and other current assets | 8,220 | 8,687 | |||||||
Total current assets | 291,391 | 312,619 | |||||||
Long-term investments | 13,177 | — | |||||||
Property and equipment, net | 26,824 | 26,328 | |||||||
Operating lease assets | 12,247 | — | |||||||
Prepaid expenses and other assets | 514 | 608 | |||||||
Total assets | $ | 344,153 | $ | 339,555 | |||||
Liabilities and Stockholders’ Equity | |||||||||
Current liabilities | $ | 38,091 | $ | 38,012 | |||||
Long term debt, net of discount | 37,268 | — | |||||||
Operating lease liabilities, non-current | 11,633 | — | |||||||
Other liabilities | 860 | 2,596 | |||||||
Stockholders’ equity | 256,301 | 298,947 | |||||||
Total liabilities and stockholders’ equity | $ | 344,153 | $ | 339,555 | |||||
__________________________ |
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(1) | Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. | |
AIMMUNE THERAPEUTICS, INC. | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(In thousands, except per share amounts) | |||||||||
Three Months Ended March 31, | |||||||||
2019 | 2018 | ||||||||
Operating Expenses | |||||||||
Research and development(1) | $ | 31,316 | $ | 33,446 | |||||
General and administrative(1) | 23,712 | 16,673 | |||||||
Total operating expenses | 55,028 | 50,119 | |||||||
Loss from operations | (55,028 | ) | (50,119 | ) | |||||
Interest income, net | 791 | 636 | |||||||
Loss before provision for income taxes | (54,237 | ) | (49,483 | ) | |||||
Provision for income taxes | 29 | 17 | |||||||
Net loss | $ | (54,266 | ) | $ | (49,500 | ) | |||
Net loss per common share, basic and diluted | $ | (0.87 | ) | $ | (0.92 | ) | |||
Shares used in computing net loss per common share, basic and diluted | 62,022 | 53,578 | |||||||
(1) Includes stock-based compensation expenses of: | |||||||||
Three Months Ended March 31, | |||||||||
2019 | 2018 | ||||||||
Research and development | $ | 2,743 | $ | 2,047 | |||||
General and administrative | 5,022 | 5,560 | |||||||
Total stock-based compensation expenses | $ | 7,765 | $ | 7,607 | |||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190508005871/en/
Source:
Investors:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Jerica Pitts
(312) 858-3469
jpitts@w2ogroup.com