News Releases
- Company prepares for
September 13, 2019 ,U.S. Food and Drug Administration (FDA)Allergenic Products Advisory Committee (APAC)Meeting for AR101 for peanut allergy - Marketing Authorization Application (MAA) for AR101 for peanut allergy submitted to the
European Medicines Agency (EMA) which has validated the filing and begun its review - Presented results from the positive phase 3 ARTEMIS trial at
European Academy of Allergy andClinical Immunology (EAACI) Congress and presented new data atInternational Society for Pharmacoeconomics Outcomes Research (ISPOR) Annual Meeting - Advanced pipeline with the initiation of a phase 2 trial of AR201 for egg allergy
- Strong balance sheet with
$250.3 million in cash, cash equivalents and investments as ofJune 30, 2019 , expected to fund commercialization of AR101 in the U.S. andEurope and development of pipeline
“The second quarter of 2019 was marked by exceptional progress on all fronts. We continue to work with the
Dr. Dallas added: “At EAACI, we presented positive results from our ARTEMIS European phase 3 trial, as well as important data that showed patients who received daily treatment with AR101 beyond one year experienced clinically meaningful improvements in disease-specific quality of life and continued immunomodulation. In addition, new and compelling patient quality of life data were presented at both EAACI and ISPOR, underscoring the urgent unmet need of people living with peanut allergy. Moreover, we began the enrollment process for our phase 2 clinical trial of AR201 in egg allergy and remain in a strong financial position to commercialize AR101 and advance our pipeline programs.”
Second Quarter 2019 Clinical and Operational Highlights
FDA informed the Company that FDA’s APAC is scheduled to advise on the review of data supporting the Company’s Biologics License Application (BLA) for AR101 at a meeting onSeptember 13, 2019 . The Company continues to prepare diligently for the meeting. InMarch 2019 , theFDA accepted the BLA for AR101 for peanut allergy in children and adolescents ages 4 to 17, under a 12-month target review period, potentially taking until lateJanuary 2020 . In addition, theFDA has completed all clinical and manufacturing site inspections scheduled to date. Following these inspections, the Company continues to anticipate approval byJanuary 2020 .- MAA for AR101 has been filed and validated for review by EMA. In
June 2019 , the Company submitted a MAA to the EMA for AR101 to reduce the incidence and severity of allergic reactions following exposure to peanuts in children and adolescents ages 4 to 17. The Company expects a standard review time of 12- to 15-months. - New data presented at EAACI and ISPOR. Aimmune presented results from the positive phase 3 ARTEMIS trial in an oral presentation at the
EAACI Congress inJune 2019 . Safety and efficacy results were consistent with the results seen in the phase 3 PALISADE trial. The lead study author of ARTEMIS, Montserrat Fernandez- Rivas, M.D., Hospital Clinico San Carlos,Madrid, Spain , was named an EAACI Award Winner 2019.
In addition, patients in the open-label extension of the phase 3 PALISADE trial who received daily treatment with AR101 beyond one year experienced clinically meaningful improvements in disease-specific quality of life. Continued immunomodulation also was observed, with almost half of patients tolerating as much as 2,000 mg of peanut protein with fewer adverse events. Further, results from APPEAL 2, the first European multi-country qualitative evaluation of the impact of living with peanut allergy, found that living in fear of a potentially fatal reaction to peanuts significantly impacts the quality of life of individuals with peanut allergy and their families.
The Company also presented data at the ISPOR 2019 Annual Meeting that showed that, over a 12-month period, more than half of participants required a visit to the emergency room or urgent care facility and one-third required hospitalization as a result of peanut exposure. This was true despite 100% of those surveyed reporting actively avoiding peanut products.
- Launched enrollment of phase 2 trial of AR201 in egg allergy. The phase 2 trial is a double-blind placebo-controlled trial in patients ages 4 to 26 diagnosed with an allergy to hen’s egg. The trial is expected to enroll approximately 84 patients at 15 clinical trial sites in the U.S.
- Commercial supply agreement with long-standing manufacturer of AR101 completed. In
May 2019 , the Company entered into a commercial supply agreement withCoreRx, Inc. , its long-standing manufacturer of AR101. The agreement will help secure sufficient supply of AR101, including at commercial launch, subject to regulatory approval. CoreRx began manufacturing commercial lots of AR101 inMay 2019 , following the consummation of the agreement, and the first commercial batch has now been released. - POSEIDON trial and AR101 with adjunctive dupilumab trial ongoing. 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 to <4 years. InOctober 2018 , a phase 2 trial of AR101 with adjunctive dupilumab was initiated in peanut-allergic patients. Aimmune continues to supply AR101 clinical trial material to Regeneron, the latter trial’s sponsor.
Upcoming Milestones
Sept. 13, 2019 |
|
|
Scheduled FDA APAC meeting to review AR101 BLA |
January 2020 |
|
|
Potential FDA approval of AR101 for peanut allergy in children and adolescents ages 4 to |
Q1 2020 |
|
|
Potential U.S. commercial launch of AR101 |
Mid-2020 |
|
|
Complete enrollment of AR201 phase 2 trial |
H2 2020
|
|
|
Potential EU approval of AR101 for peanut allergy in children and adolescents ages 4 to |
H2 2020 |
|
|
Potential EU commercial launch of AR101 |
Second Quarter 2019 Financial Results
For the quarter and six months ended
Research and development expenses for the quarter and six months ended
General and administrative expenses for the quarter and six months 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 and MAA for AR101; Aimmune’s expectations on the timing of receipt and announcement of data for its phase 2 clinical trial for AR201; Aimmune’s expectations on the planned timing for the announcement of data from its POSEIDON trial of AR101 and Regeneron’s clinical trial of AR101 in combination with dupilumab; Aimmune’s expectations regarding the adequacy and sufficiency of its commercial supply of AR101; Aimmune’s expectations regarding the sufficiency of its cash resources; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in
This press release concerns AR101 and AR201, product candidates that are under clinical investigation. Neither AR101 nor AR201 has been approved for marketing by the
AIMMUNE THERAPEUTICS, INC. |
|||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||
(In thousands) |
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2019 (Unaudited) |
|
|
December 31, 2018 (1) |
|
|
||
Assets |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
72,564 |
|
|
$ |
107,511 |
|
|
Short-term investments |
|
|
171,108 |
|
|
|
196,421 |
|
|
Prepaid expenses and other current assets |
|
|
6,859 |
|
|
|
8,687 |
|
|
Total current assets |
|
|
250,531 |
|
|
|
312,619 |
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments |
|
|
6,584 |
|
|
|
— |
|
|
Property and equipment, net |
|
|
29,414 |
|
|
|
26,328 |
|
|
Operating lease right-of-use assets |
|
|
11,736 |
|
|
|
— |
|
|
Prepaid expenses and other assets |
|
|
511 |
|
|
|
608 |
|
|
Total assets |
|
$ |
298,776 |
|
|
$ |
339,555 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
43,211 |
|
|
$ |
38,012 |
|
|
Long term debt, net of discount |
|
|
38,526 |
|
|
|
— |
|
|
Operating lease liabilities, non-current |
|
|
11,036 |
|
|
|
— |
|
|
Other liabilities |
|
|
1,029 |
|
|
|
2,596 |
|
|
Stockholders’ equity |
|
|
204,974 |
|
|
|
298,947 |
|
|
Total liabilities and stockholders equity |
|
$ |
298,776 |
|
|
$ |
339,555 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K |
AIMMUNE THERAPEUTICS, INC. |
|
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|||||||||||||||
(In thousands, except per share amounts) |
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended June 30, |
|
|
Six Months Ended |
|
||||||||||
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
||||
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development(1) |
|
$ |
31,988 |
|
|
$ |
35,254 |
|
|
$ |
63,304 |
|
|
$ |
68,700 |
|
General and administrative(1) |
|
|
31,200 |
|
|
|
18,559 |
|
|
|
54,912 |
|
|
|
35,232 |
|
Total operating expenses |
|
|
63,188 |
|
|
|
53,813 |
|
|
|
118,216 |
|
|
|
103,932 |
|
Loss from operations |
|
|
(63,188 |
) |
|
|
(53,813 |
) |
|
|
(118,216 |
) |
|
|
(103,932 |
) |
Interest income, net |
|
|
358 |
|
|
|
1,294 |
|
|
|
1,149 |
|
|
|
1,930 |
|
Loss before provision for income taxes |
|
|
(62,830 |
) |
|
|
(52,519 |
) |
|
|
(117,067 |
) |
|
|
(102,002 |
) |
Provision for income taxes |
|
|
48 |
|
|
|
33 |
|
|
|
77 |
|
|
|
50 |
|
Net loss |
|
$ |
(62,878 |
) |
|
$ |
(52,552 |
) |
|
$ |
(117,144 |
) |
|
$ |
(102,052 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(1.01 |
) |
|
$ |
(0.91 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.83 |
) |
Shares used in computing net loss per common share, basic and diluted |
|
|
62,332 |
|
|
|
57,903 |
|
|
|
62,178 |
|
|
|
55,752 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes stock-based compensation expenses of: |
|
|
|
|
|
|
|
|
|
|||||||
|
|
Quarter Ended June 30, |
|
|
Six Months Ended |
|
||||||||||
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
||||
Research and development |
|
$ |
2,957 |
|
|
$ |
2,923 |
|
|
$ |
5,700 |
|
|
$ |
4,970 |
|
General and administrative |
|
|
5,783 |
|
|
|
5,751 |
|
|
|
10,805 |
|
|
|
11,311 |
|
Total stock-based compensation expenses |
|
$ |
8,740 |
|
|
$ |
8,674 |
|
|
$ |
16,505 |
|
|
$ |
16,281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190808005665/en/
Source:
Investors:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Jerica Pitts
(312) 858-3469
jpitts@w2ogroup.com