News Releases
“This is a transformative time for the company as we prepare to launch PALFORZIATM, our first drug candidate and potentially the first
Third Quarter 2019 Clinical and Operational Highlights
The U.S. Food and Drug Administration (FDA) Allergenic Products Advisory Committee (APAC) voted to support the use of PALFORZIA in children and teens with peanut allergy onSeptember 13, 2019 . The APAC voted 7 to 2 that the efficacy data, and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of PALFORZIA. As part of Aimmune’s original Biologics License Application (BLA) submission, the Company proposed risk management measures in line with the Advisory Committee’s discussion and recommendation for a Risk Evaluation and Mitigation Strategy (REMS).- PALFORZIA U.S. launch preparations in final stages. Commercial field leadership positions have been filled and offers have been accepted for almost all of the 80 Practice Account Manager positions. The market access team has already met with payers representing nearly 90% of covered lives. Finally, in ongoing consultation with the
FDA , the Company continues to finalize the REMS program that will help support the safe and appropriate use of PALFORZIA, if approved. The European Medicines Agency (EMA) continues its review of the Marketing Authorization Application (MAA) for PALFORZIA. InJune 2019 , the Company submitted a MAA to the EMA for PALFORZIA. The Company expects to receive the Day 120 questions inNovember 2019 at which time there will be a pause while the Company prepares to answer the questions. A standard overall review period of 12- to 15-months is expected.- Ongoing clinical trials to expand pipeline and support CODIT™ platform.
- In
December 2018 , Aimmune initiated its POSEIDON phase 3 clinical trial to explore the efficacy and safety of PALFORZIA in young peanut-allergic children ages 1 to <4 years. - In
October 2018 , Regeneron initiated a phase 2 clinical trial of PALFORZIA with adjunctive dupilumab in peanut-allergic patients. - In
August 2019 , Aimmune enrolled the first patient in a phase 2 clinical trial of AR201 in patients with egg allergy.
- In
- Strong balance sheet.
$200.5 million in cash, cash equivalents and investments as ofSeptember 30, 2019 , and access to up to an additional$130 million from our loan agreement with KKR upon satisfaction of borrowing conditions.
Upcoming Milestones |
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January 2020 |
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Expected FDA review action date for PALFORZIA BLA |
Q1 2020 |
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Potential U.S. commercial launch of PALFORZIA, if approved |
H2 2020 |
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Expected completion of enrollment of AR201 phase 2 trial |
H2 2020 |
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Expected EMA action date for MAA of PALFORZIA for peanut allergy in children and adolescents ages 4 to 17 years |
H2 2020 |
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Potential EU commercial launch of PALFORZIA, if approved |
Third Quarter 2019 Financial Results
For the quarter and nine months ended
Research and development expenses for the quarter and nine months ended
General and administrative expenses for the quarter and nine months ended
Cash, cash equivalents, and investments totaled
Conference Call
In connection with this announcement,
About PALFORZIA™
PALFORZIA™ is an investigational, peanut-derived, biologic product candidate for use in oral immunotherapy in patients with peanut allergy. The drug candidate, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable major allergen content. The amount of active ingredient in each PALFORZIA capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. PALFORZIA is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
About AR201
AR201 is an investigational biologic product candidate in clinical development for use in oral immunotherapy in patients with egg allergy. Academic studies of the oral immunotherapy approach for egg allergy treatment have shown efficacy, and Aimmune is studying this more broadly with AR201 in order to enable widespread availability of a potential treatment. Aimmune has an exclusive supply agreement for egg protein with
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 PALFORZIA; Aimmune’s expectations regarding the potential commercial launch of PALFORZIA, including the review period of the BLA and MAA for PALFORZIA and launch timelines in
This press release concerns PALFORZIA and AR201, product candidates that are under clinical investigation. Neither PALFORZIA nor AR201 has been approved for marketing by the
PALFORZIA™ is a trademark of
AIMMUNE THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(In thousands) |
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September 30, |
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December 31, |
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Assets |
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Cash and cash equivalents |
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$ |
76,844 |
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$ |
107,511 |
Short-term investments |
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118,626 |
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196,421 |
Prepaid expenses and other current assets |
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6,766 |
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8,687 |
Total current assets |
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202,236 |
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312,619 |
Long-term investments |
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5,038 |
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— |
Property and equipment, net |
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28,713 |
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26,328 |
Operating lease right-of-use assets |
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11,904 |
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— |
Prepaid expenses and other assets |
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507 |
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608 |
Total assets |
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$ |
248,398 |
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$ |
339,555 |
Liabilities and Stockholders’ Equity |
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Current liabilities |
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$ |
43,605 |
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$ |
38,012 |
Long term debt, net of discount |
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39,782 |
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— |
Operating lease liabilities, non-current |
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11,153 |
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— |
Other liabilities |
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1,166 |
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2,596 |
Stockholders’ equity |
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152,692 |
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298,947 |
Total liabilities and stockholders’ equity |
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$ |
248,398 |
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$ |
339,555 |
(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. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except per share amounts) |
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Quarter Ended |
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Nine Months Ended |
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2019 |
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2018 |
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2019 |
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2018 |
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Operating Expenses |
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Research and development(1) |
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$ |
30,558 |
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$ |
31,691 |
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$ |
93,862 |
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$ |
100,391 |
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General and administrative(1) |
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34,044 |
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21,285 |
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88,956 |
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56,517 |
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Total operating expenses |
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64,602 |
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52,976 |
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182,818 |
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156,908 |
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Loss from operations |
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(64,602 |
) |
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(52,976 |
) |
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(182,818 |
) |
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(156,908 |
) |
Interest income, net |
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43 |
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1,303 |
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1,192 |
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3,233 |
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Loss before provision for income taxes |
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(64,559 |
) |
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(51,673 |
) |
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(181,626 |
) |
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(153,675 |
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(Benefit) Provision for income taxes |
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(104 |
) |
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29 |
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(27 |
) |
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79 |
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Net loss |
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$ |
(64,455 |
) |
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$ |
(51,702 |
) |
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$ |
(181,599 |
) |
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$ |
(153,754 |
) |
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Net loss per common share, basic and diluted |
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$ |
(1.03 |
) |
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$ |
(0.89 |
) |
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$ |
(2.91 |
) |
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$ |
(2.72 |
) |
Shares used in computing net loss per common share, basic and diluted |
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62,615 |
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58,274 |
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62,325 |
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56,602 |
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(1) Includes stock-based compensation expenses of: |
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Quarter Ended |
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Nine Months Ended |
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2019 |
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2018 |
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2019 |
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2018 |
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Research and development |
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$ |
2,752 |
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$ |
2,406 |
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$ |
8,452 |
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$ |
7,376 |
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General and administrative |
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5,329 |
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5,976 |
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16,134 |
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17,287 |
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Total stock-based compensation expenses |
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$ |
8,081 |
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$ |
8,382 |
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$ |
24,586 |
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$ |
24,663 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005929/en/
Source:
Investors:
DeDe Sheel
(917) 834-1494 or
dsheel@aimmune.com
Media:
Jerica Pitts
(312) 858-3469
jpitts@w2ogroup.com