Releases Details
ARS Pharmaceuticals Highlights Progress and Reports Fourth Quarter and Full Year 2022 Financial Results
New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023
Strong Financial Position with
“This is an incredibly exciting time for ARS, with potential regulatory approvals for neffy® around the corner and a resulting transition to a commercial-stage company. Our goal with neffy is to provide patients with the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in an easy to use and rapidly administered needle-free nasal spray. We believe we are well on our way to achieving this goal,” said
neffy Progress
- neffy NDA and MAA for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis, Under Review with FDA and EMA: The Company’s new drug application (NDA) and marketing authorization application (MAA) for neffy for the emergency treatment of allergic reactions (Type I), including anaphylaxis in adults and children ≥30 kg (66 lbs), were accepted for review by the
U.S. Food and Drug Administration (FDA) and theEuropean Medicines Agency (EMA), respectively. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions (Type I), including anaphylaxis.
The regulatory submissions to the FDA and EMA were based on data from four primary registrational studies showing that 2.0 mg intranasal dose of neffy met all clinical endpoints recommended by regulators and that its pharmacokinetics were within the range of approved epinephrine injection products. These data, which were presented at the 2022American College of Allergy Asthma and Immunology AnnualScientific Meeting (ACAAI) and the 2023American Academy of Allergy , Asthma and Immunology (AAAAI) meeting, included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 600 individuals receiving at least one dose, and many with repeat administration. Adverse events in the clinical trials were generally mild in nature without any meaningful nasal irritation or pain.
- Presented Data Supporting Use of neffy During the 2023 AAAAI Meeting: ARS presented positive data supporting neffy during the 2023
American Academy of Allergy , Asthma and Immunology (AAAAI) meeting. Presentations highlighted clinical trial data demonstrating that neffy delivered consistent epinephrine levels to attain a pharmacokinetic (PK) and pharmacodynamic (PD) profile within the range of approved intramuscular (IM) injection products with a dose proportional exposure between once and twice dosing.
ARS also presented findings from surveys of 300 patients identifying that the needle is the principal reason why patients do not fill their epinephrine prescription today, and why they delay epinephrine use and use OTC products first despite treatment guidelines recommending immediate use of epinephrine.
Fourth Quarter and Full Year 2022 Financial Results
- Cash Position: Cash, cash equivalents and short-term investments were
$274.4 million as ofDecember 31, 2022 . ARS believes its existing cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan for at least three years. - R&D Expenses: Research and development (R&D) expenses were
$4.7 million for the quarter endedDecember 31, 2022 , and$18.4 million for the year endedDecember 31, 2022 . - G&A Expenses: General and administrative (G&A) expenses were
$10.7 million for the quarter endedDecember 31, 2022 , and$18.5 million for the year endedDecember 31, 2022 . G&A expenses for the fourth quarter increased over the prior three quarters mainly due to costs related to the merger with Silverback Therapeutics, Inc. and beginning preparations for the potential commercialization of neffy. - Net Loss: Net loss was
$14.4 million for the quarter endedDecember 31, 2022 , and$34.7 million for the year endedDecember 31, 2022 .
About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 to 40 million people in
About
ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, ARS’s projected cash runway; the anticipated timing for regulatory review decisions on neffy and the potential approval of neffy; ARS’s commercial readiness for the potential US launch of neffy, if approved, and the timing thereof; ARS’s strategy of pursuing potential partnerships or strategic transactions for neffy in
The forward-looking statements included in this press release are made only as of the date hereof. ARS assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
ARS Investor Contact:
justinc@ars-pharma.com
Consolidated Balance Sheets
(In thousands, except par value and share amounts)
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 210,518 | $ | 60,063 | |||
Short-term investments | 63,863 | — | |||||
Prepaid expenses and other current assets | 3,319 | 667 | |||||
Total current assets | 277,700 | 60,730 | |||||
Right-of-use asset | 445 | 621 | |||||
Fixed assets, net | 329 | 72 | |||||
Other assets | 2,961 | 23 | |||||
Total assets | $ | 281,435 | $ | 61,446 | |||
Liabilities, convertible preferred stock and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable and accrued liabilities (including related party amounts of |
$ | 4,931 | $ | 3,107 | |||
Lease liability, current | 230 | 144 | |||||
Contract liability, current | 283 | 1,457 | |||||
Note payable, current | — | 3,479 | |||||
Total current liabilities | 5,444 | 8,187 | |||||
Lease liability, net of current portion | 251 | 480 | |||||
Contract liability, net of current portion | 2,854 | 2,996 | |||||
Note payable, net of current portion | — | 4,930 | |||||
Preferred stock warrant liability | — | 83 | |||||
Total liabilities | 8,549 | 16,676 | |||||
Commitments and contingencies | |||||||
Convertible preferred stock and stockholders’ equity (deficit): | |||||||
Preferred stock, |
— | — | |||||
Series A convertible preferred stock, |
— | 365 | |||||
Series B convertible preferred stock, |
— | 1,000 | |||||
Series C convertible preferred stock, |
— | 19,868 | |||||
Series D convertible preferred stock, |
— | 54,806 | |||||
Stockholders’ equity (deficit) | |||||||
Common stock, |
9 | 3 | |||||
Additional paid-in capital | 349,408 | 10,984 | |||||
Accumulated other comprehensive gain | 407 | — | |||||
Accumulated deficit | (76,938 | ) | (42,256 | ) | |||
Total stockholders’ equity (deficit) | 272,886 | (31,269 | ) | ||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 281,435 | $ | 61,446 | |||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share information)
Years Ended |
|||||||
2022 | 2021 | ||||||
Revenue under collaboration agreements | $ | 1,316 | $ | 5,506 | |||
Operating expenses: | |||||||
Research and development (including related party amounts of |
18,376 | 20,273 | |||||
General and administrative (including related party amounts of |
18,456 | 4,687 | |||||
Total operating expenses | 36,832 | 24,960 | |||||
Loss from operations | (35,516 | ) | (19,454 | ) | |||
Other income (expense): | |||||||
Other income (expense), net | 974 | (789 | ) | ||||
Change in fair value of financial instruments | (140 | ) | — | ||||
Total other income (expense): | 834 | (789 | ) | ||||
Net loss | $ | (34,682 | ) | $ | (20,243 | ) | |
Unrealized gain on available-for-sale securities | 407 | — | |||||
Comprehensive loss attributable to common stockholders | $ | (34,275 | ) | $ | (20,243 | ) | |
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.87 | ) | $ | (0.70 | ) | |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | 39,956,043 | 28,872,242 | |||||
ARS Pharmaceuticals, Inc.