Releases Details
ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates
ARS continues engagement with
Ended second quarter with
“Our primary focus is on making neffy, an investigational new drug, available to people as quickly as possible and we believe that our interactions with FDA are nearly complete,” said
Preparing for
- In May, the
U.S. Food and Drug Administration (FDA) convened an Advisory Committee meeting, which concluded a favorable benefit-risk profile of neffy, with a 16:6 vote in favor for adults and 17:5 vote in favor for children (≥30 kg) for the treatment of patients with allergic reactions (Type 1), including anaphylaxis. The Advisory Committee vote, while not binding, will be considered by FDA when making its decision regarding the potential approval of neffy. - In June, FDA extended the Prescription Drug User Fee Act (PDUFA) target action date to
September 19, 2023 , for the New Drug Application (NDA) for neffy (Intranasal (IN) Epinephrine) for the treatment of allergic reactions (Type 1), including anaphylaxis, for adults and children ≥30 kg. If approved, neffy would be the first needle-free, non-injectable epinephrine treatment available. - ARS’s
U.S. commercial preparedness activities are well underway, and its commercial leadership team and area sales managers are in place. The recruitment process for the expected 115 field-based representatives is progressing on track, pending FDA approval. The company is currently implementing marketing and market access strategies to increase awareness and readiness for the potential launch of neffy.
Additional Business Updates and Anticipated Milestones
- ARS further broadened the scope of its intellectual property position for neffy with a recently issued
U.S. patent onAugust 8, 2023 , and an allowed second patent application by theU.S. Patent and Trademark Office . The issued patent and the allowed patent application are directed to the use of intranasal epinephrine formulations, including the use of bile acid absorption enhancers, for the treatment of allergic diseases, such as urticaria. Topline data from the company’s ongoing Phase 2 randomized, placebo-controlled study of neffy in urticaria patients are expected by the fourth quarter of 2023. - Marketing authorization application (MAA) for neffy is under review by the
European Medicines Agency with a decision expected by year end 2023.
Second Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and short-term investments were
$252.2 million as ofJune 30, 2023 , which ARS believes are sufficient to fund its current operating plan for at least three years. - R&D Expenses: Research and development (R&D) expenses were
$7.3 million for the quarter endedJune 30, 2023 . - G&A Expenses: General and administrative (G&A) expenses were
$13.3 million for the quarter endedJune 30, 2023 . - Net Loss: Net loss was
$17.4 million for the quarter endedJune 30, 2023 .
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 belief that its interactions with FDA are nearly complete; the anticipated successful US launch of neffy, if approved, and the timing thereof; ARS’s expectation that it will be able to enable patient access to neffy within about eight weeks after approval; the expected number of field-based representatives and the expectation that ARS will complete its hiring goal upon approval of neffy; the expected reporting of topline data from ARS’s Phase 2 study of neffy in urticaria patients and the timing thereof; the estimated addressable patient population for neffy; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “plans,” “expects,” “on track to,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the ability to obtain and maintain regulatory approval for neffy; the Advisory Committee decision should not be relied on as an indication that neffy will ultimately be approved; the FDA is not bound by the Advisory Committee decision or any of its recommendations and there are a number of instances where the FDA has voted against the recommendations of advisory committees; the PDUFA target action date may be further delayed due to various factors outside ARS’s control; even though ARS believes its interactions with the FDA are nearly complete, there is no guarantee that new issues will not be identified which could delay or prevent the approval of neffy, and ARS’s belief that its interactions with the FDA are nearly complete should not be relied on as an indication that the FDA will ultimately approve neffy; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS’s Quarterly Report on Form 10-Q for the quarter ended
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 Contacts:
justinc@ars-pharma.com
monique@thrustsc.com
ARS Media Contact:
laura.oneill@finnpartners.com
Condensed Consolidated Balance Sheets
(in thousands, except share and par value data)
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 119,017 | $ | 210,518 | ||||
Short-term investments | 133,191 | 63,863 | ||||||
Prepaid expenses and other current assets | 2,826 | 3,319 | ||||||
Total current assets | 255,034 | 277,700 | ||||||
Right-of-use asset | 349 | 445 | ||||||
Fixed assets, net | 594 | 329 | ||||||
Other assets | 2,775 | 2,961 | ||||||
Total assets | $ | 258,752 | $ | 281,435 | ||||
Liabilities, convertible preferred stock and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities (including related party amounts of |
$ | 9,821 | $ | 4,931 | ||||
Lease liability, current | 233 | 230 | ||||||
Contract liability, current | — | 283 | ||||||
Total current liabilities | 10,054 | 5,444 | ||||||
Lease liability, net of current portion | 146 | 251 | ||||||
Contract liability, net of current portion | — | 2,854 | ||||||
Total liabilities | 10,200 | 8,549 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity | ||||||||
Preferred stock, |
— | — | ||||||
Common stock, |
9 | 9 | ||||||
Additional paid-in capital | 357,992 | 349,408 | ||||||
Accumulated other comprehensive (loss) gain, net | (180 | ) | 407 | |||||
Accumulated deficit | (109,269 | ) | (76,938 | ) | ||||
Total stockholders’ equity | 248,552 | 272,886 | ||||||
Total liabilities, convertible preferred stock and stockholders’ equity | $ | 258,752 | $ | 281,435 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
Three Months Ended |
Six Months Ended |
||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue under collaboration agreements | $ | 10 | $ | 464 | $ | 30 | $ | 1,127 | |||||||
Operating expenses: | |||||||||||||||
Research and development (including related party amounts of |
7,308 | 4,350 | 13,860 | 9,773 | |||||||||||
General and administrative (including related party amounts of |
13,305 | 2,458 | 25,486 | 4,797 | |||||||||||
Total operating expenses | 20,613 | 6,808 | 39,346 | 14,570 | |||||||||||
Loss from operations | (20,603 | ) | (6,344 | ) | (39,316 | ) | (13,443 | ) | |||||||
Other income (expense), net | 3,233 | (76 | ) | 6,985 | (227 | ) | |||||||||
Net loss | $ | (17,370 | ) | $ | (6,420 | ) | $ | (32,331 | ) | $ | (13,670 | ) | |||
Change in unrealized gains and losses on available-for-sale securities | (248 | ) | — | (587 | ) | — | |||||||||
Comprehensive loss | $ | (17,618 | ) | $ | (6,420 | ) | $ | (32,918 | ) | $ | (13,670 | ) | |||
Net loss per share, basic and diluted | $ | (0.18 | ) | $ | (0.21 | ) | $ | (0.34 | ) | $ | (0.45 | ) | |||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 94,911,268 | 30,606,773 | 94,571,180 | 30,488,749 |
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ARS Pharmaceuticals, Inc.