More than $280 million in combined cash and securities and at least three years of track operation to support the launch and commercialization of neffy® in the US, if approved
neffy® NDA currently under FDA review; PDUFA projected for mid-2023 MAA validated in the European Union under review
SAN DIEGO, November 8, 2022 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the closing of its merger with Silverback Therapeutics, Inc. (Silverback). This follows the satisfaction of all customary closing conditions, including approval of the merger by Silverback shareholders. The combined company will do business as ARS Pharmaceuticals, Inc., with common shares beginning trading under the trading symbol “SPRY” on November 9, 2022 on the Nasdaq Global Select Market. As of the closing of the merger, ARS has more than $280 million in cash and marketable securities.
ARS has designed and developed neffy® to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapid-delivery, and reliable nasal spray device for the treatment of severe type I allergic reactions, including anaphylaxis. With its needle-free administration, neffy® can help eliminate the anxiety and hesitation associated with using an epinephrine injection device.
Submission of the Company’s New Drug Application (NDA) for neffy® is currently under review by the U.S. Food and Drug Administration (FDA) with an anticipated Prescription Drug User Fee Act (PDUFA) date of mid-2023. The ARS has also filed and approved the validation of a Marketing Authorization Application (MAA) in Europe, which is currently being reviewed by the European Medicines Agency (EMA).
“This is a transformational time for ARS, enabling our move to a publicly traded organization and providing significant resources to support the potential launch and commercialization of neffy®, upon approval,” said Richard Lowenthal, ARS co-founder, president and CEO. “Millions of people suffer from severe allergic reactions, and sadly, too many do not treat their symptoms early or fail to treat their symptoms with injection devices, leading to disease progression and potentially dangerous or life-threatening outcomes. With neffy®, our goal is to take the fear out of administering epinephrine with a small, easy-to-use, needle-free nasal spray. Our team at ARS believes that neffy® can add significant clinical value to the community by providing an alternative to currently approved injection devices for patients and caregivers who do not carry, avoid using, or are hesitant to use their epinephrine injection device. With funding from our merger with Silverback, ARS is also dedicating significant efforts to patient education and support of advocacy groups working to protect the allergy community from patients with this disease.”
Post-merger, ARS has approximately 94 million common shares outstanding. Former ARS shareholders collectively own approximately 62% of the combined company and former Silverback shareholders collectively own approximately 38% of the combined company, in each case on a fully diluted basis using the treasury stock method and excluding options out of Silverback money.
As of the closing of the merger, the ARS board of directors (Board of Directors) will be comprised of eleven directors, including three Silverback directors:
Pratik Shah, Ph.D., Chairman of the Board;
Rajeev Dadoo, Ph.D., managing partner, SR One Capital Management, LP;
Saqib Islam, JD CEO of Springworks Therapeutics, Inc.;
Michael Kelly, former President of US Operations for Adapt Pharma, Inc.;
Peter Kolchinsky, Ph.D., managing partner, RA Capital Management, LP;
Jonathan Leff, Partner, Deerfield Management and President of the Deerfield Institute;
Richard Lowenthal, M.Sc., MSEL, ARS Co-Founder, President and CEO;
Brent Saunders, CEO of The Beauty Health Company
Phillip Schneider, Board Member of Longboard Pharmaceuticals Inc., former CFO and Senior Vice President of IDEC Pharmaceuticals Corporation;
Laura Shawver, Ph.D., CEO of Capstan Therapeutics and former CEO of Silverback;
Peter Thompson, MD, Private Equity Partner at Orbimed Advisors LLC.
SVB Securities LLC acted as financial advisor to Silverback and Cooley LLP acted as legal advisor to Silverback for the merger. Inceptiv Law served as legal counsel to ARS for the merger.
About type I allergic reactions, including anaphylaxis
Type I severe allergic reactions are severe, 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 auto-injectors have been shown to be highly effective, there are well-publicized limitations that cause many patients and caregivers to delay or not administer treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety issues, unreliability, and device complexity. There are approximately 25 to 40 million people in the United States who experience severe Type I allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescription autoinjector. Even if patients or caregivers carry an autoinjector, more than half delay or fail to administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.
ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from serious allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (formerly called ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions, including foods, medications, and insect stings that could lead to life-threatening anaphylaxis. For more information visit www.ars-pharma.com.
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, among others, the design and potential benefits of neffy®; the expected date of the PDUFA; the potential regulatory approval and commercialization of neffy®; the potential market opportunity for neffy®; the intended use of merger funds; and other statements that are not historical facts. 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,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current ARS expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the ability to obtain and maintain regulatory approval for neffy®; the results of clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications of neffy®; the labeling for neffy®, if approved; the scope, progress and expansion of the development and commercialization neffy®; the size and growth of the market for them and the rate and degree of acceptance of the market for them compared to 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 results to differ materially from those contemplated in forward-looking statements are included under the heading “Risk Factors” and elsewhere in the most recent ARS filings with the Securities and Exchange Commission. USA (SEC). including its preliminary proxy statement filed on August 11, 2022 and final proxy statement on October 6, 2022 and any reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time when and available at www. .sec.gov. These documents can be accessed on the ARS website at ir.ars-pharma.com by clicking on the “Financials & Filings” link.
The forward-looking statements included in this presentation 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.
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