Post-merger, ARS has approximately 94 million shares of common stock outstanding. With the funding from our merger with Silverback, ARS is also dedicated to significant efforts on patient education and support of advocacy groups working to protect the community of allergy patients with this disease.” Our team at ARS believes that neffy ® can add significant clinical value to the community by providing an alternative to the currently approved injection devices for patients and caregivers that either do not carry, avoid using or hesitate to use their epinephrine injection device. With neffy ®, our goal is to eliminate the fear of administering epinephrine with a small, needle-free and easy-to-use nasal spray. “Millions of individuals suffer from severe allergic reactions, and unfortunately, too many do not treat their symptoms in time or at all with injection devices, leading to disease progression and potentially dangerous or life-threatening outcomes. “This is a transformative time for ARS, enabling our move to a publicly traded organization and providing important resources to support the potential launch and commercialization of neffy ®, upon approval,” said Richard Lowenthal, co-founder, president and CEO of ARS. ARS has also filed and cleared validation of a Marketing Authorization Application (MAA) in Europe, which is currently under review by the European Medicines Agency (EMA). Food and Drug Administration (FDA) with an anticipated Prescription Drug User Fee Act (PDUFA) date in mid-2023. The Company’s New Drug Application (NDA) submission for neffy ® is currently under review by the U.S. With its needle-free administration, neffy ® may help eliminate the anxiety and hesitation associated with using an epinephrine injection device. Effective as of the closing of the merger, ARS has over $280 million in cash and marketable securities.ĪRS has designed and developed neffy ® to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device for the treatment of Type I severe allergic reactions, including anaphylaxis. The combined company will operate as ARS Pharmaceuticals, Inc., and shares of its common stock will commence trading under the trading symbol “SPRY” on November 9, 2022, on the Nasdaq Global Select Market. This follows the satisfaction of all customary closing conditions, including approval of the merger by the stockholders of Silverback. (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. 08, 2022 (GLOBE NEWSWIRE) - ARS Pharmaceuticals, Inc. Neffy ® NDA Currently Under FDA Review PDUFA Anticipated Mid-2023 MAA validated in the European Union Under Review All rights reserved.Over $280 Million in Combined Cash and Securities and at least Three Years Operating Runway to Support Launch and Commercialization of neffy ® in the U.S., if Approved Benzinga does not provide investment advice. ![]() Patient Square Capital Takes Medical Device Maker Hanger Private In $1.25B Dealĭon't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better. Liminal BioSciences Pulls Plug On Its Lead Development Program Price Action: SBTX shares are down 10.4% at $3.94 during the premarket session on the last check Friday. Silverback equity holders will own approximately 37%, and pre-merger ARS will own 63% of the combined company. ![]() If approved, ARS plans to launch neffy in the U.S. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector.ĪRS is preparing to submit its FDA marketing application for neffy in Q3 of 2022. ĪRS designed neffy to provide injection-like absorption of epinephrine in a small, easy-to-carry, easy-to-use, and rapidly administered nasal spray device. The combined entity is expected to have approximately $265 million in cash and equivalents at closing.Īlso Read: Silverback Therapeutics Axes Lead Immuno-Oncology Candidates, Lays Off 27% Workforce. The combined company will focus on neffy, ARS's investigational epinephrine nasal spray for Type I allergic reactions, including anaphylaxis. ARS Pharmaceuticals Inc will merge with Silverback Therapeutics Inc (NASDAQ: SBTX) in an all-stock transaction, with a new entity operating under the ARS Pharmaceuticals name and trade on NASDAQ under the SPRY symbol.
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