ARS Pharmaceuticals has recently released its 10-Q report, showcasing the company's focus on developing and commercializing treatments for severe allergic reactions. The company's flagship product, neffy, is an FDA and European Commission-approved needle-free epinephrine nasal spray for the emergency treatment of Type I allergic reactions, including anaphylaxis. The market opportunity for neffy in the United States alone is significant, with an estimated initial addressable market opportunity of approximately $3 billion in annual net sales for the 6.5 million patients currently prescribed an epinephrine autoinjector, and an additional addressable market opportunity of approximately $7 billion for the remaining 13.5 million diagnosed patients who have not been prescribed an epinephrine product.
In the Management’s Discussion and Analysis of Financial Condition and Results of Operations, the company reported a net loss from operations of $47.6 million for the six months ended June 30, 2025, compared to $15.3 million for the same period in 2024. As of June 30, 2025, the company had an accumulated deficit of $202.1 million. ARS Pharmaceuticals has funded its operations primarily through proceeds from the Merger, private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with commercialization partners, bank debt, and limited net product sales. The company does not own or operate manufacturing facilities and relies on third-party manufacturers and suppliers for its products.
The report also highlights the company's commercialization efforts, including the initiation of the U.S. commercial launch of neffy in September 2024, with the product becoming available for shipment on September 23, 2024. The commercialization effort includes a direct sales force of approximately 108 individuals targeting high-volume epinephrine prescribers, supported by branded direct-to-consumer marketing, disease awareness campaigns, and non-personal promotion. Additionally, the company received marketing authorization for EURneffy in the EU and has initiated a Phase 2b randomized, placebo-controlled outpatient clinical trial for chronic spontaneous urticaria patients.
ARS Pharmaceuticals also entered into a collaboration, license, and distribution agreement with ALK, granting ALK an exclusive license under certain patents and know-how to develop, manufacture, and commercialize products containing epinephrine administered intranasally in territories outside the United States, Japan, mainland China, Hong Kong, Taiwan, Macau, Australia, and New Zealand.
Today the company's shares have moved -5.55% to a price of $15.735. Check out the company's full 10-Q submission here.
