SAN DIEGO, November 10, 2025 — Leads & Copy — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) has released its financial results for the third quarter of 2025, along with an update on the commercial launch of neffy® (epinephrine nasal spray), a needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis, approved by the FDA and the European Commission.
According to Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma, the company is executing its commercial strategy across multiple fronts to drive momentum. Direct-to-consumer campaigns are increasing patient awareness, real-world evidence data strengthens prescriber confidence in neffy’s effectiveness, and advertising programs are reducing barriers for patients.
Total revenue for the third quarter of 2025 reached $32.5 million, which includes $31.3 million in net product revenue from neffy sales in the U.S., and $1.1 million in supply revenue from partners. Royalties from ALK-Abelló A/S (ALK) related to the launch of EURneffy® in Germany at the end of June 2025 was $0.1 million.
R&D expenses for the third quarter of 2025 were $2.8 million, which was primarily associated with the ongoing Phase 2b clinical trial in urticaria and the ongoing post-marketing registry study for the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics and other development expenses for neffy.
SG&A expenses for the third quarter of 2025 were $74.8 million, which reflects the company’s investment in the DTC marketing campaign and sales and marketing expenses associated with the U.S. commercialization of neffy. Net loss for the third quarter of 2025 was $51.2 million, or $0.52 per share.
As of September 30, 2025, ARS Pharma had cash, cash equivalents, and short-term investments of $288.2 million, with 98,844,178 shares of common stock outstanding. The company drew down $100 million from its new $250 million senior security term loan facility with an affiliate of RA Capital Management and an affiliate of OMERS Life Sciences. The company believes that its quarter-end cash position will fund operations through expected cash-flow break-even.
Since its launch late in the second quarter of 2025, the DTC campaign has significantly increased consumer awareness of neffy, growing from approximately 20% pre-campaign to 56% as of September 2025.
The company expects to achieve unrestricted payor access while maintaining steady-state gross-to-net retention guidance of at least 50%, including co-pay support programs.
Other highlights from the neffy U.S. commercial launch include:
- Over 18,000 HCPs have prescribed neffy to date, representing an 86% increase from August 2025.
- The company initiated a new integrated commercial program, “Get neffy on Us,” to eliminate the time burden of an office visit and reduce cost barriers.
- An updated analysis of real-world treatment outcomes with 680 patients showed about 90% of patients experiencing anaphylaxis were effectively treated with a single dose of neffy.
- More than 6,500 schools have opted into the neffyinSchools program, each receiving two cartons of neffy 2 mg or 1 mg at no cost for emergency use through the School Health Corp. SHConnect platform.
- The ARS Pharma post-marketing, registry-based randomized, controlled study of neffy for the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics in the U.S. is ongoing.
In September 2025, the Pharmaceutical and Medical Devices Agency (PMDA) granted approval for neffy 2 mg and 1 mg in Japan for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 15 kg. Alfresa owns the rights to market neffy in Japan and expects neffy to be available in the fourth quarter of 2025.
ALK successfully launched EURneffy® 2 mg in the U.K. in October 2025. Regulatory approval for neffy in Canada (with ALK-Abelló) is expected in the first quarter of 2026, with launch expected to start in the first half 2026. Regulatory approval for neffy in China (in partnership with Pediatrix) is expected in the first half of 2026.
A Phase 2b trial (NCT06927999) to evaluate intranasal epinephrine technology as a treatment for acute flares is enrolling patients with chronic spontaneous urticaria in the U.S. and Europe, with topline data anticipated in mid-2026.
ARS Pharma management will host a conference call and webcast at 5:30 a.m. PT / 8:30 a.m. ET today, November 10, 2025.
Investor Contact:
Justin Chakma, ARS Pharma
justinc@ars-pharma.com
Media Contact:
Christy Curran, Sam Brown Inc.
christycurran@sambrown.com
615.414.8668
Source: ARS Pharmaceuticals, Inc.
