Core Insights - ARS Pharmaceuticals reported a total revenue of $32.5 million for Q3 2025, with $31.3 million coming from U.S. net product revenue of neffy, the first FDA-approved needle-free epinephrine treatment for Type I allergic reactions [1][5] - The company has a strong cash position of $288.2 million, which is expected to support operations until cash-flow break-even [1][5] - The direct-to-consumer (DTC) marketing strategy has significantly increased consumer awareness of neffy from approximately 20% to 56% since its launch [5][11] Financial Performance - Total revenue for Q3 2025 was $32.5 million, including $31.3 million in net product revenue and $1.1 million in supply revenue [5][29] - Research and Development (R&D) expenses were $2.8 million, primarily for ongoing clinical trials and studies related to neffy [5][29] - Selling, General and Administrative (SG&A) expenses reached $74.8 million, reflecting substantial investment in DTC marketing and sales efforts [5][29] - The net loss for Q3 2025 was $51.2 million, or $0.52 per share [5][29] Commercial Launch and Strategy - The DTC campaign has been effective in increasing patient awareness and prescriber confidence in neffy's effectiveness [2][5] - Over 18,000 healthcare providers have prescribed neffy, marking an 86% increase since August 2025 [11] - The "Get neffy on Us" campaign aims to eliminate barriers for patients by offering a free virtual prescribing option and zero dollar co-pay [11] Market Expansion - neffy has received regulatory approval in Japan, with expectations for availability in Q4 2025 [11] - The launch of EURneffy in the U.K. occurred in October 2025, targeting the largest market outside the U.S. for adrenaline auto-injectors [11] - Additional regulatory approvals for neffy in Canada and China are anticipated in 2026 [11] Clinical Development - A Phase 2b trial for intranasal epinephrine technology is ongoing, with topline data expected in mid-2026 [7] - A post-marketing registry study for neffy is also underway in the U.S. [11]

Core Insights - ARS Pharmaceuticals will present significant real-world data on the effectiveness of neffy® (epinephrine nasal spray) at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, showcasing its impact on treating anaphylaxis [1][2] Group 1: Presentation Details - One late-breaking oral presentation titled "Real World Data on the Effectiveness of Epinephrine Nasal Spray in Clinical Practice – Update" will be delivered on November 8, 2025 [3] - Six poster presentations will cover various aspects of neffy, including its effectiveness compared to autoinjectors, patient surveys, and case reports from clinical settings [5][6] Group 2: Expert Opinions - Dr. Jonathan Spergel emphasized that the real-world data supports intranasal epinephrine as a reliable alternative to injections, providing confidence to clinicians and patients [2] - Sarina Tanimoto, Co-founder and Chief Medical Officer of ARS Pharma, highlighted the breadth of research reinforcing the value of neffy in allergic emergencies [2] Group 3: Product Information - Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in patients aged 4 years and older who weigh at least 33 lbs [8] - The product aims to address limitations associated with traditional epinephrine auto-injectors, such as needle fear and portability issues [17]

Core Insights - ARS Pharmaceuticals reported total revenue of $8.0 million for Q1 2025, with $7.8 million coming from neffy sales and $0.2 million from collaboration revenue with ALK-Abelló [5][21] - The company is focused on the U.S. commercial launch of neffy, a needle-free epinephrine nasal spray approved for treating severe allergic reactions, including anaphylaxis [1][10] - A co-promotion agreement with ALK-Abelló has expanded neffy's promotional reach to nearly 20,000 healthcare providers, enhancing market access [1][5] Financial Performance - Total revenue for Q1 2025 was $8.0 million, with net product revenue from neffy sales at $7.8 million and collaboration revenue at $0.2 million [5][27] - R&D expenses were $3.0 million, primarily for neffy's clinical and development costs [5] - SG&A expenses totaled $41.1 million, mainly for personnel and marketing related to neffy's commercialization [5] - The net loss for Q1 2025 was $33.9 million, equating to $0.35 per share [5][27] - As of March 31, 2025, the company had cash and short-term investments totaling $275.7 million, supporting operations for at least the next three years [5][21] Commercial Launch Progress - neffy 1 mg is now available nationwide for children aged four and older, with the 2 mg dose available for adults and older children [5][10] - Over 5,000 physicians have prescribed neffy, indicating strong demand for this treatment option [1][6] - The company is launching a national direct-to-consumer marketing campaign to increase brand awareness and drive demand [5][6] Market Access and Engagement - The sales force has engaged over 10,000 healthcare providers, with more than 50% having prescribed neffy [11] - Approximately 57% commercial coverage has been secured, with ongoing discussions to achieve over 80% access by early Q3 2025 [11][12] - More than 1,000 schools have opted into the neffyinSchools program, receiving free doses for emergency use [11][12] Clinical Development - ARS Pharma plans to initiate a Phase 2b clinical trial in Q2 2025 to evaluate intranasal epinephrine for chronic spontaneous urticaria [8] - Regulatory reviews for neffy are ongoing in the U.K. and Canada, with expected decisions by mid-2025 [12]