ARS Pharmaceuticals (SPRY) Stock News, Mar-Aug 2025

ARS Pharmaceuticals (NASDAQ:SPRY) has achieved a significant milestone as the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved EURneffy, the first needle-free adrenaline nasal spray for emergency treatment of allergic reactions. The approval covers adults and children weighing over 30 kg.

The company's partnership with ALK-Abelló A/S includes a $145 million upfront payment and potential additional payments of up to $320 million in milestones, plus tiered double-digit royalties. The UK represents the largest market outside the US for adrenaline auto-injector sales. EURneffy's launch is expected in late Q3 2025.

The product offers advantages including temperature stability up to 50°C and longer shelf life compared to auto-injectors. Additional regulatory approvals are anticipated in Canada, Japan, and Australia by end of 2025, with China following in 2026.

ARS Pharmaceuticals (NASDAQ: SPRY), a biopharmaceutical company focused on developing solutions for anaphylaxis prevention, has announced its participation in three upcoming investor conferences in June 2025:

• William Blair 45th Annual Growth Stock Conference in Chicago on June 3, 2025 at 11:20 a.m. CT
• 2025 Jefferies Global Healthcare Conference in New York City on June 4, 2025 at 5:30 p.m. ET
• Scotiabank Third Annual Healthcare Canadian Investor Day in Toronto on June 17, 2025

Company executives Richard Lowenthal (Co-Founder, President and CEO) and Eric Karas (Chief Commercial Officer) will lead presentations at the William Blair and Jefferies conferences. Live and archived webcasts will be available on the company's website for 30 days following each event.

ARS Pharmaceuticals (NASDAQ: SPRY) reported Q1 2025 financial results and progress in the U.S. launch of neffy®, their FDA-approved needle-free epinephrine nasal spray. The company achieved $7.8 million in neffy U.S. net product revenue. Key highlights include: nationwide availability of neffy 1mg for children aged 4+ and 2mg for adults, co-promotion agreement with ALK-Abelló reaching nearly 20,000 healthcare providers, and over 5,000 prescribing physicians to date. Financial results show $275.7 million in cash reserves with runway for 3+ years, though the company reported a net loss of $33.9 million. Commercial progress includes 57% commercial coverage, with United Healthcare added April 1st, and over 1,000 schools enrolled in the neffyinSchools program. The company plans to launch a comprehensive DTC marketing campaign and expects regulatory decisions in multiple international markets throughout 2025-2026.

ARS Pharmaceuticals (NASDAQ: SPRY) has announced the U.S. availability of neffy® 1 mg, their FDA-approved nasal spray epinephrine for Type I allergic reactions and anaphylaxis in children aged 4+ years weighing 15-30 kg. The needle-free design eliminates the risk of accidental injections, which affects ~3,500 cases annually. Key features include:

- 100% successful dosing rate in human factor studies - 24-month shelf life with temperature tolerance up to 122°F - Available at $199 for two doses (GoodRx price) - Eligible commercially insured patients pay as little as $25 - Partnership progress with major insurers including United Healthcare and Express Scripts

The company is implementing comprehensive support programs, including financial assistance and a Patient Assistance Program for eligible uninsured patients. The neffyinSchools program will provide the medication to participating eligible schools.

ARS Pharmaceuticals (NASDAQ: SPRY), a biopharmaceutical company focused on developing solutions for anaphylaxis protection, has scheduled a conference call and webcast for Wednesday, May 14, 2025, at 5:30 a.m. PT / 8:30 a.m. ET. The event will cover the company's first quarter 2025 financial results and business highlights.

Participants can obtain dial-in information by registering for the event. The webcast and presentation slides will be accessible through the Events & Presentations page in the Investors & Media section of the company's website. A replay will remain available for 30 days after the event.

ARS Pharmaceuticals (NASDAQ: SPRY) has announced a co-promotion agreement with ALK-Abelló A/S to expand the reach of neffy® (epinephrine nasal spray) to additional U.S. pediatricians. This four-year partnership follows their previous licensing deal which provided ARS Pharma with $145 million upfront. The agreement will expand ARS Pharma's promotional reach to nearly 20,000 healthcare providers, targeting pediatricians who represent about 55% of all community-use epinephrine prescriptions in the U.S. Under the agreement, ARS Pharma will maintain U.S. revenue recognition and commercialization responsibilities, while ALK will be eligible for performance-based payments based on market share thresholds. The company expects operating expenses to increase by $3 million per quarter starting Q3 2025.

ARS Pharmaceuticals (SPRY) reported strong financial results for Q4 and full year 2024, with total revenue of $89.1 million, including $7.3 million from neffy® sales since its September 2024 launch. The company achieved net income of $49.9 million in Q4 and $8.0 million for the full year.

Key highlights include FDA approval of neffy 1 mg for children aged four and older weighing 15-30 kg, expanding market reach to ~2 million younger children. The company secured favorable coverage decisions from major insurers and is on track for >60% commercial lives coverage by Q1 2025.

With $314.0 million in cash and investments as of December 31, 2024, ARS maintains a three-year operating runway. The company received a $145 million upfront payment from ALK-Abelló partnership, with $73.5 million recognized as Q4 revenue.

ARS Pharmaceuticals (NASDAQ: SPRY) has received FDA approval for neffy® 1 mg, the first needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis, in children aged 4+ years weighing 15-30 kg. The approval marks the first major innovation in epinephrine delivery for this patient population in over 35 years.

The approval is supported by extensive clinical trials showing pharmacokinetic and pharmacodynamic responses comparable to injectable epinephrine. Human factor studies demonstrated effective use by children as young as 10 and untrained caregivers. The device maintains stability at room temperature for 24 months.

neffy 1 mg will be available in the US by May 2025, with most commercially insured patients paying $25 or less for two devices. A cash price of $199 for two doses is available through BlinkRx, with additional support through the neffyConnect program and Patient Assistance Program for eligible individuals.

ARS Pharmaceuticals (SPRY), a biopharmaceutical company focused on anaphylaxis prevention, has scheduled its fourth quarter and full year 2024 financial results conference call for March 20, 2025, at 8:30 a.m. ET.

The company will also participate in upcoming investor events including:

• Leerink Partners Global Healthcare Conference with a fireside chat on March 10, 2025
• 37th Annual Roth Conference with investor meetings on March 16-18, 2025

A webcast replay will be available for 30 days following the earnings call on the company's website under the Events & Presentations page.