ARS Pharmaceuticals Reports Third Quarter 2025 Financial Results and Highlights for neffy® (epinephrine nasal spray)

Continued U.S. product growth driven by direct-to-consumer (DTC) investments and real-world evidence, expected to accelerate with seamless prescribing experience

Strong balance sheet of $288.2 million cash, cash equivalents and short-term investments anticipated to fund operations through cash-flow break-even

Conference call to be held today, November 10, 2025, at 5:30 a.m. PT / 8:30 a.m. ET

SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced financial results for the third quarter of 2025, and provided an update on the commercial launch ofneffy®(epinephrine nasal spray), the first and only FDA- and European Commission-approved needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis.

“We are executing our commercial strategy across multiple fronts, with each element reinforcing the others to drive momentum,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “Our direct-to-consumer campaigns are generating measurable increases in patient awareness; real-world evidence data are further strengthening prescriber confidence inneffy’s effectiveness; and we are implementing advertising programs such as a free virtual prescriber option and zero dollar co-pay to further reduce barriers for patients, so that when healthcare providers want their patients to haveneffy, we are able to assist and address potential obstacles.”

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. To access the webcast and slides, please visit theEvents & Presentationspage in the Investors & Media section of the Company’swebsite. A replay of the webcast will be available for 30 days following the event. Dial-in information for conference participants may be obtained byregistering for the event.

neffyis a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.

INDICATIONneffyis indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.

IMPORTANT SAFETY INFORMATIONneffycontains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

Always carry twoneffynasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose ofneffyif symptoms continue or come back. Eachneffycontains a single dose of epinephrine.neffyis for use in the nose only.

Useneffyright away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose ofneffy, a second dose is needed. If needed, administer a second dose using a newneffyin the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after usingneffy.

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson’s disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson’s disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies.neffyand other medications may affect each other, causing side effects.neffymay affect the way other medicines work, and other medicines may affect howneffyworks.

neffymay cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you useneffy.

Common side effects ofneffyinclude: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.

These are not all of the possible side effects ofneffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at1-877-MY-NEFFY (877-696-3339)or the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.

ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializingneffy®(trade nameEURneffy®in the EU), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients 4 years of age and older who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visitwww.ars-pharma.com.

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: evaluations, judgments, and expectations regarding ARS Pharma’s marketing and commercialization strategies; the anticipated use of proceeds from the loan facility; ARS Pharma’s guidance that its financial position is expected to support its operating plans through expected cash-flow break-even; expectations regarding the HCP prescribing experience; the projection that ARS Pharma will achieve unrestricted payor access while maintaining a steady-state gross-to-net retention of at least 50% for the long-term; the anticipated timing of regulatory decisions for neffy in Canada and China and the expected timing of commercial launches in Canada, China, and Japan; the anticipated timing of the EMA’s regulatory decisions forEURneffy1 mg; the potential to achieve regulatory milestone payments and the timing of payment thereof; the anticipated timing for topline data from the urticaria trial and the potential for ARS Pharma’s intranasal epinephrine technology to expand into the urticaria indication; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “expect,” “if,” “may,” “potential,” “plan,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications fromneffy; the ability to maintain regulatory approval forneffyin its currently approved indications; the scope, progress and expansion of developing and commercializingneffy; the risk that ARS Pharma may not realize its expected return on investment from its DTC campaign; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage forneffy; the size and growth of the market forneffyand the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission (“SEC”) on August 13, 2025 and in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, to be filed with the SEC today. These documents can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visitwww.ars-pharma.com, and follow us onLinkedInandX.