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 autoinjectors 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 autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals 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 commercializing neffy$(R)$ 2 mg (trade name EURneffy(R) in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.

Forward-Looking Statements

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: the expectation that neffy will save lives; the effectiveness of neffy; ARS Pharmaceuticals' preliminary financial results for the quarter ended December 31, 2024; ARS Pharmaceuticals' projected operating runway; the belief that ARS Pharmaceuticals is poised to accelerate the growth of neffy and how it expects to do so; ARS Pharmaceuticals' commercial coverage goals and the timing thereof; the expected timing for product availability of neffy 1 mg; 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," "expects," "if," "may," "potential," "on track to," "plans," "will," "would," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals' 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: risks related to preliminary financial results, as described above; potential safety and other complications from neffy; ARS Pharmaceuticals' reliance on its licensing partners; the ability to maintain regulatory approval for neffy in its currently approved indication and to obtain and maintain regulatory approval for neffy for additional indications; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals' ability to protect its intellectual property position; and the impact of government laws and regulations. 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 Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission ("SEC") on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals' 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 Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.

ARS Pharma Investor Contact:

Justin Chakma

ARS Pharma

justinc@ars-pharma.com

ARS Pharma Media Contact:

Christy Curran

Sam Brown Inc.

615.414.8668

christycurran@sambrown.com

(END) Dow Jones Newswires

January 13, 2025 08:00 ET (13:00 GMT)