Epinephrine Bitartrate

Offers no-hassle, free virtual visit with healthcare provider for patients to receive neffy for $0 co-pay if eligible with commercial insurance Program is available to eligible patients who may already have an auto-injector, but are looking for a smaller, easier to administer option SAN DIEGO, Nov. 04, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced the launch of “Get neffy on Us,” a new integrated commercial program to help patients access their needle-free epinephrine medicine, neffy. Get neffy on Us was created to eliminate the time burden of an in-person office visit by offering a free visit with a virtual provider who can prescribe neffy. Eligible patients with commercial insurance may have a $0 co-pay for neffy. “There are approximately 40 million people living with severe allergies, yet there are a limited number of allergists to provide care,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “Consumer surveys indicate that more than 70 percent of Type 1 allergy patients are open to using a virtual prescribing option,1 and we are pleased to help patients receive a neffy prescription conveniently and affordably through the Get neffy on Us program.” Key features of the program include: Virtual prescriber can take only five-to-ten minutes and saves patients and caregivers’ timeNo cost for the virtual visit and $0 co-pay for commercially-insured, eligible patientsDelivery of neffy to a patient’s pharmacy or directly to their home within 3-5 days For more information about Get neffy on Us, visit www.getneffy.com or call 1-877-MY-NEFFY (1-877-696-3339). The program is part of ARS Pharma’s ongoing commitment to reducing barriers for people who want to experience the ease of carrying a needle-free, lifesaving medicine to treat their allergies. Earlier this year, ARS Pharma launched the neffyInSchools program, which provides eligible K-12 schools in the U.S. with two packs of neffy (1 mg and 2 mg) for the treatment of severe allergic reactions. It has been distributed to more than 6,600 schools in over 20 states. About neffy® neffy is 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. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATION neffy is 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 INFORMATION neffy contains 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 two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in 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 using neffy. 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. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. neffy may 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 use neffy. Common side effects of neffy include: 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. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see the full Prescribing Information and Patient Information for neffy. About Type I Allergic Reactions Including AnaphylaxisType 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. About ARS Pharmaceuticals, Inc.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 commercializing neffy® (trade name EURneffy® 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, 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 patient benefits and effectiveness of neffy, including its needle-free, compact, and portable design and its ease of administration; the expected timing and launch of the Get neffy on Us program and evaluations and judgments regarding the program; 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,” “on track to/for,” “potential,” “plan,” “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: potential safety and other complications from neffy; the ability to obtain and maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; 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 for neffy; the size and growth of the market for neffy and 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 SEC on August 13, 2025. This document 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, visit www.ars-pharma.com, and follow us on LinkedIn and X. ARS Investor Contact:Justin ChakmaARS Pharmaceuticalsjustinc@ars-pharma.com ARS Media Contact:Christy CurranSam Brown Inc. 615.414.8668christycurran@sambrown.com Reference: ARS Data on File, 2025

PHILADELPHIA & BOSTON--(BUSINESS WIRE)--Thomas Jefferson University and Sempresto, Inc. are pleased to announce an exclusive licensing agreement for a novel epinephrine autoinjector designed to improve accessibility and ease of use for patients with severe allergies. This breakthrough device, originally developed at Jefferson, will be further advanced and commercialized by Sempresto under the agreement. Sempresto, Inc., co-founded by Shawn Marcell, Executive Chairman and a veteran entrepreneur with a history of raising over $400 million for private and public ventures, and Elizabeth Reczek, PhD, Chief Executive Officer, a biotech and medical device leader with broad expertise in transforming cutting edge technologies into real-world solutions, is dedicated to bringing this life-saving innovation to market. At the core of this advancement is groundbreaking technology invented by Edmund Pribitkin, MD, MBA, FACS, Chief Physician Executive and EVP at Jefferson Health, and Professor in the Department of Otolaryngology-Head & Neck Surgery. Dr. Pribitkin, who will serve as the Chair of Sempresto’s Scientific Advisory Board, developed the smartphone-integrated autoinjector to address a critical gap in the administration of epinephrine for severe allergy patients. Despite the proven benefits of early epinephrine administration in reducing hospitalizations and improving survival rates, nearly two-thirds of severe allergy patients arriving at the Emergency Department have not received epinephrine prior to arrival. This is often due to the bulkiness and inconvenience of traditional autoinjectors, which patients may forget or leave behind. Sempresto’s solution is a slim, easy-to-carry epinephrine autoinjector that seamlessly attaches to any smartphone case. This innovative design aims to eliminate common barriers to epinephrine use and is poised to become the preferred choice over current alternatives. "Our goal is to ensure that no patient ever finds themselves without access to epinephrine in a moment of need," said Dr. Pribitkin. "This sleek and convenient design has the potential to redefine emergency preparedness for severe allergy sufferers." With a strong intellectual property foundation, including several issued patents, and a well-established regulatory pathway, Sempresto is positioned for success as it seeks partnerships to bring this life-saving technology to market. About Thomas Jefferson University Thomas Jefferson University, located in Philadelphia, is a nationally recognized academic institution committed to excellence in education, research, and healthcare innovation. With a rich history dating back to 1824, Jefferson integrates interdisciplinary collaboration across its colleges, including its renowned Sidney Kimmel Medical College, and fosters breakthroughs in medical and technological advancements. The university’s dedication to translational research has led to the development of innovative solutions that improve patient care and public health outcomes worldwide. About Sempresto, Inc. Sempresto, Inc. is a medical device company focused on developing innovative solutions that enhance patient access to life-saving treatments. Led by an experienced team of biotech and medical technology experts, Sempresto is committed to advancing novel drug delivery systems that integrate seamlessly into everyday life. The company’s flagship product, a smartphone-integrated epinephrine autoinjector, represents a transformative step forward in emergency preparedness for severe allergy sufferers.