Core Viewpoint - The FDA has approved neffy® 1 mg, a needle-free epinephrine nasal spray, for treating Type I allergic reactions, including anaphylaxis, in children aged 4 years and older weighing between 15 to < 30 kilograms, marking a significant innovation in epinephrine delivery for this demographic in over 35 years [1][3]. Group 1: Product Details - Neffy 1 mg is the first needle-free epinephrine treatment approved for younger children, providing a precise dose via a nasal spray without the need for a nasal hold time [1][2]. - The device has a shelf-life of 24 months at room temperature and can withstand temperatures up to 122°F (50°C) for up to 3 months [3]. - Neffy can be effectively used by children as young as 10 and even by untrained individuals, such as babysitters or teachers [3]. Group 2: Market Context - Approximately one in 13 children in the general population have severe food allergies, with over 40% experiencing severe reactions [2]. - Despite the benefits of early epinephrine use, around 40% of patients delay treatment, and 56% of caregivers are apprehensive about using needle-based auto-injectors [2][16]. - Nearly 40% of U.S. epinephrine prescriptions are written for children under 18, with a significant portion for those weighing 15 to 30 kilograms [3]. Group 3: Company Commitment and Accessibility - ARS Pharmaceuticals aims to enhance access and affordability for neffy 1 mg, with most commercially insured patients expected to pay no more than $25 for two devices through a co-pay savings program [4]. - The neffyConnect program will assist patients and caregivers with treatment guidance, medication fulfillment, and financial support [4]. - The neffy 1 mg is anticipated to be available in the U.S. by the end of May 2025 [4][5].

Core Points - ARS Pharmaceuticals, Inc. will host a conference call on March 20, 2025, at 8:30 a.m. ET to discuss its fourth quarter and full year 2024 financial results and business highlights [1] - The company is dedicated to empowering at-risk patients and caregivers to protect against allergic reactions that could lead to anaphylaxis [3] Company Information - ARS Pharmaceuticals is commercializing neffy® 2 mg (trade name EURneffy® in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [3] - The product is indicated for emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced anaphylaxis in both adults and children [3] Upcoming Events - ARS Pharma Management will participate in several investor conferences, including a fireside chat at the Leerink Partners Global Healthcare Conference on March 10, 2025, and investor meetings at the 37th Annual Roth Conference from March 16-18, 2025 [4]

Core Insights - ARS Pharmaceuticals has expanded access to neffy, an epinephrine nasal spray, to approximately half of all patients managing Type 1 allergic reactions by adding it to 30 formularies, including those of Cigna Healthcare, Navitus Health Systems, and OptumRx [1][2][3] Group 1: Product Information - Neffy is the first FDA-approved epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, for patients weighing 30 kg or more [4][7] - The product is designed for rapid administration, is portable, and has a shelf-life of 30 months with temperature stability up to 122 degrees Fahrenheit [4] - A supplemental NDA for neffy 1 mg, aimed at children over four years old weighing 15 to 30 kg, has a target action date of March 6, 2025, with expected availability by the end of May 2025 [5] Group 2: Market Impact - The addition of neffy to formularies improves coverage for approximately 20 million individuals diagnosed with severe Type I allergic reactions who require epinephrine therapy [3][15] - Millions of patients now have improved access to neffy through commercial insurance, with a low copay of $25 available for those insured by OptumRx, Cigna Healthcare, and Navitus Health Systems [2][3] Group 3: Company Commitment - ARS Pharmaceuticals is committed to ensuring continued access to neffy for patients and caregivers, highlighting the critical demand for a nasal spray option in the severe allergy community [2][3] - The company is actively working with UnitedHealthcare to add neffy to their formulary [2]

Core Insights - ARS Pharmaceuticals, Inc. announced the presentation of nine studies at the 2025 AAAAI Annual Scientific Meeting, highlighting the efficacy and safety of neffy, an intranasal epinephrine product for managing anaphylaxis [1][2][20] - Neffy has demonstrated lower symptom scores within 10 minutes compared to traditional intramuscular auto-injectors, supporting its use as a needle-free option for anaphylaxis management [1][19] - The product is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [12][20] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and caregivers to manage severe allergic reactions effectively [20] - Neffy is the first FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in both adults and children [2][20] - The company aims to advance scientific knowledge regarding epinephrine administration and improve treatment accessibility for patients [2][20] Research Findings - Studies presented will cover pharmacokinetics and pharmacodynamics of neffy under various conditions, including self-administration and allergic challenges [1][2] - Findings from Japanese and Chinese studies confirm the efficacy and safety of neffy, demonstrating its comparable performance to intramuscular injections [1][19] - The research includes insights into the physiological responses of different age groups to epinephrine administration [6][7] Meeting Activities - The AAAAI Annual Scientific Meeting will feature oral presentations and poster sessions detailing the clinical research on neffy [2][11] - ARS Pharma will host various onsite activities, including a product theatre and an exhibit booth to engage with attendees [11][20]

Company Overview - ARS Pharmaceuticals, Inc. is a biopharmaceutical company focused on empowering at-risk patients and caregivers to protect against severe allergic reactions that could lead to anaphylaxis [3] - The company is commercializing neffy 2 mg (trade name EURneffy in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [3] Upcoming Events - Richard Lowenthal, Co-Founder, President and CEO, along with Eric Karas, Chief Commercial Officer, will participate in a fireside chat on February 12, 2025, at 2:40 p.m. ET during the Oppenheimer 35th Annual Healthcare Conference [2] - The company management will also engage in one-on-one meetings with investors, and a live webcast of the fireside chat will be available on the company's website [2]

Core Points - ARS Pharmaceuticals has launched the neffyinSchools program to provide eligible K-12 schools in the U.S. with free access to neffy® (epinephrine nasal spray) for emergency use [1][5] - The program aims to ensure that schools are prepared to handle severe allergic reactions, which can occur unexpectedly [2][3] - neffy 2 mg is approved for treating Type I allergic reactions, including anaphylaxis, in individuals weighing 30 kg (66 lbs) or more [1][6] Group 1: Program Details - Eligible schools will receive two cartons (four single-use doses) of neffy 2 mg at no cost, with replacement doses available when used or expired [1][5] - The program is specifically for undesignated use, meaning schools must ensure compliance with local laws regarding epinephrine stocking and administration [5][3] - A supplemental NDA for a 1 mg dose of neffy has been granted priority review by the FDA, with a PDUFA date set for March 6, 2025 [5] Group 2: Importance of the Program - The program addresses the critical need for immediate access to epinephrine in schools, as one-quarter of anaphylactic reactions occur in students with previously undiagnosed allergies [3][15] - Approximately 1 in 20 school-aged children are affected by food allergies, highlighting the necessity for schools to be equipped for emergencies [3][15] - The neffyinSchools program is expected to enhance the safety and preparedness of schools in managing anaphylaxis [2][3] Group 3: Company Commitment - ARS Pharmaceuticals is dedicated to making neffy freely available to eligible schools, emphasizing the importance of life-saving epinephrine in emergency situations [3][16] - The company aims to improve the accessibility and administration of epinephrine, addressing common barriers associated with traditional autoinjectors [15][16] - ARS Pharmaceuticals will host a webinar for school nurses and administrators to provide information about the neffyinSchools program [3]

Core Insights - ARS Pharmaceuticals reported preliminary fourth quarter neffy net product revenue of approximately $6.5 million, with total net product sales for 2024 reaching approximately $7.1 million since the product's launch on September 23, 2024 [4] - The company has a strong cash position, with cash, cash equivalents, and short-term investments totaling approximately $314.0 million as of December 31, 2024, which is expected to support operations for at least three years [4] - The company aims to enhance neffy sales in 2025 through targeted commercial initiatives, including increasing education and awareness among prescribers and launching direct-to-consumer marketing campaigns [3][4] Financial Performance - Preliminary neffy net product revenue for Q4 2024 was approximately $6.5 million, with over 14,500 two-pack units delivered in the quarter [4] - Total net product sales for 2024 amounted to approximately $7.1 million since the product became available [4] - The company anticipates achieving over 80% commercial insurance coverage by the end of Q3 2025 [4] Strategic Initiatives - The company plans to expand its neffy Experience Program and increase engagement with healthcare providers, with over 3,000 providers having prescribed neffy to date [4] - A branded direct-to-consumer marketing campaign is set to launch in May 2025, aimed at building brand recognition ahead of the back-to-school season [4][11] - The company is on track to secure more than 60% commercial coverage by the end of Q1 2025 [4] Upcoming Events - Richard Lowenthal, President and CEO of ARS Pharmaceuticals, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [5]

Core Viewpoint - ARS Pharmaceuticals has filed for approval of neffy (epinephrine nasal spray) 2 mg in Canada and the UK, expanding its market presence after recent approval in the U.S. for treating Type I allergic reactions, including anaphylaxis [1][2] Group 1: Product and Market Expansion - neffy will be marketed as EURneffy in Canada and the UK, representing significant markets within the ALK portfolio [1] - The company has now filed for approval in jurisdictions covering over 98% of the global epinephrine market [2] - ARS Pharma retains U.S. rights for neffy and has licensing partnerships in China, Japan, Australia, and New Zealand [3] Group 2: Licensing Agreement and Financials - Under the licensing agreement with ALK, ARS Pharma received an upfront payment of $145 million and can earn up to an additional $320 million in regulatory and sales milestones, along with tiered royalties in the teens on net sales [2] - The agreement grants ALK exclusive rights to commercialize neffy in Europe, Canada, the UK, and other regions outside the U.S. [1][2] Group 3: Clinical Development - ARS Pharma is evaluating its intranasal epinephrine technology for treating acute flares in chronic urticaria, with plans for a Phase 2b clinical trial in early 2025 [4] - The licensing agreement with ALK includes exclusive rights for any new indications in the licensed territories [4] Group 4: Product Information - neffy is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [5][14] - The product aims to address limitations of traditional epinephrine autoinjectors, which are often not carried or used in emergencies [13]

Core Insights - The inclusion of neffy on Express Scripts' commercial formularies enhances access to life-saving allergy treatment for patients managing Type 1 allergic reactions, including anaphylaxis [1][3] - neffy is the first FDA-approved epinephrine nasal spray, providing a needle-free alternative to traditional injectables, and is designed for rapid administration [2][5] - ARS Pharmaceuticals anticipates that other payers will follow Express Scripts in providing access to neffy, further expanding its market reach [3] Product Information - neffy 2 mg is indicated for emergency treatment of Type I allergic reactions in patients weighing 30 kg or greater, including both adults and children [2][5] - The product features a shelf-life of 30 months and can withstand temperatures up to 122 degrees Fahrenheit, making it portable and user-friendly [2] - neffy addresses limitations associated with epinephrine autoinjectors, such as fear of needles and complexity, which can lead to delays in treatment during emergencies [15] Market Context - Approximately 40 million people in the U.S. experience Type I allergic reactions, with around 20 million diagnosed and treated for severe reactions in the last three years [15] - Despite the high number of patients, only 3.2 million filled their active epinephrine autoinjector prescriptions in 2023, indicating a significant market opportunity for neffy [15] - The quick turnaround from product introduction to inclusion in formularies (nine weeks) demonstrates the demand and potential for neffy in the market [3]

Company Overview - ARS Pharmaceuticals, Inc. is a biopharmaceutical company focused on empowering at-risk patients and caregivers to protect against severe allergic reactions that may lead to anaphylaxis [3] - The company is commercializing neffy® 2 mg (trade name EURneffy® in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [3] Upcoming Events - ARS Pharmaceuticals will participate in the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco [1] - Richard Lowenthal, Co-Founder, President and CEO, will present on January 15, 2025, at 7:30 a.m. PT, and management will engage in one-on-one meetings with investors [2] - A live webcast of the presentation will be available on the company's website, with a replay archived for 90 days [2]