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]

主要亚太国家/地区的授权合作伙伴已向监管机构申请批准 2 毫克剂量的 neffy（肾上腺素鼻喷雾剂）圣地亚哥, Dec. 14, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) 是一家生物制药公司，致力于帮助高风险患者和护理人员更好地保护患者免于可能导致过敏性休克的过敏反应。该公司今天宣布，其在中国、日本和澳大利亚的授权合作伙伴已在各自国家申请批准 2 毫克剂量的 neffy® （肾上腺素鼻喷雾剂）。 2 毫克剂量的 neffy 最近已在美国获得批准，用于治疗体重至少达到 30 千克 (66 磅) 的成人和儿童的 I 型过敏反应，包括过敏性休克。 ARS Pharmaceuticals 联合创始人、总裁兼首席执行官 Richard Lowenthal 表示：“鉴于 neffy 在紧急治疗严重过敏反应时具有挽救生命的潜力，我们的重点工作就是让它尽快在全世界广泛普及。 neffy 可能很快就能与亚太地区的人们见面了。该产品有一些非常重要的独特属性，例如无需针头，易于处置，体积较小，能承受高达 122°F (50°C) 的温度，保质 ...

SAN DIEGO, Dec. 12, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that its licensing partners in China, Japan and Australia have filed for approval of neffy® (epinephrine nasal spray) 2 mg in their respective countries. neffy 2 mg was recently approved in the U.S. for the treatment of Type I Allergic Reac ...

Qualifying public and private K-12 Schools in the U.S. will be eligible to receive two free cartons (four single use doses) of neffy® (epinephrine nasal spray) 2mg for use in emergency treatment of allergic reactions including anaphylaxis Interested schools are encouraged to review applicable state laws and regulations to ensure neffy for undesignated use meets all requirements SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to emp ...