Aankondiging • Feb 20

ARS Pharmaceuticals, Inc. Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

ARS Pharmaceuticals, Inc. announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions. Based on the company’s analysis of the data, the company believed these results should support filing its response to the FDA’s CRL. The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023. FDA did not provide guidance on a prespecified set of endpoints, but the data are anticipated to be informative to labeling if a second dose of neffy is needed. ARS Pharma also completed the nitrosamine testing requested in the CRL per FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected. Previously reported data with a single dose of neffy under NAC conditions showed accelerated absorption of neffy with exposures higher than IM injection during the early time period when clinical response to epinephrine is expected. ARS Pharma intends to submit this repeat dose NAC study data to the FDA as part of its response to the CRL early in the second quarter of 2024. neffy Repeat Dosing Study Design: The randomized, crossover pharmacokinetic (PK) and pharmacodynamic (PD) study enrolled 43 patients with seasonal allergic rhinitis who tested positive with a Total Nasal Symptom Score (TNSS) of =5 out of 12 and a congestion score of =2 out of 3 during the screening NAC. NAC involves spraying purified antigen directly onto the nasal mucosa – a worst-case experimental condition in contrast to real-world nasal conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. All patients were dosed with epinephrine within 15 minutes of induction of the NAC during the peak effect, without allowing time for nasal symptoms to subside. A second dose of epinephrine was given to patients 10 minutes after the first dose per FDA labeling of epinephrine products. FDA explicitly requested that ARS Pharma include intramuscular (IM) epinephrine given via manual syringe as the comparator in this study, as IM is the reference-listed drug and historical basis for efficacy of all other epinephrine products. Meta-analyses (Patel et al, JACI 2021) analyzing over 30,000 anaphylaxis events demonstrate that about 90% of events respond to a single dose of epinephrine injection irrespective of the delivery device, despite significant differences in PK. PK/PD Study Results: Data from the company’s primary analysis of the completed study showed that responses on pharmacodynamic (PD) surrogate markers for efficacy in anaphylaxis, such as systolic blood pressure and heart rate, correlated well with pharmacokinetic (PK) exposures and were consistently higher for repeat doses of neffy, irrespective of dosing in the same nostril (R/R) or opposite nostrils (R/L), compared to repeat doses of IM injection. Dosing in the same nostril (R/R) resulted in higher PD than injection at all time points measured, while dosing in the opposite nostril (R/L) was higher than injection until the 40 to 60 minute time points, after which PD was indistinguishable from injection. Consistent with prior studies, significant responses on these PD surrogate markers of efficacy with neffy were observed even at one minute after dosing. The PD responses demonstrate that the epinephrine exposures achieved with repeat doses of neffy (R/R or R/L) fully activate the receptors involved in reversing anaphylaxis symptoms. The clinical data also demonstrated that mean epinephrine concentrations following repeat doses of 2 mg neffy in the same nostril (R/R) were numerically higher than repeat doses of 0.3 mg injection at all time points through at least 240 minutes under NAC conditions. Mean epinephrine concentrations of 2 mg neffy in the opposite nostril (R/L) were also numerically higher than repeat doses of 0.3 mg injection for approximately 30 minutes, which is longer than the time period when clinical response would be expected to be observed after dosing epinephrine (i.e., within 10 minutes). The PK profile of repeat doses of neffy during normal nasal conditions was shown in prior studies to be highly similar to repeat doses of EpiPen, which serves as the upper bracket for exposures established to be safe. In this study, the PK profile of repeat doses of neffy in the same nostril (R/R) during nasal allergen challenge was highly similar to repeat doses of neffy during normal nasal conditions, and therefore also in the range of exposures established to be safe. Other ARS Pharma clinical studies have evaluated neffy PK/PD in people with the same TNSS and congestion severity scores as the experimental NAC studies, but with nasal symptoms due to real-world conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. These other studies showed no meaningful difference on PK/PD compared to dosing neffy under normal nasal conditions. Repeat doses of neffy were considered safe and well-tolerated. All adverse events were mild and continue to be consistent with those observed in prior studies of neffy across more than 700 subjects. There were no serious adverse events. Regulatory Status of neffy: Additional discussions with FDA subsequent to its issuance of the CRL confirmed that the new data are anticipated to be informative to labeling of administering a second dose of neffy. In May 2023, the FDA Advisory Committee (PADAC), determined a favorable benefit-risk profile of neffy (16:6 for adults and 17:5 for children). No PADAC member requested a repeat dose study during allergen-induced allergic rhinitis. In addition, multiple PADAC members highlighted the favorable profile of neffy in the company's single dose NAC study. ARS Pharma intends to file its response to the FDA’s CRL for neffy early in the second quarter of 2024, with an expected PDUFA action date six months from filing, followed by potential U.S. launch of neffy in the second half of 2024. ARS Pharma also intends to submit this repeat dose study data to the European Medicines Agency (EMA) to inform its Committee for Medicinal Products for Human Use (CHMP) Opinion decision expected by mid-2024.

Aankondiging • Nov 10

+ 5 more updates

ARS Pharmaceuticals, Inc. Announces Board Changes

On November 8, 2022, the Delaware corporation formerly known as “Silverback Therapeutics, Inc.” completed its previously announced merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of July 21, 2022, as amended on August 11, 2022 and October 25, 2022 (the “Merger Agreement”), by and among Silverback Therapeutics, Inc. (“Silverback”), Sabre Merger Sub, Inc., a wholly owned subsidiary of Silverback (“Merger Sub”), and ARS Pharmaceuticals, Inc. (“ARS Pharma”), pursuant to which Merger Sub merged with and into ARS Pharma, with ARS Pharma surviving the merger as a wholly owned subsidiary of Silverback (the “Merger”). Additionally, on November 8, 2022, the Company changed its name from “Silverback Therapeutics, Inc.” to “ARS Pharmaceuticals, Inc.” (the “Company”). In accordance with the terms of the Merger Agreement, (i) each of Vicki L. Capps, Robert Hershberg, M.D., Ph.D., Maria Koehler, M.D., Ph.D., Andrew Powell, J.D. and Jonathan Root, M.D. resigned from the Company’s board of directors and any respective committee membership of the Company’s board of directors, effective as of the consummation of the Merger, and (ii) each of Jeffrey Pepe, Ph.D., J.D., the Company’s Interim Chief Executive Officer, General Counsel and Corporate Secretary, and Russ Hawkinson, the Company’s Interim Chief Financial Officer, were terminated in connection with the Company’s previously announced reduction in force. Appointment of Directors and Executive: At the effective time of the Merger, the Company’s board of directors (and its committees) and executive officers were reconstituted to include the following directors and executive officers: Richard Lowenthal, M.S., MSEL, age: 56, President, Chief Executive Officer and Class II Director. Sarina Tanimoto, M.D., M.B.A., age: 54, Chief Medical Officer; Eric Karas, age: 50, Chief Commercial Officer; Justin Chakma, age: 33, Chief Business Officer and Secretary. Non-Employee Directors: Pratik Shah, Ph.D., age: 52, Chair of the Board and Class I Director; Rajeev Dadoo, Ph.D., age: 52, Class I Director; Saqib Islam, J.D., age: 53, Class III Director; Michael Kelly, age: 57, Class I Director; Peter Kolchinsky, Ph.D., age: 46, Class II Director; Jonathan S. Leff, age: 53, Class III Director; Brenton L. Saunders, age: 52, Class II Director; Phillip Schneider, age: 66, Class III Director; Laura Shawver, Ph.D., age: 65, Class III Director; Peter A. Thompson, M.D., age: 63, Class II Director. Class III directors have a term expiring in 2023, Class I directors have a term expiring in 2024 and Class II directors have a term expiring in 2025. The members of the Audit Committee are Phillip Schneider (Chair), Michael Kelly and Rajeev Dadoo, Ph.D. The members of the Compensation Committee are Rajeev Dadoo, Ph.D. (Chair) and Saqib Islam, J.D. The members of the Nominating and Corporate Governance Committee are Peter Kolchinsky, Ph.D. (Chair) and Jonathan S. Leff. Pursuant to the terms of the Merger Agreement, each of (i) Mr. Lowenthal, Dr. Shah, Dr. Dadoo, Mr. Kelly, Dr. Kolchinsky, Mr. Leff, Mr. Saunders and Mr. Schneider were appointed to the board of directors of the Company as designees of ARS Pharma and (ii) Mr. Islam, Dr. Shawver and Dr. Thompson remained on the board of directors of the Company as designees of Silverback. Richard Lowenthal, M.S., MSEL is a co-founder of ARS Pharma and has served as its President and a member of the board of directors of ARS Pharma since ARS Pharma’s inception in August 2015 and as ARS Pharma’s Chief Executive Officer since September 2018. From August 2015 to November 2007, Mr. Lowenthal served as President of Pacific-Link Regulatory Consulting and Research, Inc., a medicinal product development consultancy founded by Mr. Lowenthal, where he provided leadership and mentoring on clinical development, regulatory affairs, quality assurance, licensing and investment opportunities, including supporting the clinical and regulatory development of Valtoco (diazepam nasal spray). Prior to Pacific-Link Regulatory Consulting and Research, Inc., Mr. Lowenthal held many leadership roles at several biopharmaceutical and pharmaceutical companies that included Chief Executive Officer and President of MTG Biotherapeutics Inc.; Vice President of Regulatory Affairs and quality assurance for Cadence Pharmaceuticals, Inc.; Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc.; Vice President of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc.; Global Project Leader and Global Director of Regulatory Affairs for Janssen Research Foundation; Director of Regulatory Affairs and Quality Assurance for Somerset Pharmaceuticals Inc.; and New Drug Review Chemist for the U.S. Food and Drug Administration in the Division of Neuropharmacologic Drug Products and the Division of Oncology and Pulmonary Drug Products. Mr. Lowenthal holds an M.Sc. in organic chemistry from Florida State University and a Master’s in Business Science for Executive Leadership from the University of San Diego. He has served as past chair of the American Association of Pharmaceutical Scientists (San Diego region), as well as member of the USP Biotechnology Expert Committee, chair of the Virology Working group, member of the National Organization of Rare Disease Corporate Council and has worked with various PhRMA and ICH Working Groups. The Company believes Mr. Lowenthal is qualified to serve on its board of directors due to his over 28 years of biotechnology and pharmaceutical development experience, his experience as a founder, director and executive officer of biopharmaceutical companies and his educational background.

Rente dekkingsratio	n/a
Contant	US$200.97m
Aandelen	US$61.31m
Totaal verplichtingen	US$226.26m
Totaal activa	US$287.57m

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/06/16 09:40
Aandelenkoers aan het einde van de dag	2026/06/16 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Joshua Schimmer	Cantor Fitzgerald & Co.
Roanna Clarissa Ruiz	Leerink Partners LLC
Carl Byrnes	Northland Capital Markets

ARS Pharmaceuticals Balans Gezondheid

Financiële gezondheid criteriumcontroles 5/6

Belangrijke informatie

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