Highest-materiality recent filing
ARS Pharma stockholders elect Class III directors, ratify EY, approve say-on-pay
Saqib Islam, Phillip Schneider, Laura Shawver elected as Class III directors; Schneider received 38.5M for vs 27.5M withheld.
ARS Pharma reports Q1 revenue $22.7M, neffy net product revenue $17.5M
Net loss $60.6M ($0.61/share); cash $201M; expects to fund to cash-flow break-even.
ARS Pharma appoints Donn Casale as President effective June 1, 2026
Donn Casale, 53, most recently Chief Commercial Officer at Dynavax (acquired by Sanofi), joins as President.
ARS Pharma reports $72.2M neffy sales in first full year; net loss $171.3M
Full-year U.S. neffy net product revenue $72.2M; total revenue $84.3M including $9.7M partner revenue.
ARS Pharma reports Q3 net loss $51.2M; neffy net product revenue $31.3M
Q3 2025 total revenue $32.5M, including $31.3M neffy U.S. net product revenue; net loss $51.2M ($0.52/share).
ARS Pharmaceuticals enters $250M credit facility, draws $100M upfront
$100M Term A Loan drawn Sep 29 2025; up to $250M total available in four tranches.
ARS Pharma receives Paragraph IV notice from Lupin for generic neffy; intends to sue
Lupin filed ANDA for generic version of neffy (epinephrine nasal spray) before expiration of 8 Orange Book-listed patents.
ARS Pharma Q2 revenue $15.7M, neffy volume +180% QoQ, net loss $44.9M
Total revenue $15.7M, including $12.8M neffy U.S. net product revenue and $2.6M milestone from ALK.
ARS Pharma stockholders elect four Class II directors, ratify Ernst & Young as auditor
Elect directors Richard Lowenthal, Peter Kolchinsky, Brenton Saunders, Peter Thompson to 2028 term.
ARS Pharma Q1 neffy revenue $7.8M, net loss $33.9M; commercial progress with 5,000+ prescribers
Net product revenue of $7.8M from neffy; total revenue $8.0M; net loss $33.9M ($0.35 per share).
ARS Pharma and ALK co-promote neffy nasal spray to up to 9,000 U.S. pediatricians
Co-promotion agreement with ALK-Abelló, Inc. for neffy (epinephrine nasal spray) targeting pediatricians and other prescribers.
ARS Pharma Q4 net income $49.9M, neffy sales $6.7M; pediatric approval expands market
neffy net product revenue $7.3M for FY2024 since Sep launch; Q4 net product revenue $6.7M.
FDA approves ARS Pharma's neffy 1 mg for pediatric allergic reactions
FDA approved neffy 1 mg (epinephrine nasal spray) on March 5, 2025 for children aged 4+ weighing 15-30 kg.
ARS Pharma reports preliminary Q4 2024 neffy revenue of $6.5M, cash $314M
Preliminary neffy net product revenue for Q4 2024 was approximately $6.5 million, total 2024 revenue $7.1 million since launch on Sept 23.
ARS Pharma Q3 net loss $19.1M; neffy launch progressing; ALK deal $145M
Net loss of $19.1M for Q3 2024; total revenue of $2.1M including $0.6M neffy product revenue from one week of sales.
ARS Pharma licenses neffy to ALK for $145M upfront; up to $320M milestones
Upfront $145M from ALK; regulatory/commercial milestones up to $20M and sales milestones up to $300M.
ARS Pharma enters long-term supply agreement for neffy glass microvials through 2035
Upfront payment of €3 million to Nuova Ompi for glass microvial supply.
ARS Pharmaceuticals amends manufacturing agreement with Renaissance Lakewood for neffy nasal spray
Second amendment to manufacturing agreement for neffy executed September 17, 2024.
FDA approves ARS Pharma's neffy epinephrine nasal spray for allergic reactions
FDA approved neffy on Aug 9, 2024 for emergency treatment of anaphylaxis in adults and children ≥30 kg.
ARS Pharma Q2 net loss $12.5M; neffy PDUFA Oct 2; cash $218.7M
Cash, equivalents and short-term investments $218.7M as of June 30, 2024, providing at least three years of operating runway.
CHMP recommends EU marketing authorization for ARS Pharma's epinephrine nasal spray EURneffy
CHMP adopted positive opinion for EURneffy (2 mg epinephrine nasal spray) for emergency anaphylaxis treatment.
ARS Pharmaceuticals (SPRY) filed an updated corporate presentation on June 28, 2024, under Item 7.01 FD disclosure.
Shareholders elected Rajeev Dadoo, Michael Kelly, and Pratik Shah as Class I directors for terms expiring at 2027 annual meeting.
ARS Pharmaceuticals updates corporate presentation; no specific new details disclosed
Filed an updated corporate presentation for investor meetings on May 10, 2024.
ARS Pharma reports Q1 net loss $10.3M; neffy PDUFA date Oct 2, 2024; cash $223.6M
Cash and securities $223.6M as of March 31, 2024; expected operating runway at least three years.
ARS Pharma to submit CRL response in early Q2 2024; Q4 net loss $7.2M, cash $228.4M
CRL response for neffy (epinephrine nasal spray) to be submitted early Q2 2024; FDA action and potential launch expected H2 2024.
ARS Pharma discloses $228M cash; neffy investor day presentation published
Cash and short-term investments of ~$228M as of December 31, 2023.
ARS Pharmaceuticals Q3 net loss $14.9M; neffy NDA resubmission anticipated H1 2024
Cash, equivalents and short-term investments $241.9M as of Sep 30, 2023; operating runway ≥3 years.
ARS Pharma updates corporate presentation for Q4 2023 investor meetings
Company posted updated corporate presentation on its website and furnished as Exhibit 99.1.
ARS Pharma receives FDA Complete Response Letter for neffy; plans appeal, resubmission H1 2024
FDA CRL requests a repeat-dose PK/PD study in allergen-induced allergic rhinitis conditions for approval.
ARS Pharma reports Q2 net loss $17.4M; neffy PDUFA date Sept 19, 2023
Cash, equivalents and short-term investments $252.2M as of June 30, 2023, funding at least three years.
ARS Pharmaceuticals stockholders elect three Class III directors at 2023 annual meeting
Elected Saqib Islam, Phillip Schneider, Laura Shawver as Class III directors to serve until 2026.
ARS Pharmaceuticals released a revised corporate presentation on May 16, 2023.
ARS Pharma neffy FDA Panel Vote 'Favorable'; Q1 Net Loss $15.0M, Cash $264.5M
FDA advisory committee voted 16:6 (adults) and 17:5 (children) that neffy benefit-risk is favorable.
ARS Pharma faces FDA AdCom on May 11 for neffy (intranasal epinephrine); PK/PD sufficiency debated
FDA AdCom to discuss whether PK/PD data for ARS-1 (intranasal epinephrine) sufficiently establish efficacy for anaphylaxis; meeting scheduled May 11, 2023.
ARS Pharma reports FY2022 net loss $34.7M; neffy NDA under FDA review, PDUFA mid-2023
Net loss of $14.4M for Q4 2022 and $34.7M for full year 2022; cash & investments $274.4M as of Dec 31, 2022.
ARS Pharmaceuticals updates corporate presentation; no material new details disclosed
Filed a Form 8-K on March 13, 2023, to furnish an updated corporate presentation.
Terminated License and Supply Agreement with Recordati Ireland, effective immediately.
ARS Pharma reports $275M cash as of Dec 31, 2022; updates corporate presentation
Cash and securities of approximately $275 million as of December 31, 2022.
ARS Pharma files merger financials: 2021 revenue $5.5M, net loss $20.2M
Audited 2021 revenue $5.5M vs $17.8M in 2020; net loss $20.2M vs $1.1M.
ARS Pharmaceuticals appoints Brian Dorsey as COO; salary increased to $410,000
Brian Dorsey appointed COO effective December 6, 2022; previously SVP of Operations and Project Management since 2018.
ARS Pharmaceuticals updates corporate presentation; no material new data disclosed
Company released an updated slide deck for investor meetings on December 6, 2022.
Merger completed Nov 8, 2022; ARS Pharma becomes wholly owned subsidiary of re-named ARS Pharmaceuticals, Inc.
Silverback Therapeutics announces final exchange ratio of 1.1819 for merger with ARS Pharma
Final exchange ratio set at 1.1819 per the Merger Agreement as amended on October 25, 2022.
Silverback amends merger agreement with ARS Pharma; raises net cash ceiling to $265M
Parent Net Cash condition revised: must be between $210M and $265M, increased from $255M ceiling.
FDA accepts ARS Pharma's NDA for neffy (epinephrine nasal spray) for allergic reactions
FDA accepted NDA for neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis in adults and children ≥30 kg.
Silverback Therapeutics terminates Seattle HQ lease effective Dec 31, 2022
Terminated lease for ~19,829 sq ft at 500 Fairview Ave N, Seattle; lease expires Dec 31, 2022.
Silverback terminates President/CSO and CFO; appoints interim CFO ahead of merger
Terminated Valerie Odegard (President/CSO) and Jonathan Piazza (CFO), effective Sept 2, 2022, to extend cash runway.
Silverback equity holders expected to own ~37%, ARS holders ~63% on fully-diluted basis.
Silverback Therapeutics stockholders elect directors, ratify auditor at 2022 annual meeting
Andrew Powell and Peter Thompson were elected Class II directors to serve until 2025 annual meeting.
appointed Donn Casale as the Company’s President effective as of the date he commences employment with the Company, which date is expected to be June 1, 2026.
Mr. Lowenthal previously served as President.
Effective as of December 6, 2022, ARS Pharmaceuticals, Inc. (the “Company”) appointed Brian T. Dorsey, MSc, as Chief Operations Officer of the Company.
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
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
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
Rajeev Dadoo, Ph.D. 52 Class I Director
Sarina Tanimoto, M.D., M.B.A. 54 Chief Medical Officer
Brenton L. Saunders 52 Class II Director
Peter Kolchinsky, Ph.D. 46 Class II Director
Pratik Shah, Ph.D. 52 Chair of the Board and Class I Director
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.
Max materiality 1.00 · Median 0.70 · Most common event other_material