ARS Pharma reports FY2022 net loss $34.7M; neffy NDA under FDA review, PDUFA mid-2023

ARS Pharmaceuticals, Inc.

Net loss of $14.4M for Q4 2022 and $34.7M for full year 2022; cash & investments $274.4M as of Dec 31, 2022.
NDA for neffy (intranasal epinephrine) accepted by FDA; PDUFA target action date anticipated in mid-2023.
MAA for neffy also under review by EMA; company reacquired European rights.
R&D expenses $4.7M (Q4) and $18.4M (FY); G&A $10.7M (Q4) and $18.5M (FY).
Cash runway sufficient for at least three years; preparing for potential U.S. launch in 2023 if approved.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 1.0

ARS Pharmaceuticals, Inc. reported the year ended December 31, 2022 results: net income $34.7 million.

Period: the year ended December 31, 2022
Net income: $34.7 million
Result: reported results

Exact text from the filing

Net loss was $14.4 million for the quarter ended December 31, 2022, and $34.7 million for the year ended December 31, 2022.

View on SEC.gov

Earnings Releases SEC 8-K Item 2.02 confidence 1.0

ARS Pharmaceuticals, Inc. reported the quarter ended December 31, 2022 results: net income $14.4 million.

Period: the quarter ended December 31, 2022
Net income: $14.4 million
Result: reported results

Exact text from the filing

Net loss was $14.4 million for the quarter ended December 31, 2022, and $34.7 million for the year ended December 31, 2022.

View on SEC.gov

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ARS Pharmaceuticals, Inc. filing history →

Source: SEC EDGAR

accession 0000950170-23-009485

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