Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant

Celcuity Inc.

Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).
VIKTORIA-1 PIK3CA mutant cohort: gedatolisib triplet and doublet both achieved statistically significant PFS improvement vs alpelisib+fulvestrant.
Detailed VIKTORIA-1 data to be presented at ASCO LBA oral session on June 2, 2026; sNDA submission planned for Q3 2026.
NDA for gedatolisib in PIK3CA wild-type accepted with Priority Review; PDUFA date July 17, 2026.
VIKTORIA-2 expanded: Study 2 (~740 patients) evaluating gedatolisib as first-line in endocrine-sensitive HR+/HER2- advanced breast cancer.

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Celcuity Inc. reported first quarter ended March 31, 2026 results: net income Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, EPS or $0.97 per share.

Period: first quarter ended March 31, 2026
Net income: Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share
EPS: or $0.97 per share
Result: reported results

Exact text from the filing

Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025.

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Source: SEC EDGAR

accession 0001493152-26-023065

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