CELC
Celcuity Inc.100.39
-1.79-1.75%
Dec 16, 4:00:02 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
No earnings call transcript available
Key Stats
Market Cap
4.65BP/E (TTM)
-Basic EPS (TTM)
-3.68Dividend Yield
0%Recent Filings
8-K
Appoints oncology commercial expert
Celcuity expanded its board to eight members, appointing Charles (Chip) R. Romp as independent director effective February 11, 2026, through the 2026 annual meeting. Romp brings 25+ years of oncology commercial leadership from Secura Bio, Seagen, and Genentech to guide gedatolisib's potential launch. He received a pro-rated 215 restricted stock grant. Commercial expertise bolsters approval push.
8-K
NDA submitted for gedatolisib
Celcuity completed its NDA submission to the FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer on November 17, 2025, under the expedited RTOR program. Phase 3 VIKTORIA-1 data showed the gedatolisib-triplet slashing progression risk by 76% (HR 0.24), boosting median PFS to 9.3 months from 2.0. NDA review risks delays.
10-Q
Q3 FY2025 results
Celcuity posted Q3 operating loss of $42.8M, up 43% y/y from $30.1M, driven by R&D at $34.9M (up 27%) for clinical trials and G&A at $7.9M (up 221%, stock-based comp). Net loss hit $43.8M or $(0.92) diluted EPS on 47.6M shares, versus $(0.70) last year; reconciles cleanly, anti-dilution from options/warrants. Cash burned $116.9M YTD operations, yet balance sheet bulks to $455M liquidity after $91.8M equity, $195.5M convertible notes (due 2031, 2.75%), $27.8M Term D loan (due 2029). Debt now $331M principal. Cash funds through 2027. Warrants exercised post-quarter add $23.6M. Clinical burn accelerates smartly.
8-K
Strong VIKTORIA-1 data, NDA ahead
Celcuity reported Q3 2025 net loss of $43.8M on $42.8M operating expenses, up from $29.8M last year, driven by clinical and launch ramp-up. VIKTORIA-1 Phase 3 PIK3CA WT cohort shone: gedatolisib triplet slashed progression risk 76% (HR 0.24, median PFS 9.3 vs 2.0 months); doublet cut 67% (HR 0.33, 7.4 vs 2.0 months). Cash hit $455M. NDA submission on track for Q4 2025.
8-K
Gedatolisib PFS breakthrough
Celcuity unveiled detailed Phase 3 VIKTORIA-1 results on October 18, 2025, showing gedatolisib triplet extended median PFS to 9.3 months versus 2.0 months for fulvestrant in HR+/HER2- PIK3CA wild-type advanced breast cancer patients post-CDK4/6 therapy, slashing progression risk by 76% (HR=0.24). The doublet added 5.4 months, with both regimens well-tolerated—discontinuations hit just 2.3-3.1%. NDA submission targets Q4 2025. Data may shift standards.
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