CELC
Celcuity Inc.100.39
-1.79-1.75%
Dec 16, 4:00:02 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '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
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.
8-K
Celcuity upsizes loan to $500M
Celcuity Inc. amended its loan agreement on September 9, 2025, replacing Innovatus with Oxford as collateral agent and unlocking a $30 million Term D disbursement, boosting total committed capital to $350 million while extending maturity to November 1, 2029. The deal upsizes the Term E tranche to $100 million, contingent on FDA approval for gedatolisib in second-line wild-type advanced breast cancer, and adds three $40 million Term F loans tied to revenue milestones, enhancing funding for NDA submission and commercialization. Yet lenders hold discretion over a $150 million Term G option. Warrants for 50,537 shares were issued to lenders.
10-Q
Q2 FY2025 results
Celcuity's Q2 FY2025 results show escalating R&D spend driving deeper losses, with operating expenses up 81% y/y to $44.0M and net loss widening to $45.3M from $23.7M, fueled by clinical trial ramp-up and a $5.0M Pfizer milestone. Yet cash burn reflects progress: operating cash use hit $72.1M YTD, offset by $90.1M from investment maturities, leaving $46.4M in cash equivalents and $122.0M in investments at quarter-end. Debt stands at $99.3M under the A&R Loan Agreement (maturing May 2029, ~10.6% effective rate with PIK interest), with full revolver availability and no covenant breaches flagged. Post-quarter, topline data from VIKTORIA-1's PIK3CA WT cohort boosted eligibility for a $30M Term D draw in August, alongside $91.6M equity and $194.9M convertible notes raises. Trials advance steadily. Regulatory hurdles loom large.
8-K
Gedatolisib trial success
Celcuity reported strong Q2 2025 results, highlighted by positive topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, where gedatolisib regimens slashed progression risk by 76% and 67% versus fulvestrant alone in HR+/HER2- advanced breast cancer patients, boosting median PFS to 9.3 and 7.4 months. The company plans an NDA submission to the FDA in Q4 2025, with ongoing enrollment in the mutant cohort and VIKTORIA-2 trial. A $286.5 million financing bolsters cash to $455 million pro forma, funding operations through 2027. Data changes upon full review pose risks.
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