Welcome to our dedicated page for Celcuity SEC filings (Ticker: CELC), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Celcuity Inc. filings document formal disclosures for a clinical-stage biotechnology company developing targeted oncology therapies. Recent 8-K reports cover gedatolisib and VIKTORIA-1 clinical-trial results in HR+/HER2- advanced breast cancer, FDA-related regulatory updates, financial results, Regulation FD materials, and amendments to a loan and security agreement.
Proxy materials describe annual meeting matters, director elections, auditor ratification, executive compensation votes, stock incentive plans, and employee stock purchase plan amendments. Governance filings also record board composition changes and director compensation arrangements.
Celcuity Inc. reported Q3 2025 results showing a larger net loss as it advanced late-stage oncology programs and expanded its balance sheet. For the quarter, the company recorded a net loss of $43.8 million and a nine‑month loss of $126.1 million, driven mainly by higher research and development spending of $34.9 million in Q3 and $107.4 million year to date.
To fund development, Celcuity strengthened liquidity. As of September 30, 2025, it held cash and cash equivalents of $74.3 million and U.S. Treasury bill investments of $380.7 million. During July 2025, it closed an equity offering with net proceeds of about $91.6 million and issued $201.3 million of 2.750% Senior Notes due 2031, raising net proceeds of roughly $194.9 million. Long‑term debt, including a term loan, totaled $125.2 million, and convertible debt was $195.1 million.
Clinically, Celcuity’s lead drug gedatolisib advanced meaningfully. The Phase 3 VIKTORIA‑1 trial in HR+/HER2‑ advanced breast cancer completed enrollment in both PIK3CA wild‑type and mutant cohorts, with cohort 1 showing a hazard ratio of 0.24 for progression‑free survival for a gedatolisib‑based triplet versus fulvestrant, indicating a 76% reduction in risk of progression or death. The company initiated dosing in the VIKTORIA‑2 Phase 3 first‑line trial and submitted the first portion of a New Drug Application for gedatolisib to the FDA under the Real‑Time Oncology Review program.
Celcuity Inc. (CELC) furnished an 8-K announcing its third-quarter 2025 results press release. The company reported that a press release covering financial results for the quarter ended September 30, 2025 was made available as Exhibit 99.1.
The Item 2.02 information, including Exhibit 99.1, is being furnished and not filed under the Exchange Act, and will not be incorporated by reference into other filings. Celcuity’s common stock trades on Nasdaq under the symbol CELC.
Celcuity Inc. (CELC) reported positive Phase 3 results from the VIKTORIA-1 PIK3CA wild-type cohort in HR+/HER2- advanced breast cancer. Median progression-free survival with the gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) was 9.3 months versus 2.0 months with fulvestrant (HR=0.24; p<0.0001). The gedatolisib doublet (gedatolisib + fulvestrant) achieved 7.4 months versus 2.0 months (HR=0.33; p<0.0001). Objective response rates were 31.5% for the triplet and 28.3% for the doublet, compared to 1% with fulvestrant.
Celcuity initiated a rolling NDA under the FDA’s Real-Time Oncology Review, targeting completion in Q4 2025. The company plans topline data for the PIK3CA mutant cohort in late Q1 2026 or during Q2 2026. Safety was generally manageable: common grade 3 events with the triplet included neutropenia (52.3%), stomatitis (19.2%), rash (4.6%), and hyperglycemia (2.3%); grade 4 neutropenia occurred in 10.0%. Discontinuations due to treatment-related adverse events were 2.3% (triplet) and 3.1% (doublet). Overall survival trends were described as promising but immature.
Celcuity Inc. filed an amended Form D reporting a Regulation D exempt offering under Rule 506(b) for a total offering size of $352,700,000. The issuer reports $130,000,000 sold to date with $222,700,000 remaining available. The offering includes debt, options/warrants, and the securities that may be issued upon exercise or conversion; the filing notes the conversion or exercise may not occur. The issuer indicates two investors have already participated. Sales commissions are estimated at $4,335,000. The issuer states the offering is intended to continue for more than one year and lists solicitation in all U.S. states plus certain named states. The minimum outside investment is reported as $0.
Celcuity Inc. director Richard Nigon reported exercising warrants to acquire a total of 7,917 shares of Celcuity common stock in two tranches of 4,672 and 3,245 shares at an exercise price of $7.5628 per share on September 11, 2025. After these transactions he directly holds 109,010 common shares.
Baker Bros. Advisors LP, as adviser to investment funds holding Celcuity, reported open-market purchases of 170,100 shares of Celcuity Inc. common stock on September 8, 2025 at weighted average prices of $56.2200 and $58.0236 per share. After these trades, the funds held 7,211,484 shares indirectly, with Julian and Felix Baker having only an indirect pecuniary interest in these securities.
Celcuity Inc. amended its existing loan and security agreement to expand and extend its debt facilities. The company confirmed achievement of the Term D milestone, triggering immediate disbursement of a $30.0 million Term D Loan. It increased the potential Term E Loan from $50.0 million to up to $100.0 million, available only upon U.S. Food and Drug Administration approval of gedatolisib in second line wild-type advanced breast cancer patients after CDK4/6 inhibitor therapy. Celcuity also added three new $40.0 million Term F Loans tied to future trailing three-month product revenue thresholds and replaced a prior $45.0 million Term F Loan with a discretionary $150.0 million Term G Loan available solely at the lenders’ discretion. The amendment adds an amendment fee of $50,000, updates non‑utilization fees to 3.0% of unfunded commitments for certain tranches, and extends the term loan maturity to November 1, 2029. In connection with the amendment, Celcuity issued warrants to purchase 50,537 shares of common stock to Oxford, Innovatus and affiliates, exercisable on a cashless basis for ten years from the Term D funding date.
Brian F. Sullivan, CEO and Director of Celcuity Inc. (CELC), reported acquisitions on 09/02/2025. The filing shows an acquisition of 104,340 common shares at a price of $8.05 and ownership of 104,340 warrants with an $8.05 exercise price linked to the same 104,340 underlying shares, exercisable by 10/11/2025. Following the transaction, the report lists 1,370,199 shares beneficially owned by Mr. Sullivan directly and indirectly, including holdings attributed to two family trusts (948,042 and 802,742 shares). The filing is signed by an attorney-in-fact on behalf of Mr. Sullivan on 09/04/2025.
Vicky Hahne, Chief Financial Officer of Celcuity Inc. (CELC), was granted a stock option to buy 80,000 shares of Common Stock on 08/18/2025 at an exercise price of $51.57 per share. The option becomes exercisable starting 08/18/2025 and expires on 08/18/2035. Following the grant, Ms. Hahne beneficially owns 80,000 underlying shares through this option. The vesting schedule specifies that 20,000 shares vest on 08/18/2026 and the remaining 60,000 vest monthly at 1/36th increments thereafter. The Form 4 was signed on 08/20/2025 by an attorney-in-fact on behalf of Ms. Hahne.
Celcuity Inc. reporting person Lance G. Laing, who serves as Chief Science Officer and a director, received a grant of a stock option covering 100,000 shares of common stock exercisable at $51.57 per share. The option grant is dated 08/18/2025, becomes exercisable on that date, and expires on 08/18/2035.
The filing shows Laing beneficially owns 100,000 shares underlying the option on a direct basis. Vesting terms are disclosed: 25,000 shares vest on 08/18/2026 and the remaining 75,000 vest monthly at a rate of 1/36th thereafter. The Form 4 was signed by an attorney-in-fact on behalf of Laing on 08/20/2025.