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. (CELC) director Richard E. Buller reported several insider transactions involving shares held through a trust. On 11/19/2025, the trust disposed of 500 shares of common stock in a transaction coded "G" at a reported price of $0, leaving 7,260 shares held indirectly by the trust. On 11/20/2025, the trust exercised a stock option for 3,900 shares at an exercise price of $14.83 per share, increasing indirect holdings to 11,160 shares. That same day, the trust sold 3,900 shares of common stock at a weighted average price of $96.732 per share in multiple trades, bringing indirect trust holdings back to 7,260 shares. Following these transactions, Buller also reported direct ownership of 1,029 shares of common stock and indirect ownership of 2,622 stock options through the trust, which are fully vested.
Celcuity Inc. (CELC) reported that it has submitted a New Drug Application to the U.S. Food and Drug Administration for gedatolisib as a treatment for hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This step means the company is formally asking the FDA to review gedatolisib for potential approval in this breast cancer setting. The submission focuses on patients whose tumors are HR+/HER2- and PIK3CA wild-type, a defined subset of advanced breast cancer. Celcuity disclosed this news through a press release that is furnished as an exhibit to the report.
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. 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. 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. 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.
Richard J. Nigon, a director of Celcuity Inc. (CELC), reported two related transactions on 09/11/2025 increasing his beneficial ownership. He acquired 4,672 common shares at $7.5628 and separately acquired 3,245 common shares at $7.5628. After the first reported purchase his beneficial ownership was 105,765 shares and after the second it was 109,010 shares, shown as direct holdings. The filing also reports warrants issued on the same date covering 4,672 and 3,245 shares with exercise-related dates of 01/14/2026 and 05/02/2026, respectively; the form notes those derivative instruments are currently exercisable. The Form 4 was signed by an attorney-in-fact on 09/15/2025.
Celcuity Inc. (CELC) Form 4 summary: Reporting persons associated with Baker Bros. (Baker Bros. Advisors LP, Baker Bros. Advisors (GP) LLC, Baker Biotech/ Life Sciences funds, and principals Julian C. Baker and Felix J. Baker) disclosed purchases of Celcuity common stock on 09/08/2025. Multiple purchases were executed at weighted average prices in two ranges: $56.215–$56.22 (reported as $56.22) and $57.89–$58.14 (reported as $58.0236). Reported additional shares acquired include 13,976 and 151,524 shares at ~ $56.22 and 388 and 4,212 shares at ~ $58.02. Beneficial ownership totals reported after these transactions appear as 703,920 and 7,207,272 (after the lower-price trades) and 704,308 and 7,211,484 (after the higher-price trades). The filing explains that the holdings are held directly by the Funds and that the advisers and named individuals may be deemed to have indirect pecuniary interests; signatures are dated 09/10/2025.
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.