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. director Richard Nigon reported a bona fide gift of 10,000 shares of Common Stock on April 9, 2026. The transfer was recorded at no cash consideration, reflecting a charitable or personal gift rather than a market sale. After the transaction, he directly holds 79,035 Celcuity shares.
Celcuity Inc. is asking stockholders at its May 14, 2026 annual meeting to elect eight directors, ratify Boulay PLLP as independent auditor, approve executive compensation on an advisory basis, and adopt two updated equity plans.
The company seeks approval of a new 2026 Stock Incentive Plan covering 3,000,000 shares, which will replace the existing 2017 stock plan for new grants and includes an annual share “evergreen” increase of up to 1.0% of common stock from 2027 through 2036. It also discloses an average three-year equity grant burn rate of 4.4% and a fully diluted overhang of 18.2% as of March 17, 2026.
Celcuity further proposes an amended and restated 2017 Employee Stock Purchase Plan, increasing the share pool by 289,199 to a total authorization of 1,229,370 shares and extending the ESPP term by ten years, with a standard Section 423 structure and a 15% purchase discount. As of March 17, 2026, there were 48,336,675 common shares outstanding, each entitled to one vote on these proposals.
Celcuity Inc. director Richard E. Buller reported an option exercise and related stock sales by a family trust. On March 31, 2026, a trust for which he and his spouse are trustees exercised 3,000 stock options at $5.10 per share into common stock.
The trust then sold 2,325 Celcuity common shares at a weighted average price of $110.1057 and 675 shares at a weighted average price of $110.8268 in open-market transactions, totaling 3,000 shares sold. These trades and the option exercise were carried out under a pre-arranged Rule 10b5-1 trading plan adopted on December 8, 2025. After the transactions, the trust held 6,760 shares of common stock, and Buller also held 1,029 shares directly.
Celcuity Inc. is a clinical-stage biotech focused on targeted therapies for solid tumors, led by its pan‑PI3K/mTOR inhibitor gedatolisib for HR+/HER2‑ advanced breast cancer and metastatic castration‑resistant prostate cancer. More than 1,100 people have received gedatolisib across completed and ongoing trials.
The Phase 3 VIKTORIA‑1 breast cancer trial enrolled 754 patients and showed that gedatolisib triplet and doublet regimens delivered large, statistically significant progression‑free survival benefits versus fulvestrant, including in PIK3CA wild‑type tumors. Gedatolisib has Fast Track and Breakthrough Therapy designations, is under Real‑Time Oncology Review, and its NDA has Priority Review with a July 17, 2026 PDUFA goal date.
Celcuity estimates a U.S. second‑line breast cancer market opportunity of more than $5.0 billion annually and potential peak revenue up to $2.5 billion if approved for both PIK3CA wild‑type and mutant populations. The company licenses gedatolisib from Pfizer, with up to $335.0 million in potential milestones and low‑ to mid‑teen royalties.
Celcuity Inc. reported fourth quarter and full year 2025 results alongside major regulatory and clinical milestones for its lead drug candidate, gedatolisib.
The FDA accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026. Published Phase 3 VIKTORIA-1 cohort data showed the gedatolisib triplet improved median time to definitive deterioration in patient-reported well-being to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39.
Total operating expenses rose to $49.2 million in the fourth quarter and $172.2 million for 2025, driving a GAAP net loss of $51.0 million for the quarter and $177.0 million for the year. Non-GAAP adjusted net loss was $38.4 million for the quarter and $150.8 million for 2025. Cash, cash equivalents and short-term investments were $441.5 million at year-end 2025, which the company expects will fund operations through 2027.
Baker Bros. Advisors and related entities filed an amended Schedule 13D for Celcuity Inc., reporting beneficial ownership of 9,582,874 shares of common stock, representing 19.99% of the class. This percentage is based on 46,271,259 shares outstanding as of November 6, 2025 plus 1,667,082 shares underlying $0.001 prefunded warrants exercisable within 60 days. On March 20, 2026, the funds notified Celcuity that they were increasing the beneficial ownership limitation on 481,437 and 5,666,350 $0.001 prefunded warrants held by 667 and Baker Brothers Life Sciences, respectively, from 4.99% to 19.99%, effective May 20, 2026. The reporting persons state they did not acquire additional securities in connection with this change and continue to hold their position for investment purposes, while reserving flexibility to buy or sell Celcuity securities in the future.
Celcuity Inc. (CELC) received an updated ownership filing from New Enterprise Associates–affiliated entities and managers. Growth Equity Opportunities 18 VGE, LLC is the record holder of 2,285,561 shares of Celcuity common stock, representing 4.9% of the class based on 46,271,259 shares outstanding as of November 6, 2025.
On March 5, 2026, GEO distributed 625,000 Celcuity shares to NEA 18 Venture Growth Equity, L.P., which then distributed them pro rata to its general and limited partners for no consideration. NEA Partners 18 VGE received 9,375 shares and distributed them, with 9,375 shares received by an entity for which Anthony A. Florence Jr., Mohamad H. Makhzoumi and Scott D. Sandell may be deemed beneficial owners; those shares were sold on March 6, 2026 as detailed in Schedule A.
The filing notes that the NEA-related reporting persons may dispose of additional Celcuity shares depending on market conditions and other factors, and each reporting person disclaims beneficial ownership of shares other than those held of record. The amendment also confirms no relevant securities law judgments against the reporting persons in the past five years.
Perceptive Advisors LLC filed an amended Schedule 13G reporting significant ownership of Celcuity Inc. common stock. Through Perceptive Life Sciences Master Fund, Ltd., the group beneficially owns 3,160,200 shares, representing 6.8% of Celcuity’s outstanding common stock as of November 6, 2025.
The Master Fund directly holds the shares, while Perceptive Advisors, as investment manager, and Joseph Edelman, as managing member, may be deemed to share voting and dispositive power over these shares. The filers certify the holdings are not for the purpose of changing or influencing control of Celcuity.
Celcuity Inc. (CELC) received a Schedule 13G filing showing that Avoro Capital Advisors LLC and Behzad Aghazadeh beneficially own 3,111,111 shares of Celcuity common stock, representing 6.72% of the company. The percentage is based on 46,271,259 shares outstanding as of November 6, 2025.
Avoro acquired the shares solely for investment purposes on behalf of Avoro Life Sciences Fund LLC and reports sole voting and dispositive power over the position. The reporting persons certify that the shares were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Celcuity.