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.
The Celcuity Inc. (NASDAQ: CELC) SEC filings page provides access to the company’s official regulatory disclosures as a clinical-stage biotechnology company developing targeted therapies for oncology. Through these documents, investors can review how Celcuity reports its progress with gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor being evaluated in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
Celcuity’s recent Form 8-K filings highlight material clinical and regulatory events, such as detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type advanced breast cancer, updates on the fully enrolled PIK3CA mutant cohort, and clinical data from early phase studies of gedatolisib in combination with darolutamide. Other 8-Ks describe the submission of a New Drug Application (NDA) to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, as well as quarterly financial results and corporate updates.
Filings also detail financing and capital structure transactions, including public offerings of common stock and pre-funded warrants, issuance of 2.750% Convertible Senior Notes due 2031, and amendments to Celcuity’s senior secured term loan facility with lenders such as Oxford Finance LLC and Innovatus Life Sciences Lending Fund I, LP. These documents describe new term loan tranches, warrant issuances, and conditions tied to regulatory milestones and product revenue thresholds.
On Stock Titan, users can track Celcuity’s SEC filings as they are posted to EDGAR and use AI-powered summaries to quickly interpret key points from lengthy reports. This includes understanding the implications of 8-K event disclosures, financial condition updates, loan agreement amendments, and equity or debt offerings related to the company’s efforts to advance and potentially commercialize gedatolisib.
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.
ROMP CHARLES R reported acquisition or exercise transactions in a Form 4 filing for CELC. The filing lists transactions totaling 215 shares. Following the reported transactions, holdings were 215 shares.
Celcuity Inc. director reports no share ownership. Charles R. Romp filed an initial ownership statement as a director of Celcuity Inc. The filing states that he does not beneficially own any non-derivative or derivative securities of the company. The form is signed by an attorney-in-fact on his behalf.
Soleus Capital-affiliated funds and manager Guy Levy filed an amended Schedule 13G reporting their passive ownership in Celcuity Inc. common stock. They collectively report beneficial ownership of 1,808,258 shares, representing 3.9% of Celcuity’s common stock, based on 46,271,259 shares outstanding as of November 6, 2025.
The largest position is held by Soleus Capital Master Fund, L.P. with 1,664,756 shares (3.6% of the class), while Soleus Private Equity Fund II, L.P. holds 142,118 shares (0.3%). Levy directly holds 1,384 shares and shares voting and dispositive power over the fund-held shares.
The filing is classified as a passive investment, with the group certifying the securities were not acquired and are not held to change or influence control of Celcuity. Each affiliated entity and Levy disclaim beneficial ownership beyond what is required for Section 13(d) reporting.