Current Report · Items 7.01, 8.01, 9.01 · 8-K

Celcuity Inc.

CELCNASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

Filed Aug 26, 2026Accepted Aug 26, 2026, 8:35 AM EDTCIK 1603454Accession 0001193125-26-365975

Company context

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with

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Disclosure sections

Items 7.01, 8.01, 9.01

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Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On August 26, 2026, Celcuity Inc. (the "Company") issued a press release announcing the submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer ("ABC") with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 7.01, including the accompanying exhibits, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 8.01Item 8.01 - Other Events

Item 8.01 Other Events. On August 26, 2026, the Company issued a press release announcing the submission of its sNDA to the FDA for REVTORPYK for the treatment of patients with HR+/HER2- ABC with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy.

Filed exhibits (1)

EX-99.1 (by filename) celc-ex99_1.htm

EX-99.1 2 celc-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer • If approved, REVTORPYK would be the first and only therapy for advanced breast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 MINNEAPOLIS, August 26, 2026 - Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced the submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) with a PIK3CAmutation, following progression on or after treatment with at least one line of endocrine therapy. “This submission allows us to potentially make REVTORPYK available to all patients with HR+/HER2- locally advanced or metastatic breast cancer, regardless of PIK3CA…

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