Results of Operations and Financial Condition. On August 13, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended June 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange…

Regulation FD Disclosure. On July 14, 2026, Celcuity Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of 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 without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the meta…

Regulation FD Disclosure. On July 14, 2026, the Company issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of 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 without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. A…

Forward-Looking Statements This Current Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for…

Forward-Looking Statements This Current Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for…

Entry into a Material Definitive Agreement. On June 3, 2026, Celcuity Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, J.P. Morgan Securities LLC, TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), agreeing, subject to customary conditions, to issue and sell in a public offering $500,000,000 aggregate principal amount of the Compan…

Termination of a Material Definitive Agreement On June 8, 2026, the Company completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses, equal to approximately $[137.5 million] in the aggregate (the “Payoff Amount”), under that certain Amended and Restated Loan and Security Agreement, dated as of May 30, 2024, by and among the Company, as borrower, Oxford Finance LLC, a Delaware limited liability company (“Oxford”), as collateral agent…

C reation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. The disclosure set forth in

Other Events. Press Release – Launch of Offering On June 3, 2026, the Company issued a press release announcing that it had launched the Offering. A copy of this press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference. Press Release – Pricing of Notes Offering On June 3, 2026, the Company issued a press release announcing that it priced the Offering to issue and sell $500 million aggregate principal amount of 0.250% Convertible Senior Notes due 2032. A copy of th…

Other Events. On June 2, 2026, the Company announced detailed efficacy and safety results from the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA MT, locally advanced or metastatic breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VI…

Director — Charles (Chip) R. Romp: The company appointed a new director to expand the board.

The filing is about the approval of a new stock incentive plan and an amended employee stock purchase plan, not a management change.

Results of Operations and Financial Condition. On May 14, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the first quarter ended March 31, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exch…

Other Events. On May 1, 2026, the Company issued a press release announcing positive topline results from the PIK3CA mutant cohort of the VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant, with or without palbociclib, in patients with HR+/HER2- ABC, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib demonstrated a statistically significant and clinically m…

Results of Operations and Financial Condition. On March 25, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18…

Director — Charles (Chip) R. Romp: The Board appointed Charles (Chip) R. Romp as a new director.

Results of Operations and Financial Condition. On November 12, 2025, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the third quarter ended September 30, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Se…

Other Events. On October 18, 2025, the Company announced detailed topline results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial evaluating gedatolisib plus palbociclib and fulvestrant (the “gedatolisib triplet”) and gedatolisib plus fulvestrant (the “gedatolisib doublet”) in adults with HR-positive, HER2-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the V…

Unregistered Sales of Equity Securities. The information set forth under

Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. The information set forth under

Entry into a Material Definitive Agreement. On September 9, 2025, Celcuity Inc. (the “Company”) entered into the Third Amendment to Amended and Restated Loan and Security Agreement (the “Third Amendment” and the existing Amended and Restated Loan and Security Agreement, the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”), as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as…

Results of Operations and Financial Condition. On August 14, 2025, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the second quarter ended June 30, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securiti…

Entry into a Material Definitive Agreement. On July 30, 2025, Celcuity Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering $175,000,000 aggregate principal amount of the Company’s 2.750%…

C reation of a Direct Financial Obligation or an Off-Balance Sheet Arrangement. The disclosure set forth in

Entry into a Material Definitive Agreement. On July 30, 2025, Celcuity Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 shares (the “Shares”) of the Company’s common sto…