Celcuity Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

For the quarterly period ended September 30,2026

OR

For the transition period from to

Commission File No.001-38207

CELCUITY INC.

(Exact name of registrant as specified in its charter)

2800 Campus Drive, Suite 140

Minneapolis, Minnesota 55441

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (763) 392-0123

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ NO☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ NO☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES☐ NO☒

As of October 29, 2026, there were 49,126,314 shares of the registrant’s common stock outstanding.

Table of Contents

As used in this report, the terms “we,” “us,” “our,” “Celcuity,” and the “Company” mean Celcuity Inc., unless the context indicates another meaning.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements regarding us, our business prospects and our results of operations that are subject to certain risks and uncertainties that could cause our actual business, prospects and results of operations to differ materially from those that may be anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026 (the “2025 10-K”), and Part II, Item 1A, “Risk Factors” of this Quarterly Report. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. We expressly disclaim any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are urged to carefully review and consider the various disclosures made by us in this Quarterly Report and in our other reports filed with the Securities and Exchange Commission (the “SEC”) that advise interested parties of the risks and uncertainties that may affect our business.

All statements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our plans, objectives and expectations for our business, operations and financial performance and condition, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our results, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this Quarterly Report. Additionally, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. Forward-looking statements may include, among other things, statements relating to:

•

our beliefs with respect to the potential rate and degree of market acceptance and clinical utility of REVTORPYKTM (gedatolisib) both in the United States and internationally;

•

our plans to develop and commercialize our products, and our expectations about the market opportunity for REVTORPYK in the United States and internationally, and our ability to serve those markets;

•

our revenue expectations;

•

our expectations with respect to pricing in the United States and internationally, and our ability to obtain reimbursement for REVTORPYK, including expectations as to our ability or the amount of time it will take to achieve successful reimbursement from third-party payors, such as commercial insurance companies and health maintenance organizations, and from government insurance programs, such as Medicare and Medicaid;

•

our expectations regarding our ability to maintain U.S. Food and Drug Administration (“FDA”) approval of REVTORPYK, obtain approval for supplemental new drug applications (“sNDAs”) submitted to the FDA, and obtain regulatory approvals to commercialize REVTORPYK outside the United States;

•

our expectations regarding our ability to obtain and maintain intellectual property protection for REVTORPYK, including its current and future formulations, indications and methods of use;

•

our beliefs about our ability to capitalize on the exclusive global development and commercialization rights obtained from our license agreement with Pfizer Inc. (“Pfizer”) dated April 8, 2021, with respect to gedatolisib (the "License Agreement");

•

our expectations regarding the future milestone and royalty payments that may be owed to Pfizer under the License Agreement;

•

our expectations with respect to our competitive advantages, including the potential efficacy of gedatolisib in various patient types alone or in combination with other treatments, and our interpretation of the data from the PIK3CA mutant-type (“MT”) cohort of the VIKTORIA-1 Phase 3 clinical trial;

•

our clinical trial plans and the estimated timelines and costs for such trials;

•

our expectations regarding the timeline of patient enrollment and results from clinical trials for gedatolisib, including our ongoing VIKTORIA-2 Phase 3 and CELC-G-201 Phase 1b/2 clinical trials;

•

our expectations with respect to the development, validation, required approvals, costs, and development and regulatory timelines, of investigational uses of gedatolisib;

•

our plans with respect to research and development and related expenses for the foreseeable future;

•

our expectations regarding business development activities, including collaborations with pharmaceutical companies;

•

our plans with respect to potentially raising capital and our expectations as to the use of proceeds from our financing activities;

•

our expectations with respect to availability of capital in the future, and our assumption that we will have adequate authorized shares for future equity issuances; and

•

our beliefs regarding the adequacy of our cash on hand to fund our clinical trials, anticipated commercial launch expenses, capital expenditures, working capital, and other general corporate expenses, as well as the costs associated with being a public company.

These statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, the uncertainty regarding market acceptance of REVTORPYK by physicians, patients, third-party payors and others in the medical community, and with the size of market opportunities available to us in the United States and internationally; obtaining, and maintaining continuity of, clinical and commercial supply of REVTORPYK and/or gedatolisib; challenges we may face in developing and maintaining relationships with pharmaceutical company partners, including our current and any future suppliers supporting REVTORPYK and any future product candidate; our inability to maintain regulatory approval for REVTORPYK; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to obtain regulatory approval of sNDAs for REVTORPYK and/or gedatolisib and other products we may develop; our potential inability to develop, validate, and obtain future regulatory approvals, in the United States and internationally, for additional formulations, indications and methods of use of REVTORPYK and/or gedatolisib; changes in government regulations, including, without limitation, “Most‑Favored‑Nation” ("MFN") drug pricing in the United States and internationally; obtaining and maintaining intellectual property protection for REVTORPYK and future formulations of gedatolisib, and the time and expense associated with enforcing our intellectual property rights against third parties, and defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us; the uncertainties and costs associated with clinical studies and with developing and commercializing pharmaceuticals; difficulties we may face in managing growth, such as retaining a qualified sales force and attracting and retaining key personnel; tightening credit markets and limitations on access to capital; and stock market volatility or other factors that may affect our ability to access capital on favorable terms or at all.