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EXCHANGE COMMISSION**\n\n**Washington,\nD.C. 20549**\n\n \n\n**FORM\n10-Q**\n\n \n\n**(Mark\nOne)**\n\n \n\n**☒**\n**QUARTERLY\nREPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n \n\n**For\nthe quarterly period ended March 31, 2026**\n\n \n\n**OR**\n\n \n\n**☐**\n**TRANSITION\nREPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n \n\n**For\nthe transition period from to**\n\n \n\n**Commission\nFile No. 001-38207**\n\n \n\n**CELCUITY\nINC.**\n\n**(Exact\nname of registrant as specified in its charter)**\n\n \n\n**Delaware**\n \n**No.\n82-2863566**\n\n**(State\nof incorporation)**\n \n**(IRS\nEmployer Identification No.)**\n\n \n\n**2800\nCampus Drive, Suite 140**\n\n**Minneapolis,\nMinnesota 55441**\n\n \n\n**(Address\nof principal executive offices, including zip code)**\n\n**Registrant’s\ntelephone number, including area code: (763) 392-0123**\n\n \n\nSecurities\nregistered pursuant to Section 12(b) of the Act:\n\n \n\nTitle\nof each class\n \nTrading\nSymbol(s)\n \nName\nof each exchange on which registered\n\nCommon\nStock, $0.001 par value per share\n \nCELC\n \nThe\nNasdaq Stock Market LLC\n\n \n\nIndicate\nby check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange\nAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)\nhas been subject to such filing requirements for the past 90 days. YES ☒ NO ☐\n\n \n\nIndicate\nby check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule\n405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant\nwas required to submit such files). YES ☒ NO ☐\n\n \n\nIndicate\nby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting\ncompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”\n“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\n \n\n \nLarge\naccelerated filer\n☐\nAccelerated\nfiler\n☐\n\n \nNon-accelerated\nfiler\n☒\nSmaller\nreporting company\n☒\n\n \n \n \nEmerging\ngrowth company\n☐\n\n \n\nIf\nan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying\nwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐\n\n \n\nIndicate\nby check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒\n\n \n\nAs\nof May 7, 2026, there were 48,766,288 shares of the registrant’s common stock outstanding.\n\n \n\n \n\n \n\n \n\n \n\n \n\n**Celcuity\nInc.**\n\n**Table\nof Contents**\n\n \n\n \n**Page**\n\n**PART I. FINANCIAL INFORMATION**\n \n\n[**ITEM\n1**. Financial Statements (unaudited)](#TM_002)\n5\n\n[Condensed Balance Sheets](#TM_003)\n5\n\n[Condensed Statements of Operations](#TM_004)\n6\n\n[Condensed Statements of Changes in Stockholders’ Equity](#TM_005)\n7\n\n[Condensed Statements of Cash Flows](#TM_006)\n8\n\n[Notes to Condensed Financial Statements](#TM_007)\n9\n\n[**ITEM\n2**. Management’s Discussion and Analysis of Financial Condition and Results of Operations](#TM_008)\n21\n\n[**ITEM\n3**. Quantitative and Qualitative Disclosures About Market Risk](#TM_009)\n33\n\n[**ITEM\n4**. Controls and Procedures](#TM_010)\n33\n\n \n \n\n**PART II. OTHER INFORMATION**\n \n\n[**ITEM\n1**. Legal Proceedings](#TM_012)\n34\n\n[**ITEM\n1A**. Risk Factors](#TM_013)\n34\n\n[**ITEM\n2**. Unregistered Sales of Equity Securities and Use of Proceeds](#TM_014)\n34\n\n[**ITEM\n3**. Defaults Upon Senior Securities](#TM_015)\n34\n\n[**ITEM\n4**. Mine Safety Disclosures](#TM_016)\n34\n\n[**ITEM\n5**. Other Information](#TM_017)\n34\n\n[**ITEM\n6**. Exhibits](#TM_018)\n35\n\n**Signatures**\n36\n\n \n\nAs\nused in this report, the terms “we,” “us,” “our,” “Celcuity,” and the “Company”\nmean Celcuity Inc., unless the context indicates another meaning.\n\n \n\n2\n\n \n\n** **\n\n**SPECIAL\nNOTE REGARDING FORWARD-LOOKING STATEMENTS**\n\n \n\nThe\nPrivate Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. This Quarterly\nReport on Form 10-Q (this “Quarterly Report”) contains forward-looking statements regarding us, our business prospects and\nour results of operations that are subject to certain risks and uncertainties that could cause our actual business, prospects and results\nof operations to differ materially from those that may be anticipated by such forward-looking statements. Factors that could cause or\ncontribute to such differences include, but are not limited to, those described in Part I, Item 1A, “Risk Factors” of our\nAnnual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026 (the “2025 10-K”),\nand Part II, Item 1A, “Risk Factors” of this Quarterly Report. Readers are cautioned not to place undue reliance on these\nforward-looking statements, which speak only as of the date of this Quarterly Report. We expressly disclaim any intent or obligation\nto update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are urged\nto carefully review and consider the various disclosures made by us in this Quarterly Report and in our other reports filed with the\nSecurities and Exchange Commission (the “SEC”) that advise interested parties of the risks and uncertainties that may affect\nour business.\n\n \n\nAll\nstatements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our plans,\nobjectives and expectations for our business, operations and financial performance and condition, are forward-looking statements. In\nsome cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,”\n“could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,”\n“plan,” “potential,” “predict,” “should,” “target,” “will,” “would,”\nor the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking\nstatements involve known and unknown risks, uncertainties and other factors that may cause our results, performance or achievements to\nbe materially different from the information expressed or implied by the forward-looking statements in this Quarterly Report. Additionally,\nour forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures\nor investments that we may make. Forward-looking statements may include, among other things, statements relating to:\n\n \n\n \n●\nour\nclinical trial plans and the estimated timelines and costs for such trials;\n\n \n \n \n\n \n●\nour\nplans to develop and commercialize our products, and our expectations about the market opportunity for gedatolisib in the U.S. and\ninternationally, and our ability to serve those markets;\n\n \n \n \n\n \n●\nour\nexpectations with respect to our competitive advantages, including the potential efficacy of gedatolisib in various patient types\nalone or in combination with other treatments, and our interpretation of the data from the *PIK3CA* wild-type (“WT”)\nand mutant-type (“MT”) cohorts of the Phase 3 VIKTORIA-1 clinical trial;\n\n \n \n \n\n \n●\nour\nexpectations regarding the timeline of patient enrollment and results from clinical trials for gedatolisib, including our ongoing\nPhase 3 VIKTORIA-1 clinical trial, ongoing Phase 3 VIKTORIA-2 clinical trial, and ongoing Phase 1b/2 clinical trial;\n\n \n \n \n\n \n●\nour\nexpectations regarding our ability to obtain U.S. Food and Drug Administration (“FDA”) approval of our New Drug Application\n(“NDA”) for gedatolisib, any supplemental NDAs (“sNDAs”) we submit to FDA, and approvals outside the U.S.,\nto commercialize gedatolisib;\n\n \n \n \n\n \n●\nour\nexpectations regarding governmental laws and regulations affecting our operations, including, without limitation, developments in\nlaws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in\nthe U.S., and laws that affect our operations and our laboratory;\n\n \n \n \n\n \n●\nour\nexpectations with respect to the development, validation, required approvals, costs, and development and regulatory timelines, of\ngedatolisib;\n\n \n \n \n\n \n●\nour\nbeliefs related to the potential benefits resulting from Fast Track designation and Breakthrough Therapy designation as it relates\nto the development of gedatolisib, and Real-Time Oncology Review (“RTOR”) and Priority Review as relates to the submission\nto the FDA, and FDA review of, our NDA and any sNDAs for gedatolisib;\n\n \n\n3\n\n \n\n \n\n \n●\nour\nplans with respect to research and development and related expenses for the foreseeable future;\n\n \n\n \n●\nour\nbeliefs about our ability to capitalize on the exclusive global development and commercialization rights obtained from our license\nagreement with Pfizer Inc. (“Pfizer”) with respect to gedatolisib;\n\n \n \n \n\n \n●\nour\nexpectations regarding the future payments that may be owed to Pfizer under our license agreement with them;\n\n \n \n \n\n \n●\nour\nbeliefs with respect to the potential rate and degree of market acceptance and clinical utility of gedatolisib, both in the U.S.\nand internationally;\n\n \n \n \n\n \n●\nour\nrevenue expectations;\n\n \n \n \n\n \n●\nour\nexpectations regarding business development activities, including collaborations with pharmaceutical companies;\n\n \n \n \n\n \n●\nour\nplans with respect to pricing in the U.S. and internationally, and our ability to obtain reimbursement for gedatolisib, including\nexpectations as to our ability or the amount of time it will take to achieve successful reimbursement from third-party payors, such\nas commercial insurance companies and health maintenance organizations, and from government insurance programs, such as Medicare\nand Medicaid;\n\n \n \n \n\n \n●\nour\nexpectations as to the use of proceeds from our financing activities;\n\n \n \n \n\n \n●\nour\nexpectations with respect to availability of capital, including accessing our current debt facility or any other debt facility or\nother capital sources in the future, and our assumption that we will have adequate authorized shares for future equity issuances;\n\n \n \n \n\n \n●\nour\nbeliefs regarding the adequacy of our cash on hand to fund our clinical trials, anticipated commercial launch expenses, capital expenditures,\nworking capital, and other general corporate expenses, as well as the costs associated with being a public company;\n\n \n \n \n\n \n●\nour\nplans with respect to potentially raising capital; and\n\n \n \n \n\n \n●\nour\nexpectations regarding our ability to obtain and maintain intellectual property protection for gedatolisib, including its formulations\nand methods of use.\n\n \n\nThese\nstatements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual\nresults, levels of activity, performance or achievements to be materially different from the information expressed or implied by these\nforward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, our potential inability to\ndevelop, validate, obtain regulatory approval for and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs\nassociated with clinical studies and with developing and commercializing pharmaceuticals; the complexity and difficulty of demonstrating\nthe safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges\nwe may face in developing and maintaining relationships with pharmaceutical company partners, including our current and any future suppliers\nof our product candidate; maintaining continuity of clinical and commercial supply of gedatolisib; the uncertainty and costs associated\nwith clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical\ncommunity, and with the size of market opportunities available to us; difficulties we may face in managing growth, such as hiring and\nretaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets\nand limitations on access to capital; stock market volatility or other factors that may affect our ability to access capital on favorable\nterms or at all; and obtaining and maintaining intellectual property protection for gedatolisib and time and expense associated with\nenforcing our intellectual property rights against third parties, and defending third-party claims of intellectual property infringement,\ninvestigations or litigation threatened or initiated against us.\n\n \n\n4\n\n \n\n** **\n\n**PART\nI. FINANCIAL INFORMATION**"}