Celcuity Inc. 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38207 CELCUITY INC. (Exact name of registrant as specified in its charter) Delaware No. 82-2863566 (State of incorporation) (IRS Employer Identification No.) 16305 36th Avenue North , Suite 100 Minneapolis , Minnesota 55446 (Address of principal executive offices, including zip code) Registrant’s telephone number, including area code: (763) 392-0767 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per share CELC The Nasdaq Stock Market LLC 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. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ 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 ☒ On November 6, 2025 there were 46,271,259 shares of the registrant’s common stock, $ 0.001 par value per share, outstanding. Celcuity Inc. Table of Contents PAGE PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements (unaudited) 3 Condensed Balance Sheets as of September 30, 2025 and December 31, 2024 3 Condensed Statements of Operations for the three months and nine months ended September 30, 2025 and 2024 4 Condensed Statements of Stockholders’ Equity for the three months and nine months ended September 30, 2025 5 Condensed Statements of Stockholders’ Equity for the three months and nine months ended September 30, 2024 6 Condensed Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 7 Notes to Unaudited Condensed Financial Statements 8 ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 20 ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 38 ITEM 4. Controls and Procedures 38 PART II. OTHER INFORMATION ITEM 1. Legal Proceedings 39 ITEM 1A. Risk Factors 39 ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 42 ITEM 3. Defaults Upon Senior Securities 42 ITEM 4. Mine Safety Disclosures 42 ITEM 5. Other Information 42 ITEM 6. Exhibits 43 Signatures 44 As used in this report, the terms “we,” “us,” “our,” “Celcuity,” and the “Company” mean Celcuity Inc., unless the context indicates another meaning. 2 PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements Celcuity Inc. Condensed Balance Sheets (in thousands, except share and par value amounts) September 30, 2025 December 31, 2024 (unaudited) Assets Current Assets: Cash and cash equivalents $ 74,252 $ 22,515 Investments 380,726 212,589 Other current assets 20,519 9,467 Total current assets 475,497 244,571 Property and equipment, net 417 336 Operating lease right-of-use assets 90 216 Total Assets $ 476,004 $ 245,123 Liabilities and Stockholders’ Equity: Current Liabilities: Accounts payable $ 11,418 $ 9,366 Operating lease liabilities 96 172 Accrued expenses 27,278 22,185 Total current liabilities 38,792 31,723 Operating lease liabilities - 54 Note payable, non-current 125,166 97,727 Convertible debt 195,083 - Total Liabilities 359,041 129,504 Commitments and Contingencies (Note 5) - - Stockholders’ Equity: Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 188,838 and 317,577 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. - - Common stock, $ 0.001 par value: 95,000,000 shares authorized; 43,274,548 and 37,143,242 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. 43 37 Additional paid-in capital 514,844 387,437 Accumulated deficit ( 397,924 ) ( 271,855 ) Total Stockholders’ Equity 116,963 115,619 Total Liabilities and Stockholders’ Equity $ 476,004 $ 245,123 See accompanying notes to the condensed financial statements. 3 Celcuity Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) (unaudited) 2025 2024 2025 2024 Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 34,915 $ 27,588 $ 107,364 $ 70,732 General and administrative 7,934 2,472 15,627 6,105 Total operating expenses 42,849 30,060 122,991 76,837 Loss from operations ( 42,849 ) ( 30,060 ) ( 122,991 ) ( 76,837 ) Other (expense) income Interest expense ( 4,595 ) ( 3,344 ) ( 10,982 ) ( 7,005 ) Interest income 3,640 3,612 7,904 8,716 Other (expense) income, net ( 955 ) 268 ( 3,078 ) 1,711 Net loss before income taxes ( 43,804 ) ( 29,792 ) ( 126,069 ) ( 75,126 ) Income tax benefits - - - - Net loss $ ( 43,804 ) $ ( 29,792 ) $ ( 126,069 ) $ ( 75,126 ) Net loss per share, basic and diluted $ ( 0.92 ) $ ( 0.70 ) $ ( 2.81 ) $ ( 1.96 ) Weighted average common shares outstanding, basic and diluted 47,589,731 42,793,047 44,785,236 38,299,548 See accompanying notes to the condensed financial statements. 4 Celcuity Inc. Condensed Statements of Changes in Stockholders’ Equity Three and Nine Months Ended September 30, 2025 (in thousands, except share amounts) Shares Amount Shares Amount Capital Deficit Total Common Stock Preferred Stock Additional Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total Balance at December 31, 2024 37,143,242 $ 37 317,577 $ - $ 387,437 $ ( 271,855 ) $ 115,619 Stock-based compensation - - - - 2,444 - 2,444 Stock-based compensation, shares - - - - - - - Exercise of common stock warrants 695,650 1 - - 5,599 - 5,600 Exercise of common stock options, net of shares withheld for exercise price 500 - - - 2 - 2 Net loss - - - - - ( 36,997 ) ( 36,997 ) Balance at March 31, 2025 (unaudited) 37,839,392 38 317,577 - 395,482 ( 308,852 ) 86,668 Stock-based compensation 1,029 - - 2,704 - 2,704 Employee stock purchases 26,966 - - 253 - 253 Conversion of preferred stock to common stock 1,044,260 1 ( 104,426 ) - ( 1 ) - - Exercise of common stock options, net of shares withheld for exercise price 2,561 - - - 18 - 18 Net loss - - - - - ( 45,268 ) ( 45,268 ) Balance at June 30, 2025 (unaudited) 38,914,208 39 213,151 - 398,456 ( 354,120 ) 44,375 Stock-based compensation - - - - 6,779 - 6,779 Issuance of common stock upon close of equity offering, net of underwriting discounts and offering costs 2,172,368 2 - - 91,550 - 91,552 Exercise of common stock warrants, net of shares withheld for exercise price 1,654,809 2 - - 12,868 - 12,870 Exercise of common stock options, net of shares withheld for exercise price 290,033 - - - 2,405 - 2,405 Issuance of common stock warrants in connection with note agreement - - - - 2,786 - 2,786 Conversion of preferred stock to common stock 243,130 - ( 24,313 ) - - - - Net loss - - - - - ( 43,804 ) ( 43,804 ) Balance at September 30, 2025 (unaudited) 43,274,548 $ 43 188,838 $ - $ 514,844 $ ( 397,924 ) $ 116,963 See accompanying notes to the condensed financial statements. 5 Celcuity Inc. Condensed Statements of Changes in Stockholders’ Equity Three and Nine Months Ended September 30, 2024 (in thousands, except share amounts) Common Stock Preferred Stock Additional Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total Balance at December 31, 2023 25,506,012 $ 26 854,134 $ 1 $ 299,819 $ ( 160,076 ) $ 139,770 Stock-based compensation - - - - 1,331 - 1,331 Exercise of common stock warrants, net of shares withheld for exercise price 1,742,763 2 - - 14,007 - 14,009 Exercise of common stock options, net of shares withheld for exercise price 36,550 - - - 239 - 239 Conversion of preferred to common stock 3,488,570 3 ( 348,857 ) ( 3 ) - - Net loss - - - - - ( 21,612 ) ( 21,612 ) Balance at March 31, 2024 (unaudited) 30,773,895 $ 31 505,277 $ 1 $ 315,393 $ ( 181,688 ) $ 133,737 Stock-based compensation 1,429 - - - 1,411 - 1,411 Employee stock purchases 20,426 - - - 131 - 131 Conversion of preferred stock to common stock 1,877,000 2 ( 187,700 ) ( 1 ) ( 1 ) - - Exercise of common stock warrants, net of shares withheld for exercise price 19,390 - - - 173 - 173 Exercise of common stock options, net of shares withheld for exercise price 16,197 - - - 96 - 96 Issuance of common stock in an ATM offering 435,414 - - - 7,642 - 7,642 Issuance costs associated with an ATM offering - - - - ( 264 ) - ( 264 ) Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs 3,871,000 4 - - 56,248 - 56,252 Issuance of common stock warrants, note payable - - - - 1,229 - 1,229 Net loss - - - - - ( 23,722 ) ( 23,722 ) Balance at June 30, 2024 (unaudited) 37,014,751 $ 37 317,577 $ - $ 382,058 $ ( 205,410 ) $ 176,685 Balance 37,014,751 $ 37 317,577 $ - $ 382,058 $ ( 205,410 ) $ 176,685 Stock-based compensation - - - - 1,931 - 1,931 Exercise of common stock warrants, net of shares withheld for exercise price 65,204 - - - 554 - 554 Exercise of common stock options, net of shares withheld for exercise price 36,312 - - - 331 - 331 Net loss - - - - - ( 29,792 ) ( 29,792 ) Balance at September 30, 2024 (unaudited) 37,116,267 $ 37 317,577 $ - $ 384,874 $ ( 235,202 ) $ 149,709 Balance 37,116,267 $ 37 317,577 $ - $ 384,874 $ ( 235,202 ) $ 149,709 See accompanying notes to the condensed financial statements. 6 Celcuity Inc. Condensed Statements of Cash Flows (in thousands) (unaudited) 2025 2024 Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net loss $ ( 126,069 ) $ ( 75,126 ) Adjustments to reconcile net loss to net cash and cash equivalents used in operations: Depreciation 118 95 Stock-based compensation 11,927 4,673 Amortization of debt issuance costs and discount 1,866 780 Payment-in-Kind interest 773 1,111 Non-cash operating lease expense, net ( 5 ) - Change in accrued interest income ( 840 ) ( 1,113 ) Changes in operating assets and liabilities: Other current assets ( 10,700 ) 1,741 Accounts payable 1,785 4,094 Accrued expenses 4,264 8,048 Net cash used in operating activities ( 116,881 ) ( 55,697 ) Cash flows from investing activities: Proceeds from maturities of investments 229,045 415,135 Purchases of investments ( 396,342 ) ( 515,558 ) Purchases of property and equipment ( 196 ) ( 205 ) Net cash used in investing activities ( 167,493 ) ( 100,628 ) Cash flows from financing activities: Proceeds from exercise of common stock warrants 18,470 14,736 Proceeds from exercise of employee stock options 2,384 666 Proceeds from employee stock purchases 253 131 Proceeds from equity offering, net of underwriting discounts and offering costs 91,823 56,252 Proceeds from convertible note payable, net of debt issuance cost and discount of $ 5,774 195,476 - Proceeds from note payable, net of debt issuance costs and discount of $ 2,248 and $ 2,438 in 2025 and 2024, respectively 27,752 59,226 Proceeds from an ATM offering, net of issuance costs - 7,356 Payments for secondary registration statement costs ( 47 ) ( 102 ) Net cash provided by financing activities 336,111 138,265 Net change in cash and cash equivalents 51,737 ( 18,060 ) Cash and cash equivalents: Beginning of period 22,515 30,663 End of period $ 74,252 $ 12,603 Supplemental disclosure of cash flow information: Interest paid $ 7,421 $ 5,114 Supplemental disclosures of non-cash investing and financing activities: Change in accounts payable attributed to offering and registration statement costs $ 34 $ 45 Change in accounts payable attributed to property and equipment $ 3 $ 14 Common stock warrants issued with note payable transaction $ 2,786 $ 1,229 Offering costs accrued but unpaid at the end of the period $ 273 $ - See accompanying notes to the condensed financial statements. 7 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) 1. Organization Nature of Business Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that binds to all Class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”) pathway. Gedatolisib’s 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 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported detailed results for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients. The first patient was dosed in July of 2025. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenue to date. 2. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements Basis of Presentation The accompanying unaudited condensed financial statements include the accounts of the Company and have been prepared in accordance with Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10, the unaudited condensed financial statements do not include all of the information required by accounting principles generally accepted in the United States (“U.S. GAAP”). The balance sheet at December 31, 2024 was derived from the audited financial statements at that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected during the remainder of the current year or for any other future period. Accounting Estimates Management uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenue and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, the clinical and commercial success of its initial drug product, gedatolisib, the regulatory approval of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. 8 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) Clinical Trial Costs The Company relies on third parties to conduct certain aspects of clinical studies and to formulate and manufacture our drug product. While there are alternative vendors that can perform these functions, any disruption or delay by the Company’s current third parties in carrying out their contractual duties could delay our clinical trials and/or the commercial launch of our initial drug product, gedatolisib, if approved by the U.S. Food and Drug Administration (“FDA”). The Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s research and development expenses. The Company primarily relies on a compilation of progress reports from third-party service providers, including the respective invoicing, to record actual expenses, along with determining changes to prepaid assets and accrued liabilities. To date, the Company believes utilization of third-party reports most accurately reflects expenses incurred. With the ongoing VIKTORIA-1 and VIKTORIA-2 Phase 3 clinical trials, and the CELC-G-201 Phase 1b/2 clinical trial, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations and financial position. 3. Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, the common shares underlying the preferred stock, options, warrants, convertible notes, and restricted stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and nine-month periods presented below: Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding 2025 2024 September 30, 2025 2024 Preferred stock on an as-if-converted to common stock 1,888,380 3,175,770 Options to purchase common stock 5,696,327 4,212,102 Warrants to purchase common stock 3,206,822 5,521,152 Convertible notes to common stock 5,296,053 - Restricted common stock 1,029 1,079 Total 16,088,611 12,910,103 The maximum number of shares issuable upon conversion of the Notes is 5,296,053 shares of common stock. However, based on the Company’s current stock price, management does not expect the maximum number of shares to be issued. Due to the recent increase in the Company’s stock price, the Conversion Price is currently above the minimum threshold, which would result in the issuance of approximately 3,923,002 shares if the Notes were converted in full as of September 30, 2025. Pre-funded warrant shares of 6,147,787 are included in the computation of basic and diluted net loss per share for each of the three and nine months ended September 30, 2025 and 2024, as the pre-funded warrants are exercisable for nominal consideration. 9 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) 4. Investments Debt securities for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through the establishment of an allowance for credit losses. All of the Company’s held-to-maturity investment securities are U.S. Treasury and agency securities that are guaranteed or otherwise supported by the United States government and have no history of credit losses. Accordingly, the Company does not expect to incur any credit losses on held-to-maturity investment securities and has no allowance for credit losses recorded for these securities. The following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2025 and December 31, 2024: Schedule of Investment (in thousands) Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value September 30, 2025 (in thousands) Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. Treasury Bills $ 380,726 $ - $ ( 56 ) $ 380,670 Total $ 380,726 $ - $ ( 56 ) $ 380,670 (in thousands) Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value December 31, 2024 (in thousands) Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. Treasury Bills $ 212,589 $ 82 $ - $ 212,671 Total $ 212,589 $ 82 $ - $ 212,671 The fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in active markets, that are observable either directly or indirectly and are classified as Level 2 fair value instruments. 5. Commitments Operating and Finance Leases The Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026. The lease provides for monthly rent, real estate taxes, and operating expenses. Rent expense is recorded on a straight-line basis over the lease term. Clinical Research Studies The Company enters into contracts in the normal course of business to conduct research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, contract manufacturing organizations, and contract research organizations. The Company has a license agreement in place with Pfizer Inc. (“Pfizer”) to research, develop, manufacture and commercialize gedatolisib. In conjunction with the license agreement, the Company completed a Phase 1b clinical trial, B2151009, related to gedatolisib. These patients subsequently transitioned to an Expanded Access study, CELC-G-001. Contracts related to the Expanded Access study are generally based on time and material. In addition, contracts related to the Company’s Phase 3 clinical studies (VIKTORIA-1 and VIKTORIA-2) and the Phase 1b/2 clinical trial (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subject to amendments as a result of any change orders executed by the parties. As of September 30, 2025, the Company had three material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 3.3 million. 10 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) 6. Stockholders’ Equity Capital Stock July 2025 Equity Offering On July 30, 2025, the Company entered into an underwriting agreement (the “Equity 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 stock, at a price to the public of $ 38.00 per Share and (ii) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded Warrants”), at a price to the public of $ 37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $ 0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”). In addition, pursuant to the Equity Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025. The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $ 91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. The Company may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants. Each Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $ 0.001 per share, or alternatively, at the election of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined according to the formula set forth in each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance until all of the Pre-Funded Warrants are exercised. A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to the Company. Warrants Exercised In September 2025, an investor exercised 104,340 warrants at an exercise price of $ 8.05 , which generated approximately $ 0.8 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in September 2025, the placement agent from private placements that closed in January and May 2016 exercised 7,917 warrants at an exercise price of $ 7.56 , which generated approximately $ 0.1 million in cash. In August 2025, investors exercised 200,000 warrants at an exercise price of $ 8.05 , which generated approximately $ 1.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in August 2025, the underwriter of the Company’s initial public offering that closed on September 22, 2017 exercised its warrants on a cashless basis. As a result, the Company issued 55,592 shares of common stock upon the cashless exercise of 70,000 warrants. In July 2025, an investor exercised 1,286,960 warrants at an exercise price of $ 8.05 , which generated approximately $ 10.4 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. In March 2025, an investor exercised 695,650 warrants at an exercise price of $ 8.05 , which generated approximately $ 5.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. 11 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) Preferred Stock Converted In September 2025, 24,313 shares of preferred stock were converted into 243,130 shares of common stock. In June 2025, 104,426 shares of preferred stock were converted into 1,044,260 shares of common stock General At September 30, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 43,274,548 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 188,838 shares were outstanding. As of September 30, 2025, no dividends have been declared on the Company’s capital stock. At December 31, 2024, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 37,143,242 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 317,577 shares were outstanding. 7. Stock-Based Compensation The Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30, 2025 and 2024: Schedule of Stock-based Compensation Expenses (in thousands) 2025 2024 2025 2024 Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2025 2024 2025 2024 Stock-based compensation expense in operating expenses: Research and development $ 2,057 $ 1,190 $ 5,285 $ 3,001 General and administrative 4,722 741 6,642 1,672 Total $ 6,779 $ 1,931 $ 11,927 $ 4,673 Stock-based compensation expense $ 6,779 $ 1,931 $ 11,927 $ 4,673 2017 Plan The Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”). The number of shares reserved for issuance was automatically increased by 371,432 and 255,060 shares on January 1, 2025 and 2024, respectively, and will increase automatically on January 1 of each year through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. At the Annual Meeting held on May 13, 2025, the stockholders approved a 3,000,000 share increase to the number of shares reserved for issuance under the 2017 Plan. The total remaining shares available for grant under the Company’s 2017 Plan as of September 30, 2025 was 2,864,444 . 12 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) Stock Options The following table summarizes the activity for all stock options outstanding for the nine months ended September 30: Schedule of Stock Options Activity 2025 2024 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 4,306,977 $ 10.42 2,815,392 $ 7.95 Granted 1,927,598 30.56 1,557,479 16.37 Exercised ( 293,309 ) 8.31 ( 89,059 ) 7.48 Forfeited and expired ( 244,939 ) 11.51 ( 71,710 ) 9.95 Balance at September 30 5,696,327 $ 17.30 4,212,102 $ 11.04 Options exercisable at September 30: 2,480,759 $ 9.53 1,891,297 $ 7.11 Weighted Average Grant Date Fair Value for options granted during the period: $ 21.63 $ 11.38 The following table summarizes additional information about stock options outstanding and exercisable at September 30, 2025. The stock-based compensation expense disclosed in the following paragraphs is shown in thousands. Schedule of Stock Options Outstanding and Exercisable Options Outstanding Options Exercisable Options Outstanding Weighted Average Remaining Contractual Life Weighted Average Exercise Price Aggregate Intrinsic Value ($000) Options Exercisable Weighted Average Exercise Price Aggregate Intrinsic Value ($000) 5,696,327 8.05 $ 17.30 185,003 2,480,759 $ 9.53 98,988 The Company recognized stock-based compensation expense for stock options of $ 6,452 and $ 1,844 for the three months ended September 30, 2025 and 2024, respectively, and $ 11,088 and $ 4,463 for the nine months ended September 30, 2025 and 2024, respectively. In January 2025, May 2022, December 2021 and May 2020, the Company modified previously granted stock option awards to certain employees. The total incremental compensation expense recognized as a result of the modifications was $ 48 and $ 42 for the three months ended September 30, 2025 and 2024, respectively, and $ 259 and $ 128 for the nine months ended September 30, 2025 and 2024, respectively. The effect of these modifications on stock-based compensation over the remaining service periods will be $ 298 . During the three and nine months ended September 30, 2025, options in the amount of 290,248 and 293,309 shares were exercised, respectively, with an intrinsic value of $ 11,921 and $ 12,052 , respectively. Included in the options exercised in the quarter, there were 950 options exercised in a cashless exercise whereby 215 shares were used to settle the exercise price and the remaining 735 shares were issued. During the three and nine months ended September 30, 2024, options in the amount of 36,312 and 89,059 were exercised, respectively, with an intrinsic value of $ 211 and $ 662 , respectively. The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards and the Monte Carlo simulation model was used for the performance-based awards, with the following weighted-average assumptions for the nine months ended September 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2025 2024 Risk-free interest rate 3.64 to 4.65 % 3.48 to 4.71 % Expected volatility 74.4 to 78.2 % 71.2 to 76.1 % Expected life (years) 5.01 to 10.00 5.25 to 10.00 Expected dividend yield 0 % 0 % 13 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) The inputs for the Black-Scholes valuation model and the Monte Carlo simulation model require management’s significant assumptions. Prior to the Company’s initial public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings. Subsequent to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life is based on the simplified method for the time-based awards and the life of the option for the performance-based awards, in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110. The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated volatility since being publicly traded for the time-based awards. For the performance-based awards, the Company’s full historical volatility was used to value the options. All assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled. Restricted Stock Awards Restricted stock awards (“RSAs”) granted to members of the Company’s board during the nine months ended September 30, 2025 were 1,029 shares. There were no RSAs granted during the three months ended September 30, 2025. RSAs granted to members of the Company’s board during the nine months ended September 30, 2024 were 1,429 shares. There were no RSAs granted during the three months ended September 30, 2024. During the three and nine months ended September 30, 2025, RSAs vested in the amount of zero shares and 1,709 shares, respectively. During the three and nine months ended September 30, 2024, RSAs vested in the amount of zero shares and 2,308 shares, respectively. The Company recognized stock-based compensation expense for RSAs of zero and $ 4 for the three months ended September 30, 2025 and 2024, respectively, and $ 6 and $ 18 for the nine months ended September 30, 2025 and 2024, respectively. RSAs outstanding as of September 30, 2025 and September 30, 2024 were 1,029 shares and 1,079 shares, respectively. Total unrecognized compensation cost related to stock options and RSAs that is estimated to be recognized at September 30, 2025 is as follows: Schedule of Unrecognized Compensation Cost (in thousands) 2025 $ 5,807 2026 16,825 2027 13,038 2028 9,936 2029 4,417 Total estimated compensation cost to be recognized $ 50,023 Employee Stock Purchase Plan The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 327 and $ 83 for the three months ended September 30, 2025 and 2024, respectively, and $ 833 and $ 192 for the nine months ended September 30, 2025 and 2024, respectively. The number of shares reserved for issuance was automatically increased by 185,716 on January 1, 2025, and will increase automatically on January 1 of each year through 2027 by the number of shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. The total remaining shares available for issuance under the employee stock purchase plan as of September 30, 2025 was 519,700 . 14 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) 8. Debt July 2025 Convertible Notes Offering On July 30, 2025, the Company entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters, subject to customary conditions, to issue and sell in a public offering $ 175.0 million aggregate principal amount of the Company’s 2.750 % Senior Notes due 2031 (the “Notes”) to the Underwriters (the “Note Offering”). In addition, pursuant to the Note Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional $ 26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $ 26.3 million aggregate principal amount of Notes. The issuance of $ 201.3 million aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”), dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $ 194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. The Notes are general, unsecured, senior obligations of the Company. The Notes will accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750 % per year. In addition, special interest will accrue on the Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company. Noteholders may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $ 1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $ 51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time. The Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding Notes unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption. If a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock. 15 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) Lastly, the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes; provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation in no event can exceed 19.99%. The issuance costs attributed to the Notes amounted to $ 6.3 million and were discounted from the Notes. The issuance cost discount is being amortized to interest expense over the term of the Notes based on the effective interest rate method. For each of the three and nine month periods ended September 30, 2025, discount amortization charged to interest expense related to the issuance costs was $ 0.2 million. Amended and Restated Loan and Security Agreement Third Amendment On September 9, 2025, the Company entered into the Third Amendment (the “Third Amendment”) to the 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 a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”)) and provide for the immediate disbursement of the $ 30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $ 50.0 million to up to $ 100.0 million, which Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type advanced breast cancer patients post CDK4/6 inhibitor therapy; (iv) add three new up to $ 40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), which may only be drawn upon achievement of certain trailing three months’ product revenue thresholds; (v) replace the prior $ 45.0 million Term F Loan (as defined in the A&R Loan Agreement) with a new $ 150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement), which continues to be available only in the Lenders’ sole discretion upon the Company’s request; (vi) require an amendment fee payable by the Company to the Lenders in the amount of $ 50,000 , which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that the Company may make by notice to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans to November 1, 2029. The Term E Loan and each Term F Loan also are subject to other customary conditions and limits on when the Company can request funding. With the disbursement of the $ 30.0 million Term D Loan, the Company received net proceeds of approximately $ 27.8 million. In accordance with the A&R Loan Agreement, a Final Fee equal to 4.5 % of the $ 30.0 million Term D Loan was recognized and an additional $ 1.4 million was added to debt principal and a corresponding debt discount to be amortized over the life of the loan. In connection with the Third Amendment, the Company issued warrants with an exercise price of $ 14.84 per share to purchase an aggregate of 50,537 shares of the Company’s common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment Warrants”). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant. 16 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) A portion of the proceeds from the Term D Loan in the amount of $ 2.8 million was allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional paid in capital in the accompanying condensed consolidated balance sheets and were discounted from the Term D Loan. The relative fair value of the Third Amendment Warrants was based on the Black-Scholes method with the following assumptions: risk-free interest rate of 4.08 %; expected volatility of 74.4 %; expected life of 10.0 years; and expected dividend yield 0 %. The underlying stock price used in the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense ratably over the term of the Term D Loan. Second Amendment On July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of $ 25,000 , which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to convert up to 20 % of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 . Further, in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, the Company achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $ 30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment. First Amendment On May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which the Company agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company had failed to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if the Company subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation. May 30, 2024 Amendment and Restatement On May 30, 2024, the Company entered into the A&R Loan Agreement. The A&R Loan Agreement amended and restated, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”). Funding of the first $ 100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the “Term A Loan”) and $ 21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”). As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment. Prior to the Third Amendment, the Company also would have become eligible to draw on a fifth tranche of $ 50 million (the “Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders also could have, in their sole discretion upon the Company’s request, made additional term loans to the Company of $ 45 million (the “Term F Loan”). Funding of these additional tranches was also subject to other customary conditions and limits on when the Company could have requested funding for such tranches. Costs associated with the new borrowings were approximately $ 2.4 million. 17 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) Pursuant to the A&R Loan Agreement, the Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement is secured by all assets of the Company. Proceeds are being used for working capital purposes and to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures. Prior to the Second Amendment, Innovatus also had the right, at its election and until August 9, 2025, to convert up to 20 % of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 . Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031. The A&R Loan Agreement contains a Final Fee, which is equal to 4.5 % of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization provisions related to the Term D Loan are no longer operative. The Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If the Company achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement of the Term E Milestone, of the Company’s intent not to draw the full amount of the Term E Loan, a non-utilization fee with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, the Company shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30, 2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan. In connection with the funding of each of the Term C Loan and the Term D Loans, the Company agreed to issue to Innovatus and Oxford warrants to purchase that number of shares of the Company’s common stock equal to 2.5 % of the principal amount of the applicable Term Loan divided by the exercise price, which was, with respect to the Term C Loan, equal to the lower of (i) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the A&R Loan Agreement. Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise price of $ 14.84 per share. The relative fair value of the warrants was approximately $ 1.2 million. For the Term D Loans, the exercise price was based on the lower of (i) the exercise price for the warrants issued pursuant to the Term C Loan or (ii) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the Term D Loan funding. Prior to the Third Amendment, the Company also was required to issue warrants to Innovatus and Oxford in connection with the funding of the Term E Loan and the Term F Loan. The warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding date. The number of shares of common stock for which each warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such warrant. 18 CELCUITY INC. FORM 10-Q (For the Three and Nine Months Ended September 30, 2025 and 2024) The Company evaluated the change of terms under ASC 470-50, “Debt – Modification and Extinguishment” with respect to the Third Amendment, the Second Amendment, the First Amendment and the A&R Loan Agreement and concluded the change in terms did not result in significant and consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment of the debt. Long-term debt consisted of the following at September 30, 2025 and December 31, 2024: Schedule of Long-term Debt (in thousands) September 30, 2025 December 31, 2024 Note payable $ 130,000 $ 100,000 Add: Final fee 5,850 4,500 Add: PIK interest (added to principal) 1,366 593 Less: unamortized debt issuance costs ( 3,154 ) ( 1,614 ) Less: unamortized debt discount ( 8,896 ) ( 5,752 ) Total long-term debt $ 125,166 $ 97,727 Future principal payments, including the incurred PIK interest and Final Fee, are as follows: Schedule of Long Term Debt Future Principal Payments (in thousands) Years Ending December 31, 2028 43,789 2029 93,427 Total $ 137,216 9. License Agreement On April 8, 2021, the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, a potent, investigational, multi-target PAM inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway. The Company paid Pfizer $ 5.0 million in upfront fees and issued to Pfizer $ 5.0 million of shares of the Company’s common stock pursuant to an Equity Grant Agreement. The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $ 335.0 million. One of these milestone events requires a $ 5.0 million payment within 60 days following the FDA regulatory filing of a New Drug Application (“NDA”) for gedatolisib. The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and the Company made its first NDA pre-submission in September 2025 and expects to complete its final NDA submission to the FDA in the fourth quarter of 2025. The Company has recorded the $ 5.0 million NDA filing milestone as a research and development expense in June 2025. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid patent claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product, or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, a valid claim of a licensed patent right. The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party. 10. Subsequent Events Warrants Exercised In October 2025, investors exercised 2,930,420 warrants at an exercise price of $ 8.05 , which generated approximately $ 23.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. 19 ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes appearing under Item 1 of Part I of this Quarterly Report on Form 10-Q (this “Quarterly Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and expected financial results, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, and the cautionary statements elsewhere in this Quarterly Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Overview Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that binds to all Class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“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. Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported detailed results for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients. The first patient was dosed in July of 2025. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (“mCRPC”), is ongoing. In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer. We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offer distinct advantages over currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. ● Overcomes limitations of therapies that only inhibit a single Class I PI3K isoform, AKT, or one mTOR kinase complex. Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and the mTORC1 and mTORC2 complexes. By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PAM pathway. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single Class I PI3K isoform (e.g., alpelisib, a PI3Kα inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3Kα, AKT, or mTORC1 kinase inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms, AKT, and mTOR. 20 ● Better tolerated by patients than oral PI3K and mTOR drugs. Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib’s comprehensive inhibition of the PAM pathway at low nanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels of hyperglycemia, rash, and diarrhea typically associated with oral single-node inhibitors of the PAM pathway. Isoform-specific PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis can still lead to challenging toxicities. The experience with an FDA-approved oral p110-α specific inhibitor, PIQRAY, illustrates the challenge. In its Phase 3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related AEs. By contrast, in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment. As of September 30, 2025, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials. Of the 492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials. The remaining 363 patients received gedatolisib in combination with other anti-cancer agents in five clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in nine investigator sponsored clinical trials. B2151009 Phase 1b Trial A Phase 1b clinical trial (B2151009) evaluating patients with HR+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled 138 patients. Four patients from this study continue to receive study treatment, as of September 30, 2025, each of whom has received study treatment for approximately five years. The B2151009 clinical trial was an open label, multiple arm Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib (CDK 4/6 inhibitor) and fulvestrant or letrozole in patients with HR+/HER2- advanced breast cancer. Thirty-five patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine the maximum tolerated dose (“MTD”) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy (letrozole or fulvestrant). The MTD was determined to be 180 mg administered intravenously once weekly. A total of 103 patients were subsequently enrolled in one of four expansion arms (A, B, C, and D). High objective overall response rates (“ORR”) were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA MT patients. In patients who received prior hormonal therapy alone or in combination with a CDK 4/6 inhibitor (Arms B, C, and D), the ORR (including unconfirmed partial responses) ranged from 36% to 77%. In patients who were treatment naïve in the advanced setting (Arm A), the ORR was 85%. Each arm achieved its primary endpoint target, which was reporting higher ORR in the study arm than the ORR from either the PALOMA-2 study (ORR=55%) that evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all patients enrolled in the expansion portion of the study who had evaluable tumors, the ORR observed was 63%. Median progression-free survival (“PFS”) was 12.9 months for patients who received a prior CDK 4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D). For all treatment naïve patients who received gedatolisib combined with palbociclib plus letrozole in Expansion Arm A and Escalation Arm A (N=41), median PFS was 48.6 months and ORR was 79%. These results compare favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2-advanced breast cancer. 21 Gedatolisib combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment related AEs were Grades 1 and 2. The most frequently observed AEs included stomatitis/mucosal inflammation, the majority of which were Grades 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment with palbociclib. No Grade 5 events were reported in this study. In a presentation of results from the PIK3CA WT cohort of the VIKTORIA-1 study at the European Society for Medical Oncology (“ESMO”) Congress, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- ABC was included. The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib. (Layman R., Lancet Oncol. 2024; 25:474-8). This included patients from Escalation Arm B and Expansion Arms B, C and D of the Phase 1b study. Patients in Escalation Arm B and Expansion Arms B and C received a 180 mg dose of gedatolisib once weekly (“weekly dose”). Patients in Expansion Arm D received a 180 mg dose of gedatolisib on days 1, 8, and 15 of a four-week cycle (“intermittent dose”), which was the same dose regimen patients in the VIKTORIA-1 study received. The proportion of patients who received the intermittent dose of gedatolisib was 37% for those with PIK3CA MT tumors and 25% for those with PIK3CA WT tumors. The proportion of patients who received prior treatment with a CDK4/6 inhibitor was 73% for those with PIK3CA WT tumors, and 71% for those with PIK3CA MT tumors. Median PFS and the ORR were assessed in sub-groups of patients according to their PIK3CA status (Table 1). For all analyzed patients with PIK3CA MT tumors (n=30), median PFS was 14.6 months and the ORR in response evaluable patients was 48%. Median PFS was 19.7 months and the ORR was 64% in patients with PIK3CA MT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. For patients with PIK3CA WT tumors (n=60), median PFS was 9.0 months and the ORR in response evaluable patients was 41%. Median PFS was 9.1 months and the ORR was 53% in patients with PIK3CA WT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. Table 1: Efficacy Analysis of Phase 1b Patients Treated with Gedatolisib Plus Palbociclib Plus Fulvestrant PIK3CA MT PIK3CA WT All Intermittent Dose All Intermittent dose Sample size 30 11 60 15 Median PFS (months) 14.6 19.7 9.0 9.1 ORR 48 % 64 % 41 % 53 % VIKTORIA-1 Phase 3 Trial We have completed enrollment of our Phase 3, open-label, randomized clinical trial, VIKTORIA-1, to evaluate the efficacy and safety of gedatolisib treatment regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK 4/6 therapy in combination with an aromatase inhibitor. Over two hundred clinical sites in North America, Europe, Latin America, and Asia-Pacific are participating in the study. The first patient was dosed in this trial in December 2022. 22 The VIKTORA-1 Phase 3 clinical trial involves two study cohorts that enable separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and had PIK3CA WT tumors (cohort 1) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). During the fourth quarter of 2024, we achieved our enrollment goal of 351 subjects for the PIK3CA WT cohort. The primary completion date for this cohort was achieved in May 2025 and the database cut-off date for this cohort was May 30, 2025. Subjects who met eligibility criteria and had PIK3CA MT tumors (cohort 2) were randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F). Enrollment of approximately 350 subjects who have PIK3CA MT tumors is complete. We expect topline data for this group to be available in late Q1 2026 or during Q2 2026. On July 28, 2025, we announced topline data from the PIK3CA WT cohort of the VIKTORIA-1 clinical trial and on October 18, 2025, at the ESMO Congress, additional efficacy and safety results from this cohort was presented. The key efficacy and safety data from the PIK3CA WT cohort showed: ● The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The median PFS, as assessed by blinded independent central review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. ● The gedatolisib doublet (gedatolisib and fulvestrant) also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The median PFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. ● The ORR of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months. The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. ● The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively) rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively). The primary Grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group. 23 The detailed results from cohort 1, PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer: ● The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer. ● The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer receiving at least their second line of therapy. ● Gedatolisib is the first inhibitor targeting the PAM pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/ PIK3CA WT advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. ● The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- advanced breast cancer. The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet. With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+/HER2-, PIK3CA WT advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. Additional results from cohort 1 of the VIKTORIA-1 Phase 3 clinical trial will be presented at a medical conference later this year. CELC-G-201 Phase 1b/2 Trial We received approval from the FDA in mid-2023 to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC. We have since initiated a Phase 1b/2 clinical trial, CELC-G-201, that is enrolling patients with mCRPC who progressed after treatment with an androgen receptor inhibitor. The first patient was dosed in this trial in February 2024. The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose (“RP2D”) of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic PFS at six months of patients who received the RP2D. In the Phase 1b portion of the clinical trial, 38 patients with mCRPC were randomly assigned to receive 600 mg of darolutamide twice daily combined with either 120 mg of gedatolisib in Arm 1 or 180 mg of gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis. 24 On June 30, 2025, we announced preliminary data for the CELC-G-201 Phase 1b trial, utilizing a May 30, 2025 data cut-off. Based on these data, we amended the clinical trial protocol to enable exploration of additional doses in the Phase 1b portion of this clinical trial to determine the RP2D. Once RP2D is determined, an additional 12 participants will then be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib. On October 18, 2025, at the ESMO Congress, we presented updated clinical results for the CELC-G-201 Phase 1b trial based on an August 15, 2025 data cut-off. Among the 38 patients enrolled, 61% had received one line of prior systemic th erapy and 39% had received at least 2 or more lines of prior therapy. Median duration of follow-up was 9.0 months. The six-month radiographic progression free survival (“rPFS”) rate and median rPFS for patients from both arms combined was 67 % and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months. The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE. VIKTORIA-2 Phase 3 Trial A Phase 3, open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer (“VIKTORIA-2”) is currently enrolling patients. The first patient was dosed in July of 2025. For the CDK 4/6 inhibitor, investigators may choose either ribociclib or palbociclib. This multi-center, international trial is expected to enroll approximately 12–36 evaluable subjects in the safety run-in portion of the study to evaluate the safety of gedatolisib when combined with ribociclib and fulvestrant. In the Phase 3 portion of the study, approximately 638 subjects will be randomized and assigned to Cohort 1 (PIK3CA WT) or Cohort 2 ( PIK3CA MT) based on their PIK3CA status. Subjects in each cohort will be randomized on a 1:1 basis to either Arm A (gedatolisib with fulvestrant and ribociclib or palbociclib) or Arm B (fulvestrant and ribociclib or palbociclib). It is expected that approximately 200 clinical sites across North America, Europe, Latin America, and Asia-Pacific will participate. Investigator-Sponsored Trials In an investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+/ PIK3CA mutated metastatic breast cancer were treated with gedatolisib plus standard doses of trastuzumab-pkrb. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more; 86% of patients had received at least three prior anti-HER2 therapies. The data cut-off was February 10, 2025. 25 Key efficacy and safety results, as presented at the American Society of Clinical Oncologists meeting in June 2025, showed: ● The ORR among all patients enrolled was 43%. ● Median PFS was 6.0 months (95% CI, 5.0-7.7). ● Median overall survival was 24.7 months (95% CI; 17.3-NA). ● No patients discontinued gedatolisib due to a treatment-related AE. ● One (2.3%) patient experienced Grade 3 hyperglycemia. An investigator sponsored trial has been initiated in collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer. Recent Developments On July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 Shares at a price to the public of $38.00 per Share and (ii) in lieu of Shares to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares, less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025. For a summary of the Equity Offering, see “Liquidity and Capital Resources” below. On July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of Notes to the Underwriters. In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26.3 million aggregate principal amount of Notes. The issuance of $201.3 million aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by the Indenture. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We are using the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes. For a summary of the Note Offering, see “Liquidity and Capital Resources” below. On August 27, 2025, the FDA granted our request to submit the gedatolisib NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and we made our first NDA pre-submission in September 2025. We expect to complete our final NDA submission to the FDA in the fourth quarter of 2025. On September 9, 2025, we entered into the Third Amendment to the Amended and Restated Loan and Security Agreement with Oxford Finance LLC, a Delaware limited liability company, as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership, as a lender, and the other lenders party thereto. For a summary of the Third Amendment to the A&R Loan Agreement, see “Liquidity and Capital Resources” below. On October 18, 2025, at the ESMO Congress, we presented (i) detailed efficacy and safety results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib; (ii) additional data from our Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- advanced breast cancer; and (iii) additional data from the CELC-G-201 Phase 1b clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide), an androgen receptor inhibitor, in men with mCRPC whose disease had progressed on prior treatment with a next generation androgen receptor inhibitor. For a summary of the data presented, see “Overview” above. We also announced that the PIK3CA MT cohort of the VIKTORIA-1 Phase 3 trial was fully enrolled. Results of Operations We have not generated any revenue from sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception in 2012. For the three months ended September 30, 2025 and 2024, we reported a net loss of approximately $43.8 million and $29.8 million, respectively, and for the nine months ended September 30, 2025 and 2024, we reported a net loss of approximately $126.1 million and $75.1 million, respectively. As of September 30, 2025, we had an accumulated deficit of approximately $397.9 million. As of September 30, 2025, we had cash and cash equivalents and short-term investments of approximately $455.0 million. Components of Operating Results Revenue To date, we have not generated any revenue. With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support potential regulatory approval to market gedatolisib. In August 2023, we initiated a Phase 1b/2 clinical trial, CELC-G-201. In July 2025 we dosed our first patient and are currently enrolling patients in a second Phase 3 clinical trial, VIKTORIA-2. Pursuant to the FDA’s RTOR program, in September 2025 we made the first pre-submission of our NDA to the FDA; we expect to complete the final NDA submission to the FDA in the fourth quarter of 2025. If we obtain regulatory approvals to market gedatolisib, we expect to generate revenue from sales of the drug for this and potentially additional breast cancer indications. 26 Research and Development Since our inception, we have primarily focused on research and development of gedatolisib, a PI3K/mTOR targeted therapy, and our CELsignia platform and corresponding tests. Research and development expenses primarily include: ● employee-related expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation expenses; ● laboratory supplies; ● consulting fees paid to third parties; ● clinical trial costs; ● validation costs for gedatolisib; ● facilities expenses; and ● legal costs associated with patent applications. General and Administrative General and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and support functions. Other general and administrative expenses include professional fees for auditing, tax, and legal services associated with being a public company, director and officer insurance, software costs, investor relations and travel expenses for our general and administrative personnel. Sales and Marketing Expenses and costs related to marketing, supply chain, distribution, market access and other commercial operations related activities are being incurred in anticipation of the commercialization of gedatolisib. These expenses consist primarily of employee-related expenses, professional and consulting fees related to these functions and operations, software costs, and the acquisition of data required to support our market analysis for gedatolisib. We expect sales and marketing expenses to increase as we get closer to a potential FDA approval date. Interest Expense Interest expense to date is primarily related to the A&R Loan Agreement. During the three months ended September 30, 2025, interest expense included the Convertible Notes. Interest Income Interest income consists of interest income earned on our cash, cash equivalents, and investment balances. Results of Operations Comparison of the Three Months Ended September 30, 2025 and 2024 (in thousands) Three Months Ended September 30, Change 2025 2024 $ Percent Statements of Operations Data: Operating expenses: Research and development $ 34,915 $ 27,588 $ 7,327 27 % General and administrative 7,934 2,472 5,462 221 Total operating expenses 42,849 30,060 12,789 43 Loss from operations (42,849 ) (30,060 ) (12,789 ) 43 Other (expense) income Interest expense (4,595 ) (3,344 ) (1,251 ) 37 Interest income 3,640 3,612 28 1 Other (expense) income, net (955 ) 268 (1,223 ) (456 ) Net loss before income taxes (43,804 ) (29,792 ) (14,012 ) 47 Income tax benefits - - - - Net loss $ (43,804 ) $ (29,792 ) $ (14,012 ) 47 % 27 Comparison of the Nine Months Ended September 30, 2025 and 2024 (in thousands) Nine Months Ended September 30, Change 2025 2024 $ Percent Statements of Operations Data: Operating expenses: Research and development $ 107,364 $ 70,732 $ 36,632 52 % General and administrative 15,627 6,105 9,522 156 Total operating expenses 122,991 76,837 46,154 60 Loss from operations (122,991 ) (76,837 ) (46,154 ) 60 Other (expense) income Interest expense (10,982 ) (7,005 ) (3,977 ) 57 Interest income 7,904 8,716 (812 ) (9 ) Other (expense) income, net (3,078 ) 1,711 (4,789 ) (280 ) Net loss before income taxes (126,069 ) (75,126 ) (50,943 ) 68 Income tax benefits - - - - Net loss $ (126,069 ) $ (75,126 ) $ (50,943 ) 68 % Research and Development Our research and development expenses for the three months ended September 30, 2025 were approximately $34.9 million, representing an increase of approximately $7.3 million, or 27%, compared to the same period in 2024. Of the $7.3 million increase in research and development expense, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials. Our research and development expenses for the nine months ended September 30, 2025 were approximately $107.4 million, representing an increase of approximately $36.6 million, or 52%, compared to the same period in 2024. Of the $36.6 million increase in research and development expenses, $18.1 million was related to increased employee and consulting expenses, $7.6 million of which related to commercial headcount additions and other launch activities. $13.1 million was attributable to activities supporting our ongoing clinical trials, $5.0 million was related to an anticipated development milestone payment under the license agreement with Pfizer, and $0.4 million was related to other costs. Conducting research and development is central to our business model. We plan to continue to increase our research and development expenses for the foreseeable future as we seek to continue to develop gedatolisib, including conducting the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial and the VIKTORIA-2 Phase 3 clinical trial. General and Administrative Our general and administrative expenses for the three months ended September 30, 2025 were approximately $7.9 million, representing an increase of approximately $5.4 million, or 221%, compared to the same period in 2024. Of the $5.4 million increase in general and administrative expense, $4.9 million was related to increased employee and consulting expenses. Of the $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase resulted from professional fees, expanding infrastructure and other administrative expenses. 28 Our general and administrative expenses for the nine months ended September 30, 2025 were approximately $15.6 million, representing an increase of under $9.5 million, or 156%, compared to the same period in 2024. Of the $9.5 million increase in general and administrative expense, $8.1 million was related to increased employee and consulting expenses. Of the $8.1 million increase, $5.0 million related to non-cash, stock-based compensation. The remaining $1.4 million of the $9.5 million increase was related to professional fees, expanding infrastructure and other administrative expenses. We anticipate that our general and administrative expenses will continue to increase in future periods, reflecting both increased costs in connection with the potential future commercialization of gedatolisib, an expanding infrastructure, and increased professional fees associated with public company regulatory developments and requirements, and other compliance matters. Interest Expense Interest expense for the three months ended September 30, 2025 was $4.6 million and represents an increase of $1.3 million, or 37%, compared to the same period in 2024. Interest expense is the result of Convertible Notes and the A&R Loan Agreement. The increase is due primarily to the issuance of the Convertible Notes in July 2025 and the distribution of the Term Loan D in September 2025. The $4.6 million of interest expense includes $1.1 million of non-cash interest expense. Interest expense for the nine months ended September 30, 2025 was $11.0 million and represents an increase of $4.0 million, or 57%, compared to the same period in 2024. Interest expense is the result of the Convertible Notes and the A&R Loan Agreement. The increase is primarily due to the incremental $61.7 million funding of the Term Loan C in May 2024, the issuance of the Convertible Notes in July 2025 and the distribution of the Term Loan D in September 2025. The $11.0 million of interest expense includes $2.6 million of non-cash interest expense. Interest Income Interest income for the three months ended September 30, 2025 was $3.6 million and represents a decrease of under $0.1 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates offset largely by a higher invested cash balance. Interest income for the nine months ended September 30, 2025 was $7.9 million and represents a decrease of $0.8 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates offset partially by a higher invested cash balance. Liquidity and Capital Resources Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2025, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through September 30, 2025, we raised an aggregate of approximately $481.7 million of net proceeds through sales of our securities, approximately $194.9 million of net proceeds through the issuance of the Notes, and had $130.0 million of borrowings under loan agreements, not including payable-in-kind interest. In October 2025, investors exercised 2,930,420 warrants at an exercise price of $8.05, which generated approximately $23.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. From September 30, 2025 through the report date, stock option exercises generated approximately $0.2 million in cash. As of September 30, 2025, our cash and cash equivalents and short-term investments were approximately $74.3 million and $380.7 million, respectively, and we had an accumulated deficit of approximately $397.9 million. 29 July 2025 Equity Offering On July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 Shares at a price to the public of $38.00 per Share and (ii) in lieu of Shares to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares, less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025. The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. We may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants. We are using the net proceeds from the Equity Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes. Each Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $0.001 per share, or alternatively, at the election of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined according to the formula set forth in each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance until all of the Pre-Funded Warrants are exercised. A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to us. July 2025 Convertible Notes Offering On July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of Notes to the Underwriters. In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26.3 million aggregate principal amount of Notes. The issuance of $201.3 million aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by the Indenture. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We are using the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes. The Notes are our general, unsecured, senior obligations. The Notes will accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year. In addition, special interest will accrue on the Notes upon the occurrence of certain events relating to our failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by us. 30 Noteholders may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time. The Notes will be redeemable, in whole or in part (subject to certain limitations described below), at our option at any time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we send the related redemption notice; and (ii) the trading day immediately before the date we send such notice. However, we may not redeem less than all of the outstanding Notes unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time we send the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption. If a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth in the Indenture, noteholders may require us to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock. Lastly, the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes; provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation in no event can exceed 19.99%. Private Placement Warrants In March 2025, an investor exercised 695,650 warrants at an exercise price of $8.05, which generated approximately $5.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. In July 2025, an investor exercised 1,286,960 warrants at an exercise price of $8.05, which generated approximately $10.4 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. In August 2025, investors exercised 200,000 warrants at an exercise price of $8.05, which generated approximately $1.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in August 2025, the underwriter of the Company’s initial public offering that closed on September 22, 2017 exercised its warrants on a cashless basis. As a result, the Company issued 55,592 shares of common stock upon the cashless exercise of 70,000 warrants. 31 In September 2025, an investor exercised 104,340 warrants at exercise prices of $8.05, which generated approximately $0.8 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in September 2025, the placement agent from private placements that closed in January and May 2016 exercised 7,917 warrants at an exercise price of $7.56, which generated approximately $0.1 million in cash. In October 2025, investors exercised 2,930,420 warrants at an exercise price of $8.05, which generated approximately $23.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Open Market Sale Agreement On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC (“Jefferies”), as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of up to $50.0 million, which amount was subsequently increased to $125.0 million on December 6, 2024. On July 29, 2025, prior to the pricing of the Equity Offering and the Note Offering, the aggregate offering price was reduced from $125.0 million to $50.0 million. On October 12, 2022, pursuant to this agreement, we sold 500,000 shares of common stock in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses). On December 1, 2023, pursuant to this agreement, we sold 1,034,500 shares of common stock in a single transaction at a price of $14.50 per share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and offering expenses). In April 2024 and May 2024, pursuant to this agreement, we sold 285,714 and 149,700 shares of common stock, respectively, at an average selling price of $17.55 per share, generating gross proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million. At September 30, 2025, $50.0 million of common stock remains available for sale under the Open Market Sale Agreement with Jefferies. May 2024 Equity Offering On May 30, 2024, we entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $15.50, generating gross proceeds of approximately $60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to us of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by us. Amended and Restated Loan and Security Agreement Third Amendment On September 9, 2025, we entered into the Third Amendment (the “Third Amendment”) to the 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 a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”)) and provide for the immediate disbursement of the $30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $50.0 million to up to $100.0 million, which Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type advanced breast cancer patients post CDK4/6 inhibitor therapy; (iv) add three new up to $40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), which may only be drawn upon achievement of certain trailing three months’ product revenue thresholds; (v) replace the prior $45.0 million Term F Loan (as defined in the A&R Loan Agreement) with a new $150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement), which continues to be available only in the Lenders’ sole discretion upon our request; (vi) require an amendment fee payable by us to the Lenders in the amount of $50,000, which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that we may make by notice to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans to November 1, 2029. The Term E Loan and each Term F Loan also are subject to other customary conditions and limits on when we can request funding. With the disbursement of the $30.0 million Term D Loan, the Company received net proceeds of approximately $27.8 million. In accordance with the A&R Loan Agreement, a Final Fee equal to 4.5% of the $30.0 million Term D Loan was recognized and an additional $1.4 million was added to debt principal and a corresponding debt discount to be amortized over the life of the loan. 32 In connection with the Third Amendment, we issued warrants with an exercise price of $14.84 per share to purchase an aggregate of 50,537 shares of our common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment Warrants”). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant. A portion of the proceeds from the Term D Loan in the amount of $2.8 million was allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional paid in capital in the accompanying condensed consolidated balance sheets and were discounted from the Term D Loan. The relative fair value of the Third Amendment Warrants was based on the Black-Scholes method with the following assumptions: risk-free interest rate of 4.08%; expected volatility of 74.4%; expected life of 10.0 years; and expected dividend yield 0%. The underlying stock price used in the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense ratably over the term of the Term D Loan. Second Amendment On July 28, 2025, we entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to us in the aggregate principal amount of up to $180 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by us to Oxford in the amount of $25,000, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00. Further, in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, we achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to us in connection with the Third Amendment. First Amendment On May 13, 2025, we entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which we agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if we had failed to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if we subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation. 33 May 30, 2024 Amendment and Restatement On May 30, 2024, we entered into the A&R Loan Agreement. The A&R Loan Agreement amended and restated, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between us and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”). Funding of the first $100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $16.8 million (the “Term A Loan”) and $21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $61.7 million of new borrowings (the “Term C Loan”). As described above, the Term D Loan was disbursed to us in connection with the Third Amendment. Prior to the Third Amendment, we also would have become eligible to draw on a fifth tranche of $50 million (the “Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders also could have, in their sole discretion upon our request, made additional term loans to us of $45 million (the “Term F Loan”). Funding of these additional tranches was also subject to other customary conditions and limits on when we could have requested funding for such tranches. Costs associated with the new borrowings were approximately $2.4 million. Pursuant to the A&R Loan Agreement, we are entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement is secured by all of our assets. Proceeds are being used for working capital purposes and to fund our general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures. Prior to the Second Amendment, Innovatus also had the right, at its election and until August 9, 2025, to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00. Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $14.40 through April 8, 2031. The A&R Loan Agreement contains a Final Fee, which is equal to 4.5% of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization provisions related to the Term D Loan are no longer operative. The Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If we achieve the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after our achievement of the Term E Milestone, of our intent not to draw the full amount of the Term E Loan, a non-utilization fee with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, we shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided we (i) provide written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pay to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30, 2024, we recognized the Final Fee of $4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan. 34 In connection with the funding of each of the Term C Loan and the Term D Loans, we agreed to issue to Innovatus and Oxford warrants to purchase that number of shares of our common stock equal to 2.5% of the principal amount of the applicable Term Loan divided by the exercise price, which was, with respect to the Term C Loan, equal to the lower of (i) the volume weighted average closing price of our common stock for the five-trading day period ending on the last trading day immediately preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the A&R Loan Agreement. Accordingly, on May 30, 2024, we issued 103,876 warrants with an exercise price of $14.84 per share. The relative fair value of the warrants was approximately $1.2 million. For the Term D Loans, the exercise price was based on the lower of (i) the exercise price for the warrants issued pursuant to the Term C Loan or (ii) the volume weighted average closing price of our common stock for the five-trading day period ending on the last trading day immediately preceding the Term D Loan funding. Prior to the Third Amendment, we also were required to issue warrants to Innovatus and Oxford in connection with the funding of the Term E Loan and the Term F Loan. The warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding date. The number of shares of common stock for which each warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such warrant. Liquidity and capital resource requirements We expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib, conduct the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 trial, and the VIKTORIA-2 Phase 3 clinical trial, conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and marketing expenses as we prepare for commercial launch and then commercialize gedatolisib. We expect to use cash on hand, together with the funds received or to be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses. Based on our current business plan, we believe that our current cash, cash equivalents and short-term investments, together with available borrowings under the A&R Loan Agreement, will provide sufficient cash to finance our operations through 2027. Our expectations as to how long our current capital resources will be sufficient to fund our operations are based on assumptions that may not be accurate, and we could use our current capital resources sooner than we currently expect. In addition, we may seek to raise additional capital to finance capital expenditures and operating expenses over the next several years as we seek to obtain approval for and launch gedatolisib; expand our infrastructure, commercial operations and research and development activities; and to take advantage of financing or other opportunities that we believe to be in the best interests of the Company and our stockholders. Additional capital may be raised through the sale of common or preferred equity or convertible debt securities, entry into debt facilities or other third-party funding arrangements. The sale of equity and convertible debt securities may result in dilution to our stockholders and those securities may have rights senior to those of our common stock. Agreements entered into in connection with such capital raising activities could contain covenants that would restrict our operations or require us to relinquish certain rights. Additional capital may not be available on reasonable terms, or at all. 35 Cash Flows The following table sets forth the primary sources and uses of cash for the nine months ended September 30: 2025 2024 (in thousands) Net cash (used in) provided by: Operating activities $ (116,881 ) $ (55,697 ) Investing activities (167,493 ) (100,628 ) Financing activities 336,111 138,265 Net increase (decrease) in cash and cash equivalents $ 51,737 $ (18,060 ) Operating Activities Net cash used in operating activities was approximately $116.9 million for the nine months ended September 30, 2025 and consisted primarily of a net loss of approximately $126.1 million, partially offset by non-cash expense items of approximately $13.8 million and by a working capital net cash use of $4.6 million. Non-cash expense items of approximately $13.8 million primarily consisted of $11.9 million of stock-based compensation expense and non-cash amortization of debt issuance costs and discount and payment-in-kind interest of $2.6 million in the aggregate, offset partly by non-cash interest accretion of $0.8 million. The approximately $4.7 million of working capital changes were primarily due to increases in other current assets, partly offset by increases in both accounts payable and accrued expenses. Net cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of approximately $75.1 million, partially offset by working capital changes of $13.9 million and non-cash expense items of approximately $5.5 million. Non-cash expense items of approximately $5.5 million primarily consisted of $4.7 million of stock-based compensation expense and net non-cash interest of $0.8 million. The approximately $13.9 million of working capital changes was primarily due to increases in accrued expenses and accounts payable, and a decrease in other current assets. Investing Activities Net cash used in investing activities for the nine months ended September 30, 2025 was approximately $167.5 million and consisted primarily of net purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government agency), partially offset by purchases of property and equipment. Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $100.6 million and consisted primarily of net purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities), partially offset by purchases of property and equipment. Financing Activities Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $336.1 million and consisted of net proceeds from the Note Offering of $195.5 million, net proceeds from the Equity Offering of approximately $91.8 million and net proceeds from the Term D Loan of $27.8 million. In addition, cash provided by financing activities included the exercise of common stock warrants in the amount of $18.5 million and from the exercise of employee stock options and employee stock purchases in the amount of $2.6 million, offset in part by registration costs of $47 thousand. Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $138.3 million and primarily consisted of net proceeds of approximately $59.2 million from incremental debt financing, $56.3 million from an equity offering and $7.3 million from an at-the market offering. The remaining $15.4 million consisted of proceeds from the exercise of common stock warrants, the exercise of employee stock options and employee stock purchases. 36 Recent Accounting Pronouncements From time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. Critical Accounting Policies and Use of Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates. Our significant accounting policies are more fully described in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such forward-looking information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as well as information included in oral statements or other written statements made or to be made by us). Forward-looking statements include all statements based on future expectations. This Quarterly Report contains forward-looking statements that involve risks and uncertainties including, but not limited to, (i) our clinical trial plans and the estimated timelines and costs for such trials; (ii) our plans to develop and commercialize our products, and our expectations about the market opportunity for gedatolisib and our ability to serve that market; (iii) 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 WT cohort of the Phase 3 VIKTORIA-1 clinical trial; (iv) our expectations regarding the timeline of patient enrollment and results from clinical trials, including our ongoing Phase 3 VIKTORIA-1 clinical trial, ongoing Phase 3 VIKTORIA-2 clinical trial, and ongoing Phase 1b/2 clinical trial for gedatolisib; (v) our expectations regarding the timing of submitting an NDA for, and our ability to obtain FDA approval to commercialize, gedatolisib; (vi) our expectations regarding governmental laws and regulations affecting our operations, including, without limitation, developments in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S. and laws that affect our operations and our laboratory; (vii) our expectations with respect to the development, validation, required approvals, costs and timelines of our drug candidate gedatolisib; (viii) our beliefs related to the potential benefits resulting from Breakthrough Therapy designation for gedatolisib; (ix) our plans with respect to research and development and related expenses for the foreseeable future; (x) our beliefs about our ability to capitalize on the exclusive global development and commercialization rights obtained from our license agreement with Pfizer with respect to gedatolisib; (xi) our expectations regarding the future payments that may be owed to Pfizer under the license agreement with them; (xii) our beliefs with respect to the potential rate and degree of market acceptance, both in the United States and internationally, and clinical utility of gedatolisib; (xiii) our revenue expectations; (xiv) our expectations regarding business development activities, including collaborations with pharmaceutical companies; (xv) our plans with respect to pricing in the United States and internationally, and our ability to obtain reimbursement for our drug candidate, gedatolisib, 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; (xvi) our expectations as to the use of proceeds from our financing activities; (xvii) our expectations with respect to availability of capital, including accessing our current debt facility or any other debt facility or other capital sources in the future, and our assumption that we will have adequate authorized shares for future equity issuances; (xviii) our beliefs regarding the adequacy of our cash on hand to fund our clinical trials, capital expenditures, working capital, and other general corporate expenses, as well as the increased costs associated with being a public company; (xix) our plans with respect to potentially raising capital; and (xx) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, including our gedatolisib drug candidate and our CELsignia platform and tests. 37 In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are only predictions and are not guarantees of performance. These statements are based on our management’s beliefs and assumptions, which in turn are based on their interpretation of currently available information. 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, our limited operating history; our potential inability to develop, validate, obtain regulatory approval for and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges we may face in developing and maintaining relationships with pharmaceutical company partners, including our current and any future suppliers of our product candidate; the uncertainty and costs associated with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and with the size of market opportunities available to us; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets and limitations on access to capital; stock market volatility or other factors that may affect our ability to access capital on favorable terms or at all; and obtaining and maintaining intellectual property protection for our technology and time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us. These and additional risks, uncertainties and other factors are described more fully in our Annual Report on Form 10-K for the year ended December 31, 2024 and elsewhere in this Quarterly Report. Copies of filings made with the SEC are available through the SEC’s electronic data gathering, analysis, and retrieval system (EDGAR) at www.sec.gov. You should read the cautionary statements made in this Quarterly Report as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report. We cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should read this Quarterly Report completely. Other than as required by law, we undertake no obligation to update these forward-looking statements, even though our situation may change in the future. ITEM 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, we are not required to provide disclosure pursuant to this item. ITEM 4. Controls and Procedures Evaluation of Disclosure Controls and Procedures Our Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the Certifying Officers, are responsible for establishing and maintaining our disclosure controls and procedures. The Certifying Officers have reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of September 30, 2025. Based on that review and evaluation, the Certifying Officers have concluded that, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures, as designed and implemented, are effective and provide reasonable assurance that information required to be disclosed by us in the periodic and current reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the periods specified by the SEC’s rules and forms. Changes in Internal Control Over Financial Reporting . There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 38 PART II. — OTHER INFORMATION ITEM 1. Legal Proceedings From time to time, we may be involved in disputes or litigation relating to claims arising out of our operations. We are not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and results of operations. ITEM 1A. Risk Factors In addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Private Securities Litigation Reform Act,” you should carefully consider the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. Except as set forth below, there have been no material changes to the risk factors previously disclosed in such Annual Report on Form 10-K. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results. Changes to trade policy, including new or increased tariffs and changing import and export regulations, could have a material adverse effect on our business, results of operations and financial condition. Our business, results of operations, and financial condition could be adversely affected by uncertainty and changes in U.S. or international trade policies, including tariffs, quotas, trade agreements, or other trade restrictions imposed by the U.S. or other governments. For example, the U.S. has instituted certain changes, and has proposed additional changes, in trade policies that include the negotiation or termination of trade agreements, the imposition of higher tariffs on imports into the U.S., and other government regulations affecting trade between the U.S. and other countries. The new tariffs and other changes in U.S. trade policy have triggered retaliatory actions by affected countries, and foreign governments have instituted or are considering imposing trade sanctions on U.S. goods. Several tariff announcements have been followed by announcements of limited exemptions, revisions, and temporary pauses, resulting in significant uncertainty. The imposition of tariffs and other trade restrictions, as well as the escalation of trade disputes and any downturns in the global economy resulting therefrom, could materially and adversely affect our business, financial condition and results of operations. The extent and duration of the tariffs and other trade restrictions and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that may be granted, and availability and cost of alternative sources of supply. 39 While we plan to maintain adequate inventory of the gedatolisib active pharmaceutical ingredient (“API”) and to qualify a second source of gedatolisib API, any imposition of, or increase in, tariffs or other restrictions on imports of equipment or other materials (or the components of these materials) could increase the cost for such materials and also increase the prices for such materials available domestically or locally, if any, which in turn could increase our costs. Such cost increases could materially and adversely affect our results of operations and financial condition. Tariffs or other trade restrictions may lead to continuing uncertainty and volatility in U.S. and global financial and economic conditions and commodity markets, declining consumer confidence, significant inflation, and diminished expectations for the economy. Such conditions could have a material adverse impact on our business, results of operations and financial position. Disruptions at the FDA, and other government agencies from funding cuts, personnel losses, leadership changes, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business. The FDA and comparable regulatory agencies in foreign jurisdictions, such as the European Medicines Agency , play an important role in the development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including NDAs, investigational new drug applications (“INDs”), requests for special designations and marketing applications. If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our product candidates could be impacted in a negative manner. For example, the recent loss of FDA leadership and personnel, and new leadership at the U.S. Department of Health and Human Services, the FDA and the Center for Drug Evaluation and Research could lead to disruptions and delays in FDA guidance and review and approval of our product candidate. Further, while the FDA’s review of marketing applications and other activities for new drugs is largely funded through the user fee program established under the Prescription Drug User Fee Act, it remains unclear how the administration’s recent reduction in force and budget cuts will impact this program and the ability of the FDA to provide guidance and review our product candidate in a timely manner. There is also substantial uncertainty as to how regulatory reform measures being implemented by the Trump Administration across the government will impact the FDA and other federal agencies with jurisdiction over our activities. For example, since taking office, the President has issued a number of executive orders that could have a significant impact on the manner in which the FDA conducts its operations and engages in regulatory and oversight activities. Accordingly, if any of the foregoing developments and others impact the ability of the FDA to provide us with guidance regarding our clinical development programs or delay the agency’s review and processing of our regulatory submissions, including INDs and NDAs, our business would be negatively impacted. 40 Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations. As of September 30, 2025, we had $331.3 million aggregate principal amount of indebtedness for borrowed money, of which $130.0 million was secured indebtedness consisting of the Term Loans. Included in the aggregate principal amount is $201.3 million principal amount of additional indebtedness as a result of the offering of the Notes. We may incur additional indebtedness to meet future financing needs. For example, we have an additional $220.0 million in incremental Term Loans that can be drawn under the A&R Loan Agreement upon the achievement of certain clinical milestones and product revenue thresholds. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things: ● increasing our vulnerability to adverse economic and industry conditions; ● limiting our ability to obtain additional financing on acceptable terms or at all; ● requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for other purposes; ● limiting our flexibility to plan for, or react to, changes in our business; ● diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Notes; and ● placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital. Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness, and our cash needs may increase in the future. In addition, the A&R Loan Agreement contains, and any future indebtedness that we may incur in the future may contain, financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately due and payable in full. We may be unable to raise the funds necessary to repurchase the Notes for cash following a fundamental change or to pay any cash amounts due upon maturity and our other indebtedness may limit our ability to repurchase the Notes or to pay any cash amounts due upon their maturity. Noteholders may, subject to a limited exception, require us to repurchase their Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. Upon maturity of the Notes, we must pay their principal amount and accrued and unpaid interest in cash, unless they have been previously converted, redeemed or repurchased. We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the Notes or pay any cash amounts due upon their maturity. In addition, applicable law, regulatory authorities and the agreements governing our other indebtedness may restrict our ability to repurchase the Notes or to pay any cash amounts due upon their maturity. Our failure to repurchase Notes or to pay any cash amounts due upon their maturity when required will constitute a default under the Indenture. A default under the Indenture or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full after any applicable notice or grace periods. We may not have sufficient funds to satisfy all amounts due under our indebtedness. Provisions in the Indenture could delay or prevent an otherwise beneficial takeover of us. Certain provisions in the Notes and the Indenture could make a third-party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then, subject to limited exceptions, Noteholders will have the right to require us to repurchase their Notes for cash. In addition, if a takeover constitutes a make-whole fundamental change, then we may be required to temporarily increase the conversion rate of the Notes. In either case, and in other cases, our obligations under the Notes and the Indenture could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that holders of our common stock may view as favorable. 41 ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds Recent Unregistered Sales of Equity Securities During the three months ended September 30, 2025, we issued 63,509 shares of common stock upon the exercise of previously issued warrants as follows: ● 7,917 shares were issued to the placement agent from private placements that closed on January 21, 2016 and May 2, 2016 pursuant to the exercise of warrants at an exercise price of $7.56 per share, resulting in cash proceeds of approximately $60,000; and ● 55,592 shares were issued to the underwriter of the Company’s initial public offering that closed on September 22, 2017 pursuant to the exercise of 70,000 warrants in a cashless exercise whereby 14,408 shares with a value of $10.45 per share were used to settle the exercise price and the remaining 55,592 shares were issued to the warrant holder. The shares were issued pursuant to an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended. Issuer Purchases of Equity Securities None. ITEM 3. Defaults Upon Senior Securities None. ITEM 4. Mine Safety Disclosures None. ITEM 5. Other Information Trading Plans On June 13, 2025, Brightstone Venture Capital Fund, LP (“Brightstone”) adopted a 10b5-1 plan for the sale of up to 229,335 shares of Celcuity Inc. common stock beginning December 15, 2025 through December 15, 2026. This plan, along with a 10b5-1 plan that was adopted on December 13, 2024 for the sale of up to 229,325 shares of Celcuity Inc. common stock beginning April 14, 2025 through December 13, 2025, were terminated on August 18, 2025. On August 19, 2025, Brightstone adopted a 10b5-1 plan for the sale of up to 125,000 shares of Celcuity Inc. common stock beginning November 18, 2025 through November 18, 2026. Director David Dalvey is a General Partner at Brightstone. During the three months ended September 30, 2025, none of our other directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K. 42 ITEM 6. Exhibits EXHIBIT INDEX Exhibit No. Description 3.1 Certificate of Incorporation of the Company, as amended, including the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 9, 2024). 3.2 Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2017). 4.1 Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 31, 2025). 4.2 Indenture, dated as of August 1, 2025, between Celcuity Inc. and U.S. Bank Trust Company, National Association, as trustee (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 1, 2025). 4.3 First Supplemental Indenture, dated as of August 1, 2025, between Celcuity Inc. and U.S. Bank Trust Company, National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on August 1, 2025). 4.4 Form of certificate representing the 2.750% Convertible Senior Notes due 2031 (included as Exhibit A in Exhibit 4.3 above). 4.5 Form of Warrant to Purchase Stock issued in connection with the Third Amendment to Amended and Restated Loan and Security Agreement, dated September 9, 2025 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 10, 2025). 10.1 Second Amendment to Amended and Restated Loan and Security Agreement, dated July 28 2025, by and among the Company, Innovatus Life Sciences Lending Fund I, LP, as collateral agent, the Lenders named therein and Oxford Finance LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2025). 10.2* Third Amendment to Amended and Restated Loan and Security Agreement, dated September 9, 2025, by and among the Company, Oxford Finance LLC, as collateral agent, the Lenders named therein and Innovatus Life Sciences Lending Fund I, LP (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 10, 2025). 31.1** Certification of Chairman and Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2** Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1*** Certification of Chairman and Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2*** Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 101** The following information from the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2025, formatted in Inline XBRL: (i) the Condensed Balance Sheets, (ii) the Condensed Statements of Operations, (iii) the Condensed Statements of Changes in Stockholders’ Equity, (iv) the Condensed Statements of Cash Flows, (v) the Notes to Condensed Financial Statements, and (vi) the information under Part II, Item 5, “Other Information.” 104** Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) * Pursuant to Item 601(b)(10)(iv) of Regulation S-K, certain information has been excluded from this exhibit because it both (i) is not material and (ii) is the type that the registrant treats as private or confidential. ** Filed herewith. *** Furnished herewith. 43 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized. Dated: November 13, 2025 CELCUITY INC. By /s/ Brian F. Sullivan Brian F. Sullivan Chairman and Chief Executive Officer (Principal Executive Officer) By /s/ Vicky Hahne Vicky Hahne Chief Financial Officer (Principal Financial and Accounting Officer) 44