Celcuity Inc. 10-Q

ITEM 1. Financial Statements Celcuity Inc. Condensed Balance Sheets (in thousands, except share and par value amounts) June 30, 2025 December 31, 2024 (unaudited) Assets Current Assets: Cash and cash equivalents $ 46,354 $ 22,515 Investments 122,032 212,589 Other current assets 14,718 9,467 Total current assets 183,104 244,571 Property and equipment, net 357 336 Operating lease right-of-use assets 131 216 Total Assets $ 183,592 $ 245,123 Liabilities and Stockholders’ Equity: Current Liabilities: Accounts payable $ 11,158 $ 9,366 Operating lease liabilities 139 172 Accrued expenses 28,644 22,185 Total current liabilities 39,941 31,723 Operating lease liabilities - 54 Note payable, non-current 99,276 97,727 Total Liabilities 139,217 129,504 Commitments and Contingencies (Note 5) - - Stockholders’ Equity: Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 213,151 and 317,577 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively. - - Common stock, $ 0.001 par value: 95,000,000 shares authorized; 38,914,208 and 37,143,242 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively. 39 37 Additional paid-in capital 398,456 387,437 Accumulated deficit ( 354,120 ) ( 271,855 ) Total Stockholders’ Equity 44,375 115,619 Total Liabilities and Stockholders’ Equity $ 183,592 $ 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 June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 40,222 $ 22,498 $ 72,449 $ 43,145 General and administrative 3,787 1,786 7,693 3,632 Total operating expenses 44,009 24,284 80,142 46,777 Loss from operations ( 44,009 ) ( 24,284 ) ( 80,142 ) ( 46,777 ) Other (expense) income Interest expense ( 3,204 ) ( 2,260 ) ( 6,387 ) ( 3,661 ) Interest income 1,945 2,822 4,264 5,104 Other (expense) income, net ( 1,259 ) 562 ( 2,123 ) 1,443 Net loss before income taxes ( 45,268 ) ( 23,722 ) ( 82,265 ) ( 45,334 ) Income tax benefits - - - - Net loss $ ( 45,268 ) $ ( 23,722 ) $ ( 82,265 ) $ ( 45,334 ) Net loss per share, basic and diluted $ ( 1.04 ) $ ( 0.62 ) $ ( 1.90 ) $ ( 1.26 ) Weighted average common shares outstanding, basic and diluted 43,663,364 38,444,163 43,359,748 36,028,109 See accompanying notes to the condensed financial statements. 4 Celcuity Inc. Condensed Statements of Changes in Stockholders’ Equity Three and Six Months Ended June 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 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 See accompanying notes to the condensed financial statements. 5 Celcuity Inc. Condensed Statements of Changes in Stockholders’ Equity Three and Six Months Ended June 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 Balance 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 See accompanying notes to the condensed financial statements. 6 Celcuity Inc. Condensed Statements of Cash Flows (in thousands) (unaudited) 2025 2024 Six Months Ended June 30, 2025 2024 Cash flows from operating activities: Net loss $ ( 82,265 ) $ ( 45,334 ) Adjustments to reconcile net loss to net cash and cash equivalents used in operations: Depreciation 77 61 Stock-based compensation 5,148 2,742 Amortization of debt issuance costs and discount 1,088 302 Payment-in-Kind interest 501 858 Non-cash operating lease expense, net ( 2 ) 1 Change in accrued interest income 340 ( 639 ) Changes in operating assets and liabilities: Other current assets ( 5,251 ) 1,471 Accounts payable 1,840 1,183 Accrued expenses 6,459 4,220 Net cash used in operating activities ( 72,065 ) ( 35,135 ) Cash flows from investing activities: Proceeds from maturities of investments 196,738 260,390 Purchases of investments ( 106,521 ) ( 362,767 ) Purchases of property and equipment ( 99 ) ( 154 ) Net cash provided by (used in) investing activities 90,118 ( 102,531 ) Cash flows from financing activities: Proceeds from exercise of common stock warrants 5,600 14,182 Proceeds from exercise of employee stock options 20 335 Proceeds from employee stock purchases 253 131 Proceeds from follow-on offering, net of underwriting discounts and offering costs - 56,258 Proceeds from note payable, net of debt issuance costs and discount of $ 2,430 in 2024 - 59,234 Proceeds from an ATM offering, net of issuance costs - 7,356 Payments for secondary registration statement costs ( 47 ) ( 34 ) Payments for debt issuance costs ( 40 ) - Net cash provided by financing activities 5,786 137,462 Net change in cash and cash equivalents 23,839 ( 204 ) Cash and cash equivalents: Beginning of period 22,515 30,663 End of period $ 46,354 $ 30,459 Supplemental disclosure of cash flow information: Interest paid $ 4,799 $ 2,501 Supplemental disclosures of non-cash investing and financing activities: Change in accounts payable attributed to offering and registration statement costs $ 47 $ 14 Change in accounts payable attributed to property and equipment 1 - Non-cash interest receivable - 327 Common stock warrants issued with note payable transaction - 1,229 See accompanying notes to the condensed financial statements. 7 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 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 PI3K or mTOR 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 topline data for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and is continuing to enroll 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 six months ended June 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. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 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 the clinical trials. 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, 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 six-month periods presented below: Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding 2025 2024 June 30, 2025 2024 Preferred stock on an as-if-converted to common stock basis 2,131,510 3,175,770 Options to purchase common stock 5,075,566 3,266,969 Warrants to purchase common stock 4,825,502 5,600,234 Restricted common stock 1,029 1,079 Anti-dilutive securities excluded from diluted weighted- average shares outstanding 12,033,607 12,044,052 Pre-funded warrant shares of 5,747,787 are included in the computation of basic and diluted net loss per share for each of the three and six months ended June 30, 2025 and 2024, as the pre-funded warrants are exercisable for nominal consideration. 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 agencies 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. 9 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) The following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of June 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 June 30, 2025 (in thousands) Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. Treasury Bills $ 122,032 $ - $ ( 11 ) $ 122,021 Total $ 122,032 $ - $ ( 11 ) $ 122,021 (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 June 30, 2025, the Company had three material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 3.6 million. 6. Stockholders’ Equity 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. 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. 10 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) In June 2025, 104,426 shares of preferred stock were converted into 1,044,260 shares of common stock. At June 30, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 38,914,208 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 213,151 shares were outstanding. As of June 30, 2025, no dividends have been declared on the Company’s capital stock. 7. Stock-Based Compensation The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30, 2025 and 2024: Schedule of Stock-based Compensation Expenses 2025 2024 2025 2024 Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2025 2024 2025 2024 Stock-based compensation expense in operating expenses: Research and development $ 1,722 $ 978 $ 3,227 $ 1,810 General and administrative 982 433 1,921 932 Total $ 2,704 $ 1,411 $ 5,148 $ 2,742 Stock-based compensation expense $ 2,704 $ 1,411 $ 5,148 $ 2,742 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 June 30, 2025 was 3,775,453 . Stock Options The following table summarizes the activity for all stock options outstanding for the six months ended June 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 960,548 10.77 552,179 15.77 Exercised ( 3,061 ) 6.57 ( 52,747 ) 6.35 Forfeited ( 188,898 ) 11.68 ( 47,855 ) 10.19 Balance at June 30 5,075,566 $ 10.44 3,266,969 $ 9.27 Options exercisable at June 30: 2,347,452 $ 7.91 1,710,917 $ 6.80 Weighted Average Grant Date Fair Value for options granted during the period: $ 7.53 $ 10.83 11 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) The following table summarizes additional information about stock options outstanding and exercisable at June 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) 5,075,566 7.83 $ 10.44 17,830 2,347,452 $ 7.91 13,121 The Company recognized stock-based compensation expense for stock options of $ 2,376 and $ 1,330 for the three months ended June 30, 2025 and 2024, respectively, and $ 4,636 and $ 2,620 for the six months ended June 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 $ 70 and $ 42 for the three months ended June 30, 2025 and 2024, respectively, and $ 211 and $ 86 for the six months ended June 30, 2025 and 2024, respectively. The effect of these modifications on stock-based compensation over the remaining service periods will be $ 346 . During the three and six months ended June 30, 2025, options in the amount of 2,561 and 3,061 shares were exercised, respectively, with an intrinsic value of $ 16 and $ 21 , respectively. During the three and six months ended June 30, 2024, options in the amount of 16,197 and 52,747 were exercised, respectively, with an intrinsic value of $ 170 and $ 529 , respectively. The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the six months ended June 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2025 2024 Risk-free interest rate 3.78 – 4.65 % 3.94 - 4.71 % Expected volatility 76.0 to 77.3 % 74.8 to 76.10 % Expected life (years) 5.01 to 6.42 5.25 to 6.09 Expected dividend yield 0 % 0 % The inputs for the Black-Scholes valuation 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 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. 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 three and six months ended June 30, 2025 and 2024 were 1,029 shares and 1,429 shares, respectively. During the three and six months ended June 30, 2025 and 2024, RSAs vested in the amount of 1,079 shares and 2,308 shares, respectively. The Company recognized stock-based compensation expense for RSAs of $ 2 and $ 9 for the three months ended June 30, 2025 and 2024, respectively, and $ 6 and $ 13 for the six months ended June 30, 2025 and 2024, respectively. RSAs outstanding as of June 30, 2025 and June 30, 2024 were 1,029 shares and 1,079 shares, respectively. 12 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) Total unrecognized compensation cost related to stock options and RSAs that is estimated to be recognized at June 30, 2025 is as follows: Schedule of Unrecognized Compensation Cost (in thousands) 2025 $ 4,531 2026 7,975 2027 6,505 2028 3,155 2029 325 Total estimated compensation cost to be recognized $ 22,491 Employee Stock Purchase Plan The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 326 and $ 72 for the three months ended June 30, 2025 and 2024, respectively, and $ 506 and $ 109 for the six months ended June 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 June 30, 2025 was 519,700 . 8. Debt On May 30, 2024, the Company entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford Finance LLC (“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 amends and restates, 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”). The Company became eligible to draw on a fourth tranche of $ 30 million (the “Term D Loan”) as of July 28, 2025 and will 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 may, in their sole discretion upon the Company’s request, make additional term loans to the Company of $ 45 million (the “Term F Loan”). Funding of these additional tranches is also subject to other customary conditions and limits on when the Company can request funding for such tranches. Costs associated with the new borrowings were approximately $ 2.4 million. 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 will mature on May 1, 2029 and will 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 will be 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. Innovatus has 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. 13 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) 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 both the Term D and Term E Loans. Because the Company achieved the Term D Milestone on July 28, 2025, if the Company (i) fails to draw the full amount of the Term D Loan during the Term D 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 D Milestone, of the Company’s intent not to draw the full amount of the Term D Loan, a non-utilization fee of $ 0.9 million with respect to 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 of $ 1.5 million 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, the Term D Loan, the Term E Loan and the Term F Loan, 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 shall, with respect to the Term C Loan, be 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 additional Term Loans, the exercise price will be 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 applicable Term Loan funding. 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. 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 fails 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. The Company evaluated the change of terms under ASC 470-50, “Debt – Modification and Extinguishment”, 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. 14 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) Long-term debt consisted of the following at June 30, 2025 and December 31, 2024: Schedule of Long-term Debt (in thousands) June 30, 2025 December 31, 2024 Note payable $ 100,000 $ 100,000 Add: Final fee 4,500 4,500 Add: PIK interest (added to principal) 1,093 593 Less: unamortized debt issuance costs ( 1,202 ) ( 1,614 ) Less: unamortized debt discount ( 5,115 ) ( 5,752 ) Total long-term debt $ 99,276 $ 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, 2027 $ 30,767 2028 52,744 2029 22,082 Total $ 105,593 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 U.S. Food and Drug Administration (“FDA”) regulatory filing of a New Drug Application (“NDA”) for gedatolisib. The Company has determined the NDA filing with the FDA is now probable and has recorded this as a research and development expense during the three and six months ended June 30, 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 Second Amendment to Amended and Restated Loan and Security Agreement On July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement, pursuant to which the A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes (as defined below) 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 . 15 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) 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 is eligible to draw an additional $ 30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). The Company intends to draw down such $ 30.0 million in late August 2025 prior to the expiration of the Term D Draw Period (as defined in the A&R Loan Agreement) on August 31, 2025. 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 (b) 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. July 2025 Convertible Notes Offering On July 30, 2025, the Company also entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters, subject to customary conditions, to issue and sell in a public offering $ 175,000,000 aggregate principal amount of the Company’s 2.750 % Convertible 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 $ 26,250,000 aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $ 26,250,000 aggregate principal amount of Notes. The issuance of $ 201,250,000 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. 16 CELCUITY INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) (For the Three and Six Months Ended June 30, 2025 and 2024) 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. 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%. Warrants Exercised 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. 17