Financial Statements and Supplementary Data
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
the Board of Directors and
−Removed: Stockholders of Celcuity Inc.
+Added: of Celcuity Inc.
on the Financial Statements
31 unchanged sentences
Audit Matters
−Removed: audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required
−Removed: to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements
−Removed: and (2) involved our especially challenging, subjective, or complex judgments.
+Added: audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
+Added: communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
We determined that there were no critical audit matters.
1 unchanged sentence
March 26, 2026
−Removed: Celcuity Inc.
−Removed: Balance Sheets
+Added: thousands, except share and par value amounts)
December 31, 2025
2 unchanged sentences
Cash and cash equivalents
+Added: Prepaid clinical trial costs
Other current assets
2 unchanged sentences
Operating lease right-of-use assets
−Removed: $ 245,123,047
−Removed: $ 191,219,398
+Added: Other non-current assets
Liabilities and stockholders’ equity
1 unchanged sentence
Accounts payable
−Removed: Operating lease liabilities
−Removed: Accrued expenses
+Added: Accrued clinical trial costs
+Added: Other accrued expenses
+Added: Operating lease liabilities, current
Total current liabilities
−Removed: Operating lease liabilities
+Added: Operating lease liabilities, non-current
+Added: Convertible debt
Note payable, non-current
3 unchanged sentences
Preferred stock, $ 0.001 par value:
−Removed: 2,500,000 shares authorized;
−Removed: 317,577 and 854,134 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
−Removed: Common stock, $ 0.001 par
−Removed: 95,000,000 and 65,000,000 shares
−Removed: authorized as of December 31, 2024 and December 31, 2023, respectively;
−Removed: 37,143,242 and 25,506,012
−Removed: shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
+Added: 2,500,000 shares authorized as of December 31, 2025 and 2024;
+Added: 0 and 317,577 shares issued and outstanding as of December 31, 2025 and 2024, respectively
+Added: Common stock, $ 0.001 par value:
+Added: 95,000,000 shares authorized as of December 31, 2025 and 2024;
+Added: 48,244,960 and 37,143,242 shares issued and outstanding as of December 31, 2025 and 2024, respectively
Additional paid-in capital
Accumulated deficit
−Removed: ( 271,855,108 )
−Removed: ( 160,076,003 )
Total stockholders’ equity
Total liabilities and stockholders’ equity
−Removed: $ 245,123,047
−Removed: $ 191,219,398
−Removed: See accompanying notes to the financial statements
−Removed: Celcuity Inc.
−Removed: Statements of Operations
−Removed: Twelve Months Ended December 31,
+Added: accompanying notes to the financial statements.
+Added: of Operations
+Added: thousands, except share and per share amounts)
+Added: Year Ended December 31,
Operating expenses:
Research and development
−Removed: $ 104,203,230
General and administrative
1 unchanged sentence
Loss from operations
−Removed: ( 113,266,951 )
−Removed: ( 66,230,331 )
Other (expense) income:
Interest expense
−Removed: ( 10,280,445 )
−Removed: ( 5,326,387 )
Interest income
−Removed: Other income, net
+Added: Other (expense) income, net
Net loss before income taxes
1 unchanged sentence
$ ( 111,779 )
−Removed: Income tax benefits
−Removed: $ ( 111,779,105 )
−Removed: $ ( 63,779,116 )
Net loss per share, basic and diluted
Weighted average common shares outstanding, basic and diluted
−Removed: See accompanying notes to the financial statements
−Removed: Celcuity Inc.
−Removed: Statements of Changes in Stockholders’ Equity
+Added: accompanying notes to the financial statements.
+Added: of Changes in Stockholders’ Equity
+Added: thousands, except share amounts)
Preferred Stock
−Removed: Balance at December 31, 2022
−Removed: $ 230,045,566
−Removed: $ ( 96,296,887 )
+Added: Stockholders’
+Added: Balance as of December 31, 2023
$ ( 160,076 )
Stock-based compensation
−Removed: Conversion of preferred to common stock
+Added: Conversion of preferred stock to common stock
Employee stock purchases
Exercise of common stock options, net of shares withheld for exercise price
−Removed: Exercise of common stock warrants
−Removed: Issuance costs associated with private placement offering
−Removed: Issuance of common stock in an ATM offering
−Removed: Issuance costs associated with an ATM offering
−Removed: Issuance of pre-funded warrants
−Removed: Issuance costs associated with pre-funded warrants
−Removed: ( 63,779,116 )
−Removed: ( 63,779,116 )
−Removed: Balance at December 31, 2023
−Removed: $ 299,818,965
−Removed: $ ( 160,076,003 )
−Removed: $ 139,769,322
−Removed: $ 299,818,965
−Removed: $ ( 160,076,003 )
−Removed: $ 139,769,322
+Added: Exercise of common stock warrants, net of shares withheld for exercise price
+Added: Issuance of common stock in an ATM offering, net of issuance costs
+Added: Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs
+Added: Issuance of common stock warrants, note payable
+Added: Balance as of December 31, 2024
Stock-based compensation
−Removed: Conversion of preferred to common stock
+Added: Conversion of preferred stock to common stock
Employee stock purchases
1 unchanged sentence
Exercise of common stock warrants, net of shares withheld for exercise price
−Removed: Issuance of common stock in an ATM offering
−Removed: Issuance costs associated with an ATM offering
−Removed: Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs
−Removed: Issuance of common stock warrants, note payable
−Removed: ( 111,779,105 )
−Removed: ( 111,779,105 )
−Removed: Balance at December 31, 2024
−Removed: $ 387,436,682
−Removed: $ ( 271,855,108 )
−Removed: $ 115,619,035
−Removed: $ 387,436,682
+Added: Issuance of common stock warrants in connection with note agreement
+Added: Issuance of common stock upon closing of equity offering, net of underwriting discounts and offering costs
+Added: Balance as of December 31, 2025
$ ( 448,897 )
$ ( 448,897 )
−Removed: See accompanying notes to the financial statements
−Removed: Celcuity Inc.
−Removed: Statements of Cash Flows
−Removed: Twelve Months Ended December 31,
+Added: accompanying notes to the financial statements.
+Added: of Cash Flows
+Added: Year Ended December 31,
Cash flows from operating activities:
1 unchanged sentence
$ ( 111,779 )
−Removed: Adjustments to reconcile net loss to net cash used for operations:
+Added: Adjustments to reconcile net loss to net cash and cash equivalents used in operations:
Stock-based compensation
1 unchanged sentence
Payment-in-kind interest
−Removed: Non-cash operating lease, net
+Added: Non-cash operating lease expense
Change in accrued interest income
Changes in operating assets and liabilities:
−Removed: Other current assets
−Removed: ( 3,438,018 )
+Added: Prepaid clinical trial costs
+Added: Other current and non-current assets
Accounts payable
−Removed: Accrued expenses
−Removed: Net cash used for operating activities
−Removed: ( 83,466,743 )
−Removed: ( 53,812,253 )
+Added: Accrued clinical trial costs
+Added: Other accrued expenses
+Added: Net cash used in operating activities
Cash flows from investing activities:
1 unchanged sentence
Purchases of investments
−Removed: ( 705,164,950 )
−Removed: ( 314,525,084 )
Purchases of property and equipment
−Removed: Net cash used for investing activities
−Removed: ( 63,069,283 )
−Removed: ( 5,008,207 )
+Added: Net cash used in investing activities
Cash flows from financing activities:
−Removed: Proceeds from exercise of common stock warrants
−Removed: Proceeds from exercise of employee stock options
Proceeds from employee stock purchases
−Removed: Proceeds from follow-on offering, net of underwriting discounts and offering costs
−Removed: Proceeds from note payable, net of debt issuance costs and discount of $ 2,437,644
+Added: Proceeds from exercise of common stock options
+Added: Proceeds from exercise of common stock warrants
+Added: Proceeds from convertible debt, net of debt issuance costs of $ 6,246 and $ 0 during the years ended December 31, 2025 and 2024, respectively
+Added: Proceeds from note payable, net of debt issuance costs of $ 2,255 and $ 2,438 during the years ended December 31, 2025 and 2024, respectively
+Added: Proceeds from equity offering, net of underwriting discounts and offering costs
Proceeds from an ATM offering, net of issuance costs
−Removed: Proceeds from pre-funded warrants, net of offering costs
Payments for secondary registration statement costs
−Removed: Payments for debt issuance costs
−Removed: Payments for finance leases
Net cash provided by financing activities
Net change in cash and cash equivalents
−Removed: ( 8,147,951 )
Cash and cash equivalents:
2 unchanged sentences
Supplemental disclosure of cash flow information:
−Removed: Interest paid
+Added: Cash paid for interest
+Added: Cash paid for operating leases
Supplemental disclosures of non-cash investing and financing activities:
−Removed: Deferred financing costs and offering and registration statement costs included in accounts payable
−Removed: Property and equipment included in accounts payable
Common stock warrants issued with the note payable transaction
−Removed: See accompanying notes to the financial statements
−Removed: CELCUITY INC.
−Removed: NOTES TO FINANCIAL STATEMENTS
−Removed: Nature of Business
−Removed: Celcuity Inc., a Delaware corporation (the “Company”) is a
−Removed: clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications.
−Removed: The Company’s lead therapeutic candidate is gedatolisib, a potent, well-tolerated, small molecule reversible inhibitor, administered
−Removed: intravenously, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase (“PI3K”) and the two mechanistic
−Removed: targets of rapamycin (“mTOR”) sub-complexes, mTORC1 and mTORC2.
−Removed: Gedatolisib’s mechanism of action and pharmacokinetic
−Removed: properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
−Removed: A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with
−Removed: HR+/HER2- advanced breast cancer is currently enrolling patients.
−Removed: Site selection and activation activities for a Phase 3 clinical trial,
−Removed: VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2-
−Removed: advanced breast cancer has commenced.
−Removed: The first patient is expected to be dosed in the second quarter of 2025.
−Removed: A Phase 1b/2 clinical trial,
−Removed: CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer,
−Removed: is currently underway.
−Removed: The Company was co-founded in 2012 by Brian F.
+Added: Property and equipment included in accounts payable
+Added: Deferred financing, offering and registration statement costs included in accounts payable
+Added: accompanying notes to the financial statements.
+Added: TO FINANCIAL STATEMENTS
+Added: Organization and Liquidity
+Added: Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on the development of targeted
+Added: therapies for the treatment of multiple solid tumor indications.
+Added: The Company’s lead therapeutic candidate is gedatolisib, a kinase
+Added: inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”),
+Added: mechanistic target of rapamycin (“mTOR”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and
+Added: By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”)
+Added: Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational
+Added: therapies that target PI3Kα, AKT, or mTORC1 alone or together.
+Added: A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in
+Added: combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor
+Added: receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer (“ABC”) has completed enrollment and reported
+Added: detailed results for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort
+Added: 2, patients with PIK3CA mutant-type (“MT”) tumors.
+Added: Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib
+Added: in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients
+Added: with endocrine treatment resistant HR+/HER2- ABC is ongoing.
+Added: A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib
+Added: in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.
+Added: The Company was co-founded
+Added: in 2012 by Brian F.
Sullivan and Dr.
Laing and is based in Minnesota.
−Removed: has not generated any revenues to date.
−Removed: Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
−Removed: Basis of Presentation
−Removed: The accompanying financial statements
−Removed: have been prepared in accordance with accounting principles generally accepted in the United States (“U.S.
−Removed: GAAP”) and pursuant
−Removed: to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
−Removed: Operating results for the year ended December
−Removed: 31, 2024 are not necessarily indicative of results to be expected for any future year.
−Removed: Accounting Estimates
−Removed: Management uses estimates and assumptions in preparing these
−Removed: financial statements in accordance with U.S.
−Removed: Those estimates and assumptions affect the reported amounts of assets and liabilities,
−Removed: the disclosure of contingent assets and liabilities, and the reported revenues and expenses.
−Removed: Actual results could differ from those estimates
−Removed: and the difference could be material.
−Removed: Significant items subject to such estimates and assumptions include the valuation of stock-based
−Removed: compensation and prepaid or accrued clinical trial costs.
+Added: The Company has not generated any revenue to date.
+Added: inception, the Company has not generated any revenue from product sales or other sources and has incurred operating losses and negative
+Added: cash flows from operations.
+Added: The Company’s primary uses of cash, cash equivalents, and investments to date have been funding clinical
+Added: trials and research and development activities, the scaling of commercial launch related activities such as marketing, supply chain,
+Added: distribution, market access and other commercial operations, business planning, establishing and maintaining the Company’s intellectual
+Added: property portfolio, hiring personnel, leasing premises and associated capital expenditures, raising capital, and providing general and
+Added: administrative support for these operations.
+Added: As of December 31, 2025, the Company had an accumulated deficit of $ 448.9 million.
+Added: the Company has funded operations primarily through private placements, registered offerings of its equity securities, convertible notes,
+Added: and borrowings under loan agreements.
+Added: of December 31, 2025, the Company had $ 441.5 million in cash, cash equivalents and short-term investments.
+Added: The Company believes its existing
+Added: cash, cash equivalents and short-term investments will be sufficient to fund planned operations for at least one year from the issuance
+Added: of these financial statements.
+Added: Company is subject to risks common to companies in the development stage including, but not limited to, the clinical and commercial success
+Added: of its initial drug product, gedatolisib, the regulatory approval of gedatolisib, the need for substantial additional financing to achieve
+Added: its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
+Added: Basis of Presentation and Summary of Significant Accounting Policies
+Added: of Presentation
+Added: accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
+Added: GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
+Added: Operating results during the year ended December 31, 2025, are not necessarily indicative of results to be expected for any future year.
+Added: uses estimates and assumptions in preparing these financial statements in accordance with U.S.
+Added: Those estimates and assumptions
+Added: affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenue
+Added: and expenses.
+Added: Actual results could differ from those estimates and the difference could be material.
+Added: Significant items subject to such
+Added: estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
+Added: and Cash Equivalents
+Added: Company maintains its accounts at two financial institutions.
+Added: As of December 31, 2025 and 2024, the Company had $ 165.7 million and $ 22.5
+Added: million, respectively, in business checking accounts and money market funds that are considered cash equivalents.
Cash and cash equivalents
−Removed: The Company maintains its accounts at two financial institutions.
−Removed: At times throughout the year, the Company’s cash balances may exceed amounts insured by the Federal Deposit Insurance Corporation.
−Removed: At December 31, 2024 and December 31, 2023, the Company had $ 22,514,823 and $ 30,662,774 , respectively, in business checking accounts and
−Removed: money market funds that are considered cash equivalents and not insured by the Federal Deposit Insurance Corporation.
−Removed: The Company maintains its investments in U.S.
−Removed: governmental agency
−Removed: securities and U.S.
−Removed: treasury bills and has classified them as held-to-maturity at the time of purchase.
−Removed: Held-to-maturity purchases are
−Removed: those securities in which the Company has the ability and intent to hold until maturity.
−Removed: Held-to-maturity securities are recorded at amortized
−Removed: cost, adjusted for the amortization or accretion of premiums and discounts.
−Removed: Premiums and discounts are amortized or accreted over the
−Removed: life of the related held-to-maturity security using a straight-line method.
−Removed: The difference between the carrying value, which is based
−Removed: on cost, and the aggregate fair value of the held-to-maturity securities, was immaterial as of December 31, 2024.
−Removed: At December 31, 2024
−Removed: and December 31, 2023, the Company had $ 212,588,960 and $ 149,919,974 , respectively, of short-term investments.
−Removed: Property and Equipment
−Removed: Property and equipment are stated at cost.
−Removed: Depreciation is provided
−Removed: over estimated useful lives using the straight-line method.
−Removed: Maintenance and repairs are expensed as incurred;
−Removed: major improvements and betterments
−Removed: are capitalized.
−Removed: Estimated useful lives of property and equipment are as follows for the
−Removed: major classes of assets:
+Added: are classified as Level 1 assets under the fair value hierarchy.
+Added: Company maintains its investments in U.S.
+Added: treasury securities and has classified them as held-to-maturity at the time of purchase.
+Added: Held-to-maturity
+Added: purchases are those investments which the Company has the ability and intent to hold until maturity.
+Added: Held-to-maturity investments are
+Added: recorded at amortized cost, adjusted for the amortization or accretion of premiums and discounts.
+Added: Premiums and discounts are amortized
+Added: or accreted over the life of the related held-to-maturity investment using the straight-line method.
+Added: The difference between the carrying
+Added: value, which is based on cost, and the aggregate fair value of the held-to-maturity investments, was immaterial as of December 31, 2025.
+Added: As of December 31, 2025 and 2024, the Company had $ 275.8 million and $ 212.6 million, respectively, of short-term investments.
+Added: Value of Financial Instruments
+Added: Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the
+Added: financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair
+Added: value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
+Added: The hierarchy gives the highest priority
+Added: to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements
+Added: involving significant unobservable inputs (Level 3 measurements).
+Added: The accounting guidance establishes a three-tier fair value hierarchy,
+Added: which prioritizes the inputs used in measuring fair value as follows:
+Added: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date.
+Added: Other than quoted prices included in Level 1, inputs that are observable for the asset or liability, either directly or indirectly,
+Added: for substantially the full term of the asset or liability.
+Added: Unobservable inputs that are significant to the fair value measurement and supported by little or no market activity.
+Added: level in the fair value hierarchy within which a fair value measurement in its entirety falls, is based on the lowest level input that
+Added: is significant to the fair value measurement in its entirety.
+Added: carrying values of cash equivalents, accounts payable, accrued expenses and other financial working capital items approximate fair value
+Added: as of each of December 31, 2025 and 2024, due to the short maturity nature of these items.
+Added: Refer to Note 10 for disclosures around the
+Added: Company’s 2.750 % Senior Notes due 2031 (the “Notes”) and note payable.
+Added: Concentration
+Added: of Credit Risk
+Added: instruments which potentially subject the Company to significant concentration of credit risk consist of cash, cash equivalents, and
+Added: The Company maintains deposits in federally insured financial institutions in excess of federally insured limits.
+Added: has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due
+Added: to the financial position of the depository institutions in which those deposits are held.
+Added: for Credit Losses
+Added: investments in an unrealized loss position, the Company first assesses whether it intends to sell, or it is more likely than not that
+Added: it will be required to sell, the investment before recovery of its amortized cost basis.
+Added: If either of the criteria regarding intent or
+Added: requirement to sell is met, the investment’s amortized cost basis is written down to fair value through earnings.
+Added: For investments
+Added: that do not meet the aforementioned criteria, the Company evaluates whether the decline in fair value has resulted from credit losses
+Added: or other factors.
+Added: In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes
+Added: in interest rates, and any changes to the rating of the security by a rating agency, among other factors.
+Added: If this assessment indicates
+Added: that a credit loss exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost
+Added: basis of the investment.
+Added: If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit
+Added: loss exists and an allowance for credit losses is recorded, limited by the amount that the fair value is less than the amortized cost
+Added: Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive loss.
+Added: and Equipment
+Added: and equipment are stated at cost.
+Added: Depreciation is provided over estimated useful lives using the straight-line method.
+Added: Maintenance and
+Added: repairs are expensed as incurred;
+Added: major improvements and betterments are capitalized.
+Added: useful lives of property and equipment are as follows for the major classes of assets:
Schedule of Estimated Useful Lives of Property and Equipment
Asset description
+Added: Estimated useful life
Furniture and equipment
Leasehold improvements
−Removed: Long-Lived Assets
−Removed: Long-lived assets, such as property and equipment, are reviewed for impairment
−Removed: whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
−Removed: If circumstances require
−Removed: a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be
−Removed: generated by that asset or asset group to its carrying value.
−Removed: If the carrying value of the long-lived asset or asset group is not recoverable
−Removed: on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value.
−Removed: is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent
−Removed: appraisals, as considered necessary.
−Removed: Deferred Transaction Costs
−Removed: Deferred transaction costs primarily consist of legal fees that are capitalized
−Removed: as incurred and will be offset against the proceeds from future equity financing arrangements.
−Removed: The deferred transaction costs will be
−Removed: reviewed periodically to assess the probability that future securities will be offered.
−Removed: In the event that no future offering will occur,
−Removed: any deferred transaction costs will be expensed.
−Removed: Total costs incurred, but not accounted for as a reduction in equity, were $ 235,379 and
−Removed: $ 0 as of December 31, 2024 and 2023, respectively.
−Removed: Debt Issuance Costs
−Removed: The Company recognizes debt issuance costs as deferred costs, which are
−Removed: capitalized and amortized over the term of the related debt using the effective interest method.
−Removed: These costs primarily consist of fees,
−Removed: commissions, legal, and other costs directly attributable to securing debt financing.
−Removed: Debt issuance costs are reported as a direct reduction
−Removed: of the carrying amount of the related debt on the balance sheets.
−Removed: Amortization of these costs is recorded as interest expense in the statements
−Removed: of operations over the life of the debt instrument.
−Removed: Comprehensive Loss
−Removed: Comprehensive loss includes net loss as well as other changes in stockholders’
−Removed: equity that result from transactions and economic events other than those with stockholders.
−Removed: For all periods presented, there was no difference
−Removed: between net loss and comprehensive loss.
−Removed: Risks and Uncertainties
−Removed: The Company is subject to risks common to companies in the development
−Removed: stage including, but not limited to, dependency on the clinical and commercial success of its initial drug product, gedatolisib, the ability
−Removed: to obtain regulatory approval for gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad
−Removed: adoption of its approved products, if any, by physicians and consumers, and significant competition.
−Removed: Fair Value of Financial Instruments
−Removed: The Company’s accounting for fair value measurements of
−Removed: assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis
−Removed: adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation
−Removed: techniques used to measure fair value.
−Removed: The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
−Removed: assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level
−Removed: 3 measurements).
−Removed: The three levels of the fair value hierarchy are as follows:
−Removed: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement
−Removed: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly,
−Removed: for substantially the full term of the asset or liability.
−Removed: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available,
−Removed: thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date.
−Removed: The level in the fair value hierarchy within which a fair value
−Removed: measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety.
−Removed: The carrying values of cash equivalents, accounts payable, accrued
−Removed: expenses and other financial working capital items approximate fair value at December 31, 2024 and December 31, 2023, due to the short
−Removed: maturity nature of these items.
−Removed: The Company accounts for income taxes using the asset and liability method,
−Removed: as required by the accounting standard for income taxes.
−Removed: Under this method, deferred tax assets and liabilities are recognized for the
−Removed: future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
−Removed: and their respective tax bases, as well as net operating loss and tax credit carryforwards.
−Removed: Deferred taxes are measured using enacted
−Removed: tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
−Removed: The effect on deferred taxes of a change in tax rates is recognized in results of operations in the period that includes the enactment
−Removed: The effects of any future changes in tax laws or rates have not been considered.
−Removed: The Company regularly reviews deferred tax assets
−Removed: to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if
−Removed: the Company does not consider it to be more likely than not that the deferred tax assets will be realized.
−Removed: The Company recognizes the impact of an uncertain tax position in its financial
−Removed: statements if, in management’s judgment, the position is more-likely-than-not sustainable upon audit based on the position’s
−Removed: technical merits.
−Removed: This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an
−Removed: assessment of whether a liability for an uncertain tax position is necessary.
−Removed: Stock-Based Compensation
−Removed: The Company’s stock-based compensation consists of stock
−Removed: options and restricted stock issued to certain employees and non-employees of the Company and the Company’s 2017 Employee Stock
−Removed: Purchase Plan.
−Removed: The Company recognizes compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing
−Removed: method for equity-based awards and the Monte Carlo simulation model for performance-based awards.
+Added: Shorter of remaining lease term or estimated useful life
+Added: the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and
+Added: circumstances presented in the arrangement, including whether the Company controls the use of identified assets.
+Added: The Company classifies
+Added: leases with a term greater than one year as either operating or finance leases at the lease commencement date and records a right-of-use
+Added: asset and current and non-current lease liabilities, as applicable, on the balance sheets.
+Added: The Company has elected not to recognize on
+Added: the balance sheets leases with terms of one year or less, but payments are recognized as expense on a straight-line basis over the lease
+Added: Company’s leases may include options to extend or terminate the leases.
+Added: Periods covered by an option to extend the lease are included
+Added: in the lease term when it is reasonably certain that the Company will exercise that option.
+Added: Periods covered by an option to terminate
+Added: the lease are included in the lease term when it is reasonably certain that the Company will not exercise that option.
+Added: The Company monitors
+Added: its plans to renew or terminate its material leases each reporting period.
+Added: If a lease includes provisions for leasehold improvements
+Added: for which the Company has an obligation to pay, the Company determines if the improvements should be considered lessor or lessee assets.
+Added: If the improvements are considered lessor assets, the Company records the payments in the calculation of the lease liability and corresponding
+Added: right-of-use asset.
+Added: liabilities and the corresponding right-of-use assets are recorded based on the present value of lease payments over the remaining lease
+Added: The present value of future lease payments is discounted using the interest rate implicit in the lease contracts if that rate
+Added: is readily determinable;
+Added: otherwise, the Company utilizes information available at the commencement of the lease to calculate the incremental
+Added: borrowing rate, which reflects the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar
+Added: term and in a similar economic environment.
+Added: cost is recognized on a straight-line basis over the lease term and variable lease payments are recognized as operating expenses in the
+Added: period in which the obligation for those payments is incurred.
+Added: Variable lease payments primarily include common area maintenance, utilities,
+Added: real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company.
+Added: The Company has elected to account for the lease and non-lease components together as a single component for all classes of underlying
+Added: Software Development Costs
+Added: Company capitalizes qualifying costs incurred during the application development stage related to software developed for internal use.
+Added: Capitalized software development costs are classified as other non-current assets on the balance sheets.
+Added: As of December 31, 2025 and
+Added: 2024, the Company had $ 0.1 million and no capitalized software development costs, respectively.
+Added: Company amortizes the capitalized software development costs on a straight-line basis over the estimated useful life of the software,
+Added: beginning when the asset is substantially ready for use.
+Added: The amortization of capitalized software development costs is reflected in general
+Added: and administrative expenses.
+Added: The Company did not record any amortization expense during the years ended December 31, 2025 and 2024.
+Added: assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
+Added: amount of an asset may not be recoverable.
+Added: If circumstances require a long-lived asset or asset group be tested for possible impairment,
+Added: the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value.
+Added: carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized
+Added: to the extent that the carrying value exceeds its fair value.
+Added: Fair value is determined through various valuation techniques including
+Added: discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary.
+Added: Transaction Costs
+Added: transaction costs primarily consist of legal fees that are capitalized as incurred and will be offset against the proceeds from future
+Added: equity financing arrangements.
+Added: The deferred transaction costs will be reviewed periodically to assess the probability that future securities
+Added: will be offered.
+Added: In the event that no future offering will occur, any deferred transaction costs will be expensed.
+Added: Total costs incurred,
+Added: but not accounted for as a reduction in equity, were $ 0.2 million and $ 0.2 million as of December 31, 2025 and 2024, respectively.
+Added: transaction costs are classified as other assets on the balance sheets.
+Added: Issuance Costs
+Added: Company recognizes debt issuance costs as deferred costs, which are capitalized and amortized over the term of the related debt
+Added: using the effective interest method.
+Added: These costs primarily consist of fees, commissions, and legal and other costs directly
+Added: attributable to securing debt financing.
+Added: Debt issuance costs are reported as a direct reduction of the carrying amount of the
+Added: related debt on the balance sheets.
+Added: Amortization of these costs is recorded as interest expense in the statements of operations over
+Added: the life of the debt instrument.
+Added: In the event of early extinguishment of debt, any related unamortized debt issuance costs are
+Added: written off and recognized as a component of the gain or loss on extinguishment of debt in the statements of operations.
+Added: Comprehensive
+Added: Comprehensive
+Added: loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other
+Added: than those with stockholders.
+Added: For all periods presented, there was no difference between net loss and comprehensive loss.
+Added: and Contingencies
+Added: Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the
+Added: amount can be reasonably estimated.
+Added: If some amount within a range of loss appears at the time to be a better estimate than any other
+Added: amount within the range, the Company accrues that amount.
+Added: When no amount within the range is a better estimate than any other amount,
+Added: the Company accrues the minimum amount in the range.
+Added: The Company has not recorded any such liabilities as of December 31, 2025 and 2024.
+Added: Company’s stock-based compensation consists of stock options, restricted stock awards and restricted stock units issued
+Added: to certain employees and non-employees of the Company under the 2017 Amended and Restated Stock Incentive Plan, and shares issued under
+Added: the 2017 Employee Stock Purchase Plan (the “ESPP”).
+Added: Company has elected to account for forfeitures as they occur.
+Added: Company recognizes stock-based compensation expense based on the estimated grant date fair value using the Black-Scholes
+Added: option-pricing model and the expense is recognized on a straight-line basis over the requisite service period.
+Added: Compensation expense
+Added: for awards with performance-based conditions is recognized when the achievement of the performance condition is deemed
+Added: Company utilizes the Monte Carlo simulation model for awards with market-based vesting conditions.
If the factors change and different
assumptions are used, the Company’s stock-based compensation expense could be materially different in the future.
−Removed: The Company recognizes
−Removed: stock-based compensation expense for these options on a straight-line basis over the requisite service period.
−Removed: The Company has elected
−Removed: to account for forfeitures as they occur.
−Removed: Research and Development
−Removed: Research and development costs are expensed as incurred.
−Removed: Research and development
−Removed: costs amounted to $ 104,203,230 for the year ended December 31, 2024 and $ 60,594,005 for the year ended December 31, 2023.
−Removed: Clinical Trial Costs
−Removed: The Company relies on third parties to conduct
−Removed: certain aspects of clinical studies and to formulate and manufacture our drug product.
−Removed: While there are alternative vendors that can
−Removed: perform these functions, any disruption or delay by the Company’s current third parties in carrying out their contractual
−Removed: duties could delay the clinical trials.
−Removed: The Company records prepaid assets or accrued expenses for prepaid or estimated clinical
−Removed: trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials.
−Removed: costs can be a significant component of the Company’s research and development expenses.
−Removed: The Company primarily relies on a
−Removed: compilation of progress reports from third-party service providers, including the respective invoicing, to record actual expenses,
−Removed: along with determining changes to prepaid assets and accrued liabilities.
−Removed: To date, the Company believes utilization of third-party
−Removed: reports most accurately reflects expenses incurred.
−Removed: With the ongoing VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial,
−Removed: and the commencement of the VIKTORIA-2 Phase 3 clinical trial site activation and patient enrollment anticipated in Q2 2025 ,
−Removed: the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these
−Removed: estimates may become more significant.
−Removed: Changes in these estimates that result in material changes to the Company’s prepaid
−Removed: assets or accrued expenses could materially affect the Company’s results of operations and financial position.
−Removed: In November 2023, the FASB issued ASU 2023-07:
−Removed: Improvements to Reportable
−Removed: Segment Disclosures.
−Removed: This ASU, which amends Topic 280:
−Removed: Segment Reporting, improves disclosure requirements for reportable segments
−Removed: and enhances disclosures for companies with single reportable segments.
−Removed: The Company has a single reportable segment based on the nature
−Removed: of its operations.
−Removed: The nature of business and the accounting policies of the segment are the same as described throughout Notes 1 and
−Removed: The Company’s Chief Operating Decision Maker (“CODM”) is its executive team.
−Removed: The CODM assesses the reportable segment’s performance
−Removed: and allocates resources for the reportable segment based on net income and total assets, which are the same amounts in all material respects
−Removed: as those reported on the statements of operations and balance sheets.
−Removed: The Company adopted the standard on January 1, 2024.
−Removed: did not have a material impact on the Company’s financial statements.
−Removed: Based on the Company’s cash and cash equivalents and short-term investments
−Removed: on hand at December 31, 2024 of $ 22,514,823 and $ 212,588,960 , respectively, the Company believes that its cash and short-term investments
−Removed: will be sufficient to fund the Company’s current operating plan through at least the next 12 months from the issuance date of this
−Removed: Annual Report.
+Added: inputs for the Black-Scholes valuation model and the Monte Carlo simulation model require management’s significant assumptions,
+Added: including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected
+Added: The expected volatility is estimated based on historical volatility information of peer companies that are publicly available
+Added: in combination with the Company’s calculated volatility since being publicly traded.
+Added: The expected term of the award is based on
+Added: the simplified method in accordance with SEC Staff Accounting Bulletin Nos.
+Added: The risk-free interest rate is based on the
+Added: rate for U.S.
+Added: treasury securities at the date of grant with maturity dates approximately equal to the expected term of the award at the
+Added: The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay
+Added: any dividends on its common stock.
+Added: price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date.
+Added: assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for
+Added: options granted to employees.
+Added: In the event the Company terminates any of its consulting agreements, the unvested options issued in connection
+Added: with such agreements would also be cancelled.
+Added: Company records compensation expense based on the quoted fair value of the shares on the grant date over the requisite service period.
+Added: expense for ESPP rights is recorded in line with each respective offering period.
+Added: and Development
+Added: and development costs are expensed as incurred.
+Added: Research and development costs were $ 145.0 million and $ 104.2 million during the years
+Added: ended December 31, 2025 and 2024, respectively.
+Added: Company relies on third-party service providers to conduct certain aspects of clinical studies and to formulate and manufacture its drug
+Added: While there are alternative vendors that can perform these functions, any disruption or delay by the Company’s current
+Added: third-party service providers in carrying out their contractual duties could delay its clinical trials and/or the commercial launch of
+Added: gedatolisib, if approved by the U.S.
+Added: Food and Drug Administration (“FDA”).
+Added: The Company records prepaid or accrued
+Added: clinical trial costs conducted by third-party service providers, which includes the conduct of clinical trials.
+Added: These costs can be a
+Added: significant component of the Company’s research and development expenses.
+Added: The Company uses progress reports from third-party service
+Added: providers, including the respective invoicing, to record actual expenses, along with determining changes to prepaid or accrued clinical
+Added: With the ongoing clinical trials, the Company’s estimated expenses in future periods and actual services performed
+Added: may vary from these estimates, and these estimates may become more significant.
+Added: Changes in these estimates that result in material changes
+Added: to the Company’s prepaid or accrued clinical trial costs could materially affect the Company’s results of operations and
+Added: financial position.
+Added: payments and other consideration under license agreements are expensed as research and development expense upon receipt of the license,
+Added: and annual maintenance fees under license agreements are expensed in the period in which they are incurred.
+Added: license agreements include milestone payments which are recognized when it becomes probable that the achievement of those milestones
+Added: The Company records this expense as research and development expense in its statements of operations.
+Added: Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
+Added: expenses related to making such applications) and such costs are included in general and administrative expenses in the statements of
+Added: Company accounts for income taxes using the asset and liability method, as required by the accounting standard for income taxes.
+Added: this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
+Added: financial statement carrying amounts of existing assets and liabilities and their respective tax basis, as well as net operating loss
+Added: and tax credit carryforwards.
+Added: Deferred taxes are measured using enacted tax rates expected to apply to taxable income in the years in
+Added: which those temporary differences are expected to be recovered or settled.
+Added: The effect on deferred taxes of a change in tax rates is recognized
+Added: in results of operations in the period that includes the enactment date.
+Added: The effects of any future changes in tax laws or rates have
+Added: not been considered.
+Added: The Company regularly reviews deferred tax assets to assess their potential realization and establish a valuation
+Added: allowance for portions of such assets to reduce the carrying value if the Company does not consider it to be more likely than not that
+Added: the deferred tax assets will be realized.
+Added: Company recognizes the impact of an uncertain tax position in its financial statements if, in management’s judgment, the position
+Added: is more-likely-than-not sustainable upon audit based on the position’s technical merits.
+Added: This involves the identification of potential
+Added: uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position
+Added: is necessary.
+Added: Company has one reportable operating segment, which is the development of targeted therapies for the treatment of multiple solid tumor
+Added: The Company’s chief operating decision makers (“CODMs”) are its chief executive officer, chief science
+Added: officer and chief financial officer, who, together manage the Company’s operations as one operating segment for the purpose of
+Added: evaluating financial performance and allocating resources.
+Added: The CODMs assess the performance and allocate resources for the reportable
+Added: segment based on net loss and total assets, which are the same amounts in all material respects as those reported in the statements of
+Added: operations and balance sheets.
+Added: Recently Adopted
+Added: Accounting Pronouncements
+Added: December 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-09,
+Added: Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the annual income
+Added: tax disclosures for the effective tax rate reconciliation, income taxes paid, and continuing operations.
+Added: ASU 2023-09 also eliminates
+Added: certain disclosure requirements related to unrecognized tax benefits.
+Added: ASU 2023-09 is effective for annual reporting periods beginning
+Added: after December 15, 2024, with early adoption permitted.
+Added: The Company adopted ASU 2023-09 on January 1, 2025 on a retrospective basis.
+Added: Accounting Pronouncements Not Yet Adopted
+Added: November 2024, the FASB issued ASU 2024-03 , Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures
+Added: (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities to provide
+Added: disaggregated disclosure of income statement expense.
+Added: In January 2025, the FASB issued ASU 2025-01, Income Statement—Reporting
+Added: Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Clarifying the Effective Date , to clarify the effective
+Added: date of ASU 2024-03.
+Added: ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods
+Added: beginning after December 15, 2027, with early adoption permitted.
+Added: The Company is currently evaluating the impact of ASU 2024-03 on its
+Added: financial statements and related disclosures.
+Added: July 2025 , the FASB issued ASU 2025-05 , Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU
+Added: 2025-05”), which provides certain entities with an additional practical expedient for estimating expected credit losses on current
+Added: accounts receivable and current contract assets arising from revenue transactions under Accounting Standards Codification (“ASC”)
+Added: ASU 2025-05 is effective for all entities for annual and interim periods in fiscal years beginning after December 15, 2025.
+Added: adoption is permitted for all entities.
+Added: The Company is currently evaluating the impact of ASU 2025-05 on its financial statements and
+Added: related disclosures.
+Added: September 2025, the FASB issued ASU No.
+Added: 2025-06, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40):
+Added: Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which modernizes the accounting for
+Added: internal-use software.
+Added: ASU 2025-06 removes all references to software development stages and requires capitalization of software costs
+Added: when management has committed to the software project, and it is probable the software will be completed and perform to its intended
+Added: In evaluating whether it is probable the project will be completed, management is required to consider whether there is significant
+Added: uncertainty associated with the development activities of the software.
+Added: ASU 2025-06 is effective for annual and interim periods beginning
+Added: after December 15, 2027.
+Added: The guidance may be applied on a prospective basis, a modified basis for in-process projects, or a retrospective
+Added: The Company is currently evaluating the timing, method of its adoption, and effect of ASU 2025-06 on its financial statements
+Added: and related disclosures.
Net Loss Per Common Share
−Removed: Basic and diluted net loss per common share is determined by dividing net
−Removed: loss attributable to common stockholders by the weighted-average common shares outstanding during the period.
−Removed: For all periods presented,
−Removed: the common shares underlying the preferred stock, options, warrants, and restricted stock have been excluded from the calculation because
−Removed: their effect would be anti-dilutive.
−Removed: Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss
−Removed: per common share are the same.
−Removed: The following table summarizes the potentially-dilutive shares excluded
−Removed: from the diluted weighted-average shares outstanding:
−Removed: Schedule of Potentially-Dilutive Shares Excluded from the Diluted Weighted-Average Shares Outstanding
−Removed: Potentially-dilutive shares excluded from diluted weighted-average shares outstanding:
−Removed: Preferred stock on an as-if-converted to common stock
+Added: and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average
+Added: common shares outstanding during the period.
+Added: For all periods presented, the common shares underlying the options, convertible note, warrants,
+Added: restricted stock and preferred stock have been excluded from the calculation because their effect would be anti-dilutive.
+Added: Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same.
+Added: following table summarizes the potentially-dilutive shares that have been excluded from the calculation of diluted weighted-average shares
+Added: outstanding because their inclusion would be anti-dilutive:
+Added: Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding
+Added: Year Ended December 31,
Options to purchase common stock
+Added: Convertible note as-if-converted-to-common stock
Warrants to purchase common stock
Restricted common stock
−Removed: Anti-dilutive securities excluded from
−Removed: diluted weighted- average shares outstanding
−Removed: Pre-funded warrant shares of 5,747,787 are included in the computation
−Removed: of basic and diluted net loss per share for the years ended December 31, 2024 and 2023, as the pre-funded warrants are issuable for nominal
−Removed: consideration.
−Removed: The following table summarizes the Company’s held-to-maturity investment
−Removed: securities at amortized cost as of December 31, 2024 and 2023:
+Added: Preferred stock as-if-converted-to-common stock
+Added: maximum number of shares of common stock issuable upon conversion of the Notes is 5,296,053 .
+Added: As of December 31, 2025, the number of shares
+Added: issuable based on the Company’s closing common stock price would be 3,923,002 if the Notes were converted in full.
+Added: the years ended December 31, 2025 and 2024, pre-funded warrant shares of 6,147,787 and 5,747,787 , respectively, were included in the
+Added: computation of basic and diluted net loss per share, as the pre-funded warrants are exercisable for nominal consideration.
+Added: investments for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported
+Added: at historical cost adjusted for amortization of premiums and accretion of discounts.
+Added: Expected credit losses, if any, are recorded through
+Added: the establishment of an allowance for credit losses.
+Added: All of the Company’s held-to-maturity investments are U.S.
+Added: treasury securities
+Added: that are guaranteed or otherwise supported by the United States government and have no history of credit losses.
+Added: Accordingly, the Company
+Added: does not expect to incur any credit losses on held-to-maturity investments and has no allowance for credit losses recorded for these
+Added: As of December 31, 2025, all of the Company’s held-to-maturity investments had maturities of one year or less.
+Added: following tables summarize the Company’s held-to-maturity investments (in thousands):
Schedule of Investment
3 unchanged sentences
Estimated Fair Value
−Removed: December 31, 2024
+Added: As of December 31, 2025
Amortized Cost, as Adjusted
2 unchanged sentences
Estimated Fair Value
−Removed: Treasury Bills
−Removed: $ 212,588,960
−Removed: $ 212,671,211
−Removed: $ 212,588,960
−Removed: $ 212,671,211
+Added: treasury securities
Amortized Cost, as Adjusted
2 unchanged sentences
Estimated Fair Value
−Removed: December 31, 2023
+Added: As of December 31, 2024
Amortized Cost, as Adjusted
2 unchanged sentences
Estimated Fair Value
−Removed: Treasury Bills
−Removed: $ 149,919,974
−Removed: $ 149,950,969
−Removed: $ 149,919,974
−Removed: $ 149,950,969
−Removed: The fair value of the Company’s held-to-maturity debt securities
−Removed: is determined based upon inputs, other than the quoted prices in active markets, that are observable either directly or indirectly, and
−Removed: are classified as Level 2 fair value instruments.
−Removed: Other Current Assets
−Removed: Other current assets consisted of the following at
−Removed: Schedule of Other Current Assets
−Removed: Prepaid clinical trial costs
−Removed: Miscellaneous receivable
−Removed: Directors & officers’ insurance
+Added: treasury securities
+Added: Company’s U.S.
+Added: treasury securities are classified as Level 2 investments within the fair value hierarchy.
+Added: These assets have been
+Added: valued based on quoted prices in active markets for similar assets or other inputs that are observable or can be corroborated by observable
+Added: were no changes in valuation techniques or transfers within the fair value hierarchy during the years presented.
Property and Equipment
−Removed: Property and equipment consisted of the following
−Removed: at December 31:
+Added: and equipment, net consisted of the following (in thousands):
Summary of Property and Equipment
+Added: As of December 31,
Furniture and equipment
Leasehold improvements
−Removed: Property and equipment, Gross
+Added: Total property and equipment, gross
Accumulated depreciation
−Removed: ( 1,991,937 )
−Removed: ( 1,861,990 )
−Removed: Depreciation expense
−Removed: was $ 129,947 and $ 142,772 for the years ended December 31, 2024 and 2023, respectively.
−Removed: Accrued Expenses
−Removed: Accrued expenses consisted of the following at December
−Removed: Schedule of Accrued Expenses
−Removed: Clinical trial costs
−Removed: Accrued compensation
−Removed: Employee stock purchase plan
−Removed: Operating and Finance Leases
−Removed: The Company leases its corporate space in Minneapolis,
−Removed: Minnesota, with an operating lease in place through April 30, 2026.
−Removed: The lease provides for monthly rent, real estate taxes, and operating
−Removed: Rent expense is recorded on a straight-line basis over the lease term.
−Removed: In March 2023, the Company signed the fourth amendment
−Removed: to extend this lease through April 30, 2026.
−Removed: This amendment provides for monthly rent, real estate taxes and operating expenses.
−Removed: In May 2018, the Company entered into a non-cancelable finance
−Removed: lease agreement for office equipment with a five-year term.
−Removed: The underlying assets are included in furniture and equipment.
−Removed: The lease contains
−Removed: a bargain purchase option at the end of the lease.
−Removed: The finance lease expired in May 2023 and the equipment was acquired for the bargain
−Removed: purchase option price.
−Removed: When an implicit rate is not provided, the Company uses its
−Removed: incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease
−Removed: Supplemental balance sheet information consisted of the following at December
−Removed: Schedule of Supplemental Balance Sheet Information Related to Leases
−Removed: Operating Lease
−Removed: Right-of-use assets
−Removed: Operating lease liability
−Removed: short term portion
−Removed: Long term portion
−Removed: Maturity analysis under lease agreements consisted of the following as
−Removed: of December 31, 2024:
−Removed: Schedule of Maturity Analysis Under Lease Agreements
−Removed: Operating Leases
+Added: Total property and equipment, net
+Added: expense was $ 0.2 million and $ 0.1 million during the years ended December 31, 2025 and 2024, respectively.
+Added: Other Accrued Expenses
+Added: accrued expenses consisted of the following (in thousands):
+Added: of Other Accrued Expenses
+Added: As of December 31,
+Added: Employee compensation and benefits
+Added: License milestone
+Added: Consulting and professional fees
+Added: of December 31, 2025, and 2024, accounts payable included $ 0 and $ 820 of accrued interest, respectively.
+Added: and Finance Leases
+Added: Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026 (the “Existing
+Added: The Existing Lease provides for monthly rent, real estate taxes, and operating expenses.
+Added: Rent expense is recorded on a
+Added: straight-line basis over the lease term.
+Added: November 2025, the Company entered into a lease for clinical laboratory and office space in Minnesota for 19,594 square feet.
+Added: term will commence on April 1, 2026 and is 62 months with two options to extend the lease term for five years each.
+Added: The Company also
+Added: has a one-time option to terminate the lease at the end of the third year, provided certain conditions are met.
+Added: To exercise this option,
+Added: the Company must pay a termination fee equal to eight months’ rent plus the landlord’s unamortized transaction costs, which
+Added: include abated rent, tenant improvement allowances and broker fees.
+Added: The initial annual lease payment is $ 0.3 million and increases by
+Added: 3.5% on an annual basis, resulting in total undiscounted future minimum lease payments of $ 1.5 million over the initial 62 -month term.
+Added: As of December 31, 2025, the lease has not commenced and is therefore excluded from the tables below.
+Added: an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement
+Added: date in determining the present value of the lease payments.
+Added: minimum lease payments under the Company’s Existing Lease consisted of the following (in thousands):
+Added: of Minimum Lease Payments
+Added: Year Ending December 31,
Total minimum lease payments
−Removed: Present value discount
−Removed: Present value of net minimum lease payments
−Removed: Weighted Average
−Removed: Remaining Lease Term
−Removed: Discount Rate
−Removed: Operating lease
−Removed: Lease costs for the period ended December 31:
+Added: Amount representing interest
+Added: Present value of operating lease liabilities
+Added: operating lease liabilities, current
+Added: Operating lease liabilities, non-current
+Added: weighted-average remaining lease term and discount rate under the Company’s Existing Lease were as follows:
+Added: As of December 31,
+Added: Weighted-average remaining lease term
+Added: Weighted-average discount rate
+Added: following table presents components of lease costs (in thousands):
Schedule of Lease Costs
+Added: Year Ended December 31,
Operating lease cost
−Removed: Finance lease cost:
Variable lease cost
−Removed: Supplemental cash flow information related to leases for the period ended December 31:
−Removed: Schedule of Supplemental Cash Flow Information Related to Leases
−Removed: Cash paid for amounts included in operating and finance leases:
−Removed: Operating cash outflow from operating leases
−Removed: Operating cash outflow from finance leases
−Removed: Financing cash outflow from finance leases
−Removed: Total cash paid for amounts
−Removed: included in operating and finance leases
−Removed: Clinical Research Studies
−Removed: The Company enters into contracts in the normal course of business to conduct
−Removed: research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants,
−Removed: CMOs, and CROs.
−Removed: The Company has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib.
−Removed: In conjunction with the license agreement, the Company completed a Phase 1b clinical trial – B2151009 related to gedatolisib.
−Removed: patients subsequently transitioned to an Expanded Access study – CELC-G-001.
−Removed: Contracts related to the Expanded Access study are
−Removed: generally based on time and material.
−Removed: In addition, contracts related to the Company’s Phase 3 clinical studies (VIKTORIA-1 and VIKTORIA-2)
−Removed: and the Phase 1b/2 clinical trial (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the Company’s
−Removed: obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges,
−Removed: if any, as defined in each of the respective agreements.
−Removed: In addition, these agreements may, from time to time, be subjected to amendments
−Removed: as a result of any change orders executed by the parties.
−Removed: As of December 31, 2024, the Company had five material non-cancelable contractual
−Removed: commitments with respect to these arrangements, which totaled approximately $ 9.7 million.
+Added: Total lease cost
+Added: Research Studies
+Added: Company enters into contracts in the normal course of business to conduct research and development programs internally and through third-party
+Added: service providers that include, among others, arrangements with vendors, consultants, contract manufacturing organizations, and contract
+Added: research organizations.
+Added: Contracts related to the Company’s ongoing clinical trials are generally cancelable with advance notice
+Added: and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain
+Added: cancelation charges, if any, as defined in each of the respective agreements.
+Added: In addition, these agreements may, from time to time, be
+Added: subject to amendments as a result of any change orders executed.
+Added: As of December 31, 2025, the Company had $ 5.5 million of non-cancelable
+Added: purchase commitments with respect to these arrangements.
+Added: Rights Agreement
+Added: connection with a securities purchase agreement with certain investors pursuant to which the Company agreed to sell to the investors
+Added: in a private placement pre-funded warrants to purchase up to 5,747,787 shares of the Company’s common stock in October 2023 (the “Securities Purchase Agreement”),
+Added: the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the investors.
+Added: the Registration Rights Agreement, the Company agreed to file a registration statement and to use commercially reasonable efforts to cause such registration statement to become effective and to keep such
+Added: registration statement effective until such time as there are no longer registrable securities held by the Investors.
+Added: the Company fails to meet the specified filing deadlines, effectiveness deadlines, or maintain the effectiveness of the registration
+Added: statement, the
+Added: Company is required to make pro rata payments to each holder as liquidated damages in an amount equal to 1.0% of the aggregate
+Added: amount paid pursuant to the Securities Purchase Agreement by such investor for each 30-day period or pro rata for any portion
+Added: thereof during which such event continues, provided that the maximum liquidated damages shall not exceed 6.0% of the aggregate
+Added: amount invested by each such holder in the registrable securities.
+Added: Company accounts for these arrangements in accordance with ASC 825-20, Registration Payment Arrangements .
+Added: As of December 31,
+Added: 2025, the required registration statement has been timely filed and declared effective by the SEC, and the Company remains in
+Added: compliance with the maintenance requirements.
+Added: Management has determined that it is not probable that the Company will be obligated
+Added: to pay any liquidated damages;
+Added: accordingly, no liability has been recorded for these arrangements.
Stockholders’ Equity
−Removed: Capital Stock
−Removed: At December 31, 2023, the Company’s authorized
−Removed: capital stock consisted of 65,000,000 shares of $ .001 par value common stock, of which 25,506,012 shares were outstanding, and 2,500,000
−Removed: shares of $ .001 par value preferred stock, of which 854,134 shares were outstanding.
−Removed: In 2024, several of the Company’s preferred
−Removed: shareholders elected to convert 536,557 shares of Series A Convertible Preferred Stock into 5,365,570 shares of common stock, in accordance
−Removed: with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis of the shares transferred is $ 5.75 per share.
−Removed: In 2024, several of the Company’s investors
−Removed: exercised 1,827,357 common stock warrants at exercise prices ranging between $ 8.05 and $ 9.50 per share, which generated approximately
−Removed: $ 14.7 million in cash.
−Removed: The 1,827,357 common stock warrants were net of shares withheld for exercise price.
−Removed: At December 31, 2024, the Company’s
−Removed: 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
−Removed: of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 317,577 shares were outstanding.
−Removed: December 31, 2024, no dividends have been declared on the Company’s capital stock.
−Removed: Sale and Issuance of Stock
−Removed: On April 22, 2024, pursuant to an Open Market Sale
−Removed: Agreement SM with Jefferies LLC, as agent, the Company sold 285,714 shares of common stock in a single transaction at a price
−Removed: of $ 17.50 per share, generating gross proceeds of $ 5.0 million.
−Removed: On May 8, 2024, pursuant to an Open Market
−Removed: Sale Agreement with Jefferies LLC, as agent, the Company sold 149,700 shares of common stock in a single transaction at a price of $ 17.65
−Removed: per share, generating gross proceeds of $ 2.6 million.
−Removed: Commissions and other offering expenses related to the Open Market Sale
−Removed: Agreement transactions in April and May 2024 were $ 0.3 million.
−Removed: On May 30, 2024, the Company entered into an underwriting
−Removed: agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the
−Removed: 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
−Removed: gross proceeds of approximately $ 60.0 million.
−Removed: The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately
−Removed: $ 56.3 million after deducting underwriting discounts and other offering expenses payable by the Company.
−Removed: The Company intends to use the
−Removed: net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and
−Removed: development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.
−Removed: Pre-Funded Warrants
−Removed: On October 18, 2023, the
−Removed: Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain investors (the “Investors”)
−Removed: pursuant to which the Company agreed to sell to the Investors in a private placement pre-funded warrants to purchase up to 5,747,787 shares
−Removed: of the Company’s common stock, par value $ 0.001 per share.
−Removed: Each Warrant to purchase one share had a purchase price of $ 8.699 per
−Removed: share, and an exercise price of $ 0.001 per share for the common stock issuable upon exercise of the Warrant.
−Removed: The closing of the Private
−Removed: Placement occurred on October 20, 2023, and resulted in gross proceeds to the Company of approximately $ 50.0 million, before deducting
−Removed: offering expenses of approximately $ 0.1 million.
−Removed: Each Warrant is immediately
−Removed: exercisable and will not expire.
−Removed: Under the terms of the Warrants, the Company may not effect the exercise of any such Warrant, and a holder
−Removed: will not be entitled to exercise any portion of any Warrant, if, upon giving effect to such exercise, the aggregate number of shares of
−Removed: common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting
−Removed: as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common
−Removed: stock would or could be aggregated with the holder’s or any of the holder’s affiliates for purposes of Section 13(d) or Section
−Removed: 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed 4.99% of the number of shares of
−Removed: common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is calculated in accordance with
−Removed: Section 13(d) of the Exchange Act and the applicable regulations of the SEC (the “Maximum Percentage”).
−Removed: A holder may reset
−Removed: the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective 61 days after written notice to the Company, or a lower
−Removed: percentage, effective immediately upon written notice to the Company.
−Removed: Any such increase or decrease will apply only to that holder and
−Removed: not to any other holder of Warrants.
−Removed: The Securities Purchase Agreement
−Removed: contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations
−Removed: of the Company, other obligations of the parties and termination provisions.
−Removed: Schedule of Warrants
−Removed: At December 31, 2024:
−Removed: # of Warrants
+Added: of December 31, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 48,244,960
+Added: shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock,
+Added: of which none were outstanding.
+Added: As of December 31, 2025, no dividends have been declared on the Company’s capital stock.
+Added: 2025 Equity Offering
+Added: July 30, 2025, the Company entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies
+Added: LLC (“Jefferies”), TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the
+Added: “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”) agreeing,
+Added: subject to customary conditions, to issue and sell in a public offering (i) 1,836,842
+Added: shares (the “Shares”) of the Company’s common stock, at a price to the public of $ 38.00
+Added: per Share and (ii) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000
+Added: shares of common stock (the “Pre-Funded Warrants”), at a price to the public of $ 37.999
+Added: per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $ 0.001
+Added: per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”).
+Added: In addition, pursuant to the Equity
+Added: Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional 335,526
+Added: shares of common stock (the “Option Shares”), less underwriting discounts and commissions.
+Added: The Underwriters exercised
+Added: their option to purchase the Option Shares in full on July 30, 2025.
+Added: The Equity Offering was completed on July 31, 2025.
+Added: net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were $ 91.6 million,
+Added: including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares.
+Added: The Company may also
+Added: receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.
+Added: 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
+Added: of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined
+Added: according to the formula set forth in each Pre-Funded Warrant.
+Added: The Pre-Funded Warrants are exercisable at any time after the date of
+Added: issuance until all of the Pre-Funded Warrants are exercised.
+Added: A holder (together with its “attribution parties,” as defined
+Added: in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together
+Added: with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately
+Added: after giving effect to the exercise.
+Added: However, a holder may increase or decrease such percentage to any other percentage not in excess
+Added: of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to the Company.
+Added: and Issuance of Stock
+Added: May 30, 2024, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus
+Added: & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common
+Added: stock, at a price to the public of $ 15.50 per share, generating gross proceeds of $ 60.0 million.
+Added: The offering closed on May 31, 2024
+Added: and resulted in net proceeds to the Company of $ 56.3 million after deducting underwriting discounts and other offering expenses payable
+Added: by the Company.
+Added: May 8, 2024, pursuant to an Open Market Sale Agreement with Jefferies, as agent, the Company sold 149,700 shares of common stock
+Added: in a single transaction at a price of $ 17.65 per share, generating gross proceeds of $ 2.6 million.
+Added: April 22, 2024, pursuant to an Open Market Sale Agreement with Jefferies, as agent, the Company sold 285,714 shares of common stock
+Added: in a single transaction at a price of $ 17.50 per share, generating gross proceeds of $ 5.0 million.
+Added: and other offering expenses related to the Open Market Sale Agreement transactions in May and April 2024 were $ 0.3 million.
+Added: Stock Warrants
+Added: of December 31, 2025, the Company had the following common stock warrants outstanding:
+Added: of Common Stock Warrants
Private placement offering – issued to placement agent
2 unchanged sentences
Private placement offering – issued to placement agent
−Removed: IPO - issued to underwriter
Debt financing – issued to lender
1 unchanged sentence
Debt financing – issued to lender
−Removed: securities purchase agreement - issued to institutional and other accredited investors
+Added: Debt financing – issued to lender
+Added: Debt financing – issued to lender
Private placement offering – issued to investors
+Added: Equity offering – issued to underwriters
Total warrants outstanding
−Removed: At December 31, 2024 and 2023, the Company had warrants
−Removed: to purchase 11,268,939
−Removed: and 13,011,520
−Removed: shares of common stock outstanding, at a weighted average exercise price of $ 4.04
−Removed: respectively.
−Removed: A total of 1,842,913
−Removed: warrants were exercised in the years ended December 31, 2024 and 2023, respectively.
−Removed: There were 3,544
−Removed: warrants that expired in 2024.
+Added: October 18, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain
+Added: investors (the “Investors”) pursuant to which the Company agreed to sell to the Investors in a private placement pre-funded
+Added: warrants to purchase up to 5,747,787 shares of the Company’s common stock, par value $ 0.001 per share.
+Added: Each warrant to purchase
+Added: one share had a purchase price of $ 8.699 per share, and an exercise price of $ 0.001 per share for the common stock issuable upon exercise
+Added: of the warrant.
+Added: warrant is immediately exercisable and will not expire.
+Added: Under the terms of the warrants, the Company may not effect the exercise of any
+Added: such warrant, and a holder will not be entitled to exercise any portion of any warrant, if, upon giving effect to such exercise, the
+Added: aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who
+Added: could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose
+Added: beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates for
+Added: purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed
+Added: 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership
+Added: is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC (the “Maximum Percentage”).
+Added: A holder may reset the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective 61 days after written notice to the
+Added: Company, or a lower percentage, effective immediately upon written notice to the Company.
+Added: Any such increase or decrease will apply only
+Added: to that holder and not to any other holder of warrants.
+Added: Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,
+Added: indemnification obligations of the Company, other obligations of the parties and termination provisions.
+Added: following table summarizes the activity for all common stock warrants outstanding:
+Added: of Common Stock Warrants Outstanding
+Added: Common stock warrants
+Added: Weighted- average exercise price per share
+Added: Outstanding as of December 31, 2024
+Added: ( 5,282,375 )
+Added: Surrendered upon cashless exercise
+Added: Outstanding as of December 31, 2025
+Added: the year ended December 31, 2024, several of the Company’s investors exercised 1,827,357
+Added: common stock warrants, net of shares withheld for the exercise price, at exercise prices ranging between $ 8.05
+Added: per share, which generated $ 14.7
+Added: million in cash.
+Added: During the year ended December 31, 2024, 3,544
+Added: common stock warrants expired.
+Added: A preferred stock
+Added: Series A preferred stock is non-voting, and each share is convertible at the option of the holder, subject to certain limitations, into
+Added: 10 shares of common stock.
+Added: Holders of Series A preferred stock are entitled to receive dividends, on an as-if-converted-to-common stock
+Added: basis, when, as and if, and in the same form as, dividends are actually paid on the common stock.
+Added: In the event of any voluntary or involuntary
+Added: liquidation, dissolution or winding up of the Company, or in the event of a Deemed Liquidation Event (as defined in the Certificate of
+Added: Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock), the holders of Series A preferred stock
+Added: are entitled to be paid from assets of the Company available for distribution to its stockholders, before any payment is made to the
+Added: holders of common stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the original issue price
+Added: ( $5.75 on an as-converted-to-common stock basis ), plus all accrued and unpaid dividends and (ii) the amount that the holder would have
+Added: been entitled to receive at such time if the Series A preferred stock were converted into common stock.
+Added: The Company may not, without
+Added: the consent of holders of a majority of the outstanding shares of Series A preferred stock, amend its charter in a manner that adversely
+Added: affects the powers, preferences or rights of the Series A preferred stock or issue or obligate itself to issue shares of any additional
+Added: class or series of capital stock unless the same ranks junior to the Series A preferred stock with respect to the distribution of assets
+Added: on the liquidation, dissolution or winding up of the Company and the payment of dividends.
+Added: the year ended December 31, 2025, 317,577 shares of Series A preferred stock were converted into 3,175,770 shares of common stock.
+Added: of December 31, 2025, no shares of Series A preferred stock were outstanding.
Stock-Based Compensation
Equity Incentive Plan
−Removed: The 2012 Equity Incentive Plan, as amended, was adopted by the Company’s
−Removed: board and approved by the members of Celcuity LLC on August 10, 2012.
−Removed: The Company reserved a maximum of 625,000 shares of common stock
−Removed: for issuance under the 2012 Equity Incentive Plan.
−Removed: The 2012 Equity Incentive Plan provides for options, restricted stock awards, performance
−Removed: stock awards or stock bonuses.
−Removed: The exercise price of each option granted under the 2012 Equity Incentive Plan is not less than 100% of
−Removed: the fair market value of one share on the date of grant.
−Removed: The maximum permitted term of options granted under the 2012 Equity Incentive
−Removed: Plan is ten years.
−Removed: The Company’s board administers the 2012 Equity Incentive Plan and determines the provisions of incentive awards,
−Removed: including eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive
−Removed: award and other restrictions an incentive award may be subject to.
−Removed: The 2012 Equity Incentive Plan was frozen on September 6, 2017 and
−Removed: new awards are issued under the terms of the 2017 Amended and Restated Stock Incentive Plan.
−Removed: 2017 Stock Incentive Plan
−Removed: The 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”)
−Removed: was adopted by the Company’s board on September 6, 2017, became effective following the corporate conversion on September 15, 2017,
−Removed: and was approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018.
−Removed: The 2017 Plan was amended and approved
−Removed: by stockholders at the Company’s annual stockholder meeting on May 14, 2020.
−Removed: The Company initially reserved a maximum of 750,000
−Removed: shares of common stock for issuance under the 2017 Plan.
−Removed: The number of shares reserved for issuance was automatically increased by 255,060
−Removed: and 216,673 shares on January 1, 2024 and 2023, respectively, and will increase automatically on January 1 of each of 2025 through 2027
−Removed: 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
−Removed: However, the Company’s board may reduce the amount of the increase in any particular year.
−Removed: At each of the Annual Meetings
−Removed: held on May 12, 2021 and May 12, 2022, the stockholders approved a 500,000 increase for a total of 1,000,000 increase, to the number of
−Removed: shares reserved for issuance under the 2017 Plan.
−Removed: At each of the Annual Meetings held on May 11, 2023 and May 9, 2024, the stockholders
−Removed: approved 1,500,000 increases for a total increase of 3,000,000 to the number of shares reserved for issuance under the 2017 Plan.
−Removed: 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards and stock
−Removed: The exercise price of each option granted under the 2017 Plan is not less than 100% of the fair market value of one share on
−Removed: the date of grant.
+Added: August 2012, the Company adopted the 2012 Equity Incentive Plan (the “2012 Plan”).
+Added: The 2012 Plan provided for options, restricted
+Added: stock awards, performance stock awards and stock bonuses.
+Added: The exercise price of each option granted under the 2012 Plan is not less than
+Added: 100% of the fair market value of one share on the date of grant.
+Added: The maximum permitted term of options granted under the 2012 Plan is
+Added: The Company’s board of directors administers the 2012 Plan and determines the provisions of incentive awards, including
+Added: eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive award
+Added: and other restrictions an incentive award may be subject to.
+Added: In September 2017, the 2012 Plan was frozen and no further awards may be
+Added: made under the 2012 Plan.
+Added: Amended and Restated Stock Incentive Plan
+Added: September 2017, the Company adopted the 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”).
+Added: The 2017 Plan provides
+Added: for the grant of options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards and stock bonuses.
+Added: The exercise price of each option granted under the 2017 Plan is not less than 100% of the fair market value of one share on the date
The maximum permitted term of options granted under the 2017 Plan is ten years.
−Removed: The 2017 Plan is generally administered
−Removed: by the compensation committee of the Company’s board, which has the authority to interpret the 2017 Plan, grant awards and make
−Removed: all other determinations necessary for the administration of the 2017 Plan.
−Removed: The following table summarizes the activity for all stock options outstanding
−Removed: for the years ended December 31:
+Added: The 2017 Plan is generally administered by
+Added: the compensation committee of the board of directors, which has the authority to interpret the 2017 Plan, grant awards and make all other
+Added: determinations necessary for the administration of the 2017 Plan.
+Added: number of shares reserved for issuance under the 2017 Plan will automatically increase on January 1 of each year from 2026 to 2027 by
+Added: the number of shares equal to 1.0% of the aggregate number of outstanding shares of common stock as of the immediately preceding December
+Added: However, the Company’s board of directors may reduce the amount of the increase in any particular year.
+Added: The number of shares
+Added: reserved for issuance under the 2017 Plan was automatically increased by 371,432 and 255,060 shares on January 1, 2025 and 2024, respectively.
+Added: the years ended December 31, 2025 and 2024, the board of directors and the stockholders approved additional increases of 3,000,000 and
+Added: 1,500,000 , respectively, to the number of shares reserved for issuance under the 2017 Plan.
+Added: of December 31, 2025, the number of shares available for issuance under the 2017 Plan is 2,591,634 .
+Added: granted under the 2017 Plan are exercisable at various dates as determined upon grant and will expire no more than 10 years from their
+Added: date of grant.
+Added: The exercise price of each option shall be determined by the board of directors based on the estimated fair value of the
+Added: Company’s common stock on the grant date.
+Added: The exercise price shall not be less than 100% of the fair market value of the Company’s
+Added: common stock on the grant date.
+Added: Most option grants generally vest 25 % on the first anniversary of the original vesting commencement date,
+Added: with the balance vesting monthly over the remaining three years .
+Added: The 2017 Plan is generally administered by the compensation committee
+Added: of the board of directors, which has the authority to interpret the 2017 Plan, grant awards and make all other determinations necessary
+Added: for the administration of the 2017 Plan.
+Added: following table summarizes the activity for all stock options outstanding:
Schedule of Stock Options Activity
−Removed: Weighted Average Exercise Price
−Removed: Weighted Average Exercise Price
−Removed: Options outstanding at beginning of year
−Removed: Balance at December 31:
−Removed: Options exercisable at December 31:
−Removed: Weighted Average Grant Date Fair Value for options granted during the year:
−Removed: following table summarizes additional information about stock options outstanding and exercisable at December 31, 2024:
−Removed: of Stock Options Outstanding and Exercisable
−Removed: Options Outstanding
−Removed: Options Exercisable
−Removed: Options Outstanding
−Removed: Weighted Average Remaining Contractual Life
−Removed: Weighted Average Exercise Price
−Removed: Aggregate Intrinsic Value
−Removed: Options Exercisable
−Removed: Weighted Average Exercise Price
+Added: Weighted- average exercise price per share
+Added: Weighted-average remaining contractual term
Aggregate intrinsic value
−Removed: The Company recognized stock-based compensation expense for stock options
−Removed: of $ 6,626,402 and $ 4,716,475 for the years ended December 31, 2024 and 2023, respectively.
−Removed: In May 2022, the Company modified the exercise
−Removed: price on 776,324 stock option awards to $ 5.50 , the closing market price on the Nasdaq Capital Market on May 17,2022.
−Removed: The effect of this
−Removed: modification on stock-based compensation was $ 106,000 and $ 134,000 for the years ended December 31, 2024 and 2023, respectively.
−Removed: of this modification on stock-based compensation over the remaining service period will be approximately $ 57,000 .
−Removed: In December 2021, the
−Removed: Company modified the exercise price on 311,000 stock option awards to $ 13.44 , the closing market price on the Nasdaq Capital Market on
−Removed: December 15, 2021.
−Removed: No director or officer awards were modified.
−Removed: The effect on stock-based compensation was $ 63,000 and $ 65,000 for the
−Removed: years ended December 31, 2024 and 2023, respectively.
−Removed: The effect on stock-based compensation over the remaining service period will be
−Removed: approximately $ 35,000 .
−Removed: In May 2020, the Company modified the exercise price on 203,750 stock option awards to $ 5.10 , the closing market
−Removed: price on the Nasdaq Capital Market on May 14, 2020.
−Removed: No director or officer awards were modified.
−Removed: The effect on stock-based compensation
−Removed: was $ 696 and $ 19,000 for the years ended December 31, 2024 and 2023, respectively.
−Removed: There is no effect on stock-based compensation remaining.
−Removed: The Black-Scholes option-pricing model was used to estimate the
−Removed: fair value of equity-based awards and the Monte Carlo simulation model was used to estimate the fair value of the performance-based awards,
−Removed: with the following weighted-average assumptions for the years ended December 31:
−Removed: of Assumptions for Fair Value of Equity-based Awards
+Added: (in thousands)
+Added: Options outstanding as of December 31, 2024
+Added: Options outstanding as of December 31, 2025
+Added: Options exercisable as of December 31, 2025
+Added: January 2025, the Company modified previously granted stock option awards to 44 employees by reducing the exercise price of these options
+Added: to the Company’s closing common stock price on the modification date.
+Added: During the year ended December 31, 2025, the incremental
+Added: compensation expense recognized as a result of these modifications was $ 0.2 million.
+Added: The effect of these modifications on stock-based
+Added: compensation over the remaining service periods will be $ 0.3 million.
+Added: the year ended December 31, 2025, the market conditions associated with options previously granted to an employee were satisfied following
+Added: the achievement of the specified stock price threshold.
+Added: As a result, the options vested and the Company recognized $ 8.4 million in stock-based
+Added: compensation expense related to these awards during the year ended December 31, 2025.
+Added: the years ended December 31, 2025 and 2024, the weighted-average grant date fair value of options granted was $ 25.01 and $ 11.22 per share,
+Added: respectively.
+Added: The total intrinsic value of options exercised during the years ended December 31, 2025 and 2024, was $ 35.7 million and
+Added: $ 0.6 million, respectively.
+Added: Upon the exercise of stock options, the Company will issue new shares of its common stock.
+Added: As of December
+Added: 31, 2025, the unrecognized compensation cost related to outstanding employee and non-employee options was $ 52.7 million and is expected
+Added: to be recognized as expense over a weighted-average period of 1.7 years.
+Added: assumptions used in the Black-Scholes option pricing model and Monte Carlo simulation model to determine the fair value of the employee
+Added: and non-employee stock option grants issued, were as follows:
+Added: Schedule of Assumptions for Fair Value of Employee
+Added: And Non-Employee Stock Option
+Added: Year Ended December 31,
Risk-free interest rate
5 unchanged sentences
Expected life (years)
−Removed: 5.25 to 10.00
Expected dividend yield
−Removed: The inputs for the Black-Scholes valuation model and the Monte Carlo simulation
−Removed: model require management’s significant assumptions.
−Removed: Prior to the Company’s initial public offering, the price per share of
−Removed: common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings.
−Removed: to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital
−Removed: Market on the grant date.
−Removed: The risk-free interest rates are based on the rate for U.S.
−Removed: Treasury securities at the date of grant with maturity
−Removed: dates approximately equal to the expected life at the grant date.
−Removed: The expected life is based on the simplified method for the time-based
−Removed: awards and the life of the option for the performance-based awards, in accordance with the SEC Staff Accounting Bulletin Nos.
−Removed: The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in
−Removed: combination with the Company’s calculated volatility since being publicly traded for the time-based awards.
−Removed: For the performance-based
−Removed: awards, the Company’s full historical volatility was used to value the options.
−Removed: All assumptions used to calculate the grant date fair value of non-employee
−Removed: options are generally consistent with the assumptions used for options granted to employees.
−Removed: In the event the Company terminates any of
−Removed: its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled.
−Removed: The Company had 1,079 and 1,958 shares of restricted stock outstanding
−Removed: at December 31, 2024 and 2023, respectively, and 2,308 and 3,273 shares of restricted stock vested during the years ended December 31,
−Removed: 2024 and 2023, respectively.
−Removed: The Company recognized stock-based compensation expense for restricted stock of $ 22,220 and $ 18,499 for the
−Removed: years ended December 31, 2024 and 2023, respectively.
−Removed: The total remaining shares available for grant under the Company’s
−Removed: 2017 Plan as of December 31, 2024 was 1,177,450 .
−Removed: Total unrecognized compensation cost related to stock options and restricted
−Removed: stock is estimated to be recognized at December 31:
−Removed: of Unrecognized Compensation Cost
−Removed: Total estimated compensation cost to be recognized
+Added: the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense for stock options of $ 20.0 million
+Added: and $ 6.6 million, respectively.
+Added: following table summarizes restricted stock award and restricted stock unit activity during the year ended December 31, 2025:
+Added: Schedule of Restricted Stock Award And Restricted Stock Unit Activity
+Added: Weighted-average grant date fair value per share
+Added: Outstanding as of December 31, 2024
+Added: Outstanding as of December 31, 2025
+Added: of December 31, 2025, the unrecognized compensation cost related to outstanding restricted stock was $ 2.3 million and is expected to
+Added: be recognized over a weighted-average period of 1.9 years.
+Added: The total fair value of restricted stock vested during the year ended December
+Added: 31, 2025 was less than $ 0.1 million.
+Added: the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense for restricted stock of $ 0.1 million
+Added: and less than $ 0.1 million, respectively.
Employee Stock Purchase Plan
−Removed: The Company’s 2017 Employee Stock Purchase Plan (the “ESPP”)
−Removed: was adopted by the Company’s board on September 6, 2017 and approved by stockholders at the Company’s annual stockholder meeting
−Removed: on May 10, 2018.
−Removed: The Company initially reserved a total of 100,000 shares for issuance under the ESPP.
+Added: September 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “ESPP”).
+Added: The ESPP provides participating employees
+Added: with an opportunity to purchase shares of the Company’s common stock at a discount through payroll deductions.
+Added: The ESPP is available
+Added: to all employees unless they are employed for less than 20 hours per week or own 5% or more of the total combined voting power or value
+Added: of the Company’s common stock.
+Added: The ESPP is administered using overlapping 24 month offering periods (the “Offering Periods”).
+Added: Each Offering Period has four six-month purchase periods.
+Added: A new Offering Period and purchase period begin every six months on May 1 and
+Added: November 1 of each year.
+Added: Participating employees may purchase common stock, on a voluntary after tax-basis, at a price equal to 85% of
+Added: the fair market value of a share of common stock on either the offering date or the purchase date, whichever is lower.
+Added: If the purchase
+Added: date has a lower price, the employee will automatically be placed in the Offering Period beginning immediately after the purchase date.
+Added: number of shares reserved for issuance under the ESPP automatically increases on January 1 of each year from 2023 to 2027 by the number
+Added: of shares equal to 0.5% of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31.
+Added: the Company’s board of directors may reduce the amount of the increase in any particular year.
The number of shares reserved for
−Removed: issuance was automatically increased by 127,530 and 108,337 shares on January 1, 2024 and 2023, respectively and will increase automatically
−Removed: on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of shares of Company common stock as
−Removed: of the immediately preceding December 31.
−Removed: However, the Company’s board may reduce the amount of the increase in any particular year.
−Removed: The total remaining shares available for issuance under the employee stock purchase plan as of December 31, 2024 is 360,950 .
−Removed: The ESPP provides participating employees with an opportunity to purchase
−Removed: shares of the Company’s common stock at a discount through payroll deductions.
−Removed: The ESPP is available to all employees unless they
−Removed: are employed for less than 20 hours per week or own 5% or more of the total combined voting power or value of the Company’s common
−Removed: The ESPP is administered using overlapping 24 month offering periods, referred to as an Offering Period.
−Removed: Each Offering Period has
−Removed: four six-month purchase periods.
−Removed: A new Offering Period and purchase period begin every six months on May 1 and November 1 of each year.
−Removed: Participating employees may purchase common stock, on a voluntary after tax-basis, at a price equal to 85% of the fair market value of
−Removed: a share of common stock on either the offering date or the purchase date, whichever is lower.
−Removed: If the purchase date has a lower price,
−Removed: the employee will automatically be placed in the Offering Period beginning immediately after the purchase date.
−Removed: The Company recognized
−Removed: stock-based compensation expense related to the ESPP of $ 339,719 and $ 166,460 for the years ended December 31, 2024 and 2023, respectively.
−Removed: The Company recognized total stock-based compensation
−Removed: expense as follows for the years ended December 31:
+Added: issuance under the ESPP was automatically increased by 185,716 and 127,530 shares on January 1, 2025 and 2024, respectively.
+Added: of December 31, 2025, the number of shares available for issuance under the ESPP is 469,576 .
+Added: the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense related to the ESPP of $ 1.3 million
+Added: and $ 0.3 million, respectively.
+Added: Company recognized the following stock-based compensation expense in its statements of operations (in thousands):
of Stock-based Compensation Expenses
−Removed: Stock-based compensation expense in operating expenses:
Research and development
General and administrative
−Removed: Stock-based compensation expense
−Removed: On May 30, 2024, the Company entered into an Amended
−Removed: and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a
−Removed: Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a
−Removed: Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain
−Removed: term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 million.
−Removed: The A&R Loan Agreement
−Removed: amends and restates, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and
−Removed: Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).
−Removed: Funding of the first $ 100 million under the A&R
−Removed: Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the “Term A Loan”) and $ 21.5 million
−Removed: (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind
−Removed: interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”).
−Removed: The Company will be eligible to draw on a fourth
−Removed: tranche of $ 30 million (the “Term D Loan”) and fifth tranche of $ 50 million (the “Term E Loan”), in each case
−Removed: upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a pro forma as-funded
−Removed: The Lenders may, in their sole discretion upon the Company’s request, make additional term loans to the Company of $ 45 million
−Removed: (the “Term F Loan”).
−Removed: Funding of these additional tranches is also subject to other customary conditions and limits on when
−Removed: the Company can request funding for such tranches.
−Removed: Costs associated with the new borrowings was approximately $ 2.4 million.
−Removed: Pursuant to the A&R Loan Agreement, the Company
−Removed: is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met.
−Removed: 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
+Added: compensation expense
+Added: 2025 Convertible Notes Offering
+Added: July 30, 2025, the Company entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters,
+Added: subject to customary conditions, to issue and sell in a public offering $ 175.0 million aggregate principal amount of the Notes to the
+Added: Underwriters (the “Note Offering”).
+Added: In addition, pursuant to the Note Underwriting Agreement, the Company granted the Underwriters
+Added: an option to purchase up to an additional $ 26.3 million aggregate principal amount of Notes solely to cover over-allotments.
+Added: 30, 2025, the Underwriters exercised such option to purchase an additional $ 26.3 million aggregate principal amount of the Notes.
+Added: issuance of $ 201.3 million aggregate principal amount of the Notes was completed on August 1, 2025.
+Added: Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between
+Added: the Company and U.S.
+Added: Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental
+Added: indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”),
+Added: dated as of August 1, 2025, between the Company and the Trustee.
+Added: The net proceeds from the Note Offering, after deducting underwriting
+Added: discounts and commissions and offering expenses, were $ 194.9 million, including the proceeds from the Underwriters’ exercise of
+Added: their over-allotment option in full.
+Added: Notes are general, unsecured, senior obligations of the Company.
+Added: The Notes will accrue interest payable semi-annually in arrears on February
+Added: 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750 % per year.
+Added: In addition, special interest will accrue
+Added: on the Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided
+Added: in the Indenture and as described below.
+Added: The Notes also have customary provisions relating to the occurrence of “Events of Default”
+Added: (as defined in the Indenture) with certain interest penalty provisions.
+Added: The Notes will mature on August 1, 2031, unless earlier converted,
+Added: redeemed or repurchased by the Company.
+Added: may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding
+Added: 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
+Added: is equivalent to an initial conversion price of $ 51.30 per share of common stock.
+Added: The conversion rate is subject to customary adjustments
+Added: upon the occurrence of certain events as described in the Indenture.
+Added: In addition, if certain corporate events that constitute a “Make-Whole
+Added: Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased
+Added: for a specified period of time.
+Added: Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any
+Added: 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
+Added: before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid
+Added: interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds
+Added: 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days
+Added: ending on, and including, the trading day immediately before the date the Company sends the related redemption notice;
+Added: and (ii) the trading
+Added: day immediately before the date the Company sends such notice.
+Added: However, the Company may not redeem less than all of the outstanding Notes
+Added: unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company
+Added: sends the related redemption notice.
+Added: In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with
+Added: respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances
+Added: if it is converted after it is called for redemption.
+Added: a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth
+Added: in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount
+Added: of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.
+Added: The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and
+Added: certain de-listing events with respect to the common stock.
+Added: the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert
+Added: all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect
+Added: to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder
+Added: or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s
+Added: common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes;
+Added: provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder;
+Added: provided further, that
+Added: such limitation in no event can exceed 19.99%.
+Added: fair value of the Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility
+Added: and is determined by prices for the Notes observed in market trading.
+Added: The market for trading of the Notes is not considered to be an
+Added: active market and therefore the fair value is determined using Level 2 inputs.
+Added: As of December 31, 2025, the carrying value and fair value
+Added: of the Notes was $ 195.3 million and $ 436.5 million, respectively.
+Added: issuance costs attributed to the Notes amounted to $ 6.4
+Added: million and were discounted from the Notes.
+Added: The issuance cost discount is being amortized to interest expense over the term of the
+Added: Notes based on the effective interest rate method.
+Added: As of December 31, 2025, the effective interest rate was 3.3 %.
+Added: During the year ended December 31, 2025, interest expense related to the Notes was $ 2.7
+Added: million, including $ 0.4
+Added: million related to discount amortization.
+Added: and Restated Loan and Security Agreement
+Added: September 9, 2025, the Company entered into the Third Amendment (the “Third Amendment”) to the Amended and Restated Loan
+Added: and Security Agreement (the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company
+Added: (“Oxford”), as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership
+Added: (“Innovatus”), as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the
+Added: “Lenders”), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral
+Added: (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third
+Added: Amendment (the “Amended A&R Loan Agreement”)) and provide for the immediate disbursement of the $ 30.0
+Added: million Term D Loan (as defined in the Amended A&R Loan Agreement);
+Added: (iii) increase the size of the Term E Loan (as defined in
+Added: the Amended A&R Loan Agreement) from $ 50.0
+Added: million to up to $ 100.0
+Added: million, which Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type ABC
+Added: patients post CDK4/6 inhibitor therapy;
+Added: (iv) add three new up to $ 40.0
+Added: million Term F Loans (as defined in the Amended A&R Loan Agreement), for a total of $ 120.0
+Added: million, which may only be drawn upon achievement of certain trailing three months’ product revenue thresholds;
+Added: the prior $ 45.0
+Added: million Term F Loan (as defined in the A&R Loan Agreement) with a new $ 150.0
+Added: million Term G Loan (as defined in the Amended A&R Loan Agreement), which continues to be available only in the Lenders’
+Added: sole discretion upon the Company’s request;
+Added: (vi) require an amendment fee payable by the Company to the Lenders in the amount
+Added: million, which was paid at the closing of the Third Amendment;
+Added: (vii) make certain revisions to the non-utilization fee for the Term
+Added: 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,
+Added: after taking into consideration any reductions to the applicable term loan commitment that the Company may make by notice to the
+Added: collateral agent before the date that is eight weeks after the achievement of any applicable milestones;
+Added: and (viii) extend the
+Added: maturity date of the term loans to November 1, 2029.
+Added: The Term E Loan and each Term F Loan also are subject to other customary
+Added: conditions and limits on when the Company can request funding.
+Added: With the disbursement of the $ 30.0
+Added: million Term D Loan, the Company received net proceeds of $ 27.7
+Added: 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
+Added: $ 1.4 million was added to debt principal and a corresponding debt discount to be amortized over the life of the loan.
+Added: connection with the Third Amendment, the Company issued warrants with an exercise price of $ 14.84 per share to purchase an aggregate
+Added: of 50,537 shares of the Company’s common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment
+Added: The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary
+Added: of the funding date of the Term D Loan.
+Added: The number of shares of common stock for which each Third Amendment Warrant is exercisable and
+Added: the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant.
+Added: portion of the proceeds from the Term D Loan in the amount of $ 2.8
+Added: million was allocated to the Third Amendment Warrants based
+Added: on their relative fair value to the underlying Term D Loan.
+Added: The proceeds allocated to the Third Amendment Warrants were recorded as additional
+Added: paid in capital in the accompanying balance sheets and were discounted from the Term D Loan.
+Added: The relative fair value of the Third Amendment
+Added: Warrants was based on the Black-Scholes model with the following assumptions:
+Added: risk-free interest rate of 4.1 %;
+Added: expected volatility of 74.4 %;
+Added: expected life of 10.0
+Added: and expected dividend yield of 0 %.
+Added: The underlying stock price used in the analysis was the traded market price.
+Added: The discount related to the Third Amendment Warrants is
+Added: being amortized to interest expense ratably over the term of the Term D Loan.
+Added: July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with
+Added: Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus
+Added: and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount
+Added: of up to $ 180 million.
+Added: The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of
+Added: the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common
+Added: stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection
+Added: with the pricing of the Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of less than $ 0.1 million,
+Added: which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to
+Added: 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
+Added: 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
+Added: the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $ 30.0 million of
+Added: indebtedness under the Term D Loan (as defined in the A&R Loan Agreement).
+Added: As described above, the Term D Loan was disbursed to the
+Added: Company in connection with the Third Amendment.
+Added: May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant
+Added: to which the Company agreed to (i) pay Oxford an amendment fee of less than $0.1 million on the effective date of the First Amendment,
+Added: (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term
+Added: 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
+Added: 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),
+Added: (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company
+Added: 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
+Added: Company subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders
+Added: from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.
+Added: 30, 2024 Amendment and Restatement
+Added: May 30, 2024, the Company entered into the A&R Loan Agreement.
+Added: The A&R Loan Agreement amended and restated, in its entirety,
+Added: that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and
+Added: the Lenders named therein (the “Prior Loan Agreement”).
+Added: of the first $ 100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the
+Added: “Term A Loan”) and $ 21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under
+Added: the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”).
+Added: As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment.
+Added: Prior to the Third Amendment,
+Added: the Company also would have become eligible to draw on a fifth tranche of $ 50.0 million (the “Term E Loan”), upon achievement
+Added: of certain clinical trial milestones and satisfaction of certain financial covenants.
+Added: The Lenders also could have, in their sole discretion
+Added: upon the Company’s request, made additional term loans to the Company of $ 45.0 million (the “Term F Loan”).
+Added: of these additional tranches was also subject to other customary conditions and limits on when the Company could have requested funding
+Added: for such tranches.
+Added: Costs associated with the new borrowings were approximately $ 2.4 million.
+Added: 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
+Added: if certain conditions are met.
+Added: 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
1 unchanged sentence
The A&R Loan Agreement is secured by all assets of the Company.
−Removed: Proceeds will be used for working capital purposes and to
−Removed: fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical trial.
−Removed: The A&R Loan Agreement contains
−Removed: customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity
−Removed: and other financial measures.
−Removed: Innovatus has the right, at its election and until August 9, 2025, to convert up to 20 % of the outstanding
−Removed: principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 (the “Conversion Right”).
−Removed: Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase
−Removed: 26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031.
−Removed: The A&R Loan Agreement contains a Final Fee, which
−Removed: 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
−Removed: of any Term Loan, and (c) the prepayment of the Term Loans.
−Removed: There is also a contingent non-utilization fee for both the Term D and Term
−Removed: If the Company achieves the Term D Milestone and (i) fails to draw the full amount of the Term D Loan during the Term D Draw
−Removed: Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement
−Removed: 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 $ 900,000 ,
−Removed: 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
−Removed: Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.
−Removed: If the Company achieves the
−Removed: 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
−Removed: 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
−Removed: intent not to draw the full amount of the Term E Loan, a non-utilization fee of $ 1,500,000 , with respect to the Term E Loan shall become
−Removed: 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
−Removed: Term Loan, and (iv) the prepayment in whole of the Term Loans.
−Removed: After the 18-month anniversary of the Effective Date, the Company shall
−Removed: 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
−Removed: the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven Business Days prior
−Removed: to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective
−Removed: Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon
−Removed: through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable,
−Removed: including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.
−Removed: 2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt discount to be amortized
−Removed: over the life of the loan.
−Removed: In connection with the funding of each of the Term
−Removed: 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
−Removed: 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
−Removed: 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
−Removed: of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the execution
−Removed: 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
+Added: Proceeds are being used for working capital purposes and
+Added: to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201
+Added: clinical trial, and the Phase 3 VIKTORIA-2 clinical trial.
+Added: The A&R Loan Agreement contains customary representations and warranties
+Added: and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures.
+Added: 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
+Added: principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 .
+Added: Innovatus will continue
+Added: to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of
+Added: common stock at a price per share of $ 14.40 through April 8, 2031.
+Added: 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
+Added: to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans.
+Added: There is also a contingent
+Added: non-utilization fee for the Term E Loans.
+Added: Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization
+Added: provisions related to the Term D Loan are no longer operative.
+Added: The Term D Loan shall become due and payable on the earliest of (i) the
+Added: termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole
+Added: of the Term Loans.
+Added: If the Company achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term
+Added: 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
+Added: 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
+Added: 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,
+Added: (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.
+Added: After the 18-month anniversary of the Effective
+Added: 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
+Added: Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least
+Added: seven business days prior to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance
+Added: 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
+Added: interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that
+Added: are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past
+Added: At May 30, 2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt
+Added: discount to be amortized over the life of the loan.
+Added: 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
+Added: warrants to purchase that number of shares of the Company’s common stock equal to 2.5 % of the principal amount of the applicable
+Added: 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
+Added: closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding
+Added: the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of
+Added: 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.
−Removed: fair value of the warrants was approximately $ 1.2 million.
−Removed: For the additional Term Loans, the exercise price will be based on the lower
+Added: The relative fair value of the warrants was approximately $ 1.2 million.
+Added: 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
−Removed: Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the applicable Term
−Removed: Loan funding.
−Removed: The Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding
−Removed: The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain
−Removed: proportional adjustments as set forth in such Warrant.
−Removed: The Company evaluated the change of terms under ASC
−Removed: 470-50, “Debt – Modification and Extinguishment”, and concluded the change in terms did not result in significant and
−Removed: consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment
−Removed: Long-term debt consisted of the following at December 31, 2024 and 2023:
−Removed: of Long-term Debt
−Removed: $ 100,000,000
+Added: Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the Term D Loan funding.
+Added: Prior to the Third Amendment, the Company also was required to issue warrants to Innovatus and Oxford in connection with the funding
+Added: of the Term E Loan and the Term F Loan.
+Added: The warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary
+Added: of the applicable funding date.
+Added: The number of shares of common stock for which each warrant is exercisable and the associated exercise
+Added: price are subject to certain proportional adjustments as set forth in such warrant.
+Added: Company evaluated the change of terms under ASC 470-50, Debt – Modification and Extinguishment with respect to the Third
+Added: Amendment, the Second Amendment, the First Amendment and the A&R Loan Agreement and concluded the change in terms did not result
+Added: in significant and consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not
+Added: an extinguishment of the debt.
+Added: payable, non-current consisted of the following (in thousands):
+Added: Schedule of Long-term Debt
+Added: As of December 31,
PIK interest (added to principal)
unamortized debt issuance costs
−Removed: ( 1,613,734 )
unamortized debt discount
−Removed: ( 5,752,418 )
Total long-term debt
−Removed: Future principal payments, including the incurred PIK interest and Final
−Removed: Fee, are as follows:
−Removed: of Long Term Debt Future Principal Payments
−Removed: Years Ending December 31,
−Removed: $ 105,093,288
−Removed: Following the conversion of Celcuity
−Removed: LLC to Celcuity Inc.
−Removed: on September 15, 2017, Celcuity Inc.
−Removed: began filing federal and state returns where required.
−Removed: No income tax benefit
−Removed: was recorded for the years 2024 and 2023, due to net losses and recognition of a valuation allowance.
−Removed: The following table presents a reconciliation
−Removed: of the tax expense computed at the statutory federal rate and the Company’s tax expense for the years ended December 31:
+Added: of December 31, 2025, the fair value of the note payable, which differs from its carrying value, is determined using the Company’s estimated discount rate, volatility and risk-free rate, which are
+Added: considered Level 3 inputs.
+Added: As of December 31, 2025, the fair value of the note payable was $ 160.2 million.
+Added: As of December 31, 2024,
+Added: the carrying value of the note payable approximates the fair value (Level 3 inputs).
+Added: debt issuance costs and discount will be amortized to interest expense over the term of the Notes based on the effective interest rate
+Added: As of December 31, 2025 and 2024, the effective interest rate was 12.7 % and 12.3 %, respectively.
+Added: During the year ended December
+Added: 31, 2025, interest expense related to the note payable was $ 14.4 million, including $ 2.7 million related to discount amortization.
+Added: the year ended December 31, 2024, interest expense related to the note payable was $ 10.3 million, including $ 1.3 million related to discount
+Added: amortization.
+Added: of December 31, 2025, future principal payments, including the incurred PIK interest and Final Fee, are as follows (in thousands):
+Added: Schedule of Long Term Debt Future Principal Payments
+Added: Year Ending December 31,
+Added: of December 31, 2025, the Company was in full compliance with all financial covenants of the Amended A&R Loan Agreement.
+Added: License Agreement
+Added: April 8, 2021, the Company entered into a license agreement with Pfizer Inc.
+Added: (“Pfizer”) to research, develop, manufacture
+Added: and commercialize gedatolisib.
+Added: During 2021, the Company paid $ 5.0 million in upfront fees and
+Added: issued 349,406 shares of the Company’s common stock to Pfizer pursuant to an Equity Grant Agreement.
+Added: Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events,
+Added: up to an aggregate of $ 335.0 million.
+Added: One of these milestone events requires a $ 5.0 million payment within 60 days following the FDA
+Added: regulatory filing of a New Drug Application (“NDA”) for gedatolisib.
+Added: The FDA granted the Company’s request to submit
+Added: its NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and the Company completed its final NDA submission
+Added: to the FDA in November 2025.
+Added: The Company recorded the $ 5.0 million NDA filing milestone as research and development expense in June 2025.
+Added: As of December 31, 2025, this amount was included in other accrued expenses on the Company’s balance sheets.
+Added: Additionally, the
+Added: Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject
+Added: to deductions for expiration of valid patent claims, amounts due under third-party licenses and generic competition.
+Added: Unless earlier terminated,
+Added: the license agreement will expire upon the expiration of all royalty obligations.
+Added: The royalty period will expire on a country-by-country
+Added: basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration
+Added: of all regulatory or data exclusivity in such country for such product, or (c) the date upon which the manufacture, use, sale, offer
+Added: for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement,
+Added: a valid claim of a licensed patent right.
+Added: Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice.
+Added: Pfizer may not terminate
+Added: the agreement for convenience.
+Added: Either the Company or Pfizer may terminate the license agreement if the other party is in material breach
+Added: and such breach is not cured within the specified cure period.
+Added: In addition, either the Company or Pfizer may terminate the license agreement
+Added: in the event of specified insolvency events involving the other party.
+Added: income tax benefit was recorded during the years ended December 31, 2025 and 2024, due to net losses and recognition of a valuation allowance.
+Added: The following table, which reflects the Company’s retrospective adoption of ASU 2023-09, presents a reconciliation of the
+Added: federal statutory rate to the Company’s effective tax rate, including the amount (in thousands):
Schedule of Effective Income Tax Rate Reconciliation
−Removed: Tax benefit at statutory federal rate
−Removed: $ ( 23,474,000 )
−Removed: $ ( 13,394,000 )
+Added: Year Ended December 31,
+Added: Tax benefit at statutory rate
State income tax benefit, net of federal tax effect
−Removed: Change in valuation allowance on deferred tax assets
−Removed: Research & Development Credits
−Removed: ( 1,236,000 )
−Removed: Other permanent items
−Removed: Income tax benefits
−Removed: Deferred income taxes reflect the net effects of temporary differences
−Removed: between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
−Removed: The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences.
−Removed: In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset the net deferred tax
−Removed: asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets
−Removed: at December 31, 2024.
−Removed: The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred
−Removed: tax assets are at December 31:
+Added: Federal change in valuation allowance on deferred tax assets
+Added: Federal research and development credits
+Added: Prior year adjustments
+Added: Non-deductible items
+Added: Income tax expense (benefit)
+Added: July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted, introducing a series of corporate tax changes in the
+Added: U.S., including 100% bonus depreciation on qualified property and full expensing of domestic research and development expenditures.
+Added: The impacts of OBBBA are reflected in our results of operations during the year ended December 31, 2025.
+Added: OBBBA did not have a
+Added: material impact on the Company’s effective income tax rate and its net deferred tax assets as the Company maintains a full
+Added: valuation allowance.
+Added: tax assets (liabilities) reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for
+Added: financial reporting purposes and the amounts used for income tax purposes.
+Added: The Company’s deferred tax assets relate primarily to
+Added: its net operating loss carryforwards and other balance sheet basis differences.
+Added: In accordance with ASC 740, Income Taxes , the
+Added: Company recorded a valuation allowance to fully offset the net deferred tax assets as of December 31, 2025 and 2024, because it is more
+Added: likely than not that the Company will not realize future benefits associated with these deferred tax assets.
+Added: The tax effects of temporary
+Added: differences and carryforwards that give rise to significant portions of the deferred tax assets (liabilities) were (in thousands):
Schedule of Deferred Tax Assets and Liabilities
−Removed: Deferred tax assets (liabilities):
+Added: As of December 31,
+Added: Gross deferred tax assets (liabilities):
Accrued expenses
−Removed: Share-based compensation
+Added: Stock-based compensation
Property and equipment
Right-of-use assets
−Removed: Lease liability
−Removed: IRC 174 Expenditures
+Added: Lease liabilities
+Added: Section 174 expenditures
Start-up expenditures
Net operating losses and tax credits
+Added: Deferred tax assets before valuation allowance
Valuation allowance
−Removed: ( 60,214,000 )
−Removed: ( 36,133,000 )
Net deferred tax assets
−Removed: At December 31, 2024, the Company had federal and
−Removed: state net operating loss carryforwards of approximately $ 43.2 million and $ 0.8 million, respectively.
−Removed: The federal and state net operating
−Removed: loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037.
−Removed: The federal net operating loss carryforwards starting
−Removed: in 2018 have no expiration.
−Removed: These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December
−Removed: At December 31, 2024, the Company had federal and
−Removed: state research and development tax credit carryforwards resulting in deferred tax assets of approximately $ 2.9 million and $ 1.6 million,
−Removed: respectively.
−Removed: The federal and state credit carryforwards will begin to expire in the years ending December 31, 2038 and December 31, 2033,
−Removed: respectively.
−Removed: These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December 31, 2023.
−Removed: Under the provisions of Section 382 of the Internal
−Removed: Revenue Code of 1986, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes
−Removed: in ownership due to sales of equity, may limit in the future the amount of net operating loss carryforwards available to offset future
−Removed: taxable income.
−Removed: The Company recognizes uncertain tax positions in
−Removed: accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that the tax positions will be sustained upon examination
−Removed: by tax authorities.
−Removed: For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount
−Removed: of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
−Removed: As of December 31, 2024, and 2023, the Company
−Removed: has no significant uncertain tax positions.
−Removed: There are no unrecognized tax benefits included on the balance sheet that would, if recognized,
−Removed: impact the effective tax rate.
−Removed: The Company does not anticipate there will be a significant change in unrecognized tax benefits within
−Removed: the next 12 months.
−Removed: Prior to the conversion, Celcuity was a limited liability
−Removed: company and therefore was taxed as a partnership for income tax purposes.
−Removed: Accordingly, no benefit for income taxes was recorded prior
−Removed: to the conversion.
−Removed: For years prior to 2021, the Company is no longer
−Removed: subject to U.S.
−Removed: federal or state income tax examinations and remains open for the unutilized tax attributes as of December 31, 2024, carried
−Removed: forward from these years.
−Removed: The Company’s policy is to recognize interest and penalties related to uncertain tax positions as a component
−Removed: of general and administrative expenses.
−Removed: Subsequent Event
−Removed: January 2025, the Board of Directors approved a repricing of certain outstanding stock options previously granted to employees.
−Removed: the repricing date, the exercise prices of these options were reduced to $ 11.92 per share, from their previous exercise prices ranging
−Removed: from $ 12.80 to $ 18.73 per share.
−Removed: This adjustment was made in response to the decline in the company’s stock price, with the intent
−Removed: of retaining and motivating key employees.
−Removed: As a result of this repricing, approximately 837,000 stock options held by 44 employees were
−Removed: The repriced options will continue to vest according to their original schedule.
−Removed: March 2025, an investor exercised 695,650 warrants at an exercise price of $ 8.05 , which generated approximately $ 5.6 million in cash.
−Removed: The warrants were issued pursuant to a private placement that closed and was funded on December 9, 2022.
−Removed: Changes in and Disagreements With Accountants on Accounting
−Removed: and Financial Disclosure
+Added: of December 31, 2025, the Company had federal and state net operating loss carryforwards of $ 83.3 million and $ 4.8 million, respectively.
+Added: The federal and state net operating loss carryforwards for 2017 will begin to expire during the year ending December 31, 2037.
+Added: net operating loss carryforwards starting in 2018 have no expiration.
+Added: These deferred tax assets were subject to a full valuation allowance
+Added: as of December 31, 2025 and 2024.
+Added: of December 31, 2025, the Company had federal and state research and development tax credit carryforwards resulting in deferred tax assets
+Added: of $ 4.3 million and $ 2.0 million, respectively.
+Added: The federal and state credit carryforwards will begin to expire during the years ending
+Added: December 31, 2038 and December 31, 2033, respectively.
+Added: These deferred tax assets were subject to a full valuation allowance as of December
+Added: 31, 2025 and 2024.
+Added: the provisions of Section 382 of the Internal Revenue Code of 1986, certain substantial changes in the Company’s ownership, including
+Added: a sale of the Company, or significant changes in ownership due to sales of equity, may limit in the future the amount of net operating
+Added: loss carryforwards available to offset future taxable income.
+Added: Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that
+Added: the tax positions will be sustained upon examination by tax authorities.
+Added: For those tax positions that meet the more-likely-than not recognition
+Added: threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate
+Added: As of December 31, 2025 and 2024, the Company had no significant uncertain tax positions.
+Added: There are no unrecognized tax benefits
+Added: included on the balance sheets that would, if recognized, impact the effective tax rate.
+Added: The Company does not anticipate there will be
+Added: a significant change in unrecognized tax benefits within the next 12 months.
+Added: The Company is no longer subject to U.S.
+Added: federal income
+Added: tax examinations for years before 2022, although carryforward attributes that were generated before 2022 may still be adjusted upon examination
+Added: if used in a future period.
+Added: State income tax statutes vary by jurisdiction.
+Added: In most states in which the Company operates, the statute
+Added: of limitations remains open for four years, and accordingly, the Company is generally no longer subject to state income tax examinations
+Added: for years before 2021.
+Added: The Company’s policy is to recognize interest and penalties related to uncertain tax
+Added: positions as a component of general and administrative expenses.
+Added: As of December 31, 2025, the Company had no accrued interest or penalties
+Added: and no amounts were recognized in the statements of operations.
+Added: the years ended December 31, 2025 and 2024, the Company made state tax payments which were deemed immaterial.
+Added: Subsequent Events
+Added: January 9, 2026, the Company filed a new registration statement and accompanying prospectus supplement, which increased the aggregate
+Added: offering amount under the Open Market Sale Agreement to $ 400.0 million.
+Added: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.