Financial Statements and Supplementary Data
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
the Board of Directors and
−Removed: of Celcuity Inc.
+Added: Stockholders of Celcuity Inc.
on the Financial Statements
17 unchanged sentences
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
−Removed: and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts
−Removed: and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates
−Removed: made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audits provide a
−Removed: reasonable basis for our opinion.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits,
+Added: we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
Audit Matters
4 unchanged sentences
have served as the Company’s auditor since 2017.
−Removed: FINANCIAL INFORMATION
−Removed: Financial Statements
+Added: March 31, 2025
+Added: Celcuity Inc.
+Added: Balance Sheets
December 31, 2024
11 unchanged sentences
Accounts payable
−Removed: Finance lease liabilities
Operating lease liabilities
8 unchanged sentences
2,500,000 shares authorized;
−Removed: 854,134 and 1,120,873 shares issued and outstanding as of December 31, 2023 and 2022, respectively
−Removed: Common stock, $ 0.001 par value:
−Removed: 65,000,000 shares authorized as of December 31, 2023 and 2022, respectively;
−Removed: 25,506,012 and 21,667,250 shares issued and outstanding as of December 31, 2023 and 2022, respectively
+Added: 317,577 and 854,134 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
+Added: Common stock, $ 0.001 par
+Added: 95,000,000 and 65,000,000 shares
+Added: authorized as of December 31, 2024 and December 31, 2023, respectively;
+Added: 37,143,242 and 25,506,012
+Added: shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
Additional paid-in capital
6 unchanged sentences
$ 191,219,398
−Removed: accompanying notes to the financial statements
−Removed: of Operations
−Removed: Years Ended December 31,
+Added: See accompanying notes to the financial statements
+Added: Celcuity Inc.
+Added: Statements of Operations
+Added: Twelve Months Ended December 31,
Operating expenses:
Research and development
+Added: $ 104,203,230
General and administrative
3 unchanged sentences
( 66,230,331 )
−Removed: Other income (expense)
+Added: Other (expense) income
Interest expense
2 unchanged sentences
Interest income
−Removed: Other income (expense), net
+Added: Other income, net
Net loss before income taxes
6 unchanged sentences
Weighted average common shares outstanding, basic and diluted
−Removed: accompanying notes to the financial statements
−Removed: of Changes in Stockholders’ Equity
+Added: See accompanying notes to the financial statements
+Added: Celcuity Inc.
+Added: Statements of Changes in Stockholders’ Equity
Preferred Stock
2 unchanged sentences
$ ( 96,296,887 )
+Added: $ 133,771,467
Stock-based compensation
+Added: Conversion of preferred to common stock
Employee stock purchases
Exercise of common stock options, net of shares withheld for exercise price
−Removed: Issuance of common and preferred stock upon closing of private placement offering
+Added: Exercise of common stock warrants
Issuance costs associated with private placement offering
−Removed: ( 4,316,534 )
−Removed: ( 4,316,534 )
Issuance of common stock in an ATM offering
Issuance costs associated with an ATM offering
+Added: Issuance of pre-funded warrants
+Added: Issuance costs associated with pre-funded warrants
( 63,779,116 )
11 unchanged sentences
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
+Added: Exercise of common stock warrants, net of shares withheld for exercise price
Issuance of common stock in an ATM offering
Issuance costs associated with an ATM offering
−Removed: Issuance of pre-funded warrants
−Removed: Issuance costs associated with pre-funded warrants
+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
( 111,779,105 )
7 unchanged sentences
$ 115,619,035
−Removed: accompanying notes to the financial statements
−Removed: of Cash Flows
−Removed: Years Ended December 31,
+Added: See accompanying notes to the financial statements
+Added: Celcuity Inc.
+Added: Statements of Cash Flows
+Added: Twelve Months Ended December 31,
Cash flows from operating activities:
4 unchanged sentences
Amortization of debt issuance costs and discount
+Added: Payment-in-Kind interest
Non-cash operating lease, net
3 unchanged sentences
( 3,438,018 )
−Removed: ( 5,526,381 )
Accounts payable
16 unchanged sentences
Proceeds from employee stock purchases
−Removed: Proceeds from a private placement offering, net of discounts and offering costs
−Removed: Proceeds from note payable, net of debt issuance and discount costs
−Removed: Proceeds from an ATM offering, net of commission fees and offering costs
+Added: Proceeds from follow-on offering, net of underwriting discounts and offering costs
+Added: Proceeds from note payable, net of debt issuance costs and discount of $ 2,437,644
+Added: Proceeds from an ATM offering, net of issuance costs
Proceeds from pre-funded warrants, net of offering costs
13 unchanged sentences
Property and equipment included in accounts payable
−Removed: accompanying notes to the financial statements
−Removed: TO FINANCIAL STATEMENTS
−Removed: Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company pursuing development for oncology.
−Removed: The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor.
−Removed: Its mechanism of action and pharmacokinetic
−Removed: properties are highly 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
−Removed: with HR+/HER2- advanced breast cancer is currently enrolling patients.
−Removed: A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib
−Removed: in combination with darolutamide in patients with metastatic castration resistant prostate cancer, was initiated in the first quarter
−Removed: of 2024 and is currently enrolling patients.
−Removed: The Company’s CELsignia companion diagnostic platform is uniquely able to analyze
−Removed: live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.
−Removed: was co-founded in 2012 by Brian F.
+Added: Common stock warrants issued with the note payable transaction
+Added: See accompanying notes to the financial statements
+Added: CELCUITY INC.
+Added: NOTES TO FINANCIAL STATEMENTS
+Added: Nature of Business
+Added: Celcuity Inc., a Delaware corporation (the “Company”) is a
+Added: clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications.
+Added: The Company’s lead therapeutic candidate is gedatolisib, a potent, well-tolerated, small molecule reversible inhibitor, administered
+Added: intravenously, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase (“PI3K”) and the two mechanistic
+Added: targets of rapamycin (“mTOR”) sub-complexes, mTORC1 and mTORC2.
+Added: Gedatolisib’s mechanism of action and pharmacokinetic
+Added: properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
+Added: A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with
+Added: HR+/HER2- advanced breast cancer is currently enrolling patients.
+Added: Site selection and activation activities for a Phase 3 clinical trial,
+Added: VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2-
+Added: advanced breast cancer has commenced.
+Added: The first patient is expected to be dosed in the second quarter of 2025.
+Added: A Phase 1b/2 clinical trial,
+Added: CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer,
+Added: is currently underway.
+Added: The Company was co-founded in 2012 by Brian F.
Sullivan and Dr.
Laing and is based in Minnesota.
−Removed: The Company has not generated any revenues
+Added: has not generated any revenues to date.
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
−Removed: of Presentation
−Removed: accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
−Removed: GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
−Removed: Operating results for the year ended December 31, 2023 are not necessarily indicative of results to be expected for any future year.
−Removed: uses estimates and assumptions in preparing these financial statements in accordance with U.S.
−Removed: Those estimates and assumptions
−Removed: affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues
−Removed: and expenses.
−Removed: Actual results could differ from those estimates and the difference could be significant.
−Removed: Significant items subject to
−Removed: such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.
−Removed: and Cash Equivalents
−Removed: Company maintains its accounts at two financial institutions.
−Removed: At times throughout the year, the Company’s cash balances may exceed
−Removed: amounts insured by the Federal Deposit Insurance Corporation.
−Removed: At December 31, 2023 and December 31, 2022, the Company had $ 30,662,774
−Removed: and $ 24,571,557 , respectively, in business checking accounts and money market funds that are considered cash equivalents and not insured
−Removed: by the Federal Deposit Insurance Corporation.
−Removed: Company maintains its investments in U.S.
−Removed: governmental agency securities and U.S.
−Removed: treasury bills and has classified them as held-to-maturity
−Removed: at the time of purchase.
−Removed: Held-to-maturity purchases are those securities in which the Company has the ability and intent to hold until
−Removed: Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums and discounts.
−Removed: Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security using a straight-line method.
−Removed: The difference between the carrying value, which is based on cost, and the aggregate fair value of the held-to-maturity securities, was
−Removed: immaterial as of December 31, 2023.
−Removed: At December 31, 2023 and December 31, 2022, the Company had $ 149,919,974 and $ 144,015,954 , respectively,
−Removed: of short-term investments.
−Removed: and Equipment
−Removed: and equipment are stated at cost.
−Removed: Depreciation is provided over estimated useful lives using the straight-line method.
−Removed: Maintenance and
−Removed: repairs are expensed as incurred;
−Removed: major improvements and betterments are capitalized.
−Removed: useful lives of property and equipment are as follows for the major classes of assets:
+Added: Basis of Presentation
+Added: The accompanying financial statements
+Added: have been prepared in accordance with accounting principles generally accepted in the United States (“U.S.
+Added: GAAP”) and pursuant
+Added: to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
+Added: Operating results for the year ended December
+Added: 31, 2024 are not necessarily indicative of results to be expected for any future year.
+Added: Accounting Estimates
+Added: Management uses estimates and assumptions in preparing these
+Added: financial statements in accordance with U.S.
+Added: Those estimates and assumptions affect the reported amounts of assets and liabilities,
+Added: the disclosure of contingent assets and liabilities, and the reported revenues and expenses.
+Added: Actual results could differ from those estimates
+Added: and the difference could be material.
+Added: Significant items subject to such estimates and assumptions include the valuation of stock-based
+Added: compensation and prepaid or accrued clinical trial costs.
+Added: Cash and Cash Equivalents
+Added: The Company maintains its accounts at two financial institutions.
+Added: At times throughout the year, the Company’s cash balances may exceed amounts insured by the Federal Deposit Insurance Corporation.
+Added: At December 31, 2024 and December 31, 2023, the Company had $ 22,514,823 and $ 30,662,774 , respectively, in business checking accounts and
+Added: money market funds that are considered cash equivalents and not insured by the Federal Deposit Insurance Corporation.
+Added: The Company maintains its investments in U.S.
+Added: governmental agency
+Added: securities and U.S.
+Added: treasury bills and has classified them as held-to-maturity at the time of purchase.
+Added: Held-to-maturity purchases are
+Added: those securities in which the Company has the ability and intent to hold until maturity.
+Added: Held-to-maturity securities are recorded at amortized
+Added: cost, adjusted for the amortization or accretion of premiums and discounts.
+Added: Premiums and discounts are amortized or accreted over the
+Added: life of the related held-to-maturity security using a straight-line method.
+Added: The difference between the carrying value, which is based
+Added: on cost, and the aggregate fair value of the held-to-maturity securities, was immaterial as of December 31, 2024.
+Added: At December 31, 2024
+Added: and December 31, 2023, the Company had $ 212,588,960 and $ 149,919,974 , respectively, of short-term investments.
+Added: Property and Equipment
+Added: Property and equipment are stated at cost.
+Added: Depreciation is provided
+Added: over estimated useful lives using the straight-line method.
+Added: Maintenance and repairs are expensed as incurred;
+Added: major improvements and betterments
+Added: are capitalized.
+Added: Estimated useful lives of property and equipment are as follows for the
+Added: major classes of assets:
Schedule of Estimated Useful Lives of Property and Equipment
Asset Description
−Removed: Estimated Lives
Furniture and Equipment
Leasehold Improvements
−Removed: assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying
−Removed: amount of an asset may not be recoverable.
−Removed: If circumstances require a long-lived asset or asset group be tested for possible impairment,
−Removed: the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value.
−Removed: carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized
−Removed: to the extent that the carrying value exceeds its fair value.
−Removed: Fair value is determined through various valuation techniques including
−Removed: discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary.
−Removed: Transaction Costs
−Removed: transaction costs in 2022 primarily consist of legal fees that are capitalized as incurred and will be offset against the proceeds
−Removed: from future ATM offerings.
−Removed: The deferred transaction costs will be reviewed periodically to assess the probability that future
−Removed: securities will be offered.
−Removed: In the event that no future offering will occur, any deferred transaction costs will be expensed.
−Removed: costs incurred, but not accounted for as a reduction in equity, were $ 0
−Removed: and $ 33,195 as
−Removed: of December 31, 2023 and 2022, respectively.
−Removed: Comprehensive
−Removed: Comprehensive
−Removed: loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other
−Removed: than those with stockholders.
−Removed: For all periods presented, there was no difference between net loss and comprehensive loss.
−Removed: and Uncertainties
−Removed: Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and
−Removed: commercial success of its initial drug product, gedatolisib, the clinical and commercial success of its diagnostic tests, ability to
−Removed: obtain regulatory approval for gedatolisib and its diagnostic tests, the need for substantial additional financing to achieve its goals,
−Removed: uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition.
−Removed: Value of Financial Instruments
−Removed: Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the
−Removed: financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair
−Removed: value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
−Removed: The hierarchy gives the highest priority
−Removed: to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements
−Removed: involving significant unobservable inputs (Level 3 measurements).
+Added: Long-Lived Assets
+Added: Long-lived assets, such as property and equipment, are reviewed for impairment
+Added: whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
+Added: If circumstances require
+Added: a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be
+Added: generated by that asset or asset group to its carrying value.
+Added: If the carrying value of the long-lived asset or asset group is not recoverable
+Added: on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value.
+Added: is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent
+Added: appraisals, as considered necessary.
+Added: Deferred Transaction Costs
+Added: Deferred transaction costs primarily consist of legal fees that are capitalized
+Added: as incurred and will be offset against the proceeds from future equity financing arrangements.
+Added: The deferred transaction costs will be
+Added: reviewed periodically to assess the probability that future securities will be offered.
+Added: In the event that no future offering will occur,
+Added: any deferred transaction costs will be expensed.
+Added: Total costs incurred, but not accounted for as a reduction in equity, were $ 235,379 and
+Added: $ 0 as of December 31, 2024 and 2023, respectively.
+Added: Debt Issuance Costs
+Added: The Company recognizes debt issuance costs as deferred costs, which are
+Added: capitalized and amortized over the term of the related debt using the effective interest method.
+Added: These costs primarily consist of fees,
+Added: commissions, legal, and other costs directly attributable to securing debt financing.
+Added: Debt issuance costs are reported as a direct reduction
+Added: of the carrying amount of the related debt on the balance sheets.
+Added: Amortization of these costs is recorded as interest expense in the statements
+Added: of operations over the life of the debt instrument.
+Added: Comprehensive Loss
+Added: Comprehensive loss includes net loss as well as other changes in stockholders’
+Added: equity that result from transactions and economic events other than those with stockholders.
+Added: For all periods presented, there was no difference
+Added: between net loss and comprehensive loss.
+Added: Risks and Uncertainties
+Added: The Company is subject to risks common to companies in the development
+Added: stage including, but not limited to, dependency on the clinical and commercial success of its initial drug product, gedatolisib, the ability
+Added: to obtain regulatory approval for gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad
+Added: adoption of its approved products, if any, by physicians and consumers, and significant competition.
+Added: Fair Value of Financial Instruments
+Added: The Company’s accounting for fair value measurements of
+Added: assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis
+Added: adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation
+Added: techniques used to measure fair value.
+Added: The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
+Added: assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level
+Added: 3 measurements).
The three levels of the fair value hierarchy are as follows:
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
−Removed: indirectly, 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
−Removed: available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement
−Removed: level in the fair value hierarchy within which a fair value measurement in its entirety falls, is based on the lowest level input that
−Removed: is significant to the fair value measurement in its entirety.
−Removed: carrying values of cash equivalents, accounts payable, accrued expenses and other financial working capital items approximate fair value
−Removed: at December 31, 2023 and December 31, 2022, due to the short maturity nature of these items.
−Removed: Company accounts for income taxes using the asset and liability method, as required by the accounting standard for income taxes.
−Removed: this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
−Removed: financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss
−Removed: and tax credit carryforwards.
−Removed: Deferred taxes are measured using enacted tax rates expected to apply to taxable income in the years in
−Removed: 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
−Removed: in results of operations in the period that includes the enactment date.
−Removed: The effects of any future changes in tax laws or rates have
−Removed: not been considered.
−Removed: The Company regularly reviews deferred tax assets to assess their potential realization and establish a valuation
−Removed: 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
−Removed: the deferred tax assets will be realized.
−Removed: Company recognizes the impact of an uncertain tax position in its financial statements if, in management’s judgment, the position
−Removed: is more-likely-than-not sustainable upon audit based on the position’s technical merits.
−Removed: This involves the identification of potential
−Removed: uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position
−Removed: is necessary.
−Removed: Company’s stock-based compensation consists of stock options and restricted stock issued to certain employees and nonemployees
−Removed: of the Company and the Company’s 2017 Employee Stock Purchase Plan.
−Removed: The Company recognizes compensation expense based on an estimated
−Removed: grant date fair value using the Black-Scholes option-pricing method.
−Removed: If the factors change and different assumptions are used, the Company’s
−Removed: stock-based compensation expense could be materially different in the future.
−Removed: The Company recognizes stock-based compensation expense
−Removed: for these options on a straight-line basis over the requisite service period.
−Removed: The Company has elected to account for forfeitures as they
−Removed: and Development
−Removed: and development costs are expensed as incurred.
−Removed: Research and development costs amounted to $ 60,594,005 , for the year ended December 31,
−Removed: 2023 and $ 35,289,548 , for the year ended December 31, 2022.
−Removed: Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service
−Removed: providers, which includes the conduct of preclinical studies and clinical trials.
−Removed: These costs can be a significant component of the
−Removed: Company’s research and development expenses.
−Removed: The Company primarily relies on a compilation of progress reports from
−Removed: third-party service providers, including the respective invoicing, to record actual expenses, along with determining changes to
−Removed: prepaid assets and accrued liabilities.
−Removed: To date, the Company believes utilization of third-party reports most accurately reflects
−Removed: expenses incurred.
−Removed: As the current VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials ramp up site activation and patient
−Removed: enrollment, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates,
−Removed: and these estimates may become more significant.
−Removed: Changes in these estimates that result in material changes to the Company’s
−Removed: prepaid assets or accrued expenses could materially affect the Company’s results of operations.
−Removed: Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.
−Removed: on the Company’s cash and cash equivalents and short-term investments on hand at December 31, 2023 of $ 30,662,774 and $ 149,919,974 ,
−Removed: respectively, the Company believes that its cash and short-term investments will be sufficient to fund the Company’s current operating
−Removed: plan through at least the next 12 months from the issuance date of this Annual Report.
+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 for the asset or liability used to measure fair value to the extent that observable inputs are not available,
+Added: thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date.
+Added: The level in the fair value hierarchy within which a fair value
+Added: measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety.
+Added: The carrying values of cash equivalents, accounts payable, accrued
+Added: expenses and other financial working capital items approximate fair value at December 31, 2024 and December 31, 2023, due to the short
+Added: maturity nature of these items.
+Added: The Company accounts for income taxes using the asset and liability method,
+Added: as required by the accounting standard for income taxes.
+Added: Under this method, deferred tax assets and liabilities are recognized for the
+Added: future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
+Added: and their respective tax bases, as well as net operating loss and tax credit carryforwards.
+Added: Deferred taxes are measured using enacted
+Added: tax rates expected to apply to taxable income in the years in 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 in results of operations in the period that includes the enactment
+Added: The effects of any future changes in tax laws or rates have not been considered.
+Added: The Company regularly reviews deferred tax assets
+Added: to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if
+Added: the Company does not consider it to be more likely than not that the deferred tax assets will be realized.
+Added: The Company recognizes the impact of an uncertain tax position in its financial
+Added: statements if, in management’s judgment, the position is more-likely-than-not sustainable upon audit based on the position’s
+Added: technical merits.
+Added: This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an
+Added: assessment of whether a liability for an uncertain tax position is necessary.
+Added: Stock-Based Compensation
+Added: The Company’s stock-based compensation consists of stock
+Added: options and restricted stock issued to certain employees and non-employees of the Company and the Company’s 2017 Employee Stock
+Added: Purchase Plan.
+Added: The Company recognizes compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing
+Added: method for equity-based awards and the Monte Carlo simulation model for performance-based awards.
+Added: If the factors change and different
+Added: assumptions are used, the Company’s stock-based compensation expense could be materially different in the future.
+Added: The Company recognizes
+Added: stock-based compensation expense for these options on a straight-line basis over the requisite service period.
+Added: The Company has elected
+Added: to account for forfeitures as they occur.
+Added: Research and Development
+Added: Research and development costs are expensed as incurred.
+Added: Research and development
+Added: costs amounted to $ 104,203,230 for the year ended December 31, 2024 and $ 60,594,005 for the year ended December 31, 2023.
+Added: Clinical Trial Costs
+Added: The Company relies on third parties to conduct
+Added: certain aspects of clinical studies and to formulate and manufacture our drug product.
+Added: While there are alternative vendors that can
+Added: perform these functions, any disruption or delay by the Company’s current third parties in carrying out their contractual
+Added: duties could delay the clinical trials.
+Added: The Company records prepaid assets or accrued expenses for prepaid or estimated clinical
+Added: trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials.
+Added: costs can be a significant component of the Company’s research and development expenses.
+Added: The Company primarily relies on a
+Added: compilation of progress reports from third-party service providers, including the respective invoicing, to record actual expenses,
+Added: along with determining changes to prepaid assets and accrued liabilities.
+Added: To date, the Company believes utilization of third-party
+Added: reports most accurately reflects expenses incurred.
+Added: With the ongoing VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial,
+Added: and the commencement of the VIKTORIA-2 Phase 3 clinical trial site activation and patient enrollment anticipated in Q2 2025 ,
+Added: the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these
+Added: estimates may become more significant.
+Added: Changes in these estimates that result in material changes to the Company’s prepaid
+Added: assets or accrued expenses could materially affect the Company’s results of operations and financial position.
+Added: In November 2023, the FASB issued ASU 2023-07:
+Added: Improvements to Reportable
+Added: Segment Disclosures.
+Added: This ASU, which amends Topic 280:
+Added: Segment Reporting, improves disclosure requirements for reportable segments
+Added: and enhances disclosures for companies with single reportable segments.
+Added: The Company has a single reportable segment based on the nature
+Added: of its operations.
+Added: The nature of business and the accounting policies of the segment are the same as described throughout Notes 1 and
+Added: The Company’s Chief Operating Decision Maker (“CODM”) is its executive team.
+Added: The CODM assesses the reportable segment’s performance
+Added: and allocates resources for the reportable segment based on net income and total assets, which are the same amounts in all material respects
+Added: as those reported on the statements of operations and balance sheets.
+Added: The Company adopted the standard on January 1, 2024.
+Added: did not have a material impact on the Company’s financial statements.
+Added: Based on the Company’s cash and cash equivalents and short-term investments
+Added: 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
+Added: will be sufficient to fund the Company’s current operating plan through at least the next 12 months from the issuance date of this
+Added: Annual Report.
Net Loss Per Common Share
−Removed: and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average
−Removed: common shares outstanding during the period.
−Removed: For all periods presented, the common shares underlying the preferred stock, options, warrants,
−Removed: and restricted stock have been excluded from the calculation because their effect would be anti-dilutive.
−Removed: Therefore, the weighted-average
−Removed: shares outstanding used to calculate both basic and diluted loss per common share are the same.
−Removed: following table summarizes the potentially-dilutive shares excluded from the diluted weighted-average shares outstanding:
+Added: Basic and diluted net loss per common share is determined by dividing net
+Added: loss attributable to common stockholders by the weighted-average common shares outstanding during the period.
+Added: For all periods presented,
+Added: the common shares underlying the preferred stock, options, warrants, and restricted stock have been excluded from the calculation because
+Added: their effect would be anti-dilutive.
+Added: Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss
+Added: per common share are the same.
+Added: The following table summarizes the potentially-dilutive shares excluded
+Added: from the diluted weighted-average shares outstanding:
Schedule of Potentially-Dilutive Shares Excluded from the Diluted Weighted-Average Shares Outstanding
4 unchanged sentences
Restricted common stock
−Removed: warrant shares of 5,747,787 are included in the computation of basic and diluted net loss per share for the year ended December 31, 2023,
−Removed: as the pre-funded warrants are issuable for nominal consideration.
−Removed: accordance with ASU 2021-04, for purposes of calculating basic and diluted net loss per share for the year ended December 31, 2022, the
−Removed: reported net loss was increased by approximately $ 272,000 related to the deemed dividend resulting from the amendment to the warrant
−Removed: agreement as further discussed in Note 10.
−Removed: This adjustment increased the basic and diluted net loss per share by $ 0.02 for the year ending
−Removed: December 31, 2022.
−Removed: following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of December 31, 2023 and 2022:
+Added: Anti-dilutive securities excluded from
+Added: diluted weighted- average shares outstanding
+Added: Pre-funded warrant shares of 5,747,787 are included in the computation
+Added: 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
+Added: consideration.
+Added: The following table summarizes the Company’s held-to-maturity investment
+Added: securities at amortized cost as of December 31, 2024 and 2023:
Schedule of Investment
2 unchanged sentences
Gross Unrealized Holding Losses
+Added: Estimated Fair Value
December 31, 2024
2 unchanged sentences
Gross Unrealized Holding Losses
+Added: Estimated Fair Value
Treasury Bills
6 unchanged sentences
Gross Unrealized Holding Losses
+Added: Estimated Fair Value
December 31, 2023
2 unchanged sentences
Gross Unrealized Holding Losses
−Removed: Governmental Agency Securities
−Removed: Treasury Notes
+Added: Estimated Fair Value
+Added: Treasury Bills
$ 149,919,974
$ 149,950,969
−Removed: fair value of the Company’s held-to-maturity debt securities are determined based upon inputs, other than the quoted prices in
−Removed: active markets, that are observable either directly or indirectly, and are classified as level 2 fair value instruments.
+Added: $ 149,919,974
+Added: $ 149,950,969
+Added: The fair value of the Company’s held-to-maturity debt securities
+Added: is determined based upon inputs, other than the quoted prices in active markets, that are observable either directly or indirectly, and
+Added: are classified as Level 2 fair value instruments.
Other Current Assets
−Removed: current assets consisted of the following at December 31:
+Added: Other current assets consisted of the following at
Schedule of Other Current Assets
−Removed: Prepaid clinical trial
+Added: Prepaid clinical trial costs
Miscellaneous receivable
−Removed: Prepaid directors & officers’ insurance
−Removed: Prepaid research & development
+Added: Directors & officers’ insurance
Property and Equipment
−Removed: and equipment consisted of the following at December 31:
+Added: Property and equipment consisted of the following
+Added: at December 31:
Summary of Property and Equipment
5 unchanged sentences
( 1,861,990 )
−Removed: expense was $ 142,772 and $ 210,918 for the years ended December 31, 2023 and 2022, respectively.
+Added: Depreciation expense
+Added: was $ 129,947 and $ 142,772 for the years ended December 31, 2024 and 2023, respectively.
Accrued Expenses
−Removed: expenses consisted of the following at December 31:
+Added: Accrued expenses consisted of the following at December
Schedule of Accrued Expenses
2 unchanged sentences
Employee stock purchase plan
−Removed: and Finance Leases
−Removed: The Company leases its corporate space in Minneapolis, Minnesota, with
−Removed: an operating lease in place through April 30, 2026.
−Removed: The lease provides for monthly rent, real estate taxes, and operating expenses.
−Removed: expense is recorded on a straight-line basis over the lease term.
−Removed: In March 2023, the Company signed the fourth amendment to extend this
−Removed: lease through April 30, 2026.
+Added: Operating and Finance Leases
+Added: The Company leases its corporate space in Minneapolis,
+Added: Minnesota, with an operating lease in place through April 30, 2026.
+Added: The lease provides for monthly rent, real estate taxes, and operating
+Added: Rent expense is recorded on a straight-line basis over the lease term.
+Added: In March 2023, the Company signed the fourth amendment
+Added: to extend this lease through April 30, 2026.
This amendment provides for monthly rent, real estate taxes and operating expenses.
−Removed: The Company recorded
−Removed: an incremental $355,578 in the operating right-of-use (“ROU”) asset and lease liability pertaining to this amendment.
−Removed: May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term.
−Removed: The underlying
−Removed: assets are included in furniture and equipment.
−Removed: The lease contains a bargain purchase option at the end of the lease.
−Removed: The finance lease
−Removed: expired in May 2023 and the equipment was acquired for the bargain purchase option price.
−Removed: an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement
−Removed: date in determining the present value of the lease payments.
−Removed: balance sheet information consisted of the following at December 31, 2023:
+Added: In May 2018, the Company entered into a non-cancelable finance
+Added: lease agreement for office equipment with a five-year term.
+Added: The underlying assets are included in furniture and equipment.
+Added: The lease contains
+Added: a bargain purchase option at the end of the lease.
+Added: The finance lease expired in May 2023 and the equipment was acquired for the bargain
+Added: purchase option price.
+Added: When an implicit rate is not provided, the Company uses its
+Added: incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease
+Added: Supplemental balance sheet information consisted of the following at December
Schedule of Supplemental Balance Sheet Information Related to Leases
4 unchanged sentences
Long term portion
−Removed: analysis under lease agreements consisted of the following as of December 31, 2023:
+Added: Maturity analysis under lease agreements consisted of the following as
+Added: of December 31, 2024:
Schedule of Maturity Analysis Under Lease Agreements
4 unchanged sentences
Weighted Average
+Added: Remaining Lease Term
Discount Rate
5 unchanged sentences
Variable lease cost
−Removed: cash flow information related to leases period ended December 31:
+Added: Supplemental cash flow information related to leases for the period ended December 31:
Schedule of Supplemental Cash Flow Information Related to Leases
5 unchanged sentences
included in operating and finance leases
−Removed: Research Studies
−Removed: Company enters into contracts in the normal course of business to conduct research and development programs internally and through
−Removed: third parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s.
−Removed: currently has three Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia
−Removed: Timing of milestone payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for
−Removed: termination following a certain period after notice, therefore the Company believes that non-cancelable obligations under the
−Removed: agreements are not material.
−Removed: The Company also has a license agreement in place with Pfizer to research, develop, manufacture and
−Removed: commercialize gedatolisib.
−Removed: In conjunction with the license agreement, the Company continued a Phase 1b study – B2151009
−Removed: related to gedatolisib.
−Removed: These patients subsequently transitioned to an Expanded Access study – CELC-G-001.
−Removed: Contracts related
−Removed: to the Phase 1B study and the Expanded Access study, are generally based on time and material.
−Removed: In addition, contracts related to the
−Removed: Company’s Phase 3 clinical study (VIKTORIA-1) and Phase 1b/2 clinical study (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the
−Removed: Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain
−Removed: cancelation charges, if any, as defined in each of the respective agreements.
−Removed: In addition, these agreements may, from time to time,
−Removed: be subjected to amendments as a result of any change orders executed by the parties.
−Removed: As of December 31, 2023, the Company had two
−Removed: material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately $ 2.1
+Added: Clinical Research Studies
+Added: The Company enters into contracts in the normal course of business to conduct
+Added: research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants,
+Added: CMOs, and CROs.
+Added: The Company has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib.
+Added: In conjunction with the license agreement, the Company completed a Phase 1b clinical trial – B2151009 related to gedatolisib.
+Added: patients subsequently transitioned to an Expanded Access study – CELC-G-001.
+Added: Contracts related to the Expanded Access study are
+Added: generally based on time and material.
+Added: In addition, contracts related to the Company’s Phase 3 clinical studies (VIKTORIA-1 and VIKTORIA-2)
+Added: and the Phase 1b/2 clinical trial (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the Company’s
+Added: obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges,
+Added: if any, as defined in each of the respective agreements.
+Added: In addition, these agreements may, from time to time, be subjected to amendments
+Added: as a result of any change orders executed by the parties.
+Added: As of December 31, 2024, the Company had five material non-cancelable contractual
+Added: commitments with respect to these arrangements, which totaled approximately $ 9.7 million.
Stockholders’ Equity
−Removed: December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 21,667,250 shares
−Removed: were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which
−Removed: 1,120,873 shares were outstanding.
−Removed: May 16, 2022, the Company designated 1,850,000 shares of the authorized preferred stock as Series A Convertible Preferred Stock (“Series
−Removed: A Preferred Stock”).
−Removed: The Series A Preferred Stock is non-voting, and each share is convertible at the option of the holder, subject
−Removed: to certain limitations, into 10 shares of common stock.
−Removed: Holders of Series A Preferred Stock are entitled to receive dividends, on an
−Removed: as-if-converted-to-common stock basis, when, as and if, and in the same form as, dividends are actually paid on the common stock.
−Removed: the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or in the event of a Deemed Liquidation
−Removed: Event (as defined in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock),
−Removed: the holders of Series A Preferred Stock are entitled to be paid from assets of the Company available for distribution to its stockholders,
−Removed: before any payment is made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the greater
−Removed: of (i) the original issue price ($ 5.75 on an as-converted-to-common stock basis), plus all accrued and unpaid dividends and (ii) the
−Removed: amount that the holder would have been entitled to receive at such time if the Series A Preferred Stock were converted into common stock.
−Removed: The Company may not, without the consent of holders of a majority of the outstanding shares of Series A Preferred Stock, amend its charter
−Removed: in a manner that adversely affects the powers, preferences or rights of the Series A Preferred Stock or issue or obligate itself to issue
−Removed: shares of any additional class or series of capital stock unless the same ranks junior to the Series A Preferred Stock with respect to
−Removed: the distribution of assets on the liquidation, dissolution or winding up of the Company and the payment of dividends.
−Removed: March 31, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
−Removed: Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis of
−Removed: the shares transferred is $ 5.75 .
−Removed: June 29, 2023, one of the Company’s preferred shareholders elected to convert 10,000 shares of Series A Convertible Preferred Stock
−Removed: into 100,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis of the shares
−Removed: transferred is $ 5.75 .
−Removed: September 21, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
−Removed: Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis of
−Removed: the shares transferred is $ 5.75 .
−Removed: October 16, 2023, one of the Company’s preferred shareholders elected to convert 181,739 shares of Series A Convertible Preferred
−Removed: Stock into 1,817,390 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis
−Removed: of the shares transferred is $ 5.75 .
−Removed: December 12, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred
−Removed: Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.
−Removed: The cost basis of
−Removed: the shares transferred is $ 5.75 .
−Removed: December 31, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 25,506,012 shares
−Removed: were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which
−Removed: 854,134 shares were outstanding.
−Removed: As of December 31, 2023, no dividends have been declared on the Company’s capital stock.
−Removed: and Issuance of Stock
−Removed: February 4, 2022, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent (“Jefferies”),
−Removed: pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of common stock having an aggregate offering
−Removed: price of up to $ 50,000,000 .
−Removed: The Company will pay Jefferies a commission equal to 3.0 % of the aggregate gross proceeds from each sale
−Removed: of such shares.
−Removed: On October 12, 2022, pursuant to the above agreement, the Company sold 500,000 shares of common stock in a single transaction
−Removed: at a price of $ 10.35 per share, generating gross proceeds of $ 5.2 million before deducting commissions and other offering expenses of
−Removed: $ 0.4 million.
−Removed: December 9, 2022, the Company issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants exercisable
−Removed: for 6,956,450 shares of common stock to certain institutional and other accredited investors pursuant to a securities purchase agreement
−Removed: entered into on May 15, 2022.
−Removed: Pursuant to the securities purchase agreement, the closing (funding) of the private placement occurred
−Removed: following dosage of the first patient in the Company’s Phase 3 study, VIKTORIA-1.
−Removed: Investors purchased shares of common stock and
−Removed: Series A Preferred Stock at a price of $ 5.75 per share (on an as converted to common stock basis), with forty percent ( 40 %) warrant coverage
−Removed: (on an as converted to common stock basis) and customary resale registration rights.
−Removed: The private placement generated gross proceeds of
−Removed: approximately $ 100 million before deducting placement agent fees and other offering expenses of $ 4.3 million.
−Removed: December 1, 2023, pursuant to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company sold 1,034,500 shares
−Removed: of common stock in a single transaction at a price of $ 14.50 per share, generating gross proceeds of $ 15 million before deducting commissions
−Removed: and other offering expenses of $ 0.6 million.
−Removed: October 18, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain
−Removed: investors (the “Investors”) pursuant to which the Company agreed to sell to the Investors in a private placement pre-funded
−Removed: warrants to purchase up to 5,747,787 shares of the Company’s common stock, par value $ 0.001 per share.
−Removed: Each Warrant to purchase
−Removed: one share has a purchase price of $ 8.699 per share, and an exercise price of $ 0.001 per share for the Common Stock issuable upon exercise
−Removed: of the Warrant.
−Removed: closing of the Private Placement occurred on October 20, 2023, and resulted in gross proceeds to the Company of approximately $ 50 million,
−Removed: before deducting offering expenses of approximately $ 0.1 million.
−Removed: Warrant is immediately exercisable and will not expire.
−Removed: Under the terms of the Warrants, the Company may not effect the exercise of any
−Removed: such Warrant, and a holder will not be entitled to exercise any portion of any Warrant, if, upon giving effect to such exercise, the
−Removed: aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates, other persons acting or who
−Removed: 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
−Removed: beneficial ownership of Common Stock would or could be aggregated with the holder’s or any of the holder’s affiliates for
−Removed: purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed
−Removed: 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership
−Removed: is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the Securities and Exchange Commission
−Removed: (the “Maximum Percentage”).
−Removed: A holder may reset the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective
−Removed: 61 days after written notice to the Company, or a lower percentage, effective immediately upon written notice to the Company.
−Removed: increase or decrease will apply only to that holder and not to any other holder of Warrants.
−Removed: Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,
−Removed: indemnification obligations of the Company, other obligations of the parties and termination provisions.
+Added: Capital Stock
+Added: At December 31, 2023, the Company’s authorized
+Added: 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
+Added: shares of $ .001 par value preferred stock, of which 854,134 shares were outstanding.
+Added: In 2024, several of the Company’s preferred
+Added: shareholders elected to convert 536,557 shares of Series A Convertible Preferred Stock into 5,365,570 shares of common stock, in accordance
+Added: with the Securities Purchase Agreement dated May 15, 2022.
+Added: The cost basis of the shares transferred is $ 5.75 per share.
+Added: In 2024, several of the Company’s investors
+Added: exercised 1,827,357 common stock warrants at exercise prices ranging between $ 8.05 and $ 9.50 per share, which generated approximately
+Added: $ 14.7 million in cash.
+Added: The 1,827,357 common stock warrants were net of shares withheld for exercise price.
+Added: At December 31, 2024, the Company’s
+Added: 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
+Added: of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 317,577 shares were outstanding.
+Added: December 31, 2024, no dividends have been declared on the Company’s capital stock.
+Added: Sale and Issuance of Stock
+Added: On April 22, 2024, pursuant to an Open Market Sale
+Added: Agreement SM with Jefferies LLC, as agent, the Company sold 285,714 shares of common stock in a single transaction at a price
+Added: of $ 17.50 per share, generating gross proceeds of $ 5.0 million.
+Added: On May 8, 2024, pursuant to an Open Market
+Added: 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
+Added: per share, generating gross proceeds of $ 2.6 million.
+Added: Commissions and other offering expenses related to the Open Market Sale
+Added: Agreement transactions in April and May 2024 were $ 0.3 million.
+Added: On May 30, 2024, the Company entered into an underwriting
+Added: agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the
+Added: 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
+Added: gross proceeds of approximately $ 60.0 million.
+Added: The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately
+Added: $ 56.3 million after deducting underwriting discounts and other offering expenses payable by the Company.
+Added: The Company intends to use the
+Added: net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and
+Added: development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.
+Added: Pre-Funded Warrants
+Added: On October 18, 2023, the
+Added: Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain investors (the “Investors”)
+Added: 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
+Added: of the Company’s common stock, par value $ 0.001 per share.
+Added: Each Warrant to purchase one share had a purchase price of $ 8.699 per
+Added: share, and an exercise price of $ 0.001 per share for the common stock issuable upon exercise of the Warrant.
+Added: The closing of the Private
+Added: Placement occurred on October 20, 2023, and resulted in gross proceeds to the Company of approximately $ 50.0 million, before deducting
+Added: offering expenses of approximately $ 0.1 million.
+Added: Each Warrant is immediately
+Added: exercisable and will not expire.
+Added: Under the terms of the Warrants, the Company may not effect the exercise of any such Warrant, and a holder
+Added: will not be entitled to exercise any portion of any Warrant, if, upon giving effect to such exercise, the aggregate number of shares of
+Added: common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting
+Added: as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common
+Added: 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
+Added: 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed 4.99% of the number of shares of
+Added: common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is calculated in accordance with
+Added: Section 13(d) of the Exchange Act and the applicable regulations of the SEC (the “Maximum Percentage”).
+Added: A holder may reset
+Added: the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective 61 days after written notice to the Company, or a lower
+Added: percentage, effective immediately upon written notice to the Company.
+Added: Any such increase or decrease will apply only to that holder and
+Added: not to any other holder of Warrants.
+Added: The Securities Purchase Agreement
+Added: contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations
+Added: of the Company, other obligations of the parties and termination provisions.
Schedule of Warrants
−Removed: December 31, 2023:
−Removed: Expiration Date
+Added: At December 31, 2024:
# of Warrants
−Removed: Exercise Price
private placement offering - issued to placement agent
2 unchanged sentences
private placement offering - issued to placement agent
−Removed: purchasers of convertible notes
IPO - issued to underwriter
debt financing - issued to lender
+Added: debt financing – issued to lender
+Added: debt financing – issued to lender
securities purchase agreement - issued to institutional and other accredited investors
1 unchanged sentence
Total Warrants Outstanding
−Removed: December 9, 2022, in connection with entering into a securities purchase agreement on May 15, 2022, the Company issued warrants to certain
−Removed: institutional and other accredited investors to purchase 6,956,450 shares of the Company’s common stock at a price of $ 8.05 .
−Removed: warrants may be exercised at any time or from time to time on or after the date of issuance and on or before the earlier of (i) 5:00
−Removed: (New York City time) on December 9, 2027 or (ii) seventy-five (75) days after the Company publicly announces (x) whether the progression-free
−Removed: survival (PFS) of gedatolisib in combination with palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in the Phase 3 study met
−Removed: its primary endpoint target, (y) whether the PFS of gedatolisib in combination with fulvestrant (Arm B) to fulvestrant (Arm C) in the
−Removed: Phase 3 study met its primary endpoint target, and (z) the associated hazard ratios and median PFS values for each of Arm A, Arm B, and
−Removed: The warrants are equity classified and the $ 21.8 million of fair value allocated to the warrants is reflected as Additional Paid-in
−Removed: September 13, 2022, the Company entered into a First Amendment to Representative’s Warrant (the “Warrant Amendment”)
−Removed: with Craig-Hallum Capital Group LLC (“Craig-Hallum”), amending the terms of that certain Representative’s Warrant,
−Removed: dated September 22, 2017 (the “Representative’s Warrant”) issued by the Company to Craig-Hallum in connection with
−Removed: the Company’s initial public offering.
−Removed: Under the terms of the Warrant Amendment, (i) the number of shares of the Company’s
−Removed: common stock issuable upon exercise of the Representative’s Warrant was reduced from 138,000 shares to 70,000 shares, and (ii)
−Removed: the exercise period of the Representative’s Warrant was extended three years to September 19, 2025 .
−Removed: There were no other material
−Removed: amendments or modifications to the Representative’s Warrant.
−Removed: The estimated incremental fair value of the Representative’s
−Removed: Warrant at the date of amendment was $ 271,988 .
−Removed: As the Company has an accumulated deficit balance in Retained Earnings, the incremental
−Removed: impact will be recorded as a deemed dividend, classified within Additional Paid-in Capital.
−Removed: December 31, 2023 and 2022, the Company had warrants to purchase 13,011,520 and 7,266,102 shares of common stock outstanding, at a weighted
−Removed: average exercise price of $ 4.53 and $ 8.12 , respectively.
−Removed: A total of 2,369 and zero warrants were exercised in the years ended December
−Removed: 31, 2023 and 2022, respectively.
+Added: At December 31, 2024 and 2023, the Company had warrants
+Added: to purchase 11,268,939
+Added: and 13,011,520
+Added: shares of common stock outstanding, at a weighted average exercise price of $ 4.04
+Added: respectively.
+Added: A total of 1,842,913
+Added: warrants were exercised in the years ended December 31, 2024 and 2023, respectively.
+Added: There were 3,544
+Added: warrants that expired in 2024.
Stock-Based Compensation
2012 Equity Incentive Plan
−Removed: 2012 Equity Incentive Plan, as amended, was adopted by the Company’s board and approved by the members of Celcuity LLC on August
−Removed: The Company reserved a maximum of 625,000 shares of common stock for issuance under the 2012 Equity Incentive Plan.
−Removed: Equity Incentive Plan provides for options, restricted stock awards, performance stock awards or stock bonuses.
−Removed: The exercise price of
−Removed: each option granted under the 2012 Equity Incentive Plan is not less than 100% of 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 Plan is ten years.
−Removed: The Company’s board administers
−Removed: the 2012 Equity Incentive Plan and determines the provisions of incentive awards, including eligible recipients, number of shares subject
−Removed: to an incentive award, exercise price, vesting schedule, duration of an incentive award and other restrictions an incentive award may
−Removed: be subject to.
−Removed: The 2012 Equity Incentive Plan was frozen on September 6, 2017 and any new awards will be issued under the terms of the
−Removed: 2017 Amended and Restated Stock Incentive Plan.
+Added: The 2012 Equity Incentive Plan, as amended, was adopted by the Company’s
+Added: board and approved by the members of Celcuity LLC on August 10, 2012.
+Added: The Company reserved a maximum of 625,000 shares of common stock
+Added: for issuance under the 2012 Equity Incentive Plan.
+Added: The 2012 Equity Incentive Plan provides for options, restricted stock awards, performance
+Added: stock awards or stock bonuses.
+Added: The exercise price of each option granted under the 2012 Equity Incentive Plan is not less than 100% of
+Added: the fair market value of one share on the date of grant.
+Added: The maximum permitted term of options granted under the 2012 Equity Incentive
+Added: Plan is ten years.
+Added: The Company’s board administers the 2012 Equity Incentive Plan and determines the provisions of incentive awards,
+Added: including eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive
+Added: award and other restrictions an incentive award may be subject to.
+Added: The 2012 Equity Incentive Plan was frozen on September 6, 2017 and
+Added: new awards are issued under the terms of the 2017 Amended and Restated Stock Incentive Plan.
2017 Stock Incentive Plan
−Removed: 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”) was adopted by the Company’s board on September 6,
−Removed: 2017, became effective following the corporate conversion on September 15, 2017, and was approved by stockholders at the Company’s
−Removed: annual stockholder meeting on May 10, 2018.
−Removed: The 2017 Plan was amended and approved by stockholders at the Company’s annual stockholder
−Removed: meeting on May 14, 2020.
−Removed: The Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Plan.
−Removed: The number of shares reserved for issuance was automatically increased by 216,673 and 149,189 shares on January 1, 2023 and 2022, respectively
−Removed: and will increase automatically on January 1 of each of 2024 through 2027 by the number of shares equal to 1.0% of the aggregate number
−Removed: of outstanding shares of Company common stock as of the immediately preceding December 31.
−Removed: However, the Company’s board may reduce
−Removed: the amount of the increase in any particular year.
−Removed: At the Annual Meeting held on May 12, 2021 and May 12, 2022, the stockholders approved
−Removed: a one-time, 500,000 increase each year for a total of 1,000,000 increase, to the number of shares reserved for issuance under the 2017
−Removed: At the Annual Meeting held on May 11, 2023, the stockholders approved a one-time, 1,500,000 increase to the number of shares reserved
−Removed: for issuance under the 2017 Plan.
−Removed: The 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted
−Removed: stock units, performance awards and stock bonuses.
−Removed: The exercise price of each option granted under the 2017 Plan is not less than 100%
−Removed: of the fair market value of one share on the date of grant.
−Removed: The maximum permitted term of options granted under the 2017 Plan is ten
−Removed: The 2017 Plan is generally administered by the compensation committee of the Company’s board, which has the authority to
−Removed: interpret the 2017 Plan, grant awards and make all other determinations necessary for the administration of the 2017 Plan.
−Removed: following table summarizes the activity for all stock options outstanding for the years ended December 31:
+Added: The 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”)
+Added: was adopted by the Company’s board on September 6, 2017, became effective following the corporate conversion on September 15, 2017,
+Added: and was approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018.
+Added: The 2017 Plan was amended and approved
+Added: by stockholders at the Company’s annual stockholder meeting on May 14, 2020.
+Added: The Company initially reserved a maximum of 750,000
+Added: shares of common stock for issuance under the 2017 Plan.
+Added: The number of shares reserved for issuance was automatically increased by 255,060
+Added: and 216,673 shares on January 1, 2024 and 2023, respectively, and will increase automatically on January 1 of each of 2025 through 2027
+Added: 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
+Added: However, the Company’s board may reduce the amount of the increase in any particular year.
+Added: At each of the Annual Meetings
+Added: 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
+Added: shares reserved for issuance under the 2017 Plan.
+Added: At each of the Annual Meetings held on May 11, 2023 and May 9, 2024, the stockholders
+Added: 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.
+Added: 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards and stock
+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
+Added: the date of grant.
+Added: The maximum permitted term of options granted under the 2017 Plan is ten years.
+Added: The 2017 Plan is generally administered
+Added: by the compensation committee of the Company’s board, which has the authority to interpret the 2017 Plan, grant awards and make
+Added: all other determinations necessary for the administration of the 2017 Plan.
+Added: The following table summarizes the activity for all stock options outstanding
+Added: for the years ended December 31:
Schedule of Stock Options Activity
−Removed: Weighted Average
−Removed: Exercise Price
−Removed: Weighted Average
−Removed: Exercise Price
+Added: Weighted Average Exercise Price
+Added: Weighted Average Exercise Price
Options outstanding at beginning of year
1 unchanged sentence
Options exercisable at December 31:
−Removed: Weighted Average Grant Date Fair Value for options granted during the period:
+Added: Weighted Average Grant Date Fair Value for options granted during the year:
following table summarizes additional information about stock options outstanding and exercisable at December 31, 2024:
−Removed: Schedule of Stock Options Outstanding and Exercisable
−Removed: Weighted Average
−Removed: Contractual Life
−Removed: Exercise Price
−Removed: Exercise Price
−Removed: Company recognized stock-based compensation expense for stock options of $ 4,716,475 and $ 4,415,415 for the years ended December 31, 2023
−Removed: and 2022, respectively.
+Added: of Stock Options Outstanding and Exercisable
+Added: Options Outstanding
+Added: Options Exercisable
+Added: Options Outstanding
+Added: Weighted Average Remaining Contractual Life
+Added: Weighted Average Exercise Price
+Added: Aggregate Intrinsic Value
+Added: Options Exercisable
+Added: Weighted Average Exercise Price
+Added: Aggregate Intrinsic Value
+Added: The Company recognized stock-based compensation expense for stock options
+Added: of $ 6,626,402 and $ 4,716,475 for the years ended December 31, 2024 and 2023, respectively.
+Added: In May 2022, the Company modified the exercise
+Added: price on 776,324 stock option awards to $ 5.50 , the closing market price on the Nasdaq Capital Market on May 17,2022.
+Added: The effect of this
+Added: modification on stock-based compensation was $ 106,000 and $ 134,000 for the years ended December 31, 2024 and 2023, respectively.
+Added: of this modification on stock-based compensation over the remaining service period will be approximately $ 57,000 .
+Added: In December 2021, the
+Added: Company modified the exercise price on 311,000 stock option awards to $ 13.44 , the closing market price on the Nasdaq Capital Market on
+Added: December 15, 2021.
+Added: No director or officer awards were modified.
+Added: The effect on stock-based compensation was $ 63,000 and $ 65,000 for the
+Added: years ended December 31, 2024 and 2023, respectively.
+Added: The effect on stock-based compensation over the remaining service period will be
+Added: approximately $ 35,000 .
In May 2020, the Company modified the exercise price on 203,750 stock option awards to $ 5.10 , the closing market
price on the Nasdaq Capital Market on May 14, 2020.
−Removed: The effect of this modification on stock-based compensation was $ 134,000 and $ 517,000
−Removed: for the years ended December 31, 2023 and 2022, respectively.
−Removed: The effect of this modification on stock-based compensation over the remaining
−Removed: service period will be approximately $ 163,000 .
−Removed: In December 2021, the Company modified the exercise price on 311,000 stock option awards
−Removed: to $ 13.44 , the closing market price on the Nasdaq Capital Market on December 15, 2021.
No director or officer awards were modified.
−Removed: effect on stock-based compensation was $ 65,000 and $ 92,000 for the years ended December 31, 2023 and 2022, respectively.
−Removed: The effect on
−Removed: stock-based compensation over the remaining service period will be approximately $ 98,000 .
−Removed: In May 2020, the Company modified the exercise
−Removed: price on 203,750 stock option awards to $ 5.10 , the closing market price on the Nasdaq Capital Market on May 14, 2020.
−Removed: No director or
−Removed: officer awards were modified.
−Removed: The effect on stock-based compensation was $ 19,000 and $ 38,000 for the years ended December 31, 2023 and
−Removed: 2022, respectively.
−Removed: The effect on stock-based compensation over the remaining service period is not material.
−Removed: Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions
−Removed: for the years ended December 31:
−Removed: Schedule of Assumptions for Fair Value of Equity-based Awards
+Added: The effect on stock-based compensation
+Added: was $ 696 and $ 19,000 for the years ended December 31, 2024 and 2023, respectively.
+Added: There is no effect on stock-based compensation remaining.
+Added: The Black-Scholes option-pricing model was used to estimate the
+Added: fair value of equity-based awards and the Monte Carlo simulation model was used to estimate the fair value of the performance-based awards,
+Added: with the following weighted-average assumptions for the years ended December 31:
+Added: of Assumptions for Fair Value of Equity-based Awards
Risk-free interest rate
3.48 % - 4.71 %
+Added: 3.41 % - 4.86 %
Expected volatility
71.2 % - 76.20 %
+Added: 77.1 % - 79.8 %
Expected life (years)
+Added: 5.25 to 10.00
Expected dividend yield
−Removed: inputs for the Black-Scholes valuation model require management’s significant assumptions.
−Removed: Prior to the Company’s initial
−Removed: public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock
−Removed: sold in private offerings.
−Removed: Subsequent to the initial public offering, the price per share of common stock is determined by using the
−Removed: closing market price on the Nasdaq Capital Market on the grant date.
+Added: The inputs for the Black-Scholes valuation model and the Monte Carlo simulation
+Added: model require management’s significant assumptions.
+Added: Prior to the Company’s initial public offering, the price per share of
+Added: common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings.
+Added: to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital
+Added: Market on the grant date.
The risk-free interest rates are based on the rate for U.S.
−Removed: securities at the date of grant with maturity dates approximately equal to the expected life at the grant date.
−Removed: The expected life is
−Removed: based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos.
−Removed: The expected volatility is estimated
−Removed: based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated
−Removed: volatility since being publicly traded.
−Removed: assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for
−Removed: options granted to employees.
−Removed: In the event the Company terminates any of its consulting agreements, the unvested options issued in connection
−Removed: with the agreements would also be cancelled.
−Removed: Company had 1,958 and 3,273 shares of restricted stock outstanding at December 31, 2023 and 2022, respectively, and 3,273 and 3,214 shares
−Removed: of restricted stock vested during the years ended December 31, 2023 and 2022, respectively.
−Removed: The Company recognized stock-based compensation
−Removed: expense for restricted stock of $ 18,499 and $ 41,431 for the years ended December 31, 2023 and 2022, respectively.
−Removed: total remaining shares available for grant under the Company’s 2017 Plan as of December 31, 2023 was 1,019,149 .
−Removed: unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at December 31:
−Removed: Schedule of Unrecognized Compensation Cost
+Added: Treasury securities at the date of grant with maturity
+Added: dates approximately equal to the expected life at the grant date.
+Added: The expected life is based on the simplified method for the time-based
+Added: awards and the life of the option for the performance-based awards, in accordance with the SEC Staff Accounting Bulletin Nos.
+Added: The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in
+Added: combination with the Company’s calculated volatility since being publicly traded for the time-based awards.
+Added: For the performance-based
+Added: awards, the Company’s full historical volatility was used to value the options.
+Added: All assumptions used to calculate the grant date fair value of non-employee
+Added: options are generally consistent with the assumptions used for options granted to employees.
+Added: In the event the Company terminates any of
+Added: its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled.
+Added: The Company had 1,079 and 1,958 shares of restricted stock outstanding
+Added: at December 31, 2024 and 2023, respectively, and 2,308 and 3,273 shares of restricted stock vested during the years ended December 31,
+Added: 2024 and 2023, respectively.
+Added: The Company recognized stock-based compensation expense for restricted stock of $ 22,220 and $ 18,499 for the
+Added: years ended December 31, 2024 and 2023, respectively.
+Added: The total remaining shares available for grant under the Company’s
+Added: 2017 Plan as of December 31, 2024 was 1,177,450 .
+Added: Total unrecognized compensation cost related to stock options and restricted
+Added: stock is estimated to be recognized at December 31:
+Added: of Unrecognized Compensation Cost
Total estimated compensation cost to be recognized
2017 Employee Stock Purchase Plan
−Removed: Company’s 2017 Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board on September 6, 2017
−Removed: and approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018.
−Removed: The Company initially reserved a total
−Removed: of 100,000 shares for issuance under the ESPP.
−Removed: The number of shares reserved for issuance was automatically increased by 108,337 and
−Removed: 74,595 shares on January 1, 2023 and 2022, respectively and will increase automatically on each subsequent January 1 by the number of
−Removed: shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31.
−Removed: the Company’s board may reduce the amount of the increase in any particular year.
−Removed: The total remaining shares available for issuance
−Removed: under the employee stock purchase plan as of December 31, 2023 is 266,635 .
−Removed: ESPP provides participating employees with an opportunity to purchase shares of the Company’s common stock at a discount through
−Removed: payroll deductions.
−Removed: The ESPP is available to all employees unless they are employed for less than 20 hours per week or own 5% or more
−Removed: of the total combined voting power or value of the Company’s common stock.
−Removed: The ESPP is administered using overlapping 24 month
−Removed: offering periods, referred to as an Offering Period.
−Removed: Each Offering Period has four six-month purchase periods.
−Removed: A new Offering Period
−Removed: and purchase period begin every six months on May 1 and November 1 of each year.
−Removed: Participating employees may purchase common stock, on
−Removed: a voluntary after tax-basis, at a price equal to 85% of the fair market value of a share of common stock on either the offering date
−Removed: or the purchase date, whichever is lower.
−Removed: If the purchase date has a lower price, the employee will automatically be placed in the Offering
−Removed: Period beginning immediately after the purchase date.
−Removed: The Company recognized stock-based compensation expense related to the ESPP of
−Removed: $ 166,460 and $ 181,359 for the years ended December 31, 2023 and 2022, respectively.
−Removed: Company recognized total stock-based compensation expense as follows for the years ended December 31:
−Removed: Schedule of Stock-based Compensation Expense
+Added: The Company’s 2017 Employee Stock Purchase Plan (the “ESPP”)
+Added: was adopted by the Company’s board on September 6, 2017 and approved by stockholders at the Company’s annual stockholder meeting
+Added: on May 10, 2018.
+Added: The Company initially reserved a total of 100,000 shares for issuance under the ESPP.
+Added: The number of shares reserved for
+Added: issuance was automatically increased by 127,530 and 108,337 shares on January 1, 2024 and 2023, respectively and will increase automatically
+Added: 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
+Added: of the immediately preceding December 31.
+Added: However, the Company’s board may reduce the amount of the increase in any particular year.
+Added: The total remaining shares available for issuance under the employee stock purchase plan as of December 31, 2024 is 360,950 .
+Added: The ESPP provides participating employees with an opportunity to purchase
+Added: shares of the Company’s common stock at a discount through payroll deductions.
+Added: The ESPP is available to all employees unless they
+Added: 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
+Added: The ESPP is administered using overlapping 24 month offering periods, referred to as an Offering Period.
+Added: Each Offering Period has
+Added: four six-month purchase periods.
+Added: A new Offering Period and purchase period begin every six months on May 1 and 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 the fair market value of
+Added: a share of common stock on either the offering date or the purchase date, whichever is lower.
+Added: If the purchase date has a lower price,
+Added: the employee will automatically be placed in the Offering Period beginning immediately after the purchase date.
+Added: The Company recognized
+Added: stock-based compensation expense related to the ESPP of $ 339,719 and $ 166,460 for the years ended December 31, 2024 and 2023, respectively.
+Added: The Company recognized total stock-based compensation
+Added: expense as follows for the years ended December 31:
+Added: of Stock-based Compensation Expenses
Stock-based compensation expense in operating expenses:
1 unchanged sentence
General and administrative
−Removed: April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences
−Removed: Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender.
−Removed: Lender agreed to loan up to $ 25 million in three tranches consisting of (i) a $ 15.0 million non-contingent term A loan that was funded
−Removed: on April 8, 2021, (ii) a $ 5 million term B loan with a deadline of March 31, 2022 and (iii) a $ 5 million term C loan to be funded upon
−Removed: request, subject to our ability to achieve certain milestones, no later than March 31, 2023 (collectively the “Term Loans”).
−Removed: Loan Agreement also contains certain events of default, warranties and covenants of the Company.
−Removed: In connection with each funding of the
−Removed: Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s
−Removed: stock equal to 2.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the
−Removed: lower of (i) $14.40 per share or (ii) the volume weighted
−Removed: price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the
−Removed: funding date of the Term B or Term C Loan, as applicable.
−Removed: The warrants may be exercised on a cashless basis and are immediately exercisable
−Removed: through the tenth anniversary of the applicable funding date.
−Removed: In connection with the first tranche of the Term Loans, the Company issued
−Removed: a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $ 14.40 per share.
−Removed: evaluated the warrant under ASC 470, debt, and recognized an additional debt discount of approximately $ 0.3 million based on the relative
−Removed: fair value of the base instruments and warrants.
−Removed: The Company calculated the fair value of the warrant using the Black-Scholes model.
−Removed: In connection with the funding of the first tranche of the Term Loans, a final fee of approximately
−Removed: $ 0.7 million was recorded as additional principal as a debt discount, and a facility fee of approximately $ 0.1 million was recorded as
−Removed: additional debt discount.
−Removed: The Company is also required to maintain a minimum cash balance in agreement with the term loans’ default
−Removed: August 9, 2022, the Company amended the Loan Agreement.
−Removed: Under the amended Loan Agreement, Innovatus, as Lender, has agreed to loan up
−Removed: to $ 75 million, a $ 50 million increase from the original Loan Amount, in five tranches consisting of:
−Removed: (i) a $ 15 million term A loan that
−Removed: was funded on April 8, 2021 upon entering into the original Loan Agreement, (ii) a $ 20 million term B loan to be funded upon request
−Removed: of the Company no later than December 31, 2023, with such funding conditioned upon the closing of the Company’s $ 100 million private
−Removed: placement announced on May 16, 2022, (iii) a $ 10 million term C loan to be funded upon request of the Company no later than April 1,
−Removed: 2024, (iv) a $ 20 million term D loan to be funded upon request of the Company no later than November 1, 2024, and (v) a $ 10 million term
−Removed: E loan to be funded upon request of the Company no later than February 28, 2025.
−Removed: As of December 31, 2023, term loans totaling $ 35 million
−Removed: are outstanding under the Loan Agreement, including the initial Term A loan of $ 15 million which was funded on April 8, 2021, and a $ 20
−Removed: million Term B loan which was funded on December 22, 2022 following the closing of the $ 100 million private placement described above.
−Removed: Funding of the term C, D, and E loans are conditioned upon satisfaction of certain clinical trial milestones and certain financial covenants
−Removed: determined on a pro forma as-funded basis.
−Removed: In connection with the original and amended Loan Agreement and the funding of the first and
−Removed: second tranche of the Term Loans, the Company incurred debt issuance costs of approximately $ 1.1 million.
−Removed: The debt issuance costs and
−Removed: the debt discount are amortized to interest expense using the effective interest method over the life of the Term Loans.
−Removed: value of the debt approximates fair value as of December 31, 2023.
−Removed: the amended Loan Agreement, Innovatus has the right, at its election and until August 9, 2025, the third anniversary of the loan amendment
−Removed: date, to convert into Common Stock up to (1) 20% of the outstanding principal amount of term A loan, and (ii) an additional 7% of the
−Removed: amount by which the aggregate principal amount of the funded term B, C, D, and E loans exceed $35 million, provided that the aggregate
−Removed: outstanding principal amount of all term loans is at least $35 million, which such conversion based upon a price per share equal to $10.00.
−Removed: No additional warrants are required to be issued under the funding of term B, C, D, and E.
−Removed: Company is entitled to make interest-only payments for forty-eight months, or up to sixty months from the original Loan Agreement date
−Removed: if certain conditions are met.
−Removed: The Term Loans will mature on April 8, 2027, the sixth anniversary of the initial funding date, and will
−Removed: bear interest at a rate equal to the sum of (a) the greater of (i) Prime Rate (as defined in the amended Loan Agreement) or (ii) 3.25%,
−Removed: Additionally, the Company elected to make 4.95% of the interest rate as payable in-kind, which shall accrue as principal monthly.
−Removed: The Amended Loan Agreement includes certain other fees, such as a final fee of 4.5% of the funded loan amounts not converted into equity
−Removed: by the lender, which apply if prepayment, an event of default, or change of control occurs prior to August 9, 2025, the third anniversary
−Removed: of the Amendment date.
−Removed: Subject to certain other conditions, no final fee will be payable after August 9, 2025.
−Removed: The Company has the option
−Removed: to prepay the loan at any time following the first anniversary of the amended loan agreement date, with tiered prepayment fees ranging
−Removed: from 0 to 1% based on when the prepayment occurs.
−Removed: Upon a change in control or event of default, mandatory prepayment will be required,
−Removed: and if such an event occurs prior to the first anniversary of the Amendment date, an additional prepayment fee of 3.0 % applies.
−Removed: amended Loan Agreement remains secured by all assets of the Company.
−Removed: Proceeds will be used for working capital purposes and to fund the
−Removed: Company’s general business requirements.
−Removed: The amended Loan Agreement contains customary representations and warranties and covenants,
−Removed: subject to customary carve outs, and includes financial covenants related to or based upon liquidity, trailing twelve months revenue
−Removed: and the funded loan amounts.
−Removed: debt consisted of the following at December 31, 2023 and 2022:
−Removed: Schedule of Long-term Debt
+Added: Stock-based compensation expense
+Added: On May 30, 2024, the Company entered into an Amended
+Added: and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a
+Added: Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a
+Added: Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain
+Added: term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 million.
+Added: The A&R Loan Agreement
+Added: amends and restates, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and
+Added: Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).
+Added: Funding of the first $ 100 million under the A&R
+Added: Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the “Term A Loan”) and $ 21.5 million
+Added: (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind
+Added: interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”).
+Added: The Company will be eligible to draw on a fourth
+Added: tranche of $ 30 million (the “Term D Loan”) and fifth tranche of $ 50 million (the “Term E Loan”), in each case
+Added: upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a pro forma as-funded
+Added: The Lenders may, in their sole discretion upon the Company’s request, make additional term loans to the Company of $ 45 million
+Added: (the “Term F Loan”).
+Added: Funding of these additional tranches is also subject to other customary conditions and limits on when
+Added: the Company can request funding for such tranches.
+Added: Costs associated with the new borrowings was approximately $ 2.4 million.
+Added: Pursuant to the A&R Loan Agreement, the Company
+Added: is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met.
+Added: 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: 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
+Added: amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May
+Added: The A&R Loan Agreement is secured by all assets of the Company.
+Added: Proceeds will be used for working capital purposes and to
+Added: fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical trial.
+Added: The A&R Loan Agreement contains
+Added: customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity
+Added: and other financial measures.
+Added: Innovatus has 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 (the “Conversion Right”).
+Added: Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase
+Added: 26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031.
+Added: The A&R Loan Agreement contains a Final Fee, which
+Added: 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
+Added: of any Term Loan, and (c) the prepayment of the Term Loans.
+Added: There is also a contingent non-utilization fee for both the Term D and Term
+Added: 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
+Added: 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 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 ,
+Added: 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
+Added: Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.
+Added: If the Company achieves the
+Added: 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
+Added: 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
+Added: 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
+Added: 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
+Added: Term Loan, and (iv) the prepayment in whole of the Term Loans.
+Added: After the 18-month anniversary of the Effective Date, the Company shall
+Added: 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
+Added: the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven Business Days prior
+Added: to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective
+Added: Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon
+Added: through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable,
+Added: including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.
+Added: 2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt discount to be amortized
+Added: over the life of the loan.
+Added: In connection with the funding of each of the Term
+Added: 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
+Added: 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
+Added: 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
+Added: of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the execution
+Added: 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: Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise price of $ 14.84 per share.
+Added: fair value of the warrants was approximately $ 1.2 million.
+Added: For the additional Term Loans, the exercise price will be based on the lower
+Added: 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
+Added: Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the applicable Term
+Added: Loan funding.
+Added: The Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding
+Added: The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain
+Added: proportional adjustments as set forth in such Warrant.
+Added: The Company evaluated the change of terms under ASC
+Added: 470-50, “Debt – Modification and Extinguishment”, and concluded the change in terms did not result in significant and
+Added: consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment
+Added: Long-term debt consisted of the following at December 31, 2024 and 2023:
+Added: of Long-term Debt
+Added: $ 100,000,000
PIK interest (added to principal)
unamortized debt issuance costs
+Added: ( 1,613,734 )
unamortized debt discount
+Added: ( 5,752,418 )
Total long-term debt
−Removed: principal payments are as follows:
−Removed: Schedule of Long Term Debt Future Principal Payments
−Removed: the conversion of Celcuity LLC to Celcuity Inc.
+Added: Future principal payments, including the incurred PIK interest and Final
+Added: Fee, are as follows:
+Added: of Long Term Debt Future Principal Payments
+Added: Years Ending December 31,
+Added: $ 105,093,288
+Added: Following the conversion of Celcuity
+Added: LLC to Celcuity Inc.
on September 15, 2017, Celcuity Inc.
began filing federal and state returns where required.
−Removed: No income tax benefit was recorded for the years 2023 and 2022, due to net losses and recognition of a valuation allowance.
−Removed: The following
−Removed: table presents a reconciliation of the tax expense computed at the statutory federal rate and the Company’s tax expense for the
−Removed: years ending December 31:
+Added: No income tax benefit
+Added: was recorded for the years 2024 and 2023, due to net losses and recognition of a valuation allowance.
+Added: The following table presents a reconciliation
+Added: of the tax expense computed at the statutory federal rate and the Company’s tax expense for the years ended December 31:
Schedule of Effective Income Tax Rate Reconciliation
8 unchanged sentences
Income tax benefits
−Removed: income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
−Removed: purposes and the amounts used for income tax purposes.
−Removed: The Company’s deferred tax assets relate primarily to its net operating
−Removed: loss carryforwards and other balance sheet basis differences.
−Removed: In accordance with ASC 740, “Income Taxes,” the Company recorded
−Removed: a valuation allowance to fully offset the net deferred tax asset, because it is more likely than not that the Company will not realize
−Removed: future benefits associated with these deferred tax assets at December 31, 2023.
−Removed: The tax effects of temporary differences and carryforwards
−Removed: that give rise to significant portions of the deferred tax assets are at December 31:
+Added: Deferred income taxes reflect the net effects of temporary differences
+Added: between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
+Added: The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences.
+Added: In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset the net deferred tax
+Added: asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets
+Added: at December 31, 2024.
+Added: The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred
+Added: tax assets are at December 31:
Schedule of Deferred Tax Assets and Liabilities
12 unchanged sentences
Net deferred tax assets
−Removed: December 31, 2023, the Company had federal and state net operating loss carryforwards of approximately $ 25.9 million and $ 0.7 million,
+Added: At December 31, 2024, the Company had federal and
+Added: state net operating loss carryforwards of approximately $ 43.2 million and $ 0.8 million, respectively.
+Added: The federal and state net operating
+Added: loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037.
+Added: The federal net operating loss carryforwards starting
+Added: in 2018 have no expiration.
+Added: These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December
+Added: At December 31, 2024, the Company had federal and
+Added: state research and development tax credit carryforwards resulting in deferred tax assets of approximately $ 2.9 million and $ 1.6 million,
respectively.
−Removed: The federal and state net operating loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037.
−Removed: The federal net operating loss carryforwards starting in 2018 have no expiration.
−Removed: These deferred tax assets were subject to a full valuation
−Removed: allowance as of December 31, 2023 and December 31, 2022.
−Removed: December 31, 2023, the Company had federal and state research and development tax credit carryforwards resulting in deferred tax assets
−Removed: of approximately $ 2.0 million and $ 1.3 million, respectively.
−Removed: The federal and state credit carryforwards will begin to expire in the
−Removed: years ending December 31, 2038 and December 31, 2033, respectively.
−Removed: These deferred tax assets were subject to a full valuation allowance
−Removed: as of December 31, 2023 and December 31, 2022.
−Removed: the provisions of Section 382 of the Internal Revenue Code of 1986, certain substantial changes in the Company’s ownership, including
−Removed: 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
−Removed: loss carryforwards available to offset future taxable income.
−Removed: Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that
−Removed: the tax positions will be sustained upon examination by tax authorities.
−Removed: For those tax positions that meet the more-likely-than not recognition
−Removed: threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
−Removed: As of December 31, 2023, and 2022, the Company has no significant uncertain tax positions.
−Removed: There are no unrecognized tax benefits included
−Removed: on the balance sheet that would, if recognized, impact the effective tax rate.
−Removed: The Company does not anticipate there will be a significant
−Removed: change in unrecognized tax benefits within the next 12 months.
−Removed: to the conversion, Celcuity was a limited liability company and therefore was taxed as a partnership for income tax purposes.
−Removed: no benefit for income taxes was recorded prior to the conversion.
−Removed: years prior to 2020, the Company is no longer subject to U.S.
−Removed: federal or state income tax examinations and remains open for the unutilized
−Removed: tax attributes as of December 31, 2023, carried forward from these years.
−Removed: The Company’s policy is to recognize interest and penalties
−Removed: related to uncertain tax positions as a component of general and administrative expenses.
+Added: The federal and state credit carryforwards will begin to expire in the years ending December 31, 2038 and December 31, 2033,
+Added: respectively.
+Added: These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December 31, 2023.
+Added: Under the provisions of Section 382 of the Internal
+Added: Revenue Code of 1986, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes
+Added: in ownership due to sales of equity, may limit in the future the amount of net operating loss carryforwards available to offset future
+Added: taxable income.
+Added: The Company recognizes uncertain tax positions in
+Added: 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
+Added: by tax authorities.
+Added: For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount
+Added: of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
+Added: As of December 31, 2024, and 2023, the Company
+Added: has no significant uncertain tax positions.
+Added: There are no unrecognized tax benefits included on the balance sheet that would, if recognized,
+Added: impact the effective tax rate.
+Added: The Company does not anticipate there will be a significant change in unrecognized tax benefits within
+Added: the next 12 months.
+Added: Prior to the conversion, Celcuity was a limited liability
+Added: company and therefore was taxed as a partnership for income tax purposes.
+Added: Accordingly, no benefit for income taxes was recorded prior
+Added: to the conversion.
+Added: For years prior to 2021, the Company is no longer
+Added: subject to U.S.
+Added: federal or state income tax examinations and remains open for the unutilized tax attributes as of December 31, 2024, carried
+Added: forward from these years.
+Added: The Company’s policy is to recognize interest and penalties related to uncertain tax positions as a component
+Added: of general and administrative expenses.
Subsequent Event
−Removed: In March 2024, an investor exercised 1,739,080 warrants at an exercise
−Removed: price of $ 8.05 , which generated approximately $ 14 million in cash.
−Removed: The warrants were issued pursuant to a private placement that closed
−Removed: and was funded on December 9, 2022.
−Removed: Changes in and Disagreements With Accountants on Accounting and Financial Disclosures
+Added: January 2025, the Board of Directors approved a repricing of certain outstanding stock options previously granted to employees.
+Added: the repricing date, the exercise prices of these options were reduced to $ 11.92 per share, from their previous exercise prices ranging
+Added: from $ 12.80 to $ 18.73 per share.
+Added: This adjustment was made in response to the decline in the company’s stock price, with the intent
+Added: of retaining and motivating key employees.
+Added: As a result of this repricing, approximately 837,000 stock options held by 44 employees were
+Added: The repriced options will continue to vest according to their original schedule.
+Added: March 2025, an investor exercised 695,650 warrants at an exercise price of $ 8.05 , which generated approximately $ 5.6 million in cash.
+Added: The warrants were issued pursuant to a private placement that closed and was funded on December 9, 2022.
+Added: Changes in and Disagreements With Accountants on Accounting
+Added: 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.