Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 19, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-40654 | ||
Entity Registrant Name | CONTEXT THERAPEUTICS INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 86-3738787 | ||
Entity Address, Address Line One | 2001 Market Street | ||
Entity Address, Address Line Two | Suite 3915 | ||
Entity Address, Address Line Three | Unit #15 | ||
Entity Address, City or Town | Philadelphia | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19103 | ||
City Area Code | 267 | ||
Local Phone Number | 225-7416 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | CNTX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | |||
Document Financial Statement Error Correction | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 23.8 | ||
Entity Common Stock, Shares Outstanding | 15,966,053 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for its 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001842952 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor Information [Abstract] | |
Auditor Name | CohnReznick LLP |
Auditor Location | Parsippany, New Jersey |
Auditor Firm ID | 596 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 14,449,827 | $ 35,497,445 |
Prepaid expenses and other current assets | 1,597,384 | 2,356,213 |
Total current assets | 16,047,211 | 37,853,658 |
Operating lease right-of-use asset | 0 | 51,967 |
Property and equipment, net | 15,524 | 27,568 |
Other assets | 0 | 32,750 |
Total assets | 16,062,735 | 37,965,943 |
Current liabilities: | ||
Accounts payable | 2,383,016 | 936,330 |
Accrued expenses and other current liabilities | 1,808,699 | 2,216,169 |
Operating lease liability - current | 0 | 55,078 |
Total current liabilities | 4,191,715 | 3,207,577 |
Total liabilities | 4,191,715 | 3,207,577 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 shares authorized; 15,966,053 issued and outstanding at December 31, 2023 and December 31, 2022 | 15,966 | 15,966 |
Additional paid-in capital | 79,909,644 | 78,832,779 |
Accumulated deficit | (68,054,590) | (44,090,379) |
Total stockholders' equity | 11,871,020 | 34,758,366 |
Total liabilities and stockholders' equity | $ 16,062,735 | $ 37,965,943 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 15,966,053 | 15,966,053 |
Common stock, shares outstanding (in shares) | 15,966,053 | 15,966,053 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses: | ||
Acquired in-process research and development | $ 0 | $ 500,000 |
Research and development | 17,782,731 | 7,091,163 |
General and administrative | 7,289,885 | 7,790,040 |
Loss from operations | (25,072,616) | (15,381,203) |
Interest income | 1,163,975 | 547,268 |
Other expense | (55,570) | (2,004) |
Net loss | $ (23,964,211) | $ (14,835,939) |
Net income (loss) per share - basic (in dollars per share) | $ (1.50) | $ (0.93) |
Net income (loss) per share - diluted (in dollars per share) | $ (1.50) | $ (0.93) |
Weighted average common shares outstanding - basic (in shares) | 15,966,053 | 15,966,053 |
Weighted average common shares outstanding - diluted (in shares) | 15,966,053 | 15,966,053 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 15,966,053 | |||
Beginning balance at Dec. 31, 2021 | $ 48,272,335 | $ 15,966 | $ 77,510,809 | $ (29,254,440) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Fair value of warrants issued | 345,530 | 345,530 | ||
Share-based compensation expense | 976,440 | 976,440 | ||
Net loss | (14,835,939) | (14,835,939) | ||
Ending balance (in shares) at Dec. 31, 2022 | 15,966,053 | |||
Ending balance at Dec. 31, 2022 | 34,758,366 | $ 15,966 | 78,832,779 | (44,090,379) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 1,076,865 | 1,076,865 | ||
Net loss | (23,964,211) | (23,964,211) | ||
Ending balance (in shares) at Dec. 31, 2023 | 15,966,053 | |||
Ending balance at Dec. 31, 2023 | $ 11,871,020 | $ 15,966 | $ 79,909,644 | $ (68,054,590) |
Consolidated Statement of Cash
Consolidated Statement of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (23,964,211) | $ (14,835,939) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | 0 | 500,000 |
Share-based compensation expense | 1,076,865 | 976,440 |
Depreciation and amortization expense | 12,044 | 9,268 |
Reduction in the carrying amount of operating lease right-of-use asset | 51,967 | 78,521 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 758,829 | (736,049) |
Other assets | 32,750 | (32,750) |
Accounts payable | 1,446,686 | (787,893) |
Accrued expenses and other current liabilities | (407,470) | 1,354,578 |
Operating lease liability | (55,078) | (75,410) |
Cash used in operating activities | (21,047,618) | (13,549,234) |
Cash flows from investing activities: | ||
Acquired in-process research and development | 0 | (500,000) |
Purchase of property and equipment | 0 | (36,836) |
Cash used in investing activities | 0 | (536,836) |
Cash flows from financing activities: | ||
Payments for offering costs related to the private placement of common stock | 0 | (102,071) |
Cash used in financing activities | 0 | (102,071) |
Net decrease in cash, cash equivalents and restricted cash | (21,047,618) | (14,188,141) |
Cash and cash equivalents at beginning of period | 35,497,445 | 49,685,586 |
Cash and cash equivalents at end of period | 14,449,827 | 35,497,445 |
Supplemental disclosure of non-cash activities: | ||
Issuance of warrants for services provided | 0 | 345,530 |
Right-of-use asset obtained in exchange for lease obligation | $ 0 | $ 130,488 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Context Therapeutics Inc. (the “Company”) is a biopharmaceutical company advancing medicines for solid tumors. The Company’s preclinical product candidate, CTIM-76, is anti-Claudin 6 (“CLDN6”) x an anti-CD3 bispecific antibody (“bsAb”) that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. The Company had also been developing onapristone extended release (“ONA-XR”). However, in March 2023, the Company announced its plan to discontinue the development of this product candidate and focus its efforts on the development of CTIM-76. All estimated close-out costs associated with the ONA-XR program were recognized in research and development expense during the first quarter of 2023. The Company does not expect to incur future material expenses related to this program. |
Risks and Liquidity
Risks and Liquidity | 12 Months Ended |
Dec. 31, 2023 | |
Risks And Liquidity [Abstract] | |
Risks and Liquidity | Risks and Liquidity The Company has incurred losses and negative cash flows from operations since inception and had an accumulated deficit of $68.1 million as of December 31, 2023. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its current or any future product candidates. The Company believes its cash and cash equivalents of $14.4 million as of December 31, 2023 are not sufficient to fund its projected operations for a period of at least 12 months from the issuance date of these consolidated financial statements. As a result, the Company has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Substantial additional funding will be needed by the Company to fund its operations and to commercially develop its current and any future product candidates. Management plans to seek additional capital in the future through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements to carry out the Company’s planned development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations until such funding is received. There is no assurance that such financing will be available when needed or on acceptable terms. Various internal and external factors will affect whether and when the Company’s current or any future product candidates become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s current and any future product candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the approval process will materially affect the Company’s financial condition and future operations. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the accounts of the Company, Context Therapeutics LLC, Context Biopharma, Inc. and Context Ireland Ltd., the Company’s wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Estimates and assumptions are periodically reviewed, and the effects of the revisions are reflected in the accompanying consolidated financial statements in the period they are determined to be necessary. Significant estimates and assumptions made in the accompanying consolidated financial statements include, but are not limited to, share-based compensation arrangements, the fair value of warrants, and in recording the prepayments, accruals and associated expense for research and development activities performed for the Company by third parties. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values given their short-term nature. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments that have original maturities of three months or less when acquired to be cash equivalents. Cash equivalents consist of amounts invested in money market accounts. At December 31, 2023, the Company’s cash and cash equivalent balances exceeded federally insured limits by approximately $14.0 million. The Company maintained approximately $50,000 as collateral for the Company’s credit card program at December 31, 2021, which was previously reported as restricted cash on its consolidated balance sheets. There were no amounts restricted as of December 31, 2023 and 2022, as the collateral was released to the Company in the first quarter of 2022. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, the costs are recorded as a reduction of additional paid-in capital generated as a result of such offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations. As of December 31, 2021, there was $0.1 million of offering costs included in accounts payable that were subsequently paid in the first quarter of 2022. Property and Equipmen t Property and equipment consist of office equipment, furniture, and leasehold improvements and are recorded at cost. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. Leasehold improvements are amortized over the shorter of their economic lives or the remaining lease term. Leases The Company determines if an arrangement is a lease at inception. Balances recognized related to operating leases are included in operating lease right-of-use assets and operating lease liabilities in the consolidated balance sheets. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. Acquired In-Process Research and Development Costs Acquired in-process research and development (IPR&D) expense consists of payments incurred in connection with the acquisition or licensing of products or technologies that do not meet the definition of a business under FASB ASC Topic 805, Business Combinations. Payments for product development milestones are initially treated as the acquisition of an asset but then immediately expensed as there is no future alternative use for the asset. These development milestone payments are reflected as an investing activity outflow on the Company’s consolidated statements of cash flows due to the nature of the underlying acquisition of an asset. See Note 8 for further discussion. Research and Development Costs Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, salaries, share-based compensation, and other operational costs related to the Company’s research and development activities. Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company's estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. Share-Based Compensation The Company measures and recognizes share-based compensation expense for both employee and non-employee awards based on the grant date fair value of the awards. The Company recognizes share-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company recognizes forfeitures as they occur. The Company classifies share-based compensation expense in its consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. The Company estimates the fair value of employee and non-employee stock awards as of the date of grant using the Black-Scholes option pricing model. The Company lacks Company-specific historical and implied volatility information. Therefore, management estimates the expected share price volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own publicly traded share price. The expected term of the Company’s stock awards has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” stock awards. The risk-free interest rate is determined by reference to the yield curve of a zero-coupon U.S. Treasury bond on the date of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ( “ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. Net Loss Per Share Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible promissory notes, preferred stock, warrants and share-based awards, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding, as they would be anti-dilutive: December 31, 2023 2022 Stock options 2,164,031 1,341,504 Warrants 5,860,000 5,860,000 8,024,031 7,201,504 Amounts in the above table reflect common stock equivalents. Recently Issued but Not yet Adopted Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company utilizes a valuation hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques related to its financial assets and financial liabilities. The three levels of inputs used to measure fair value are described as follows: Level 1 – Observable inputs such as quoted prices in active markets. Level 2 – Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly. Level 3 – Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. In accordance with the fair value hierarchy described above, the following table sets forth the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2023 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents $ 14,017,306 $ 14,017,306 $ — $ — December 31, 2022 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents $ 1,723,893 $ 1,723,893 $ — $ — |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: December 31, 2023 2022 Compensation and benefits $ 652,804 $ 770,055 Research and development costs 1,084,009 1,358,707 Professional fees 63,393 3,951 Other 8,493 83,456 Total $ 1,808,699 $ 2,216,169 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Temporary Equity Disclosure [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Warrants for Common Stock In connection with the Company's initial public offering (“IPO”) and private placement in 2021, the Company issued warrants to purchase shares of common stock. In March 2022, the Company issued 360,000 warrants to purchase common stock with an exercise price of $10.00 per share and a term of 5.76 years as compensation for professional consulting services performed in 2021. The estimated fair value of the warrants of $0.3 million was recorded in general and administrative expense during the year ended December 31, 2021 and was also reflected as a liability on the consolidated balance sheets as of December 31, 2021. The liability was reclassified into additional paid-in capital in March 2022 upon the issuance of the warrants. At December 31, 2023, the Company had the following warrants outstanding to acquire common stock: Outstanding Exercise price Expiration dates Issued in connection with 2021 IPO 250,000 $ 6.25 October 2026 Issued in connection with 2021 private placement 5,250,000 $ 6.25 June 2027 Issued in 2022 for consulting services 360,000 $ 10.00 December 2027 5,860,000 |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation | Share-based Compensation In April 2021, the Company adopted the 2021 Long-Term Performance Incentive Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company can grant stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”) and stock grants. The 2021 Incentive Plan allows for the issuance of up to 1,266,092 shares of common stock (the “Share Limit”). The Share Limit automatically increases on January 1 st of each year, during the term of the 2021 Incentive Plan, commencing on January 1 of the year following the year in which the effective date occurs, in an amount equal to four percent (4%) of the total number of shares of the Company’s common stock outstanding on December 31 st of the preceding calendar year; provided that the board of directors may determine that there will be no such increase or a smaller increase for any particular year. As of December 31, 2023, 362,650 shares remained available for future grants. Share-based awards generally vest over a period of one year to four years, and share-based awards that lapse or are forfeited are available to be granted again. The contractual life of all share-based awards is ten years. The expiration dates of the outstanding share-based awards range from January 2028 to May 2033. The Company measures share-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the service period of the awards. Share-based compensation is allocated to employees and consultants based on their respective departments. All board of directors’ compensation is charged to general and administrative expense. Share-based compensation expense related to the issuance of stock options was as follows for the years ended December 31, 2023 and 2022: Year ended December 31, 2023 2022 Research and development $ 61,545 $ 96,311 General and administrative 1,015,320 880,129 $ 1,076,865 $ 976,440 The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option awards granted during 2023 and 2022 were as follows: 2023 2022 Expected stock price volatility 91.98% 87.02% Expected term (in years) 6.00 5.95 Risk-free interest rate 3.86% 2.17% Expected dividend yield — — As the Company began trading publicly in October 2021, there is a lack of Company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following table summarizes the share-based award activity for the periods presented: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2023 1,341,504 $ 3.27 8.9 Granted 949,142 $ 0.84 Forfeited (126,615) $ 5.65 Outstanding at December 31, 2023 2,164,031 $ 2.20 8.4 $ 260,688 Vested and exercisable at December 31, 2023 858,101 $ 3.63 7.6 $ — Vested and expected to vest at December 31, 2023 2,164,031 $ 2.20 8.4 $ 260,688 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Patent License Agreement with Drexel University In November 2015, the Company entered into a patent license agreement, as amended, (the “Drexel License Agreement”) with Drexel University (“Drexel”) for license rights to patents for certain intellectual property and know-how related to certain technology. As part of the Drexel License Agreement, the Company issued Drexel 16,666 shares of common stock. In partial consideration of the Drexel License Agreement, the Company is required to pay to Drexel certain milestone payments, ranging from $10,000 to $0.2 million on the achievement of certain milestone events for each licensed product. The Company has agreed to pay Drexel a royalty in the low single digits of net sales for each licensed product on a country-by-country, licensed product-by-licensed product basis on issued or pending valid claims. The Company may credit against amounts payable to Drexel, on a country-by-country, licensed product-by-licensed product basis up to 50% of any third-party payments which the Company must make on account of third-party license agreements. In partial consideration of the Drexel License Agreement, the Company will pay to Drexel a de-escalating sublicense fee on a quarterly basis of a high single-digit percentage that decreases to a mid-single digit percentage as time passes. In addition, the Company will make payments of the fair market value of all other consideration received by the Company from sublicensees during the quarter, other than: (a) royalties paid to the Company by a sublicensee based upon sales or net sales by the sublicensee; (b) equity investments in the Company by a sublicensee up to the amount of fair market value of the equity purchased on the date of the investment; (c) loan proceeds paid to the Company by a sublicensee in an arm’s length, full recourse debt financing to the extent that such loan is not forgiven; and (d) sponsored research funding, paid to the Company by a sublicensee in a bona fide transaction for future research to be performed by the Company. As part of a strategic review of its pipeline, the Company terminated the Drexel License Agreement, effective as of April 27, 2022. Collaboration Agreement with Tyligand Bioscience In March 2020, the Company entered into a process development agreement (the “Tyligand Process Development Agreement”) with Tyligand Bioscience (Shanghai) Limited (“Tyligand”) for the development, manufacturing, registration and future commercialization of onapristone extended release (“ONA-XR”). Under the terms of the Tyligand Process Development Agreement, Tyligand was solely responsible for the design and optimization of an improved manufacturing process for ONA-XR. Upon completion of specific performance-based milestones, the Company and Tyligand entered into a license agreement (the “Tyligand License Agreement”) whereby Tyligand was granted the exclusive right to ONA-XR and is solely responsible for the development and commercialization of ONA-XR in China, Hong Kong and Macau (the “Territory”). The Company retained rights in the rest of the world to commercialize ONA-XR. The Tyligand License Agreement provides for termination in the event of (a) insolvency, (b) a material breach of the agreement, and (c) in the event that Tyligand does not meet certain regulatory milestones. For example, the Company has the ability to terminate the Tyligand License Agreement if Tyligand fails to file and receive acceptance of an investigational new drug for an ONA-XR related product in the People’s Republic of China by August 23, 2024. Under the Tyligand Process Development Agreement, the Company paid Tyligand $0.8 million and issued 111,576 warrants to purchase shares of common stock at an exercise price of $7.17 per share upon successful completion of the manufacturing development plan in 2021. The warrants were cancelled in connection with the Company’s IPO. In addition, $2.0 million would be payable upon the completion of scale-up of the first cumulative 100 kilograms of the Good Manufacturing Practices (“GMP”)-grade compound and $3.0 million upon the Company’s completion of scale-up of the first cumulative 300 kilograms of the GMP-grade compound. In consideration of and upon Tyligand’s successful completion of the development plan, within 30 days at the end of each calendar quarter, the Company shall pay Tyligand 1% of net sales of finished product utilizing the compound substantially manufactured in accordance with the process and specifications outlined in the Tyligand Process Development Agreement. This agreement terminated in August 2021, subject to certain surviving and ongoing obligations, including the scale up payments and the 1% net sales payment obligations. Per the Tyligand License Agreement, Tyligand shall pay the Company a non-refundable, non-creditable royalty at a rate in the mid-single digits of the net sales of each product in the Territory in each calendar quarter commencing with the first commercial sale of such product in the field in the Territory and ending upon the latest of (i) the sale of a generic product in the Territory and (ii) 15 years after the date of the first commercial sale of product in the Territory. Collaboration and Licensing Agreement with Integral Molecular In April 2021, the Company entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bispecific monoclonal antibody for cancer therapy. Under the terms of the agreement, Integral and the Company will develop CLDN6 bispecific antibodies that trigger the activation of T cells and eliminate cancer cells displaying CLDN6. The Company will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. The Company paid an upfront license fee of $0.3 million, granted 418,559 shares of Series A Stock with a fair market value of approximately $2.8 million, and expensed these costs to acquired in-process research and development during the year ended December 31, 2021. As a part of the agreement, Integral will be eligible to receive remaining development and regulatory milestone payments totaling approximately $55 million, sales milestone payments totaling up to $130.0 million, and tiered royalties of up to 12% of net sales of certain products developed under this agreement. During the year ended December 31, 2022, the Company expensed $0.5 million in acquired in-process research related to a development milestone achieved under the agreement with Integral. On March 20, 2023, the Company amended the Integral License Agreement (“First Amendment”) to remove the previously agreed to second milestone payment and to change the amount of the third milestone payment to increase such payment by the amount of the prior second milestone payment and to add payment for third-party research funding obtained and used by Integral in connection with the development of CTIM-76. On February 29, 2024, the Company further amended the Integral License Agreement ("Second Amendment") to reflect updated financial terms. Integral’s right to receive certain future payments will be reduced as follows: aggregate development and regulatory milestone payments will be reduced from $55 million to $15 million, aggregate sales milestone payments will be reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale will be reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrows the license grant from Integral to the Company to only cover CTIM-76, removes any further obligation to reimburse Integral for any third-party research funding Integral applied against CTIM-76 research, and includes mutual releases by the parties. Research and Development Arrangements In the course of normal business operations, the Company enters into agreements with universities and contract research organizations to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls-related expenses. Expenditures to contract research organizations represent a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash. Operating Leases In January 2022, the Company entered into a noncancellable operating sublease for corporate office space in Philadelphia, Pennsylvania. The sublease for this space commenced on February 1, 2022 and expired on July 31, 2023. In March 2023, the Company entered into a direct lease for this same office space that commenced on August 1, 2023 and was set to expire on August 31, 2024 if the Company did not renew the lease for an additional year. In March 2024, the Company amended the lease, which now expires on November 30, 2024 and will automatically renew for successive three-month periods unless the Company or the landlord provides the other with a termination notice at least 90 days before any such successive renewal. As of December 31, 2023, the operating lease right-of-use asset and the operating lease liabilities were immaterial. The remaining term of the Company’s noncancellable operating lease is 0.58 years. Future minimum lease payments under the sublease are $83,000 at December 31, 2023. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. Rent expense was approximately $94,000 and $84,000 for the years ended December 31, 2023 and 2022, respectively. Employee Benefit Plans In the first quarter of 2022, the Company established a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company contributes a safe harbor minimum contribution equivalent to 3% of employees’ compensation. The Company generally assumes all administrative costs of the plan. For the years ended December 31, 2023 and 2022, the Company provided contributions of approximately $66,000 and $62,000, respectively. Litigation Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. The Company believes no matters existed at either December 31, 2023 or 2022 that will have a material impact to the Company’s financial position, results of operations or cash flows. Indemnification In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by applicable law. The Company currently has directors and officers insurance. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Prior to April 2021, the Company was a limited liability company that was treated as a pass-through entity for income tax purposes. In April 2021, upon the completion of its reverse triangular merger, the Company converted to a corporation and is subject to federal, state and local corporate income taxes which have been provided for in the consolidated financial statements based upon ASC 740. Context BioPharma, Inc. has always been subject to corporate income taxes. The Company had no income tax expense due to operating losses incurred for the years ended December 31, 2023 and 2022. The Company had also not recorded any income tax benefits for the net operating losses incurred in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s losses before income taxes were generated in the United States. The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets and liabilities were as follows: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 7,749,636 $ 5,865,305 Research and development credits 1,231,315 703,630 Capitalized research and development Section 174 expense 6,799,428 2,091,787 Share-based compensation 843,345 527,146 Other accruals 201,671 268,105 Gross deferred tax assets 16,825,395 9,455,973 Deferred tax liabilities: Prepaid expenses (215,507) (256,052) Property and equipment (4,585) (8,181) Net deferred tax assets 16,605,303 9,191,740 Less: valuation allowance (16,605,303) (9,191,740) $ — $ — In assessing the need for a valuation allowance, management must determine that there will be sufficient taxable income to allow for the realization of deferred tax assets. Based upon the historical and anticipated future losses, management has determined that the deferred tax assets do not meet the more likely than not threshold for realizability. Accordingly, a full valuation allowance has been recorded against the Company’s net deferred tax assets as of December 31, 2023 and 2022. The valuation allowance increased by $7.4 million and $3.9 million during the years ended December 31, 2023 and 2022, respectively. A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2023 2022 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 7.8 3.7 Permanent differences — — Research and development credit 2.2 1.9 Change in valuation allowance (31.0) (26.6) Effective income tax rate — % — % The following table summarizes carryforwards of federal, state and local net operating losses (“NOL”) and research tax credits: December 31, 2023 2022 NOL carryforwards—Federal $ 27,502,184 $ 20,543,576 NOL carryforwards—State 27,502,184 20,543,576 NOL carryforwards—Local 19,390,882 15,665,662 Research tax credits—Federal 1,231,315 703,630 The NOL carryforwards begin expiring in 2037 for federal and state income tax purposes; however, all federal NOL carryforwards generated subsequent to January 1, 2018 are able to be carried forward indefinitely. Local NOL carryforwards expire after three years with the 2021 NOL set to expire in 2024. As of December 31, 2023 and 2022, the Company had federal research and development tax credit carryforwards of $1.2 million and $0.7 million, respectively, that will begin to expire in 2037, unless previously utilized. The NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. To date, the Company has not performed an analysis to determine whether or not ownership changes have occurred since inception. State and local NOLs may also be limited. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event The Company has evaluated subsequent events from the consolidated balance sheet date through March 21, 2024 , the issuance date of these consolidated financial statements, and has not identified any requiring disclosure except as noted below. On February 29, 2024, the Company entered into the Second Amendment with Integral to reflect updated financial terms and to narrow the license grant to only cover CTIM-76. See Note 8 for further discussion. In March 2024, the Company amended its lease for corporate office space. See Note 8 for further discussion. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net loss | $ (23,964,211) | $ (14,835,939) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Concentrations of Credit Risk | Concentrations of Credit Risk |
Segment Information | Segment Information |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values given their short-term nature. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash |
Deferred Offering Costs | Deferred Offering Costs |
Leases | Leases The Company determines if an arrangement is a lease at inception. Balances recognized related to operating leases are included in operating lease right-of-use assets and operating lease liabilities in the consolidated balance sheets. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. |
Acquired In-Process Research and Development Costs | Acquired In-Process Research and Development Costs Acquired in-process research and development (IPR&D) expense consists of payments incurred in connection with the acquisition or licensing of products or technologies that do not meet the definition of a business under FASB ASC Topic 805, Business Combinations. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, salaries, share-based compensation, and other operational costs related to the Company’s research and development activities. Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company's estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. |
Patent Costs | Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. |
Share-based Compensation | Share-Based Compensation The Company measures and recognizes share-based compensation expense for both employee and non-employee awards based on the grant date fair value of the awards. The Company recognizes share-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company recognizes forfeitures as they occur. The Company classifies share-based compensation expense in its consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ( “ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible promissory notes, preferred |
Recently Issued but Not yet Adopted Accounting Pronouncements | Recently Issued but Not yet Adopted Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | December 31, 2023 2022 Stock options 2,164,031 1,341,504 Warrants 5,860,000 5,860,000 8,024,031 7,201,504 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | In accordance with the fair value hierarchy described above, the following table sets forth the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2023 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents $ 14,017,306 $ 14,017,306 $ — $ — December 31, 2022 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents $ 1,723,893 $ 1,723,893 $ — $ — |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses and other current liabilities consisted of the following: December 31, 2023 2022 Compensation and benefits $ 652,804 $ 770,055 Research and development costs 1,084,009 1,358,707 Professional fees 63,393 3,951 Other 8,493 83,456 Total $ 1,808,699 $ 2,216,169 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Temporary Equity Disclosure [Abstract] | |
Schedule of Warrants Outstanding | At December 31, 2023, the Company had the following warrants outstanding to acquire common stock: Outstanding Exercise price Expiration dates Issued in connection with 2021 IPO 250,000 $ 6.25 October 2026 Issued in connection with 2021 private placement 5,250,000 $ 6.25 June 2027 Issued in 2022 for consulting services 360,000 $ 10.00 December 2027 5,860,000 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount | Share-based compensation expense related to the issuance of stock options was as follows for the years ended December 31, 2023 and 2022: Year ended December 31, 2023 2022 Research and development $ 61,545 $ 96,311 General and administrative 1,015,320 880,129 $ 1,076,865 $ 976,440 |
Schedule of Assumptions Used to Determine Fair Value of Share-Based Awards | The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option awards granted during 2023 and 2022 were as follows: 2023 2022 Expected stock price volatility 91.98% 87.02% Expected term (in years) 6.00 5.95 Risk-free interest rate 3.86% 2.17% Expected dividend yield — — |
Schedule of Share-Based Award Activity | The following table summarizes the share-based award activity for the periods presented: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2023 1,341,504 $ 3.27 8.9 Granted 949,142 $ 0.84 Forfeited (126,615) $ 5.65 Outstanding at December 31, 2023 2,164,031 $ 2.20 8.4 $ 260,688 Vested and exercisable at December 31, 2023 858,101 $ 3.63 7.6 $ — Vested and expected to vest at December 31, 2023 2,164,031 $ 2.20 8.4 $ 260,688 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets and liabilities were as follows: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 7,749,636 $ 5,865,305 Research and development credits 1,231,315 703,630 Capitalized research and development Section 174 expense 6,799,428 2,091,787 Share-based compensation 843,345 527,146 Other accruals 201,671 268,105 Gross deferred tax assets 16,825,395 9,455,973 Deferred tax liabilities: Prepaid expenses (215,507) (256,052) Property and equipment (4,585) (8,181) Net deferred tax assets 16,605,303 9,191,740 Less: valuation allowance (16,605,303) (9,191,740) $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2023 2022 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 7.8 3.7 Permanent differences — — Research and development credit 2.2 1.9 Change in valuation allowance (31.0) (26.6) Effective income tax rate — % — % |
Summary of Operating Loss Carryforwards | The following table summarizes carryforwards of federal, state and local net operating losses (“NOL”) and research tax credits: December 31, 2023 2022 NOL carryforwards—Federal $ 27,502,184 $ 20,543,576 NOL carryforwards—State 27,502,184 20,543,576 NOL carryforwards—Local 19,390,882 15,665,662 Research tax credits—Federal 1,231,315 703,630 |
Risks and Liquidity - Narrative
Risks and Liquidity - Narrative (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Risks And Liquidity [Abstract] | ||
Accumulated deficit | $ (68,054,590) | $ (44,090,379) |
Cash and cash equivalents | $ 14,449,827 | $ 35,497,445 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Accounting Policies [Abstract] | |||
Number of operating segments | segment | 1 | ||
Cash uninsured amount | $ 14,000,000 | ||
Restricted cash, noncurrent | 0 | $ 50,000 | |
Payments for offering costs related to the private placement of common stock | $ 0 | $ (102,071) | $ (100,000) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares of common stock outstanding | 8,024,031 | 7,201,504 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares of common stock outstanding | 2,164,031 | 1,341,504 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares of common stock outstanding | 5,860,000 | 5,860,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of assets and liabilities measured at fair value on a recurring basis (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Financial assets | |||
Cash equivalents | $ 14,449,827 | $ 35,497,445 | $ 49,685,586 |
Recurring | Money market funds | |||
Financial assets | |||
Cash equivalents | 14,017,306 | 1,723,893 | |
Recurring | Money market funds | Level 1 | |||
Financial assets | |||
Cash equivalents | 14,017,306 | 1,723,893 | |
Recurring | Money market funds | Level 2 | |||
Financial assets | |||
Cash equivalents | 0 | 0 | |
Recurring | Money market funds | Level 3 | |||
Financial assets | |||
Cash equivalents | $ 0 | $ 0 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Compensation and benefits | $ 652,804 | $ 770,055 |
Research and development costs | 1,084,009 | 1,358,707 |
Professional fees | 63,393 | 3,951 |
Other | 8,493 | 83,456 |
Total | $ 1,808,699 | $ 2,216,169 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2023 | Mar. 31, 2022 | |
Class of Warrant or Right [Line Items] | |||
Warrants prior to conversion (in shares) | 5,860,000 | ||
Issued for Professional Consulting Services | |||
Class of Warrant or Right [Line Items] | |||
Warrants prior to conversion (in shares) | 360,000 | 360,000 | |
Warrant exercise price (in dollars per share) | $ 10 | $ 10 | |
Warrants, term from date of issuance | 5 years 9 months 3 days | ||
Fair value adjustment of warrants | $ 0.3 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - $ / shares | Dec. 31, 2023 | Mar. 31, 2022 |
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 5,860,000 | |
Issued to placement agents | ||
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 250,000 | |
Warrant exercise price (in dollars per share) | $ 6.25 | |
December 2021 Private Placement Agent Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 5,250,000 | |
Warrant exercise price (in dollars per share) | $ 6.25 | |
Issued for Professional Consulting Services | ||
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 360,000 | 360,000 |
Warrant exercise price (in dollars per share) | $ 10 | $ 10 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total shares of common stock authorized for issuance (in shares) | 1,266,092 | ||
Annual rate at which authorized shares of common stock increase | 4% | ||
Shares of common stock available for grant (in shares) | 362,650 | ||
Share-based award contractual life | 10 years | ||
Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted (in dollars per share) | $ 0.65 | $ 1.38 | |
Unrecognized expense related to RSUs | $ 1.1 | ||
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based awards vesting period | 1 year | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based awards vesting period | 4 years | ||
Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected period for recognition | 2 years 2 months 12 days |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,076,865 | $ 976,440 |
Research and Development Expense | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 61,545 | 96,311 |
General and Administrative Expense | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,015,320 | $ 880,129 |
Share-Based Compensation - Sc_2
Share-Based Compensation - Schedule of Assumptions Used to Determine Fair Value of Share-Based Awards (Details) - Stock options | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected stock price volatility | 91.98% | 87.02% |
Expected term (in years) | 6 years | 5 years 11 months 12 days |
Risk-free interest rate | 3.86% | 2.17% |
Expected dividend yield | 0% | 0% |
Share-Based Compensation - Sc_3
Share-Based Compensation - Schedule of Share-Based Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Outstanding at beginning of period ( in shares) | 1,341,504 | |
Granted during the period (in shares) | 949,142 | |
Forfeited (in shares) | (126,615) | |
Outstanding at period end (in shares) | 2,164,031 | 1,341,504 |
Exercisable at period end (in shares) | 858,101 | |
Vested and expected to vest at period end (in shares) | 2,164,031 | |
Weighted Average Exercise Price Per Share | ||
Outstanding at beginning of period (in dollars per share) | $ 3.27 | |
Granted (in dollars per share) | 0.84 | |
Forfeited (in dollars per share) | 5.65 | |
Outstanding at period end (in dollars per share) | 2.20 | $ 3.27 |
Exercisable at period end (in dollars per share) | 3.63 | |
Vested and expected to vest at period end (in dollars per share) | $ 2.20 | |
Weighted Average Remaining Contractual Term (years) | ||
Outstanding at beginning of period | 8 years 4 months 24 days | 8 years 10 months 24 days |
Outstanding at end of period | 8 years 4 months 24 days | 8 years 10 months 24 days |
Vested and exercisable | 7 years 7 months 6 days | |
Vested and expected to vest | 8 years 4 months 24 days | |
Options outstanding, Aggregate Intrinsic Value | $ 260,688 | |
Options exercisable, Aggregate Intrinsic Value | 0 | |
Options expected to vest, Aggregate Intrinsic Value | $ 260,688 |
Commitment and Contingencies (D
Commitment and Contingencies (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Mar. 31, 2020 USD ($) | Nov. 30, 2015 USD ($) shares | Mar. 31, 2022 | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Feb. 29, 2024 USD ($) | Aug. 31, 2021 $ / shares shares | Apr. 30, 2021 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Operating lease right-of-use asset | $ 0 | $ 51,967 | ||||||
Remaining term | 6 months 29 days | |||||||
Future minimum lease payments under sublease | $ 83,000 | |||||||
Rent expense | 94,000 | 84,000 | ||||||
Employee contribution maximum percentage | 100% | |||||||
Company matching percentage | 3% | |||||||
Contributions | 66,000 | $ 62,000 | ||||||
Drexel University | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Percentage of payments as to credits accounts payable | 0.50 | |||||||
Drexel University | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Milestone payment | $ 10,000 | |||||||
Drexel University | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Milestone payment | $ 200,000 | |||||||
Drexel University | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Redeemable Common Stock | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Temporary equity new shares issued (in shares) | shares | 16,666 | |||||||
Tyligand | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Maximum obligation amount | $ 800,000 | |||||||
Number of securities called by warrants (in shares) | shares | 111,576 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 7.17 | |||||||
Quarterly sales payment due upon completion, percentage | 1% | |||||||
Quarterly sales payment due upon completion, period of payment | 15 years | |||||||
Integral | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Maximum obligation amount | 300,000 | |||||||
Maximum development and regulatory milestone payments | $ 55,000,000 | |||||||
Maximum sales milestone payments | $ 130,000,000 | |||||||
Tiered royalty payment, percent (up to) | 12% | |||||||
Expensed acquired in-process research | $ 500,000 | |||||||
Integral | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Subsequent event | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Maximum development and regulatory milestone payments | $ 15,000,000 | |||||||
Maximum sales milestone payments | $ 12,500,000 | |||||||
Tiered royalty payment, percent (up to) | 6% | |||||||
Integral | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Tiered royalty payment, percent (up to) | 8% | |||||||
Integral | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Tiered royalty payment, percent (up to) | 12% | |||||||
Integral | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Series A Preferred Stock | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Temporary equity, stock issued for services (in shares) | shares | 418,559 | |||||||
Temporary equity, stock issued for services | $ 2,800,000 | |||||||
Scale-up, 100 kilograms of GMP-grade compound | Tyligand | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Milestone payment | $ 2,000,000 | |||||||
Scale-up, 300 kilograms of GMP-grade compound | Tyligand | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Milestone payment | $ 3,000,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense | $ 0 | $ 0 |
Increase in valuation allowance | 7,400,000 | 3,900,000 |
Accrued interest related to uncertain tax positions | 0 | 0 |
Expensed interest related to uncertain tax positions | 0 | 0 |
Research tax credits—Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward | $ 1,231,315 | $ 703,630 |
NOL carryforwards—Local | ||
Operating Loss Carryforwards [Line Items] | ||
Local NOL expiration term | 3 years |
Income Taxes - Schedule of Tax
Income Taxes - Schedule of Tax Effects of Temporary Differences That Give Rise To The Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 7,749,636 | $ 5,865,305 |
Research and development credits | 1,231,315 | 703,630 |
Capitalized research and development Section 174 expense | 6,799,428 | 2,091,787 |
Share-based compensation | 843,345 | 527,146 |
Other accruals | 201,671 | 268,105 |
Net deferred tax assets | 16,825,395 | 9,455,973 |
Deferred tax liabilities: | ||
Prepaid expenses | (215,507) | (256,052) |
Property and equipment | (4,585) | (8,181) |
Net deferred tax assets | 16,605,303 | 9,191,740 |
Less: valuation allowance | (16,605,303) | (9,191,740) |
Deferred tax assets, net | $ 0 | $ 0 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rate | 21% | 21% |
State income tax, net of federal benefit | 7.80% | 3.70% |
Permanent differences | 0% | 0% |
Research and development credit | 2.20% | 1.90% |
Change in valuation allowance | (31.00%) | (26.60%) |
Effective income tax rate | 0% | 0% |
Income Taxes - Summary of Opera
Income Taxes - Summary of Operating Loss Carryforwards (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Research tax credits—Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward | $ 1,231,315 | $ 703,630 |
NOL carryforwards—Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 27,502,184 | 20,543,576 |
NOL carryforwards—State | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 27,502,184 | 20,543,576 |
Local | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 19,390,882 | $ 15,665,662 |