Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 05, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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, 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 $0.001 per share | |
Trading Symbol | CNTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,966,053 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001842952 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 29,768,990 | $ 35,497,445 |
Prepaid expenses and other current assets | 2,116,737 | 2,356,213 |
Total current assets | 31,885,727 | 37,853,658 |
Operating lease right-of-use asset | 29,892 | 51,967 |
Property and equipment, net | 24,375 | 27,568 |
Other assets | 26,188 | 32,750 |
Total assets | 31,966,182 | 37,965,943 |
Current liabilities: | ||
Accounts payable | 1,210,261 | 936,330 |
Accrued expenses and other current liabilities | 1,991,442 | 2,216,169 |
Operating lease liability - current | 31,669 | 55,078 |
Total current liabilities | 3,233,372 | 3,207,577 |
Total liabilities | 3,233,372 | 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 shares issued and outstanding at March 31, 2023 and December 31, 2022 | 15,966 | 15,966 |
Additional paid-in capital | 79,115,541 | 78,832,779 |
Accumulated deficit | (50,398,697) | (44,090,379) |
Total stockholders' equity | 28,732,810 | 34,758,366 |
Total liabilities and stockholders' equity | $ 31,966,182 | $ 37,965,943 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 4,534,676 | $ 1,351,495 |
General and administrative | 2,131,872 | 2,091,467 |
Loss from operations | (6,666,548) | (3,442,962) |
Interest income | 355,542 | 5,864 |
Other income (expense) | 2,688 | (1,239) |
Net loss | $ (6,308,318) | $ (3,438,337) |
Net income (loss) per share - basic (in dollars per share) | $ (0.40) | $ (0.22) |
Net income (loss) per share - diluted (in dollars per share) | $ (0.40) | $ (0.22) |
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 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - 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 for services | 345,530 | 345,530 | ||
Share-based compensation expense | 214,958 | 214,958 | ||
Net loss | (3,438,337) | (3,438,337) | ||
Ending balance (in shares) at Mar. 31, 2022 | 15,966,053 | |||
Ending balance at Mar. 31, 2022 | 45,394,486 | $ 15,966 | 78,071,297 | (32,692,777) |
Beginning balance (in shares) at Dec. 31, 2022 | 15,966,053 | |||
Beginning 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 | 282,762 | 282,762 | ||
Net loss | (6,308,318) | (6,308,318) | ||
Ending balance (in shares) at Mar. 31, 2023 | 15,966,053 | |||
Ending balance at Mar. 31, 2023 | $ 28,732,810 | $ 15,966 | $ 79,115,541 | $ (50,398,697) |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (6,308,318) | $ (3,438,337) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 282,762 | 214,958 |
Depreciation and amortization expense | 3,193 | 0 |
Reduction in the carrying amount of operating lease right-of-use asset | 22,075 | 14,021 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 239,476 | 491,053 |
Other assets | 6,562 | (24,000) |
Accounts payable | 273,931 | (1,269,389) |
Accrued expenses and other current liabilities | (224,727) | 198,324 |
Operating lease liability | (23,409) | (6,911) |
Cash used in operating activities | (5,728,455) | (3,820,281) |
Cash flows from investing activities: | ||
Purchase of property and equipment | 0 | (34,999) |
Cash used in investing activities | 0 | (34,999) |
Cash flows from financing activities: | ||
Cash used in financing activities | 0 | (102,071) |
Net decrease in cash, cash equivalents and restricted cash | (5,728,455) | (3,957,351) |
Cash, cash equivalents and restricted cash at beginning of period | 35,497,445 | 49,685,586 |
Cash and cash equivalents at end of period | 29,768,990 | 45,728,235 |
Supplemental disclosure of non-cash activities: | ||
Right-of-use asset obtained in exchange for lease obligation | 0 | 130,488 |
Private Placement | ||
Cash flows from financing activities: | ||
Payments for offering costs related to the private placement sale of common stock | 0 | (102,071) |
Issued for services | ||
Supplemental disclosure of non-cash activities: | ||
Issuance of warrants for services provided | $ 0 | $ 345,530 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 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 dedicated to improving the lives of patients living with cancer. The Company’s preclinical product candidate, CTIM-76, is an anti-CD3 x anti-Claudin 6 (“CLDN6”) antigen bispecific monoclonal 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 closeout 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 | 3 Months Ended |
Mar. 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 $50.4 million as of March 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 $29.8 million as of March 31, 2023 are sufficient to fund its projected operations for at least the next 12 months from the issuance date of these condensed consolidated financial statements. However, substantial additional financing will be needed by the Company to fund its operations and to commercially develop its current and any future product candidates. There is no assurance that such financing will be available when needed or on acceptable terms. The Company plans to seek additional capital in the future through equity and/or debt financings, partnerships, collaborations, or other sources 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. 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. The Company faces risks associated with companies whose products are in development. These risks include the need for additional financing to complete its research and development, achieving its research and development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key members of management, among others. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 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 unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2023, and its results of operations and cash flows for the three months ended March 31, 2023 and 2022. Operating results for the three months ended March 31, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The unaudited condensed consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022. The consolidated financial information as of December 31, 2022 included herein has been derived from the annual audited consolidated financial statements. The unaudited condensed 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. Use of Estimates The preparation of condensed 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 condensed 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 unaudited condensed consolidated financial statements in the period they are determined to be necessary. Significant estimates and assumptions made in the accompanying unaudited condensed 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. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, 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 March 31, 2023, the Company's cash and cash equivalent balances exceeded federally insured limits by approximately $29.5 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 March 31, 2023 and December 31, 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 condensed consolidated statements of operations. 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. 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 condensed 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 unaudited condensed 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. 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: March 31, 2023 2022 Stock options 2,165,646 1,180,222 Warrants 5,860,000 5,860,000 8,025,646 7,040,222 Amounts in the above table reflect common stock equivalents. Emerging Growth Company Status |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 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: March 31, 2023 Total Quoted Prices in Active Significant Other Significant Financial assets Cash equivalents $ 2,150,810 $ 2,150,810 $ — $ — December 31, 2022 Total Quoted Prices in Active Significant Other Significant Financial assets Cash equivalents (Money Market Accounts) $ 1,723,893 $ 1,723,893 $ — $ — |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: March 31, 2023 December 31, 2022 Compensation and benefits $ 215,050 $ 770,055 Research and development costs 1,629,014 1,358,707 Professional fees 103,131 3,951 Other 44,247 83,456 Total $ 1,991,442 $ 2,216,169 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 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 condensed 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 March 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 | 3 Months Ended |
Mar. 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 1st 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 31st of the preceding calendar year; provided that the Board may determine that there will be no such increase or a smaller increase for any particular year. As of March 31, 2023, 361,035 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 February 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 three months ended March 31, 2023 and 2022: Three months ended March 31, 2023 2022 Research and development $ 21,087 $ 32,960 General and administrative 261,675 181,998 $ 282,762 $ 214,958 The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of share-based awards granted to employees during the three months ended March 31, 2023 and 2022 were as follows: 2023 2022 Expected stock price volatility 91.85% 86.86% Risk-free interest rate 3.88% 1.91% Expected term (in years) 6.08 6.03 Expected dividend yield — — The following table summarizes the share-based award activity for the periods presented: Number of Shares Weighted Average Weighted Average Outstanding at January 1, 2023 1,341,504 $ 3.27 8.9 Granted 824,142 $ 0.84 Forfeited — $ — Outstanding at March 31, 2023 2,165,646 $ 2.35 9.1 Vested and exercisable at March 31, 2023 526,574 $ 4.43 8.3 Vested and expected to vest at March 31, 2023 2,165,646 $ 2.35 9.1 |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Lease 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 is set to expire on July 31, 2023. As of March 31, 2023, the operating lease right-of-use asset and the operating lease liabilities were $29,892 and $31,669, respectively. The discount rate used to account for the Company’s operating leases was the Company’s estimated incremental borrowing rate of 5.0%. The remaining term of the Company’s noncancellable operating lease is 0.33 years. Future minimum lease payments under the sublease are $32,000 at March 31, 2023. Rent expense related to the Company’s operating lease was approximately $23,000 and $15,000 for the three months ended March 31, 2023 and 2022, respectively. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. In March 2023, the Company entered into a direct lease for this same office space that commences on August 1, 2023 and is set to expire on August 31, 2024, pursuant to which the Company retains the right to renew the lease for an additional one-year term. 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 three months ended March 31, 2023 and 2022, the Company provided contributions of approximately $40,000 and $25,000, respectively. 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 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, Tyligand and the Company 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 retains rights in the rest of the world to commercialize ONA-XR. Under the Tyligand Process Development Agreement, the Company paid Tyligand certain milestone payments upon successful completion of the manufacturing development plan in 2021. In addition, $2.0 million will 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. 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 CLND6. 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 payment for the initial upfront license fee as well as subsequent payments for milestones achieved were expensed to acquired in-process research and development. See Note 3. 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. On March 20, 2023, the Company amended the Integral License Agreement 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. 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. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Principles of Consolidation | The unaudited condensed 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. |
Use of Estimates | Use of Estimates The preparation of condensed 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 condensed 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 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. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, and accounts payable, approximate their fair values given their short-term nature. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted CashThe 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. |
Deferred Offering Costs | 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 condensed consolidated statements of operations. |
Property and Equipment | Property and Equipmen t |
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 condensed 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 | 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. |
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 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. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | 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: March 31, 2023 2022 Stock options 2,165,646 1,180,222 Warrants 5,860,000 5,860,000 8,025,646 7,040,222 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 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: March 31, 2023 Total Quoted Prices in Active Significant Other Significant Financial assets Cash equivalents $ 2,150,810 $ 2,150,810 $ — $ — December 31, 2022 Total Quoted Prices in Active Significant Other Significant Financial assets Cash equivalents (Money Market Accounts) $ 1,723,893 $ 1,723,893 $ — $ — |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses and other current liabilities consisted of the following: March 31, 2023 December 31, 2022 Compensation and benefits $ 215,050 $ 770,055 Research and development costs 1,629,014 1,358,707 Professional fees 103,131 3,951 Other 44,247 83,456 Total $ 1,991,442 $ 2,216,169 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Temporary Equity Disclosure [Abstract] | |
Schedule of Warrants Outstanding | At March 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) | 3 Months Ended |
Mar. 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 three months ended March 31, 2023 and 2022: Three months ended March 31, 2023 2022 Research and development $ 21,087 $ 32,960 General and administrative 261,675 181,998 $ 282,762 $ 214,958 |
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 share-based awards granted to employees during the three months ended March 31, 2023 and 2022 were as follows: 2023 2022 Expected stock price volatility 91.85% 86.86% Risk-free interest rate 3.88% 1.91% Expected term (in years) 6.08 6.03 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 Weighted Average Outstanding at January 1, 2023 1,341,504 $ 3.27 8.9 Granted 824,142 $ 0.84 Forfeited — $ — Outstanding at March 31, 2023 2,165,646 $ 2.35 9.1 Vested and exercisable at March 31, 2023 526,574 $ 4.43 8.3 Vested and expected to vest at March 31, 2023 2,165,646 $ 2.35 9.1 |
Risks and Liquidity - Narrative
Risks and Liquidity - Narrative (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Risks And Liquidity [Abstract] | ||
Accumulated deficit | $ 50,398,697 | $ 44,090,379 |
Cash and cash equivalents | $ 29,768,990 | $ 35,497,445 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | |||
Uninsured amount | $ 29,500,000 | ||
Restricted cash | $ 0 | $ 0 | $ 50,000 |
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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 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 | 8,025,646 | 7,040,222 |
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 | 2,165,646 | 1,180,222 |
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) - Recurring - Money market funds - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Financial assets | ||
Cash equivalents | $ 2,150,810 | $ 1,723,893 |
Level 1 | ||
Financial assets | ||
Cash equivalents | 2,150,810 | 1,723,893 |
Level 2 | ||
Financial assets | ||
Cash equivalents | 0 | 0 |
Level 3 | ||
Financial assets | ||
Cash equivalents | $ 0 | $ 0 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Compensation and benefits | $ 215,050 | $ 770,055 |
Research and development costs | 1,629,014 | 1,358,707 |
Professional fees | 103,131 | 3,951 |
Other | 44,247 | 83,456 |
Accrued expenses and other current liabilities | $ 1,991,442 | $ 2,216,169 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Class of Warrant or Right [Line Items] | |||
Warrants prior to conversion (in shares) | 5,860,000 | ||
Issued in 2022 for 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 | Mar. 31, 2023 | Mar. 31, 2022 |
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 5,860,000 | |
Issued in connection with 2021 IPO | ||
Class of Warrant or Right [Line Items] | ||
Warrants prior to conversion (in shares) | 250,000 | |
Warrant exercise price (in dollars per share) | $ 6.25 | |
Issued in connection with 2021 private placement | ||
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 in 2022 for 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 | 3 Months Ended | |
Apr. 30, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Annual rate at which authorized shares of common stock increase | 4% | ||
Share-based award contractual life | 10 years | ||
Weighted average fair value of grants during period (in dollars per share) | $ 0.65 | $ 1.33 | |
Unrecognized compensation expense | $ 1.9 | ||
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 | ||
Common Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total shares of common stock authorized for issuance (in shares) | 1,266,092 | ||
Shares of common stock available for grant (in shares) | 361,035 | ||
Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected period for recognition | 2 years 5 months 26 days |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 282,762 | $ 214,958 |
Research and development | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 21,087 | 32,960 |
General and administrative | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 261,675 | $ 181,998 |
Share-Based Compensation - Sc_2
Share-Based Compensation - Schedule of Assumptions Used to Determine Fair Value of Share-Based Awards (Details) - Stock options | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected stock price volatility | 91.85% | 86.86% |
Risk-free interest rate | 3.88% | 1.91% |
Expected term (in years) | 6 years 29 days | 6 years 10 days |
Expected dividend yield | 0% | 0% |
Share-Based Compensation - Sc_3
Share-Based Compensation - Schedule of Share-Based Activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Outstanding at beginning of period ( in shares) | 1,341,504 | |
Granted during the period (in shares) | 824,142 | |
Forfeited (in shares) | 0 | |
Outstanding at period end (in shares) | 2,165,646 | 1,341,504 |
Exercisable at period end (in shares) | 526,574 | |
Vested and expected to vest at period end (in shares) | 2,165,646 | |
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) | 0 | |
Outstanding at period end (in dollars per share) | 2.35 | $ 3.27 |
Exercisable at period end (in dollars per share) | 4.43 | |
Vested and expected to vest at period end (in dollars per share) | $ 2.35 | |
Weighted Average Remaining Contractual Term (years) | ||
Outstanding at beginning of period | 9 years 1 month 6 days | 8 years 10 months 24 days |
Outstanding at end of period | 9 years 1 month 6 days | 8 years 10 months 24 days |
Vested and exercisable at March 31, 2023 | 8 years 3 months 18 days | |
Vested and expected to vest at March 31, 2023 | 9 years 1 month 6 days |
Commitment and Contingencies -
Commitment and Contingencies - Operating Lease (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Leases [Abstract] | |||
Operating lease right-of-use asset | $ 29,892 | $ 51,967 | |
Operating lease liabilities | $ 31,669 | ||
Weighted average discount rate | 5% | ||
Remaining lease term | 3 months 29 days | ||
Future minimum payments due | $ 32,000 | ||
Rent expense | $ 23,000 | $ 15,000 | |
Additional renewal term | 1 year |
Commitment and Contingencies _2
Commitment and Contingencies - Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Maximum annual contributions per employee, percent | 100% | |
Employer matching contribution, percent of employees compensation | 3% | |
Employer contribution amount | $ 40,000 | $ 25,000 |
Commitment and Contingencies _3
Commitment and Contingencies - Collaboration Agreements (Details) - Collaborative Arrangement, Transaction with Party to Collaborative Arrangement - USD ($) $ in Millions | 1 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2023 | Apr. 30, 2021 | |
Tyligand | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Quarterly sales payment due upon completion, percentage | 1% | ||
Quarterly sales payment due upon completion, period of payment | 15 years | ||
Integral | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Maximum development and regulatory milestone payments | $ 55 | ||
Maximum sales milestone payments | $ 130 | ||
Tiered royalty payment, percent (up to) | 12% | ||
Scale-up, 100 kilograms of GMP-grade compound | Tyligand | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payment | $ 2 | ||
Scale-up, 300 kilograms of GMP-grade compound | Tyligand | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payment | $ 3 |