Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | Coya Therapeutics, Inc. | |
Entity Central Index Key | 0001835022 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Security12b Title | Common Stock, par value $0.0001 per share | |
Trading Symbol | COYA | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-41583 | |
Entity Incorporation State Country Code | DE | |
Entity Tax Identification Number | 85-4017781 | |
Entity Address Address Line1 | 5850 San Felipe St., Suite 500 | |
Entity Address City Or Town | Houston | |
Entity Address State Or Province | TX | |
Entity Address Postal Zip Code | 77057 | |
City Area Code | 800 | |
Local Phone Number | 587-8170 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 9,947,915 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 13,102,392 | $ 5,933,702 |
Prepaids and other current assets | 1,287,213 | 1,251,264 |
Total current assets | 14,389,605 | 7,184,966 |
Fixed assets, net | 79,630 | 93,310 |
Deferred financing costs | 1,117,290 | |
Total assets | 14,469,235 | 8,395,566 |
Current liabilities: | ||
Accounts payable | 237,579 | 1,815,270 |
Accrued expenses | 983,633 | 2,008,361 |
Total current liabilities | 1,221,212 | 3,823,631 |
Convertible promissory notes | 12,965,480 | |
Total liabilities | 1,221,212 | 16,789,111 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity (deficit): | ||
Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none and 7,500,713 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 8,793,637 | |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 9,947,915 and 2,590,197 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 996 | 259 |
Additional paid-in capital | 36,947,411 | 681,106 |
Accumulated deficit | (23,700,384) | (17,868,547) |
Total stockholders' equity (deficit) | 13,248,023 | (8,393,545) |
Total liabilities and stockholders' equity (deficit) | $ 14,469,235 | $ 8,395,566 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Series A convertible preferred stock, par value | $ 0.0001 | $ 0.0001 |
Series A convertible preferred stock, shares authorized | 10,000,000 | |
Series A convertible preferred stock, shares issued | 0 | 7,500,713 |
Series A convertible preferred stock, shares outstanding | 0 | 7,500,713 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | |
Common stock, shares issued | 9,947,915 | 2,590,197 |
Common stock, shares outstanding | 9,947,915 | 2,590,197 |
CONDENSED UNAUDITED INTERIM STA
CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating Expenses: | ||||
Research and development | $ 1,067,952 | $ 1,447,373 | $ 2,299,664 | $ 2,426,177 |
In-process research and development | 350,000 | 350,000 | ||
General and administrative | 1,829,553 | 1,994,783 | 3,491,097 | 2,712,307 |
Depreciation | 6,840 | 4,033 | 13,680 | 8,066 |
Total operating expenses | 3,254,345 | 3,446,189 | 6,154,441 | 5,146,550 |
Loss from operations | (3,254,345) | (3,446,189) | (6,154,441) | (5,146,550) |
Other income: | ||||
Change in fair value of convertible promissory notes | 22,345 | 22,345 | ||
Other income, net | 158,970 | 10,940 | 322,604 | 7,923 |
Net loss | $ (3,095,375) | $ (3,412,904) | $ (5,831,837) | $ (5,116,282) |
Per share information: | ||||
Net loss per share of common stock, basic | $ (0.31) | $ (1.32) | $ (0.59) | $ (1.98) |
Net loss per share of common stock, diluted | $ (0.31) | $ (1.32) | $ (0.59) | $ (1.98) |
Weighted-average shares of common stock outstanding, basic | 9,947,915 | 2,590,197 | 9,835,505 | 2,590,148 |
Weighted-average shares of common stock outstanding, diluted | 9,947,915 | 2,590,197 | 9,835,505 | 2,590,148 |
CONDENSED UNAUDITED INTERIM S_2
CONDENSED UNAUDITED INTERIM STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Initial Public Offering Convertible Promissory Notes | Initial Public Offering and Over-Allotment Option | Convertible Preferred Stock Series A | Convertible Preferred Stock Series A Initial Public Offering | Common Stock | Common Stock Initial Public Offering | Common Stock Initial Public Offering Convertible Promissory Notes | Common Stock Initial Public Offering and Over-Allotment Option | Additional Paid-in Capital | Additional Paid-in Capital Initial Public Offering | Additional Paid-in Capital Initial Public Offering Convertible Promissory Notes | Additional Paid-in Capital Initial Public Offering and Over-Allotment Option | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 3,643,727 | $ 8,793,637 | $ 259 | $ 473,602 | $ (5,623,771) | |||||||||
Beginning balance, shares at Dec. 31, 2021 | 7,500,713 | 2,590,051 | ||||||||||||
Exercise of stock options | 158 | 158 | ||||||||||||
Exercise of stock options (in shares) | 146 | |||||||||||||
Stock-based compensation expense | 21,425 | 21,425 | ||||||||||||
Net loss | (1,703,378) | (1,703,378) | ||||||||||||
Balance at Mar. 31, 2022 | 1,961,932 | $ 8,793,637 | $ 259 | 495,185 | (7,327,149) | |||||||||
Ending balance, shares at Mar. 31, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Balance at Dec. 31, 2021 | 3,643,727 | $ 8,793,637 | $ 259 | 473,602 | (5,623,771) | |||||||||
Beginning balance, shares at Dec. 31, 2021 | 7,500,713 | 2,590,051 | ||||||||||||
Net loss | (5,116,282) | |||||||||||||
Balance at Jun. 30, 2022 | (1,406,314) | $ 8,793,637 | $ 259 | 539,843 | (10,740,053) | |||||||||
Ending balance, shares at Jun. 30, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Balance at Mar. 31, 2022 | 1,961,932 | $ 8,793,637 | $ 259 | 495,185 | (7,327,149) | |||||||||
Beginning balance, shares at Mar. 31, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Stock-based compensation expense | 44,658 | 44,658 | ||||||||||||
Net loss | (3,412,904) | (3,412,904) | ||||||||||||
Balance at Jun. 30, 2022 | (1,406,314) | $ 8,793,637 | $ 259 | 539,843 | (10,740,053) | |||||||||
Ending balance, shares at Jun. 30, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Balance at Dec. 31, 2022 | (8,393,545) | $ 8,793,637 | $ 259 | 681,106 | (17,868,547) | |||||||||
Beginning balance, shares at Dec. 31, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Conversion of convertible instruments upon offering | $ 12,965,480 | $ (8,793,637) | $ 132 | $ 274 | $ 8,793,505 | $ 12,965,206 | ||||||||
Conversion of convertible instruments upon offering (in shares) | (7,500,713) | 1,316,926 | 2,736,488 | |||||||||||
Sale of common stock in offering and overallotment option, net of issuance costs | $ 14,136,428 | $ 329 | $ 14,136,099 | |||||||||||
Sale of common stock in offering and overallotment option, net of issuance costs (in shares) | 3,287,804 | |||||||||||||
Stock-based compensation expense and vesting of restricted stock units | 180,387 | $ 2 | 180,385 | |||||||||||
Stock-based compensation expense and vesting of restricted stock units (in shares) | 16,500 | |||||||||||||
Net loss | (2,736,462) | (2,736,462) | ||||||||||||
Balance at Mar. 31, 2023 | 16,152,288 | $ 996 | 36,756,301 | (20,605,009) | ||||||||||
Ending balance, shares at Mar. 31, 2023 | 9,947,915 | |||||||||||||
Balance at Dec. 31, 2022 | (8,393,545) | $ 8,793,637 | $ 259 | 681,106 | (17,868,547) | |||||||||
Beginning balance, shares at Dec. 31, 2022 | 7,500,713 | 2,590,197 | ||||||||||||
Net loss | (5,831,837) | |||||||||||||
Balance at Jun. 30, 2023 | 13,248,023 | $ 996 | 36,947,411 | (23,700,384) | ||||||||||
Ending balance, shares at Jun. 30, 2023 | 9,947,915 | |||||||||||||
Balance at Mar. 31, 2023 | 16,152,288 | $ 996 | 36,756,301 | (20,605,009) | ||||||||||
Beginning balance, shares at Mar. 31, 2023 | 9,947,915 | |||||||||||||
Stock-based compensation expense | 191,110 | 191,110 | ||||||||||||
Net loss | (3,095,375) | (3,095,375) | ||||||||||||
Balance at Jun. 30, 2023 | $ 13,248,023 | $ 996 | $ 36,947,411 | $ (23,700,384) | ||||||||||
Ending balance, shares at Jun. 30, 2023 | 9,947,915 |
CONDENSED UNAUDITED INTERIM S_3
CONDENSED UNAUDITED INTERIM STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Common Stock | Initial Public Offering and Over-Allotment Option | |
Issuance costs | $ 2.3 |
CONDENSED UNAUDITED INTERIM S_4
CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (5,831,837) | $ (5,116,282) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 13,680 | 8,066 |
Change in fair value of convertible promissory notes | (22,345) | |
Stock-based compensation, including the issuance of restricted stock | 371,497 | 66,083 |
Debt issuance costs | 997,367 | |
Acquired in-process research and development asset | 350,000 | |
Changes in operating assets and liabilities: | ||
Prepaids and other current assets | (35,949) | 204,215 |
Accounts payable | (574,283) | 403,611 |
Accrued expenses | (1,024,729) | 34,548 |
Net cash used in operating activities | (6,731,621) | (3,424,737) |
Cash flows from investing activities: | ||
Purchase of in-process research and development asset | (350,000) | |
Net cash used in investing activities | (350,000) | |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock upon initial public offering, net of offering costs | 14,250,311 | |
Proceeds from issuance of convertible promissory notes | 10,468,970 | |
Payment of debt issuance costs | (997,367) | |
Proceeds from the exercise of stock options | 158 | |
Net cash provided by financing activities | 14,250,311 | 9,471,761 |
Net increase in cash and cash equivalents | 7,168,690 | 6,047,024 |
Cash and cash equivalents as of beginning of the period | 5,933,702 | 4,340,178 |
Cash and cash equivalents as of end of the period | 13,102,392 | $ 10,387,202 |
Supplemental disclosures of non-cash financing and investing activities: | ||
Conversion of convertible preferred stock upon initial public offering | 8,793,637 | |
Conversion of convertible promissory notes upon initial public offering | $ 12,965,480 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and des cription of business Coya Therapeutics, Inc. (“Coya”, or the “Company”) is a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of Regulatory T cells (“Tregs”). Coya’s initial developmental programs are focused on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases of high unmet medical need. Going Concern and Liquidity The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $ 23,700,384 as of June 30, 2023. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates. No assurance can be given that any such financing will be available when needed or that the Company’s research and development efforts will be successful. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern , which requires management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued (or when applicable, one year after the date that the financial statements are available to be issued). As of June 30, 2023, the Company had cash and cash equivalents of $ 13,102,392 , which is expected to enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2024, at which time the Company will need to secure additional funding. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects. As a result of these factors, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued. The accompanying condensed unaudited interim 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 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. Management is currently evaluating different strategies to obtain the required funding of future operations. These strategies may include, but are not limited to, additional funding from current investors, funding from new investors including strategic corporate investors, and additional registrations of the Company’s common stock. There can be no assurance these future funding efforts will be successful. On January 3, 2023 , the Company completed its initial public offering (“IPO”) in which the Company sold 3,050,000 shares of its common stock and accompanying warrants to purchase 1,525,000 shares of common stock. The warrants were sold at the rate of one warrant for every two shares of common stock purchased in the IPO, with each full warrant having an exercise price of $ 7.50 per share. Each share of common stock and accompanying warrant was sold at a combined offering price of $ 5.00 for net proceeds of $ 13,432,500 after deducting underwriting discounts, commissions, and other offering expenses paid by the Company. On January 25, 2023, the underwriters exercised their overallotment option in part and thereby purchased an additional 237,804 shares of common stock and 145,000 warrants to purchase common stock at a combined offering price of $ 5.00 per share. The warrants have an exercise price of $ 7.50 per share. In total the Company raised $ 16,439,020 in gross proceeds and $ 14,136,428 in net proceeds in its IPO (as discussed in detail in Note 6). Risks and uncertainties The Company is subject to a number of risks associated with companies at a similar stage, including dependence on key individuals, competition from similar products and larger companies, volatility of the industry, ability to obtain adequate financing to support growth, the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company, and general economic conditions. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of presentation and significant accounting policies Basis of presentation The accompanying condensed unaudited condensed financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB. In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s balance sheet as of June 30, 2023, its statements of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and its cash flows for the six months ended June 30, 2023. Operating results for the three and six months ended June 30, 2023 and 2022, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The condensed unaudited interim financial statements, presented herein do not contain the required disclosures under GAAP for annual financial statements. The accompanying condensed unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2022 found in the Annual Report filed in the Form 10-K. Use of estimates The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include fair value of the Company’s convertible promissory notes, the fair value of the Company's equity, prior to being publicly traded, and related inputs, including discount for lack of marketability and volatility, the grant date fair value of stock options (Note 7), and accrued research and development expenses. Fair value of financial instruments Management believes that the carrying amounts of the Company’s cash equivalents, accounts payable, and accrued expenses approximate fair value due to the short-term nature of those instruments. Concentration 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 deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”). At times, the Company’s cash balances may exceed the current insured amounts provided by the FDIC. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents. Research and development costs Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, regulatory compliance costs, and personnel and stock-based compensation expenses. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record a net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. In-Process Research and Development Research and development costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which has no alternative future use. The licenses purchased by the Company, which are further described in Note 5, require substantial completion of research and development and regulatory and marketing approval efforts in order to reach technological feasibility. As such, since inception, the purchase price of licenses acquired is classified as acquired in-process research and development expenses in the statements of operations. Stock-based compensation The Company measures share-based employee and nonemployee awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards. The Company accounts for forfeitures in the period in which they occur. Estimating the fair value of share-based awards requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, prior to being a publicly-traded company, and, for stock options, the expected life of the options and stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in estimating the fair value of share-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgments. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards. The expected term of the stock options is estimated using the “simplified method” as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected term of the option. The expected dividend yield is 0 % because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. Income taxes Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities, and the expected benefits of net operating loss and income tax credit carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of June 30, 2023 , the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest, or penalties in the accompanying financial statements. Although there are no unrecognized income tax benefits, when applicable, the Company’s policy is to report interest and penalties related to unrecognized income tax benefits as a component of income tax expense. 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 preferred stock, common stock warrants and stock options, 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, potentially dilutive securities are not included in the calculation when 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 (unaudited): As of June 30, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 1,044,498 Common stock warrants 2,174,737 92,184 Stock options 1,129,543 506,728 3,304,280 2,960,336 Amounts in the above table reflect the common stock equivalents. Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company adopted the guidance using a modified retrospective approach as of January 1, 2023 which resulted in no cumulative-effect adjustment to retained earnings. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | 3. Fair value measurements The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: • Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. • Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. 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: June 30, 2023 (unaudited) Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 13,102,392 $ 13,102,392 December 31, 2022 Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 5,933,702 $ 5,933,702 Liabilities: Convertible promissory notes Note 6 Level 3 $ 12,965,480 $ 12,965,480 In connection with the IPO, the Company's convertible promissory notes converted into an aggregate of 2,736,488 shares of common stock. As a result, the remaining convertible promissory note balance, including accrued interest, was eliminated, increasing additional paid-in capital. Balance at December 31, 2022 $ 12,965,480 Conversion of convertible promissory notes upon IPO ( 12,965,480 ) Balance at June 30, 2023 $ — |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 4. Accrued expenses Accrued expenses consist of: (unaudited) June 30, December 31, 2023 2022 Accrued research and development $ 495,457 $ 135,864 Accrued payroll 415,514 927,006 Accrued professional fees 72,662 945,491 $ 983,633 $ 2,008,361 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies License Agreements Dr. Reddy's License and Supply Agreement In March 2023, the Company entered into an exclusive License and Supply Agreement (the "DRL Agreement") with Dr. Reddy's Laboratories ("DRL"). The DRL Agreement became effective on April 1, 2023. Pursuant to the terms of the DRL Agreement, the Company will in-license DRL’s proposed abatacept biosimilar for use in the development of Coya’s combination product for neurodegenerative diseases ("COYA 302"). COYA 302 is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways, for the treatment of neurodegenerative conditions. The DRL Agreement also provides for the license of the Company's low dose IL-2 ("COYA 301") to DRL to permit the commercialization by DRL of COYA 302 in territories not otherwise granted to Coya. In consideration for the license the Company has paid a non-refundable upfront fee of $ 350,000 . The Company will pay to DRL up to an aggregate of approximately $ 2,900,000 of pre-approval regulatory milestone payments for the first indication in the Field (as defined in the DRL Agreement) and an additional approximately $ 20,000,000 if all other development, regulatory approval and sales milestones are incurred under the DRL Agreement. The Company will also pay to DRL a low-six figure milestone payment per additional indication. Further, pursuant to the DRL Agreement, the Company will pay to DRL single-digit royalties on Net Sales (as defined in the DRL Agreement). ARScience License Agreement In August 2022, the Company entered into a License Agreement (the “ARS License Agreement”) with ARScience Biotherapeutics, Inc. (“ARS”) pursuant to which ARS granted the Company an option to acquire an exclusive, royalty-bearing license for two patents regarding certain formulations of IL-2, with the right to grant sublicenses through multiple tiers under these patents (the “ARS Option”). The Company may owe tiered payments to ARS based on its achievement of certain developmental milestones. Under the ARS License Agreement, the Company will pay an aggregate of $ 13,250,000 in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. The Company will then pay an aggregate of $ 11,600,000 in developmental milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement) the Company will pay an aggregate of $ 11,750,000 in developmental milestone payments. The Company will then pay an aggregate of $ 5,850,000 in developmental milestone payments for each Mono Product in each subsequent new indication, and an aggregate of $ 5,850,000 if all developmental milestones are achieved for each new indication. The Company will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event the Company sublicenses its rights under the ARS License Agreement, the Company will owe royalties on sublicense income within the range of 10 % to 20 %. Houston Methodist Agreements In September 2022, the Company entered into an Amended and Restated Patent Know How and License Agreement, effective as of October 2020 (the “Methodist License Agreement”), with The Methodist Hospital (“Methodist”) to make, sell and sublicense products and services using the intellectual property and know-how of Methodist. As part of the Methodist License Agreement, the Company will pay Methodist a four-figure license maintenance fee annually until the first sale of licensed product occurs. The term of the Methodist License Agreement is effective until no intellectual property patent rights remain, unless terminated sooner by (1) bankruptcy or insolvency, (2) the failure by the Company to monetize the intellectual property within five years of the date of the agreement (further discussed below), (3) due to breach of contract, or (4) at our election for any or no reason. In addition to the equity issuance and reimbursement of patent related expenses, the Methodist License requires the Company to make payments of up to $ 425,000 per product candidate in aggregate upon the achievement of specific development and regulatory milestone events by such licensed product. The Company is also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, tiered royalties (subject to customary reductions) equal to high-single digit to low-double digit percentages of annual worldwide net sales of such licensed product during a defined royalty term. The Company is also required to pay a low single digit percentage for certain licensed services. Commencing on January 1, 2025, the minimum amount which will be owed by the Company once commercialization occurs is $ 50,000 annually. The Methodist License Agreement provides that in the event the Company sublicense products and services covered by the Methodist License Agreement, then royalties owed to Houston Methodist would be computed as a percentage of payments received by the Company from the sublicensee. In addition, the termination provisions provide that Houston Methodist may only terminate the Methodist License Agreement, among other things, in the event that after five years the Company is not “Actively Attempting to Develop or Commercialize,” as such term is defined in the Methodist License Agreement. Sponsored Research Agreement In February 2021, the Company entered into a one-year Sponsored Research Agreement (“SRA”) with Houston Methodist Research Institute (“HMRI”), a Texas nonprofit corporation and an affiliate of Methodist, which can be extended or renewed by mutual agreement. Under the SRA, the Company agreed to fund up to $ 1,547,094 in research in the area of neurodegenerative diseases performed by HRMI. In return, the Company will gain expanded access to data methods and know-how per the SRA, and, if the research produces intellectual property, the Company will have all first rights to the intellectual property. As of September 15, 2022, the Company provided notice to HMRI regarding termination of the SRA in expectation that a reduced yearly budget be negotiated post termination. On May 4, 2023, the Company executed the SRA with HMRI, in which the Company agreed to fund $ 0.5 million through May 2024. The Company received a refund from HMRI of $ 74,778 in May 2023 due to paying in excess of HMRI's expenses during the three months ended June 30, 2023, resulting in a $ 27,596 credit to research and development expenses under the SRA during the three months ended June 30, 2023. The Company incurred $ 736,015 in research and development expenses under the SRA during the three months ended June 30, 2022. The Company incurred $ 102,404 and $ 987,281 in research and development expenses under the SRA during the six months ended June 30, 2023 and 2022, respectively. Employment contracts The Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined in the agreements. In addition, in the event of termination of employment following a change in control, as defined in each agreement, either by the Company without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately vested. |
Convertible Promissory Notes, C
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 6. Convertible promissory notes, convertible preferred stock and stockholders’ equity (deficit) Initial Public Offering On January 3, 2023 , the Company completed its IPO in which the Company sold 3,050,000 shares of its common stock and accompanying warrants to purchase 1,525,000 shares of common stock. The warrants were sold at the rate of one warrant for every two shares of common stock purchased in the IPO, with each full warrant having an exercise price of $ 7.50 per share. Each share of common stock and accompanying warrant was sold at a combined offering price of $ 5.00 . The Company received net proceeds of $ 13,030,639 after deducting underwriting discounts, commissions, and other offering expenses paid by the Company, including additional costs incurred during the three months ended March 31, 2023. In connection with the closing of the IPO, (i) all of the Company's outstanding shares of Series A converted into an aggregate of 1,316,926 shares of common stock, (ii) the Company's Notes converted into an aggregate of 2,736,488 shares of common stock, and (iii) the Company filed an amended and restated certificate of incorporation to, among other things, increase the number of authorized shares of common stock to 200,000,000 and increase the number of authorized shares of preferred stock to 10,000,000 . In connection with the IPO, the Company granted its underwriters a 30-day over-allotment option ("Over-Allotment") to purchase up to an additional 290,000 shares of common stock and warrants to purchase 145,000 shares of common stock to cover over-allotments at a combined offering price of $ 5.00 , less underwriting discount. The warrants have an exercise price of $ 7.50 per share. On January 25, 2023, the underwriters purchased 237,804 shares of common stock and 145,000 warrants to purchase common stock at a combined offering price of $ 5.00 per share in connection with Over-Allotment. Upon the sale of the Over-Allotment, the Company issued its underwriters an additional 16,646 warrants with an exercise price of $ 6.25 per warrant and a contractual life of four years . The Company received net proceeds of $ 1,105,789 after deducting underwriting discounts for the common stock and warrants issued in connection with the Over-Allotment. Common Stock Warrants During its evaluation of equity classification for the Company's common stock warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity. The conditions within ASC 815-40 are not subject to a probability assessment. The warrants do not fall under the liability criteria within ASC 480 Distinguishing Liabilities from Equity as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. As of June 30, 2023 , the Company had the following warrants outstanding to acquire shares of its common stock (unaudited): Warrant Type Outstanding Exercise price per share Expiration date Common stock warrants issued related to the IPO 1,525,000 $ 7.50 December 2024 Common stock warrants issued related to the Over-Allotment option 145,000 $ 7.50 December 2024 Common stock warrants issued to underwriters as compensation for IPO 230,146 $ 6.25 December 2026 Common stock warrants issued to placement agent as part of the convertible promissory notes conversion 182,407 $ 6.00 January 2028 Common stock warrants issued in connection with the Series A convertible preferred stock issued in 2020 92,184 $ 9.15 December 2025 2,174,737 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | 7. Stock-based compensation In January 2021, the Company adopted the 2021 Equity Incentive Plan (“2021 Plan”). The 2021 Plan provides for the granting of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, equity appreciation rights, performance awards, and other equity-based awards. The Company's employees, officers, independent directors, and other persons are eligible to receive awards under the 2021 Plan. As of June 30, 2023 , 1,244,859 shares of the Company’s common stock were authorized to be issued, of which 114,879 shares were available for future issuance. The amount, terms of grants, and exercisability provisions are determined and set by the Company's Board of Directors or compensation committee. The Company measures employee stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company has recorded stock-based compensation related to its options and RSU's in the accompanying statements of operations as follows (unaudited): Three Months Ended Six Months Ended 2023 2022 2023 2022 General and administrative $ 112,291 $ 28,776 $ 244,505 $ 35,637 Research and development 78,819 15,882 126,992 30,446 $ 191,110 $ 44,658 $ 371,497 $ 66,083 Stock options The Company has issued service-based stock options that generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board of Directors. Vesting generally occurs over a period of not greater than four years . The following table summarizes the activity for the periods indicated (unaudited): Weighted Weighted average Aggregate exercise contractual intrinsic Options price term (years) value Outstanding at January 1, 2023 478,570 $ 1.85 8.7 Granted 650,973 $ 3.89 Outstanding at June 30, 2023 1,129,543 $ 3.02 9.0 $ 1,184,445 Exercisable at June 30, 2023 401,061 $ 1.98 8.3 $ 837,204 Vested and expected to vest at June 30, 2023 1,129,543 $ 3.02 9.0 $ 1,184,445 As of June 30, 2023, the unrecognized compensation cost was $ 1.9 million , and will be recognized over an estimated weighted-average amortization period of 2.55 years. The fair value of options is estimated using the Black-Scholes option pricing model, which takes into account inputs such as the exercise price, the estimated fair value of the underlying common stock at the grant date, expected term, estimated stock price volatility, risk-free interest rate, and dividend yield. The fair value of stock options granted during the period ended June 30, 2023 was determined using the methods and assumptions discussed below. • The expected term of employee stock options with service-based vesting is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin (“SAB”) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. • The expected stock price volatility is based on historical volatility of comparable public entities within the Company’s industry, which were commensurate with the expected term assumption as described in SAB No. 107. • The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term. • The expected dividend yield is 0 % because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. • The Company's common stock became publicly traded on December 29, 2022. However, prior to the Company's common stock being publicly traded, its Board of Directors periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The grant date fair value of each option grant for the period ended June 30, 2023 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions (unaudited): Six Months Ended 2023 2022 Risk-free interest rate 4.0 % 3.3 % Expected term (years) 5.8 5.6 Expected volatility 89.80 % 83.48 % Expected dividend yield - - Restricted Stock Unit Awards During the six months ended June 30, 2023 , the Company issued restricted stock ("RSU") to external consultants which immediately vested upon grant. The fair value of an RSU is equal to the fair market value price of the Company's common stock on the date of grant. The Company recorded stock-based compensation expense of $ 76,080 for the six months ended June 30, 2023. The following table summarizes activity related to RSU stock-based payment awards (unaudited): Weighted Number of grant date Shares fair value Outstanding at January 1, 2023 - $ - Granted and Vested 16,500 4.61 Outstanding at June 30, 2023 16,500 $ 4.61 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 8. Subsequent events The Company has evaluated subsequent events through August 8, 2023, the date at which the condensed unaudited interim financial statements were available to be issued and has determined that there are no such events to report outside of the below: As disclosed on Form 8-K's filed on July 10 and July 14, 2023, the Company’s President and Chief Medical Officer (CMO) resigned from these positions but will continue to be an employee of the Company. The Company hired and appointed a new President and CMO, Dr. Fred Grossman, effective July 17, 2023. |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The accompanying condensed unaudited condensed financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB. In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s balance sheet as of June 30, 2023, its statements of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and its cash flows for the six months ended June 30, 2023. Operating results for the three and six months ended June 30, 2023 and 2022, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The condensed unaudited interim financial statements, presented herein do not contain the required disclosures under GAAP for annual financial statements. The accompanying condensed unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2022 found in the Annual Report filed in the Form 10-K. |
Use of Estimates | Use of estimates The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include fair value of the Company’s convertible promissory notes, the fair value of the Company's equity, prior to being publicly traded, and related inputs, including discount for lack of marketability and volatility, the grant date fair value of stock options (Note 7), and accrued research and development expenses. |
Fair Value of Financial Instruments | Fair value of financial instruments Management believes that the carrying amounts of the Company’s cash equivalents, accounts payable, and accrued expenses approximate fair value due to the short-term nature of those instruments. |
Concentration of Credit Risk | Concentration 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 deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”). At times, the Company’s cash balances may exceed the current insured amounts provided by the FDIC. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents. |
Research and Development Costs | Research and development costs Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, regulatory compliance costs, and personnel and stock-based compensation expenses. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record a net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. |
In-Process Research and Development | In-Process Research and Development Research and development costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which has no alternative future use. The licenses purchased by the Company, which are further described in Note 5, require substantial completion of research and development and regulatory and marketing approval efforts in order to reach technological feasibility. As such, since inception, the purchase price of licenses acquired is classified as acquired in-process research and development expenses in the statements of operations. |
Stock-based Compensation | Stock-based compensation The Company measures share-based employee and nonemployee awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards. The Company accounts for forfeitures in the period in which they occur. Estimating the fair value of share-based awards requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, prior to being a publicly-traded company, and, for stock options, the expected life of the options and stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in estimating the fair value of share-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgments. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards. The expected term of the stock options is estimated using the “simplified method” as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected term of the option. The expected dividend yield is 0 % because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. |
Income Taxes | Income taxes Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities, and the expected benefits of net operating loss and income tax credit carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of June 30, 2023 , the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest, or penalties in the accompanying financial statements. Although there are no unrecognized income tax benefits, when applicable, the Company’s policy is to report interest and penalties related to unrecognized income tax benefits as a component of income tax expense. |
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 preferred stock, common stock warrants and stock options, 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, potentially dilutive securities are not included in the calculation when 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 (unaudited): As of June 30, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 1,044,498 Common stock warrants 2,174,737 92,184 Stock options 1,129,543 506,728 3,304,280 2,960,336 Amounts in the above table reflect the common stock equivalents. |
Recently Adopted Accounting Pronouncements | Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company adopted the guidance using a modified retrospective approach as of January 1, 2023 which resulted in no cumulative-effect adjustment to retained earnings. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares of Common Stock Outstanding | 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 (unaudited): As of June 30, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 1,044,498 Common stock warrants 2,174,737 92,184 Stock options 1,129,543 506,728 3,304,280 2,960,336 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Company's Assets and Liabilities Measured at Fair Value on a 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: June 30, 2023 (unaudited) Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 13,102,392 $ 13,102,392 December 31, 2022 Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 5,933,702 $ 5,933,702 Liabilities: Convertible promissory notes Note 6 Level 3 $ 12,965,480 $ 12,965,480 In connection with the IPO, the Company's convertible promissory notes converted into an aggregate of 2,736,488 shares of common stock. As a result, the remaining convertible promissory note balance, including accrued interest, was eliminated, increasing additional paid-in capital. |
Summary of Changes in the Fair Value of Level 3 Contingent Consideration | Balance at December 31, 2022 $ 12,965,480 Conversion of convertible promissory notes upon IPO ( 12,965,480 ) Balance at June 30, 2023 $ — |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of: (unaudited) June 30, December 31, 2023 2022 Accrued research and development $ 495,457 $ 135,864 Accrued payroll 415,514 927,006 Accrued professional fees 72,662 945,491 $ 983,633 $ 2,008,361 |
Convertible Promissory Notes,_2
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Acquire Shares of Common Stock | As of June 30, 2023 , the Company had the following warrants outstanding to acquire shares of its common stock (unaudited): Warrant Type Outstanding Exercise price per share Expiration date Common stock warrants issued related to the IPO 1,525,000 $ 7.50 December 2024 Common stock warrants issued related to the Over-Allotment option 145,000 $ 7.50 December 2024 Common stock warrants issued to underwriters as compensation for IPO 230,146 $ 6.25 December 2026 Common stock warrants issued to placement agent as part of the convertible promissory notes conversion 182,407 $ 6.00 January 2028 Common stock warrants issued in connection with the Series A convertible preferred stock issued in 2020 92,184 $ 9.15 December 2025 2,174,737 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Based Compensation in Statement of Operations | The Company has recorded stock-based compensation related to its options and RSU's in the accompanying statements of operations as follows (unaudited): Three Months Ended Six Months Ended 2023 2022 2023 2022 General and administrative $ 112,291 $ 28,776 $ 244,505 $ 35,637 Research and development 78,819 15,882 126,992 30,446 $ 191,110 $ 44,658 $ 371,497 $ 66,083 |
Summary of Stock Options Activity | The following table summarizes the activity for the periods indicated (unaudited): Weighted Weighted average Aggregate exercise contractual intrinsic Options price term (years) value Outstanding at January 1, 2023 478,570 $ 1.85 8.7 Granted 650,973 $ 3.89 Outstanding at June 30, 2023 1,129,543 $ 3.02 9.0 $ 1,184,445 Exercisable at June 30, 2023 401,061 $ 1.98 8.3 $ 837,204 Vested and expected to vest at June 30, 2023 1,129,543 $ 3.02 9.0 $ 1,184,445 |
Summary of Estimated Black-Scholes Option-Pricing Model Using the Weighted-Average Assumptions | The grant date fair value of each option grant for the period ended June 30, 2023 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions (unaudited): Six Months Ended 2023 2022 Risk-free interest rate 4.0 % 3.3 % Expected term (years) 5.8 5.6 Expected volatility 89.80 % 83.48 % Expected dividend yield - - |
Summary of RSU Stock-Based Payment Awards Activity | The following table summarizes activity related to RSU stock-based payment awards (unaudited): Weighted Number of grant date Shares fair value Outstanding at January 1, 2023 - $ - Granted and Vested 16,500 4.61 Outstanding at June 30, 2023 16,500 $ 4.61 |
Organization and Description _2
Organization and Description of Business - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jan. 25, 2023 | Jan. 03, 2023 | Mar. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||
Accumulated deficit | $ 23,700,384 | $ 17,868,547 | |||
Gross proceeds from IPO | $ 16,439,020 | ||||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 14,136,428 | 14,250,311 | |||
Cash and cash equivalents | $ 13,102,392 | $ 5,933,702 | |||
IPO | |||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||
Transaction date | Jan. 03, 2023 | ||||
Shares issued | 3,050,000 | ||||
Class of warrant purchase | 1,525,000 | ||||
Sale of stock per share | $ 5 | ||||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 13,432,500 | $ 13,030,639 | |||
Class of warrant exercise price | $ 7.5 | ||||
Over-Allotment | |||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||
Shares issued | 237,804 | ||||
Class of warrant purchase | 145,000 | 145,000 | |||
Sale of stock per share | $ 5 | $ 5 | |||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 1,105,789 | ||||
Class of warrant exercise price | $ 7.5 | $ 7.5 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Significant Accounting Policies [Line Items] | |
Expected dividend yield | 0% |
Basis of Presentation and Sig_5
Basis of Presentation and Significant Accounting Policies - Schedule of Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares of Common Stock Outstanding (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,304,280 | 2,960,336 |
Series A Convertible Preferred Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,316,926 | |
Convertible Promissory Notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,044,498 | |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 2,174,737 | 92,184 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,129,543 | 506,728 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Jan. 03, 2023 shares |
IPO | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Notes converted into common stock | 2,736,488 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary Of Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents (money market funds), Carrying Value | $ 13,102,392 | $ 5,933,702 |
Fair Value, Recurring | Level 1 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents (money market funds), Fair Value | 13,102,392 | 5,933,702 |
Cash and cash equivalents (money market funds), Carrying Value | $ 13,102,392 | 5,933,702 |
Fair Value, Recurring | Level 3 | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Convertible promissory notes, Fair Value | 12,965,480 | |
Convertible promissory notes, Carrying Value | $ 12,965,480 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary Of Changes in the Fair Value of Level 3 Contingent Consideration (Details) | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Balance at December 31, 2022 | $ 12,965,480 |
Conversion of convertible promissory notes upon IPO | $ (12,965,480) |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development | $ 495,457 | $ 135,864 |
Accrued payroll | 415,514 | 927,006 |
Accrued professional fees | 72,662 | 945,491 |
Accrued expenses | $ 983,633 | $ 2,008,361 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Jan. 01, 2025 | Mar. 16, 2023 | Aug. 01, 2022 | Oct. 06, 2020 | Aug. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | May 04, 2023 | Feb. 28, 2021 | |
Minimum | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Percentage of royalties owed on sublicense income | 10% | ||||||||||
Maximum | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Percentage of royalties owed on sublicense income | 20% | ||||||||||
DRL Agreement | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
License agreement upfront fee | $ 350,000 | ||||||||||
Pre-approval regulatory milestone payments | 2,900,000 | ||||||||||
Additional payments of other development and sales milestones | $ 20,000,000 | ||||||||||
ARScience License Agreement | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Developmental milestones | $ 5,850,000 | ||||||||||
ARScience License Agreement | First Combination Product | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Developmental milestones | 13,250,000 | ||||||||||
ARScience License Agreement | Combination Product | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Developmental milestones | 11,600,000 | ||||||||||
ARScience License Agreement | First Mono Product | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Developmental milestones | 11,750,000 | ||||||||||
ARScience License Agreement | Mono Product | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Developmental milestones | $ 5,850,000 | ||||||||||
Methodist License | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
License termination condition description. | The Methodist License Agreement provides that in the event the Company sublicense products and services covered by the Methodist License Agreement, then royalties owed to Houston Methodist would be computed as a percentage of payments received by the Company from the sublicensee. In addition, the termination provisions provide that Houston Methodist may only terminate the Methodist License Agreement, among other things, in the event that after five years the Company is not “Actively Attempting to Develop or Commercialize,” as such term is defined in the Methodist License Agreement. | ||||||||||
Maximum aggregate amount payable upon milestone achievement of specific development and regulatory events. | $ 425,000 | ||||||||||
Methodist research fund | $ 500,000 | ||||||||||
Research and development expenses | $ 74,778 | ||||||||||
Methodist License | Scenario Forecast | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Minimum annual amount owned upon commercialization | $ 50,000 | ||||||||||
Sponsored Research Agreement | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Methodist research fund | $ 1,547,094 | ||||||||||
Research and development expenses | $ 27,596 | $ 736,015 | $ 102,404 | $ 987,281 |
Convertible Promissory Notes,_3
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jan. 25, 2023 | Jan. 03, 2023 | Mar. 31, 2023 | Jun. 30, 2023 | |
Class of Stock [Line Items] | ||||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 14,136,428 | $ 14,250,311 | ||
Common stock, shares authorized | 200,000,000 | |||
Preferred stock, shares authorized | 10,000,000 | |||
IPO | ||||
Class of Stock [Line Items] | ||||
Transaction date | Jan. 03, 2023 | |||
Shares issued | 3,050,000 | |||
Class of warrant purchase | 1,525,000 | |||
Sale of stock per share | $ 5 | |||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 13,432,500 | $ 13,030,639 | ||
Stock issued during the period, converted shares | 1,316,926 | |||
Notes converted into common stock | 2,736,488 | |||
Common stock, shares authorized | 200,000,000 | |||
Preferred stock, shares authorized | 10,000,000 | |||
Class of warrant exercise price | $ 7.5 | |||
Over-Allotment | ||||
Class of Stock [Line Items] | ||||
Shares issued | 237,804 | |||
Class of warrant purchase | 145,000 | 145,000 | ||
Sale of stock per share | $ 5 | $ 5 | ||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 1,105,789 | |||
Underwriter over allotment option period | 30 days | |||
Class of warrant exercise price | $ 7.5 | $ 7.5 | ||
Over-Allotment | Maximum | ||||
Class of Stock [Line Items] | ||||
Shares issued | 290,000 | |||
Underwriters | ||||
Class of Stock [Line Items] | ||||
Class of warrant purchase | 16,646 | |||
Warrant contractual life | 4 years | |||
Class of warrant exercise price | $ 6.25 |
Convertible Promissory Notes,_4
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Schedule of Warrants Outstanding to Acquire Shares of Common Stock (Details) - $ / shares | 6 Months Ended | ||
Jun. 30, 2023 | Jan. 25, 2023 | Jan. 03, 2023 | |
IPO | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 1,525,000 | ||
Exercise price per share | $ 7.5 | ||
Over-Allotment | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 145,000 | 145,000 | |
Exercise price per share | $ 7.5 | $ 7.5 | |
Underwriters | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 16,646 | ||
Exercise price per share | $ 6.25 | ||
Common Stock Warrants | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 2,174,737 | ||
Common Stock Warrants | Series A Convertible Preferred Stock | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 92,184 | ||
Exercise price per share | $ 9.15 | ||
Expiration date | 2025-12 | ||
Common Stock Warrants | IPO | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 1,525,000 | ||
Exercise price per share | $ 7.5 | ||
Expiration date | 2024-12 | ||
Common Stock Warrants | Over-Allotment | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 145,000 | ||
Exercise price per share | $ 7.5 | ||
Expiration date | 2024-12 | ||
Common Stock Warrants | Underwriters | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 230,146 | ||
Exercise price per share | $ 6.25 | ||
Expiration date | 2026-12 | ||
Common Stock Warrants | Placement Agent | Convertible Promissory Notes | |||
Class of Warrant or Right [Line Items] | |||
Outstanding | 182,407 | ||
Exercise price per share | $ 6 | ||
Expiration date | 2028-01 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Service-based stock options that generally have a contractual life | 9 years | 8 years 8 months 12 days | |||
Unrecognized compensation cost | $ 1,900,000 | $ 1,900,000 | |||
Weighted-average amortization period | 2 years 6 months 18 days | ||||
Expected dividend yield | 0% | ||||
Stock-based compensation expense | $ 191,110 | $ 44,658 | $ 371,497 | $ 66,083 | |
Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Expected dividend yield | 0% | ||||
Stock Options | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Service-based stock options that generally have a contractual life | 10 years | ||||
Vesting period | 4 years | ||||
Restricted Stock Unit Awards | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 76,080 | ||||
2021 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock were authorized to be issued | 1,244,859 | 1,244,859 | |||
Shares were available for future issuance | 114,879 | 114,879 |
Stock-based compensation - Summ
Stock-based compensation - Summary of Stock Based Compensation in Statement of Operations (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | $ 191,110 | $ 44,658 | $ 371,497 | $ 66,083 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | 112,291 | 28,776 | 244,505 | 35,637 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation | $ 78,819 | $ 15,882 | $ 126,992 | $ 30,446 |
Stock-based compensation - Su_2
Stock-based compensation - Summary of Stock Options Activity (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding at January 1, 2023, Options | 478,570 | |
Granted, Options | 650,973 | |
Outstanding at June 30, 2023, Options | 1,129,543 | 478,570 |
Exercisable at June 30, 2023, Options | 401,061 | |
Vested and expected to vest at June 30, 2023, Options | 1,129,543 | |
Outstanding at January 1, 2023, Weighted average exercise price | $ 1.85 | |
Granted, Weighted average exercise price | 3.89 | |
Outstanding at June 30, 2023, Weighted average exercise price | 3.02 | $ 1.85 |
Exercisable at June 30, 2023, Weighted average exercise price | 1.98 | |
Vested and expected to vest at June 30, 2023, Weighted average exercise price | $ 3.02 | |
Outstanding, Weighted average remaining contractual term (years) | 9 years | 8 years 8 months 12 days |
Exercisable at June 30, 2023, Weighted average remaining contractual term (years) | 8 years 3 months 18 days | |
Vested and expected to vest at June 30, 2023, Weighted average remaining contractual term (years) | 9 years | |
Outstanding at January 1, 2023, Aggregate intrinsic value | $ 1,184,445 | |
Outstanding at June 30, 2023, Aggregate intrinsic value | 1,184,445 | |
Exercisable at June 30, 2023, Aggregate intrinsic value | 837,204 | |
Vested and expected to vest at June 30, 2023, Aggregate intrinsic value | $ 1,184,445 |
Stock-based compensation - Su_3
Stock-based compensation - Summary of Estimated Black-Scholes Option-Pricing Model Using the Weighted-Average Assumptions (Details) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 4% | 3.30% |
Expected term (years) | 5 years 9 months 18 days | 5 years 7 months 6 days |
Expected volatility | 89.80% | 83.48% |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of RSU Stock-Based Payment Awards Activity (Details) - Restricted Stock Unit Awards | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Granted and Vested, Number of Shares | shares | 16,500 |
Outstanding at June 30, 2023, Number of Shares | shares | 16,500 |
Granted and Vested, Weighted average grant date fair value | $ / shares | $ 4.61 |
Outstanding at June 30, 2023, Weighted average grant date fair value | $ / shares | $ 4.61 |