Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 11, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Coya Therapeutics, Inc. | ||
Entity Central Index Key | 0001835022 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 36,439,109 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Security12b Title | Common Stock, par value $0.0001 per share | ||
Trading Symbol | COYA | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-41583 | ||
Entity Incorporation State Country Code | DE | ||
Entity Tax Identification Number | 85-4017781 | ||
Entity Address Address Line1 | 5850 San Felipe St., Suite 500 | ||
Entity Address City Or Town | Houston | ||
Entity Address State Or Province | TX | ||
Entity Address Postal Zip Code | 77057 | ||
City Area Code | 800 | ||
Local Phone Number | 587-8170 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated By Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s proxy statement for the 2024 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year ended December 31, 2023, are incorporated by reference in Part III of this Form 10-K. | ||
Auditor Firm ID | 410 | ||
Auditor Name | Weaver and Tidwell, L.L.P. | ||
Auditor Location | Austin, Texas | ||
Entity Common Stock, Shares Outstanding | 14,542,579 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 32,626,768 | $ 5,933,702 |
Collaboration receivable | 7,500,000 | |
Prepaids and other current assets | 1,069,557 | 1,251,264 |
Total current assets | 41,196,325 | 7,184,966 |
Fixed assets, net | 65,949 | 93,310 |
Deferred financing costs | 1,117,290 | |
Total assets | 41,262,274 | 8,395,566 |
Current liabilities: | ||
Accounts payable | 1,155,656 | 1,815,270 |
Accrued expenses | 2,973,215 | 2,008,361 |
Deferred collaboration revenue | 923,109 | |
Total current liabilities | 5,051,980 | 3,823,631 |
Deferred collaboration revenue | 574,685 | |
Convertible promissory notes | 12,965,480 | |
Total liabilities | 5,626,665 | 16,789,111 |
Commitments and contingencies (Note 7) | ||
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 December 31, 2023 and December 31, 2022, respectively | 8,793,637 | |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 14,405,325 and 2,590,197 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively | 1,441 | 259 |
Additional paid-in capital | 61,501,801 | 681,106 |
Subscription receivable | (11,250) | |
Accumulated deficit | (25,856,383) | (17,868,547) |
Total stockholders' equity (deficit) | 35,635,609 | (8,393,545) |
Total liabilities and stockholders' equity (deficit) | $ 41,262,274 | $ 8,395,566 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 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 | 200,000,000 |
Common stock, shares issued | 14,405,325 | 2,590,197 |
Common stock, shares outstanding | 14,405,325 | 2,590,197 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 6,002,206 | $ 0 |
Operating Expenses [Abstract] | ||
Research and development | 5,501,527 | 4,412,498 |
In-process research and development | 543,186 | 525,000 |
General and administrative | 7,833,481 | 4,847,080 |
Depreciation | 27,361 | 27,361 |
Total operating expenses | 13,905,555 | 9,811,939 |
Loss from operations | (7,903,349) | (9,811,939) |
Other income: | ||
Change in fair value of convertible promissory notes | 0 | (2,496,510) |
Other income, net | 639,365 | 63,673 |
Pre-tax loss | (7,263,984) | (12,244,776) |
Income tax expense | (723,852) | 0 |
Net loss | $ (7,987,836) | $ (12,244,776) |
Share information: | ||
Net loss per share of common stock, basic | $ (0.79) | $ (4.73) |
Net loss per share of common stock, diluted | $ (0.79) | $ (4.73) |
Weighted-average shares of common stock outstanding, basic | 10,163,850 | 2,590,173 |
Weighted-average shares of common stock outstanding, diluted | 10,163,850 | 2,590,173 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Initial Public Offering Convertible Promissory Notes | Initial Public Offering and Over-Allotment Option | 2023 Private Placement | 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 | Common Stock 2023 Private Placement | 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 | Additional Paid-in Capital 2023 Private Placement | Subscription Receivable | 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 | 207,346 | 207,346 | ||||||||||||||||
Net loss | (12,244,776) | (12,244,776) | ||||||||||||||||
Balance at Dec. 31, 2022 | (8,393,545) | $ 8,793,637 | $ 259 | 681,106 | (17,868,547) | |||||||||||||
Ending 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 , net of issuance costs | $ 14,136,428 | $ 23,952,887 | $ 329 | $ 437 | $ 14,136,099 | $ 23,952,450 | ||||||||||||
Sale of common stock, net of issuance costs (in shares) | 3,287,804 | 4,370,382 | ||||||||||||||||
Exercise of stock options | $ 89,947 | $ 8 | 89,939 | |||||||||||||||
Exercise of stock options (in shares) | 85,528 | 85,528 | ||||||||||||||||
Exercise of warrants | 11,250 | $ (11,250) | ||||||||||||||||
Exercise of warrants (in shares) | 1,500 | |||||||||||||||||
Stock-based compensation expense and vesting of restricted stock units | $ 872,248 | $ 2 | 872,246 | |||||||||||||||
Stock-based compensation expense and vesting of restricted stock units (in shares) | 16,500 | |||||||||||||||||
Net loss | (7,987,836) | (7,987,836) | ||||||||||||||||
Balance at Dec. 31, 2023 | $ 35,635,609 | $ 0 | $ 1,441 | $ 61,501,801 | $ (11,250) | $ (25,856,383) | ||||||||||||
Ending balance, shares at Dec. 31, 2023 | 0 | 14,405,325 |
STATEMENTS OF STOCKHOLDERS' E_2
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - Common Stock $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Initial Public Offering and Over-Allotment Option | |
Net of issuance costs | $ 2.3 |
2023 Private Placement | |
Issuance costs incurred | $ 2.5 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (7,987,836) | $ (12,244,776) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 27,361 | 27,361 |
Change in fair value of convertible promissory notes | 0 | 2,496,510 |
Stock-based compensation, including the issuance of restricted stock | 872,248 | 207,346 |
Debt issuance costs | 997,367 | |
Acquired in-process research and development assets | 543,186 | 525,000 |
Changes in operating assets and liabilities: | ||
Collaboration receivable | (7,500,000) | |
Prepaids and other current assets | 181,707 | (920,002) |
Accounts payable | 298,816 | 845,284 |
Accrued expenses | 877,913 | 826,556 |
Deferred collaboration revenue | 1,497,794 | |
Net cash used in operating activities | (11,188,811) | (7,239,354) |
Cash flows from investing activities: | ||
Purchase of in-process research and development assets | (543,186) | (525,000) |
Net cash used in investing activities | (543,186) | (525,000) |
Cash flows from financing activities: | ||
Proceed from sale of common stock from 2023 Private Placement, net of offering costs | 24,084,805 | |
Proceeds from issuance of common stock upon IPO, net of offering costs | 14,250,311 | |
Payment of deferred financing costs related to the IPO | (113,883) | |
Proceeds from issuance of convertible promissory notes | 10,468,970 | |
Payments of debt issuance costs | (997,367) | |
Proceeds from the exercise of stock options | 89,947 | 158 |
Net cash provided by financing activities | 38,425,063 | 9,357,878 |
Net increase in cash and cash equivalents | 26,693,066 | 1,593,524 |
Cash and cash equivalents as of beginning of the year | 5,933,702 | 4,340,178 |
Cash and cash equivalents as of end of the year | 32,626,768 | 5,933,702 |
Supplemental disclosures of non-cash financing activities: | ||
Conversion of convertible preferred stock upon IPO | 8,793,637 | |
Conversion of convertible promissory notes upon IPO | 12,965,480 | |
Subscription receivable related to warrant exercise | 11,250 | |
Financing costs related to the 2023 Private Placement in accrued expenses | 86,940 | |
Financing costs related to the 2023 Private Placement in accounts payable | $ 44,978 | |
Deferred financing costs related to the IPO in accrued expenses | $ 1,003,408 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (7,987,836) | $ (12,244,776) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and de scription 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 $ 25.9 million as of December 31, 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 assess its ability to continue as a going concern within 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). In the year ended December 31, 2023, the following events occurred: in January 2023, the Company received net proceeds of $ 14.1 million from the closing of its initial public offering (Note 8); in December 2023, the Company received net proceeds of $ 24.0 million from the closing of its private placement (Note 8), and in December 2023, the Company entered into a Development and License Agreement (the “DRL Development Agreement”) with Dr. Reddy’s Laboratories Ltd. (“DRL”), and its affiliate, Dr. Reddy’s Laboratories SA (collectively, “Dr. Reddy’s”), pursuant to which the Company received an upfront payment of $ 7.5 million in January 2024. As a result of these events, the going concern uncertainty that was disclosed in the financial statements for the year ended December 31, 2022 was alleviated during 2023. As of December 31, 2023, the Company had cash and cash equivalents of $ 32.6 million , which is expected to enable the Company to fund its operating expenses and capital expenditure requirements into 2026. The accompanying 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. 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 | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of presentation and significant accounting policies Basis of presentation The accompanying 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. 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, and the grant date fair value of stock options (Note 9), useful life of fixed assets, the allocation of transaction price as it relates to the Company's DRL Development Agreement, and accrued research and development expenses. Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. Fair value of financial instruments 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. Convertible promissory notes were recorded at fair value on a recurring basis (Note 3). Collaboration Revenues The Company’s revenues have been solely generated through the DRL Development Agreement Note 12,which falls under the scope of ASC Topic 808, Collaborative Arrangements ("ASC 808") as both parties are active participants in the arrangement that are exposed to significant risks and rewards. While this arrangement is within the scope of ASC 808, the Company analogizes to ASC 606 for some aspects of this arrangement, including delivery of a good or service (i.e. unit of account). Revenue recognized by analogizing to ASC 606 is recorded as collaboration revenue on the statements of operations. The terms of the arrangement includes payments to the Company of the following: nonrefundable, up-front license fees; regulatory and commercial milestone payments and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps:(i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company's revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Royalties: If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Amounts due to the Company for satisfying the revenue recognition criteria or that are contractually due based upon the terms of the collaboration agreements are recorded as collaboration receivable in the Company’s balance sheet. Contract liabilities consist of amounts received prior to satisfying the revenue recognition criteria, which are recorded as deferred collaboration revenue in the Company’s balance sheet. See Note 12 for a full discussion of the Company’s collaboration arrangement. There was no deferred revenue or receivables as of December 31, 2022. 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 maintains deposits in federally insured financial institutions in excess of federally insured limits. 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. Cash and cash equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in a money market account. Deferred financing costs The Company capitalizes costs that are directly associated with in-process equity and debt financing until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred financing costs are expensed. During the year ended December 31, 2023, the Company had incurred $ 2.5 million and $ 1.2 million in fees associated with its 2023 Private Placement and IPO, respectively, which were recorded against gross proceeds of each respective financing event within additional paid-in capital in the balance sheet. During the year ended December 31, 2022 , the Company incurred $ 1.1 million in fees associated with the IPO, which are recognized as deferred financing costs on the balance sheet as of December 31, 2022, and were subsequently recorded against gross proceeds upon the closing of the IPO in January 2023. The Company elected to account for its convertible promissory notes (Note 8) using the fair value option under ASC 815, and as such, issuance costs of $ 1.0 million were immediately expensed as a component of general and administrative expense in the statements of operations during the year ended December 31, 2022. 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. In-Process Research and Development Research and development costs incurred in obtaining technology licenses are charged to in-process 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 7, 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. Patent costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs were $ 0.1 million during the years ended December 31, 2023 and 2022, which are included in general and administrative expenses in the accompanying 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, 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 estimate and involve inherent uncertainties and the application of management’s judgment. 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. Fixed assets Fixed assets, which consist mainly of lab equipment, are carried at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful life of the assets. Research medical equipment is depreciated over the assets estimated useful lives of five years . Long-Lived Assets Long-lived assets, such as fixed assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Considerable management judgment is necessary to estimate discounted future cash flows. Accordingly, actual results could vary significantly from such estimates. The Company did no t recognize any impairment of long‑lived assets for the years ended December 31, 2023 or 2022 . 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 December 31, 2023 and 2022 , 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 attributable to common stockholders 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 two-class method is not applicable during periods with a net loss, as the holders of the convertible preferred stock have no obligation to fund losses. 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: As of December 31, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 2,736,488 Common stock warrants 2,492,241 92,184 Stock options 1,134,145 478,570 3,626,386 4,624,168 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 accumulated deficit. Recently issued but not yet adopted accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years beginning after December 16, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The company is currently evaluating the effect of this pronouncements on its disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | 3. Fa ir 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: December 31, 2023 Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 32,626,768 $ 32,626,768 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 8 Level 3 $ 12,965,480 $ 12,965,480 In April 2022 the Company issued unsecured convertible promissory notes to various investors. Due to the number of embedded provisions contained in the convertible promissory notes, the fair value option, as prescribed by ASC 815, was elected and applied in connection with the preparation of these financial statements. The fair value of the convertible promissory notes is determined using a scenario-based analysis that estimates the fair value based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the noteholders, including various IPO, settlement, equity financing, corporate transaction and dissolution scenarios. The Company adjusts the carrying value of the Notes to their estimated fair value at each reporting date, with qualifying increases or decreases in the fair value recorded as change in fair value of convertible promissory notes in the statements of operations. Changes in the fair value resulting from changes in the instrument-specific credit risk will be presented separately in other comprehensive income, however, through December 31, 2022, these changes have not been material to the financial statements. The Company measured the change in fair value related to instrument-specific credit risk by isolating the change in the fair value of the Notes resulting from the change in CCC option-adjusted spreads between measurement dates. 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 January 1, 2022 $ - Issuance of convertible promissory notes 10,468,970 Fair value adjustments 2,496,510 Balance at December 31, 2022 12,965,480 Conversion of convertible promissory notes upon IPO ( 12,965,480 ) Balance at December 31, 2023 $ - |
Prepaids and Other Current Asse
Prepaids and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid And Other Current Assets | 4. Prepaids and other current assets Prepaids and other current assets consist of: As of December 31, 2023 2022 Prepaid research and development $ 125,000 $ 175,860 Prepaid insurance 858,541 1,051,329 Prepaid other 86,016 24,075 $ 1,069,557 $ 1,251,264 |
Fixed Assets, Net
Fixed Assets, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets, Net | 5. Fixed assets, net Fixed assets, net consist of: As of December 31, 2023 2022 Lab equipment $ 136,804 $ 136,804 136,804 136,804 Less: accumulated depreciation ( 70,855 ) ( 43,494 ) $ 65,949 $ 93,310 Depreciation expense for both the years ended December 31, 2023, and 2022 was $ 27,361 . |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 6. Accrued expenses Accrued expenses consist of: As of December 31, 2023 2022 Accrued research and development $ 686,883 $ 135,864 Accrued payroll 1,081,262 927,006 Accrued professional fees 481,218 945,491 Accrued income tax 723,852 - $ 2,973,215 $ 2,008,361 |
Commitments and Contingencies,
Commitments and Contingencies, Including License and Sponsored Research Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies, Including License and Sponsored Research Agreements | 7 . Commitments and contingencies, including license and sponsored research agreements 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 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 $ 0.4 million. The Company will pay to DRL up to an aggregate of approximately $ 2.9 million of pre-approval regulatory milestone payments for the first indication in the Field (as defined in the DRL Agreement), of which the Company has paid an aggregate of $ 0.2 million to date, and an additional approximately $ 20.0 million 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). ARS 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, with the right to grant sublicenses through multiple tiers under these patents (the “ARS Option”). In consideration for the ARS Option, the Company paid ARS a one-time, non-refundable, non-creditable option fee of $ 0.1 million and a mid-six figure up-front fee, which were expensed as in-process research and development expense in the accompanying statements of operations for the year ended December 31, 2022. The Company may also 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 $ 13.3 million 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 $ 11.6 million 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 $ 11.8 million in developmental milestone payments. The Company will then pay an aggregate of $ 5.9 million in developmental milestone payments for each Mono Product in each subsequent new indication, and an aggregate of $ 5.9 million 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. Patent reimbursements paid by the Company to Methodist and its attorneys are included in general and administrative expenses in the accompanying statements of operations. Such costs were immaterial for the years ended December 31, 2023 and 2022 . In addition to the equity issuance and reimbursement of patent related expenses, the Methodist License requires the Company to make payments of up to $ 0.4 million 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 $ 0.1 million 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 (“HRMI”), 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 $ 1.5 million 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 approximately $ 0.5 million through May 2024. The Company incurred $ 0.3 million and $ 1.6 million in research and development expenses under the SRA during the years ended December 31, 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. Litigation Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. There are no matters currently outstanding. |
Convertible Promissory Notes, C
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Convertible Preferred Stock and Stockholders' Equity | 8. Convertible promissory notes, convertible preferred stock and stockholders’ equity (deficit) Private Placement On December 5, 2023, the Company entered into a securities purchase agreement with certain accredited investors for the issuance and sale in a private placement of 4,370,382 shares of its common stock at a price of $ 6.06 per share of common stock (the "2023 Private Placement"). The offering resulted in net proceeds of $ 24.0 million after deducting placement agent commissions and other offering expenses. In connection with the 2023 Private Placement and as a form of payment for services provided by a co-placement agent and financial advisor, the Company issued warrants to purchase up to 319,004 shares of common stock at an exercise price of $ 7.58 per share. Such warrants have a term of four years from issuance, and will be exercisable beginning six months from the closing of the 2023 Private Placement. 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 $ 13.0 million after deducting underwriting discounts, commissions, and other offering expenses paid by the Company, including additional costs incurred during the year ended December 31, 2023. The Company issued its underwriters 213,500 warrants with an exercise price of $ 6.25 per warrant and a contractual term of four years as additional consideration. In connection with the closing of the IPO, (i) all of the Company's outstanding shares of Series A convertible preferred stock ("Series A") converted into an aggregate of 1,316,926 shares of common stock, (ii) the Company's convertible promissory 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 term of four years . The Company received net proceeds of $ 1.1 million 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. During the year ended December 31, 2023, warrants related to the IPO were exercised for 1,500 shares of common stock. Such shares of common stock were released to the warrant holder prior to the receipt of proceeds for the exercise price of $ 7.50 per share, resulting in a subscription receivable in the balance sheet as of December 31, 2023. As of December 31, 2023, the Company had the following warrants outstanding to acquire shares of its common stock: Warrant Type Outstanding Exercise price per share Expiration date Common stock warrants issued related to the IPO 1,523,500 $ 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 Common stock warrants issued as compensation for the 2023 Private Placement 319,004 $ 7.58 December 2027 2,492,241 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | 9. 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 December 31, 2023, 1,244,857 shares of the Company’s common stock were authorized to be issued, of which 24,746 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 in the accompanying statements of operations as follows: Years Ended December 31, 2023 2022 General and administrative $ 545,149 $ 91,635 Research and development 327,099 115,711 $ 872,248 $ 207,346 Stock options The Company has issued service-based stock options that generally have a contractual term 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 years ended December 31, 2023: Weighted Weighted average Aggregate exercise contractual intrinsic Options price term (years) value Outstanding at January 1, 2023 478,570 $ 1.85 8.7 Granted 760,042 $ 3.90 Exercised ( 85,528 ) $ 1.17 $ 345,293 Forfeited ( 18,939 ) $ 3.48 Outstanding at December 31, 2023 1,134,145 $ 3.24 8.7 $ 4,724,761 Exercisable at December 31, 2023 442,679 $ 2.53 8.2 $ 2,158,479 Vested and expected to vest at December 31, 2023 1,134,145 $ 3.24 8.7 $ 4,724,761 As of December 31, 2023, the unrecognized compensation cost was $ 1.8 million , and will be recognized over an estimated weighted-average amortization period of 2.1 years. During the year ended December 31, 2023 , 2,784 options were net share settled, resulting in the issuance of 3,007 shares of common stock and 82,521 options were exercised on a cash basis. 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 years ended December 31, 2023 and 2022 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 term 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 years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions: Years Ended December 31, 2023 2022 Risk-free interest rate 4.0 % 3.3 % Expected term (years) 5.8 5.6 Expected volatility 93.82 % 83.48 % Expected dividend yield - - Restricted Stock Unit Awards During the year ended December 31, 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 $ 0.1 million for the year ended December 31, 2023. The following table summarizes activity related to RSU stock-based payment awards: Weighted Number of grant date Shares fair value Beginning balance at January 1, 2023 - $ - Granted and Vested 16,500 4.61 Ending balance at December 31, 2023 16,500 $ 4.61 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income taxes Income tax expense for the years ended December 31, 2023 and 2022 consists of the following: As of December 31, 2023 2022 U.S. federal Current $ 718,582 $ - Deferred - - Total U.S. federal 718,582 - State and local Current 5,270 - Deferred - - Total State and local 5,270 - Income tax expense $ 723,852 $ - A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: As of December 31, Rate reconciliation: 2023 2022 Federal tax benefit at statutory rate ( 21.0 ) % ( 21.0 ) % Permanent differences 0.2 4.6 State income tax ( 0.1 ) - Research and development credits ( 2.9 ) - Change in tax rate ( 0.2 ) - Change in valuation allowance 34.2 16.4 Other ( 0.1 ) - Total provision 10.1 % - % Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for years in which differences are expected to reverse. Significant components of the Company's deferred tax assets consisted of the following: As of December 31, Deferred tax assets 2023 2022 Startup costs $ 2,945,099 $ 1,502,023 Section 174 capitalization 1,860,806 873,687 Share-based compensation 144,105 51,795 Net operating losses 439,349 608,738 Accrued expenses and other 45,133 60,521 Capitalized license fees 47,526 47,250 Credit carryforwards 30,035 - Deferred revenue 121,388 - Fixed assets ( 8,325 ) ( 60 ) Valuation allowance ( 5,625,116 ) ( 3,143,954 ) Deferred tax assets, net of valuation allowance $ - $ - As of December 31, 2023 and 2022 , the Company had net operating loss carryforwards for federal income tax purposes of approximately $ 2.1 million and $ 2.9 million, respectively. Net operating losses are available to offset future federal taxable income. Generally, net operating losses generated after 2017 may be carried forward indefinitely but limited to 80 % of federal taxable income each year. In assessing the recoverability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company has determined that it is more likely than not that certain future tax benefits may not be realized as a result of current and future income. Accordingly, a valuation allowance has been recorded against all of the Company’s deferred tax assets. Net operating loss and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and are subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50 % as defined under Sections 382 and 383 in the Internal Revenue Code. Based upon our analysis, we have determined that such an ownership change has occurred and a Section 382 limitation has been applied in the current year to limit the amount of tax attributes utilized. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. The Company had no interest or penalties related to uncertain tax positions. All tax years of the Company from inception are open to examination by federal tax and state tax authorities. To the extent utilized in future years’ tax returns, net operating loss carryforwards as of December 31, 2023 will remain subject to examination until utilized. The Company has not been informed by any tax authorities for any jurisdiction that any of its tax years is under examination as of December 31, 2023 . |
Related Party Disclosures
Related Party Disclosures | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. Related party transactions During the year ended December 31, 2022 , in connection with issuance of the convertible promissory notes, the Company incurred debt issuance costs of $ 1.0 million, of which $ 0.7 million was paid to a related party, which was expensed as a component of general and administrative expense in the statements of operations. In addition, the Company incurred $ 0.7 million placement agent fees in connection with the issuance of the Company’s Series A, which were paid to an affiliate of the pre-Merger owners of Coya Therapeutics, Inc. As described in Note 8, the placement agent also received warrants for the purchase of 92,184 shares of the Company’s common stock. |
DRL Development Agreement
DRL Development Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DRL Development Agreement | 12. DRL Development Agreement In December 2023, the Company entered into a Development and License Agreement (the “DRL Development Agreement”) with DR. Reddy's, pursuant to which, among other things, the Company granted to DR. Reddy's an exclusive, royalty-bearing right and license (the "License") to commercialize COYA 302, a proprietary co-pack kit containing low dose IL-2 and CTLA4-Ig, (“COYA 302” or the “Product”) solely for use in patients with amyotrophic lateral sclerosis (“ALS" or the “Field”) in the United States, Canada, the European Union and the United Kingdom (collectively, the “New Territories”). The Company previously granted DRL an exclusive license to obtain regulatory approval and commercialize the Product for ALS and certain other indications in all other countries (other than the New Territories, Japan, Mexico, and in each country in South America), pursuant to the DRL Agreement entered between the Company and DRL, effective as of April 1, 2023 (Note 7). As part of the DRL Development Agreement, the Company is responsible for certain development activities to advance the Product through clinical development ("R&D Services"). The collaboration is managed by a joint steering committee (“JSC”) which is comprised of representatives from both parties. Decisions of the JSC are made by consensus. If the JSC is unable to reach a consensus, and the parties’ executives are not able to resolve the dispute, then Dr. Reddy’s has final decision-making authority, subject to specified limitations (as set forth in the DRL Development Agreement). Pursuant to the DRL Development Agreement, the Company is entitled to an up-front, nonrefundable payment of $ 7.5 million which was recorded as collaboration receivable as of December 31, 2023. Additionally, the Company is entitled to receive (i) an additional $ 4.2 million upon FDA acceptance of an Investigational New Drug, or IND, application for COYA 302 for the treatment of ALS and (ii) an additional $ 4.2 million payment upon the dosing of the first patient in the first phase 2 clinical trial for COYA 302 for the treatment of ALS in the United States. The DRL Development Agreement also calls for up to an aggregate of approximately $ 40.0 million in development milestones and up to an aggregate of approximately $ 677.3 million in sales milestones, related to the New Territories, should all such development and sales milestones be achieved. The Company will also be owed royalties by Dr. Reddy's on Net Sales (as defined in the DRL Development Agreement) of the Product in the low to mid-teens. Both parties shall discuss in good faith and agree in writing on the terms of a commercial supply agreement for the purpose of supply of COYA 302 to Dr. Reddy’s. No such agreement has been entered into at the time of the filing of this Annual Report on Form 10-K. The DRL Development Agreement expires on a country-by-country basis upon expiration of Dr. Reddy's obligation to make royalty payments for Product in each territory. Dr. Reddy's has the right to terminate the agreement upon specified prior written notice to the Company. Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or insolvency of, the other party. Either party may terminate the agreement in the event that the other party commences a legal action challenging the validity, enforceability or scope of any licensed patent rights. 7.5 million upfront payment in the transaction price as of the outset of the arrangement and allocated that transaction price to the two performance obligations based on the estimated stand-alone selling prices at contract inception. The stand-alone selling price of the License was based on a discounted cash flow approach and considered several factors including, but not limited to, discount rate, development timeline, regulatory risks, estimated market demand and future revenue potential using an adjusted market approach. The stand-alone selling price of the R&D Services was estimated using the expected cost-plus margin approach. During the year ended December 31, 2023, the Company allocated the transaction price to the performance obligations and recorded $ 6.0 million in transaction price associated with the License as collaboration revenue for the year ended December 31, 2023. The Company will recognize the remaining transaction price of $ 1.5 million allocated to the R&D Services over the period of performance, using an inputs approach. Any portion of a change in transaction price that is allocated to a satisfied or partially satisfied performance obligation will be recognized as revenue (or as a reduction in revenue) in the period of the transaction price change on a cumulative catch-up basis. The commercial milestones and sales-based royalties will be recognized when earned (i.e., the later of when the subsequent sales occur or the performance obligation has been satisfied). |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent events The Company has evaluated subsequent events from the balance sheet date through March 19, 2024, the date at which the financial statements were issued and has determined that there are no such events to report outside of the below: In January 2023, the Company received the up-front, nonrefundable payment of $ 7.5 million from Dr. Reddy's, pursuant to the DRL Development Agreement. |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The accompanying 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. |
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, and the grant date fair value of stock options (Note 9), useful life of fixed assets, the allocation of transaction price as it relates to the Company's DRL Development Agreement, and accrued research and development expenses. |
Segment Information | Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. |
Fair Value of Financial Instruments | 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. Convertible promissory notes were recorded at fair value on a recurring basis (Note 3). |
Collaboration Revenues | Collaboration Revenues The Company’s revenues have been solely generated through the DRL Development Agreement Note 12,which falls under the scope of ASC Topic 808, Collaborative Arrangements ("ASC 808") as both parties are active participants in the arrangement that are exposed to significant risks and rewards. While this arrangement is within the scope of ASC 808, the Company analogizes to ASC 606 for some aspects of this arrangement, including delivery of a good or service (i.e. unit of account). Revenue recognized by analogizing to ASC 606 is recorded as collaboration revenue on the statements of operations. The terms of the arrangement includes payments to the Company of the following: nonrefundable, up-front license fees; regulatory and commercial milestone payments and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps:(i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company's revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Royalties: If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Amounts due to the Company for satisfying the revenue recognition criteria or that are contractually due based upon the terms of the collaboration agreements are recorded as collaboration receivable in the Company’s balance sheet. Contract liabilities consist of amounts received prior to satisfying the revenue recognition criteria, which are recorded as deferred collaboration revenue in the Company’s balance sheet. See Note 12 for a full discussion of the Company’s collaboration arrangement. There was no deferred revenue or receivables as of December 31, 2022. |
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 maintains deposits in federally insured financial institutions in excess of federally insured limits. 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. |
Cash and Cash Equivalents | Cash and cash equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in a money market account. |
Deferred Financing Costs | Deferred financing costs The Company capitalizes costs that are directly associated with in-process equity and debt financing until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred financing costs are expensed. During the year ended December 31, 2023, the Company had incurred $ 2.5 million and $ 1.2 million in fees associated with its 2023 Private Placement and IPO, respectively, which were recorded against gross proceeds of each respective financing event within additional paid-in capital in the balance sheet. During the year ended December 31, 2022 , the Company incurred $ 1.1 million in fees associated with the IPO, which are recognized as deferred financing costs on the balance sheet as of December 31, 2022, and were subsequently recorded against gross proceeds upon the closing of the IPO in January 2023. The Company elected to account for its convertible promissory notes (Note 8) using the fair value option under ASC 815, and as such, issuance costs of $ 1.0 million were immediately expensed as a component of general and administrative expense in the statements of operations during the year ended December 31, 2022. |
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. |
In-Process Research and Development | In-Process Research and Development Research and development costs incurred in obtaining technology licenses are charged to in-process 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 7, 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. |
Patent Costs | Patent costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs were $ 0.1 million during the years ended December 31, 2023 and 2022, which are included in general and administrative expenses in the accompanying 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, 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 estimate and involve inherent uncertainties and the application of management’s judgment. 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. |
Fixed Assets | Fixed assets Fixed assets, which consist mainly of lab equipment, are carried at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful life of the assets. Research medical equipment is depreciated over the assets estimated useful lives of five years . |
Long-Lived Assets | Long-Lived Assets Long-lived assets, such as fixed assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Considerable management judgment is necessary to estimate discounted future cash flows. Accordingly, actual results could vary significantly from such estimates. The Company did no t recognize any impairment of long‑lived assets for the years ended December 31, 2023 or 2022 . |
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 December 31, 2023 and 2022 , 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 attributable to common stockholders 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 two-class method is not applicable during periods with a net loss, as the holders of the convertible preferred stock have no obligation to fund losses. 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: As of December 31, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 2,736,488 Common stock warrants 2,492,241 92,184 Stock options 1,134,145 478,570 3,626,386 4,624,168 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 accumulated deficit. Recently issued but not yet adopted accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years beginning after December 16, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The company is currently evaluating the effect of this pronouncements on its disclosures. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 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: As of December 31, 2023 2022 Series A Convertible Preferred Stock - 1,316,926 Convertible promissory notes (as converted) - 2,736,488 Common stock warrants 2,492,241 92,184 Stock options 1,134,145 478,570 3,626,386 4,624,168 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 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: December 31, 2023 Note Input Level Fair Value Carrying Assets: Cash and cash equivalents (money market funds) Level 1 $ 32,626,768 $ 32,626,768 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 8 Level 3 $ 12,965,480 $ 12,965,480 |
Summary of Changes in the Fair Value of Level 3 Contingent Consideration | 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 January 1, 2022 $ - Issuance of convertible promissory notes 10,468,970 Fair value adjustments 2,496,510 Balance at December 31, 2022 12,965,480 Conversion of convertible promissory notes upon IPO ( 12,965,480 ) Balance at December 31, 2023 $ - |
Prepaids and Other Current As_2
Prepaids and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaids and other current assets consist of: As of December 31, 2023 2022 Prepaid research and development $ 125,000 $ 175,860 Prepaid insurance 858,541 1,051,329 Prepaid other 86,016 24,075 $ 1,069,557 $ 1,251,264 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of Fixed Assets | Fixed assets, net consist of: As of December 31, 2023 2022 Lab equipment $ 136,804 $ 136,804 136,804 136,804 Less: accumulated depreciation ( 70,855 ) ( 43,494 ) $ 65,949 $ 93,310 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of: As of December 31, 2023 2022 Accrued research and development $ 686,883 $ 135,864 Accrued payroll 1,081,262 927,006 Accrued professional fees 481,218 945,491 Accrued income tax 723,852 - $ 2,973,215 $ 2,008,361 |
Convertible Promissory Notes,_2
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Acquire Shares of Common Stock | As of December 31, 2023, the Company had the following warrants outstanding to acquire shares of its common stock: Warrant Type Outstanding Exercise price per share Expiration date Common stock warrants issued related to the IPO 1,523,500 $ 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 Common stock warrants issued as compensation for the 2023 Private Placement 319,004 $ 7.58 December 2027 2,492,241 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Options Activity | The following table summarizes the activity for the years ended December 31, 2023: Weighted Weighted average Aggregate exercise contractual intrinsic Options price term (years) value Outstanding at January 1, 2023 478,570 $ 1.85 8.7 Granted 760,042 $ 3.90 Exercised ( 85,528 ) $ 1.17 $ 345,293 Forfeited ( 18,939 ) $ 3.48 Outstanding at December 31, 2023 1,134,145 $ 3.24 8.7 $ 4,724,761 Exercisable at December 31, 2023 442,679 $ 2.53 8.2 $ 2,158,479 Vested and expected to vest at December 31, 2023 1,134,145 $ 3.24 8.7 $ 4,724,761 |
Summary of Stock Based Compensation in Statement of Operations | The Company has recorded stock-based compensation in the accompanying statements of operations as follows: Years Ended December 31, 2023 2022 General and administrative $ 545,149 $ 91,635 Research and development 327,099 115,711 $ 872,248 $ 207,346 |
Summary of Estimated Black-Scholes Option-Pricing Model Using the Weighted-Average Assumptions | The grant date fair value of each option grant for the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions: Years Ended December 31, 2023 2022 Risk-free interest rate 4.0 % 3.3 % Expected term (years) 5.8 5.6 Expected volatility 93.82 % 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: Weighted Number of grant date Shares fair value Beginning balance at January 1, 2023 - $ - Granted and Vested 16,500 4.61 Ending balance at December 31, 2023 16,500 $ 4.61 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of IncomeTax Expense | Income tax expense for the years ended December 31, 2023 and 2022 consists of the following: As of December 31, 2023 2022 U.S. federal Current $ 718,582 $ - Deferred - - Total U.S. federal 718,582 - State and local Current 5,270 - Deferred - - Total State and local 5,270 - Income tax expense $ 723,852 $ - |
Summary of Reconciliation of Income Tax Benefit at the Statutory Federal Income Tax Rate and Income Taxes | A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: As of December 31, Rate reconciliation: 2023 2022 Federal tax benefit at statutory rate ( 21.0 ) % ( 21.0 ) % Permanent differences 0.2 4.6 State income tax ( 0.1 ) - Research and development credits ( 2.9 ) - Change in tax rate ( 0.2 ) - Change in valuation allowance 34.2 16.4 Other ( 0.1 ) - Total provision 10.1 % - % |
Components of Deferred Tax Assets | Significant components of the Company's deferred tax assets consisted of the following: As of December 31, Deferred tax assets 2023 2022 Startup costs $ 2,945,099 $ 1,502,023 Section 174 capitalization 1,860,806 873,687 Share-based compensation 144,105 51,795 Net operating losses 439,349 608,738 Accrued expenses and other 45,133 60,521 Capitalized license fees 47,526 47,250 Credit carryforwards 30,035 - Deferred revenue 121,388 - Fixed assets ( 8,325 ) ( 60 ) Valuation allowance ( 5,625,116 ) ( 3,143,954 ) Deferred tax assets, net of valuation allowance $ - $ - |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jan. 25, 2023 | Jan. 31, 2024 | Dec. 31, 2023 | Jan. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Accumulated deficit | $ 25,856,383 | $ 25,856,383 | $ 17,868,547 | |||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | 14,250,311 | |||||
Cash and cash equivalents | 32,626,768 | 32,626,768 | $ 5,933,702 | |||
Subsequent Event | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Upfront payment received | $ 7,500,000 | |||||
DRL Development Agreement | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Proceeds from issuance of private placement | $ 24,000,000 | |||||
IPO | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 14,100,000 | $ 13,000,000 | ||||
Over-Allotment | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Net proceeds from issuance of common stock upon initial public offering, net of offering costs | $ 1,100,000 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | |
Significant Accounting Policies [Line Items] | ||
Number of operating segments | Segment | 1 | |
Deferred revenue | $ 0 | |
Deferred receivables | 0 | |
Deferred financing costs | 1,117,290 | |
Expected dividend yield | 0% | |
Impairment of long-lived assets | $ 0 | 0 |
Uncertain tax positions, interest, or penalties | 0 | 0 |
Unrecognized income tax benefits | $ 0 | 0 |
ASU 2016-03 | ||
Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | |
IPO | ||
Significant Accounting Policies [Line Items] | ||
Deferred financing costs | 1,100,000 | |
Issuance costs incurred | $ 1,200,000 | |
2023 Private Placement | ||
Significant Accounting Policies [Line Items] | ||
Issuance costs incurred | $ 2,500,000 | |
Research Medical Equipment | ||
Significant Accounting Policies [Line Items] | ||
Estimated useful lives | 5 years | |
General and Administrative Expense | Convertible Notes | ||
Significant Accounting Policies [Line Items] | ||
Debt issuance costs | 1,000,000 | |
Patent | General and Administrative Expense | ||
Significant Accounting Policies [Line Items] | ||
Patent costs | $ 100,000 | $ 100,000 |
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 | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,626,386 | 4,624,168 |
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 | 2,736,488 | |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 2,492,241 | 92,184 |
Employee Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,134,145 | 478,570 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary Of Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents (money market funds), Carrying Value | $ 32,626,768 | $ 5,933,702 |
Fair Value, Recurring | Level 1 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents (money market funds), Fair Value | 32,626,768 | 5,933,702 |
Cash and cash equivalents (money market funds), Carrying Value | $ 32,626,768 | 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 - 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 - Sum_2
Fair Value Measurements - Summary Of Changes in the Fair Value of Level 3 Contingent Consideration (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Balance at beginning of year | $ 12,965,480 | |
Issuance of convertible promissory notes | $ 10,468,970 | |
Conversion of convertible promissory notes upon IPO | $ (12,965,480) | |
Fair value adjustments | 2,496,510 | |
Balance at ending of year | $ 12,965,480 |
Prepaid and Other Current Asset
Prepaid and Other Current Assets - Schedule of Prepaid and Other Current Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 125,000 | $ 175,860 |
Prepaid insurance | 858,541 | 1,051,329 |
Prepaid other | 86,016 | 24,075 |
Prepaid and other current assets | $ 1,069,557 | $ 1,251,264 |
Fixed Assets, Net - Summary of
Fixed Assets, Net - Summary of Fixed Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 136,804 | $ 136,804 |
Less: accumulated depreciation | (70,855) | (43,494) |
Property, plant and equipment, net | 65,949 | 93,310 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 136,804 | $ 136,804 |
Fixed Assets, Net - Additional
Fixed Assets, Net - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 27,361 | $ 27,361 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development | $ 686,883 | $ 135,864 |
Accrued payroll | 1,081,262 | 927,006 |
Accrued professional fees | 481,218 | 945,491 |
Accrued income tax | 723,852 | |
Accrued expenses | $ 2,973,215 | $ 2,008,361 |
Commitments and Contingencies_2
Commitments and Contingencies, Including License and Sponsored Research Agreements - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||
Jan. 01, 2025 USD ($) | Mar. 16, 2023 USD ($) | Oct. 06, 2020 USD ($) | Aug. 31, 2022 USD ($) Patents | Feb. 28, 2021 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | May 04, 2023 USD ($) | |
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] | ||||||||
Pre-approval regulatory milestone payments | $ 2,900,000 | |||||||
Aggregate regulatory milestone payments | 200,000 | |||||||
Additional payments of other development and sales milestones | 20,000,000 | |||||||
License agreement upfront fee | $ 400,000 | |||||||
ARS License Agreement | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Number of patent acquired | Patents | 2 | |||||||
License agreement option fee | $ 100,000 | |||||||
Developmental milestones | $ 5,900,000 | |||||||
ARS License Agreement | First Combination Product | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Developmental milestones | 13,300,000 | |||||||
ARS License Agreement | Combination Product | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Developmental milestones | 11,600,000 | |||||||
ARS License Agreement | First Mono Product | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Developmental milestones | 11,800,000 | |||||||
ARS License Agreement | Mono Product | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Developmental milestones | $ 5,900,000 | |||||||
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. | $ 400,000 | |||||||
Methodist research fund | $ 500,000 | |||||||
Methodist License | Scenario Forecast | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Minimum annual amount owned upon commercialization | $ 100,000 | |||||||
Sponsored Research Agreement | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Methodist research fund | $ 1,500,000 | |||||||
Agreement Period | 1 year | |||||||
Research and development expenses | $ 300,000 | $ 1,600,000 |
Convertible Promissory Notes -
Convertible Promissory Notes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Jan. 03, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||
Proceeds from issuance of convertible notes | $ 10,468,970 | ||
Change in fair value of convertible promissory notes | $ 0 | (2,496,510) | |
Payments of debt issuance costs | 997,367 | ||
Common stock issued | $ 1,441 | $ 259 | |
IPO | |||
Debt Instrument [Line Items] | |||
Convertible into share of common stock | 1,316,926 | ||
Class of warrant purchase | 1,525,000 | ||
Class of warrant exercise price | $ 7.5 | $ 7.5 |
Convertible Promissory Notes,_3
Convertible Promissory Notes, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||||
Dec. 05, 2023 USD ($) $ / shares shares | Jan. 25, 2023 USD ($) $ / shares shares | Jan. 03, 2023 $ / shares shares | Jan. 31, 2023 USD ($) | Dec. 31, 2022 $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Class of Stock [Line Items] | |||||||
Proceeds from issuance of common stock upon IPO, net of offering costs | $ | $ 14,250,311 | ||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||||
Preferred stock, shares authorized | 10,000,000 | ||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Series A convertible preferred stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Reverse stock split, conversion ratio | 0.1756 | ||||||
Reverse stock split description | one-for-5.6955 | ||||||
2023 Private Placement | |||||||
Class of Stock [Line Items] | |||||||
Stock issued during period, shares | 4,370,382 | ||||||
Sale of stock per share | $ / shares | $ 6.06 | ||||||
Proceeds from issuance of private placement | $ | $ 24,000,000 | ||||||
Class of warrant purchase | 319,004 | ||||||
Class of warrant exercise price | $ / shares | $ 7.58 | ||||||
Stock issued during period, value | $ | $ 23,952,887 | ||||||
IPO | |||||||
Class of Stock [Line Items] | |||||||
Sale of stock per share | $ / shares | $ 5 | ||||||
Class of warrant purchase | 1,525,000 | ||||||
Class of warrant exercise price | $ / shares | $ 7.5 | $ 7.5 | |||||
Transaction date | Jan. 03, 2023 | ||||||
Shares issued | 3,050,000 | ||||||
Proceeds from issuance of common stock upon IPO, net of offering costs | $ | $ 14,100,000 | $ 13,000,000 | |||||
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 | ||||||
Warrants exercised | 1,500 | ||||||
Underwriters | |||||||
Class of Stock [Line Items] | |||||||
Class of warrant purchase | 16,646 | 213,500 | |||||
Class of warrant exercise price | $ / shares | $ 6.25 | $ 6.25 | |||||
Warrant contractual life | 4 years | 4 years | |||||
Over-Allotment | |||||||
Class of Stock [Line Items] | |||||||
Sale of stock per share | $ / shares | $ 5 | $ 5 | |||||
Class of warrant purchase | 145,000 | 145,000 | |||||
Class of warrant exercise price | $ / shares | $ 7.5 | ||||||
Shares issued | 237,804 | ||||||
Proceeds from issuance of common stock upon IPO, net of offering costs | $ | $ 1,100,000 | ||||||
Underwriter over allotment option period | 30 days | ||||||
Over-Allotment | Maximum | |||||||
Class of Stock [Line Items] | |||||||
Shares issued | 290,000 |
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 | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 05, 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 | $ 7.5 | ||
Over-Allotment | ||||
Class of Warrant or Right [Line Items] | ||||
Outstanding | 145,000 | 145,000 | ||
Exercise price per share | $ 7.5 | |||
Underwriters | ||||
Class of Warrant or Right [Line Items] | ||||
Outstanding | 16,646 | 213,500 | ||
Exercise price per share | $ 6.25 | $ 6.25 | ||
2023 Private Placement | ||||
Class of Warrant or Right [Line Items] | ||||
Outstanding | 319,004 | |||
Exercise price per share | $ 7.58 | |||
Common Stock Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Outstanding | 2,492,241 | |||
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 | 1,523,500 | |||
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 | |||
Common Stock Warrants | 2023 Private Placement | ||||
Class of Warrant or Right [Line Items] | ||||
Outstanding | 319,004 | |||
Exercise price per share | $ 7.58 | |||
Expiration date | 2027-12 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Service-based stock options that generally have a contractual life | 8 years 8 months 12 days | 8 years 8 months 12 days |
Unrecognized compensation cost | $ 1,800,000 | |
Weighted-average amortization period | 2 years 1 month 6 days | |
Expected dividend yield | 0% | |
Stock-based compensation expense | $ 872,248 | $ 207,346 |
Common stock, shares issued | 14,405,325 | 2,590,197 |
Options exercised | 85,528 | |
Employee Stock Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Options, net share settled | 2,784 | |
Common stock, shares issued | 3,007 | |
Options exercised | 82,521 | |
Employee Stock Option | 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 | $ 100,000 | |
2021 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock were authorized to be issued | 1,244,857 | |
Shares were available for future issuance | 24,746 |
Stock-based compensation - Summ
Stock-based compensation - Summary of Stock Based Compensation in Statement of Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 872,248 | $ 207,346 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | 545,149 | 91,635 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 327,099 | $ 115,711 |
Stock-based compensation - Su_2
Stock-based compensation - Summary of Stock Options Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding at January 1, 2023, Options | 478,570 | |
Granted, Options | 760,042 | |
Exercised, Options | (85,528) | |
Forfeited, Options | (18,939) | |
Outstanding at December 31, 2023, Options | 1,134,145 | 478,570 |
Exercisable at December 31, 2023, Options | 442,679 | |
Vested and expected to vest at December 31, 2023, Options | 1,134,145 | |
Outstanding at January 1, 2023, Weighted average exercise price | $ 1.85 | |
Granted, Weighted average exercise price | 3.9 | |
Exercised, Weighted average exercise price | 1.17 | |
Forfeited, Weighted average exercise price | 3.48 | |
Outstanding at December 31, 2023, Weighted average exercise price | 3.24 | $ 1.85 |
Exercisable at December 31, 2023, Weighted average exercise price | 2.53 | |
Vested and expected to vest at December 31, 2023, Weighted average exercise price | $ 3.24 | |
Outstanding, Weighted average remaining contractual term (years) | 8 years 8 months 12 days | 8 years 8 months 12 days |
Exercisable at December 31, 2023, Weighted average remaining contractual term (years) | 8 years 2 months 12 days | |
Vested and expected to vest at December 31, 2023, Weighted average remaining contractual term (years) | 8 years 8 months 12 days | |
Exercised, Aggregate intrinsic value | $ 345,293 | |
Outstanding at December 31, 2023, Aggregate intrinsic value | 4,724,761 | |
Exercisable at December 31, 2023, Aggregate intrinsic value | 2,158,479 | |
Vested and expected to vest at December 31, 2023, Aggregate intrinsic value | $ 4,724,761 |
Stock-based compensation - Su_3
Stock-based compensation - Summary of Estimated Black-Scholes Option-Pricing Model Using the Weighted-Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 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 | 93.82% | 83.48% |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of RSU Stock-Based Payment Awards Activity (Details) - Restricted Stock Unit Awards | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Granted and Vested, Number of Shares | shares | 16,500 |
Ending Balance at December 31, 2023, Number of Shares | shares | 16,500 |
Granted and Vested, Weighted average grant date fair value | $ / shares | $ 4.61 |
Ending Balance at December 31, 2023, Weighted average grant date fair value | $ / shares | $ 4.61 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
U.S. federal | ||
Current | $ 718,582 | |
Total U.S. federal | 718,582 | |
State and local | ||
Current | 5,270 | |
Total State and local | 5,270 | |
Income tax expense | $ 723,852 | $ 0 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Tax Benefit at the Statutory Federal Income Tax Rate and Income Taxes (Detail) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal tax benefit at statutory rate | (21.00%) | (21.00%) |
Permanent differences | 0.20% | 4.60% |
State income tax | (0.10%) | |
Research and development credits | (2.90%) | |
Change in tax rate | (0.20%) | |
Change in valuation allowance | 34.20% | 16.40% |
Other | (0.10%) | |
Total provision | 10.10% | 0% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Startup costs | $ 2,945,099 | $ 1,502,023 |
Section 174 capitalization | 1,860,806 | 873,687 |
Share-based compensation | 144,105 | 51,795 |
Net operating losses | 439,349 | 608,738 |
Accrued expenses and other | 45,133 | 60,521 |
Capitalized license fees | 47,526 | 47,250 |
Credit carryforwards | 30,035 | |
Deferred revenue | 121,388 | |
Fixed assets | (8,325) | (60) |
Valuation allowance | (5,625,116) | (3,143,954) |
Deferred tax assets, net of valuation allowance | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Operating loss carry forward percentage, limited | 80% | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 2.1 | $ 2.9 |
Internal Revenue Service (IRS) | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, limitations on use | Net operating loss and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and are subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50% as defined under Sections 382 and 383 in the Internal Revenue Code. Based upon our analysis, we have determined that such an ownership change has occurred and a Section 382 limitation has been applied in the current year to limit the amount of tax attributes utilized. | |
Operating loss carry forwards, excess percentage of ownership interest | 50% |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) shares | |
Related Party Transaction [Line Items] | |
Payments of debt issuance costs | $ 997,367 |
Convertible Promissory Notes | General and Administrative Expense | |
Related Party Transaction [Line Items] | |
Debt issuance costs | 1,000,000 |
Payments of debt issuance costs | 700,000 |
Affiliate of Pre-Merger Owners of Coya Therapeutics, Inc. | Series A Convertible Preferred Stock | |
Related Party Transaction [Line Items] | |
Placement agent fees | $ 700,000 |
Common Stock Warrants | |
Related Party Transaction [Line Items] | |
Purchase of warrant | shares | 92,184 |
DRL Development Agreement - Add
DRL Development Agreement - Additional Information (Details) - DRL Development Agreement $ in Millions | 1 Months Ended | 12 Months Ended |
Dec. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Upfront nonrefundable payment receivable | $ 7.5 | $ 7.5 |
Transaction price allocated to performance obligation, revenue recognized | 6 | |
Maximum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Development milestones | 40 | |
Sales milestones | 677.3 | |
Treatment for ALS | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Additional Payment entitled to receive | 4.2 | |
Addtional payment receivable upon dosing of the first patient | 4.2 | |
R&D Services | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Transaction price allocated to performance obligation | $ 1.5 | $ 1.5 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ in Millions | Jan. 31, 2023 USD ($) |
DRL Development Agreement | |
Subsequent Event [Line Items] | |
Upfront nonrefundable payment received | $ 7.5 |