Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CINC | |
Entity Registrant Name | CinCor Pharma, Inc. | |
Entity Central Index Key | 0001868734 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.00001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-41201 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4931245 | |
Entity Address, Address Line One | 230 Third Avenue, | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 844 | |
Local Phone Number | 531-1834 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity Common Stock Shares Outstanding | 43,764,323 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 292,556,851 | $ 136,605,613 |
Marketable securities | 229,939,796 | 0 |
Prepaid research and development contracts | 5,925,991 | 1,769,074 |
Prepaid expenses and other current assets | 596,728 | 2,731,953 |
Total current assets | 529,019,366 | 141,106,640 |
Long term assets: | ||
Property and equipment, net | 99,722 | 0 |
Assets, Noncurrent, Total | 99,722 | 0 |
Total assets | 529,119,088 | 141,106,640 |
Current liabilities: | ||
Accounts payable | 2,588,400 | 642,143 |
Related-party accounts payable | 0 | 7,323 |
Warrant derivative liabilities | 0 | 10,636,921 |
Accrued legal expenses | 430,131 | 2,104,766 |
Accrued research and development contracts | 4,681,756 | 1,751,530 |
Accrued expenses and other liabilities | 2,481,232 | 1,406,506 |
Total current liabilities | 10,181,519 | 16,549,189 |
Stockholders' equity (deficit): | ||
Common stock, $0.00001 par value per share; 95,000,000 and 13,731,721 shares authorized, and 43,764,323 and 2,557,341 outstanding at September 30, 2022 and December 31, 2021, respectively | 438 | 26 |
Additional paid-in capital | 656,273,482 | 13,986,033 |
Accumulated deficit | (136,452,934) | (77,703,069) |
Accumulated other comprehensive loss | (883,417) | 0 |
Total stockholders equity (deficit) | 518,937,569 | (63,717,010) |
Total liabilities, redeemable convertible preferred stock, and stockholders equity (deficit) | 529,119,088 | 141,106,640 |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Current liabilities: | ||
Redeemable convertible preferred stock | 0 | 47,173,259 |
Series B Redeemable Convertible Preferred Stock [Member] | ||
Current liabilities: | ||
Redeemable convertible preferred stock | $ 0 | $ 141,101,202 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock, par value per share | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 95,000,000 | 13,731,721 |
Common stock, shares outstanding | 43,764,323 | 2,557,341 |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Temporary equity, par value | $ 0.00001 | $ 0.00001 |
Temporary equity, shares authorized | 0 | 35,714,282 |
Temporary equity, shares outstanding | 0 | 35,714,282 |
Series B Redeemable Convertible Preferred Stock [Member] | ||
Temporary equity, par value | $ 0.00001 | $ 0.00001 |
Temporary equity, shares authorized | 0 | 35,716,249 |
Temporary equity, shares outstanding | 0 | 35,716,249 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses | ||||
Research and development | $ 17,725,092 | $ 4,647,620 | $ 44,576,704 | $ 12,135,441 |
General and administrative | 4,519,288 | 3,042,278 | 12,724,801 | 5,141,861 |
Total operating expenses | 22,244,380 | 7,689,898 | 57,301,504 | 17,277,302 |
Loss from operations | (22,244,380) | (7,689,898) | (57,301,504) | (17,277,302) |
Other (income) expense: | ||||
Interest income | (1,266,821) | (1,947) | (1,595,646) | (7,899) |
Change in fair value of warrant derivative liabilities | 0 | 1,335,852 | 3,044,006 | 3,755,509 |
Total other (income) expense, net | 1,266,821 | (1,333,905) | 1,448,360 | 3,747,610 |
Net loss | $ (20,977,559) | $ (9,023,803) | $ (58,749,865) | $ (21,024,912) |
Earnings Per Share, Basic [Abstract] | ||||
Net loss per share attributable to common stockholders, basic | $ (0.51) | $ (5.19) | $ (1.57) | $ (14.59) |
Net loss per share attributable to common stockholders, diluted | $ (0.51) | $ (5.19) | $ (1.57) | $ (14.59) |
Weighted average number of common shares used in computing net loss per share attributable to common stockholders, basic | 40,806,123 | 1,739,516 | 37,343,549 | 1,440,916 |
Weighted average number of common shares used in computing net loss per share attributable to common stockholders, diluted | 40,806,123 | 1,739,516 | 37,343,549 | 1,440,916 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (20,977,559) | $ (9,023,803) | $ (58,749,865) | $ (21,024,912) |
Other comprehensive loss: | ||||
Unrealized losses on available-for-sale securities | (171,651) | 0 | (883,417) | 0 |
Comprehensive loss | $ (21,149,210) | $ (9,023,803) | $ (59,633,282) | $ (21,024,912) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (unaudited) - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Series A Redeemable Convertible Preferred Stock [Member] | Series A Redeemable Convertible Preferred Stock [Member] Preferred Stock [Member] | Series B Redeemable Convertible Preferred Stock [Member] | Series B Redeemable Convertible Preferred Stock [Member] Preferred Stock [Member] |
Temporary equity balance, Value at Dec. 31, 2020 | $ 47,173,259 | ||||||||
Temporary equity balance, Shares at Dec. 31, 2020 | 35,714,282 | ||||||||
Balance at Dec. 31, 2020 | $ (27,264,652) | $ 13 | $ 69,330 | $ (27,333,995) | |||||
Balance, Shares at Dec. 31, 2020 | 1,250,000 | ||||||||
Stock-based compensation expense | 1,389,955 | 1,389,955 | |||||||
Net loss | (5,618,411) | (5,618,411) | |||||||
Temporary equity balance, Value at Mar. 31, 2021 | 47,173,259 | ||||||||
Temporary equity balance, Shares at Mar. 31, 2021 | 35,714,282 | ||||||||
Balance at Mar. 31, 2021 | (31,493,108) | $ 13 | 1,459,285 | (32,952,406) | |||||
Balance, Shares at Mar. 31, 2021 | 1,250,000 | ||||||||
Temporary equity balance, Value at Dec. 31, 2020 | 47,173,259 | ||||||||
Temporary equity balance, Shares at Dec. 31, 2020 | 35,714,282 | ||||||||
Balance at Dec. 31, 2020 | (27,264,652) | $ 13 | 69,330 | (27,333,995) | |||||
Balance, Shares at Dec. 31, 2020 | 1,250,000 | ||||||||
Proceeds from exercise of stock options | 1,232,799 | ||||||||
Other comprehensive loss | 0 | ||||||||
Balance at Sep. 30, 2021 | (44,805,615) | $ 14 | 3,553,279 | (48,358,908) | 47,173,259 | $ 133,352,758 | |||
Balance, Shares at Sep. 30, 2021 | 1,392,636 | 35,714,282 | 33,702,500 | ||||||
Temporary equity balance, Value at Mar. 31, 2021 | 47,173,259 | ||||||||
Temporary equity balance, Shares at Mar. 31, 2021 | 35,714,282 | ||||||||
Balance at Mar. 31, 2021 | (31,493,108) | $ 13 | 1,459,285 | (32,952,406) | |||||
Balance, Shares at Mar. 31, 2021 | 1,250,000 | ||||||||
Stock options exercised | 1,232,800 | $ 1 | 1,232,799 | ||||||
Stock options exercised, shares | 142,636 | ||||||||
Stock-based compensation expense | 293,849 | 293,849 | |||||||
Net loss | (6,382,699) | (6,382,699) | |||||||
Temporary equity balance, Value at Jun. 30, 2021 | 47,173,259 | ||||||||
Temporary equity balance, Shares at Jun. 30, 2021 | 35,714,282 | ||||||||
Balance at Jun. 30, 2021 | (36,349,158) | $ 14 | 2,985,933 | $ 0 | (39,335,105) | ||||
Balance, Shares at Jun. 30, 2021 | 1,392,636 | ||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs, shares | 33,702,500 | ||||||||
Issuance of redeemable convertible preferred stock, net of issuance costs | $ 134,219,013 | ||||||||
Allocation of proceeds to warrant derivavative liabilities | (866,255) | ||||||||
Stock-based compensation expense | 567,346 | 567,346 | |||||||
Other comprehensive loss | 0 | ||||||||
Net loss | (9,023,803) | (9,023,803) | |||||||
Balance at Sep. 30, 2021 | (44,805,615) | $ 14 | 3,553,279 | (48,358,908) | 47,173,259 | 133,352,758 | |||
Balance, Shares at Sep. 30, 2021 | 1,392,636 | 35,714,282 | 33,702,500 | ||||||
Temporary equity balance, Value at Dec. 31, 2021 | $ 47,173,259 | 47,173,259 | $ 141,101,202 | 141,101,202 | |||||
Temporary equity balance, Shares at Dec. 31, 2021 | 35,714,282 | 35,716,249 | |||||||
Balance at Dec. 31, 2021 | (63,717,010) | $ 26 | 13,986,033 | (77,703,069) | |||||
Balance, Shares at Dec. 31, 2021 | 2,557,341 | ||||||||
Issuance of common stock | 193,550,726 | $ 133 | 193,550,593 | ||||||
Issuance of common stock, shares | 13,290,813 | ||||||||
Conversion of preferred stock in connection with the initial public offering | 188,274,343 | $ 210 | 188,274,133 | $ (47,173,259) | $ (141,101,202) | ||||
Conversion of preferred stock in connection with the initial public offering, shares | 21,008,970 | (35,714,282) | (35,716,249) | ||||||
Automatic conversion of the Roche warrants | 13,644,608 | $ 9 | 13,644,599 | ||||||
Automatic conversion of the Roche warrants, shares | 852,788 | ||||||||
Stock-based compensation expense | 1,224,208 | 1,224,208 | |||||||
Other comprehensive loss | (317,611) | (317,611) | |||||||
Net loss | (16,696,903) | (16,696,903) | |||||||
Balance at Mar. 31, 2022 | 315,962,361 | $ 378 | 410,679,566 | (317,611) | (94,399,972) | ||||
Balance, Shares at Mar. 31, 2022 | 37,709,912 | ||||||||
Temporary equity balance, Value at Dec. 31, 2021 | $ 47,173,259 | $ 47,173,259 | $ 141,101,202 | $ 141,101,202 | |||||
Temporary equity balance, Shares at Dec. 31, 2021 | 35,714,282 | 35,716,249 | |||||||
Balance at Dec. 31, 2021 | (63,717,010) | $ 26 | 13,986,033 | (77,703,069) | |||||
Balance, Shares at Dec. 31, 2021 | 2,557,341 | ||||||||
Proceeds from exercise of stock options | 400,000 | ||||||||
Other comprehensive loss | (883,417) | ||||||||
Temporary equity balance, Value at Sep. 30, 2022 | $ 0 | $ 0 | |||||||
Temporary equity balance, Shares at Sep. 30, 2022 | 0 | 0 | |||||||
Balance at Sep. 30, 2022 | 518,937,569 | $ 438 | 656,273,482 | (883,417) | (136,452,934) | ||||
Balance, Shares at Sep. 30, 2022 | 43,793,734 | ||||||||
Balance at Mar. 31, 2022 | 315,962,361 | $ 378 | 410,679,566 | (317,611) | (94,399,972) | ||||
Balance, Shares at Mar. 31, 2022 | 37,709,912 | ||||||||
Stock-based compensation expense | 1,241,157 | 1,241,157 | |||||||
Other comprehensive loss | (394,155) | (394,155) | |||||||
Net loss | (21,075,404) | (21,075,404) | |||||||
Balance at Jun. 30, 2022 | 295,733,959 | $ 378 | 411,920,723 | (711,766) | (115,475,376) | ||||
Balance, Shares at Jun. 30, 2022 | 37,709,912 | ||||||||
Issuance of common stock | $ 242,650,156 | $ 60 | 242,650,096 | ||||||
Issuance of common stock, shares | 6,054,411 | ||||||||
Stock options exercised, shares | 29,411 | ||||||||
Stock-based compensation expense | $ 1,302,663 | 1,302,663 | |||||||
Proceeds from exercise of stock options | 400,000 | 400,000 | |||||||
Proceeds from stock options , Shares | 29,411 | ||||||||
Other comprehensive loss | (171,651) | (171,651) | |||||||
Net loss | (20,977,559) | (20,977,559) | |||||||
Temporary equity balance, Value at Sep. 30, 2022 | $ 0 | $ 0 | |||||||
Temporary equity balance, Shares at Sep. 30, 2022 | 0 | 0 | |||||||
Balance at Sep. 30, 2022 | $ 518,937,569 | $ 438 | $ 656,273,482 | $ (883,417) | $ (136,452,934) | ||||
Balance, Shares at Sep. 30, 2022 | 43,793,734 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (unaudited) (Parenthetical) - USD ($) | 3 Months Ended | ||
Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | |
Common Stock [Member] | |||
Net of underwriting, discounts and commissions costs | $ 574,818 | $ 19,420,580 | $ 897,567 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Operating activities: | |||||
Net loss | $ (20,977,559) | $ (9,023,803) | $ (58,749,865) | $ (21,024,912) | |
Adjustments to reconcile net and comprehensive loss to net cash used in operating activities: | |||||
Stock-based compensation | 3,768,028 | 2,251,150 | |||
Change in fair value of warrant derivative liabilities | 0 | 1,335,852 | 3,044,006 | 3,755,509 | |
Accretion of discounts on available for sale securities | (432,227) | ||||
Depreciation | 5,620 | ||||
Changes in operating assets and liabilities: | |||||
Prepaid research and development contracts | (4,156,917) | (2,664,497) | |||
Prepaid expenses and other current assets | (471,058) | (1,303,409) | |||
Accounts payable | 1,659,978 | (226,547) | |||
Related-party accounts payable | (7,323) | 350,650 | |||
Accrued expenses and other liabilities | 2,958,983 | (546,317) | |||
Net cash used in operating activities | (52,380,775) | (18,955,279) | |||
Investing activities: | |||||
Purchases of investment securities | (335,390,925) | ||||
Maturities of investment securities | 105,000,000 | ||||
Purchase of fixed assets | (105,340) | ||||
Net cash used in investing activities | (230,496,265) | ||||
Financing activities: | |||||
Proceeds from issuance of common stock and sale of pre-funded warrants, net of underwriting discounts | 440,992,224 | ||||
Issuance costs on common stock offerings and sale of pre-funded warrants | (2,563,946) | ||||
Proceeds from issuance of Series B redeemable convertible preferred stock inclusive of proceeds attributable to warrant derivavitive liailitiies | 134,250,326 | ||||
Issuance cost of redeemable convertible preferred stock | (897,567) | ||||
Proceeds From Stock Options Exercise | 400,000 | 400,000 | 1,232,799 | ||
Net cash provided by financing activities | 438,828,278 | 134,585,558 | |||
Net increase (decrease) in cash and cash equivalents | (155,951,238) | (115,630,279) | |||
Cash and cash equivalents at beginning of period | 136,605,613 | 26,078,064 | $ 26,078,064 | ||
Cash and cash equivalents at end of period | 292,556,851 | 141,708,343 | 292,556,851 | 141,708,343 | $ 136,605,613 |
Supplemental disclosures for non-cash financing activities | |||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering | $ 188,274,133 | $ 188,274,133 | |||
Automatic conversion of the Roche warrants into common stock upon initial public offering | 13,644,608 | 13,644,608 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) $ in Millions | Sep. 30, 2022 USD ($) |
Statement Of Cash Flows [Abstract] | |
Cash And Cash Equivalents And Excludes Marketable Securities | $ 229.9 |
Cash, Cash equivalents and Marketable Securities | $ 522.5 |
Nature of Organization and Oper
Nature of Organization and Operations | 9 Months Ended |
Sep. 30, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Organization and Operations | 1. Nature of Organization and Operations CinCor Pharma, Inc. and Subsidiary (the “Company”) is a clinical-stage biopharmaceutical company focused on developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases. Baxdrostat is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. The Company is conducting multiple Phase 2 clinical trials using baxdrostat in differing populations of patients, all of whom are hypertensive. The Company was incorporated in March 2018 and founded as a subsidiary of CinRx Pharma, LLC (“CinRx”), a biotechnology company focused on developing novel therapeutics. In May 2019, the Company entered into an agreement with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc. (collectively, “Roche”) for an exclusive, worldwide, royalty-bearing license to certain Roche technology to research, develop, manufacture, and commercialize a novel aldosterone synthase inhibitor compound, baxdrostat, for any and all diseases and conditions. In connection with the in-licensing transaction with Roche, the Company was spun out as an independent company. On August 17, 2022, the Company established a wholly-owned subsidiary, CinCor Pharma Bermuda Ltd ("CinCor Bermuda"). CinCor Bermuda is the Company’s only subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. Liquidity On January 11, 2022, the Company completed an initial public offering (the "IPO") of its common stock pursuant to which the Company issued and sold 13,290,813 shares of common stock at a price to the public of $ 16.00 per share. The aggregate net proceeds from the IPO were approximately $ 193.6 million after deducting underwriting discounts and commissions of $ 14.9 million and offering expenses of approximately $ 4.5 million. Upon completion of the IPO, all outstanding shares of Series A and Series B redeemable convertible preferred stock converted to 21,008,970 shares of common stock at a ratio of 3.4 :1. In addition, the IPO also resulted in the automatic net exercise of the three outstanding warrants to purchase common stock issued to Roche for an aggregate of 852,788 shares of common stock (collectively, the “Roche Warrants”). On August 12, 2022, the Company closed an underwritten public offering of 6,025,000 shares of its common stock at a public offering price of $ 30.00 per share and pre-funded warrants (the "Pre-Funded Warrants") to purchase 2,600,000 shares of common stock at a public offering price of $ 29.99999 per share, which represented the per share public offering price for the common stock less the $ 0.00001 per share exercise price for each such Pre-Funded Warrant. Proceeds, net of underwriting discounts and commissions, from the Pre-Funded Warrants were $ 73.3 million and net proceeds raised by the Company from the public offering of common shares was $ 169.6 million, after deducting underwriting discounts and commissions and other estimated offering expenses, bringing the total net proceeds to $ 242.9 million. The Company incurred significant losses from operations and had negative cash flows from operating activities for the three and nine months ended September 30, 2022 and 2021, and since inception. The Company’s current operating plan indicates it will continue to incur losses from operations and generate negative cash flows from operating activities, given ongoing expenditures related to extensive research and development and the Company’s lack of revenue-generating activities at this point in the Company’s life cycle. The Company expects that its existing cash and cash equivalents and marketable securities is sufficient to fund its operating expenses and capital expenditure requirements into 2026, including completing all of its ongoing Phase 2 trials, its currently planned Phase 3 clinical program in hypertension, CMC (chemistry manufacturing and control) development and GMP (good manufacturing practice) batch production, the additional activities needed to complete its planned new drug application submission and preparation for commercialization. The future viability of the Company beyond that point, including completing the development and commercialization, if approved, of baxdrostat for hypertension as well as any indication expansion opportunities, is dependent on its ability to raise additional capital to fund its operations. If the Company is unable to obtain future funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Securities and Exchange Commission (“SEC”) regulations and include all of the information and disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”) for interim financial reporting, and, in the opinion of management include all adjustments necessary for a fair presentation of the condensed consolidated financial statements for each period presented. All adjustments are normal and recurring in nature. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. The results of operations for the interim periods are not necessarily indicative of results of operations for a full year. The Company’s condensed consolidated financial statements are stated in U.S. Dollars. 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 operating segment. All the assets and operations of the Company’s sole operating segment are located in the United States. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates have been or are used in the following areas, among others: prepaid research and development contracts, fair value of the Company's common stock prior to the IPO, fair value of the Pre-Funded Warrants, fair value of warrant derivative liabilities, stock compensation expense and income taxes. Prior to its IPO, the Company utilized estimates and assumptions in determining the fair value of its common stock. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock prior to its IPO. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company's common stock at the time, and a probability analysis of various liquidity events at that time, such as a public offering or sale of the Company, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date. The Company's results and business operations can also be affected or disrupted by economic, political, legislative, health concerns, such as the COVID-19 pandemic, regulatory, legal actions and geopolitical events, such as the ongoing military conflict between Ukraine and Russia and the related sanctions against Russia, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on operations. In addition, the conflict between Russia and Ukraine and related sanctions have had significant ramifications on global financial markets, including volatility and uncertainty in the U.S. and global financial markets, which has led and could continue to lead to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has caused and may continue to cause volatility in the price of the Company’s common stock, which may adversely impact the Company’s ability to raise capital on favorable terms or at all. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time. Concentration of Credit Risk and Other Risks and Uncertainties The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of money market funds that invest primarily in short term U.S. government securities and short-term marketable securities that are primarily invested in fixed income securities. The Company has not yet generated any revenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biopharmaceutical companies that devote substantially all of their efforts to research and development and clinical trials and do not yet have commercial products. The Company expects to continue incurring operating losses for the foreseeable future. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value. Marketable Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed consolidated balance sheet date. The Company classified all of its marketable securities at September 30, 2022 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income over the maturity of the fixed income security. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. There were no material realized gains or losses on marketable securities recognized for the three and nine months ended September 30, 2022 or 2021 . Initial Public Offering Costs Costs directly attributable to the Company’s IPO which were incurred in 2021 were deferred and capitalized as prepaid expenses and other current assets at December 31, 2021. These costs primarily represented legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Any additional costs incurred during the nine months ended September 30, 2022 were deferred until the completion of the IPO, which occurred on January 11, 2022, at which time they were reclassified to additional paid in capital as a reduction of the IPO gross proceeds. At December 31, 2021, the Company had capitalized $ 2.6 million of deferred IPO costs, as prepaid expenses and other current assets. A total of $ 4.5 million of IPO issuance costs were incurred through January 11, 2022, which were recorded as a reduction of the IPO gross proceeds and included the $ 2.6 million previously capitalized at December 31, 2021. Redeemable Convertible Preferred Stock In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption features in a Deemed Liquidation Event (as defined in our Amended and Restated Certificate of Incorporation) is required to be presented outside of stockholders' equity (deficit) on the face of the condensed consolidated balance sheet and certain disclosures are required to be included in the notes to the condensed consolidated financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed consolidated balance sheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including accounts payable and other current liabilities approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. Where quoted prices are available in an active market, assets or liabilities are classified as Level 1. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2022 and 2021. Research and Development The Company charges all research and development costs, both internal and external, to expense when incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company's research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees. Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and restricted stock units, to be recognized in the condensed consolidated statements of operations based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards in the form of employee stock options, using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Prior to its IPO, the Company had based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment , to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options. Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term. Derivative Instruments, Including Warrant Derivative Liabilities The Company accounts for derivatives, specifically freestanding detachable stock purchase warrants, in accordance with ASC Topic 815, Derivatives and Hedging ("ASC 815"). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts. Pre-Funded Warrants The Company accounts for its Pre-Funded Warrants in accordance with ASC 480 and ASC 815. The Pre-Funded Warrants to purchase 2,600,000 shares of common stock were sold on August 15, 2022 pursuant to the Company's underwritten public offering price of $ 29.99999 per share, which represented the per share public offering price for the common stock sold in the August public offering less the $ 0.00001 per share exercise price for each such Pre-Funded Warrant. The Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in capital and were recorded at the date of sale. The Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holder to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such Pre-Funded Warrants do not provide any guarantee of value or return. The Company valued the Pre-Funded warrants at date of sale, concluding that their sales price approximated their fair value of $ 73.3 million which was recorded as a component of additional paid-in capital. Net Loss Per Share The Company's basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock prior to the Company's IPO, stock options to purchase common stock, restricted stock units and the Pre-Funded Warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive. Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the condensed consolidated financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of September 30, 2022, and December 31, 2021, the Company does not have any significant uncertain tax positions. If the Company were to incur interest and penalties on uncertain tax positions, it would classify them as income tax expense. The Company files U.S. federal and state income tax returns. The Company did not record a current or deferred income tax expense or benefit for the three and nine months ended September 30, 2022 and 2021, due to the C ompany’s net and comprehensive losses and increases in its deferred tax asset valuation allowance. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the three and nine months ended September 30, 2022, the Company’s only element of other comprehensive loss was unrealized losses on available-for-sale securities. Comprehensive loss for the three and nine months ended September 30, 2021, equaled net loss for those periods. Litigation and Other Contingencies The Company may be subject to legal proceedings and claims arising from the ordinary course of its business, including contract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred, and the amount of the liability can be reasonably estimated. In the opinion of management, the aggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company. Reverse Stock Split On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. The par value of the common stock was not adjusted as a result of the reverse stock split. Shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the appropriate securities agreements. Shares of common stock reserved for issuance upon the conversion of our convertible preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. All common share and per share data have been retrospectively revised including the three and nine months ended September 30, 2021, to reflect the reverse stock split. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Fair Value of Measurements
Fair Value of Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Measurements | 3. Fair Value Measurements The following table represents the financial instruments measured at fair value on a recurring basis based on the fair value hierarchy at: September 30, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 292,556,851 $ — $ — $ 292,556,851 Marketable securities: US Treasury bills 34,858,896 — — 34,858,896 Certificate of deposit 62,592,523 — — 62,592,523 US Government agency securities — 132,488,377 — 132,488,377 Total assets at fair value $ 390,008,270 $ 132,488,377 $ — $ 522,496,647 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 136,605,613 $ — $ — $ 136,605,613 Total assets at fair value $ 136,605,613 $ — $ — $ 136,605,613 Liabilities: Warrant derivative liabilities $ — $ — $ 10,636,921 $ 10,636,921 Total liabilities at fair value $ — $ — $ 10,636,921 $ 10,636,921 The amortized cost basis of marketable securities as of September 30, 2022 was $ 255.8 million. The fair value of money market funds, U.S. Treasury bills and certificates of deposits are based on unaudited quoted market prices, which are considered Level 1 inputs in the fair value hierarchy. Level 2 assets consists of U.S. Government agency securities and are based upon quoted market prices for similar securities in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and reference data. The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing a recurring measurement that is classified within Level 3 of the fair value hierarchy: January 1, 2022 $ 10,636,921 Change in fair value of warrant derivative liabilities 3,044,006 Automatic conversion of Roche warrants into common stock upon initial public offering ( 13,680,927 ) September 30, 2022 $ - The Company estimated the fair value of the warrant derivative liabilities using a Black-Scholes option pricing model. The valuation model used the following assumptions at December 31, 2021: Fair value of common stock $ 12.44 Volatility 64.00 % Expected term (in years) 0.52 Risk-free interest rate 0.21 % Dividend yield — The preceding methods described may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, although the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date. |
License Agreement
License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
License Agreement Disclosure [Abstract] | |
License Agreement | 4. License Agreement In May 2019, the Company entered into a license agreement (“Roche Agreement”) with Roche, pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and covering certain specified small molecule aldosterone synthase inhibitors (“Roche Technology”) to research, develop and commercialize products containing such aldosterone synthase inhibitors (“Licensed Products”) for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals. Pursuant to the Roche Agreement, the Company paid Roche a one-time, upfront non-refundable license fee of $ 2.0 million. Additionally, the Company is required to pay Roche certain regulatory event-based milestone payments, certain one time sales-based milestone payments, as well as tiered royalty payments based on the net sales of the Licensed products. The Roche Agreement will expire, unless earlier terminated by either party, upon expiration of all royalty or other payment obligations under the Roche Agreement are or will become due. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Redeemable Convertible Preferred Stock | 5. Redeemable Convertible Preferred Stock Series A Redeemable Convertible Preferred Stock In May 2019, the Company authorized the issuance of 35,714,282 shares to be issued in the form of Series A redeemable convertible preferred stock (“Series A preferred stock”). The Company issued 35,714,282 shares of Series A preferred stock at $ 1.40 per share for total proceeds of $ 50 million. The Company incurred $ 2.1 million of Series A preferred stock issuance costs, which was recorded against the carrying amount of the Series A preferred stock as of December 31, 2021. The rights, preferences, and privileges of the Company’s Series A preferred stock prior to IPO were as follows: Voting Up until the IPO, the holders of Series A preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series A preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series A preferred stock vote together with the holders of common stock as a single class. Up until the IPO, the holders of Series A preferred stock, voting as a separate class, were entitled to elect three members of the Board of Directors. The holders of the common stock, voting as a separate class, were entitled to elect two members of the Board of Directors. The holders of Series A preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors. Dividends Dividends were payable, if permitted by law, in accordance with the Series A preferred stock terms if and when declared by the Board of Directors. Holders of the Series A preferred stock were entitled to receive dividends out of any assets at the time legally available, at the applicable dividend rate specified for such shares of the Series A preferred stock. Dividends were not mandatory and were not cumulative. No dividends were declared or paid since inception of the Company. Liquidation In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared but unpaid. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. The remaining available proceeds would be distributed pro rata among the holders of the shares of the Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company. Conversion Each share of the Series A preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series A preferred stock original issue price by the Series A preferred stock conversion price in effect at the time of conversion. The applicable conversion price was subject to future adjustments upon the occurrence of certain events. However, holders of the Series A preferred stock did not have the right to convert any shares of the Series A preferred stock at the applicable conversion ratio in effect for preferred shares upon either (i) the closing of a qualified initial public offering of its common stock at a price per share of at least $ 14.28 per share (subject to adjustment for any share split, combination or dividend or distribution payable) resulting in at least $ 50 million in gross proceeds to the Company net of the underwriting discount and commissions, or (ii) the election to convert the preferred shares by at least two of the following three holders of the Company’s Series A preferred stock: (i) Sofinnova Venture Partners X, L.P., (ii) Sofinnova Capital IX and (iii) 5AM Ventures VI, L.P. The Company evaluated the Series A preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series A preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series A preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series A preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series A preferred stock were entitled to dividends, (iv) the voting rights of the Series A preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series A preferred stock represents an equity host, the conversion feature included in the Series A preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation. The Company accounts for potentially beneficial conversion features under ASC Topic 470-20, Debt with Conversion and Other Options ( "ASC 470-20 ") . At the time of the issuances of the shares of Series A preferred stock, the Company’s common stock into which the Company’s Series A preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series A preferred stock. Therefore, there was no beneficial conversion element on the issuance dates. On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series A preferred stock was converted into 10,504,199 shares of the Company’s common stock. Redemption The holders of the Company’s redeemable convertible preferred stock have no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control. Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series A preferred stock was deemed to be the price paid by the Series A preferred stockholders. Due to this redemption option, Series A preferred stock is recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption value immediately. Warrant Derivative Liabilities In connection with the Series A preferred stock financing, the Company issued two freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 411,765 and 329,552 shares of common stock (“2019 Warrants”). The 2019 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remain issued, outstanding, and exercisable at December 31, 2021. The 2019 Warrants were issued with an initial exercise price of $ 0.04 and an expiration date of May 13, 2029 . The 2019 Warrants qualify as derivative liabilities, which must be accounted for separately from the Series A preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2019 Warrants were valued at $ 9.2 million, with the change in fair value included in the condensed consolidated statements of operations in the period the change occurred. On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2019 Warrants were converted into 739,463 shares of the Company’s common stock and are no longer outstanding. Series B Redeemable Convertible Preferred Stock In September 2021, the Company authorized the issuance of 35,716,249 shares to be issued in the form of Series B redeemable convertible preferred stock ("Series B preferred stock"). The Company issued 35,716,249 shares of Series B preferred stock at $ 4.00 per share for total proceeds of $ 142.9 million. The Company incurred $ 0.9 million of Series B preferred stock issuance costs which were recorded against the carrying amount of the Series B preferred stock at December 31, 2021. The rights, preferences, and privileges of the Company’s Series B preferred stock prior to the IPO were as follows: Voting Up until the IPO, the holders of Series B preferred stock were entitled to a number of votes equal to the number of whole shares of common stock into which the shares of Series B preferred stock were convertible. Except as provided by law or otherwise, the holders of the Series B preferred stock vote together with the holders of common stock as a single class. Up until the IPO, holders of Series B preferred stock, voting as a separate class, were entitled to elect one member of the Board of Directors. The holders of preferred stock and common stock, voting together as a single class on an as-converted basis, were entitled to elect any additional members of the Board of Directors other than directors elected by the holders of Series A preferred stock and directors elected by holders of the common stock. Dividends Dividends at the rate per annum of $ 0.32 per share accrued on shares of Series B preferred stock. Dividends on the shares of Series B preferred stock were not cumulative and were payable, if and when declared by the Board of Directors. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company unless the holders of preferred stock then outstanding first or simultaneously receive a dividend on each outstanding share of redeemable convertible preferred stock in an amount at least equal to the sum of (i) the amount of the aggregate dividends accrued but unpaid on such shares of preferred stock and (ii) that dividend per share of preferred stock as would equal the product of (1) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into common stock and (2) the number of shares of common stock issuable upon conversion of a share of preferred stock. No dividends were declared or paid since inception of the Company. Liquidation In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the Series B preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of Series A preferred stock or common stock by reason of their ownership thereof, an amount per share equal to the Series B preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series B preferred stock the full amount to which they were entitled, the holders of shares of the Series B preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. In the event that the assets of the Company available for distribution exceeded the amount necessary to pay the holders of Series B preferred stock, the holders of shares of Series A preferred stock then outstanding were entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders were insufficient to pay the holders of shares of Series A preferred stock the full amount to which they were entitled, the holders of shares of the Series A preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. The remaining available proceeds would have been distributed pro rata among the holders of the shares of the Series B preferred stock, Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation, dissolution, or winding up of the Company. Conversion Each share of the Series B preferred stock was convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series B preferred stock original issue price by the Series B preferred stock conversion price in effect at the time of conversion. The Series B preferred stock conversion price shall initially be equal to the Series B original issue price. The applicable conversion price is subject to future adjustments upon the occurrence of certain events. Upon either (i) the closing of a qualified initial public offering of the Company’s common stock resulting in at least $ 100 million in proceeds net of the underwriting discount and commissions; (ii) the closing of a transaction or series of transactions in which the Company’s outstanding shares of capital stock are exchanged for or converted into securities that are publicly listed on a securities exchange through a merger, acquisition, business combination or similar transaction with a “special purpose acquisition company” where the surviving or parent entity receives aggregate gross proceeds, excluding the cash resources of the Company, of at least $100 million; or (iii) the date and time, or the occurrence of an event, specified by vote or written consent of the requisite holders and the Series B requisite holders, then all outstanding shares of preferred stock shall automatically be converted into shares of common stock at the effective conversion rate. The Company evaluated the Series B preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series B preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series B preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including (i) whether the Series B preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series B preferred stock were entitled to dividends, (iv) the voting rights of the Series B preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series B preferred stock represents an equity host, the conversion feature included in the Series B preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation. The Company accounts for potentially beneficial conversion features under ASC 470-20. At the time of the issuances of the shares of Series B preferred stock, the Company’s common stock into which the Company’s Series B preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series B preferred stock. Therefore, there was no beneficial conversion element on the issuance dates. On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the Series B preferred stock was converted into 10,504,771 shares of the Company’s common stock. Redemption The holders of the Company’s redeemable convertible preferred stock had no rights to cause the redemption of their shares outside of a Deemed Liquidation Event. A Deemed Liquidation Event would constitute a redemption event that may be outside of the Company’s control. Any redemption was deemed to be remote at December 31, 2021, and the fair value of Series B preferred stock was deemed to be the price paid by the Series B preferred stockholders. Due to this redemption option, Series B preferred stock was recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company elected to recognize changes in redemption value immediately. Warrant Derivative Liabilities In connection with the Series B preferred stock, the Company issued freestanding detachable stock purchase warrants to an unrelated third party to separately purchase 113,610 shares of common stock ("2021 Warrants"). The 2021 Warrants were exercisable in whole immediately prior to an initial public offering by the Company and, as such, remained issued, outstanding, and exercisable at December 31, 2021. The 2021 Warrants were issued with an initial exercise price of $ 0.01 and an expiration date of May 13, 2029 . The 2021 Warrants qualified as derivative liabilities, which must be accounted for separately from the Series B preferred stock and are measured at fair value on a recurring basis. At December 31, 2021, the 2021 Warrants were valued at $ 1.4 million with the change in fair value from the date of issuance included in the condensed consolidated statements of operations in the period the change occurred. On January 11, 2022, the Company completed its IPO. Upon the closing of the IPO, the 2021 Warrants were converted into 113,325 shares of the Company’s common stock. |
Stockholder's Deficit and Stock
Stockholder's Deficit and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Deficit and Stock-Based Compensation | 6. Stockholders’ Equity (Deficit) and Stock-Based Compensation Stock Options On December 30, 2021, the Board of Directors adopted, and the Company’s stockholders approved, the 2022 Equity Incentive Plan (“2022 Plan”). The 2022 Plan provides for the grant of incentive stock options to employees of the Company, and for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors, and consultants, including employees and consultants of affiliates of the Company (collectively, “stock based awards”). The 2022 Plan is a successor to the 2019 Stock Option Plan. (“2019 Plan”). Initially, the maximum number of shares of common stock that may be issued under the 2022 Plan after it became effective was 6,787,652 shares, which is the sum of (i) 3,905,911 new shares; plus (ii) the number of shares that was available for issuance under the 2019 Plan at the time the 2022 Plan became effective; and (iii) any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminated, expired or are otherwise not issued. In addition, the number of shares of common stock reserved for issuance under the 2022 Plan will automatically increase on January 1 st of each calendar year, starting on January 1, 2023 and continuing through January 1, 2032, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board of Directors. The maximum number of shares of common stock that may be issued on the exercise of incentive stock options under the 2022 Plan is 20,362,956 . As of September 30, 2022 and December 31, 2021, a total of 3,984,910 and 3,368,572 awards, respectively, were available for issuance under the 2022 Plan and 2019 Plan, respectively. The following is a summary of the Company’s outstanding stock option activity: Stock Weighted Average Weighted Average Aggregate Outstanding, January 1, 2022 2,617,072 $ 6.19 9.56 — Granted 68,525 16.51 9.79 — Exercised — — — — Expired/cancelled — — — — Outstanding, March 31, 2022 2,685,597 $ 6.96 9.37 — Granted 101,637 $ 16.26 6.43 — Exercised — — — — Expired/cancelled ( 4,400 ) 16.00 — — Outstanding, June 30, 2022 2,782,834 $ 7.27 9.15 — Granted 1,365 $ 25.53 6.50 — Exercised ( 29,411 ) 13.60 — — Expired/cancelled ( 11,596 ) 11.89 — — Outstanding, September 30, 2022 2,743,192 $ 7.19 8.90 $ 70,309,316 Expected to vest, September 30, 2022 2,743,192 $ 7.19 8.90 $ 70,309,316 Options exercisable, September 30, 2022 865,350 $ 6.58 8.71 $ 22,708,847 Unrecognized compensation cost related to stock option awards of $ 12.3 mi llion as of September 30, 2022, is expected to be recognized as expense over a weighted average period o f 2.82 years. The total fair value of options vested was $ 1.8 million and $ 0.1 million for the three months period ended September 30, 2022 and 2021, respectively. The total fair value of options vested was $ 3.4 million and $ 1.6 million, for the nine months period ended September 30, 2022 and 2021, respectively. Outstanding stock options, if not exercise d, expire ten years from the date of grant. The Company issues new shares of common stock upon exercise of stock optio ns. The weighted average grant date fair value per share for the outstanding options at September 30, 2022 and December 31, 2021 was $ 10.30 and $ 5.42 , respectively. The Company determined the grant-date fair value of stock options using the Black-Scholes option pricing model. The fair value of each stock option grant was determined using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with a term equivalent to the option. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the therapeutics and pharmaceutical industries. The expected term of stock options represents the weighted average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts at the time of grant. The Company recognizes forfeitures on an actual basis and, as such, did not estimate forfeitures to calculate stock-based compensation. The following table presents the weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the following periods : Three Months Ended September 30, Nine Months Ended September 30, 2022 2022 Exercise price $ 7.19 $ 7.19 Stock price on date of grant $ 7.19 $ 7.19 Expected term (years) 6.5 3.9 Expected stock price volatility 76.37 % 45.40 % Risk-free rate of interest 3.13 % 1.67 % Expected dividend yield 0 % 0 % There is a high degree of subjectivity involved when using option-pricing models to estimate stock-based compensation. There are currently no market-based mechanisms or other practical applications to verify the reliability and accuracy of the estimates stemming from these models, nor is there a means to compare and adjust the estimates to actual values. Although the fair value of the employee stock-based awards is determined using an option-pricing model, the value may not be indicative of the fair value that would be observed in a market transaction between a willing buyer and a willing seller. If factors change and the Company employs different assumptions when valuing its options, the compensation expense that the Company records in the future may differ significantly from what it has historically reported. Restricted Stock Units In 2022, certain employees were awarded restricted stock units with time-based vesting. During the three and nine months ended September 30, 2022, the Company granted to certain employe es 30,148 time-ba sed vesting restricted stock units, with a weighted average grant date fair value of $ 16.00 . As of September 30, 2022, none of the restricted stock units had vested. As of September 30, 2022, the Company had unrecognized stock-based compensation expense related to restricted stock units of approximately $ 0.4 million with a wei ghted average vesting period of approximately 1 .25 years. The expense is recognized over the vesting period of the award. The Company recognized the following compensation cost related to employee stock-based compensation activity: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 278,961 $ 40,673 $ 764,087 $ 572,603 General and administrative 1,023,702 485,711 3,003,941 1,678,547 Total $ 1,302,663 $ 526,384 $ 3,768,028 $ 2,251,150 |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net and Comprehensive Loss Per Share (Restated) | 7. Net Loss per Share Attributable to Common Stockholders Net loss per share is computed by dividing net loss by the weighted average number of common stock outstanding during the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the following periods: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Redeemed convertible preferred stock (if converted) — 10,504,199 — 10,504,199 2019 Warrants — 739,463 — 739,463 2021 Warrants 113,325 113,325 Pre-Funded Warrants 2,600,000 — 2,600,000 — Outstanding equity awards exercisable 1,625,896 172,051 1,305,585 65,128 |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 8. Related-Party Transactions CinRx Pharma LLC and Subsidiaries (“CinRx”) Certain former executives and employees of the Company, including the Company’s former chief executive officer and a former member of the Company’s board of directors, are members of CinRx’s board of managers and/or have equity investments in CinRx. The Company received business management services from CinRx from time to time as needed, under a management services agreement, which was terminated on February 2, 2022. There were no business management service fees from CinRx during the three and nine months ended September 30, 2022. During the three and nine months ended September 30, 2021, the Company recorded business management fees totaling $ 0.3 million and $ 1.1 million, respectively. For the three months ended September 30, 2021, $ 0.2 million are included in research and development expenses, while $ 0.01 million are in general and administrative expenses on the condensed consolidated statement of operations. For the nine months ending September 30, 2021, $ 0.8 million of the fees a re included in research and development expenses, while $ 0.3 millio n are in general and administrative expenses on the condensed consolidated statement of operations. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Lease On February 24, 2022, the Company entered into a license agreement, commencing April 1, 2022 , for 5,400 square feet of office space in Waltham, Massachusetts, which is the Company's new headquarters. The annual rent is $ 0.3 million. As this license agreement has a term of less than 12 months, the Company has not recorded it on the condensed consolidated balance sheet, as allowed under ASC Topic 842, Leases ("ASC 842"). The Company also has an agreement to lease 221 square feet of office space at 7875 Montgomery Rd. Suite 42, Cincinnati, OH 45236 from COHatch Cincinnati for $ 2,850 per month. As this lease has a term of less than 12 months, the Company has not recorded it on the condensed consolidated balance sheet, as allowed under ASC 842. The Company's total rent expense for the three and nine months ended September 30, 2022, were $ 0.1 million and $ 0.2 million, respectively, recorded in general and administrative expense on our condensed consolidated statements of operations. No rent expense was recognized for the three and nine months ended September 30, 2021. |
Employee Benefit Plan
Employee Benefit Plan | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement, Disclosure [Abstract] | |
Employee Benefit Plan | 10. Employee Benefit Plan The Company maintains a defined contribution 401(k) plan available to full time employees. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. The Company provides a safe harbor contribution of 4 % of the employee's salary. The Company’s safe harbor contributions recorded for the three and nine months ending September 30, 2022, totaled approximately $ 0.1 million and $ 0.2 million, respectively, and are included in research and development expense and general and administrative expense on the condensed consolidated statements of operations. The 401(k) plan was not in place during the three and nine months ended September 30, 2021. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Securities and Exchange Commission (“SEC”) regulations and include all of the information and disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”) for interim financial reporting, and, in the opinion of management include all adjustments necessary for a fair presentation of the condensed consolidated financial statements for each period presented. All adjustments are normal and recurring in nature. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. The results of operations for the interim periods are not necessarily indicative of results of operations for a full year. The Company’s condensed consolidated financial statements are stated in U.S. Dollars. |
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 operating segment. All the assets and operations of the Company’s sole operating segment are located in the United States. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates have been or are used in the following areas, among others: prepaid research and development contracts, fair value of the Company's common stock prior to the IPO, fair value of the Pre-Funded Warrants, fair value of warrant derivative liabilities, stock compensation expense and income taxes. Prior to its IPO, the Company utilized estimates and assumptions in determining the fair value of its common stock. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock prior to its IPO. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company's common stock at the time, and a probability analysis of various liquidity events at that time, such as a public offering or sale of the Company, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date. The Company's results and business operations can also be affected or disrupted by economic, political, legislative, health concerns, such as the COVID-19 pandemic, regulatory, legal actions and geopolitical events, such as the ongoing military conflict between Ukraine and Russia and the related sanctions against Russia, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on operations. In addition, the conflict between Russia and Ukraine and related sanctions have had significant ramifications on global financial markets, including volatility and uncertainty in the U.S. and global financial markets, which has led and could continue to lead to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has caused and may continue to cause volatility in the price of the Company’s common stock, which may adversely impact the Company’s ability to raise capital on favorable terms or at all. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of money market funds that invest primarily in short term U.S. government securities and short-term marketable securities that are primarily invested in fixed income securities. The Company has not yet generated any revenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biopharmaceutical companies that devote substantially all of their efforts to research and development and clinical trials and do not yet have commercial products. The Company expects to continue incurring operating losses for the foreseeable future. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value. |
Marketable Securities | Marketable Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed consolidated balance sheet date. The Company classified all of its marketable securities at September 30, 2022 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income over the maturity of the fixed income security. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. There were no material realized gains or losses on marketable securities recognized for the three and nine months ended September 30, 2022 or 2021 . |
Initial Public Offering Costs | Initial Public Offering Costs Costs directly attributable to the Company’s IPO which were incurred in 2021 were deferred and capitalized as prepaid expenses and other current assets at December 31, 2021. These costs primarily represented legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Any additional costs incurred during the nine months ended September 30, 2022 were deferred until the completion of the IPO, which occurred on January 11, 2022, at which time they were reclassified to additional paid in capital as a reduction of the IPO gross proceeds. At December 31, 2021, the Company had capitalized $ 2.6 million of deferred IPO costs, as prepaid expenses and other current assets. A total of $ 4.5 million of IPO issuance costs were incurred through January 11, 2022, which were recorded as a reduction of the IPO gross proceeds and included the $ 2.6 million previously capitalized at December 31, 2021. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption features in a Deemed Liquidation Event (as defined in our Amended and Restated Certificate of Incorporation) is required to be presented outside of stockholders' equity (deficit) on the face of the condensed consolidated balance sheet and certain disclosures are required to be included in the notes to the condensed consolidated financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed consolidated balance sheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price. |
Fair Value Measurements | Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including accounts payable and other current liabilities approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. Where quoted prices are available in an active market, assets or liabilities are classified as Level 1. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2022 and 2021. |
Research and Development | Research and Development The Company charges all research and development costs, both internal and external, to expense when incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company's research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and restricted stock units, to be recognized in the condensed consolidated statements of operations based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards in the form of employee stock options, using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Prior to its IPO, the Company had based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment , to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options. Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term. |
Derivative Instruments, Including Warrant Derivative Liabilities | Derivative Instruments, Including Warrant Derivative Liabilities The Company accounts for derivatives, specifically freestanding detachable stock purchase warrants, in accordance with ASC Topic 815, Derivatives and Hedging ("ASC 815"). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts. |
Pre Funded Warrants | Pre-Funded Warrants The Company accounts for its Pre-Funded Warrants in accordance with ASC 480 and ASC 815. The Pre-Funded Warrants to purchase 2,600,000 shares of common stock were sold on August 15, 2022 pursuant to the Company's underwritten public offering price of $ 29.99999 per share, which represented the per share public offering price for the common stock sold in the August public offering less the $ 0.00001 per share exercise price for each such Pre-Funded Warrant. The Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in capital and were recorded at the date of sale. The Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holder to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such Pre-Funded Warrants do not provide any guarantee of value or return. The Company valued the Pre-Funded warrants at date of sale, concluding that their sales price approximated their fair value of $ 73.3 million which was recorded as a component of additional paid-in capital. |
Net Loss Per Share | Net Loss Per Share The Company's basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock prior to the Company's IPO, stock options to purchase common stock, restricted stock units and the Pre-Funded Warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the condensed consolidated financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of September 30, 2022, and December 31, 2021, the Company does not have any significant uncertain tax positions. If the Company were to incur interest and penalties on uncertain tax positions, it would classify them as income tax expense. The Company files U.S. federal and state income tax returns. The Company did not record a current or deferred income tax expense or benefit for the three and nine months ended September 30, 2022 and 2021, due to the C ompany’s net and comprehensive losses and increases in its deferred tax asset valuation allowance. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the three and nine months ended September 30, 2022, the Company’s only element of other comprehensive loss was unrealized losses on available-for-sale securities. Comprehensive loss for the three and nine months ended September 30, 2021, equaled net loss for those periods. |
Litigation And Other Contingencies | Litigation and Other Contingencies The Company may be subject to legal proceedings and claims arising from the ordinary course of its business, including contract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred, and the amount of the liability can be reasonably estimated. In the opinion of management, the aggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company. |
Reverse Stock Split | Reverse Stock Split On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. The par value of the common stock was not adjusted as a result of the reverse stock split. Shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the appropriate securities agreements. Shares of common stock reserved for issuance upon the conversion of our convertible preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. All common share and per share data have been retrospectively revised including the three and nine months ended September 30, 2021, to reflect the reverse stock split. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Fair Value of Measurements (Tab
Fair Value of Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Instruments Measured at Fair Value on Recurring Basis Based on Fair Value Hierarchy | The following table represents the financial instruments measured at fair value on a recurring basis based on the fair value hierarchy at: September 30, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 292,556,851 $ — $ — $ 292,556,851 Marketable securities: US Treasury bills 34,858,896 — — 34,858,896 Certificate of deposit 62,592,523 — — 62,592,523 US Government agency securities — 132,488,377 — 132,488,377 Total assets at fair value $ 390,008,270 $ 132,488,377 $ — $ 522,496,647 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 136,605,613 $ — $ — $ 136,605,613 Total assets at fair value $ 136,605,613 $ — $ — $ 136,605,613 Liabilities: Warrant derivative liabilities $ — $ — $ 10,636,921 $ 10,636,921 Total liabilities at fair value $ — $ — $ 10,636,921 $ 10,636,921 |
Schedule of Changes in Fair Value of Warrant Derivative Liabilities | The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing a recurring measurement that is classified within Level 3 of the fair value hierarchy: January 1, 2022 $ 10,636,921 Change in fair value of warrant derivative liabilities 3,044,006 Automatic conversion of Roche warrants into common stock upon initial public offering ( 13,680,927 ) September 30, 2022 $ - |
Schedule of Fair Value of Warrant Derivative Liabilities | The Company estimated the fair value of the warrant derivative liabilities using a Black-Scholes option pricing model. The valuation model used the following assumptions at December 31, 2021: Fair value of common stock $ 12.44 Volatility 64.00 % Expected term (in years) 0.52 Risk-free interest rate 0.21 % Dividend yield — |
Stockholder's Deficit and Sto_2
Stockholder's Deficit and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Summary of Outstanding Stock Option Activity | The following is a summary of the Company’s outstanding stock option activity: Stock Weighted Average Weighted Average Aggregate Outstanding, January 1, 2022 2,617,072 $ 6.19 9.56 — Granted 68,525 16.51 9.79 — Exercised — — — — Expired/cancelled — — — — Outstanding, March 31, 2022 2,685,597 $ 6.96 9.37 — Granted 101,637 $ 16.26 6.43 — Exercised — — — — Expired/cancelled ( 4,400 ) 16.00 — — Outstanding, June 30, 2022 2,782,834 $ 7.27 9.15 — Granted 1,365 $ 25.53 6.50 — Exercised ( 29,411 ) 13.60 — — Expired/cancelled ( 11,596 ) 11.89 — — Outstanding, September 30, 2022 2,743,192 $ 7.19 8.90 $ 70,309,316 Expected to vest, September 30, 2022 2,743,192 $ 7.19 8.90 $ 70,309,316 Options exercisable, September 30, 2022 865,350 $ 6.58 8.71 $ 22,708,847 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following table presents the weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the following periods : Three Months Ended September 30, Nine Months Ended September 30, 2022 2022 Exercise price $ 7.19 $ 7.19 Stock price on date of grant $ 7.19 $ 7.19 Expected term (years) 6.5 3.9 Expected stock price volatility 76.37 % 45.40 % Risk-free rate of interest 3.13 % 1.67 % Expected dividend yield 0 % 0 % |
Schedule Of Compensation Cost Related to Employee Stock-Based Compensation Activity | The Company recognized the following compensation cost related to employee stock-based compensation activity: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 278,961 $ 40,673 $ 764,087 $ 572,603 General and administrative 1,023,702 485,711 3,003,941 1,678,547 Total $ 1,302,663 $ 526,384 $ 3,768,028 $ 2,251,150 |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net and Comprehensive Loss Per Share | The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the following periods: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Redeemed convertible preferred stock (if converted) — 10,504,199 — 10,504,199 2019 Warrants — 739,463 — 739,463 2021 Warrants 113,325 113,325 Pre-Funded Warrants 2,600,000 — 2,600,000 — Outstanding equity awards exercisable 1,625,896 172,051 1,305,585 65,128 |
Nature of Business (Additional
Nature of Business (Additional Information) (Details) | Aug. 15, 2022 USD ($) | Aug. 12, 2022 USD ($) $ / shares shares | Jan. 11, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2021 $ / shares |
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, par value per share | $ / shares | $ 0.00001 | $ 0.00001 | |||
Convertible preferred stock converted to common stock | 3.4 | ||||
Class of warrant, exercise price of warrants | $ / shares | $ 0.00001 | ||||
Series B [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Preferred stock converted into common stock | shares | 21,008,970 | ||||
Common Stock [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, par value per share | $ / shares | $ 30 | ||||
Underwritten public offering | $ 6,025,000 | ||||
Proceeds from Issuance of Warrants | $ 73,300,000 | ||||
Underwritten public offering purchase shares | shares | 2,600,000 | ||||
Class of warrant, exercise price of warrants | $ / shares | $ 29.99999 | ||||
IPO [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | shares | 13,290,813 | ||||
Common stock, par value per share | $ / shares | $ 16 | ||||
Offering expenses | $ 2,600,000 | ||||
IPO [Member] | Series A [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Preferred stock converted into common stock | shares | 10,504,199 | ||||
IPO [Member] | Common Stock [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from IPO | $ 169,600,000 | ||||
Total net proceeds from public offering | 242,900,000 | ||||
Over-allotment [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from IPO | $ 193,600,000 | ||||
Underwriting discounts and commissions | 14,900,000 | ||||
Offering expenses | $ 4,500,000 | ||||
Roche Warrants [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Preferred stock converted into common stock | shares | 852,788 | ||||
Pre Fund [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from Issuance of Warrants | $ 73,300,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | |||
Aug. 15, 2022 | Sep. 30, 2022 | Jan. 11, 2022 | Dec. 31, 2021 | |
Accounting Policies [Line Items] | ||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | On December 30, 2021, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 3.4-for-1 reverse stock split of the Company’s common stock, which was effected on December 30, 2021. | |||
Warrants to purchase shares of common stock | 2,600,000 | |||
Pre fund warrant public offering purchase price | $ 0.00001 | |||
Common Stock [Member] | ||||
Accounting Policies [Line Items] | ||||
Proceeds from issuance of pre-funded warrants | $ 73.3 | |||
Pre fund warrant public offering purchase price | $ 29.99999 | |||
IPO | ||||
Accounting Policies [Line Items] | ||||
Deferred IPO costs | $ 2.6 | |||
Reduction in IPO gross proceeds | $ 4.5 | |||
IPO | Prepaid Expenses and Other Current Assets | ||||
Accounting Policies [Line Items] | ||||
Deferred IPO costs | $ 2.6 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments - Schedule of Financial Instruments Measured at Fair Value on Recurring Basis Based on Fair Value Hier (Details) - Fair Value Measurements Recurring [Member] - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Cash and cash equivalents | $ 292,556,851 | $ 136,605,613 |
Marketable Securities: | ||
Total assets at fair value | 522,496,647 | 136,605,613 |
Liabilities: | ||
Warrant derivative liabilities | 10,636,921 | |
Total liabilities at fair value | 10,636,921 | |
Level 1 [Member] | ||
Assets: | ||
Cash and cash equivalents | 292,556,851 | 136,605,613 |
Marketable Securities: | ||
Total assets at fair value | 390,008,270 | 136,605,613 |
Liabilities: | ||
Warrant derivative liabilities | 0 | |
Total liabilities at fair value | 0 | |
Level 2 [Member] | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Marketable Securities: | ||
Total assets at fair value | 132,488,377 | 0 |
Liabilities: | ||
Warrant derivative liabilities | 0 | |
Total liabilities at fair value | 0 | |
Level 3 [Member] | ||
Assets: | ||
Cash and cash equivalents | 0 | 0 |
Marketable Securities: | ||
Total assets at fair value | 0 | 0 |
Liabilities: | ||
Warrant derivative liabilities | 10,636,921 | |
Total liabilities at fair value | $ 10,636,921 | |
US Treasury Bills [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | 34,858,896 | |
US Treasury Bills [Member] | Level 1 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | 34,858,896 | |
US Treasury Bills [Member] | Level 2 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | ||
US Treasury Bills [Member] | Level 3 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | ||
Certificates of Deposit [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | 62,592,523 | |
Certificates of Deposit [Member] | Level 1 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | 62,592,523 | |
Certificates of Deposit [Member] | Level 2 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | ||
Certificates of Deposit [Member] | Level 3 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | ||
Debt Securities in government sponsored entities [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | 132,488,377 | |
Debt Securities in government sponsored entities [Member] | Level 2 [Member] | ||
Marketable Securities: | ||
Debt Securities, Available-for-Sale | $ 132,488,377 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments - Change in Fair Value of Warrant Liabilities (Details) - Level 3 | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Balance | $ 10,636,921 |
Change in fair value of warrant derivative liabilities | 3,044,006 |
Automatic conversion of Roche warrants into common stock upon initial public offering | (13,680,927) |
Balance | $ 0 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Fair Value of Warrant Derivative Liabilities (Details) | Dec. 31, 2021 USD ($) |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant outstanding | $ 12.44 |
Volatility | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | 64 |
Expected term (in years) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | 6 months 7 days |
Risk-free interest rate | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | 0.21 |
Dividend yield | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments (Additional Information) (Details) | Sep. 30, 2022 USD ($) |
Fair Value Disclosures [Abstract] | |
Amortized cost of marketable securities | $ 255.8 |
License Agreement - Additional
License Agreement - Additional Information (Details) $ in Millions | 1 Months Ended |
May 31, 2019 USD ($) | |
Roche License Agreement [Member] | |
Finite Lived Intangible Assets [Line Items] | |
Nonrefundable payment received | $ 2 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock - Additional Information (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) shares | Sep. 30, 2022 USD ($) Warrants $ / shares shares | Sep. 30, 2021 USD ($) shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2019 USD ($) $ / shares shares | Aug. 12, 2022 $ / shares | Jan. 11, 2022 shares | Jun. 30, 2021 shares | Mar. 31, 2021 shares | Dec. 31, 2020 shares | May 31, 2019 shares | |
Temporary Equity [Line Items] | ||||||||||||
Payments of stock issuance costs | $ 2,563,946 | |||||||||||
Class of warrant, exercise price of warrants | $ / shares | $ 0.00001 | |||||||||||
Change in fair value of warrant derivative liabilities | $ 0 | $ 1,335,852 | $ 3,044,006 | $ 3,755,509 | ||||||||
2019 Warrant [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Warrants converted into common stock | shares | 739,463 | |||||||||||
2021 Warrant [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Change in fair value of warrant derivative liabilities | $ 1,400,000 | |||||||||||
Warrants converted into common stock | shares | 113,325 | |||||||||||
IPO | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Sale of stock, price per share | $ / shares | $ 14.28 | $ 14.28 | ||||||||||
Series A | IPO | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Proceeds of underwriting discount and commissions net | $ 50,000,000 | $ 50,000,000 | ||||||||||
Series B | IPO | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Proceeds of underwriting discount and commissions net | $ 100,000,000 | $ 100,000,000 | ||||||||||
Series A Redeemable Convertible Preferred Stock [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Temporary equity, shares authorized | shares | 0 | 0 | 35,714,282 | 35,714,282 | ||||||||
Temporary equity, shares outstanding | shares | 0 | 0 | 35,714,282 | 35,714,282 | 35,714,282 | 35,714,282 | ||||||
Temporary Equity, Redemption Price Per Share | $ / shares | $ 1.40 | |||||||||||
Payments of stock issuance costs | $ 2,100,000 | |||||||||||
Dividends payable | $ 0 | $ 0 | ||||||||||
Proceeds from issuance of convertible preferred stock | $ 50,000,000 | |||||||||||
Beneficial conversion feature | $ 0 | |||||||||||
Series A Redeemable Convertible Preferred Stock [Member] | Preferred Stock [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Temporary equity, shares issued | shares | 35,714,282 | |||||||||||
Series A Redeemable Convertible Preferred Stock [Member] | 2019 Warrant [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Warrant purchased | shares | 329,552 | 329,552 | ||||||||||
Valuation of Warrants | $ 9,200,000 | |||||||||||
Class of warrant, exercise price of warrants | $ / shares | $ 0.04 | $ 0.04 | ||||||||||
Class of Warrant, expiration date | May 13, 2029 | |||||||||||
Series A Redeemable Convertible Preferred Stock [Member] | Warrant [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Number of warrant issued | Warrants | 2 | |||||||||||
Warrant purchased | shares | 411,765 | 411,765 | ||||||||||
Series B Redeemable Convertible Preferred Stock [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Temporary equity, shares authorized | shares | 0 | 35,716,249 | 0 | 35,716,249 | 35,716,249 | |||||||
Temporary equity, shares issued | shares | 35,716,249 | |||||||||||
Temporary equity, shares outstanding | shares | 0 | 0 | 35,716,249 | |||||||||
Temporary Equity, Redemption Price Per Share | $ / shares | $ 4 | |||||||||||
Payments of stock issuance costs | $ 900,000 | |||||||||||
Dividends payable | $ 0 | $ 0 | ||||||||||
Proceeds from issuance of convertible preferred stock | $ 142,900,000 | |||||||||||
Dividends payable, amount per share | $ / shares | $ 0.32 | $ 0.32 | ||||||||||
Beneficial conversion feature | $ 0 | |||||||||||
Preferred stock converted into common stock | shares | 10,504,771 | |||||||||||
Series B Redeemable Convertible Preferred Stock [Member] | 2021 Warrant [Member] | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Warrant purchased | shares | 113,610 | 113,610 | ||||||||||
Class of warrant, exercise price of warrants | $ / shares | $ 0.01 | $ 0.01 | ||||||||||
Class of Warrant, expiration date | May 13, 2029 | |||||||||||
Series A Preferred Stock [Member] | IPO | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Preferred stock converted into common stock | shares | 10,504,199 |
Stockholder's Deficit and Sto_3
Stockholder's Deficit and Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Dec. 30, 2021 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock Option Shares outstanding, Granted | 1,365 | 101,637 | 68,525 | |||||
Stock Option Shares outstanding, Options exercisable | 865,350 | 865,350 | ||||||
Restricted Stock [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock Option Shares outstanding, Granted | 30,148 | |||||||
Unrecognized compensation costs | $ 0.4 | $ 0.4 | ||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 3 months | |||||||
Weighted average grant date fair value | $ 16 | |||||||
2019 Stock Option Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation costs | 12.3 | $ 12.3 | ||||||
Share-based compensation options, vested in period, fair value | $ 1.8 | $ 0.1 | $ 3.4 | $ 1.6 | ||||
Option expiration from the date of grant | 10 years | |||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 9 months 25 days | |||||||
Weighted average grant date fair value | $ 10.30 | $ 5.42 | ||||||
2022 Stock Option Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 3,984,910 | 3,984,910 | 3,368,572 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminated, expired or are otherwise not issued. In addition, the number of shares of common stock reserved for issuance under the 2022 Plan will automatically increase on January 1st of each calendar year, starting on January 1, 2023 and continuing through January 1, 2032, in an amount equal to 5% of the total number of shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board of Directors. | |||||||
Common stock, shares issued | 3,905,911 | |||||||
2022 Stock Option Plan | Maximum [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock, shares issued | 6,787,652 | 20,362,956 | 20,362,956 |
Stockholder's Deficit and Sto_4
Stockholder's Deficit and Stock-Based Compensation - Summary of Outstanding Stock Option Activity (Details) - USD ($) | 3 Months Ended | ||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Equity [Abstract] | |||
Stock Option Shares outstanding, Beginning Balance | 2,782,834 | 2,685,597 | 2,617,072 |
Stock Option Shares outstanding, Granted | 1,365 | 101,637 | 68,525 |
Stock Option Shares outstanding, Exercised | (29,411) | ||
Stock Option Shares outstanding, Expired/cancelled | (11,596) | (4,400) | |
Stock Option Shares outstanding, Ending Balance | 2,743,192 | 2,782,834 | 2,685,597 |
Stock Option Shares outstanding, Expected to vest | 2,743,192 | ||
Stock Option Shares outstanding, Options exercisable | 865,350 | ||
Weighted average exercise price, Beginning Balance | $ 7.27 | $ 6.96 | $ 6.19 |
Weighted average exercise price, granted | 25.53 | 16.26 | 16.51 |
Weighted average exercise price, exercised | 13.60 | ||
Weighted average exercise price, Expired/cancelled | 11.89 | 16 | |
Weighted average exercise price, Ending Balance | 7.19 | $ 7.27 | $ 6.96 |
Weighted average exercise price, expected to vest | 7.19 | ||
Weighted average exercise price, exercisable | $ 6.58 | ||
Weighted Average Remaining Contractual Term (in Years) | 9 years 1 month 24 days | 9 years 4 months 13 days | 9 years 6 months 21 days |
Weighted Average Remaining Contractual Term, Granted (in Years) | 6 years 6 months | 6 years 5 months 4 days | 9 years 9 months 14 days |
Weighted Average Remaining Contractual Term | 8 years 10 months 24 days | ||
Weighted Average Remaining Contractual Term, Expected to vest (in Years) | 8 years 10 months 24 days | ||
Weighted Average Remaining Contractual Term, Options exercisable (in Years) | 8 years 8 months 15 days | ||
Aggregate Intrinsic Value Outstanding, Ending Balance | $ 70,309,316 | ||
Expected to vest, June 30, 2022 | 70,309,316 | ||
Options exercisable, June 30, 2022 | $ 22,708,847 |
Stockholder's Deficit and Sto_5
Stockholder's Deficit and Stock-Based Compensation - Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions (Details) - $ / shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Equity [Abstract] | ||
Exercise price | $ 7.19 | $ 7.19 |
Stock price on date of grant | $ 7.19 | $ 7.19 |
Expected term (years) | 6 years 6 months | 3 years 10 months 24 days |
Expected stock price volatility% | 76.37% | 45.40% |
Risk-free rate of interest% | 3.13% | 1.67% |
Expected dividend yield% | 0% | 0% |
Stockholders' Deficit and Stock
Stockholders' Deficit and Stock-Based Compensation - Schedule of compensation cost related to employee stock-based compensation activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | $ 1,302,663 | $ 526,384 | $ 3,768,028 | $ 2,251,150 |
Research and development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | 278,961 | 40,673 | 764,087 | 572,603 |
General and administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | $ 1,023,702 | $ 485,711 | $ 3,003,941 | $ 1,678,547 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders - Schedule of Weighted Average Common Stock Equivalents (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Redeemable Convertible Preferred Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Redeemed convertible preferred stock (if converted) | 0 | 10,504,199 | 0 | 10,504,199 |
2019 Warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Redeemed convertible preferred stock (if converted) | 0 | 739,463 | 0 | 739,463 |
2021 Warrant [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Redeemed convertible preferred stock (if converted) | 113,325 | 113,325 | ||
Pre-Funded Warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Redeemed convertible preferred stock (if converted) | 2,600,000 | 0 | 2,600,000 | 0 |
Outstanding options exercisable | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Redeemed convertible preferred stock (if converted) | 1,625,896 | 172,051 | 1,305,585 | 65,128 |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Details) - CinRx [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Related Party Transaction [Line Items] | ||
Management fee expense | $ 300 | $ 1,100 |
Research and Development Expense [Member] | ||
Related Party Transaction [Line Items] | ||
Related part transaction research and development expenses | 200 | 800 |
General and Administrative Expense [Member] | ||
Related Party Transaction [Line Items] | ||
Related part transaction research and development expenses | $ 10 | $ 300 |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Feb. 24, 2022 ft² | |
Floor Area Size | ft² | 5,400 | ||||
Lease commencing date | Apr. 01, 2022 | ||||
Payments for rent | $ 300,000 | ||||
Rent expense | $ 100,000 | $ 0 | 200,000 | $ 0 | |
COHatch Cincinnati [Member] | |||||
Lease Payment | $ 2,850 | ||||
Floor Area Size | ft² | 221 | 221 |
Employee Benefit Plan (Addition
Employee Benefit Plan (Additional Information) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Retirement Benefits [Abstract] | ||
Defined contribution plan, employer matching contribution, percent | 4% | |
Defined contribution plan, administrative expenses | $ 0.1 | $ 0.2 |