Nature of the Business | 1. Nature of the Business Third Harmonic Bio, Inc., or the Company, is a biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases. The Company was incorporated in 2019 as a Delaware corporation, and it has offices located in San Francisco, California and Cambridge, Massachusetts. In December 2021, the Company formed THB MS, Inc., a Delaware corporation and wholly-owned subsidiary of the Company, which is classified as a Security Corporation in Massachusetts. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion and success of clinical testing, development by competitors of new technological innovations, compliance with governmental regulations, dependence on key personnel and protection of proprietary technology and the ability to secure additional capital to fund operations. The development of a drug candidate requires extensive research, development and clinical testing prior to regulatory approval and 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 significant revenue from product sales. Initial public offering On September 19, 2022, the Company closed its initial public offering, or the IPO, and issued 12,535,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,635,000 additional shares of common stock, at a public offering price of $ 17.00 per share. The Company received $ 198.2 million, net of underwriting discounts and commissions, but before deducting offering costs payable by the Company, which were $ 2.3 million. Immediately prior to the closing of the IPO, all outstanding shares of redeemable convertible preferred stock converted into 21,967,316 shares of common stock (see Note 7). In connection with the closing of its IPO, on September 19, 2022, the Company amended its certificate of incorporation to authorize the issuance of up to 500,000,000 shares of $ 0.0001 par value common stock and 10,000,000 shares of $ 0.0001 par value preferred stock. Liquidity In accordance with Accounting Standards Codification, or ASC 205-40, Going Concern , the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements were issued. As an emerging growth entity, the Company has devoted substantially all of its resources since inception to organizing and staffing the Company, business planning, raising capital, establishing its intellectual property portfolio, acquiring or discovering product candidates, research and development activities for THB335 or any future KIT inhibitor and other compounds, establishing arrangements with third parties for the manufacture of its product candidates and component materials, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future. Since its inception, the Company has funded its operations primarily with proceeds from sales of shares of its redeemable convertible preferred stock and most recently with proceeds from the IPO. The Company has incurred recurring losses since its inception, including net losses of $ 8.2 million and $ 7.3 million for the three months ended September 30, 2022 and 2023, respectively, and net losses of $ 23.7 million and $ 24.0 million for the nine months ended September 30, 2022 and 2023, respectively. As of September 30, 2023, the Company had an accumulated deficit of approximately $ 107.4 million. To date the Company has not generated any revenues and expects to continue to generate operating losses for the foreseeable future. As of the issuance date of these condensed consolidated financial statements, the Company expects that its existing cash and cash equivalents of $ 273.9 million as of September 30, 2023, will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed consolidated financial statements. Correction of Previously Reported Interim and Annual Consolidated Financial Statements As previously reported by the Company in its Quarterly Report on Form 10-Q for the period ended June 30, 2023, management determined that the weighted average shares outstanding, or WASO, of the Company’s common stock used in the calculation of basic and fully diluted loss per share was misstated for certain previously reported interim, year-to-date, and annual consolidated financial statements, or the previously reported periods. This resulted in the incorrect presentation of WASO and basic and fully diluted loss per share, collectively the error, on the Company’s Condensed Consolidated Statements of Operations and within the related notes thereto for the impacted previously reported periods. The cause of the error was due to clerical errors that were symptomatic to the previously disclosed material weakness related to the lack of segregation of duties, certain system limitations in our accounting software, and the overall control environment. Management prepared a quantitative and qualitative analysis of the error in accordance with SEC Staff Accounting Bulletin Nos. 99 and 108, or SAB 99/108, and concluded the impact of the error was not material to any of the previously reported periods. As a result, and in accordance with SAB 99/108, management has corrected the error in this Quarterly Report on Form 10-Q by presenting the correct WASO and basic and fully diluted loss per share on the face of the Company’s Condensed Consolidated Statements of Operations impacted by the error. Management also plans to correct the error for any relevant future periods. The correction of the error had no impact on the Company’s previously reported interim, year-to-date, or annual Condensed Consolidated Balance Sheet, Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity, or Condensed Consolidated Statements of Cash Flows. With respect to the Company’s previously reported interim, year-to-date, and annual Condensed Consolidated Statements of Operations impacted by the error, the correction of the error had no impact on the Company’s previously reported net loss in any of those periods. The correction of the error was limited to correcting the presentation of WASO and basic and fully diluted loss per share. A summary of the impact of the correction of the error on the Company’s previously reported interim, year-to-date, and annual Condensed Consolidated Statements of Operations impacted by the error that will be corrected and disclosed on a prospective basis the next time such previously reported periods and the related notes thereto are issued is, as follows: For the three months ended September 30, 2021 For the three months ended September 30, 2022 For the nine months ended September 30, 2022 As Previously Reported As Corrected As Previously Reported As Corrected As Previously Reported As Corrected Net loss per share of common stock, basic and diluted $ 0.90 $ 1.80 $ 0.69 $ 0.90 $ 2.26 $ 3.99 Weighted-average number of common shares used in net loss per share, basic and diluted 8,159,044 4,103,241 11,827,663 9,118,937 10,451,300 5,935,206 For the three months ended March 31, 2022 For the three months ended March 31, 2023 As Previously Reported As Corrected As Previously Reported As Corrected Net loss per share of common stock, basic and diluted $ 0.81 $ 1.82 $ 0.40 $ 0.23 Weighted-average number of common shares used in net loss per share, basic and diluted 9,643,963 4,271,681 22,792,781 39,438,572 For the Year Ended December 31, 2022 As Previously Reported As Corrected Net loss per share of common stock, basic and diluted $ 2.62 $ 2.45 Weighted-average number of common shares used in net loss per share, basic and diluted 13,426,066 14,353,102 |