UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41498 THIRD HARMONIC BIO, INC. (Exact Name of Registrant as Specified in its Charter) D ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) (Exact Name of Registrant as Specified in its Charter) Delaware 83-4553503 (State or other jurisdiction of incorporation or organization) 1700 Montgomery Street, Suite 210 San Francisco, California 94111 (Address, including zip code of registrant's principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (209) 727-2457 | Securities registered purs ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41498 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) | Securities registered pursuant to Section 12(b) of the Act: | | | | --- | --- | --- ...

Financial Performance and Losses - The company has incurred significant net losses of $35.2 million and $29.6 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of $83.4 million as of December 31, 2022[161]. - The company has not generated any revenue to date and does not expect to do so until regulatory approval and successful commercialization of future oral KIT inhibitor product candidates[163]. - The company anticipates substantial increases in expenses as it continues research and development, which may lead to further significant losses in the foreseeable future[162]. - The company has incurred substantial losses and does not expect to achieve profitability in the near future, with net operating losses limited to 80% of current year taxable income[233]. Funding and Capital Requirements - As of December 31, 2022, the company had $288.9 million in cash and cash equivalents, which is expected to fund operations for at least the next twelve months[166]. - The company will require substantial additional funds for product development, regulatory approvals, and commercialization efforts, which may not be available on acceptable terms[165]. - Future funding requirements will depend on various factors, including the timing and cost of clinical development activities and regulatory submissions[167]. - The company may need to seek additional funding through public or private equity offerings, debt financings, or collaborations, which could dilute existing stockholders' equity[169]. - The company may need significant additional capital in the future, which could lead to dilution of existing stockholders[323]. Clinical Development and Regulatory Challenges - The company has a limited operating history and has not completed any clinical trials beyond Phase 1, making it difficult to evaluate its business performance and predict future viability[159]. - The company announced the discontinuation of its Phase 1b trial of the prior product candidate, THB001, due to safety concerns[184]. - Future product revenue generation is not expected for many years, if at all, and will depend heavily on successful development and commercialization of future product candidates[182]. - The company plans to seek regulatory approval for future oral KIT inhibitor product candidates in the U.S., EU, UK, and Japan, which will require significant resources and compliance with varying regulatory requirements[181]. - The success of future product candidates will depend on factors such as successful completion of clinical trials, regulatory approvals, and market acceptance[182]. - The company may face delays in clinical trials due to various unforeseen events, including regulatory issues and patient enrollment challenges[185]. - The company has faced setbacks in clinical trials, with the design of trials being critical for supporting product approval[189]. - Variability in safety or efficacy results between different clinical trials may negatively impact development timelines and regulatory approval[190]. - Adverse events observed in clinical trials could inhibit regulatory approval or market acceptance of future product candidates[193]. - The ongoing COVID-19 pandemic may continue to impact the company's business operations and clinical trial activities[170]. Internal Controls and Compliance - The company identified a material weakness in its internal control over financial reporting, which has not been fully remediated since December 31, 2021, and remains as of December 31, 2022[176]. - Management implemented measures to improve internal controls, including hiring additional qualified personnel and engaging financial consultants, with an expectation of full implementation in the 2023 fiscal year[177]. - The company expects to incur additional costs to remediate control deficiencies, with no assurance of success in avoiding future material weaknesses[179]. - The company is engaged in a process to document and evaluate its internal control over financial reporting, which is expected to be costly and time-consuming[330]. Market and Competitive Landscape - The company faces competition from numerous established and emerging products, which may have superior safety, efficacy, or cost advantages[204]. - Competition from other companies developing novel treatments may adversely affect the company's ability to commercialize its product candidates[201]. - Market acceptance of future oral KIT inhibitor product candidates will depend on factors such as safety, efficacy, ease of administration, and reimbursement coverage[207]. - The addressable patient population for future oral KIT inhibitor product candidates may be smaller than estimated, potentially impacting profitability[208]. Intellectual Property and Patent Risks - The company relies on obtaining and maintaining patents for future oral KIT inhibitor product candidates, which may not be successfully granted or enforced, potentially impacting commercialization efforts[247]. - The company is dependent on licensors for patent protection, and if licensors fail to maintain or enforce these patents, competitors may enter the market, adversely affecting the business[248]. - Future patents may not provide sufficient protection against competitors, and the patent position in biotechnology can be uncertain, affecting market position[249]. - The company may face challenges in obtaining necessary licenses from third parties, which could limit its ability to generate revenue and achieve profitability[271]. Operational Risks and Challenges - The company may face significant challenges in managing growth and expanding operations, which could disrupt its business[216]. - Retaining key employees is critical for the company's success, as the loss of management or technical personnel could adversely affect research and development[217]. - The company operates in competitive regions like Cambridge, Massachusetts, and San Francisco, where attracting skilled personnel is challenging[218]. - The company relies on third-party organizations for clinical trials and manufacturing, which poses risks if these relationships are not effectively managed[215]. Legal and Regulatory Environment - The company faces potential penalties, including civil and criminal penalties, if found in violation of healthcare laws and regulations, which could adversely affect financial results[294]. - Compliance with data privacy and security obligations is critical, with potential consequences including regulatory investigations, fines, and reputational harm[296]. - The company is subject to stringent and changing obligations related to data privacy and security, with potential adverse business consequences for non-compliance[299]. Stockholder and Market Considerations - The market price of the company's common stock is likely to be highly volatile, influenced by various factors including clinical trial results and regulatory developments[316]. - The company is classified as an "emerging growth company" and a "smaller reporting company," which may impact its attractiveness to investors[325]. - The company’s stockholders may have interests that conflict with those of other investors, potentially affecting control and market price[324].

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41498 THIRD HARMONIC BIO, INC. (Exact Name of Registrant as Specified in its Charter) D ...