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Third Harmonic Bio Inc. (THRD) reports corporate-status and clinical-development updates tied to its stockholder-approved Plan of Liquidation and Dissolution and its THB335 program. The company has operated as a clinical-stage biopharmaceutical developer of highly selective, small-molecule KIT inhibitors for mast-cell-mediated inflammatory diseases affecting dermal, respiratory, and gastrointestinal systems.
Recurring updates include THB335 Phase 1 clinical data, chronic spontaneous urticaria development disclosures, regulatory-readiness activity, operating and financial results, shareholder voting matters, governance actions, and capital-structure developments connected with the company's liquidation and dissolution process.
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Third Harmonic Bio (THRD) reported its financial results for the fourth quarter and full year ended December 31, 2022. The company has a robust cash position of $288.9 million, sufficient to support operations for at least the next twelve months. Research and development expenses rose to $9.3 million in Q4 2022, up from $4.3 million in Q4 2021, and full-year R&D expenses increased to $24.4 million, compared to $15.7 million in 2021. Although the company achieved a decrease in net loss to $11.5 million for Q4 2022, the full-year net loss was $35.2 million, up from $29.6 million in 2021. The company is progressing towards selecting a next-generation KIT inhibitor candidate.
Third Harmonic Bio (THRD) announced the discontinuation of its Phase 1b study of THB001 due to asymptomatic liver transaminitis observed in two subjects at the 200mg BID dose. Although disappointing, preliminary analyses indicate clinical activity at this dose. The company is prioritizing patient safety and will conduct nonclinical studies to investigate the liver effects. In 2023, THRD aims to nominate a new development candidate from its next-generation oral wild-type KIT inhibitors.
Third Harmonic Bio (Nasdaq: THRD) successfully completed an upsized IPO, raising approximately $213.1 million to advance its THB001 treatment for chronic hives and asthma. The company has begun dosing patients in its Phase 1b trial for chronic inducible urticaria and plans to initiate an asthma trial in 2023. As of September 30, 2022, it had cash and equivalents of $299.5 million, sufficient to fund operations through 2025. While R&D expenses rose, G&A expenses significantly increased due to personnel costs and the IPO, leading to a net loss of $8.2 million in Q3 2022, versus $7.4 million in Q3 2021.
Third Harmonic Bio (Nasdaq: THRD) has closed its initial public offering of 12,535,000 shares at $17.00 per share, raising approximately $213.1 million in gross proceeds. This includes the full exercise of the underwriters' option for an additional 1,635,000 shares. The shares began trading on the Nasdaq Global Market on September 15, 2022. Morgan Stanley, Jefferies, and Cowen acted as joint bookrunning managers for this offering, which aims to support the development of its lead product, THB001, a selective oral KIT inhibitor for severe inflammatory diseases.