U.S. FDA clears Investigational New Drug application for THB335 Phase 1 SAD/MAD clinical trial initiated and subject screening underway, with results expected during 1H'25 Strengthened leadership team with the appointment of Christopher J. Dinsmore, Ph.D., to Chief Scientific Officer, Dennis Dean, Ph.D., to Chief Non-Clinical Development Officer, and the promotion of Jennifer Dittman to Chief Development Operations Officer Strong financial position with cash and cash equivalents totaling $262.8 million as of March 31, 2024 SAN FRANCISCO, May 15, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (NASDAQ:THRD), a clinical stage biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases, today announced financial results for the first quarter March 31, 2024, recent business updates, and anticipated milestones. As part of its business update, the Company announced U.S. FDA clearance of its Investigational New Drug (IND) application to initiate a first-in-human clinical trial of THB335, a potent, highly selective, oral, small molecule KIT inhibitor that is in development for the treatment of mast cell-mediated diseases, with an initial focus in chronic spontaneous urticaria (CSU). The Company has initiated a Phase 1 single and multiple ascending doses (SAD/MAD) clinical trial of THB335 to evaluate safety, pharmacokinetics, and pharmacodynamics in healthy volunteers, and expects to report clinical results from the trial during the first half of 2025. The Phase 1 trial is expected to be followed by a Phase 2 trial in CSU, with planned rapid expansion into additional mast cell-mediated disorders. "With the initiation of THB335 clinical trials, we are advancing the development of our potentially best-in-class oral KIT inhibitor toward becoming an important treatment for patients living with chronic spontaneous urticaria and other mast-cell mediated inflammatory diseases," said Natalie Holles, Chief Executive Officer at Third Harmonic Bio. "We are continuing to conduct our development efforts with urgency given the significant unmet need in CSU and the potentially transformative benefit that TBH335 may deliver to patients." The Phase 1 SAD/MAD clinical trial of THB335 is being conducted in healthy volunteers to assess safety and tolerability, characterize pharmacokinetics, and to measure the pharmacodynamic effect by reductions in serum tryptase, a biomarker associated with mast cell activation and correlated with clinical response in urticaria studies. Results are expected in the first half of 2025. Leadership Team Updates The Company also announced the appointment and promotion of key executive leaders to the organization. Christopher J. Dinsmore, Ph.D., was appointed to Chief Scientific Officer, Dennis Dean, Ph.D., was appointed to Chief Non-Clinical Development Officer, and Jennifer Dittman was promoted to Chief Development Operations Officer. "We are excited to expand the executive team with the appointments of Chris, Dennis and Jennifer to their respective leadership roles in these critical discovery, research and development functions," continued Natalie Holles. "In addition to their outstanding collective track record in our industry, all three embody our core operating principles of open collaboration, enterprise-level thinking and drive. I look forward to our future achievements under this outstanding leadership team." Chris is a seasoned leader with a strong track record of advancing early targets to drug candidate identification and through clinical development. In his role as Chief Scientific Officer, he will oversee the Company's scientific research strategy from discovery through preclinical proof-of-concept, IND filing, and also support early clinical development. Chris joins Third Harmonic Bio from Kronos Bio, where he was Chief Scientific Officer, responsible for the discovery functions, and played a key role in the company's initial public offering and partnership with Genentech. Prior to Kronos, he served as an Entrepreneur-in-Residence at Third Rock Ventures, focusing on the launch of new biomedical companies. Earlier in his career, he served as Vice President, Head of Chemistry, of Forma Therapeutics, where he oversaw chemistry functions in support of discovery and early development. He began his career at Merck Research Laboratories where he held positions of increasing responsibility in discovery chemistry. He received his Ph.D. in organic chemistry from University of Minnesota, Minneapolis, and was a NIH Postdoctoral Fellow in organic chemistry at Harvard University. Dennis brings extensive experience across multiple therapeutic areas of drug discovery and development, with a particular focus in DMPK, preclinical safety assessment, clinical pharmacology, biomarkers, and modeling and simulation. In his role as Chief Non-Clinical Development Officer, he will be responsible for leading the selection of high-quality development candidates, including toxicology, DMPK and translation functions. Prior to joining Third Harmonic Bio, Dennis has served as Chief Development Officer of IFM Therapeutics, where he oversaw preclinical and clinical development, advancing multiple programs into early clinical development leading to three acquisitions by global pharmaceutical companies. Before IFM Therapeutics, he was Senior Vice President, Head of Preclinical Development at Vertex Pharmaceuticals, where he linked key preclinical translational groups, effectively progressed the pipeline, and bridged transition for discovery into development. Earlier in his career, he held positions of increasing responsibility in DMPK at Merck Research Laboratories. He received his Ph.D. in medicinal chemistry at State University of New York, Buffalo, and was a Postdoctoral Fellow at Emory University. Jennifer joined Third Harmonic Bio in November 2022 as Vice President of Regulatory Affairs. In her expanded role as Chief Development Operations Officer, she is now responsible for regulatory affairs, program management, quality, and CMC. Prior to joining Third Harmonic Bio, Jennifer was Vice President of Regulatory Affairs and Medical Writing at Generation Bio, where she was responsible for platform and pipeline regulatory activities. Before Generation Bio, she held roles of increasing responsibility at Vertex Pharmaceuticals, most recently serving as Executive Director, Therapeutic Area Head, in Regulatory Affairs, where she helped set the global regulatory strategy for multiple pipeline products in development, including small molecule and gene therapy/editing programs. Earlier in her career, Jennifer served in roles of increasing responsibility in Regulatory Affairs at bluebird bio and was Adjunct Faculty in the Regulatory Affairs program at Northeastern University. She holds a M.S. in regulatory affairs for drugs, biologics, and medical devices from Northeastern University. Summary of Financial Results Cash Position: Cash and cash equivalents totaled $262.8 million as of March 31, 2024. Based on the company's current operating plan, Third Harmonic Bio believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 2026. R&D Expenses: Research and development (R&D) expenses decreased to $6.2 million for the three months ended March 31, 2024, from $6.7 million for the same period in 2023. The decreases were primarily due to decreases in development costs relating to the termination of the THB001 program, ...