Third Harmonic Bio Reports Q1 2024 Financial Results and Business Update

Third Harmonic Bio, Inc., a clinical-stage biopharmaceutical company, recently announced its financial outcomes for the first quarter ending on March 31, 2024, along with significant business developments and future milestones. With a focus on creating innovative treatments for dermal, respiratory, and gastrointestinal inflammatory diseases, Third Harmonic Bio is advancing its research in mast cell-mediated conditions.

A key highlight is the clearance from the U.S. FDA for the Investigational New Drug (IND) application for THB335, marking a significant step forward in its development. THB335 is a potent, highly selective, oral, small molecule KIT inhibitor, initially targeting chronic spontaneous urticaria (CSU). The company has initiated a Phase 1 clinical trial involving single and multiple ascending doses (SAD/MAD) to evaluate the drug's safety, pharmacokinetics, and pharmacodynamics in healthy volunteers. The results from this trial are expected in the first half of 2025. Upon successful completion, a Phase 2 trial in CSU is anticipated, with plans to rapidly extend into other mast cell-mediated disorders.

CEO Natalie Holles expressed enthusiasm, noting the urgency in addressing the unmet needs in CSU and the potential transformative benefits THB335 may bring to patients.

The Phase 1 SAD/MAD trial aims to assess the safety and tolerability of THB335, characterize its pharmacokinetics, and measure pharmacodynamic effects, particularly reductions in serum tryptase. These findings are crucial as they correlate with clinical response in urticaria studies.

In addition to the clinical trial advancements, Third Harmonic Bio has strengthened its leadership team. Christopher J. Dinsmore, Ph.D., has been appointed Chief Scientific Officer, Dennis Dean, Ph.D., is now Chief Non-Clinical Development Officer, and Jennifer Dittman has been promoted to Chief Development Operations Officer.

Dinsmore, with extensive experience in advancing drug candidates through clinical development, will oversee the company’s scientific research strategy. He joins from Kronos Bio, where he played a pivotal role in the company’s initial public offering and partnership with Genentech.

Dean brings a wealth of experience across multiple therapeutic areas of drug discovery and development, particularly in DMPK, preclinical safety assessment, and clinical pharmacology. He previously served as Chief Development Officer at IFM Therapeutics and Senior Vice President at Vertex Pharmaceuticals.

Dittman, who joined Third Harmonic Bio in 2022 as Vice President of Regulatory Affairs, will now oversee regulatory affairs, program management, quality, and CMC. Her background includes significant roles at Generation Bio and Vertex Pharmaceuticals.

Financially, Third Harmonic Bio reported a robust position with cash and cash equivalents totaling $262.8 million as of March 31, 2024. This financial strength is expected to support the company’s operations through at least 2026. Research and development expenses decreased slightly to $6.2 million compared to the previous year's $6.7 million, mainly due to the termination of the THB001 program. General and administrative expenses also saw a slight decrease to $5.1 million. Overall, the company reported a net loss of $7.9 million for the quarter, an improvement from the $9.1 million loss in the same period in 2023, primarily due to increased interest income and reduced operating expenses.

Third Harmonic Bio continues to advance its lead product candidate, THB335, aiming to revolutionize the treatment of a broad range of mast cell-mediated inflammatory diseases.