THB335 / Third Harmonic Bio - LARVOL DELTA

THB335 Asset Sale (GlobeNewswire) - "The Company also announced it is initiating a sale process of THB335 and related intellectual property."

Commercial • Chronic Spontaneous Urticaria

Updated THB335 Phase 1 Clinical Data and Phase 2 Readiness Activities (GlobeNewswire) - P1 | N=56 | NCT06425861 | Sponsor: Third Harmonic Bio, Inc. | "The 100mg QD dose showed pharmacokinetics and pharmacodynamics largely consistent with the 164mg dose level evaluated in a prior MAD cohort of the Phase 1 clinical trial, with mean plasma trough exposures exceeding the 90% inhibition concentration (IC90) of KIT by over six-fold, and an 85% mean reduction from baseline of serum tryptase, a biomarker of mast cell activation....The Company has now completed all clinical, toxicology and manufacturing activities to support a Phase 2 clinical trial of THB335 for the treatment of chronic spontaneous urticaria, and it plans to submit imminently a regulatory filing with the US Food and Drug Administration (FDA) to seek clearance for trial initiation."

New P2 trial • P1 data • Chronic Spontaneous Urticaria

Third Harmonic Bio Announces Plan of Liquidation and Dissolution (GlobeNewswire) - "Third Harmonic Bio...announced that the Company’s board of directors, after considering opportunities to maximize stockholder value, has approved and adopted a Plan of Liquidation and Dissolution (the 'Plan of Dissolution') for the liquidation and dissolution of the Company and the distribution of remaining cash to stockholders following an orderly wind down of the Company’s operations, including any proceeds from a sale of the Company’s assets and intellectual property, including but not limited to the THB335 program. Per previous financial and operational guidance, the Company will complete all Phase 2 readiness activities for THB335 by mid-year to maximize the value of the program that may be obtained for stockholders in the asset sale process. If its stockholders authorize the dissolution, the Company currently plans to file a Certificate of Dissolution with the Secretary of the State of Delaware in the third quarter of 2025."

Commercial • Chronic Spontaneous Urticaria • Immunology

Third Harmonic Bio Announces Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "R&D Expenses: Research and development (R&D) expenses increased to $10.5 million for the three months ended December 31, 2024, from $5.9 million for the same period in 2023. R&D expenses for the year ended December 31, 2024 increased to $36.5 million, from $24.0 million for the same period in 2023. The increases were primarily due to increased spend related to the THB335 program and increased personnel-related expenses..."

Commercial • Chronic Spontaneous Urticaria

Third Harmonic Bio Announces Phase 1 Clinical Results for THB335 and Provides Corporate Strategic Update (GlobeNewswire) - P1 | N=56 | NCT06425861 | Sponsor: Third Harmonic Bio, Inc. | "Third Harmonic Bio, Inc....announced results from its Phase 1 single and multiple ascending dose (SAD/MAD) clinical trial of THB335 in healthy volunteers....THB335 has shown a half-life of approximately 40 hours, enabling once daily (QD) dosing. Dose-dependent increases in exposure were observed across all SAD and MAD cohorts, with trough plasma exposures exceeding the KIT IC90 at MAD dose levels of 41 mg QD and greater. A mild positive food effect was observed as well. Pharmacodynamics: Dose-dependent reductions in serum tryptase, a biomarker of mast cell activation, were observed in the MAD cohorts, with mean reductions from baseline ranging from 13% to 84% at Day 15."

P1 data • Chronic Spontaneous Urticaria

THB335 Program Next Steps (GlobeNewswire) - "The Company intends to continue THB335 development activities through the first half of 2025 to prepare for the initiation of a 12-week, placebo-controlled Phase 2 study in CSU by mid-year 2025. Key near-term activities include completion of ongoing subchronic toxicology studies and submission of regulatory filings to position THB335 for Phase 2 initiation."

New P2 trial • Chronic Spontaneous Urticaria

First-in-human study of THB335, an oral small molecule inhibitor of Wild Type KIT Receptor Tyrosine Kinase: Initial Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) Results from Single Ascending Dose Cohorts (AAAAI-WAO 2025) - "Conclusions A single oral dose of THB335 in healthy participants was well-tolerated across doses. The MAD cohorts are underway, and data will be forthcoming."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • Cardiovascular • Contact Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Urticaria

THB335 is a potent and selective oral small molecule inhibitor of wild type KIT (AAAAI-WAO 2025) - "In the PCA model, THB335 oral administration resulted in a dose-dependent depletion of dermal mast cells achieving a 91.7% (p<0.0001) reduction with a concomitant reduction in cutaneous anaphylaxis of 86.5% (p<0.0001). Conclusions THB335 is a potent and selective inhibitor of wild type KIT that demonstrated efficacy in a rat model of passive cutaneous anaphylaxis."

Inflammation • CSF1R • FLT3 • PDGFRB

Third Harmonic Bio Announces Third Quarter 2024 Financial Results (GlobeNewswire) - "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 quarter of 2025....Research and development (R&D) expenses increased to $11.3 million for the three months ended September 30, 2024, from $6.0 million for the same period in 2023. R&D expenses for the nine months ended September 30, 2024, increased to $26.0 million, from $18.1 million for the same period in 2023. The increases were primarily due to increased spend related to the THB335 program and increased personnel-related expenses, partially offset by decreases in development costs relating to the termination of the THB001 program."

Commercial • P1 data • Chronic Spontaneous Urticaria • Immunology • Urticaria

A First in Human Trial Evaluating THB335 in Healthy Participants (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Third Harmonic Bio, Inc.

New P1 trial

Third Harmonic Bio Appoints Christopher Murphy as Chief Financial and Business Officer and Provides Business Update (GlobeNewswire) - "IND-enabling toxicology studies of THB335 nearing completion; Pre-IND interaction with the U.S. FDA now complete; Program remains on track to file a U.S. IND and initiate a Phase 1 study of THB335 during the first half of 2024."

FDA event • IND • New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Urticaria

Third Harmonic Bio Announces Third Quarter 2023 Financial Results (GlobeNewswire) - "Third Harmonic Bio, Inc...today announced financial results for the third quarter ended September 30, 2023...With IND-enabling studies continuing to progress, the company is on track to file a U.S. IND and initiate a Phase 1 SAD/14-day MAD study of THB335 to evaluate safety, pharmacokinetics and pharmacodynamics during the first half of 2024...Research and development (R&D) expenses increased to $6.0 million for the three months ended September 30, 2023, from $4.8 million for the same period in 2022....The increases were primarily due to increases in discovery and development and personnel-related costs relating to the research and nonclinical development of THB335 and other next-generation discovery efforts."

Commercial • IND • New P1 trial • Dermatology • Immunology • Urticaria

Third Harmonic Bio Announces Second Quarter 2023 Financial Results (GlobeNewswire) - P1b | N=5 | NCT05510843 | Sponsor: Third Harmonic Bio | "Third Harmonic Bio, Inc...today announced financial results for the second quarter ended June 30, 2023...the company announced its next-generation product candidate, THB335, and disclosed topline results of the Phase 1b clinical trial of THB001 for the treatment of chronic inducible urticaria, which was discontinued in December 2022 due to observed liver transaminitis in two of five patients enrolled. The results demonstrated evidence of clinical benefit in four of the five patients, achieving partial or complete responses despite early termination of the trial...The company plans to file a U.S. IND and initiate clinical trials of THB335 in the first half of 2024....Cash and cash equivalents totaled $278.1 million as of June 30, 2023."

Commercial • IND • P1 data • Dermatology • Immunology • Urticaria