Third Harmonic Bio Announces Stockholder Approval of Plan of Liquidation and Dissolution, Updated THB335 Phase 1 Clinical Data, and Initiation of Sale of THB335
Stockholders overwhelmingly approved liquidation and dissolution of the Company
at the June 5, 2025 Annual Meeting
Initial distribution currently expected in the range between approximately $5.30 and $5.35 per share of common stock, expected in the third quarter of 2025
THB335 demonstrated 85% serum tryptase reduction with an encouraging safety profile in an additional Phase 1 cohort evaluating 100mg dose with new drug product capsule formulation
Company initiating a sale process of THB335
SAN FRANCISCO, June 12, 2025 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (NASDAQ:THRD) today announced that its stockholders overwhelmingly approved the previously proposed Plan of Liquidation and Dissolution (the "Plan of Dissolution") at the Company's Annual Meeting of Stockholders held on June 5, 2025. In addition, The Company also announced the results of a recently completed additional cohort in its Phase 1 clinical trial of its oral wild-type KIT inhibitor development candidate, THB335, and that it is initiating the sale process of THB335 as part of the Plan of Dissolution.
Subject to final approval by its Board of Directors, the Company currently expects to finalize the Plan of Dissolution and make the initial distribution to stockholders in the third quarter of 2025. The proposal to adopt the Plan of Dissolution received the affirmative vote of holders of 99.9% of the shares casting votes and 83.7% of the Company's total outstanding common shares.
Based on the information currently available to the Company, the Company estimates that the total distributions will be in the range between approximately $5.30 and $5.44 per share of common stock. The initial distribution, currently expected in the third quarter of 2025, is estimated to be between approximately $5.30 and $5.35 per share of common stock. These estimates do not include cash that may become available for distribution from the proceeds from any sales of the Company's remaining assets and intellectual property, including but not limited to a sale of THB335. The amount distributable, however, may vary substantially from any estimate provided by the Company based on a number of factors.
Updated THB335 Phase 1 Clinical Data and Phase 2 Readiness Activities
As part of the previously announced ongoing Phase 2 readiness activities, the Company recently completed an additional 14-day multiple ascending dose cohort (n=10) in the Phase 1 clinical trial of THB335 in healthy volunteers. The cohort evaluated the pharmacokinetics, pharmacodynamics and safety of THB335 at a once-daily (QD) dose of 100mg utilizing a new drug product capsule formulation that is intended for use in future clinical development.
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.
All adverse events were mild, with the exception of one moderate adverse event of neutrophil reduction. There were no adverse events due to hemoglobin reduction, nor any other clinically significant laboratory value changes reported in the cohort. One subject experienced mild hair color change and mild taste loss, which resolved during the follow-up period.
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.
THB335 Asset Sale
The Company also announced it is initiating a sale process of THB335 and related intellectual property. Interested parties should contact Chris Murphy, Chief Financial and Business Officer, at [email protected] for more information.
Forward Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the dissolution and Plan of Dissolution, the timing and amount of any distribution to the Company's stockholders pursuant to the Plan of Dissolution, the Company's strategic review process, and the Company's ability to enter into any agreements or transactions for the sale of its remaining assets and intellectual property, including THB335, or if entered into, that any such agreements or transactions will be successful or on attractive terms. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the availability, timing and amount of the distribution to stockholders in connection with the dissolution; the amounts that will need to be set aside by the Company; the adequacy of such reserves to satisfy the Company's obligations; the Company's ability to favorably resolve potential tax claims, any litigation matters and other unresolved contingent liabilities; the amount of proceeds that might be realized from the sale or other disposition of the Company's assets, including THB335; the application of, and any changes in, applicable tax laws, regulations, administrative practices, principles and interpretations; the incurrence of expenses relating to the dissolution; the Company's ability to retain employees, consultants and other resources required to carry out the dissolution; and the ability of the board of directors to abandon, modify or delay implementation of the Plan of Dissolution, even after stockholder approval, that could cause actual results to differ materially from what the Company expects. Further information on potential risk factors that could affect the Company's business and its financial results are detailed under the heading "Risk Factors" included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, and in the Company's other filings filed from time to time with the SEC. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Business Development, Investor and Media Contact:
Chris Murphy
[email protected]
