San Diego, California--(Newsfile Corp. - September 11, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric diseases, today announced the results of its Annual General Meeting of Shareholders ("AGM") held on September 5, 2025, and provided a corporate update highlighting recent clinical and regulatory milestones.
AGM Results
Shareholders re-elected all incumbent directors to the board to serve until the next AGM or until a successor is appointed: Dr. Christopher Starr (Chair), Kim Tsuchimoto (Audit Committee Chair), Hogan Mullally, Dr. Patrice Rioux, and Brook Riggins. MNP LLP was also reappointed as the Company's auditor until the next AGM or until a successor is appointed.
Corporate Highlights
August 14, 2025 - Thiogenesis closed C$4.15 million in an oversubscribed private placement. Proceeds are being allocated to support the Company's Phase 2 Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes ("MELAS") clinical trial, manufacture of additional TTI-0102 clinical supply, and general working capital.
June 25, 2025 - Thiogenesis received scientific advice from the European Medicines Agency ("EMA") supporting an Investigational Medicinal Product Dossier ("IMPD") submission for a planned Phase 2a trial in pediatric Metabolic Dysfunction-Associated Steatohepatitis ("MASH"). Submission is targeted for Q4 2025.
June 11, 2025 - U.S Food and Drug Administration ("FDA") cleared the Company's Investigational New Drug ("IND") application for TTI-0102 in Leigh Syndrome Spectrum ("LSS"). Clinical supply production has commenced, and Institutional Review Board ("IRB") approval plus other administrative steps are underway with a leading U.S. children's hospital for the planned Phase 2a clinical trial launch.
May 14, 2025 - First two patients dosed in the Company's Phase 2 clinical trial in MELAS at Radboud University Medical Center (Netherlands). A 3-month interim analysis of the first 6 patients is anticipated for October 2025, assessing tolerability, safety, pharmacokinetics/pharmacodynamics, and efficacy of TTI-0102 versus placebo in MELAS. The GSH:GSSG ratio, reduced vs. oxidized glutathione, will serve as the main oxidative stress marker.
"We are extremely encouraged by the clinical and regulatory progress we've made in so far in 2025," said Dr. Christopher Starr, Chairman of the Board of Thiogenesis. "Our MELAS Phase 2 clinical trial is actively enrolling, and we are poised to launch additional Phase 2 studies in Leigh Syndrome Spectrum and pediatric MASH: three serious pediatric diseases with no approved therapies. With TTI-0102's potential to overcome historical limitations of cysteamine, we believe we are well-positioned to deliver a differentiated therapeutic option for patients affected by oxidative stress and corresponding mitochondrial dysfunction."
The Company also announces that pursuant to the terms of the Company's Omnibus Equity Incentive Plan, on September 10, 2025, the Company's board of directors approved a total grant of 150,000 common share purchase options exercisable at $0.75 to two directors of the Company. The common share purchase options vest 25% every six months following the date of grant and expire on September 10, 2030.
About Thiogenesis
Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) is a clinical-stage biopharmaceutical company with operations based in San Diego, CA. The Company is publicly traded on the TSX Venture Exchange and in the U.S. on the OTCQX. Thiogenesis is developing sulfur-containing prodrugs that act as precursors to previously approved thiol-active compounds, with the potential to treat serious pediatric diseases with unmet medical needs. Thiogenesis' lead product candidate, TTI-0102 has an active Phase 2 clinical trial in Mitochondrial Encephalopathy Lactic Acidosis and Stroke ("MELAS"), an IND-cleared Phase 2a clinical trial in Leigh Syndrome Spectrum and is planning a Phase 2 clinical trial in pediatric Metabolic Dysfunction-Associated Steatohepatitis ("MASH").
For further information, please contact:
Brook Riggins, Director and CFO
Email: info@thiogenesis.com
Tel.: (888) 223-9165
Forward-Looking Statements
This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as forward-looking statements) within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions, or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) nor the OTC Markets Group Inc. (OTCQX: OTCM) accepts responsibility for the adequacy or accuracy of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/265967
SOURCE: Thiogenesis Therapeutics, Corp.
