Thiogenesis Reports on 2025 Annual General Meeting of Shareholders and Provides Corporate Update

Rhea-AI Summary

Thiogenesis Therapeutics (OTCQX:TTIPF), a clinical-stage biopharmaceutical company, held its Annual General Meeting and provided significant corporate updates. The company successfully raised C$4.15 million through an oversubscribed private placement in August 2025.

Key developments include FDA clearance for TTI-0102's IND application in Leigh Syndrome Spectrum, EMA scientific advice for pediatric MASH trial, and progress in the Phase 2 MELAS trial with first two patients dosed. An interim analysis of the MELAS trial is expected in October 2025.

The company reappointed its board members and granted 150,000 stock options to two directors, exercisable at $0.75 per share.

Positive

• Successful C$4.15 million oversubscribed private placement completed
• FDA clearance received for TTI-0102 IND application in Leigh Syndrome Spectrum
• EMA scientific advice supports IMPD submission for Phase 2a pediatric MASH trial
• Phase 2 MELAS trial progressing with first two patients dosed

Negative

• Company continues to require additional funding through private placements
• Multiple clinical trials in early phases with no approved products yet

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

FAQ

What was the outcome of Thiogenesis (TTIPF) 2025 Annual General Meeting?

At the AGM, shareholders re-elected all incumbent directors including Dr. Christopher Starr as Chair, and MNP LLP was reappointed as the company's auditor.

How much funding did Thiogenesis (TTIPF) raise in its August 2025 private placement?

Thiogenesis raised C$4.15 million through an oversubscribed private placement to support its Phase 2 MELAS trial and manufacture of TTI-0102 clinical supply.

What are the key clinical trials Thiogenesis (TTIPF) is currently conducting?

Thiogenesis is conducting a Phase 2 trial in MELAS, preparing for Phase 2a trials in Leigh Syndrome Spectrum, and planning a Phase 2a trial in pediatric MASH.

When will Thiogenesis (TTIPF) report interim results from its MELAS trial?

A 3-month interim analysis of the first 6 patients in the MELAS trial is anticipated for October 2025.

What stock options did Thiogenesis (TTIPF) grant to directors in September 2025?

The company granted 150,000 common share purchase options to two directors, exercisable at $0.75, vesting 25% every six months and expiring on September 10, 2030.