Thiogenesis Reports Results of 2026 Annual and Special Meeting of Shareholders and Provides Corporate Update

September 21, 2026 4:00 AM EDT | Source: Thiogenesis Therapeutics, Corp.

San Diego, California--(Newsfile Corp. - September 21, 2026) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQB: 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 and Special Meeting of Shareholders ("Meeting") held on September 8, 2026, and provided a corporate update highlighting recent clinical, regulatory, and financial milestones.

Meeting Results

All items of business put before shareholders at the Meeting were approved by the requisite majority of votes cast.

Shareholders elected the following directors to serve until the next annual meeting or until their successors are elected or appointed: Dr. Christopher Starr (Chair), Kim Tsuchimoto (Audit Committee Chair), Hogan Mullally, Dr. Gilad Aharon (Co-Founder and Portfolio Manager, Rosalind Advisors, Inc.), Dr. Patrice Rioux, and Brook Riggins. MNP LLP was also reappointed as the Company's auditor until the next annual meeting or until a successor is appointed.

A majority of the disinterested Shareholders also approved an amendment to the Company's 2024 Omnibus Equity Incentive Plan.

Pipeline Update

Nephropathic Cystinosis

Nephropathic cystinosis is a rare genetic disease that prevents the body from properly clearing a toxic amino acid, cystine, out of cells. Left inadequately treated, cystine buildup progressively damages the kidneys and other organs, often leading to kidney failure in childhood. The current standard of care, Procysbi®, requires patients to swallow, depending on body weight, between 16 and 28 capsules a day, twice daily, on a strict fasting schedule, a pill burden and rigid routine that becomes increasingly difficult to sustain over a lifetime of therapy, with lapses in adherence allowing toxic cystine buildup to resume and cause further organ damage.

TTI-0102 is designed to replace that regimen with the potential for a once-daily powder, available in different strengths so dosing can be tailored to each patient's weight, eliminating pills entirely while continuing to clear cystine from cells.

The Company plans to initiate an investigator-initiated study of TTI-0102 in patients with nephropathic cystinosis in the fourth quarter of 2026, in collaboration with Dr. Larry Greenbaum at Emory University. The study will enroll approximately 6 adult patients already on standard cysteamine therapy, who will switch to once-daily TTI-0102 for a short treatment period before returning to their regular medication. The primary goal is to confirm that a single daily dose of TTI-0102 can keep cystine levels suppressed over a full 24-hour period, the standard needed to potentially reduce dosing frequency from the current multiple-times-per-day regimen. Topline data from the study are anticipated in the first quarter of 2027.

Leigh syndrome

Leigh syndrome is a rare, severe mitochondrial disease that typically appears in infancy or early childhood, progressively impairing the body's ability to produce cellular energy. There are currently no approved treatments, and care is limited to managing symptoms. TTI-0102 is designed to boost the body's natural antioxidant defenses and reduce the cellular stress associated with the disease.

The Company plans to initiate its Phase 2a clinical trial of TTI-0102 in Leigh syndrome in the fourth quarter of 2026, in collaboration with a leading U.S. children's hospital, under an active U.S. FDA Investigational New Drug application. The randomized, placebo-controlled trial will enroll approximately 9 adolescent and adult patients, two-thirds of whom will receive TTI-0102 daily for a 12-week treatment period. The study will measure changes in biomarkers of oxidative stress and cellular energy production, including glutathione, alongside patient-reported measures of fatigue and daily functioning. Topline data are anticipated in the second quarter of 2027.

Corporate Highlights

  • July 13, 2026 - The U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease ("RPD") designation to TTI-0102 for the treatment of Leigh syndrome. The designation provides the potential, upon approval of a future New Drug Application, to receive a Priority Review Voucher, and further supports the Company's Phase 2a clinical program in Leigh syndrome.
  • June 1, 2026 - Thiogenesis closed a non-brokered private placement, issuing 18,143,700 common shares at $0.50 per share for gross proceeds of $9,071,850, to support continued clinical development of TTI-0102 across the Company's pipeline and general working capital.
  • February 2, 2026 - Thiogenesis announced an investigator-initiated study collaboration with Dr. Larry Greenbaum at Emory University, evaluating TTI-0102 in patients with nephropathic cystinosis to further characterize once-daily dosing, tolerability, and white blood cell cystine control.
  • January 23, 2026 - Interim data from the Company's Phase 2 (EU) MELAS study of TTI-0102 were presented at Mitocon 2026. Results demonstrated that once-daily, weight-based dosing could achieve sustained 24-hour cysteamine exposure, and in patients who achieved appropriate weight-adjusted exposure, treatment was associated with improvements in patient-reported fatigue and pharmacodynamic biomarker changes consistent with reduced oxidative stress and improved cellular energy metabolism.

"We are entering a pivotal stretch for Thiogenesis," said Dr. Patrice Rioux, Chief Executive Officer of Thiogenesis. "With new clinical studies set to begin this quarter in both nephropathic cystinosis and Leigh syndrome, and topline data expected across both programs in the first half of 2027, shareholders can look forward to a series of meaningful catalysts over the coming months. Together with the FDA's Rare Pediatric Disease designation and our strengthened balance sheet following the June financing, we believe Thiogenesis is well-positioned to advance TTI-0102 across multiple serious pediatric diseases, each representing significant unmet medical need."

The Company also announces that, pursuant to the terms of the Company's Omnibus Equity Incentive Plan and in accordance with the policies of the TSX Venture Exchange, the Company's board of directors approved a grant of 200,000 common share purchase options to a director of the Company, exercisable at $0.50 per share until September 17, 2031. The options vest in 4 equal instalments every six months commencing March 17, 2027.

About Thiogenesis

Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQB: 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 OTCQB. 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 completed a Phase 2 clinical trial in Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes ("MELAS"), has an IND-cleared Phase 2a clinical trial in Leigh syndrome, and is advancing an investigator-initiated study in nephropathic cystinosis.

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 development and regulatory progress of TTI-0102 and the Company's future capital requirements. 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. (OTCQB: 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/315046

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Source: Thiogenesis Therapeutics, Corp.

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