Thiogenesis Initiates Clinical Studies for Nephropathic Cystinosis and Leigh Syndrome

Thiogenesis Therapeutics, Corp., a clinical-stage biopharmaceutical company based in San Diego, California, has announced the results of its Annual and Special Meeting of Shareholders and provided a corporate update on its pipeline of sulfur-based therapeutics for serious pediatric diseases. The meeting, held on September 8, 2026, saw all business items approved by the requisite majority of votes cast. Shareholders elected a new slate of directors, including Dr. Christopher Starr, Kim Tsuchimoto, Hogan Mullally, Dr. Gilad Aharon, and Dr. Patrice Rioux, with MNP LLP reappointed as the Company’s auditor.

The Company also approved an amendment to its 2024 Omnibus Equity Incentive Plan. Additionally, Thiogenesis announced a non-brokered private placement, issuing 18,143,700 common shares at $0.50 per share for gross proceeds of $9,071,850. These funds will support the continued clinical development of TTI-0102 and general working capital.

Thiogenesis is advancing its pipeline with several key studies. 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 six 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.

In a related development, 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 nine 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.

The U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to TTI-0102 for the treatment of Leigh syndrome. This 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.

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.

The Company also announced 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 four equal instalments every six months commencing March 17, 2027.