Thiogenesis Stock Price, News & Analysis

Thiogenesis Therapeutics announced that CEO Dr. Patrice Rioux will participate in a clinical panel discussion at UMDF's 2025 Mitochondrial Medicine Conference in St. Louis on June 20, 2025. The conference, gathering over 700 experts, will feature updates on Thiogenesis' two Phase 2 clinical programs for their drug TTI-0102. The programs include a European multicenter trial for MELAS patients initiated May 14, 2025, and a U.S.-based trial for Leigh Syndrome Spectrum following FDA IND clearance on June 11, 2025. TTI-0102 is a thiol-based prodrug designed to increase intracellular levels of glutathione and taurine to combat oxidative stress in mitochondrial disorders.

Thiogenesis Therapeutics announced the activation of its second clinical site at Angers University Hospital Center in France for its Phase 2 MELAS clinical trial of TTI-0102. The trial has begun enrolling patients, with the first French patient dosed last week. The study is a multicenter, randomized, double-blind, placebo-controlled trial evaluating TTI-0102 in 12 MELAS patients across the Netherlands and France, with 8 receiving the treatment and 4 receiving placebo. The company has already reached the enrollment threshold required for a three-month interim analysis, expected in September 2025. The trial will assess safety, tolerability, PK/PD, and efficacy over six months, with key endpoints including the 12-Minute Walk Test, Fatigue Severity Scale, and WHOQOL-BREF Quality of Life assessment.

Thiogenesis Therapeutics (OTCQX: TTIPF), a clinical-stage biotech company focused on developing disulfide-based therapeutics, has announced a stock option grant. The company's board approved 400,000 common share purchase options to two directors on June 11, 2025. The options are exercisable at $0.77 per share, with a vesting schedule of 25% every six months from the grant date. These options will expire on June 11, 2030. The grant was made under the company's Omnibus Equity Incentive Plan.

Thiogenesis Therapeutics (TTIPF) has received FDA clearance for its Investigational New Drug application for TTI-0102, targeting Leigh syndrome spectrum (LSS), a rare pediatric mitochondrial disease. The Phase 2a clinical trial is set to begin in H2 2025 in collaboration with Children's Hospital of Philadelphia (CHOP). TTI-0102, classified as a New Chemical Entity and prodrug, is designed to drive intracellular cysteine production, crucial for generating glutathione and other therapeutic compounds. The trial will be conducted under the leadership of Dr. Zarazuela Zolkipli-Cunningham at CHOP, a leading institution in pediatric mitochondrial medicine.

Thiogenesis Therapeutics (OTCQX: TTIPF) has initiated its Phase 2 clinical trial for TTI-0102, its lead product candidate targeting MELAS (Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes). The first two patients were dosed on May 12th at Radboud University Medical Center in Netherlands.

The multi-center trial will be conducted in the Netherlands and France, enrolling 12 patients total (8 receiving TTI-0102, 4 receiving placebo) in a randomized, double-blind, placebo-controlled study over 6 months. Key clinical endpoints include the 12-Minute Walking Test, Fatigue Severity Scale, and Quality of Life Assessment, with an interim analysis planned at 3 months.

TTI-0102 is designed to increase intracellular antioxidant glutathione and amino acid taurine, both deficient in MELAS patients. Currently, there are no approved drugs for MELAS in the EU or U.S.

Thiogenesis Therapeutics (TSXV: TTI) (OTCQX: TTIPF), a clinical-stage biotech company, has entered into a consulting and investor relations agreement with Bull Markets Media GmbH, effective February 15, 2025. The German-based digital stock market news portal will analyze opportunities to expand the company's European shareholder base and network.

The agreement includes a C$60,000 consulting fee, with 50% payable upon signing and the remainder due June 1, 2025. Additionally, the consultant will receive 100,000 stock options at $0.64 per share, valid for 3 years, vesting in four equal tranches of 25,000 between May 2025 and February 2026. The 12-month agreement can be renewed annually for up to two additional years.

The TSXV has also given final acceptance of Thiogenesis's IR contract with Triomphe Holdings (Capital Analytica).

Thiogenesis Therapeutics (TSXV: TTI) (OTCQX: TTIPF) has announced its common shares are now trading on the OTCQX Best Market under the symbol TTIPF. This represents a significant milestone as OTCQX is the highest-level market of OTC Markets, hosting 12,000 U.S. and global securities.

The company has also secured DTC eligibility status, enabling electronic settlement of shares across the United States and 131 other countries. Thiogenesis will maintain its listing on the TSX Venture Exchange under TTI.

Additionally, the company recently received final regulatory clearance to initiate a Phase 2 clinical trial in Europe for the treatment of Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like episodes (MELAS). The trial's commencement is pending completion of administrative procedures and material provision to trial sites.

Thiogenesis Therapeutics (TSXV: TTI) has received final EMA clearance for its Clinical Trial Application (CTA) Part II to begin a Phase 2 clinical trial of TTI-0102 for MELAS treatment. The trial will be conducted in France and the Netherlands as a randomized, double-blind, placebo-controlled study over 6 months.

The study will involve 12 patients total, with 8 receiving TTI-0102 and 4 receiving placebo. An interim analysis will be conducted after 3 months to assess safety data, pharmacokinetics/pharmacodynamics, and biomarkers. The trial's efficacy endpoints include the 12-Minute Walking Test, Fatigue Severity Scale, and Quality of Life Assessment.

TTI-0102 is designed to increase intracellular antioxidant glutathione and amino acid taurine levels, which are typically deficient in MELAS patients. Currently, there are no approved drugs for MELAS treatment.

Thiogenesis Therapeutics presented updates on two clinical programs in mitochondrial disease at the UMDF Webcast. The company received acceptance of its Clinical Trial Application Part I for MELAS in Europe and submitted Part II in December 2024, planning a Phase 2 trial with 12 patients in Netherlands and France by Q1 2025.

For Leigh Syndrome (LS), following a pre-IND meeting with the FDA in November 2024, the company is filing an IND and plans to initiate a Phase 2a trial in Q1 2025. The company's lead product, TTI-0102, targets oxidative stress in both conditions. MELAS affects approximately 15,000 patients in the US and 20,000 in the EU, while LS occurs in about 1/40,000 births.