06:09:51 EDT Fri 17 May 2024
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or Name
USA
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Thiogenesis Therapeutics Corp
Symbol TTI
Shares Issued 38,862,075
Close 2023-11-16 C$ 0.82
Market Cap C$ 31,866,902
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Thiogenesis arranges $4.5-million private placement

2023-11-20 13:44 ET - News Release

Mr. Brook Riggins reports

THIOGENESIS ANNOUNCES NON-BROKERED PRIVATE PLACEMENT OF COMMON SHARES

Thiogenesis Therapeutics Corp. will undertake a non-brokered private placement of $4.5-million through the issuance of six million common shares of the company at a price of 75 cents per common share.

This Offering is subject to the approval of the TSX Venture Exchange (the "Exchange"). The Company anticipates closing of the Offering as soon as practicable subject to receipt of all necessary regulatory approvals. Upon issuance, the Offered Shares will be subject to a four-month and one day hold period pursuant to securities laws in Canada and, where applicable, Exchange policies.

In connection with the Offering, the Company may pay finder's fees to eligible persons in compliance with applicable securities laws and Exchange policies. The proceeds from the Offering will be used for the completion of regulatory submissions and clearances for its three clinical trial programs, manufacture of its lead compound TTI-0102 for clinical trials and inventory, administration of clinical trials and general working capital purposes.

Corporate Update and Milestones

  • On October 5th, 2023, the Company filed its European Investigational Medical Product Dossier ("IMPD") application, the equivalent of an Investigational New Drug ("IND") in the US, for a Phase 2 clinical trial for the treatment of MELAS in France and the Netherlands. The trial will be conducted with the powder formulation of TTI-0102, that was also used in a prior human safety trial. The primary endpoint is improvement in a 12-minute walk test, secondary endpoints are to be determined. The trial is anticipated to begin in Q1-2024, with an interim data analysis in H2-2024.
  • Thiogenesis has developed a new tablet formulation of TTI-0102 with its lead supplier, WuXi STA, that will provide for more convenient drug administration and an extended shelf life. A new, faster and cheaper production process has been finalized and a new salt has been added for stability, after pharmacokinetic bioequivalence studies were completed in animals. Additional intellectual property has been filed to extend the Company's patent protection based on this new salt. The tablet formulation will be used in future clinical trials and commercially if it is approved for marketing.
  • Subsequent to the anticipated clearance of the IMPD for MELAS, the Company will complete and submit an IMPD for a Phase 2 clinical trial for the treatment of Rett syndrome, to be conducted at a leading academic hospital in France. The Rett syndrome Phase 2 trial is anticipated to start in mid-2024, using the tablet formulation. The primary endpoint will be improvement of behavioral disorders as measured by the ABC behavior scale ("Aberrant Behavior Checklist").
  • Thiogenesis is also planning to file an IND for a Phase 2 pediatric NASH clinical trial in Q1-2024, to be conducted at sites in the US. Subject to regulatory clearance by the FDA, the trial is anticipated to begin in mid-2024 using the tablet formulation. The primary endpoint will be the change in percentage of hepatic steatosis (fatty liver disease) following 61 days of treatment. Secondary endpoints will be measuring the change in a number of established liver biomarkers; for example, aspartate aminotransferase ("ALT").

About MELAS

Mitochondrial dysfunction and resulting oxidative stress are thought to be at the core of many metabolic and cellular disorders. Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes ("MELAS") is the most prevalent of the family of mitochondrial diseases. Many different transfer RNA ("tRNA") mutations can cause MELAS. The most common mutation is in the MTTL1 mitochondrial gene. A single base pair mutation, m.3243A>G, is found in 80% of patients, and a second common mutation, m.3271T>C, is found in 10% of patients. MELAS involves the buildup of lactic acid in the body, known as lactic acidosis. Symptoms include muscle weakness, headaches, seizures, vomiting, loss of appetite and stroke-like episodes. Patients are generally identified in childhood and before the age of 20. The prevalence is over 25,000 patients in Europe, and it is an orphan indication. There are no approved therapies for MELAS in Europe.

TTI-0102 has multiple mechanisms of action that have potential as a therapeutic for MELAS. It is a precursor to the important antioxidant glutathione, which reduces oxidative stress in the mitochondria. It also crosses the blood brain barrier and is a precursor to hypo-taurine which oxidizes into the amino acid taurine. Taurine is well known to reduce seizures.

About Rett Syndrome

Rett syndrome is a neurological disorder that affects young girls and is caused by mutations in the MECP2 gene. Its symptoms include intellectual disability, loss of speech, difficulty breathing, sleep apnea but its most identifiable symptoms are rapid hand movements and seizures. There are over 20,000 girls with Rett syndrome in Europe and there are no approved therapies. It is considered an orphan disease by the European Medicines Agency ("EMA"). TTI-0102 was granted the orphan medicine designation for Rett syndrome by EMA in 2021.

TTI-0102 has two key mechanisms of action that have potential as a therapeutic for Rett syndrome. The first is that it promotes Brain Derived Neurotropic Factor ("BDNF") which is beneficial for neurological disorders because it plays an important role in developing the health of neurons and synapses and in maintaining the health of the brain. Second, recent studies have shown that oxidative stress in the mitochondria is an important contributor to Rett syndrome. TTI-0102, as a precursor to the antioxidant glutathione, which helps combat oxidative stress and restore healthy mitochondrial function.

About Pediatric NASH

Nonalcoholic fatty liver disease ("NAFLD") is a condition in which excess fat builds up in the liver. If left untreated NAFLD often progresses to nonalcoholic steatohepatitis ("NASH") that results in pronounced liver inflammation, irreversible liver damage and fibrosis. Historically, NASH was mostly observed in adult patients but with the world-wide increase in childhood obesity, there has been a significant escalation of NASH in children. In the US alone there is estimated to be over 1.5 million children with NASH. Pediatric NASH can lead to severe and irreversible liver disease in children resulting in cirrhosis ("scarring"), liver failure and liver cancer. There are currently no drugs approved for NASH in the US and there is far lower activity in clinical trials for pediatric NASH.

Pediatric NASH is considered a metabolic disease, many of which have now been studied for signs of oxidative stress in the mitochondria. Recent publications have shown that a functional, healthy mitochondria is an important feature of healthy liver function. TTI-0102's most significant mechanism of action is as a precursor to one of the most important antioxidants, glutathione. Increased rates of glutathione have shown potential in reducing inflammation and fibrosis in pediatric NASH patients in previous human trials.

About Thiogenesis

Thiogenesis Therapeutics, Corp. (TSXV: TTI) is a clinical-stage biopharmaceutical company operating through its wholly owned subsidiary based in San Diego, CA. The Company is publicly traded on the TSX Venture Exchange. Thiogenesis is developing sulfur-containing prodrugs that act as precursors to thiol-active compounds with the potential to treat serious pediatric diseases with unmet medical needs. Thiols have been the subject of promising medical research for many decades and are known for having powerful antioxidant properties and other potential therapeutic activities. The Company's initial target indications include Mitochondrial Encephalopathy Lactic Acidosis and Stroke (MELAS), Rett syndrome and pediatric NASH.

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