San Diego, California--(Newsfile Corp. - May 10, 2023) - Thiogenesis Therapeutics Corp. (TSXV: TTI) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing thiol-active compounds for unmet pediatric diseases, today reports on full year 2022 financial results and provides a corporate update.
Patrice Rioux, M.D., Ph.D., Thiogenesis' founder and Chief Executive Officer stated, "We are pleased to report on a very eventful 2022, including: completing a going public transaction through a reverse takeover leading to the listing of our shares on the TSX Venture Exchange ("TSXV"), a successful human safety and pharmacokinetic trial for TTI-0102, and an over-subscribed secondary financing." Dr Rioux continued, "We also wish to provide an update on our activities as we drive towards our first human efficacy clinical trial in mitochondrial disease and additional corporate activities."
Key Corporate Highlights and Updates
- March 2022: The Company completed its Qualifying Transaction on the TSXV through a reverse takeover by Thiogenesis Therapeutics, Inc., a U.S. Delaware private company, leading to the listing of our shares on TSXV on April 13, 2022.
In a concurrent financing with the Qualifying Transaction, Thiogenesis raised CDN$3.5 million at CDN$0.35 per share.
- May 2022: Thiogenesis announced results from its initial TTI-0102 Phase 1, open label, dose-escalation, safety, and pharmacokinetics clinical trial on 12 healthy volunteers. The results from the clinical trial successfully demonstrated that TTI-0102, a prodrug, could be dosed up to 4x the cysteamine dose-equivalent that is used in the treatment of [nephropathic] cystinosis and still be well-tolerated with only mild side effects. The clinical trial also showed that minimum therapeutic levels associated with cystinosis were maintained for up to 24 hours, offering the potential to be dosed once-a-day. These positive results, indicate TTI-0102's potential to address the issues facing cysteamine and other thiol-based drugs, including their short half-life and serious gastrointestinal side effects.
- November 2022: Thiogenesis completed an oversubscribed secondary financing, raising CDN$5.3 million gross in a non-brokered private placement at CDN$0.50 per share.
- Q1 2023: Thiogenesis engaged Pharmalex (recently acquired by AmerisourceBergen), a leading provider of specialized services for pharma and biotech companies, to prepare and support Thiogenesis' IMPD/CTA submission (the equivalent of an Investigational New Drug in the U.S.) to begin a Phase 2 clinical trial in France and in the Netherlands to treat Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes or MELAS.
MELAS is a genetic disorder of the mitochondria and that tends to appear before the age of 20. It is a mitochondrial disease that affects the function and development of the brain; causing neurological impairment, lowers oxygen levels in the blood and leads to seizures. There is no approved treatment and according to the U.S. National Institutes of Health, the estimated prevalence of MELAS is 1 in 8500 live births. The key mechanisms of action for TTI-0102 in treating MELAS are as a thiol-disulfide balancing mechanism (redox activity), as a precursor to glutathione and as a precursor to hypo-taurine.
- March 2023: Thiogenesis' key patent in the U.S. (number US 11,612,576 B2) was issued, "Methods for the Treatment of Cysteamine Sensitive Disorders." This patent covers the administration of a disulfide convertible to cysteamine in vivo, which makes it a pro drug. Thiogenesis has a robust patenting strategy with patents pending covering both "Compositions of Matter" and "Methods of Use" for the U.S., Europe, and parts of Asia.
- Q2 2023: Thiogenesis started working with WuXi STA, a leading pharmaceutical development and manufacturing company, its lead manufacturer of TTI-0102, on a second-generation formulation that would allow TTI-0102 to be administered in a more stable tablet or sachet, rather than its current powder formulation. The new formulation is anticipated to be ready in Q3-2023 to support regulatory applications for Rett Syndrome and pediatric non-alcoholic steatohepatitis ("NASH") in clinical trials.
Full Year 2022 Financial Highlights (in Canadian Dollars)
- Cash and cash equivalents were $6.2 million as of December 31, 2022, compared to $0.1 million as of December 31, 2021. The $6.1 million increase is due to the concurrent financing with the Qualifying Transaction of $3.5 million and a secondary financing of $5.3 million, in 2022 less 2022 operating and transaction/listing expenses.
- Research and development expenses were $1.1 million for 2022, compared to $1.4 million for 2021. The decrease in research and development was primarily related to the Phase 1 dose-escalation and safety clinical trial of TTI-0102 that was initiated in 2021 and completed in Q2-2022.
- General and administration were $0.9 million for 2022, compared to $0.3 million for 2021. The increase was primarily related to the additional costs attributable to being a public company, including general and administrative salaries and administration costs of being a TSXV listed company.
- Net loss was $3.9 million for 2022, compared to $1.2 million for 2021. The increase includes the costs related to going public in the Qualifying Transaction.
About TTI-0102
Thiogenesis Therapeutics, Corp. lead compound TTI-0102 is a disulfide, made up of two thiols that lead to independent cysteamine molecules; it has been developed to address the important obstacles for thiol-based drugs, including cysteamine: their short half-life, strong GI side effects and dosing limitations. As a prodrug, TTI-0102 is metabolized into cysteamine after it is ingested, the metabolic process acts as a gating mechanism that eliminates the spike in cysteamine that is linked to side-effects; and it also allows for increased dosing, providing the potential to administer TTI-0102 once-a-day.
About Thiogenesis
Thiogenesis Therapeutics Corp. (TSXV: TTI) is a clinical-stage biopharmaceutical company operating through its wholly owned U.S. subsidiary based in San Diego, California. 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 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 Encephalomyopathy Lactic Acidosis and Stroke-like episodes (MELAS), Retts syndrome and pediatric non-alcoholic steatohepatitis (NASH).
For further information, please contact:
Brook Riggins, Director, and CFO
Email: info@thiogenesis.com
Tel.: (888) 223-9165
Forward-Looking Statements
This news release includes certain "forward-looking statements" within the meaning of that phrase under Canadian securities laws. Without limitation, statements regarding future plans and objectives of the Company are forward-looking statements that involve various degrees of risk. Forward-looking statements reflect management's current views with respect to possible future events and conditions and, by their nature, are based on management's beliefs and assumptions and subject to known and unknown risks and uncertainties, both general and specific to the Company. Although the Company believes the expectations expressed in such forward-looking statements are reasonable, such statements are not guarantees of future performance and actual results or developments may differ materially from those in our forward-looking statements. The following are important factors that could cause the Company's actual results to differ materially from those expressed or implied by such forward-looking statements: world-wide economic challenges due to inflation, COVID-19 and the Russia-Ukraine war, general market conditions, risks inherent in drug development, the uncertainty of future profitability and the uncertainty of access to additional capital. Additional information regarding the material factors and assumptions that were applied in making these forward-looking statements as well as the various risks and uncertainties we face are described in greater detail in the "Risk Factors" section of our annual Management's Discussion and Analysis of our financial results and other continuous disclosure documents and financial statements we file with the Canadian securities regulatory authorities which are available at www.sedar.com. The Company undertakes no obligation to update this forward-looking information except as required by applicable law. The Company relies on litigation protection for forward-looking statements.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
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