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Thiogenesis Therapeutics Reports on Full Year 2022 Financial Results and Provides Corporate Update

Thiogenesis Therapeutics Reports on Full Year 2022 Financial Results and Provides Corporate Update

Thiogenesis Therapeutics 報告了 2022 年全年財務業績並提供公司最新情況
newsfile ·  2023/05/10 09:00

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.

加利福尼亞州聖地亞哥-(Newsfile Corp.-2023年5月10日)-硫化療法公司(TSXV:TTI)(“硫化”或“公司”)一家臨床階段的生物技術公司開發用於未治療的兒科疾病的硫醇活性化合物,該公司今天報告了2022年全年的財務業績,並提供了公司的最新情況。

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."

Thigenation的創始人兼首席執行官Patrice Rioux醫學博士博士說:“我們很高興報告2022年發生的重大事件,包括:通過反向收購完成上市交易,使我們的股票在多倫多證券交易所創業板上市,TTI-0102成功的人體安全性和藥代動力學試驗,以及超額認購的二次融資。”Rioux博士繼續說:“在我們邁向線粒體疾病和其他企業活動的首次人類功效臨床試驗之際,我們還希望提供我們活動的最新情況。”

Key Corporate Highlights and Updates

主要企業亮點和最新消息

  • 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.
  • 2022年3月:2022年4月13日,公司通過美國特拉華州一傢俬人公司Thigenation Treateutics,Inc.的反向收購完成了TSXV的合格交易,從而使我們的股票在TSXV上市。

In a concurrent financing with the Qualifying Transaction, Thiogenesis raised CDN$3.5 million at CDN$0.35 per share.

在與符合條件的交易同時進行的融資中,Thienetic以每股0.35加元的價格籌集了350萬加元。

  • 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.
  • 2022年5月:硫代生成在12名健康志願者身上宣佈了其最初的TTI-0102第一階段、開放標籤、劑量遞增、安全性和藥代動力學臨床試驗的結果。臨床試驗的結果成功地證明,前藥TTI-0102的劑量可以達到用於治療[腎病]胱氨酸病的半胱胺劑量當量的4倍,而且仍然耐受性良好,副作用輕微。臨床試驗還顯示,與胱氨酸病相關的最低治療水準可維持長達24小時,有可能每天給藥一次。這些積極的結果表明,TTI-0102有潛力解決半胱胺和其他硫醇類藥物面臨的問題,包括它們的半衰期短和嚴重的胃腸道副作用。
  • 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.
  • 2022年11月:Thigenation完成了超額認購的二次融資,以每股0.50加元的價格在非經紀私募中籌集了530萬加元。
  • 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.
  • 2023年第一季度:為製藥和生物技術公司提供專業服務的領先供應商PharMalex(最近被amerisourceBergen收購)委託PharMalex準備和支持該公司提交的IMPD/CTA檔案(相當於美國的一種研究新藥)。在法國和荷蘭開始第二階段臨床試驗,治療線粒體腦肌病、乳酸中毒和卒中樣發作或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.

黑色素沉著症是一種線粒體遺傳性疾病,往往在20歲之前出現。它是一種線粒體疾病,會影響大腦的功能和發育;導致神經功能障礙,降低血液中的氧氣水準,並導致癲癇發作。目前還沒有得到批准的治療方法,根據美國國立衛生研究院的數據,估計MELAS的患病率為每8500名活產兒中就有一名。TTI-0102治療MELAS的關鍵作用機制是作為硫醇-二硫鍵平衡機制(氧化還原活性)、作為谷胱甘肽的前體和作為次牛磺酸的前體。

  • 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.
  • 2023年3月:在美國的關鍵專利(編號為US 11,612,576B2)被頒發,《半胱胺敏感症的治療方法》這項專利涉及一種可轉化為半胱胺的二硫化物的給藥。在體內,這使它成為一種有利的藥物。 硫代擁有強大的專利戰略,正在申請專利,涵蓋了美國、歐洲和亞洲部分地區的“物質組成”和“使用方法”。
  • 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.
  • 2023年第二季度:Thigenation開始與其TTI-0102的主要製造商、領先的藥物開發和製造公司無錫STA合作開發第二代配方,使TTI-0102能夠以更穩定的片劑或香包形式給藥,而不是目前的粉末配方。新配方預計將在2023年第三季度準備就緒,以支持臨床試驗中對Rett綜合徵和兒科非酒精性脂肪性肝炎(NASH)的監管應用。

Full Year 2022 Financial Highlights (in Canadian Dollars)

2022年全年財務亮點(加元)

  • 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.
  • 截至2022年12月31日,現金和現金等價物為620萬美元,而截至2021年12月31日為10萬美元。610萬美元的增長是由於同時融資350萬美元的合格交易和530萬美元的二次融資,減去2022年的運營和交易/上市費用。
  • 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.
  • 2022年的研發費用為110萬美元,而2021年為140萬美元。研究和開發的減少主要與TTI-0102的第一階段劑量升級和安全性臨床試驗有關,該試驗於2021年啟動,於2022年第二季度完成。
  • 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.
  • 2022年一般和行政費用為90萬美元,而2021年為30萬美元。這一增長主要是由於作為一家上市公司的額外成本,包括作為一家TSXV上市公司的一般和行政薪酬以及行政成本。
  • 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.
  • 2022年淨虧損為390萬美元,而2021年為120萬美元。這一增加包括了與符合資格的交易中上市相關的成本。

About TTI-0102

關於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.

硫化療法公司的先導化合物TTI-0102是一種二硫化物,由兩個硫醇組成,形成獨立的半胱胺分子;它的開發是為了解決基於硫醇的藥物的重要障礙,包括半胱胺:半衰期短、強烈的胃腸道副作用和劑量限制。作為一種前體藥物,TTI-0102在被攝取後被代謝成半胱胺,代謝過程起到了門控機制的作用,消除了與副作用有關的半胱胺峰值;它還允許增加劑量,從而有可能每天給藥一次。

About Thiogenesis

關於硫化物的發生

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).

硫化療法公司(TSXV:TTI)是一家臨床階段的生物製藥公司,通過其設在加利福尼亞州聖地亞哥的全資子公司運營。該公司在多倫多證券交易所創業板上市交易。硫化作用正在開發作為硫醇活性化合物前體的含硫前體藥物,有可能治療嚴重的兒科疾病,但醫療需求尚未得到滿足。幾十年來,硫醇一直是有希望的研究對象,並以具有強大的抗氧化性和其他潛在的治療活性而聞名。該公司最初的目標適應症包括線粒體腦肌病、乳酸酸中毒和卒中樣發作(MELAS)、Retts綜合徵和兒科非酒精性脂肪性肝炎(NASH)。

For further information, please contact:

如需更多資訊,請聯繫:

Brook Riggins, Director, and CFO

布魯克·裡金斯、董事和首席財務官

Email: info@thiogenesis.com
Tel.: (888) 223-9165

電子郵件:info@thienesis.com
電話:(888)223-9165

Forward-Looking Statements

前瞻性陳述

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 . 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.

根據加拿大證券法,本新聞稿包括該短語所指的某些“前瞻性陳述”。但不限於,有關公司未來計劃和目標的陳述是前瞻性陳述,涉及不同程度的風險。前瞻性陳述反映了管理層對未來可能發生的事件和情況的當前看法,從本質上講,是基於管理層的信念和假設,會受到已知和未知的風險和不確定性的影響,這些風險和不確定性既有一般性的,也有公司特有的。儘管公司認為這些前瞻性陳述中表達的預期是合理的,但這些陳述並不能保證未來的業績,實際結果或發展可能與我們的前瞻性陳述中的大不相同。以下是可能導致該公司的實際結果與這些前瞻性陳述中明示或暗示的結果大不相同的重要因素:通貨膨脹、新冠肺炎和俄烏戰爭帶來的世界性經濟挑戰、總體市場狀況、藥物開發固有的風險、未來盈利能力的不確定性以及獲得額外資本的不確定性。有關作出這些前瞻性陳述時採用的重大因素和假設以及我們面臨的各種風險和不確定因素的更多資訊,請參閱我們的年度管理層對我們財務結果的討論和分析的“風險因素”部分以及我們提交給加拿大證券監管機構的其他持續披露檔案和財務報表,這些檔案和財務報表可在上查閱。除適用法律要求外,公司不承擔更新這些前瞻性資訊的義務。公司的前瞻性陳述依賴於訴訟保護。

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.

多倫多證券交易所創業板交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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