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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 报告了 2022 年全年财务业绩并提供公司最新情况
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.

加利福尼亚州圣地亚哥-(Newsfile Corp.-2023年5月10日)-硫化疗法公司(TSXV:TTI)(“硫化”或“公司”)一家临床阶段的生物技术公司开发用于未治疗的儿科疾病的硫醇活性化合物,该公司今天报告了2022年全年的财务业绩,并提供了公司的最新情况。

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的创始人兼首席执行官Patrice Rioux医学博士博士说:“我们很高兴报告2022年发生的重大事件,包括:通过反向收购完成上市交易,使我们的股票在多伦多证券交易所创业板上市,TTI-0102成功的人体安全性和药代动力学试验,以及超额认购的二次融资。”Rioux博士继续说:“在我们迈向线粒体疾病和其他企业活动的首次人类功效临床试验之际,我们还希望提供我们活动的最新情况。”

Key Corporate Highlights and Updates

主要企业亮点和最新消息

  • 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,公司通过美国特拉华州一家私人公司Thigenation Treateutics,Inc.的反向收购完成了TSXV的合格交易,从而使我们的股票在TSXV上市。

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

在与符合条件的交易同时进行的融资中,Thienetic以每股0.35加元的价格筹集了350万加元。

  • 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名健康志愿者身上宣布了其最初的TTI-0102第一阶段、开放标签、剂量递增、安全性和药代动力学临床试验的结果。临床试验的结果成功地证明,前药TTI-0102的剂量可以达到用于治疗[肾病]胱氨酸病的半胱胺剂量当量的4倍,而且仍然耐受性良好,副作用轻微。临床试验还显示,与胱氨酸病相关的最低治疗水平可维持长达24小时,有可能每天给药一次。这些积极的结果表明,TTI-0102有潜力解决半胱胺和其他硫醇类药物面临的问题,包括它们的半衰期短和严重的胃肠道副作用。
  • 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完成了超额认购的二次融资,以每股0.50加元的价格在非经纪私募中筹集了530万加元。
  • 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:为制药和生物技术公司提供专业服务的领先供应商PharMalex(最近被amerisourceBergen收购)委托PharMalex准备和支持该公司提交的IMPD/CTA文件(相当于美国的一种研究新药)。在法国和荷兰开始第二阶段临床试验,治疗线粒体脑肌病、乳酸中毒和卒中样发作或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.

黑色素沉着症是一种线粒体遗传性疾病,往往在20岁之前出现。它是一种线粒体疾病,会影响大脑的功能和发育;导致神经功能障碍,降低血液中的氧气水平,并导致癫痫发作。目前还没有得到批准的治疗方法,根据美国国立卫生研究院的数据,估计MELAS的患病率为每8500名活产儿中就有一名。TTI-0102治疗MELAS的关键作用机制是作为硫醇-二硫键平衡机制(氧化还原活性)、作为谷胱甘肽的前体和作为次牛磺酸的前体。

  • 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:在美国的关键专利(编号为US 11,612,576B2)被颁发,《半胱胺敏感症的治疗方法》这项专利涉及一种可转化为半胱胺的二硫化物的给药。在体内,这使它成为一种有利的药物。 硫代拥有强大的专利战略,正在申请专利,涵盖了美国、欧洲和亚洲部分地区的“物质组成”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开始与其TTI-0102的主要制造商、领先的药物开发和制造公司无锡STA合作开发第二代配方,使TTI-0102能够以更稳定的片剂或香包形式给药,而不是目前的粉末配方。新配方预计将在2023年第三季度准备就绪,以支持临床试验中对Rett综合征和儿科非酒精性脂肪性肝炎(NASH)的监管应用。

Full Year 2022 Financial Highlights (in Canadian Dollars)

2022年全年财务亮点(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,现金和现金等价物为620万美元,而截至2021年12月31日为10万美元。610万美元的增长是由于同时融资350万美元的合格交易和530万美元的二次融资,减去2022年的运营和交易/上市费用。
  • 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年的研发费用为110万美元,而2021年为140万美元。研究和开发的减少主要与TTI-0102的第一阶段剂量升级和安全性临床试验有关,该试验于2021年启动,于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年一般和行政费用为90万美元,而2021年为30万美元。这一增长主要是由于作为一家上市公司的额外成本,包括作为一家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年净亏损为390万美元,而2021年为120万美元。这一增加包括了与符合资格的交易中上市相关的成本。

About TTI-0102

关于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.

硫化疗法公司的先导化合物TTI-0102是一种二硫化物,由两个硫醇组成,形成独立的半胱胺分子;它的开发是为了解决基于硫醇的药物的重要障碍,包括半胱胺:半衰期短、强烈的胃肠道副作用和剂量限制。作为一种前体药物,TTI-0102在被摄取后被代谢成半胱胺,代谢过程起到了门控机制的作用,消除了与副作用有关的半胱胺峰值;它还允许增加剂量,从而有可能每天给药一次。

About Thiogenesis

关于硫化物的发生

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).

硫化疗法公司(TSXV:TTI)是一家临床阶段的生物制药公司,通过其设在加利福尼亚州圣地亚哥的全资子公司运营。该公司在多伦多证券交易所创业板上市交易。硫化作用正在开发作为硫醇活性化合物前体的含硫前体药物,有可能治疗严重的儿科疾病,但医疗需求尚未得到满足。几十年来,硫醇一直是有希望的研究对象,并以具有强大的抗氧化性和其他潜在的治疗活性而闻名。该公司最初的目标适应症包括线粒体脑肌病、乳酸酸中毒和卒中样发作(MELAS)、Retts综合征和儿科非酒精性脂肪性肝炎(NASH)。

For further information, please contact:

如需更多信息,请联系:

Brook Riggins, Director, and CFO

布鲁克·里金斯、董事和首席财务官

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

电子邮件:info@thienesis.com
电话:(888)223-9165

Forward-Looking Statements

前瞻性陈述

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.

根据加拿大证券法,本新闻稿包括该短语所指的某些“前瞻性陈述”。但不限于,有关公司未来计划和目标的陈述是前瞻性陈述,涉及不同程度的风险。前瞻性陈述反映了管理层对未来可能发生的事件和情况的当前看法,从本质上讲,是基于管理层的信念和假设,会受到已知和未知的风险和不确定性的影响,这些风险和不确定性既有一般性的,也有公司特有的。尽管公司认为这些前瞻性陈述中表达的预期是合理的,但这些陈述并不能保证未来的业绩,实际结果或发展可能与我们的前瞻性陈述中的大不相同。以下是可能导致该公司的实际结果与这些前瞻性陈述中明示或暗示的结果大不相同的重要因素:通货膨胀、新冠肺炎和俄乌战争带来的世界性经济挑战、总体市场状况、药物开发固有的风险、未来盈利能力的不确定性以及获得额外资本的不确定性。有关作出这些前瞻性陈述时采用的重大因素和假设以及我们面临的各种风险和不确定因素的更多信息,请参阅我们的年度管理层对我们财务结果的讨论和分析的“风险因素”部分以及我们提交给加拿大证券监管机构的其他持续披露文件和财务报表,这些文件和财务报表可在上查阅。除适用法律要求外,公司不承担更新这些前瞻性信息的义务。公司的前瞻性陈述依赖于诉讼保护。

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.

多伦多证券交易所创业板交易所及其监管服务提供商(该术语在多伦多证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

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

要查看本新闻稿的源版本,请访问

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