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Hemostemix Offers up to 500 6% Convertible Debentures, Convertible Into an ACP-01 Therapeutic Production Slot That Is Subject to Compassionate Exemption From Regulatory Approval

Hemostemix Offers up to 500 6% Convertible Debentures, Convertible Into an ACP-01 Therapeutic Production Slot That Is Subject to Compassionate Exemption From Regulatory Approval

Hemostemix 提供高达 500 6% 的可转换债券,可转换为 ACP-01 治疗性生产时段,但须获得监管部门同情豁免
newsfile ·  2023/03/07 09:07

Calgary, Alberta--(Newsfile Corp. - March 7, 2023) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("HEM" or the "Company") is pleased to announce it is selling up to 500 five-year 6% unsecured convertible debentures ("CD") at USD $35,000 each. The CD can be converted into one of 500 ACP-01 therapeutic production slots ("TPS"), subject to patients' compassionate exemption from regulatory approval, or is convertible into Common Shares of Hemostemix as described below.

加拿大阿尔伯塔省卡尔加里-(Newsfile Corp.-2023年3月7日)-Hemostemix Inc.(多伦多证券交易所股票代码:HEM)(场外交易代码:HMTXF)(FSE:2VF0)(以下简称“HEM”或“公司”)欣然宣布,将发售最多500只五年期6%无担保可转换债券(CD),每股价格为35,000美元。CD可以转换为500个ACP-01治疗产品槽(“TPS”)中的一个,但须获得患者的同情豁免,不受监管部门批准,或可转换为Hemostemix的普通股,如下所述。

Tranche 1 of the CD TPS program is structured to sell 500 units to raise capital of up to USD $17,500,000 that may convert to future revenue of up to USD $17,500,000. For example, each $35,000 CD could generate future revenue of up to $35,000 when it is converted by the purchaser into an ACP-01 TPS.

CD TPS计划的第一批将出售500个单位,以筹集高达17,500,000美元的资金,这些资金可能会转化为未来高达17,500,000美元的收入。例如,当购买者将每张35,000美元的CD转换为ACP-01 TPS时,可以产生高达35,000美元的未来收入。

"43 of 46 (93.5%) ACP-01 recipients in the phase II clinical trial saved a limb from amputation, so forward sales of ACP-01 promises to vastly improve quality of life, and generate capital that converts to revenue," stated Thomas Smeenk, CEO. "Sold in tranches, exempt compassionate treatment revenue will de-risk the company, ramp-up production based on sales, fund necessary clinical trials and the scale-up of production to 4,000 batches per month, and enable us to work on the first dividend to our shareholders of a new company that will further realize the value of our technologies" Smeenk said.

首席执行官Thomas Smeenk说:“在第二阶段临床试验中,46名接受ACP-01治疗的患者中有43名(93.5%)免于截肢,因此ACP-01的远期销售有望极大地提高生活质量,并产生可转化为收入的资本。Smeenk说:“分批出售,免收的恩恤治疗收入将降低公司的风险,在销售的基础上提高产量,为必要的临床试验提供资金,并将生产规模扩大到每月4,000批,并使我们能够致力于向新公司的股东支付第一笔股息,这将进一步实现我们技术的价值。”

Each CD TPS will be sold to purchasers who seek a compassionate treatment, or to clinics who seek to offer a compassionate treatment of ACP-01, on a sequential first-come first-serve basis. The CD will convert to a TPS when the purchaser provides Hemostemix with the compassionate exemption from regulatory approval in the jurisdiction of treatment.

每张CD TPS将按先到先得的顺序出售给寻求体恤治疗的购买者,或提供体恤治疗的诊所。当购买者向Hemostemix提供恩恤豁免,使其免受司法管辖区内的监管批准时,CD将转换为TPS。

Hemostemix may contract with the purchaser to compile the purchaser's compassionate exemption application, to generate additional revenue, and the Company may follow each patient in the same way it followed subjects in its Phase II clinical trial, to define the safety and statistical efficacy of ACP-01 in this cohort of patients.

Hemostemix可能会与买方签订合同,编写买方的体恤豁免申请,以产生额外的收入,该公司可能会以其在第二阶段临床试验中跟踪受试者的相同方式跟踪每个患者,以确定ACP-01在这组患者中的安全性和统计有效性。

The target markets are the 17 Phase II clinical trial sites, clinicians, podiatrists, and the patients who suffer from critical limb ischemia ("CLI") with no surgical options, globally. CLI is the most severe form of peripheral arterial disease ("PAD"). Worldwide, approximately 200 million suffer from PAD. Leg amputation, as a result of end stage CLI, gives rise to an annual leg amputation risk of 40% and a 5-year survival rate of <30%. (Brodmann, M., Critical Limb Ischemia:Epidemiology and Clinical Presentation).

目标市场是全球17个II期临床试验地点、临床医生、足科医生以及患有严重肢体缺血(“CLI”)但没有手术选择的患者。CLI是外周动脉疾病(PAD)中最严重的形式。在全球范围内,约有2亿人患有PAD。作为终末期CLI的结果,腿部截肢每年导致40%的腿部截肢风险和严重肢体缺血的5年存活率:流行病学和临床表现).

The CD may convert into a TPS, or into Hemostemix Common Shares at the greater of $1 per share or the 10-day weighted average price on the date preceding conversion. Each CD accrues simple interest of 6% per year, or part thereof, payable in common shares at redemption or conversion. Each CD is transferable to a third party, including to charitable organizations, and each CD can be redeemed at any time by the Company at cost plus accrued interest. At maturity, the Company may choose to convert each CD into Common Shares at the greater of $1 per share or the 10-day weighted average price on the date preceding conversion.

CD可按每股1美元或转换前一日的10日加权平均价中的较大者转换为TPS或Hemostemix普通股。每张CD每年应计6%的简单利息或部分利息,在赎回或转换时以普通股支付。每张CD可转让给第三方,包括转让给慈善组织,每张CD可随时由公司按成本加应计利息赎回。到期时,公司可选择以每股1美元或转换前一日的10日加权平均价中的较大者将每张CD转换为普通股。

The Convertible Debenture is subject to all necessary regulatory approvals including acceptances from securities regulators and the TSX Venture Exchange. All securities and Convertible Debentures issued in connection with the Offering will be subject to definitive documentation and applicable Canadian securities laws. In addition, other restrictions may apply under applicable securities laws when sold in jurisdictions outside of Canada.

可转换债券须获得所有必要的监管批准,包括证券监管机构和多伦多证券交易所风险交易所的认可。与此次发行相关的所有证券和可转换债券将以最终文件和适用的加拿大证券法为准。此外,在加拿大以外的司法管辖区销售时,根据适用的证券法,其他限制可能适用。

The Company will use the funds raised for the re-establishment of the production facility, hiring and training of staff, manufacturing of ACP-01 for both clinical trials and therapeutic production slots, and general working capital. There is a risk that ACP-01 TPS will not be available to the purchaser in their jurisdiction. While the Company has produced ACP-01 and holds the know-how, show-how and formulations of ACP-01, there is no guarantee that the proceeds raised from the CD will be sufficient to fund the re-establishment of ACP-01 production, be sufficient to produce ACP-01, or be sufficient to manufacture ACP-01 for a treatment once it is exempted from regulatory approval.

该公司将把募集的资金用于重建生产设施、雇用和培训员工、生产用于临床试验和治疗生产的ACP-01以及一般营运资金。在其管辖范围内,购买者可能无法获得ACP-01 TPS。虽然该公司已经生产了ACP-01并持有ACP-01的技术诀窍、技术诀窍和配方,但不能保证从CD筹集的收益将足以为重新建立ACP-01生产提供资金,足以生产ACP-01,或一旦获得监管批准,足以生产用于治疗的ACP-01。

ABOUT HEMOSTEMIX

关于Hemostemix

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. For more information, please visit .

Hemostemix是一家自体干细胞治疗公司,成立于2003年。作为世界经济论坛技术先锋奖的获得者,该公司已经开发、申请了专利,并正在扩展患者的基于血液的干细胞治疗平台,其中包括血管生成细胞前体、神经细胞前体和心肌细胞前体。欲了解更多信息,请访问.

For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder
EM: tsmeenk@hemostemix.com PH: 905-580-4170

如需更多信息,请联系:托马斯·斯米克,总裁,首席执行官兼联合创始人
EM:邮箱:tsmeenk@hemstymx.com电话:905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多伦多证券交易所创业板交易所及其监管服务提供商(该术语由多伦多证券交易所创业板政策定义)均不对本新闻稿的充分性或准确性负责.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the sale of a block of 500 treatments as a financial instrument in the form of a convertible debenture convertible into an ACP-01 treatment that is subject to regulatory approvals of securities regulators and the TSX Venture Exchange and other regulators including healthcare regulators, financing of the Company and its lead product ACP-01, the Phase II Clinical Trial of ischemic cardiomyopathy and related results, the retrospective study of ischemic and dilated cardiomyopathy, and generally the commercialization of ACP-01 via the sale of compassionate treatments approved by regulators. ‎‎There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory ‎approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the ‎economy generally; consumer ‎interest in Hemostemix's services and products; competition and ‎Hemostemix's competitive advantages; and Hemostemix obtaining satisfactory financing to ‎ fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation ‎affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete;‎ lack of qualified, skilled labour or loss of key individuals; and risks ‎related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to ‎try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and ‎financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a ‎possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at . Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

前瞻性信息:本新闻稿包含适用于加拿大证券法的“前瞻性信息”。本文中除有关历史事实的陈述外,其他所有陈述均为前瞻性信息。特别是,本新闻稿包含有关以下方面的前瞻性信息:以可转换债券的形式出售500种治疗药物作为一种金融工具,可转换为ACP-01治疗药物,有待证券监管机构和多伦多证券交易所以及包括医疗监管机构在内的其他监管机构的监管批准;公司及其主导产品ACP-01的融资;缺血性心肌病的第二阶段临床试验和相关结果;对缺血性和扩张型心肌病的回顾性研究;以及一般情况下,通过销售监管机构批准的体恤治疗将ACP-01商业化。‎‎不能保证这些前瞻性信息将被证明是准确的。实际结果和未来事件可能与这些前瞻性信息中预期的大不相同。这些前瞻性信息反映了Hemostemix公司目前的信念,并基于Hemostemix公司目前可获得的信息和Hemostemix公司认为合理的假设。这些假设包括但不限于:Hemostemix及其普通股的潜在价值;Hemostemix正在进行或辩护的诉讼的成功解决(The诉讼“);ACP-01研究、试验、研究和分析的结果,包括分析结果等于或好于以前的研究、试验或研究;研究、试验或研究获得所有必要的监管‎批准;医疗保健部门的活动水平、市场接受度和市场趋势;‎经济总体情况;消费者‎对Hemostemix服务和产品的兴趣;竞争和‎Hemostemix的竞争优势;以及Hemostemix获得满意的融资以资助‎Hemostemix的运营,包括任何研究、试验或研究和任何诉讼。前瞻性信息受已知和未知的风险、不确定性和其他因素的影响,这些风险、不确定性和其他因素可能会导致Hemostemix的实际结果、活动水平、业绩或成就与此类前瞻性信息明示或暗示的结果大不相同。此类风险和其他因素可能包括但不限于:Hemostemix完成临床试验、完成令人满意的分析并提交此类分析结果以获得监管机构对ACP-01第二阶段或第三阶段临床试验的批准的能力;Hemostemix可能面临的潜在诉讼;一般商业、经济、竞争、政治和社会不确定性;证券的总体资本市场状况和市场价格;延迟或未能获得董事会或监管机构的批准;未来运营的实际结果,包括未来研究、试验或研究的实际结果;竞争;影响Hemostemix的立法‎的变化;在可接受的条件下获得外部融资的时机和可用性;Hemostemix的市场和它预计将参与竞争的市场的长期资本要求和未来发展;‎缺乏合格的, 与新冠肺炎大流行有关的风险‎包括政府当局向‎提出的各种建议、命令和措施,包括旅行限制、边境关闭、非必要企业关闭、服务中断、隔离、自我隔离、原地避难所和社会距离、市场中断、经济活动和‎融资中断、供应链和销售渠道中断以及一般经济状况恶化,包括‎可能出现的国家或全球衰退或萧条;新冠肺炎大流行可能对血统产生潜在影响,其中可能包括对血统提供的服务的需求减少;以及金融市场恶化,可能限制血统获得外部融资的能力。有关可能导致实际结果与前瞻性信息大不相同的其他风险因素的描述,可在SEDAR网站上的Hemostemix披露文件中找到。尽管Hemostemix试图确定可能导致实际结果与前瞻性信息中包含的结果大不相同的重要因素,但可能还有其他因素导致结果与预期、估计或预期的不同。提醒读者,前面列出的因素并不是详尽的。进一步告诫读者不要过度依赖前瞻性信息,因为不能保证这些信息所依据的计划、意图或期望一定会发生。本新闻稿中包含的前瞻性信息明确受本警示声明的限制。本新闻稿中包含的前瞻性信息代表了截至本新闻稿发布之日对Hemostemix的期望,因此, 在该日期之后,它可能会发生变化。然而,除非适用的证券法明确要求,否则Hemostemix明确不会因为新信息、未来事件或其他原因而更新或修改任何前瞻性信息,也不承担任何义务。

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