Calgary, Alberta--(Newsfile Corp. - June 16, 2020) - Hemostemix Inc. ("Hemostemix" or the "Company") (TSXV: HEM) (OTC: HMTXF) announces, that it has not met the revised filing date, as provided in Alberta Blanket Order 51-517 Temporary Exemption from Certain Corporate Finance Requirements (the "Alberta Order") of the Alberta Securities Commission (and similar exemptions provided by the securities commission in British Columbia) of June 15, 2020, for filing of the following continuous disclosure documents (collectively, the "Documents"):
- the Company's Annual Audited Financial Statements for the year ended December 31, 2019, as required by section 4.2 of National Instrument 51-102 - Continuous Disclosure Obligations ("NI 51-102"); and
- the Company's Management Discussion & Analysis for the year ended December 31, 2019, as required by section 5.1(2) of NI 51-102.
The default is due, in part, to business and administrative disruption experienced by the Company in respect of both its own personnel and the Company's auditors inability to complete the work required to issue the Documents due to the restrictions on business activities as a result of COVID-19 in Canada. The default is also due to the additional amount of work required by the Company and its auditors in connection with the Documents in connection with the necessary review of actions and the accounting records maintained by previous management of the Company.
Accordingly, the Company has applied to the Alberta Securities Commission for a Management Cease Trade Order that will prohibit the management of the Company from trading in the securities of the Company until such time as the Documents are filed. No decision has yet been made by the Alberta Securities Commission on this application. The Alberta Securities Commission may grant the application and issue the Management Cease Trade Order or it may impose an issuer cease trade order if the Documents are not filed in a timely fashion.
The Company is undertaking additional work in conjunction with their auditor to confirm amounts related to clinical trial costs due to incomplete information provided by Aspire Health Science, LLC ("Aspire"). As previously announced, the Company is in active litigation with Aspire. The Company is seeking direct information from parties involved in the clinical trial in order to review and verify this information, and in order to remedy the default and to be able to file the Documents by July 15, 2020. During the period of default and until filing of the Documents, the Company intends to satisfy the provisions of the alternative information guidelines as required by National Policy 12-203 Management Cease Trade Orders.
Until the Company has filed the Documents, members of the Company's management and other insiders are subject to an insider trading black-out policy as per its internal Insider Trading Policy that is consistent with the principles in Section 9 of National Policy 11-207 - Failure-to-File Cease Trade Orders and Revocations in Multiple Jurisdictions. The Company confirms that, other than as disclosed in prior press releases and material change reports, there have been no material business developments since the filing on November 29, 2019 of the Company's latest interim financial reports for the period ended September 30, 2019.
ABOUT HEMOSTEMIX
Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.
On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract presentation entitled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01Trial With 4.5 Year Follow-up" which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.
The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy. For more information, please visit www.hemostemix.com.
Contact: Thomas Smeenk, President, CEO & Co-Founder
TSmeenk@Hemostemix.com
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.
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 regarding: the filing of the Documents, including the timing for the filing of the Documents; the issuance of a Management Cease Trade Order in respect of Hemostemix; and the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate, and 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 ability of Hemostemix to complete the Documents in the noted timeframe;the Management Cease Trade Order application process and the applicability of that process to Hemostemix; the results of ACP-01 research, trials and studies being equivalent to or better than previous research, trials or studies as well as management's expectations of anticipated results; Hemostemix's general and administrative costs remaining constant; the receipt of all required regulatory approvals for research, trials or studies as well as any required or desired financings of Hemostemix, including TSX Venture Exchange acceptance and any third party consents; 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 obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies. 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 its current CLI clinical trial, complete a satisfactory futility analysis and the results of such and future clinical trials;litigation and potential litigation that 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 the Company'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, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession;the potential impact that the COVID-19 pandemic may have on Hemostemix 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 www.sedar.com. 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, 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.
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