04:08:47 EDT Sun 19 Sep 2021
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Hemostemix Inc (2)
Symbol HEM
Shares Issued 55,535,638
Close 2021-02-11 C$ 0.45
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Hemostemix contracts document verification services

2021-02-11 13:05 ET - News Release

Mr. Thomas Smeenk reports


Hemostemix Inc. has contracted Protocol First to provide it with source document verification services. Protocol First's P1 source upload solution, which runs alongside any EDC system, allows site co-ordinators to upload unredacted source data at the click of a button. The CRA/monitor can remote monitor the data, mark them as reviewed, issue queries to the site and create reports for management, all within an FDA approved solution.

"Protocol First will enable us to complete clinical trial site remote monitoring and source document verification by the end of March," stated Thomas Smeenk, chief executive officer.

"Hemostemix needed a regulatory solution that could be deployed rapidly and provide immediate operational relief to the difficult task of source document verification. We are very happy to provide such a solution and help Hemostemix in this critical process," said Hugh P. Levaux, PhD, founder and chief executive officer for Protocol First.

A total 65 subjects who were enrolled in the trial, randomized two-to-one to receive ACP-01 or a placebo, will have completed the last follow-up appointments by March 31, 2021. The company will provide additional information once the trial data have been analyzed.

Warrant amendments

The TSX Venture Exchange has granted approval to amend the exercise price and expiration date of outstanding warrants previously issued in connection with non-brokered private placements which closed on March 5, 2020, and March 25, 2020.

Subject to the accelerator provisions and restrictions applicable to insiders described herein, the warrants of the company that were scheduled to expire on March 5, 2021, and March 25, 2021, are repriced to 55 cents each and the expiry date extended to March 5, 2023, and March 25, 2023,. In accordance with TSX-V policies, the warrants are amended to include an acceleration clause whereunder the exercise period of warrants will be reduced to 30 days, if, for any 10 consecutive trading days during the unexpired term of the warrants, the closing price of the company's listed shares achieves or exceeds the price of 120 per cent of the applicable exercise price 66 cents. The 30-day expiry period commences on the day the company either (i) disseminates a press release or (ii) sends a written notice to the holders of the warrants advising of the commencement of the exercise period.

A total of 13,618,522 warrants were issued to subscribers under the original private placements, including 5.18 million warrants issued to certain directors and officers of the Company. In accordance with the polices of the TSX-V, only 1,361,852 warrants held by the insiders, representing 10 per cent of the amended warrants, will be repriced to 55 cents. The remainder of the warrants held by the insiders (3,818,148) remain exercisable at $1 per share, subject to all amendments described in this news release.

A portion of the warrants are held by the insiders considered to be related parties of the company. Therefore, the amendment of warrants constitutes a related party transaction as contemplated by Multilateral Instrument 61-101 Protection of Minority Shareholders in Special Transactions, and TSX-V Policy 5.9 -- Protection of Minority Shareholders in Special Transactions. However, the exemptions from formal valuation and minority approval requirements provided for by these guidelines can be relied upon as the fair market value of the warrants does not exceeds 25 per cent of the market capitalization of the company. A material change report in respect of this related party transaction will be filed by the company.

The company believes that the repricing of the warrants is reasonable and necessary in the context of the market, as it increases the likelihood that the company will be financed through the exercise of the warrants.

About Hemostemix Inc.

Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. 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 500 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 Oct. 21, 2019, the company announced the results from its phase 2 CLI trial abstract presentation entitled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up," which noted healing of ulcers and resolution of ischemic rest pain occurred in 83 per cent 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.

We seek Safe Harbor.

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