CALGARY, Alberta, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF), is a biotechnology company developing and commercializing blood-derived stem cell therapies for unmet medical conditions, announces that it has conducted a comprehensive assessment of the status, timeline and financial requirements for the Company to complete its current ACP-01 Phase II clinical study for critical limb ischemia (“CLI”). Currently, Hemostemix has enrolled 46 of the 95 patients into the Phase II clinical study. A third party clinical research organization has estimated that for the current trial design at the current enrollment rate, it would cost an additional $11.2 million to complete the trial and obtain top line results in Q2 2022. Over the past 12 months, the Company has been pursuing various financing, partnering and licensing options for its ACP-01 program. In August 2019, the Company completed a bridge financing through a secured loan agreement with J.M. Wood Investments Ltd. (“JMWI”) in an aggregate principal amount of up to $2,000,000 (the “Loan”). The Company has used those funds to continue the ongoing Phase II clinical trial, and for general working capital and the Company has not been successful in raising additional financing or investment. The Company has continued to search for strategic alternatives for financing, licensing or partnering to complete the current Phase II clinical trial for CLI. In connection with this strategy, the Company has entered into discussions with our manufacturing and licensing partner, Aspire Health Sciences, LLC.
“In the past year we focused on onboarding additional clinical trial sites, patient recruitment campaigns, and investor relations, while simultaneously reducing vendor costs and optimizing the management of the trial. The protracted history of the company, clinical trial costs, delayed timelines and our share structure have made it very difficult to secure new investment in the Company. The Company is required to look into other strategic alternatives to complete the ACP-01 clinical trial and finance operations,” said Kyle Makofka, Hemostemix’s CEO.
ABOUT HEMOSTEMIX INC.
Hemostemix is a publicly traded clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is one of the first clinical-stage biotech companies to test a stem-cell therapy in an international, multicenter, Phase II clinical trial for patients with critical limb ischemia (“CLI”), a severe form of peripheral artery disease (“PAD”) caused by reduced blood flow to the legs. The Phase II trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. The Company’s intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLC (“Aspire”), for the production of ACP-01 and for research and development purposes at Aspire’s Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.
For more information, please visit www.hemostemix.com or email office@hemostemix.com.
Contact:
Kyle Makofka, CEO
Suite 2150, 300 – 5th Avenue S.W.
Calgary, Alberta T2P 3C4
Phone: (403) 506-3373
E-Mail: kmakofka@hemostemix.com
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 Statements
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Company’s stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Company’s markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Company’s operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.