- The U.S. Food and Drug Administration (FDA) has scheduled Hemostemix’s basket protocol Pre-IND meeting for January 16, 2026; and
- Subject to TSXV approval, the Company announces a non-brokered private placement of up to $960,000.
FDA Schedules Hemostemix Basket Protocol Pre-IND Meeting
The FDA has scheduled Hemostemix’s Pre-IND meeting for January 16, 2026 to review the Company’s basket clinical trial protocol for the treatment of ischemia, including:
- Vascular dementia
- Ischemic cardiomyopathy
- Peripheral arterial disease (PAD)
- Generalized ischemia
The basket protocol unifies these conditions under a single ischemia-based mechanism of action for ACP-01. Hemostemix will present its clinical rationale, manufacturing platform, and regulatory pathway, to advance toward FDA clearance of its Phase I basket clinical trial of ACP-01.
Non-Brokered Private Placement (NBPP)
The Company announces a non-brokered private placement of up to $960,000, consisting of the issuance of 8,000,000 common shares at a price of $0.12 per share, with no warrants.
All securities issued will be subject to a four-month hold period in accordance with applicable securities laws and TSX Venture Exchange (“TSXV”) policies. The financing is subject to final TSXV approval.
CEO Comment
“The FDA Pre-IND meeting brings us closer to a unified ischemia-based clinical trial program,” stated Thomas Smeenk, CEO. “It makes sense to address ischemia in multiple indications, given our success rate in these conditions as published in 11 peer reviewed articles. Why a Phase I clinical trial? First, Lantrida, an allogenic stem cell treatment, was approved on phase I only data. That is a precedent. Second, we can charge patients to be studied (treated) and followed. Third, we can publish the interim results and end points, comparing improvements in cognition (vascular dementia), LVEF% (ICM), wound healing (PAD), reduction of pain (general ischemia, ICM + PAD), and improvement in quality of life (all indications) for all participants. Plus, it generates a protocol for all patients who are treated, who do not meet inclusion criteria. Thus we study every patient treated with ACP-01 to generate the scientific basis for its approval,” Smeenk said.
Use of Proceeds
Proceeds will be used to advance:
- FDA regulatory preparations and meeting execution
- Clinical operations expansion in Florida, The Bahamas and Canada
- General corporate working capital
ABOUT HEMOSTEMIX
Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient’s own) blood-based stem cell therapy, VesCell™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 50% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit www.hemostemix.com.
For further information, please contact: Thomas Smeenk, President, CEO EM: tsmeenk@hemostemix.com / PH: 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 in relation to the Phase I basket protocol clinical trial of ACP-01 as a treatment for multiple indications of ischemia including Vascular Dementia, and the treatment of pain in Florida related related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) in furtherance of sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. 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 any 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 www.sedarplus.ca. 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.
The issuer is solely responsible for the content of this announcement.
