Calgary, Alberta -
Newsfile Corp. - December 10, 2025 -
Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0)
("Hemostemix" or the "Company"), the leading autologous (patient's own)
stem cell therapy company offering VesCell™ (ACP-01) to individuals
suffering from vascular dementia, angina, ischemic cardiomyopathy,
congestive heart failure, non-ischemic dilated cardiomyopathy, pain,
total body ischemia, peripheral arterial disease and chronic limb
threatening ischemia, with ACP-01 at Doctors Hospital, Nassau, The
Bahamas, is pleased to announce two major corporate developments:
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The U.S. Food and Drug Administration (FDA) has scheduled
Hemostemix's basket protocol Pre-IND meeting for January 16, 2026; and
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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:
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Vascular dementia
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Ischemic cardiomyopathy
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Peripheral arterial disease (PAD)
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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:
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FDA regulatory preparations and meeting execution
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Clinical operations expansion in Florida, The Bahamas and Canada
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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.