Hemostemix Inc. (“
Hemostemix” or the
“
Company”) (TSX VENTURE: HEM; OTCQB: HMTXF), a
biotechnology company developing and commercializing blood-derived
stem cell therapies for unmet medical conditions, announces that
the Company and Kingsman Scientific Management Inc.
(“
KSM”) have agreed to the early termination of
the KSM management services agreement dated April 19, 2019 (the
“
Management Agreement”), with such termination
effective October 31, 2019. KSM may continue to provide basic
accounting and administrative services to the Company in the future
but, as of the date hereof, there is no formal agreement in place
in respect of this. In connection with the termination of the
Management Agreement, Kyle Makofka has resigned as the Company’s
CEO. The Company has commenced the search for a suitable
replacement and will announce any appointment in due course.
The Company further announces that it entered
into an amended license agreement (the “Amended
License”) dated September 30, 2019 with Aspire Health
Science, LLC (“Aspire”). The Amended License was
made to amend the original license agreement (the “Original
License”) between the Company and Aspire dated February
15, 2018 in respect of the Company’s lead therapeutic product
technology, ACP-01, granting Aspire exclusive rights to use, sell,
and import ACP-01 in certain jurisdictions. The terms of the
Original License were set forth in a press release of the Company
dated February 23, 2018. Under the terms of the Amended License,
Aspire has the exclusive rights to use, sell and manufacture ACP-01
worldwide for the treatment of certain approved medical
indications, namely Coronary Artery Disease (CAD), Peripheral
Artery Disease (PAD), CLI, Congestive Heart Failure (CHF) and other
indications applicable to ACP-01, as well as related rights to
manufacture ACP-01 at its Orlando, Florida facilities for such
purposes. Under the terms of the Amended License, Hemostemix is
entitled to receive, as a condition precedent under the Amended
License, an up-front payment of US$1,000,000 (the “Amended
License Payment”) from Aspire within 30 days of the date
first written in the Amended License (which Amended License Payment
has not been received as of the date of this press release), a 4%
royalty on gross revenue generated from gross revenues of Aspire in
respect of ACP-01, and a share of net proceeds in respect of any
partnering event of certain specified monetary value with a third
party in respect of the development, manufacturing and
commercialization of ACP-01 and the intellectual property of the
Company. Under the Amended License, Aspire will assume
responsibility for the conduct and completion of the Phase II
clinical trial for CLI, be responsible for all costs to plan,
implement, oversee and complete the clinical trial within 24 months
of the effective date of the Amended License, and will pay for all
production of all products required to continue and complete the
trial, pay for all research and development necessary to meet all
necessary regulatory requirements to advance ACP-01 to a Phase III
clinical trial. Upon successful completion of the Phase II clinical
trial, Aspire will be required to advance ACP-01 to a Phase III
clinical trial for CLI and be responsible for all costs associated
with the trial including all necessary regulatory approvals,
oversight costs, production costs, all related costs for
commercialization of ACP-01. Under the Amended License, Aspire has
the right to plan, implement and conduct further clinical trials
related to ACP-01 for other allowed medical conditions applicable
to ACP-01 and Hemostemix will continue to maintain control of all
aspects of its intellectual property subject to the Amended
License, including manufacturing protocols, intellectual property
rights, all improvements in the related technology, as well as the
use of the technology for other products such as NCP-01 and BCP-01.
The Amended License has a term which continues until the later of
10 years from the effective date of the Amended License or to the
end of the life of Hemostemix’s patents. Aspire may terminate the
Amended License upon 90 days’ written notice to Hemostemix or if
ACP-01 is determined to not be safe or lacks the clinical efficacy
required to continue its development. Hemostemix may
terminate the Amended License should Aspire cease to actively make
or market ACP-01. Either party may terminate the Amended License
should there be a breach of a material condition or on bankruptcy
or insolvency of either party to the Amended License.
As of the date of this release, the Company has
not received the Amended License Payment from Aspire as required
under the Amended License.
The Company received confirmation of acceptance
for filing from the TSX Venture Exchange in respect of the Original
License and the Amended License on November 4, 2019.
The Company will continue to seek other means to
reduce costs and will continue to look at available financing and
restructuring alternatives.
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, a severe form of peripheral artery
disease 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. 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:
Angus Jenkins, Chairman of the Board Suite 1150, 707 – 7th
Avenue S.W. Calgary, Alberta T2P 3H6E-Mail:
office@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
Certain statements in this press release are
forward-looking statements and are prospective in nature.
Forward-looking statements are statements that are not based on
historical facts but rather on current expectations and projections
about future events, and are therefore subject to risks and
uncertainties which could cause actual results to differ materially
from the future results expressed or implied by the forward-looking
statements. These statements can generally, but not always, be
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. Forward-looking statements in
this release include the disclosure regarding the respective
obligations of the parties under the Amended License, which may not
be fulfilled in a timely manner or at all, including the payment by
Aspire of the Amended License Payment, which has not been received
by the Company as of the date of this release, the finding and
hiring of a suitable replacement candidate for the officer position
of CEO, the ability to seek other means to reduce costs, the
ability of Hemostemix to obtain future necessary financing and
complete restructuring in the future, and the anticipated
completion of the Phase II CLI trials in Canada and the United
States. 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 also 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.
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