Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC:
HMTXF) provides the following update:
On February 21, 2020, the Court Queen’s Bench of
Alberta (the “Court”), after having heard the
concerns raised by the Company with respect to an application by
J.M. Wood Investments Ltd (“Wood”) for the
issuance of an order appointing a receiver, ordered that: (i) the
application of Wood be further adjourned to February 27,
2020; (ii) the Company provide Grant Thornton Limited, as court
appointed agent, a copy of Thomas Smeenk’s affidavit and unredacted
copies of the exhibits (subscription agreements) no later than 4:00
p.m. EST on February 21, 2020 (which the Company complied with);
(iii) provide additional rights to Grant Thornton Limited to
prepare a report for the Court by February 27, 2020 to set out the
viability and veracity of closing of the proposed financings of the
Company by March 2, 2020; and (iv) comment on the ability and
viability of the Company to repay Wood in full.
Further to its news release issued in February
10, 2020, the Company wishes to clarify that on February 3, 2020,
the Company was served with a claim filed by Aspire in the Circuit
Court of the 9th Judicial Circuit in and for Orange County,
Florida. On February 13, 2020, Aspire issued a press release that
it filed an amended motion for a speedy hearing in relation to the
previously announced legal proceeding initiated against the
Company. Management of the Company believes that both actions are
attempts by Wood to prevent the Company from closing its financing
announced on January 2, 2020 and to force the Company into
receivership. On February 20, 2020 Thomas Smeenk, President and CEO
of the Company, filed an affidavit through the Company’s attorney,
Allen Dyer Doppelt + Gilchrist, P.A. in Florida, that the dispute
should be governed by the Laws of the Province of Alberta and
attorn to the venue and jurisdiction of Alberta courts.
PRIVATE PLACEMENT UPDATE
The Company expects to close its financing, as
previously announced on January 2, 2020, consisting of up to 300
million units at one cent per unit for gross proceeds of up to
$3-million on or about February 27, 2020, subject to receiving TSX
Venture Exchange approval, which is expected shortly. Each
unit will comprise of one common share of the Company and one share
purchase warrant. Each warrant will entitle the holder to acquire
one additional common share in the capital of the Company at a
price of five cents per warrant, for a period of one year from the
date the units are issued. The proceeds of the private placement
will be used to repay all indebtedness owning to Wood. Please refer
to the January 2, 2020 news release for additional terms and
conditions of the private placement.
The private placement of convertible debentures
announced on February 19, 2020 has been withdrawn.
LITIGATION UPDATE
Management of the Company believe that Jed Wood
and J.M. Wood Investments Ltd. are using the application for the
appointment of a receiver to obtain a collateral advantage in
litigation and using the proceedings to prevent the Company from
closing the private placement, which is a necessary prerequisite to
repaying the outstanding debt.
The Company provides the following chronological
update and recap of the events leading up to the application to the
Court of Queen’s Bench of Alberta by J.M. Wood Investments Ltd. for
an order appointing a receiver and the action filed against the
Company by Aspire Health Science, LLC in Orange County,
Florida.
On May 3, 2019, the Company issued a news
release announcing a $1,000,000 secured convertible debenture
financing (“Convertible Debenture”). On May
16, 2019, the Company announced the first closing for proceeds of
$525,000, including $500,000 from J.M. Wood Investments Ltd.
(“Wood”) and secured by a general security
agreement over all assets of the Company, including intellectual
property rights over the Company’s stem cell technology. The
repayment of principal and interest was due December 31, 2019. The
funds were used for general working capital purposes and to fund
ongoing clinical trial costs.
In a news release dated August 1, 2019, the
Company announced it had secured a demand loan from Wood for up to
$2,000,000 and secured by a general security agreement over all
assets of the Company, including intellectual property rights over
the Company’s stem cell technology (the “Demand
Loan”). After September 30, 2019, Wood could provide the
Company with at least 60 days’ written notice requiring repayment
of the outstanding principal amount of the Demand Loan plus any
accrued and unpaid interest.
The Company used those funds to continue the
phase 2 clinical trial and for general working capital, however the
Company was not successful in raising additional financing or
investment to complete the ACP-01 clinic trial and finance
operations. Therefore, the Company continued to search for
strategic alternatives for financing, licensing or partnering to
complete the current phase 2 clinical trial for CLI. In connection
with this strategy, the Company entered into discussions with its
manufacturing and licensing partner, Aspire Health Science, LLC.
(“Aspire”).
With no other alternative funding available to
continue the clinical trial, the Company entered into an Amended
License Agreement dated September 30, 2019 with Aspire. The
Amended License Agreement amended the original License Agreement
between the Company and Aspire dated February 15, 2018 and
included, among other amendments, the payment of USD$1,000,000 to
the Company within 30 business days from execution of the Amended
License Agreement.
On October 1, 2019, Wood sent the Company a
demand notice for the repayment of all outstanding indebtedness.
The demand letter included certain forbearance provisions delaying
repayment by up to 120 days, which the Company complied with.
On November 19, 2019, the Company announced that
Kyle Makofka resigned as Chief Executive Officer of the Company.
Mr. Makofka is currently the President and CEO of Aspire.
Following the reconstitution of the Company’s
Board of Directors and management team in December of 2019, the
Company provided written notice to Aspire that the Amended License
Agreement was rescinded as a result of Aspire’s failure to pay the
Company USD $1,000,000 as required under the Amended License
Agreement.
On January 2, 2020, the Company announced a
non-brokered private placement financing of up to $3,000,000 to
repay all indebtedness to Wood.
On January 9, 2020, Wood sent the Company a
Notice of Default and Demand for the immediate repayment of
$500,000 Convertible Debenture and $1,172,175.33 Demand Loan plus
12% interest. The Company disputes the effective dates and
principal amounts owing of the Notice of Default and Demand.
The Company believes the total principal amount owing to Wood
is $1,956,180.50 plus interest.
On January 24, 2020, Wood made an application to
the Court of Queen’s Bench of Alberta (the
“Court”) for the issuance of an order appointing a
receiver. The Company responded with a 347 page affidavit
including appendices, sworn on January 30, 2020 by David Wood, the
Chairman of the Company. On January 31, 2020, the Court
granted a consent order to: (i) adjourn the receivership
application to February 20, 2020; (ii) appoint Grant Thornton as
inspector; and (iii) the costs of the application of January 31,
2020 would only be payable by the Company if the receivership
application proceeds on February 20th.
On February 3, 2020, the Company was served with
a claim filed by Aspire in the Circuit Court of the 9th Judicial
Circuit in and for Orange County, Florida regarding the dispute
settlement mechanism under the Amended License Agreement. On
February 13, 2020, Aspire issued a press release that it filed an
amended motion for a speedy hearing in relation to the previously
announced legal proceeding initiated against the Company.
Management of the Company believes this is merely another attempt
to prevent the Company from closing its financing and forcing the
Company into receivership. On February 20, 2020 Thomas Smeenk, on
behalf of the Company, filed an affidavit through the Company’s
attorney, Allen Dyer Doppelt + Gilchrist, P.A. in Florida.
On February 21, 2020, the Court, after having
heard the concerns raised by the Company, ordered that: (i) the
application of Wood be further adjourned to February 27, 2020; (ii)
the Company to provide Grant Thornton Limited, as court appointed
agent, a copy of Thomas Smeenk’s affidavit and unredacted copies of
the exhibits (subscription agreements) no later than 4:00 p.m. EST
on February 21, 2020; (iii) provide additional rights to Grant
Thornton Limited to prepare a report for the Court by February 27,
2020 to set out the viability and veracity of closing of the
proposed private placement by March 2, 2020; and (iv) comment on
the ability and viability of the Company to repay Wood in full.
APPOINTMENT TO SCIENTIFIC ADVISORY
BOARD
The Company is pleased to announce the
appointment of Dr. Pierre Leimgruber, MD, FACC to its Scientific
Advisory Board, as a specialist in the prevention and treatment of
cardiovascular disease (CVD). Dr. Leimgruber is board-certified in
internal medicine, cardiovascular diseases, and interventional
cardiology and he has worked for 32 years as an interventional
cardiologist, affiliated with four leading Spokane hospitals. Dr.
Leimgruber also serves as Clinical Associate Professor of Medicine
at the University of Washington School of Medicine in
Seattle. Dr. Leimgruber received his medical degree from
University of Zurich Medical School and trained with Andreas
Gruentzig, MD, the inventor of balloon angioplasty, at Emory
University Hospital in Atlanta. Dr. Leimgruber is the author of 26
peer-reviewed research studies published in leading medical
journals.
“After performing thousands of angioplasties and
stent placements in patients with severe coronary, carotid artery
but also patients with PAD and severe/critical limb ischemia , I am
excited to be working with the scientific advisory board, to advise
Hemostemix’ officers and directors from a science-based,
cardiology-practice-based, clinical trial and business
development-based perspectives,” said Dr. Leimgruber. “ACP-01’s
clinical trial data and open label study data in both critical limb
ischemia and heart disease is world class to-date,” he said. “Its
medical applications – CLI & PAD, Angina, Ischemic &
Dilated Cardiomyopathy - are unmet needs at a global scale,”
continued Dr. Leimgruber. “Management, I know, now understands what
it is going to take to build a profitable autologous stem cell
therapy company,” said Dr. Leimgruber.
“I have known Dr. Leimgruber since 2008, when he
was graciously introduced to me by my good friend Roger, patient
number 35, and I am delighted to recruit him to the scientific
advisory board” said Thomas Smeenk, President. His open
communication style and multifaceted-experience-based counsel is
going to be a great addition to our SAB and our team” Smeenk
said.
ABOUT HEMOSTEMIX
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 300 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 October 21, 2019, the Company announced the
results from its Phase II 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 Followup” which noted healing of ulcers and
resolution of ischemic rest pain occurred in 83% 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. For more information,
please visit
www.hemostemix.com.
Contact: Thomas Smeenk, President, CEO &
FounderSuite 1150, 707 – 7th Avenue S.W., Calgary, Alberta T2P 3H6,
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 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 ability to fund operations and access the
capital required to continue operations, the Company’s stage of
development, the ability to complete its current CLI clinical
trial, complete a futility analysis and the results of such, future
clinical trials and results, long-term capital requirements and
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. Additional information identifying risks and
uncertainties are contained in the Company’s filing with the
Canadian securities regulators, which filings are available at
www.sedar.com.
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