Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC:
HMTXF) provides the following update:
Further to the Company’s press release dated
February 25, 2020, the Company confirms it will be appearing in the
Court Queen’s Bench of Alberta (the “Court”) on
February 27, 2020 at 1PM MST to consider the report to be provided
by Grant Thornton Limited (“Grant Thornton”), as court appointed
agent, in regards to the viability and veracity of closing of the
proposed financings of the Company by March 2, 2020 and comment on
the ability and viability of the Company to repay amounts owing to
J.M Wood Investments Ltd. (“Wood”) in full. The Company confirms it
provided Grant Thornton with unredacted copies of subscription
agreements required pursuant to the February 21, 2020 Court
order.
This Court proceeding is further to Wood’s
application to the Court for the issuance of an order appointing a
receiver on January 24, 2020, the January 31, 2020 Consent Order
and the February 21, 2020 Court order. The Company initially
received a demand letter from Wood on October 1, 2019 in regards to
US$1,100,000 (Cdn$1,456,140.63) advanced pursuant to the July 31,
2019 loan agreement between Wood and the Company (the “Demand
Loan”). The demand letter included certain forbearance provisions
delaying repayment by up to 120 days, which the Company complied
with. On January 9, 2020, Wood sent the Company a Notice of Default
and Demand for the immediate repayment of the May 15, 2019 $500,000
Convertible Debenture issued to Wood 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 amounts owing to Wood is
$1,956,180.50 plus interest. The Company’s press release dated
February 25, 2020 provides additional disclosure of the demand
letters provided by Wood and recap of the events leading to the
receivership application, Court proceedings, Court orders, and
appointment of Grant Thornton.
PRIVATE PLACEMENT UPDATE
The Company expects to complete a first closing
of its unit financing (the “Financing”), as previously announced on
January 2, 2020 and February 25, 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 28, 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. As previously disclosed on January 2,
2020, the Financing is being conducted in reliance on the
Exchange’s temporary relief measures set out in the Exchange’s
bulletin of April 7, 2014, (the "Temporary Relief Measures". In
order to comply with the Temporary Relief Measures, the closing of
the Financing is also subject to providing to the Exchange with
written confirmation from subscribers and shareholders holding not
less than 50% of Company’s issued and outstanding shares (after
giving effect to the Financing) that they will vote in favour of
the proposed ten for one share consolidation (the “Consolidation”).
The net proceeds of the private placement will be used to repay all
indebtedness owning to Wood ($2,089,000 to be paid into Court),
legal expenses ($30,000), audit expense ($30,000), costs for a
statistician to perform an interim clinical trial analysis and
report ($50,000), pay certain accounts payable ($50,000) and the
balance for unallocated working capital. Please refer to the
January 2, 2020 news release for additional terms and conditions of
the private placement. Insiders of the Company intend to subscribe
for units under the Financing. Any subsequent closings must
be completed on or before April 4, 2020.
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.
Further to the Company’s press release dated
February 25, 2020, the Company provides the following additional
chronological update and recap of the events leading up to the
action filed against the Company by Aspire Health Science, LLC
(“Aspire”) in Orange County, Florida.The Company and Aspire entered
into an original license agreement dated February 15, 2018 (the
“Original License”) which granted Aspire a limited license for the
Company’s ACP-01 technology in certain jurisdictions. The Company
also entered into a Contract Manufacturing Agreement with Aspire
dated February 15, 2018 (the “Manufacturing Agreement”) for the
manufacturing of the Company’s ACP-01 product for the clinical
trial and for research and development. The Manufacturing Agreement
was terminated on October 31, 2019.
As previously announced, the Company and Aspire
entered into an amended license agreement dated September 30, 2019
(the “Amended License”) which 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.
Following the reconstitution of the Company’s
Board of Directors and management team in December of 2019, on
December 5, 2019 the Company provided written notice to Aspire that
the Amended License was rescinded as a result of Aspire’s failure
to pay the Company USD $1,000,000 as required under the Amended
License, as announced in the Company’s press release dated December
11, 2019.
Aspire alleges that they paid a total of
USD$1,000,000 to Hemostemix creditors on December 12, 2019 in
satisfaction of the Amended License payment, which Aspire noted in
their January 28, 2020 action. The Company disputes these purported
payments as satisfaction of the license fee and reaffirms its
position that it had rescinded the Amended License on December 5,
2019 as Aspire did not pay the Company the USD$1,000,000 payment as
required under the Amended License.
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. 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 and the Company filed a motion to
dismiss this action.
Subsequent to closing the first tranche of the
Financing and full payment to Wood to discharge the current
security interests in favour of Wood, the Company intends to:
- Set a record date for an Annual and Special Meeting of
Shareholders within 60 days of the first closing, which includes a
resolution to approve a consolidation of the Company’s common
shares on a ten old for one new basis;
- Complete a second closing of the Financing on or before April
4, 2020;
- Appoint a clinical trial manager or chief scientific officer to
take over management of the current Phase II clinical trial and
complete a midpoint analysis of the data, including assessing a
futility analysis of the data; and
- Appoint a Chief Financial Officer and search for a permanent
Chief Executive Officer.
The Company intends to hire a clinical trial
manager or chief scientific officer to take over management of its
Phase II clinical trial from Aspire. The Company will also need to
engage a new manufacturing partner should the Company wish to
enroll additional patients in its trial. There is no certainty that
the Company will be able to identify a new manufacturing partner
nor enter into an agreement on terms suitable to the Company, or at
all. To-date, the Company has requested that Aspire provide all
clinical trial data and material to the Company. However, Aspire
has not provided such information and continued to manage the
clinical trial pursuant to the Amended License even though the
Company rescinded such Amended License on December 5, 2019.
Aspire’s press release dated February 13, 2020 also announced that
it had suspended patient recruitment for the Hemostemix clinical
trial due to lack of certainty regarding the Amended License until
the outstanding legal matters are sufficiently resolved. The
Company intends to aggressively support its position that the
Amended License was rescinded and that Aspire must return all
Company clinical trial material immediately. The Company intends to
appoint a new Chief Financial Officer shortly after the full
payment to Wood and discharge of the current security interests.
The Company is continuing its search for a new CEO and will provide
a further update on management appointments when available.
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, close the $3,000,000 unit
financing, the appointment of a clinical trial manager or chief
scientific officer and other management including a CFO and CEO,
the Company’s stage of development, the ability to take over and
complete its current CLI clinical trial, the ability to engage a
new manufacturing company to manufacture ACP-01, complete an
interim clinical trial review and report and futility analysis and
the results of such, the success of litigation involving Aspire,
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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