DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for neurological disorders and kidney diseases (“DiaMedica” or the
“Company”), today announced it has entered into definitive
agreements to sell its common shares in a private placement with
accredited investors. The transaction is expected to result in
gross proceeds of $37.5 million.
Pursuant to the terms of the securities purchase agreements, the
Company will issue a total of 11,011,406 common shares at a
purchase price of $3.40 per share, equal to the average per share
closing price of the Company’s common shares for the five trading
days ended June 20, 2023, except in the case of DiaMedica
management who agreed to a higher purchase price of $3.91 per
share, equal to the closing sale price of the Company’s common
shares on June 20, 2023. The private placement is expected to close
on or about June 23, 2023, subject to the satisfaction of customary
closing conditions.
The Company expects to use the net proceeds from the private
placement to continue its clinical and product development
activities for DM199, including its pivotal Phase 2/3, ReMEDy2
clinical trial, and for other working capital and general corporate
purposes. The Company believes that with the addition of this
funding, the Company’s cash resources will be sufficient to fund
the Company’s ReMEDy2 trial through the completion of the interim
analysis.
Earlier today, DiaMedica also announced that the U.S. Food and
Drug Administration (“FDA”) has removed the clinical hold on the
Company’s Phase 2/3 ReMEDy2 clinical trial studying the use of the
Company’s product candidate, DM199, to treat acute ischemic stroke
patients.
Craig-Hallum Capital Group LLC acted as the placement agent for
the private placement investment by certain of the investors. Lake
Street Capital Markets, LLC acted as financial advisor to the
Company. Fox Rothschild LLP and Pushor Mitchell LLP acted as
counsel to DiaMedica in the private placement and Mintz Levin acted
as counsel for certain investors in the private placement.
The offer and sale of the foregoing securities in the private
placement have not been registered under the U.S. Securities Act of
1933, as amended (the “Securities Act”), or any state or other
applicable jurisdiction’s securities laws, and may not be offered
or sold in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements of the Securities Act and applicable
state and other securities laws. The Company has agreed to file a
registration statement with the U.S. Securities and Exchange
Commission registering the resale of the common shares issued in
the private placement.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy the foregoing securities, nor shall
there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or other jurisdiction.
Required Canadian Related Party Transaction
Disclosure
DiaMedica has received binding commitments for participation in
the private placement from certain related parties, including
members of its board of directors and management team, in the
aggregate amount of $751,900 or 192,301 common shares. Accordingly,
the private placement constitutes a "related party transaction" as
such term is defined in Multilateral Instrument 61-101 – Protection
of Minority Security Holders in Special Transactions ("MI
61-101") of the Canadian Securities Administrators. The private
placement will be exempt from the valuation and the minority
shareholder approval requirements of MI 61-101 under the exemptions
contained in section 5.5(a) and 5.7(1)(a), respectively, as neither
the fair market value of the common shares nor the fair market
value of the consideration paid for the common shares insofar as it
involves the related parties is more than 25% of the Company’s
market capitalization. The private placement was unanimously
approved by a special committee comprised of independent members of
the Company’s board of directors. As the material change report
relating to the completion of the private placement will be filed
on SEDAR less than 21 days before the completion of the private
placement, there is a requirement under MI 61–101 to explain why
the shorter period is reasonable or necessary in the circumstances.
In DiaMedica’s view, the shorter period is reasonable and necessary
in the circumstances because the related parties and the Company
wished to complete the private placement in a fashion that resulted
in the invested funds being received directly by the Company in a
timely manner such that the funds could be accessed immediately by
the Company to advance its ongoing research and development
activities.
Required Canadian Early Warning Reporting
Upon closing of the private placement, Thomas von Koch (the “von
Koch”), c/o EQT Partners AB, Box 16509, 103 27 Stockholm, Sweden,
will acquire indirect ownership, through TomEqt Private AB, of an
aggregate of 1,470,588 common shares (the “von Koch Shares”) of
DiaMedica (the “von Koch Acquisition”). The Company’s head office
is located at 301 Carlson Parkway, Suite 210, Minneapolis,
Minnesota, 55305, U.S.A. Immediately prior to the completion of the
von Koch Acquisition, von Koch had ownership of, and exercised
control and direction over, an aggregate of 2,855,847 common shares
of the Company representing approximately 10.6% of the issued and
outstanding common shares of the Issuer on a non-diluted basis.
Immediately following the completion of the von Koch Acquisition,
von Koch will have ownership of, and exercise control and direction
over, an aggregate of 4,326,435 common shares of the Company
representing approximately 11.4% of the issued and outstanding
common shares of the Company on a non-diluted basis. von Koch will
pay aggregate cash consideration of US$5,000,000 (approximately
C$6,620,500) for the von Koch Shares at a price of US$3.40 per
common share (approximately C$4.50). The von Koch Shares are being
acquired for investment purposes. von Koch may, from time to time,
take such actions in respect of his holdings in securities of the
Company as he may deem appropriate in light of the circumstances
then existing, including the purchase of additional common shares
or other securities of the Company or the disposition of all or a
portion of his security holdings in the Company, subject in each
case to applicable securities laws and the terms of such
securities.
Upon closing of the private placement, Trill AB (“Trill”),
Sveavägen 17, 18th Floor, SE-111 57, Stockholm, Sweden, acquired
ownership of an aggregate of 1,470,588 common shares (the “Trill
Shares”) of the Company (the “Trill Acquisition”). Immediately
prior to the completion of the Trill Acquisition, Trill had
ownership of, and exercised control and direction over, an
aggregate of 2,551,020 common shares of the Company representing
approximately 9.5% of the issued and outstanding common shares of
the Company on a non-diluted basis. Immediately following the
completion of the Trill Acquisition, Trill will have ownership of,
and exercise control and direction over, an aggregate of 4,021,608
common shares of the Company representing approximately 10.6% of
the issued and outstanding common shares of the Company on a
non-diluted basis. Trill will pay aggregate cash consideration of
US$5,000,000 (approximately C$6,620,500) for the 1,470,588 Trill
Shares at a price of US$3.40 per common share (approximately
C$4.50). The Trill Shares are being acquired for investment
purposes. Trill may, from time to time, take such actions in
respect of its holdings in securities of the Company as it may deem
appropriate in light of the circumstances then existing, including
the purchase of additional common shares or other securities of the
Company or the disposition of all or a portion of its security
holdings in the Company, subject in each case to applicable
securities laws and the terms of such securities.
Upon closing of the private placement, NFS/FMTC Roth IRA FBO
Richard Jacinto II (“Jacinto”), c/o Fidelity Investments, 100
Crosby Parkway, Mailzone KC1H, Covington, KY 41015, will acquire
ownership of an aggregate of 2,058,824 common shares (the “Jacinto
Shares”) of the Company (the “Jacinto Acquisition”). Immediately
prior to the completion of the Jacinto Acquisition, Jacinto had
ownership of, and exercised control and direction over, an
aggregate of 2,500,000 common shares of the Company representing
approximately 9.3% of the issued and outstanding common shares of
the Company on a non-diluted basis. Immediately following the
completion of the Jacinto Acquisition, Jacinto will have ownership
of, and exercise control and direction over, an aggregate of
4,558,823 common shares of the Company representing approximately
12.0% of the issued and outstanding common shares of the Company on
a non-diluted basis. Jacinto paid aggregate cash consideration of
US$7,000,000 (approximately C$9,258,935) for the 2,058,824 Jacinto
Shares at a price of US$3.40 per common share (approximately
C$4.50). The Jacinto Shares are being acquired for investment
purposes. Jacinto may, from time to time, take such actions in
respect of its holdings in securities of the Company as it may deem
appropriate in light of the circumstances then existing, including
the purchase of additional common shares or other securities of the
Company or the disposition of all or a portion of its security
holdings in the Company, subject in each case to applicable
securities laws and the terms of such securities.
Pursuant to National Instrument 62-103 - The Early Warning
System and Related Take-Over Bid and Insider Reporting Issues,
following the closing of the private placement, each of von Koch,
Trill and Jacinto will file an early warning report in respect of
the von Koch Acquisition, Trill Acquisition and Jacinto
Acquisition, respectively, with the applicable Canadian securities
regulators, copies of which will be available under the Company’s
profile at www.sedar.com. Following closing of the private
placement, a copy of the early warning report relating to the von
Koch Acquisition can be obtained by contacting von Koch at
+46706034564, Per Colleen, CEO TomEqt Private AB. A copy of the
early warning report relating to the Trill Acquisition can be
obtained by contacting Trill at Sveavägen 17, 18th Floor, SE-111
57, Stockholm, Sweden. A copy of the early warning report relating
to the Jacinto Acquisition can be obtained by contacting Jacinto at
301 Carlson Parkway, Suite 210, Minneapolis, MN 55305.
The Canadian dollar values referred to above were determined
using the Bank of Canada daily exchange rate on June 20, 2023.
About the ReMEDy2 Trial
The ReMEDy2 trial is an adaptive design, randomized,
double-blind, placebo-controlled trial studying the use of the
Company’s product candidate, DM199, to treat acute ischemic stroke
(AIS) patients. The trial is intended to enroll approximately 350
patients at 75 sites in the United States. Patients enrolled in the
trial will be treated for three weeks with either DM199 or placebo,
beginning within 24 hours of the onset of AIS symptoms, with the
final follow-up at 90 days. The trial excludes patients treated
with tissue plasminogen activator (tPA) and/or mechanical
thrombectomy. The study population is representative of the
approximately 80% of AIS patients who do not have treatment options
today, primarily due to the limitations on treatment with tPA or
mechanical thrombectomy. DiaMedica believes that the proposed trial
has the potential to serve as a pivotal registration study of DM199
in this patient population.
About DM199
DM199 is a recombinant (synthetic) form of human tissue
kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays
an important role in the regulation of diverse physiological
processes including blood flow, inflammation, fibrosis, oxidative
stress and neurogenesis via a molecular mechanism that increases
production of nitric oxide and prostaglandin. KLK1 deficiency may
play a role in multiple vascular and fibrotic diseases such as
stroke, chronic kidney disease, retinopathy, vascular dementia, and
resistant hypertension where current treatment options are limited
or ineffective. DiaMedica is the first company to have developed
and clinically studied a recombinant form of the KLK1 protein. The
KLK1 protein, produced from the pancreas of pigs and human urine,
has been used to treat patients in Japan, China and South Korea for
decades. DM199 is currently being studied in patients with acute
ischemic stroke (AIS). In September 2021, the FDA granted Fast
Track Designation to DM199 for the treatment of AIS.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage
biopharmaceutical company committed to improving the lives of
people suffering from serious diseases with a focus on acute
ischemic stroke. DiaMedica’s lead candidate DM199 is the first
pharmaceutically active recombinant (synthetic) form of the KLK1
protein, an established therapeutic modality in Asia for the
treatment of acute ischemic stroke and other vascular diseases. For
more information visit the Company’s website at
www.diamedica.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and forward-looking information that are based on the beliefs
of management and reflect management’s current expectations. When
used in this press release, the words “expects,” “estimate,”
“believe,” “anticipate,” “intend,” “expect,” “plan,” “continue,”
“look forward,” “will,” “may” or “should,” the negative of these
words or such variations thereon or comparable terminology and the
use of future dates are intended to identify forward-looking
statements and information. The forward-looking statements and
information in this press release include statements regarding the
Company’s expectations regarding the private placement, the timing
for closing, the anticipated gross proceeds and use of net proceeds
from the private placement, including its belief that its cash
resources will be sufficient to fund the ReMEDy2 trial through the
completion of the interim analysis. Such statements and information
reflect management’s current view and DiaMedica undertakes no
obligation to update or revise any of these statements or
information. By their nature, forward-looking statements involve
known and unknown risks, uncertainties and other factors which may
cause actual results, performance or achievements, or other future
events, to be materially different from any future results,
performance or achievements expressed or implied by such
forward-looking statements. Applicable risks and uncertainties
include, among others, risks and uncertainties surrounding the
private placement; uncertainties relating to regulatory
applications and related filing and approval timelines; the
possibility of additional future adverse events associated with or
unfavorable results from the ReMEDy2 trial; the possibility of
unfavorable results from DiaMedica’s ongoing or future clinical
trials of DM199; the risk that existing preclinical and clinical
data may not be predictive of the results of ongoing or later
clinical trials; DiaMedica’s plans to develop, obtain regulatory
approval for and commercialize its DM199 product candidate for the
treatment of acute ischemic stroke and chronic kidney disease and
its expectations regarding the benefits of DM199; DiaMedica’s
ability to conduct successful clinical testing of DM199 and within
its anticipated parameters, enrollment numbers, costs and
timeframes; the adaptive design of the ReMEDy2 trial and the
possibility that the targeted enrollment and other aspects of the
trial could change depending upon certain factors, including
additional input from the FDA and the blinded interim analysis; the
perceived benefits of DM199 over existing treatment options; the
potential direct or indirect impact of COVID-19, hospital and
medical facility staffing shortages, and worldwide global supply
chain shortages on DiaMedica’s business and clinical trials,
including its ability to meet its site activation and enrollment
goals; DiaMedica’s reliance on collaboration with third parties to
conduct clinical trials; DiaMedica’s need for additional financing
and ability to continue to obtain funding for its operations,
including funding necessary to complete planned clinical trials and
obtain regulatory approvals for DM199 for acute ischemic stroke and
chronic kidney disease, and the risks identified under the heading
“Risk Factors” in DiaMedica’s annual report on Form 10-K for the
fiscal year ended December 31, 2022 and subsequent U.S. Securities
and Exchange Commission filings, including DiaMedica’s quarterly
report on Form 10-Q for the quarterly period ended March 31, 2023.
The forward-looking information contained in this press release
represents the expectations of DiaMedica as of the date of this
press release and, accordingly, is subject to change after such
date. Readers should not place undue importance on forward-looking
information and should not rely upon this information as of any
other date. While DiaMedica may elect to, it does not undertake to
update this information at any particular time except as required
in accordance with applicable laws.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230621958321/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
Paul Papi Corporate Communications Phone: 617-899-5941
ppapi@diamedica.com
DiaMedica Therapeutics (NASDAQ:DMAC)
과거 데이터 주식 차트
부터 8월(8) 2024 으로 9월(9) 2024
DiaMedica Therapeutics (NASDAQ:DMAC)
과거 데이터 주식 차트
부터 9월(9) 2023 으로 9월(9) 2024