Executive with Strong Track Record in
Advancing Pipelines Through Clinical Development
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for neurological disorders and cardio-renal disease, announced
today the appointment of Lorianne Masuoka, M.D. as Chief Medical
Officer. Dr. Masuoka is a board-certified neurologist with more
than 25 years of experience and a successful track record of
managing clinical programs from early stage to drug approvals and
strategic alliances.
“We are delighted to have Lorianne join our executive leadership
team,” said Rick Pauls, DiaMedica’s President and Chief Executive
Officer. “She is a board-certified neurologist and recognized
clinical leader in the neurology with a demonstrated track record
in progressing the development of therapeutics for multiple
neuroscience indications. Having worked with several early and
mid-stage companies, she is very experienced in clinical research
and managing drug candidates through the clinical development and
regulatory process. Her experience also includes playing a key role
in the acquisition of multiple biotechnology companies. We welcome
Lorianne and believe her extensive expertise will benefit us
tremendously as our ReMEDy 2 trial for acute ischemic stroke is now
recruiting patients.”
“This is a very exciting time to join DiaMedica as it resumes
enrollment in its ReMEDy2 trial,” said Dr. Masuoka, “I look forward
to accelerating the development of DM199 and bringing a treatment
option to the large number of ischemic stroke patients who
currently have no good treatment options.”
Dr. Masuoka has more than 25 years of experience building and
expanding high value pipelines in the biopharmaceutical industry
that have resulted in drug approvals and strategic alliances. She
is a board-certified neurologist, experienced in treating stroke
patients, who has successfully created and overseen high performing
teams to lead the clinical development of new medicines, with a
focus in neurology and oncology. Dr. Masuoka served as Chief
Medical Officer of Epygenix Therapeutics, Marinus Pharmaceuticals
(Nasdaq: MRNS), Cubist Pharmaceuticals ($9.5B acquisition by
Merck), and Nektar Therapeutics (Nasdaq: NKTR) where, as a member
of executive management, she managed teams in the areas of clinical
research, pharmacovigilance, biostatistics and data management,
regulatory affairs, and clinical operations. Previously, she held
various roles of increasing responsibility at FivePrime
Therapeutics ($1.9B acquisition by Amgen) and Chiron (now
Novartis). In addition to her executive roles, Dr. Masuoka most
recently served as a Board member at Pfenex Inc. ($516M acquisition
by Ligand) and serves as a Board member at Opiant Pharmaceuticals
(up to $500M acquisition by Indivior). Dr. Masuoka received her
medical degree from the University of California, Davis, where she
also completed her residency in neurology. She completed her
epilepsy fellowship at Yale University and is board certified by
the American Board of Psychiatry and Neurology.
Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
In connection with Dr. Masuoka’s appointment, DiaMedica granted
her an inducement stock option to purchase 285,000 shares of
DiaMedica’s common stock pursuant to the DiaMedica Therapeutics,
Inc. 2021 Employment Inducement Incentive Plan. The inducement
grant was approved by the Company’s compensation committee of the
board of directors and was effective as of Dr. Masuoka’s first date
of employment, January 22, 2024, and was a material inducement to
her acceptance of employment with the Company in accordance with
Nasdaq Listing Rule 5635(c)(4) as a component of her
compensation.
About 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 up to 100 sites globally. 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. DiaMedica believes that the ReMEDy2 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 China for the
treatment of acute ischemic stroke and other vascular diseases, to
be clinically studied in the United States. 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 “anticipates,” “believes,”
“look forward,” “continue,” “could,” “expects,” “intends,” “may,”
“plans,” “potential,” “should,” or “will,” 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. The forward-looking statements in this press release
include statements regarding the anticipated clinical benefits and
success of DM199 and the Company’s belief that the ReMEDy2 trial
has the potential to serve as a pivotal registration study of DM199
in acute ischemic stroke patients. Such statements reflect
management’s current view and DiaMedica undertakes no obligation to
update or revise any of these statements. 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, DiaMedica’s ability to conduct successful clinical testing
of DM199 for the treatment of acute ischemic stroke and within its
anticipated parameters, enrollment numbers, costs and timeframes,
and other 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 September 30, 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/20240122533463/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
Paul Papi Corporate Communications Phone: (508) 444-6790
ppapi@diamedica.com
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