EXHIBIT 99.1
Tenax Therapeutics, Inc. Expands Board of Directors
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New Board appointments strengthen Tenax with world-class expertise
in cardiovascular drug development, commercial strategy, and
business development
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New Directors will provide significant guidance as Tenax is poised
to advance its two leading drug candidates into late-stage clinical
testing
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Transformational step as Tenax strengthens its positioning as a
leading specialty pharmaceutical company focused on
cardio-pulmonary therapeutics
Morrisville, NC, March 2, 2021 - Tenax Therapeutics, Inc.
(Nasdaq: TENX), a
specialty pharmaceutical company focused on identifying and
developing therapeutics that address cardio-pulmonary diseases with
high unmet medical need, today announced the appointment of four
new members to its board of directors: June Almenoff, MD, PhD,
Michael Davidson, MD, Delcan Doogan, MD, and Stuart Rich,
MD.
“We
are thrilled to welcome June, Michael, Declan and Stuart to our
Board of Directors,” said Anthony DiTonno, Chief Executive
Officer of Tenax Therapeutics. “Together, these highly
accomplished professionals will provide the Board with significant
scientific and commercial perspectives that will prove invaluable
as we execute on our long-term corporate strategy. Over the next
several months, we expect to advance our two leading pipeline
assets into late-stage clinical testing, so the expansion of our
board to include such expertise from both the medical community and
the pharmaceutical industry could not come at a better time for our
company and our shareholders.”
The
Tenax pipeline includes two de-risked, Phase 3 ready drug
candidates: (1) a reformulation of imatinib for the treatment of
pulmonary arterial hypertension (WHO Group 1) with the potential to
be the first disease modifying treatment for this indication, and
(2) an oral formulation of levosimendan for the treatment of
pulmonary hypertension (WHO Group 2), recently in-licensed from
Orion. Intravenous Levosimendanwas already approved by the EMA in
2002 for treatment of acute heart failure.
About New Board Members
Dr.
Almenoff is an accomplished biopharma executive with over 20 years
of senior leadership experience. She served as President and Chief
Medical Officer of Furiex Pharmaceuticals, which was acquired by
Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline
(Viberzi®), which is approved in both the United States and
Europe. Prior to joining Furiex, Dr. Almenoff was at
GlaxoSmithKline (GSK) for 12 years, where she held various
positions of increasing responsibility. She was a Vice President in
the Clinical Safety Organization, chaired a PhRMA-FDA working
group, and worked in the area of scientific licensing. Dr. Almenoff
also led the development of pioneering systems for minimizing risk
in drug development, which have been widely adopted by industry and
regulators. Dr. Almenoff led or contributed to numerous regulatory
submissions and product approvals. She is currently Chief
Scientific Officer of RedHill Biopharma (Nasdaq: RDHL). She also
serves on the investment advisory board of the Harrington Discovery
Institute and the boards of Brainstorm Cell Therapeutics (Nasdaq:
BCLI) and Kurome Therapeutics. Dr. Almenoff has strong expertise in
translational medicine, clinical development, commercial strategy,
and business development, and has previously advised biotech boards
and management in these areas. .
Dr.
Almenoff received her B.A. cum laude from Smith College and
graduated with AOA honors from the M.D.-Ph.D. program at the Icahn
(Mt. Sinai) School of Medicine. She completed post-graduate medical
training at Stanford University Medical Center and served on the
faculty of Duke University School of Medicine. She is an adjunct
professor at Duke, a Fellow of the American College of Physicians
(FACP) and has authored close to 60 publications.
Dr.
Michael Davidson was the Founder and former Chief Scientific
Officer of Corvidia Therapeutics, which was recently acquired by
Novo-Nordisk for $2.1 billion. Dr. Davidson also serves as Clinical
Professor and Director of the Lipid Clinic at the University of
Chicago Pritzker School of Medicine. He is a leading expert in the
field of Lipidology and was named in The Best Doctors in America
for the past 10 years. Dr. Davidson was the co-founding Chief
Medical Officer of Omthera Pharmaceuticals in 2008, which was later
acquired by Astra Zeneca Pharmaceutical in 2013 for $443M. He also
founded the Chicago Center for Clinical Research, which became the
largest investigator site in the United States and was acquired by
Pharmaceutical Product Development in 1996. His research background
encompasses both pharmaceutical and nutritional clinical trials
including extensive research on statins, novel lipid-lowering
drugs, and omega-3 fatty acids. Dr. Davidson is board-certified in
internal medicine, cardiology, and clinical lipidology and served
as President of the National Lipid Association from 2010 to 2011.
He received his BA/MS from Northwestern University and MD from The
Ohio State University School of Medicine.
Dr.
Declan Doogan has over 30 years of industry experience in both
major pharma and biotech. He was the Senior Vice President and Head
of Worldwide Development at Pfizer, where many multibillion-dollar
programs were delivered (e.g., Viagra, Lipitor and Zoloft). He has
held a number of executive positions in Pfizer in the U.S., the
U.K. and Japan. Since leaving Pfizer in 2007 he has been engaged in
executive roles in small pharma. Declan was CMO and acting CEO of
Amarin (AMRN: Nasdaq), transforming it from a failing neuroscience
company to a vibrant cardiovascular company with a market
capitalization of over one billion dollars before his departure. He
is Chairman and co-founder of Biohaven (BHVN:NYSE) and an investor
in emerging biotechnology and technology companies. He holds a
number of Board appointments, principally in pharma companies, and
is also a visiting professor at Glasgow University Medical School.
Dr. Doogan received his medical degree from Glasgow University in
1975. He is a Fellow of the Royal College of Physicians and the
Faculty Pharmaceutical Medicine and holds a Doctorate of Science at
the University of Kent in the U.K.
Dr.
Stuart Rich joined the Company as Chief Medical Officer in 2021
from PHPrecisionMed (PHPM), where he was a co-founder and held the
positions of Chief Executive Officer and Director from October 2018
until January 2021. Prior to PHPM, Dr. Rich served as the Chief
Medical Officer (part-time) of United Therapeutics from October
2003 until December 2004. Dr. Rich currently serves as Professor of
Medicine at Northwestern University Feinberg School of Medicine and
as senior faculty of the Pulmonary Vascular Disease Program at the
Bluhm Cardiovascular Institute. Dr. Rich was co-founder of the
Pulmonary Vascular Research Institute and a member of the Board of
Trustees, a U.K. based charity, and a member of the Board of
Directors of the Cardiovascular Medical and Research Foundation, a
U.S. based charity. Prior to Northwestern University, Dr. Rich was
the Professor of Medicine and Chief of the Section of Cardiology at
the University of Illinois College of Medicine in Chicago from July
1980 until July 1996, was Professor of Medicine at the Rush Heart
Institute of the Rush University School of Medicine from July 1996
until September 2004, and was Professor of Medicine at the Section
of Cardiology of the University of Chicago Pritzker School of
Medicine from September 2004 until July 2015. Dr. Rich received his
B.S. in Biology at the University of Illinois and his M.D. at
Loyola University Stritch School of Medicine, and he completed his
residency in medicine at the Washington University of St. Louis and
his fellowship in cardiology at the University of
Chicago.
About Tenax Therapeutics
Tenax
Therapeutics, Inc., is a specialty pharmaceutical company focused
on identifying, developing, and commercializing products that
address cardiovascular and pulmonary diseases with high unmet
medical need. The Company has a world-class scientific advisory
team including recognized global experts in pulmonary hypertension.
The Company owns North American rights to develop and commercialize
levosimendan and has recently released topline data regarding their
Phase 2 clinical trial for the use of levosimendan in the treatment
of Pulmonary Hypertension associated with Heart Failure and
preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a
delayed release oral formulation of imatinib, designed to avoid the
gastric irritation, into a single pivotal trial pursuant to the
505(b)(2) pathway. For more information,
visit www.tenaxthera.com.
About Levosimendan
Levosimendan
is a calcium sensitizer that works through a unique triple
mechanism of action. It initially was developed for intravenous use
in hospitalized patients with acutely decompensated heart failure.
It was discovered and developed by Orion Pharma, Orion Corporation
of Espoo Finland, and is currently approved in over 60 countries
for this indication and not available in the United States. Tenax
Therapeutics acquired North American rights to develop and
commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib
is an antiproliferative agent developed to target the BCR-ABL
tyrosine kinase in patients with chronic myeloid leukemia. The
inhibitory effects of imatinib on PDGF receptors and c-KIT
suggested that it may be efficacious in PAH. Imatinib reversed
experimentally induced pulmonary hypertension and has pulmonary
vasodilatory effects in animal models and proapoptotic effects on
pulmonary artery smooth muscle cells from patients with idiopathic
PAH. In a phase 3 clinical trial imatinib produced significant
improvements in exercise capacity, but a high rate of dropouts
attributed largely to gastric intolerance prevented regulatory
approval.
Caution Regarding Forward-Looking Statements
This
news release contains certain forward-looking statements by the
Company that involve risks and uncertainties and reflect the
Company’s judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to matters beyond the
Company’s control that could lead to delays in the clinical
study, new product introductions and customer acceptance of these
new products; matters beyond the Company’s control that could
impact the Company’s continued compliance with Nasdaq listing
requirements; the impact of management changes on the
Company’s business and unanticipated charges, costs and
expenditures not currently contemplated that may occur as a result
of management changes; and other risks and uncertainties as
described in the Company’s filings with the Securities and
Exchange Commission, including in its annual report on Form 10-K
filed on March 30, 2020, and its quarterly report on Form 10-Q
filed on November 16, 2020, as well as its other filings with the
SEC. The Company disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release.
Statements in this press release regarding management’s
future expectations, beliefs, goals, plans or prospects constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995.
Contacts
Investor
Contact:
John
Mullaly
Managing
Director
LifeSci
Advisors, LLC
C:
617-429-3548
jmullaly@lifesciadvisors.com