- Expands pipeline into Pulmonary Arterial Hypertension (PAH), a
progressive, fatal orphan disease without a cure
- Imatinib, a tyrosine kinase inhibitor (TKI), has been shown to
block critical disease promoting pathways and has demonstrated
improved exercise capacity and hemodynamics in patients with
advanced PAH
- Acquisition strengthens leadership team with appointment of Dr.
Stuart Rich as Chief Medical Officer
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing, and
commercializing products for the critical care market, today
announced the acquisition of PH Precision Med (PHPM), a
privately-held clinical stage biotech company focused on developing
imatinib for the treatment of pulmonary arterial hypertension
(PAH). The FDA has granted Orphan Drug Designation for imatinib for
the treatment of PAH, an indication with a high unmet medical
need.
The acquisition expands Tenax’s pulmonary hypertension pipeline
with the addition of imatinib, a Phase 3 ready candidate. Imatinib
is a tyrosine kinase inhibitor (TKI) that transformed the treatment
of cancer by blocking the underlying pathways resulting in long
lasting remissions. Subsequent preclinical and clinical studies in
PAH indicate that imatinib may provide antiproliferative and
disease-modifying effects in PAH patients through its ability to
inhibit several growth factors including platelet-derived growth
factor (PDGF). PDGF regulates vascular smooth muscle cell
proliferation in PAH and is thought to be associated with the
disease progression. Multiple clinical studies of imatinib in PAH
patients provide convincing evidence that imatinib can provide
impressive improvements in exercise capacity and hemodynamics in
patients with advanced PAH. The strong efficacy results from these
trials, combined with imatinib’s antiproliferative mechanism
action, have raised the possibility that imatinib may work by
modifying the underlying PAH disease process. Pursuant to the
acquisition, Tenax’s clincial development plan includes advancing 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.
“The acquisition of PHPM immediately expands Tenax’s pipeline to
include a second de-risked Phase 3 ready candidate with the
potential to be the first disease modifying treatment of pulmonary
arterial hypertension,” said Anthony DiTonno, Chief Executive
Officer of Tenax. “The previous clinical trial designs led to high
dropout rates and raised questions related to safety and
tolerability, which limited further development of imatinib in PAH.
We believe that PHPM’s innovative clinical development plan, which
includes a novel formulation that mitigates the side effects
without diminishing the bioavailability, has the potential to yield
positive clinical outcomes in a single pivotal Phase 3 trial
requisite for regulatory approval.”
Stuart Rich, MD, co-founder of PHDM, has been appointed Chief
Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as
Professor of Medicine at Northwestern University Feinberg School of
Medicine, and Director of the Pulmonary Vascular Disease Program at
the Bluhm Cardiovascular Institute. He previously served as FDA
Cardio-Renal Advisory Committee Member.
Mr. DiTonno continued, “In addition to this transformative
asset, we are also pleased to welcome PHPM’s co-founder Dr. Rich to
the Tenax management team. Dr. Rich is a pioneer in the field of
pulmonary hypertension and its treatments. In addition, his many
years of experience as an FDA advisory committee member provides
Tenax with extraordinary knowledge of pulmonary hypertension
disease mechanisms and modern regulatory strategies. I am confident
this strengthened team is well positioned to maximize the clinical
potential of imatinib and advance the clinical development of
levosimendan for PH-HFpEF, which together have the potential to
address significant unmet needs and large market
opportunities.”
At the next regularly scheduled Board meeting, Dr. Rich is
expected to be appointed to Tenax’s Board of Directors. In
addition, in connection with Tenax’s 2021 Annual Meeting of
Stockholders, two additional co-founders of PHPM, Declan Doogan, MD
and Michael Davidson, MD, are expected to be nominated to join to
Tenax’s Board of Directors. Dr. Doogan is a drug development
executive with more than 30 years of experience in the
pharmaceutical industry. After retiring from Pfizer in 2007 as the
Senior VP Head of World Drug Development he was Head of R&D at
Amarin where he helped raised $100 million to fund the
reorganization leading to completion of a Phase 3 program and
approval for Vascepa. He is cofounder and Chair of Biohaven (BHVN:
NYSE) and co-founder of the healthy aging company Juvenescence. Dr.
Davidson was founder of Omthera Pharmaceuticals, co-founder of
Corvidia Therapeutics, Inc., and is currently Chief Executive
Officer of New Amsterdam Pharma. Together they bring extensive
experience of successful biotech development and leadership.
Dr. Rich remarked, “This acquisition by Tenax, a clinical-stage
publicly traded company with a pulmonary hypertension focus, is
testament to the PHPM team’s success in developing our novel and
highly innovative clinical development plan. We will now focus
advancing therapeutic candidates for Group 1 and Group 2 pulmonary
hypertension with a precision medicine approach, to allow us to
achieve the optimal treatment effects in our clinical trials. I
look forward to joining the Tenax team to unlock the clinical
potential of imatinib for patients with severe PAH.”
In connection with his appointment, on January 15, 2021, Dr.
Rich was awarded an option to purchase 250,000 shares of the
Company’s common stock. This award was made in accordance with the
employment inducement award exemption provided by Nasdaq Rule
5635(c)(4) and was therefore not awarded under the Company’s
stockholder approved equity plan. The option award will vest as
follows: 25% upon initiation of a Phase 3 trial; 25% upon database
lock; 25% upon acceptance for review of an NDA; and 25% upon
approval. The options have a 10-year term and an exercise price of
$1.78 per share, the January 15, 2021 closing price of the
Company's common stock.
In connection with the acquisition, Tenax will issue to PHPM’s
stockholders in a private placement an aggregate of approximately
12.1 million unregistered shares of common stock and securities
convertible into common stock. These securities were issued as
follows at closing:
(i) 1,892,905 shares of Tenax Common Stock,
representing approximately 15% of Tenax's outstanding Common Stock
prior to closing, and
(ii) 10,232 shares of Class B Preferred Stock
that, following stockholder approval, will be converted into up to
10,232,000 shares of Common Stock. The Preferred Stock will have
voting rights equal to approximately 4.99% of the Company's
pre-transaction shares outstanding, such that the total voting
rights of shares issued in the transaction prior to stockholder
approval will not exceed 19.99% of the pre-transaction outstanding
common stock.
Stockholder approval was not required and was not sought for the
consummation of the acquisition; however, Tenax intends to seek
stockholder approval for the full issuance of the securities
contemplated in the transaction. A more complete description of the
acquisition is available in the Form 8-K filed by Tenax
Therapeutics with the Securities and Exchange Commission (the
“SEC”) on January 19, 2021. This press release is neither an offer
to sell nor a solicitation of an offer to buy any of the Tenax
Therapeutics’ securities. No offer, solicitation, or sale will be
made in any jurisdiction in which such offer, solicitation, or sale
is unlawful. The terms and conditions of the transactions described
in this press release are qualified in their entirety by reference
to the transaction documents, which were filed on January 19, 2021
with the SEC on Form 8-K.
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). 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 of 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210119005256/en/
Westwicke, an ICR Company Stephanie Carrington, 646-277-1282
stephanie.carrington@westwicke.com
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