UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of
1934
Date of Report (Date of earliest event reported): May 29,
2020
Tenax Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-34600
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26-2593535
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(State
or other jurisdiction of incorporation)
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(CommissionFile
Number)
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(IRS
EmployerIdentification No.)
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ONE Copley Parkway, Suite 490
Morrisville, NC 27560
(Address
of principal executive offices) (Zip Code)
919-855-2100
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
⬜ Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
⬜ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⬜ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
⬜ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Trading
Symbol(s)
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Name of
each exchange on which registered
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Common
Stock, $0.0001 par value per share
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TENX
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The
Nasdaq Stock Market LLC
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR
230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17
CFR 240.12b-2).
Emerging growth
company
⬜
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange
Act. ⬜
On June
2, 2020, Tenax Therapeutics, Inc. (the “Company”)
issued a press release announcing that on May 29, 2020 the Company
received top line data results on its Phase 2 clinical study of
levosimendan for the treatment of patients with pulmonary
hypertension and heart failure with preserved ejection fraction
(PH-HFpEF).
The
Company also held a webcast call on June 2, 2020 to review the
results. A copy of the press release is attached hereto as Exhibit
99.1 and the presentation materials for the webcast call is
attached hereto as Exhibit 99.2, both of which are incorporated
herein by reference.
Item
9.01
Financial
Statements and Exhibits.
Exhibit No.
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Description
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Press
Release dated June 2, 2020.
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Presentation
materials dated June 2, 2020.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Date: June 2, 2020
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Tenax Therapeutics, Inc.
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By: /s/ Michael B. Jebsen
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Michael
B. Jebsen
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President
and Chief Financial Officer
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Exhibit 99.1
Tenax
Therapeutics Reports Positive Results from Phase 2 Trial of
Levosimendan in Patients with Pulmonary Hypertension and Heart
Failure with Preserved Ejection Fraction (PH-HFpEF)
– Demonstrated a significant reduction in right atrial and
pulmonary capillary wedge pressures
– Demonstrated a significant improvement with 6-minute walk
distance
– No significant safety issues.
– Management to host conference call and webcast today at
8:30 a.m. EDT
Morrisville, NC – June 2, 2020 -- Tenax Therapeutics,
Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on
identifying, developing and commercializing products that address
cardiovascular and pulmonary diseases with high unmet medical need,
today announced positive Phase 2 results for levosimendan for the
treatment of patients with pulmonary hypertension and heart failure
with preserved ejection fraction (PH-HFpEF). In this 37 patient
study, the primary efficacy analysis, pulmonary capillary wedge
pressure (PCWP) during exercise did not demonstrate a statistically
significant reduction from baseline. Levosimendan did demonstrate a
statistically significant reduction in PCWP compared to baseline
(p=<0.0017) and placebo (p=<0.0475)when the measurements at
rest, with legs up and on exercise were combined. Levosimendan also
demonstrated a statistically significant improvement in 6-minute
walk distance (6MWD) as compared to placebo
(p=0.0329).
Dr.
Stuart Rich, Professor of
Medicine at the Bluhm Cardiovascular Institute at Northwestern
University commented “Levosimendan is the first drug
to ever show a favorable mechanism of action with biventricular
effects in patients with PH-HFpEF. The consistency of the
hemodynamic data and improvement in 6-minute walk demonstrates that
levosimendan has great promise as a treatment for PH-HFpEF which
has a serious unmet need. The favorable safety profile, especially
the absence of any proarrhythmic effects, supports the further
development with a phase 3 trial.”
Hemodynamic Results
Hemodynamic
measurements were made at rest (supine), after leg raise on a
supine bicycle (a test of rapid increase in ventricular filling)
and during exercise (25 watts for 3 minutes or until the patient
tired). Levosimendan demonstrated a statistically significant
reduction in PCWP compared to baseline (p=<0.0017) and placebo
(p=<0.0475) when the measurements at rest, with legs up and on
exercise were combined. While there was no significant change in
PCWP during exercise, patients receiving levosimendan had
reductions from baseline at Week 6 in PCWP, pulmonary artery
pressure (PAP), and right atrial pressure (RAP) that were
significant when patients were “at rest” and/or with
their “legs raised” (p<0.05).
Clinical Results (6 Minute Walk Distance)
The
clinical efficacy was confirmed by a statistically significant
improvement in 6-minute walk distance of 29 meters. (p=0.0329). The
6-minute walk distance was a secondary endpoint in the trial and is
a validated and accepted endpoint used in many pulmonary
hypertension registration trials. Levosimendan was given in
once-weekly home infusions for 6 weeks.
Safety
The
incidence of AEs or SAEs between the control and treated groups
were similar. In addition, there were no arrhythmias observed,
atrial or ventricular, when comparing baseline electrocardiographic
monitoring with 72-hour monitoring after 5 weeks of treatment. The
company plans to present the full study results at future medical
meetings and will submit a full manuscript of the trial results to
a peer-reviewed journal.
"The
positive outcome of this Phase 2 trial represents a major milestone
for Tenax and our development of levosimendan for the treatment of
patients suffering from this debilitating illness”
stated Anthony DiTonno, Chief Executive Officer of
Tenax. "It is particularly exciting to report these positive
results that support our confidence that levosimendan’s
unique pharmacologic profile and mechanism of action may be ideally
suited to treat PH-HFpEF. We believe these results support a Phase
3 trial that will translate into the first approved therapy to
treat these patients.”
Conference Call & Webcast Information
The
Tenax Therapeutics management team will host a conference call and
live webcast with slides with the investment community
today, Tuesday, June 2, 2020, at 8:30 a.m. EDT to
discuss the information in this press release. Dr. Stuart Rich,
Professor of Medicine at the Bluhm Cardiovascular Institute at
Northwestern University, will join the call.
When: June
2, 2020 at 8:30 a.m. EDT
Audio Only Dial-in: (877) 407-9124 (United States) or (201)
689-8584 (International)
Replay:
Toll Free: 877-481-4010 (United States)/International:
919-882-2331
Replay
Passcode: 35158
Audio
replay available until June 16, 2020
Webcast with Audio: https://www.webcaster4.com/Webcast/Page/2404/35158.
Webcast
reply available until September 30, 2020.
Please
join the conference call at least 10 minutes early to
register.
A replay of the conference call will be archived under
the investor
relations section of
Tenax's website for 30 days shortly after the
call.
About Phase 2 HELP Trial
The
HELP Trial – Hemodynamic Evaluation of Levosimendan in
PH-HFpEF is a
multi-center, double-blind, placebo-controlled Phase 2 clinical
trial designed to evaluate levosimendan in 36 patients with
pulmonary hypertension and heart failure with preserved ejection
fraction (PH-HFpEF). The trial has a predefined response criterion
that patients must meet following a 24-hour open-label infusion of
levosimendan before they can be randomized to the 6-week
double-blind phase of the trial. The criterion for randomization is
a reduction in PCWP during supine exercise of ≥ 4mmHg
following the open-label infusion when compared with each
patient’s baseline exercise PCWP. The primary endpoint of the
HELP Trial is based on change in PCWP vs baseline compared to
placebo.
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.
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 May 15, 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:
ICR
Stephanie
Carrington, 646-277-1282
Stephanie.carrington@icrinc.com