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): October 9,
2020
Tenax Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
001-34600
|
|
26-2593535
|
|
(State
or other jurisdiction of incorporation)
|
|
(CommissionFile
Number)
|
|
(IRS
EmployerIdentification No.)
|
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
|
Trading
Symbol(s)
|
Name of
each exchange on which registered
|
|
Common
Stock, $0.0001 par value per share
|
TENX
|
The
Nasdaq Stock Market LLC
|
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. ☐
Item 1.01. Entry into a Material Definitive Agreement.
On
October 9, 2020, Tenax Therapeutics, Inc. (the
“Company”) entered into an Amendment (the
“Amendment”) to the License Agreement between the
Company and Orion Corporation (“Orion”), dated as of
September 20, 2013 (the “Agreement”), to include two
new oral products containing Levosimendan, in capsule and solid
dosage form, and a subcutaneously administered product containing
Levosimendan to the scope of the Agreement, subject to specified
limitations. The Amendment also amends the tiered royalty payments
based on net sales of the Product in the Territory (each as defined
in the Agreement, as amended by the Amendment) made by the Company
and its sublicensees. Pursuant to the Amendment, the term of the
Agreement has been extended until 10 years after the launch of the
Product in the Territory, provided that the Agreement will
continue after the end of the term in each country in the Territory
until the expiration of Orion’s patent rights in the Product
in such country. In the event that no regulatory approval for the
Product has been granted in the United States on or before
September 20, 2028, however, either party will have the right to
terminate the Agreement with immediate effect.
The foregoing description of the Amendment is qualified by
reference to the full text of the Amendment, which is attached to
this Current Report on Form 8-K as Exhibit 10.1 and is incorporated
herein by reference.
Item
8.01 Other Items.
On
October 15, 2020, the Company issued a press release announcing
that it gained the North American rights to oral Levosimendan
through the Amendment with Orion.
Pursuant
to the General Instruction B.2 of Current Report on Form 8-K, the
information in Item 8.01 of this report, including the press
release attached as Exhibit 99.1, is furnished and shall not be
deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject
to the liabilities of that section. Furthermore, such information
shall not be deemed incorporated by reference into the filings of
the Company under the Securities Act of 1933, as
amended.
Item 9.01. Exhibits.
(d)
Exhibits.
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
|
Amendment
to License Agreement, dated as of October 9, 2020, by and between
Tenax Therapeutics, Inc. and Orion Corporation*
|
|
|
|
Press
Release dated October 15, 2020
|
*
Asterisks located within the exhibit denote information which has
been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K
because it is both not material and would likely cause competitive
harm to the Company if publicly disclosed.
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: October 15, 2020
|
Tenax Therapeutics, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
By: /s/ Michael B. Jebsen
|
|
|
|
Michael
B. Jebsen
|
|
|
|
President
and Chief Financial Officer
|
|
Exhibit 10.1
Portions of this exhibit marked as “[***]” have been
excluded because they are both not material and would likely cause
competitive harm to the registrant if publicly
disclosed.
AMENDMENT
TO
THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013
This
amendment agreement (hereinafter referred to as the
“Amendment”) is made and
executed as of this 9th day of October,
2020 (“Effective
Date of Amendment”) by and between:
Orion Corporation, Business Identity Code 1999212-6, a
company registered under the laws of Finland and having its
principal office at Orionintie 1, 02200 Espoo, Finland (hereinafter
referred to as “Orion”); and
Tenax Therapeutics, Inc., Business Identity Code 26-2593535,
a company registered under the laws of the State of Delaware, and
having its principal office at ONE Copley Parkway, Suite 490,
Morrisville, NC 27560, USA (hereinafter referred to as
“Licensee”).
Orion
and Licensee are collectively referred to herein as the
“Parties” and each
individually as a “Party”.
WHEREAS,
this Amendment
pertains to that certain agreement titled “License
Agreement” and existing between the Parties and dated
September 20, 2013 (hereinafter referred to as the
“Agreement”);
and
WHEREAS,
it is the intention
of the Parties to amend the Agreement by, inter alia, adding a
certain orally administered Levosimendan product as well as a
subcutaneously administered Levosimendan product (as both having
been defined in more detail herein) to the scope of the Agreement
and to modify the term of the Agreement on the terms and conditions
set out hereinafter.
NOW,
THEREFORE, the Parties, in consideration of the premises and of the
mutual agreement, covenants and conditions hereinafter set forth,
hereby agree and convene as follows:
1
TERMS
USED IN THIS AMENDMENT
1.1
Unless otherwise
explicitly agreed herein, all capitalized terms used herein shall
have the same meaning as given to them under the
Agreement.
2
AMENDMENTS
AND CLARIFICATIONS TO THE AGREEMENT
2.1
The following
pharmaceutical product shall be referred to as the
“Oral
Product” under this Amendment and the
Agreement:
o
The orally
administered pharmaceutical product in capsule formulation,
containing Levosimendan as an active pharmaceutical ingredient and
having a strength of 1mg/capsule, the composition of which has been
described in Schedule 1 to this Amendment (attached
hereto).
2.2
The following
pharmaceutical product shall be referred to as the
“Modified Oral
Product” under this Amendment and the
Agreement:
o
An orally
administered pharmaceutical product in solid dosage form,
containing Levosimendan as an active pharmaceutical ingredient,
which deviates from the Oral Product solely in terms of its
excipients and/or strength of the active pharmaceutical
ingredient.
2.3
The following
pharmaceutical product shall be referred to as the
“Subcutaneously
Administered Product” under this Amendment and the
Agreement:
o
A subcutaneously
administered injectable pharmaceutical product containing
Levosimendan as an active pharmaceutical ingredient.
2.4
The definition of
“Development” under the Agreement shall be replaced
with the following:
o
“Development” means any
and all technical formulation development, as well as any and all
pre-clinical and clinical development activities reasonably related
to the submission of information to a Regulatory Authority and
other activities related to obtaining Regulatory Approval for the
Product in the Field in the Territory, but excluding
Commercialization activities. When used as a verb,
“Develop” means to engage
in Development.
2.5
The Oral Product,
the Modified Oral Product and the Subcutaneously Administered
Product shall be added to the definition of the
“Product” under the Agreement. However, notwithstanding
the foregoing, no manufacturing or supply obligations of Orion with
respect to the Product under the Agreement shall be applicable to
the Modified Oral Product or the Subcutaneously Administered
Product, unless the Parties separately agree
otherwise.
2.6
For purposes of
this Amendment and the Agreement, the “Phase III Study” shall
mean the phase III study to be conducted by Licensee in respect of
the Product and initiated before the end of 2022 and completed
before the end of 2026.
2.7
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, the “Field” shall be
restricted to mean:
o
The use of the Oral
Product, the Modified Oral Product and the Subcutaneously
Administered Product solely for Type 2 pulmonary hypertension in
heart failure patients with preserved ejection fraction (PH-HFpEF),
or other pulmonary hypertension or heart failure related
indications, or any other human indication for which the Oral
Product, the Modified Oral Product or the Subcutaneously
Administered Product (as applicable) has been registered in the
Territory by Licensee on the basis of the results of the Phase III
Study.
2.8
Solely with respect
to the Oral Product, Orion undertakes to provide to Licensee any
relevant CMC (chemistry, manufacture and controls) and safety data
relating to the Oral Product generated by or for Orion that are in
Orion’s possession or control. For clarity, Orion shall be
under no obligation to generate any additional data or
documentation for the purposes of the Agreement and the rights and
licenses granted to Licensee thereunder. Moreover, upon
Licensee’s request, Orion may, at Orion’s sole
discretion, provide to Licensee scientific support and advice in
relation to the Oral Product to a reasonable extent, in which case
Licensee shall reimburse Orion for any out-of-pocket expenses paid
to third parties and incurred by Orion in connection therewith. The
practicalities relating to such possible provision of scientific
support and advice shall be separately agreed upon by the
Parties.
2.9
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, Section 7.8 and Section 8.9 of
the Agreement shall not be applicable. Instead, the provisions
under Exhibit D (Key Terms For The Supply Agreement –
Development) and Exhibit E (Key Terms For The Supply Agreement
– Commercial) shall as such apply to the deliveries of the
Oral Product (but not, for clarity, of the Modified Oral Product or
the Subcutaneously Administered Product) by Orion to Licensee;
however, subject to the
following amendments to the Agreement:
i.
Orion shall have
the right and the obligation to supply the required amounts of the
Oral Product as well as the respective Placebo-Product to Licensee
for the Phase III Study. Orion shall charge a transfer price from
Licensee in respect of such supplies of the Oral Product and the
Placebo-Product corresponding to [***], respectively.
ii.
Orion shall have
the right but not the obligation to supply the Oral Product to
Licensee for Commercialization in the Territory (the
“Supply
Option”). In the event Orion uses the Supply Option,
the Parties shall separately negotiate on such supply of the Oral
Product, it being agreed that Orion may not require a higher
transfer price for the Oral Product than [***]. In the event Orion
has chosen not to supply the Oral Product to Licensee for
Commercialization in the Territory, Orion undertakes to arrange the
transfer of the relevant manufacturing information and know-how in
respect of the Oral Product existing in Orion’s possession to
Licensee, or a Third Party manufacturer appointed by Licensee for
such purpose (the “Technical Transfer”). The
costs and expenses of such Technical Transfer incurred by Orion
shall be borne by the Parties in equal shares. Following such
Technical Transfer, Orion may, at Licensee’s sole discretion,
supply Levosimendan to Licensee (or a Third Party manufacturer
appointed by Licensee) at a supply price mutually agreed upon. In
the event Orion chooses not to use the Supply Option, Orion shall
notify Licensee thereof in writing at the latest before the end of
2021. Further, if Orion does use the Supply Option, Orion shall
provide a minimum of twenty-four (24) months advance notice to
Licensee if Orion intends to terminate its supplies of the Oral
Product to Licensee. For the avoidance of doubt, in the event of
Orion not having used the Supply Option or Orion having terminated
its supplies of the Oral Product to Licensee, Licensee may source
the Oral Product from a Third Party manufacturer. For clarity, the
Modified Oral Product and the Subcutaneously Administered Product
are not covered by the Supply Option, and, Licensee is entitled to
source the Modified Oral Product and the Subcutaneously
Administered Product from a Third Party manufacturer
accordingly.
2.10
Subsection 4.1.1 of
the Agreement, pertaining to the royalty payments on Net Sales in
Territory, shall be replaced with the following:
(a)
[***] of Annual Net
Sales of the Product in the Territory during the relevant Calendar
Year [***]; and
(b)
[***] of Annual Net
Sales of the Product in the Territory during the relevant Calendar
Year [***].
2.11
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, the Product Trademark shall be
defined to mean the following:
o
A trademark other
than Simdax®
selected by the Parties, to be registered and owned by Orion to be
used for the Oral Product, the Modified Oral Product or the
Subcutaneously Administered Product (as applicable) in the
Territory.
2.12
Section 16.1 (Term)
of the Agreement shall be replaced with the following:
o
16.1 Term. This Agreement shall
become binding upon the Effective Date and shall continue
thereafter in full force and effect, unless terminated sooner
pursuant to this Section 16, for ten (10) years after the launch of
the Product in the Territory; provided, however, that, to the
extent any of the Orion Patent Rights continue in existence in any
country in the Territory at the end of such ten (10) year period,
this Agreement shall continue in full force and effect on a
country-by-country basis until the expiration of such Orion Patent
Rights (the “Term”). For purposes of
this Agreement, the Product shall be considered launched upon the
occurrence of the first commercial sale of the Product by Licensee
to a Third Party in an arm’s length transaction following the
grant of the Regulatory Approval for the Product in the United
States of America by the FDA or in Canada by the relevant
Regulatory Authority. However, notwithstanding the foregoing, in
the event no Regulatory Approval for the Product has been granted
in the United States of America on or before September 20, 2028,
either Party shall have the right to terminate this Agreement with
immediate effect by notifying the other Party thereof in
writing.
2.13
For the avoidance
of doubt, any product containing the proprietary chemical entity of
Orion, which has been previously known as [***] and is currently
identified by Orion by [***], and whose chemical composition is
[***] shall not constitute a Product or a Line Extension Product
under the Agreement.
3.1
The amendments to
the Agreement agreed upon herein shall become effective as of the
Effective Date of Amendment.
4.1
For the avoidance
of doubt it is stated that except for what has been stipulated
herein above, all other terms and conditions of the Agreement will
remain unchanged.
4.2
The terms and
conditions of the Agreement with regard to the choice of law and
dispute resolution will apply to this Amendment.
***Balance of page left blank. Signature page
follows.***
IN WITNESS WHEREOF, the Parties, through their authorized
representatives, have executed two (2) identical counterparts of
this Amendment.
|
Orion
Corporation
|
|
|
|
By:
|
/s/
Satu Ahomäki
|
By:
|
/s/
Jukka Muhonen
|
|
Name:
|
Satu
Ahomäki
|
Name:
|
Jukka
Muhonen
|
|
Title:
|
Senior
Vice President, Commercial Operations
|
Title:
|
Director
/ Global Business Development and Alliance Management
|
|
Tenax Therapeutics, Inc.
|
|
|
|
By:
|
/s/
Anthony DiTonno
|
By:
|
/s/
Michael Jebsen
|
|
Name:
|
Anthony
Ditonno
|
Name:
|
Michael
Jebsen
|
|
Title:
|
CEO
|
Title:
|
CFO/President
|
SCHEDULE 1
to the Amendment to the License Agreement of September 20,
2013
Description of the composition of the
Oral Product:
|
Component
|
Quantity
(mg/capsule)
|
|
Levosimendan
|
1.0
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]capsule[***]
|
1
capsule
|
Tenax Therapeutics Gains North American Rights to Oral Levosimendan
through Expanded License Agreement with Orion
Corporation
●
Tenax gains developmental and commercial rights for a
fully-developed oral levosimendan formulation in the U.S. and
Canada
●
Oral formulation expected to be used in upcoming Phase 3
registration trial
Morrisville, NC, October 15, 2020 - Tenax Therapeutics, Inc.
(Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing, and
commercializing products for the critical care market, today
announced that it has entered into an amendment to the existing
licensing agreement with Orion Corporation to include the rights to
develop and commercialize in the United States and Canada an oral
formulation of levosimendan for use with Type 2 pulmonary
hypertension in heart failure patients with preserved ejection
fraction (PH-HFpEF), or other pulmonary hypertension or heart
failure related indications. The Company recently completed a Phase
2 study in PH-HFpEF using an intravenous formulation of
levosimendan, which the Company has exclusive development and
commercialization rights to in the US and Canada under the existing
license agreement. The Company now plans to utilize the oral
formulation in its upcoming Phase 3 trial in PH-HFpEF. Currently,
there are no approved products for treating PH-HFpEF.
Tenax
CEO Anthony DiTonno stated “Adding the oral formulation to
our existing agreement represents a significant opportunity for us.
Use of the currently available 1mg capsule of levosimendan should
allow us to conduct our upcoming Phase 3 trial with significantly
faster enrollment versus the IV formulation. We expect an oral
formulation will also enable us to enjoy greater market acceptance
upon FDA approval for marketing”.
The
oral formulation is a fully developed capsule that has already been
used in a large number of patients over an extended period of time,
up to one year in many cases. The amendment allows Tenax to access
all of the manufacturing, preclinical and clinical data generated
on oral levosimendan to support its use in the US and Canada, which
we anticipate will expedite development efforts.
The
Company intends to review its plans to use the oral levosimendan
formulation in a Phase 3 trial in PH-HFpEF patients with the FDA
during its End-of-Phase 2 meeting.
About Phase 2 HELP Trial
The
HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was
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). Endpoints in the trial evaluated various
invasive hemodynamic and clinical measures including a 6-minute
walk test. The Company previously announced positive topline
results from this Phase 2 trial. The trial demonstrated significant
reduction in right atrial and pulmonary capillary wedge pressures.
It also demonstrated a significant improvement with 6-minute walk
distance.
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 including delays in patient enrollment, 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 August 14, 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:
Westwicke
Stephanie
Carrington, 646-277-1282
Stephanie.carrington@westwicke.com
