Tenax Therapeutics, Inc S-3, filed Aug 20, 2021
Tenax Therapeutics, Inc. (TENX)
S-3
2021-08-20
View Original
Added on
October 17, 2026
As filed with the Securities and Exchange Commission on August 20,
2021
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
TENAX THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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26-2593535
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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ONE Copley Parkway, Suite 490
Morrisville, NC 27560
(919) 855-2100
(Address, including zip code, and telephone number, including area
code, of registrant’s principal executive
offices)
Michael B. Jebsen
President and Chief Financial Officer
Tenax Therapeutics, Inc.
ONE Copley Parkway, Suite 490
Morrisville, NC 27560
(919) 855-2100
(Name, address, including zip code, and telephone number, including
area code, of agent for service)
Please send copies of all communications to:
Margaret Rosenfeld
K&L Gates LLP
4350 Lassiter at North Hills Avenue
Suite 300
Raleigh, North Carolina 27609
(919) 743-7351
Approximate date of commencement of proposed sale to the
public:
From time to time after the effective date of the Registration
Statement.
If the only securities being registered on this Form are being
offered pursuant to dividend or interest reinvestment plans, please
check the following box. ☐
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, other than securities offered
only in connection with dividend or interest reinvestment plans,
check the following box. ☑
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same
offering.
☐
If this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following
box.
☐
If this Form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the
following box.
☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth
company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act.
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Large
accelerated filer ☐
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Accelerated
filer ☐
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Non-accelerated
filer ☑
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Smaller
reporting company ☑
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Emerging
growth company ☐
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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 7(a)(2)(B) of the Securities Act.
☐
______________________________
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Title
of each class of securities to be registered
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Amount
to be
Registered
(1)
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Proposed
maximum offering
price
per unit (2)
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Proposed
maximum
aggregate
offering price (2)
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Amount
of
registration
fee
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Common
Stock,
$0.0001
par value per share
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9,546,538
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$1.49
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$14,224,342
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$1,551.88
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(1)
Pursuant to Rule 416 under the Securities Act of 1933, as amended,
or the Securities Act, there are also being registered hereunder an
indeterminate number of shares of common stock as may be issuable
with respect to the shares being registered hereunder as a result
of stock splits, stock dividends, or similar
transactions.
(2)
Estimated solely for the purpose of calculating the registration
fee pursuant to Rule 457(c) under the Securities Act. Based on the
average of the high and low reported prices of common stock as
reported on the Nasdaq Capital Market on August 16,
2021.
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The
registrant hereby amends this registration statement on such date
or dates as may be necessary to delay its effective date until the
registrant shall file a further amendment which specifically states
that this registration statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933, as
amended, or until the registration statement shall become effective
on such date as the Commission acting pursuant to said Section
8(a), may determine.
The information in this prospectus is not complete and may be
changed. The selling stockholders may not sell these securities
until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy
these securities in any jurisdiction where the offer or sale is not
permitted.
SUBJECT TO COMPLETION, DATED AUGUST 20, 2021
PROSPECTUS
Tenax Therapeutics, Inc.
9,546,538 Shares of Common Stock
This prospectus relates to the resale of up to 9,546,538 shares of
our common stock, $0.0001 par value per share, from time to time in
one or more offerings by selling stockholders named herein and any
additional selling stockholders who will be identified in one or
more prospectus supplements.
The 9,546,538 shares offered hereby are issuable upon exercise of
the Unregistered Pre-Funded Warrants and Unregistered Warrants sold
in the private placement described under
“Summary—Recent Developments” in this
prospectus.
We will
not receive any proceeds from the resale of the shares of our
common stock offered hereby, although we will receive the exercise
price of any exercised warrants paid to us by the selling
stockholders, which will be used for working capital and general
corporate purposes.
Our
common stock is traded on the Nasdaq Capital Market and is quoted
under the symbol TENX. On August 16, 2021, the last reported sale
price of our common stock was $1.44 per share.
The
selling stockholders may offer all or part of the shares registered
hereby for resale from time to time directly to purchasers, through
agents selected by the selling stockholders, or to or through
underwriters or dealers, at either prevailing market prices or at
privately negotiated prices. If agents, underwriters or dealers are
used in the sale of the shares by the selling stockholders, such
agents, underwriters or dealers will be named and their
compensation described in any applicable prospectus
supplement.
Investing
in our securities involves a high degree of risk. You should review
carefully the risks and uncertainties described under the heading
“Risk Factors” on page 8 of this prospectus and the
documents that are incorporated by reference into this
prospectus.
Neither
the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
This
prospectus is dated August , 2021.
Table of Contents
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ABOUT
THIS PROSPECTUS
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ii
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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ii
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SUMMARY
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1
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RISK
FACTORS
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8
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USE OF
PROCEEDS
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9
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SELLING
STOCKHOLDERS
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9
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PLAN
OF DISTRIBUTION
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11
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LEGAL
MATTERS
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12
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EXPERTS
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12
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WHERE
YOU CAN FIND MORE INFORMATION
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12
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INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
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ABOUT THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we
filed with the Securities and Exchange Commission, or the SEC,
utilizing a “shelf” registration process. Under this
process, the selling stockholders may from time to time, in one or
more offerings, sell the shares of common stock described in this
prospectus.
A
prospectus supplement may also add, update, or change the
information contained or incorporated in this prospectus. Any
prospectus supplement will supersede this prospectus to the extent
it contains information that is different from, or that conflicts
with, the information contained or incorporated in this prospectus.
The registration statement we filed with the SEC includes exhibits
that provide more detail of the matters discussed in this
prospectus. You should read and consider all information contained
in this prospectus and the related registration statement and
exhibits filed with the SEC and any accompanying prospectus
supplement in making your investment decision. You should also read
and consider the information contained in the documents identified
under the headings “Where You Can Find More
Information” and “Incorporation of Certain Information
by Reference” in this prospectus.
You
should rely only on the information contained or incorporated by
reference in this prospectus and in any prospectus supplement. We
have not authorized any dealer, salesman, or other person to give
any information or to make any representation other than those
contained or incorporated by reference in this prospectus. The
selling stockholders are offering to sell and seeking offers to buy
the common stock only in jurisdictions where offers and sales are
permitted. You should assume that the information appearing in this
prospectus is accurate only as of the date of this prospectus, and
that any information incorporated by reference is accurate only as
of the date of the document incorporated by reference, unless we
indicate otherwise. Our business, financial condition, results of
operations, and prospects may have changed since those
dates.
When we
refer to “Tenax Therapeutics,” “the
Company,” “we,” “our,” and
“us” in this prospectus, we mean Tenax Therapeutics,
Inc., a Delaware corporation, unless otherwise specified.
References to our “common stock” refer to the common
stock, par value $0.0001 per share, of Tenax Therapeutics,
Inc.
Information set
forth in this prospectus and the information incorporated by
reference may contain various “forward-looking
statements” within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. All information relative to future
markets for our products and trends in and anticipated levels of
revenue, gross margins, and expenses, as well as other statements
containing words such as “believe,”
“project,” “may,” “will,”
“anticipate,” “target,” “plan,”
“estimate,” “expect,” and
“intend” and other similar expressions constitute
forward-looking statements. These forward-looking statements are
subject to business, economic, and other risks and uncertainties,
both known and unknown, and actual results may differ materially
from those contained in the forward-looking statements. Examples of
risks and uncertainties that could cause actual results to differ
materially from historical performance and any forward-looking
statements include, but are not limited to, the risks described
under the heading “Risk Factors” on page 8 of this
prospectus, in our most recent Annual Report on Form 10-K, our
most recent Quarterly Report on Form 10-Q, and subsequent reports
filed with the SEC. Given these risks, uncertainties, and other
factors, you should not place undue reliance on these
forward-looking statements. Also, these forward-looking statements
represent our estimates and assumptions only as of the date such
forward-looking statements are made. You should read carefully this
prospectus and the information incorporated by reference completely
and with the understanding that our actual future results may be
materially different from what we expect. We hereby qualify all of
our forward-looking statements by these cautionary statements.
Except as required by law, we assume no obligation to update these
forward-looking statements publicly or to update the reasons actual
results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future.
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SUMMARY
This summary is not complete and does not contain all of the
information you should consider before investing in the securities
offered by this prospectus. You should read this summary together
with the entire prospectus, including our financial statements, the
notes to those financial statements, and the other documents
identified under the headings “Where You Can Find More
Information” and “Incorporation of Certain Information
by Reference” in this prospectus before making an investment
decision. See the Risk Factors section of this prospectus on page 8
for a discussion of the risks involved in investing in our
securities.
Overview
Tenax
Therapeutics is a specialty pharmaceutical company focused on
identifying, developing and commercializing products that
address cardiovascular and pulmonary diseases of high unmet medical
need. On November 13, 2013, through our wholly owned subsidiary,
Life Newco, Inc., or Life Newco, we acquired a license granting
Life Newco an exclusive, sublicenseable right to develop and
commercialize pharmaceutical products containing levosimendan, 2.5
mg/ml concentrate for solution for infusion / 5ml vial in the
United States and Canada. On October 9, 2020, we entered into an
amendment to the license 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 license, subject to specified limitations. On January
15, 2021, we acquired PHPrecisionMed Inc. (“PHPM”) as a
wholly owned subsidiary. As a result of the transaction, we plan to
develop and commercialize pharmaceutical products containing
imatinib for the treatment of pulmonary arterial
hypertension.
Our
principal executive offices are located at ONE Copley Parkway,
Suite 490, Morrisville, North Carolina 27560, and our telephone
number is (919) 855-2100. Our Internet address is
http://www.tenaxthera.com. The information on our website is not
incorporated by reference into this prospectus, and you should not
consider it part of this prospectus.
Tenax
Therapeutics was originally formed as a New Jersey corporation in
1967 under the name Rudmer, David & Associates, Inc., and
subsequently changed its name to Synthetic Blood International,
Inc. Effective June 30, 2008, we changed the domiciliary state of
the corporation to Delaware and changed the company name to Oxygen
Biotherapeutics, Inc. On September 19, 2014, we changed the company
name to Tenax Therapeutics, Inc.
Business Strategy
Our
principal business objective is to identify, develop, and
commercialize novel therapeutic products for disease indications
that represent significant areas of clinical need and commercial
opportunity. The key elements of our business strategy are outlined
below.
Efficiently conduct clinical
development to establish clinical proof of concept with our current
product candidates. Levosimendan and imatinib, both of which
represent novel therapeutic modalities for the treatment of
pulmonary hypertension and other cardiovascular and pulmonary
diseases of high unmet medical need. We are conducting
clinical development with the intent to establish proof of concept
in several important disease areas where these therapeutics would
be expected to have benefit. Our focus is on conducting
well-designed studies to establish a robust foundation for
subsequent development, partnership and expansion into
complementary areas.
Efficiently explore new high
potential therapeutic applications, leveraging third-party research
collaborations and our results from related
areas. Our product candidates
have shown promise in multiple disease areas. We are committed to
exploring potential clinical indications where our therapies may
achieve best-in-class profile, and where we can address significant
unmet medical needs. In order to achieve this goal, we have
established collaborative research relationships with investigators
from research and clinical institutions and our strategic partners.
These collaborative relationships have enabled us to cost
effectively explore where our product candidates may have
therapeutic relevance, and how it may be utilized to advance
treatment over current clinical care. Additionally, we believe we
will be able to leverage clinical safety data and preclinical
results from some programs to support accelerated clinical
development efforts in other areas, saving substantial development
time and resources compared to traditional drug
development.
Continue to expand our
intellectual property portfolio. Our intellectual property is important to our
business and we take significant steps to protect its value. We
have ongoing research and development efforts, both through
internal activities and through collaborative research activities
with others, which aim to develop new intellectual property and
enable us to file patent applications that cover new applications
of our existing technologies or product
candidates.
Enter into licensing or
product co-development arrangements. In addition to our internal development efforts,
an important part of our product development strategy is to work
with collaborators and partners to accelerate product development,
reduce our development costs, and broaden our commercialization
capabilities. We believe this strategy will help us to develop a
portfolio of high-quality product development opportunities,
enhance our clinical development and commercialization
capabilities, and increase our ability to generate value from our
proprietary technologies.
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Our Current Programs
Levosimendan Background
Levosimendan was discovered and developed by Orion
Corporation, a Finnish company, or Orion. Levosimendan is
a calcium sensitizer/K-ATP
activator developed for
intravenous use in hospitalized patients with acutely decompensated
heart failure. It is currently approved in over 60 countries for
this indication and not available in the United States or Canada.
It is estimated that to date over 1.5 million patients have been
treated worldwide with levosimendan.
Levosimendan is a novel, first in
class calcium sensitizer/K-ATP
activator. The therapeutic
effects of levosimendan are mediated through:
●
Increased
cardiac contractility by calcium sensitization of troponin C,
resulting in a positive inotropic effect which is not associated
with substantial increases in oxygen demand.
●
Opening
of potassium channels in the vasculature smooth muscle, resulting
in a vasodilatory effect on all vascular beds.
●
Opening
of mitochondrial potassium channels in cardiomyocytes, resulting in
a cardioprotective effect.
This triple mechanism of action helps to preserve heart function
during cardiac surgery. Several studies have demonstrated that
levosimendan protects the heart and improves tissue perfusion while
minimizing tissue damage during cardiac surgery.
In
2013, we acquired certain assets of Phyxius Pharma, Inc., or
Phyxius, including its North American rights to develop and
commercialize levosimendan for any indication in the United States
and Canada. In the countries where levosimendan is marketed,
levosimendan is indicated for the short-term treatment of acutely
decompensated severe chronic heart failure in situations where
conventional therapy is not sufficient, and in cases where
inotropic support is considered appropriate. In acute
decompensated heart failure patients, levosimendan has been shown
to significantly improve patients’ symptoms as well as acute
hemodynamic measurements such as increased cardiac output, reduced
preload and reduced afterload.
The
European Society of Cardiology, or the ESC, recommends levosimendan
as a preferable agent over dobutamine to reverse the effect of beta
blockade if it is thought to be contributing to hypotension. The
ESC guidelines also state that levosimendan is not appropriate for
patients with systolic blood pressure less than 85mmHg or in
patients in cardiogenic shock unless it is used in combination with
other inotropes or vasopressors. Other unique properties of
levosimendan include sustained efficacy through the formation of a
long acting metabolite, lack of impairment of diastolic function,
and evidence of better compatibility with beta blockers than
dobutamine.
Levosimendan Development for Pulmonary Hypertension
Patients
We
recently completed a Phase 2 clinical trial of levosimendan in
North America for the treatment of patients with pulmonary
hypertension associated with heart failure with preserved ejection
fraction, or PH-HFpEF. PH-HFpEF is defined hemodynamically by
a mean pulmonary artery pressure, or mPAP, ≥25 mmHg, and a
pulmonary capillary wedge pressure, or PCWP, >15 mmHg. Pulmonary
hypertension in these patients is believed to arise from a passive
backward transmission of elevated filling pressures from left-sided
heart failure. These mechanical components of pulmonary venous
congestion may trigger pulmonary vasoconstriction, decreased nitric
oxide availability, increased endothelin expression,
desensitization to natriuretic peptide induced vasodilation, and
vascular remodeling. Over time, these changes often lead to
advanced pulmonary arterial and venous disease, increased right
ventricle afterload, and right ventricle failure.
PH-HFpEF
is a common form of pulmonary hypertension with an estimated US
prevalence exceeding 1.5 million patients. Currently, no
pharmacologic therapies are approved for treatment of
PH-HFpEF. Despite the fact that many therapies have been
studied in PH-HFpEF patients, including therapies approved to treat
pulmonary arterial hypertension patients, no therapies have been
shown to be effective in treating PH-HFpEF patients.
Published
pre-clinical and clinical studies indicate that levosimendan may
provide important benefits to patients with pulmonary hypertension.
Data from these published trials indicate that levosimendan may
reduce pulmonary vascular resistance and improve important
cardiovascular hemodynamics such as reduced pulmonary capillary
wedge pressure in patients with pulmonary hypertension. In
addition, several published studies provide evidence that
levosimendan may improve right ventricular dysfunction which is a
common comorbidity in patients with pulmonary hypertension. While
none of these studies have focused specifically on PH-HFpEF
patients, the general hemodynamic improvements in these published
studies of various types of pulmonary hypertension provide an
indication that levosimendan may be beneficial in PH-HFpEF
patients.
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In March 2018, we met with the United States Food
and Drug Administration, or FDA, to discuss development of
levosimendan in PH-HFpEF patients. The FDA agreed with our planned
Phase 2 design, patient entry criteria, and endpoints. It was
agreed the study could be conducted under the existing
investigational new drug application with no additional nonclinical
studies required to support full development. The FDA recognized
there were no approved drug therapies to treat PH-HFpEF patients
and acknowledged this provided an opportunity for a limited Phase 3
clinical program. This topic will be discussed further at the
End-of-Phase 2 Meeting following completion of the Phase 2 study in
PH-HFpEF patients, which is known as the HELP Study –
Hemodynamic
Evaluation
of Levosimendan in PH-HFpEF. We initiated the first of our expected
10-12 HELP Study clinical sites in November 2018 and the first of
36 patients was enrolled in the HELP Study in March 2019.
Enrollment in the HELP Study was completed in March 2020. The
primary endpoint of the HELP Study is based on change in PCWP vs
baseline compared to placebo. The HELP Study utilizes a
double-blind randomized design following five weekly infusions of
levosimendan.
On
June 2, 2020, we announced preliminary, top-line data from the
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).
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
detailed results from the Phase 2 HELP Study of levosimendan in
PH-HFpEF were presented at the Heart Failure Society of America
Virtual Annual Scientific Meeting on October 3, 2020 and at the
American Heart Association Scientific Sessions 2020 on November 13,
2020. Additionally, the full manuscript has been accepted for
publication in the peer-reviewed journal JACC:Heart
Failure.
Next
Steps
On
October 9, 2020, we entered into an amendment, or the Amendment, to
the License between the Company and Orion to include two new
product formulations containing levosimendan, in a capsule solid
oral dosage form, and a subcutaneously administered dosage form
containing levosimendan, to the scope of the License, subject to
specified limitations.
We
plan to study the utility of the levosimendan oral capsule dosage
form in patients who have participated in the open-label extension
of the HELP Study and who continue to receive weekly infusions of
intravenous levosimendan. These patients are now eligible to
participate in the amendment to the HELP Study that will transition
them from the intravenous to an oral formulation. The investigators
at the centers that participated in the HELP Study have been
invited to participate and enroll their patients into this
study.
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In
October 2020, we met with the FDA for an End-of-Phase 2 Meeting to
discuss the Phase 2 clinical data and further development of
levosimendan in PH-HFpEF patients. The FDA agreed that one or two
Phase 3 clinical studies (depending on the size) with a primary
endpoint of change in 6-minute walk distance over 12 weeks or a
single Phase 3 trial with clinical worsening (e.g., death,
hospitalization for heart failure, or decline in exercise capacity)
over 24 weeks would be sufficient to demonstrate the effectiveness
of levosimendan in PH-HFpEF. The FDA also agreed to a plan to
replace weekly intravenous levosimendan dosing with daily oral
levosimendan doses in a Phase 3 clinical study. The FDA expressed
concern about a safety database as potentially necessary and
indicated that the need for a further safety database could be
dependent on the final design of the Phase 3 study. We expect that
this will be addressed when the final Phase 3 protocol is submitted
which will better characterize the trial design and primary
endpoints.
The
HELP Study design was novel in several respects. To date, no other
multi-center study has evaluated levosimendan in heart failure
patients with preserved ejection fraction, or HFpEF, patients or
PH-HFpEF patients. Instead, all previous levosimendan heart failure
studies have enrolled heart failure patients with reduced ejection
fraction, or HFrEF, which specifically excluded HFpEF patients.
Also, the HELP Study utilized a unique 24-hour weekly infusion
regimen of 0.075- 0.1µm/kg/min. Finally, the HELP Study
employed a unique home-based intravenous infusion administration
via an ambulatory infusion pump. This home-based weekly intravenous
administration is unlike all other chronic dosing studies of
levosimendan that have typically employed a shorter duration and
less frequent infusion regimen administered in a hospital setting.
Despite the unique patient population, weekly dosing, and
home-based administration, there have been no reported serious
adverse events. We plan 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.
Imatinib Background
Imatinib
(also known as “Gleevec”), is a tyrosine kinase
inhibitor, which revolutionized the treatment of chronic myeloid
leukemia, or CML, in 2001. The first clinical trial of imatinib
took place in 1998 and the drug received FDA approval in May 2001.
Encouraged by the success of Imatinib in treating CML patients,
scientists explored its effect in other cancers, and it was found
to produce a similar positive effect in other cancers where
tyrosine kinases were overexpressed.
Tyrosine
kinases are important mediators of the signaling cascade,
determining key roles in diverse biological processes like growth,
differentiation, metabolism, and apoptosis in response to external
and internal stimuli. Deregulation of protein kinase activity has
been shown to play a central role in the pathogenesis of human
cancers. Imatinib, a 2-phenyl amino pyrimidine derivative, is a
tyrosine kinase inhibitor with activity against ABL, BCR-ABL,
PDGFRA, and c-KIT. Imatinib works by binding close to the ATP
binding site therefore inhibiting the enzyme activity of the
protein. Imatinib also inhibits the ABL protein of noncancer cells.
Imatinib is well absorbed after oral administration with a
bioavailability exceeding 90%. It is extensively metabolized,
principally by cytochrome P450 (CYP)3A4 and CYP3A5 and can
competitively inhibit the metabolism of drugs that are CYP3A4 or
CYP3A5 substrates. Imatinib is generally well tolerated in cancer
patients. Common side effects include fluid retention, headache,
diarrhea, loss of appetite, weakness, nausea and vomiting,
abdominal distention, edema, rash, dizziness, and muscle cramps.
Serious side effects may include myelosuppression, heart failure,
and liver function abnormalities. Novartis is the manufacturer of
Gleevec.
Previous
Imatinib Development for Pulmonary Arterial Hypertension
Patients
In
pulmonary arterial hypertension, or PAH, a rare disease, subjects
who remain symptomatic despite available therapies have a high
morbidity and mortality. Though several therapies are now
available, there is no cure for the disease, and there is no data
supporting that the existing therapies, all of which are pulmonary
vasodilators, halt progression or induce regression of the disease.
Imatinib is a tyrosine kinase inhibitor that has been shown in
animal models of pulmonary hypertension to induce disease reversal
by an effect on platelet derived growth factor, or PDGF, which
appears to be causal in the disease. After that discovery was made,
several case reports and small case series of patients with
advanced PAH failing combination pulmonary vasodilator therapy were
published showing a dramatic effect of imatinib on stabilizing and
improving these patients. This led Novartis to develop imatinib as
a treatment of PAH.
Novartis
sponsored a Phase 2 proof-of-concept trial to evaluate the safety,
tolerability, and efficacy of imatinib as an adjunct to PAH
specific therapy in patients with PAH. This was a 24-week
randomized, double-blind, placebo-controlled study of PAH subjects
who remained symptomatic on one or more PAH therapies in WHO
Functional Class (FC) II-IV. The Phase 2 trial of imatinib in PAH
caused significant hemodynamic improvement in some patients but
failed to meet the primary endpoint of an increase in 6-minute walk
distance (22 meters, p=NS). Novartis then sponsored a Phase 3 trial
(IMPRES) which met its primary endpoint of significant increase in
6-minute walk (32 meters, p=0.002), an effect maintained in the
extension study in patients remaining on imatinib. However, the
data were confounded by a high rate of dropouts in the patients
randomized to imatinib attributed largely to gastric intolerance
during the first eight weeks. The sponsor proposed consideration of
a surrogate endpoint under the subpart H provision as a basis for
approval but was denied. Consequently, Novartis chose to withdraw
the Investigational New Drug application as the drug went off
patent.
Current
Imatinib Development for Pulmonary Arterial Hypertension
Patients
On
May 30, 2019, PHPM met with the FDA to discuss a proposal for a
Phase 3 trial of imatinib for PAH. At that meeting, PHPM received
agreement for a single Phase 3 trial using change in 6-minute walk
distance as the primary endpoint (p<0.05). PHPM also received
agreement for submission under the 505(b)(2) regulatory pathway,
and thereafter received orphan designation. In August of 2019, PHPM
was given preliminary advice on its plans to submit an application
for Breakthrough Therapy Designation. In July 2020, PHPM received
agreement from the FDA for the development of a modified release
formulation that would require only a small comparative
PK/bioavailability study in 12 volunteers receiving a single dose
of the modified release formulation to be compared to a single dose
of the existing immediate release formulation. A Phase 3 study is
planned with the modified release formulation of
imatinib.
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4
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Intellectual Property
We
rely on a combination of patent applications, patents, trade
secrets, proprietary know-how, trademarks, and contractual
provisions to protect our proprietary rights. We believe that to
have a competitive advantage, we must develop and maintain the
proprietary aspects of our technologies. Currently, we require our
officers, employees, consultants, contractors, manufacturers,
outside scientific collaborators and sponsored researchers, and
other advisors to execute confidentiality agreements in connection
with their employment, consulting, or advisory relationships with
us, where appropriate. We also require our employees, consultants,
and advisors who we expect to work on our products to agree to
disclose and assign to us all inventions conceived during the
workday, developed using our property, or which relate to our
business.
To
date, we own or in-license the rights to one U.S. and three foreign
patents. In addition, we have three U.S. patent application pending
related to a product candidate and proprietary process, method and
technology. Our issued and in-licensed patents, as well as our
pending patents, expire between 2023 and 2039.
We
have:
●
one
U.S. patent (8,404,752), one Australian Patent (209,271,530) and
one European patent (EPO9798325.8) held jointly with Virginia
Commonwealth University Intellectual Property Foundation for the
treatment of traumatic brain injury;
●
one
Israeli patent (215516) and numerous patent applications, including
one U.S. patent application, for the formulation of perfluorocarbon
emulsion with an average remaining life of approximately 13 years;
and
Our
patent and patent applications include claims covering all various
uses of levosimendan, our lead product candidate currently under
development, as well as the manufacturing and use of our
perfluorocarbon emulsion formulation. We have filed a patent
application for a subcutaneous formulation of levosimendan that we
have developed in collaboration with a formulation development
partner. In addition, we have filed a provisional patent
application for the use of levosimendan in the treatment of
PH-HFpEF patients based on several discoveries that have emerged
from the HELP Study. The HELP Study is the first and only trial to
evaluate the use of levosimendan to treat PH-HFpEF patients, a
patient population where all previously tested therapies have
failed to show effectiveness. In addition to levosimendan, we have
recently acquired three patent applications for pharmaceutical
compositions for the treatment of pulmonary hypertension with the
use of imatinib
The
U.S. trademark registration for Simdax® is owned by Orion
and is licensed to us for sales and marketing purposes for any
pharmaceutical products containing levosimendan that are
commercialized in the United States and Canada.
Recent Developments
On July
6, 2021, Tenax Therapeutics, Inc. (the “Company”)
entered into a securities purchase agreement (the “Purchase
Agreement”) with Armistice Capital Master Fund, Ltd. (the
“Investor”) pursuant to which the Company agreed to
sell and issue to the Investor 4,773,269 units
(“Units”) in a private placement at a purchase price of
$2.095 per Unit. Each Unit consisted of one unregistered pre-funded
warrant to purchase one share of common stock, par value $0.0001
(collectively the “Unregistered Pre-Funded Warrants”)
and one unregistered warrant to purchase one share of common stock
(collectively the “Unregistered Warrants” and together
with the Unregistered Pre-Funded Warrants, the
“Warrants”). In the aggregate, 9,546,538 shares of the
Company’s common stock are underlying the Warrants. The
aggregate gross proceeds to the Company of the Offering were
approximately $10 million.
Each
Unregistered Pre-Funded Warrant has an exercise price of $0.0001
per share of common stock, is immediately exercisable, may be
exercised at any time until exercised in full and is subject to
customary adjustments. Each Unregistered Warrant has an exercise
price of $1.97 per share of common stock, is immediately
exercisable, will expire five and one-half years from the date of
issuance and is subject to customary adjustments. The Warrants may
not be exercised if the aggregate number of shares of the
Company’s common stock beneficially owned by the holder
(together with its affiliates) would exceed 9.99% of the
Company’s outstanding common stock immediately after
exercise. However, the holder may increase (upon 61 days’
prior notice from the holder to the Company) or decrease such
percentage, provided that in no event such percentage exceeds
9.99%.
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The
Company intends to use the net proceeds from the Offering to
further its clinical trials of levosimendan and imatinib for
research and development and for general corporate purposes,
including working capital and potential acquisitions.
Also on
July 6, 2021 and in connection with the private placement, the
Company entered into a registration rights agreement (the
“Registration Rights Agreement”) with the Investor,
pursuant to which the Company agreed to register for resale the
shares of the Company’s common stock issuable upon exercise
of the Warrants within 120 days following the date of the
Registration Rights Agreement.
Under
certain circumstances, including, but not limited to, (i) if the
registration statement is not filed by the earlier of 45 days after
the date of the Registration Rights Agreement or 10 days after the
Company files its next Form 10-Q (ii) if the registration statement
has not been declared effective (A) by the 120th day after the date
of the Registration Rights Agreement (or, in the event of a
“full review” by the Securities and Exchange Commission
(the “SEC”), the 150th day after the date of the
Registration Rights Agreement) or (B) within five trading days
following the date the Company is notified by the SEC that the
registration statement will not be reviewed or is no longer subject
to further review and comments then the Company has agreed to pay
the Investor, as partial liquidated damages, an amount equal to
1.0% of the Investor’s aggregate subscription amount paid
pursuant to the Purchase Agreement.
H.C.
Wainwright & Co., LLC (“HCW”) was entitled to fees
related to the Offering under a tail provision in an engagement
letter with the Company that relates to HCW’s assistance as a
Placement Agent in a prior offering in July 2020 between the
Investor and the Company (the “Tail Provision”).
Pursuant to the Tail Provision, the Company paid to HCW a cash fee
equal to 7.5% of the gross proceeds received by the Company in the
Offering, totaling approximately $750,000. In addition, the Company
has agreed to issue to HCW or its designees warrants to purchase up
to 357,995 shares of common stock (representing 7.5% of the
aggregate number of shares of common stock equivalents sold in the
Offering) (the “HCW Warrants”). The HCW Warrants have
substantially the same terms as the Unregistered, except that the
HCW Warrants have an exercise price equal to $2.46, or 125% of the
offering price per share of common stock, and will be exercisable
for five years from the effective date of the
Offering.
The
issuance and sale of the Units, the Warrants, the HCW Warrants and
the shares of common stock issuable upon exercise of the Warrants
and the HCW Warrants were not registered under the Securities Act
of 1933, as amended, were not offered pursuant to the registration
statement and were offered pursuant to the exemption provided in
Section 4(a)(2) under the Securities Act and Rule 506(b)
promulgated thereunder.
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6
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The
Offering
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Common Stock Offered by Selling
Stockholders:
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9,546,538
shares
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Use of Proceeds:
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Tenax
Therapeutics will not receive any proceeds from the sale of our
shares of common stock by the selling stockholders, although we
will receive proceeds from the exercise price of any warrants
exercised on a cash basis. We intend to use those proceeds, if any,
for working capital and general corporate purposes.
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Risk
Factors:
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Investing
in our common stock involves a high degree of risk. See “Risk
Factors” and other information contained in this prospectus
or otherwise incorporated by reference before deciding to invest in
shares of our common stock.
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Nasdaq
Capital Market Symbol:
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Our
common stock is listed on the Nasdaq Capital Market under the
symbol “TENX.”
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7
An
investment in any securities offered pursuant to this prospectus
and any applicable prospectus supplement is speculative and
involves a high degree of risk. You should carefully consider the
risk factors incorporated by reference from our most recent
Annual Report on Form
10-K, our most recent
Quarterly Report on Form
10-Q, and all other information contained or
incorporated by reference into this prospectus, as updated by our
subsequent filings under the Exchange Act, and the risk factors and
other information contained in any applicable prospectus
supplement, before acquiring any of such securities. If any of the
risks actually occur, our business, results of operations,
financial condition, and prospects could be materially adversely
affected, the trading price of our common stock could decline
significantly, and you might lose all or part of your investment.
You should also refer to our financial statements and the notes to
those statements, which are incorporated by reference into this
prospectus.
8
We will
not receive any proceeds from the sale of common stock by the
selling stockholders. To the extent we receive proceeds from the
exercise of warrants held by the selling stockholders, we will use
those proceeds for working capital and other general corporate
purposes.
The
selling stockholders will pay any underwriting discounts and
commissions and expenses they incur for brokerage, accounting, tax,
or legal services, or any other expenses they incur in disposing of
their shares. We will incur certain expenses in connection with the
registration with the SEC of the shares of our common stock to be
sold by the selling stockholders.
This
prospectus covers the resale from time to time by the selling
stockholders identified in the table below of up to 9,546,538
shares of common stock issuable upon exercise of the Unregistered
Pre-Funded Warrants and Unregistered Warrants sold in the private
placement described under “Summary—Recent
Developments” above.
Except as described in this “Selling Stockholders”
section and under “Summary—Recent Developments,”
the selling stockholders have not had any material relationship
with us within the past three years. The names of any additional
selling stockholders and information about their holdings and any
offering of the shares by them will be set forth in one or more
prospectus supplements.
The
table below lists the selling stockholders and other information
regarding the beneficial ownership of the shares of common stock by
each of the selling stockholders. The second column lists the
number of shares of common stock beneficially owned by each selling
stockholder, based on its ownership of the shares of common stock
and warrants, as of August 16, 2021, assuming exercise of the
warrants held by the selling stockholders on that date, without
regard to any limitations on exercises.
The
third column lists the shares of common stock being offered by this
prospectus by the selling stockholders. This prospectus generally
covers the resale of the maximum number of shares of common stock
issuable upon exercise of the related warrants, determined as if
the outstanding warrants were exercised in full as of the trading
day immediately preceding the date this registration statement was
initially filed with the SEC, each as of the trading day
immediately preceding the applicable date of determination and all
subject to adjustment, without regard to any limitations on the
exercise of the warrants. The fourth column assumes the sale
of all of the shares offered by the selling stockholders pursuant
to this prospectus.
Under
the terms of the warrants, a selling stockholder may not exercise
the warrants to the extent such exercise would cause such selling
stockholder, together with its affiliates and attribution parties,
to beneficially own a number of shares of common stock which would
exceed 9.99% of our then outstanding common stock following such
exercise, excluding for purposes of such determination shares of
common stock issuable upon exercise of the warrants which have not
been exercised. The number of shares in the second column does not
reflect this limitation. The selling stockholders may sell all,
some or none of their shares in this offering. See “Plan of
Distribution.”
9
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Name of Selling
Security Holder
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Number of Shares of
Common Stock Owned Prior to Offering
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Maximum Number of
Shares of Common Stock to be Sold Pursuant to this
Prospectus
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Number of Shares of
Common Stock Owned After Offering
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Percentage of
Common Stock Owned After Offering (1)
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Armistice Capital
Master Fund, Ltd. (2)
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29,043,005
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9,546,538
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19,496,467
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77%
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(1)
As of August 16,
2021, there were 25,201,312 shares of our common stock
outstanding.
(2)
Steven J. Boyd is
the chief investment officer and Keith
Maher, MD is the managing director of Armistice Capital, LLC, which
is the investment manager of Armistice Capital Master Fund, Ltd.
Mr. Boyd and Dr. Maher are members of our Board of Directors. Each
of Armistice Capital, LLC, Mr. Boyd and Dr. Maher disclaims
beneficial ownership of the listed securities except to the extent
of their pecuniary interest therein.
10
Each
selling stockholder of the securities and any of their pledgees,
assignees and successors-in-interest may, from time to time, sell
any or all of their securities covered hereby on the principal The
Nasdaq Stock Market LLC or any other stock exchange, market or
trading facility on which the securities are traded or in private
transactions. These sales may be at fixed or negotiated prices. A
selling stockholder may use any one or more of the following
methods when selling securities:
●
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
●
block
trades in which the broker-dealer will attempt to sell the
securities as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
●
purchases
by a broker-dealer as principal and resale by the broker-dealer for
its account;
●
an
exchange distribution in accordance with the rules of the
applicable exchange;
●
privately
negotiated transactions;
●
settlement
of short sales;
●
in
transactions through broker-dealers that agree with the selling
stockholders to sell a specified number of such securities at a
stipulated price per security;
●
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
●
a
combination of any such methods of sale; or
●
any
other method permitted pursuant to applicable law.
The
selling stockholders may also sell securities under Rule 144 or any
other exemption from registration under the Securities Act, if
available, rather than under this prospectus.
Broker-dealers
engaged by the selling stockholders may arrange for other
brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the selling stockholders (or, if any
broker-dealer acts as agent for the purchaser of securities, from
the purchaser) in amounts to be negotiated, but, except as set
forth in a supplement to this prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in
compliance with FINRA Rule 2121; and in the case of a principal
transaction a markup or markdown in compliance with FINRA Rule
2121.
In
connection with the sale of the securities or interests therein,
the selling stockholders may enter into hedging transactions with
broker-dealers or other financial institutions, which may in turn
engage in short sales of the securities in the course of hedging
the positions they assume. The selling stockholders may also sell
securities short and deliver these securities to close out their
short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The selling stockholders
may also enter into option or other transactions with
broker-dealers or other financial institutions or create one or
more derivative securities which require the delivery to such
broker-dealer or other financial institution of securities offered
by this prospectus, which securities such broker-dealer or other
financial institution may resell pursuant to this prospectus (as
supplemented or amended to reflect such transaction).
The
selling stockholders and any broker-dealers or agents that are
involved in selling the securities may be deemed to be
“underwriters” within the meaning of the Securities Act
in connection with such sales. In such event, any commissions
received by such broker-dealers or agents and any profit on the
resale of the securities purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
Each selling stockholder has informed us that it does not have any
written or oral agreement or understanding, directly or indirectly,
with any person to distribute the securities.
We
are required to pay certain fees and expenses incurred by us
incident to the registration of the securities. We have agreed to
indemnify the selling stockholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities
Act.
We
agreed to keep this prospectus effective until the earlier of (i)
the date on which the securities may be resold by the selling
stockholders without registration and without regard to any volume
or manner-of-sale limitations by reason of Rule 144, without the
requirement for the Company to be in compliance with the current
public information requirement under Rule 144 under the Securities
Act or any other rule of similar effect or (ii) all of the
securities have been sold pursuant to this prospectus or Rule 144
under the Securities Act or any other rule of similar effect. The
resale securities will be sold only through registered or licensed
brokers or dealers if required under applicable state securities
laws. In addition, in certain states, the resale securities covered
hereby may not be sold unless they have been registered or
qualified for sale in the applicable state or an exemption from the
registration or qualification requirement is available and is
complied with.
Under
applicable rules and regulations under the Exchange Act, any person
engaged in the distribution of the resale securities may not
simultaneously engage in market making activities with respect to
the common stock for the applicable restricted period, as defined
in Regulation M, prior to the commencement of the distribution. In
addition, the selling stockholders will be subject to applicable
provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of
purchases and sales of the common stock by the selling stockholders
or any other person. We will make copies of this prospectus
available to the selling stockholders and have informed them of the
need to deliver a copy of this prospectus to each purchaser at or
prior to the time of the sale (including by compliance with Rule
172 under the Securities Act).
11
The
validity of our securities issuable hereunder and certain other
legal matters have been passed upon for us by K&L Gates LLP,
Raleigh, North Carolina.
The
consolidated financial statements of Tenax Therapeutics, Inc. as of
December 31, 2020 and 2019, and for each of the years in the
two-year period ended December 31, 2020, included in our Annual
Report on Form 10-K, have been incorporated by reference herein in
reliance upon the report of Cherry Bekaert LLP, independent
registered public accounting firm, incorporated by reference
herein, and upon the authority of said firm as experts in
accounting in auditing.
We file
annual reports, quarterly reports, current reports, and proxy and
information statements and other information with the SEC. Copies
of reports and other information from us are available on the
SEC’s website at http://www.sec.gov. Such filings are also
available at our website at http://www.tenaxthera.com. Our website
and the information contained therein or connected thereto are not
part of this prospectus.
The SEC
allows us to “incorporate by reference” in this
prospectus the information we file with the SEC, which means that
we can disclose important information to you by referring you to
those documents. The following documents filed with the SEC are
hereby incorporated by reference in this prospectus:
●
Our Annual Report
on Form 10-K for the year ended December 31, 2020, filed with the
SEC on
March 31,
2021, as amended by the Form 10-K/A subsequently filed
with the SEC on
April 16,
2021;
●
The information
specifically incorporated by reference into our Annual Report
on Form 10-K from our
Definitive Proxy Statement on Schedule 14A, filed
with the SEC on
April 30,
2021;
●
Our Quarterly
Reports on Form 10-Q for the quarterly period ended March 31, 2021,
filed with the SEC on
May 17, 2021,
and for the quarterly period ended June 30, 2021, filed with the
SEC on
August 16,
2021;
●
Our Current Reports
on Form 8-K filed with the SEC on
January 19,
2021 (as amended by Form 8-K/A filed with the SEC on
March 30,
2021),
March 2, 2021,
April 7, 2021,
June 1, 2021,
June 11, 2021,
and
July 8, 2021;
and
●
The description of
our common stock contained in
Exhibit 4.2 to our Annual Report on Form 10-K for the year
ended December 31, 2020, filed with the SEC on March 31, 2021,
including any amendments or reports filed for the purpose of
updating such description..
In
addition, all documents we subsequently filed pursuant to Sections
13(a), 13(c), 14, and 15(d) of the Exchange Act, including prior to
the filing of a post-effective amendment which indicates that all
securities offered have been sold or which deregisters all
securities then remaining unsold and also between the date of the
registration statement that contains this prospectus and prior to
effectiveness of such registration statement, shall be deemed to be
incorporated by reference in this prospectus and to be a part
hereof from the date of filing of such documents.
However, any documents or portions thereof, whether specifically
listed above or filed in the future, that are not deemed
“filed” with the SEC, including without limitation any
information furnished pursuant to Item 2.02 or 7.01 of Form 8-K or
certain exhibits furnished pursuant to Item 9.01 of Form 8-K, shall
not be deemed to be incorporated by reference in this
prospectus.
Any
statement contained herein or in a document incorporated or deemed
to be incorporated by reference herein shall be deemed to be
modified or superseded for purposes of this prospectus to the
extent that a statement contained herein or in any other
subsequently filed document which also is incorporated or deemed to
be incorporated by reference herein modifies or supersedes such
statement. Any statement so modified or superseded shall
not be deemed, except as so modified or superseded, to constitute a
part of this prospectus.
We will
furnish without charge to you, upon written or oral request, a copy
of any or all of the documents incorporated by reference herein,
other than exhibits to such documents that are not specifically
incorporated by reference therein. All requests should be sent to
the attention of Nancy Hecox, Vice President of Legal Affairs and
General Counsel, Tenax Therapeutics, Inc., ONE Copley Parkway,
Suite 490, Morrisville, North Carolina 27560 or made via telephone
at (919) 855-2100.
Copies
of the documents incorporated by reference may also be found on our
website at http://www.tenaxthera.com.
12
9,546,538 Shares of Common Stock
________________________________
PROSPECTUS
________________________________
Part
II
Information Not Required in the Prospectus
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Item 14.
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Other Expenses of Issuance and Distribution
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The
following table sets forth an itemization of the various expenses,
all of which we will pay, in connection with the issuance and
distribution of the securities being registered. The selling
stockholders will not be responsible for any of the expenses of
this offering. All of the amounts shown are estimated except the
SEC registration fee.
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SEC
registration fee
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$1,552
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Legal fees and
expenses
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25,000
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Accounting fees and
expenses
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5,000
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Miscellaneous
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2,500
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Total
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$34,052
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Item 15.
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Indemnification of Directors and Officers
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Section
145 of the Delaware General Corporation Law provides that a
corporation has the power to indemnify a director, officer,
employee, or agent of the corporation and certain other persons
serving at the request of the corporation in related capacities
against amounts paid and expenses incurred in connection with an
action or proceeding to which he or she is or is threatened to be
made a party by reason of such position, if such person acted in
good faith and in a manner he or she reasonably believed to be in
or not opposed to the best interests of the corporation, and, in
any criminal proceeding, if such person had no reasonable cause to
believe his or her conduct was unlawful. In the case of actions
brought by or in the right of the corporation, no indemnification
shall be made with respect to any matter as to which such person
has been adjudged to be liable to the corporation unless and only
to the extent that the adjudicating court determines that such
indemnification is proper under the circumstances.
Our
Certificate of Incorporation and Bylaws provide that our directors
and officers will be indemnified by us to the fullest extent
authorized by the Delaware General Corporation Law. In addition,
the Certificate of Incorporation provides, as permitted by Section
102(b)(7) of the Delaware General Corporation Law, that our
directors will not be liable for monetary damages to us for
breaches of their fiduciary duty as directors, unless they (i)
violated their duty of loyalty to us or our stockholders, (ii)
acted, or failed to act, in good faith, (iii) acted with
intentional misconduct, (iv) knowingly or intentionally violated
the law, (v) authorized unlawful payments of dividends, unlawful
stock purchases or unlawful redemptions, or (vi) derived an
improper personal benefit from their actions as
directors.
Our
Bylaws also permit us to secure insurance on behalf of any officer,
director, employee, or agent for any liability arising out of his
or her actions, regardless of whether Delaware General Corporation
Law would permit indemnification. We have purchased a policy of
directors’ and officers’ liability insurance that
insures our directors and officers.
In
addition, we have also entered into an indemnification agreement
with certain of our directors and officers. The indemnification
agreements require us to indemnify and hold harmless and advance
expenses to each indemnitee in respect of acts or omissions
occurring prior to the time the indemnitee ceases to be an officer
and/or director of the Company to the fullest extent permitted by
applicable law. The rights provided in the indemnification
agreements are in addition to the rights provided in our
Certificate of Incorporation, Bylaws, and the Delaware General
Corporation Law.
II-1
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Item 16.
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Exhibits
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The
following exhibits have been or are being filed herewith and are
numbered in accordance with Item 601 of Regulation
S-K:
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Exhibit No.
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Description
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Agreement
and Plan of Merger between Synthetic Blood International, Inc. and
Oxygen Biotherapeutics, Inc. dated April 28, 2008 (incorporated
herein by reference to Exhibit 2.01 to the registrant’s
Current Report on Form 8-K filed with the Commission on
June 30, 2008)
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Asset
Purchase Agreement by and between Oxygen Biotherapeutics, Inc.,
Life Newco, Inc., Phyxius Pharma, Inc., and the stockholders of
Phyxius Pharma, Inc. dated October 21, 2013 (incorporated herein by
reference to Exhibit 2.1 to the registrant’s Current Report
on Form 8-K filed with the Commission on October 25,
2013)
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Agreement
and Plan of Merger among PHPrecisionMed Inc., Tenax Therapeutics,
Inc., Life Newco II, Inc., and Dr. Stuart Rich dated January 15,
2021 (incorporated herein by reference to Exhibit 2.1 to the
registrant’s Current Report on Form 8-K filed with the
Commission on January 19, 2021)
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Certificate
of Incorporation (incorporated herein by reference to Exhibit 3.1
to the registrant’s Current Report on Form 8-K filed with the
Commission on June 30, 2008)
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Certificate
of Amendment of the Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to
the registrant’s Current Report on Form 8-K filed with the
Commission on November 13, 2009)
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Certificate
of Amendment of the Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to
the registrant’s Current Report on Form 8-K filed with the
Commission on May 15, 2013)
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Certificate
of Amendment of the Certificate of Incorporation (incorporated herein by reference to Exhibit 3.4 to
the registrant’s Quarterly Report on Form 10-Q filed with the
Commission on December 15, 2014)
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Certificate
of Amendment of the Certificate of Incorporation (incorporated herein by reference to Exhibit 3.5 to
the registrant’s Current Report on Form 8-K filed with the
Commission on February 23, 2018)
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Certificate
of Designation of Series A Convertible Preferred Stock
(incorporated herein by reference to Exhibit 4.1 to the
registrant’s Current Report on Form 8-K filed with the
Commission on December 11, 2018)
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Third
Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to
the registrant’s Quarterly Report on Form 10-Q filed with the
Commission on September 9, 2015)
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Specimen
Stock Certificate (incorporated herein by reference to Exhibit 4.1
to the registrant’s Annual Report on Form 10-K filed with the
Commission on July 23, 2010)
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Form of
Unregistered Pre-Funded Warrant (incorporated herein by reference
to Exhibit 4.1 to the registrant’s Current Report on Form 8-K
filed with the Commission on July 8, 2021)
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Form of
Unregistered Warrant (incorporated herein by reference to Exhibit
4.2 to the registrant’s Current Report on Form 8-K filed with
the Commission on July 8, 2021)
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Form of
HCW Warrant (incorporated herein by reference to Exhibit 4.3 to the
registrant’s Current Report on Form 8-K filed with the
Commission on July 8, 2021)
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Opinion
of K&L Gates LLP *
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Securities
Purchase Agreement for Units, dated as of July 6, 2021, by and
between the Company and the Investor (incorporated herein by
reference to Exhibit 10.1 to the registrant’s Current Report
on Form 8-K filed with the Commission on July 8, 2021)
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Registration
Rights Agreement, dated as of July 6, 2021, by and between the
registrant and the Investor (incorporated herein by reference to
Exhibit 10.2 to the registrant’s Current Report on Form 8-K
filed with the Commission on July 8, 2021)
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Consent
of Cherry Bekaert LLP *
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Consent
of K&L Gates LLP (contained in Exhibit 5.1) *
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Power
of Attorney (contained on signature page) *
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*Filed
herewith
II-2
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Item 17.
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Undertakings
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(a)
The
undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration
statement:
(i)
to include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii)
to reflect in the prospectus any facts or events arising after the
effective date of this registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of a prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no
more than a 20% change in the maximum aggregate offering price set
forth in the “Calculation of Registration Fee” table in
the effective registration statement; and
(iii)
to include any material information with respect to the plan of
distribution not previously disclosed in this registration
statement or any material change to such information in the
registration statement;
provided, however, that paragraphs (1)(i), (1)(ii), and (1)(iii) do
not apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in
reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934 that are incorporated by reference in the registration
statement or is contained in a form of prospectus filed pursuant to
Rule 424(b) that is part of the registration
statement.
(2)
That, for the purpose of determining any liability under the
Securities Act, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering
thereof.
(3)
To remove from registration, by means of a post-effective
amendment, any of the securities being registered which remain
unsold at the termination of the offering.
(4) That, for the purpose of determining liability
under the Securities Act of 1933 to any purchaser, each prospectus
filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying
on Rule 430B or other than prospectuses filed in reliance on Rule
430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after
effectiveness. Provided,
however, that no statement
made in a registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of
first use.
(b)
The
undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each
filing of the registrant’s annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 that
is incorporated by reference in this registration statement shall
be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
(c)
Insofar
as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling
persons of the registrants, pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is, therefore,
unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
II-3
SIGNATURES
Pursuant to the
requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused
this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the Town of Morrisville, State of North
Carolina, on August 20, 2021.
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TENAX THERAPEUTICS, INC.
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By:
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/s/
Michael B. Jebsen
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Michael B. Jebsen
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President and Chief Financial Officer
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POWER OF ATTORNEY
KNOW
ALL MEN BY THESE PRESENTS that each individual whose signature
appears below constitutes and appoints Michael B. Jebsen his true
and lawful attorney-in-fact and agent with full power of
substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign any and all amendments
(including post-effective amendments) to this Registration
Statement, and to file the same, with all exhibits thereto, and all
documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorney-in-fact and agent full
power and authority to do and perform each and every act and thing
requisite and necessary to be done in and about the premises, as
fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said
attorney-in-fact and agent, or his substitute, may lawfully do or
cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, as amended, this Registration Statement has been
signed by the following persons in the capacities and on the dates
indicated.
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Signature
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Title
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Date
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/s/
Christopher T. Giordano
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Chief Executive Officer and Director
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August 20, 2021
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Christopher T. Giordano
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(Principal Executive Officer)
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/s/
Michael B. Jebsen
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President and Chief Financial Officer
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August 20, 2021
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Michael B. Jebsen
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(Principal Financial and Accounting Officer)
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/s/
Stuart Rich
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Chief Medical Officer and Director
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August 20, 2021
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Stuart Rich
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/s/
Michael Davidson
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Director
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August 20, 2021
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Michael Davidson
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/s/
Steven Boyd
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Director
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August 20, 2021
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Steven Boyd
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/s/
James Mitchum
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Director
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August 20, 2021
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James Mitchum
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/s/
June Almenoff
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Director
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August 20, 2021
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June Almenoff
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/s/ Gerald Proehl
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Director
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August 20, 2021
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Gerald Proehl
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/s/ Declan Doogan
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Director
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August 20, 2021
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Declan Doogan
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/s/ Keith Maher
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Director
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August 20, 2021
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Keith Maher
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EEE
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Exhibit 5.1
August
20, 2021
ONE
Copley Parkway
Suite
490
Morrisville,
North Carolina 27560
Ladies
and Gentlemen:
We have
acted as counsel to Tenax Therapeutics, Inc., a Delaware
corporation (the “Company”), in connection with the Registration
Statement on Form S-3 (the “Registration Statement”)
filed on the date hereof with the Securities and Exchange
Commission (the “SEC”) under the Securities Act of
1933, as amended (the “Securities Act”), with respect
to the resale from time to time by the selling stockholder listed
in the Registration Statement under the heading “Selling
Stockholders” (the “Selling Stockholder”), as
detailed in the Registration Statement, of 9,546,538 shares of
common stock, $0.0001 par value per share (the
“Shares”), issuable upon exercise of warrants (the
“Warrants”) issued in the Company’s July 2021
private placement pursuant to that certain Securities Purchase
Agreement for Units, dated July 6, 2021 (the “Purchase
Agreement”).
You
have requested our opinion as to the matters set forth below in
connection with the Registration Statement. For purposes of
rendering that opinion, we have examined: (a) the Registration
Statement; (b) the Company’s Certificate of Incorporation, as
amended through the date hereof; (c) the Company’s Third
Amended and Restated Bylaws; (d) the Purchase Agreement; (e) the
Warrants; (f) corporate actions of the Company’s Board of
Directors that provide for the authorization of the Purchase
Agreement and the Rights Agreement and the issuance of the
Warrants, including the issuance of the Shares upon exercise of the
Warrants; and (g) a certificate of an officer of the Company, dated
as of the date hereof. Other than our review of the documents
listed in (a) through (g) above, we have not reviewed any other
documents or made any independent investigation for the purpose of
rendering this opinion.
For the
purposes of this opinion letter, we have assumed that: (a) each
document submitted to us is accurate and complete; (b) each such
document that is an original is authentic; (c) each such document
that is a copy conforms to an authentic original; (d) all
signatures on each such document are genuine; and (e) the Company
is and shall remain at all times a corporation duly incorporated,
validly existing and in good standing under the laws of the State
of Delaware. In rendering our opinion below, we have also assumed
that: (i) on the date of exercise of each of the Warrants, the
Company will have sufficient authorized and unissued shares of its
common stock issuable upon the exercise of such Warrant to provide
for the issuance of the shares of common stock issuable thereunder;
(ii) the corporate actions of the Company referenced in clause (f)
of the previous paragraph will be in full force and effect, and
will not have been, revoked, modified or amended; and (iii) the
issuance of the Shares will be noted in the Company’s stock
ledger. We have further assumed the legal capacity of natural
persons, and we have assumed that each party to the documents we
have examined or relied on has the legal capacity or authority and
that each such document constitutes a legal, valid, and binding
obligation of the parties thereto, enforceable against each such
party in accordance with its terms. We have not verified any of
those assumptions.
Our
opinion set forth below is limited to the Delaware General
Corporation Law (“DGCL”) and reported decisions
interpreting the DGCL.
Based
upon and subject to the foregoing, it is our opinion that the
issuance of the Shares has been duly authorized by the Company and,
when issued and delivered by the Company against payment therefor
upon the exercise of the Warrants in accordance with the terms
thereof, the Shares will be validly issued, fully paid, and
non-assessable.
This
opinion is rendered solely in connection with the registration of
the Shares for resale by the Selling Stockholders under the
Registration Statement. This opinion is expressed as of the date
hereof, and we disclaim any undertaking to advise you of any
subsequent changes in the facts stated or assumed herein or of any
subsequent changes in applicable laws.
We
hereby consent to the filing of this opinion letter with the SEC as
Exhibit 5.1 to the Registration Statement. In giving our consent,
we do not thereby admit that we are in the category of persons
whose consent is required under Section 7 of the Securities Act or
the rules and regulations thereunder.
Very
truly yours,
/s/ K&L Gates
LLP
K&L
Gates LLP
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Exhibit 23.1
Consent of Independent Registered Public Accounting
Firm
We
hereby consent to the incorporation by reference in the
Registration Statement on Form S-3 of our report dated March 31,
2021, relating to the consolidated financial statements of Tenax
Therapeutics, Inc. (the “Company”), appearing in
the Annual Report on Form 10-K of the Company as of and for the
years ended December 31, 2020 and 2019. Our report contains an
explanatory paragraph regarding the Company’s ability to
continue as a going concern. We also consent to the reference of
our firm under the heading “Experts” in the
prospectus.
/s/ Cherry Bekaert LLP
Raleigh,
North Carolina
August
20, 2021