Tenax Therapeutics Reports Second Quarter 2020 Results and Provides Business Update
August 17 2020 - 08:00AM
Business Wire
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products for the critical care market, today
reported financial results for the second quarter 2020 and provided
a business update.
“The recently completed Phase 2 trial of patients with pulmonary
hypertension and heart failure with preserved ejection fraction
(PH-HFpEF) has garnered significant attention from the medical
community. Specifically members of our Scientific Advisory Board
are very encouraged by the statistically significant biventricular
hemodynamic response and statistically significant clinical effect
on the 6 minute walk parameter.” stated Anthony DiTonno, Chief
Executive Officer of Tenax. “We believe these Phase 2 data support
advancing into pivotal trials and ultimately pursuing a potential
registration. As such, we intend to seek regulatory feedback on
next steps for this program during the fourth quarter. Moreover, we
plan to provide additional data from this trial at medical meetings
later this year.”
Recent Highlights
- In June 2020, Tenax reported positive data from its recently
completed Phase 2 HELP trial of levosimendan in patients with
PH-HFpEF. In this 37 patient study, the primary efficacy analysis,
pulmonary capillary wedge pressure (PCWP) during exercise did not
demonstrate a statistically significant reduction from baseline.
Levosimendan did demonstrate a statistically significant reduction
in PCWP compared to baseline (p=<0.0017) and placebo
(p=<0.0475), when the measurements at rest, with legs up and on
exercise were combined. The clinical efficacy of levosimendan was
confirmed in this trial by a statistically significant improvement
in 6-minute walk distance (6MWD) as compared to placebo
(p=0.0329).
- In June 2020, Tenax received approximately $1.7 million and
issued 877,203 shares of common stock upon the exercise of
previously outstanding warrants.
- On July 6, 2020, the Company entered into a Securities Purchase
Agreement for Class C and Class D Units (the “RDO Purchase
Agreement”) and a Securities Purchase Agreement for Class E and
Class F Units (the “PIPE Purchase Agreement” and, together with the
RDO Purchase Agreement, the “Purchase Agreements”) with the
Investor, pursuant to which the Company agreed to issue in a
registered direct offering 2,523,611 shares of the company’s common
stock, $0.0001 par value per share, at a purchase price of $1.02780
per share and pre-funded warrants (the “Registered Pre-Funded
Warrants”) to purchase up to 652,313 shares of common stock at a
purchase price of $1.02770 per Registered Pre-Funded Warrant, and
issuing a concurrent private placement unregistered pre-funded
warrants (the “Unregistered Pre-Funded Warrants”) to purchase up to
4,607,692 shares of common stock at the same purchase price as the
Registered Pre-Funded Warrants, and unregistered common stock
warrants (the “Unregistered Warrants”) to purchase up to 7,783,616
shares of common stock (such registered direct offering and private
placement, collectively, the “Offerings”). The aggregate net
proceeds to the Company of the Offerings was approximately $6.5
million.
- On July 20, 2020, pursuant to the terms of the PIPE Purchase
Agreement, Tenax appointed Steven J. Boyd and Keith Maher, MD to
its Board of Directors.
Financial Results
- Research and development expenses for the second quarter of
2020 were $1.3 million, compared to $650,000 for the second quarter
of 2019.
- General and administrative expenses for the second quarter of
2020 were $870,000, compared to $1.2 million for the second quarter
of 2019.
- Net loss for the second quarter of 2020 was $2.1 million, or
$0.23 per share, compared to a net loss of $1.8 million, or $0.28
per share, for the second quarter of 2019.
- Cash, cash equivalents and marketable securities totaled $4.6
million as of June 30, 2020, compared with $5.4 million as of
December 31, 2019.
- Management expects that current cash, cash equivalents and
marketable securities, including the proceeds from the July
offerings, will be sufficient to fund current operations into the
third quarter of 2021.
About Phase 2 HELP Trial
The HELP Trial – Hemodynamic Evaluation of Levosimendan in
PH-HFpEF is a multi-center, double-blind, placebo-controlled Phase
2 clinical trial designed to evaluate levosimendan in 36 patients
with pulmonary hypertension and heart failure with preserved
ejection fraction (PH-HFpEF). The trial has a predefined response
criterion that patients must meet following a 24-hour open-label
infusion of levosimendan before they can be randomized to the
6-week double-blind phase of the trial. The criterion for
randomization is a reduction in PCWP during supine exercise of ≥
4mmHg following the open-label infusion when compared with each
patient’s baseline exercise PCWP. The primary endpoint of the HELP
Trial is based on change in PCWP vs baseline compared to
placebo.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company
focused on identifying, developing, and commercializing products
that address cardiovascular and pulmonary diseases with high unmet
medical need. The Company has a world-class scientific advisory
team including recognized global experts in pulmonary hypertension.
The Company owns North American rights to develop and commercialize
levosimendan and has recently released topline data regarding their
Phase 2 clinical trial for the use of levosimendan in the treatment
of Pulmonary Hypertension associated with Heart Failure and
preserved Ejection Fraction (PH-HFpEF). For more information, visit
www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique
triple mechanism of action. It initially was developed for
intravenous use in hospitalized patients with acutely decompensated
heart failure. It was discovered and developed by Orion Pharma,
Orion Corporation of Espoo Finland, and is currently approved in
over 60 countries for this indication and not available in the
United States. Tenax Therapeutics acquired North American rights to
develop and commercialize levosimendan from Phyxius Pharma,
Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
the Company that involve risks and uncertainties and reflect the
Company’s judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to matters beyond the
Company’s control that could lead to delays in the clinical study,
new product introductions and customer acceptance of these new
products; matters beyond the Company’s control that could impact
the Company’s continued compliance with Nasdaq listing
requirements; the impact of management changes on the Company’s
business and unanticipated charges, costs and expenditures not
currently contemplated that may occur as a result of management
changes; and other risks and uncertainties as described in the
Company’s filings with the Securities and Exchange Commission,
including in its annual report on Form 10-K filed on March 30,
2020, and its quarterly report on 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.
TENAX THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
Three months ended June 30, Six months ended June
30,
2020
2019
2020
2019
(Unaudited) (Unaudited) (Unaudited)
(Unaudited) Operating expenses General and
administrative
$
869,206
$
1,170,405
$
2,192,165
$
2,349,415
Research and development
1,274,837
649,254
2,617,363
1,132,020
Total operating expenses
2,144,043
1,819,659
4,809,528
3,481,435
Net operating loss
2,144,043
1,819,659
4,809,528
3,481,435
Interest expense
406
-
406
-
Other expense (income), net
2,101
(58,122
)
(8,740
)
(102,453
)
Net loss
$
2,146,550
$
1,761,537
$
4,801,194
$
3,378,982
Unrealized gain on marketable securities
(3,238
)
(474
)
(1,616
)
(1,763
)
Total comprehensive loss
$
2,143,312
$
1,761,063
$
4,799,578
$
3,377,219
Net loss per share, basic and diluted
$
(0.23
)
$
(0.28
)
$
(0.59
)
$
(0.60
)
Weighted average number of common shares outstanding, basic and
diluted
9,339,309
6,385,381
8,156,848
5,640,367
TENAX THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
June 30, 2020 December 31, 2019
(Unaudited) ASSETS Current assets Cash and cash
equivalents
$
4,085,305
$
4,905,993
Marketable securities
468,218
493,884
Prepaid expenses
660,906
780,952
Total current assets
5,214,429
6,180,829
Marketable securities
10,723
-
Right of use asset
115,225
169,448
Property and equipment, net
4,409
6,559
Other assets
8,435
8,435
Total assets
$
5,353,221
$
6,365,271
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities Accounts payable
$
1,555,038
$
1,661,054
Accrued liabilities
524,356
871,341
Note payable
107,606
-
Total current liabilities
2,187,000
2,532,395
Long term liabilities Note payable
137,051
-
Lease liability
-
60,379
Total long term liabilities
137,051
60,379
Total liabilities
2,324,051
2,592,774
Commitments and contingencies; see Note 7
Stockholders' equity Preferred stock, undesignated, authorized
9,999,790 shares; See Note 8 Series A Preferred stock, par value
$.0001, issued and outstanding 210 and 38,606, respectively
-
4
Common stock, par value $.0001 per share; authorized 400,000,000
shares; issued and outstanding 10,095,758 and 6,741,860,
respectively
1,010
674
Additional paid-in capital
243,995,716
239,939,797
Accumulated other comprehensive gain
2,074
458
Accumulated deficit
(240,969,630
)
(236,168,436
)
Total stockholders’ equity
3,029,170
3,772,497
Total liabilities and stockholders' equity
$
5,353,221
$
6,365,271
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Investor Contact: Westwicke, an ICR Company Stephanie
Carrington, 646-277-1282 stephanie.carrington@westwicke.com
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