- Conference Call Today at 8:30 a.m. ET -
Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products for the critical care market, today
announced financial results for the full year ended December
31, 2016 and provided a corporate update.
“While we were disappointed that the LEVO-CTS trial did not meet
its dual or quad primary endpoints, there are positive data in the
results. Levosimendan demonstrated statistically significant
reductions in clinically meaningful secondary endpoints including a
reduction in low cardiac output syndrome (LCOS) and reduction in
postoperative use of secondary inotropes. There was also a
statistically significant increase in cardiac index in the
levosimendan arm. Additionally, levosimendan was found to be safe
with no clinically significant increases in hypotension or cardiac
arrhythmias and the clinical data showed a numerical reduction in
90-day mortality,” said John Kelley, CEO of Tenax Therapeutics.
Dr. John Alexander of the Duke Clinical Research Institute
presented the results of the LEVO-CTS trial on Sunday, March 19,
2017, during a late-breaking clinical trial session at the American
College of Cardiology 66th Annual Scientific Session in Washington,
D.C. Dr. Alexander concluded “levosimendan is effective and safe as
an inotrope to increase cardiac output in patients at risk for
perioperative low cardiac output syndrome.” Slides from the
presentation can be found on the Tenax website at
www.tenaxthera.com. The trial results were also simultaneously
published in The New England Journal of Medicine.
“Based on these positive findings, we continue to evaluate
cardiac surgery and other indications that may benefit from
levosimendan,” said John Kelley, CEO of Tenax Therapeutics. “We
have initiated discussions with the U.S. Food and Drug
Administration (FDA) regarding the approval of levosimendan to
treat Acute Decompensated Heart Failure (ADHF). Levosimendan is
approved and on the market in Europe and South America for ADHF,
where it has been used to treat over one million patients. We have
a pre-NDA meeting scheduled with FDA to discuss a New Drug
Application (NDA) for this indication in the U.S. based on existing
data in ADHF, along with the positive data generated in the
secondary endpoints in the LEVO-CTS trial. We are also planning to
begin the process of filing an application for approval to Health
Canada,” continued Mr. Kelley.
While the company is working on its regulatory options for
levosimendan, it will explore additional strategic options to
broaden its product lines. To this end, the company will engage an
investment bank to assist in these efforts.
Full Year 2016 Financial Results
The Company reported a net loss of $44.0 million, or $(1.56) per
share, for the year ended December 31, 2016, compared to a net loss
of $15.9 million, or $(0.57) per share, for the prior year.
The Company reported general and administrative expenses of $6.2
million for the year ended December 31, 2016, compared to $6.7
million for the prior year.
The Company reported research and development expenses of $13.1
million for the year ended December 31, 2016, compared to $8.9
million for the prior year.
The Company reported a loss on impairment of assets of $33.3
million for the year ended December 31, 2016, compared to $1.0
million for the prior year.
As of December 31, 2016, the Company had $21.9 million in cash,
including the fair value of its marketable securities, compared to
$38.2 million at December 31, 2015.
Financial Guidance
Tenax expects that its cash balance, including the fair value of
its marketable securities, will be sufficient for it to accomplish
its corporate goals through the first half of 2018, including the
full close-out of its recently completed Phase 3 LEVO-CTS trial, as
it continues to evaluate the potential for filing a New Drug
Application for levosimendan for cardiac surgery or other
indications in 2017.
Conference Call
The Tenax management team will host a call today at 8:30 a.m. ET
to discuss fourth quarter and year-end 2016 financial results.
To participate in the call, please dial (866) 682-6100
(domestic) or (862) 255-5401 (international). A live webcast of the
call can be accessed under “Events and Presentations” in the
Investors section of the Company’s website at www.tenaxthera.com.
An archived webcast recording will be available on the Tenax
Therapeutics website beginning approximately two hours after the
call.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company
focused on identifying, developing and commercializing products for
the critical care market. The Company owns the North American
rights to develop and commercialize levosimendan, a novel, first in
class calcium sensitizer/K-ATP activator. For more information,
visit www.tenaxthera.com.
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,
delays in new product introductions and customer acceptance of
these new products, 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 16, 2017, 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 BALANCE SHEETS December 31,
December 31, 2016 2015 ASSETS Current
assets Cash and cash equivalents $ 9,995,955 $ 3,660,453 Marketable
securities 3,284,616 16,528,494 Accounts receivable 72,599 49,448
Prepaid expenses 275,005 321,958
Total current assets 13,628,175 20,560,353 Marketable securities
8,586,110 18,019,054 Property and equipment, net 19,105 35,786
Intangible assets, net - 22,000,000 Goodwill - 11,265,100 Other
assets 1,106,785 1,106,785 Total assets
$ 23,340,175 $ 72,987,078
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $
727,599 $ 972,483 Accrued liabilities 5,245,546 3,104,807 Warrant
liabilities 226,092 524,340
Total current liabilities 6,199,237 4,601,630 Deferred tax
liability - 7,962,100 Total liabilities
6,199,237 12,563,730 Stockholders' equity
Common stock, par value $.0001 per share; authorized 400,000,000
shares; issued and outstanding 28,120,021 and 28,119,694,
respectively 2,812 2,812 Additional paid-in capital 221,816,447
221,285,677 Accumulated other comprehensive gain/(loss) (18,718 )
(129,442 ) Accumulated deficit (204,659,603 )
(160,735,699 ) Total stockholders’ equity 17,140,938
60,423,348 Total liabilities and stockholders' equity
$ 23,340,175 $ 72,987,078
TENAX
THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS Year ended December 31,
2016 2015 (Unaudited) Government
grant revenue $ - $ 49,286 Operating expenses General and
administrative 6,245,958 6,671,568 Research and development
13,139,681 8,904,787 Impairment loss 33,265,100
1,034,863 Total operating expenses 52,650,739
16,611,218 Net operating loss 52,650,739 16,561,932
Interest expense - 3,851 Other (income) expense (764,735 ) (633,632
) Income tax benefit (7,962,100 ) - Net loss $
43,923,904 $ 15,932,151 Unrealized (gain) loss
on marketable securities (110,724 ) (29,332 ) Total
comprehensive loss $ 43,813,180 $ 15,902,819
Net loss per share, basic and diluted $ (1.56 ) $ (0.57 ) Weighted
average number of common shares outstanding, basic and diluted
28,119,835 28,119,538
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version on businesswire.com: http://www.businesswire.com/news/home/20170321005525/en/
Stern Investor Relations, Inc.Will O‘Connor,
212-362-1200will@sternir.com
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