[March 18, 2015] |
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Tenax Therapeutics Announces Third Quarter Fiscal Year 2015 Financial Results
Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical
company focused on developing and commercializing a portfolio of
products for the critical care market, today announced financial results
for the third quarter fiscal year 2015 ended January 31, 2015.
"We have continued to execute on our development plan for levosimendan,
with 41 patients now enrolled in our Phase 3 LEVO-CTS (News - Alert) trial in low
cardiac output syndrome and 40 hospitals activated," said John Kelley,
Chief Executive Officer of Tenax. "We anticipate continued enrollment
acceleration through the first half of this calendar year, and we will
benefit greatly from the clinical leadership of Dr. Paula Bokesch, our
new chief medical officer.
"We also highlighted 2 recent scientific publications that clearly show
the potential benefits of levosimendan in the cardiac surgery setting,
including superiority compared to other inodilatory agents, which
reinforces our confidence in a positive readout for LEVO-CTS in early
2016. We look forward to discussing this data for levosimendan at our
upcoming Analyst Day in New York on April 13, which will feature a
number of outside speakers with significant levosimendan clinical
experience.
"Finally, we remain very encouraged by the pace of enrollment in the
LeoPARDS trial for levosimendan in septic shock being conducted by
Imperial College London, which we provided supplementary funding to in
August 2014. Following our meeting with the U.S. Food and Drug
Administration (FDA) in November, we are currently evaluating the
potential statistical analysis plan for this trial with Imperial College
London."
Recent Highlights
-
Today, Tenax announced that the Company has currently enrolled 41
patients in the LEVO-CTS trial, and has 40 clinical sites activated
with an additional 8 sites where contract negotiations have been
completed. The Company also disclosed that it has discussions ongoing
with an additional 13 U.S. sites.
-
In February, Health Canada gave Tenax approval to include Canadian
hospitals in the LEVO-CTS trial. Thus far, 11 hospitals have been
identified as possible sites.
-
In February, Tenax announced the appointment of Paula Bokesch, M.D.,
as chief medical officer. Dr. Bokesch will direct clinical development
for the Company's lead asset, levosimendan, including the current
Phase 3 LEVO-CTS trial to evaluate the use of levosimendan for the
reduction of morbidity and mortality in cardiac surgery patients at
risk for developing LCOS.
-
In March, the Company highlighted two recently-published scientific
articles on the potential benefits of levosimendan in patients
undergoing cardiac surgery:
-
Toller, et al (International Journal of Cardiology)
provided a review of the scientific literature as well as
consensus recommendations from a panel of 27 experts from 18
countries regarding the preoperative use of levosimendan in
cardiac surgery patients. Their recommendations support the
LEVO-CTS study design in several ways and conclude that
levosimendan acts as a "safety net in the surgical setting" by
improving haemodynamics and "reducing the need for inotropic
agents and mechanical circulatory support."
-
Greco, et al (British Journal of Anaesthesia) detailed a
meta-analysis that assesses differences in mortality associated
with various inodilator products that are commonly used in
critical care patients. Their study included 46 trials published
between 1995-2014 and concluded that levosimendan appears to be
the most efficacious inodilator product to improve survival when
used in cardiac surgery patients.
-
In August 2014, the Company announced a collaboration with Imperial
College London to provide $500,000 in supplemental funding to support
the accelerated enrollment and completion of the ongoing LeoPARDS
trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in
Sepsis). The LeoPARDS trial is designed to determine whether
levosimendan reduces the incidence and severity of acute organ
dysfunction in adult patients who have septic shock, as well as
evaluate its safety profile. As of March 16, 2015, the trial had
enrolled 250 out of an estimated 516 patients.
Upcoming Expected Milestones and Events
-
Analyst Day on April 13, 2015, in New York City, featuring outside
speakers with significant levosimendan clinical experience and
multiple LEVO-CTS steering committee members
-
Expected event rate interim analysis following enrollment of 200
patients in LEVO-CTS trial, by summer of 2015
-
Two interim analyses during LEVO-CTS trial testing for efficacy or
futility after 50% and 70% of the planned primary endpoint events have
been recorded, in the second half of calendar year 2015
-
Enrollment completed for LEVO-CTS trial by end of calendar year 2015
-
Full data reported from Phase 3 LEVO-CTS trial in first calendar
quarter of 2016
-
Data reported from LeoPARDS trial for levosimendan in septic shock in
calendar year 2016
Third Quarter Fiscal Year 2015 Financial Results
The Company reported a net loss of $2.9 million or $0.10 per share in
the third quarter fiscal year 2015, compared to a net loss of $3.4
million, or $0.43 per share in the same period in fiscal 2014.
The Company reported general and administrative expenses of $1.9 million
in the third quarter fiscal year 2015, compared to $1.8 million in the
same period in fiscal 2014.
The Company reported research and development expenses of $1.2 million
in the third quarter fiscal year 2015, compared to $0.7 million in the
same period in fiscal 2014.
As of January 31, 2015, the Company had $50.1 million in cash, including
the fair value of its marketable securities, compared to $58.3 million
at April 30, 2014.
Financial Guidance
The Company continues to expect that its cash balance, including the
fair value of its marketable securities, will be sufficient for it to
accomplish its corporate goals through fiscal year 2017.
Michael Jebsen, Chief Financial Officer, said: "We believe that our
current capital will be sufficient to fund our levosimendan program in
LCOS through a New Drug Application filing. We also remain in a strong
position to proactively evaluate business development opportunities
during calendar year 2015, including levosimendan's expansion in septic
shock and potential additional candidates that fit into our critical
care pipeline strategy."
Conference Call
The Tenax management team will host a call today at 8:30am ET to discuss
financial results for the third quarter fiscal year 2015.
To participate in the call, please dial 877-407-8029 (domestic) or
201-689-8029 (international) and refer to conference ID 13603008. 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. (formerly Oxygen Biotherapeutics) is a
specialty pharmaceutical company focused on developing and
commercializing a portfolio of products for the critical care market.
The company owns the North American rights to develop and commercialize
levosimendan, and the United States Food and Drug Administration (FDA)
has granted Fast Track status for levosimendan for the reduction of
morbidity and mortality in cardiac surgery patients at risk for
developing Low Cardiac Output Syndrome (LCOS). The company is currently
enrolling a Phase 3 trial with levosimendan in that indication. 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 quarterly report on Form 10-Q
filed on March 17, 2015 and annual report on Form 10-K filed on July 29,
2014, as well as its other filings with the SEC (News - Alert). 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.
CONSOLIDATED BALANCE
SHEETS
|
|
|
|
|
|
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January 31, 2015
|
|
|
April 30, 2014
|
|
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(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
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Current assets
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
9,915,479
|
|
$
|
58,320,555
|
Marketable securities
|
|
7,159,176
|
|
|
-
|
Accounts receivable
|
|
64,662
|
|
|
36,358
|
Government grant receivable
|
|
-
|
|
|
29,750
|
Prepaid expenses
|
|
348,151
|
|
|
401,964
|
Other current assets
|
|
181,834
|
|
|
177,406
|
Total current assets
|
|
17,669,302
|
|
|
58,966,033
|
Marketable securities
|
|
32,995,677
|
|
|
-
|
Property and equipment, net
|
|
67,460
|
|
|
124,374
|
Debt issuance costs, net
|
|
-
|
|
|
21,427
|
Intangible assets, net
|
|
23,038,469
|
|
|
22,999,744
|
Goodwill
|
|
11,265,100
|
|
|
11,265,100
|
Other assets
|
|
1,156,785
|
|
|
52,762
|
Total assets
|
$
|
86,192,793
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|
$
|
93,429,440
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
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Current liabilities
|
|
|
|
|
|
Accounts payable
|
$
|
425,231
|
|
$
|
411,145
|
Accrued liabilities
|
|
1,711,012
|
|
|
858,136
|
Warrant liabilities
|
|
579,660
|
|
|
954,876
|
Notes payable, net
|
|
151,255
|
|
|
346,890
|
Total current liabilities
|
|
2,867,158
|
|
|
2,571,047
|
Other liabilities
|
|
-
|
|
|
10,932
|
Deferred tax liability
|
|
7,962,100
|
|
|
7,962,100
|
Total liabilities
|
|
10,829,258
|
|
|
10,544,079
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, undesignated, authorized 9,947,439
|
|
-
|
|
|
-
|
Common stock, par value $.0001 per share; authorized 400,000,000 shares;
issued and outstanding 28,119,436 and 27,858,000, respectively
|
|
2,812
|
|
|
2,786
|
Additional paid-in capital
|
|
220,987,935
|
|
|
219,468,498
|
Accumulated other comprehensive gain
|
|
53,432
|
|
|
-
|
Accumulated deficit
|
|
(145,680,644)
|
|
|
(136,585,923)
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Total stockholders' equity
|
|
75,363,535
|
|
|
82,885,361
|
Total liabilities and stockholders' equity
|
$
|
86,192,793
|
|
$
|
93,429,440
|
TENAX THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
Three months ended January 31,
|
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Nine months ended January 31,
|
|
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2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue
|
|
$
|
-
|
|
$
|
590
|
|
$
|
-
|
|
$
|
60,669
|
Cost of sales
|
|
|
-
|
|
|
410
|
|
|
-
|
|
|
31,275
|
Net product revenue
|
|
|
-
|
|
|
180
|
|
|
-
|
|
|
29,394
|
Government grant revenue
|
|
|
-
|
|
|
41,684
|
|
|
-
|
|
|
233,981
|
Total net revenue
|
|
|
-
|
|
|
41,864
|
|
|
-
|
|
|
263,375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
1,907,482
|
|
|
1,783,596
|
|
|
4,943,683
|
|
|
4,187,522
|
Research and development
|
|
|
1,227,190
|
|
|
689,666
|
|
|
4,750,556
|
|
|
2,211,124
|
Total operating expenses
|
|
|
3,134,672
|
|
|
2,473,262
|
|
|
9,694,239
|
|
|
6,398,646
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss
|
|
|
3,134,672
|
|
|
2,431,398
|
|
|
9,694,239
|
|
|
6,135,271
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
968
|
|
|
69,967
|
|
|
47,288
|
|
|
2,142,627
|
Other (income) expense
|
|
|
(267,294)
|
|
|
849,556
|
|
|
(646,806)
|
|
|
849,782
|
Net loss
|
|
$
|
2,868,346
|
|
$
|
3,350,921
|
|
$
|
9,094,721
|
|
$
|
9,127,680
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (gain) loss on marketable securities
|
|
|
(95,738)
|
|
|
-
|
|
|
(53,432)
|
|
|
-
|
Total comprehensive loss
|
|
$
|
2,772,608
|
|
$
|
3,350,921
|
|
$
|
9,041,289
|
|
$
|
9,127,680
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of net loss to net loss attributable to common
stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
2,868,346
|
|
|
3,350,921
|
|
|
9,094,721
|
|
|
9,127,680
|
Preferred stock dividend
|
|
|
-
|
|
|
1,095,822
|
|
|
-
|
|
|
5,742,162
|
Net loss attributable to common stockholders
|
|
$
|
2,868,346
|
|
$
|
4,446,743
|
|
$
|
9,094,721
|
|
$
|
14,869,842
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic
|
|
$
|
(0.10)
|
|
$
|
(0.43)
|
|
$
|
(0.32)
|
|
$
|
(2.56)
|
Weighted average number of common shares outstanding, basic
|
|
|
28,119,360
|
|
|
10,260,021
|
|
|
28,064,589
|
|
|
5,811,162
|
Net loss per share, diluted
|
|
$
|
(0.10)
|
|
$
|
(0.44)
|
|
$
|
(0.32)
|
|
$
|
(2.58)
|
Weighted average number of common shares outstanding, diluted
|
|
|
28,119,360
|
|
|
10,266,601
|
|
|
28,064,589
|
|
|
5,817,819
|
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