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 fourth quarter and fiscal year 2015 ended April 30, 2015, and provided a corporate update.

“We continue to be encouraged by the significant progress and expansion of our levosimendan development program,” said John Kelley, Chief Executive Officer of Tenax. “We now have 51 sites activated in our Phase 3 LEVO-CTS trial in low cardiac output syndrome, with 35 having enrolled at least one patient, and we expect to eventually have at least 70 total hospitals participating in the trial. With 130 patients enrolled thus far, we expect these additional sites to increase enrollment; and we now expect to report results from the LEVO-CTS trial in calendar year 2016.

“In addition, enrollment for the LeoPARDS trial in septic shock conducted by Imperial College London continues to accelerate, and the study now has 385 patients enrolled out of an estimated 516 patients and appears on track to finish enrollment during calendar year 2015,” Kelley continued. “We have worked with our colleagues there to develop a statistical analysis plan for this trial following our previous guidance from the U.S. Food and Drug Administration (FDA), and expect to submit that SAP to the FDA this summer. If positive, we believe that this data could support a New Drug Application (NDA) for levosimendan in septic shock.

“We also were pleased to host our first Analyst Day in New York City in April, which included some of the leading experts on levosimendan. Additionally, we recently highlighted two academic papers outlining potential benefits for levosimendan in both the septic shock and cardiac surgery settings. With a strong cash position that will enable us to complete LEVO-CTS in 2016 while opportunistically supporting the LeoPARDS study, we are well-equipped to execute on our development plan as we continue building Tenax into a fully-integrated critical care company.”

Recent Highlights

  • Today, Tenax announced that the Company has currently enrolled 130 patients in the Phase 3 LEVO-CTS trial, and has activated 51 clinical sites. The company also has 6 more sites where contract negotiations have been completed (including the Cleveland Clinic and the trial’s first Canadian site) with an additional 19 hospitals where contract negotiations are ongoing.
  • In April, the Company hosted an Analyst Day in New York City highlighting its levosimendan program in cardiac surgery and septic shock. The event included some of the leading experts on levosimendan in the European Union, including Dr. Anthony Gordon, the lead investigator of the LeoPARDS trial in the United Kingdom. A webcast of the event and full presentation slides can be found in the “Events and Presentations” section of the Company’s IR website.
  • In April, Tenax also announced that it will adopt a fiscal year beginning on January 1 and ending on December 31 of each year, beginning as of January 1, 2016.
  • The Company highlighted two recently-published scientific articles on the potential benefits of levosimendan in septic shock and cardiac surgery:
    • Zangrillo, et al (Journal of Critical Care) is a meta analysis examining mortality reduction in severe sepsis and septic shock patients compared to standard inotropic therapy (primarily dobutamine). The paper examines pertinent randomized trials in septic shock from existing academic publications and analyzes the pooled results to establish a primary outcome measure in mortality, alongside additional secondary outcomes. The paper concludes that: “In patients with severe sepsis and septic shock, levosimendan is associated with a significant reduction in mortality compared with standard inotropic therapy. A large ongoing multicenter randomized trial will have to confirm these findings.”
    • Lim, et al (Journal of Cardiac Surgery) provides a meta-analysis on the role of levosimendan in cardiac surgery patients by pooling the result of 14 previous clinical studies, showing that levosimendan decreased early mortality in patients with reduced ejection fraction (5.5% for levosimendan compared to 9.1% for the control group). Additional endpoint analysis showed a reduction in postoperative acute renal failure, a shorter stay in the intensive care unit, and a lower incidence of low cardiac output syndrome (LCOS) for the levosimendan group in trials. All endpoint conclusions were based only upon studies which reported those respective measures.
    • 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 July 16, 2015, the trial had enrolled 385 out of an estimated 516 patients.

Upcoming Expected Milestones and Events

  • 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
  • Full data reported from Phase 3 LEVO-CTS trial in calendar year 2016
  • Enrollment completed for LeoPARDS trial for levosimendan in septic shock in late calendar year 2015
  • Data reported from LeoPARDS trial in calendar year 2016

Fiscal Year 2015 Financial Results

The Company reported a net loss of $14.1 million or $0.50 per share for the full fiscal year 2015, compared to a net loss of $25.3 million, or $2.71 per share in fiscal 2014.

The Company reported general and administrative expenses of $7.2 million for the full fiscal year 2015, compared to $13.8 million in fiscal 2014.

The Company reported research and development expenses of $6.7 million for the full fiscal year 2015, compared to $3.0 million in fiscal 2014.

As of April 30, 2015, the Company had $48.1 million in cash, including the fair value of its marketable securities, compared to $58.3 million at April 30, 2014.

Financial Guidance

The Company expects that its cash balance, including the fair value of its marketable securities, will be sufficient for it to accomplish its corporate goals through calendar year 2017, including the full readout of its ongoing Phase 3 LEVO-CTS trial.

Michael Jebsen, Chief Financial Officer, said: "Our strong financial position is sufficient to fund our levosimendan program in LCOS through full data and a potential New Drug Application filing in calendar year 2016, while still enabling us to proactively evaluate opportunities like the LeoPARDS trial to further enrich our developing critical care pipeline.”

Conference Call

The Tenax management team will host a call today at 8:30am ET to discuss financial results for the fiscal year 2015.

To participate in the call, please dial 877?407?8029 (domestic) or 201?689?8029 (international) and refer to conference ID 13614267. 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, 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, and is also supporting Imperial College London’s ongoing LeoPARDS trial for levosimendan in septic shock. 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 July 14, 2015, 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.





  April 30, 2015   April 30, 2014
Current assets
Cash and cash equivalents $ 7,926,491 $ 58,320,555
Marketable securities 9,200,082 -
Accounts receivable 76,475 36,358
Government grant receivable - 29,750
Prepaid expenses 249,505 401,964
Other current assets   58,623     177,406  
Total current assets 17,511,176 58,966,033
Marketable securities 30,974,961 -
Property and equipment, net 50,322 124,374
Debt issuance costs, net - 21,427
Intangible assets, net 22,000,000 22,999,744
Goodwill 11,265,100 11,265,100
Other assets   1,106,785     52,762  
Total assets $ 82,908,344   $ 93,429,440  
Current liabilities
Accounts payable $ 1,183,939 $ 411,145
Accrued liabilities 2,660,666 858,136
Warrant liabilities 572,445 954,876
Notes payable, net   100,160     346,890  
Total current liabilities 4,517,210 2,571,047
Other liabilities - 10,932
Deferred tax liability   7,962,100     7,962,100  
Total liabilities 12,479,310 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 221,067,239 219,468,498
Accumulated other comprehensive gain 26,718 -
Accumulated deficit   (150,667,735 )   (136,585,923 )
Total stockholders’ equity   70,429,034     82,885,361  
Total liabilities and stockholders' equity $ 82,908,344   $ 93,429,440  




Year ended April 30,
  2015       2014  
Product revenue $ - $ 25,731
Cost of sales   -     129,800  
Net product revenue - (104,069 )
Government grant revenue   49,286     262,995  
Total net revenue - 158,926
Operating expenses
General and administrative 7,170,779 13,773,325
Research and development 6,660,387 2,996,721
Loss on impairment of long-lived assets   1,034,863     -  
Total operating expenses 14,866,029 16,770,046
Net operating loss 14,816,743 16,611,120
Interest expense 49,081 2,212,283
Other (income) expense   (784,012 )   718,436  
Net loss $ 14,081,812   $ 19,541,839  
Unrealized (gain) loss on marketable securities   (26,718 )   -  
Total comprehensive loss $ 14,055,094   $ 19,541,839  
Reconciliation of net loss to net loss attributable to common stockholders
Net loss 14,081,812 19,541,839
Preferred stock dividend   -     5,803,362  
Net loss attributable to common stockholders $ 14,081,812   $ 25,345,201  
Net loss per share, basic and diluted $ (0.50 ) $ (2.71 )
Weighted average number of common shares outstanding, basic and diluted 28,077,963 9,362,031


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