[December 17, 2014]

Tenax Therapeutics Announces Second 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 second quarter fiscal year 2015 ended October 31, 2014.

"We made significant progress during this fiscal quarter, as we enrolled the first patients in our ongoing Phase 3 LEVO-CTS (News - Alert) trial for levosimendan in the U.S. and continued to expand the number of activated clinical sites," said John Kelley, Chief Executive Officer of Tenax.

"We have now enrolled 14 patients in the trial and have 21 active clinical sites, with another 8 signed contracts that are awaiting site activation. Following our successful investigator meeting in October, we continue to expect approximately 50 active hospitals in the trial by the end of the first calendar quarter in 2015.

"We have also started to execute on our longer-term vision as a multi-faceted critical care company. In August, we entered into an important strategic collaboration with Imperial College London for its LeoPARDS trial for levosimendan in septic shock, a therapeutic area in which clinical results indicate a potential for benefit with levosimendan. We have begun developing the clinical plan for this indication, including a positive meeting last month with the U.S. Food and Drug Administration (FDA) around a development path and potential implications of the LeoPARDS trial, in which the agency provided us specific guidance on a path forward. We look forward to providing more detail and updates in calendar 2015."

Recent Highlights

• In September, Tenax announced the dosing of the first patients in its Phase 3 LEVO-CTS trial for levosimendan, a double-blind, randomized, placebo-controlled study that will evaluate the use of levosimendan administered before and during cardiac surgery to reduce the incidence of LCOS and associated morbidity and mortality.
• In October, the Company held an investigator meeting with current and prospective clinical site participants around the LEVO-CTS trial.
• Today, Tenax announced that the Company has currently enrolled 14 patients in the LEVO-CTS trial, and has 21 clinical sites activated. The Company also disclosed that it has signed an additional 8 contracts with hospital sites, and is in discussion with an additional 26 sites. It expects to have approximately 50 hospital sites activated by the end of the first calendar quarter of 2015.
• In August, 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 December 16, 2014, the trial had enrolled 150 out of an estimated 516 patients (www.leopards-trial.org).
• In November, the Company held a meeting with the FDA to discuss the development of levosimendan in septic shock. Dr. Anthony Gordon, the lead investigator for the LeoPARDS trial, was also in attendance. Dr. Gordon provided the FDA with the rationale for why levosimendan could provide a benefit for septic shock patients, and the significant unmet medical need. He also reviewed the protocol for the LeoPARDS trial, and discussed the primary endpoints to be measured. The FDA provided Dr. Gordon and the company with guidance on how the data might be analyzed to support a regulatory filing. Dr. Gordon and the LeoPARDS trial team are evaluating that feedback.

Upcoming Expected Milestones

• Expected event rate interim analysis following enrollment of 200 patients in LEVO-CTS trial, by the first half of calendar year 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
• Last patient enrolled in LEVO-CTS trial in the fourth calendar quarter of 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

Second Quarter Fiscal Year 2015 Financial Results

The Company reported a net loss of $4.1 million or $0.14 per share for the second quarter fiscal year 2015, compared to a net loss of $3.5 million, or $1.23 per share in the same period in fiscal 2014.

The Company reported general and administrative expenses of $1.6 million in the second quarter fiscal year 2015, compared to $1.4 million in the same period in fiscal 2014.

The Company reported research and development expenses of $2.6 million in the second quarter fiscal year 2015, compared to $0.7 million in the same period in fiscal 2014.

At the end of the second quarter fiscal year 2015, the Company had $53.3 million in cash, including the fair value of available for sale 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 available for sale securities, will be sufficient for it to accomplish its corporate goals through fiscal year 2017.

Michael Jebsen, Chief Financial Officer, said: "We continue to expect that our current capital will be sufficient to fund our clinical development plan through the filing of a potential New Drug Application for levosimendan. With our strategic decision to maximize capital efficiency during the past 12 months, including the halting of our Phase 2 Oxycyte trial, we also remain in a strong position to act opportunistically with partnerships like our LeoPARDS trial collaboration."

Conference Call

The Tenax management team will host a call today at 8:30am ET to discuss financial results for the second 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 13597527. 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 initiated a Phase 3 trial with levosimendan in that indication in July 2014. 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 December 15, 2014 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.

[ Back To TMCnet.com's Homepage ]