Tenax Therapeutics Announces Third Quarter 2016 Financial Results And Provides Corporate Update

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 third quarter ended September 30, 2016, and provided a corporate update.

"We are pleased to be enrolling our last patients in the Phase 3 LEVO-CTS trial, after which we will begin preparing to lock our database," said John Kelley, CEO of Tenax Therapeutics. "We currently expect top-line data for the trial to readout in January 2017. This is the largest study ever conducted for levosimendan in the LCOS indication and we believe that our drug has the potential to provide an important treatment option for this critical care population. The growing interest and participation in LEVO-CTS confirms the significant commercial opportunity in North America and we are prepared to move forward with an NDA submission and subsequent product launch if this data is positive. We look forward to sharing these results with you shortly."

Recent Highlights
  • Today, Tenax announced that it has currently enrolled 863 total patients for its Phase 3 LEVO-CTS trial for lead candidate levosimendan in cardiac surgery patients. The Company plans to lock the database 30 days after the enrollment of that final patient to begin the data analysis process. In conjunction with the study's lead investigators at Duke Clinical Research Institute (DCRI), Tenax now expects to release top-line results from the study around the primary endpoint in January 2017.
  • In October, the Company announced that the LEVO-CTS trial's Data and Safety Monitoring Board (DSMB) recently completed the final safety review from the first 621 patients enrolled and recommended that the study continue as planned.
  • In October, Tenax announced that based on the initial results from the LeoPARDS trial (Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis) presented at the ESICM Annual Congress by Dr. Anthony Gordon of Imperial College London, the Company does not anticipate undertaking further development with levosimendan in the septic shock indication.

Upcoming Expected Milestones and Events
  • Locking of the LEVO-CTS trial database near the end of 2016 to enable top-line analysis
  • Top-line data reported from the LEVO-CTS trial in January 2017
  • Full data reported from the LEVO-CTS trial at a medical meeting during the second half of 2017

Third Quarter 2016 Financial Results

The Company reported a net loss of $4.3 million, or $(0.15) per share, for the third quarter 2016, compared to a net loss of $2.9 million, or $(0.10) per share, during the same period in the prior year.

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