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Tenax Therapeutics Announces First Quarter 2016 Financial Results and Provides Corporate UpdateTenax 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 first quarter ended March 31, 2016, and provided a corporate update. "We were very pleased to receive a recommendation from the Data and Safety Monitoring Board (DSMB) to continue with our Phase 3 LEVO-CTS (News - Alert) trial as planned following a comprehensive interim analysis from the first 451 patients in the study," said John Kelley, CEO of Tenax Therapeutics. "With enrollment rates holding strong across our clinical sites and 620 patients now in the trial, we currently anticipate completing enrollment near the end of this summer and reading out top-line data during the fourth quarter of 2016. "We also continue to expect late-stage results for levosimendan in septic shock to be reported by Imperial College London during the second half of the year, which would enable us to complete our own analysis of that data and assess any regulatory implications moving forward. These readouts have the potential to position levosimendan as a much-needed treatment option for patients in both the cardiac surgery and septic shock settings, and we remain focused on execution for both programs prior to sharing those results publicly later this year." Recent Highlights
Upcoming Expected Milestones and Events
First Quarter 2016 Financial Results The Company reported a net loss of $5.4 million, or $0.19 per share, for the first quarter 2016, compared to a net loss of $2.9 million, or $0.10 per share, during the same period in the prior year. The Company reported general and administrative expenses of $1.8 million for the first quarter 2016, compared to $1.6 million during the same period in the prior year. The Company reported research and development expenses of $3.9 million the first quarter 2016, compared to $1.6 million during the same period in the prior year. As of March 31, 2016, the Company had $34.8 million in cash, including the fair value of its marketable securities, compared to $38.2 million at December 31, 2015. 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 2017, including the full readout of its ongoing Phase 3 LEVO-CTS trial and a potential New Drug Application for levosimendan in the LCOS indication. Conference Call The Tenax management team will host a call today at 8:30 a.m. ET to discuss financial results for the first quarter 2016. To participate in the call, please dial 877-407-8029 (domestic) or 201-689-8029 (international) and refer to conference ID 13637260. 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 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 transition report on Form 10-KT (News - Alert) filed on March 14, 2016, its quarterly report on Form 10-Q filed on May 10, 2016 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.
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