TMCnet News
Tenax Therapeutics Announces First Quarter Fiscal Year 2016 Financial ResultsTenax 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 fiscal year 2016 ended July 31, 2015, and provided a corporate update. "Throughout this calendar year, we have continued to execute on our clinical plan for levosimendan as we work to increase the enrollment speed for our Phase 3 LEVO-CTS (News - Alert) trial in Low Cardiac Output Syndrome (LCOS)," said John Kelley, Chief Executive Officer of Tenax Therapeutics. "With 179 patients enrolled thus far and 62 sites activated, we have made significant progress increasing our trial's visibility within different regions and educating our participating sites; and we expect enrollment pace to increase throughout the rest of 2015 to enable a topline data readout in calendar year 2016." "Meanwhile, the LeoPARDS trial in septic shock conducted by Imperial College London has continued to progress nicely, with 428 patients enrolled now out of an estimated 516 patients," continued Mr. Kelley. "Upon full enrollment, we look forward to seeing the eventual presentation of data next year by our Imperial College colleagues, which will inform our regulatory pathway with this additional indication. We were also pleased to announce our recent partnership with Sepsis Alliance to help raise awareness of this deadly condition that still has few effective treatment options. "And on the corporate side, we were excited to announce the nomination of James Mitchum to our Board of Directors, where we believe his extensive and diverse pharmaceutical experience will be a valuable resource to help guide our developing critical care pipeline." Recent Highlights
Upcoming Expected Milestones and Events
Fiscal Quarter Fiscal Year 2016 Financial Results The Company reported a net loss of $3.0 million or $0.11 per share for the first quarter fiscal year 2016, compared to a net loss of $2.2 million, or $0.08 per share in the same period in fiscal 2015. The Company reported general and administrative expenses of $1.4 million for the first quarter fiscal year 2016, compared to $1.4 million in the same period in fiscal 2015. The Company reported research and development expenses of $1.8 million for the first quarter fiscal year 2016, compared to $1.0 million in the same period in fiscal 2015. As of July 31, 2015, the Company had $43.9 million in cash, including the fair value of its marketable securities, compared to $48.1 million at April 30, 2015. 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 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 fiscal year 2016. To participate in the call, please dial 877-407-8029 (domestic) or 201-689-8029 (international) and refer to conference ID 13619395. 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 quarterly report on Form 10-Q filed on September 9, 2015, and annual report on Form 10-K filed on July 14, 2015, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150914005231/en/ |