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April 6, 2017

Tenax Explores Strategic Alternatives as CEO Resigns

  • After the resignation of its CEO, Tenax Therapeutics said its board is evaluating strategic alternatives that include a merger or sale of the company.

    The moves, disclosed yesterday, come more than two months after Tenax acknowledged that its lead candidate, levosimendan, failed the Phase III LEVO-CTS trial assessing the calcium sensitizer for reduced morbidity and mortality in cardiac surgery patients at risk of low cardiac output syndrome (LCOS).

    In LEVO-CTS, Tenax said, levosimendan did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days.

    The company added, however, that levosimendan showed statistically significant reductions in two of LEVO-CTS’ three secondary endpoints, including reduction in LCOS, and a reduction in postoperative use of secondary inotropes.

    That was not enough to satisfy investors, who sent Tenax shares tumbling 76% the day of the trial failure announcement, from $1.95 to 46 cents a share. After bouncing back to 80 cents on February 2, the share price declined again, closing yesterday at 48 cents.

    “The Company continues to evaluate the results of the LEVO-CTS clinical trial and feedback provided by the FDA in preparation for the pre-NDA meeting with the FDA to occur in May, while simultaneously exploring additional strategic options and alternatives that might enhance stockholder value,” Tenax said in a statement.

    At the same time, Tenax insisted that it had faith in levosimendan: “The Company continues to believe levosimendan is an effective and safe inotrope to increase cardiac output in patients at risk for, or with, perioperative low cardiac output.”

    To that end, Tenax said, it plans to continue pursuing a regulatory filing for levosimendan in Canada.

    The company also plans to pursue hiring of a new permanent CEO following the resignation of John Kelley after 3-1/2 years in the position, effective this past Monday. Kelley also resigned from Tenax’s board of directors, which has named the company’s president and CFO, Michael Jebsen, as interim CEO, a position he held from 2011 to 2013, when Kelley took the helm.

    “We thank John for his contributions and wish him well for the future,” Tenax Chairman Ronald Blanck stated. “This development does not change the focus or direction of the Company, which remains dedicated to enhancing shareholder value through the development and commercialization of products for the critical care market and we have complete confidence in Michael’s ability to lead the Company once again during this transitional stage of its development.”

    Levosimendan was initially developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, and is approved for that indication in more than 60 countries, but not the U.S. Under its former name of Oxygen Biotherapeutics, Tenax acquired North American rights to develop and commercialize levosimendan in 2013 from Phyxius Pharma, whose co-founder and chief executive was Kelley; he became Oxygen’s CEO as part of the deal.

    Oxygen changed its name to Tenax in September 2014.

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