MORRISVILLE, N.C.--(BUSINESS WIRE)--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 full year ended December 31, 2016 and provided a corporate update.
“While we were disappointed that the LEVO-CTS trial did not meet its dual or quad primary endpoints, there are positive data in the results. Levosimendan demonstrated statistically significant reductions in clinically meaningful secondary endpoints including a reduction in low cardiac output syndrome (LCOS) and reduction in postoperative use of secondary inotropes. There was also a statistically significant increase in cardiac index in the levosimendan arm. Additionally, levosimendan was found to be safe with no clinically significant increases in hypotension or cardiac arrhythmias and the clinical data showed a numerical reduction in 90-day mortality,” said John Kelley, CEO of Tenax Therapeutics.
Dr. John Alexander of the Duke Clinical Research Institute presented the results of the LEVO-CTS trial on Sunday, March 19, 2017, during a late-breaking clinical trial session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C. Dr. Alexander concluded “levosimendan is effective and safe as an inotrope to increase cardiac output in patients at risk for perioperative low cardiac output syndrome.” Slides from the presentation can be found on the Tenax website at www.tenaxthera.com. The trial results were also simultaneously published in The New England Journal of Medicine.
“Based on these positive findings, we continue to evaluate cardiac surgery and other indications that may benefit from levosimendan,” said John Kelley, CEO of Tenax Therapeutics. “We have initiated discussions with the U.S. Food and Drug Administration (FDA) regarding the approval of levosimendan to treat Acute Decompensated Heart Failure (ADHF). Levosimendan is approved and on the market in Europe and South America for ADHF, where it has been used to treat over one million patients. We have a pre-NDA meeting scheduled with FDA to discuss a New Drug Application (NDA) for this indication in the U.S. based on existing data in ADHF, along with the positive data generated in the secondary endpoints in the LEVO-CTS trial. We are also planning to begin the process of filing an application for approval to Health Canada,” continued Mr. Kelley.
While the company is working on its regulatory options for levosimendan, it will explore additional strategic options to broaden its product lines. To this end, the company will engage an investment bank to assist in these efforts.
Full Year 2016 Financial Results
The Company reported a net loss of $44.0 million, or $(1.56) per share, for the year ended December 31, 2016, compared to a net loss of $15.9 million, or $(0.57) per share, for the prior year.
The Company reported general and administrative expenses of $6.2 million for the year ended December 31, 2016, compared to $6.7 million for the prior year.
The Company reported research and development expenses of $13.1 million for the year ended December 31, 2016, compared to $8.9 million for the prior year.
The Company reported a loss on impairment of assets of $33.3 million for the year ended December 31, 2016, compared to $1.0 million for the prior year.
As of December 31, 2016, the Company had $21.9 million in cash, including the fair value of its marketable securities, compared to $38.2 million at December 31, 2015.
Tenax expects that its cash balance, including the fair value of its marketable securities, will be sufficient for it to accomplish its corporate goals through the first half of 2018, including the full close-out of its recently completed Phase 3 LEVO-CTS trial, as it continues to evaluate the potential for filing a New Drug Application for levosimendan for cardiac surgery or other indications in 2017.
The Tenax management team will host a call today at 8:30 a.m. ET to discuss fourth quarter and year-end 2016 financial results.
To participate in the call, please dial (866) 682-6100 (domestic) or (862) 255-5401 (international). 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, a novel, first in class calcium sensitizer/K-ATP activator. 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 annual report on Form 10-K filed on March 16, 2017, 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.
|TENAX THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$||9,995,955||$||3,660,453|
|Total current assets||13,628,175||20,560,353|
|Property and equipment, net||19,105||35,786|
|Intangible assets, net||-||22,000,000|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||6,199,237||4,601,630|
|Deferred tax liability||-||7,962,100|
|Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,120,021 and 28,119,694, respectively||2,812||2,812|
|Additional paid-in capital||221,816,447||221,285,677|
|Accumulated other comprehensive gain/(loss)||(18,718||)||(129,442||)|
|Total stockholders’ equity||17,140,938||60,423,348|
|Total liabilities and stockholders' equity||$||23,340,175||$||72,987,078|
|TENAX THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|Year ended December 31,|
|Government grant revenue||$||-||$||49,286|
|General and administrative||6,245,958||6,671,568|
|Research and development||13,139,681||8,904,787|
|Total operating expenses||52,650,739||16,611,218|
|Net operating loss||52,650,739||16,561,932|
|Other (income) expense||(764,735||)||(633,632||)|
|Income tax benefit||(7,962,100||)||-|
|Unrealized (gain) loss on marketable securities||(110,724||)||(29,332||)|
|Total comprehensive loss||$||43,813,180||$||15,902,819|
|Net loss per share, basic and diluted||$||(1.56||)||$||(0.57||)|
|Weighted average number of common shares outstanding, basic and diluted||28,119,835||28,119,538|