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 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.”
- 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.
The Company reported general and administrative expenses of $1.3 million for the third quarter 2016, compared to $1.4 million during the same period in the prior year.
The Company reported research and development expenses of $3.2 million for the third quarter 2016, compared to $1.7 million during the same period in the prior year.
As of September 30, 2016, the Company had $25.1 million in cash, including the fair value of its marketable securities, compared to $38.2 million at December 31, 2015.
Tenax 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 in 2017. Tenax continues to anticipate that its cash balance at the end of 2016 will be between $19 and $20 million.
The Tenax management team will host a call today at 8:30 a.m. ET to discuss financial results for the third quarter 2016.
To participate in the call, please dial 866-932-0173 (domestic) or 785-424-1630 (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, 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 in a Phase 3 trial with levosimendan for that indication. 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 filed on March 14, 2016, its quarterly report on Form 10-Q filed on November 9, 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.
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||722,152||$||3,660,453|
|Total current assets||7,667,083||20,560,353|
|Property and equipment, net||23,526||35,786|
|Intangible assets, net||22,000,000||22,000,000|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||5,057,028||4,601,630|
|Deferred tax liability||7,962,100||7,962,100|
|Common stock, par value $.0001 per share; authorized|
|400,000,000 shares; issued and outstanding 28,119,934|
|and 28,119,694, respectively||2,812||2,812|
|Additional paid-in capital||221,652,664||221,285,677|
|Accumulated other comprehensive gain/(loss)||49,543||(129,442)|
|Total stockholders’ equity||46,692,800||60,423,348|
|Total liabilities and stockholders' equity||$||59,711,928||$||72,987,078|
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|Three months ended September 30,||Nine months ended September 30,|
|Government grant revenue||$||-||$||-||$||-||$||49,286|
|General and administrative||1,256,880||1,425,048||4,267,218||4,977,323|
|Research and development||3,234,686||1,678,517||10,609,912||5,208,518|
|Total operating expenses||4,500,566||3,103,565||14,877,130||11,220,704|
|Net operating loss||4,500,566||3,103,565||14,877,130||11,171,418|
|Other (income) expense||(226,914)||(183,605)||(600,610)||(567,505)|
|Unrealized loss (gain) on marketable securities||39,324||(12,651)||(178,985)||(122,612)|
|Total comprehensive loss||$||4,312,916||$||2,907,880||$||14,097,535||$||10,485,096|
|Net loss per share, basic and diluted||$||(0.15)||$||(0.10)||$||(0.51)||$||(0.38)|
|Weighted average number of common|
|shares outstanding, basic and|