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 second quarter ended June 30, 2016, and provided a corporate update.
“We are very pleased that the increased enrollment rate in our Phase 3 LEVO-CTS cardiac surgery trial has largely continued during the summer, and we now anticipate completing enrollment at the end of September at approximately 880 patients to ensure sufficient powering and allow for a top-line data readout during the fourth quarter of this year,” said John Kelley, CEO of Tenax Therapeutics.
“We believe the clinical data to date shows that levosimendan has the potential to provide a much-needed treatment option in this critical care setting, and we continue to develop an efficient, targeted launch strategy if the trial reads out positively. Meanwhile, we still expect to see results from the LeoPARDS trial in septic shock from our colleagues at Imperial College London during the fourth quarter of this year. We are excited to share both readouts during the next several months, as we work to build Tenax into a fully-integrated commercial pharmaceutical company.”
- Today, Tenax announced that it has currently enrolled 767 patients in its Phase 3 LEVO-CTS trial for lead candidate levosimendan in cardiac surgery as of August 10, 2016. This compares to 620 patients as of May 19, 2016, and 487 patients as of March 15, 2016.
- The Company also announced today that it currently plans to continue enrolling patients through the end of September to reach a final total of approximately 880 patients – 120 more than the original target enrollment number of 760 patients. These additional patients will be used to ensure sufficient powering and are necessary due to:
1. A small percentage of patients who were randomized but did not receive study drug
2. A small percentage of patients who are missing one or more component measurements of the primary endpoint
3. A slightly lower primary endpoint event rate than originally projected
With the study projected to complete enrollment at the end of September, Tenax still expects to report top-line data from the trial during the fourth quarter of 2016.
As announced in May 2016, Tenax has also elected to forego the second interim analysis planned at 600 patients due to its close proximity with the completion of enrollment for the full study – a decision made in consultation with both the trial’s steering committee and the Data and Safety Monitoring Board (DSMB).
- Tenax continues to expect that its partners at Imperial College London will present data from the LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis) at a medical meeting during the fourth quarter of 2016. Tenax is scheduled to receive the data within 30 days of its publication or presentation, and following a recommendation from the FDA, plans to conduct its own separate analysis of these data based on a statistical analysis plan (SAP) submitted to the FDA that incorporates dialogue with the agency around clinically meaningful primary and secondary endpoints.
Upcoming Expected Milestones and Events
- Completion of enrollment for the LEVO-CTS trial at the end of September 2016
- Top-line data reported from LEVO-CTS trial during the fourth quarter of 2016
- Data from LeoPARDS trial during the fourth quarter of 2016 – with a scientific meeting presentation/publication by Imperial College London, and a subsequent separate data analysis by Tenax based on the current statistical analysis plan submitted to the FDA
Second Quarter 2016 Financial Results
The Company reported a net loss of $4.6 million, or $0.17 per share, for the second quarter 2016, compared to a net loss of $4.7 million, or $0.17 per share, during the same period in the prior year.
The Company reported general and administrative expenses of $1.2 million for the second quarter 2016, compared to $1.9 million during the same period in the prior year.
The Company reported research and development expenses of $3.4 million for the second quarter 2016, compared to $1.9 million during the same period in the prior year.
As of June 30, 2016, the Company had $29.5 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. Tenax currently anticipates 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 second quarter 2016.
To participate in the call, please dial 877?407?8029 (domestic) or 201?689?8029 (international) and refer to conference ID 13642237. 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 filed on March 14, 2016, its quarterly report on Form 10-Q filed on August 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
|June 30, 2016||
|Cash and cash equivalents||$||1,928,025||$||3,660,453|
|Total current assets||10,172,362||20,560,353|
|Property and equipment, net||28,959||35,786|
|Intangible assets, net||22,000,000||22,000,000|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||5,277,674||4,601,630|
|Deferred tax liability||7,962,100||7,962,100|
|Common stock, par value $.0001 per share; authorized|
|400,000,000 shares; issued and outstanding 28,119,847|
|and 28,119,694, respectively||2,812||2,812|
|Additional paid-in capital||221,541,252||221,285,677|
|Accumulated other comprehensive gain/(loss)||88,867||(129,442)|
|Total stockholders’ equity||50,894,364||60,423,348|
|Total liabilities and stockholders' equity||$||64,134,138||$||72,987,078|
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|Three months ended June 30,||Six months ended June 30,|
|Government grant revenue||$||-||$||49,286||$||-||$||49,286|
|General and administrative||1,239,644||1,934,137||3,001,339||3,552,276|
|Research and development||3,431,591||1,947,264||7,375,225||3,530,001|
|Total operating expenses||4,671,235||4,916,264||10,376,564||8,117,140|
|Net operating loss||4,671,235||4,866,978||10,376,564||8,067,854|
|Other (income) expense||(30,027)||(120,482)||(373,696)||(383,900)|
|Unrealized (gain) loss on marketable securities||(78,073)||67,978||(218,309)||(109,961)|
|Total comprehensive loss||$||4,563,135||$||4,815,875||$||9,784,559||$||7,577,217|
|Net loss per share, basic and diluted||$||(0.17)||$||(0.17)||$||(0.36)||$||(0.27)|
|Weighted average number of common|
|shares outstanding, basic and|
Stern Investor Relations, Inc.
Jesse Baumgartner, 212-362-1200