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 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 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
- Today, Tenax announced that the Company has currently enrolled 179 patients in the Phase 3 LEVO-CTS trial, and has activated 62 clinical sites. The company also has 4 more sites where contract negotiations have been completed, with an additional 11 hospitals where contract negotiations are ongoing.
- In September 2015, Tenax announced that it has become a national event partner for Sepsis Alliance in 2015 and 2016 to raise awareness of sepsis and septic shock. As part of this collaboration, Tenax will be the second Lead Sponsor of Sepsis Alliance’s Sepsis Challenge National Events program during the remainder of 2015 and 2016. In addition, the company will be a sponsor at the Sepsis Heroes event, taking place in New York City on September 17, 2015, during Sepsis Awareness Month.
- In August 2015, Tenax announced that James Mitchum has been nominated to be elected to the Company’s Board of Directors at the annual meeting of stockholders scheduled for September 15, 2015. Mr. Mitchum is an experienced, highly-regarded pharmaceutical executive and has served as the chief executive officer of Heart to Heart International, a non-profit humanitarian organization, since September 2014. From 2009 to July 2012, Mr. Mitchum served as president of the Americas for EUSA Pharma (USA), Inc., where he oversaw the streamlining of that business as well as the development, FDA approval and successful launch of a pediatric oncology drug in 2011. Previously, he served as president and chief executive officer of Enturia, Inc., as the president and chief executive officer of Sanofi-Aventis Group Japan, and as chief executive for Aventis Pharma UK, along with a variety of other senior financial roles. Mr. Mitchum currently serves as a director for NephroGenex Inc., and has also served as a director on numerous private company and organization boards.
- In August 2014, the Company announced a collaboration with Imperial College London to provide $500,000 in supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. As of September 11, 2015, the trial had enrolled 428 out of an estimated 516 patients.
Upcoming Expected Milestones and Events
- Two interim analyses during LEVO-CTS trial testing for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded, in the second half of calendar year 2015
- Full data reported from Phase 3 LEVO-CTS trial in calendar year 2016
- Enrollment completed for LeoPARDS trial for levosimendan in septic shock in late calendar year 2015
- Data reported from LeoPARDS trial in calendar year 2016
- Updated regulatory strategy for levosimendan in septic shock following LeoPARDS data in calendar year 2016
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. 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.
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TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
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| July 31, 2015 | April 30, 2015 | ||||
| ASSETS | (Unaudited) | ||||
| Current assets | |||||
| Cash and cash equivalents | $ | 3,650,855 | $ | 7,926,491 | |
| Marketable securities | 17,661,213 | 9,200,082 | |||
| Accounts receivable | 98,594 | 76,475 | |||
| Prepaid expenses | 162,689 | 249,505 | |||
| Other current assets | 29,144 | 58,623 | |||
| Total current assets | 21,602,495 | 17,511,176 | |||
| Marketable securities | 22,561,050 | 30,974,961 | |||
| Property and equipment, net | 54,361 | 50,322 | |||
| Intangible assets, net | 22,000,000 | 22,000,000 | |||
| Goodwill | 11,265,100 | 11,265,100 | |||
| Other assets | 1,106,785 | 1,106,785 | |||
| Total assets | $ | 78,589,791 | $ | 82,908,344 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities | |||||
| Accounts payable | $ | 680,692 | $ | 1,183,939 | |
| Accrued liabilities | 1,919,580 | 2,660,666 | |||
| Warrant liabilities | 606,118 | 572,445 | |||
| Notes payable, net | 48,376 | 100,160 | |||
| Total current liabilities | 3,254,766 | 4,517,210 | |||
| Deferred tax liability | 7,962,100 | 7,962,100 | |||
| Total liabilities | 11,216,866 | 12,479,310 | |||
| Stockholders' equity | |||||
| Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,119,607 and 28,119,520, respectively | 2,812 | 2,812 | |||
| Additional paid-in capital | 221,111,504 | 221,067,239 | |||
| Accumulated other comprehensive gain | (39,156) | 26,718 | |||
| Accumulated deficit | (153,702,235) | (150,667,735) | |||
| Total stockholders’ equity | 67,372,925 | 70,429,034 | |||
| Total liabilities and stockholders' equity | $ | 78,589,791 | $ | 82,908,344 | |
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TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
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| Three months ended July 31, | ||||||
| 2015 | 2014 | |||||
| (Unaudited) | (Unaudited) | |||||
| Operating expenses | ||||||
| General and administrative | $ | 1,368,604 | $ | 1,449,859 | ||
| Research and development | 1,745,901 | 966,514 | ||||
| Total operating expenses | 3,114,505 | 2,416,373 | ||||
| Net operating loss | 3,114,505 | 2,416,373 | ||||
| Interest expense | 1,103 | 46,260 | ||||
| Other income | (81,108) | (291,221) | ||||
| Net loss | $ | 3,034,500 | $ | 2,171,412 | ||
| Unrealized loss on marketable securities | 65,874 | 65,560 | ||||
| Total comprehensive loss | $ | 3,100,374 | $ | 2,236,972 | ||
| Net loss per share, basic and diluted | $ | (0.11) | $ | (0.08) | ||
| Weighted average number of common shares outstanding, basic and diluted | 28,119,521 | 27,661,499 | ||||
