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 second quarter fiscal year 2016 ended October 31, 2015, and provided a corporate update.
“We made significant progress on all fronts during the last several months, as we prepare for a potentially transformative 2016 with two expected late-stage data readouts for levosimendan,” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “Following the recent protocol amendment in our Phase 3 LEVO-CTS trial in cardiac surgery and expanded activity from several of our new sites, we have seen a significant increase in enrollment pace and now have 301 patients enrolled, giving us confidence that we will be able to read out top-line data near the end of next year and potentially begin preparations for a New Drug Application.
“In addition, the LeoPARDS trial for levosimendan in septic shock conducted by our colleagues at Imperial College London has continued to rapidly progress with our financial support. They now have 512 of the 516 patients enrolled and should complete enrollment shortly. We currently expect these data to be presented during the first half of calendar year 2016, and if positive we would expect to file an NDA based on the statistical analysis plan we submitted to the FDA with additional secondary endpoints that we believe to be clinically meaningful.”
Recent Highlights
- Today, Tenax announced that the Company has currently enrolled 301 patients in the Phase 3 LEVO-CTS trial out of an estimated 760 total, compared to 200 patients as of October 1, 2015. The Company has now activated 72 total clinical sites, including 10 in Canada.
- In October 2015, Tenax announced that the FDA had approved an amendment for the LEVO-CTS study to change the inclusion criteria to cardiac surgery patients with a left ventricular ejection fraction (LVEF) of ≤ 35% undergoing a coronary artery bypass grafting (CABG) procedure, CABG and an aortic valve procedure, and CABG and/or a mitral valve procedure. Thus far, 62 activated hospitals have IRB approval of the amendment, and 82 patients have been enrolled under the amended protocol.
- Today, the Company also announced that its colleagues at Imperial College London were near completing enrollment of the LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). The LeoPARDS trial has enrolled 512 of the expected 516 total patients and 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. The primary endpoint for the study is the mean SOFA score between treatment groups.
- In August 2014, Tenax announced a collaboration with Imperial College London to provide $500,000 in supplemental funding to support the accelerated enrollment and completion of this trial. The Company has also submitted a statistical analysis plan (SAP) to the FDA that includes additional secondary endpoints that it believes to be clinically meaningful.
- In September 2015, Tenax announced that it would be 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.
- On September 15, 2015, James Mitchum was elected to the Company’s Board of Directors at the annual meeting of stockholders. 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.
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 calendar year 2016
- Data reported from LeoPARDS trial in first half of calendar year 2016
- Data reported from Phase 3 LEVO-CTS trial in calendar year 2016
- Updated regulatory strategy for levosimendan in septic shock following LeoPARDS data in first half of calendar year 2016
Fiscal Quarter Fiscal Year 2016 Financial Results
The Company reported a net loss of $3.5 million or $0.13 per share for the second quarter fiscal year 2016, compared to a net loss of $4.0 million, or $0.14 per share in the same period in fiscal 2015.
The Company reported general and administrative expenses of $1.2 million for the second quarter fiscal year 2016, compared to $1.6 million in the same period in fiscal 2015.
The Company reported research and development expenses of $2.5 million for the second quarter fiscal year 2016, compared to $2.6 million in the same period in fiscal 2015.
As of October 31, 2015, the Company had $40.8 million in cash, including the fair value of its marketable securities, compared to $43.9 million at July 31, 2015.
Financial Guidance
The Company 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 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 second 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 13626769. 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 December 10, 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.
| TENAX THERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| October 31, 2015 | April 30, 2015 | |||||||
| ASSETS | (Unaudited) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 5,099,183 | $ | 7,926,491 | ||||
| Marketable securities | 16,584,777 | 9,200,082 | ||||||
| Accounts receivable | 86,271 | 76,475 | ||||||
| Prepaid expenses | 93,433 | 249,505 | ||||||
| Other current assets | — | 58,623 | ||||||
| Total current assets | 21,863,664 | 17,511,176 | ||||||
| Marketable securities | 19,176,661 | 30,974,961 | ||||||
| Property and equipment, net |
42,054 |
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 | $ | 75,454,264 | $ | 82,908,344 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 521,232 | $ | 1,183,939 | ||||
| Accrued liabilities | 2,538,659 | 2,660,666 | ||||||
| Warrant liabilities | 502,693 | 572,445 | ||||||
| Notes payable, net | — | 100,160 | ||||||
| Total current liabilities | 3,562,584 | 4,517,210 | ||||||
| Deferred tax liability | 7,962,100 | 7,962,100 | ||||||
| Total liabilities | 11,524,684 | 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 | 221,171,247 | 221,067,239 | ||||||
| Accumulated other comprehensive (loss)/gain | (17,873 | ) | 26,718 | |||||
| Accumulated deficit | (157,226,606 | ) | (150,667,735 | ) | ||||
| Total stockholders’ equity | 63,929,580 | 70,429,034 | ||||||
| Total liabilities and stockholders' equity | $ | 75,454,264 | $ | 82,908,344 | ||||
| TENAX THERAPEUTICS, INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||||||
| Three months ended October 31, | Six months ended October 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | 1,230,618 | $ | 1,586,343 | $ | 2,599,222 | $ | 3,036,202 | ||||||||
| Research and development | 2,518,588 | 2,556,852 | 4,264,489 | 3,523,365 | ||||||||||||
| Total operating expenses | 3,749,206 | 4,143,195 | 6,863,711 | 6,559,567 | ||||||||||||
| Net operating loss | 3,749,206 | 4,143,195 | 6,863,711 | 6,559,567 | ||||||||||||
| Interest expense | 404 | 59 | 1,506 | 46,320 | ||||||||||||
| Other (income) expense | (225,238 | ) | (88,291 | ) | (306,346 | ) | (379,512 | ) | ||||||||
| Net loss | $ | 3,524,372 | $ | 4,054,963 | $ | 6,558,871 | $ | 6,226,375 | ||||||||
| Unrealized (gain) loss on marketable securities | (21,283 | ) | (23,254 | ) | 44,591 | 42,306 | ||||||||||
| Total comprehensive loss | $ | 3,503,089 | $ | 4,031,709 | $ | 6,603,462 | $ | 6,268,681 | ||||||||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.23 | ) | $ | (0.22 | ) | ||||
| Weighted average number of common shares outstanding, basic | 28,119,609 | 28,107,395 | 28,119,565 | 28,037,204 | ||||||||||||
