Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today provided a business update around the Company’s recently-filed 2015 Transitional Report for the eight-month period ending December 31, 2015.
“We continue to be very encouraged by the increased enrollment rate for our Phase 3 LEVO-CTS trial in cardiac surgery, which we believe has been driven by our improved protocol, new high-volume hospitals brought online during the past eight months, and our continued proactive education efforts with all of our investigational sites,” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “With 487 patients now enrolled, we are confident that we will be able to complete enrollment near the end of the third quarter and report top-line data before the end of 2016."
“Furthermore, our colleagues and partners at Imperial College London finished their enrollment of the LeoPARDS trial in septic shock in December 2015 and have since informed us that they anticipate presenting their data analysis publicly during the second half of 2016. Based on a recommendation from the U.S. Food and Drug Administration (FDA), we now expect to conduct our own separate analysis of the data during the second half of 2016 using a statistical analysis plan formed in collaboration with the agency around endpoints that they deem to be clinically meaningful. If positive, we continue to believe that this data set could support an NDA filing.”
- Today, Tenax announced that the Company has currently enrolled 487 patients in the Phase 3 LEVO-CTS trial out of an estimated 760 total, compared to 388 patients as of January 31, 2016, and 301 patients as of December 15, 2015. Sixty-three patients were enrolled in January and 62 patients were enrolled in February, with an additional 37 thus far in March – prior to the start of 2016, the trial’s previous monthly high had been 44 patients.
- In February 2016, the Company announced that the Independent Data and Safety Monitoring Board (DSMB) for LEVO-CTS completed its review of the first 254 patients enrolled in the trial and recommended that Tenax continue with the trial as planned without any alterations. The DSMB recommendation was primarily based on a review for any potential safety signal in the study. The DSMB will next review data on the first 400 patients enrolled in the trial and conduct the first interim analysis testing for efficacy or futility. The second interim analysis is planned when 600 patients have been enrolled.
- In December 2015, the Company announced that its partners at Imperial College London had completed enrollment of the LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). The LeoPARDS trial enrolled 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. Imperial College London currently expects to present the data from this study at a scientific conference during the second half of 2016.
- 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 is scheduled to receive the data from Imperial College London within 30 days of its publication or presentation; and following a recommendation from the FDA, Tenax now plans to conduct its own separate analysis of the 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.
- In April 2015, Tenax announced that its Board of Directors had approved a change in the Company’s fiscal year to a fiscal year beginning on January 1 and ending on December 31, such change beginning as of January 1, 2016. The Company’s next Annual Report on Form 10-K will be for the fiscal year ending December 31, 2016. The Company filed a Transition Report on Form 10-KT with the Securities and Exchange Commission (SEC) for the eight-month period ending December 31, 2015 on March 14, 2016, and will file its next Form 10-Q for the first quarter 2016 ending March 31, 2016.
Upcoming Expected Milestones and Events
- Two interim analyses during LEVO-CTS trial after 400 patients and 600 patients – with the 400-patient analysis testing for efficacy or futility expected during the second quarter of 2016
- Top-line data reported from Phase 3 LEVO-CTS trial by the end of 2016
- Data from LeoPARDS trial in the second half 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
Transition Period Financial Results for the eight months ended December 31, 2015
The Company reported a net loss of $10.1 million, or $0.36 per share, for the eight months ended December 31, 2015, compared to a net loss of $8.2 million, or $0.29 per share, during the same period in the prior year.
The Company reported general and administrative expenses of $3.9 million for the eight months ended December 31, 2015, compared to $4.4 million during the same period in the prior year.
The Company reported research and development expenses of $6.5 million for the eight months ended December 31, 2015, compared to $4.2 million during the same period in the prior year.
As of December 31, 2015, the Company had $38.2 million in cash, including the fair value of its marketable securities, compared to $48.1 million at April 30, 2015.
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 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.
The Tenax management team will host a call today at 8:30 a.m. ET to discuss its corporate update and 2015 transitional report financials.
To participate in the call, please dial 877?407?8029 (domestic) or 201?689?8029 (international) and refer to conference ID 13631862. 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, 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.
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||3,660,453||$||7,926,491||$||58,320,555|
|Government grant receivable||-||-||29,750|
|Other current assets||-||58,623||177,406|
|Total current assets||20,560,353||17,511,176||58,966,033|
|Property and equipment, net||35,786||50,322||124,374|
|Debt issuance costs, net||-||-||21,427|
|Intangible assets, net||22,000,000||22,000,000||22,999,744|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Notes payable, net||-||100,160||346,890|
|Total current liabilities||4,601,630||4,517,210||2,571,047|
|Deferred tax liability||7,962,100||7,962,100||7,962,100|
Preferred stock, undesignated, authorized 10,000,000
Common stock, par value $.0001 per share; authorized 400,000,000
|Additional paid-in capital||221,285,677||221,067,239||219,468,498|
|Accumulated other comprehensive (loss) gain||(129,442||)||26,718||-|
|Total stockholders’ equity||60,423,348||70,429,034||82,885,361|
|Total liabilities and stockholders' equity||$||72,987,078||$||82,908,344||$||93,429,440|
TENAX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|Year ended April 30,|
|Cost of sales||-||-||129,800||43,111|
|Net product revenue||-||-||(104,069||)||49,572|
|Government grant revenue||-||49,286||262,995||1,141,356|
|Total net revenue||-||49,286||158,926||1,190,928|
|General and administrative||3,940,631||7,170,779||13,773,325||3,676,145|
|Research and development||6,484,867||6,660,387||2,996,721||2,455,816|
|Loss on impairment of long-lived assets||-||1,034,863||-||27,279|
|Total operating expenses||10,425,498||14,866,029||16,770,046||6,379,955|
|Net operating loss||10,425,498||14,816,743||16,611,120||5,189,027|
|Other (income) expense||(359,041||)||(784,012||)||718,436||(11,683||)|
|Unrealized loss (gain) on marketable securities||156,160||(26,718||)||-||-|
|Total comprehensive loss||$||10,224,124||$||14,055,094||$||19,541,839||$||9,415,800|
|Reconciliation of net loss to net loss attributable to common stockholders|
|Preferred stock dividend||-||-||5,803,362||958,071|
|Net loss attributable to common stockholders||$||10,067,964||$||14,081,812||$||25,345,201||$||10,373,871|
|Net loss per share, basic||$||(0.36||)||$||(0.50||)||$||(2.71||)||$||(6.29||)|
|Weighted average number of common shares outstanding, basic||28,119,597||28,077,963||9,362,031||1,650,280|
|Net loss per share, diluted||$||(0.36||)||$||(0.50||)||$||(2.71||)||$||(6.68||)|
|Weighted average number of common shares outstanding, diluted||28,119,597||28,077,963||9,362,031||1,759,025|
Stern Investor Relations, Inc.
Jesse Baumgartner, 212-362-1200