Tenax Therapeutics Announces Third Quarter Fiscal Year 2015 Financial Results
- Significant enrollment progress for Phase 3 LEVO-CTS trial in LCOS and LeoPARDS trial in septic shock –
- Announced appointment of Paula Bokesch, M.D., as Chief Medical Officer –
- Analyst Day on April 13 in New York City –
- Conference call today at 8:30 am ET –
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced financial results for the third quarter fiscal year 2015 ended January 31, 2015.
“We have continued to execute on our development plan for levosimendan, with 41 patients now enrolled in our Phase 3 LEVO-CTS trial in low cardiac output syndrome and 40 hospitals activated,” said John Kelley, Chief Executive Officer of Tenax. “We anticipate continued enrollment acceleration through the first half of this calendar year, and we will benefit greatly from the clinical leadership of Dr. Paula Bokesch, our new chief medical officer.
“We also highlighted 2 recent scientific publications that clearly show the potential benefits of levosimendan in the cardiac surgery setting, including superiority compared to other inodilatory agents, which reinforces our confidence in a positive readout for LEVO-CTS in early 2016. We look forward to discussing this data for levosimendan at our upcoming Analyst Day in New York on April 13, which will feature a number of outside speakers with significant levosimendan clinical experience.
“Finally, we remain very encouraged by the pace of enrollment in the LeoPARDS trial for levosimendan in septic shock being conducted by Imperial College London, which we provided supplementary funding to in August 2014. Following our meeting with the U.S. Food and Drug Administration (FDA) in November, we are currently evaluating the potential statistical analysis plan for this trial with Imperial College London.”
Recent Highlights
- Today, Tenax announced that the Company has currently enrolled 41 patients in the LEVO-CTS trial, and has 40 clinical sites activated with an additional 8 sites where contract negotiations have been completed. The Company also disclosed that it has discussions ongoing with an additional 13 U.S. sites.
- In February, Health Canada gave Tenax approval to include Canadian hospitals in the LEVO-CTS trial. Thus far, 11 hospitals have been identified as possible sites.
- In February, Tenax announced the appointment of Paula Bokesch, M.D., as chief medical officer. Dr. Bokesch will direct clinical development for the Company’s lead asset, levosimendan, including the current Phase 3 LEVO-CTS trial to evaluate the use of levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing LCOS.
-
In March, the Company highlighted two recently-published scientific
articles on the potential benefits of levosimendan in patients
undergoing cardiac surgery:
- Toller, et al (International Journal of Cardiology) provided a review of the scientific literature as well as consensus recommendations from a panel of 27 experts from 18 countries regarding the preoperative use of levosimendan in cardiac surgery patients. Their recommendations support the LEVO-CTS study design in several ways and conclude that levosimendan acts as a “safety net in the surgical setting” by improving haemodynamics and “reducing the need for inotropic agents and mechanical circulatory support.”
- Greco, et al (British Journal of Anaesthesia) detailed a meta-analysis that assesses differences in mortality associated with various inodilator products that are commonly used in critical care patients. Their study included 46 trials published between 1995-2014 and concluded that levosimendan appears to be the most efficacious inodilator product to improve survival when used in cardiac surgery patients.
- 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 March 16, 2015, the trial had enrolled 250 out of an estimated 516 patients.
Upcoming Expected Milestones and Events
- Analyst Day on April 13, 2015, in New York City, featuring outside speakers with significant levosimendan clinical experience and multiple LEVO-CTS steering committee members
- Expected event rate interim analysis following enrollment of 200 patients in LEVO-CTS trial, by summer of 2015
- 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
- Enrollment completed for LEVO-CTS trial by end of calendar year 2015
- Full data reported from Phase 3 LEVO-CTS trial in first calendar quarter of 2016
- Data reported from LeoPARDS trial for levosimendan in septic shock in calendar year 2016
Third Quarter Fiscal Year 2015 Financial Results
The Company reported a net loss of $2.9 million or $0.10 per share in the third quarter fiscal year 2015, compared to a net loss of $3.4 million, or $0.43 per share in the same period in fiscal 2014.
The Company reported general and administrative expenses of $1.9 million in the third quarter fiscal year 2015, compared to $1.8 million in the same period in fiscal 2014.
The Company reported research and development expenses of $1.2 million in the third quarter fiscal year 2015, compared to $0.7 million in the same period in fiscal 2014.
As of January 31, 2015, the Company had $50.1 million in cash, including the fair value of its marketable securities, compared to $58.3 million at April 30, 2014.
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 fiscal year 2017.
Michael Jebsen, Chief Financial Officer, said: "We believe that our current capital will be sufficient to fund our levosimendan program in LCOS through a New Drug Application filing. We also remain in a strong position to proactively evaluate business development opportunities during calendar year 2015, including levosimendan’s expansion in septic shock and potential additional candidates that fit into our critical care pipeline strategy.”
Conference Call
The Tenax management team will host a call today at 8:30am ET to discuss financial results for the third quarter fiscal year 2015.
To participate in the call, please dial 877‐407‐8029 (domestic) or 201‐689‐8029 (international) and refer to conference ID 13603008. 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. (formerly Oxygen Biotherapeutics) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of 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. 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 March 17, 2015 and annual report on Form 10-K filed on July 29, 2014, 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.CONSOLIDATED BALANCE SHEETS
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|||||
| January 31, 2015 | April 30, 2014 | ||||
| (Unaudited) | |||||
| ASSETS | |||||
| Current assets | |||||
| Cash and cash equivalents | $ | 9,915,479 | $ | 58,320,555 | |
| Marketable securities | 7,159,176 | - | |||
| Accounts receivable | 64,662 | 36,358 | |||
| Government grant receivable | - | 29,750 | |||
| Prepaid expenses | 348,151 | 401,964 | |||
| Other current assets | 181,834 | 177,406 | |||
| Total current assets | 17,669,302 | 58,966,033 | |||
| Marketable securities | 32,995,677 | - | |||
| Property and equipment, net | 67,460 | 124,374 | |||
| Debt issuance costs, net | - | 21,427 | |||
| Intangible assets, net | 23,038,469 | 22,999,744 | |||
| Goodwill | 11,265,100 | 11,265,100 | |||
| Other assets | 1,156,785 | 52,762 | |||
| Total assets | $ | 86,192,793 | $ | 93,429,440 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities | |||||
| Accounts payable | $ | 425,231 | $ | 411,145 | |
| Accrued liabilities | 1,711,012 | 858,136 | |||
| Warrant liabilities | 579,660 | 954,876 | |||
| Notes payable, net | 151,255 | 346,890 | |||
| Total current liabilities | 2,867,158 | 2,571,047 | |||
| Other liabilities | - | 10,932 | |||
| Deferred tax liability | 7,962,100 | 7,962,100 | |||
| Total liabilities | 10,829,258 | 10,544,079 | |||
| Stockholders' equity | |||||
| Preferred stock, undesignated, authorized 9,947,439 | - | - | |||
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Common stock, par value $.0001 per share; authorized 400,000,000shares; issued and outstanding 28,119,436 and 27,858,000,respectively |
2,812 | 2,786 | |||
| Additional paid-in capital | 220,987,935 | 219,468,498 | |||
| Accumulated other comprehensive gain | 53,432 | - | |||
| Accumulated deficit | (145,680,644) | (136,585,923) | |||
| Total stockholders’ equity | 75,363,535 | 82,885,361 | |||
| Total liabilities and stockholders' equity | $ | 86,192,793 | $ | 93,429,440 | |
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TENAX THERAPEUTICS, INC.CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
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| Three months ended January 31, | Nine months ended January 31, | |||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||
| Product revenue | $ | - | $ | 590 | $ | - | $ | 60,669 | ||||
| Cost of sales | - | 410 | - | 31,275 | ||||||||
| Net product revenue | - | 180 | - | 29,394 | ||||||||
| Government grant revenue | - | 41,684 | - | 233,981 | ||||||||
| Total net revenue | - | 41,864 | - | 263,375 | ||||||||
| Operating expenses | ||||||||||||
| General and administrative | 1,907,482 | 1,783,596 | 4,943,683 | 4,187,522 | ||||||||
| Research and development | 1,227,190 | 689,666 | 4,750,556 | 2,211,124 | ||||||||
| Total operating expenses | 3,134,672 | 2,473,262 | 9,694,239 | 6,398,646 | ||||||||
| Net operating loss | 3,134,672 | 2,431,398 | 9,694,239 | 6,135,271 | ||||||||
| Interest expense | 968 | 69,967 | 47,288 | 2,142,627 | ||||||||
| Other (income) expense | (267,294) | 849,556 | (646,806) | 849,782 | ||||||||
| Net loss | $ | 2,868,346 | $ | 3,350,921 | $ | 9,094,721 | $ | 9,127,680 | ||||
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Unrealized (gain) loss on marketablesecurities |
(95,738) | - | (53,432) | - | ||||||||
| Total comprehensive loss | $ | 2,772,608 | $ | 3,350,921 | $ | 9,041,289 | $ | 9,127,680 | ||||
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Reconciliation of net loss to net lossattributable to common stockholders |
||||||||||||
| Net loss | 2,868,346 | 3,350,921 | 9,094,721 | 9,127,680 | ||||||||
| Preferred stock dividend | - | 1,095,822 | - | 5,742,162 | ||||||||
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Net loss attributable to commonstockholders |
$ | 2,868,346 | $ | 4,446,743 | $ | 9,094,721 | $ | 14,869,842 | ||||
| Net loss per share, basic | $ | (0.10) | $ | (0.43) | $ | (0.32) | $ | (2.56) | ||||
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Weighted average number of commonshares outstanding, basic |
28,119,360 | 10,260,021 | 28,064,589 | 5,811,162 | ||||||||
| Net loss per share, diluted | $ | (0.10) | $ | (0.44) | $ | (0.32) | $ | (2.58) | ||||
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Weighted average number of commonshares outstanding, diluted |
28,119,360 | 10,266,601 | 28,064,589 | 5,817,819 | ||||||||
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Source: Tenax Therapeutics, Inc.