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 reported financial results for the third quarter 2020 and provided a business update.
Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) on Wednesday, November 18, 2020 at 4:30 p.m. EST. The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. A live webcast of the Virtual R&D Webinar and accompanying slides will be available under “Events and Presentations” in the Investors section of the Company’s website at www.tenaxthera.com. The Virtual R&D Webinar can also be accessed by dialing (866) 301-1155 from the U.S. and (914) 987-7396 internationally, followed by the conference ID: 5783678. An archived webinar recording of the event will be available on the website for approximately 30 days.
“We are moving forward with our plan to enter Phase 3 of our clinical development program of levosimendan in PH-HFpEF and expect to reach an agreement with the FDA on a path forward before the end of the first quarter next year. The recent announcement related to adding the oral formulation of levosimendan by expanding our license agreement with Orion is an exciting opportunity for us. We believe an oral dosage form will be more convenient to patients in the Phase 3 program, thus potentially making the trial easier to enroll and perhaps shortening the overall time to complete the program. (Read more…) As we finalize our plans, we will provide additional updates,” stated Anthony DiTonno, Chief Executive Officer of Tenax. “We recently convened our Scientific Advisory Board to provide an in-depth review of the results of the HELP trial. The results of the Phase 2 trial received significant interest from the academic community at detailed presentations at the recent AHA and HFSA medical meetings. The R&D webinar on November 18th will be our first opportunity to provide access to a comprehensive review of the data to the investor community.”
Recent Highlights
- On November 13, 2020, data from the 24-hour open-label portion of the HELP Study was presented during the American Heart Association (AHA) Scientific Sessions 2020 by Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al. The Phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan’s hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the pre-specified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.
- On October 9, 2020, Tenax signed an amendment to the existing licensing agreement with Orion Pharmaceuticals to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure related indications. The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive development and commercialization rights to in the US and Canada under the existing license agreement. Tenax expects to use the oral formulation in its upcoming Phase 3 trial in PH-HFpEF.
- On October 3, 2020, detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting by Barry Borlaug, MD, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic.
Financial Results
- Research and development expenses for the third quarter of 2020 were $1.0 million, compared to $900,000 for the third quarter of 2019.
- General and administrative expenses for the third quarter of 2020 were $1.2 million, compared to $1.3 million for the third quarter of 2019.
- Net loss for the third quarter of 2020 was $2.2 million, or $0.18 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the third quarter of 2019.
- Cash, cash equivalents and marketable securities totaled $8.7 million as of September 30, 2020, compared with $5.4 million as of December 31, 2019.
- Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.
About Phase 2 HELP Trial
The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated a significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
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, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, 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 STATEMENTS OF COMPREHENSIVE LOSS |
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Three months ended September 30, |
|
|
Nine months ended September 30, |
||||||||||||||
|
2020 |
|
2019 |
|
|
2020 |
|
2019 |
||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
| Operating expenses | |||||||||||||||||
| General and administrative |
$ |
1,172,725 |
|
$ |
1,343,429 |
|
$ |
3,364,890 |
|
$ |
3,692,843 |
|
|||||
| Research and development |
|
1,052,398 |
|
|
916,984 |
|
|
3,669,761 |
|
|
2,049,004 |
|
|||||
| Total operating expenses |
|
2,225,123 |
|
|
2,260,413 |
|
|
7,034,651 |
|
|
5,741,847 |
|
|||||
| Net operating loss |
|
2,225,123 |
|
|
2,260,413 |
|
|
7,034,651 |
|
|
5,741,847 |
|
|||||
| Interest expense |
|
610 |
|
|
– |
|
|
1,016 |
|
|
– |
|
|||||
| Other income, net |
|
(5,298 |
) |
|
(36,709 |
) |
|
(14,038 |
) |
|
(139,161 |
) |
|||||
| Net loss |
$ |
2,220,435 |
|
$ |
2,223,704 |
|
$ |
7,021,629 |
|
$ |
5,602,686 |
|
|||||
| Unrealized loss (gain) on marketable securities |
|
1,171 |
|
|
960 |
|
|
(445 |
) |
|
(803 |
) |
|||||
| Total comprehensive loss |
$ |
2,221,606 |
|
$ |
2,224,664 |
|
$ |
7,021,184 |
|
$ |
5,601,883 |
|
|||||
| Net loss per share, basic and diluted |
$ |
(0.18 |
) |
$ |
(0.33 |
) |
$ |
(0.73 |
) |
$ |
(0.93 |
) |
|||||
| Weighted average number of common shares outstanding, basic and diluted |
|
12,427,355 |
|
|
6,741,084 |
|
|
9,590,741 |
|
|
6,011,304 |
|
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TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
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| September 30, 2020 | December 31, 2019 | ||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents |
$ |
8,235,532 |
|
$ |
4,905,993 |
|
|
| Marketable securities |
|
472,648 |
|
|
493,884 |
|
|
| Prepaid expenses |
|
189,275 |
|
|
780,952 |
|
|
| Total current assets |
|
8,897,455 |
|
|
6,180,829 |
|
|
| Right of use asset |
|
87,285 |
|
|
169,448 |
|
|
| Property and equipment, net |
|
3,461 |
|
|
6,559 |
|
|
| Other assets |
|
8,435 |
|
|
8,435 |
|
|
| Total assets |
$ |
8,996,636 |
|
$ |
6,365,271 |
|
|
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable |
$ |
1,052,824 |
|
$ |
1,661,054 |
|
|
| Accrued liabilities |
|
295,451 |
|
|
871,341 |
|
|
| Note payable |
|
30,900 |
|
|
– |
|
|
| Total current liabilities |
|
1,379,175 |
|
|
2,532,395 |
|
|
| Long term liabilities | |||||||
| Note payable |
|
213,757 |
|
|
– |
|
|
| Lease liability |
|
– |
|
|
60,379 |
|
|
| Total long term liabilities |
|
213,757 |
|
|
60,379 |
|
|
| Total liabilities |
|
1,592,932 |
|
|
2,592,774 |
|
|
| Commitments and contingencies; see Note 7 | |||||||
| Stockholders’ equity | |||||||
| Preferred stock, undesignated, authorized 9,999,790 shares; See Note 8 | |||||||
| Series A Preferred stock, par value $.0001, issued and outstanding 210 and 38,606, respectively |
|
– |
|
|
4 |
|
|
| Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 12,619,369 and 6,741,860, respectively |
|
1,262 |
|
|
674 |
|
|
| Additional paid-in capital |
|
250,591,604 |
|
|
239,939,797 |
|
|
| Accumulated other comprehensive gain |
|
903 |
|
|
458 |
|
|
| Accumulated deficit |
|
(243,190,065 |
) |
|
(236,168,436 |
) |
|
| Total stockholders’ equity |
|
7,403,704 |
|
|
3,772,497 |
|
|
| Total liabilities and stockholders’ equity |
$ |
8,996,636 |
|
$ |
6,365,271 |
|
|
Contacts
Investor Contact:
Westwicke, an ICR Company
Stephanie Carrington, 646-277-1282
stephanie.carrington@westwicke.com