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 second quarter 2020 and provided a business update.
“The recently completed Phase 2 trial of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) has garnered significant attention from the medical community. Specifically members of our Scientific Advisory Board are very encouraged by the statistically significant biventricular hemodynamic response and statistically significant clinical effect on the 6 minute walk parameter.” stated Anthony DiTonno, Chief Executive Officer of Tenax. “We believe these Phase 2 data support advancing into pivotal trials and ultimately pursuing a potential registration. As such, we intend to seek regulatory feedback on next steps for this program during the fourth quarter. Moreover, we plan to provide additional data from this trial at medical meetings later this year.”
Recent Highlights
- In June 2020, Tenax reported positive data from its recently completed Phase 2 HELP trial of levosimendan in patients with PH-HFpEF. In this 37 patient study, the primary efficacy analysis, pulmonary capillary wedge pressure (PCWP) during exercise did not demonstrate a statistically significant reduction from baseline. Levosimendan did demonstrate a statistically significant reduction in PCWP compared to baseline (p=<0.0017) and placebo (p=<0.0475), when the measurements at rest, with legs up and on exercise were combined. The clinical efficacy of levosimendan was confirmed in this trial by a statistically significant improvement in 6-minute walk distance (6MWD) as compared to placebo (p=0.0329). (Read more…)
- In June 2020, Tenax received approximately $1.7 million and issued 877,203 shares of common stock upon the exercise of previously outstanding warrants.
- On July 6, 2020, the Company entered into a Securities Purchase Agreement for Class C and Class D Units (the “RDO Purchase Agreement”) and a Securities Purchase Agreement for Class E and Class F Units (the “PIPE Purchase Agreement” and, together with the RDO Purchase Agreement, the “Purchase Agreements”) with the Investor, pursuant to which the Company agreed to issue in a registered direct offering 2,523,611 shares of the company’s common stock, $0.0001 par value per share, at a purchase price of $1.02780 per share and pre-funded warrants (the “Registered Pre-Funded Warrants”) to purchase up to 652,313 shares of common stock at a purchase price of $1.02770 per Registered Pre-Funded Warrant, and issuing a concurrent private placement unregistered pre-funded warrants (the “Unregistered Pre-Funded Warrants”) to purchase up to 4,607,692 shares of common stock at the same purchase price as the Registered Pre-Funded Warrants, and unregistered common stock warrants (the “Unregistered Warrants”) to purchase up to 7,783,616 shares of common stock (such registered direct offering and private placement, collectively, the “Offerings”). The aggregate net proceeds to the Company of the Offerings was approximately $6.5 million.
- On July 20, 2020, pursuant to the terms of the PIPE Purchase Agreement, Tenax appointed Steven J. Boyd and Keith Maher, MD to its Board of Directors.
Financial Results
- Research and development expenses for the second quarter of 2020 were $1.3 million, compared to $650,000 for the second quarter of 2019.
- General and administrative expenses for the second quarter of 2020 were $870,000, compared to $1.2 million for the second quarter of 2019.
- Net loss for the second quarter of 2020 was $2.1 million, or $0.23 per share, compared to a net loss of $1.8 million, or $0.28 per share, for the second quarter of 2019.
- Cash, cash equivalents and marketable securities totaled $4.6 million as of June 30, 2020, compared with $5.4 million as of December 31, 2019.
- Management expects that current cash, cash equivalents and marketable securities, including the proceeds from the July offerings, will be sufficient to fund current operations into the third quarter of 2021.
About Phase 2 HELP Trial
The HELP Trial – Hemodynamic Evaluation of Levosimendan in PH-HFpEF is 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). The trial has a predefined response criterion that patients must meet following a 24-hour open-label infusion of levosimendan before they can be randomized to the 6-week double-blind phase of the trial. The criterion for randomization is a reduction in PCWP during supine exercise of ≥ 4mmHg following the open-label infusion when compared with each patient’s baseline exercise PCWP. The primary endpoint of the HELP Trial is based on change in PCWP vs baseline compared to placebo.
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 August 14, 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.
|
TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
|||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
| Operating expenses | |||||||||||||||||
| General and administrative |
$ |
869,206 |
|
$ |
1,170,405 |
|
$ |
2,192,165 |
|
$ |
2,349,415 |
|
|||||
| Research and development |
|
1,274,837 |
|
|
649,254 |
|
|
2,617,363 |
|
|
1,132,020 |
|
|||||
| Total operating expenses |
|
2,144,043 |
|
|
1,819,659 |
|
|
4,809,528 |
|
|
3,481,435 |
|
|||||
| Net operating loss |
|
2,144,043 |
|
|
1,819,659 |
|
|
4,809,528 |
|
|
3,481,435 |
|
|||||
| Interest expense |
|
406 |
|
|
– |
|
|
406 |
|
|
– |
|
|||||
| Other expense (income), net |
|
2,101 |
|
|
(58,122 |
) |
|
(8,740 |
) |
|
(102,453 |
) |
|||||
| Net loss |
$ |
2,146,550 |
|
$ |
1,761,537 |
|
$ |
4,801,194 |
|
$ |
3,378,982 |
|
|||||
| Unrealized gain on marketable securities |
|
(3,238 |
) |
|
(474 |
) |
|
(1,616 |
) |
|
(1,763 |
) |
|||||
| Total comprehensive loss |
$ |
2,143,312 |
|
$ |
1,761,063 |
|
$ |
4,799,578 |
|
$ |
3,377,219 |
|
|||||
| Net loss per share, basic and diluted |
$ |
(0.23 |
) |
$ |
(0.28 |
) |
$ |
(0.59 |
) |
$ |
(0.60 |
) |
|||||
| Weighted average number of common shares outstanding, basic and diluted |
|
9,339,309 |
|
|
6,385,381 |
|
|
8,156,848 |
|
|
5,640,367 |
|
|||||
|
TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
| June 30, 2020 | December 31, 2019 | ||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents |
$ |
4,085,305 |
|
$ |
4,905,993 |
|
|
| Marketable securities |
|
468,218 |
|
|
493,884 |
|
|
| Prepaid expenses |
|
660,906 |
|
|
780,952 |
|
|
| Total current assets |
|
5,214,429 |
|
|
6,180,829 |
|
|
| Marketable securities |
|
10,723 |
|
|
– |
|
|
| Right of use asset |
|
115,225 |
|
|
169,448 |
|
|
| Property and equipment, net |
|
4,409 |
|
|
6,559 |
|
|
| Other assets |
|
8,435 |
|
|
8,435 |
|
|
| Total assets |
$ |
5,353,221 |
|
$ |
6,365,271 |
|
|
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable |
$ |
1,555,038 |
|
$ |
1,661,054 |
|
|
| Accrued liabilities |
|
524,356 |
|
|
871,341 |
|
|
| Note payable |
|
107,606 |
|
|
– |
|
|
| Total current liabilities |
|
2,187,000 |
|
|
2,532,395 |
|
|
| Long term liabilities | |||||||
| Note payable |
|
137,051 |
|
|
– |
|
|
| Lease liability |
|
– |
|
|
60,379 |
|
|
| Total long term liabilities |
|
137,051 |
|
|
60,379 |
|
|
| Total liabilities |
|
2,324,051 |
|
|
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 10,095,758 and 6,741,860, respectively |
|
1,010 |
|
|
674 |
|
|
| Additional paid-in capital |
|
243,995,716 |
|
|
239,939,797 |
|
|
| Accumulated other comprehensive gain |
|
2,074 |
|
|
458 |
|
|
| Accumulated deficit |
|
(240,969,630 |
) |
|
(236,168,436 |
) |
|
| Total stockholders’ equity |
|
3,029,170 |
|
|
3,772,497 |
|
|
| Total liabilities and stockholders’ equity |
$ |
5,353,221 |
|
$ |
6,365,271 |
|
|
Contacts
Investor Contact:
Westwicke, an ICR Company
Stephanie Carrington, 646-277-1282
stephanie.carrington@westwicke.com