We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Tenax Therapeutics Inc | NASDAQ:TENX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.12 | -3.33% | 3.48 | 3.50 | 3.57 | 3.5694 | 3.47 | 3.55 | 16,887 | 00:21:27 |
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
Financial Results
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200817005136/en/
Investor Contact: Westwicke, an ICR Company Stephanie Carrington, 646-277-1282 stephanie.carrington@westwicke.com
1 Year Tenax Therapeutics Chart |
1 Month Tenax Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions