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Tenax Therapeutics, Inc. (NASDAQ:TENX) Is a professional pharmaceutical company that focuses on identifying, developing and commercializing cardiovascular and pulmonary disease products with highly unmet medical needs. It today reported its financial results for the first quarter of 2021 and provided a business update.
Tenax CEO Anthony DiTonno said: “The merger with PHPrecisionMed Inc. has been completed. We now have product development plans in the first and second groups of patients with pulmonary hypertension, which accounts for more than 70% of the entire market.
“We have started an open-label transition study using the oral formulation of Levosimendan, which was obtained from our agreement with Orion. The purpose of this study is to determine the dose that we will enter the Phase III trial in 2022. Participants who participated in the study took them back to the clinic in our publicly labelled Phase 2 HELP trial and converted them to oral dosage forms. We believe that oral delivery is more convenient for patients than intravenous administration once a week, and The blood level of Levosimendan is more stable.
“As far as the Imatinib program is concerned, we are in the final stage of formulation development. As a reminder, this new formulation is expected to solve the gastrointestinal side effects previously associated with oral administration. A properly formulated formulation will be used in pulmonary arterial hypertension (PAH). ) It has shown great clinical benefits in the patient population and may become the first disease-relief therapy for this indication. The new preparation will be tested in the Phase 1 study, and we expect it to be completed in the second half of this year.”
Recent highlights
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On April 9, 2021, Tenax announced the release of positive data from the company’s Phase 2 HELP study, which evaluated levosimendan’s ejection fraction (PH-HFpEF) maintenance in patients with pulmonary hypertension and heart failure constant.The title of the new publication is Levosimendan improves hemodynamics and exercise tolerance of PH-HFpEF: results of a placebo-controlled HELP trial And published in Journal of the American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
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On January 19, 2021, Tenax announced the acquisition of PHPrecisionMed Inc. (PHPM), a private clinical stage biotechnology company dedicated to the development of imatinib to treat pulmonary arterial hypertension (PAH). The FDA has granted imatinib the title of orphan drug for the treatment of PAH, which is an indication for unmet medical needs. The acquisition of PHPM immediately expanded Tenax’s business scope to include the second phase 3 ready drug candidate that has been out of danger, which is expected to become the first disease treatment to improve PAH.
Financial performance
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Research and development expenses in the first quarter of 2021 are US$22.4 million, while research and development expenses in the first quarter of 2020 are US$1.3 million. The increase in research and development expenses during the current period is mainly due to the confirmation that approximately US$21.8 million in ongoing research and development (IPR&D) expenses is attributable to the acquisition of PHPM in January 2021.
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General and administrative expenses for the first quarter of 2021 are US$1.4 million, while general and administrative expenses for the first quarter of 2020 are US$1.3 million.
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The net loss for the first quarter of 2021 was $23.7 million, or $1.64 per share, while the net loss for the first quarter of 2020 was $2.7 million, or $0.38 per share.
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As of March 31, 2021, cash, cash equivalents and marketable securities totaled $4 million, while as of December 31, 2020, cash, cash equivalents and marketable securities totaled $6.7 million.
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Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund the current business in the third quarter of 2021.
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a professional pharmaceutical company dedicated to identifying, developing and commercializing products for cardiovascular and pulmonary diseases that meet high unmet medical needs. The company has a world-class scientific consulting team, including globally recognized experts in pulmonary hypertension. The company has the North American rights to develop and commercialize Levosimendan, and recently released the Heart Failure Association of America (HFSA) on Levosimendan for the treatment of Levosimendan related to pulmonary hypertension related to heart failure and ejection fraction. Detailed results of the second phase of the HELP study) virtual annual scientific conference. Tenax is also developing a sustained-release oral formulation of imatinib based on the 505(b)(2) route as a pivotal trial, which aims to avoid gastric irritation.For more information, please visit www.tenaxthera.com.
About Zuoximendan
Levosimendan is a calcium sensitizer that works through a unique triple action mechanism. It was originally developed for intravenous use in hospitalized patients with acute decompensated heart failure. It was discovered and developed by Orion Pharma of Orion Corporation of Espoo, Finland, and is currently approved for this indication in more than 60 countries and is not available in the United States. Tenax Therapeutics obtained the development and commercialization rights of Levosimendan in North America from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative drug developed to target BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. Imatinib’s inhibitory effect on PDGF receptor and c-KIT indicates that it may be effective in PAH. Imatinib can reverse experimentally induced pulmonary hypertension, has a pulmonary vasodilator effect in animal models, and has a pro-apoptotic effect on pulmonary artery smooth muscle cells in patients with idiopathic PAH. In phase 3 clinical trials, imatinib can significantly improve exercise performance, but the high dropout rate due largely to gastric intolerance prevented regulatory approval.
Warning about forward-looking statements
This press release contains certain forward-looking statements of the company that involve risks and uncertainties and reflect the company’s judgment on the date of this press release. Forward-looking statements are subject to a variety of risks and uncertainties, including but not limited to matters outside the company’s control, which may cause delays in clinical research, new product launches, and customer acceptance of these new products; the company has no control , The matters that may affect the company’s continued compliance with the NASDAQ listing requirements; the impact of management changes on the company’s business and the unexpected expenses, costs and expenditures that may occur due to management changes; and the company’s submission to U.S. Securities Other risks and uncertainties described in the Exchange Commission’s documents include the annual report on Form 10-K filed on March 31, 2021 and the quarterly report on Form 10-Q filed on May 17, 2021, as well as to U.S. Securities Other documents submitted by the Exchange Commission (SEC). The company assumes no intention or obligation to update these forward-looking statements after the date of this news release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995.
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TENAX THERAPEUTICS, INC. |
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|
Condensed comprehensive loss table |
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For the three months ended March 31, |
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|
2021 |
2020 year |
|||||||
|
(Unaudited) |
(Unaudited) |
|||||||
| Operating expenses | ||||||||
| General and administrative |
$ |
1,373,460 |
|
$ |
1,322,959 |
|
||
| Research and development |
|
22,376,202 |
|
|
1,342,526 |
|
||
| Total operating expenses |
|
23,749,662 |
|
|
2,665,485 |
|
||
| Net operating loss |
|
23,749,662 |
|
|
2,665,485 |
|
||
| Interest expense |
|
613 |
|
|
– |
|
||
| Other income, net |
|
(2,135 |
) |
|
(10,841 |
) |
||
| Net loss |
$ |
23,748,140 |
|
$ |
2,654,644 |
|
||
| Unrealized loss of securities |
|
332 |
|
|
1,622 |
|
||
| Total comprehensive loss |
$ |
23,748,472 |
|
$ |
2,656,266 |
|
||
| Basic and diluted net loss per share |
$ |
(1.64 |
) |
$ |
(0.38 |
) |
||
| Weighted average number of issued, basic and diluted common shares |
|
14,515,088 |
|
|
6,974,387 |
|
||
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TENAX THERAPEUTICS, INC. |
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Concise comprehensive balance sheet |
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March 31, 2021 |
December 31, 2020 |
||||||
|
(Unaudited) |
|||||||
|
assets |
|||||||
| Current assets | |||||||
| Cash and cash equivalents |
$ |
3,536,787 |
|
$ |
6,250,241 |
|
|
| Securities |
|
494,877 |
|
|
462,687 |
|
|
| Prepaid fees |
|
485,935 |
|
|
82,578 |
|
|
| Total current assets |
|
4,517,599 |
|
|
6,795,506 |
|
|
| Right-of-use asset |
|
29,690 |
|
|
58,778 |
|
|
| Property and equipment net |
|
4,837 |
|
|
5,972 |
|
|
| Other assets |
|
8,435 |
|
|
8,435 |
|
|
| Total assets |
$ |
4,560,561 |
|
$ |
6,868,691 |
|
|
|
Liabilities and shareholders’ equity |
|||||||
| Current liabilities | |||||||
| accounts payable |
$ |
997,443 |
|
$ |
757,856 |
|
|
| Estimated liabilities |
|
222,780 |
|
|
1,240,616 |
|
|
| Bills payable |
|
213,577 |
|
|
120,491 |
|
|
| Total current liabilities |
|
1,433,800 |
|
|
2,118,963 |
|
|
| Long-term liabilities | |||||||
| Bills payable |
|
31,080 |
|
|
124,166 |
|
|
| Total long-term liabilities |
|
31,080 |
|
|
124,166 |
|
|
| Total liabilities |
|
1,464,880 |
|
|
2,243,129 |
|
|
| Commitments and contingencies; see note 8 | |||||||
| Shareholders’ equity | |||||||
| Not designated preferred shares, 9,989,558 authorized shares; see Note 9 | |||||||
| Issue 5,181,346 shares, A shares, A series preferred shares with a par value of $ .0001; Excellent 210 |
|
– |
|
|
– |
|
|
| B shares, preferred shares with a par value of $.0001, 10,232 shares have been issued; outstanding 10,232 and 0 respectively |
|
1 piece |
|
|
– |
|
|
| Common shares with a par value of $.0001 each; 400,000,000 authorized shares; 14,969,312 and 12,619,369 issued and outstanding |
|
1,497 |
|
|
1,262 |
|
|
| Additional payment of capital |
|
272,862,552 |
|
|
250,644,197 |
|
|
| Cumulative other comprehensive loss |
|
(402 |
) |
|
(70 |
) |
|
| Accumulated deficit |
|
(269,767,967 |
) |
|
(246,019,827 |
) |
|
| Total shareholders’ equity |
|
3,095,681 |
|
|
4,625,562 |
|
|
| Total liabilities and shareholders’ equity |
$ |
4,560,561 |
|
$ |
6,868,691 |
|
|
View the source code version on businesswire.com: https://www.businesswire.com/news/home/20210517005819/zh/
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