TENX Tenax Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
Levosimendan
Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
|
Phase 2
Phase 2
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
|
Phase 3
Phase 3
|
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
|
|
Levosimendan
Septic shock
|
Phase 2b
Phase 2b
|
Phase 2b trial did not meet primary endpoint.
|
Latest News
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Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that management is scheduled to present and conduct one-on-one meetings at the H.C. Wainwright 22nd Annual Global Investment Conference to be held virtually on September 14th-16th. Anthony DiTonno, Chief Executive Officer, is scheduled to present on Wednesday, September 16th at 10:30 a.m. Eastern Time.
A webcast of the presentation will be available on the "Events and Presentations" page of the Investors section of the Company's website. A replay of the webcast will be available for 30 days following the event. For more information, please visit investors.tenaxthera.com.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200901005031/en/
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- HELP Study results, evaluating levosimendan in patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF), will be presented during a Late-Breaking Clinical Trial session during the HFSA Annual Scientific Meeting
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF have been accepted for presentation as a Late-Breaking Clinical Trial at this year's Heart Failure Society of America (HFSA) Annual Scientific Meeting to be held September 30, 2020-October 6, 2020.
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.
Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.
Tenax CEO Anthony DiTonno stated "We are very excited to have the HELP Study results accepted for presentation as a late-breaking abstract at the HFSA Annual Meeting. The positive results of the HELP Study represent a major milestone for Tenax and our development of levosimendan for the treatment of patients suffering from this debilitating illness. Based on feedback from our advisors, we believe the results may represent a potential breakthrough in the treatment of PH-HFpEF patients, and we look forward to having the detailed trial results presented at this major scientific forum."
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 of 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200831005037/en/
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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).
- 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200817005136/en/
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Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the expansion of its Board of Directors with the appointment of Steven Boyd and Keith Maher, M.D. Both Directors are from Armistice Capital, LLC, which recently purchased the Company's equity securities for aggregate gross proceeds of approximately $8.0 million in a registered direct offering and concurrent private placement.
Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics remarked, "We are pleased to welcome Steven and Keith to our Board. Steve has an outstanding reputation as a healthcare investor and brings a wealth of experience advising and investing in specialty pharmaceutical companies like Tenax. We believe his experience and insights will serve the Company well as we continue to build upon our recently reported positive Phase 2 results for levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). We also believe Keith's background will be invaluable to Tenax as the Company engages with the FDA and finalizes its Phase 3 program for levosimendan in PH-HFpEF patients. We look forward to working with Steve and Keith as our newest Board members as we seek to grow our product portfolio and expand the Company's development and commercial capabilities."
Mr. Boyd stated, "I am honored to join the Board of Directors of Tenax. Levosimendan represents a pipeline within a product and we look forward to working with Ron and Tony to expeditiously realize its tremendous value for patients and shareholders."
Mr. Boyd has served since 2012 as the chief investment officer of Armistice Capital, LLC ("Armistice"), a long-short equity hedge fund focused on the health care and consumer sectors. From 2005 to 2012, Mr. Boyd was a research analyst at Senator Investment Group, York Capital and SAB Capital Management, where he focused on health care. Mr. Boyd began his career as an analyst at McKinsey & Company. Mr. Boyd currently serves as a member of the boards of directors of Tetraphase Pharmaceuticals Inc., Aytu BioScience, Inc., Cerecor Inc., EyeGate Pharmaceuticals, Inc. and Vaxart, Inc. Mr. Boyd received a B.S. in economics and a B.A. in political science from The Wharton School of the University of Pennsylvania.
Dr. Maher has served as a managing director at Armistice since 2019. From 2007 to 2018, Dr. Maher held senior roles at Schroder Investment Management, Omega Advisors and Gracie Capital. Dr. Maher joined Gracie from Valesco Healthcare Partners, a global healthcare fund he founded in partnership with Paramount Bio Capital. Prior to starting Valesco, Dr. Maher was a managing director at Weiss, Peck & Greer Investments ("WPG"). He joined WPG from Lehman Brothers, where he worked as an equity research analyst covering medical device and technology companies. Dr. Maher currently serves on the boards of directors of Tetraphase Pharmaceuticals Inc., EyeGate Pharmaceuticals, Inc. and Vaxart, Inc. Dr. Maher received a B.A. in biology from Boston University, an M.B.A. from Northwestern University's Kellogg Graduate School of Management and an M.D. from Albany Medical College. Dr. Maher completed his clinical training at the Mount Sinai Medical Center in the Department of Medicine.
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 reported positive results from its 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 of Form 10-Q filed on May 15, 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.View source version on businesswire.com: https://www.businesswire.com/news/home/20200720005145/en/
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Tenax Therapeutics, Inc. (NASDAQ:TENX) ("Tenax" or the "Company"), a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 2,523,611 shares of its common stock at a purchase price of $1.02780 per share and pre-funded warrants to purchase up to 652,313 shares of common stock, at a purchase price of $1.02770 per pre-funded warrant (which represents the per share offering price for the common stock less the $0.0001, the exercise price of each pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, Tenax has also agreed to issue to the investor pre-funded warrants to purchase up to 4,607,692 shares of common stock, at the same purchase price as in the registered direct offering, as well as unregistered warrants to purchase up to an aggregate of 7,783,616 shares of common stock. The aggregate gross proceeds to the Company of both offerings is expected to be approximately $8.0 million. As part of the offerings and subject to Nasdaq rules, the investor will have the right to designate two directors to the Company's Board of Directors. The offerings are expected to close on or about July 8, 2020, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.
The unregistered warrants will have an exercise price $0.903 per share and exercise period commencing immediately upon issuance date and a term of five and one-half (5.5) years.
Tenax currently intends to use the net proceeds from the offerings to further its clinical trials of levosimendan, for research and development and general corporate purposes, including working capital and potential acquisitions.
The shares of common stock and pre-funded warrants offered in the registered direct offering (including the shares of common stock underlying the pre-funded warrants) are being offered and sold by Tenax pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-2244951), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC) on May 23, 2018. The offering of the shares of common stock and the pre-funded warrants to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].
The unregistered pre-funded warrants and unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the pre-funded warrants, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
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.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 market and other conditions, the completion of the offerings, the satisfaction of customary closing conditions related to the offerings and the intended use of net proceeds from the offerings, as well as 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 May 15, 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, except as required by law. 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.View source version on businesswire.com: https://www.businesswire.com/news/home/20200706005615/en/