TENX Tenax Therapeutics Inc.

1.73
-0.02  -1%
Previous Close 1.75
Open 1.75
52 Week Low 0.8037
52 Week High 3.68
Market Cap $43,598,270
Shares 25,201,312
Float 20,847,723
Enterprise Value $40,346,033
Volume 37,030
Av. Daily Volume 137,826
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Upcoming Catalysts

Drug Stage Catalyst Date
Imatinib
Pulmonary arterial hypertension (PAH)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Levosimendan
Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
Phase 2
Phase 2
Phase 2 top-line data released June 2, 2020. Primary endpoint (Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise) not met. Various secondary endpoints met. Phase 3 trial planned.
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

  1. Anthony DiTonno Retires from Tenax; Christopher Giordano Appointed as CEO –

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company that address cardiovascular and pulmonary diseases with high unmet medical need, today announced a CEO transition in connection with the retirement of its current CEO:

    • Effective July 13, 2021, Mr. Anthony A. DiTonno will retire as Chief Executive Officer and Director of the Company, following a successful decade of service with the Company.
    • The Board has appointed Mr. Christopher T. Giordano to serve as Chief Executive Officer and a Director of the Company, effective July 14, 2021. From July 6, 2021 through July 14, 2021, Mr. Giordano will serve as an employee of the Company to assist with…

    Anthony DiTonno Retires from Tenax; Christopher Giordano Appointed as CEO –

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company that address cardiovascular and pulmonary diseases with high unmet medical need, today announced a CEO transition in connection with the retirement of its current CEO:

    • Effective July 13, 2021, Mr. Anthony A. DiTonno will retire as Chief Executive Officer and Director of the Company, following a successful decade of service with the Company.
    • The Board has appointed Mr. Christopher T. Giordano to serve as Chief Executive Officer and a Director of the Company, effective July 14, 2021. From July 6, 2021 through July 14, 2021, Mr. Giordano will serve as an employee of the Company to assist with the smooth transition of Mr. DiTonno's duties.

    The Company also announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 4,773,269 Units at a purchase price of $2.095 per Unit. Each Unit consists of one unregistered pre-funded warrant to purchase one share of common stock, par value $0.0001 and one unregistered warrant to purchase one share of common stock. In the aggregate, 9,546,538 shares of the Company's common stock are underlying the warrants.

    The unregistered pre-funded warrants have an exercise price of $0.0001 per share of common stock, are immediately exercisable, and may be exercised at any time until exercised in full. The unregistered warrants have an exercise price of $1.97 per share of common stock, are immediately exercisable, and will expire five and one-half years from the date of issuance.

    The aggregate gross proceeds to the Company of the offering are expected to be approximately $10 million. The offering is expected to close on or about July 8, 2021, subject to the satisfaction of customary closing conditions.

    Gerald Proehl, Chairman of the Board of Directors for the Company, said: "We thank Tony for his dedicated service and many contributions to Tenax and wish him the best in his well-deserved retirement from executive management. While we will miss Tony's services and involvement in our Company, this transition will not affect Tenax's focus or direction. We are looking forward to having Chris contribute his extensive experience with bringing pharmaceutical products to market as Tenax's new leader, and to continuing to enhance shareholder value through the development and approval of our products for use by patients suffering from cardiovascular and pulmonologic diseases, which is further supported by the financing we are announcing today."

    Mr. Giordano, age 47, brings more than 20 years of experience in the clinical research industry. He most recently served as President of IQVIA Biotech and IQVIA MedTech (formerly Novella Clinical), where he led an executive team that executed a clinical trial portfolio that grew from 250 to 400 active projects during his three years of leadership from March 2018 through his departure in April 2021 and saw double-digit annual growth in sales each year of his tenure. Mr. Giordano has been involved in the pharmaceutical development industry since 1998. In January 2001, he joined PPD, another global clinical research organization, in a sales role. Over the next seven years, he grew into increasing operational responsibility, and in August 2008 transitioned to Quintiles as a Vice President, where he oversaw all consulting, regulatory, commercial, and clinical development services (including early-phase pharmacology through phase IV registry and safety studies) offered to his clients in the oncology, auto-immune, CNS, cardiovascular, and renal disease areas. He served in roles of increasing responsibility at Quintiles, being appointed Global Vice President of the cardiovascular, renal, and metabolic group in February 2016, a position he held until his appointment as President of IQVIA Biotech and IQVIA MedTech.

    Certain Securities and Nasdaq Disclosures

    The Units 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 Units have not been registered under the Act, or applicable state securities laws. Accordingly, the Units 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.

    In connection with his appointment, on July 6, 2021, Mr. Giordano was awarded options to purchase 350,000 shares of the Company's common stock under two separate awards. These awards were made in accordance with the employment inducement award exemption provided by NASDAQ Rule 5635(c)(4) and were therefore not awarded under the Company's stockholder approved equity plan. Under one award, 250,000 shares will vest over a four year period, with one-quarter vesting per year, beginning one year from the grant date. Under the second award, 100,000 shares will vest upon the achievement of certain performance metrics related to the clinical trials of the Company. The options have a 10-year term and will have an exercise price equal to $1.97 per share.

    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 detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting. Tenax is also developing a delayed release oral formulation of imatinib, designed to avoid gastric irritation, in a single pivotal trial in patients with pulmonary artery hypertension (PAH). 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 the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

    About Imatinib

    Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

    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 31, 2021 and its quarterly report on Form 10-Q filed on May 17, 2021, 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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  2. 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, is set to join the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution effect after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Our inclusion in…

    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, is set to join the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution effect after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Our inclusion in the Russell Microcap Index comes at an exciting time for our company, as we expect to advance our two lead drug development programs (imatinib and levosimendan) towards Phase 3 clinical trials", said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics. "Over the next several months, we also anticipate a series of important research publications that will support Tenax's pioneering approach towards the treatment of Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction. We therefore value our inclusion into this widely followed Index, which should increase our visibility among institutional investors at such an important time in our company's growth."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About FTSE Russell

    FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

    FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.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 detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting. Tenax is also developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. 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.

    About Imatinib

    Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

    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 31, 2021 and its quarterly report on Form 10-Q filed on May 17, 2021, 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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  3. 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 reported financial results for the first quarter of 2021 and provided a business update.

    "Having completed the merger with PHPrecisionMed Inc., we now have product development programs in group one and group two pulmonary hypertension patients," stated Anthony DiTonno, Chief Executive Officer of Tenax, "which represent more than 70% of the overall market.

    "We have begun the open label transition study using the oral formulation of Levosimendan, which was recently acquired from our agreement with Orion. The purpose of…

    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 reported financial results for the first quarter of 2021 and provided a business update.

    "Having completed the merger with PHPrecisionMed Inc., we now have product development programs in group one and group two pulmonary hypertension patients," stated Anthony DiTonno, Chief Executive Officer of Tenax, "which represent more than 70% of the overall market.

    "We have begun the open label transition study using the oral formulation of Levosimendan, which was recently acquired from our agreement with Orion. The purpose of this study is to determine the dose we will take into Phase 3 trials in 2022. Study participants who enrolled in our open label Phase 2 HELP trial are being brought back into their clinics and converted to the oral dosage form. We believe oral delivery will be more convenient for patients and provide more consistent blood levels of Levosimendan compared to weekly IV administration.

    "With respect to the imatinib program, we are in the final stages of formulation development. As a reminder, this new formulation is expected to address the previous GI-related side effects associated with its oral administration. We remain highly enthusiastic that imatinib, when formulated correctly, will show substantial clinical benefit in the pulmonary arterial hypertension (PAH) patient population, with the potential to be the first disease-modifying therapy for this indication. The new formulation will be tested in a Phase 1 study, which we anticipate completing in the second half of this year."

    Recent Highlights

    • On April 9, 2021, Tenax announced the publication of positive data from the company's Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
    • On January 19, 2021, Tenax announced the acquisition of PHPrecisionMed Inc. (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH). The FDA has granted Orphan Drug Designation for imatinib for the treatment of PAH, an indication with a high unmet medical need. The acquisition of PHPM immediately expands Tenax's pipeline to include a second de-risked Phase 3 ready candidate with the potential to be the first disease modifying treatment of PAH.

    Financial Results

    • Research and development expenses for the first quarter of 2021 were $22.4 million, compared to $1.3 million for the first quarter of 2020. The increase in research and development expense in the current period is due primarily to the recognition of approximately $21.8 million of in-process research and development (IPR&D) expense attributed to the acquisition of PHPM in January 2021.
    • General and administrative expenses for the first quarter of 2021 were $1.4 million, compared to $1.3 million for the first quarter of 2020.
    • Net loss for the first quarter of 2021 was $23.7 million, or $1.64 per share, compared to a net loss of $2.7 million, or $0.38 per share, for the first quarter of 2020.
    • Cash, cash equivalents and marketable securities totaled $4.0 million as of March 31, 2021, compared with $6.7 million as of December 31, 2020.
    • Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.

    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 detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting. Tenax is also developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. 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.

    About Imatinib

    Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

    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 31, 2021 and its quarterly report on Form 10-Q filed on May 17, 2021, 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 March 31,

    2021

    2020

    (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 on marketable securities

     

    332

     

     

    1,622

     

    Total comprehensive loss

    $

    23,748,472

     

    $

    2,656,266

     

     
    Net loss per share, basic and diluted

    $

    (1.64

    )

    $

    (0.38

    )

    Weighted average number of common shares outstanding, basic and diluted

     

    14,515,088

     

     

    6,974,387

     

     

    TENAX THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     

    March 31, 2021

    December 31, 2020

     
     

    (Unaudited)

    ASSETS

    Current assets
    Cash and cash equivalents

    $

    3,536,787

     

    $

    6,250,241

     

    Marketable securities

     

    494,877

     

     

    462,687

     

    Prepaid expenses

     

    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 STOCKHOLDERS' EQUITY

    Current liabilities
    Accounts payable

    $

    997,443

     

    $

    757,856

     

    Accrued liabilities

     

    222,780

     

     

    1,240,616

     

    Note payable

     

    213,577

     

     

    120,491

     

    Total current liabilities

     

    1,433,800

     

     

    2,118,963

     

    Long term liabilities
    Note 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
    Stockholders' equity
    Preferred stock, undesignated, authorized 9,989,558 shares; See Note 9
    Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively

     

    -

     

     

    -

     

    Series B Preferred stock, par value $.0001, issued 10,232 shares; outstanding 10,232 and 0, respectively

     

    1

     

     

    -

     

    Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 14,969,312 and 12,619,369, respectively

     

    1,497

     

     

    1,262

     

    Additional paid-in capital

     

    272,862,552

     

     

    250,644,197

     

    Accumulated other comprehensive loss

     

    (402

    )

     

    (70

    )

    Accumulated deficit

     

    (269,767,967

    )

     

    (246,019,827

    )

    Total stockholders' equity

     

    3,095,681

     

     

    4,625,562

     

    Total liabilities and stockholders' equity

    $

    4,560,561

     

    $

    6,868,691

     

     

     

    View Full Article Hide Full Article
    • 84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase
    • Levosimendan improved cardiovascular hemodynamics and exercise capacity in PH-HFpEF patients
    • Levosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients
    • Levosimendan was well tolerated in PH-HFpEF patients

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the publication of positive data from the company's Phase 2…

    • 84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase
    • Levosimendan improved cardiovascular hemodynamics and exercise capacity in PH-HFpEF patients
    • Levosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients
    • Levosimendan was well tolerated in PH-HFpEF patients

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the publication of positive data from the company's Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).

    The HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study was designed as a randomized placebo-controlled trial to evaluate the hemodynamic and clinical effects of weekly levosimendan IV infusions in PH-HFpEF patients. This 6-week study design evaluated invasive cardiovascular hemodynamics as well as secondary clinical endpoints including a 6-minute walk test.

    Results reported in the publication include an impressive responder rate of 84% during the open-label phase as 37 of 44 patients met responder criteria and were randomized to levosimendan (n=18) or placebo (n=19). Compared with placebo, levosimendan did not significantly reduce the primary endpoint of exercise-PCWP (-1.4 mmHg, 95% CI -7.8, 4.8, p=0.65), but effectively reduced PCWP measured across all exercise stages (-3.9±2.0 mmHg, p=0.047). Levosimendan treatment resulted in a 29.3 meter (95% CI [2.5, 56.1], p=0.033) improvement in 6 MWD compared to placebo. The authors concluded that further study of levosimendan in PH-HFpEF patients is warranted since levosimendan is the first drug to demonstrate improved cardiovascular hemodynamics and a statistically significant increase in six-minute walk distance seen compared to placebo

    Dr. Daniel Burkhoff, MD PhD, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation led the blinded hemodynamic core lab and analysis for the HELP trial and is the first author on the publication. Dr. Burkhoff stated "The cardiovascular hemodynamic effects seen in this trial following levosimendan administration were impressive, especially in the first 24 hours. The reductions in cardiac filling pressures and associations with improved exercise performance are important early markers of clinical benefit and signify meaningful improvements in the wellbeing of PH-HFpEF patients. Levosimendan has the potential to have a major impact on the treatment of PH-HFpEF."

    Dr. Stuart Rich, Chief Medical Officer at Tenax Therapeutics and Principal Investigator of the study stated "PH-HFpEF, which is Group 2 Pulmonary Hypertension, is a progressive and fatal disease with no effective medical treatments. Previous attempts to identify an effective treatment from clinical trials using approved pulmonary vasodilators have all failed. This is the first multi-center, randomized, placebo-controlled trial in PH-HFpEF patients to report a statistically significant improvement in 6-minute walk distance. Levosimendan has unique pulmonary vascular and cardiovascular properties which we identified as central to its clinical efficacy. The fact that 84% of the patients enrolled in the initial lead-in phase had a significant hemodynamic response at rest and with exercise during cardiac catheterization provides confidence that levosimendan may be an important treatment for these patients who have a large unmet need."

    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). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.

    About Levosimendan

    Levosimendan is a calcium sensitizer and K-ATP Channel activator that works through a unique 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.

    About Imatinib

    Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

    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 31, 2021 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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  4. 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 that Ronald R. Blanck, D.O., Gregory Pepin and Chris A. Rallis have voluntarily agreed to step down from the Board of Directors of Tenax Therapeutics, effective as of the Annual Meeting of Stockholders of Tenax, currently scheduled for June 10, 2021, retiring after years of service to the Board.

    The retirements of Dr. Blanck and Messrs. Pepin and Rallis from the Board were voluntary decisions as part of a Board refreshment program. This program included the onboarding of four new directors in the first quarter…

    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 that Ronald R. Blanck, D.O., Gregory Pepin and Chris A. Rallis have voluntarily agreed to step down from the Board of Directors of Tenax Therapeutics, effective as of the Annual Meeting of Stockholders of Tenax, currently scheduled for June 10, 2021, retiring after years of service to the Board.

    The retirements of Dr. Blanck and Messrs. Pepin and Rallis from the Board were voluntary decisions as part of a Board refreshment program. This program included the onboarding of four new directors in the first quarter of calendar 2021, as previously announced by Tenax. The Tenax Board will maintain 12 members until the Annual Meeting of Stockholders, which will then be reduced to nine members upon their retirement from the Board.

    Dr. Blanck has served on the Tenax Board since 2009 and as Chairman since 2011. Gerald Proehl, who has served on the Tenax Board since April 2014, shall assume role of Chairman upon Dr. Blanck's retirement from the Board. Mr. Pepin has served as a director since August 2009, and Mr. Rallis has served as a director since 2011.

    "We would like to honor and thank Ron, Gregory and Chris for their stellar service to Tenax's Board, its management and, most importantly, its shareholders. Each of them has contributed their invaluable experience and sound judgment in guiding the company through times of opportunity and challenge. Each has been integral to strategically positioning Tenax for continued success and shareholder value-creation," said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics.

    "I want to express my deep appreciation for their participation in and willingness to support our board refreshment program," said Gerald Proehl. "In particular, we appreciate them agreeing to an overlapping time period of service with the new Board members to ensure continuity of strong, independent leadership as we focus on creating shareholder value." Mr. Proehl continued, "Ron, Chris and Gregory provided important leadership since joining the Tenax board, resulting in a specialty pharmaceutical company with two late clinical stage products that may provide important treatment options for patients with cardiovascular diseases. I speak for the entire Tenax Board in thanking each of them for their dedication and years of service."

    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). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. 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.

    About Imatinib

    Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

    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 31, 2021 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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