1. 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 that management will present a company overview and hold virtual investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference being held September 13-15, 2021.

    Webcast link to presentation: https://journey.ct.events/view/926bd710-4ba5-44f5-bfab-51a6170965c6

    The pre-recorded presentation will be available for viewing on-demand beginning Monday, September 13 at 7:00 A.M. (EST). This presentation will also be available on the Investors section of Tenax Therapeutics' website at tenaxthera.com.

    About Tenax Therapeutics

    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 that management will present a company overview and hold virtual investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference being held September 13-15, 2021.

    Webcast link to presentation: https://journey.ct.events/view/926bd710-4ba5-44f5-bfab-51a6170965c6

    The pre-recorded presentation will be available for viewing on-demand beginning Monday, September 13 at 7:00 A.M. (EST). This presentation will also be available on the Investors section of Tenax Therapeutics' website at 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. Tenax is developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, and expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. The Company also 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. For more information, visit www.tenaxthera.com.

    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.

    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 31, 2021 and its quarterly report on Form 10-Q filed on August 16, 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, today reported financial results for the second quarter of 2021 and provided a business update.

    "We are entering an exciting period for Tenax Therapeutics, with continued progress being made for our two lead clinical programs – imatinib for the treatment of pulmonary arterial hypertension and levosimendan for the treatment of pulmonary hypertension associated with left heart failure," said Christopher T. Giordano, Chief Executive Officer of Tenax Therapeutics.

    "Our imatinib program for PAH remains on track, and we are presently…

    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 second quarter of 2021 and provided a business update.

    "We are entering an exciting period for Tenax Therapeutics, with continued progress being made for our two lead clinical programs – imatinib for the treatment of pulmonary arterial hypertension and levosimendan for the treatment of pulmonary hypertension associated with left heart failure," said Christopher T. Giordano, Chief Executive Officer of Tenax Therapeutics.

    "Our imatinib program for PAH remains on track, and we are presently completing the final stages of the formulation work. We believe our new, delayed release, oral formulation of imatinib will confer significant therapeutic advantages over the prior oral formulation, including improved GI tolerability and the potential for disease-modifying clinical activity."

    "With respect to levosimendan, our open label transition study using the oral formulation also remains on track. As a reminder, the purpose of this study is to determine the optimal dosage for levosimendan for our planned Phase 3 trial, which is expected to start in 2022. We believe oral delivery of levosimendan will provide more consistent blood levels compared to weekly IV administration, with the added benefit of administrative convenience to the patient. More than 50% of the subjects in this open label extension study have already transitioned from weekly IV infusion to the daily oral formulation."

    Recent Highlights

    • On August 16, 2021, Tenax held a KOL webinar on Levosimendan for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The webinar featured a presentation by Key Opinion Leader (KOL) Daniel Burkhoff, M.D., Ph.D. (Cardiovascular Research Foundation) who discussed the current treatment landscape and unmet medical need in treating patients with pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) and how levosimendan could become an important new treatment option for this patient population.
    • On August 12, 2021, Tenax announced the publication of a new article that identifies a novel mechanism of action behind the improved cardiovascular hemodynamics and exercise tolerance that was reported in the recent Phase 2 HELP Study (Burkhoff et al., JACC Heart Failure 2021; 9:360-70). The new publication, "Changes in Stressed Blood Volume with Levosimendan in Pulmonary Hypertension from Heart Failure with Preserved Ejection Fraction: Insights Regarding Mechanism of Action" appears in the Journal of Cardiac Failure. The article is available online as an "Article In Press." https://www.onlinejcf.com/article/S1071-9164(21)00215-3/fulltext
    • Effective July 14, 2021, the Tenax Board of Directors appointed Mr. Christopher T. Giordano to serve as Chief Executive Officer and a Director of the Company. On July 7, 2021, Tenax announced a transition in connection with the retirement of its former CEO Mr. Anthony A. DiTonno following a successful decade of service with the Company.
    • On July 7, 2021, Tenax announced that it 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 was approximately $10 million

    Financial Results

    • Research and development expenses for the second quarter of 2021 were $0.7 million, compared to $1.3 million for the second quarter of 2020.
    • General and administrative expenses for the second quarter of 2021 were $1.3 million, compared to $0.9 million for the second quarter of 2020.
    • Net loss for the second quarter of 2021 was $1.7 million, or $0.10 per share, compared to a net loss of $2.1 million, or $0.23 per share, for the second quarter of 2020.
    • Cash, cash equivalents and marketable securities totaled $2.2 million as of June 30, 2021, compared with $6.7 million as of December 31, 2020. Following the close of the second quarter, Tenax raised $10 million in gross proceeds from an equity offering with a single institutional investor. Including the proceeds from this offering, management expects that current cash, cash equivalents and marketable securities, including the net proceeds from the July 2021 offering, will be sufficient to fund current operations through the second quarter of 2022.

    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 August 16, 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 June 30,

     

    Six months ended June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

     

     

    (Unaudited)

     

    (Unaudited)

     

    (Unaudited)

     

    (Unaudited)

     
    Operating expenses
    General and administrative

    $

    1,271,278

     

    $

    869,206

     

    $

    2,644,738

     

    $

    2,192,165

     

    Research and development

     

    693,222

     

     

    1,274,837

     

     

    23,069,424

     

     

    2,617,363

     

    Total operating expenses

     

    1,964,500

     

     

    2,144,043

     

     

    25,714,162

     

     

    4,809,528

     

     
    Net operating loss

     

    1,964,500

     

     

    2,144,043

     

     

    25,714,162

     

     

    4,809,528

     

     
    Interest expense

     

    336

     

     

    406

     

     

    949

     

     

    406

     

    Other (income) expense, net

     

    (247,820

    )

     

    2,101

     

     

    (249,955

    )

     

    (8,740

    )

    Net loss

    $

    1,717,016

     

    $

    2,146,550

     

    $

    25,465,156

     

    $

    4,801,194

     

     
    Unrealized (gain) loss on marketable securities

     

    (128

    )

     

    (3,238

    )

     

    204

     

     

    (1,616

    )

    Total comprehensive loss

    $

    1,716,888

     

    $

    2,143,312

     

    $

    25,465,360

     

    $

    4,799,578

     

     
    Net loss per share, basic and diluted

    $

    (0.10

    )

    $

    (0.23

    )

    $

    (1.60

    )

    $

    (0.59

    )

    Weighted average number of common shares outstanding, basic and diluted

     

    17,218,103

     

     

    9,339,309

     

     

    15,874,062

     

     

    8,156,848

     

    TENAX THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     
    June 30, 2021 December 31, 2020
    (Unaudited)
    ASSETS
    Current assets
    Cash and cash equivalents

    $

    1,671,422

     

    $

    6,250,241

     

    Marketable securities

     

    510,943

     

     

    462,687

     

    Prepaid expenses

     

    349,862

     

     

    82,578

     

    Total current assets

     

    2,532,227

     

     

    6,795,506

     

    Right of use asset

     

    338,698

     

     

    58,778

     

    Property and equipment, net

     

    5,821

     

     

    5,972

     

    Other assets

     

    8,435

     

     

    8,435

     

    Total assets

    $

    2,885,181

     

    $

    6,868,691

     

     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities
    Accounts payable

    $

    791,947

     

    $

    757,856

     

    Accrued liabilities

     

    383,063

     

     

    1,240,616

     

    Note payable

     

    -

     

     

    120,491

     

    Total current liabilities

     

    1,175,010

     

     

    2,118,963

     

    Long term liabilities
    Lease liability

     

    239,039

     

     

    -

     

    Note payable

     

    -

     

     

    124,166

     

    Total long term liabilities

     

    239,039

     

     

    124,166

     

    Total liabilities

     

    1,414,049

     

     

    2,243,129

     

     
     
    Commitments and contingencies; see Note 8
    Stockholders' equity
    Preferred stock, undesignated, authorized 9,999,790 shares; See Note 9
    Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively

     

    -

     

     

    -

     

    Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 25,201,312 and 12,619,369 respectively

     

    2,520

     

     

    1,262

     

    Additional paid-in capital

     

    272,953,869

     

     

    250,644,197

     

    Accumulated other comprehensive loss

     

    (274

    )

     

    (70

    )

    Accumulated deficit

     

    (271,484,983

    )

     

    (246,019,827

    )

    Total stockholders' equity

     

    1,471,132

     

     

    4,625,562

     

    Total liabilities and stockholders' equity

    $

    2,885,181

     

    $

    6,868,691

     

     

    View Full Article Hide Full Article
    • Levosimendan was shown to Reduce Stressed Blood Volume (SBV), a Novel and Highly Relevant Mechanism of Action for PH-HFpEF Patients
    • Stressed Blood Volume Reductions Accompany Previously Reported Improvements in Important Cardiovascular Hemodynamic Measurements
    • Reduction in Stressed Blood Volume Suggests the Effects of Levosimendan are Modulated Through K-ATP Channel Activation and Resulting Venodilation

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardiopulmonary diseases with a high unmet medical need, today announced a new publication that identifies a novel mechanism of action behind the improved cardiovascular hemodynamics and exercise…

    • Levosimendan was shown to Reduce Stressed Blood Volume (SBV), a Novel and Highly Relevant Mechanism of Action for PH-HFpEF Patients
    • Stressed Blood Volume Reductions Accompany Previously Reported Improvements in Important Cardiovascular Hemodynamic Measurements
    • Reduction in Stressed Blood Volume Suggests the Effects of Levosimendan are Modulated Through K-ATP Channel Activation and Resulting Venodilation

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardiopulmonary diseases with a high unmet medical need, today announced a new publication that identifies a novel mechanism of action behind the improved cardiovascular hemodynamics and exercise tolerance that was reported in the recent Phase 2 HELP Study (Burkhoff et al., JACC Heart Failure 2021; 9:360-70). The HELP Study evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication, "Changes in Stressed Blood Volume with Levosimendan in Pulmonary Hypertension from Heart Failure with Preserved Ejection Fraction: Insights Regarding Mechanism of Action" appears in the Journal of Cardiac Failure. The article is available online as an "Article In Press". https://www.onlinejcf.com/article/S1071-9164(21)00215-3/fulltext

    The authors conducted an in-depth analysis of data from the HELP Study to elucidate the underlying mechanism behind the improved hemodynamic and exercise capacity effects seen in levosimendan-treated patients. Their analysis found that the reductions in pulmonary wedge pressure (PCWP) and central venous pressure (CVP) were independent of any inotropic effect of the drug. Instead, the authors conclude that the reduction in PCWP and CVP shown in the HELP Study was attributable to levosimendan's ability to lower stressed blood volume (SBV) through its effect on K+ATP channel activation. The splanchnic circulation is composed of the blood that supplies all of the abdominal viscera, and serves as a reservoir to increase or decrease venous return (referred to as stressed blood volume) to the heart as dictated by physiologic conditions. It has been validated that dilating the splanchnic circulation will lower SBV and hence CVP and PCWP in PH-HFpEF (Fudim et al., JACC Heart Failure 2021; 9:293-300). As a result, patients have less shortness of breath and improved exercise tolerance.

    "Recently, it has been shown that the splanchnic, or abdominal, circulation is responsible for maintaining normal venous pressure in the systemic and pulmonary vasculature via stressed blood volume levels," said Stuart Rich, MD, Chief Medical Officer at Tenax Therapeutics stated. "This is an old concept with new relevance, as elevated venous pressures underlie the systemic and pulmonary vascular congestion in PH-HFpEF. Levosimendan is now the first drug ever to demonstrate dilatation of the splanchnic blood vessels which effectively lowers the CVP and PCWP, at rest and during exercise. As a result, it now is the only medication shown to improve exercise capacity in PH-HFpEF as well."

    Chris Giordano, CEO of Tenax Therapeutics, stated, "This publication shares new, and very important mechanistic knowledge about the effects of levosimendan in PH-HFpEF patients. Levosimendan has been acknowledged for years to be a pleiotropic drug with vasodilatory properties. This explanation of its impact on splanchnic venous capacity, in the light of the HELP primary analysis that showed levosimendan improves significantly patients' 6-minute walk distance, provides further evidence that levosimendan is a novel therapy with the potential to provide important benefits to PH-HFpEF patients. There are currently no approved therapies for these patients."

    Doctor Daniel Burkhoff, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at the Cardiovascular Research Foundation in New York City, will lead a KOL discussion on Monday, August 16th, at 10:00 am eastern, to review this mechanism of action and the potential levosimendan has shown to help patients with PH-HFpEF. Audience members must register in advance for the webcast.

    Tenax Therapeutics expects to commence a Phase III study of levosimendan in this population in the first half of 2022.

    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 pleiotropic drug that works through a unique triple mechanism of action. It initially was developed as an inotrope 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. Recently it has been shown to be an effective potassium channel activator which targets mechanisms that underlie pulmonary vascular disease and HFpEF. 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 Pulmonary Arterial Hypertension. Imatinib reversed the pulmonary vascular disease in animal models of pulmonary hypertension by blocking the PDGF pathway, which has also been shown to be activated in the human disease. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity and hemodynamics, 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 of 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.

    View Full Article Hide Full Article
  3. Event to Focus on Current Treatment Landscape and Therapeutic Potential of Levosimendan in PH-HFpEF

    Monday, August 16th @ 10AM ET

    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, announced that it will hold a KOL webinar on Levosimendan for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The webinar will be held on August 16,2021 at 10:00am Eastern Time.

    The webinar will feature a presentation by Key Opinion Leader (KOL) Daniel Burkhoff, M.D., Ph.D. (Cardiovascular Research Foundation) who will discuss the current treatment landscape…

    Event to Focus on Current Treatment Landscape and Therapeutic Potential of Levosimendan in PH-HFpEF

    Monday, August 16th @ 10AM ET

    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, announced that it will hold a KOL webinar on Levosimendan for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The webinar will be held on August 16, 2021 at 10:00am Eastern Time.

    The webinar will feature a presentation by Key Opinion Leader (KOL) Daniel Burkhoff, M.D., Ph.D. (Cardiovascular Research Foundation) who will discuss the current treatment landscape and unmet medical need in treating patients with pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) and how Levosimendan could become an important new treatment option for this patient population. Dr. Burkhoff will be available to answer questions following the formal presentations.

    Tenax's Chief Medical Officer, cardiologist Stuart Rich, M.D., will then discuss the clinical development plan for their novel therapy Levosimendan, a first-in-class K-ATP activator/ calcium sensitizer, as the first treatment for PH-HFpEF (WHO Group 2 Pulmonary Hypertension).

    A live Q&A session will follow the formal presentations.

    You are required to register in advance for the webcast.

    Daniel Burkhoff, M.D., Ph.D.

    Dr. Burkhoff obtained Doctor of Philosophy and Medical degrees from The Johns Hopkins School of Medicine and completed a fellowship in Cardiology at The Johns Hopkins Hospital. Dr. Burkhoff then moved to Columbia University in the City of New York where he established and ran the Cardiovascular Research Laboratory through 2003 and then took the position of Director of the Jack Skirball Center for Cardiovascular Research of the Cardiovascular Research Foundation (CRF) through 2005. His focus shifted to development and research of medical devices in his capacity as Medical Director of several startup companies involved in diagnostics and therapies for heart failure. Dr. Burkhoff then returned to CRF as Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research. In this capacity, he also directs CRF's educational program called "TEACH" (Training and Education in Advanced Cardiovascular Hemodynamics). Dr. Burkhoff's interests include cardiovascular modeling and research in basic and clinical aspects of ventricular mechanics, cardiovascular monitoring, heart failure, device and pharmacologic treatments for heart failure, including left ventricular assist devices. He is also the author of Harvi, an interactive simulation-based application available on the world wide web for teaching and researching many aspects of ventricular mechanics and hemodynamics.

    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 pleiotropic drug that works through a unique triple mechanism of action. It initially was developed as an inotrope 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. Recently it has been shown to be an effective potassium channel activator which targets mechanisms that underlie pulmonary vascular disease and HFpEF. 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 Pulmonary Arterial Hypertension. Imatinib reversed the pulmonary vascular disease in animal models of pulmonary hypertension by blocking the PDGF pathway, which has also been shown to be activated in the human disease. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity and hemodynamics, 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 of 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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 year ended December 31, 2020 and provided a business update.

    "Now that the merger with PH Precision Medicine is complete, we have clinical 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."

    "Having acquired the oral formulation rights of Levosimendan from our agreement with Orion, we have set up an open label transition study to determine the…

    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 year ended December 31, 2020 and provided a business update.

    "Now that the merger with PH Precision Medicine is complete, we have clinical 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."

    "Having acquired the oral formulation rights of Levosimendan from our agreement with Orion, we have set up an open label transition study to determine the dose we will take into Phase 3 trials in 2022. The Phase 2 HELP trial still has patients in the open label phase of the trial. We will be bringing those patients back to their clinics and converting them to the oral dosage form. We believe an oral dosage form will be more convenient to patients and provide more consistent blood levels of drug as opposed to weekly IV administration."

    "With respect to the imatinib program, we continue to make good progress on developing a formulation that will address 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. As we finalize our plans, we will provide additional updates."

    Recent Highlights

    • On March 2, 2021, Tenax announced the appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Declan Doogan, MD, and Stuart Rich, MD. Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, Tenax expects to advance its two leading pipeline assets into late-stage clinical testing, so the expansion of its board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for the company and its shareholders.
    • On January 19, 2021, Tenax announced the acquisition of PH Precision Med (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.
    • On January 15, 2021, Tenax appointed Stuart Rich, MD, co-founder of PHPM, Chief Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine, and Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. He previously served as FDA Cardio-Renal Advisory Committee Member. His many years of experience as an FDA advisory committee member provides Tenax with an extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies. With his appointment, Tenax is well positioned to maximize the clinical potential of imatinib and advance the clinical development of levosimendan for PH-HFpEF, which together have the potential to address significant unmet needs and large market opportunities.

    Financial Results

    • Research and development expenses for the year ended December 31, 2020 were $4.6 million, compared to $3.5 million for the year ended December 31, 2019.
    • General and administrative expenses for year ended December 31, 2020 were $5.3 million, compared to $5.1 million for the year ended December 31, 2019.
    • Net loss for the year ended December 31, 2020 was $9.9 million, or $1.33 per share, compared to a net loss of $8.4 million, or $1.35 per share, for the year ended December 31, 2019.
    • Cash, cash equivalents and marketable securities totaled $6.7 million as of December 31, 2020, compared with $5.4 million as of December 31, 2019.
    • 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 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.

     

    TENAX THERAPEUTICS, INC.

    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

     

    Year ended December 31,

    2020

     

    2019

     
     
    Operating expenses
    General and administrative

    $

    5,307,206

     

    $

    5,084,111

     

    Research and development

     

    4,560,724

     

     

    3,471,153

     

    Total operating expenses

     

    9,867,930

     

     

    8,555,264

     

     
    Net operating loss

     

    9,867,930

     

     

    8,555,264

     

     
    Interest expense

     

    1,627

     

     

    -

     

    Other income, net

     

    (18,166

    )

     

    (160,901

    )

    Net loss

    $

    9,851,391

     

    $

    8,394,363

     

     
    Unrealized loss on marketable securities

     

    528

     

     

    58

     

    Total comprehensive loss

    $

    9,851,919

     

    $

    8,394,421

     

     
    Net loss per share, basic and diluted

    $

    (1.33

    )

    $

    (1.35

    )

    Weighted average number of common shares outstanding, basic and diluted

     

    7,416,215

     

     

    6,195,444

     

     
     

    TENAX THERAPEUTICS, INC.

    CONSOLIDATED BALANCE SHEETS

     

     

     

     

     

    December 31, 2020

     

    December 31, 2019

     
    ASSETS
    Current assets
    Cash and cash equivalents

    $

    6,250,241

     

    $

    4,905,993

     

    Marketable securities

     

    462,687

     

     

    493,884

     

    Prepaid expenses

     

    82,578

     

     

    780,952

     

    Total current assets

     

    6,795,506

     

     

    6,180,829

     

    Right of use asset

     

    58,778

     

     

    169,448

     

    Property and equipment, net

     

    5,972

     

     

    6,559

     

    Other assets

     

    8,435

     

     

    8,435

     

    Total assets

    $

    6,868,691

     

    $

    6,365,271

     

     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities
    Accounts payable

    $

    757,856

     

    $

    1,661,054

     

    Accrued liabilities

     

    1,240,616

     

     

    871,341

     

    Note payable

     

    120,491

     

     

    -

     

    Total current liabilities

     

    2,118,963

     

     

    2,532,395

     

    Long term liabilities
    Lease liability

     

    -

     

     

    60,379

     

    Note payable

     

    124,166

     

     

    -

     

    Total long term liabilities

     

    124,166

     

     

    60,379

     

    Total liabilities

     

    2,243,129

     

     

    2,592,774

     

     
     
    Commitments and contingencies; see Note F
    Stockholders' equity
    Preferred stock, undesignated, authorized 4,818,654 shares; See Note E
    Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210 and 38,606, respectively

     

    -

     

     

    4

     

    Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 12,619,369 and 6,741,860, respectively

     

    1,262

     

     

    674

     

    Additional paid-in capital

     

    250,644,197

     

     

    239,939,797

     

    Accumulated other comprehensive (loss) gain

     

    (70

    )

     

    458

     

    Accumulated deficit

     

    (246,019,827

    )

     

    (236,168,436

    )

    Total stockholders' equity

     

    4,625,562

     

     

    3,772,497

     

    Total liabilities and stockholders' equity

    $

    6,868,691

     

    $

    6,365,271

     

     

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  9. 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 that management will present a company overview and hold virtual investor meetings at the H.C. Wainwright Global Life Sciences Virtual Conference being held March 9-10, 2021.

    The pre-recorded presentation will be available for viewing on-demand beginning March 9 at 7:00 A.M. (EST). This presentation will also be available on the Investors section of Tenax Therapeutics' website at tenaxthera.com.

    About Tenax Therapeutics

    Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing…

    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 that management will present a company overview and hold virtual investor meetings at the H.C. Wainwright Global Life Sciences Virtual Conference being held March 9-10, 2021.

    The pre-recorded presentation will be available for viewing on-demand beginning March 9 at 7:00 A.M. (EST). This presentation will also be available on the Investors section of Tenax Therapeutics' website at 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). 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 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 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.

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    • New Board appointments strengthen Tenax with world-class expertise in cardiovascular drug development, commercial strategy, and business development
    • New Directors will provide significant guidance as Tenax is poised to advance its two leading drug candidates into late-stage clinical testing
    • Transformational step as Tenax strengthens its positioning as a leading specialty pharmaceutical company focused on cardio-pulmonary therapeutics

    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 appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael…

    • New Board appointments strengthen Tenax with world-class expertise in cardiovascular drug development, commercial strategy, and business development
    • New Directors will provide significant guidance as Tenax is poised to advance its two leading drug candidates into late-stage clinical testing
    • Transformational step as Tenax strengthens its positioning as a leading specialty pharmaceutical company focused on cardio-pulmonary therapeutics

    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 appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Delcan Doogan, MD, and Stuart Rich, MD.

    "We are thrilled to welcome June, Michael, Declan and Stuart to our Board of Directors," said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics. "Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, we expect to advance our two leading pipeline assets into late-stage clinical testing, so the expansion of our board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for our company and our shareholders."

    The Tenax pipeline includes two de-risked, Phase 3 ready drug candidates: (1) a reformulation of imatinib for the treatment of pulmonary arterial hypertension (WHO Group 1) with the potential to be the first disease modifying treatment for this indication, and (2) an oral formulation of levosimendan for the treatment of pulmonary hypertension (WHO Group 2), recently in-licensed from Orion. Intravenous Levosimendanwas already approved by the EMA in 2002 for treatment of acute heart failure.

    About New Board Members

    Dr. Almenoff is an accomplished biopharma executive with over 20 years of senior leadership experience. She served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline (Viberzi®), which is approved in both the United States and Europe. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. Dr. Almenoff also led the development of pioneering systems for minimizing risk in drug development, which have been widely adopted by industry and regulators. Dr. Almenoff led or contributed to numerous regulatory submissions and product approvals. She is currently Chief Scientific Officer of RedHill Biopharma (NASDAQ:RDHL). She also serves on the investment advisory board of the Harrington Discovery Institute and the boards of Brainstorm Cell Therapeutics (NASDAQ:BCLI) and Kurome Therapeutics. Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development, and has previously advised biotech boards and management in these areas. .

    Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored close to 60 publications.

    Dr. Michael Davidson was the Founder and former Chief Scientific Officer of Corvidia Therapeutics, which was recently acquired by Novo-Nordisk for $2.1 billion. Dr. Davidson also serves as Clinical Professor and Director of the Lipid Clinic at the University of Chicago Pritzker School of Medicine. He is a leading expert in the field of Lipidology and was named in The Best Doctors in America for the past 10 years. Dr. Davidson was the co-founding Chief Medical Officer of Omthera Pharmaceuticals in 2008, which was later acquired by Astra Zeneca Pharmaceutical in 2013 for $443M. He also founded the Chicago Center for Clinical Research, which became the largest investigator site in the United States and was acquired by Pharmaceutical Product Development in 1996. His research background encompasses both pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Dr. Davidson is board-certified in internal medicine, cardiology, and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. He received his BA/MS from Northwestern University and MD from The Ohio State University School of Medicine.

    Dr. Declan Doogan has over 30 years of industry experience in both major pharma and biotech. He was the Senior Vice President and Head of Worldwide Development at Pfizer, where many multibillion-dollar programs were delivered (e.g., Viagra, Lipitor and Zoloft). He has held a number of executive positions in Pfizer in the U.S., the U.K. and Japan. Since leaving Pfizer in 2007 he has been engaged in executive roles in small pharma. Declan was CMO and acting CEO of Amarin (AMRN: Nasdaq), transforming it from a failing neuroscience company to a vibrant cardiovascular company with a market capitalization of over one billion dollars before his departure. He is Chairman and co-founder of Biohaven (BHVN:NYSE) and an investor in emerging biotechnology and technology companies. He holds a number of Board appointments, principally in pharma companies, and is also a visiting professor at Glasgow University Medical School. Dr. Doogan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians and the Faculty Pharmaceutical Medicine and holds a Doctorate of Science at the University of Kent in the U.K.

    Dr. Stuart Rich joined the Company as Chief Medical Officer in 2021 from PHPrecisionMed (PHPM), where he was a co-founder and held the positions of Chief Executive Officer and Director from October 2018 until January 2021. Prior to PHPM, Dr. Rich served as the Chief Medical Officer (part-time) of United Therapeutics from October 2003 until December 2004. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine and as senior faculty of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. Dr. Rich was co-founder of the Pulmonary Vascular Research Institute and a member of the Board of Trustees, a U.K. based charity, and a member of the Board of Directors of the Cardiovascular Medical and Research Foundation, a U.S. based charity. Prior to Northwestern University, Dr. Rich was the Professor of Medicine and Chief of the Section of Cardiology at the University of Illinois College of Medicine in Chicago from July 1980 until July 1996, was Professor of Medicine at the Rush Heart Institute of the Rush University School of Medicine from July 1996 until September 2004, and was Professor of Medicine at the Section of Cardiology of the University of Chicago Pritzker School of Medicine from September 2004 until July 2015. Dr. Rich received his B.S. in Biology at the University of Illinois and his M.D. at Loyola University Stritch School of Medicine, and he completed his residency in medicine at the Washington University of St. Louis and his fellowship in cardiology at the University of Chicago.

    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 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 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.

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  10. -Conference to be held at 4:30 pm EST on January 21, 2021-

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host an investor conference call for analysts and investors on Thursday, January 21, 2021 at 4:30 p.m. EST. On the call, management will review the previously announced acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH), and the clinical development plan to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single…

    -Conference to be held at 4:30 pm EST on January 21, 2021-

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host an investor conference call for analysts and investors on Thursday, January 21, 2021 at 4:30 p.m. EST. On the call, management will review the previously announced acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH), and the clinical development plan 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.

    A live webcast of the conference call and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at investors.tenaxthera.com. The conference call can be accessed by dialing (877) 405-1242 from the U.S. and (201) 389-0852 internationally, followed by the conference ID: 13715313. An archived webinar recording of the event will be available on the website for approximately 30 days.

    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 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 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 Full Article Hide Full Article
    • Expands pipeline into Pulmonary Arterial Hypertension (PAH), a progressive, fatal orphan disease without a cure
    • Imatinib, a tyrosine kinase inhibitor (TKI), has been shown to block critical disease promoting pathways and has demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH
    • Acquisition strengthens leadership team with appointment of Dr. Stuart Rich as Chief Medical Officer

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced the acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary…

    • Expands pipeline into Pulmonary Arterial Hypertension (PAH), a progressive, fatal orphan disease without a cure
    • Imatinib, a tyrosine kinase inhibitor (TKI), has been shown to block critical disease promoting pathways and has demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH
    • Acquisition strengthens leadership team with appointment of Dr. Stuart Rich as Chief Medical Officer

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced the acquisition of PH Precision Med (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 expands Tenax's pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate. Imatinib is a tyrosine kinase inhibitor (TKI) that transformed the treatment of cancer by blocking the underlying pathways resulting in long lasting remissions. Subsequent preclinical and clinical studies in PAH indicate that imatinib may provide antiproliferative and disease-modifying effects in PAH patients through its ability to inhibit several growth factors including platelet-derived growth factor (PDGF). PDGF regulates vascular smooth muscle cell proliferation in PAH and is thought to be associated with the disease progression. Multiple clinical studies of imatinib in PAH patients provide convincing evidence that imatinib can provide impressive improvements in exercise capacity and hemodynamics in patients with advanced PAH. The strong efficacy results from these trials, combined with imatinib's antiproliferative mechanism action, have raised the possibility that imatinib may work by modifying the underlying PAH disease process. Pursuant to the acquisition, Tenax's clincial development plan includes advancing 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.

    "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 pulmonary arterial hypertension," said Anthony DiTonno, Chief Executive Officer of Tenax. "The previous clinical trial designs led to high dropout rates and raised questions related to safety and tolerability, which limited further development of imatinib in PAH. We believe that PHPM's innovative clinical development plan, which includes a novel formulation that mitigates the side effects without diminishing the bioavailability, has the potential to yield positive clinical outcomes in a single pivotal Phase 3 trial requisite for regulatory approval."

    Stuart Rich, MD, co-founder of PHDM, has been appointed Chief Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine, and Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. He previously served as FDA Cardio-Renal Advisory Committee Member.

    Mr. DiTonno continued, "In addition to this transformative asset, we are also pleased to welcome PHPM's co-founder Dr. Rich to the Tenax management team. Dr. Rich is a pioneer in the field of pulmonary hypertension and its treatments. In addition, his many years of experience as an FDA advisory committee member provides Tenax with extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies. I am confident this strengthened team is well positioned to maximize the clinical potential of imatinib and advance the clinical development of levosimendan for PH-HFpEF, which together have the potential to address significant unmet needs and large market opportunities."

    At the next regularly scheduled Board meeting, Dr. Rich is expected to be appointed to Tenax's Board of Directors. In addition, in connection with Tenax's 2021 Annual Meeting of Stockholders, two additional co-founders of PHPM, Declan Doogan, MD and Michael Davidson, MD, are expected to be nominated to join to Tenax's Board of Directors. Dr. Doogan is a drug development executive with more than 30 years of experience in the pharmaceutical industry. After retiring from Pfizer in 2007 as the Senior VP Head of World Drug Development he was Head of R&D at Amarin where he helped raised $100 million to fund the reorganization leading to completion of a Phase 3 program and approval for Vascepa. He is cofounder and Chair of Biohaven (BHVN: NYSE) and co-founder of the healthy aging company Juvenescence. Dr. Davidson was founder of Omthera Pharmaceuticals, co-founder of Corvidia Therapeutics, Inc., and is currently Chief Executive Officer of New Amsterdam Pharma. Together they bring extensive experience of successful biotech development and leadership.

    Dr. Rich remarked, "This acquisition by Tenax, a clinical-stage publicly traded company with a pulmonary hypertension focus, is testament to the PHPM team's success in developing our novel and highly innovative clinical development plan. We will now focus advancing therapeutic candidates for Group 1 and Group 2 pulmonary hypertension with a precision medicine approach, to allow us to achieve the optimal treatment effects in our clinical trials. I look forward to joining the Tenax team to unlock the clinical potential of imatinib for patients with severe PAH."

    In connection with his appointment, on January 15, 2021, Dr. Rich was awarded an option to purchase 250,000 shares of the Company's common stock. This award was made in accordance with the employment inducement award exemption provided by Nasdaq Rule 5635(c)(4) and was therefore not awarded under the Company's stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $1.78 per share, the January 15, 2021 closing price of the Company's common stock.

    In connection with the acquisition, Tenax will issue to PHPM's stockholders in a private placement an aggregate of approximately 12.1 million unregistered shares of common stock and securities convertible into common stock. These securities were issued as follows at closing:

    (i) 1,892,905 shares of Tenax Common Stock, representing approximately 15% of Tenax's outstanding Common Stock prior to closing, and

    (ii) 10,232 shares of Class B Preferred Stock that, following stockholder approval, will be converted into up to 10,232,000 shares of Common Stock. The Preferred Stock will have voting rights equal to approximately 4.99% of the Company's pre-transaction shares outstanding, such that the total voting rights of shares issued in the transaction prior to stockholder approval will not exceed 19.99% of the pre-transaction outstanding common stock.

    Stockholder approval was not required and was not sought for the consummation of the acquisition; however, Tenax intends to seek stockholder approval for the full issuance of the securities contemplated in the transaction. A more complete description of the acquisition is available in the Form 8-K filed by Tenax Therapeutics with the Securities and Exchange Commission (the "SEC") on January 19, 2021. This press release is neither an offer to sell nor a solicitation of an offer to buy any of the Tenax Therapeutics' securities. No offer, solicitation, or sale will be made in any jurisdiction in which such offer, solicitation, or sale is unlawful. The terms and conditions of the transactions described in this press release are qualified in their entirety by reference to the transaction documents, which were filed on January 19, 2021 with the SEC on Form 8-K.

    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.

    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 30, 2020, and its quarterly report of Form 10-Q filed on November 16, 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.

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  11. 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 third quarter 2020 and provided a business update.

    Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) on Wednesday, November 18, 2020 at 4:30 p.m. EST. The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. A live webcast of the Virtual…

    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 third quarter 2020 and provided a business update.

    Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) on Wednesday, November 18, 2020 at 4:30 p.m. EST. The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. A live webcast of the Virtual R&D Webinar and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at www.tenaxthera.com. The Virtual R&D Webinar can also be accessed by dialing (866) 301-1155 from the U.S. and (914) 987-7396 internationally, followed by the conference ID: 5783678. An archived webinar recording of the event will be available on the website for approximately 30 days.

    "We are moving forward with our plan to enter Phase 3 of our clinical development program of levosimendan in PH-HFpEF and expect to reach an agreement with the FDA on a path forward before the end of the first quarter next year. The recent announcement related to adding the oral formulation of levosimendan by expanding our license agreement with Orion is an exciting opportunity for us. We believe an oral dosage form will be more convenient to patients in the Phase 3 program, thus potentially making the trial easier to enroll and perhaps shortening the overall time to complete the program. As we finalize our plans, we will provide additional updates," stated Anthony DiTonno, Chief Executive Officer of Tenax. "We recently convened our Scientific Advisory Board to provide an in-depth review of the results of the HELP trial. The results of the Phase 2 trial received significant interest from the academic community at detailed presentations at the recent AHA and HFSA medical meetings. The R&D webinar on November 18th will be our first opportunity to provide access to a comprehensive review of the data to the investor community."

    Recent Highlights

    • On November 13, 2020, data from the 24-hour open-label portion of the HELP Study was presented during the American Heart Association (AHA) Scientific Sessions 2020 by Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al. The Phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan's hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the pre-specified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.
    • On October 9, 2020, Tenax signed an amendment to the existing licensing agreement with Orion Pharmaceuticals to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure related indications. The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive development and commercialization rights to in the US and Canada under the existing license agreement. Tenax expects to use the oral formulation in its upcoming Phase 3 trial in PH-HFpEF.
    • On October 3, 2020, detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting by Barry Borlaug, MD, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic.

    Financial Results

    • Research and development expenses for the third quarter of 2020 were $1.0 million, compared to $900,000 for the third quarter of 2019.
    • General and administrative expenses for the third quarter of 2020 were $1.2 million, compared to $1.3 million for the third quarter of 2019.
    • Net loss for the third quarter of 2020 was $2.2 million, or $0.18 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the third quarter of 2019.
    • Cash, cash equivalents and marketable securities totaled $8.7 million as of September 30, 2020, compared with $5.4 million as of December 31, 2019.
    • Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.

    About Phase 2 HELP Trial

    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. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated a significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

    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 November 16, 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 September 30,

     

     

    Nine months ended September 30,

    2020

     

    2019

     

     

    2020

     

    2019

    (Unaudited) (Unaudited) (Unaudited) (Unaudited)
     
    Operating expenses
    General and administrative

    $

    1,172,725

     

    $

    1,343,429

     

    $

    3,364,890

     

    $

    3,692,843

     

    Research and development

     

    1,052,398

     

     

    916,984

     

     

    3,669,761

     

     

    2,049,004

     

    Total operating expenses

     

    2,225,123

     

     

    2,260,413

     

     

    7,034,651

     

     

    5,741,847

     

     
    Net operating loss

     

    2,225,123

     

     

    2,260,413

     

     

    7,034,651

     

     

    5,741,847

     

     
    Interest expense

     

    610

     

     

    -

     

     

    1,016

     

     

    -

     

    Other income, net

     

    (5,298

    )

     

    (36,709

    )

     

    (14,038

    )

     

    (139,161

    )

    Net loss

    $

    2,220,435

     

    $

    2,223,704

     

    $

    7,021,629

     

    $

    5,602,686

     

     
    Unrealized loss (gain) on marketable securities

     

    1,171

     

     

    960

     

     

    (445

    )

     

    (803

    )

    Total comprehensive loss

    $

    2,221,606

     

    $

    2,224,664

     

    $

    7,021,184

     

    $

    5,601,883

     

     
    Net loss per share, basic and diluted

    $

    (0.18

    )

    $

    (0.33

    )

    $

    (0.73

    )

    $

    (0.93

    )

    Weighted average number of common shares outstanding, basic and diluted

     

    12,427,355

     

     

    6,741,084

     

     

    9,590,741

     

     

    6,011,304

     

     

    TENAX THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     
    September 30, 2020 December 31, 2019
    (Unaudited)
    ASSETS
    Current assets
    Cash and cash equivalents

    $

    8,235,532

     

    $

    4,905,993

     

    Marketable securities

     

    472,648

     

     

    493,884

     

    Prepaid expenses

     

    189,275

     

     

    780,952

     

    Total current assets

     

    8,897,455

     

     

    6,180,829

     

    Right of use asset

     

    87,285

     

     

    169,448

     

    Property and equipment, net

     

    3,461

     

     

    6,559

     

    Other assets

     

    8,435

     

     

    8,435

     

    Total assets

    $

    8,996,636

     

    $

    6,365,271

     

     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities
    Accounts payable

    $

    1,052,824

     

    $

    1,661,054

     

    Accrued liabilities

     

    295,451

     

     

    871,341

     

    Note payable

     

    30,900

     

     

    -

     

    Total current liabilities

     

    1,379,175

     

     

    2,532,395

     

    Long term liabilities
    Note payable

     

    213,757

     

     

    -

     

    Lease liability

     

    -

     

     

    60,379

     

    Total long term liabilities

     

    213,757

     

     

    60,379

     

    Total liabilities

     

    1,592,932

     

     

    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 12,619,369 and 6,741,860, respectively

     

    1,262

     

     

    674

     

    Additional paid-in capital

     

    250,591,604

     

     

    239,939,797

     

    Accumulated other comprehensive gain

     

    903

     

     

    458

     

    Accumulated deficit

     

    (243,190,065

    )

     

    (236,168,436

    )

    Total stockholders' equity

     

    7,403,704

     

     

    3,772,497

     

    Total liabilities and stockholders' equity

    $

    8,996,636

     

    $

    6,365,271

     

     

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    • HELP Study results presentation will be available online beginning on November 13, 2020 at 9:00 a.m CST

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that data from the 24-hour open-label portion of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be presented during the American Heart Association (AHA) Scientific Sessions 2020 that is being conducted online from November 13, 2020 – November 17, 2020.

    The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan's hemodynamic and…

    • HELP Study results presentation will be available online beginning on November 13, 2020 at 9:00 a.m CST

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that data from the 24-hour open-label portion of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be presented during the American Heart Association (AHA) Scientific Sessions 2020 that is being conducted online from November 13, 2020 – November 17, 2020.

    The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan's hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the prespecified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.

    The 24-hour HELP Study results being presented at AHA include data from a total of 44 patients, of which 36 (~85%) were determined to be responders. Details regarding the presentation are as follows:

     

    Title:

    24-hour Levosimendan Infusion Decreases Biventricular Filling Pressures at Rest and Exercise in PH-HFpEF

     

    Author:

    Daniel Burkhoff, MD PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al

     

    Session:

    Novel Translational Insights for Pulmonary Vascular and RV Remodeling

     

    Date/Time:

    Available OnDemand beginning Friday, November 13, 2020 at 9:00 a.m. CST

     

    The above presentation will be available to conference registrants for viewing on the AHA Scientific Session's Virtual Platform at https://professional.heart.org/es/meetings/scientific-sessions.

    Tenax Therapeutics' CEO, Tony Ditonno, stated, "We are very excited to have these additional HELP Study results presented at the American Heart Association meeting. The results are very complimentary and supportive of the 6 week-double blind randomized phase of the HELP Study that was recently presented as a late-breaking clinical trial at the Heart Failure of Society of America, and we are very excited to have this additional 24-hour data being shared at this major scientific forum."

    About Phase 2 HELP Trial

    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. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

    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.

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  12. Webinar Scheduled for 4:30 pm EST on November 18

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host a virtual R&D webinar for analysts and investors on Wednesday, November 18, 2020 at 4:30 p.m. EST.

    Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel…

    Webinar Scheduled for 4:30 pm EST on November 18

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host a virtual R&D webinar for analysts and investors on Wednesday, November 18, 2020 at 4:30 p.m. EST.

    Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. The speakers will include:

    - Stuart Rich, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine

    - Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation

    - Barry Borlaug, MD, Professor of Medicine, Mayo Clinic

    A live webcast of the Virtual R&D Webinar and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at www.tenaxthera.com. An archived webinar recording of the event will be available on the website for approximately 30 days. If you are a member of the investment community and would like to attend, please RSVP to stephanie.carrington@westwicke.com.

    About Phase 2 HELP Trial

    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. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

    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 Full Article Hide Full Article
    • Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada
    • Oral formulation expected to be used in upcoming Phase 3 registration trial

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that it has entered into an amendment to the existing licensing agreement with Orion Corporation to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension…

    • Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada
    • Oral formulation expected to be used in upcoming Phase 3 registration trial

    Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that it has entered into an amendment to the existing licensing agreement with Orion Corporation to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure related indications. The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive development and commercialization rights to in the US and Canada under the existing license agreement. The Company now plans to utilize the oral formulation in its upcoming Phase 3 trial in PH-HFpEF. Currently, there are no approved products for treating PH-HFpEF.

    Tenax CEO Anthony DiTonno stated, "Adding the oral formulation to our existing agreement represents a significant opportunity for us. Use of the currently available 1mg capsule of levosimendan should allow us to conduct our upcoming Phase 3 trial with significantly faster enrollment versus the IV formulation. We expect an oral formulation will also enable us to enjoy greater market acceptance upon FDA approval for marketing."

    The oral formulation is a fully developed capsule that has already been used in a large number of patients over an extended period of time, up to one year in many cases. The amendment allows Tenax to access all of the manufacturing, preclinical and clinical data generated on oral levosimendan to support its use in the US and Canada, which we anticipate will expedite development efforts.

    The Company intends to review its plans to use the oral levosimendan formulation in a Phase 3 trial in PH-HFpEF patients with the FDA during its End-of-Phase 2 meeting.

    About Phase 2 HELP Trial

    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. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

    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 including delays in patient enrollment, 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.

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    • HELP Study results will be presented on Saturday, October 3, 2020 at 4:30 pm EDT

    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 will be presented at the upcoming Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting to be held September 30, - October 6. Scheduling details and registration information are provided below:

    Title:

     

    Levosimendan Improves Hemodynamics and Submaximal Exercise Capacity In PH-HFpEF: Primary Results From The HELP-PH-HFpEF Multicenter Randomized Controlled Trial

     

     

    Speaker:

    • HELP Study results will be presented on Saturday, October 3, 2020 at 4:30 pm EDT

    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 will be presented at the upcoming Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting to be held September 30, - October 6. Scheduling details and registration information are provided below:

    Title:

     

    Levosimendan Improves Hemodynamics and Submaximal Exercise Capacity In PH-HFpEF: Primary Results From The HELP-PH-HFpEF Multicenter Randomized Controlled Trial

     

     

    Speaker:

     

    Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic

     

     

    Session:

     

    Late-Breaking Clinical Trials I (LBCT I)

     

     

    Date/Time:

     

    Saturday, October 3, 4:30 - 5:30 PM

       

    Registration and additional HFSA information are available at the HFSA website: https://hfsa.org/hfsa-announces-late-breaking-clinical-trials-sessions-hfsa-virtual-asm-2020.

    Tenax CEO Anthony DiTonno stated, "We are very excited to have the HELP Study results presented as a late-breaking clinical trial at the HFSA Annual Meeting. We believe the results may represent a potential advance in the treatment of PH-HFpEF patients who currently have no FDA-approved therapies to treat their condition. We look forward to having the detailed trial results presented at this major scientific forum."

    About Phase 2 HELP Trial

    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. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

    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.

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  13. 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

    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 Full Article Hide Full Article
    • 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…

    • 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.

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  14. 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…

    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

     

     

     

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  15.  

    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…

     

    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.

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  16. 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…

    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 placements@hcwco.com.

    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.

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  17. 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 it received notice from The Nasdaq Stock Market, LLC ("Nasdaq") on June 2, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The Nasdaq Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and the matter is now closed.

    About Tenax Therapeutics

    Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing…

    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 it received notice from The Nasdaq Stock Market, LLC ("Nasdaq") on June 2, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The Nasdaq Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and the matter is now closed.

    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 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.

     

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  18. Top-line Data Readout Remains on Track for Late Q2 2020

    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 the last patient has completed their final visit in the Company's Phase 2 clinical trial of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Study (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF).

    • The 36-subject clinical trial began enrollment in late March 2019 and patients were randomized in 10 hospitals across the U.S.
    • Trial…

    Top-line Data Readout Remains on Track for Late Q2 2020

    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 the last patient has completed their final visit in the Company's Phase 2 clinical trial of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Study (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF).

    • The 36-subject clinical trial began enrollment in late March 2019 and patients were randomized in 10 hospitals across the U.S.
    • Trial finalization leading to data lock and top-line data readout has now begun.
    • Top-line data readout remains on track for late June 2020

    PH-HFpEF represents an area of very high unmet medical need. PH-HFpEF patients suffer from increased mortality as well as a reduced quality of life. No approved or effective therapies currently exist to treat the many patients who suffer with PH-HFpEF.

    Tenax CEO Tony Di Tonno stated: "We are thankful for the dedicated physicians, study coordinators and home health providers who were able to close out our study with minimal disruption from the current COVID-19 pandemic crisis. We are continuing to work very closely with everyone involved in collecting and finalizing the data required to report top line data before the end of the second quarter."

    Dr. Stuart Rich, Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute at Northwestern University stated, "As a principal investigator who helped to design and execute the HELP Study, I am eagerly looking forward to seeing the results of the HELP Study. Based on the remarkably favorable response reported by investigators during the open label pre-randomization phase of the trial, I am hopeful the results of the randomized double-blind phase of the trial will demonstrate that levosimendan could represent a breakthrough therapy for PH-HFpEF patients."

    About Phase 2 HELP Study

    The HELP Study is a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

    Initial Response

    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 was a reduction in PCWP during supine exercise of ≥ 4mmHg following the open-label infusion when compared with each patient's baseline exercise PCWP. 37 of 44 patients, approximately 84%, achieved this predefined responder criterion. Investigator reported invasive exercise hemodynamic measurements from 35 evaluable patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction of 7.8 mmHg PCWP, an average reduction in pulmonary arterial pressure (mPAP) of 4.8mmHg, an average reduction in right atrial pressure (RAP) of 5.3 mmHg, and an average increase in cardiac output (CO) of 0.4 liters/min. All of these open-label lead-in phase hemodynamic improvements, with the exception of cardiac output, achieved statistical significance (P≤0.001, paired t-Test).

    Adverse Events

    There have been no drug-related serious adverse events, and only 2 patients did not complete the 6 week study. All of the patients who completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.

    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 is currently enrolling 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 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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    • HELP study exceeds target enrollment with 37 patients
    • 84% initial open-label lead-in response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.5 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date
    • Top-line data expected in second quarter 2020

    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 it has completed enrollment of their Phase 2 clinical trial of levosimendan.

    The multi-center, double-blind, placebo-controlled…

    • HELP study exceeds target enrollment with 37 patients
    • 84% initial open-label lead-in response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.5 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date
    • Top-line data expected in second quarter 2020

    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 it has completed enrollment of their Phase 2 clinical trial of levosimendan.

    The multi-center, double-blind, placebo-controlled Phase 2 trial is designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The primary endpoint is the change from baseline Pulmonary capillary wedge pressure (PCWP) with bicycle exercise (25Watts) at week 6 following five weekly infusions of levosimendan post randomization. There is an 80% power to detect a ≥ 4.8 mmHg reduction in PCWP from baseline. The Company expects to report top-line data in the second quarter 2020.

    "We are delighted that enrollment has been completed in this Phase 2 trial and anticipate top line data to be reported during the second quarter 2020 following the completion of dosing and data analysis," stated Anthony DiTonno, CEO of Tenax Therapeutics. "Pulmonary hypertension due to left heart disease represents a significant unmet medical need given the lack of effective therapies for over an estimated two million patients in the US. Levosimendan with its triple mechanism of action has the potential to represent a breakthrough treatment option for these patients."

    Initial Response

    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. 37 of 44 patients who received the open-label lead in infusion, approximately 84%, achieved this predefined responder criterion.

    Invasive exercise hemodynamic measurements from the first 30 evaluable patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction in pulmonary capillary wedge pressure (PCWP) of 7.5 mmHg , an average reduction in pulmonary arterial pressure (mPAP) of 5.1 mmHg, an average reduction in right atrial pressure (RAP) of 5.0 mmHg, and an average increase in cardiac output (CO) of 0.6 liters/min. All of these open-label lead-in phase hemodynamic improvements achieved statistical significance (p≤0.01, paired t-Test)

    Adverse Events

    There have been no drug-related serious adverse events, and only 1 patient has withdrawn from the study prior to completing the 6-week double-blind phase of the trial . All of the patients who have completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.

    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 team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has completed enrollment of 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 April 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 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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  19. 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 750,000 shares of its common stock at a purchase price of $1.1651 per share and pre-funded warrants to purchase up to 1,610,313 shares of common stock, at a purchase price of $1.1650 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), for gross proceeds…

    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 750,000 shares of its common stock at a purchase price of $1.1651 per share and pre-funded warrants to purchase up to 1,610,313 shares of common stock, at a purchase price of $1.1650 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), for gross proceeds of approximately $2.75 million, 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 unregistered warrants to purchase up to 2,360,313 shares of common stock. The offering is expected to close on or about March 13, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The unregistered warrants will have an exercise price $1.04 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 offering 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 securities will be 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 placements@hcwco.com.

    The 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 warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the 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 is currently enrolling 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 offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering, 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 April 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 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.

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  20. 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 Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic has joined our scientific advisory board. Tenax CEO Tony DiTonno stated: "We are very excited to have someone of Dr. Borlaug's stature joining our scientific advisory board. Dr. Borlaug is a global leader in the fields of HFpEF and PH-HFpEF clinical research and is the leading enroller in the HELP Study. Dr. Borlaug's expertise in the field, and his firsthand experience gained…

    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 Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic has joined our scientific advisory board. Tenax CEO Tony DiTonno stated: "We are very excited to have someone of Dr. Borlaug's stature joining our scientific advisory board. Dr. Borlaug is a global leader in the fields of HFpEF and PH-HFpEF clinical research and is the leading enroller in the HELP Study. Dr. Borlaug's expertise in the field, and his firsthand experience gained as a HELP Study investigator, make him an ideal addition to our scientific advisory board."

    Tenax is conducting a multi-center, double-blind, placebo-controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The Company has activated all 16 sites which it believes will be sufficient to fully enroll the targeted 36 patients. Given the current pace of patient enrollment, we expect full enrollment in the first quarter of 2020 with top-line data in the first half of 2020.

    Dr. Borlaug was the first investigator to enroll a patient in the HELP Study and is the highest enrolling investigator to date with a total of 8 patients randomized at the Mayo Clinic. Dr. Borlaug stated, "I am excited to join my distinguished colleagues Dr. Stuart Rich, Dr. Sanjiv Shah, and Dr. Dan Burkhoff as members of the Tenax scientific advisory board and to be an investigator in the HELP Study. Hemodynamic responses observed during the open-label lead-in phase of the HELP Study have been impressive and I am hopeful that if we observe similar results in the double-blind phase of the trial that it could lead to the first therapy ever approved to treat PH-HFpEF patients."

    Dr. Borlaug joins the other distinguished members of our advisory board including Stuart Rich, MD, Northwestern, Professor of Medicine Northwestern University Feinberg School of Medicine and Director, Pulmonary Vascular Disease Program, Bluhm Cardiovascular Institute, Daniel Burkhoff MD, Ph.D., Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation and Adjunct Associate Professor of Medicine, Columbia University, and Sanjiv Shah, MD, Professor of Medicine Director, T1 Center for Cardiovascular Therapeutics, and Director, Northwestern HFpEF Program, Division of Cardiology, Department of Medicine Northwestern University Feinberg School 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 is currently enrolling 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 April 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 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 Full Article Hide Full Article
    • 24 patients have been randomized
    • 86% initial response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.6 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date

    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 provided an update on its on-going clinical trial of levosimendan.

    Enrollment Update

    Tenax is conducting a multi-center, double-blind, placebo-controlled Phase 2 trial designed to evaluate levosimendan in patients with…

    • 24 patients have been randomized
    • 86% initial response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.6 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date

    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 provided an update on its on-going clinical trial of levosimendan.

    Enrollment Update

    Tenax is conducting a multi-center, double-blind, placebo-controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The Company has activated all 16 sites which it believes will be sufficient to fully enroll the trial. 24 patients, up from 15 at the end of October, are currently enrolled, out of the targeted 36 patients. Given the current pace of patient enrollment, we expect full enrollment in the first quarter of 2020 with top-line data in the first half of 2020.

    Initial Response

    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. 24 of 28 patients, approximately 86%, achieved this predefined responder criterion.

    Invasive exercise hemodynamic measurements from 22 enrolled patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction of 7.6 mmHg PCWP, an average reduction in pulmonary arterial pressure (mPAP) of 4.9mmHg, an average reduction in right atrial pressure (RAP) of 5.2 mmHg, and an average increase in cardiac output (CO) of 0.8 liters/min. All of these open-label lead-in phase hemodynamic improvements achieved statistical significance (P≤0.01, paired t-Test)

    Adverse Events

    There have been no drug-related serious adverse events, and no patients have withdrawn from the study. All of the patients who have completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.

    "We are pleased that enrollment rates have been consistently increasing and initial responses continue to exceed our expectations," said Tony DiTonno, CEO of Tenax Therapeutics. "We anticipate completing this trial in the months to come and quickly moving forward to the next phase of our development efforts to make levosimendan available to those patients suffering from this debilitating disease."

    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 team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and is currently enrolling 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 April 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 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 Full Article Hide Full Article
    • 15 patients have been randomized
    • 83% initial response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced , on average, by 8 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date

    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 provided an update on its on-going clinical trial of levosimendan.

    Enrollment Update

    Tenax is conducting a multi-center, double-blind placebo controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary…

    • 15 patients have been randomized
    • 83% initial response rate to qualify for randomization
    • Pulmonary capillary wedge pressure (PCWP) was reduced , on average, by 8 mmHg during exercise following the initial levosimendan infusion
    • No serious drug-related adverse events have been reported to date

    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 provided an update on its on-going clinical trial of levosimendan.

    Enrollment Update

    Tenax is conducting a multi-center, double-blind placebo controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The Company has activated all of its anticipate 15 sites which it believes will be sufficient to fully enroll the trial. 15 patients, up from eight at the end of August, are currently enrolled, out of the targeted 36 patients. Given the current pace of patient enrollment, we continue to expect full enrollment and top-line data in the first quarter of 2020.

    Initial Response

    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 that PCWP measured during supine exercise is ≥ 4mmHg less after the open-label infusion than at baseline. 15 of the 18 patients, approximately 83%, achieved this predefined responder criterion with a mean reduction of 8 mmHg in PCWP.

    Adverse Events

    There have been no drug-related serious adverse events, and no patients have withdrawn from the study. All of the patients who have completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.

    Tenax CEO Tony DiTonno stated, "We are excited to provide this interim update regarding the HELP Study enrollment and preliminary responder information. While these open-label hemodynamic responses are preliminary, it is encouraging to see such favorable responses. We are very fortunate to have so many prominent investigators and leading academic centers participating in the HELP Study."

    Dr. Stuart Rich, Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute at Northwestern University and the principal investigator and architect for the HELP Study stated, "The high initial response rate, and the magnitude of the initial response with exercise has exceeded my expectations. I remain very hopeful that we may have an effective treatment for PH-HFpEF for the first time."

    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 team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and is currently enrolling 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 April 1, 2019, its quarterly report on Form 10-Q filed on August 14, 2019 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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  21. 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 management is scheduled to present and conduct one-on-one meetings at the H.C. Wainwright 21st Annual Global Investment Conference to be held in New York, NY on September 8th-10th. Anthony DiTonno, Chief Executive Officer, is scheduled to present on Tuesday, September 10th at 2:10 p.m. Eastern Time.

    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…

    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 management is scheduled to present and conduct one-on-one meetings at the H.C. Wainwright 21st Annual Global Investment Conference to be held in New York, NY on September 8th-10th. Anthony DiTonno, Chief Executive Officer, is scheduled to present on Tuesday, September 10th at 2:10 p.m. Eastern Time.

    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 team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan and is currently enrolling 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 acute 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.

    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 April 1, 2019, its quarterly report on Form 10-Q filed on August 14, 2019 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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