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Tenax Therapeutics, Inc. (Nasdaq: TENX) is a specialty pharmaceutical company dedicated to identifying, developing, and commercializing innovative treatments for cardiovascular and pulmonary diseases with significant unmet medical needs. Headquartered in Chapel Hill, North Carolina, Tenax holds the North American rights to develop and commercialize levosimendan, a unique potassium ATP channel activator and calcium sensitizer with multiple mechanisms of action.
The company’s flagship product, levosimendan, is currently under development for treating pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF). This condition affects a growing number of patients and has high morbidity and mortality rates with no approved drug treatments. Levosimendan has shown promise in improving exercise capacity through potent dilation of central and pulmonary venous circulations, as demonstrated in the Phase 2 HELP trial.
Tenax is advancing levosimendan through the Phase 3 LEVEL study, a double-blind, randomized, placebo-controlled trial evaluating the efficacy of oral levosimendan in improving exercise tolerance in PH-HFpEF patients. The study aims to enroll approximately 152 subjects and measure outcomes through the six-minute walk distance test.
Recent milestones include the initiation of trial sites and patient enrollment in the LEVEL study, as well as securing expanded global rights for the development and commercialization of oral and subcutaneous formulations of levosimendan beyond North America. The United States Patent and Trademark Office (USPTO) recently granted Tenax a patent covering various formulations of levosimendan for improving exercise performance in PH-HFpEF patients, providing protections through December 2040.
In addition to levosimendan, Tenax is also developing a novel oral formulation of imatinib for pulmonary hypertension. The company continues to explore strategic partnerships to maximize the commercial potential of its therapies.
For more information about Tenax Therapeutics and their ongoing projects, visit www.tenaxthera.com. The company’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Tenax Therapeutics (Nasdaq: TENX) announced a significant publication about levosimendan, detailing its mechanism of action that improves cardiovascular hemodynamics in pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The publication reveals that levosimendan reduces stressed blood volume, leading to lower pulmonary wedge pressure and central venous pressure without inotropic effects. This positions levosimendan as the first therapy to enhance exercise capacity in PH-HFpEF. A Phase III study is expected to start in the first half of 2022.
Tenax Therapeutics, Inc. (Nasdaq: TENX) announced a KOL webinar on Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) scheduled for August 16, 2021. KOL Daniel Burkhoff, M.D., Ph.D., will discuss treatment gaps and the potential of Levosimendan as a new therapy. Tenax's Chief Medical Officer, Stuart Rich, M.D., will outline the clinical development plan for Levosimendan, emphasizing its role as a first-in-class K-ATP activator. The event will include a Q&A session. Levosimendan has already shown potential benefits in clinical settings.
Tenax Therapeutics, Inc. (Nasdaq: TENX) announced a CEO transition with Anthony A. DiTonno retiring on July 13, 2021, after a decade of service. Christopher T. Giordano has been appointed as the new CEO, effective July 14, 2021. The company also secured a deal for selling 4,773,269 Units at $2.095 each, expecting gross proceeds of approximately $10 million. The Units consist of unregistered pre-funded and regular warrants to purchase common stock, with an aggregate of 9,546,538 underlying shares. This financing aims to enhance shareholder value through product development in cardiovascular and pulmonary diseases.
Tenax Therapeutics, Inc. (Nasdaq: TENX) will join the Russell Microcap® Index effective June 28, following the annual reconstitution. This inclusion increases visibility among institutional investors and aligns with the company’s growth strategy, as it advances its two lead drug programs, imatinib and levosimendan, towards Phase 3 trials. The Russell Microcap Index is widely recognized, with approximately $10.6 trillion in assets benchmarked to it, indicating significant attention for Tenax as it aims to address cardiovascular and pulmonary diseases.
Tenax Therapeutics (Nasdaq: TENX) reported its Q1 2021 financial results and business updates, highlighting its merger with PHPrecisionMed Inc. This merger enhances its portfolio for pulmonary hypertension treatments, targeting over 70% of the market. The transition to an oral formulation of Levosimendan is underway, potentially improving patient convenience. R&D expenses surged to $22.4 million due to the acquisition, resulting in a net loss of $23.7 million, or $1.64 per share. As of March 31, 2021, cash reserves stand at $4.0 million, expected to sustain operations until Q3 2021.
Tenax Therapeutics, Inc. (Nasdaq: TENX) has released positive results from its Phase 2 HELP Study, evaluating levosimendan for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study showed an 84% responder rate in the open-label phase, although levosimendan did not significantly reduce exercise-PCWP compared to placebo. Notably, it improved the six-minute walk distance by 29.3 meters compared to placebo (p=0.033). The publication emphasizes the need for further studies on levosimendan, which demonstrates potential as a treatment for this severe condition.
Tenax Therapeutics (Nasdaq: TENX) announces the voluntary retirements of Ronald R. Blanck, D.O., Gregory Pepin, and Chris A. Rallis from its Board of Directors, effective June 10, 2021. This decision is part of a Board refreshment program, introducing four new directors earlier this year. Dr. Blanck, who served since 2009, will be succeeded by Gerald Proehl as Chairman. The Board will be reduced from 12 to 9 members post-retirement. Tenax focuses on developing treatments for cardiovascular and pulmonary diseases and owns North American rights to levosimendan, aimed at addressing high unmet medical needs.
Tenax Therapeutics, Inc. (Nasdaq: TENX) reported its financial results for the year ended December 31, 2020, revealing a net loss of $9.9 million ($1.33 per share), up from $8.4 million ($1.35 per share) in 2019. Research and development expenses increased to $4.6 million from $3.5 million, while general and administrative expenses rose to $5.3 million from $5.1 million. The completion of the merger with PH Precision Medicine has expanded Tenax's pipeline, including the acquisition of oral formulation rights for Levosimendan. The company aims to advance its leading candidates into late-stage clinical trials.
Tenax Therapeutics, Inc. (Nasdaq: TENX) announced its presentation and virtual investor meetings at the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021. The pre-recorded presentation will be available on-demand starting March 9 at 7:00 A.M. (EST) on their website, tenaxthera.com. Tenax focuses on developing therapeutics for cardio-pulmonary diseases, with rights to levosimendan and plans for a pivotal trial of imatinib. Both drugs target significant unmet medical needs in their respective areas.
Tenax Therapeutics, Inc. (Nasdaq: TENX) announced the appointment of four new board members: June Almenoff, MD, PhD, Michael Davidson, MD, Declan Doogan, MD, and Stuart Rich, MD. CEO Anthony DiTonno expressed enthusiasm for their expertise, which is seen as crucial for advancing the company’s two leading pipeline assets into late-stage clinical testing. These assets include a new formulation of imatinib for pulmonary arterial hypertension and an oral formulation of levosimendan, which has been in-licensed from Orion. The new board members bring extensive experience in biopharma and clinical development.
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