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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 the successful completion of its pharmacokinetic study for TNX-201, a modified release formulation of imatinib for treating pulmonary arterial hypertension (PAH). The new formulation significantly enhances relative bioavailability while minimizing gastric release, addressing gastrointestinal side effects. Manufacturing is underway to support the upcoming Phase 3 trial, IMPROVE, with patient enrollment expected to start in the second half of 2022.
Tenax Therapeutics, Inc. (NASDAQ: TENX) announced an agreement to issue 10,596,027 Units at $0.755 each, raising approximately $8 million. Each Unit includes a pre-funded warrant and a warrant to purchase shares of common stock. The gross proceeds will support clinical trials for levosimendan and imatinib, R&D, and general corporate purposes. Additionally, existing warrants for 9,206,120 shares will have their exercise price reduced to $0.63 and their term extended by two years, along with other warrants for 7,783,616 shares.
Tenax Therapeutics, Inc. (TENX) reported financial results for the year ended December 31, 2021, with a net loss of $32.5 million, equating to a loss of $1.58 per share, up from a loss of $9.9 million in 2020. R&D expenses surged to $25.1 million from $4.6 million, reflecting intensified efforts on their oral formulation of imatinib, TNX-201, aimed at treating pulmonary arterial hypertension (PAH). The company plans to initiate a Phase 3 study of TNX-201 in the second half of 2022. Cash reserves stood at $5.6 million, expected to last until Q2 2022.
Tenax Therapeutics (NASDAQ: TENX) will present its late-stage drug candidates, imatinib and levosimendan, at the American College of Cardiology (ACC) Scientific Sessions from April 2-4, 2022, in Washington, D.C. The presentations include insights from the HELP trial on levosimendan for pulmonary hypertension related to left heart failure and discussions on next-generation tyrosine kinase inhibitors for PAH. These sessions feature renowned experts, including Professors Barry Borlaug and Stuart Rich, highlighting important advancements in cardiopulmonary therapies.
Tenax Therapeutics (TENX) announced the appointment of Robyn Hunter to its Board of Directors, effective January 28, 2022. Hunter, an independent director with extensive experience in development-stage biotechnology, will chair the audit and compliance committee. President and CEO Christopher T. Giordano expressed optimism about her contributions as the company advances its lead candidates, TNX-201 and TNX-102, into pivotal testing. Tenax focuses on treatments for cardiovascular and pulmonary diseases with high unmet needs.
Tenax Therapeutics (TENX) announced that the USPTO granted a patent for TNX-102, its subcutaneous formulation of levosimendan, aimed at treating pulmonary hypertension related to left heart failure (PH-HFpEF). The patent, issued on January 4, 2022, extends until at least 2039, allowing for treatment claims for various health conditions beyond PH-HFpEF. This development underscores the company's commitment to address unmet medical needs in cardiovascular diseases. Tenax plans to advance TNX-102 into pivotal Phase 3 testing based on encouraging clinical trial results.
Tenax Therapeutics (TENX) announced significant updates regarding its lead product candidates, TNX-102 and TNX-201. The company received a Notice of Allowance from the USPTO for patent claims on subcutaneous levosimendan, expected to be issued in January 2022, extending coverage until 2039. Additionally, TNX-103 successfully transitioned patients from IV to oral levosimendan, demonstrating comparable efficacy and safety. Tenax plans to initiate a Phase 3 study for TNX-201 in pulmonary arterial hypertension in the second half of 2022, supported by a new Scientific Advisory Board of experts.
Tenax Therapeutics, a specialty pharmaceutical company, reported its third quarter 2021 financial results. The company is advancing its clinical programs, initiating a pharmacokinetic study for its novel imatinib formulation, with a Phase 3 trial expected to start in Q2 2022. Tenax has received FDA clearance for its IND application and published findings on levosimendan's novel mechanism. Third quarter R&D expenses rose to $1.2 million, while G&A expenses increased to $2.6 million. The net loss was $3.8 million, with $8.4 million in cash as of September 30, 2021, expected to sustain operations until Q2 2022.
Tenax Therapeutics (NASDAQ: TENX) has received FDA approval for its Investigational New Drug (IND) application for a reformulated delayed-release imatinib for pulmonary arterial hypertension (PAH). The company aims to initiate a Phase 3 trial in Q2 2022 following a comparative pharmacokinetic study starting in October 2021. This new formulation seeks to mitigate gastric intolerance seen in prior studies, enhancing patient tolerance and potentially offering a disease-modifying treatment option for this critical condition.
Tenax Therapeutics, Inc. (NASDAQ: TENX) has announced a presentation at the virtual Benzinga Healthcare Small Cap Conference on September 29, 2021, at 1:35 p.m. ET. The company's focus is on developing therapeutics for cardio-pulmonary diseases. Attendees can register for the webcast here. Tenax is advancing a delayed-release formulation of imatinib for pulmonary arterial hypertension (PAH), expecting to commence a pivotal trial in 1H 2022. They also hold rights to levosimendan, demonstrating promising Phase 2 results in heart failure.
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