Tenax Therapeutics, Inc. (NASDAQ: TENX)

Tenax Therapeutics, Inc. (TENX) is a biopharmaceutical company that operates in the healthcare industry, with a specific focus on the development of novel treatments for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The company, which was originally founded as Rudmer, David & Associates, Inc. in 1967, has its headquarters in San Diego, California, and its shares are listed on the NASDAQ Capital Market.

The main business activities of Tenax Therapeutics involve the development of pharmaceutical products containing levosimendan, a calcium sensitizer/K-ATP activator, for the treatment of PH-HFpEF and other indications. Levosimendan is a novel drug that has been approved in 58 countries for the treatment of acutely decompensated heart failure. The company has a portfolio of products, including TNX-101 (intravenous levosimendan), TNX-102 (subcutaneous levosimendan), and TNX-103 (oral levosimendan), and has acquired the rights to develop and commercialize levosimendan in the United States and Canada through a license agreement with Orion Corporation, the originator of levosimendan. The company's business strategy involves conducting clinical development to establish clinical proof of principle in new indications, refining formulation, and commencing Phase 3 testing of its current product candidates. Tenax Therapeutics also plans to expand its intellectual property portfolio and enter into licensing or product co-development arrangements to accelerate product development and commercialization.

The primary product candidate of Tenax Therapeutics is TNX-103 (oral levosimendan), which is being developed for the treatment of PH-HFpEF. The company has completed a Phase 2 clinical trial of TNX-103 in PH-HFpEF patients, known as the HELP Study, which demonstrated statistically significant improvements in hemodynamics and exercise tolerance compared to placebo. The company is currently planning to initiate a Phase 3 clinical trial of TNX-103 in PH-HFpEF patients, known as the LEVEL Study, which is expected to enroll patients in the fourth quarter of 2023. In addition to TNX-103, the company is also developing TNX-201 (imatinib), a tyrosine kinase inhibitor, for the treatment of pulmonary arterial hypertension (PAH).

Tenax Therapeutics has a strong intellectual property portfolio, with several patents issued or pending for its product candidates. The company has also received orphan drug designation for TNX-103 from the U.S. Food and Drug Administration (FDA) for the treatment of PH-HFpEF. The company's position within the industry is that of a relatively small biopharmaceutical company, competing with larger biopharmaceutical companies that have a broader range of products and a larger market presence. The company's key competitors include pharmaceutical companies such as Pfizer, Johnson & Johnson, and Gilead Sciences, as well as smaller biopharmaceutical companies that have a focus on the development of treatments for pulmonary hypertension and heart failure.

In terms of manufacturing and supply, Tenax Therapeutics contracts with third-party manufacturers for the production of its product candidates and for pre-clinical and clinical studies. The company does not own or operate any manufacturing facilities and has no plans to build any owned clinical or commercial scale manufacturing capabilities. The company relies on its license agreement with Orion Corporation for the supply of levosimendan, and has engaged various third-party suppliers and contract drug manufacturing organizations (CMOs) for the supply and manufacture of imatinib.