Tenax Therapeutics, Inc. (NASDAQ:TENX) is a biopharmaceutical company focused on developing innovative therapies for cardiovascular and pulmonary diseases. The company's lead product candidate, levosimendan, has shown promising results in clinical trials for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition with significant unmet medical need.
Business Overview
Tenax Therapeutics was originally formed in 1967 and has since evolved its focus to developing novel therapies for cardiovascular and pulmonary diseases. In 2013, the company acquired the exclusive rights to develop and commercialize levosimendan in the United States and Canada. Levosimendan is a calcium sensitizer that has been approved and used globally for the treatment of acute decompensated heart failure.Tenax has been exploring the potential of levosimendan in various cardiovascular and pulmonary indications, including PH-HFpEF, a condition characterized by elevated pulmonary pressures and impaired left ventricular filling, which often leads to exercise intolerance and poor quality of life. The company's focus on levosimendan is supported by positive results from a Phase 2 open-label extension study, which demonstrated durable improvements in exercise capacity and quality of life in PH-HFpEF patients.
In February 2024, Tenax announced an amendment to its license agreement with Orion Corporation, the originator of levosimendan, which provides the company with global rights to oral and subcutaneous formulations of levosimendan for the treatment of PH-HFpEF. This amendment also revises the royalty structure, lowers the royalty rates, and modifies certain regulatory and commercial milestones.
Intellectual Property and Clinical Development
Tenax's intellectual property position for levosimendan has been strengthened with the issuance of three U.S. patents in 2023 and 2024. These patents cover the use of intravenous and oral levosimendan in the treatment of PH-HFpEF, providing exclusivity through 2040.The company is currently focused on advancing the development of levosimendan and has initiated the LEVEL trial, a Phase 3 study evaluating the efficacy and safety of oral levosimendan in patients with PH-HFpEF. The LEVEL trial is designed to build on the positive results observed in the previous Phase 2 open-label extension study. Tenax expects to continue enrolling patients in the LEVEL trial throughout 2024 and into the first half of 2025.
Financial Performance
For the three months ended March 31, 2024, Tenax reported no revenue, a net loss of $3.8 million, and negative operating cash flow of $5.2 million. The company's research and development expenses increased significantly to $2.7 million in the first quarter of 2024, primarily due to the initiation of the LEVEL trial for oral levosimendan. General and administrative expenses remained relatively stable at $1.2 million.For the full year 2023, Tenax reported no revenue, a net loss of $7.7 million, and negative operating cash flow of $5.9 million. The company's free cash flow for the year was also negative at $5.9 million.
Liquidity and Capital Resources
As of March 31, 2024, Tenax had $12.5 million in cash and cash equivalents, providing the company with sufficient capital to fund its operations through the remainder of 2024. However, the company will need to secure additional financing to complete the LEVEL trial and support the continued development and potential commercialization of levosimendan and other product candidates.In February 2024, Tenax raised approximately $8.0 million in net proceeds from a registered public offering of common stock and warrants. This capital injection will help the company advance the LEVEL trial and explore other strategic initiatives.
Risks and Outlook
Tenax faces several risks, including the potential failure of the LEVEL trial, difficulties in obtaining regulatory approval for levosimendan, and the need for substantial additional funding to complete the development and potential commercialization of its product candidates. The company also faces competition from other therapies for PH-HFpEF and other cardiovascular and pulmonary indications.Despite these risks, Tenax remains focused on advancing levosimendan through the LEVEL trial and leveraging its expanded intellectual property protection to potentially bring this therapy to patients with PH-HFpEF, a condition with limited treatment options. The company's recent amendment to the Orion license agreement, which provides global rights and more favorable terms, further strengthens its strategic position.