Tenax Therapeutics Q1 2024 Financial Results and Corporate Update

Tenax Therapeutics, previously known as Oxygen Biotherapeutics, Inc., has made significant strides in 2024, particularly in the first quarter, as a Phase 3, development-stage pharmaceutical company, concentrating on cardiovascular and pulmonary diseases with unmet medical needs. On May 14, 2024, the company declared its financial results for the first quarter and provided a corporate update, showcasing multiple achievements and ongoing projects.

Under the leadership of Chris Giordano, President and CEO, Tenax Therapeutics has commenced its pivotal Phase 3 LEVEL study, which is examining the efficacy of TNX-103 (oral levosimendan) for treating Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The company has also broadened its patent portfolio and secured global commercial rights to levosimendan for this purpose. Additionally, an April event titled “LEVEL Setting” brought together four heart failure experts to discuss PH-HFpEF and the potential of levosimendan.

The company continues to activate trial sites and enroll patients in the LEVEL study, with the cardiology community showing strong support. Updates on the TNX-103 program are anticipated later in the year.

Key milestones in recent months include the United States Patent and Trademark Office (USPTO) granting a new patent (U.S. Patent No. 11,969,424), which covers the use of TNX-103, TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), and their active metabolites (OR1896 and OR18955), along with combinations of cardiovascular drugs with levosimendan, to enhance exercise performance in PH-HFpEF patients.

In a significant event in April 2024, Tenax Therapeutics hosted “LEVEL Setting,” where experts like Sanjiv Shah, M.D. from Northwestern University, Daniel Burkhoff, M.D., Ph.D. from Columbia, Barry Borlaug, M.D. from the Mayo Clinic, and Javed Butler, M.D., M.P.H., M.B.A. from Baylor Scott & White, discussed the need for effective treatments for PH-HFpEF and the mechanisms of action of levosimendan.

In February 2024, Dr. Sanjiv Shah also presented at the Cardiovascular Research Foundation’s THT 2024 Conference in Boston, reviewing the scientific basis for using levosimendan in PH-HFpEF patients.

The company's financial standing saw a boost in February 2024, when it raised approximately $8 million from a public offering. The funds are being used to advance the LEVEL study site initiation and patient enrollment, as well as for general corporate purposes. The LEVEL study is a structured, double-blind, randomized, placebo-controlled trial involving 152 patients to assess the efficacy of levosimendan in improving exercise tolerance over a 12-week period. Following the trial, participants have the option for an extensive 92-week open-label extension.

Levosimendan, a drug initially developed by Orion Corporation in Finland, is a potassium ATP channel activator and calcium sensitizer with multiple action mechanisms on the heart and vascular system. It has already received marketing authorization in over 60 countries for treating acutely decompensated heart failure in hospitalized patients. Tenax Therapeutics' Phase 2 HELP study demonstrated that levosimendan significantly improves exercise capacity in PH-HFpEF patients, laying the groundwork for the current LEVEL study.

Financially, Tenax Therapeutics reported cash and cash equivalents of $12.5 million as of March 31, 2024. Research and Development expenses for the first quarter were $2.7 million, reflecting the increased costs of the ongoing LEVEL study, while General and Administrative expenses remained stable at $1.2 million. The net loss for the first quarter of 2024 was $3.8 million, compared to $1.4 million in the same period of the previous year.

Tenax Therapeutics, trading on Nasdaq under the symbol “TENX,” continues to focus on developing and commercializing treatments for cardiovascular and pulmonary diseases, with levosimendan as a key near-term priority. The company is also considering resuming the development of its oral formulation of imatinib.