Tenax Therapeutics Reports 137% Increase in Operating Expenses and Raises $125 Million for Clinical Trials

Tenax Therapeutics, Inc. reported significant financial developments in its recent 10-K filing for the fiscal year ending December 31, 2024. The company recorded total operating expenses of $19.5 million, a 137% increase from $8.2 million in the previous year. This rise was primarily driven by a substantial increase in research and development expenses, which surged to $12.7 million from $3.2 million, reflecting intensified efforts in clinical trials, particularly the ongoing Phase 3 LEVEL study for oral levosimendan. General and administrative expenses also rose to $6.8 million, up from $5.0 million, largely due to increased compensation and legal fees.

In terms of funding, Tenax successfully raised approximately $100 million in a private placement in August 2024, followed by an additional $25 million in March 2025. These funds are earmarked for advancing the Phase 3 oral levosimendan program and initiating a second global Phase 3 study, LEVEL-2. The company aims to submit marketing authorization applications upon completion of these trials. As of December 31, 2024, Tenax reported cash and cash equivalents of $94.9 million, which it believes will sustain operations for at least the next 12 months.

Operationally, Tenax is focused on developing levosimendan and has deprioritized the Phase 3 clinical trial of imatinib. The company is leveraging its existing clinical data and the established safety profiles of both drugs, which have been prescribed globally for over 20 years. The ongoing LEVEL trial is designed to evaluate the efficacy of oral levosimendan in patients with pulmonary hypertension, a condition for which there are currently no approved therapies.

The company’s workforce remains small, with only five full-time employees as of the filing date. This limited headcount underscores the reliance on third-party contract research organizations (CROs) for clinical trials and other operational activities. Tenax's strategy includes expanding its intellectual property portfolio and exploring new therapeutic applications, particularly in areas with significant unmet medical needs.

Looking ahead, Tenax anticipates continued financial losses as it invests heavily in clinical development. The company has acknowledged the need for substantial additional funding to support its ongoing and future clinical trials. The success of its product candidates, particularly levosimendan, will depend on the outcomes of these trials and the ability to secure regulatory approvals, which remain uncertain.