Tenax Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Tenax Therapeutics has successfully completed private placements with aggregate gross proceeds of approximately $125 million to support the advancement of two registrational studies for TNX-103 in pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) and to fund operations through 2027 [1][6] - The Phase 3 LEVEL study expansion aims to increase statistical power, with enrollment completion targeted around the end of 2025 and topline data expected in mid-2026 [1][5] - A second Phase 3 study, LEVEL-2, is expected to be initiated this year [1] Financial Performance - As of December 31, 2024, Tenax reported cash and cash equivalents of$94.9 million, with an additional 25 million raised in March 2025 [5][6] - Research and development (R&D) expenses for Q4 2024 were 4.6 million, up from 1.7 million in Q4 2023, and total R&D expenses for the year were 12.7 million compared to 3.2 million in 2023 [7] - General and administrative (G&A) expenses for Q4 2024 were 2.7 million, compared to 1.6 million in Q4 2023, with total G&A expenses for the year at 6.8 million versus $5.0 million in 2023 [8] - The net loss for Q4 2024 was$6.3 million, compared to a net loss of $3.2 million in Q4 2023, and the total net loss for the year was$17.6 million compared to $7.7 million in 2023 [9] Corporate Developments - The FDA has completed its review of the updated Phase 3 development plan for TNX-103, which includes an amendment to expand enrollment and enhance the statistical power of the ongoing Phase 3 LEVEL study [5] - In January 2025, Tenax appointed Gillian Andor as Vice President of Clinical Operations, bringing over 20 years of experience in the biotechnology industry [5] - Tenax has received U.S. Patent No. 11,969,424 covering the use of TNX-103 and related compounds for improving exercise performance in patients with PH-HFpEF [5]