8-K: Tenax Therapeutics Secures $125 Million to Advance TNX-103 for PH-HFpEF, Phase 3 Enrollment Targeted for Year-End 2025

Tenax Therapeutics reports financial results for 2024 and provides a corporate update, highlighting successful private placements totaling $125 million to support the development of TNX-103 for PH-HFpEF and fund operations through 2027.

Summary

• Tenax Therapeutics announced its financial results for the fourth quarter and full year ended December 31, 2024.
• The company successfully completed private placements, raising approximately $125 million to support the advancement of TNX-103 and fund operations through 2027.
• The Phase 3 LEVEL study is expanding to increase statistical power, with enrollment completion targeted around year-end 2025 and topline data expected in mid-2026.
• A second Phase 3 study, LEVEL-2, is expected to commence in 2025.
• Tenax reported cash and cash equivalents of $94.9 million as of December 31, 2024, and an additional $25 million was raised in March 2025.
• R&D expenses for 2024 were $12.7 million, compared to $3.2 million in 2023, primarily due to the Phase 3 LEVEL study.
• The net loss for 2024 was $17.6 million, compared to $7.7 million in 2023.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. The successful private placements and advancement of TNX-103 are positive, but the increased net loss is a concern.

Positives

• Successful private placements secured approximately $125 million, providing funding through 2027.
• Advancement of TNX-103, an oral levosimendan drug candidate, for the treatment of PH-HFpEF.
• Expansion of the Phase 3 LEVEL study to increase statistical power.
• Initiation of a second Phase 3 study, LEVEL-2, expected in 2025.
• Appointment of Gillian Andor as Vice President of Clinical Operations to support the Phase 3 TNX-103 program.
• Grant of U.S. Patent No. 11,969,424, providing intellectual property protection for levosimendan.

Negatives

• The company reported a net loss of $17.6 million for the year ended December 31, 2024, which is higher than the $7.7 million net loss reported for the year ended December 31, 2023.
• Increased R&D expenses due to the Phase 3 LEVEL study contributed to the higher net loss.

Risks

• The timing, delays, costs, design, initiation, enrollment, and results of clinical trials could impact the company's progress.
• Delays in regulatory review and approval of product candidates could affect the timeline for commercialization.
• Reliance on third parties, including Orion Corporation, manufacturers, and CROs, poses a risk to the company's operations.
• Volatility and uncertainty in the global economy and financial markets could impact the company's financial stability.
• Changes in legal, regulatory, and legislative environments could affect the company's ability to obtain regulatory approval for its products.

Future Outlook

Tenax Therapeutics believes it is funded through 2027 and expects to share topline data from the LEVEL study in the middle of 2026.

Management Comments

• With the continued support of investors, we are now well-positioned to expand our investment in TNX-103 and accelerate development timelines, paving the way for an earlier potential regulatory filing, said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics.
• We remain committed to a lean cost structure and responsible capital stewardship, ensuring our current funding sustains Tenax well beyond topline LEVEL data readout.
• We believe TNX-103 has the potential to improve the quality of life of patients living with PH-HFpEF, and expect to share topline data from LEVEL in the middle of 2026.

Industry Context

Tenax Therapeutics is focused on developing novel cardiopulmonary therapies, specifically for PH-HFpEF, a prevalent form of pulmonary hypertension with no currently approved products.

Comparison to Industry Standards

• It is difficult to compare Tenax directly to industry standards without knowing the specific benchmarks for PH-HFpEF drug development.
• However, companies like Bayer and Novartis have invested in cardiovascular therapies, and their R&D spending and clinical trial timelines could provide a general comparison.
• The success of TNX-103 will depend on its ability to demonstrate significant improvements in exercise capacity and quality of life compared to existing treatments or placebo.

Management Changes

Stakeholder Impact

• Shareholders: The successful private placements and advancement of TNX-103 are positive for shareholders.
• Employees: The expansion of the Clinical Operations function and the appointment of Gillian Andor could impact employees.
• Patients: The development of TNX-103 could provide a new treatment option for patients with PH-HFpEF.
• Investors: The company's financial performance and clinical trial results will impact investor confidence.

Next Steps

• Complete enrollment of 230 patients in the Phase 3 LEVEL study around the end of 2025.
• Initiate the second Phase 3 study, LEVEL-2, in 2025.
• Share topline data from the LEVEL study in the middle of 2026.

Key Dates

Keywords

TNX-103, Levosimendan, PH-HFpEF, Phase 3, Clinical Trials, Tenax Therapeutics, Financial Results, Private Placement, Cardiopulmonary Therapies, FDA