Tenax Therapeutics, Inc.

What they do

Tenax is a clinical-stage cardiopulmonary drug developer. Its prioritized candidate is levosimendan, a K-ATP channel activator/calcium sensitizer with IV (TNX-101) and oral (TNX-103) forms, which it is testing in PH-HFpEF. The company is running the Phase 3 LEVEL trial (U.S. and Canada) and the global Phase 3 LEVEL-2 trial, and it has deprioritized its Phase 3 imatinib program with no significant imatinib development activities ongoing.

Revenue drivers

• No product revenue — Reported annual revenue was $0 in 2024 and 2025 and $0 in the quarters ended March 31, 2025 and March 31, 2026; the company has no approved product and no commercial sales.
• TNX-103 (oral levosimendan) — Future revenue depends entirely on this unapproved candidate; management plans marketing authorization applications after the two Phase 3 levosimendan trials are complete.
• Levosimendan global rights — Tenax states it owns global rights to develop and commercialize levosimendan; the drug is approved in other indications in 60 countries but is not available in the United States or Canada.
• Imatinib (deprioritized) — A Phase 3 imatinib trial has been deprioritized and the company reports no significant imatinib development activities ongoing, so it is not a current cash-generating line.

Recent performance

For the second quarter of 2026, Tenax reported a net loss of $17.8 million versus a net loss of $10.9 million in the second quarter of 2025. R&D expense rose to $12.9 million from $6.1 million, driven by the ongoing Phase 3 LEVEL trial and LEVEL-2, which began in December 2025. SG&A was $5.9 million, roughly flat versus $5.7 million a year earlier. Cash and cash equivalents were $118.0 million as of June 30, 2026, with $13.4 million of second-quarter proceeds from exercises of previously issued warrants. Full-year 2025 net loss was $52.6 million with operating cash use of $35.8 million.

Strategy

Tenax is funding a clinician-driven development plan built on already-approved drugs with established safety profiles. It completed randomization of more than 230 patients in the LEVEL trial of TNX-103 before the end of the first quarter of 2026 and expects to report topline data from the 12-week randomized treatment period in August 2026. LEVEL-2, the second global Phase 3 trial, is enrolling with completion anticipated by the end of 2027. The company raised gross proceeds of approximately $125 million across private placements in August 2024 and March 2025 and plans marketing authorization applications after both Phase 3 trials finish.

Risks

• No approved product or revenue — The company generated $0 revenue in 2024 and 2025 and its prospects depend on unapproved product candidates, so any clinical or regulatory failure would leave it without a commercial business.
• Binary topline readout — Topline results from the Phase 3 LEVEL trial are expected in August 2026, and the 12-week randomized data will determine whether the program advances.
• Cash burn and financing need — Net loss was $17.8 million in the second quarter of 2026 and operating cash use was $35.8 million in 2025, so continued funding depends on external capital.
• Third-party dependence — The 10-K risk factors cite reliance on third-party manufacturers and clinical research organizations, and potential delays in clinical testing, enrollment and regulatory review.

Outlook

Management expects to report topline data from the Phase 3 LEVEL clinical trial in August 2026 and has said an accepted abstract may allow presentation of those results at the European Society of Cardiology Congress 2026, August 28-31 in Munich. Enrollment in LEVEL-2 is expected to complete by the end of 2027, with marketing authorization applications planned after both Phase 3 levosimendan trials conclude. Based on its current operating plan, Tenax believes existing cash as of June 30, 2026 plus post-quarter warrant exercise proceeds fund operations through the second quarter of 2028.