Every material Form 8-K TENAX THERAPEUTICS, INC. has filed with the SEC since September 09, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Tenax Therapeutics reported a third-quarter 2026 net loss of $16.7 million, up from $15.8 million a year earlier, and no revenue was reported. The company paused enrollment in its ongoing LEVEL-2 Phase 3 trial while it amends the protocol to target a narrower patient group, and it has a Type C meeting with the FDA pending. Shareholders face a larger loss and a trial whose future plan depends on that FDA meeting.
Net loss for the quarter ended September 30, 2026 was $16.7 million, compared with $15.8 million for the same quarter of 2025.
Research and development expenses rose to $12.1 million from $10.3 million; SG&A fell to $5.7 million from $6.5 million.
Cash and cash equivalents were $113.7 million at September 30, 2026; the company expects cash to fund operations through fiscal 2028, subject to the FDA Type C meeting outcome.
LEVEL-2 enrollment is temporarily paused after the LEVEL trial did not meet its primary endpoint, announced August 10, 2026.
Tenax Therapeutics temporarily paused enrollment in its LEVEL-2 Phase 3 trial of TNX-103 while it amends the enrollment criteria to target patients with lower baseline 6-minute walk distance, based on results from the LEVEL trial. The company also said it has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The pause delays enrollment in a pivotal trial, and the company's investor presentation states that the LEVEL trial did not meet its primary endpoint in the overall population.
Enrollment in LEVEL-2 is paused and may resume at each site as the amended protocol takes effect there.
The amendment targets patients with baseline 6-minute walk distance of 100m to 300m, or above 300m to 400m with a right atrial volume index of 25 mL/m2 or more.
The LEVEL trial's overall primary endpoint difference was 3.5 M (p = 0.63), according to the investor presentation attached as Exhibit 99.1, dated October 8, 2026.
Tenax Therapeutics furnished an investor presentation at the Cantor Global Healthcare Conference on September 9, 2026, reviewing full results of its Phase 3 LEVEL trial of TNX-103 (oral levosimendan) in PH-HFpEF. The trial did not reach statistical significance on its primary endpoint, the change in 6-minute walk distance, which was a 3.5-meter treatment difference (p = 0.63). The company says the results will guide the design of its follow-on trial, LEVEL-2, and the presentation includes subgroup results for patients with baseline walk distance below the median.
Primary endpoint, 6MWD change at week 12: 3.5 m treatment difference vs. placebo (p = 0.63); the company describes the trial as not meeting its primary endpoint.
Overall population NT-proBNP fell 49% vs. placebo at week 12 (nominal p < 0.0001); RVSP fell 3.5 mmHg vs. placebo.
Prespecified subgroup with baseline 6MWD below 333 m: +26.3 m treatment effect (95% CI 6.0 to 46.7; nominal p = 0.0112); these are subgroup results from a trial whose primary endpoint was not met.
Adverse events were higher on TNX-103 (86.7% vs. 71.9% any adverse event); serious adverse events were 10.8% vs. 10.7%.
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