Every 8-K that Tenax Therapeutics, Inc. (TENX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TENX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TENX filings page.
Tenax Therapeutics, Inc. (TENX) furnished an investor presentation summarizing full Phase 3 LEVEL trial results for oral levosimendan (TNX-103) in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Over 12 weeks, levosimendan did not meet the primary endpoint of improving 6-minute walk distance (6MWD) versus placebo, with a least-squares mean treatment difference of 3.5 meters and a p-value of 0.63.
The presentation highlights prespecified and post-hoc subgroup analyses suggesting larger treatment effects in patients with greater baseline functional limitation (baseline 6MWD below 333 meters), including a 26.3-meter placebo-adjusted LS mean improvement in 6MWD with nominal p=0.0112. Across the overall population, NT-proBNP was reduced by about 49% versus placebo and right ventricular systolic pressure declined by 3.5 mmHg. Safety data show similar rates of serious adverse events between arms, with higher treatment-related adverse events, dose reductions and discontinuations on levosimendan, mainly headache, palpitations and hypotension. Tenax states that insights from LEVEL are being used to refine the design and patient selection strategy for a planned LEVEL-2 study.
Tenax Therapeutics reported topline Phase 3 LEVEL trial results for TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). The study randomized 241 patients 1:1 to TNX-103 or placebo across 41 sites in the United States and Canada.
The trial did not meet its primary endpoint of improvement in 6-minute walk distance at Week 12, with a treatment difference of 3.5 meters (p=0.63), nor the key secondary endpoint in Kansas City Cardiomyopathy Questionnaire total symptom score. Prespecified exploratory analyses showed a 49% reduction in NT-proBNP versus placebo (nominal p<0.0001) and a 3.5 mmHg reduction in right ventricular systolic pressure (nominal p=0.0045). A prespecified subgroup with baseline 6-minute walk distance below 333 meters had a 26.3-meter benefit versus placebo (95% CI 6.0, 46.7; nominal p=0.0112). TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across arms. Tenax plans to request a Type C meeting with the FDA and parallel EMA consultation to refine its Phase 3 development plan and enrichment strategy for TNX-103.
Tenax Therapeutics reported second quarter 2026 results, posting a net loss of $17.8 million ($0.35 per share) as late‑stage development spending increased. Research and development expenses were $12.9 million and selling, general and administrative expenses were $5.9 million for the quarter.
The company held $118.0 million in cash and cash equivalents as of June 30, 2026, including $13.4 million of warrant‑exercise proceeds, and expects this to fund operations through the second quarter of 2028. Tenax also reported progress on oral levosimendan (TNX‑103) for PH‑HFpEF, expecting Phase 3 LEVEL topline data in August 2026 and planning to complete enrollment in the second Phase 3 trial, LEVEL‑2, by the end of 2027.
Tenax Therapeutics, Inc. filed an update stating that results from its Phase 3 LEVEL clinical trial of TNX-103 (oral levosimendan) in pulmonary hypertension in heart failure with preserved ejection fraction will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology Congress 2026 in Munich.
The company now plans to report topline LEVEL data in August 2026 and is moving toward database lock and statistical analysis in the coming weeks. The registrational trial enrolled over 230 patients in the United States and Canada and is powered at well over 90% to detect a 25-meter change in 6-minute walk distance, its primary endpoint.
Tenax Therapeutics, Inc. entered into a new Supply Agreement with Orion Corporation giving Orion responsibility for manufacturing and supplying Tenax’s orally administered levosimendan product for development and, if approved, commercial use. The agreement covers forecasting, ordering, delivery, pricing, quality and cost-sharing for manufacturing scale-up.
The Supply Agreement runs for an initial five-year term from first delivery of product, with automatic three-year renewals unless either party gives 24 months’ written notice. It may be terminated for material breach after a 60-day cure period, insolvency or termination of the related License Agreement.
Concurrently, Tenax and Orion signed a Sixth Amendment to their existing License Agreement. This extends to December 31, 2035 the deadline to obtain U.S. regulatory approval for the product before a termination right based on missing that milestone becomes effective and adds information and cybersecurity requirements for Tenax, while leaving other license terms unchanged.
Tenax Therapeutics updated its executive employment agreements and adopted new company-wide severance and change in control plans. The Board approved amendments for Christopher Giordano, Thomas Staab, and Stuart Rich that align their severance and equity vesting protections with the new plans.
Outside a change in control, each executive may receive 12 months of base salary plus up to 12 additional months based on tenure, a pro-rated target bonus, and 12 months of COBRA reimbursements, with full equity acceleration for Dr. Rich. If a qualifying termination occurs from three months before to 12 months after a change in control, Mr. Giordano can receive 18 months of salary and COBRA reimbursements, while all three receive at least 12 months of salary, a full target bonus, and accelerated vesting.
The company also adopted a Change in Control Plan offering double-trigger equity acceleration and cash severance, and a Severance Plan for terminations without cause, both for eligible employees other than executive officers and conditioned on a release of claims.
Tenax Therapeutics, Inc. reported the results of its 2026 annual meeting of stockholders held on June 2, 2026. Stockholders elected seven directors, including June Almenoff, Michael Davidson, Declan Doogan, Christopher T. Giordano, Robyn M. Hunter, Gerald T. Proehl, and Stuart Rich, each to serve a one-year term expiring in 2027.
Each director nominee received between 15,762,162 and 17,397,413 votes in favor, with additional withheld votes and 3,742,678 broker non-votes recorded for each. Stockholders also ratified the appointment of Cherry Bekaert LLP as the company’s independent registered public accounting firm for the year ending December 31, 2026, with 21,304,543 votes for, 3,688 against, and 11,073 abstentions.
Tenax Therapeutics reported a first quarter 2026 net loss of $15.7 million, wider than the $10.4 million loss a year earlier, as it increased investment in late-stage clinical trials.
Cash and cash equivalents were $118.8 million as of March 31, 2026, up from $97.6 million on December 31, 2025, and the company now expects its cash to last through at least the first quarter of 2028. Research and development spending rose to $11.5 million from $5.7 million, mainly to support the Phase 3 LEVEL and LEVEL-2 studies of TNX-103. General and administrative expenses declined slightly to $5.0 million from $5.7 million.
Tenax completed randomization of more than 230 patients in the Phase 3 LEVEL trial and plans to report topline data in the third quarter of 2026. Enrollment is ongoing in the global LEVEL-2 Phase 3 trial, with completion anticipated by the end of 2027. The company also strengthened its leadership team by appointing Thomas Staab as Chief Financial Officer and Timothy Healey, MBA, as Chief Commercial Officer.
Tenax Therapeutics is appointing Thomas R. Staab, II as Chief Financial Officer effective May 11, 2026, replacing interim CFO Thomas McGauley after the company files its Quarterly Report for the quarter ended March 31, 2026. Mr. McGauley will continue as a consultant through at least the end of May 2026.
Under an executive employment agreement, Mr. Staab will receive a $428,000 annual base salary and a target bonus equal to 45% of salary, plus inducement equity awards of 10,000 restricted stock units and options to purchase 450,000 shares of common stock, with multi‑year vesting and severance protections of nine to twelve months’ salary, bonus and COBRA reimbursements depending on termination circumstances.
Tenax Therapeutics reported 2025 results and highlighted major progress in its Phase 3 program for levosimendan (TNX-103) in pulmonary hypertension with preserved ejection fraction (PH-HFpEF). The company reached its randomization target of 230 patients in the Phase 3 LEVEL trial and expects topline data in the third quarter of 2026. A second global registrational Phase 3 study, LEVEL-2, began in December 2025, with enrollment anticipated to complete by the end of 2027, and an open-label extension will allow continued TNX-103 access.
Cash and cash equivalents were $97.6 million as of December 31, 2025, and Tenax expects this to fund operations through 2027. R&D expenses rose to $10.5 million for the fourth quarter and $32.7 million for the full year 2025, compared with $4.6 million and $12.7 million in 2024, mainly due to advancing LEVEL and initiating LEVEL-2. G&A expenses increased to $5.9 million for the quarter and $23.7 million for the year, versus $2.7 million and $6.8 million in 2024, largely from higher stock-based compensation and professional fees. Net loss widened to $15.5 million for the quarter and $52.6 million for 2025, compared with $6.3 million and $17.6 million in 2024.
Tenax Therapeutics, Inc. reported an update to the employment terms of its Chief Medical Officer, Dr. Stuart Rich. Effective January 1, 2026, Dr. Rich will devote an average of four days per week to his duties as Chief Medical Officer under a second amendment to his Executive Employment Agreement.
His annual base salary will be prorated to reflect this modified work schedule. The amendment was approved by the Board of Directors on December 22, 2025, and formally entered into on January 6, 2026. The complete terms are set out in the Second Amendment to Executive Employment Agreement, filed as Exhibit 10.1.
Tenax Therapeutics reported new clinical progress for its lead drug candidate TNX-103 in patients with pulmonary hypertension related to heart failure with preserved ejection fraction. A planned blinded sample size re-estimation for the LEVEL Phase 3 trial showed the study is powered at well over 90% to detect a 25 meter change in 6-minute walk distance, the primary measure of effectiveness. This supports keeping the existing enrollment target and previously communicated timelines for finishing enrollment and reporting topline data. Tenax also started LEVEL-2, a second global Phase 3 registrational trial of TNX-103 in the same patient population, indicating a broader late-stage development program.
Tenax Therapeutics (TENX) filed an 8-K stating it issued a press release announcing financial results for the third quarter ended September 30, 2025. The press release is furnished as Exhibit 99.1 and, as noted under Item 2.02, is not deemed “filed” for purposes of Section 18 of the Exchange Act. The company’s common stock trades on Nasdaq under the symbol TENX.
Tenax Therapeutics filed a report describing a new intellectual property development for its pulmonary hypertension program. On September 16, 2025, the company announced that the European Patent Office has issued an Intention to Grant a patent covering TNX-103 (oral levosimendan), other formulations of levosimendan, and its active metabolites for use in treating pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). This kind of protection helps define how long and how broadly Tenax can control use of this drug approach in that indication. The details are provided in a press release attached as an exhibit.
Tenax Therapeutics entered into an amendment to its long-standing license agreement with Orion Corporation covering levosimendan. The amendment grants Tenax exclusive worldwide rights to develop, commercialize, manufacture, and have manufactured any orally-administered pharmaceutical product containing levosimendan.
In addition to its existing rights for subcutaneously administered levosimendan products, Tenax now also gains rights to manufacture or have manufactured those subcutaneous products. Orion will supply Tenax with levosimendan for orally-administered products under agreed terms, including pricing in the low triple-digit thousands in Euros per kilogram and defined payment and active ingredient specifications.
Tenax Therapeutics has furnished a press release disclosing its financial results for the quarter ended June 30, 2025, attaching that release as Exhibit 99.1 to this Form 8-K. The company also included an interactive XBRL cover page as Exhibit 104 and reconfirmed that the press release is furnished rather than filed, so it is not subject to Section 18 liability and is not incorporated by reference into other filings except by specific reference. The 8-K itself does not include any numerical financial figures; readers must consult the attached press release for detailed results and metrics.