TENAX THERAPEUTICS, INC.

Current report

Our Phase 3 LEVEL trial of TNX-103 did not meet its primary endpoint or its key secondary endpoint, which has materially harmed our business.

Current report

On August 10, 2026, we announced topline results from LEVEL, the first Phase 3 trial of TNX-103 (oral levosimendan) in patients with PH-HFpEF. LEVEL did not meet its primary endpoint, change from baseline in 6-minute walk distance (6MWD) at Week 12 or its key secondary endpoint, change in Kansas City Cardiomyopathy Questionnaire total symptom score. We had previously disclosed that we expected two adequate and well-controlled Phase 3 trials, LEVEL and LEVEL-2, to support a marketing application. Because LEVEL missed its primary endpoint, it cannot serve as designed as one of two positive, completed trials. TNX-103 is our only product candidate in active clinical development, and we have deprioritized development of imatinib (TNX-201). If LEVEL-2 fails, or if the FDA or other regulators require additional trials beyond LEVEL-2, we may be unable to continue development of TNX-103. In that case we may need to pursue strategic alternatives, including a sale, merger, license or wind-down, and stockholders could lose all or substantially all of their investment.

Current report

Our plan to continue development of TNX-103 rests on subgroup and post hoc analyses of LEVEL, which may not be confirmed in LEVEL-2 and which regulators, physicians or investors may not accept.

Current report

Our decision to amend and continue LEVEL-2 is based largely on prespecified subgroup and post hoc analyses of LEVEL. Subgroup and post hoc findings from a trial that failed its primary endpoint might not be reproduced in later trials, and might reflect chance, regression to the mean or other statistical artifacts. Additionally, the FDA and other regulators, the medical community and investors may not agree with our interpretation of the LEVEL data. They may also disagree with our view that the result reflects patient selection rather than lack of drug effect, or with our view that hypotheses generated by, and an enrichment strategy resulting from, analysis of LEVEL data reduce risk in LEVEL-2. Restricting enrollment to a narrower population may also slow enrollment, reduce the commercial opportunity for TNX-103 if approved, and result in narrower labeling.

Current report

We have paused enrollment in LEVEL-2 while we implement a protocol amendment at each clinical site enrolling patients in LEVEL-2, and the FDA may not agree with such amendment or other aspects of our revised development plan.

Current report

As announced on October 8, 2026, we temporarily paused screening and randomization in LEVEL-2 to implement a protocol amendment that restricts enrollment to patients meeting more stringent baseline 6MWD and right atrial volume index criteria. We shared topline LEVEL results with the FDA in August 2026, and have been granted a Type C meeting to discuss the overall development of levosimendan in PH-HFpEF. We cannot predict the outcome of that meeting. The FDA may:

Current report

disagree with the amended LEVEL-2 design, its enrichment criteria or its primary endpoint;

Current report

require one or more additional adequate and well-controlled trials beyond LEVEL-2;

Current report

question whether patients enrolled before the amendment can be included in the primary efficacy analysis; or

Current report

require a larger or longer-duration safety database.

Current report

The enrollment pause, any additional protocol amendments and any further FDA requirements could materially delay LEVEL-2, increase its cost, and extend the time before we submit a marketing application, if ever.

Current report

The LEVEL results may make it substantially more difficult to raise additional capital on acceptable terms, and any financing will likely be highly dilutive.

Current report

As of September 30, 2026, we had cash and cash equivalents of $113.7 million. We believe this will be sufficient to fund operations through fiscal 2028. This estimate assumes the amended LEVEL-2 design, the current anticipated enrollment timeline of LEVEL-2 and no additional clinical trials beyond LEVEL-2, and it may prove wrong. Following the LEVEL announcement, the market price of our common stock declined by approximately 90%, from $13.44 on August 7, 2026 to $1.38 on August 10, 2026. We may need substantial additional funding to complete LEVEL-2, conduct any additional trials the FDA may require, and prepare and submit any marketing application. Our reduced market capitalization, the LEVEL results and the uncertainty about our regulatory path may limit our access to capital or make financing available only on terms that are highly dilutive or that impose restrictive covenants. If we cannot obtain funding when needed, we may be required to delay, reduce or eliminate LEVEL-2 or our other activities, or to pursue strategic alternatives.

Current report

We may become subject to additional securities litigation, derivative lawsuits and related claims arising from the LEVEL results, which could be costly and divert management's attention.

Current report

Following our announcement of the LEVEL results, several law firms announced investigations into whether we made false or misleading statements or failed to disclose material information to investors, and a putative securities class action lawsuit has been filed against us and certain of our current and former officers, as described in Part II, Item 1 of this Quarterly Report on Form 10-Q. We may become subject to additional securities class action lawsuits, derivative lawsuits, books-and-records demands under Section 220 of the Delaware General Corporation Law, or regulatory inquiries relating to our prior disclosures about LEVEL, the HELP clinical trial, trial design and our statements about the likelihood of success. Defending such matters could be costly and could divert management's attention. Our directors' and officers' liability insurance may be insufficient to cover losses, and any adverse outcome could harm our financial condition. Insurance costs and retention levels may also increase.

Current report

We may be unable to retain key personnel following the LEVEL results.

Current report

We depend heavily on a small number of executives and clinical development personnel. The LEVEL results and the decline in our stock price have significantly reduced the value of outstanding equity awards, many of which are now underwater. In addition, certain of our current officers were named as defendants in the pending securities class action, which may place additional demands on their time. This may impair our ability to retain and motivate our employees and to recruit new talent.

Previous report

On May 11, 2026, the Company granted an inducement RSU award to an executive newly hired by the Company for 10,000 shares of common stock and an inducement stock option award of 450,000 shares of common stock. One quarter of the RSU award vested 10 days after issuance and the remainder will vest in three equal installments on the four-month, eight-month, and twelve-month anniversaries of issuance. One quarter of the option award will vest on the first anniversary of issuance with the remainder vesting in 36 approximately equal installments on the monthly anniversaries thereafter.

Previous report — wording carried elsewhere

Additionally, between April 28, 2026 and June 1, 2026, the Company made four non-negotiated inducement stock option awards to non-executive individuals newly hired by the Company in various clinical operations, medical, product development, and commercial roles. The employees received, in the aggregate, stock option awards to purchase 657,500 shares of common stock. One quarter of each option award will vest on the first anniversary of issuance with the remainder vesting in 36 approximately equal installments on the monthly anniversaries thereafter.