TENX 10-K & 10-Q changes, risk factors and insider trading

Our business, financial condition and operating results may be affected by a number of factors, including but not limited to those described below. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from our past or anticipated future results of operations and financial condition. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, results of operations and stock price. The following information should be read in conjunction with Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the accompanying financial statements and related notes in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.

At present we are focusing our resources on developing levosimendan for the treatment of PH-HFpEF, while imatinib for the treatment of PAH remains part of our portfolio. We intend to commit most of our resources to advancing levosimendan to the point it receivesfor regulatory approval for the treatment of pulmonary hypertension in patients with HFpEF. Depending on whether we raise additional funds in the future, as well as on decisions made by the USPTO, clinical trial results and other information revealed by competitors, and other factors, we will prioritize our funding and other resources.resources accordingly. If as a consequence of the results of our planned Phase 3 trials for levosimendan, or the results of prior clinical trials performed using levosimendan or imatinib, we are unable to receive regulatory approval of one or both of our existing product candidates, then we may not have resources to pursue development of any other products and our business could terminate.

The process of developing new drugs and/or therapeutic products is inherently complex, unpredictable, time-consuming, expensive and uncertain. We must make long-term investments and commit significant resources before knowing whether our development programs will result in products that will receive regulatory approval and achieve market acceptance. Product candidates that appear to be promising at some or all stages of development may not receive approval or reach the market for a number of reasons that may not be predictable based on results and data of the clinical program. Product candidates may be found ineffective or may cause harmful side effects during clinical trials, may take longer to progress through clinical trials than had been anticipated, may not be able to achieve the pre-defined clinical endpoints due to statistical anomalies even though clinical benefit may have been achieved, may fail to receive necessary regulatory approvals, may prove impracticable to manufacture in commercial quantities at reasonable cost and with acceptable quality, or may fail to achieve market acceptance. Even if we believe the preclinical or clinical data for our product candidates are favorable, such data may not be sufficient to support approval by the FDA and other regulatory authorities. Additionally, the FDA may require us to conduct additional preclinical studies or clinical trials for our product candidates either prior to or post-approval, or it may object to elements of our clinical development program.

Delays in the commencement, enrollment and completion of clinical testing could significantly affect our ability to gain FDA approval of current product candidates, and to gain this approval in the timeline planned, and could significantly increase our future product development costs. The completion of clinical trials requires us to identify and maintain a sufficient number of trial sites, many of which might already be engaged in other clinical trial programs for the same indication as our product candidates, might be required to withdraw from our clinical trial as a result of changing standards of care, might suffer from staff shortages at the institutional or clinic level that impact their ability to enroll and treat patients under our protocols, or might become ineligible to participate in clinical studies. The enrollment and completion of clinical trials can be delayed for a variety of other reasons, including delays related to:

maintaining and supplying clinical trial material on a timely basis; and collecting, analyzing and reporting final data from the clinical trials;trials.

the efficacy, safety and potential advantages of our product candidates and alternative treatments, if any;

our ability to offer our products for sale at competitive prices and the availability of third-party coverage and adequate reimbursement;

Nonfinal results from our clinical trials announced or published from time to time on an interim, preliminary,top-line, or “top-line”preliminary basis, and conclusions that may be drawn from such results, may change as more patient data become available, and these results are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish or reference interim, top-line, or preliminary results from our clinical trials, including offrom blinded or unblinded data. Interim or top-line results from clinical trials that we may complete are subject to the risk that one or more of the clinical outcome measurements may materially change as patient enrollment and treatment extends and more patient experience is observed. PreliminaryTop-line or top-linepreliminary results also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interiminterim, top-line and preliminary data should be viewed with caution until the final and complete data are available. Differences between preliminaryinterim, top-line or interimpreliminary data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

We will require substantial additional funding to further developdevelop, file marketing authorization applications, and if approved, commercialize our product candidates, including to complete the open label extension stage of our ongoing Phase 3 LEVEL trial and toLEVEL-2 completetrials aof second planned global Phase 3 study, Level-2,levosimendan; as well as to initiate or complete anany future imatinib Phase 3 trial. Failure to obtain this necessary capital when needed on acceptable terms, or at all, or execute on an alternative strategic path, could force us to delay, limit, reduce or terminate our clinical trials, product development efforts and business operations.

As of December 31, 2024,2025, we had $94.9$97.6 million of cash and cash equivalents on hand and subsequent to year end, onas of March 5,9, 20252026 we have raised an additional $25.0$14.5 million of gross proceeds from anthe offeringexercises of commonoutstanding stockwarrants and pre-funded warrants. We will need substantial additional capital in order to develop our product candidates, including to complete the LEVEL and LEVEL-2 trials, to complete the regulatory approval process and commercialization of levosimendan, and, potentially, imatinib, or any future product candidates. We continue to evaluate pursuing additional public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding may not be available on favorable terms, if at all.

our ability to develop and commercialize our current product candidates, and any product candidate which we may develop or in-license in the future; delays in the commencement,commencement of a trial, recruitment and initiation of sites, enrollment of patients, and completion of clinical testing, as well as the analysis and reporting of results from such clinical testing;

the costs and timing of regulatory approvalapproval, if any;

potential side effects or adverse events of our product candidates that could delay or prevent commercialization;

our ability to establish or maintain collaborations, licensing or other arrangements and risks related thereto;

costs related to and outcomes of potential litigationlitigation, including any product liability claims;

compliance with obligations under intellectual property licenses with third partiesparties, including milestone payments and royalties;

We have incurred losses since inception. For the years ended December 31, 20242025 and 2023,2024, we incurred net operating losses of $19.5$56.4 million and $8.2$19.5 million, respectively. We have funded our operations since 2013 principally through the issuance of debt and equity securities. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan for pulmonary hypertension and other potential indications, imatinib for PAH, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.

Many of our current competitors have significant financial, marketing and personnel resources and development capabilities. For example, many large, well-capitalized companies already offer cardiovascular and pulmonary products and services in the United States and Europe that target the indications for which our product candidates are being developed, or related indications. Currently, as an example, at least twelve vasodilators are marketed in the U.S. for use in patients with PAH, and sales teams from Janssen, Pfizer, Bayer, United Therapeutics, and other large companies with marketing and sales capabilities represent these products in the specialized care centers where the disease is treated. While there are no products currently marketed to treat PH-HFpEF, specifically, some products such as sotatercept and relaxins under development by Astra Zeneca and others are under development to treat this prevalent disease, and some products marketed for other conditions or for HFpEF alone, are used in these patients and could constitute competition at the patient, payor, or overall market level in future.

Our activities are and will continue to be subject to extensive government regulation, which is difficult to predict, expensive and time-consuming, and we will not be able to sell our products without regulatory approval.

The FDA and other regulatory agencies continue to review products even after they receive agency approval. If and when the FDA or another regulatory agency outside the United States approves one of our products, its manufacture and marketing will be subject to ongoing regulation, which could includeincludes compliance with current good manufacturing practices, adverse event reporting requirements and general prohibitions against promoting products for unapproved or “off-label” uses. We are also subject to inspection and market surveillance by the FDA for compliance with these and other requirements. Any enforcement action resulting from failure, even by inadvertence, to comply with these requirements could affect the manufacture and marketing of levosimendan,any imatinib or our otherapproved products. In addition, the FDA or other regulatory agencies could withdraw a previously approved product from the market upon receipt of newly discovered information. The FDA or another regulatory agency could also require us to conduct additional, and potentially expensive, studies in areas outside our approved indicated uses.

Obtaining an Orphan Drug Designation from the FDA may not effectively protect our product candidates from competition because different drugs can be approved for the same condition, and orphan drug exclusivity does not prevent the FDA from approving the same or a different drug in another indication. Even after an orphan drug is approved, the FDA can subsequently approve a later application for the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer in a substantial portion of the target populations, more effective, or makes a major contribution to patient care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Moreover, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to manufacture sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Orphan Drug Designation neither shortens the development time ornor regulatory review time of a drug norand givesdoes not give the drug any advantage in the regulatory review or approval process. Furthermore, U.S. law and the application of law to the exclusivity of approved therapies for orphan diseases, has evolved, including with the Consolidated Appropriations Act of 2026, and this evolution may continue to evolve, impairing our ability to be assured of the same exclusivity and the resulting reimbursement for TNX-201 for its intended use.

Even after products are commercialized, we would expect to spend considerable time and money complying with federalfederal, state, and stateforeign laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties.

Our failure to comply with any of these federal and state health care laws and regulations, or health care laws in foreign jurisdictions, as may be applicable, could have a material adverse effect on our business, financial condition, result of operations and cash flows.

The containment of healthcare costs is a priority of federal, state and foreign governments and the prices of drug products have been a focus in this effort. The continuing efforts of government, private insurance companies and other organizations to contain or reduce costs of healthcare, including through such recent legislation as the Inflation Reduction Act in the U.S.,United States, the effects of which are evolving over time, may adversely affect our ability to set as high a price for our products as we might otherwise and the rate and scope of adoption of our products by healthcare providers. We expect that federal, state and local governments in the United States, as well as governments in other countries, will continue to consider legislation directed at lowering the total cost of healthcare. In addition, in certain foreign markets, the pricing of drug products is subject to government control and reimbursement may in some cases be unavailable or insufficient. It is uncertain whether and how future legislation, whether domestic or abroad, could affect prospects for our product candidates or what actions governmental or private payers for healthcare treatment and services may take in response to any such healthcare reform proposals or legislation. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, may prevent or limit our ability to generate revenue, attain profitability or commercialize our product candidates.

Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion,cyber-intrusion, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates could be delayed.

We do not currently employ personnel or possess the facilities necessary to conduct many of the activities associated with our development programs. We have historically and we will continue to engage consultants, advisors, CROsmanufacturers, expert physicians and scientists, CROs, laboratories, and others to assist in the design and conduct of nonclinical and clinical studies of our product candidates, with interpretation of the results of those studies and with regulatory activities and expect to continue to outsource all or a significant amount of such activities. As a result, many important aspects of our development programs are and will continue to be outside our direct control and our third-party service providers may not perform their activities as required or expected, including the maintenance of Good Laboratory Practices (“GLP”) or Good Clinical Practices (“GCP”) compliance, which are ultimately our responsibility to ensure. Further, such third parties may not be as committed to the success of our programs as our own employees and, therefore, may not devote the same time, thoughtfulness, or creativity to completing projects or problem-solving as our own employees would. To the extent we are unable to successfully manage the performance of third-party service providers, our business may be adversely affected.

The CROs and other vendors we engage or may engage to execute our clinical studies play a significant role in the conduct of the studies, including the collection and analysis of study data, and we likely will depend on CROs and clinical investigators to conduct future clinical studies and to assist in analyzing data from completed studies and developing regulatory strategies for our product candidates. Individuals working at the CROs with which we contract, as well as investigators at the sites at which our studies are conducted, are not our employees, and we have limited control over the amount or timing of resources that they devote to their programs. If our CROs, study investigators, and/or third-party sponsors fail to devote sufficient time and resources to studies of our product candidates, if we and/or our CROs do not comply with all GLP and GCP regulatory and contractual requirements, or if their performance is substandard, it could adversely affect the development of our product candidates.

Pursuant to the terms of our license for levosimendan, Orion is at present our sole manufacturing source for TNX-103; should they opt not to provide us the product, our license agreement provides for 24 months’ notice to the Company of same, to allow an alternative manufacturer to be brought onboard. We might engage other third-party suppliers and CMOs for the supply and manufacture of TNX-102, or other formulations we might develop. Accordingly, our business is susceptible to disruption, and our results of operations can be adversely affected, by any disruption in supply or other adverse developments in our relationship with Orion. If supply from Orion is delayed or terminated, or if its facilities suffer any damage or disruption, we may need to successfully qualify an alternative supplier in a timely manner in order to avoid disruption of our business. If we cannot obtain an alternate manufacturer in a timely manner, we would experience a significant interruption in supply of levosimendan, which could negatively affect our clinical trial conduct and other product development efforts and timelines, financial condition, results of operations and cash flows.

We have historically operated with a limited number of employees. As of December 31, 2024,2025, we had fourfourteen full-time employees and two part-time employees,employees. Numerous additional contract staff, separate to the CROs and invendors thewith firstwhom quarterwe ofcontract, 2025support addedour oneadministrative additionaland full-timeR&D employee.functions. Therefore,Still, institutional knowledge is concentrated within athis small numbergroup of employees.employees and contract team members. Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel to continue the development, regulatory approval and commercialization of our product candidates. We will need to hire or contract with additional qualified personnel with expertise in preclinical testing, clinical research and testing, government regulation, formulation and manufacturing, and sales and marketing. Additionally, our future success is highly dependent upon the contributions of our senior management team. The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, completion of our planned clinical trials or the commercialization of our product candidates.

To commercialize our products, if approved, in the United States and other jurisdictions in which we may seek approvals, we must build our marketing, sales, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. We have not decided upon a commercialization strategy in these areas. We have no experience in the sale and marketing of approved medical products and marketing the licensing of such products before FDA or other regulatory approval. We dohave not knowidentified ofor anyengaged a third party that is prepared to distribute our products should they be approved. If we decide to establish our own commercialization capability, we will need to recruit, train and retain a marketing staff and sales force with sufficient technical expertise. We do not know whether we can establish a commercialization program at a cost that is acceptable in relation to revenue or whether we can be successful in commercializing our product. Factors that may inhibit our efforts to commercialize our products directly and without strategic partners include:

we may not be able to control the amount and timing of resources that our distributors or collaborators may devote to the marketing and commercialization of our product candidates;

our distributors or collaborators may notexperience devotefinancial sufficient time to the marketing and sales of our productsdifficulties; and business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement.

We are pursuing a multi-faceted IP strategy for levosimendan that includes filing patent applications in the U.S. and Canada, Europe, and multiple other countries that, if granted, could protect various uses and formulations of levosimendan In January 2022, the USPTO granted us a patent protecting claims for different uses of various cyclodextrin-based subcutaneous formulations of levosimendan, including a claim for its use in the treatment of PH-HFpEF patients. In 2026, the USPTO issued Tenax a Notice of Allowance for claims directed to the subcutaneous administration of levosimendan in a broad range of indications. The range of indications includes but is not limited to PH-HFpEF. In addition, we received in March 2023 another U.S. patent protecting the use of levosimendan in the treatment of PH-HFpEF. Two subsequent U.S. patents expanded these protections on the use of levosimendan in the treatment of PH-HFpEF. Other patent applications are pending globally.globally, or will be granted in 2026 according to patent authorities in Canada in Europe.

Our strategy to maximize market exclusivity for imatinib relies on two forms of exclusivity. First, we have been granted Orphan Drug Designation for the treatment of PAH by the FDA whichwhich, woulddepending on evolving law and policy in this arena, could provide seven years of regulatory exclusivity in the U.S. if our imatinib formulation is the first to receive FDA approval for PAH. In addition, we may file one or more patent applications to cover patentable subject matter that may result from our imatinib development. If granted, a patent would provide protection for 20 years from its filing date.

results of clinical trials of our competitors’ products, or comments made on the observed results of their, or our, products;

competition from existing products or new products that may emergeemerge, or on which development work is terminated for safety, efficacy or other reasons;

Certain provisions in our Amended and Restated Certificate of Incorporation, as amendedIncorporation (the “Charter”), and our Fourth Amended and Restated Bylaws (the “Bylaws”), may make it difficult for a third party to acquire, or attempt to acquire, control of the Company, even if a change in control was considered favorable by the stockholders. For example, our Board of Directors has the authority to issue up to 10,000,000 shares of preferred stock. The Board can fix the price, rights, preferences, privileges and restrictions of the preferred stock without any further vote or action by our stockholders. The issuance of shares of preferred stock may delay or prevent a change in control transaction. As a result, the market price of our common stock and the voting and other rights of our stockholders may be adversely affected. An issuance of shares of preferred stock may result in the loss of voting control toof other stockholders.

require that stockholders give advance notice to nominate directors or submit proposals for consideration at stockholder meetings; and authorize the Board of Directors,Board, by a majority vote, to amend the Bylaws.

Tenax Therapeutics is a clinical-stagePhase 3, development-stage pharmaceutical company usingleveraging clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-focusedclinician-driven drug development approach, led by key opinion leaders and advised by thought leaders who are pulmonary hypertension and heart failure experts and informed by their clinical insights to precisely target disease pathophysiology. We are currently actively conducting the LEVEL and LEVEL-2 clinical trialtrials to evaluate levosimendan as our prioritized product candidate, and have deprioritized a Phase 3 clinical trial of imatinib, two drugs supported by promising evidence that they may significantly improve the lives of patients with pulmonary hypertension. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world for more than 20 years, and we believe their mechanisms of action are uniquely suitable to target and treat pulmonary hypertension. We believe this derisked approach of using already-approved drugs that provide well-established safety profiles from millions of patients, combined with a development path led by preeminent cardiologycardiovascular and pulmonary hypertension experts, puts us in a strong position to deliver breakthrough cardiopulmonary therapies designed to improve patients’ functionfunctioning and quality of life.

In AugustMarch 2024,2025, we closed a private placement financing (the “August 2024 Offering”) raising gross proceeds of approximately $100 million and in March 2025 we closed a private placement financing (“the March 2025 Offering”) raising gross proceeds of $25.0 million. We intend to use the net proceeds from the August 2024 and March 2025 OfferingsOffering, in addition to approximately $100.0 million raised in August 2024, to advance our Phase 3 oral levosimendan program,program. bySpecifically, completingwe plan to complete our ongoing Phase 3 LEVEL study andof initiatingTNX-103 ain PH-HFpEF. We also plan to advance our second planned global Phase 3 study, LEVEL-2.LEVEL-2, Wewhich intendcommenced toin submitDecember marketing2025. authorization applications followingFollowing completion of the two Phase 3 trialslevosimendan trials, we intend to submit marketing authorization applications. We also plan to submit an application for imatinib following completion of levosimendan and, when appropriate, a single Phase 3 trialtrial, ofwhen imatinib. Given our resources on December 31, 2024 and gross proceeds of $25.0 million from our March 2025 offering, we believe we can continue our operations for at least the next 12 months.appropriate.

Research and development expenses were $12.7 million for the year ended December 31, 2024 as compared to $3.2 million for the same period in the prior year. Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct a substantial portion of our pre-clinical and our clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the years ended December 31, 20242025 and 2023,2024, respectively, are as follows (in thousands):

Clinical and preclinical development costs increased $8.8$14.9 million for the year ended December 31, 20242025 as compared to the same period in the prior year. Clinical and preclinical development costs for 2024,the year ended December 31, 2025 consists primarily of expenses associated with our ongoing Phase 3 LEVEL trial forand oralour levosimendan,second global Phase 3 study, LEVEL-2, which commenced in December 2025, compared with costs for 2023,the year ended December 31, 2024, associated primarily with ourthe Phaseplanning 2of HELP Open Label Extension Study for levosimendan,LEVEL and imatinibthe formulationearly development.progress initiating LEVEL sites and enrolling the first LEVEL patients.

Salary and benefits expense increased $218$1.1 thousandmillion for the year ended December 31, 20242025 as compared to the same period in the prior year primarily due tothe higherincreased salariesnumber of employees as we expanded our LEVEL trial and bonusesdesigned, inplanned, 2024.and commenced our LEVEL-2 trial. Stock-based compensation expense increased $286$3.6 thousandmillion for the year ended December 31, 20242025, as compared to the same period in the prior year due to stock option grants made late in 2024.2024 and during 2025.

Other costs increased $161$0.3 thousandmillion for the year ended December 31, 20242025, as compared to the same period in the prior year, primarily due to higher regulatory costs over the prior year as we expanded our clinical trial during 2024.

General and administrative expenses were $6.8 million for the year ended December 31, 2024, compared to $5.0 million for the same period in 2023. General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including non-cash stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the years ended December 31, 20242025 and 2023,2024, respectively, are as follows (in thousands):

Salary and benefits expense increasedremained $271relatively thousandunchanged for the year ended December 31, 20242025, as compared to the same period in the prior year due primarily to higherlower salariesbonuses offsetting salary increases and bonuses.new employee salaries. Stock-based compensation expense increased $648$14.4 thousandmillion for the year ended December 31, 2024 due to stock option grants in 2024.late 2024 and during 2025.

Legal fees consist of the cost of our legal counsel as well as legal costs related to our intellectual property. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors. Legal and professional fees increased $725$1.7 thousandmillion for the year ended December 31, 20242025 compared to the same period in the prior year primarily related to increased capital market expenses, consulting expenses, and accounting expenses, offset by a decrease in intellectual property related legal costs.

Other costs increased $136$0.7 thousandmillion for the year ended December 31, 20242025 compared to the same period in the prior year. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation and other miscellaneous charges. The increase was primarily attributable to increased costs for franchise and other taxes.

Interest Income, Interest Expense, and Other Income and(Expense), Expense, Netnet

We are currently conducting the LEVEL trial and intend to recruit patients through approximatelyinto the endfirst half of 2025.2026 and we commenced our LEVEL-2 trial in December 2025 and are currently enrolling patients. Our ability to continue to pursue development of our products, including completion of a second Phase 3 oral levosimendan trial, beyond 2027, will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.

On FebruaryMarch 8,5, 2024,2025, we sold in a registered public offering (the “FebruaryMarch 20242025 Offering”) (i) an aggregate of 421,260378,346 shares of our common stock and pre-funded warrants to purchase an aggregate of 1,178,740 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,0003,760,726 shares of our common stock at a combinedan offering price of $5.65$6.04 per share of common stock and accompanying warrant, or $5.649$6.03 per pre-funded warrant and accompanying warrant, resulting in gross proceeds toof the$25.0 Companymillion. The pre-funded warrants do not expire and have an exercise price of $9.0 million.$0.01. Net proceeds offrom the offering were $8.0$23.2 million, after deducting the placement agent fees and offering expenses payable by the Company.

On FebruaryAugust 3,8, 2023,2024, we sold in a registeredprivate publicplacement offering (the "February 2023 Offering") (i)financing an aggregate of 86,9941,450,661 shares of our common stockstock, and pre-funded warrants to purchase an aggregate of 21,34131,882,671 shares of our common stockstock, and (ii) accompanying warrants to purchase up to an aggregate of 216,66716,666,666 shares of our common stock with an exercise price of $4.50, at a combined offering price of $144.00$3.00 per share of common stock and accompanying warrant, or $143.92$2.99 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of $15.6$99.7 million. Net proceeds offrom the offering were $14.1$92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.

Net cash used in operating activities was $35.8 million for the year ended December 31, 2025, compared to $14.8 million for the year ended December 31, 2024 compared to $5.9 million for the year ended December 31, 2023.2024. The increase in cash used for operating activities was primarily due to higher study expense activity and increased employee hiring in the year ended December 31, 20242025 as compared to the prior year.

There was no net cash provided or consumed by investing activities for the yearyears ended December 31, 2024,2025 compared to net cash provided by investing activities of $3 thousand in the year endedand December 31, 2023 from the sale of office furniture when the Company relocated its' headquarters.2024.

Based on our working capital on December 31, 2024,2025, we believe we have sufficient capital on hand to continue to fund operations through the end of 2027.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted.2024. The Company isadopted evaluatingand applied the amendments of this standardASU to determineits ifdisclosures. adoptionThe willapplication of this ASU did not have a material impact on the Company’s consolidatedCompany's financial statements.position, results of operations or cash flows.

Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-driven drug development approach, led by key opinion leaders and pulmonary hypertension and heart failure experts and informed by their clinical insights to precisely target disease pathophysiology. We are currently actively conducting the LEVEL and LEVEL-2 clinical trials to evaluate levosimendan as our prioritized product candidate, and have deprioritized a Phase 3 clinical trial of imatinib, two drugs supported by promising evidence that they may significantly improve the lives of patients with pulmonary hypertension. Currently, we do not have any significant imatinib development activities ongoing. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world forstarting more than 2025 years,years ago, and we believe their mechanisms of action are uniquely suitable to target and treat pulmonary hypertension. We believe this derisked approach of using already-approved drugs that provide well-established safety profiles from millions of patients, combined with a development path led by preeminent cardiovascular and pulmonary hypertension experts, puts us in a strong position to deliver breakthrough cardiopulmonary therapies designed to improve patients’ functioning and quality of life.

In March 2025,2025 and August 2024, we closedcompleted atwo private placement financingfinancings raising gross proceedsproceeds, in the aggregate, of approximately $25.0$125 million. We intend to use the net proceeds from these financings, together with proceeds received from the subsequent exercise of warrants and pre-funded warrants sold in the March 2025 Offering, in addition to approximately $100.0 million raised inand August 2024,2024 offerings, to advance our Phase 3 oral levosimendan program. Specifically, we plan to complete our ongoing Phase 3 LEVEL studyclinical trial of TNX-103 in PH-HFpEF.PH-HFpEF and make public before the end of 2026 the results of the 12-week randomized treatment period. The open-label stage of the trial will continue after this. We also plan to advancecontinue our secondsecond, globalglobal, Phase 3 study,clinical trial, LEVEL-2, which commencedbegan in December 2025. Following completion of the two Phase 3 levosimendan trials, we intend to submit marketing authorization applications. We also plan to submit an application for imatinib following completion of a single Phase 3 trial, when appropriate.

Our Phase 3 LEVEL studyclinical trial continues, with high rates of studyclinical trial and therapy continuation during the blinded and open-label extension stages. We achievedcompleted ourrandomization targetin enrollmentthe LEVEL clinical trial of more than 230 patients before the end of the first quarter of 2026, and we expect to report initial topline data in MarchAugust of 2026. LEVEL is being conducted in the United States and Canada. Our second Phase 3 clinical trial, LEVEL-2, is ongoing globally, with enrollment completion anticipated by the end of 2027.

Based on our current operating plan, we believe that our existing cash and cash equivalents as of MarchJune 31,30, 2026, along with cash received from warrant exercises subsequent to quarter end, will be sufficient to fund our planned operations through at least the firstsecond quarter of 2028.

Financial Overview – Three and Six Months Ended MarchJune 31,30, 2026 (in thousands)

Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct a substantial portion of our pre-clinical and our clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to CROs as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three and six months ended MarchJune 31,30, 2026 and 2025 are as follows (in thousands):

Clinical and preclinical development costs increased $5.8$6.5 million and $12.2 million for the three and six months ended MarchJune 31,30, 2026, respectively, as compared to the same period in the prior year. Clinical and preclinical development costs for the three and six months ended MarchJune 31,30, 2026 consist primarily of expenses associated with our ongoing Phase 3 LEVEL trial and our secondsecond, globallarger, global, Phase 3 study,clinical trial, LEVEL-2, which commencedbegan in December 2025, as compared to the three and six months ended MarchJune 31,30, 2025, which consisted primarily of costs associated with our Phase 3 LEVEL trial.

Salary and benefits costs increased $0.3by $0.5 million and $1.0 million for the three and six months ended MarchJune 31,30, 2026, respectively, as compared to the same period in 2025.the Theprior change wasyear primarily attributabledue to increasedthe headhiring countof additional development personnel resulting in higher salary and salaries,benefit and related compensation.costs.

InterestSalary incomeand decreasedbenefits byincreased $0.1$0.5 million and $0.8 million for the three and six months ended MarchJune 31,30, 2026, as compared to the same period in the2025. priorThe yearchange was primarily dueattributable to lowerincreased interest rates. The Company had an immaterial other expense for the three months ended March 31, 2026personnel and nonetheir forrelated thecompensation comparableand period in the prior year.benefits.

We have incurred losses since our inception and, as of MarchJune 31,30, 2026, we had an accumulated deficit of $383.2$401.0 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan and, over the long term,potentially, imatinib for PAH, and other potential indications, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.

The process of conducting preclinical studies and clinical trials necessary to obtain approval from the FDA is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our two product candidates, levosimendan and imatinib, and have prioritized levosimendan;levosimendan. however, weWe will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially developreinitiate the development of imatinib, and to continue with the development of other potential product candidates.

We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had total current assets of $123.2$121.7 million and $104.2 million and working capital of $114.7$113.6 million and $97.1 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively. Warrant exercises resulted in approximately $13.4 million and $43.8 million of cash for the Company in the three and six months ended June 30, 2026, respectively. There is the potential to raise an additional $34 million if all outstanding warrants from the August 2024 Offering and February 2024 Offering as of June 30, 2026 are exercised. Our practice is to invest excess cash, where available, in short-term money market investment instruments and high quality corporate and government bonds.

We arecompleted currentlyrandomization conductingin the LEVEL trial andat intendthe toend recruit patients intoof the first halfquarter of 2026 and expect to report topline data in August 2026. We commencedbegan our LEVEL-2 trial in December 2025 and are currently enrolling patients.patients, with enrollment completion anticipated by the end of 2027. Our ability to continue to pursue development of our products beyond Marchthe second quarter of 2028, including completion of athis second Phase 3 oral levosimendan trial,trial (LEVEL-2), will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or other financial resources. There is no assurance that we will obtain any license agreement or other financing or that we will otherwise succeed in obtaining any necessary resources.

On March 5, 2025, we sold in the March 2025 Offering an aggregate of 378,346 shares of our common stock and pre-funded warrants to purchase an aggregate of 3,760,726 shares of our common stock at an offering price of $6.04 per share of common stock and $6.03 per pre-funded warrant, resulting in gross proceeds of $25.0 million. The pre-funded warrants do not expire and have an exercise price of $0.01. Net proceeds from the offeringMarch 2025 Offering were $23.2 million, after deducting the placement agent fees and offering expenses payable by the Company.

Net cash used in operating activities was $9.3$23.5 million for the threesix months ended MarchJune 31,30, 2026, compared to $7.0$13.2 million for the threesix months ended MarchJune 31,30, 2025. The increase in cash used in operating activities was primarily due to increased expenses as we expanded our clinical trials and increased payroll costs. The increase in payroll costs was primarily driven by the addition of new employees and targeted salary adjustments, reflecting a necessary investment to support our expanded clinical trial activity during the threesix months ended MarchJune 31,30, 2026 as compared to the prior year period.

There was no net cash provided or consumed by investing activities for the threesix months ended MarchJune 31,30, 2026 or the threesix months ended MarchJune 31,30, 2025.

Net cash provided by financing activities was $30.5$43.9 million for the threesix months ended MarchJune 31,30, 2026, compared to $23.6$23.8 million for the threesix months ended MarchJune 31,30, 2025, an increase of $6.9$20.0 million. During the threesix months ended MarchJune 31,30, 2026, the Company received proceeds of $30.5$43.8 million from the exercise of warrants and pre-funded warrants. During the threesix months ended MarchJune 31,30, 2025, the Company received proceeds of $23.2 million net cash provided from the sale of common stock and pre-funded warrants in the March 2025 Offering and $0.3$0.6 million from the exercise of warrants and pre-funded warrants.

the initiation, design, footprint, progress, timing and completion of clinical trials for our product candidates and potential product candidates;

Based on our working capital on MarchJune 31,30, 2026, and additional cash received subsequent to quarter end of $7.9$8.1 million, we believe we have sufficient capital on hand to fund operations through at least the firstsecond quarter of 2028.