TENAX THERAPEUTICS, INC.

Overview

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 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. 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 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, 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 March 2025 Offering, in addition to the approximately $100.0 million raised in August 2024, to advance our Phase 3 oral levosimendan program. Specifically, we plan to complete our ongoing Phase 3 LEVEL study of TNX-103 in pulmonary hypertension in heart failure with preserved ejection fraction (“PH-HFpEF”). We also plan to advance our second global Phase 3 study, LEVEL-2, which was initiated 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 a single Phase 3 trial, when appropriate.

The Company was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. Effective June 30, 2008, we changed the domiciliary state of the corporation to Delaware and changed the Company name to Oxygen Biotherapeutics, Inc. On September 19, 2014, with the commencement of our focus on developing and ultimately commercializing levosimendan, we changed the Company name to Tenax Therapeutics, Inc.

Our Strategy

The key elements of our business strategy are outlined below.

Efficiently conduct clinical development to establish clinical proof of principle in new indications, refine dosage levels and dosing strategies, conduct other required clinical and nonclinical testing as U.S. Federal Drug Administration (the“FDA”) and other regulators may require, and continue Phase 3 testing of oral levosimendan, as our prioritized product candidate.

Levosimendan and imatinib have already been approved and prescribed in other indications in many countries around the world. We are conducting clinical development with the intent to establish proof of beneficial activity in cardiopulmonary diseases in which these therapeutics would be expected to provide benefit to patients with diseases for which either no pharmaceutical therapies are approved at all, or in the case of pulmonary arterial hypertension, where numerous, expensive therapies generally offer a modest reduction of symptoms. Our focus is primarily on designing and executing formulation and dosing regimen improvements, protecting these innovations with patents and other forms of exclusivity, and employing innovative clinical trial science to establish a robust foundation for subsequent development, product approval, and commercialization. We intend to submit marketing authorization applications following the second Phase 3 trial of levosimendan, which we commenced in December 2025, as our prioritized drug candidate. Our trials are designed to incorporate and reflect advanced clinical trial design science and the regulatory and advisory experience of our team. We intend to continue partnering with innovative companies, renowned biostatisticians and trialists, medical leaders, formulation and regulatory experts, and premier preclinical and clinical testing organizations to help expedite development, and continue expanding into complementary areas when opportunities arise through our development, research, and discoveries. We also intend to continue outsourcing to clinical research organizations, and seeking and acting upon the advice of preeminent scientists focused on cardiovascular and pulmonary drug development, when designing and executing our research.

Efficiently explore new high-potential therapeutic applications, in particular where expedited regulatory pathways are available, leveraging third-party research collaborations and our results from related areas.

Levosimendan has shown promise in multiple disease areas during its development and in the more than two decades following its approval. Our own Phase 2 study and open-label extension has demonstrated that levosimendan’s property of relaxing the venous circulation, a formerly under-appreciated mechanism of action of levosimendan, brings durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. The FDA has not approved a therapy for this disease. We are committed to exploring potential clinical indications in which our therapies may achieve best-in-class profile, demonstrate novelty, and where we can address significant unmet medical needs and maintain market exclusivity.

We believe these factors will support approval by the FDA of this product candidate based on positive Phase 3 data. Through our agreement with our licensor, Orion Corporation, we have access to a library of ongoing and completed trials and research projects, including certain documentation, which we believe, in combination with positive Phase 3 data we hope to generate in at least one indication, will support FDA approval of levosimendan. In order to achieve our objective of developing this medicine for new groups of patients, we have established collaborative research relationships with investigators from leading research and clinical institutions, and our strategic partners. These collaborative relationships have enabled us to explore where our product candidate may have therapeutic relevance, gain the advice and support of key opinion leaders in medicine and clinical trial science, and invest in development efforts to exploit opportunities to advance beyond current clinical care.

Continue to expand our intellectual property portfolio.

Our intellectual property, as more fully described below, and the confidentiality of all our Company information is important to our business and we take significant steps to help protect its value. Our research and development efforts, both through internal activities and through collaborative research activities with others, aim to develop new intellectual property and enable us to file patent applications that cover new uses of our existing technologies, alone or in combination with existing therapies, as well as other product candidates.

Enter into licensing or product co-development arrangements.

In addition to our internal development efforts, an important part of our product development strategy is to work with collaborators and partners to accelerate product development, maintain our low development and business operations costs, and broaden our commercialization capabilities globally. We believe this strategy will help us develop a portfolio of high-quality product development opportunities, enhance our clinical development and commercialization capabilities, and increase our ability to generate value from our proprietary technologies.

We also continue to position ourselves to execute upon licensing and other partnering opportunities. To do so, we need to continue to maintain our strategic direction, manage and deploy our available cash efficiently, and strengthen our collaborative research development and partner relationships.

Our Pipeline and Drug Candidates

PH-HFpEF

Pulmonary hypertension in heart failure with preserved ejection fraction is the most common form of pulmonary hypertension in the world, according to the World Health Organization. Prevalence in the United States is currently estimated to be greater than 1.5 million, although PH-HFpEF may be significantly underdiagnosed because diagnosis typically requires catheterization. Currently, there are no therapies approved for treatment of PH-HFpEF. Even though many therapies have been studied in this indication in the past, none have proven to be effective in treating patients with the disease.

Levosimendan

Levosimendan is a novel, first-in-class K-ATP activator and calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It has been granted market authorization in 60 countries for use in this indication, although it is not available in the United States or Canada. It is estimated that over 2.2 million patients have been treated worldwide with levosimendan to date.

In the countries where it is marketed, intravenous levosimendan is indicated for the short-term treatment of acutely decompensated heart failure in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate. In acute decompensated heart failure patients, levosimendan has been shown to significantly improve patient symptoms as well as acute hemodynamic measurements such as increased cardiac output, reduced pulmonary capillary wedge pressure, reduced preload and reduced afterload.

The therapeutic effects of levosimendan are mediated through:

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Opening of potassium-ATP channels in the vasculature smooth muscle, resulting in a vasodilatory effect on vascular beds;

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Increasing cardiac contractility by calcium sensitization of troponin C, resulting in a positive inotropic effect which is not associated with substantial increases in oxygen demand; and

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Opening of mitochondrial potassium channels in cardiomyocytes, resulting in a cardioprotective effect.

Several studies have demonstrated that levosimendan protects the heart and improves tissue perfusion while minimizing tissue damage during cardiac surgery.

Importantly, several published studies provide evidence that levosimendan may improve right ventricular dysfunction, a common comorbidity in patients with pulmonary hypertension. While none of these studies focused specifically on PH-HFpEF patients, the general hemodynamic improvements in these published studies of various types of pulmonary hypertension provide a basis for further evaluation of potential clinical benefit in PH-HFpEF.

Phase 2 HELP Study

Insights from published studies led us to initiate the HELP Study (“Hemodynamic Evaluation of Levosimendan in PH-HFpEF”), a Phase 2, double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy and safety of intravenous levosimendan (“TNX-101”) in patients with PH-HFpEF. The primary endpoint of the HELP Study was change from baseline in pulmonary capillary wedge pressure (“PCWP”) during exercise, along with various other secondary endpoints. The first patient was enrolled in the study in March 2019, and the enrollment and dosing of 44 patients was completed in March 2020.

The HELP Study design was novel in several respects. To date, no other multi-center study has evaluated levosimendan in PH-HFpEF patients, or any patients with an ejection fraction greater than 40%. Instead, all previous levosimendan heart failure studies have enrolled patients with heart failure with reduced ejection fraction (“HFrEF”), thereby excluding HFpEF patients from the study. Also, the HELP Study utilized a unique 24-hour weekly infusion regimen of 0.075- 0.1µm/kg/min. Finally, the HELP Study employed a unique home-based intravenous infusion administration via an ambulatory infusion pump. This home-based weekly intravenous administration is unlike all other chronic dosing studies of levosimendan that have typically employed a shorter duration and less frequent infusion regimen administered in a hospital setting.

In June 2020, we announced preliminary, top-line data from the HELP study. Hemodynamic measurements were made at rest (supine), after leg raise on a supine bicycle (a test of rapid increase in ventricular filling) and during exercise (25 watts for three minutes or until the patient tired). In the initial open-label phase, 84% of the patients responded to the degree required by the protocol in order to be randomized (including reduction of PCWP of at least 4mm Hg during exercise). In the randomized, placebo-controlled, double-blinded 6-week trial stage, levosimendan did not demonstrate a statistically significant reduction from baseline in PCWP during exercise, the primary endpoint. However, patients receiving levosimendan had statistically significant reductions from baseline at Week 6 in PCWP and PAP at rest or after leg raise (p<0.05). Furthermore, the study demonstrated a statistically significant reduction in PCWP compared to baseline (p=<0.0017) and placebo (p=<0.0475) when the three patient measurements (i.e., at rest, with legs up, and during exercise) were combined.

Levosimendan also demonstrated a statistically significant improvement in the change in 6-minute walk distance (“6MWD”), a secondary end-point commonly used in many pulmonary hypertension registration trials. Clinical efficacy was confirmed by a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.0329).

The incidence rate of adverse events or serious adverse events between the treatment and placebo groups was similar. In addition, there were no arrhythmias observed, atrial or ventricular, when comparing baseline electrocardiographic monitoring with 72-hour monitoring after five weeks of treatment.

Detailed results from HELP were presented at the Heart Failure Society of America Virtual Annual Scientific Meeting in October 2020, at the American Heart Association Scientific Sessions in November 2020, and several subsequent scientific congresses.

Open-Label Extension Study of Oral Levosimendan (TNX-103)

Following completion of the randomized treatment phase of the HELP Study, patients were able to enter an open-label extension study (“OLE”) to remain on intravenous therapy and to facilitate the continued evaluation of safety. Later, the HELP study protocol was modified to introduce a substudy within this open-label extension stage that allowed the investigators and Tenax to evaluate the safety and efficacy of an oral formulation of levosimendan (“TNX-103”). Patients who agreed to participate in the OLE substudy were safely transitioned from intravenous to oral formulation in late 2021, and the study was continued by the Company and our HELP investigators for over two years, concluding in the first half of 2023. Positive signs of efficacy were observed across all measured parameters during the OLE, which provided us with sufficient data to discuss further development of oral levosimendan with the FDA.

The transition of patients in the OLE from intravenous to oral formulation occurred safely. Improvements in all measures of efficacy taken in the transition from intravenous to 3mg daily oral levosimendan were observed.

We believe these findings from the HELP Study and the OLE IV-to-oral substudy represent important discoveries related to the use of levosimendan in PH-HFpEF patients. Not only is HELP the first study to evaluate levosimendan in PH-HFpEF patients, but to our knowledge it is also the first study conducted of any therapy in PH-HFpEF patients to show such positive improvements in hemodynamics and 6MWD. Taken together, the encouraging data to date demonstrate that levosimendan’s property of relaxing the venous circulation, a formerly under-appreciated mechanism of action of levosimendan, brings durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF.

Phase 3 LEVEL and LEVEL-2 Studies

In October 2020, we met with the FDA for an End-of-Phase 2 Meeting to discuss the Phase 2 clinical data and further development of levosimendan in PH-HFpEF. Subsequently, a path to registration was agreed upon involving two confirmatory Phase 3 studies, as well as a plan to replace weekly intravenous levosimendan dosing with daily oral levosimendan doses in the upcoming clinical trials. In February 2022, the FDA provided a written response advising that the safety database required for filing a New Drug Application (“NDA”) only needs to meet two of the three minimum International Clinical Harmonization (“ICH”) standards for a chronic medication in treating a non-life-threatening condition: 300 patients treated for 6 months, and 100 patients treated for 12 months. Subsequently, based on the below-described continuing dialogue with FDA, Tenax introduced into the LEVEL-2 certain study design features intended to ensure 100 patients assigned to levosimendan are treated for 12 months with their treatment assignment double-blinded. Tenax plans to continue to discuss with the FDA and other global regulators this requirement and other requirements that will determine the size and timing of its completed Phase 3 program, throughout the execution of its Phase 3 program.

On November 13, 2023, we announced that the FDA had reviewed and cleared our Investigational New Drug (“IND”) application for oral levosimendan for the treatment PH-HFpEF, enabling us to proceed with the first of two Phase 3 studies.

In the fourth quarter of 2023, we initiated the LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients), an ongoing, registrational Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate TNX-103 in patients with PH-HFpEF in the United States and Canada. The primary endpoint is change in 6MWD from baseline to Week 12.

On December 17, 2025, we announced that the prespecified Blinded Sample Size Re-estimation (BSSR) of the LEVEL Study, demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6MWD, the primary endpoint. Based on these results, we confirmed the previously announced target enrollment number and expected enrollment completion timeframe as well as topline data timeframe.

On December 17, 2025, we also announced that we initiated LEVEL-2 (NCT07288398), the second registrational study of TNX-103 in patients with PH-HFpEF. LEVEL-2 (NCT07288398) in a global, Phase 3, double-blind, randomized, placebo-controlled study of TNX-103. Tenax plans to enroll approximately 540 PH-HFpEF patients in LEVEL-2, randomized 2:1 to receive TNX-103 or placebo. The primary endpoint of the study is change from baseline in 6MWD at Week 26. Secondary endpoints include change from baseline in Kansas City Cardiomyopathy Questionnaire and New York Heart Association Functional Class.

In addition, LEVEL-2, like LEVEL, includes an OLE phase following the completion of the randomized phase to treat patients under protocol can receive open label levosimendan, allowing for additional weeks of safety observation that will contribute to the safety data on TNX-103.

Patients who complete a total study duration of 104 weeks in both protocols can continue to receive oral levosimendan by subscribing in an open-level study to bridge them from LEVEL or LEVEL-2 to commercialized product. This protocol will begin to enroll subjects from LEVEL in the first half of 2026.

PAH

Pulmonary arterial hypertension (“PAH”) is a type of pulmonary hypertension and a rare, progressive, and serious disease. Although several therapies are now available, none are cures for the disease and patients remain symptomatic with high morbidity and mortality. Importantly, all currently approved PAH therapies are pulmonary vasodilators, and there is no data supporting that these types of treatments halt progression or induce regression of the disease.

Imatinib

Imatinib (marketed in the United States as Gleevec®) is a tyrosine kinase inhibitor. It is the first curative treatment for chronic myeloid leukemia (“CML”) and has significantly impacted patients since receiving FDA approval in 2001.

Separately, imatinib has been shown in animal models of pulmonary hypertension to induce disease reversal by affecting platelet derived growth factor, which may be causal in the disease. Several case reports and small case series of patients with advanced PAH failing combination pulmonary vasodilator therapy that were treated with imatinib were subsequently published, showing dramatic effects on disease stabilization and improvements in symptom and function.

These results led Novartis to develop imatinib as a treatment of PAH. Novartis sponsored a Phase 2 proof-of-concept trial to evaluate the safety, tolerability, and efficacy of imatinib as an adjunct to PAH-specific therapy in patients with PAH. Novartis then sponsored a Phase 3 trial (IMPRES) which met its primary endpoint of significant increase in 6MWD (32 meters, p=0.002), an effect maintained in an extension study in patients remaining on imatinib. However, the data were confounded by a high rate of dropouts in the patients randomized to imatinib, attributed largely to gastric intolerance during the first eight weeks in the study. Consequently, Novartis chose to withdraw the IND application.

On May 30, 2019, PHPrecisionMed Inc. (“PHPM”) met with the FDA to discuss a proposal for a Phase 3 trial of imatinib in PAH using change in 6MWD as the primary endpoint. PHPM received agreement for submission under the 505(b)(2) regulatory pathway, and thereafter received orphan designation. In July 2020, PHPM received agreement from the FDA for the development of a modified release formulation that would require only a small comparative pharmacokinetic and bioavailability study.

In January 2021, Tenax acquired PHPM and renamed the modified release formulation of imatinib TNX-201. Given our prioritization of the LEVEL trials, we have suspended plans to launch an imatinib Phase 3 trial.

Intellectual Property

We rely on a combination of patent applications, patents, trade secrets, proprietary know-how, trademarks, and contractual provisions to protect our proprietary rights. We believe that to have a competitive advantage, we must develop and maintain the proprietary aspects of our technologies. Currently, we require our officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, and other advisors to execute confidentiality agreements in connection with their employment, consulting, or advisory relationships with us, where appropriate. We also require employees, consultants, and advisors whom we expect to work on our products to agree to disclose and assign to us all inventions conceived during the workday, developed using our property, or which relate to our business.

As of the date of this filing, we have been granted four U.S. patents, and have been notified of the impending granting of a Canadian, a European, and a fifth U.S. patent, all related to product candidates and proprietary process, method and technology. Our issued levosimendan patents expire in 2039 and December 2040.

On January 4, 2022, we received a patent from the United States Patent and Trademark Office(“USPTO”) for the subcutaneous administration of levosimendan (TNX-102), whether through the prototype formulation we have developed in collaboration with a formulation development partner, or other subcutaneous formulations meeting certain broad characteristics defined in the patent. This patent expires in 2039. On March 21, 2023, we were granted a patent for the use of IV levosimendan in the treatment of PH-HFpEF patients. This patent expires in 2040. On July 19, 2023, we announced the USPTO issuance of another patent, this one including claims covering the use of oral levosimendan in patients with PH-HFpEF. This issued patent provides exclusivity through December 2040. On February 6, 2024, we announced the fourth levosimendan USPTO patent broadening IP protection for oral, I.V., and subcutaneous use of levosimendan and its active metabolites in PH-HFpEF, at all therapeutic doses and in combination with various cardiovascular drugs.

On September 16, 2025, we announced that the European Patent Office (EPO) notified the Company of its Intention to Grant a patent to us that will provide intellectual property protection for TNX-103 and other formulations of levosimendan, as well as its active metabolites, for use in PH-HFpEF.This new patent will have a patent term until December 2040, and it may qualify for European patent supplementary protection certificates (SPC) that would extend the period of patent protection beyond 2040. Similarly, in 2025, the Canadian government notified us that it will issue a patent for the use of oral levosimendan for the treatment of PH-HFpEF. We also have multiple patent applications pending in Europe and other countries for the treatment of PH-HFpEF, for oral and combination products.

The U.S. trademark registration for Simdax® is owned by Orion Corporation (“Orion”) and is licensed to us for sales and marketing purposes for any intravenous pharmaceutical products containing levosimendan that are commercialized in the United States and Canada.

Our success will in part depend on the ability to obtain and maintain patent and other proprietary rights in commercially important technology, inventions and know-how related to our business, the validity and enforceability of our patents, the continued confidentiality of our trade secrets and our ability to operate without infringing the valid and enforceable patents and proprietary rights of third parties. We also rely on continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position.

We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications we may own or license in the future, nor can we be sure that any of our existing patents or any patents we may own or license in the future will be useful in protecting our technology and products.

Comprehensive risks related to our intellectual property are described under the heading “Risk Factors - Risks Related to Our Intellectual Property” included elsewhere in this Annual Report on Form 10-K.

Simdax License Agreement

On November 13, 2013, we acquired certain assets of Phyxius Pharma, Inc. (“Phyxius”) pursuant to an asset purchase agreement by and among the Company, Phyxius and the stockholders of Phyxius, dated October 21, 2013. Among these assets was a license with Orion Corporation (“Orion”) for the exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada (as amended from time to time, the “License”). On October 9, 2020 and January 25, 2022, we entered into amendments to the License to include in the scope of the License two new product formulations containing levosimendan, in capsule and solid dosage form (TNX-103) and a subcutaneously administered dosage form (TNX-102), subject to specified limitations (together, the “Product”).

On February 19, 2024, we entered into an amendment to the License providing global rights to oral and subcutaneous formulations of levosimendan used in the treatment of PH-HFpEF. The amendment also reduced the tiered royalties based on worldwide net sales of the product by the Company and its sublicensees, increased the License’s existing milestone payment due to Orion upon the grant of FDA approval of a levosimendan-based product to $10.0 million and added a milestone payment to Orion of $5.0 million due upon the grant of regulatory approval for a levosimendan-based product in Japan. The amendment also (i) increased the Company’s obligations to make certain non-refundable commercialization milestone payments to Orion, aggregating to up to $45.0 million, contingent upon achievement of certain cumulative worldwide sales of the product by the Company, and (ii) reduced the maximum price per capsule payable by the Company to Orion, under a yet-to-be-negotiated supply agreement, for the commercial supply of oral levosimendan-based product. Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of the dosage forms.

On September 3, 2025, we entered into an amendment License providing exclusive worldwide rights to develop, commercialize, manufacture, and have manufactured any orally-administered pharmaceutical product containing levosimendan and, in addition to the Company’s existing rights to develop and commercialize subcutaneously administered products containing levosimendan, to manufacture or have manufactured such products. The amendment also calls for Orion to supply the Company with levosimendan to the extent reasonably necessary or useful to manufacture orally-administered products containing levosimendan for purposes of developing such products, and sets forth the terms for such supply, including the price of levosimendan ordered by the Company of low triple-digit thousands in Euros per kilogram, payment terms, and active pharmaceutical ingredient specifications.

The term of the License extends until 10 years after the launch of the Product in the territory, provided that the License will continue after the end of the term in each country in the territory until the expiration of Orion’s patent rights in the Product in such country. In the event that no regulatory approval for the Product has been granted in the United States on or before September 20, 2030, however, either party will have the right to terminate the License with immediate effect.

The License also grants the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication but, pursuant to the February 2024 amendment, excluding new applications of levosimendan for neurological diseases and disorders developed by Orion.

As of December 31, 2025, the Company has not met any of the developmental milestones under the License and, accordingly, has not recorded any liability for the contingent payments due to Orion.

Manufacturing and Supply

We contract with third parties for the manufacturing of all of our product candidates and for pre-clinical and clinical studies and intend to continue to do so in the future. We do not own or operate any manufacturing facilities and we have no plans to build any owned clinical or commercial scale manufacturing capabilities. We believe that the use of third-party manufacturers and contract drug manufacturing organizations (“CMOs”) eliminates the need to directly invest in manufacturing facilities, equipment and additional employees.

Pursuant to the terms of the License, Orion is contractually our sole manufacturing source for TNX-103. We may engage other third-party suppliers and CMOs for the supply and manufacture of TNX-102, or other formulations we may develop.

We have engaged various third-party suppliers and CMOs for the supply and manufacture of imatinib for potential future clinical trials and relied on such contractors for material contributing to TNX-201, for testing in our two completed Phase 1 trials.

As we further develop our product pipeline, we expect to consider secondary or back-up manufacturers for both active pharmaceutical ingredient and drug product manufacturing. To date, our third-party manufacturers have met the manufacturing requirements for our product candidates. We expect third-party manufacturers to be capable of providing sufficient quantities of our product candidates to meet anticipated full-scale commercial demands, but we have not assessed these capabilities beyond the supply of clinical materials to date.

We believe alternate sources of manufacturing will be available to satisfy our clinical and future commercial requirements however, we cannot guarantee that identifying and establishing alternative relationships with such sources will be successful, cost effective, or completed on a timely basis without significant delay in the development or commercialization of our product candidates. All of the vendors we use are required to conduct their operations under current Good Manufacturing Practices, a regulatory standard for the manufacture of pharmaceuticals.

Competition

The pharmaceutical and biotechnology industries are intensely competitive. Many companies, including biotechnology, chemical, and pharmaceutical companies, are actively engaged in activities similar to ours, including research and development of drugs for the treatment of cardiovascular, pulmonary, and related medical conditions, both rare and common. Many of these companies have substantially greater financial and other resources, larger research and development staff and more extensive marketing and manufacturing organizations than we do. In addition, many of them have considerable experience in preclinical testing, clinical trials and other regulatory approval procedures. There are also academic institutions, governmental agencies and other research organizations that are conducting research in areas in which we are working. Our success will be based in part on our ability to identify, develop and manage a portfolio of product candidates that are safer and more effective than any competing products.

We believe the concept of using TNX-101/102/103 (levosimendan) to treat patients with PH-HFpEF is novel, and the patent granted for this use in March 2023 demonstrates the USPTO’s concurrence. Because no therapies are approved to treat PH-HFpEF, we believe our ability to succeed in the market is primarily dependent on our ability to change the established practice paradigm, which could be difficult. Key factors on which we will compete with regards to the development and marketing of levosimendan for the treatment of pulmonary hypertension in these patients include, among others, the ability to obtain adequate efficacy data, safety data, cost effectiveness data and hospital formulary approval, marketing exclusivity, and sufficient distribution and handling. Furthermore, while we believe the mechanism of action of levosimendan is novel, other low-priced, generically available products possess some similar qualities, which could present competition in the form of therapeutic substitution. Other companies, including for example Astra Zeneca, Tectonic, and Merck, are currently conducting Phase 1 and Phase 2 clinical trials of potential new therapies to treat PH-HFpEF. Merck’s sotatercept is approved for PAH and is being tested in a subset of PH patients with HFpEF, with a Phase 2 data readout predicted in the first quarter of 2026. Merck executives have confirmed their intention to conduct a Phase 3 program testing this product in PH-HFpEF patients with combined pre-capillary and post-capillary PH, among other characteristics to be shared with the public in future. GSK recently acquired a private company with a sotatercept-like compound that may in future be developed in Group 2 PH. These companies may be successful in their efforts to gain market approval for a product in some of the same patients we aim to treat with levosimendan, whether before or after we could do so. Some classes of medical therapy such as SGLT-2 inhibitors and GLP-1 agonists are or may be approved for use in patients with heart failure, and may or may not be developed specifically for PH-HFpEF, creating competition in the future. Some approved products to treat common conditions such as diabetes and obesity are theorized, or proven, to provide benefit in patients with heart failure, and are sometimes used in these patients, including off-label. Products approved for PAH, including endothelin receptor agonists (ERAs) and phosphodiesterase type 5 (PDE5) inhibitors, even though trials have not shown benefit and have sometimes demonstrated harm, and manufacturers of which have not sought approval in patients with PH-HFpEF by filing an NDA or BLA, are nevertheless prescribed off-label by some physician who care for patients with

PH associated with HFpEF, and who state in our own market research that they do so out of a desire to provide something helpful for patients with this disease.

TNX-201 (imatinib) has the potential to be the first disease-modifying treatment of PAH, a fatal orphan disease. Pulmonary vasodilators, the only approved medications for PAH, do not have disease modifying properties. We do not expect these products, other than one which is not widely used today, to be contraindicated in patients taking TNX-201, and our intended protocol design tests TNX-201 as an additional therapy to one or more of these vasodilators.

In order to compete successfully, we must develop proprietary positions in patented drugs for therapeutic markets that have not been satisfactorily addressed by conventional research strategies. Our product candidates, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

Government Regulation

The manufacture and distribution of levosimendan will require the approval of U.S. government authorities as well as those of other countries. In the United States, the FDA regulates medical products. The Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our medical products. In addition to FDA regulations, we are also subject to other federal and state regulations, such as the Occupational Safety and Health Act and the Environmental Protection Act. Product development and approval within this regulatory framework requires a number of years and involves the expenditure of substantial funds.

Preclinical tests include evaluation of product chemistry and studies to assess the safety and effectiveness of the product and its formulation. The results of the preclinical tests are submitted to the FDA as part of the application. The goal of clinical testing is the demonstration in adequate and well-controlled studies of substantial evidence of the safety and effectiveness of the product in the setting of its intended use. The results of preclinical and clinical testing are submitted to the FDA from time to time throughout the trial process. In addition, before approval for the commercial sale of a product can be obtained, results of the preclinical and clinical studies must be submitted to the FDA. The testing and approval process requires substantial time and effort and there can be no assurance that any approval will be granted on a timely basis, if at all. The approval process is affected by a number of factors, including the severity of the condition being treated, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. Additional preclinical studies or clinical trials may be requested during the FDA review process and may delay product approval. After FDA approval for its initial indications, further clinical trials may be necessary to gain approval for the use of a product for additional indications. The FDA may also require post-marketing testing to monitor for adverse effects, which can involve significant expense.

The effects of government regulations on our business are discussed under the heading “Risk Factors - Risks Relating to Our Industry” included elsewhere in this Annual Report on Form 10-K.

Employees and Human Capital

We have assembled a high-quality team of clinical development managers and executives with significant experience in the biotechnology and pharmaceutical industries.

As of December 31, 2025, we had 14 full-time employees and two part-time employees. In addition to our employees, we also rely on the service and support of outside consultants and advisors. None of our employees are represented by a union, and we believe relationships with our employees are good.

Available Information

Our website address iswww.tenaxthera.com, and our investor relations website is located athttp://investors.tenaxthera.com. Information on our website is not incorporated by reference herein. Copies of our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and our proxy statements for our meetings of stockholders, and any amendments to those reports, as well as Section 13 and 16 reports filed by our insiders, are available free of charge on our website as soon as reasonably practicable after we file the reports with, or furnish the reports to, the SEC. Our SEC filings are also publicly available on the SEC’s website located at www.sec.gov, which contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.