TENX

In patients with a baseline 6MWD below the trial median of 333 meters, treatment with TNX-103 resulted in a 26.3-meter improvement compared to placebo (p = 0.0112) In the same patient population, TNX-103 produced a 47% reduction in NT-proBNP (p With full statistics analysis now complete, Company confirms TNX-103’s biological effects include marked reductions in pulmonary artery pressure and NT-proBNP, a biomarker reflecting increased cardiac wall stress. Results will inform protocol population enrichment and changes to overall registrational path CHAPEL HILL, N.C., Aug. 29, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) today announced that additional results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) were presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. Data confirmed findings from prespecified analyses which identified a favorable treatment effect in patients with a lower baseline 6MWD, supported by consistent changes in prespecified endpoints measuring cardiac stress and pulmonary pressures. “The independent analysis of LEVEL data we presented today sharpens what the earlier topline results initially indicated: patients with the lowest baseline walking distance had the greatest improvement, on top of state-of-the-art background therapy. What was particularly striking was that even patients who did not show a significant improvement in exercise capacity had the same magnitude of reduction in cardiac wall stress and pulmonary artery pressures, changes that correspond to a reduction in heart failure hospitalizations over longer follow-up,” said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University Feinberg School of Medicine and LEVEL’s Principal Investigator. “The magnitude of the reduction in NT-proBNP and the accompanying lowering of pulmonary pressure indicate that TNX-103 may provide clinical benefit to the majority of patients with PH-HFpEF independent of its effect on walk distance. The data are compelling and consistently point toward a potential therapeutic benefit in PH-HFpEF patients.” “The full set of prespecified analyses we completed in the last week, and Dr. Shah’s presentation of the results today, continue to emphasize that the treatment effect of TNX-103 is concentrated in patients walking less than the trial median of 333 meters at baseline. The finding of biologic efficacy in the majority of patients in LEVEL validates that the unique mechanism of action demonstrated in the Phase 2 HELP study can address patient function. That gives us conviction and a clear strategy to enrich LEVEL-2 for a study population of patients in whom the treatment effect is demonstrable,” said Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. “LEVEL has been enormously informative in shaping what comes next, and we intend to move quickly on behalf of patients who currently have no approved treatment options.” Key Takeaways from Late-Breaking Presentation The Phase 3 LEVEL clinical trial (NCT05983250) randomized 241 patients with PH-HFpEF across 41 sites in the United States and Canada. In this population, the primary endpoint of change in 6-minute walk distance (6MWD) at Week 12 did not achieve statistical significance, nor did the key secondary endpoint, change in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS); however, marked improvements were noted in exploratory endpoints that demonstrate the biologic effects of the therapy, notably N-terminal pro-B-type natriuretic peptide (NT-proBNP) and right ventricular systolic pressure (RVSP). Several key observations made in the trial, and their potential influence on the future development of levosimendan for patients with pulmonary hypertension and heart failure, were emphasized: Across the overall trial population (n = 241), TNX-103 was safe and well tolerated, with no significant arrhythmias. This population of older, symptomatic patients presented with multiple comorbidities, and was well-treated on guideline-directed medical therapy (GDMT): across these categories of increasing disease severity, with emphasis placed on atrial fibrillation and exercise tolerance, and increasing therapeutic intervention like MRAs/diuretics, and SGLT-2 inhibitors, levosimendan’s benefit appears to increase. An inverse linear relationship between baseline 6MWD and treatment effect was described and demonstrated not to be explained by regression to the mean. Patients in LEVEL whose baseline 6MWD match those reported in HELP and the recent CADENCE trial with sotatercept (274-285 meters) demonstrated an approximate 20-meter placebo-adjusted improvement in 6MWD. The overall trial population in LEVEL, however, had a median about 50-60 meters higher than in these previous PH-HFpEF trials. Prognostic implications include the impact of levosimendan on NT-proBNP compared to multiple classes of heart failure therapies, including some currently being tested, with commentary of the magnitude of effect in relation to heart failure events. As noted in the presentation, no data from a Phase 3 randomized trial has demonstrated even half the impact on this key indicator of cardiac wall stress, when compared to placebo. In an analysis of the relationship between heart failure outcomes and NT-proBNP change across these classes, Dr. Shah noted that the magnitude of levosimendan’s effect on cardiac wall stress suggests potential impact on outcomes in these HFpEF patients. In addition to RVSP, many echocardiographic endpoints show improvement with levosimendan compared to placebo. Across each domain of echocardiography, approximately 20 echocardiographic parameters improved, even when adjusting for multiple comparisons. Dr. Shah referenced these results in the prespecified subgroup of patients with a baseline 6MWD below the trial median of 333 meters (n = 119), at Week 12: 6MWD: least-squares mean change was +23.7 meters on TNX-103 versus −2.6 meters on placebo; treatment difference of +26.3 meters (p = 0.0112). KCCQ-TSS: change was +9.8 points on TNX-103 versus +4.1 points on placebo; a 5-point threshold is generally considered clinically meaningful. RVSP: change of −4.4 mmHg on TNX-103 versus +0.5 mmHg on placebo; treatment difference −4.9 mmHg (p = 0.009). (post-hoc analysis) NT-proBNP: geometric least-squares mean ratio of 0.53 from baseline on TNX-103 (p The Company intends that the LEVEL-2 population be enriched on the basis of clear evidence provided by the LEVEL results, and in a manner consistent with longstanding FDA guidance for sponsors. Tenax will continue to focus on the global development of this product for patients with high unmet need. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning our clinical data, our regulatory plans, our future trial designs, and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the results of such trials, and the design, timing, delays, costs, location, initiation, and enrollment of any future trials; any delays in regulatory review and approval of product candidates in development; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates;   risks related to our business strategy, including the prioritization and development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; our estimates regarding the potential market opportunity for our product candidates; cash usage and runway may not be within management’s expected ranges; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and members of our Board of Directors; risks associated with our cash needs; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media:Argot [email protected]

Company expects to report topline data from Phase 3 LEVEL clinical trial in August 2026 CHAPEL HILL, N.C., July 31, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) today reported financial results for the quarter ended June 30, 2026 and provided an update on its corporate progress. “We are approaching an exciting moment, one for which we have been preparing since we began developing a therapy uniquely suited for PH-HFpEF. As we announced at the start of July, we expect to have topline data from the LEVEL clinical trial in August,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. "In parallel, our team continues to activate sites and advance enrollment in LEVEL-2, our second global pivotal trial. We expect to complete LEVEL-2 enrollment by the end of 2027. Thank you to the entire team at Tenax for their commitment and dedication to rapidly advancing TNX-103 for patients.” Recent Corporate and Clinical Highlights In July 2026, Tenax announced that it plans to present the results from the Phase 3 LEVEL clinical trial in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany. In anticipation of potentially receiving topline results from the LEVEL clinical trial in time for presentation at ESC, an abstract was submitted and subsequently accepted. Second Quarter 2026 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $118.0 million as of June 30, 2026. Proceeds of $13.4 million during the second quarter from exercises of previously issued warrants has enabled Tenax to extend its cash runway, and the Company now expects to fund its operations through the second quarter of 2028. Research and development (R&D): R&D expenses for the second quarter of 2026 were $12.9 million, compared to $6.1 million for the second quarter of 2025. The increase is primarily attributable to increased clinical and preclinical development costs associated with our ongoing Phase 3 LEVEL trial and our second global Phase 3 clinical trial, LEVEL-2, which began in December 2025. Selling, general and administrative (SG&A): SG&A expenses for the second quarter of 2026 were $5.9 million, compared to $5.7 million for the second quarter of 2025. The increase is primarily attributable to an increase in legal and professional fees as well as salary and benefit costs related to an increase in personnel, all partially offset by a decrease in stock-based compensation expense. Net loss: Tenax Therapeutics reported a net loss of $17.8 million for the second quarter of 2026, compared to a net loss of $10.9 million for the second quarter of 2025. About Levosimendan Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication; although, it is not available in the United States or Canada. Tenax’s Phase 2 HELP clinical trial, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning our clinical trials and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; risks related to our business strategy, including the prioritization and development of product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and members of our Board of Directors; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact:Argot [email protected]

On track to report topline data from Phase 3 LEVEL study of TNX-103 in third quarter of 2026 Global Phase 3 LEVEL-2 clinical trial ongoing, enrollment completion anticipated by end of 2027 Strengthened leadership team with appointments of Thomas Staab as Chief Financial Officer and Timothy Healey, MBA, as Chief Commercial Officer CHAPEL HILL, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, reported today financial results for the quarter ended March 31, 2026 and provided an update on its recent corporate progress. “We continued to make significant progress in advancing TNX-103, completing randomization of more than 230 patients in the Phase 3 LEVEL study at the end of the first quarter which positions us to deliver topline data in the third quarter of 2026,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Our team continues to activate clinical sites around the world to advance the enrollment in LEVEL-2, our second pivotal trial of TNX-103. We are also thrilled to welcome Tom and Tim to our leadership team in key financial and commercial roles, further deepening the breadth of experience and knowledge at Tenax. Their appointments underscore our commitment to execution excellence as we advance the potential first therapy indicated for the treatment of PH-HFpEF.” Recent Corporate and Clinical Highlights All patients have been randomized in the LEVEL study. Tenax continues to anticipate sharing topline data from LEVEL in the third quarter of 2026. In April 2026, Tenax announced the appointment of Thomas R. Staab, II, as Chief Financial Officer (CFO). Mr. Staab has over 25 years of financial and executive experience across the healthcare industry, having previously served as CFO of LENSAR, BioCryst Pharmaceuticals, Inspire Pharmaceuticals, and Triangle Pharmaceuticals. In May 2026, Tenax further expanded its leadership team with the appointment of Timothy Healey, MBA, as Chief Commercial Officer (CCO). Mr. Healey is a seasoned pharmaceutical executive with a strong track record of successful commercial leadership experience, having most recently served as CCO at Eversana. In May 2026, Tenax also appointed So-Young Kim, MD, as Executive Vice President of Clinical Development and Strategy. Dr. Kim has extensive industry experience spanning global drug development and commercial strategy at Bayer AG, with a deep focus on cardiovascular and cardiometabolic medicine. First Quarter 2026 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $118.8 million as of March 31, 2026. The proceeds from exercises of previously issued warrants during the quarter have enabled Tenax to extend its cash runway, and the Company now expects cash and cash equivalents to fund it through at least the first quarter of 2028. Research and development (R&D): R&D expenses for the first quarter of 2026 were $11.5 million, compared to $5.7 million for the first quarter of 2025. The increase is primarily attributable to increased clinical and preclinical development costs associated with our ongoing Phase 3 LEVEL trial and our second global Phase 3 study, LEVEL-2, which commenced in December 2025, as well as increased salary and benefit costs related to new employees, partially offset by decreased stock-based compensation due to timing of option vesting. General and administrative (G&A): G&A expenses for the first quarter of 2026 were $5.0 million, compared to $5.7 million for the first quarter of 2025. The decrease is primarily attributable to a decrease in stock-based compensation due to timing of vesting, partially offset by an increase in salary and benefits related to new employees. Net loss: Tenax Therapeutics reported a net loss of $15.7 million for the first quarter of 2026, compared to a net loss of $10.4 million for the first quarter of 2025. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media:Argot [email protected]

Achieved randomization target of 230 patients in LEVEL study, topline data expected in third quarter of 2026 Initiated global Phase 3 LEVEL-2 clinical trial and opened long-term OLE study for patients to remain on drug CHAPEL HILL, N.C., March 10, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, reported today financial results for the year ended December 31, 2025 and provided an update on its recent corporate progress. “We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study. As we strive to make significant progress executing on our registrational LEVEL program, achievement of this important milestone demonstrates our team’s commitment to rapidly advancing TNX-103,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The screening period for LEVEL has closed. Patients already screening will have the opportunity to qualify for randomization, which we anticipate finishing this month. We expect to share initial results from LEVEL in the third quarter of 2026.” Mr. Giordano continued, “In parallel, we remain focused on activating clinical sites around the world to advance the global LEVEL-2 study, which we continue to anticipate will complete enrollment by the end of 2027. With a continued focus on execution, we aim to rapidly advance the development of TNX-103, a novel and potential first-in-class therapy for patients with PH-HFpEF who have no approved treatment options for their debilitating disease.” Recent Corporate and Clinical Highlights In November 2025, Tenax hosted a virtual call with key opinion leaders to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), as well as its Phase 3 TNX-103 program. In December 2025, Tenax announced the results from a prespecified Blinded Sample Size Re-estimation (BSSR) of the ongoing LEVEL study, demonstrating the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance. Also in December 2025, Tenax announced the initiation of LEVEL-2, a global and second registrational Phase 3 clinical trial of TNX-103 in patients with PH-HFpEF. Tenax also announced it will initiate a global, multi-center open-label extension (OLE) study, which will provide patients enrolled in either LEVEL or LEVEL-2 continued access to TNX-103 after study completion and until potential availability of a commercialized product. In January 2026, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance expanding protection to cover any formulation of levosimendan that is administered subcutaneously in a broad range of indications including pulmonary hypertension, essential and secondary hypertension, HFpEF, heart failure with reduced ejection fraction (HFrEF), PH-HFpEF and PH with HFrEF (PH-HFrEF). In March 2026, Tenax achieved its randomization target of 230 patients in the LEVEL study, and closed screening. All patients currently in screening will have the opportunity to qualify for randomization, which is expected to occur by the end of March. The Company anticipates sharing topline data in the third quarter of 2026. Fourth Quarter and Full Year 2025 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $97.6 million as of December 31, 2025. Tenax expects its cash and cash equivalents to fund the Company through 2027. Research and development (R&D): R&D expenses for the fourth quarter of 2025 were $10.5 million, compared to $4.6 million for the fourth quarter of 2024. R&D expenses for the year ended December 31, 2025 were $32.7 million, compared to $12.7 million for the year ended December 31, 2024. The increase for both periods is primarily attributable to increased expenses during the year ended December 31, 2025 associated with the Company’s ongoing Phase 3 LEVEL trial and the second global Phase 3 study, LEVEL-2, which commenced in December 2025, compared with costs for prior year periods associated with the planning of LEVEL, the initiation of the first LEVEL sites, and the enrollment of the first LEVEL patients. Additionally, salary and related benefits expense, including stock-based compensation expense, increased for the periods ended December 31, 2025 as compared to the prior year due to the increased number of employees needed for the Company to expand its LEVEL trial and commence LEVEL-2. General and administrative (G&A): G&A expenses for the fourth quarter of 2025 were $5.9 million, compared to $2.7 million for the fourth quarter of 2024. G&A expenses for the year ended December 31, 2025 were $23.7 million, compared to $6.8 million for the year ended December 31, 2024. The increase during both periods is primarily the result of stock-based compensation expense, as well as increased professional fees. Net loss: Tenax Therapeutics reported a net loss of $15.5 million for the fourth quarter of 2025, compared to a net loss of $6.3 million for the fourth quarter of 2024. Tenax Therapeutics reported a net loss of $52.6 million for the year ended December 31, 2025, compared to a net loss of $17.6 million for the year ended December 31, 2024. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media: Argot Partners [email protected]

Phase 3 LEVEL Study Ongoing, Enrollment Completion (230 Patients) Expected in First Half of 2026, with Topline Data Expected in Second Half of 2026 On Track to Initiate Second Phase 3 Study, LEVEL-2, in 2025 Tenax to Host Virtual KOL Call Tomorrow, Thursday, November 13, 2025 at 4:30 p.m. ET CHAPEL HILL, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today reported financial results for the quarter ended September 30, 2025 and provided an update on its recent corporate progress. “We continued to advance our lead program, TNX-103, in patients with PH-HFpEF and remain on track to enroll 230 patients in the ongoing Phase 3 LEVEL study in the first half of 2026, and initiate the global LEVEL-2 study this year,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “PH-HFpEF is a debilitating, often fatal disease and the most common form of pulmonary hypertension, yet no drugs are approved for this indication. We look forward to our upcoming virtual KOL call with some of the leading minds in this field, who intend to discuss the physiology of PH-HFpEF, the strategy for using levosimendan to aleviate symptoms and improve exercise ability, and how this product is differentiated from other efforts to develop medicines for Group 2 PH patients” Recent Corporate and Clinical Highlights In September 2025, the European Patent Office (EPO) notified Tenax of its Intention to Grant the Company’s patent application titled “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF),” which will provide intellectual property (IP) protection for the treatment of PH-HFpEF with TNX-103 (oral levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), and transdermal levosimendan, as well as the active metabolites of levosimendan (OR1896 and OR1855). The patent will also expressly provide protection in Europe for a wide range of doses of levosimendan, as well as for use of levosimendan in combination with various cardiovascular drugs, in PH-HFpEF. This new patent, once granted, 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. Enrollment in the Phase 3 LEVEL study of TNX-103 in PH-HFpEF is progressing well, with high rates of study and therapy continuation through both the blinded and open-label extension stages. Tenax expects to enroll 230 patients in the first half of 2026. LEVEL is being conducted in the United States and Canada. Tenax remains on track to initiate a second registrational Phase 3 study of TNX-103, LEVEL-2, in patients with PH-HFpEF this year. LEVEL-2 will have a global footprint. To date, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study. Virtual KOL Call On Treatment Landscape for PH-HFpEF and Phase 3 TNX-103 Programs The Company will host a conference call and webcast on Thursday, November 13, 2025, at 4:30 p.m. ET to discuss the clinical development landscape for PH-HFpEF and the ongoing late-stage development program for TNX-103. Members of Tenax’s management team will be joined on the call by recognized key opinion leaders in cardiovascular medicine. To participate in the conference call, please dial one of the following numbers and ask to join the Tenax Therapeutics call: +1-877-317-6789 for callers in the United States +1-412-317-6789 for international callers The live and archived webcast of the call will be accessible on the Company’s investor relations webpage. Third Quarter 2025 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $99.4 million as of September 30, 2025. Tenax expects its cash and cash equivalents to fund the Company through 2027. Research and development (R&D): R&D expenses for the third quarter of 2025 were $10.3 million, compared to $3.1 million for the third quarter of 2024. The increase was primarily attributable to increased clinical development costs associated with our ongoing Phase 3 LEVEL study and our second global Phase 3 study, LEVEL-2, for which we are conducting start-up activities in anticipation of patient enrollment. Additionally, our R&D employee headcount increased during 2025, resulting in an increase in personnel costs compared to the same quarter in 2024. Our R&D expenses for the third quarter of 2025 includes $1.1 million of non-cash stock-based compensation expense, representing an increase of $1.1 million compared to the same period in 2024. General and administrative (G&A): G&A expenses for the third quarter of 2025 were $6.5 million, compared to $1.5 million for the third quarter of 2024. The increase is primarily due to increased non-cash stock-based compensation expense. Our G&A expenses for the third quarter of 2025 include $4.5 million of non-cash stock-based compensation expense, representing an increase of $4.5 million compared to the same period in 2024. Additionally, legal and professional fees increased during the third quarter of 2025 compared to the same period in 2024. Net loss: Tenax Therapeutics reported a net loss of $15.8 million for the third quarter of 2025, compared to a net loss of $4.0 million for third quarter of 2024. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; intellectual property risks; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks associated with our cash needs; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate, including any changes resulting from government shut downs, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media: Argot Partners [email protected]

Phase 3 LEVEL Study Ongoing, Enrollment Completion (230 Patients) Expected in First Half of 2026, with Topline Data Expected in Second Half of 2026 On Track to Initiate Second Phase 3 Study, LEVEL-2, in 2025 CHAPEL HILL, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today reported financial results for the quarter ended June 30, 2025 and provided an update on its recent corporate progress. “We are pleased with the progress achieved in the second quarter, and remain in a strong position to execute and advance our lead program, TNX-103, in patients with PH-HFpEF,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Our sites in North America continue recruiting toward the expanded target of 230 patients, which increased the statistical powering of the LEVEL study. We now anticipate completing enrollment in the first half of 2026. Importantly, we remain on track to initiate our global Phase 3 study, LEVEL-2, this year. Together, both registrational studies are expected to satisfy the requirements, including safety data expectations, to file for approval in the U.S. and other geographies.” Recent Corporate and Clinical Highlights Patient enrollment in the Phase 3 LEVEL study of TNX-103 (oral levosimendan) in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF) continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. Tenax expects to complete enrollment of 230 patients in the first half of 2026. LEVEL is being conducted in Canada and the United States. A LEVEL protocol design paper, titled “Oral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial,” was published in the Journal of Cardiac Failure. Tenax remains on track to initiate a second registrational Phase 3 study of TNX-103, LEVEL-2, in patients with PH-HFpEF this year. The protocol for LEVEL-2 has been finalized, and the study will have a global footprint. To date, over 85 sites new to the program, in 15 additional countries, have received qualification visits. Year to date, Tenax has expanded its operations team, with new heads of Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance joining the organization to help oversee the execution of the LEVEL program. In August 2025, the Canadian Intellectual Property Office (CIPO) informed Tenax it has allowed claims within the Company’s patent application covering the use of TNX-103, TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” Once granted, the patent’s protections will extend to 2040. Second Quarter 2025 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $105.5 million as of June 30, 2025. Tenax expects its cash and cash equivalents to fund the Company through 2027. Research and development (R&D): R&D expenses for the second quarter of 2025 were $6.1 million, compared to $2.3 million for the second quarter of 2024. The increase was primarily attributable to increased clinical development costs associated with our ongoing Phase 3 LEVEL study and our second global Phase 3 study, LEVEL-2, for which we have begun preliminary work, compared with costs for the prior year period, associated with the planning of LEVEL, the initiation of the first LEVEL sites and enrollment of the first LEVEL patients. Additionally, our R&D employee headcount increased during the second quarter of 2025, resulting in an increase in personnel costs as compared to the same quarter in 2024. This increase was comprised of an increase in salary costs as well as an increase in non-cash stock compensation expense. Also, our R&D expenses for the second quarter of 2025 includes $1.0 million of non-cash stock-based compensation expense, representing an increase of $1.0 million as compared to the same period in 2024. This non-cash expense is due to stock options granted in December 2024 that resulted in an associated expense being amortized over a one-year vesting term, in addition to new option grants made in May 2025 that vest and are being expensed over four years. General and administrative (G&A): G&A expenses for the second quarter of 2025 were $5.7 million, compared to $1.3 million for the second quarter of 2024. The increase is primarily due to increased non-cash stock-based compensation expense. Our G&A expenses for the second quarter of 2025 include $3.6 million of non-cash stock-based compensation expense, representing an increase of $3.6 million as compared to the same period in 2024. This is a result of option grants made in December 2024 that resulted in an associated expense being amortized over a one year vesting term, in addition to new option grants made in May 2025 that vest and are being expensed over four years. Additionally, salaries and related performance-based compensation expense, as well as legal and professional fees, increased during the second quarter of 2025 as compared to the same period in 2024. Net loss: Tenax Therapeutics reported a net loss of $10.9 million for the second quarter of 2025, compared to a net loss of $3.6 million for second quarter of 2024. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; intellectual property risks; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks associated with our cash needs; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media: Argot Partners [email protected]