TENX

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 Ex...

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Tuesday reported a loss of $15.7 million in its first quarter. The Chapel Hill, North Carolina-based company said it had a loss of 35 cents per share. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 40 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Tuesday reported a loss of $15.5 million in its fourth quarter. The Chapel Hill, North Carolina-based company said it had a loss of 38 cents per share. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of $1.26 per share. For the year, the company reported a loss of $52.6 million, or $1.34 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX

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...

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Wednesday reported a loss of $15.8 million in its third quarter. The Chapel Hill, North Carolina-based company said it had a loss of 40 cents per share. The results beat Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of $1.33 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX

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 protect...

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, Tena...

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Wednesday reported a loss of $10.8 million in its second quarter. The Chapel Hill, North Carolina-based company said it had a loss of 27 cents per share. The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 50 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Wednesday reported a loss of $10.4 million in its first quarter. The Chapel Hill, North Carolina-based company said it had a loss of 28 cents per share. The results beat Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 48 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX

Phase 3 LEVEL Enrollment Completion for TNX-103 in PH-HFpEF Targeted Around Year-End 2025, with Topline Data Expected Middle of 2026 Initiation of Second Phase 3 Study, LEVEL-2, Expected This Year CHAPEL HILL, N.C., May 14, 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 March 31, 2025 and provided an update on its recent corporate progress. “2025 is off to a strong start. We continued to make meaningful progress in both the ongoing LEVEL study as well as preparations to commence our second registrational Phase 3 study, LEVEL-2,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We also continued to engage with key stakeholders over the past quarter to discuss how levosimendan can control splanchnic blood volume and reduce blood flow to the left ventricle, potentially providing desirable effects for patients suffering from PH-HFpEF. We expect to share topline data from our first Phase 3 study, LEVEL, in the middle of 2026 and establish TNX-103 as a powerful therapeutic option for this disease currently without any available treatments.” Recent Corporate and Clinical Highlights Patient enrollment in the Phase 3 LEVEL study of TNX-103 in PH-HFpEF continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. Tenax anticipates completing enrollment of 230 patients in LEVEL around the end of 2025. LEVEL is being conducted in Canada and the U.S. Tenax remains on track to commence in 2025 a second registrational Phase 3 study of TNX-103, LEVEL-2, in patients with PH-HFpEF. This trial will have a global footprint. First Quarter 2025 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $111.4 million as of March 31, 2025. In March 2025, the Company raised approximately $25 million in gross proceeds from a private placement financing. Tenax expects its cash and cash equivalents to fund the Company through 2027. Research and development (R&D): R&D expenses for the first quarter of 2025 were $5.7 million, compared to $2.7 million for the first quarter of 2024. The increase was primarily attributable to increased...

Successfully Completed Private Placements with Aggregate Gross Proceeds of Approximately $125 Million to Support Advancement of Two Registrational Studies for TNX-103 in PH-HFpEF and Fund Operations through 2027 Phase 3 LEVEL Study Expansion Increases Statistical Power; Enrollment Completion Targeted Around Year-End 2025, with Topline Data Expected Middle of 2026 Initiation of Second Phase 3 Study, LEVEL-2, Expected This Year CHAPEL HILL, N.C., March 25, 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 year ended December 31, 2024 and provided an update on its recent corporate progress. “The past year has been transformational for Tenax Therapeutics in our quest to advance TNX-103, our oral levosimendan drug candidate, and bring meaningful clinical benefit to patients suffering from PH-HFpEF. With the continued support of investors, we are now well-positioned to expand our investment in TNX-103 and accelerate development timelines, paving the way for an earlier potential regulatory filing,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We remain committed to a lean cost structure and responsible capital stewardship, ensuring our current funding sustains Tenax well beyond topline LEVEL data readout. We believe TNX-103 has the potential to improve the quality of life of patients living with PH-HFpEF, and expect to share topline data from LEVEL in the middle of 2026.” Recent Corporate and Clinical Highlights In March 2025, Tenax closed a private placement financing, securing approximately $25 million in gross proceeds. In March 2025, Tenax reported that the U.S. Food and Drug Administration (FDA) had completed its review of the Company’s updated Phase 3 development plan for TNX-103 (oral levosimendan). The plan includes an amendment to expand enrollment and enhance the statistical power of the ongoing Phase 3 LEVEL study, as well as the protocol for LEVEL-2, Tenax’s second registrational Phase 3 study. The Company anticipates completing enrollment of 230 patients in LEVEL around the end of 2025. LEVEL-2, a global study, is expected to commence in 2025. In January 2025, Tenax appointed Gillian Andor,...

CHAPEL HILL, N.C. (AP) — CHAPEL HILL, N.C. (AP) — Tenax Therapeutics Inc. (TENX) on Tuesday reported a loss of $6.3 million in its fourth quarter. On a per-share basis, the Chapel Hill, North Carolina-based company said it had a loss of 18 cents. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 52 cents per share. For the year, the company reported a loss of $17.6 million, or $1.15 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TENX at https://www.zacks.com/ap/TENX