Tenax Therapeutics (NasdaqCM:TENX) FY Conference December 02, 2025 04:15 PM ET Company ParticipantsChris Giordano - President and CEOStuart Rich - CMOModeratorNext up, we have Chris Giordano and Stuart Rich from Tenax Therapeutics. I'm going to turn it right over to you guys for an introduction of the company, where things stand today. Then we'll come back for some questions.Chris GiordanoGreat, great. Hi, I'm Chris Giordano. Thanks for attending. We're currently enrolling in a U.S. and Canadian phase III t ...

CHAPEL HILL, N.C., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced that the Company will present at the following investor conferences: 8th Annual Evercore Healthcare ConferenceFormat: Fireside chatParticipants: Chris Giordano, President & Chief Executive Officer, Stuart Rich, M.D., Chief Medical OfficerDate ...

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Core Insights - Tenax Therapeutics is developing TNX-103, an oral formulation of levosimendan, aimed at treating pulmonary hypertension with preserved ejection fraction (PH-HFpEF), which is currently in late-stage development with Phase III study data expected in the second half of 2026 [2] - The company emphasizes its unique mechanism of action and trial design, differentiating its approach from other investigational strategies in the PH-HFpEF space, which addresses a significant unmet medical need [3] Company Development - TNX-103 is positioned as a potential first-in-class treatment for PH-HFpEF, with a global Phase III study (LEVEL-2) set to initiate this year [2] - The company is focused on a different physiological target compared to other drugs in development, highlighting its innovative approach in the treatment landscape [3]

Tenax Therapeutics Conference Call Summary Company Overview - **Company**: Tenax Therapeutics (NasdaqCM:TENX) - **Focus**: Development of TNX-103, an oral formulation of levosimendan for treating pulmonary hypertension with heart failure preserved ejection fraction (PH-HFpEF) [2][3] Key Industry Insights - **Market Need**: There is a significant unmet need for effective treatments for PH-HFpEF, as no drugs are currently approved for this condition [2] - **Research Landscape**: Tenax is not alone in this space; other investigational strategies are being evaluated for PH-HFpEF, highlighting the growing interest in this area [2] Core Development Program - **Current Studies**: - TNX-103 is in late-stage development, specifically in the phase 3 LEVEL study, with top-line data expected in the second half of 2026 [2] - LEVEL II, a global phase 3 study, is set to initiate this year [2] - **Unique Mechanism**: Tenax's approach targets a different physiological mechanism compared to other drugs in development, focusing on venous blood volume and its impact on heart function [3][5] Scientific Discussion Points - **Volume Overload**: Excessive blood volume in the heart and lungs is a critical issue in patients with PH-HFpEF, leading to symptoms and hospitalizations [5][6] - **Physiological Mechanism**: The discussion highlighted the importance of understanding the physiological changes in patients with PH-HFpEF, particularly the role of splenic blood volume and its impact on heart function [8][9] - **Proof of Concept**: Data from mechanical preload-reducing devices and nerve block studies support the hypothesis that reducing blood volume can lead to hemodynamic improvements without negatively impacting cardiac output [17][19] Clinical Trial Insights - **Phase 2 HELP Study**: Demonstrated that levosimendan significantly reduces wedge pressure during exercise, with 85% of patients responding positively [20][29] - **Transition to Oral Formulation**: Patients transitioning from IV to oral levosimendan reported improved symptoms and exercise capacity, indicating the potential for better outcomes with chronic oral administration [32][39] Comparison with Other Treatments - **Pulmonary Vasodilators**: The call discussed the limitations of existing pulmonary vasodilators in treating HFpEF, emphasizing that many trials have failed due to the complexity of the disease and the body's compensatory mechanisms [50][52] - **Relaxin Trials**: The outcomes of trials involving Relaxin analogs were discussed, highlighting the challenges faced in achieving positive results in HFpEF patients [60][61] Regulatory and Patent Considerations - **FDA Filing**: The potential for accelerated approval is contingent on the magnitude of benefit observed in the LEVEL trial, with a robust safety database being a critical requirement [67][68] - **Patent Protection**: Tenax holds multiple method of use patents for levosimendan, which are considered strong and extend to various formulations and combinations [69][70] Additional Insights - **Patient Experience**: Feedback from patients involved in the HELP and LEVEL studies indicates significant improvements in their quality of life and functional capacity [73] - **Future Directions**: The company is focused on ensuring that the transition from IV to oral formulations maintains efficacy and safety, with ongoing studies to support this [74] This summary encapsulates the key points discussed during the Tenax Therapeutics conference call, providing insights into the company's development programs, industry context, and future directions.

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (919) 855-2 ...

Financial Performance - Tenax Therapeutics reported cash and cash equivalents of $99.4 million as of September 30, 2025, expected to fund operations through 2027[7]. - Tenax reported a net loss of $15.8 million for Q3 2025, compared to a net loss of $4.0 million for Q3 2024[10]. - Tenax's net loss per share for Q3 2025 was $0.40, compared to $0.19 for Q3 2024[17]. - Total operating expenses for Q3 2025 were $16.8 million, compared to $4.6 million in Q3 2024[17]. - The total stockholders' equity as of September 30, 2025, was $96.2 million, an increase from $92.0 million at the end of 2024[21]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $10.3 million, a significant increase from $3.1 million in Q3 2024, primarily due to clinical development costs[8]. - The ongoing Phase 3 LEVEL study is on track to enroll 230 patients by the first half of 2026, with a second Phase 3 study, LEVEL-2, expected to initiate this year[2][5]. - The company has qualified over 160 investigative sites across 15 countries for the LEVEL-2 study[5]. General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2025 were $6.5 million, up from $1.5 million in Q3 2024, largely due to increased non-cash stock-based compensation[9]. Intellectual Property - The European Patent Office intends to grant a patent for levosimendan treatment in PH-HFpEF, providing protection until December 2040[3].

Core Insights - Tenax Therapeutics is advancing its lead program, TNX-103, for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), with enrollment of 230 patients expected to complete in the first half of 2026 and a second Phase 3 study, LEVEL-2, set to initiate in 2025 [2][6] Corporate Progress - The company reported a cash position of $99.4 million as of September 30, 2025, which is expected to fund operations through 2027 [8] - Tenax is conducting a virtual KOL call on November 13, 2025, to discuss the treatment landscape for PH-HFpEF and the ongoing development of TNX-103 [4] Clinical Development - The ongoing Phase 3 LEVEL study is progressing well, with high rates of study and therapy continuation, and is being conducted in the United States and Canada [6] - The European Patent Office has indicated its intention to grant a patent for levosimendan for treating PH-HFpEF, which will provide IP protection until December 2040 [6] Financial Results - For Q3 2025, Tenax reported R&D expenses of $10.3 million, up from $3.1 million in Q3 2024, primarily due to increased clinical development costs [9] - General and administrative expenses for Q3 2025 were $6.5 million, compared to $1.5 million in Q3 2024, largely due to increased non-cash stock-based compensation [10] - The net loss for Q3 2025 was $15.8 million, compared to a net loss of $4.0 million in Q3 2024 [11]

Tenax Therapeutics Conference Call Summary Company Overview - **Company**: Tenax Therapeutics (NasdaqCM:TENX) - **Focus**: Development of Levosimendan for the treatment of pulmonary hypertension with preserved ejection fraction (PH-HFpEF) [2][3] Industry Context - **Market Size**: Estimated prevalence of PH-HFpEF in the U.S. is about 2 million patients, with an additional 2 million in Europe, indicating a significant market opportunity [12][13] - **Unmet Need**: No approved therapies for PH-HFpEF exist, and some existing treatments have been harmful, highlighting a substantial unmet medical need [12][13] Core Points and Arguments - **Drug Development**: - Levosimendan is currently in phase three trials, with the first trial ongoing and a second trial expected to start soon [2][25] - The drug has been approved in over 60 countries for IV use but has not been previously studied for HFpEF in the U.S. [6][7] - Tenax's approach involves treating volume overload rather than directly targeting left ventricular compliance, which has been a common failure point in past drug developments [4][5] - **Trial Design**: - The phase two HELP trial demonstrated significant improvements in hemodynamics, specifically in wedge pressure and central venous pressure, without affecting contractility [15][16] - The primary endpoint for the phase three trials is the six-minute walk distance, which is a recognized endpoint for approval in pulmonary hypertension [17][27] - **Licensing and Rights**: - Tenax has secured a worldwide license for Levosimendan, allowing for various formulations, including oral and modified oral forms [9] - **Patient Transition**: - Transition from IV to oral formulation has shown positive outcomes, with patients reporting improved symptoms and walking distances [20][24] Additional Important Insights - **Regulatory Pathway**: The use of six-minute walk as an endpoint is seen as a straightforward regulatory path for approval, especially given the lack of existing effective therapies [17][27] - **Market Research**: Feedback from key opinion leaders (KOLs) indicates that the three-times-a-day dosing of the oral formulation is not seen as a barrier to patient compliance due to the significant symptom relief it provides [32][33] - **Future Opportunities**: There are plans for lifecycle management, including potential dosing changes to improve market penetration and patient adherence [33][34] Financial Position - **Cash Runway**: As of the last reported quarter, Tenax had over $100 million in cash, which is expected to support ongoing research and development efforts [35]

Core Insights - Tenax Therapeutics is hosting a conference call on November 13, 2025, to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) and the ongoing development of TNX-103 [1][2] Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on novel cardiopulmonary therapies, specifically targeting PH-HFpEF, which currently lacks approved treatments [5] - The company has global rights to develop and commercialize levosimendan, a first-in-class K-ATP channel activator/calcium sensitizer [4][5] Product Development - TNX-103 (oral levosimendan) is being advanced in two registrational Phase 3 studies, LEVEL and LEVEL-2, with enrollment ongoing in the North American LEVEL study and the global LEVEL-2 study set to initiate in 2025 [3] - Previous studies, including the Phase 2 HELP study, indicated that both intravenous (TNX-101) and oral (TNX-103) formulations of levosimendan could improve exercise capacity and quality of life in patients with PH-HFpEF [4]