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.

Financing and Capital - Tenax Therapeutics raised approximately $25.0 million in a private placement financing in March 2025 to advance its Phase 3 oral levosimendan program[78]. - The company raised gross proceeds of $25.0 million from the March 2025 Offering, with net proceeds of $23.2 million after expenses[93]. - The company received $3.7 million from the exercise of warrants and pre-funded warrants during the nine months ended September 30, 2025[100]. - The company has sufficient capital on hand to fund operations through 2027 based on working capital as of September 30, 2025[101]. Clinical Development - The company expects to enroll 230 patients in the ongoing Phase 3 LEVEL study in the first half of 2026, which is being conducted in the United States and Canada[79]. - The company plans to recruit patients for the LEVEL trial, concluding in approximately the first half of 2026[92]. - Clinical and preclinical development costs increased by $5.7 million for the three months ended September 30, 2025, primarily due to expenses associated with the ongoing Phase 3 LEVEL trial[82]. - The company is focused on developing two product candidates, levosimendan and imatinib, with a priority on levosimendan[90]. Financial Performance - The net loss for the three months ended September 30, 2025, was $15.8 million, a 299% increase from a net loss of $4.0 million in the same period in 2024[81]. - Research and development expenses for the three months ended September 30, 2025, increased by 232% to $10.3 million compared to $3.1 million in the same period in 2024[81]. - General and administrative expenses for the three months ended September 30, 2025, increased by 330% to $6.5 million compared to $1.5 million in the same period in 2024[81]. - Interest income increased by 53% to $1.0 million for the three months ended September 30, 2025, compared to $0.7 million in the same period in 2024[81]. - Net cash used in operating activities increased to $22.4 million for the nine months ended September 30, 2025, compared to $11.3 million for the same period in 2024[97]. - Net cash provided by financing activities was $26.9 million for the nine months ended September 30, 2025, a decrease of $72.9 million from $99.8 million in the same period of 2024[100]. - The accumulated deficit as of September 30, 2025, was $351.9 million, with expectations of continued net losses for several years[89]. Expenses and Costs - Non-cash stock-based compensation expense increased by $1.1 million for the three months ended September 30, 2025, compared to the same period in 2024[83]. - Legal and professional fees increased by $0.2 million for the three months ended September 30, 2025, primarily due to increased capital market and consulting expenses[86]. - Total current assets as of September 30, 2025, were $102.8 million, with working capital of $96.2 million[91]. - The company reported no net cash provided or consumed by investing activities for the nine months ended September 30, 2025[98]. - The company has not engaged in any off-balance sheet arrangements since inception[103].

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]

Core Insights - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [3] - The company will present at the Guggenheim Annual Healthcare Innovation Conference from November 10-12, 2025, in Boston, MA [1][2] Presentation Details - The presentation will be in a fireside chat format featuring Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer [2] - Scheduled date and time for the presentation is November 10, 2025, at 4:00 p.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2] Company Overview - Tenax Therapeutics owns global rights to develop and commercialize levosimendan, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension [3] - Currently, there are no approved products for PH-HFpEF, highlighting a significant market opportunity for the company [3] - The company's common stock is listed on The Nasdaq Stock Market under the symbol "TENX" [3]

Core Insights - Tenax Therapeutics has received an Intention to Grant notification from the European Patent Office for a patent that will protect TNX-103 (oral levosimendan) and other formulations for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) until at least December 2040 [1][2] - The patent will cover various routes of administration and a wide range of doses, as well as the use of levosimendan in combination with other cardiovascular drugs [2][3] - This patent is crucial as the company prepares to initiate its second registrational Phase 3 study, LEVEL-2, which will recruit patients across Europe [2][4] Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [4] - The company holds global rights to develop and commercialize levosimendan, targeting PH-HFpEF, which is the most prevalent form of pulmonary hypertension globally [4] - Levosimendan has received market authorization in 60 countries for treating acutely decompensated heart failure, although it is not available in the U.S. or Canada [3]

Summary of Tenax Therapeutics (TENX) Conference Call Company Overview - Tenax Therapeutics is focused on the Phase III development of an oral formulation of a drug for group two pulmonary hypertension (PH) patients with an ejection fraction greater than 40% [4][5] - The drug has been approved in 60 countries and has a history of 25 years for a different indication [4] Industry Context - Pulmonary hypertension (PH) is characterized by elevated pulmonary pressure in the lungs and is categorized into five subgroups, with group two associated with left heart disease [6] - Approximately 50% of heart failure patients develop pulmonary hypertension, with a significant portion being HFpEF (Heart Failure with preserved Ejection Fraction) [6] Market Opportunity - The American heart failure population was about 6.7 million in 2020, projected to rise to 8.5 million by 2030 [7] - More than half of new diagnoses in March are patients with an ejection fraction greater than 40% [8] - The addressable market for the drug is estimated at $10 billion, given that 50-80% of HFpEF patients may have pulmonary hypertension [8] Drug Development Insights - The company is leveraging legacy data and previous studies to support the development of their drug, which aims to lower wedge pressure without significantly affecting pulmonary artery pressure [24] - The Phase II HELP trial demonstrated a significant reduction in pulmonary wedge pressure during exercise, indicating the drug's potential efficacy [17][31] Clinical Trials - The ongoing Phase III trial (Level) is enrolling 230 subjects, with a primary endpoint of the six-minute walk test [36] - A second Phase III trial (Level 2) is planned to start this year, with a larger patient population and a longer duration [37][48] - The company is focused on careful site selection for trials to ensure effective enrollment and data collection [49][51] Safety and Efficacy - No new safety signals have been observed in the ongoing trials, and the drug has shown to be well-tolerated [40] - The drug's hemodynamic effects are well understood, and it has a favorable safety profile compared to surgical alternatives [30][31] Financial Outlook - The company is funded through 2027, with key value drivers including patient enrollment milestones and the potential to address a significant unmet medical need in the pulmonary hypertension market [58] Conclusion - Tenax Therapeutics is positioned to address a critical gap in the treatment of pulmonary hypertension, with a strong focus on clinical development and leveraging existing data to support its drug's efficacy and safety [58]