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]

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 Viewpoint - Tenax Therapeutics is advancing its lead program TNX-103 for treating pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), with ongoing Phase 3 studies and a strong financial position to support its operations through 2027 [2][3][5]. Corporate Progress - The company is on track to complete enrollment of 230 patients in the Phase 3 LEVEL study by the first half of 2026, which is expected to enhance the statistical power of the study [3][7]. - Tenax plans to initiate a second Phase 3 study, LEVEL-2, in 2025, with the protocol finalized and over 85 new sites in 15 countries prepared for qualification [3][7]. - Recent patent claims covering TNX-103 and related compounds have been allowed by the Canadian Intellectual Property Office, with protections expected to extend to 2040 [7]. Financial Results - As of June 30, 2025, Tenax reported cash and cash equivalents of $105.5 million, which is projected to fund operations through 2027 [5]. - Research and development expenses for Q2 2025 were $6.1 million, a significant increase from $2.3 million in Q2 2024, primarily due to higher clinical development costs [6]. - General and administrative expenses for Q2 2025 were $5.7 million, up from $1.3 million in Q2 2024, largely due to increased non-cash stock-based compensation [9]. - The company reported a net loss of $10.9 million for Q2 2025, compared to a net loss of $3.6 million in Q2 2024 [10].