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Tenax Therapeutics(TENX) - 2025 Q2 - Quarterly Results

Corporate and Clinical Highlights Tenax Therapeutics is advancing its lead program, TNX-103, for patients with PH-HFpEF, with Phase 3 LEVEL study enrollment ongoing and a second global Phase 3 study, LEVEL-2, set to begin in 2025, alongside operational team strengthening and patent protection extension to 2040 - Enrollment for the Phase 3 LEVEL study of TNX-103 (oral levosimendan) is ongoing, with the target expanded to 230 patients to increase statistical power, expecting completion in the first half of 2026 and topline data in the second half of 2026126 - A second registrational Phase 3 study, LEVEL-2, is on track to be initiated in 2025, with a global footprint including over 85 new sites in 15 additional countries already qualified126 - The company expanded its operations team with new heads of Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance to oversee the LEVEL program6 - In August 2025, the Canadian Intellectual Property Office allowed claims for a patent covering the use of levosimendan (TNX-103, TNX-102, TNX-101) in PH-HFpEF patients, extending patent protection to 2040 once granted6 Second Quarter 2025 Financial Results For the second quarter of 2025, Tenax Therapeutics reported a net loss of $10.9 million, driven by increased R&D and G&A expenses, while maintaining a strong cash position of $105.5 million expected to fund operations through 2027 - The company reported cash and cash equivalents of $105.5 million as of June 30, 2025, which is expected to fund operations through 20275 Financial Metric Comparison (in millions) | Financial Metric | Q2 2025 | Q2 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $6.1 | $2.3 | +$3.8 | Increased clinical development costs for LEVEL & LEVEL-2 studies, higher personnel costs | | G&A Expenses | $5.7 | $1.3 | +$4.4 | Primarily due to a $3.6 million increase in non-cash stock-based compensation | | Net Loss | $10.9 | $3.6 | +$7.3 | Driven by higher operating expenses | Financial Statements The consolidated financial statements detail the company's financial performance and position, showing a significant year-over-year increase in operating expenses and net loss for both the three and six months ended June 30, 2025, alongside a strong cash position and increased total assets and stockholders' equity compared to year-end 2024 Consolidated Statements of Operations For the three months ended June 30, 2025, total operating expenses were $11.8 million, leading to a net loss of $10.8 million, primarily driven by higher R&D and G&A spending compared to the same period in 2024 Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $6,121 | $2,327 | | General and administrative | $5,671 | $1,344 | | Total operating expenses | $11,792 | $3,671 | | Net loss | ($10,847) | ($3,575) | | Net loss per share | ($0.27) | ($1.83) | Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $11,804 | $5,003 | | General and administrative | $11,326 | $2,577 | | Total operating expenses | $23,130 | $7,580 | | Net loss | ($21,255) | ($7,374) | | Net loss per share | ($0.56) | ($4.65) | Consolidated Balance Sheets As of June 30, 2025, Tenax reported total assets of $105.9 million, primarily cash and cash equivalents, with total liabilities of $2.5 million and stockholders' equity of $103.3 million, indicating an increase in cash and equity from December 31, 2024 Balance Sheet Comparison (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $105,462 | $94,851 | | Total assets | $105,857 | $96,686 | | Total liabilities | $2,527 | $4,693 | | Total stockholders' equity | $103,330 | $91,993 | About Tenax Therapeutics and Levosimendan Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies, with its lead candidate, levosimendan, being developed for PH-HFpEF, a condition currently lacking approved treatments - Tenax is a Phase 3 development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies11 - The lead candidate, levosimendan, is a novel, first-in-class K-ATP channel activator/calcium sensitizer being evaluated in oral (TNX-103), IV (TNX-101), and subcutaneous (TNX-102) formulations10 - The company is developing levosimendan for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date11