Tenax Therapeutics (TENX -0.93%), a development-stage biopharmaceutical company focused on treatments for cardiovascular and pulmonary diseases, released its results for the second quarter of fiscal 2025 on August 13, 2025. The company posted a GAAP EPS loss of $(0.27) for Q2 2025, and reported a GAAP net loss of $10.85 million for Q2 2025. Total operating expenses (GAAP) rose sharply in Q2 2025 versus Q2 2024, while the company maintained its status as a pre-commercial entity with no revenue. Cash and cash equivalents totaled $105.5 million as of June 30, 2025, providing a multi-year funding runway. The quarter showed continued pipeline progress but no new clinical or regulatory data. Overall, the period featured expanding clinical and operational efforts, significant cost increases, and a stable financial position that supports the company’s ongoing trials.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.27) | $(0.27) | $(1.83) | 85.2 % |
| Revenue (GAAP) | $0 | $0 | $0 | 0% |
| Research & Development Expense | $6.1 million | $2.3 million | 165.2 % | |
| General & Administrative Expense | $5.7 million | $1.3 million | 338.5% | |
| Cash & Cash Equivalents (end of period) | $105.5 million | N/A | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Key Success Factors
Tenax Therapeutics develops advanced therapies for serious cardiovascular and pulmonary conditions. Its lead programs target pulmonary hypertension in patients with heart failure with preserved ejection fraction (PH-HFpEF), a disease area with limited treatment options.
The company’s current focus is on advancing levosimendan, a drug intended to treat PH-HFpEF, through late-stage clinical development. Success for Tenax hinges on executing its clinical programs, achieving positive regulatory milestones, securing strong intellectual property rights, and maintaining financial discipline to support ongoing research and development.
Quarter Highlights and Financial Developments
During the period, Tenax undertook major steps to advance its most important clinical program. The pivotal Phase 3 LEVEL study testing oral levosimendan (TNX-103) in patients with PH-HFpEF expanded its enrollment target to 230 patients to increase statistical reliability. The company now expects to finish enrolling patients in the first half of 2026, with results expected in the second half of that year. Tenax also finalized plans for a second global Phase 3 trial, named LEVEL-2, which is scheduled to begin in 2025 with participation from over 85 new sites across 15 countries. High retention and therapy continuation rates in existing trial participants were reported, an important marker for overall study integrity and future results.
Financially, both Research and administrative expenses rose substantially in Q2 2025 versus Q2 2024. Research and development expense more than doubled, reaching $6.1 million in Q2 2025 compared to $2.3 million in Q2 2024. Despite the rising cost structure, net cash increased to $105.5 million at June 30, 2025, driven by a successful fundraising round of approximately $100.0 million in August 2024 and $25.0 million in March 2025. The company now estimates its available cash will sufficiently fund operations through 2027.
The quarter did not include new regulatory approvals. However, Tenax highlighted expanded intellectual property protection, specifically a new Canadian patent covering levosimendan and its key metabolites for PH-HFpEF, which will extend exclusivity through 2040. This strengthens the company’s competitive positioning as it advances toward potential commercial milestones in future years.
No new clinical or regulatory milestones were announced for other pipeline candidates, such as imatinib, which remain early-stage within the company’s research pipeline. There was also no mention of new business partnerships, product launches, or commercial revenues, as Tenax continues to operate as a pre-commercial research and development company without marketed products. The company did expand its clinical and operations leadership, adding talent in trial management and safety monitoring to support future program execution.
Looking Ahead
Management’s commentary reiterated the company’s plan to initiate the LEVEL-2 global Phase 3 trial for oral levosimendan in 2025, with full enrollment in the current LEVEL study targeted for the first half of 2026. The next major milestones will be the completion of patient recruitment and the eventual release of topline efficacy and safety data, expected in the second half of 2026. These milestones are critical for pursuing eventual regulatory submissions in the United States and abroad. No new quantifiable financial outlook or full-year guidance was provided for future quarters.
Tenax Therapeutics does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
