TENAX THERAPEUTICS, INC. Annual Report: 2025 Performance and Future Outlook

TENAX THERAPEUTICS, INC. (TENX), a clinical-stage pharmaceutical company listed on The Nasdaq Stock Market LLC, stands at a critical juncture in its mission to develop novel treatments for cardiovascular and pulmonary diseases. This summary provides a comprehensive overview of the company's financial and operational performance for the fiscal year ended December 31, 2025, highlighting key risks and strategic initiatives.

Business Overview

Tenax Therapeutics, a clinical-stage pharmaceutical company, focuses on developing novel treatments for cardiovascular and pulmonary diseases. Its core strategy involves advancing lead product candidates through clinical development, aiming for regulatory approval and commercialization. As of December 31, 2025, Tenax remains in the development phase, generating no revenue from approved products.

• Lead Product Candidate - Oral Levosimendan: This is the company's primary focus, targeting pulmonary hypertension with preserved ejection fraction (PH-pEF), a serious and underserved cardiovascular condition.
  • Clinical Trials: Tenax is advancing two pivotal Phase 3 clinical trials:
    • LEVEL: The company completed enrollment for this trial in Q4 2025, and expects top-line results in Q3 2026.
    • LEVEL-2: Enrollment for this trial continues, with completion projected for Q2 2027.
    • Open-Label Extension (OLE): Patients who complete LEVEL and LEVEL-2 can enroll in an open-label extension study. This study will provide long-term safety and efficacy data, crucial for regulatory submissions and understanding chronic treatment effects.
  • Commercialization Strategy: If approved, Tenax plans to seek strategic partnerships for commercialization. This approach would leverage existing sales and marketing infrastructure, as the company currently lacks an internal sales force.
• Pre-clinical Product Candidate - Imatinib: Tenax is also evaluating Imatinib, a pre-clinical product candidate, for a new indication: potentially pulmonary arterial hypertension (PAH). Its development, however, depends on the success and funding of oral levosimendan.

Financial Performance

Tenax Therapeutics' financial performance for the fiscal year ended December 31, 2025, reflects its status as a clinical-stage company with no commercialized products.

• Revenue (FY2025): $0.0 million. Tenax generated no revenue from product sales or other significant operations in FY2025.
• Net Loss (FY2025): ($42.5 million). The company reported a net loss of ($42.5 million), primarily due to substantial research and development expenses for ongoing clinical trials.
• Year-over-Year Changes: Tenax has a history of operating losses and expects to incur substantial losses for the foreseeable future as it continues its development activities.

Financial Health

As of December 31, 2025, Tenax's financial health shows a limited cash position and significant funding requirements.

• Cash and Cash Equivalents (as of Dec 31, 2025): $12.3 million.
• Operating Cash Burn (FY2025): The company's operating cash burn was approximately $10.5 million per quarter, rapidly depleting its cash reserves.
• Debt: The company has no significant long-term debt.
• Liquidity: Tenax's current cash position is insufficient to fund operations for the next 12 months, raising a critical liquidity concern.

Management's Discussion and Analysis (MD&A) Highlights

Management emphasizes the company's pre-revenue stage and the significant investment required for clinical development. The $42.5 million net loss for FY2025 primarily stemmed from research and development activities, particularly costs for the pivotal Phase 3 LEVEL and LEVEL-2 trials for oral levosimendan. General and administrative expenses also contributed to this operating loss.

A key focus for management is the company's liquidity and capital resources. With only $12.3 million in cash and cash equivalents as of December 31, 2025, and an operating cash burn of approximately $10.5 million per quarter, Tenax urgently needs to raise substantial additional capital within the next 3-6 months. This funding is critical to continue operations and finance its clinical trials. This situation raises substantial doubt about the company's ability to continue as a going concern without successful fundraising. Management expects additional financing, likely through equity offerings, to fund the completion of the LEVEL-2 trial, analyze results, and prepare for a potential New Drug Application (NDA). These activities are estimated to require an additional $75-100 million.

Competitive Position

The pharmaceutical industry, especially in cardiovascular and pulmonary therapeutics, is highly competitive and rapidly evolving. Tenax Therapeutics operates in a landscape dominated by larger pharmaceutical companies with significantly greater financial, technical, and human resources.

• PH-pEF Market: The PH-pEF treatment market represents a significant unmet medical need, as no FDA-approved therapies currently exist specifically for this condition. This presents an opportunity for Tenax's oral levosimendan. However, other companies may be developing or researching competing therapies. Additionally, existing treatments for other forms of pulmonary hypertension or heart failure could be used off-label, creating indirect competition.
• PAH Market: For its pre-clinical Imatinib program targeting PAH, the market is more established with several approved therapies. Any entry into this market would face intense competition from existing drugs and companies.
• Differentiation: Tenax's strategy hinges on oral levosimendan potentially becoming the first approved therapy specifically for PH-pEF, addressing a critical unmet need. Its competitive position will depend on the clinical efficacy and safety profile demonstrated in its Phase 3 trials, its ability to secure regulatory approval, and its effectiveness in commercializing the product, potentially through strategic partnerships.

Risk Factors

Investing in Tenax Therapeutics carries substantial risks, primarily due to its early-stage nature, reliance on a limited pipeline, and significant funding requirements.

Risks Related to Business & Operations:

• Product Concentration: The company's future depends almost entirely on the successful development, regulatory approval, and commercialization of oral levosimendan. Failure of this single product candidate would severely impact the company.
• No Approved Products & Revenue: Tenax has no current revenue-generating products and may never achieve profitability.
• Clinical Trial Uncertainty:
  • High Costs & Long Timelines: Clinical trials are extremely expensive and time-consuming. The company estimates it will require an additional $75-100 million to complete the LEVEL-2 trial, analyze results, and prepare for a potential New Drug Application (NDA) for oral levosimendan.
  • Unpredictable Outcomes: Even with promising early data, Phase 3 trials can fail. Top-line results for LEVEL in Q3 2026 are a critical near-term catalyst, but success is not guaranteed.
  • Enrollment Delays: Delays in patient enrollment for LEVEL-2 could push back timelines and increase costs further.
• Market Acceptance: Even if approved, there is no guarantee that oral levosimendan will gain market acceptance against existing or future competitors.
• Partnership Dependence: Tenax may need to rely on third parties for development, manufacturing, and commercialization, which could lead to unfavorable terms or execution risks.

Risks Related to Financial Health:

• Significant Funding Needs: With only $12.3 million in cash as of December 31, 2025, and an operating burn rate of approximately $10.5 million per quarter, Tenax urgently needs to raise substantial additional capital within the next 3-6 months. This funding is essential to continue operations and finance its clinical trials.
• Going Concern Risk: Without successful fundraising, the company faces a significant risk of being unable to continue as a going concern, potentially leading to delays, reduction, or cessation of all development programs.
• Continued Losses: The company has a history of significant losses and expects to incur substantial losses for the foreseeable future.
• Milestone & Royalty Payments: If oral levosimendan is successful, Tenax will owe significant milestone payments and royalties to the licensor, reducing potential future profits.

Risks Related to Industry & Regulation:

• Intense Competition: The pharmaceutical industry is highly competitive, with larger companies possessing greater resources.
• Regulatory Hurdles: The drug development and approval process is highly regulated, complex, expensive, and subject to unpredictable changes.
• Healthcare Policy Changes: Changes in healthcare laws, reimbursement policies, or pricing pressures could negatively impact future sales.

Risks Related to Intellectual Property & Outsourcing:

• IP Protection: The ability to obtain and maintain patent protection for its product candidates is critical.
• Reliance on Third Parties: Tenax relies heavily on contract research organizations (CROs) for clinical trials and contract manufacturing organizations (CMOs) for drug supply, introducing execution risks.
• Talent Acquisition: Attracting and retaining key scientific and management personnel is crucial for success.

Risks for Stockholders:

• Stock Price Volatility: TENX's stock price has historically been, and is expected to remain, highly volatile.
• Dilution: To raise necessary capital, Tenax will likely issue additional shares of common stock. This would dilute the ownership percentage of existing shareholders. The company has a history of equity financing.
• No Dividends: Tenax does not anticipate paying cash dividends in the foreseeable future, meaning any return on investment would depend solely on stock price appreciation.

Future Outlook

Tenax Therapeutics stands at a pivotal stage, with critical clinical trial results for oral levosimendan expected in 2026 and 2027. Securing significant additional funding in the near term is paramount for the company's continued operations and pipeline advancement.

• Key Milestones:
  • Top-line results for the LEVEL Phase 3 trial are anticipated in Q3 2026.
  • Enrollment completion for the LEVEL-2 Phase 3 trial is projected for Q2 2027.
• Strategic Direction: The company's strategy focuses on advancing oral levosimendan through clinical development toward potential regulatory approval and exploring strategic partnerships for commercialization. Imatinib's development, however, depends on the lead program's success and funding.

Investors should carefully consider the substantial financial and operational risks inherent in this clinical-stage biotechnology company.