Executive Summary / Key Takeaways

• Focused Pipeline & De-risked Approach: Tenax Therapeutics is strategically concentrating on levosimendan (TNX-103) for Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF), leveraging a molecule with a well-established safety profile from over 60 countries, aiming for a first-in-class therapy in a high-unmet-need indication.
• Accelerated Clinical Momentum: The company is advancing two registrational Phase 3 studies, LEVEL and LEVEL-2, for TNX-103. LEVEL enrollment (230 patients) is expected to complete in H1 2026 with topline data in H2 2026, while LEVEL-2 is set to commence in 2025, positioning Tenax for a robust regulatory submission.
• Strong Financial Runway: Recent private placements, including $25 million in March 2025 and $99.7 million in August 2024, have significantly bolstered the cash position to $105.5 million as of June 30, 2025, providing sufficient capital to fund operations through 2027, well beyond key data readouts.
• Significant Market Opportunity: PH-HFpEF is described as a "growing epidemic with high morbidity and mortality and no treatment," presenting a substantial, open market for TNX-103 if approved, offering a dual value proposition of improved patient outcomes and potential healthcare cost savings.
• Execution Risks Remain: As a development-stage company, Tenax faces inherent risks associated with clinical trial outcomes, regulatory approvals, and the need for future financing beyond 2027 to support commercialization, despite its current strong liquidity.

The Quest for Cardiopulmonary Innovation

Tenax Therapeutics, Inc. (TENX) stands as a Phase 3, development-stage pharmaceutical company dedicated to addressing critical unmet needs in cardiopulmonary diseases. The company's journey, originating from Oxygen Biotherapeutics, Inc. in 1967, has been marked by strategic evolution, culminating in a focused pipeline centered on levosimendan. This clinician-driven approach, informed by insights from leading experts, aims to precisely target disease pathophysiology, particularly in pulmonary hypertension.

A pivotal moment arrived in 2013 with the acquisition of exclusive rights to develop and commercialize levosimendan in the U.S. and Canada. This laid the groundwork for a strategic pivot, solidified by the company's rebranding to Tenax Therapeutics in 2014 and the subsequent prioritization of levosimendan. While early explorations included trials for Low Cardiac Output Syndrome (LCOS) in cardiac surgery and septic shock, the company has since refined its focus, learning from both successes and setbacks to concentrate resources on its most promising path forward.

Levosimendan: A Differentiated Technology with a De-risked Profile

At the heart of Tenax's investment thesis is levosimendan, a unique molecule with a multi-faceted mechanism of action. Levosimendan functions as a calcium sensitizer and a potassium ATP channel activator, impacting both the heart and vascular system. This dual action enhances cardiac contractility and induces vasodilatory effects, critically, without increasing myocardial oxygen consumption. This profile is particularly advantageous in compromised cardiac conditions where increased oxygen demand could be detrimental.

The tangible benefits of this technology were highlighted in Tenax's Phase 2 HELP study of intravenous levosimendan (TNX-101) in patients with HFpEF. This study demonstrated "potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity." This direct improvement in a key functional metric forms the scientific bedrock for the ongoing Phase 3 LEVEL study. For investors, the "so what" of this technological differentiation is significant: levosimendan's established mechanism and prior clinical data suggest a genuine potential to improve patient function in PH-HFpEF, a condition currently lacking approved treatments.

Furthermore, Tenax employs a "de-risked approach" by developing levosimendan. This molecule is already approved and marketed in over 60 countries for acutely decompensated heart failure (ADHF), boasting a well-established safety profile from millions of patients over two decades. This extensive real-world experience significantly mitigates safety risks typically associated with novel drug development, potentially accelerating regulatory pathways and enhancing market acceptance upon approval. This derisked profile is a crucial competitive advantage, allowing Tenax to focus development efforts on efficacy in a new, high-need indication.

Competitive Landscape and Market Opportunity in PH-HFpEF

Tenax operates in a competitive pharmaceutical landscape dominated by larger players such as United Therapeutics (UTHR), Gilead Sciences (GILD), Merck (MRK), and Pfizer (PFE), all of whom have established portfolios in cardiovascular and pulmonary therapies. These larger entities benefit from extensive R&D capabilities, global distribution networks, and robust financial resources. However, Tenax strategically carves out its niche through a focused R&D strategy and the unique profile of levosimendan.

The company's competitive advantage lies in its agility and specialized focus on PH-HFpEF, an area where, as Tenax's Chief Medical Officer, Dr. Stuart Rich, noted, there are "no currently approved treatment options." This represents a significant "first-in-class" opportunity. While larger competitors may have broader pipelines, Tenax's targeted approach with a repurposed drug like levosimendan could offer a more efficient and potentially faster path to market in this specific indication. The absence of approved therapies for PH-HFpEF, described by an AHA Scientific Advisory as "a growing epidemic with high morbidity and mortality," underscores a substantial, open market opportunity for TNX-103. This unmet need provides Tenax with a strong strategic position, as it is not directly competing for market share against established drugs but rather aiming to define a new treatment paradigm.

Historically, Tenax's prior efforts in LCOS in cardiac surgery, despite not meeting primary endpoints, revealed a large addressable market of 80,000 to 90,000 patients annually in North America, with LCOS driving significant additional hospital costs of approximately $14,500 per admission. This prior market research, though for a different indication, demonstrates the company's understanding of critical care market dynamics and the potential for therapies that offer both clinical and pharmacoeconomic benefits.

Operational Momentum and Financial Strength

Tenax Therapeutics is currently executing an ambitious clinical development plan for TNX-103 in PH-HFpEF. The Phase 3 LEVEL study, being conducted in Canada and the United States, has been expanded to enroll 230 patients, significantly increasing its statistical powering to over 95%. Enrollment completion for LEVEL is anticipated in the first half of 2026, with topline data expected in the second half of 2026. This accelerated timeline is further bolstered by the planned initiation of LEVEL-2, a second global registrational Phase 3 study, in 2025. LEVEL-2 will feature a larger sample size and a full year of double-blind, placebo-controlled therapy, designed to provide a robust safety database for global regulatory submissions.

The company's financial performance reflects this intensified clinical activity. For the six months ended June 30, 2025, Tenax reported a net loss of $21.255 million, a notable increase from $7.374 million in the prior year. This rise in losses is directly attributable to increased investment in its pipeline. Research and development expenses surged by 136% to $11.804 million, driven by the ongoing LEVEL trial and preliminary work for LEVEL-2.

General and administrative expenses also saw a substantial 340% increase to $11.326 million, reflecting higher payroll, stock-based compensation, and capital market expenses associated with recent financings.

Despite these increased expenditures, Tenax maintains a robust liquidity position. As of June 30, 2025, the company held $105.462 million in cash and cash equivalents, with total current assets of $105.90 million. This strong cash balance is a direct result of successful financing activities, including a $25 million private placement in March 2025 and a $99.7 million private placement in August 2024. These capital raises have provided Tenax with a significant runway, with management stating confidence in funding operations through 2027. This funding extends well beyond the anticipated topline data readout for the LEVEL study, positioning the company to advance its registrational studies without immediate financing pressures.

Outlook, Guidance, and Remaining Risks

Tenax's outlook is firmly centered on the successful execution of its Phase 3 levosimendan program. Management anticipates completing LEVEL enrollment in H1 2026 and releasing topline data in H2 2026, while LEVEL-2 is on track to commence in 2025. The company intends to submit marketing authorization applications following the completion of both Phase 3 trials, aiming to meet regulatory requirements for approval in the U.S. and other geographies. The current cash position provides a solid foundation through 2027, supporting these critical milestones.

However, as with any development-stage pharmaceutical company, significant risks persist. The success of TNX-103 hinges entirely on positive clinical trial results, which are inherently uncertain. Delays in enrollment, unexpected safety signals, or a failure to meet primary endpoints could severely impact the investment thesis. Regulatory approval processes are also complex and can be lengthy, with no guarantee of success even with positive data. Furthermore, while currently well-funded, Tenax's ability to continue operations beyond 2027 and to support commercialization efforts will depend on securing additional financing through license income, warrant exercises, or further equity/debt offerings, which could lead to shareholder dilution or restrictive covenants. The company's reliance on third parties, including Orion Corporation for licensing and manufacturers/CROs for development, also introduces operational dependencies.

Conclusion

Tenax Therapeutics presents a compelling investment narrative, anchored by its focused development of levosimendan for PH-HFpEF – a condition with a profound unmet medical need. The company's strategic use of a de-risked asset with an established safety profile, coupled with a robust clinical plan involving two registrational Phase 3 studies, positions it for a potential first-in-class market entry. Recent capital raises have provided a strong financial runway through 2027, enabling the execution of these critical clinical milestones.

While the path to commercialization is fraught with inherent risks common to the biotechnology sector, Tenax's differentiated technology, clear market opportunity, and disciplined operational execution offer a unique value proposition. Investors should closely monitor the upcoming enrollment completion and topline data from the LEVEL study in 2026, as these events will serve as pivotal catalysts in determining the future trajectory of this promising cardiopulmonary innovator.