Tenax Therapeutics awaits Phase 3 LEVEL readout as R&D spend doubles
Tenax Therapeutics has reported its second-quarter 2026 financial results as the Chapel Hill, North Carolina-based company approaches what its chief executive described as an inflection point: topline data from the Phase 3 LEVEL trial of oral levosimendan (TNX-103) in pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), expected before the end of August.
The company confirmed that the LEVEL results have been accepted for presentation in a late-breaking clinical science session at the European Society of Cardiology Congress 2026, scheduled for 28–31 August in Munich. That acceptance underlines the clinical community's interest in the readout, though it does not signal anything about outcome.
Financial position
Tenax reported cash and cash equivalents of $118.0 million at 30 June 2026, up from $97.6 million at the end of 2025. The increase partly reflects $13.4 million raised in the quarter through exercises of previously issued warrants. The company now says it expects its cash to fund operations through the second quarter of 2028, providing a runway that should cover both the LEVEL readout and completion of enrolment in the follow-on Phase 3 study, LEVEL-2.
Research and development expenses more than doubled year-on-year, rising to $12.9 million in Q2 2026 from $6.1 million in Q2 2025. The company attributed the increase to costs associated with running two simultaneous Phase 3 trials. LEVEL-2 began in December 2025 and is expected to complete enrolment by the end of 2027. SG&A costs were broadly flat at $5.9 million versus $5.7 million a year earlier. Net loss for the quarter widened to $17.8 million from $10.9 million.
President and chief executive Chris Giordano said the team had been "preparing since we began developing a therapy uniquely suited for PH-HFpEF" and pointed to the forthcoming readout as the culmination of that work.
Market context
PH-HFpEF is a condition for which no therapy has received regulatory approval to date, making it an area of high unmet need and significant commercial interest. Levosimendan itself is not a new molecule: it has market authorisation in around 60 countries as an intravenous treatment for acutely decompensated heart failure, though it remains unapproved in the United States and Canada in any indication. Tenax holds global rights to develop and commercialise the compound in PH-HFpEF, which is described by the company as the most prevalent form of pulmonary hypertension worldwide.
The cardiopulmonary space more broadly has seen renewed activity from both established pharmaceutical companies and clinical-stage biotechs seeking to address HFpEF, a condition historically resistant to pharmacological intervention. Several companies are pursuing different mechanistic approaches, and a positive LEVEL readout would considerably strengthen the case for levosimendan's K-ATP channel activator and calcium-sensitiser mechanism in this patient population.
The August ESC presentation will be closely watched by cardiologists and investors alike. A positive result would set the stage for regulatory filings, while a negative outcome would place significant pressure on the LEVEL-2 programme and the company's broader development thesis. With the cash runway extending to mid-2028, Tenax has sufficient capital to pursue the regulatory path should the data support it, but the next few weeks represent the most consequential milestone in the company's recent history.