Tenax Pulls LEVEL Results Forward to August

The Tip Desk · July 31, 2026 · 3 min read

The cardiopulmonary developer now expects topline data from its Phase 3 LEVEL trial in August 2026, with cash of $118.0 million as of June 30.

Tenax Therapeutics, Inc. (TENX), a Phase 3, development-stage pharmaceutical company developing levosimendan for pulmonary hypertension associated with heart failure with preserved ejection fraction, said it expects topline data from its Phase 3 LEVEL clinical trial in August 2026, earlier than the third-quarter window it had given in May.

President and Chief Executive Officer Chris Giordano said the company is approaching a moment it has been preparing for since it began developing a therapy for PH-HFpEF. In July, Tenax announced it plans to present LEVEL results in a Late-Breaking Clinical Science session at the European Society of Cardiology Congress, Aug. 28–31 in Munich, and that an abstract was submitted and accepted.

In May, after completing randomization of more than 230 patients in LEVEL at the end of the first quarter, the company had said it continued to anticipate sharing topline data in the third quarter of 2026. The July update compressed that timeline to August.

LEVEL-2, the second global pivotal trial of TNX-103, remains on the same enrollment path. Giordano said the team continues to activate sites and advance enrollment, with completion expected by the end of 2027. That outlook was unchanged from the prior-quarter update. LEVEL-2 began in December 2025.

Cash and cash equivalents were $118.0 million as of June 30, 2026. Proceeds of $13.4 million from exercises of previously issued warrants in the second quarter enabled the company to extend its cash runway; it now expects to fund operations through the second quarter of 2028, later than the prior guide of at least the first quarter of 2028.

Common shares outstanding were 31,949,785 as of June 30, 2026, compared with 9,314,130 as of Dec. 31, 2025. Additional paid-in capital was $514.6 million.

Research and development expenses were $12.9 million in the second quarter of 2026, up from $11.5 million in the first quarter, as LEVEL-2 costs continued after the trial began in December 2025. The increase was primarily attributable to higher clinical and preclinical development costs associated with LEVEL and LEVEL-2.

Selling, general and administrative expenses were $5.9 million in the second quarter. The rise reflected higher legal and professional fees and salary and benefit costs related to more personnel, partly offset by a decrease in stock-based compensation.

Net loss was $17.8 million for the second quarter of 2026, or $0.35 a share, compared with $11.5 million, or $0.27 a share, in the first quarter. Weighted average shares outstanding, basic and diluted, were 50,869,259.

Levosimendan is a K-ATP channel activator/calcium sensitizer being evaluated for PH-HFpEF. Tenax owns global rights to develop and commercialize the molecule, which has received market authorization in 60 countries for intravenous use in hospitalized patients with acutely decompensated heart failure and is not available in the United States or Canada. TNX-103, oral levosimendan, is the candidate in LEVEL and LEVEL-2.

Tenax is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, targeting PH-HFpEF, which is the most prevalent form of pulmonary hypertension globally and for which no product has been approved to date.

Giordano closed the update by thanking the team for advancing TNX-103 for patients. The next dated clinical event the company named is the August LEVEL readout and the ESC Late-Breaking session, with LEVEL-2 enrollment still targeted for completion by the end of 2027.