Tenax Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported cash and cash equivalents of $113.7 million as of September 30, 2026, an increase of $16.2 million from December 31, 2025.
• Utilized $4.3 million in cash during the third quarter of 2026.
• Research and development (R&D) expenses were $12.1 million for the quarter, up from $10.3 million in the same period in 2025.
• Selling, general and administrative (SG&A) expenses were $5.7 million for the quarter, down from $6.5 million in the same period in 2025.
• Reported a net loss of $16.7 million for the third quarter of 2026, compared to a net loss of $15.8 million in the third quarter of 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $53.1 million, compared to $39.9 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $50.2 million, compared to $37.1 million for the same period in 2025.
• Net loss per share (basic and diluted) was $(0.31) for the quarter ended September 30, 2026, compared to $(0.40) in the prior year period.
• Total current assets were $117.0 million as of September 30, 2026, compared to $104.2 million as of December 31, 2025.
• Total liabilities were $8.4 million as of September 30, 2026, compared to $7.2 million as of December 31, 2025.
• Total stockholders' equity was $108.7 million as of September 30, 2026, compared to $97.1 million as of December 31, 2025.

Guidance and Future Outlook:

• Expects cash runway to fund operations through fiscal 2028, subject to change pending the outcome of the FDA Type C meeting.
• Plans to publish the LEVEL-2 protocol design paper and provide further updates on levosimendan development in the first quarter of 2027.
• The current operating plan is subject to change based on regulatory feedback from the upcoming FDA Type C meeting.

Business Segments and Product Lines:

• The Phase 3 LEVEL clinical trial of TNX-103 (oral levosimendan) in patients with PH-HFpEF did not achieve its primary endpoint of improvement in 6-minute walk distance (6MWD) versus placebo in the overall population.
• Subgroup analyses identified a meaningful treatment effect in patients with the most advanced disease; those with a baseline 6MWD below the trial median of 333 meters showed a 26.3-meter improvement compared to placebo.
• Patients meeting specific enrichment criteria (baseline 6MWD of 100-300 meters, or 301-400 meters with RAVI ≥25 mL/m²) demonstrated a 34-meter improvement in 6MWD compared to placebo at Week 12.
• Prespecified analyses showed a 49% reduction in NT-proBNP and a 3.5 mmHg reduction in right ventricular systolic pressure (RVSP) in the overall population treated with levosimendan.
• Approximately 20 echocardiographic parameters improved with TNX-103 compared to placebo, with no significant arrhythmias observed.
• Enrollment in the ongoing Phase 3 LEVEL-2 trial has been temporarily paused to implement a protocol amendment based on predictive enrichment strategies derived from LEVEL data.
• TNX-103 is a first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated for PH-HFpEF, a condition for which no approved product exists to date.

Market and Competitive Landscape:

• Levosimendan has received market authorization in 60 countries for acutely decompensated heart failure, though it is not available in the United States or Canada.
• Tenax Therapeutics holds global rights to develop and commercialize levosimendan for the treatment of PH-HFpEF.
• The company aims to bring the first approved therapy to patients with PH-HFpEF.

Risks and Challenges:

• The LEVEL trial did not meet its primary endpoint, and there is a risk that subgroup and post hoc analyses may not be confirmed in LEVEL-2 or accepted by regulators, physicians, or investors.
• Enriching enrollment in LEVEL-2 may slow enrollment, reduce the commercial opportunity, or result in narrower labeling.
• There is a risk that the FDA may disagree with the revised development plan or amended LEVEL-2 design, or require additional trials or a larger safety database.
• If LEVEL-2 fails or regulators require additional trials, the company may be unable to continue development of TNX-103 and may need to pursue strategic alternatives.
• Risks include the potential for highly dilutive financing, securities litigation, and volatility in global economic and financial markets.

Management Commentary and Tone:

• CEO Chris Giordano stated that the company has taken necessary steps to ensure the LEVEL-2 protocol population will be enriched with patients demonstrating significant treatment benefit.
• CMO Stuart Rich noted that robust reductions in NT-proBNP and PAP support the hypothesis that levosimendan will provide meaningful chronic clinical effectiveness.
• Management shared topline LEVEL data with the FDA in mid-August and has been granted a Type C meeting to discuss the overall development of levosimendan in PH-HFpEF.
• The company remains focused on its mission to bring the first approved therapy to patients with PH-HFpEF.

Other Key Points:

• The Company has been granted a Type C meeting with the FDA to discuss the overall development of levosimendan in PH-HFpEF.
• The LEVEL-2 protocol amendment defines enrichment criteria based on baseline 6MWD and right atrial volume index (RAVI).
• The company reported a 49% reduction in NT-proBNP (nominal p<0.0001) and a 3.5 mmHg reduction in RVSP (nominal p=0.0045) in the overall trial population.
• TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment groups.
• The company expects to publish the LEVEL-2 protocol design paper in the first quarter of 2027.