Tonix Pharmaceuticals (TNXP) Q4 2025 earnings summary

Executive summary

• Achieved FDA approval and commercial launch of TONMYA for fibromyalgia, the first new medicine for this indication in over 15 years, with over 4,200 prescriptions since launch in November 2025.

• Advanced clinical pipeline with IND clearance for TNX-102 SL in major depressive disorder and in-licensed TNX-4800 for Lyme disease prevention.

• Strengthened financial position with $207.6 million in cash and cash equivalents at year-end 2025 and completed a $20 million direct offering.

Financial highlights

• Full year 2025 net product revenue was $13.1 million, up from $10.1 million in 2024; Q4 2025 revenue was $5.4 million, up from $2.6 million in Q4 2024.

• Net loss for 2025 was $124.0 million ($14.57 per share), compared to $130.0 million ($176.60 per share) in 2024.

• Research and development expenses rose to $44.5 million in 2025 from $40.0 million in 2024; selling, general, and administrative expenses increased to $87.7 million from $40.1 million.

• Cash used in operations was $99.8 million for 2025, up from $60.9 million in 2024.

Outlook and guidance

• Plans to initiate U.S. field study for TNX-4800 in 2027, pending FDA clearance.

• Enrollment for Phase 2 HORIZON study of TNX-102 SL in major depressive disorder expected to begin mid-2026.

• Cash resources expected to fund operations into Q1 2027.