Tonix Pharmaceuticals (TNXP) investor relations material

Commercial execution and financial position

• Launched Tonmya, a sublingual tablet for fibromyalgia, in November 2025, marking the first new FDA-approved treatment for the condition in over 15 years.

• Achieved net sales of $5.1 million from launch through March 31, 2026, with over 11,000 prescriptions written by May 2026.

• Cash and cash equivalents totaled approximately $185.5 million as of March 31, 2026, with no debt and expected runway into early Q2 2027.

• Secured two commercial coverage agreements and broad Medicare and Medicaid access, covering over 52 million commercial lives and 75 million Medicaid lives.

Product innovation and clinical pipeline

• Tonmya is a non-opioid, sublingual formulation designed for long-term use, showing statistically significant pain reduction and rapid onset in pivotal Phase 3 trials.

• Proprietary eutectic formulation enables transmucosal absorption, bypassing first-pass liver metabolism and reducing exposure to active metabolites.

• Pipeline includes mid- and late-stage candidates for major depressive disorder, acute stress disorder, Lyme disease prevention, organ transplant rejection, Prader-Willi syndrome, and cocaine intoxication.

• Upcoming milestones include multiple Phase 2 study initiations and data readouts through 2027.

Market opportunity and unmet needs

• Fibromyalgia affects over 10 million people in the U.S., with high dissatisfaction among patients and providers due to limited efficacy and tolerability of existing therapies.

• Off-label opioid use remains prevalent despite lack of efficacy and risk of worsening pain sensitivity.

• Tonmya addresses a large, underserved market with a differentiated mechanism and robust efficacy and safety profile.