Tonix Pharmaceuticals (TNXP) Investor presentation summary

Commercial execution and financial position

• Launched Tonmya, the first FDA-approved fibromyalgia treatment for adults in over 15 years, in November 2025; net sales reached $5.1 million by March 31, 2026, with over 11,000 prescriptions written by May 2026.

• Maintains a strong cash position of $185.5 million as of March 31, 2026, with no debt and expected runway into early Q2 2027.

• Achieved commercial coverage agreements and Medicaid availability for Tonmya, with a major Medicare payer agreement effective January 2027.

Product innovation and clinical pipeline

• Tonmya is a non-opioid, sublingual cyclobenzaprine tablet with a unique eutectic formulation, offering rapid absorption and robust efficacy for fibromyalgia.

• Two pivotal Phase 3 studies demonstrated statistically significant pain reduction and a favorable safety profile for Tonmya.

• Pipeline includes mid-stage assets for major depressive disorder, acute stress disorder, Lyme disease prevention, organ transplant rejection, Prader-Willi syndrome, and cocaine intoxication, with multiple Phase 2 studies planned or enrolling in 2026–2027.

Market opportunity and unmet needs

• Fibromyalgia affects over 10 million people in the U.S., with high dissatisfaction and failure rates for existing therapies; Tonmya addresses a large, underserved market.

• High rates of off-label opioid use persist despite lack of efficacy and risk of harm, highlighting the need for non-opioid alternatives.

• No FDA-approved vaccines or prophylactics for Lyme disease; TNX-4800 aims to fill this gap with a long-acting monoclonal antibody.