Tonix Pharmaceuticals (TNXP) Investor presentation summary

Business overview and financial position

• Three FDA-approved products: Tonmya (fibromyalgia), Tosymra (migraine), and Zembrace (migraine).

• Focus areas include CNS, infectious disease, immunology, and rare diseases.

• Fully integrated operations: research, development, manufacturing, and commercial.

• Cash position of ~$208M as of December 31, 2025, with no debt and expected runway into Q1 2027.

• Strategic partnerships with major universities and the US federal government.

Tonmya: Market opportunity and launch

• First FDA-approved fibromyalgia treatment in over 15 years, addressing a market of over 10 million US adults.

• Commercial launch began November 17, 2025, with $1.4M net sales in the first six weeks.

• Targeted approach: 90 sales reps focusing on 5% of HCPs who write 70% of fibromyalgia prescriptions.

• Robust patient access programs, copay assistance, and payer engagement strategies in place.

• Patent exclusivity extends to 2034, with potential for further extension.

Clinical efficacy and safety of Tonmya

• Demonstrated significant and durable pain reduction in pivotal Phase 3 trials (RELIEF and RESILIENT).

• Higher percentage of patients achieved ≥30% pain reduction versus placebo (47% vs 35% and 46% vs 27%).

• Generally well tolerated; most common adverse reactions were oral hypoesthesia, discomfort, and somnolence.

• No evidence of abuse potential or significant weight/blood pressure changes.

• Contraindicated with MAO inhibitors, certain cardiac conditions, and in pregnancy; caution with serotonergic drugs.