Tonix Pharmaceuticals (TNXP) Investor presentation summary

Mission and vision

• Focused on developing innovative therapies and vaccines for unmet needs in CNS, immunology/oncology, and infectious diseases.

• Utilizes broad in-house capabilities and creative collaborations to advance its pipeline.

Key programs and pipeline

• Lead candidate TNX-102 SL targets fibromyalgia, with FDA Fast Track and NDA submitted; PDUFA date set for August 15, 2025, and commercial launch targeted for Q4 2025.

• Additional programs include treatments for acute stress disorder, organ transplant rejection, autoimmune conditions, cancer, and infectious diseases.

• Existing commercial CNS products include Tosymra and Zembrace for acute migraine.

Market opportunity and unmet need

• Over 10 million U.S. adults affected by fibromyalgia, with high dissatisfaction and turnover on current therapies.

• No new FDA-approved fibromyalgia therapies in over 15 years; 85% of patients fail first-line therapy.

• High prescription volume and polypharmacy common among patients.