Tonix Pharmaceuticals (TNXP) Investor presentation summary

Commercial portfolio

• TONMYA launched in the U.S. in Nov. 2025 as the first FDA-approved fibromyalgia treatment for adults in 15+ years; designed as a non-opioid, bedtime treatment for long-term use.

• Portfolio also includes migraine products Tosymra nasal spray and Zembrace SymTouch injection, acquired to establish commercial infrastructure.

• Total net product revenue was $13.5M in 2Q'26; TONMYA net sales were ~$11M, with 12,592 prescriptions and 197% QoQ growth.

• TONMYA access reached ~166M covered lives, or 53% of U.S. covered lives; two commercial agreements cover 61M lives and two managed Medicare agreements cover 32M lives.

TONMYA opportunity and differentiation

• U.S. fibromyalgia population exceeds 10M, while 2.7M patients are diagnosed and treated annually; average time from first complaint to diagnosis is ~6.42 years.

• Company-cited research found 85% of first-line treatments fail, 79% of patients use multiple therapies, and ~15M prescriptions are written annually across on- and off-label use.

• Proprietary sublingual cyclobenzaprine formulation is designed to bypass first-pass metabolism, reduce exposure to the active metabolite nCBP, and provide rapid absorption.

• Two pivotal Phase 3 studies showed statistically significant pain improvement vs. placebo at Week 14; ≥30% pain improvement occurred in 47% vs. 35% in RELIEF and 46% vs. 27% in RESILIENT.

• Commercial strategy targets ~25K HCPs, supported by ~150 sales representatives, patient access programs, managed-care engagement, and disease-awareness marketing.

Clinical pipeline

• TNX-102 SL for MDD: Phase 2 HORIZON is enrolling ~360 adults at ~30 U.S. sites; the candidate is designed to target disturbed sleep associated with depression.

• TNX-102 SL for acute stress disorder/reaction: investigator-initiated Phase 2 study with UNC; topline data expected mid-2027.

• TNX-4800 is a long-acting anti-OspA human monoclonal antibody for Lyme disease prevention; adaptive Phase 2 field study initiation is targeted for 1Q'27, pending FDA review and agreement on the protocol.

• TNX-4800 Phase 1 results showed a 62–69-day mean half-life; levels remained quantifiable for up to 12 months in most subjects, and the candidate was generally safe and well tolerated.

• Mosdaprubart (TNX-1500) kidney-transplant Phase 2 study is expected to start in 2H'26, pending FDA clearance; Phase 1 results showed a 34–38-day mean half-life at 10 and 30 mg/kg.