Tonix Pharmaceuticals (TNXP) investor relations material

Commercial execution and financial highlights

• Achieved ~$11M net sales for TONMYA in 2Q'26, with 197% quarter-over-quarter growth and 12,592 prescriptions filled.

• $176.2M in cash and cash equivalents as of June 30, 2026, with no debt and expected runway into early Q2'27.

• TONMYA is the first FDA-approved fibromyalgia treatment for adults in over 15 years, launched in November 2025.

• Commercial infrastructure expanded through acquisition of migraine products, supporting CNS portfolio.

Product portfolio and pipeline

• TONMYA is a first-in-class, non-opioid, sublingual tablet for fibromyalgia, showing rapid onset, sustained efficacy, and a favorable safety profile.

• Pipeline includes TNX-102 SL for major depressive disorder (MDD) and acute stress disorder, TNX-4800 for Lyme disease prevention, and TNX-1500 for organ transplant rejection.

• Phase 2 studies for TNX-102 SL in MDD and TNX-4800 in Lyme disease prevention are enrolling or planned for 2027.

• Additional programs include TNX-1300 for cocaine intoxication and TNX-2900 for Prader Willi Syndrome, both advancing toward Phase 2 studies.

Market opportunity and patient need

• Over 10 million people in the U.S. have fibromyalgia, but only 2.7 million are diagnosed and treated annually; 85% of first-line treatments fail due to efficacy and tolerability issues.

• TONMYA addresses dissatisfaction with current therapies and high rates of off-label opioid use, offering a non-opioid alternative.

• Strategic marketing targets the 5% of HCPs who write 70% of fibromyalgia prescriptions, supported by a 150-rep sales force and robust patient access programs.