Tonix Pharmaceuticals (TNXP) investor relations material

Strategic focus and financial position

• Commercial-stage biotech focused on chronic and complex conditions with large unmet needs.

• $185.5M in cash and cash equivalents as of March 31, 2026, with no debt; expected runway into early Q2 2027.

• Diversified pipeline in CNS, infectious disease, immunology, and rare diseases.

• Priorities include driving TONMYA launch and advancing mid-stage clinical programs.

TONMYA for fibromyalgia: launch and differentiation

• First FDA-approved fibromyalgia treatment for adults in over 15 years, launched Nov 2025.

• Unique sublingual, non-opioid formulation with rapid absorption and robust efficacy.

• Two pivotal Phase 3 studies showed significant pain reduction and rapid, durable benefit.

• Patent protection extends to 2034, with potential exclusivity to 2044.

• Net sales reached $5.1M from launch to March 31, 2026, with over 11,000 prescriptions by May 2026.

Market opportunity and commercial execution

• Over 10 million U.S. fibromyalgia patients; only 2.7 million diagnosed and treated annually.

• High dissatisfaction with existing therapies; 85% of first-line treatments fail.

• TONMYA has 100% share of voice as the only marketed fibromyalgia prescription drug.

• Targeted sales force (~150 reps), focused HCP targeting, and robust patient support programs.

• Two commercial payer agreements, Medicaid coverage in most states, and major Medicare agreement effective 2027.