Tonix Pharmaceuticals (TNXP) investor relations material

Company overview and strategy

• Focused on developing innovative treatments for fibromyalgia, infectious diseases, immunology, and rare diseases.

• Achieved FDA approval and launch of a new fibromyalgia treatment, with internal development from concept to commercialization.

• Reported $11 million in net sales for the latest quarter, tripling from Q1, indicating strong market uptake.

• Evolved into a fully integrated organization, handling research through to commercialization.

• Current strategic focus is on expanding the launch of the lead fibromyalgia product through 2025.

Product differentiation and market positioning

• Lead product is a sublingual, non-opioid cyclobenzaprine targeting disturbed sleep in fibromyalgia, differentiating it from existing therapies.

• Only product tested under modern diagnostic criteria and rigorous FDA requirements for missing data.

• Unique eutectic formulation provides four years of stability and strong patent protection until 2034.

• Patents have withstood legal challenges in Europe, reinforcing exclusivity.

• Product is generally well-tolerated, addressing a key limitation of existing treatments.

Commercial performance and market access

• Achieved significant sequential growth in prescriptions and positive feedback from prescribers and patients.

• Marketing targets patients dissatisfied with prior therapies, with FDA approval for first-line use.

• Secured contracts with major pharmacy benefit managers and expanded sales force from 100 to 150, with full deployment expected in September.

• Access wins attributed to non-opioid status and the high cost burden of chronic pain.

• Product is positioned for long-term, nightly use in a chronic condition.