Tonix Pharmaceuticals (TNXP) investor relations material

Commercial and pipeline overview

• Successfully launched TONMYA for fibromyalgia, with net sales rising from $3.7M in Q1 2026 to $11M in Q2 2026, and sales force expanded to 150 reps.

• Achieved managed care access with two of three major PBM GPOs and one major managed Medicare contract, expected to cover 46% of Americans by January 2027.

• TONMYA differentiates itself by targeting disturbed sleep in fibromyalgia, offering a unique mechanism and favorable tolerability profile compared to older therapies.

• Early feedback highlights strong tolerability and life-changing benefits for some patients, with broader prescriber targeting beyond rheumatologists.

• Growth is currently linear, with a potential inflection point anticipated as access improves, especially with Medicare coverage in 2027.

Fibromyalgia market and product positioning

• Fibromyalgia remains poorly understood, with 3 million diagnosed and treated patients and 7 million undiagnosed, representing significant commercial upside.

• Recent diagnostic criteria and recognition of nociplastic pain have improved diagnosis and awareness, supporting TONMYA's positioning.

• TONMYA is designed for long-term use, with the most common side effect being mild oral sensations, not seen as a barrier to adherence.

• Prescriber targeting is data-driven, focusing on those with a history of fibromyalgia treatment, including rheumatologists, primary care, pain anesthesia, neurology, and psychiatry.

• Patient and physician feedback underscores tolerability and meaningful efficacy for some, though quantitative efficacy data is still emerging.

Pipeline highlights and clinical development

• TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, is set to enter phase II, targeting a large unmet need with 87 million Americans at risk.

• The antibody acts uniquely in the tick's midgut, providing protection within two days, and the phase II study will enroll 3,300 participants over two Lyme seasons.

• Site selection for the trial focuses on high-risk demographics, especially those 60 and older, to optimize event rates.

• A competitor's vaccine approval could help market education, but TNX-4800's rapid onset and tolerability may offer competitive advantages.

• TNX-1500 (mostiprubart), an anti-CD40 ligand antibody, is phase II ready for kidney transplant rejection and broader autoimmune indications, with a study planned at Massachusetts General Hospital.