Tonix Pharmaceuticals Holding Q2 FY26 earnings call TNXP

Tonmaya, the first FDA-approved fibromyalgia treatment in over 15 years, achieved $11 million in net sales in Q2 FY26, representing 197% QoQ growth. This performance is attributed to strong patient and prescriber recognition, with prescriptions totaling 12,592 (up 100% QoQ) and refills increasing 207% QoQ. The company has secured market access covering 136 million lives (43% of US), expanding to 145 million (46%) by January 1, 2027, and is expanding its sales force to 150 reps by September 2026.

Tonix has randomized the first patient in the Horizon study, a potentially pivotal Phase 2 trial evaluating TNX-102SL as a first-line monotherapy for Major Depressive Disorder (MDD). The study targets approximately 360 adult patients, with the primary endpoint being the change from baseline in Madras total score at week six. This program leverages observations from previous studies where TNX-102SL nominally improved depression symptoms in fibromyalgia and PTSD patients, with a novel mechanism targeting disturbed sleep.

The company received positive FDA Type C meeting minutes for its planned adaptive Phase 2 study of TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, expected to begin enrollment in Q1 2027. TNX-4800 targets the OSP-A protein on Borrelia bacteria, which causes 99.9% of US Lyme cases, and is engineered for an extended half-life to provide rapid, long-duration protection within two days of dosing, unlike vaccines. The study will enroll approximately 3,300 participants from Lyme-endemic areas.

Medical affairs efforts are focused on raising awareness among healthcare providers regarding current fibromyalgia diagnostic criteria, emphasizing that it is not a diagnosis of exclusion. This updated understanding recognizes that fibromyalgia often co-occurs with other conditions like long COVID, chronic Lyme, and autoimmune diseases, and that these co-morbidities should not preclude a fibromyalgia diagnosis. Broader understanding is expected to grow the addressable patient population and facilitate earlier diagnosis, as it currently takes over six years on average for patients to be diagnosed.

Net product revenue for Q2 FY26 was $13.5 million, comprising $11 million from Tonmaya and $2.5 million from migraine products. R&D expenses increased to $19.4 million, primarily due to pipeline prioritization and increased headcount, while SG&A expenses rose to $36 million, driven by sales and marketing investments for Tonmaya and migraine product launches. The company ended the quarter with $176.2 million in cash and cash equivalents, expecting these resources, plus subsequent equity offerings, to fund operations into early Q2 2027.