Tonix Pharmaceuticals (TNXP) TD Cowen 46th Annual Health Care Conference summary

Key product and market updates

• Focused on the launch of Tonmya, a first-in-class, sublingual treatment for fibromyalgia, approved in August and launched in November, with $1.4 million in net sales reported for the initial period.

• Tonmya targets disturbed sleep in fibromyalgia, addressing a high unmet need among an estimated 10 million U.S. adults, with potential expansion to long COVID patients.

• Commercial strategy includes 90 field reps targeting the top 5% of prescribers, robust patient access programs, and a WAC of $1,860/month.

• Existing migraine products Tosymra and Zembrace are being deprioritized in promotion.

• Company maintains $208 million in cash, no debt, and a simple capital structure.

Clinical and scientific insights

• Tonmya’s unique sublingual, transmucosal formulation enables durable pain relief, with clinical trials showing significant and clinically meaningful reductions in pain.

• Most common side effects are mild oral symptoms; no weight, blood pressure, cognitive, or sexual dysfunction changes observed.

• Tonmya is a non-opioid analgesic, aligning with healthcare priorities to reduce opioid use in chronic pain.

• Fibromyalgia is underdiagnosed and undertreated, with many patients receiving inappropriate opioid prescriptions.

• Educational efforts aim to improve prescriber knowledge and promote holistic treatment approaches.

Pipeline and future plans

• Advancing a Lyme disease prophylactic (licensed from UMass) with a planned human challenge study in 2027; aims for annual dosing.

• TNX-102 SL being developed for major depressive disorder (study starting mid-year) and acute stress disorder (in partnership with UNC, DoD-funded).

• Additional programs include a monoclonal antibody for kidney transplant (phase II starting mid-year) and an intranasal oxytocin for Prader-Willi syndrome (study planned for Q1 2027).

• Multiple partnerships with leading institutions support pipeline development.

• Company expects significant milestones in 2026 and 2027, including key clinical trial initiations.