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Tonix Pharmaceuticals Holding (TNXP) investor relations material
Tonix Pharmaceuticals Holding Stifel 2025 Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Financial and operational highlights
Ended September with $190 million in cash, no debt, and a simple cap table; cash runway extends into Q1 2027, fully funding the product launch.
Commercial launch of newly approved fibromyalgia treatment Tonmya set for before end of November, with experienced sales team and omnichannel prescriber engagement.
Tonmya added to existing wholesaler and specialty pharmacy contracts; robust patient access and support services planned at launch.
25,000 healthcare providers write 70% of fibromyalgia prescriptions; 90 sales reps to target 70% of these prescribers.
Recent acquisition of two acute headache products provided commercial foundation for Tonmya launch.
Product and market insights
Tonmya is the first new fibromyalgia drug approved in over 15 years, with unique sublingual cyclobenzaprine formulation and patent exclusivity until 2034.
Addresses significant unmet need: 10 million Americans affected, only 3 million diagnosed and treated; high dissatisfaction with current therapies and high off-label opioid use.
Tonmya’s efficacy demonstrated by higher responder rates in clinical trials and favorable tolerability profile, with minimal withdrawal due to side effects.
Commercial strategy includes proportional pricing for different patient groups and early prescriber outreach.
Pipeline and R&D updates
Multiple pipeline programs advancing: TNX-102 SL for acute stress disorder (enrolling), major depressive disorder (study starts next summer), and prior PTSD studies provided strong mechanistic rationale.
Anti-CD40 ligand antibody completed phase 1, phase 2 kidney transplant study to start in first half of next year in partnership with Mass General Hospital.
TNX-4800, a long-acting antibody for Lyme disease, licensed from University of Massachusetts, phase 2 ready, offers immediate and season-long protection.
Intranasal oxytocin/magnesium for Prader-Willi syndrome to enter pivotal study in second half of next year, supported by compelling animal data.
Next Tonix Pharmaceuticals Holding earnings date
Next Tonix Pharmaceuticals Holding earnings date
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