Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments addressing high unmet medical needs [2] - The company’s marketed products include TONMYA, the first new treatment for fibromyalgia in over 15 years, and acute migraine products Zembrace Symtouch and Tosymra [2] - Tonix is advancing a pipeline that includes investigational drugs for major depressive disorder, acute stress disorder, Prader-Willi syndrome, Lyme disease prophylaxis, and kidney transplant rejection [2] Upcoming Presentation - Seth Lederman, MD, the CEO of Tonix, will present at BIO-Europe Spring 2026 on March 24, 2026, from 1:30 to 1:45 p.m. WET in Lisbon, Portugal [1][2] - The presentation will take place in Presentation Theatre A [2] Product Development - TONMYA is currently being evaluated in Phase 2 clinical trials for its potential in treating major depressive disorder and acute stress disorder [2] - TNX-2900 is Phase 2 ready for treating Prader-Willi syndrome, a rare disease [2] - The immunology pipeline includes monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor aimed at preventing kidney transplant rejection [2]

Core Insights - Tonix Pharmaceuticals Holding Corp. announced a poster presentation for its product Tonmya™ (cyclobenzaprine HCl sublingual tablets) at the 2026 AAPM PainConnect Annual Meeting, highlighting its significance in treating fibromyalgia [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments, addressing areas of high unmet medical need [3]. - The company’s flagship medicine, Tonmya, is the first new treatment for fibromyalgia in over 15 years [3]. - Tonix's CNS commercial infrastructure supports marketed products, including acute migraine treatments Zembrace® SymTouch® and Tosymra® [3]. Product Development - Tonix is conducting Phase 2 clinical trials to evaluate Tonmya's potential in major depressive disorder and acute stress disorder [3]. - The company is advancing TNX-2900, which is Phase 2 ready for treating Prader-Willi syndrome, a rare disease [3]. - Tonix is also developing immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for preventing kidney transplant rejection [3].

Financial Performance & Pipeline - Axsome reported a total net product revenue of $121.5 million in 1Q 2025, representing a 62% year-over-year growth compared to 1Q 2024[16] - AUVELITY net product sales reached $96.2 million in 1Q 2025, reflecting an 80% year-over-year growth[16, 18] - SUNOSI net product revenue was $25.2 million in 1Q 2025, a 17% increase year-over-year[16, 18] - The company's cash and cash equivalents stood at $300.9 million as of March 31, 2025, expected to fund operations into cash flow positivity[16] - Axsome anticipates peak sales potential of $16.5 billion driven by current commercial and late-stage assets[13] Regulatory & Clinical Milestones - SYMBRAVO was approved in the U S for the acute treatment of migraine in January 2025, with commercial launch anticipated in June 2025[16, 17, 23] - An NDA for AXS-14 for fibromyalgia was submitted to the FDA[16] - A supplemental NDA submission for AXS-05 in Alzheimer's disease agitation is on track for 3Q 2025[16, 61] - An NDA submission for AXS-12 for cataplexy in patients with narcolepsy is anticipated in 2H 2025[16, 96] - Positive topline results were announced for the FOCUS Phase 3 trial of solriamfetol in ADHD and the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders[16, 70] Market & Therapeutic Areas - Approximately 7 million people in the U S are affected by Alzheimer's disease[56] - Agitation is reported in approximately 70% of people with Alzheimer's disease[58] - An estimated 22 million people in the U S are affected by ADHD, including approximately 7 million children aged 3-17 years old[7, 67] - Approximately 17 million people in the U S are affected by fibromyalgia[7, 101]