Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biopharmaceutical company focused on pain management therapies and vaccines for public health challenges [4] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [4] Product Development - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, with a PDUFA goal date set for August 15, 2025, which could mark the first new treatment option for fibromyalgia patients in 15 years [2][4] - TNX-102 SL has received Fast Track designation from the FDA and is also being developed for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [4] - Other notable products in development include TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [4] Financial and Strategic Partnerships - Tonix has secured a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [4]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively engaging with investors through a virtual presentation, highlighting its biopharmaceutical pipeline and recent developments in its product candidates [1][2]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on pain management therapies and vaccines for public health challenges [4]. - The company is advancing TNX-102 SL, a candidate for fibromyalgia management, with a New Drug Application (NDA) submitted based on two significant Phase 3 studies, and a PDUFA goal date set for August 15, 2025 [4]. - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management and is also being studied for acute stress reactions and disorders [4]. - The CNS portfolio includes TNX-1300, a biologic in Phase 2 for cocaine intoxication, which has FDA Breakthrough Therapy designation [4]. - Tonix's immunology portfolio features TNX-1500, a monoclonal antibody for organ transplant rejection and autoimmune diseases, which has completed a positive Phase I trial [4]. - The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. Department of Defense [4]. Upcoming Events - Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present at the Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 3:30 p.m. ET [1]. - Investors can pre-register for the event and will have the opportunity to ask questions in real-time [2][3].

Core Points - The World Health Organization (WHO) has declared the spread of new clade Ib Mpox a public health emergency of international concern (PHEIC), marking the second such declaration in two years [1][2] - Tonix Pharmaceuticals has received a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801, a vaccine for mpox and smallpox [1][2] - TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox, requiring only a single dose for long-term protection and showing better tolerability compared to traditional vaccines [2][3] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on pain management therapies and vaccines for public health challenges [3] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [3] - Tonix's portfolio includes various candidates targeting CNS disorders, immunology, and infectious diseases, including TNX-801 for mpox and smallpox [3] Market Potential - TNX-801 addresses a significant global unmet need for mpox prevention and control, positioning the company to potentially impact public health positively [2][3] - The MCDC grant will facilitate comprehensive market analyses and commercialization planning for TNX-801 in both private and government markets [1][2]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively engaging with investors and showcasing its product pipeline, particularly focusing on its lead candidate TNX-102 SL for fibromyalgia management, with a PDUFA goal date set for August 15, 2025 [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company that develops therapies for pain management and vaccines addressing public health challenges [3]. - The company’s development portfolio emphasizes central nervous system (CNS) disorders, with TNX-102 SL being a priority candidate for fibromyalgia [3]. Product Pipeline - TNX-102 SL has been submitted for NDA based on two statistically significant Phase 3 studies and has received Fast Track designation from the FDA [3]. - The product is also being explored for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3]. - Other notable candidates include TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [3]. - Tonix is developing TNX-801, a vaccine for mpox, and has secured a contract with the U.S. Department of Defense for up to $34 million to develop TNX-4200, a broad-spectrum antiviral [3]. Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch and Tosymra for the treatment of acute migraine in adults [3].

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, showing statistically significant pain reduction in two Phase 3 studies [1][2] - The FDA has set a PDUFA goal date of August 15, 2025, for TNX-102 SL's marketing authorization, potentially making it the first new treatment for fibromyalgia in over 15 years [1][2] - TNX-102 SL targets non-restorative sleep, which is linked to pain reduction, and is designed to have a durable effect lasting up to three months [2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and CNS disorders [6] - The company has a pipeline that includes TNX-102 SL for fibromyalgia and other candidates for various conditions, including acute stress reaction and cocaine intoxication [6][7] - Tonix's product candidates are investigational and have not yet established efficacy and safety [8] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, fatigue, and cognitive dysfunction [3][4] - Current treatments for fibromyalgia have been inadequate, leading to many patients being prescribed chronic opioids, which are often ineffective [2][4] - Fibromyalgia is recognized as a chronic overlapping pain condition, with a growing understanding of its mechanisms and treatment needs [4]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. reported preliminary financial results for the year ended December 31, 2024, highlighting a strong cash position and upcoming FDA decision on TNX-102 SL for fibromyalgia management. Financial Summary - The company had approximately $98.8 million in cash and cash equivalents as of December 31, 2024, which is expected to fund operations into the first quarter of 2026 [5][2] - Net cash used in operating activities was approximately $60.9 million, a decrease from $102.0 million in the prior year [5] - Capital expenditures were approximately $0.1 million, significantly lower than $29.1 million for the prior year [5] - The net operating loss was approximately $126.6 million, including non-cash impairment charges of approximately $59.0 million, compared to a net operating loss of $116.7 million in the prior year [5] - Net revenue from marketed products was approximately $10.1 million, an increase from $7.8 million in the prior year [5] Debt Status - The company is now debt-free after repaying a mortgage with JGB Capital and related parties [5] Product Development - TNX-102 SL, a product candidate for fibromyalgia, has a PDUFA goal date of August 15, 2025, for FDA marketing authorization [3][6] - The FDA has granted Fast Track designation to TNX-102 SL for fibromyalgia management [6] - The company is also developing TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases [6] Market Position - Tonix Pharmaceuticals is focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio centered on CNS disorders [6]

Core Insights - Tonix Pharmaceuticals announced positive topline results from its Phase 1 trial of TNX-1500, supporting the advancement to a Phase 2 trial for preventing kidney transplant rejection [1][2][4] - TNX-1500 demonstrated effective immune modulation by blocking primary and secondary antibody responses at doses of 10 mg/kg and 30 mg/kg [2][8] - The drug exhibited a favorable safety profile, with no serious adverse events reported [3][4] Group 1: Study Results - TNX-1500 was administered intravenously at doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg, with 26 participants enrolled [3] - The mean half-life of TNX-1500 was found to be 19.6 days at 3 mg/kg, 37.8 days at 10 mg/kg, and 33.7 days at 30 mg/kg, supporting monthly dosing [8] - The only treatment-emergent adverse event was mild aphthous ulcer, with no thromboembolic events reported [3][4] Group 2: Future Development - The company plans to discuss the Phase 1 results with the U.S. FDA in an End-of-Phase 1 meeting to align on the Phase 2 study [4] - TNX-1500 is being developed not only for kidney transplant rejection but also for autoimmune diseases and graft-versus-host disease [5][7] Group 3: Competitive Landscape - TNX-1500 is positioned as a next-generation anti-CD40L monoclonal antibody, designed to improve safety compared to first-generation therapies like ruplizumab [2][5] - The drug's design aims to preserve therapeutic activity while reducing the risk of thrombosis associated with earlier treatments [2][5]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively engaging with investors and presenting its pipeline of biopharmaceutical products at the upcoming BIO CEO & Investor Conference, highlighting its focus on pain management and CNS disorders [1][2][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges [3]. - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [3]. - TNX-102 SL has received Fast Track designation from the FDA and is also being developed for acute stress reaction and acute stress disorder [3]. Product Pipeline - Tonix's CNS portfolio includes TNX-1300, a biologic in Phase 2 development for cocaine intoxication, which has FDA Breakthrough Therapy designation [3]. - The immunology development portfolio includes TNX-1500, targeting CD40-ligand for organ transplant rejection and autoimmune diseases [3]. - The company is developing TNX-801, a vaccine for mpox, and has secured a contract with the U.S. DoD for up to $34 million to develop TNX-4200, broad-spectrum antiviral agents [3]. Commercial Operations - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for the treatment of acute migraine in adults [3].

Core Insights - Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on pain management therapies and vaccines for public health challenges, with a significant emphasis on central nervous system (CNS) disorders [3] Group 1: Company Overview - Tonix Pharmaceuticals is advancing TNX-102 SL for fibromyalgia management, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025, for marketing authorization [3] - The FDA has granted Fast Track designation to TNX-102 SL for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] - Tonix's CNS portfolio includes TNX-1300, a biologic in Phase 2 development for cocaine intoxication, which has received FDA Breakthrough Therapy designation [3] - The immunology development portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand for organ transplant rejection and autoimmune diseases [3] - Tonix is developing a vaccine for mpox, TNX-801, and has a contract with the U.S. Department of Defense for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [3] Group 2: Market Presence - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for acute migraine treatment in adults [3][7] - Zembrace and Tosymra are not intended for migraine prevention and are not approved for use in children under 18 years of age [8]

Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development Tonix is Preparing for Potential Launch of TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025 CHATHAM, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the promotion of ...