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 ...

CHATHAM, N.J., Feb. 03, 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 that it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading on February 5, 2025. The reverse stock split is intended to increase the per sha ...

Company Updates - Tonix Pharmaceuticals appointed Gary Ainsworth as Vice President, Market Access, effective immediately Mr Ainsworth brings over two decades of industry and market access experience, including leadership roles at Eversana Intouch, Havas Gemini, Baxter International, Roche Laboratories, and Sanofi predecessor companies [1][2] - The U S Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for marketing authorization of TNX-102 SL for fibromyalgia management TNX-102 SL is a non-opioid, centrally-acting analgesic targeting a chronic pain condition that predominantly affects women [1][3] Product Pipeline - Tonix's development portfolio focuses on central nervous system (CNS) disorders, with TNX-102 SL as a priority candidate for fibromyalgia management The product candidate has completed two statistically significant Phase 3 studies and received FDA Fast Track designation [4] - The company is developing TNX-1300 (cocaine esterase) for cocaine intoxication, which has FDA Breakthrough Therapy designation and is supported by a grant from the U S National Institute of Drug Abuse and Addiction [4] - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) for preventing allograft rejection and treating autoimmune diseases [5] - The company is advancing TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox Additionally, Tonix secured a $34 million contract with the U S DoD's Defense Threat Reduction Agency (DTRA) to develop TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45 [5] Commercial Operations - Tonix Medicines, the company's commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for acute migraine treatment in adults [5] - The company operates a state-of-the-art infectious disease research facility in Frederick, Md [5]