Core Insights - Tonix Pharmaceuticals Holding Corp. announced presentations on its preclinical immuno-oncology portfolio at the AACR Annual Meeting 2026, scheduled for April 17–22, 2026, in San Diego, California [1] Oral Presentation Details - The oral presentation titled "TFF2 deficiency amplifies IL-1β-driven inflammation and promotes aging-associated gastric tumor progression" will take place on April 21, 2026, from 2:30–4:30 p.m. PT [2] - Presenters include Shuang Li, MD, PhD, and Timothy C. Wang, MD, with Tonix co-authors Seth Lederman, MD, and Bruce L. Daugherty, PhD, MBA [2] Poster Presentation Details - The first poster presentation titled "In vitro characterization of fully human antagonistic anti-BTLA monoclonal antibodies" is scheduled for April 21, 2026, from 2:00-5:00 p.m. PT [3] - The second poster presentation titled "Pharmacokinetics of TNX-1700 in non-human primates and human FcRn/serum albumin transgenic mice" will occur on April 22, 2026, from 9:00 a.m.–12:00 p.m. PT [3] - Both presentations will be led by Bruce Daugherty, PhD, MBA [3] About TNX-1700 - TNX-1700 is a fusion protein of TFF2 and albumin, currently in preclinical development for treating gastric and colorectal cancer in combination with PD-1 blockade [4] - The drug is in the pre-Investigational New Drug (IND) stages of development and was in-licensed from Columbia University [4] Company Overview - Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on CNS and immunology treatments for high unmet medical needs [5] - The company’s marketed products include TONMYA for fibromyalgia, Zembrace® Symtouch® for acute migraines, and Tosymra® [5] - Tonix is also investigating TONMYA in Phase 2 clinical trials for major depressive disorder and acute stress disorder, and has a pipeline including TNX-2900 for Prader-Willi syndrome and monoclonal antibodies for Lyme disease prophylaxis and kidney transplant rejection [5]

Core Insights - Tonix Pharmaceuticals achieved FDA approval and launched TONMYA, the first new medicine for fibromyalgia in over 15 years, with over 1,500 healthcare providers prescribing it to approximately 2,500 patients by February 27, 2026 [2][4] - The company reported a net product revenue of approximately $13.1 million for the full year 2025, an increase from $10.1 million in 2024, with TONMYA contributing approximately $1.4 million from its launch until year-end [17][19] - Tonix has a robust clinical pipeline, including TNX-4800 for Lyme disease prevention and TNX-102 SL for major depressive disorder, with plans for further development and FDA discussions in 2026 [2][6][9] Commercial Updates - TONMYA was launched on November 17, 2025, and has shown favorable early prescription trends, with cumulative prescriptions totaling approximately 4,200 by February 27, 2026 [4][3] - The company has deployed a salesforce of approximately 90 members to support the commercialization of TONMYA and enhance awareness among healthcare providers and patients [2][4] Financial Highlights - As of December 31, 2025, Tonix had approximately $207.6 million in cash and cash equivalents, a significant increase from $98.8 million in 2024 [13][30] - The company completed a $20.0 million registered direct offering with Point72 in December 2025 to fund commercialization and pipeline development [14] - Research and development expenses for 2025 were approximately $44.5 million, reflecting increased investment in pipeline projects [18] Product Pipeline - TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, is set for FDA discussions regarding Phase 2/3 development in 2026 [6][9] - TNX-102 SL has received IND clearance for a Phase 2 study in major depressive disorder, with enrollment expected to begin in mid-2026 [9][12] - TNX-2900, targeting Prader-Willi syndrome, is planned for a Phase 2 trial initiation in Q1 2027 [11] Operational Highlights - The company has established partnerships for distribution and patient access programs to facilitate the commercialization of TONMYA [8] - Tonix is focusing on expanding payer engagement and establishing contracts with commercial payers while progressing discussions with Medicare and Medicaid [8]

Core Insights - Tonix Pharmaceuticals has launched TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia treatment, marking the first new prescription medicine for this condition in over 15 years [2][7] - The drug demonstrated statistically significant pain reduction in Phase 3 trials and was well tolerated by patients [1][2] Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company focused on central nervous system (CNS) and immunology treatments, addressing high unmet medical needs [8] - The company’s flagship product, TONMYA, is supported by a commercial infrastructure that includes other marketed products for acute migraine [8] Product Details - TONMYA is designed to provide rapid absorption and reduce the formation of the active metabolite norcyclobenzaprine, which can interfere with treatment durability [2][6] - The FDA approved TONMYA in August 2025 based on the results of the Phase 3 RESILIENT trial, which involved 457 patients [2][7] Clinical Trial Results - The Phase 3 RESILIENT trial showed a statistically significant reduction in mean daily pain at 14 weeks, with an increase in the number of patients achieving a 30% reduction in pain compared to placebo [2] - Common adverse events were mild and primarily related to oral cavity reactions, leading to low withdrawal rates from the study [2] Market Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., with a significant majority being women, and is characterized by chronic pain, fatigue, and sleep disturbances [5] - Current FDA-approved treatments for fibromyalgia are limited by side effects and high discontinuation rates, positioning TONMYA as a promising alternative [2][5]

Core Insights - Tonix Pharmaceuticals has launched TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia treatment, marking the first new prescription medicine for this condition in over 15 years [2][7] - The drug demonstrated statistically significant pain reduction in Phase 3 trials and was well tolerated by patients [1][2] Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company focused on central nervous system (CNS) and immunology treatments, with TONMYA as its flagship product [8] - The company is also developing other treatments, including those for major depressive disorder and acute stress disorder, alongside its immunology pipeline [8] Product Details - TONMYA is designed to provide rapid absorption and reduce the formation of the active metabolite norcyclobenzaprine, which can interfere with treatment efficacy [2][6] - The FDA approved TONMYA in August 2025 based on the results of the Phase 3 RESILIENT trial, which involved 457 patients [2][7] Clinical Trial Results - The Phase 3 RESILIENT trial showed a statistically significant reduction in mean daily pain at 14 weeks, with a notable increase in patients achieving a 30% reduction in pain compared to placebo [2] - Common adverse events were mild and primarily related to oral cavity reactions, leading to minimal study withdrawals [2] Market Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [5] - Current FDA-approved treatments for fibromyalgia have limitations related to side effects and adherence, positioning TONMYA as a promising alternative [2][5]

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].

Core Viewpoint - Tonix Pharmaceuticals has received approval to transfer its common stock listing from the Nasdaq Capital Market to the Nasdaq Global Select Market, effective March 3, 2026, which may enhance its visibility and liquidity among institutional investors [1][2]. Group 1: Company Overview - Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments for high unmet medical needs [3]. - The company's flagship product, TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in over 15 years [3]. - Tonix's CNS portfolio includes products for acute migraine and ongoing clinical trials for major depressive disorder and acute stress disorder [3]. Group 2: Market Position and Future Outlook - The uplisting to the Nasdaq Global Select Market signifies compliance with higher financial and corporate governance standards, potentially leading to increased trading volumes and access to institutional investors [2]. - The company aims to leverage this enhanced market position to drive growth and create shareholder value [2].

Core Insights - Tonix Pharmaceuticals Holding Corp. is participating in two investor conferences in March 2026, highlighting its engagement with the investment community [1][2]. Group 1: Upcoming Conferences - The company will present at the TD Cowen 46th Annual Healthcare Conference on March 4, 2026, with CEO Seth Lederman as the presenter [1]. - Management will be available for one-on-one meetings at the Barclays 28th Annual Healthcare Conference from March 10 to 12, 2026 [2]. Group 2: Company Overview - Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on treatments for central nervous system (CNS) and immunology conditions [3]. - The company's flagship product, TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in over 15 years [3]. - Tonix is advancing its CNS portfolio, including products for acute migraines and ongoing Phase 2 clinical trials for major depressive disorder and acute stress disorder [3]. - The company is also developing immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500 for kidney transplant rejection prevention [3].

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively engaging with investors through presentations and meetings at various conferences in January 2026, showcasing its innovative pipeline and marketed products in the biotechnology sector [1][2][3]. Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a robust pipeline of development candidates [4]. - The company markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic for fibromyalgia, which is the first new prescription medicine approved for this condition in over 15 years [4]. - Tonix also offers treatments for acute migraine, including Zembrace® SymTouch® and Tosymra® [4]. Product Pipeline - Tonix's development portfolio focuses on central nervous system (CNS) disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4]. - Key candidates include: - TNX-102 SL for acute stress reaction and major depressive disorder [4]. - TNX-1500, a Phase 2-ready monoclonal antibody for organ transplant rejection and autoimmune diseases [4]. - TNX-2900 for Prader-Willi syndrome, expected to start a pivotal Phase 2 study in 2026 [4]. - TNX-801, a vaccine for mpox and smallpox, and TNX-4800, a monoclonal antibody for Lyme disease prevention [4]. - TNX-4200, a broad-spectrum antiviral agent with a contract for up to $34 million from the U.S. Department of Defense [4]. Upcoming Conferences - Tonix's management will present at the Sachs Associates 9th Annual Neuroscience Innovation Forum on January 11, 2026, and at the Biotech Showcase 2026 on January 13, 2026 [2][3]. - The presentations will be led by Seth Lederman, M.D., the President and CEO of Tonix Pharmaceuticals [2][3]. Investor Relations - Investors interested in meetings with the company's management during the conferences can contact the provided email [4]. - Additional information about Tonix and its products can be found on the company's website [6].

Group 1: Offering Details - Tonix Pharmaceuticals has entered into a securities purchase agreement with Point72 for the purchase of 615,025 shares of common stock at an offering price of $16.26 per share, along with pre-funded warrants to purchase an equal number of shares at a price of $16.259 per warrant [1] - The gross proceeds from the offering are expected to be approximately $20.0 million before deducting fees and expenses [2] - The closing of the offering is anticipated to occur on or about December 30, 2025, pending customary closing conditions [1][2] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund the commercialization of marketed products, the development of the product pipeline, and for general working capital and corporate purposes [2] Group 3: Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [5] - The company markets FDA-approved TONMYA™, a non-opioid analgesic for fibromyalgia, and two treatments for acute migraine: Zembrace® SymTouch® and Tosymra® [5] - Tonix's development portfolio includes investigational drugs for various conditions, including TNX-102 SL for acute stress reaction and major depressive disorder, and TNX-1500 for organ transplant rejection and autoimmune diseases [5][6]

Core Insights - Tonix Pharmaceuticals is developing TNX-4800, a long-acting human monoclonal antibody targeting Borrelia burgdorferi, the causative agent of Lyme disease, with plans for clinical trials to begin in early 2027 [1][2][3] Group 1: Product Development - TNX-4800 is designed for annual seasonal use, administered subcutaneously in the spring to provide protection against Lyme disease throughout the tick season [1][3] - The company plans to meet with the FDA in 2026 to discuss Phase 2/3 development options, including a controlled human infection model (CHIM) study [2] - TNX-4800 has shown 95% effectiveness in preventing infection in non-human primates after exposure to infected ticks [3] Group 2: Market Potential - Approximately 70 million people in the U.S. living in Lyme disease-endemic areas could benefit from TNX-4800 as a pre-exposure prophylactic [1] - There are currently no FDA-approved vaccines or prophylactics available for Lyme disease in the U.S., highlighting a significant market opportunity for TNX-4800 [1][2] Group 3: Safety and Efficacy - TNX-4800 demonstrated rapid systemic absorption, with serum concentrations remaining quantifiable for over 200 days in 80% of volunteers at the lowest dose [4][5] - The mean half-life of TNX-4800 ranged from 62 to 69 days across different dosage groups, indicating prolonged efficacy [4] - Most adverse events reported were mild or moderate, and TNX-4800 was generally well tolerated [5] Group 4: Lyme Disease Overview - Lyme disease is the most common vector-borne infection in the U.S., with increasing incidence, particularly in the Northeast, mid-Atlantic, and upper-Midwest regions [6] - Typical symptoms include fever, headache, fatigue, and a characteristic skin rash, with untreated cases potentially leading to severe complications [6]