BERKELEY HEIGHTS, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced that the management team will participate in two upcoming investor conferences in March 2026: TD Cowen 46th Annual Healthcare ConferenceCompany PresentationPresenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix PharmaceuticalsDate: Wednesday March 4, 2026Place: Boston Marriott Cop ...

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]

Core Insights - Tonix Pharmaceuticals has received FDA clearance for the IND application of TNX-102 SL, a sublingual tablet formulation for treating major depressive disorder (MDD) in adults, with plans to initiate a pivotal Phase 2 HORIZON study in mid-2026 [1][2][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on central nervous system disorders, immunology, and infectious diseases, and markets FDA-approved products including TONMYA for fibromyalgia [7][8] - The company is developing TNX-102 SL not only for MDD but also for other indications such as Long COVID, PTSD, and agitation in Alzheimer's disease [5][7] Clinical Development - The Phase 2 HORIZON study will be a 6-week, randomized, double-blind, placebo-controlled trial involving approximately 360 patients across 30 U.S. sites, targeting adults aged 18 and older experiencing moderate to severe MDD [2][4] - The primary endpoint of the study is the change in MADRS total score from baseline at Week 6, with secondary endpoints including global impression scores and measures of sleep disturbance [2][4] Mechanism of Action - TNX-102 SL is designed to address disturbed sleep associated with depression, utilizing a novel mechanism of action that differentiates it from traditional antidepressants [3][5] - The formulation allows for rapid absorption and minimizes the production of the active metabolite, potentially reducing side effects commonly associated with traditional antidepressants [5][6] Market Need - Over 21 million adults in the U.S. experience a major depressive episode annually, highlighting the urgent need for effective and well-tolerated treatment options [4][5] - Many existing antidepressants are not adequately effective for all patients, and side effects often lead to discontinuation of treatment, underscoring the demand for innovative therapies [4][5]

Core Insights - Tonix Pharmaceuticals is anticipating FDA approval for TNX-102SL for fibromyalgia by August 15, 2025, which would mark the first new drug for this condition in over 16 years [1][2] - The company reported a cash position of $125.3 million as of June 30, 2025, which is expected to fund operations into the third quarter of 2026 [1][8][9] - Recent Phase 3 trial results for TNX-102SL demonstrated statistically significant pain reduction in fibromyalgia patients, supporting the ongoing New Drug Application (NDA) review [5][10] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges, with a strong emphasis on central nervous system disorders [15] - The company has a diverse pipeline, including TNX-102SL for fibromyalgia and acute stress reactions, TNX-1500 for organ transplant rejection, and TNX-801 as a vaccine candidate [15][6] Financial Performance - For the second quarter of 2025, Tonix reported net product revenue of approximately $2.0 million, a slight decrease from $2.2 million in the same period of 2024 [10] - Research and development expenses increased to $10.8 million in Q2 2025 from $9.7 million in Q2 2024, primarily due to heightened clinical and manufacturing costs [11] - Selling, general, and administrative expenses rose significantly to $16.2 million in Q2 2025, compared to $7.5 million in Q2 2024, reflecting increased spending on pre-launch activities for TNX-102SL [12] Pipeline Developments - The company is advancing TNX-102SL for acute stress reaction and acute stress disorder, with the first patient dosed in the OASIS trial funded by the U.S. Department of Defense [4][15] - TNX-1500 has shown positive Phase 1 results and is being prepared for a Phase 2 study targeting kidney transplant rejection [6] - TNX-801 has demonstrated durable protection in animal models against mpox and rabbitpox, supporting its potential as a vaccine candidate [6] Market Position - In June 2025, Tonix was added to the Russell 3000® and Russell 2000® Indexes, enhancing its visibility among institutional investors as it approaches key regulatory milestones [1][13]

Core Insights - Tonix Pharmaceuticals Holding Corp. presented new findings on TNX-801, a recombinant horsepox live virus vaccine, demonstrating its potential for durable immunity against mpox and smallpox with significantly reduced virulence compared to traditional vaccines [1][2][3] Group 1: TNX-801 Vaccine Development - TNX-801 is shown to be up to 100,000-fold less virulent than live smallpox vaccine strains, providing robust immunogenicity and protection for over one year in animal studies [1][2] - Subcutaneous administration of TNX-801 offers equivalent protection to traditional percutaneous methods, potentially reducing risks of administration-site infections and scarring [2][3] - Preclinical studies indicate that a single dose of TNX-801 generates strong antibody responses across various animal models, including immunocompromised subjects, with all vaccinated macaques surviving lethal mpox challenges [2][3] Group 2: Strategic Importance and Future Directions - The vaccine's unique risk-benefit profile may make it a critical tool for public health, particularly in response to mpox outbreaks and potential smallpox threats [2][3] - Tonix Pharmaceuticals aims to advance TNX-801 into clinical evaluation, focusing on subcutaneous delivery to streamline vaccination processes [2][3] - The ongoing classification of mpox as a public health concern by organizations like the WHO and CDC underscores the importance of developing effective vaccines like TNX-801 [3] Group 3: Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [4] - Tonix's infectious disease portfolio includes TNX-801 and TNX-4200, the latter being a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. Department of Defense [4]

Core Insights - The combination treatment of mTNX-1700 with anti-PD1 antibody has shown increased survival and decreased metastases in animal models of gastric cancer compared to anti-PD1 treatment alone [1][3] - mTNX-1700 activates cancer-killing CD8+ T cells and limits neutrophil-mediated immune evasion, indicating its potential in overcoming resistance to anti-PD-1 immunotherapy [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, focusing on immunology and oncology [1][7] - The company is developing TNX-1700, a fusion protein for the treatment of gastric and colorectal cancers, under a license from Columbia University [4][5] Research Findings - The study published in Cancer Cell demonstrates that mTNX-1700 in combination with anti-PD-1 therapy shrank primary tumors, reduced liver and lung metastases, and increased survival in mouse models [2][3] - The research highlights the role of Trefoil Factor 2 (TFF2) in reducing immunosuppressive neutrophils and enhancing anti-tumoral CD8+ T cell responses [3][4] Future Development - Tonix Pharmaceuticals aims to further develop TNX-1700 to address the challenges of anti-PD-1 resistant cancers, with ongoing studies to identify potential clinical biomarkers [2][3] - The collaboration with Columbia University is expected to enhance understanding of TFF2's role in the tumor microenvironment and its impact on immunotherapy resistance [3][4]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges [5] - The company is advancing TNX-102 SL, a product candidate for the management of fibromyalgia, with a PDUFA goal date of August 15, 2025, for marketing authorization [5] - Tonix's development portfolio includes biologics for organ transplant rejection, autoimmunity, and cancer, as well as vaccines for infectious diseases [5] Market Position - Tonix Pharmaceuticals will be added to the Russell 3000® Index and automatically included in the small-cap Russell 2000® Index as part of the 2025 Russell indexes reconstitution [1][3] - The Russell indexes are widely used by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them as of June 2024 [3] Strategic Goals - The inclusion in the Russell Indexes is expected to enhance the company's visibility and awareness as it progresses towards potential FDA approval for TNX-102 SL [3] - The company is also developing TNX-4200, a broad-spectrum antiviral agent, under a contract with the U.S. Department of Defense for up to $34 million over five years [5]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges [8] - The company is advancing TNX-102 SL, a product candidate for managing fibromyalgia, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies [8] - TNX-102 SL has received Fast Track designation from the FDA for the management of fibromyalgia and is also being developed for acute stress reaction and acute stress disorder [8] Clinical Trial Details - The OASIS trial, an investigator-initiated Phase 2 trial, aims to evaluate TNX-102 SL's potential to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) [2][3] - The trial is sponsored by the University of North Carolina (UNC) and supported by a $3 million grant from the U.S. Department of Defense [2][3] - Approximately 180 motor vehicle collision (MVC) trauma survivors will be enrolled in the trial, which will randomize participants to receive either TNX-102 SL 5.6 mg or a placebo for two weeks [3] Market Need and Background - There is a significant unmet need for treating ASR after traumatic events, with about 60% of men and 50% of women in the U.S. experiencing at least one trauma in their lives [5] - One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluations after trauma exposures [5] - Currently, no medication is available to treat the initial reaction to traumatic events and support long-term health, which could prevent the development or worsening of ASD and PTSD [5] Drug Mechanism and Composition - TNX-102 SL is a non-opioid investigational drug designed for chronic use, formulated as a sublingual tablet of cyclobenzaprine hydrochloride for bedtime dosing [6][7] - The formulation aims to improve sleep quality and manage fibromyalgia symptoms by targeting non-restorative sleep [6][7] - Patents for TNX-102 SL's formulation provide market protection until 2034, with successful maintenance of its European Patent [7] Research Initiatives - The OASIS trial builds upon the knowledge and infrastructure from the UNC-led AURORA initiative, a $40 million national research effort to improve understanding and recovery from traumatic events [4] - AURORA is supported by funding from the National Institutes of Health (NIH) and partnerships with leading tech companies [4]