BERKELEY HEIGHTS, N.J., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully integrated, commercial biotechnology company, announced today that Tonix management will present and host investor meetings at the following January 2026 investor conferences. Sachs Associates 9th Annual Neuroscience Innovation Forum Company Presentation Presenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals Date: Sunday, January ...

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]

Core Insights - Tonix Pharmaceuticals is on track to potentially launch TNX-102 SL, a new non-opioid analgesic for fibromyalgia, with a PDUFA goal date set for August 15, 2025, marking the first new drug for this condition in over 15 years [1][2][4] - The company reported positive topline results from a Phase 1 study of TNX-1500, an anti-CD40L monoclonal antibody aimed at preventing kidney transplant rejection and treating autoimmune disorders [1][8] - As of March 31, 2025, Tonix had cash and cash equivalents of $131.7 million, sufficient to fund operations into the second quarter of 2026 [1][12][14] Product Development Highlights - TNX-102 SL is designed to improve sleep disturbances associated with fibromyalgia, with FDA Fast Track designation granted in 2024 [4][20] - The NDA for TNX-102 SL was accepted by the FDA based on two Phase 3 studies demonstrating significant pain reduction in fibromyalgia patients [4][20] - TNX-1500 has shown a favorable safety profile and pharmacokinetics, supporting its progression to a Phase 2 trial for kidney transplant recipients [8][6] Financial Overview - For Q1 2025, net product revenue was approximately $2.4 million, slightly down from $2.5 million in Q1 2024 [16] - Research and development expenses decreased to $7.4 million in Q1 2025 from $12.9 million in Q1 2024, primarily due to reduced clinical and manufacturing costs [17] - The net loss for Q1 2025 was $16.8 million, or $2.84 per share, compared to a net loss of $14.9 million, or $535.72 per share, in the same period of 2024 [19][24] Pipeline and Partnerships - TNX-801, a live-virus vaccine, is in development for mpox and smallpox, with positive preclinical efficacy data presented at the World Vaccine Congress [15][9] - The company has entered a collaborative research agreement with Makana Therapeutics to study TNX-1500 in combination with xenotransplantation [15] - Tonix is also developing TNX-1300 for cocaine intoxication, which has received Breakthrough Therapy designation from the FDA [7][6]