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]

Core Insights - Tonix Pharmaceuticals will present at the World Vaccine Congress Washington 2025, focusing on a novel mpox vaccine and leading a panel discussion on vaccine development and biosecurity policy [1][2][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, and has received Fast Track designation from the FDA [4] - Tonix's CNS portfolio includes TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [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. DoD [4] Upcoming Events - The oral presentation will be led by Dr. Farooq Nasar on April 23, 2025, at 10:10 a.m., discussing a single-dose mpox vaccine [2] - A panel discussion moderated by Dr. Zeil Rosenberg will take place on the same day at 3:25 p.m., addressing mpox and smallpox threats [3]

Core Viewpoint - The collaboration between Tonix Pharmaceuticals and Makana Therapeutics aims to utilize Tonix's TNX-1500 monoclonal antibody in conjunction with Makana's genetically engineered pig organs to enhance organ compatibility and reduce rejection in xenotransplantation [1][2]. Group 1: Collaboration Details - Tonix and Makana have established a research agreement to study TNX-1500 in combination with Makana's human-compatible organs for organ failure treatment [1]. - The collaboration will support preclinical studies for kidney, heart, and islet cell transplant programs, aiming for regulatory filings for potential human use [1][2]. - The goal is to submit an investigational new drug application (IND) to the FDA for compassionate use in patients undergoing xenotransplantation [1]. Group 2: Product and Technology Insights - TNX-1500 is an investigational humanized monoclonal antibody targeting CD40L, which plays a crucial role in immune system activation and transplant immunomodulation [2][8]. - Makana's genetically engineered pigs, particularly the SLA DR knockout pig, have shown improved compatibility and potential for producing viable organs for transplantation [2][3][4]. - The collaboration aims to leverage the best-in-class pharmacokinetics and pharmacodynamics of TNX-1500, which has demonstrated effectiveness in preventing rejection in animal studies [2][7]. Group 3: Industry Context - The field of xenotransplantation faces challenges in organ compatibility and rejection, making this collaboration significant for advancing clinical applications [2][5]. - Makana's focus on antigen discovery and deletion, rather than relying on transgenic modifications, positions it favorably for future commercialization of xenotransplantation products [6][5]. - The partnership is expected to streamline the development of safer and more effective transplantation solutions, addressing the critical shortage of available human organs [2][4].