UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Securities ...

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 is advancing TNX-1700, a combination therapy involving TFF2 and anti-PD1 antibody, showing potential in enhancing anti-tumor immune responses in gastric and colorectal cancers [1][2] - The company presented promising preclinical data at the AACR 2025 Annual Meeting, indicating that TFF2-mediated CXCR4 partial agonism is more effective than antagonism in reducing gastric cancer in animal models [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with a focus on developing therapies for pain management, immunology, and infectious diseases [7] - The company is also working on TNX-102 SL for fibromyalgia, which has received Fast Track designation from the FDA, with a PDUFA goal date of August 15, 2025 [7] Research and Development - TNX-1700 is being developed under a license from Columbia University, with Dr. Timothy Wang as the inventor, who has demonstrated the protective role of TFF2 against cancer development [3] - The research indicates that TFF2 can suppress immunosuppressive neutrophils (PMN-MDSCs) and enhance the activation of CD8+ T cells, which are crucial for anti-tumor immunity [2][3] Clinical Implications - The combination of TFF2 and anti-PD1 therapy has shown promise in reducing immunosuppression in the tumor microenvironment, potentially leading to improved treatment outcomes for patients with gastric cancer [2] - The correlation between TFF2 levels and PMN-MDSCs in gastric cancer patients suggests a potential biomarker for treatment efficacy [2]

Core Viewpoint - TNX-801 is a promising single-dose live virus vaccine in development to protect against mpox and smallpox, demonstrating positive preclinical efficacy and tolerability, particularly in immunocompromised animals [1][2][3]. Group 1: Vaccine Efficacy and Safety - TNX-801 has shown the ability to protect immunocompromised animals from lethal challenges with both clade IIa monkeypox virus and rabbitpox, with a demonstrated six-month durability of protection [1][2]. - The vaccine is well tolerated, with no spreading to blood or tissues observed even at high doses in immunocompromised animals [1][2]. - After a single dose, TNX-801 prevented clinical disease and lesion formation in non-human primates, indicating effective mucosal immunity and potential to block forward transmission [3][4]. Group 2: Market Need and Regulatory Context - The ongoing clade IIb and clade Ib mpox epidemics, declared by the WHO as Public Health Emergencies of International Concern, underscore the urgent need for additional vaccine options, particularly single-dose vaccines [2][4]. - TNX-801 aligns with the WHO's preferred target product profile, which emphasizes single-dose administration, durable protection, and stability at ambient temperature [2][4]. Group 3: Company Overview and Development Plans - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on developing therapies for public health challenges, including TNX-801 for mpox and smallpox [5]. - The company has received feedback from the FDA regarding the development of TNX-801 and is collaborating with the Kenya Medical Research Institute to plan a Phase I clinical study [3][4]. - Tonix's broader portfolio includes other candidates for CNS disorders and infectious diseases, highlighting its commitment to addressing significant health challenges [5].

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]

Agreement includes the use of Tonix's TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana's genetically engineered pig organs in xenotransplantation Establishes framework for Makana's kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), ("Tonix") a fully-integrated biophar ...

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].

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 Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL, which, if approved, would be the first new non-opioid analgesic for fibromyalgia in over 15 years [1][6] - The drug targets non-restorative sleep, a common symptom in fibromyalgia, and has a favorable tolerability profile [2][5] Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on CNS disorders and pain management, with TNX-102 SL as a priority product candidate [6] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [6] - Tonix also has a diverse portfolio, including products for acute stress reaction, cocaine intoxication, organ transplant rejection, and infectious diseases [6] 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 have been inadequate, leading to reliance on chronic opioids, which are often ineffective [2][3] - Fibromyalgia is recognized as a chronic overlapping pain condition, with a growing understanding of its mechanisms and treatment needs [3][4]

CHATHAM, N.J., April 02, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 Jones Trading Healthcare and Innovation Conference on Wednesday, April, 9, 2025, at 10:00 a.m. PT (1:00 p.m. ET) in Las Vegas, Nev. Investors interested in arranging a meeting with the ...

CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in ...