TONIX PHARMACEUTICALS HOLDING CORP. 8-K EXHIBIT 99.01 Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejectio ...

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 ...

FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund o ...

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]

TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses CHATHAM, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding C ...

CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company's presentation will be available under the Scientific P ...

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 biopharmaceutical company with marketed products and a pipeline of development candidates, and Makana Therapeutics, Inc. ("Makana"), a global leader in the field of xenotransplantatio ...

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 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 ...