TONIX PHARMACEUTICALS HOLDING CORP. 8-K EXHIBIT 99.01 Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies Granted Fast Track Designation by FDA in July 2024 for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women Expect FDA decision in December 2024 on TNX-102 SL ...

New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals TNX-801, has characteristics that align closely with the World Health Organization’s (WHO) preferred target product profile (TPP) criteria for mpox vaccines WHO-declared public health emergency of international concern (PHEIC)1-4: Mpox cases of the new clade Ib mpox detected in Sweden, Thailand, Singapore ...

CHATHAM, N.J., Oct. 25, 2024 (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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Wednesday, October 30, 2024, at 9:30 a.m. ET, and host investor meetings. The conference is being held at the Mandarin Oriental, New York in New ...

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral program TNX-4200 ...

New patent expected to provide market exclusivity into 2036 Zembrace® SymTouch® (sumatriptan succinate injection) 10mg is indicated for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 27, 2024 (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 United States Patent and Trademark Office issued U.S. Patent No. 12,097,18 ...

World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years Worldwide availability and affordability of single-dose mpox vaccine with durable protection will be required to address global health emergency The newest Clade 1 strain represents a new global threat with mortality up to 10% Bilthoven Biologicals to develop manufacturing processes in preparation for potential GMP manufacturing CHATHAM, ...

Tonix Pharmaceuticals Holding Corp. 8-K Exhibit 99.01 Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024 FDA granted Fast Track designation for TNX-102 SL for fibromyalgia Commercial planning continues for U.S. launch of TNX-102 SL, a potential new first-line, centrally-acting, non-opioid analgesic for the management of ...

Core Insights - Tonix Pharmaceuticals is on track to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia in the second half of 2024, having completed successful pre-NDA meetings with the FDA [1][4] - The FDA has granted Fast Track designation for TNX-102 SL, indicating its potential to address an unmet medical need in treating fibromyalgia [2][4] - The company has received a contract from the U.S. Department of Defense for up to $34 million over five years to develop a broad-spectrum antiviral drug [1][12] Product Development Highlights - TNX-102 SL is a centrally-acting, non-opioid analgesic intended for the management of fibromyalgia, with a once-daily administration at bedtime [3] - The company is also advancing TNX-4200, a broad-spectrum antiviral program, supported by the DoD contract [2][12] - TNX-801, a vaccine in development for mpox, has shown positive preclinical efficacy, providing immune protection against lethal challenges [14] Financial Overview - As of June 30, 2024, Tonix had $4.2 million in cash and cash equivalents, down from $24.9 million at the end of 2023 [19] - Net product revenue for the second quarter of 2024 was approximately $2.2 million, with a cost of sales of about $3.4 million [20] - The net loss available to common stockholders for the second quarter of 2024 was $78.8 million, compared to a net loss of $28.4 million for the same period in 2023 [23] Market Strategy and Research - Tonix is collaborating with EVERSANA to assess the U.S. market opportunity for TNX-102 SL, indicating a high level of physician interest in the product [5] - The company plans to conduct a Phase 2 trial for TNX-102 SL to treat Acute Stress Disorder, supported by a $3 million contract from the DoD [5][6] - TNX-1300, a biologic for cocaine intoxication, is expected to enter Phase 2 clinical studies in the third quarter of 2024 [6] Pipeline and Future Prospects - The company has a diverse pipeline including TNX-1500 for organ transplant rejection and autoimmune disorders, and TNX-2900 for Prader-Willi syndrome [9][10] - Tonix's immunology and infectious disease portfolios are being developed to address significant health challenges, with ongoing studies and collaborations [10][12] - The company aims to leverage its infrastructure to expedite the launch of TNX-102 SL pending FDA approval, expected in 2025 [24]

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 June 30, 2024 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) | --- | --- ...

Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2 Dr. Lederman continued, "Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately 5.3% of U.S. adults suffer from ...