{"id":874183,"date":"2025-08-11T17:42:37","date_gmt":"2025-08-11T21:42:37","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tonix-pharmaceuticals-reports-second-quarter-2025-financial-results-and-operational-highlights\/"},"modified":"2025-08-11T17:42:37","modified_gmt":"2025-08-11T21:42:37","slug":"tonix-pharmaceuticals-reports-second-quarter-2025-financial-results-and-operational-highlights","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tonix-pharmaceuticals-reports-second-quarter-2025-financial-results-and-operational-highlights\/","title":{"rendered":"Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights"},"content":{"rendered":"
\n

\n FDA PDUFA goal date of<\/em>
\n \u202f<\/em>
\n August<\/em>
\n \u202f<\/em>
\n 15<\/em>
\n , 2025,<\/em>
\n for TNX<\/em>
\n \u2011<\/em>
\n 102<\/em>
\n \u202f<\/em>
\n SL for fibromyalgia: if approved by FDA, TNX<\/em>
\n \u2011<\/em>
\n 102<\/em>
\n \u202f<\/em>
\n SL would be the first new drug for fibromyalgia in more than 16<\/em>
\n \u202f<\/em>
\n years<\/em>
\n \u202f<\/em>\n <\/p>\n

\n In<\/em>
\n \u202f<\/em>
\n June<\/em>
\n \u202f<\/em>
\n 2025, the Company was added to the Russell<\/em>
\n \u202f<\/em>
\n 3000\u00ae<\/sup> and Russell<\/em>
\n \u202f<\/em>
\n 2000\u00ae<\/sup> Indexes following the annual reconstitution<\/em>\n <\/p>\n

\n Phase<\/em>
\n \u202f<\/em>
\n 3<\/em>
\n \u202f<\/em>
\n RESILIENT results published in peer-reviewed journal, Pain<\/em>
\n \u202f<\/em>
\n Medicine, including statistically significant reduction in fibromyalgia pain with once<\/em>
\n \u2011<\/em>
\n nightly TNX<\/em>
\n \u2011<\/em>
\n 102<\/em>
\n \u202f<\/em>
\n SL; generally well tolerated<\/em>\n <\/p>\n

\n Cash and cash equivalents of $125.3<\/em>
\n \u202f<\/em>
\n million reported as of<\/em>
\n \u202f<\/em>
\n June\u00a0<\/em>
\n 30, 2025; current cash runway expected to fund operations into the third quarter<\/em>
\n \u202f<\/em>
\n of<\/em>
\n \u202f<\/em>
\n 2026<\/em>\n <\/p>\n

CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq:\u00a0TNXP) (\u201cTonix\u201d or the \u201cCompany\u201d), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended\u00a0June\u00a030,\u00a02025, and provided an overview of recent operational highlights.<\/p>\n

\u201cWith the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, we are\u00a0excited about the potential to make this important new therapy available to patients in the fourth quarter of this year,\u201d said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. \u201cFDA considers fibromyalgia a serious condition and awarded TNX-102 SL Fast Track designation last year. There has been no new treatment for this debilitating condition approved in over 16 years. Additionally, our RESILIENT Phase 3 study results were recently published in the peer-reviewed journal, Pain Medicine<\/em>.\u201d<\/p>\n

Dr. Lederman continued, \u201cOur pipeline momentum remains strong. In the second quarter, we dosed the first patient in the U.S. Department of Defense (DoD)-funded, investigator-initiated, OASIS trial of TNX-102 SL for acute stress reaction. We also presented new data for our live-virus vaccine, TNX-801, which demonstrated durable single-dose protection against mpox and rabbitpox in animal models. We previously reported positive Phase 1 safety and pharmacokinetic data for TNX-1500, advancing this next-generation anti-CD40L antibody toward a Phase 2 kidney-transplant study.\u00a0We are well-positioned to translate these milestones into meaningful value for patients and shareholders alike.\u201d<\/p>\n\n\n\n
\n Key Investigational Product Candidates<\/strong>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n<\/table>\n

\n
\n Central Nervous System (CNS) Pipeline<\/em>
\n <\/strong>
\n
\n TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg): two tablets (5.6 mg), once-daily at bedtime for fibromyalgia (FM) \u2013 a centrally-acting, non-opioid <\/em>
\n
\n analgesic<\/em>.<\/p>\n