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Tonix Pharmaceuticals Reports First Quarter 2021 Financial Results and Operational Highlights
Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800 Interim Analysis of Second Confirmatory Phase 3 Study in
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800 Interim Analysis of Second Confirmatory Phase 3 Study in Fibromyalgia Expected in Third Quarter 2021 Deep Pipeline Progressing with Three Central Nervous System (CNS) Programs Expected to Enter Phase 2 Trials This Year At March 31, 2021, Cash and Cash Equivalents Totaled Approximately $164 Million CHATHAM, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent operational highlights. “Tonix possesses a deep pipeline of high-value programs ranging from preclinical to mid-Phase 3 development, with three CNS programs poised to enter Phase 2 trials this year,” said Seth Lederman, M.D., President and Chief Executive Officer. “Our strategy is to in-license, acquire or internally invent high impact therapeutic programs which we can validate, de-risk and advance in clinical development through potentially value-creating milestones. We believe successful Phase 2 and Phase 3 trials can be inflection points for program value.” Dr. Lederman continued, “Our clinical, manufacturing, and regulatory teams are progressing programs across multiple modalities including small molecule drugs, synthetic peptides, biologics, monoclonal antibodies and live virus vaccines. The three CNS drug candidates we expect to enter Phase 2 trials this year include: TNX-1300, an E. coli produced biologic in development as an i.v. administered antidote for cocaine intoxication; TNX-1900, a synthetic peptide in development as an intranasally delivered therapeutic for the treatment of chronic migraine; and TNX-601 CR, a controlled release oral formulation in development for the treatment of major depressive disorder.” “Our most advanced program is a confirmatory Phase 3 trial of TNX-102 SL for the management of fibromyalgia. We expect to report an interim analysis in the third quarter of this year and topline data in the first quarter of next year,” continued Dr. Lederman. “We believe that if the topline results are positive, this study will support a New Drug Application, which we would expect to submit in 2022.” Recent Highlights Research and Development* TNX-102 ...