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Tonix - Sachs Conf - 1-12-25 vFinal5.pdf

上传人: c** 编号:604022 2025-02-03 42页 1.80MB

1、 2025 Tonix Pharmaceuticals Holding Corp.Corporate PresentationSachs ConferenceJanuary 12,2025NASDAQ:TNXPPO6034,January 12,2025(Doc 1550)2 2025 Tonix Pharmaceuticals Holding Corp.Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans,expectati

2、ons and objectives for future operations or results are“forward-looking statements”as defined by the Private Securities Litigation Reform Act of 1995.These statements may be identified by the use of forward-looking words such as“anticipate,”“believe,”“forecast,”“estimate”and“intend,”among others.The

3、se forward-looking statements are based on Tonixs current expectations and actual results could differ materially.There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.These factors include,but are not limited to,the

4、 risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations;risks related to the failure to successfully market any of our products;risks related to the timing and progress of clinical development of our product candidates;our need for additional financing;

5、uncertainties of patent protection and litigation;uncertainties of government or third party payor reimbursement;limited research and development efforts and dependence upon third parties;and substantial competition.As with any pharmaceutical under development,there are significant risks in the deve

6、lopment,regulatory approval and commercialization of new products.The forward-looking statements in this presentation are made as of the date of this presentation,even if subsequently made available by Tonix on its website or otherwise.Tonix does not undertake an obligation to update or revise any f

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本文主要介绍了Tonix公司研发的TNX-102 SL药物,这是一种用于治疗纤维肌痛症的药物。TNX-102 SL是一种独特的、用于舌下的环苯扎林(CBP)配方,旨在优化吸收和递送。该药物的临床试验显示,与安慰剂相比,TNX-102 SL能显著降低纤维肌痛症患者的每日疼痛。TNX-102 SL的NDA(新药申请)已于2024年10月提交给FDA,FDA已为该药物设定了PDUFA目标日期为2025年8月15日。此外,Tonix公司还计划将TNX-102 SL用于治疗急性应激反应/急性应激障碍,并计划于2025年第一季度启动第二阶段临床试验。
什么是TNX-102 SL? TNX-102 SL如何治疗纤维肌痛? TNX-102 SL的上市前景如何?
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