Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showcase
Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showcase
Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showcase
Tonix製藥宣佈在Planet MicroCap展示會上發表演講
April 24, 2024 8:00am EDT Download as PDF
美國東部時間 2024 年 4 月 24 日上午 8:00 以 PDF 格式下載
CHATHAM, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present at the Planet MicroCap Showcase in Las Vegas, Nev. on May 1, 2024, at 8:00 a.m. PT (11:00 a.m. ET). The presentation will include data from the recently reported positive Phase 3 RESILIENT trial of Tonmya (also known as TNX-102 SL) for the management of fibromyalgia.
新澤西州查塔姆，2024年4月24日（環球新聞專線）——擁有上市產品和候選開發渠道的生物製藥公司託尼克斯製藥控股公司（納斯達克股票代碼：TNXP）（Tonix或公司）今天宣佈，首席執行官塞思·萊德曼醫學博士將於2024年5月1日出席在內華達州拉斯維加斯舉行的Planet MicroCap展示會。太平洋時間上午 8:00（美國東部時間上午 11:00）。該演示將包括最近報告的用於治療纖維肌痛的Tonmya（也稱爲 TNX-102 SL）的3期陽性試驗的數據。
The presentation will be webcast here. A copy of the Company's presentation will be available under the Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the showcase website.
演示將是 在這裏進行網絡直播。公司演示文稿的副本將在 演示 Tonix 網站的選項卡位於 www.tonixpharma.com 會議之後。其他會議信息可在以下網址找到 展示網站。
Tonix Pharmaceuticals Holding Corp.*
託尼克斯製藥控股公司*
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
Tonix是一家生物製藥公司，專注於開發、許可和商業化治療和預防人類疾病並減輕痛苦的療法。Tonix的開發產品組合側重於中樞神經系統（CNS）疾病。Tonix的首要任務是在2024年下半年向美國食品藥品管理局提交Tonmya的新藥申請（NDA）1，該候選產品已經完成了兩項具有統計學意義的纖維肌痛管理的3期研究。TNX-102 SL也在開發中，用於治療急性應激反應以及纖維肌痛型的長冠狀病毒。Tonix 的中樞神經系統產品組合包括 TNX-1300（可卡因酯酶），這是一種旨在治療可卡因中毒的生物製劑，被指定爲突破性療法。Tonix 的免疫學開發產品組合包括用於解決器官移植排斥反應、自身免疫和癌症的生物製劑，包括 TNX-1500，這是一種靶向 CD40 配體（CD40L 或 CD154）的人源化單克隆抗體，正在開發用於預防同種異體移植排斥反應和治療自身免疫性疾病。Tonix還在罕見病和傳染病領域開發候選產品。我們的商業子公司 Tonix Medicines 銷售 Zembrace SymTou （舒馬曲坦注射液）3 mg 和 Tosymra （舒馬曲坦鼻腔噴霧劑）10 mg，用於治療成人有或沒有先兆的急性偏頭痛。
*Tonix's product development candidates are investigational new drugs or biologics and have not been approved for any indication.
*Tonix 的候選產品開發是研究性新藥或生物製劑，尚未獲得任何適應症的批准。
1Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
1美國食品藥品監督管理局（FDA）有條件地接受 Tonmya 作爲 TNX-102 SL 的商品名，用於治療纖維肌痛。Tonmya尚未獲得任何適應症的批准。
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
Zembrace SymTouch 和 Tosymra 是 Tonix Medicines 的註冊商標。所有其他商標均爲其各自所有者的財產。
This press release and further information about Tonix can be found at www.tonixpharma.com.
本新聞稿和有關 Tonix 的更多信息可在以下網址找到 www.tonixpharma.com。
Forward Looking Statements
前瞻性陳述
Certain statements in this press release are forward-looking within the meaning of 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," "expect," and "intend," among others. These forward-looking statements are based on Tonix's 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, risks related to the 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; 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 development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the "SEC") on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
根據1995年《私人證券訴訟改革法》，本新聞稿中的某些陳述是前瞻性的。這些陳述可以通過使用前瞻性詞語來識別，例如 “預期”、“相信”、“預測”、“估計”、“預期” 和 “打算” 等。這些前瞻性陳述基於Tonix當前的預期，實際業績可能存在重大差異。有許多因素可能導致實際事件與此類前瞻性陳述所示事件存在重大差異。這些因素包括但不限於與未能獲得美國食品藥品管理局許可或批准以及不遵守美國食品藥品管理局法規相關的風險；與未能成功銷售我們的任何產品相關的風險；與候選產品臨床開發的時間和進展相關的風險；我們對額外融資的需求；專利保護和訴訟的不確定性；政府或第三方付款人補償的不確定性；研發工作有限以及對第三方的嚴重依賴；以及大量的依賴競爭。與任何正在開發的藥物一樣，新產品的開發、監管批准和商業化也存在重大風險。Tonix沒有義務更新或修改任何前瞻性陳述。投資者應閱讀2024年4月1日向美國證券交易委員會（“SEC”）提交的截至2023年12月31日年度的10-K表年度報告以及該報告當天或之後向美國證券交易委員會提交的定期報告中列出的風險因素。Tonix的所有前瞻性陳述均受所有這些風險因素和其他警示性陳述的明確限制。此處提供的信息僅反映截至發佈之日的信息。
Investor Contact
投資者聯繫人
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
傑西卡莫里
託尼克斯製藥
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
彼得·沃佐
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
媒體聯繫人
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151
凱蒂道奇
Lavoie 健康科學
kdodge@lavoiehealthscience.com(978) 360-3151
Released April 24, 2024
2024 年 4 月 24 日發佈
譯文內容由第三人軟體翻譯。