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MOUNTAIN VIEW, Calif.--(
加利福尼亚州山景城--(
BUSINESS WIRE
商业热线
)--RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath
)--RenovoRx,Inc.(“RenovoRx”或“公司”)(纳斯达克:RNXT),一家生命科学公司,开发新型靶向肿瘤疗法并将RenovoCath商业化
®
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, a novel, FDA-cleared delivery platform, today announced that it has commenced an underwritten public offering of shares of its common stock or pre-funded warrants to purchase shares of common stock. All of the securities to be sold in the proposed offering will be offered by RenovoRx. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering..
美国食品和药物管理局(FDA)批准的新型交付平台今日宣布,该公司已开始承销其普通股股票或预先出资的认股权证,以购买普通股股票。拟发售的所有证券将由RenovoRx发售。拟议的发售受市场和其他条件的限制,并且无法保证发售是否或何时完成,或者发售的实际规模或条款。。
RenovoRx intends to use the net proceeds received from the offering for working capital and general corporate purposes, including continued progression of its Phase III TIGeR-PaC study and the continued development and execution of commercial sales and marketing activities for RenovoCath as a standalone device..
RenovoRx打算将从发售中获得的净收益用于营运资金和一般公司目的,包括继续推进其第三阶段TIGeR PaC研究,以及继续开发和执行RenovoCath作为独立设备的商业销售和营销活动。。
Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.
Titan Partners Group是美国资本合作伙伴的一个部门,是此次发行的唯一账簿管理人。
The offering is being made by RenovoRx pursuant to a shelf registration statement on Form S-3 (File No. 333-268302) previously filed with the Securities and Exchange Commission (the “SEC”) on November 10, 2022, which became effective on November 21, 2022. The offering is being made only by means of a preliminary prospectus supplement and the accompanying base prospectus that form a part of the registration statement.
RenovoRx根据S-3表格(文件号333-268302)上的货架登记声明进行发售,该表格先前于2022年11月10日提交给证券交易委员会(“SEC”),并于2022年11月21日生效。本次发行仅通过初步补充招股说明书和作为注册声明一部分的随附基本招股说明书进行。
A preliminary prospectus supplement and the accompany base prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at .
与本次发行相关的初步补充招股说明书和配套基本招股说明书将提交给美国证券交易委员会,并可在美国证券交易委员会的网站上查阅。
www.sec.gov
www.sec.gov
. Copies of the preliminary prospectus supplement and the accompanying base prospectus, and when available, copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, may be obtained by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at .
.初步补充招股说明书和随附基本招股说明书的副本,以及与本次发行相关的最终补充招股说明书和随附基本招股说明书的副本(如有),可通过电话(929)833-1246或电子邮件联系Titan Partners Group LLC获得,Titan Partners Group LLC是American Capital Partners,LLC的一个部门,地址:4 World Trade Center,29th Floor,New York,NY 10007。
prospectus@titanpartnersgrp.com
prospectus@titanpartnersgrp.com
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This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction..
本新闻稿不构成出售要约或招揽购买要约,也不构成在根据该州或司法管辖区的证券法律登记或取得资格之前,在任何州或司法管辖区出售这些证券是非法的。。
About RenovoRx, Inc.
关于RenovoRx, Inc.
RenovoRx is a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath
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, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery platform, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy.
,一个新颖的,美国食品和药物管理局(FDA)批准的当地药物输送平台,针对高度未满足的医疗需求。RenovoRx获得专利的经动脉微灌注(TAMP™)治疗平台旨在确保通过肿瘤部位附近的动脉壁进行精确的治疗输送,以沐浴目标肿瘤,同时与全身静脉治疗相比,可能最大限度地降低治疗的毒性。
RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents..
RenovoRx的新型靶向治疗方法具有提高安全性,耐受性和改善疗效的潜力,其使命是通过提供创新的解决方案来实现诊断和治疗药物的靶向递送,从而改变癌症患者的生活。。
RenovoRx’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath
RenovoRx的III期先导产品候选产品是一种新型肿瘤药物-装置组合产品。目前正在根据美国FDA的21 CFR 312途径监管的美国研究性新药申请进行调查。研究药物装置组合候选人利用RenovoCath
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the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of chemotherapy, gemcitabine, utilizing the RenovoCath catheter is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA)..
该公司的FDA批准的药物输送装置,适用于动脉造影,术前闭塞和化疗药物输注等应用中的临时血管闭塞。目前,药物评估和研究中心(FDA药物部门)正在评估使用RenovoCath导管动脉内输注化疗吉西他滨治疗局部晚期胰腺癌(LAPC)。。
The intra-arterial infusion of gemcitabine by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA..
目前正在研究RenovoCath导管动脉内输注吉西他滨,尚未批准商业销售。RenovoCath和吉西他滨获得了胰腺癌和胆管癌的孤儿药指定,在FDA批准NDA后提供了7年的市场排他性。。
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, over ten medical institutions have initiated the process for RenovoCath purchase orders.
RenovoRx还利用其TAMP技术和FDA批准的RenovoCath输送系统作为独立设备,实施商业化战略。2024年12月,RenovoRx宣布收到其第一批RenovoCath设备的商业采购订单。此外,十多家医疗机构已经启动了RenovoCath采购订单的流程。
To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner..
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For more information, visit
有关更多信息,请访问
www.renovorx.com
www.renovorx.com
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Cautionary Note Regarding Forward-Looking Statements
关于前瞻性声明的警示说明
This press release and statements of the Company’s management made in connection therewith and at the investor conference described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the timing, size and completion of the proposed public offering as well as the expected use of proceeds related thereto.
本新闻稿和本公司管理层就此发表的声明以及在本文所述的投资者会议上发表的声明包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的前瞻性声明,包括但不限于有关拟议公开发行的时间、规模和完成情况以及相关收益的预期用途的声明。
Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon the Company’s current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of the Company’s control and involve assumptions that may never materialize or may prove to be incorrect.
不纯粹是历史性的陈述是前瞻性陈述。本文所含的前瞻性陈述基于公司目前对未来事件的期望和信念,其中许多本质上是不确定的,不在公司的控制范围内,并且涉及可能永远不会实现或可能被证明是不正确的假设。
These may include estimates, projections and statements relating to the Company’s research and development plans, intellectual property development, clinical trials, the Company’s therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements.
这些可能包括与公司研发计划、知识产权开发、临床试验、公司治疗平台、商业计划、融资计划、目标和预期经营成果有关的估计、预测和陈述,这些估计、预测和陈述基于当前的预期和假设,这些预期和假设受到已知和未知风险和不确定性的影响,这些风险和不确定性可能导致实际结果与这些前瞻性陈述所表达或暗示的结果产生重大不利影响。
These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words.
这些陈述可以使用“可能”、“预期”、“计划”、“目标”、“预期”、“相信”、“预测”、“估计”、“打算”和“潜在”等词语,或者这些词语的否定词或其他与RenovoRx的预期策略、计划或意图有关的类似术语来识别,尽管并非所有前瞻性陈述都包含这些词语。
These forward-looking statements are subject to a number of ris.
这些前瞻性声明受到许多风险投资的约束。
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
本文件中包含的前瞻性声明是在本文件签署之日做出的,除法律要求外,RenovoRx不承担任何义务公开更新此类前瞻性声明以反映后续事件或情况。