RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
life sciences company developing novel targeted oncology therapies
and commercializing RenovoCath®, 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.
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.
Titan Partners Group, a division of American Capital Partners,
is acting as the sole bookrunner for the offering.
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. 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
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 prospectus@titanpartnersgrp.com.
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.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing novel targeted
oncology therapies and commercializing RenovoCath®, 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. 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’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, 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).
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.
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. 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.
For more information, visit www.renovorx.com. Follow RenovoRx on
Facebook, LinkedIn, and X.
Cautionary Note Regarding Forward-Looking Statements
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. 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. 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. 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. These forward-looking statements are subject to a
number of risks, uncertainties and assumptions, that could cause
actual events to differ materially from those projected or
indicated by such statements, including, among other things:
RenovoRx’s ability to complete the offering on the proposed terms,
or at all, changes in market conditions, and RenovoRx’s
expectations related to the use of proceeds from the proposed
offering. Information regarding the foregoing and additional risks
may be found in the section entitled “Risk Factors” in documents
that the Company files from time to time with the SEC.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20250206312664/en/
KCSA Strategic Communications Valter Pinto or Jack Perkins
T:212-896-1254 RenovoRX@KCSA.com
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