Shaun Bagai to discuss the momentum of
RenovoRx’s commercialization efforts for its RenovoCath® device,
including an update on initial revenues generated, and continued
progress on the ongoing Phase III TIGeR-PaC clinical trial
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq:
RNXT), a life sciences company developing innovative targeted
oncology therapies and commercializing RenovoCath, a novel,
FDA-cleared drug-delivery device, today announced that it will host
a fireside chat with Shaun Bagai, Chief Executive Officer, on
Thursday, April 3, 2025, at 12:00 p.m. ET.
Mr. Bagai will discuss RenovoRx’s continued momentum of its
RenovoCath commercial efforts, including new purchase orders and
reorders received from cancer center customers, and the realization
of initial revenues.
Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase
III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating the Company’s
lead drug-device combination product candidate (intra-arterial
delivery of gemcitabine via the RenovoCath catheter), known as
IAG which uses the proprietary Trans-Arterial
Micro-Perfusion (TAMP™) therapy platform for the treatment of
locally advanced pancreatic cancer (LAPC). The combination product
candidate (IAG), which is enabled by the FDA-cleared RenovoCath
device, is currently under investigation and has not been approved
for commercial sale.
Fireside Chat Details: Date: Thursday, April 3,
2025 Time: 12:00 p.m. ET Webcast:
https://ir.renovorx.com/news-events/ir-calendar-events
A question and answer session will occur at the end of the call,
and a link to the recording of this presentation will be available
on RenovoRx’s Investor Relations website after the event.
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the
isolation of blood flow and delivery of fluids, including
diagnostic and/or therapeutic agents, to selected sites in the
peripheral vascular system. RenovoCath is also indicated for
temporary vessel occlusion in applications including arteriography,
preoperative occlusion, and chemotherapeutic drug infusion. For
further information regarding our RenovoCath Instructions for Use
(“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center study
evaluating the proprietary TAMP™ (Trans-Arterial
Micro-Perfusion) therapy platform for the treatment of LAPC.
RenovoRx’s first investigational drug-device combination product
candidate (intra-arterial delivery of gemcitabine via RenovoCath,
known as IAG) using the TAMP therapy platform enabled with
the Company’s FDA-cleared RenovoCath® device for the
intra-arterial administration of chemotherapy, gemcitabine.
The first interim analysis in the Phase III clinical trial was
completed in March 2023, with the Data Monitoring Committee
recommending a continuation of the study. The TIGeR-PaC study is
investigating TAMP in LAPC. The study’s primary endpoint is an
overall survival benefit with secondary endpoints including reduced
side effects versus standard of care. The second interim analysis
for this study will be triggered by the 52nd event (i.e., patient
death), which is estimated to occur in the second quarter of 2025.
The second interim data readout would follow thereafter, with the
timing for such readout depending on customary factors such as time
needed for analysis. RenovoRx is also aiming to complete patient
enrollment in the TIGeR-PaC study in mid-2025.
About RenovoRx, Inc.
RenovoRx (Nasdaq: RNXT) is a life sciences company
developing innovative targeted oncology therapies and
commercializing RenovoCath®, a novel, U.S. Food and Drug
Administration (FDA)-cleared local drug delivery device, targeting
high unmet medical needs. RenovoRx’s patented Trans-Arterial
Micro-Perfusion (TAMP™) therapy platform is designed to ensure
targeted 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.
In addition to the RenovoCath device, RenovoRx is also
evaluating our novel Phase III drug-device combination oncology
product candidate (intra-arterial gemcitabine, known as
IAG). IAG is being evaluated under a U.S. investigational
new drug application that is regulated by the FDA’s 21 CFR 312
pathway. The investigational IAG 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 device is currently being evaluated for the treatment of
LAPC by the Center for Drug Evaluation and Research (the drug
division of FDA).
IAG 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 new drug application approval by the FDA.
RenovoRx is also engaged in implementing commercialization
strategies utilizing its TAMP technology and FDA-cleared RenovoCath
device as stand-alone device. In December 2024, RenovoRx announced
the receipt of its first commercial purchase orders for RenovoCath
devices. Additionally, certain of these customers have already
initiated repeat orders as RenovoRx works to expand the number
medical institutions that have initiated the process for RenovoCath
purchase orders, including several esteemed, high volume National
Cancer Institute-designated centers. 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, the fireside chat referred to herein, and
statements of the Company’s management made in connection therewith
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 (i) our pre-clinical and clinical trials and
studies, including the overall timing and timing for additional
interim data readouts for our ongoing TIGeR-PaC Phase III clinical
trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as
standalone commercial products, our anticipated timing for revenue
generation from RenovoCath sales, and our commercialization plans
in general, (iii) the potential for our product candidates to treat
or provide clinically meaningful outcomes for certain medical
conditions or diseases and (iv) our efforts to explore
commercialization strategies utilizing our TAMP technology.
Statements that are not purely historical are forward-looking
statements. The forward-looking statements contained herein are
based upon our current expectations and beliefs regarding future
events, many of which, by their nature, are inherently uncertain,
outside of our control and involve assumptions that may never
materialize or may prove to be incorrect. These may include
estimates, projections and statements relating to our research and
development plans, commercial plans, intellectual property
development, clinical trials, our therapy platform, business plans,
financing plans, objectives and expected operating results, which
are based on current expectations and assumptions that are subject
to significant 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: (i) the risk that our
execution of our commercial strategy for RenovoCath or our TAMP
technology may not lead to viable or repeating revenue generating
operations; (ii) circumstances which would adversely impact our
ability to efficiently utilize our cash resources on hand or raise
additional funding, (iii) the timing of the initiation, progress
and potential results (including the results of interim analyses)
of TIGeR-PaC and any other preclinical studies, clinical trials and
our research programs; (iv) the possibility that interim results
may not be predictive of the outcome of our clinical trials, which
may not demonstrate sufficient safety and efficacy to support
regulatory approval of our product candidate, (v) that the
applicable regulatory authorities may disagree with our
interpretation of the data; research and clinical development plans
and timelines, and the regulatory process for our product
candidates; (vi) future potential regulatory milestones for our
product candidates, including those related to current and planned
clinical studies; (vii) our ability to use and expand our therapy
platform to build a pipeline of product candidates; (viii) our
ability to advance product candidates into, and successfully
complete, clinical trials; (ix) the timing or likelihood of
regulatory filings and approvals; (x) our estimates of the number
of patients who suffer from the diseases we are targeting and the
number of patients that may enroll in our clinical trials; (xi) the
commercialization potential of our product candidates, if approved;
(xii) our ability and the potential to successfully manufacture and
supply our product candidates for clinical trials and for
commercial use, if approved; (xiii) future strategic arrangements
and/or collaborations and the potential benefits of such
arrangements; (xiv) our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing
and our ability to obtain additional capital; (xv) the sufficiency
of our existing cash and cash equivalents to fund our future
operating expenses and capital expenditure requirements; (xvi) our
ability to retain the continued service of our key personnel and to
identify, and hire and retain additional qualified personnel;
(xvii) the implementation of our strategic plans for our business
and product candidates; (xviii) the scope of protection we are able
to establish and maintain for intellectual property rights,
including our therapy platform, product candidates and research
programs; (xix) our ability to contract with third-party suppliers
and manufacturers and their ability to perform adequately; (xx) the
pricing, coverage and reimbursement of our product candidates, if
approved; and (xxi) developments relating to our competitors and
our industry, including competing product candidates and therapies.
Information regarding the foregoing and additional risks may be
found in the section entitled “Risk Factors” in documents that we
file from time to time with the Securities and Exchange
Commission.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250320966417/en/
KCSA Strategic Communications Valter Pinto or Jack Perkins T:
212-896-1254 RenovoRX@KCSA.com
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