RenovoRx, Inc. (“RenovoRx” or the
“Company”) (Nasdaq: RNXT), a clinical-stage
biopharmaceutical company developing novel precision oncology
therapies based on a local drug-delivery platform, today announced
that Shaun Bagai, Chief Executive Officer, will present at H.C.
Wainwright’s 26th Annual Global Investment Conference being held at
the Lotte New York Palace Hotel in New York City. The conference
will be held September 9-11, 2024, with Mr. Bagai’s presentation on
September 9, 2024, at 7:00 a.m. ET.
Mr. Bagai will discuss recent corporate
achievements including progress on RenovoRx’s pivotal ongoing Phase
III TIGeR-PaC clinical trial evaluating the proprietary
TAMP™ (Trans-Arterial Micro-Perfusion) therapy
platform for the treatment of Locally Advanced Pancreatic Cancer
(LAPC.)
He will also discuss RenovoRx’s ongoing
exploration of new commercial business development opportunities
with its proprietary therapy platform technology and FDA-cleared
RenovoCath® delivery
system as a stand-alone device.
RenovoCath is indicated for temporary vessel
occlusion in applications including arteriography, preoperative
occlusion, and chemotherapeutic drug infusion. In connection with
this effort, RenovoRx appointed Ryan Witt as Senior Vice President
of Corporate Strategy and Partnerships in June 2024.
Presentation Details:
Date: Monday, September 9,
2024Time: 7:00 a.m.
ETLocation: Lotte New York Palace Hotel, New
YorkSpeaker: Shaun Bagai,
CEOWebcast: https://journey.ct.events/view/c647b446-97cc-44c8-9cbf-37b1af70039c
To schedule a one-on-one investor meeting with
Mr. Bagai, please contact your H.C. Wainwright representative or
KCSA Strategic Communications at RenovoRx@KCSA.com.
A replay of this presentation will be available
for 90 days following the date of the presentation on the Company’s
website at
https://ir.renovorx.com/news-events/ir-calendar-events.
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 Locally Advanced Pancreatic Cancer
(LAPC.) RenovoRx’s first product candidate using the TAMP
technology, is a novel investigational oncology drug-delivery
combination utilizing the Company’s FDA-cleared
RenovoCath® device for the
intra-arterial administration of chemotherapy, gemcitabine HCl.
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 a 6-month 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, which is estimated to occur in late 2024 or early
2025.
About RenovoRx, Inc.RenovoRx is
a clinical-stage biopharmaceutical company developing novel
precision oncology therapies based on a local drug delivery
platform for high unmet medical need with a goal to improve
therapeutic outcomes for cancer patients undergoing treatment.
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 and patented approach to targeted treatment offers
the potential for increased safety, tolerance, and improved
efficacy. Our 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 gemcitabine HCl by 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).
RenovoRx is also actively exploring other
commercialization strategies utilizing its TAMP technology and
FDA-cleared RenovoCath delivery system as a stand-alone device.
RenovoRx is committed to transforming the lives
of patients by delivering innovative solutions to change the
current paradigm of cancer care. The intra-arterial infusion of
gemcitabine HCl by the RenovoCath catheter is currently under
investigation and has not been approved for commercial sale.
For more information,
visit www.renovorx.com. Follow RenovoRx
on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding
Forward-Looking StatementsThis 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 (i)
our clinical trials and studies, including anticipated timing,
statements regarding the potential of RenovoCath® or TAMP™ or
regarding our ongoing TIGeR-PaC Phase III clinical trial study in
LAPC, (ii) the potential for our product candidates to treat or
provide clinically meaningful outcomes for certain medical
conditions or diseases and (iii) 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, 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 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 exploration of commercial opportunities for our
TAMP technology may not lead to viable, 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 our 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.
Contact:KCSA Strategic
CommunicationsValter Pinto or Jack
PerkinsT:212-896-1254RenovoRX@KCSA.com
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