Recent financing will drive Company towards
second interim analysis on pivotal Phase III TIGeR-PaC clinical
trial by end of 2024
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 provided a letter to shareholders from Chief
Executive Officer, Shaun Bagai.
Dear Fellow RenovoRx Shareholders,
2023 was a pivotal year for RenovoRx, and we believe our
accomplishments bode well for the achievement of our anticipated
2024 milestones.
Our team worked diligently on advancing the development of our
proprietary targeted combination therapy platform,
Trans-Arterial Micro-Perfusion (TAMP™), involving our novel
and proprietary delivery system, designed to improve the standard
of care for patients diagnosed with difficult-to-treat cancers. We
are proud to have achieved several key milestones described below,
including, importantly, an initial positive interim analysis on our
pivotal Phase III TIGeR-PaC clinical trial in locally advanced
pancreatic cancer (LAPC).
Among our significant milestones achieved, our recent completion
of a $6.1 million private placement has extended our cash runway,
allowing us to drive towards our key goal of a second interim
analysis for our TIGeR-PaC study, which is expected by late
2024.
TIGeR-PaC is an ongoing Phase III randomized multi-center study
evaluating our lead product candidate, RenovoGem™ for
the treatment of LAPC. RenovoGem is a novel oncology drug-device
combination product utilizing our TAMP administration technology
combined with the FDA-approved cancer drug, gemcitabine. The study
is comparing treatment with RenovoGem to the current standard of
care of systemic intravenous chemotherapy.
The first interim analysis in the TIGeR-PaC study at the 26th
event of the specified events (deaths), was completed in March
2023, with the Data Monitoring Committee recommending a
continuation of the study. The TIGeR-PaC study’s primary endpoint
is a 6-month Overall Survival benefit with secondary endpoints
including reduced side effects versus standard of care. The data
was first presented at the 2023 American Association for Cancer
Research Annual Meeting in April 2023 and then as a Late Breaker
Oral Presentation with additional secondary endpoint data at the
2023 European Society of Medical Oncology World Congress on
Gastrointestinal Cancer in June 2023. The second interim analysis
for this study is expected to occur at the 52nd event which is
estimated to occur in late 2024.
In a further validation of our TAMP platform, in July 2023, we
announced a collaboration with Imugene (ASX: IMU) to explore
expansion of our TAMP product pipeline with Imugene’s CF33
oncolytic virus therapy for the treatment of difficult-to-access
tumors. We are constantly in discussions regarding similar
collaborations and potentially out-licenses of RenovoGem as we gear
up for the New Drug Application filing (assuming we meet our study
endpoints) and commercialization of RenovoGem (if approved by
FDA).
As a result of the positive progress that we have made in
advancing TAMP with our TIGeR-PaC study, we made important
additions to our management team, Board of Directors, and
Scientific Advisory Board, bolstering our strong leadership. These
additions enhance our already deep expertise resident at
RenovoRx.
As we make strong progress on our clinical pathway, it is
critically important that we continue to invest in our intellectual
property. In December 2023, we filed an additional international
patent application under the Patent Cooperation Treaty for our
novel TAMP therapy platform. RenovoRx already holds a strong
intellectual property portfolio with nine patents issued and nine
pending patents for our proprietary TAMP platform and delivery
system in the US, EU, and Asia.
This patent application further bolsters the value of TAMP as a
novel platform in oncology, beyond our current Phase III clinical
asset, and may expand its use into the delivery of larger
therapeutic assets across DNA/RNA Altering Modalities, Cell
Therapy, and Antibody-Based Therapies. If issued, this new patent
will broaden our intellectual property coverage, creating new
market potential, while increasing TAMP’s commercial value.
While many companies are tackling cancer treatment in a variety
of ways, we believe we are building a better way, with benefits not
only for oncology patients, and their clinicians and loved ones,
but for our shareholders. There is no question that cancer
treatment needs a better, more effective method for drug delivery.
Our data thus far suggests that we may be on the forefront of
innovating the standard of care for treatment of
difficult-to-access tumors. Your support enables our steadfast
commitment to improve patients’ lives and lifespans by delivering
therapies that have the potential to revolutionize the current
paradigm of cancer care.
We encourage anyone interested to visit our website,
renovorx.com, to learn more, and email us at renovorx@kcsa.com to
get in touch with us.
Sincerely,
Shaun R. Bagai CEO RenovoRx
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company
developing proprietary targeted combination therapies for high
unmet medical need with a goal to improve therapeutic outcomes for
cancer patients undergoing treatment. The Company’s proprietary
Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed
to ensure precise therapeutic delivery to directly target the tumor
while potentially minimizing a therapy’s toxicities versus systemic
(intravenous (IV) therapy). RenovoRx’s unique approach to targeted
treatment offers the potential for increased safety, tolerance, and
improved efficacy. Our Phase III lead product candidate,
RenovoGem™, a novel oncology drug-device combination product, is
being investigated under a US IND that is regulated by FDA 21 CFR
312 pathway. RenovoGem 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 committed to transforming the lives of patients by
delivering innovative solutions to change the current paradigm of
cancer care. RenovoGem is currently under investigation for TAMP
therapeutic delivery of gemcitabine 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 Statements
This press release contains 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) the use of proceeds from
the Company’s January 2024 private placement described herein and
(ii) our clinical trials and studies, including anticipated timing,
statements regarding the potential of RenovoCath®, RenovoGem™ or
TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial
study in LAPC, (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 expand our
intellectual property. 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) circumstances which
would adversely impact our ability to efficiently utilize our cash
resources on hand or raise additional funding, (ii) 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; (iii) 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,
(iv) 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; (v) future potential regulatory milestones for our
product candidates, including those related to current and planned
clinical studies; (vi) our ability to use and expand our therapy
platform to build a pipeline of product candidates; (vii) our
ability to advance product candidates into, and successfully
complete, clinical trials; (viii) the timing or likelihood of
regulatory filings and approvals; (ix) 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; (x) the
commercialization potential of our product candidates, if approved;
(xi) our ability and the potential to successfully manufacture and
supply our product candidates for clinical trials and for
commercial use, if approved; (xii) future strategic arrangements
and/or collaborations and the potential benefits of such
arrangements; (xiii) our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing
and our ability to obtain additional capital; (xiv) the sufficiency
of our existing cash and cash equivalents to fund our future
operating expenses and capital expenditure requirements; (xv) our
ability to retain the continued service of our key personnel and to
identify, and hire and retain additional qualified personnel; (xvi)
the implementation of our strategic plans for our business and
product candidates; (xvii) the scope of protection we are able to
establish and maintain for intellectual property rights, including
our therapy platform, product candidates and research programs;
(xviii) our ability to contract with third-party suppliers and
manufacturers and their ability to perform adequately; (xix) the
pricing, coverage and reimbursement of our product candidates, if
approved; and (xx) 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240206749299/en/
KCSA Strategic Communications Valter Pinto or Jack Perkins
T:212-896-1254 renovorx@kcsa.com
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