With Material Participation From Insiders,
Offering Proceeds to Help Drive Company Towards Second Interim
Analysis of the Pivotal TIGeR-PaC Phase III Clinical Trial by Late
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
announced that it has closed a private placement (the “private
placement” or the “financing”) resulting in gross proceeds of
approximately $6.1 million, before deducting offering expenses.
The closing of this private placement extends RenovoRx’s cash
runway as RenovoRx continues its ongoing pivotal TIGeR-PaC Phase
III clinical trial, with a second interim analysis for this study
to occur at the 52nd event (death), which is expected in late
2024.
RenovoRx insiders, including members of the management team and
Board of Directors, participated in the private placement. Through
the execution of this financing, RenovoRx sold an aggregate of
6,133,414 shares of common stock and warrants exercisable for up to
an aggregate of 6,133,414 shares of common stock. Investors who are
not insiders of RenovoRx paid $0.99 per share for the common stock
and associated warrants, but RenovoRx’s management team and
directors purchased shares and warrants at the market price for
Nasdaq Stock Market purposes at $1.22 per share and associated
warrant, reflecting their strong belief in the Company. The
warrants are exercisable at a price equal to the per share price
paid by the applicable investor and are exercisable for a period of
five years following the closing of the private placement.
Shaun Bagai, CEO of RenovoRx, stated, “We are thrilled to start
the new year with the closing of this important financing,
especially in a challenging market climate. The net proceeds
bolster our balance sheet and will allow us to drive our pivotal
trial towards what we hope will be another positive interim
analysis by the end of this year. We are particularly grateful for
the participation in this financing from members of our board and
management team as well as existing and new investors. With the net
proceeds of this financing, in alignment with our consistent focus
on efficient use of capital, we anticipate that we will be able to
fund our operations through late 2024, even as we continue to
explore additional capital raising opportunities. We are at a
critical inflection point, and our efforts are laser focused on
advancing multiple late-stage programs, reaching clinical
milestones, and helping cancer patients live a longer, fuller
life.”
“Last year, I joined RenovoRx’s Board as a Director,” said Dr.
Robert J. Spiegel. “I have now chosen to join as an investor in
this private placement financing. RenovoRx’s proprietary
Trans-Arterial Micro-Perfusion (TAMP™) platform has the possibility
to extend across a variety of high unmet needs by expanding our
pipeline into other difficult-to-treat solid tumor cancers with
additional therapeutics.”
The first interim analysis in RenovoRx’s pivotal Phase III
TIGeR-PaC clinical trial at the 26th specified event, was completed
in March 2023, and the Data Monitoring Committee (DMC) recommended
a continuation of the study. The second interim analysis will occur
at the 52nd of the specified events. The 52nd event is estimated to
occur in late 2024. TIGeR-PaC is an ongoing randomized multi-center
study in locally advanced pancreatic cancer (LAPC) using RenovoRx’s
proprietary TAMP therapy platform to evaluate its first product
candidate, RenovoGem™, a novel oncology drug-device combination
product. The study is comparing treatment with TAMP to the current
standard of care of systemic intravenous chemotherapy.
The TIGeR-PaC study is prespecified to provide a primary
endpoint of a 6-month Overall Survival benefit and secondary
endpoints including reduced side effects versus standard of care.
Interim analysis data was presented at the 2023 American
Association for Cancer Research Annual Meeting and as a Late
Breaker Oral Presentation at the 2023 European Society of Medical
Oncology World Congress on Gastrointestinal Cancer.
The financing will also allow RenovoRx to begin to engage
additional clinical trial sites in preparation for the Company’s
Phase III CouGar study in bile duct cancer, which is the second
late-stage clinical trial to evaluate RenovoGem in a
difficult-to-access solid tumor cancer. RenovoRx has also
identified other potential pipeline indication opportunities in
non-small cell lung cancer, uterine tumors, glioblastoma, and
sarcoma. The Company will require additional funding to fully
pursue these opportunities.
Paulson Investment Company, LLC acted as the exclusive placement
agent in connection with this financing.
“We are excited to assist RenovoRx in securing funding with
Paulson’s high-net-worth clients for the Phase III study on its
TAMP therapy for LAPC treatment,” said Marta Wypych, Head of
Investment Banking at Paulson Investment Company. “By doing so, we
aim to facilitate the Company's journey towards FDA approval,
bringing forth this innovative combination therapy to the market
for the well-being of pancreatic cancer patients.”
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities nor will there be
any sale of these securities in any state or other jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
state or other jurisdiction.
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 3 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 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, and (iii)
the potential for our product candidates to treat or provide
clinically meaningful outcomes for certain medical conditions or
diseases. 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, clinical trials,
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 the net proceeds of the private placement
described herein, (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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240129429218/en/
KCSA Strategic Communications Valter Pinto or Jack Perkins
T:212-896-1254 renovorx@kcsa.com
RenovoRx (NASDAQ:RNXT)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
RenovoRx (NASDAQ:RNXT)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024