- Cash position now expected to fund current operating plan into
2026
- Financing provides cash runway to advance the ongoing pivotal
Phase III TIGeR-PaC trial through the second interim readout and
towards completion of the trial
- Financing also enables the expansion of RenovoRx’s TAMP™
(Trans-Arterial Micro-Perfusion) clinical development pipeline into
additional cancer indications
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 the execution of definitive
subscription agreements with accredited investors for a private
placement which is expected to result in gross proceeds of
approximately $11.1 million to RenovoRx, before deducting offering
expenses.
The proceeds from this financing, in addition to RenovoRx’s
previously announced private placement on January 29, 2024 for
gross proceeds of approximately $6.1 million, extend the Company’s
cash runway into 2026. The financing allows RenovoRx to advance its
lead program, the pivotal Phase III TIGeR-PaC clinical trial in
locally advanced pancreatic cancer (LAPC), through the second
interim readout and towards completion of the trial. The TIGeR-PaC
study is an ongoing randomized multi-center study in LAPC using
RenovoRx’s proprietary TAMP (Trans-Arterial Micro-Perfusion)
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 (systemic intravenous chemotherapy). RenovoRx
expects that the second interim analysis for this study will be
triggered by the 52nd event in the trial, which is estimated to
occur in late 2024.
Proceeds from the financing are also expected to enable the
expansion of the TAMP clinical development pipeline into additional
cancer indications.
The definite subscription agreements were executed based on the
closing price of RenovoRx’s common stock on April 4, 2024, and the
private placement is expected to close on April 11, 2024, subject
to customary closing conditions. Newbridge Securities Corporation
is acting as sole placement agent for the transaction.
Terms of the Private Placement
In connection with the private placement, the Company will issue
7,912,364 shares of common stock, five-year Series A Warrants to
purchase an aggregate of up to 7,912,364 shares of common stock,
and two-year Series B Warrants, to purchase an aggregate of up to
3,956,182 shares of common stock, with the Series A Warrants and
Series B Warrants together constituting 150% warrant coverage.
Investors will pay a purchase price of $1.4075 for each share and
associated Series A Warrant and Series B Warrant, with such price
being at the market for purposes of Nasdaq Stock Market rules. The
Series A Warrants and Series B Warrants are each exercisable for
$1.22 per share. The Series B Warrants are callable by the Company
after 6 months if certain price and volume thresholds are
achieved.
The securities being sold in the private placement have not been
registered under the Securities Act of 1933, as amended, or state
securities laws and may not be offered or sold in the United States
absent registration with the SEC or an applicable exemption from
such registration requirements. The Company has agreed to file a
registration statement with the SEC covering the resale of the
shares and the shares underlying the Series A Warrants and Series B
Warrants issuable in connection with the private placement.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
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. RenovoRx’s patented
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 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, RenovoGem™, a novel oncology drug-device
combination product, is being investigated under a U.S.
investigational new drug application that is regulated by the FDA’s
21 CFR 312 pathway. RenovoGem is currently being evaluated for the
treatment of locally advanced pancreatic cancer 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 anticipated closing and
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 “will,” “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/20240408031443/en/
KCSA Strategic Communications Valter Pinto, Managing Director
T:212-896-1254 renovorx@kcsa.com
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