Full Press Release Details
Regains Compliance with
Nasdaq Stockholders' Equity Requirement
ALTOS, CA - April 18, 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, in light of its recent successful fundraising activity, it has received written confirmation from The Nasdaq Stock Market
LLC ("Nasdaq") that the Company has regained compliance with the $2.5 million minimum stockholders' equity requirement
in Nasdaq Listing Rule 5550(b)(1). As a result, the Company's previously announced hearing before a Nasdaq Hearings Panel on this
matter is no longer required and has been cancelled. Further, the Company will not require any ongoing Nasdaq Hearings Panel monitor.
Bagai, Chief Executive Officer of RenovoRx, stated, "Regaining compliance with Nasdaq's listing requirements represents another
critical achievement for RenovoRx. This win for our company is the natural outgrowth of our successful 2024 capital raising efforts,
which in addition to keeping us listed on Nasdaq, has provided $17.2 million in gross proceeds and a cash runway into 2026. We can now
focus our efforts on value creation events over the next two years. These events include the continuation of our pivotal Phase III TIGeR-PaC
clinical trial in locally advanced pancreatic cancer as we move towards a second interim readout and ultimate completion, expansion of
our TAMP (Trans-Arterial Micro-Perfusion) clinical development pipeline into additional cancer indications, and our ongoing exploration
of new commercial business development opportunities with our therapeutic technologies."
is a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a proprietary 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 (TAMPTM) 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, RenovoGemTM, 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.)
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.
more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Note Regarding Forward-Looking Statements
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 Company's cash runway and ability
to maintain its listing on Nasdaq, (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) the Company's exploration of new commercial business development opportunities. 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 maintain our listing on Nasdaq, (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.
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.
Strategic Communications
Pinto, Managing Director