Full Press Release Details
Reports Initial Revenues from RenovoCath Commercialization, and Provides Update on Ongoing Pivotal Phase III TIGeR-PaC
from RenovoCath Expected to Grow Sequentially During 2025 with
Expansion of New Customer Purchase Orders and Customer Reorders
of TIGeR-PaC Clinical Trial Enrollment and Review of Second Interim Analysis by Data Monitoring Committee on Target for 2025
2024 Financial Results Including $7.2 Million Cash Position as of December 31, 2024, with Additional $12.1 Million in Gross Proceeds
Raised in February 2025
to Host Fireside Chat on Thursday, April 3rd at 12 p.m. ET
VIEW, Calif. - April 1, 2025 - RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq:
RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ,
a novel, FDA-cleared drug-delivery device, today announced its financial results and business updates for the fourth quarter and full
year ended December 31, 2024.
fourth quarter of 2024 marks a significant milestone in our company history as we have generated our first revenue from sales of our
proprietary RenovoCath device on a standalone basis, with expectations for meaningful revenue growth going forward. Importantly, we believe
our current commercial strategy can be accomplished without a material increase in our capital expenditures, regardless of whether we
self-commercialize or choose to partner with a larger organization and use their existing sales force and channels. Further, we believe
that the gross proceeds from our February 2025 public offering of $12.1 million together
with our cash on hand of $7.2 million at year end fully funds our current operational plan as we look to scale RenovoCath revenues and
progress our Phase III TIGeR-PaC clinical trial towards key milestones. Moreover, we expect
that growing RenovoCath revenues will reduce our burn rate as we prudently deploy our cash on hand to drive shareholder value,"
said Shaun Bagai, CEO of RenovoRx.
on our internal analysis with current clinical applications, we believe that our initial total addressable market (TAM) for RenovoCath
represents an estimated $400 million peak annual U.S. sales opportunity. Beyond this, there are expansion opportunities across other
indications that could create the potential for a several billion-dollar U.S. TAM for RenovoCath over time," continued Mr. Bagai.
"We expect revenue to increase to the low six figure range for the first quarter of 2025 followed by sequential quarter-over-quarter
increases for the remainder of the year."
Commercialization Update
December 2024, RenovoRx received first commercial purchase orders for its RenovoCath device, which resulted in revenue generation of
approximately $43,000 for the fourth quarter of 2024.
is seeing strong organic demand for RenovoCath. More than ten medical institutions have initiated the process for RenovoCath purchase
orders, and purchase orders have already been received from several esteemed, high volume National Cancer Institute-designated centers.
Additionally, utilization of RenovoCath devices by initial customers has led to repeat purchase orders. Moreover, RenovoRx believes the
twenty cancer centers that have used RenovoCath as part of its TIGeR-PaC trial could also be potential customers for RenovoCath after
completion of TIGeR-PaC enrollment later this year.
has identified its initial target market for RenovoCath to be approximately $400 million in peak annual U.S. sales, based on the Company's
internal assumptions1. Moreover, expansion opportunities across other clinical indications could create a several billion-dollar
total addressable market potential for RenovoCath over time. Its management's belief is that the Company can achieve meaningful
market penetration with a small commercial team targeting the top 200 high-volume treatment centers.
there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering procedures utilizing specialty pressure-mediated
delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.
Pivotal Phase III TIGeR-PaC Clinical Trial Update
the fourth quarter 2024, RenovoRx added several additional renowned clinical oncology sites to participate in the TIGeR-PaC study. The
initiation of these sites allows for new patient enrollment at the Sarah Cannon Research Institute Oncology Partners in Nashville, TN
and at the Northwell Health Cancer Institute Clinical Site in New Hyde Park, NY which are key additions to the number of clinical sites
to support RenovoRx's path to completing patient enrollment for the trial. RenovoRx is continuing to target additional clinical
oncology sites, with the expectation that the study will achieve full enrollment during 2025.
current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary
to complete the final analysis. As of March 28, 2025, 90 patients have been randomized with 50 events having occurred. A second interim
analysis will be triggered by the 52nd event.
timing required to analyze the data after the 52nd event is expected to take several months and includes a full review with
recommendations by the TIGeR-PaC Data Monitoring Committee. RenovoRx currently anticipates the 52nd event to occur during
the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on
the data reviewed is expected to be announced in the second half of 2025.
Chat Strategic Update
will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET. During the
event, Mr. Bagai will discuss the momentum of RenovoRx's commercialization efforts for its RenovoCath device, including an update
on initial revenues generated, and continued progress on the ongoing Phase III TIGeR-PaC clinical trial. Additionally, one of RenovoCath's
initial customers, Gregory Tiesi, MD, FACS, FSSO, Medical Director of Hepatobiliary Surgery, Division of Surgical Oncology, Hackensack
Meridian Jersey Shore University Medical Center, will join Mr. Bagai. He will share his insights on the Trans-Arterial Micro-Perfusion
(TAMP ) therapy platform and its impact on patient care. Hackensack Meridian Jersey
Shore University Medical Center began using the RenovoCath device with oncology patients in December 2024.
Thursday, April 3, 2025
Assumptions: (i) pressure-mediated delivery catheters on market today, which are analogous to RenovoCath, have an average selling
price of $6,500-$8,500 per unit; (ii) approximately 7,000 initial target patients at peak market penetration; and (iii) an average of
approximately 8 annual procedures per patient.
question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on
RenovoRx's Investor Relations website after the event.
Key Fourth Quarter 2024 and Subsequent Highlights
the fourth quarter, RenovoRx expanded its Intellectual property Portfolio to include 18 issued patents and 13 pending patents for the
novel TAMP therapy platform. In addition, during and subsequent to the fourth quarter, RenovoRx presented abstracts at the ASCO Gastrointestinal
Cancers Symposium 2025, the Society of Interventional Oncology 2025, and the Society of Surgical Oncology 2025 supporting the TAMP therapy
platform via additional human pharmacokinetic (PK) data and pre-clinical data. Additionally, a publication supporting TAMP for targeted
locoregional drug delivery will be recognized in the Journal of Vascular and Interventional Radiology Award-Winning Paper Scientific
Session during the upcoming the Society of Interventional Radiology 2025.
Highlights for the Year Ended December 31, 2024
| Revenue: Beginning December 2024, RenovoRx reported initial revenues of approximately $43,000 through sales of RenovoCath devices on a standalone basis directly to end users. | ||
| Cash Position: Cash and cash equivalents as of December 31, 2024, were $7.2 million, with an additional $12.1 million in gross ($10.9 million in net) proceeds raised in a common stock only public offering in February 2025. | ||
| R&D Expenses: Research and development expenses were $6.0 million for the year ended December 31, 2024, compared to $5.7 million for the year ended December 31, 2023, an increase of $0.3 million. This increase in research and development expenses is due to an increase in manufacturing and non-recurring engineering costs to scale manufacturing to support the commercial effort on our RenovoCath delivery system of $0.3 million and other research development expenses including personnel expenses for employees and benefits of $0.3 million. This increase was offset by a decrease in clinical development and regulatory costs of $0.3 million. | ||
| SG&A Expenses: Selling, general, and administrative expenses were $5.0 million for the year ended December 31, 2024, compared to $5.7 million for the year ended December 31, 2023, a decrease of $0.7 million. The decrease in selling, general, and administrative expenses was due to lower professional and consulting costs, including directors and officers' insurance and legal fees of $0.9 million. This decrease was offset by an increase in personnel expenses for employees and benefits of $0.2 million, which is primarily due to an increase in employee incentive compensation. | ||
| Net Loss: Net loss was $8.8 million for the year ended December 31, 2024, compared to net loss of $10.2 million for the year ended December 31, 2023. | ||
| Shares Outstanding: Shares of common stock outstanding as of March 25, 2025, were 36,546,752. |
information regarding RenovoRx's business and results of operations for 2024 can be found in its Annual Report on Form 10-K for
the fiscal year ended December 31, 2024, which was filed with the SEC on March 31, 2025.
on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or
therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion
in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding
our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
the TIGeR-PaC Clinical Trial
is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion)
therapy platform for the treatment of LAPC. RenovoRx's first investigational drug-device combination product candidate using the
TAMP therapy platform enabled with the Company's FDA-cleared RenovoCath device for the intra-arterial administration
of chemotherapy, gemcitabine (IAG).
Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ,
a novel, U.S. Food and Drug Administration (FDA)-cleared local drug delivery device, targeting high unmet medical needs. RenovoRx's
patented Trans-Arterial Micro-Perfusion (TAMP ) therapy platform is designed to ensure targeted 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 approach to targeted treatment offers the potential for increased safety, tolerance, and
improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted
delivery of diagnostic and therapeutic agents.
addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate
(intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a U.S. investigational new drug application that is regulated
by the FDA's 21 CFR 312 pathway. The investigational IAG 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 combination of intra-arterial infusion of chemotherapy, gemcitabine, and the RenovoCath device is currently being
evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).