Full Press Release Details
Reports First Quarter 2025 Financial Results and Business Highlights
2025 RenovoCath Revenues of ~$200,000, Exceeding Expectations and Anticipated to Continue Growing Sequentially with New
Customer Purchase Orders and Reorders
on Hand of $14.6 Million Anticipated to Fully Fund both RenovoCath Commercialization Scale-up and Continued Progress Towards the Completion
of the Ongoing Phase III TIGeR-PaC Clinical Trial
of the TIGeR-PaC Clinical Trial Enrollment and Review of Second Interim Analysis by Data Monitoring Committee on Target for 2025
to Host Conference Call at 4:30 p.m. ET
VIEW, Calif. - May 15, 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 first quarter ended March
31, 2025. RenovoCath powers RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP )
am pleased to report a milestone event for RenovoRx: Q1 was our first full quarter of RenovoCath commercial sales, generating approximately
$200,000 in revenue. Moreover, this revenue exceeded our internal expectations, and we anticipate this positive trend to continue as
we expect sequential quarterly growth for the foreseeable future," said Shaun Bagai, CEO of RenovoRx. "Additionally, we believe
that the approximately twenty cancer centers that have used RenovoCath as part of our ongoing Phase III TIGeR-PaC trial could also become
potential customers after the planned completion of trial enrollment later this year. Our enthusiasm about the value proposition of our
company has never been higher as we dual track the growth of our commercial efforts and progress our clinical trial towards important
milestones later this year."
Commercialization Update
first quarter of 2025 represented RenovoRx's first full quarter of generating revenue from commercial sales. This is the result
of the important strategic decision in 2024 to focus on implementing a commercial strategy for RenovoCath in tandem with the ongoing
Phase III TIGeR-PaC trial.
planned to launch its commercial efforts for RenovoCath during the first quarter of this year in response to anticipated strong demand
for the patented RenovoCath device. However, the Company received purchase orders ahead of schedule, generating $43,000 in revenue in
December alone. RenovoCath is gaining strong traction,
with over ten non-TIGeR-PaC medical institutions including several esteemed, high-volume, academic and community, and National Cancer
Institute-designated centers who have initiated purchase orders. RenovoRx believes that many of the twenty cancer centers that have used
RenovoCath as part of the TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment,
anticipated for later this year. Additionally, early utilization of RenovoCath devices by initial customers has led to repeat purchase
believes that the initial total addressable market for RenovoCath (TAM) represents an estimated $400 million peak annual U.S. sales opportunity.
In calculating this sales opportunity, the Company is assuming an average of 8 procedures per patient and 7,000 initial target patients
at peak market penetration in patient populations where RenovoRx already has clinical usage, with catheter pricing between $6,500-$8,500
ahead, RenovoRx sees expansion opportunities across other cancer indications that could create the potential for a several-billion-dollar
U.S. TAM for RenovoCath over time. The prospect of penetrating even a small portion of this market combined with the potential to help
patients is driving the Company's excitement about this opportunity.
Pivotal Phase III TIGeR-PaC Trial Update
the first quarter of 2025, RenovoRx announced that Johns Hopkins Medicine has now initiated enrollment in the ongoing Phase III TIGeR-PaC
trial. This is a valuable addition to the distinguished network of clinical cancer sites across the U.S. participating in this important
trial as RenovoRx works towards full enrollment. RenovoRx is continuing to evaluate additional sites and expects that Phase III
TIGeR-PaC trial will achieve full enrollment during 2025.
current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events,
or deaths, necessary to complete the final analysis. As of May 2, 2025, 91 patients have been randomized and 56 events have occurred,
triggering the second interim analysis. RenovoRx anticipates the Phase III TIGeR-PaC Data Monitoring Committee will review trial
data in the third quarter of 2025 and looks forward to receiving their recommendations and feedback.
Quarter 2025 and Subsequent Key Highlights
and subsequent to the first 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 was recognized in
the Journal of Vascular and Interventional Radiology Award-Winning Paper Scientific Session during the Society of Interventional Radiology
to the first quarter of 2025, RenovoRx announced the issuance of a new U.S. patent for the Company's TAMP therapy platform, further
enhancing the Company's intellectual property protection. RenovoRx now holds a robust portfolio of 19 patents in multiple countries
across the globe, including 9 U.S. patents as well as 7 U.S. patents pending. RenovoRx's strong and growing intellectual
property portfolio provides key support to the Company's continuing commercialization of RenovoCath. The issuance of this new patent
highlights the innovation behind the TAMP therapy platform and strengthens the Company's competitive position.
during the first quarter 2025, RenovoRx announced that in the most recent open trading window, members of the management team
and Board purchased an aggregate of approximately 143,000 shares of the Company's stock in multiple open market purchases.
Highlights for the First Quarter Ended March 31, 2025:
| Revenue : RenovoRx reported revenues of approximately $200 thousand from commercial sales of the RenovoCath device. | ||
| Cash Position : As of March 31, 2025, the Company had $14.6 million in cash and cash equivalents. The Company anticipates that the growing revenues from RenovoCath will reduce its burn rate, and that cash as of March 31, 2025, will fully fund both the RenovoCath scale-up and the continued progress towards completion in the Phase III TIGeR-PaC trial. | ||
| R&D Expenses : Research and development expenses were $1.7 million , compared to $1.3 million in Q1 2024. The $0.4 million increase was due to an increase in employee compensation due to cost-of-living adjustments, an increase in manufacturing and non-recurring engineering costs to support commercial scale-up, an increase in conference and trade show activity, and an increase in other R&D activity. | ||
| SG&A Expenses : Selling, general, and administrative expenses were approximately $1.6 million , up from $1.2 million for Q1 2024. The $0.4 million increase was due to an increase in personnel and benefits, an increase in professional and consulting fees to support commercialization, and an increase in other G&A activity. | ||
| Net Loss : Net loss was $2.4 million , compared to $1.1 million in Q1 2024. The $1.3 million increase was due to an increase in loss from operations of $0.6 million and a $0.8 million decrease in the fair value of the common warrant liability. | ||
| Shares Outstanding : As of May 9, 2025, shares of common stock outstanding totaled 36,572,232 . |
| Event: | RenovoRx First Quarter 2025 Financial Results Conference Call |
| Date: | Thursday, May 15, 2025 |
| Time: | 4:30 p.m. ET |
| Live Call: | 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International) |
| Webcast: | https://ir.renovorx.com/news-events/ir-calendar-events |
interested individuals unable to join the conference call, a dial-in replay of the call will be available until May 29, 2025, and can
be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13753595.
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.
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash and cash equivalents | $ | 14,582 | $ | 7,154 | ||||
| Total assets | $ | 16,014 | $ | 8,118 | ||||
| Total liabilities | $ | 2,857 | $ | 3,640 | ||||
| Total stockholders' equity | 13,157 | 4,478 | ||||||
| Total liabilities and stockholders' equity | $ | 16,014 | $ | 8,118 |
Statement of Operations Data
thousands, except for share and per share amount)
| Three Months Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | 197 | $ | - | ||||
| Cost of revenues | 94 | - | ||||||
| Gross profit | 103 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,642 | 1,257 | ||||||
| Selling, general and administrative | 1,571 | 1,219 | ||||||
| Total Operating expenses | 3,213 | 2,476 | ||||||
| Loss from operations | (3,110 | ) | (2,476 | ) | ||||
| Change in fair value of warrant liability | 584 | 1,363 | ||||||
| Interest and dividend income | 106 | 37 | ||||||
| Total other income | 690 | 1,400 | ||||||
| Net loss | $ | (2,420 | ) | $ | (1,076 | ) | ||
| Net loss per share, basic and diluted | $ | (0.08 | ) | $ | (0.07 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 31,395,888 | 14,947,500 |
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 Phase III TIGeR-PaC Trial
is an ongoing Phase III randomized multi-center trial 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 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 TIGeR-PaC trial drug-device combination oncology
product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated by the Center for Drug Evaluation and Research
(the drug division of FDA) under a U.S. investigational new drug application that is regulated by the FDA's 21 CFR 312 pathway.
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.
combination product candidate, which is enabled the RenovoCath device, is currently under investigation and has not been approved for
commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides
7 years of market exclusivity upon new drug application approval by the FDA.
is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone
device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally,
certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have
initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers.
To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on
its own or in tandem with a medical device commercial partner.
more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
Note Regarding Forward-Looking Statements
press release and statements of the Company's management made in connection therewith contain forward-looking statements within