RenovoRx Q1 2025 Earnings Report

RenovoRx EPS Results

• Actual EPS: -$0.08
• Consensus EPS: -$0.08
• Beat/Miss: Met Expectations
• One Year Ago EPS: N/A

RenovoRx Revenue Results

• Actual Revenue: $0.20 million
• Expected Revenue: $0.23 million
• Beat/Miss: Missed by -$28.00 thousand
• YoY Revenue Growth: N/A

RenovoRx Announcement Details

• Quarter: Q1 2025
• Date: 5/15/2025
• Time: After Market Closes
• Conference Call Date: Thursday, May 15, 2025
• Conference Call Time: 4:30PM ET

RenovoRx (NASDAQ:RNXT), a clinical-stage biopharmaceutical company, focuses on developing proprietary targeted combination therapies to improve therapeutic outcomes for cancer patients undergoing treatment. Its lead product candidate is RenovoGem, an oncology drug-device combination product, consisting of intra-arterial gemcitabine and RenovoCath that is in Phase III clinical trials for the locally advanced pancreatic cancer. The company has a research collaboration with Imugene Limited to deliver oncolytic virus therapy for the treatment of difficult-to-access tumors. RenovoRx, Inc. was founded in 2009 and is headquartered in Los Altos, California.

RenovoRx Q1 2025 Earnings Call Transcript

Key Takeaways

• RenovaRx’s Phase III TIGERPAC interim data showed median overall survival improved from 10 months with standard systemic chemotherapy to 16 months using TAMP delivery of gemcitabine, along with a 65% reduction in adverse events such as nausea and fatigue.
• In Q1 2025 the company generated approximately $200,000 in revenue from commercial sales of its FDA-cleared RenovaCath device, exceeding internal forecasts and driven by repeat orders from over 10 non-TIGERPAC institutions.
• RenovaRx estimates a $400 million peak U.S. annual sales opportunity for RenovaCath based on current reimbursement codes and 7,000 target patients, with potential for a several-billion-dollar TAM as it expands into additional cancer indications.
• The Phase III TIGERPAC trial is advancing toward full enrollment in 2025, with 91 patients randomized and 56 events recorded, triggering a second interim analysis scheduled for Q3 2025.
• With $14.6 million in cash as of March 31, 2025, RenovaRx expects to fund both RenovaCath scale-up and the TIGERPAC trial through full enrollment, and management’s open-market purchases of ~143,000 shares underscore leadership’s confidence in the company’s outlook.

Presentation

[Operator]

Good afternoon, everyone, and welcome to the Renovo Rx q one twenty twenty five financial and operational highlights conference call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press and then 1 on your touch tone phones. To withdraw your questions, you may press and 2.

[Operator]

Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Walter Pinto, Managing Director at KCSA Strategic Communications. Sir, please go ahead.

[Valter Pinto, Managing Director at KCSA Strategic Communications]

Thank you, operator. Good afternoon, and welcome, everyone, to the RenovaRx first quarter twenty twenty five conference call. I'm joined today by RenovaRx's leadership team, including Doctor. Ramtan Aga, Founder and Chief Medical Officer Sean Bagay, Chief Executive Officer and Ronald Kozak, VP Controller and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call may be deemed forward looking statements within the meaning of the Safe Harbor of the Private Securities Litigation Reform Act of 1995, and applicable federal securities laws, and that actual results may differ materially and adversely from what is contemplated by such forward looking statements due to a variety of substantial risks, uncertainties, and other factors.

[Valter Pinto, Managing Director at KCSA Strategic Communications]

The company's forward looking statements are based on management's current plans and assumptions and are subject to the risks and uncertainties more fully described in the company's filings with the SEC. These statements reflect management's view of current and future market conditions, including but not limited to statements regarding the company's clinical trials and other research studies, including timing for potential additional interim data readouts and full patient enrollment for RenovRx's ongoing Phase III TIGRPAC clinical trials studying intra arterial gemcitabine and locally advanced pancreatic cancer. The potential of the Renovocast device as a standalone commercial product or the transarterial microperfusion therapy platform as a mechanism of action, the anticipated timing for and levels of revenue generation from Renovocast sales and the company's commercialization plans in general, the potential for intra arterial gemcitabine to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovRx's efforts to explore commercialization strategies utilizing the transarterial microperfusion therapy platform. For a detailed discussion of some of the material risks and uncertainties facing RenovaRx, I refer you to the company's annual report on Form 10 ks for the year ended 12/31/2024, as well as the company's investor presentation and other reports filed periodically with the SEC, including our Form 10 Q for the first quarter of twenty twenty five, which was just filed with the SEC.

[Valter Pinto, Managing Director at KCSA Strategic Communications]

Renovo Rx disclaims any intention or obligation to update or revise any forward looking statements whether as a result of new information, future events, or otherwise, except as required by law. With that, it's my pleasure to turn the call over to Doctor. Ramtan Aga, Founder and Chief Medical Officer of RenovaRx. Ramten, please go ahead.

[Ramtin Agah, Chief Medical Officer & Founder at RenovoRx]

Thank you, Walter, and good afternoon, everyone. I appreciate everyone joining us today. At RenovaRx, we're pioneering a new era in cancer care through our transarterial microperfusion or TAP therapy platform. By localizing and targeting delivery of therapeutic agents like chemotherapy near the tumor site via the peripheral system, TAMP is designed to optimize drug concentration precisely where it's needed while potentially minimizing systemic exposure and related toxicities. This target approach addresses the longstanding challenge in cancer care where there is poor tumor blood supply.

[Ramtin Agah, Chief Medical Officer & Founder at RenovoRx]

I believe TAMPRA presents a significant advancement in the way cancer treatment can be approached. Our mission is to transform patients outcome by providing a safer, more effective way to deliver therapy directly to hard to treat tumors. Our ongoing Phase three target pack clinical trial evaluating the target delivery of chemotherapy gemcitabine with TAP via our patented FDA cleared Renova Cap device to patients with locally advanced pancreatic cancer is advancing with encouraging results. Our initial interim data showed that the patients experienced median overall survival with standard systemic chemotherapy delivery of ten months versus sixteen months with our targeted approach. This is from the time of randomization.

[Ramtin Agah, Chief Medical Officer & Founder at RenovoRx]

It is important to note that both median overall survival arms calculation for the study interim analysis data do not include approximately five and a half months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial. Moreover, we observed a sixty five percent reduction in adverse events such as nausea and fatigue, significantly improving patient quality of life. These results strengthen our conviction that TAMP can redefine outcomes for patients facing some of the most difficult to treat cancer. As we are continuing to increase exposure to TAMP and Renova CATs through our TIGER PACT trial and more recently to our commercial efforts for Renova CAT as a standalone device. The reception from physician community has been overwhelmingly positive.

[Ramtin Agah, Chief Medical Officer & Founder at RenovoRx]

Clinical investigators have expressed strong support and enthusiasm to our approach in drug delivery. Recognizing the potential clinical benefit and improved tolerability profile that the use of Renova CABP offers. Their feedback reinforces our belief that RenovaRx is well positioned to establish a new standard of care for LAPC and potentially other indications. As we advance our clinical and commercialization efforts, I'm energized by the transformative potential of our platform and deeply appreciate your continued support as we work to change the future of cancer treatment. Thank you for attending and for your support of RenovaRx.

[Ramtin Agah, Chief Medical Officer & Founder at RenovoRx]

With that, I turn over to our CEO, Sean Begay.

[Shaun R. Bagai, CEO at RenovoRx]

Thank you Ramtan. Q1 of twenty twenty five represented our first quarter of generating revenue from commercial sales. This is the result of the important strategic decision we made in 2024 to focus on implementing a commercial strategy for Novocath in tandem with our ongoing phase three trial. We plan to launch our commercial efforts for Novocath during Q1 of this year in response to anticipated strong demand for our technology. However, we received purchase orders ahead of schedule generating $43,000 of revenue in December.

[Shaun R. Bagai, CEO at RenovoRx]

I'm proud of our team for quickly implementing a go to market strategy to meet the demand from the oncology community and therefore made the decision to increase our US based Renovocath production last year. Last month I stated that we expected Q1 revenue to be in the low 6 figure range followed by sequential quarter over quarter increases for the remainder of the year. I'm pleased to report that revenue from Renovocath exceeded our internal expectations to approximately $200,000 in the first quarter and we anticipate this trend to continue going forward with sequential quarterly growth for the foreseeable future. We are encouraged by the strong organic demand for Inovacath with more than 10 medical institutions that are not current TIGRPAC sites having initiated the process for Renovacath purchase orders. These include several esteemed high volume academic and community and National Cancer Institute designated centers.

[Shaun R. Bagai, CEO at RenovoRx]

Further, we believe the approximately 20 centers that have used Renovacath as part of our TIGRPAC trial could also be potential customers for Renovocath after completion of TIGRPAC enrollment anticipated for later this year. Additionally, utilization of Renovocath devices by initial customers has led to repeat purchase orders. Based on our internal analysis of clinical interest and FDA cleared applications of the device, we believe that our initial total addressable market for Novocath represents an estimated $400,000,000 peak U. S. Annual sales opportunity.

[Shaun R. Bagai, CEO at RenovoRx]

We're assuming an average of eight annual procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where we already have clinical usage. While we haven't publicly disclosed our catheter pricing, technologies utilizing the same reimbursement coding are charging between $6,500 and $8,500 per device. Looking ahead we see expansion opportunities across other cancer indications that could create the potential for a several billion dollar U. S. TAM for Novocath over time.

[Shaun R. Bagai, CEO at RenovoRx]

The prospect of generating even a small portion of this market combined with the potential to help so many patients is driving our excitement about this opportunity. We believe we can manage meaningful market penetration with a small yet focused commercial team targeting the top 200 high volume treatment centers. Importantly, we believe this strategy can be executed without a material increase in our expenses, whether through direct commercialization or by partnering with a larger organization with an established sales force, which is a strategy we are actively exploring. We expect that the growing revenues from Renovocath will reduce our burn rate and that our cash on hand of $14,600,000 at the end of the first quarter will fully fund both our Renovacath scale up and the continued progress of our Phase three TIGER PATCH clinical trial. On the topic of our TIGER PACT clinical trial, during the first quarter of twenty twenty five, we announced that Johns Hopkins Medicine has now initiated enrollment in our ongoing Phase three TIGER PACT trial.

[Shaun R. Bagai, CEO at RenovoRx]

This is a valuable addition to the distinguished network of clinical cancer sites across The U. S. Participating in this important trial as we work towards full enrollment. We are continuing to target additional sites and expect that TIGRPAC will achieve full enrollment during 2025. As a reminder, the current protocol and statistical analysis plan for the TIGRPAC trial requires 114 randomized patients with 86 events or deaths necessary to complete the final analysis.

[Shaun R. Bagai, CEO at RenovoRx]

As of 05/02/2025, '90 '1 patients have been randomized and 56 events have occurred triggering the second interim analysis. We expect the study's data monitoring committee to review the data in Q3 and eagerly await their recommendations and feedback. Last week we announced the issuance of a new U. S. Patent for our TANF therapy platform further enhancing our IP production.

[Shaun R. Bagai, CEO at RenovoRx]

RenovRx'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 our TANT therapy platform and strengthens our competitive position. Before closing, I want to highlight one final point. During the first quarter we announced that in our most recent open trading window members of the management team and board purchased an aggregate of approximately 143,000 shares of Renovo Rx stock in multiple open market purchases. This signals our confidence in our company and its future and underscores our enthusiasm for our company's long term value proposition.

[Shaun R. Bagai, CEO at RenovoRx]

In conclusion, I want to reaffirm our belief that the approximately 20 cancer centers that have used Renovacath as part of our TIGER PACT trial could also be potential customers after the planned completion of enrollment later this year. Building upon our recent success, we expect revenue from Renovocath to increase from the low 6 figure range with sequential quarter over quarter increases for the remainder of the year as we move along the path to becoming cash flow positive in the future. With that I'll turn it over to Ron who will take us through some of the numbers.

[Ronald B. Kocak, VP Controller & Principal Accounting Officer at RenovoRx]

Thank you Sean. For the first quarter of twenty twenty five Renovo reported revenue of approximately $200,000 from commercial sales of its FDA cleared RenovoCast device, exceeding our initial expectations in our first quarter of revenue. Research and development expenses were $1,700,000 for the quarter, up from $1,300,000 in the first quarter of twenty twenty four. This $400,000 increase was primarily driven by the following, higher employee compensation due to cost of living adjustments, increased manufacturing and non recurring engineering costs to support commercial scale up, greater participation in conferences and trade shows and other ongoing R and D activities. Selling, general and administrative expenses were approximately $1,600,000 for the quarter, an increase from $1,200,000 in the prior year period.

[Ronald B. Kocak, VP Controller & Principal Accounting Officer at RenovoRx]

This $400,000 rise was attributed to increase in personnel related costs, professional and consulting fees to support commercialization and other selling, general and administrative activities. As of 03/31/2025, the company had $14,600,000 in cash and cash equivalents. As of 05/09/2025, shares of our common stock outstanding totaled 36,572,232. And now, I'll turn the call back to the operator for Q and A.

[Operator]

Ladies and gentlemen, at this time we'll begin the question and answer session. To ask a question, you may press star and then one on your touch tone phones. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To answer all your questions, you may press and 2. We'll pause momentarily to assemble the roster.

[Operator]

And once again, if you would like to ask a question, please press and 1. And I'm showing no questions. I would like to turn the floor back over to Sean Bagay for closing comments.

[Shaun R. Bagai, CEO at RenovoRx]

Thank you all again for participating in today's presentation. We were very excited about the key strategic steps we've taken over the last year to build long term value in our company. And we are beginning to see the tangible results from these efforts. We look forward to the rest of the year unfolding and to providing you with important updates on our progress. Have a great evening.

[Operator]

And ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. Actually, one moment. We do someone that has joined the question queue late. Let me join in, Raffa Khalid from Ascendiant Capital Markets. Please go ahead with your question.

[Analyst]

Hi. Thank you. This is Raffa for Edward Wu, Ascendiant Capital Markets. Can you talk about your plans for the Renovocast for international markets?

[Shaun R. Bagai, CEO at RenovoRx]

Thanks, Rupei, for the question. At this point, we don't have a current CE mark. We're looking into that for the future. We haven't disclosed publicly on timing of international markets, but obviously there's high demand for this type of technology, given the unmet need in these types of tumors in both the European countries, as well as in a very large market in China, Korea and Japan as well. So there's interest there.

[Shaun R. Bagai, CEO at RenovoRx]

We've talked to physicians, but we plan on really driving hard in The U. S. Commercial market given the reimbursement landscape and then approaching outside The U. S. Markets later, exploring that later this year, potentially next year.

[Analyst]

Great. And one more question. Do you have plans to increase, you talked about partnering with the potentially top 200 cancer centers. Would you use their sales force or would you use distributors to target those partners? So I have, yeah, thank you for the question.

[Shaun R. Bagai, CEO at RenovoRx]

I have said publicly that we are talking to a handful of strategic partners. These are large companies that have sales forces that cater to the interventional oncologists who do the procedures or the interventional radiologists. So we're looking at from a business perspective, if it makes more sense to hire a small sales force, the handful of reps to get to drive meaningful revenue for the company and or partner with a strategic partner that has an existing distribution channel. So we're exploring both currently and both are actually well on their way in terms of proving out which plan makes the most financial sense for the company.

[Analyst]

Great, thank you very much.

Participants

Executives

• Ramtin Agah, Chief Medical Officer & Founder
• Shaun R. Bagai, CEO
• Ronald B. Kocak, VP Controller & Principal Accounting Officer

Analysts

• Valter Pinto, Managing Director at KCSA Strategic Communications
• Analyst