RenovoRx, Inc. (RNXT) Q3 2026 Earnings Report, Transcript and Summary

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded. [Operator Instructions] I will now turn the call over to Stephanie Carrington, Managing Director of ICR Healthcare. Please go ahead.

Thank you, operator. Good afternoon, and welcome, everyone, to the RenovoRx Third Quarter 2026 Earnings Results Conference Call. I am joined today by members of the leadership team, including Shaun Bagai, Chief Executive Officer; Dr. Ramtin Agah, Chief Medical Officer, Executive Chair and Founder; and Mark Voll, Chief Financial Officer. Before we begin, I'd like to remind everyone that statements made during today's call contain or may contain forward-looking statements covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding RenovoRx's commercial activities and strategies, clinical plans, and expectations of financial or operational performance, including projected revenues, projected active commercial cancer centers and timing for completion and data readout of the company's TIGeR-PaC trial are based on management's current plans and assumptions, and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the quarter ended September 30, 2026, for detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd like to turn over the call to our Chief Executive Officer, Shaun Bagai.

Thank you, Stephanie, and good afternoon, everyone. The third quarter of 2026 was a milestone quarter for RenovoRx as we continue to deliver on all three of our core priorities. First, for the first time in our history, quarterly revenue exceeded the $1 million threshold. Second, we grew our customer base of active commercial cancer centers, expanded our sales pipeline and completed the build-out of our sales organization. Third, we advanced the expansion for our TAMP platform and RenovoCath device beyond locally advanced pancreatic cancer. In sum, we continue to deliver on multiple fronts. During the third quarter, RenovoRx generated record revenue of approximately $1.1 million, our strongest quarterly performance to date, increasing approximately 17% sequentially and nearly a 300% increase or more than 4x higher year-over-year. Revenue for the first 9 months of 2026 was approximately $2.5 million, more than double our full year 2025 revenue of $1.1 million. This is a direct measurable result of the commercial model we have described. Every new commercial cancer center we activate drives more procedures and revenue, accelerating growth. Driving much of our growth is our fully staffed sales team that continues to gain traction and accelerate customer engagement and adoption of TAMP. The sales team comprised of a Vice President of Sales and Market Development and 5 regional market development managers is strategically deployed to cover major U.S. cancer centers. Our focused and regionally deployed sales team is sufficiently sized to address the market and effectively penetrate cancer centers that treat solid tumors such as pancreatic cancer. For example, approximately 98% of pancreatic cancer diagnoses occur within roughly 200 cancer centers nationwide. When you analyze these centers further, the market concentration becomes even more pronounced. The top 25 centers account for about 40% of all U.S. pancreatic cancer diagnoses, and the top 100 centers represent more than 75% of total diagnosis. Given this distribution, a focused and regionally deployed team of 5 field representatives is appropriately sized to effectively access and support these centers. Let's refresh on the predictors of future revenue growth. The leading indicator of continued revenue growth for RenovoCath in the coming quarters and the metric I would encourage investors to continue to watch most closely is new account activations. Our activated commercial cancer center customers to date have been a source of recurring repeat demand. So the pace at which we activate accounts is what gives us confidence. We ended the third quarter 2026 with 26 active commercial cancer center customers compared to 21 at the end of second quarter 2026. We remain confident in our ability to meet our year-end 2026 target of 36 active commercial cancer center customers as we continue to activate centers in the commercial funnel and convert sites from our fully enrolled Phase III TIGeR-PaC trial to active centers. Our customer pipeline beyond these active sites is robust and expanding. In addition to the 26 active centers today, we have more than 40 additional centers in various stages of evaluation, approval or activation in our commercial funnel. Combined, this represents a total commercial funnel of more than 65 centers. Another key metric of commercial success is repeat orders. We continue to see strong repeat ordering from the majority of our existing customers, which we believe signals physician satisfaction and confidence in RenovoCath as a drug delivery option in interventional oncology. RenovoCath adoption is increasingly driven by physicians sharing firsthand experience with the device. This sharing continues to generate evidence and practical insights shared through peer-reviewed publications, medical meetings and clinician-to-clinician discussions. Because interventional, surgical and gastrointestinal oncology specialists work closely together, a positive RenovoCath experience at one center can accelerate adoption at the next. Physicians' confidence in our technology is reinforced by the growing body of clinical evidence that supports the use of TAMP and RenovoCath, which includes two recently peer-reviewed publications. Ramtin will walk you through both studies in greater detail. As we continue to commercialize, feedback from physicians tells us that the clinical need we are addressing is consistent across active centers. TAMP is most often used in patients whose tumors cannot be surgically removed and whose disease has not sufficiently responded to systemic chemotherapy to allow for surgery. We, therefore, have a clear picture of where and how TAMP is being utilized. I want to take a moment to touch on the current overall pancreatic cancer market and how we believe this benefits us. There has been significant industry attention recently on new therapies for pancreatic cancer, and we believe those developments may represent a meaningful opportunity for RenovoRx. Given that RenovoCath is a device designed to offer the potential to deliver treatments more optimally, we see breakthroughs in pancreatic cancer therapy as complementary and as an important potential tailwind for our business. I want to remind everyone that our TAMP platform enabled by RenovoCath is a collaborative localized drug delivery platform with two ways emerging therapies can strengthen our opportunity. First, for standard of care therapeutics, our platform can deliver established drugs locally near to the tumor site sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed and providing more treatment options for patients with difficult-to-treat disease. Second, as new drugs come to market, the range of therapies that can be delivered locally via our RenovoCath device may expand. And in both cases, our view is that novel improved therapies make the potential for our targeted drug delivery platform even more valuable. Turning to potential market expansion. We announced in August that a physician at one of our active centers used RenovoCath to deliver chemotherapy to a patient with sarcoma. This marks the first commercial use beyond locally advanced pancreatic cancer or LAPC and real-world potential for localized delivery of chemotherapy in other solid tumors. Additionally, the University of Vermont treated its first patient in late October in an investigator-initiated trial or IIT evaluating TAMP before surgery in patients with planned surgical resection for the first time in the neoadjuvant setting. IITs are capital efficient and enable independent investigators to generate safety and tolerability data of new applications for TAMP. Ramtin will go into more detail about physician-driven expansions beyond LAPC, an important and encouraging element as we look towards the potential for broader adoption of RenovoCath. We have also continued to strengthen our intellectual property position. The U.S. Patent and Trademark Office issued a notice of allowance in Q3 for a new patent covering our RenovoCath dual-occlusion catheter system, bringing our portfolio to 10 issued or allowed U.S. patents, 10 issued OUS patents, 6 pending U.S. cases, 7 pending OUS cases and two pending PCT applications. In closing, I could not be prouder of our team for their execution and hard work. The third quarter was a record quarter as we exceeded the $1 million threshold. Active commercial cancer centers grew from 21 to 26, and our total commercial funnel now surpasses 65 centers. Moreover, in October, the 1st patient was treated in an IIT evaluating TAMP before surgery in patients with planned surgical resection in the neoadjuvant setting. With our sales organization now fully staffed and the activity of the team still ramping, we are well positioned to continue executing as we close out 2026. With the commercial progress we continue to see to date, we are maintaining our full year 2026 revenue guidance of $3.75 million to $4.25 million. I'll now turn the call over to our Chief Medical Officer, Executive Chair and Founder, Dr. Ramtin Agah.

Before turning to the broader opportunity, I want to briefly revisit the science underpinning our potential TAMP platform. TAMP is designed to deliver therapeutic agents, including chemotherapy and potentially other therapies through the arterial wall near the tumor, concentrating treatment at the target site while potentially reducing toxicity compared with systemic intravenous therapy. For patients facing both solid tumors and burdensome treatment side effects, the distinction can be meaningful. Cancer treatment has traditionally relied on three primary approaches: surgery, radiation and systemic chemotherapy. We believe TAMP enabled by RenovoCath can augment these approaches. RenovoRx reached a major company milestone at the end of August. We completed enrollment in our Phase III TIGeR-PaC trial for locally advanced pancreatic cancer. This achievement advances our lead clinical program. TIGeR-PaC is evaluating whether our patented targeted delivery of gemcitabine can improve survival, safety and tolerability compared with the standard systemic intravenous gemcitabine + Abraxane. We expect initial top line data in the second half of 2027 and expect the data readout to support and potentially expand current clinical adoption of TAMP by providing more rigorous evidence of tolerability and reduced side effects. The trial may also show whether TAMP can improve survival in this study. Additionally, in August, we announced pharmacokinetic and pharmacodynamic data from a substudy of the TIGeR-PaC trial in the Journal of Cancer Chemotherapy and Pharmacology. The findings from this PK/PD study provide additional meaningful mechanistic support for our TAMP platform's targeted drug delivery approach. In short, data from this randomized study demonstrated significant drug uptake directly near the tumor site with reduced systemic drug levels. These results provide direct pharmacokinetic evidence supporting TAMP's potential to deliver chemotherapy more selectively to the tumor while limiting systemic exposures. These findings strengthen TAMP enabled by our RenovoCath device as a differentiated approach to potentially improve the therapeutic index of chemotherapy in patients with locally advanced pancreatic cancer. And in October, researchers at Hackensack Meridian Health, Jersey Shore University Medical Center published a peer-reviewed case series in Case Reports in Oncology. In it, physicians share their own experience using TAMP to treat patients diagnosed with locally advanced pancreatic cancer whose tumors were not surgically removable due to significant complex blood vessel involvement despite receiving extensive prior therapy. We are encouraged that physicians are independently documenting and sharing their experiences with TAMP and its potential to provide clinical benefit for patients. Independent peer-reviewed publications such as this add to the growing body of clinical evidence supporting TAMP enabled by RenovoCath. We believe these findings strengthen the scientific rationale for our drug delivery platform and support our broader mission to bring meaningful new options to patients with difficult-to-treat tumors, especially as promising pancreatic cancer treatments emerge that could be delivered via RenovoCath. Building on what Shaun mentioned, we're expanding our footprint in other solid tumors. Our very early endeavor in sarcoma this summer has generated continuing interest in treating this type of cancer using our TAMP platform. As a reminder, sarcoma is a cancer that starts in soft tissues or bones. On another front, in October, University of Vermont treated its first patient in a physician-led investigator-initiated trial or IIT evaluating TAMP before surgery in patients with planned surgical resection for the first time in the neoadjuvant setting. This is the 1st IIT that we're supporting that has begun enrolling and it reflects physicians' own interest in exploring TAMP early in the disease, upstream of locally advanced disease. We are encouraged to see physicians leading these efforts and are proud to support their work. In summary, before turning the call over to Mark, I would like to mention, as I did on the last call, clinical evidence builds physicians' confidence. Physician confidence drives adoption and adoption drives revenue. Thank you. And with that, I turn it over to Mark.

Thank you, Ramtin, and good afternoon, everyone. The third quarter was a strong quarter and continues to showcase the meaningful progress on our commercial plan. Let me walk you through the numbers. For the third quarter ended September 30, 2026, RenovoRx reported record revenue of $1.07 million, our strongest quarter to date. This represents approximately 17% sequential quarterly growth and revenue that was more than 4x higher than the $266,000 we reported in the third quarter of 2025. Exceeding the $1 million quarterly revenue milestone for the first time underscores the momentum in our commercial business, driven by the expansion of active commercial centers and consistent repeat ordering from our existing customers. Gross profit for the third quarter was $878,000, representing a gross margin of 82%. Margin performance in the quarter reflects the conversion of three devices from one site in our Phase III trial to a commercial center customer at no gross margins in accordance with generally accepted accounting principles. These transactions represent reclassification of line items on the P&L. We believe there may be a few additional transactions of this nature in future quarters. Excluding this transaction, our underlying gross margin for the quarter was 85%, consistent with the approximately 84% gross margin we reported in the first half of the year and reflecting the strong fundamental economics of RenovoCath. Research and development expenses for the third quarter were approximately $1.2 million compared to $1.7 million in the third quarter of 2025. Our third quarter research and development expenses reflects our continued investment in our investigator-initiated trial programs, partially offset by lower costs associated with our Phase III TIGeR-PaC trial following completion of the patient enrollment as we previously announced. Selling, general and administrative expenses were approximately $2.9 million compared to the $1.7 million in the same quarter a year ago. The increase reflects the disciplined investment we have made to build and support our commercial infrastructure necessary to advance our commercialization strategy. Loss from operations for the quarter was approximately $3.2 million, improving from the $3.4 million of operating losses in the prior quarter. As revenue continues to scale, we expect operating losses to narrow further as we advance towards our goal of sustained profitability. Net loss for the quarter was $3.6 million or a loss of $0.08 per share based on approximately 48.2 million shares. On a cash basis, eliminating the noncash charges for stock-based compensation and the change in fair value of common warrant liability, net loss was $2.7 million or a loss of $0.06 per share. As of September 30, RenovoRx had approximately $10.4 million in cash and cash equivalents compared to approximately $9.5 million at June 30, 2026. The increase was driven by $3.5 million of warrant exercises, which offset the cash impact of our operating loss for the quarter. We believe our cash position provides sufficient runway to fund operations into the second half of 2027 as we continue to work towards our goal of cash flow positive operations. As we close out the third quarter, our results underscore the continuing strength of our commercial foundation and the operating leverage inherent in our model. We delivered record revenues of $1.07 million, achieved strong underlying gross margins and improved our loss from operations to approximately $3.2 million, reflecting the benefit from scaling revenue. Our improved cash position of $10.4 million provides a clear runway into the second half of 2027, supporting disciplined investment in our commercial expansion. Importantly, our commercial footprint continues to grow. We increased the number of active centers to 26 during the quarter and expanded the pipeline of cancer centers evaluating, approving or activating RenovoCath to more than 40 centers. We believe that both metrics are important leading indicators of future demand and reflect the continued progress in the commercialization of RenovoCath. Taken together, these results demonstrate momentum building across our business and reinforce our confidence in the path ahead. We remain focused on executing with discipline, expanding access to RenovoCath and advancing towards profitable operations. Thank you for your continued support as we deliver meaningful impact for patients and long-term value for shareholders. Thank you. I'll turn the call back to the operator for Q&A.

[Operator Instructions] The first question comes from Justin Walsh with JonesTrading.

You alluded to changes in the pancreatic cancer landscape. I'm wondering if you can provide additional color on whether the approval of [ RASONQUE ] could impact the use of chemo in pancreatic cancer. And as a follow-up, how you envision physicians potentially testing new drugs locally with RenovoCath and how that could transfer to a broader commercial reach?

Thanks for the question, Justin. So yes, that's one of the new potential therapies I was alluding to is the latest approval. I believe it won't impact the use of chemotherapy initially as the studies were done in a second-line metastatic pancreatic cancer setting, and that was in conjunction with other chemotherapy. I believe they're looking at single-agent studies now in lieu of chemotherapy. We'll have to see how that data plays out. But to date, I've not heard of patients going in treatment naive and going straight for a RAS inhibitor. It is an exciting opportunity, though, as we are hopefully treating pancreatic cancer in a more efficient pathway. And I do believe that there is an opportunity for us either with giving a RAS inhibitor or other agents upfront in induction therapy prior to our TAMP technology or adjacent to or concurrently. And then down the road, I can see that there's an opportunity to put other agents through our device and deliver. And I mentioned this on previous calls, we are exploring other agents like the use of oxaliplatin even for metastatic pancreatic cancer. So these advancements can really help our technology by enhancing what good data we have today.

The next question is from [ Henry Ware ] with H.C. Wainwright.

This is Henry on for RK. Regarding the PRISM-TAMP, could you tell us a little bit more about where TAMP fits between systemic chemo and surgery? And are patients receiving the usual course of treatment before TAMP, or is it modifying that as well?

Thanks for the question, Henry. PRISM-TAMP is actually very exciting for us because as we've been primarily focusing on locally advanced pancreatic cancer to date, this takes treatment further up the pathway to potentially Stage 2 or kind of 2, 3 patients for neoadjuvant for borderline resectable patients. These are patients that are not quite resectable yet, but are planning on potential resection. So it's a similar pathway as what we've seen in TIGeR-PaC and other studies where they get upfront systemic chemotherapy followed by radiation therapy and then TAMP therapy. So it's very similar, although the treatment course for radiation is slightly truncated with the goal of getting through the TAMP procedures and getting to potential surgical resection or removal of the tumor faster.

The next question is from Ed Woo with Ascendant Capital.

As your commercialization for TAMP seems to be progressing very well, have you considered accelerating the investment in your sales and commercial team?

Well, I think we announced during the quarter, during our call that we're now fully staffed at 5 salespeople throughout the United States. We announced on this call earlier that we see a really concentrated market where there's just -- the top 100 centers really represent almost 3/4 of the total market. So we think 5 is sufficient. If we -- as we go along, if we see that's not, we'll add to that at some point in time. But we think -- currently, we think that's sufficiently sized to address the market.

This concludes our question-and-answer session. I would like to turn the conference back over to Shaun Bagai for any closing remarks.

Thank you, everyone, for joining, and I look forward to seeing you either virtually or in person at the Canaccord Conference next Wednesday.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.