RenovoRx, Inc. Q1 FY2025 earnings call

• Pioneering a new era in cancer care through the transarterial microperfusion (TAMP) therapy platform, targeting delivery of therapeutic agents near tumor sites to optimize drug concentration and minimize systemic exposure.
• Ongoing Phase 3 TIGeR-PaC clinical trial evaluating targeted delivery of gemcitabine with TAMP via RenovoCath device showing encouraging results, with median overall survival improvement and reduced adverse events.
• Q1 2025 revenue from RenovoCath exceeded internal expectations at approximately $200,000, with strong organic demand and potential for sequential quarterly growth.
• Plans for commercialization of RenovoCath, targeting top 200 high-volume treatment centers in the U.S., with an estimated $400 million peak U.S. annual sales opportunity initially.
• Johns Hopkins Medicine initiated enrollment in the TIGeR-PaC trial, with 91 patients randomized and 56 events occurred by May 2, 2025, triggering second interim analysis.
• Issuance of a new U.S. patent for the TAMP therapy platform enhancing IP portfolio.
• Management team and board members purchased aggregate of approximately 143,000 shares in recent open trading window.

In the first quarter of 2025, Renovo reported revenue of approximately $200,000 from commercial sales of its FDA-cleared RenovoCath device. Research and development expenses were $1.7 million for the quarter, an increase from $1.3 million in the first quarter of 2024, primarily driven by higher employee compensation, increased manufacturing and nonrecurring engineering costs, greater participation in conferences and trade shows, and other ongoing R&D activities. Selling, general, and administrative expenses were approximately $1.6 million for the quarter, an increase from $1.2 million in the prior year period, attributed to increase in personnel-related costs, professional and consulting fees to support commercialization, and other selling, general, and administrative activities.

• Q1 revenue from RenovoCath was approximately $200,000, exceeding internal expectations, and anticipation of sequential quarterly growth for the foreseeable future.
• Cash on hand of $14.6 million at the end of Q1 will fully fund RenovoCath scale-up and continued progress of Phase 3 TIGeR-PaC clinical trial.
• TIGeR-PaC trial expected to achieve full enrollment during 2025, with Studies Data Monitoring Committee to review data in Q3.
• Expectation to drive hard on U.S. commercial market first, then explore international markets later this year or next year.

Q: Can you talk about your plans for the RenovoCath for international markets?

A: 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 a very large market in China, Korea, and Japan as well. So there's interest there. We've talked to positions, but we plan on really driving hard on the U.S. commercial market given the reimbursement landscape and then approaching outside the U.S. markets exploring that later this year, potentially next year.

Q: Do you have plans to increase -- you talked about partnering with potentially the top 200 cancer centers? Would you use their sales force or would you use distributors to target those partners?

A: I have stated 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 with a 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 to the company.