RenovoRx, Inc. Q2 FY2025 earnings call

• Launched commercialization of RenovoCath device in late 2024, achieving over $400,000 in sales in Q2 despite no sales and marketing team in place.
• Phase III TIGR PACT trial: Fifty-second event triggered pre-planned second interim analysis, DMC recommended continuing the trial, with 95 patients randomized and 61 events occurred as of 08/12/2025, on track to complete enrollment later in 2025 or early 2026.
• Launched Panther multicenter post-marketing registry study to follow patients undergoing cancer treatment with RenovoCath, evaluating safety and effectiveness in real-world settings.
• Hired Phil Stockton as Senior Director of Sales and Market Development to build commercialization momentum and gather market data.

In the second quarter of 2025, RenovoRx reported revenues of approximately $422,000 from commercial sales of the RenovoCath device. This revenue was generated from new customer purchase orders and early repeat orders from initial sites, with RenovoCath contributing as the main product segment.

• Anticipates enrollment completion in Phase III TIGR PACT trial by end of 2025 or early 2026.
• Believes RenovoCath has significant market potential with an initial US total addressable market of an estimated $400 million peak annual sales opportunity, and potential for several billion dollar total addressable market as expanded into additional cancer applications.
• Plans to engage with FDA regarding potential accelerated approval pathway for the RenovoCath device based on trial outcomes.

Q: Clarification on trial maintenance and why second interim data wasn't published A: Shaun Bagai explained that early interim data didn't bias the trial, and with nearing trial end and enthusiasm for potential positivity, not publishing second interim data protected trial integrity for FDA approval.

Q: Enrollment pace for TIGR PACT trial A: Shaun Bagai stated enrollment is on track to complete later in 2025 or early 2026, with larger cancer centers added recently expected to accelerate enrollment.

Q: Revenue from Panther study and TIGR PACT trial A: Shaun Bagai clarified $422,000 revenue is from external commercial sales, TIGR PACT sites using catheters don't recognize revenue yet but Panther study revenues count towards recognition.

Q: International plans for RenovoCath A: Shaun Bagai mentioned hyper-focus on US market first, but will explore international markets once US traction is established.

Q: Phil Stockton's role and revenue trajectory A: Shaun Bagai stated Phil Stockton's hire is to start ramping commercialization efforts now, with expectation of revenue growth as market penetration increases Q: Engagement with FDA on accelerated approval A: Shaun Bagai said they will engage FDA to explore accelerated approval pathway as trial nears completion Q: Sequential gains in catheter revenue A: Shaun Bagai indicated seeing growth over next half of 2025 but ramping to take place more in 2026 with sales hires Q: Preclinical studies for other drugs with RenovoCath A: Shaun Bagai said they are exploring other drugs, will perform preclinical studies and disclose data when publishable Q: Partnerships and distribution for RenovoCath A: Shaun Bagai mentioned manufacturing partnership with Medical Murray is complete, and ongoing discussions with distribution partners, but initial focus on capturing revenue in-house