RI
RenovoRx, Inc. (RNXT)·Q1 2025 Earnings Summary
Executive Summary
- First full quarter of commercial revenue: ~$0.20M from RenovoCath, exceeding internal expectations; management expects sequential quarterly growth for the foreseeable future .
- EPS was approximately in line with consensus at -$0.08*, and revenue modestly beat consensus ($0.197M* vs. $0.183M*), aided by >10 non-trial institutions initiating POs and early reorder activity .
- Cash of $14.6M at 3/31/25; management believes this will fully fund RenovoCath scale-up and continued progress toward TIGeR-PaC completion as device revenues ramp .
- Key near-term catalyst: second interim analysis for TIGeR-PaC triggered (56/86 events as of May 2); DMC review expected in Q3 2025; full enrollment still targeted for 2025 .
- Insider alignment: management and board purchased ~143K shares during the recent open window, signaling confidence in trajectory .
What Went Well and What Went Wrong
What Went Well
- Strong commercial traction: “Q1 was our first full quarter of RenovoCath commercial sales, generating approximately $200,000 in revenue… we anticipate this positive trend to continue as we expect sequential quarterly growth” — CEO Shaun Bagai .
- Demand signals broadened: >10 non‑TIGeR‑PaC medical institutions (including high‑volume NCI centers) initiated POs; early utilization led to repeat orders .
- Operating preparedness and IP strengthening: Increased U.S. production to meet demand; new U.S. patent issued; portfolio now 19 issued patents globally (9 U.S.), plus 7 U.S. pending .
What Went Wrong
- Loss widened YoY: Net loss was -$2.4M vs. -$1.1M in Q1’24, driven by higher operating loss and a $0.8M decrease in fair value of common warrant liability .
- Opex up YoY as commercialization scales: R&D +$0.4M YoY on compensation, manufacturing/NRE, conferences; SG&A +$0.4M YoY on personnel and commercialization support .
- International remains future optionality: No CE mark currently; company is prioritizing U.S. commercialization before pursuing OUS opportunities, which may defer ex-U.S. revenue ramp .
Financial Results
P&L vs prior periods and consensus
Notes: “—” indicates not disclosed in the referenced primary document for that period.
Values marked with * retrieved from S&P Global.
Operating expense detail (YoY)
Balance sheet snapshot
Commercial & clinical KPIs
Guidance Changes
No formal numerical guidance was issued; management continues to provide qualitative directional commentary.
Earnings Call Themes & Trends
Management Commentary
- “Q1 was our first full quarter of RenovoCath commercial sales, generating approximately $200,000 in revenue… we anticipate this positive trend to continue as we expect sequential quarterly growth for the foreseeable future.” — CEO Shaun Bagai .
- “We expect the study’s data monitoring committee to review the data in Q3 and eagerly await their recommendations and feedback.” — CEO Shaun Bagai .
- “As of March 31, 2025, the company had $14.6 million in cash and cash equivalents.” — VP Controller & PAO Ronald Kocak .
- “The reception from the physician community has been overwhelmingly positive… [we observed] a 65% reduction in adverse events… and median overall survival… 10 months vs 16 months with our targeted approach.” — Founder & CMO Dr. Ramtin Agah (study interim context) .
Q&A Highlights
- International expansion: No current CE mark; company prioritizes U.S. commercialization given favorable reimbursement, exploring OUS later this year or next .
- Go-to-market model: Actively evaluating building a small internal sales force versus partnering with a strategic with existing interventional oncology distribution; both paths in progress to determine best financial outcome .
Estimates Context
- Q1 2025 revenue modestly beat consensus: $0.197M* vs $0.183M*; EPS in line at -$0.08* with 3 estimates for both revenue and EPS*; target price consensus $5.44* (4 estimates).
Values retrieved from S&P Global.
Key Takeaways for Investors
- Early commercialization is working: sequential growth is underway, with ~$0.20M in Q1 device revenue and clear demand signals (top centers initiating POs, early reorders) .
- Operating leverage potential: Management believes a small focused team or a strategic partner can drive meaningful penetration at ~200 top centers, potentially limiting opex growth as revenue scales .
- Runway to catalysts: $14.6M cash should fund RenovoCath scale-up and TIGeR-PaC progress through a Q3 DMC review; full enrollment targeted for 2025—both key stock catalysts .
- Clinical narrative building: interim data previously cited show survival and tolerability advantages; a positive DMC outcome would strengthen the device+therapy platform story .
- Insider conviction: ~143K open-market purchases by management/board underscore confidence and can be a sentiment tailwind .
- Watch for partner optionality: A distribution partnership could accelerate adoption and improve capital efficiency; near-term updates on commercial model could move shares .
- Risk monitor: Losses widened YoY as the company invests in commercialization; revenue scale and DMC outcomes are central to de‑risking the path to cash flow positivity .
Footnotes:
Values marked with * retrieved from S&P Global.
Company reported “approximately $200 thousand” of Q1 2025 revenue .