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RenovoRx, Inc. (RNXT)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $0.266M, below consensus $0.304M (miss), while EPS matched consensus at $(0.08); gross profit was $0.213M and net loss was $(2.9)M . Estimates from S&P Global: Revenue Consensus Mean $0.304M vs Actual $0.266M; Primary EPS Consensus Mean $(0.08) vs Actual $(0.08); 4 estimates for both metrics (Values retrieved from S&P Global)*
  • Commercial adoption expanded: 14 cancer centers approved to purchase RenovoCath and 5 active centers treating patients, with 10 additional centers requesting product quotes .
  • TIGeR-PaC Phase III guidance shifted: enrollment completion now expected in early 2026 (from “late 2025/early 2026”), final data anticipated in 2027 .
  • Margin trajectory improving; mgmt cites reduced COGS and strong U.S.-based supply chain resilience, positioning device gross margins to increase as scale builds .
  • Financing flexibility enhanced via plan to refresh shelf registration and establish an at-the-market offering; cash was $10.0M at quarter-end, funding commercialization and TIGeR-PaC enrollment completion .

What Went Well and What Went Wrong

  • What Went Well

    • Early commercial traction sustained with expanding approved centers (14), repeat orders, and growing multi-disciplinary interest across oncology specialties . “We are encouraged by the increasing physician-to-physician advocacy for our TAMP platform…positioning RenovoRx for long-term success.”
    • Gross margin improvement supported by manufacturing collaboration and U.S.-sourced components; “we’ve already reduced our COGS and increased our margins…RenovoCath has over a two-year shelf life” . Q2 gross margin was ~64% .
    • DMC recommended continuing TIGeR-PaC after second interim review, reinforcing confidence in the trial’s potential outcome .

  • What Went Wrong

    • Revenue missed consensus ($0.266M actual vs $0.304M est.) (Values retrieved from S&P Global)*; mgmt highlighted early-stage commercialization and variability as a few patients can move orders day-to-day .
    • Net loss widened vs prior year ($2.9M in Q3 2025 vs $2.5M in Q3 2024), reflecting ongoing investment in R&D and SG&A build-out .
    • TIGeR-PaC enrollment timeline pushed to early 2026 (vs “later this year or early next year”), extending the pivotal data catalyst into 2027 .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.200 $0.422 $0.266
Net Loss ($USD Millions)$(2.420) $(2.895) $(2.912)
EPS (Basic & Diluted, $USD)$(0.08) $(0.08) $(0.08)
Cost of Revenues ($USD Millions)N/A$0.152 $0.053
Gross Profit ($USD Millions)N/A$0.270 $0.213
Gross Margin (%)N/A64.0% 80.1% (derived from )
R&D Expense ($USD Millions)$1.7 $1.426 $1.685
SG&A Expense ($USD Millions)$1.6 $1.522 $1.728
Cash & Equivalents ($USD Millions)$14.6 $12.3 $10.0
Shares Outstanding (Millions)36.572 36.646 36.6
Q3 2025 vs Estimates (S&P Global)ConsensusActualBeat/Miss
Revenue ($USD Millions)$0.304*$0.266 Miss (Values retrieved from S&P Global)*
Primary EPS ($USD)$(0.08)*$(0.08) In line (Values retrieved from S&P Global)*
EBITDA ($USD Millions)N/A*$(3.200)*N/A (Values retrieved from S&P Global)*
# of Estimates (Revenue/EPS)4 / 4*—— (Values retrieved from S&P Global)*

Segment breakdown: Not applicable; device sales are reported as a single revenue line .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
TIGeR-PaC Enrollment CompletionTrialLater 2025 or early 2026 Early 2026 Lowered (slightly delayed)
TIGeR-PaC Final Data ReadoutTrialNot specified2027 New guidance (added)
Cash RunwayCorporateCash to fund commercialization and trial progress Cash funds enrollment completion and commercial scale-up; cash $10.0M at 9/30/25 Clarified, more specific
RenovoCath Revenue TrajectoryCommercialSequential growth; early-stage variability expected Revenue expected to grow in 2026; continue to offset burn Maintained directional; emphasis on 2026
Sales Organization Build-outCommercialHiring Sr. Director of Sales; add small team in H2’25 Sr. Director onboard; two regional managers added; plan to add marketing director Raised (expanded team)
Financing FlexibilityCorporateNot specifiedRefresh shelf registration; establish ATM offering New (added flexibility)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
Commercial AdoptionQ1: First full quarter device revenue ~$0.200M; >10 non-trial institutions initiating POs; TAM ~$400M . Q2: Revenue $0.422M; 13 centers approved; 4 using with repeat orders .14 centers approved; 5 active centers; 10 additional centers requested quotes; growing physician advocacy Broadening footprint; repeat use expanding
Supply Chain & MarginsQ2: Manufacturer Medical Murray; increasing production . Gross margin ~64% .Reduced COGS, increased margins; two-year shelf life; U.S.-based manufacturing/sourcing; insulated from global macro issues Improving margins; low supply-chain risk
Clinical Trial Progress (TIGeR-PaC)Q1: 91 randomized; 56 events; second interim planned . Q2: DMC recommended continuation; 95 randomized, 61 events .Enrollment completion early 2026; final data 2027 Extended timeline; continued confidence
Post-Marketing Registry (PANTHER)Q2: Launched multi-center registry; centers will purchase devices for study .First procedure at Univ. of Vermont; sites added (Baptist Health Miami, UPMC) Building real-world evidence
Market Opportunity & StrategyQ1/Q2: TAM ~$400M initial; several-billion potential across tumor types; lean team targeting top 200 centers .Vision for deep market penetration; add sales/marketing; revenue acceleration targeted for 2026 Scaling commercial foundation

Management Commentary

  • “Year-to-date revenue through the end of Q3 was approximately $900,000…on track to finish out the year strong…enable meaningful revenue acceleration in 2026 and beyond.” — CEO Shaun Bagai .
  • “We’ve already reduced our COGS and increased our margins…RenovoCath actually has over a two-year shelf life…manufactured in the U.S., components largely U.S.-sourced.” — CEO Shaun Bagai .
  • “Enrollment expected to be completed in early 2026 and final data anticipated in 2027.” — Chief Clinical Officer Lisa Gentry .
  • “We are seeing light at the end of the tunnel…multiple potential opportunities to strengthen our balance sheet…refreshing shelf registration…establishing an at-the-market offering.” — CEO Shaun Bagai .

Q&A Highlights

  • International expansion: Focus remains on U.S. given reimbursement tailwinds; international markets to be explored later .
  • Supply chain: U.S.-based manufacturer near Chicago; reduced COGS and margin expansion; ability to ramp production; >2-year device shelf life .
  • Sales cycle & pipeline: Approval timelines range from weeks to several months; 24 formal quote requests and “dozens” of interested physicians; adding regional managers to shorten timelines .
  • TIGeR-PaC details: 114 randomized patients needed; 86 deaths trigger final analysis; updated timeline to early 2026 enrollment; DMC continuation recommendation .
  • Registry & indications: Real-world data collection underway; interest beyond pancreatic cancer (e.g., biliary), and exploring additional agents (platinum, immunotherapy) via TAMP .

Estimates Context

  • Q3 2025 revenue missed consensus ($0.304M est. vs $0.266M actual); EPS was in line ($(0.08) est. vs $(0.08) actual); 4 estimates each (Values retrieved from S&P Global)*.
  • EBITDA consensus not available; actual EBITDA from S&P Global was approximately $(3.200)M (Values retrieved from S&P Global)*.
  • Given the miss on revenue and in-line EPS, near-term estimate revisions may tweak top-line expectations to reflect early commercialization variability highlighted by management .

Key Takeaways for Investors

  • Commercial traction is building (14 approved centers; 5 active; 10 additional quotes), but quarter-to-quarter revenue variability will persist until the sales footprint and installed base deepen; expect stronger growth in 2026 .
  • Device margins are trending higher as COGS fall and production scales with a resilient U.S. supply chain—supportive of operating leverage as volumes increase .
  • TIGeR-PaC timeline extension shifts the pivotal clinical data catalyst to 2027; continued DMC support mitigates risk perception, but pushes the clinical inflection point out .
  • Financing flexibility (shelf refresh, ATM) could reduce funding overhang; cash of $10.0M supports commercialization and trial enrollment completion into early 2026 .
  • Short-term trading: Revenue misses vs consensus can pressure shares, offset by visible adoption milestones and margin commentary; watch press flow on additional center approvals and registry site activations .
  • Medium-term thesis: A niche, high-margin device opportunity with TAM expansion potential across solid tumors, coupled with a pivotal trial that, if positive, can materially enhance adoption and valuation .
  • Monitor: Sequential revenue trajectory, gross margin progression, center activation pace, and any updates on interim enrollment/events in TIGeR-PaC .

S&P Global disclaimer: All consensus estimates and related actuals marked with an asterisk (*) are values retrieved from S&P Global.