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RenovoRx, Inc. (RNXT)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $0.422M, up from ~$0.200M in Q1 and $0.0M in Q2 2024; revenue significantly exceeded Wall Street consensus of $0.247M, driven by early commercial traction for RenovoCath at 13 approved cancer centers and repeat orders from 4 active sites . Revenue consensus $0.247M; Actual $0.422M (+71% surprise)*.
  • Net loss was $(2.895)M versus $(2.389)M a year ago, primarily due to a $(0.9)M unfavorable change in warrant liability, partly offset by a $0.4M improvement in loss from operations; diluted EPS was $(0.08) vs. $(0.10) in Q2 2024 .
  • Independent Data Monitoring Committee (DMC) recommended continuing the pivotal Phase III TIGeR-PaC trial after the second pre-planned interim analysis; management will defer publishing interim data to preserve trial integrity. As of 8/12/25, 95 patients randomized and 61 events, keeping enrollment completion on track for late 2025 or early 2026 .
  • Gross profit of $0.270M on $0.422M revenue implies ~64% gross margin; management expects device margins to rise into the 70–90% range as scale improves, supporting a lean commercialization model .

What Went Well and What Went Wrong

What Went Well

  • Commercial traction accelerated: 13 cancer centers approved to purchase RenovoCath (up from 5 in Q1), with 4 active centers placing repeat orders; Q2 revenue reached $0.422M without a dedicated salesforce, underscoring early demand .
  • Positive DMC outcome: “The independent DMC… has recommended that we continue the study… an expression of confidence in the potential for a positive outcome” (CEO) . Enrollment progress (95 randomized; 61 events) supports target to complete enrollment late 2025/early 2026 .
  • Organization build-out and ecosystem momentum: Hired Senior Director of Sales & Market Development (Philip Stocton) to coordinate commercialization; launched multi-center PanTheR post-marketing registry with participating sites purchasing devices, broadening real-world data and use across solid tumors .

What Went Wrong

  • Wider YoY net loss: $(2.895)M vs. $(2.389)M, driven by a $(0.350)M other expense vs. prior-year other income (reflecting a $(0.9)M) change in warrant liability), despite lower operating loss; underscores sensitivity to non-operating items .
  • Limited near-term visibility: Management declined to give numerical revenue guidance, characterizing 2025 as a “learning year,” with more substantial ramp expected in 2026; could temper near-term expectations and introduce quarterly variability .
  • Interim data optics: Decision to defer publishing second interim results may delay incremental clinical data catalysts (though preserves FDA trial integrity), leaving investors to await enrollment completion and final analysis triggers .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.000 ~$0.200 $0.422
Gross Profit ($USD Millions)$0.000 N/A$0.270
Gross Margin (%)N/AN/A~64.0% (derived from $0.270/$0.422)
R&D ($USD Millions)$1.542 $1.700 $1.426
SG&A ($USD Millions)$1.492 ~$1.600 $1.522
Net Loss ($USD Millions)$(2.389) $(2.420) $(2.895)
Diluted EPS ($)$(0.10) $(0.08)*$(0.08)
Cash & Equivalents ($USD Millions)N/A$14.6 $12.3

Notes: Gross margin shown is calculated from reported revenue and gross profit (citations in cell). EPS for Q1 2025 marked with an asterisk reflects S&P Global data where company document did not specify the figure.

Consensus vs. Actual

MetricQ1 2025Q2 2025
Revenue Consensus Mean ($)183,330*247,250*
Revenue Actual ($)~200,000 422,000
Revenue Surprise ($ / %)+16,670 / +9.1%+174,750 / +70.7%
EPS Consensus Mean ($)-0.080*-0.085*
EPS Actual ($)-0.08*-0.08
EPS Surprise ($)~0.00+0.005

Values with asterisks (*) retrieved from S&P Global.

KPIs and Operating Metrics

KPIQ4 2024 / Early 2025Q1 2025Q2 2025 (Current)
Approved customer centers>10 institutions initiated POs >10 non-TIGeR-PaC institutions with POs/reorders 13 approved; 4 active with repeat orders
TIGeR-PaC patients randomized90 (as of 3/28/25) 91 (as of 5/2/25) 95 (as of 8/12/25)
TIGeR-PaC events (deaths)50 (as of 3/28/25) 56 (as of 5/2/25) 61 (as of 8/12/25)
ManufacturingMedical Murray as principal manufacturer —Ongoing; options issued to Medical Murray to support ramp

No reportable segments disclosed; RenovoCath device sales are the primary commercial driver.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
TIGeR-PaC enrollment completion timing2025–2026“Full enrollment during 2025” “On target to complete enrollment this year or early next year” (as of 8/12/25) Slightly widened (late 2025 to early 2026)
Revenue trajectory2025–2026Sequential quarterly growth anticipated No numeric guidance; 2025 a learning year; expect continued growth in H2’25 and a more material ramp in 2026 Lower near-term specificity; emphasis on 2026 ramp
Device gross marginMulti-yearN/AExpect to increase toward 70–90% as scale improves New disclosure
Cash runway2025–trial progressCash at 3/31/25 expected to fully fund commercialization scale-up and TIGeR-PaC progress Cash at 6/30/25 expected to fully fund commercialization scale-up and TIGeR-PaC progress Maintained
Sales organization2025–2026Operating without dedicated sales team Hired Sr. Director of Sales; add small number of sales personnel in H2’25 to widen penetration Progressed execution

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q2 2025)Trend
Commercialization momentumInitial revenues began Dec-2024; >10 institutions initiated POs; sequential growth expected 13 centers approved; 4 active; repeat orders; Q2 revenue $0.422M Improving adoption and revenue ramp
Clinical DMC and timelineSecond interim expected in Q2’25 DMC recommended continuation; defer interim data publication; 95 randomized/61 events; enrollment on track late ’25/early ’26 Positive continuation; disciplined data handling
Sales organization buildLean model, no dedicated team Hire of Senior Director; plan selective additions H2’25; broader push in 2026 Building for 2026 scale
Gross margin/profitabilityN/AImplied ~64% GM in Q2; pathway to 70–90% with scale Structural margin tailwind
Registry/real-world evidenceN/ALaunched PanTheR registry; participating centers purchase devices New RWE engine; revenue-supportive
TAM/indication expansion$400M initial U.S. TAM; several-billion potential over time Continued emphasis; interest beyond pancreatic (e.g., cholangiocarcinoma; head & neck; others) Broadening indications interest
Reimbursement & utilizationCMS code supportive; multiple procedures per patient 5–10 treatments per patient; supports revenue leverage Utilization supports unit economics
Partnerships & internationalConsidering distribution partners; U.S.-first focus Ongoing partner discussions; international later after U.S. traction Optionality maintained

Management Commentary

  • “We are pleased to report second quarter 2025 revenue of over $400,000… achieved without a dedicated sales and marketing team… our goal is to stay lean, while also continuing to build commercialization momentum.” — Shaun Bagai, CEO .
  • “The independent Data Monitoring Committee… has recommended that we continue the study. This is great news… an expression of confidence in the potential for a positive outcome in the trial overall.” — Shaun Bagai, CEO .
  • “We believe RenovoCath is positioned to address a significant unmet need… [with] an estimated initial $400,000,000 peak annual U.S. sales opportunity.” — Management commentary .
  • “Each cancer center participating in the [PanTheR] registry study will purchase RenovoCath devices… [PanTheR] is designed to assess long-term safety and survival outcomes… across a broader range of tumor types.” — Management .

Q&A Highlights

  • DMC outcome and trial integrity: DMC continued the trial without increasing sample size; company will defer publishing second interim data to avoid bias near the finish line, with eyes on eventual NDA preparation .
  • Revenue composition: All $0.422M Q2 revenue is non–TIGeR-PaC (commercial). Catheters used in the TIGeR-PaC trial are treated as R&D offsets, not recognized revenue; PanTheR site purchases will be recognized as revenue .
  • Gross margin and cash flow: Management expects device gross margins to trend into the 70–90% range with scale, supporting accretive economics with a small sales force; utilization of 5–10 treatments per patient enhances revenue per patient .
  • Commercial trajectory: No quarter-by-quarter guidance; 2025 is a “learning year” with growth expected in H2 and a more material ramp in 2026 as sales hires are in place .
  • Expansion pathways: Interest from top 200 U.S. cancer centers; international opportunities considered after U.S. scaling; potential for other agents (platinum, immunotherapies) and tumor types via registry and IITs .

Estimates Context

  • Q2 2025: Revenue beat — $0.422M actual vs. $0.247M consensus (+71%); EPS beat — $(0.08) vs. $(0.085) consensus (+$0.005) — driven by stronger-than-expected early device adoption and repeat orders . Consensus figures from S&P Global.*
  • Q1 2025: Revenue ~$0.200M vs. $0.183M consensus (+9%); EPS roughly in line at $(0.08).*
  • Coverage depth remains thin (3–4 estimates), so estimate dispersion is possible and revisions could be sensitive to limited datapoints.*

Values with asterisks (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Commercial inflection building: Sequential revenue acceleration and repeat orders at early adopters signal product-market fit; expansion to 13 approved centers without a full salesforce is a credible set-up for 2026 scaling .
  • Clinical risk moderated by DMC: Continued trial recommendation is an incremental positive; deferring interim data protects regulatory integrity as enrollment completion approaches late 2025/early 2026 .
  • High-margin device economics: ~64% implied Q2 GM with a pathway to 70–90% supports a lean sales model and improving cash burn as volumes grow .
  • RWE flywheel and TAM expansion: PanTheR registry and IITs should catalyze data across additional tumors and agents, supporting broader adoption and a larger addressable market; registry also directly adds device demand .
  • Near-term variability, medium-term ramp: Management is not giving quarterly guidance; expect lumpiness in 2025 with a more pronounced ramp in 2026 as sales hiring lands and more centers activate .
  • Balance sheet adequate for plan: $12.3M cash as of 6/30/25 expected to fully fund commercialization scale-up and TIGeR-PaC progress, limiting near-term financing risk if execution continues .
  • Trading setup: Near-term catalysts include additional center activations/reorders, PanTheR site initiations, and enrollment milestones; medium-term catalyst is TIGeR-PaC completion and regulatory path clarity — both likely to drive estimate revisions and narrative re-rating .

Citations:

  • Q2 2025 8-K/Press Release:
  • Q2 2025 Earnings Call Transcript:
  • Additional Press Releases (Q3 dates within Q2 reporting window relevance): commercialization expansion ; PanTheR launch
  • Prior quarter references: Q1 2025 8-K ; April 1 update with Q4 2024/Q1 context

Values with asterisks (*) retrieved from S&P Global.