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Xilio Therapeutics, Inc. (XLO)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a revenue beat versus S&P Global consensus on collaboration/license revenue recognition from AbbVie and Gilead, while EPS missed due to a large non-cash loss from warrant revaluation; cash runway extended into Q1 2027, a positive funding inflection for this clinical-stage biotech *.
  • Clinical catalysts were strong: late-breaking SITC Phase 2 data for vilastobart showed a 40% ORR in plasma TMB-high MSS mCRC without liver metastases, with plans to partner the program for combination development; Phase 1 data for efarindodekin alfa (IL‑12) showed promising monotherapy activity and broad safety margin, and XTX501 remains on track for IND mid-2026 .
  • Operating cadence improved: collaboration/license revenue scaled to $19.1M in Q3; R&D and G&A rose modestly year over year reflecting clinical and platform build-out; net loss widened year over year primarily due to the $15.4M non-cash warrant liability mark-to-market .
  • Stock reaction drivers: clinical differentiation and biomarker strategy (plasma TMB, ctDNA) for vilastobart, cash runway extension, and platform validation via masked T cell engagers provide medium-term narrative support, while quarterly EPS headline sensitivity may persist due to warrant liability volatility .

What Went Well and What Went Wrong

What Went Well

  • “Late-breaking” SITC data for vilastobart showed a 40% ORR in heavily pretreated, plasma TMB‑high MSS mCRC patients without liver metastases, with statistical correlation to plasma TMB (p=0.05), supporting a differentiated combination opportunity and a partnerable asset pathway .
  • Efarindodekin alfa (IL‑12) Phase 1 monotherapy data at SITC demonstrated promising anti‑tumor activity and a generally well‑tolerated safety profile at doses over 100‑fold higher than the MTD of recombinant human IL‑12, reinforcing mechanism and therapeutic window .
  • Cash runway extended into Q1 2027, supported by $52.0M upfront from AbbVie, $47.0M follow-on offering proceeds, and a $17.5M milestone from Gilead in Q4, improving funding visibility for pipeline execution .

What Went Wrong

  • EPS missed consensus, driven by a $15.4M non‑cash charge from the change in fair value of common stock warrant liabilities, introducing headline volatility unrelated to operating performance .
  • Operating expenses increased year over year: R&D to $14.3M on clinical development, IND‑enabling work, and early programs; G&A to $6.7M on professional/consulting fees—necessary investments but pressure on bottom line .
  • No earnings call transcript was available for Q3 2025, limiting real-time clarity on partner discussions, timelines, and Q&A clarifications; company communicated via press release and SEC filings .

Financial Results

Revenue and EPS vs Prior Periods and Estimates

MetricQ1 2025Q2 2025Q3 2025
Actual Revenue ($USD Millions)$2.930 $8.084 $19.066
Consensus Revenue ($USD Millions)$23.200*$8.210*$18.635*
Actual EPS ($USD)-$0.18 -$0.16 -$0.11
Consensus EPS ($USD)$0.095*-$0.08*-$0.03*

Values with an asterisk were retrieved from S&P Global.

YoY Comparison (Q3 2024 vs Q3 2025)

MetricQ3 2024Q3 2025
Revenue ($USD Millions)$2.263 $19.066
EPS ($USD)-$0.22 -$0.11
Net Loss ($USD Millions)$14.020 $16.287
R&D ($USD Millions)$10.759 $14.321
G&A ($USD Millions)$6.307 $6.674

Margins

MetricQ2 2025Q3 2025
Net Income Margin %-195.992%*-85.424%*

Values with an asterisk were retrieved from S&P Global.

KPIs and Balance Sheet Items

KPIQ1 2025Q2 2025Q3 2025
Cash & Equivalents ($USD Millions)$89.073 $121.551 $103.764
Deferred Revenue ($USD Millions)$78.994 $70.910 $69.344
License Agreement Receivable ($USD Millions)——$17.500
Common Stock Warrant Liabilities ($USD Millions)—$38.550 $53.930
Net Loss ($USD Millions)$13.265 $15.844 $16.287
Weighted Avg Shares (Basic & Diluted)74,700,364 96,447,672 144,106,869

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q2 2025Through end of Q3 2026 Into Q1 2027 Raised
XTX501 IND SubmissionCalendarMid‑2026 Mid‑2026 (unchanged) Maintained
Vilastobart Partnering PlanProgramSeeking partners (ongoing) Actively seeking partner for PD-(L)1 or PD1‑VEGF combo Maintained/Progressing
Masked T Cell Engager Dev. CandsPSMA/CLDN18.2/STEAP1PSMA Q3’25, CLDN18.2 Q4’25, STEAP1 H1’26 PSMA nominated in Q3’25; CLDN18.2 Q4’25; STEAP1 H1’26 On Track
INDs for TCE ProgramsCalendarSubmit INDs in 2027 INDs in 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Vilastobart clinical efficacy in MSS CRCPreliminary 27% ORR without liver metastases; updated data at ASCO; positioning as I‑O combination agent 40% ORR in plasma TMB‑high, no liver metastases; ctDNA as early predictive biomarker Strengthening efficacy signal; biomarker strategy emerging
Efarindodekin alfa (IL‑12)Phase 1 dose escalation ongoing; advancing with Gilead Promising monotherapy activity; RP2D selected; Phase 2 dosing initiated; $17.5M milestone Advancing to Phase 2; validation via milestone
XTX501 (PD‑1/IL‑2)IND‑enabling; IND mid‑2026 IND‑enabling; IND mid‑2026 Steady execution
Masked T Cell EngagersAnticipated dev. cands (PSMA, CLDN18.2, STEAP1) in H2’25/H1’26 PSMA candidate nominated; CLDN18.2 and STEAP1 timelines reaffirmed; preclinical SITC data support best‑in‑class potential Pipeline progressing; platform validation
Partnering/CapitalAbbVie $52M upfront; June 2025 financing ~$50M; runway to Q3’26 Runway into Q1’27; active partnering for vilastobart Improved funding visibility

Note: No Q3 2025 earnings call transcript was available in our document catalog; company communications were via press release/8‑K .

Management Commentary

  • “We continue to provide additional validation of our proprietary masking technology… including data supporting the best‑in‑class potential of our masked T cell engager programs…” — René Russo, Pharm.D., President & CEO .
  • “New data for vilastobart leveraging plasma TMB… showed a 40% response rate… supporting the significant opportunity for vilastobart as a combination therapy.” — René Russo, Pharm.D. .
  • “We are focused on execution across our clinical programs, while rapidly advancing XTX501… toward a planned IND submission in mid 2026.” — René Russo, Pharm.D. .

Q&A Highlights

  • No Q3 2025 earnings call transcript available to extract Q&A themes; company did not provide call logistics in the press release, and third-party trackers list no conference call resources for the date .

Estimates Context

  • Q3: Revenue beat S&P Global consensus ($19.066M actual vs. $18.635M consensus; +2.3%); EPS missed (‑$0.11 actual vs. ‑$0.03 consensus), driven primarily by a $15.4M non‑cash change in fair value of common stock warrant liabilities *.
  • Q2: Revenue roughly in line/slight miss ($8.084M actual vs. $8.210M consensus), while EPS missed (‑$0.16 actual vs. ‑$0.08 consensus), reflecting ongoing operating and platform investments *.
  • Q1: Significant miss vs. consensus (revenue $2.930M actual vs. $23.200M consensus; EPS ‑$0.18 actual vs. $0.095 consensus) as collaboration accounting timing differed materially from expectations—an important modeling consideration for future quarters *.

Values with an asterisk were retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue recognition from AbbVie/Gilead collaborations is the primary driver of quarterly top‑line variability; modeling focus should be on collaboration milestones, deferred revenue dynamics, and license receivables timing .
  • EPS volatility is partly driven by non‑cash warrant liability marks; consider tracking warrant liability line and isolating operating loss trends for core performance assessment .
  • Clinical differentiation in MSS CRC via plasma TMB and ctDNA biomarkers may accelerate partnering for vilastobart; partnering outcomes are a key stock catalyst in 2026 .
  • Funding visibility improved with runway into Q1 2027, lowering near‑term financing overhang and enabling continued IND‑enabling and Phase 2 execution across programs .
  • Watch mid‑2026 XTX501 IND and 2027 INDs for masked T cell engager programs as platform validation milestones; preclinical SITC data support a broad therapeutic index narrative .
  • R&D spend will likely remain elevated as programs advance; near‑term margin improvement is unlikely in the absence of product revenue—expect operating expense cadence to track clinical timelines .
  • Estimate revisions: modest upward revenue revision likely for Q3 actual beat; EPS models should incorporate warrant liability volatility and non‑cash effects to avoid misinterpreting operating trends *.