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Inmune Bio, Inc. (INMB)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS of $-0.24 beat Wall Street consensus ($-0.325), driven by sharply lower R&D spending; net loss improved to $6.5M from $24.5M in Q2 (which had a $16.5M impairment) and $12.1M in Q3 2024 .
  • Cash and cash equivalents were $27.7M; management guided cash runway “into Q4 2026,” extending from “into 2026” in Q2 .
  • Program updates: CORDStrom on track for UK MAA mid-2026 and BLA a few months thereafter; XPro EOP2 meeting shifted to Q1 2026 with no ARIA safety signal; INKmune CARE-PC trial closed to recruitment, informing a randomized Phase 2 design in less advanced disease .
  • Near-term catalysts (Q4 2025): CORDStrom additional data, MINDFuL imaging endpoints, and final INKmune CARE-PC data — potential stock reaction on regulatory clarity and efficacy signal reinforcement .

What Went Well and What Went Wrong

What Went Well

  • EPS beat vs consensus with disciplined OpEx: Q3 EPS $-0.24 vs consensus $-0.325; R&D down to $4.9M (vs $10.1M YoY) and G&A $2.5M (vs $2.2M YoY), reflecting tighter spend while advancing programs .
  • Regulatory and manufacturing execution for CORDStrom: successful pilot-scale runs at CGT Catapult; on track for UK MAA mid-2026 and BLA shortly thereafter — “we are now in the process of preparing for submission for marketing approval” .
  • XPro safety and enriched efficacy signals: no ARIA even among high-risk patients; dose-compliance analyses show larger effect sizes (EMACC 0.27; NPI -0.23; pTau217 -0.18) in the predefined ADi population, supporting a targeted path forward .

What Went Wrong

  • XPro regulatory timeline slipped: End of Phase 2 meeting moved from Q4 2025 to Q1 2026 to finalize data; management cited need for more data and conservative timing for FDA minutes .
  • INKmune trial recruitment halted: CARE-PC closed to recruitment due to very high disease burden limiting tumor-load reduction by PSMA-PET, necessitating a randomized trial in earlier-stage patients; tumor response endpoints not met in advanced disease .
  • No revenue and limited near-term catalysts to de-risk financing: revenue was $0 in Q3; while cash runway extended, partnership timing for XPro likely post-EOP2/FDA feedback, pushing potential non-dilutive funding out .

Financial Results

Results vs Prior Periods and Prior Year

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.05 $0.00 $0.00
Net Loss ($USD Millions)$9.74 $24.54 $6.47
Diluted EPS ($USD)$-0.43 $-1.05 $-0.24
R&D Expense ($USD Millions)$7.64 $5.88 $4.89
G&A Expense ($USD Millions)$2.32 $2.25 $2.55
Other Income, Net ($USD Millions)$0.17 $0.11 $0.96
Weighted Avg Shares (Millions)22.50 23.30 26.59
Cash & Equivalents ($USD Millions, end-period)$19.34 $33.37 $27.73
MetricQ3 2024Q3 2025
Net Loss ($USD Millions)$12.09 $6.47
Diluted EPS ($USD)$-0.60 $-0.24
R&D Expense ($USD Millions)$10.07 $4.89
G&A Expense ($USD Millions)$2.22 $2.55

Results vs Wall Street Consensus

MetricQ1 2025Q2 2025Q3 2025Q4 2025 (Next)
EPS Actual ($USD)$-0.43 $-1.05 $-0.24 —
EPS Consensus Mean ($USD)$-0.47*$-0.3817*$-0.325*$-0.285*
EPS SurpriseBeat*Miss*Beat*—
Revenue Actual ($USD Millions)$0.05 $0.00 $0.00 —
Revenue Consensus Mean ($USD Millions)$0.00*$0.00*$0.00*$0.00*
# of EPS Estimates5*6*6*6*
# of Revenue Estimates3*6*6*6*

Values retrieved from S&P Global.*

KPIs and Program Milestones

KPI / MilestoneDetailPeriod
CORDStrom infusions>120 infusions in >30 children; no severe adverse events Mission EB (UK)
XPro dose-compliant set≥21 of 23 doses; larger effect sizes (EMACC 0.27; NPI -0.23; pTau217 -0.18) Q3 2025
Cash runwaySufficient “into Q4 2026” Q3 2025
Shares outstanding~26.6M common shares (Oct 30, 2025) Q3 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
End of Phase 2 Meeting (XPro)TimingQ4 2025 Q1 2026 (incl. 30-day minutes post-meeting) Lowered/Delayed
UK MAA (CORDStrom)Filing TimingMid-2026 Mid-2026 Maintained
US BLA (CORDStrom)Filing TimingMid-2026 (stated alongside MAA) “A few months after MAA” (post mid-2026) Clarified sequencing
Cash RunwayDuration“Into 2026” “Into Q4 2026” Raised/Extended
INKmune CARE-PCEnrollment StatusOngoing; more data to be released Closed to recruitment; finalize follow-up by end of Q4 2025 Lowered/Concluded Phase
Formal Financial GuidanceRevenues/Margins/Tax/DividendsNot providedNot providedMaintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
CORDStrom regulatory/mfgAnnounced BLA plans; CGT Catapult partnership; independent statistical analysis of RDEB data in process Pilot-scale manufacturing runs completed; UK MAA mid-2026; BLA shortly after; MHRA scientific advice package being prepared Improving execution; timeline maintained
XPro Alzheimer’sTop-line MINDFuL missed primary; enriched inflammation subgroup showed positive effect sizes; preparing EOP2 EOP2 shifted to Q1 2026; no ARIA; dose-compliance analyses strengthen efficacy signal; pursuing accelerated pathways/publication Mixed: safety strong; timing delayed
INKmune (mCRPC)Phase II opened; biomarkers positive; designing next trial; endpoints met in early cohorts Closed to recruitment due to high disease burden; plan randomized trial in earlier-stage disease; NK activation/proliferation met Reset strategy to earlier disease
Manufacturing economicsEmphasis on scalable, low-cost, consistent cell therapies (CORDStrom/INKmune) Reinforced batch-to-batch consistency and margin potential vs peers Strengthened narrative
PartnershipsEarly XPro outreach; post-EOP2 likely Tone: partners want FDA alignment and imaging data; “not short-term” pre-EOP2 Expectations pushed out
Cash runway~$33.4M at Q2; “into 2026” $27.7M at Q3; “into Q4 2026” Extended duration despite cash use

Management Commentary

  • “Cordstrom is our most advanced program… preparing for submission for marketing approval to the regulatory bodies in both the UK and the US.”
  • “No ARIA-related safety signals were observed, even among high-risk individuals.”
  • “We believe Cordstrom is potentially one of the first systemic treatments for RDEB… reduction in systemic itch was a major reported benefit.”
  • “Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4 2026.”
  • “We’re very optimistic about filing an MAA and BLA in Cordstrom next year… despite the setbacks of missing the top line on the Mindful trial.”

Q&A Highlights

  • XPro EOP2 timing and content: Meeting shifted to Q1 2026; aims to align on EMACC endpoint, enrichment biomarkers, and safety database requirements .
  • Partnership trajectory: Deeper engagement likely post-publication and FDA feedback; imaging data in Q4 could be pivotal; financial structuring TBD .
  • CORDStrom regulatory pathway: MHRA scientific advice targeted around year-end/early next year; MAA by Q2/Q3 2026; systemic benefits vs topical gene therapies discussed .
  • UK treatment landscape: Vyjuvek approved but not reimbursed by NICE; unmet need and pricing considerations support CORDStrom adoption potential .
  • INKmune strategy: Shift to earlier-stage disease; partnership openness; randomized Phase 2 planning in 2026 as resources allow .

Estimates Context

  • Q3 2025 EPS beat: Actual $-0.24 vs consensus $-0.325 (beat); Q2 miss: $-1.05 vs $-0.3817; Q1 beat: $-0.43 vs $-0.47. Revenue estimates are effectively $0 across quarters, consistent with minimal reported revenue. Values retrieved from S&P Global.*
  • Post-quarter estimate adjustments likely to reflect lower R&D run-rate and the EOP2 timing shift for XPro. The near-term estimate dispersion may widen pending Q4 MRI/imaging data release and MHRA scientific advice outcomes .

Key Takeaways for Investors

  • Near-term trade: Leaner OpEx and an EPS beat set a constructive base into Q4 catalysts (CORDStrom data; MINDFuL imaging); watch for headline risk on MHRA advice timing and substance .
  • Medium-term thesis: CORDStrom’s systemic profile and scalable manufacturing economics offer differentiated value vs topical gene therapies; regulatory sequencing (UK first) could accelerate U.S. BLA acceptance .
  • XPro path: Safety profile (no ARIA) and enriched efficacy favor a biomarker-driven registration path; but timeline now Q1 2026 for EOP2 — partnership optionality likely post-FDA alignment .
  • INKmune recalibration: Data support NK activation/proliferation; efficacy likely in earlier-stage settings — randomized Phase 2 planning in 2026 can re-rate oncology optionality .
  • Liquidity: Cash runway extended “into Q4 2026” reduces near-term financing risk; still monitor for trial and manufacturing scale-up needs .
  • Stock catalysts: Q4 2025 readouts (CORDStrom, imaging), MHRA scientific advice window, and any partnership signals; bold moves likely on clear regulatory guidance and imaging validation .
  • Risk watch: XPro’s endpoint acceptance (EMACC) and enrichment strategy by FDA, UK/NICE reimbursement dynamics for RDEB, and timing of statistical analyses for CORDStrom data .