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II

IN8BIO, INC. (INAB)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 focused execution improved operating efficiency and narrowed cash burn while preserving clinical momentum: net loss narrowed to $6.2M ($0.08/share) vs $7.6M ($0.22/share) in Q4 2023; R&D/G&A both declined YoY amid September pipeline prioritization and workforce reduction .
  • Clinical narrative strengthened: INB-100 continued to show 100% relapse‑free AML patients with durable in vivo γδ T‑cell persistence; FDA confirmed relapse‑free survival (RFS) as an acceptable primary endpoint for a future pivotal trial .
  • Balance sheet extended: year‑end cash was $11.1M, supplemented by $4.1M in Feb-2025 ATM/warrant proceeds; management now guides cash runway into March 2026 .
  • New platform disclosed: INB‑600 γδ T‑cell engager (INB‑619, CD19) introduced with Q2‑2025 preclinical data planned; partnership pathways under exploration .
  • Estimates context: External sources indicate Q4 EPS was in line with consensus at -$0.08 and revenue $0; S&P Global consensus could not be retrieved (rate limit) .

What Went Well and What Went Wrong

  • What Went Well

    • INB‑100 durability: “100% long term durable response rates as of January 17, 2025,” with favorable safety (no CRS/ICANS) supporting a clear registrational path using RFS .
    • GBM signal: In INB‑200, 92% surpassed median standard‑of‑care PFS of 6.9 months; one patient progression‑free >40.5 months; biopsy confirmed intratumoral γδ T‑cell persistence .
    • Cost discipline and runway: R&D/G&A down YoY; cash runway extended to March 2026 following financings and cost actions .
  • What Went Wrong

    • Program pause: Enrollment in Phase 2 INB‑400 (GBM) suspended to conserve capital despite “compelling data,” signaling funding constraints and execution risk in solid tumors .
    • Dilution optics: Basic shares outstanding rose to 72.5M at year‑end 2024 (from 43.3M in 2023) due to financings, diluting per‑share metrics even as losses narrowed .
    • Limited revenue visibility: Pre‑revenue profile persists; near‑term catalysts are clinical rather than commercial. Q4 revenue reported as $0 by external sources, matching consensus .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
R&D Expense ($M)$5.156 $3.309 $3.6
G&A Expense ($M)$3.533 $2.732 $2.6
Net Loss ($M)$8.629 $7.086 $6.2
Diluted EPS ($)-$0.19 -$0.15 -$0.08
Cash & Equivalents ($M, period-end)$10.217 $4.001 $11.120

Notes:

  • Q4 YoY: R&D $3.6M vs $4.5M; G&A $2.6M vs $3.1M; net loss $6.2M vs $7.6M; EPS -$0.08 vs -$0.22 .
  • External sources report Q4 revenue $0, consistent with the company’s pre‑revenue status .

KPI snapshot (clinical)

KPIQ2 2024Q3 2024Q4 2024
INB‑100 (AML) durability100% of treated patients remained progression‑free ≥1 year; in vivo persistence at 365 days All AML patients in CR as of Aug 31, 2024 100% treated AML relapse‑free (as of Jan 17, 2025); no CRS/ICANS
INB‑200 (GBM) efficacy/safety92% exceeded 6.9‑mo SOC median PFS; strong safety profile SNO 2024 plenary update planned 92% surpassed SOC PFS; one patient progression‑free >40.5 months; intratumoral γδ T‑cells confirmed; no CRS/ICANS

Drivers/why:

  • Expense reductions reflect workforce reduction and pipeline prioritization in Sept‑2024; lower personnel and facility costs partially offset higher trial costs earlier in the year .
  • Cash increase from Q3 to Q4 driven by October private placement; additional ATM/warrant proceeds in Feb‑2025 further extended runway .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayOperating runway“Into the first quarter of 2026” (post Oct‑2024 financing) “Into March 2026” Slight extension
INB‑100 expansion enrollmentPhase 1 expansion cohortComplete additional enrollment in 1H 2025 Aim to complete enrollment in 2025 Timing broadened
Registrational path (INB‑100)Pivotal trial endpointFDA registrational path discussed (Type B) FDA confirmed RFS acceptable as primary endpoint Clarified/derisked
INB‑600/INB‑619 dataPreclinical milestonesNot previously guidedPresent preclinical data in Q2 2025 New
IND timing (INB‑100 Phase 2)RegulatoryNot previously guidedPotential IND submission in 2026 (funding‑dependent) New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
Pipeline prioritization/costAnnounced 49% workforce reduction; GBM Phase 2 (INB‑400) enrollment suspended; focus on INB‑100 Cost discipline reflected in lower R&D/G&A; reiterates focus on high‑impact programs Efficiency gains continuing
INB‑100 efficacy/path100% progression‑free ≥1 yr; FDA Type B meeting on registrational path Confirms RFS primary endpoint; accelerating enrollment; additional site; data 2H‑2025 De‑risking trajectory
INB‑200 GBM92% exceeded SOC PFS; plenary at SNO planned Durable remissions; 40.5‑mo PFS case; intratumoral γδ persistence; safety clean Encouraging but funding constrained
Financing/runwayPrivate placement net $11.6M (Oct‑2024) Runway into March 2026; added $4.1M in Feb‑2025 Stabilized liquidity
INB‑600 platformNot disclosedINB‑619 (CD19 γδ TCE) unveiled; Q2‑2025 data planned; partnership options explored New optionality

Management Commentary

  • “In 2024, IN8bio made significant progress… The INB‑100 program continues to demonstrate 100% long term durable response rates… We have also disclosed our novel INB‑600 platform… Throughout 2025, we remain focused on driving innovation, advancing our clinical programs and delivering value” — William Ho, CEO .
  • “Paused enrollment in the Phase 2 INB‑400 glioblastoma program… Implemented cost‑saving measures to extend cash runway and prioritize pipeline development” .
  • GBM investigator perspective (SNO plenary): the approach is “highly feasible with a well‑tolerated safety profile,” with evidence of γδ T‑cell infiltration in tumor biopsies .

Q&A Highlights

  • An earnings call transcript for Q4 2024 was not available in our corpus; Seeking Alpha also shows “Transcripts are not available” for INAB .
  • The press release clarifies key items commonly raised in Q&A: RFS as pivotal endpoint, enrollment acceleration and additional site for INB‑100, and runway into March 2026 .

Estimates Context

  • EPS: External sources indicate Q4 2024 GAAP EPS of -$0.08, in line with consensus -$0.08; S&P Global consensus could not be retrieved due to access limits .
  • Revenue: Reported and consensus revenue were $0, consistent with pre‑revenue status .
  • Implications: With no revenue line, estimate revisions should center on OpEx cadence and runway post‑cost actions; clinical milestones (INB‑100 expansion data in 2H‑2025; Q2‑2025 INB‑600 data) are likely to drive model probability‑of‑success and opex phasing .

Key Takeaways for Investors

  • INB‑100 continues to de‑risk: durable 100% relapse‑free signal and FDA confirmation of RFS as primary endpoint bolster pivotal readiness, contingent on funding .
  • Operating discipline is working: sequential net loss improvement and YoY lower R&D/G&A reflect tangible cost controls after the Sept‑2024 restructuring .
  • Liquidity extended: year‑end cash of $11.1M plus Feb‑2025 proceeds supports operations into March 2026, reducing near‑term financing overhang but not eliminating longer‑term capital needs .
  • GBM maintains optionality with encouraging Phase 1 data (efficacy and safety), but further advancement hinges on partnerships/funding after INB‑400 pause .
  • New γδ TCE platform (INB‑600/INB‑619) adds medium‑term upside optionality across oncology/autoimmune; watch Q2‑2025 preclinical readouts and any BD activity .
  • Near‑term stock catalysts: INB‑100 enrollment progress/additional site activation, regulatory interactions, and upcoming data timelines; risk remains around capital markets access and execution in a lean footprint .
  • Trading lens: With results in line with low expectations (EPS ~consensus, revenue $0), narrative‑driven moves likely hinge on clinical updates and financing signals rather than quarterly P&L variability .