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II

IN8BIO, INC. (INAB)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 net loss was $8.629M ($0.19 EPS) vs $8.562M in Q1 and $7.715M in Q2 2023; cash was $10.217M at June 30, down from $13.015M at March 31 .
  • Clinical execution strengthened the pipeline: INB-100 showed 100% 1‑year relapse‑free survival in leukemia (n=10), and INB-200 showed 92% of GBM patients exceeded the 7‑month PFS median with standard-of-care .
  • The company received a Nasdaq minimum bid price deficiency notice on Aug 6, 2024, introducing a listing compliance risk if shares do not close above $1.00 for 10 consecutive days by Feb 3, 2025 .
  • Regulatory path clarity: FDA guidance supports a registrational program for INB‑100 in AML; IND submission anticipated in Q1 2025, shifting the expected timeline from potential 2024 submission communicated in Q1 .
  • No Q2 earnings call transcript was found and the company did not provide financial guidance; estimate comparisons were unavailable due to S&P Global retrieval limits .

What Went Well and What Went Wrong

What Went Well

  • Robust clinical signals: “Gamma-delta T cell therapies have the potential to revolutionize cancer treatment,” with INB‑100 and INB‑200 driving durable complete remissions and extended PFS in aggressive cancers (GBM, AML) .
  • INB‑200 GBM program: 92% of evaluable patients exceeded 7‑month PFS; multiple patients in higher dose cohorts have exceeded expected overall survival relative to historical data .
  • Manufacturing leadership: Multiple 2024 conference presentations highlighted a reproducible DeltEx γδ T‑cell platform with upregulated markers of potency, effector functions and trafficking capabilities .

What Went Wrong

  • Cash burn and lower cash balance: Cash declined to $10.217M at June 30 from $13.015M at March 31 and $21.282M at Dec 31, 2023, underscoring funding needs in multi‑center Phase 2 expansion .
  • Nasdaq listing compliance risk: Received minimum bid price deficiency notice; potential for delisting absent remediation or transfer to Capital Market with reverse split option .
  • Operating loss widened year over year: Q2 net loss increased to $8.629M from $7.715M in Q2 2023; R&D up to $5.156M driven by personnel and clinical enrollment costs .

Financial Results

Income Statement and EPS (USD Millions, except per-share)

MetricQ2 2023 (Oldest)Q4 2023Q1 2024Q2 2024 (Newest)
Revenuen/a n/a n/a n/a
R&D Expense$4.134 $4.500 $4.903 $5.156
G&A Expense$3.581 $3.100 $3.742 $3.533
Net Loss$7.715 $7.600 $8.562 $8.629
EPS (Basic & Diluted)$0.27 $0.22 $0.20 $0.19

Notes:

  • No revenue line reported; company is pre-revenue .
  • Operating expenses increased reflecting higher personnel and clinical trial costs .

Liquidity

MetricQ4 2023 (Oldest)Q1 2024Q2 2024 (Newest)
Cash and Cash Equivalents$21.282 $13.015 $10.217

KPIs and Clinical Program Metrics

KPIQ4 2023Q1 2024Q2 2024
INB‑100 (AML/hematologic) 1‑year relapse-free/CR100% of evaluable patients (n=10) in durable CR; first-ever durable persistence of allogeneic cellular therapy at 365 days Planned expansion cohort at RP2D; potential 2024 IND noted 100% of treated leukemia patients (n=10/10) remained progression-free ≥1 year; 2 patients >3.5 years relapse-free
INB‑200 (GBM) PFSAll patients who completed mandated doses exceeded 7‑month PFS; one patient 28.5+ months as of Oct 20, 2023 ASCO update planned; INB‑400 autologous arm dosing initiated 92% of evaluable patients exceeded 7‑month PFS; multiple higher-dose cohort patients exceeding expected OS; no CRS/ICANS
Manufacturing platform—ASGCT oral presentation planned; product characterization Robust, reproducible DeltEx platform with upregulated potency/trafficking markers

Estimates vs Actuals

MetricConsensus (S&P Global)Actual Q2 2024Beat/Miss
RevenueUnavailable – SPGI request limit exceededn/a n/a
EPSUnavailable – SPGI request limit exceeded$(0.19) n/a

Estimates were unavailable due to S&P Global daily request limits.

Guidance Changes

Metric/ProgramPeriodPrevious GuidanceCurrent GuidanceChange
INB‑100 IND submission (AML registrational)TimelinePotentially submit IND for Phase 2 randomized control trial in 2024 IND submission anticipated Q1 2025 for AML registrational program Deferred
INB‑100 Expansion Cohort (RP2D)2024Enroll +10 patients at RP2D (plan) Enrollment ongoing; full enrollment of 10‑patient expansion expected by end of 2024 Maintained, status update
INB‑400 (GBM, Phase 2 autologous)2024–2025Dosed first patient; expects to treat up to 40 patients in Arm A across US sites Actively enrolling and treating patients at multiple centers Maintained, progressing
Financial Guidance2024None providedNone providedMaintained

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was available; themes below reflect company disclosures and conference updates.

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
Regulatory/LegalStrengthened financial position; cash runway into 1Q 2025 (private placement in Dec 2023) Nasdaq minimum bid price deficiency notice; compliance deadline Feb 3, 2025 Negative risk introduced
R&D ExecutionINB‑200 exceeded PFS benchmarks; INB‑100 long‑term persistence reported Continued strong safety; no CRS/ICANS; expanded INB‑100 data at EHA and INB‑200 data at ASCO Positive momentum
ManufacturingProcess characterization and capabilities highlighted at ASGCT Robust, reproducible DeltEx platform with potency/trafficking markers Positive validation
Clinical PathwayPotential 2024 IND for INB‑100; INB‑400 dosing begins FDA guidance for INB‑100 registrational path; IND in Q1 2025 Clarity; timeline extended
GBM Product PerformancePatients exceeding expected PFS; 28.5+ month case 92% exceeded 7‑month PFS; durability signals; higher dose cohorts favorable Strengthening efficacy profile

Management Commentary

  • “Gamma-delta T cell therapies have the potential to revolutionize cancer treatment…our gamma-delta T cell therapeutic approach in INB‑100 and INB‑200 can drive durable complete remissions compared to the current standard‑of‑care in certain aggressive cancers like GBM and AML” — William Ho, CEO .
  • “Our gamma‑delta T cell therapies…continue to demonstrate their potential to eliminate residual cancer cells…The safety profile…with no significant cell therapy‑related toxicities reported to date” — William Ho, CEO .
  • “100% of evaluable patients remain in complete remission at one year…Achieving these outcomes…with a median age of 68 is very encouraging” — Trishna Goswami, MD, CMO (INB‑100) .
  • “The addition of multiple intracranial injections of…gamma‑delta T cells shows the potential for extending progression‑free survival in…newly diagnosed glioblastoma” — Burt Nabors, M.D. .

Q&A Highlights

  • No Q2 2024 earnings call transcript was found; the company hosted conference calls for clinical updates on June 13 (EHA INB‑100 update) and Aug 12 (clinical data/FDA guidance), but no earnings Q&A content is available to synthesize .

Estimates Context

  • Wall Street consensus EPS and revenue for Q2 2024 were unavailable due to S&P Global request limits; as a pre‑revenue biotech, revenue estimates are typically minimal, and EPS sensitivity is driven by R&D spend cadence and share count .
  • Given higher R&D and stable G&A, future EPS estimates may need to reflect elevated clinical enrollment costs, offset by any financing developments; formal updates contingent on access to S&P Global consensus.

Key Takeaways for Investors

  • Clinical momentum is the core driver: INB‑100’s 100% 1‑year relapse‑free/CR and INB‑200’s 92% PFS outperformance underpin the medium‑term thesis around γδ T‑cell efficacy and durability .
  • Regulatory path clarity for INB‑100 in AML de‑risks development but shifts the IND timeline to Q1 2025; watch for IND submission and registrational study initiation as key catalysts in 2025 .
  • Cash declined to $10.217M at Q2 end; funding optionality (e.g., capital raises or partnerships) is likely needed to support multi‑center Phase 2 progression and IND‑ready activities .
  • Listing compliance risk from Nasdaq bid price deficiency introduces event‑driven volatility; management may consider remedies (transfer to Capital Market/reverse split) if needed .
  • Strong safety profile (no CRS/ICANS) across programs is a differentiator in cell therapy; durability and persistence data strengthen potential competitiveness vs other modalities .
  • Near‑term catalysts: expansion cohort completion (INB‑100) by year‑end and additional GBM data in Q4; medium‑term: IND submission and registrational design details for AML .
  • Absent financial guidance and with estimates unavailable, focus on clinical readouts, regulatory interactions, and balance sheet developments as primary stock reaction drivers .