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II

IN8BIO, INC. (INAB)·Q3 2024 Earnings Summary

Executive Summary

  • IN8bio reported Q3 2024 net loss of $7.09M ($0.15 per share) as it executed a strategic pivot: pipeline prioritization to focus on INB-100, a 49% workforce reduction, and a subsequent October private placement to extend runway, while maintaining zero product revenue .
  • Clinical momentum centered on INB-100: 100% of AML patients remained in complete remission (CR) as of Aug 31, 2024; FDA provided Type B feedback outlining a registrational path with plans to expand the Phase 1 cohort to ~25 patients and potentially add a prospective observational control arm .
  • Operating discipline showed through lower G&A and R&D versus the prior year and recognition of $1.1M of severance costs tied to the restructuring; cash was $4.0M at quarter-end before the $11.6M October financing .
  • Runway commentary shows a discrepancy: the 10‑Q indicates funding through December 2025, while the press release states into Q1 2026; we anchor on the 10‑Q for conservatism and disclosure formality .
  • Near-term catalysts include INB-200 plenary at SNO in Nov 2024 and an INB-100 poster at ASH in Dec 2024, which could influence sentiment around the clinical thesis and financing optionality .

What Went Well and What Went Wrong

What Went Well

  • INB-100 clinical durability: “All AML patients treated with INB-100 have remained in CR as of August 31, 2024,” with dose-dependent in vivo expansion and persistence to 365 days; FDA Type B guidance provides a clear registrational path .
  • Strategic focus and cost discipline: Prioritization of INB-100, suspension of INB-400 enrollment, and 49% workforce reduction to preserve capital and focus on high‑signal programs .
  • Funding progress and visibility: $11.6M in net proceeds from an October 2024 private placement to support continued INB-100 development and add enrollment sites/control arm options .

What Went Wrong

  • Liquidity pressures and going concern: Management disclosed substantial doubt about going concern; cash fell to $4.0M at 9/30/24 pre‑financing, necessitating the October raise and cost measures .
  • Program de-prioritization: Suspension of the GBM Phase 2 (INB-400) enrollment reduces near‑term diversification; severance charges ($1.1M) reflect the cost of restructuring .
  • Nasdaq compliance risk (context from prior 8‑K): The company received a minimum bid price deficiency notice in August 2024, underscoring market and financing sensitivities common to micro‑cap biotech (monitor listing status) .

Financial Results

Note: IN8bio is pre‑revenue.

MetricQ1 2024Q2 2024Q3 2024
Revenue ($USD Millions)$0.00 (no product revenue) $0.00 (no product revenue) $0.00 (no product revenue)
R&D Expense ($USD Millions)$4.90 $5.16 $3.31
G&A Expense ($USD Millions)$3.74 $3.53 $2.73
Severance & Related ($USD Millions)$0.00 $0.00 $1.07
Total Operating Expenses ($USD Millions)$8.65 $8.69 $7.11
Net Loss ($USD Millions)$(8.56) $(8.63) $(7.09)
Diluted EPS ($)$(0.20) $(0.19) $(0.15)
Cash & Equivalents ($USD Millions, period-end)$13.02 $10.22 $4.00

Estimate comparison (S&P Global):

  • Consensus EPS/Revenue for Q3 2024 were unavailable at the time of analysis due to data access limits; thus, no beat/miss determination can be made. Values from S&P Global were not retrievable.

Segment and KPIs:

  • Segments: Not applicable (single pipeline-stage biotech) .
  • Clinical KPIs: 100% AML CR rate in INB-100 as of 8/31/24; expansion cohort to ~25 patients at RP2D; potential observational control cohort; SNO/ASH updates slated .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough FY2025/Q1 2026Not specified in Q2 press release10‑Q: funding through Dec 2025; press release: into Q1 2026 Maintained/clarified; note discrepancy between filings vs PR
Operating Focus2H24+Broader (INB-100, INB-200, INB-400) Focus on INB-100; suspend INB-400 enrollment; 49% workforce reduction Refined focus; lowered OpEx trajectory
Clinical Plans (INB-100)2H24–2025Ongoing Phase 1Expand to ~25 patients at RP2D; FDA Type B guidance on registrational path; potential observational control arm Enhanced path toward registrational program

No revenue, margin, OI&E, tax rate, dividend guidance provided .

Earnings Call Themes & Trends

Note: We did not locate a Q3 2024 earnings call transcript; themes derived from press releases and the 10‑Q.

TopicPrevious Mentions (Q1 & Q2 2024)Current Period (Q3 2024)Trend
INB-100 clinical durability & pathAnticipated updates at EHA; discussion of potential Phase 2/registrational planning 100% AML CR as of 8/31/24; FDA Type B guidance; expand to ~25 pts; potential observational control Strengthening clinical case; clearer regulatory path
GBM (INB-200/400)Positive PFS signals; active programs INB-400 enrollment suspended; INB-200 update at SNO De‑emphasis on Phase 2; focus on data readouts/partnering
Operating disciplineR&D and G&A steady to higher in 1H; no severance Workforce reduction (49%); severance $1.1M; lower R&D/G&A y/y in Q3 Cost base reset; OpEx rationalization
Liquidity/runwayCash $13.0M (Q1), $10.2M (Q2) Cash $4.0M at Q3‑end pre‑raise; $11.6M raised in Oct; runway through Dec 2025 per 10‑Q (PR notes into Q1 2026) Improved post‑financing; still constrained, reliant on milestones
Regulatory strategyPlanning future steps; nsCAR preclinical PoC FDA Type B feedback for INB-100 registrational plan More defined path to pivotal

Management Commentary

  • “This strategic realignment enhances our capacity to deliver on the potential of gamma-delta T cell therapies... The FDA’s guidance... provides a clear path forward for a potential registrational trial.” — William Ho, CEO .
  • Focus on expanding INB-100 at RP2D to ~25 patients, adding sites and potentially an observational control to de-risk future pivotal design .
  • Company framed financing proceeds as enabling continued INB-100 advancement and working capital, within a leaner organization .

Q&A Highlights

  • No Q3 2024 earnings call transcript was found in the document set; no Q&A details available despite targeted searches [Search returned none for earnings-call-transcript in Oct–Dec 2024 window].

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue could not be retrieved due to data access limits at the time of analysis; therefore, no beat/miss assessment versus consensus is included. Values from S&P Global were unavailable at the time of this report.

Key Takeaways for Investors

  • Clinical de‑risking in INB-100 is the core equity driver: sustained 100% AML CR in treated patients and FDA Type B guidance frame a credible registrational path; watch enrollment pace toward ~25 patients and any control cohort implementation .
  • Operating pivot lowers burn near‑term; severance recognized and G&A/R&D y/y down in Q3, but sustained funding needs remain typical of clinical‑stage biotech; runway extends through Dec 2025 per 10‑Q (note PR into Q1 2026) .
  • Near-term catalysts: SNO plenary for INB‑200 (GBM) in Nov 2024 and ASH poster for INB‑100 in Dec 2024—incremental positive data could support partnering discussions or additional capital access .
  • Strategic focus reduces breadth risk but concentrates outcome risk on INB‑100; partnering options for GBM programs could monetize non-core assets if data hold .
  • Compliance and micro‑cap dynamics (prior bid price notice) underscore sensitivity to news flow and financing; delivery on clinical milestones and enrollment execution likely to drive stock reaction .
  • Monitor disclosures for reconciliation of runway language between filings and press releases; default to 10‑Q for formal guidance .

Supporting Documents Reviewed

  • Q3 2024 8‑K (Item 2.02) & Press Release (financials, clinical updates, restructuring and financing) .
  • Q3 2024 10‑Q (financial statements, MD&A, going concern, pipeline updates) .
  • Q2 2024 press release/8‑K (trend analysis) .
  • Q1 2024 8‑K press release (trend analysis) .
  • Pipeline prioritization press release (Sept 4, 2024) .