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II

IN8BIO, INC. (INAB)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was a pre‑revenue quarter with operating expenses up 10% YoY; net loss widened to $8.6M and diluted EPS was −$0.20, versus −$0.30 a year ago and −$0.22 in Q4 2023. Cash declined to $13.0M, prompting a going‑concern warning with runway into January 2025 .
  • Pipeline execution advanced: first patient dosed in INB‑400 Phase 2; new nsCAR preclinical data showcased at AACR; and INB‑100 Phase 1 showed durable 1‑year CRs (100% evaluable) presented at EHA in June, reinforcing clinical momentum into Q2 events .
  • Guidance narrative shifted: INB‑100 potential IND moved from Phase 3 (Q4’23 view) to Phase 2 randomized control trial “this year”; INB‑400 Arm A patient target expanded to up to 40 from 15 earlier, increasing execution scope .
  • Near‑term stock catalysts: further INB‑100/INB‑200 updates at major 2024 meetings and potential warrant proceeds contingent on INB‑100 data; counterbalance is financing overhang and dilution risk given cash runway and baby‑shelf constraints .
  • Estimate comparison: S&P Global consensus could not be retrieved; third‑party trackers reported a modest EPS miss (−$0.20 vs −$0.17), but we cannot confirm via S&P; treat estimate context as unavailable from S&P Global [InvestorPlace: https://investorplace.com/earning-results/2024/05/inab-stock-earnings-in8bio-for-q1-of-2024/].

What Went Well and What Went Wrong

  • What Went Well

    • “Significant progress advancing gamma‑delta T cell programs” with nsCAR proof‑of‑concept targeting CD33/CD123 while sparing healthy bone marrow; positioned to tackle “undruggable” targets .
    • First patient dosed in INB‑400 Phase 2 autologous arm; plan to treat up to 40 patients across U.S. sites, scaling clinical execution footprint .
    • INB‑100 updated data at EHA (June): 100% evaluable remained alive, progression‑free, and in durable CR at one year; favorable safety with no DLTs, CRS, or ICANS, underscoring differentiated profile .
  • What Went Wrong

    • Cash fell to $13.0M with substantial doubt about going concern; runway only into January 2025 without additional capital, increasing financing and dilution risk .
    • Operating expenses climbed to $8.6M (+$0.8M YoY) driven by personnel and clinical costs; net loss widened, reflecting continued investment ahead of revenue generation .
    • Guidance recalibration for INB‑100 from Phase 3 to Phase 2 randomized trial indicates sequencing/pacing adjustments in registrational strategy amid capital constraints .

Financial Results

  • Notes: Company reports no product revenue. Margins are not meaningful in a pre‑revenue quarter.
MetricQ1 2023Q3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.00 $0.00 $0.00 $0.00
Total Operating Expenses ($USD Millions)$7.86 $7.17 $7.60 $8.65
Net Loss ($USD Millions)$(7.53) $(7.17) $(7.60) $(8.56)
Diluted EPS ($USD)$(0.30) $(0.23) $(0.22) $(0.20)
Cash And Equivalents ($USD Millions)N/A$12.85 $21.28 $13.02

KPIs

KPIQ1 2023Q1 2024
R&D Expense ($USD Millions)$4.39 $4.90
G&A Expense ($USD Millions)$3.47 $3.74
Program Direct R&D – INB‑100 ($USD Millions)$0.09 $0.13
Program Direct R&D – INB‑200 ($USD Millions)$0.06 $0.25
Program Direct R&D – INB‑400 ($USD Millions)$1.14 $0.99
Weighted‑Average Shares (Basic & Diluted)24.73M 43.29M

Segment breakdown: Not applicable (no revenue‑generating segments) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
INB‑100 IND strategy2024Potential IND for Phase 3 randomized control trial in 2024 Could potentially submit IND for Phase 2 randomized control trial this year Lowered trial phase (Phase 3 → Phase 2)
INB‑100 Enrollment2024Enroll additional 10 patients at RP2D Anticipate enrolling ten additional patients at RP2D Maintained
INB‑400 Phase 2 Autologous Arm size2024Dose first patient; treat up to 15 patients across sites Treat up to 40 patients in Arm A across U.S. sites Raised
INB‑200 Updates2024Report long‑term follow‑up at meetings Report interim Phase 1 long‑term follow‑up (ASCO 2024) Maintained
ASGCT Manufacturing PresentationMay 2024N/AOral presentation on DeltEx DRI product characterization (May 10) New event guidance

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found in filings or our document catalog.

TopicPrevious Mentions (Q3’23 and Q4’23)Current Period (Q1’24)Trend
R&D execution (gamma‑delta T cell programs)Completed INB‑100 dose escalation; initiated INB‑400 Phase 2; positive INB‑200/SITC updates First patient dosed in INB‑400 Phase 2; nsCAR proof‑of‑concept presented at AACR Improving execution cadence
Manufacturing & process characterizationEmphasis on capabilities; iPSC platform potential ASGCT oral presentation on DeltEx product characterization; ISCT posters Strengthening manufacturing narrative
Regulatory pathway (INB‑100)Eyeing Phase 3 IND in 2024 Potential Phase 2 randomized IND this year Re‑sequenced to Phase 2 first
Cash runway / financingCash $12.9M (Q3), $21.3M (Q4); private placement extended runway Cash $13.0M; going‑concern; ATM and warrants described Weaker liquidity vs Q4
Clinical data signals (efficacy/durability)Positive INB‑100/INB‑200 signals discussed June EHA: 100% evaluable INB‑100 at 1‑year CR; durability and safety Strengthening efficacy narrative

Management Commentary

  • CEO William Ho: “We presented new preclinical data on our nsCAR platform… targeting CD33 and/or CD123… while preserving healthy bone marrow cells… reinforcing our technology’s ability to precisely target ‘undruggable’ cancer targets…” and outlined updates/timeline for INB‑100 and INB‑200 in 2024 conferences .
  • Corporate highlights: initiation of INB‑400 Phase 2 autologous arm with expectation to treat up to 40 patients across multiple sites .
  • CMO Trishna Goswami (EHA, June): “100% of evaluable patients remain in complete remission at one year… in an older population with median age 68… encouraging,” underscoring the benefit/risk profile of INB‑100 .

Q&A Highlights

  • No Q1 2024 earnings call transcript or Q&A available in our document set; the company disseminated updates via press releases and the 10‑Q .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 could not be retrieved due to data limits; treat S&P consensus as unavailable for this recap.
  • Third‑party aggregator reported EPS −$0.20 vs consensus −$0.17, a modest miss; revenue was not reported (pre‑revenue). Note: this source is not S&P Global; use with caution [InvestorPlace: https://investorplace.com/earning-results/2024/05/inab-stock-earnings-in8bio-for-q1-of-2024/].

Key Takeaways for Investors

  • Liquidity and dilution risk are the central overhang: runway into January 2025 and explicit going‑concern language indicate urgency for capital; warrants/ATM provide optionality but are contingent and dilutive .
  • Clinical momentum is real and near‑term: INB‑400 Phase 2 dosing, nsCAR data, and strong INB‑100 1‑year CRs presented at EHA support efficacy durability and could be catalysts for sentiment and partnering discussions .
  • Strategy re‑sequencing (INB‑100 Phase 2 randomized IND) suggests a pragmatic regulatory path under capital constraints; success could unlock warrant proceeds and future financing on better terms if data remain compelling .
  • Expense discipline needed: OpEx increased to $8.6M; careful pacing of trial spend, site activation, and manufacturing scale‑up will be critical for extending runway without sacrificing critical milestones .
  • Trading implication: pre‑revenue biotech with binary‑like clinical catalysts; near‑term upside linked to additional INB‑100/INB‑200 readouts and clarity on registrational path; downside from financing events and potential estimate misses, though S&P consensus was unavailable this quarter .
  • Partnering could be a value lever: manufacturing capability and differentiated safety profile may attract collaboration interest, reducing capital intensity while advancing programs .
  • Monitor events cadence: ASCO/ASGCT/ISCT updates and any FDA interactions on INB‑100; track Arm A enrollment scale to 40 patients for INB‑400 and any operational bottlenecks .