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Lyell Immunopharma, Inc. (LYEL)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 reported minimal revenue alongside a large GAAP net loss driven by acquisition-related and impairment charges; non-GAAP net loss was far smaller, reflecting exclusion of non-cash items .
  • The ImmPACT Bio acquisition adds IMPT-314 (dual-targeting CD19/CD20 CAR T) and accelerates pivotal timelines: 3rd-line LBCL trial mid-2025 and 2nd-line by early-2026; Fast Track Designation is in place .
  • Clinical KPIs for IMPT-314 are strong: 94% ORR, 71% CR at 3 months, manageable safety (no Grade 3+ CRS; Grade 3 ICANS in 13%) with rapid resolution .
  • 2025 net cash use guided to $175–$185M and cash runway into 2027, supporting multiple clinical milestones .
  • No earnings call transcript was found for the period; investor narrative centers on pipeline prioritization and pivotal readiness for IMPT-314.

What Went Well and What Went Wrong

  • What Went Well

    • IMPT-314 delivered high response rates and favorable safety in LBCL (ORR 94%, CR 71%; no Grade 3+ CRS; Grade 3 ICANS 13% with median 5-day resolution) .
    • Clear pivotal path: 3rd-line LBCL mid-2025; 2nd-line early-2026; CEO emphasized confidence in improving complete responses and durability over CD19-only CAR Ts: “We believe IMPT-314 has the potential to deliver improved outcomes...” — Lynn Seely, M.D. .
    • Cash runway into 2027 maintained, enabling clinical execution across milestones .
  • What Went Wrong

    • Q4 GAAP net loss spiked to $191.9M due to $87.2M acquired IPR&D and $51.3M impairment of long-lived assets; underlying operations show elevated operating expenses from acquisition and facilities costs .
    • Revenue remained de minimis ($11K) and declined YoY vs Q4 2023 ($13K), underscoring pre-commercial status .
    • Reported impairment reflects continued decline in stock price and market cap, signaling market skepticism that management must overcome with pivotal data .

Financial Results

Quarterly trend (oldest → newest):

Metric (USD)Q2 2024Q3 2024Q4 2024
Revenue ($ Thousands)$13 $34 $11
GAAP Net Loss ($ Thousands)$45,809 $44,583 $191,935
R&D Expense ($ Thousands)$40,261 $39,500 $48,668
G&A Expense ($ Thousands)$12,256 $11,769 $14,522
Non-GAAP Net Loss ($ Thousands)$39,059 $37,064 $45,867
Cash, Cash Equivalents & Marketable Securities ($ Thousands, period-end)$491,119 (Jun 30) $460,659 (Sep 30) $383,541 (Dec 31)

YoY comparison (Q4 2024 vs Q4 2023):

Metric (USD)Q4 2023Q4 2024
Revenue ($ Thousands)$13 $11
GAAP Net Loss ($ Thousands)$52,930 $191,935
R&D Expense ($ Thousands)$46,995 $48,668
G&A Expense ($ Thousands)$13,167 $14,522
Non-GAAP Net Loss ($ Thousands)$43,938 $45,867

Special items (Q4 2024):

ItemQ4 2024 ($ Thousands)
Acquired IPR&D (ImmPACT Bio)$87,184
Impairment of long-lived assets$51,297

KPIs (IMPT-314 Phase 1/2 LBCL, CAR T-naïve, data cutoff Oct 22, 2024):

KPIQ4 2024
Overall Response Rate (ORR)94% (16/17 efficacy-evaluable)
Complete Response (CR) rate at 3 months71% (12/17)
Median follow-up6.3 months (range 1.2–12.5)
Response ongoing at last follow-up71% of patients
Grade 3+ CRS0% (none reported)
Grade 3 ICANS13% (3/23), median resolution 5 days
PK ExpansionRobust; median Tmax ~10 days

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net cash useFY 2025n/a$175M–$185M Introduced
Cash runwayMulti-yearInto 2027 Into 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
IMPT-314 pivotal timingExpect to initiate pivotal in 2025 (Q3) On track for mid-2025 (3rd-line), early-2026 (2nd-line) Firming timelines
Pipeline prioritizationQ2 emphasized LYL797, LYL845, LYL119 IND cleared ; Q3 added IMPT-314 via acquisition Focus on IMPT-314 and next-gen solid tumor program; discontinuations announced Oct 24 Strategic concentration
Cash runwayInto 2027 (Q2/Q3) Into 2027 reiterated Maintained
Regulatory/statusFast Track for IMPT-314 noted Fast Track reiterated; pivotal designs outlined Strengthened positioning
R&D execution (LYL119)IND cleared; SITC poster (Q2/Q3) Next-gen solid tumor IND targeted for 2026 Longer-dated milestone

Management Commentary

  • “We believe IMPT-314 has the potential to deliver improved outcomes for patients by increasing complete response rates and prolonging the duration of response over approved CD19 CAR T-cell therapies...” — Lynn Seely, M.D., President & CEO .
  • “We plan to initiate two pivotal programs for IMPT-314: one for patients in the 3rd line and later setting by the middle of this year and a second program for patients in the 2nd line setting by early 2026.” — Lynn Seely, M.D. .
  • “With our acquisition of ImmPACT now complete, we plan to accelerate the development of IMPT-314...” — Lynn Seely, M.D. (Q3) .

Q&A Highlights

  • No earnings call transcript was available in the document catalog for Q4 2024; therefore, Q&A themes and clarifications cannot be assessed from primary sources.

Estimates Context

  • We attempted to retrieve S&P Global consensus estimates (EPS and revenue) for Q4 2024 and prior quarters; access was unavailable due to request limits, so beats/misses versus consensus cannot be quantified this quarter. S&P Global consensus unavailable.

Key Takeaways for Investors

  • IMPT-314 clinical profile (94% ORR, 71% CR) and Fast Track status support a near-term pivotal path; mid-2025 data updates are likely to be the next stock-moving catalysts .
  • The large GAAP loss was driven by non-recurring items (acquired IPR&D and asset impairment); non-GAAP net loss ($45.9M) better reflects operating trajectory post-acquisition .
  • Guidance for 2025 net cash use ($175–$185M) and runway into 2027 provide funding clarity through pivotal initiations and data maturation .
  • Strategic focus has tightened (IMPT-314 and next-gen solid tumor CAR T), potentially improving capital efficiency and execution velocity .
  • Near-term events: pivotal initiation (3rd-line LBCL mid-2025), 2nd-line program by early-2026, and more mature IMPT-314 data — monitor timelines closely for execution signals .
  • With minimal revenue and pre-commercial status, valuation sensitivity is driven by clinical outcomes and regulatory milestones; any durability/safety updates and manufacturing transfer progress could materially impact sentiment .
  • Absent consensus estimates, focus on qualitative milestone delivery and non-GAAP expense discipline to gauge trajectory until broader street coverage clarifies expectations.

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