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Lyell Immunopharma, Inc. (LYEL)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 results were steady operationally: net loss improved year over year to $(52.2)M from $(60.7)M, while revenue remained de minimis at $0.007M; cash and marketable securities were $330.1M, supporting runway into 2027 .
  • EPS modestly beat consensus: diluted EPS was approximately $(3.54)* vs Wall Street consensus of $(3.60); revenue of $0.007M modestly exceeded consensus of $0.000M (small base effects; biotech with limited revenue streams) .
  • Strategic progress and regulatory tailwinds: LYL314 received FDA RMAT designation; LyFE Manufacturing Center now supplies clinical product; pivotal 3L LBCL trial initiation remains on track for mid-2025, 2L by early 2026 .
  • Near-term catalysts: June ICML oral presentation of updated LYL314 data (including initial 2L); manufacturing transfer completed; continued regulatory engagement under RMAT could accelerate development discussions .

What Went Well and What Went Wrong

What Went Well

  • RMAT designation for LYL314 in 3L+ DLBCL strengthens regulatory path and increases FDA interaction frequency .
  • Manufacturing transfer completed: LYL314 clinical supply now produced at LyFE in Bothell, with capacity >1,000 CAR T doses/year, supporting pivotal and potential commercial needs .
  • Management confidence on pivotal timelines and upcoming data: “We are pleased with the progress… remain on track to initiate two pivotal programs for LYL314… and look forward to presenting new clinical data… in June” — Lynn Seely, M.D., President & CEO .

What Went Wrong

  • Non‑GAAP net loss increased YoY to $(46.3)M (vs $(37.5)M in Q1 2024), driven by higher personnel costs and lower interest income; GAAP net loss improved YoY due to absence of prior-year impairments .
  • Interest income fell by ~$3.0M YoY, reflecting lower rates and smaller cash balances, a headwind to other income .
  • R&D/G&A pressures from workforce/severance and ImmPACT integration: R&D $43.4M (+$0.3M YoY), G&A $14.0M (+$0.6M YoY), with severance and acquisition-related headcount offsetting lower stock-based compensation .

Financial Results

Summary financials (GAAP)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Thousands)$34 $11 $7
Net Loss ($USD Thousands)$(44,583) $(191,935) $(52,195)

Operating expenses (GAAP)

MetricQ3 2024Q4 2024Q1 2025
R&D Expenses ($USD Thousands)$39,500 $48,668 $43,447
G&A Expenses ($USD Thousands)$11,769 $14,522 $14,046

Non‑GAAP

MetricQ3 2024Q4 2024Q1 2025
Non‑GAAP Net Loss ($USD Thousands)$(37,064) $(45,867) $(46,296)

EPS comparison

MetricQ1 2024Q4 2024Q1 2025
Diluted EPS – Continuing Ops ($USD)$(4.77)*$(13.71)*$(3.54)*

Values with asterisk retrieved from S&P Global.

Cash and marketable securities

MetricQ3 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)$460,659 $383,541 $330,126

Results vs Wall Street consensus (Q1 2025)

MetricActual Q1 2025Consensus Q1 2025Surprise
Diluted EPS – Continuing Ops ($USD)$(3.54)*$(3.60)*+$0.06* (Beat)
Revenue ($USD Millions)$0.007$0.000*+$0.007 (Beat)

Values with asterisk retrieved from S&P Global.

Notes:

  • Margins are not meaningful given minimal revenue and biotech development-stage profile; focus is on OpEx, cash runway, and pipeline catalysts .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Cash UseFY 2025$175–$185M No update provided; focus remains on pivotal LYL314 programs and solid tumor R&D Maintained
Cash RunwayMulti‑yearInto 2027 Into 2027 Maintained
LYL314 Pivotal Trial (3L LBCL)Mid‑2025Mid‑2025 initiation Mid‑2025 initiation Maintained
LYL314 Pivotal Trial (2L LBCL)Early 2026Early 2026 initiation Early 2026 initiation Maintained
Manufacturing (LYL314 Clinical Supply)2025Planned transfer to LyFE (implied) Transfer completed; LyFE supplying clinical product Achieved milestone

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was published; management communication for the quarter occurred via press release and 8‑K .

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory/designationsFast Track for IMPT‑314 Fast Track reiterated RMAT + Fast Track for LYL314 Strengthening
Clinical efficacy (LYL314)ASH 2024 initial data planned ASH 2024 data: ORR 94%, CR 71% (third-line, CAR T‑naïve, n=17 efficacy evaluable) ICML oral presentation in June with more mature 3L data and initial 2L data Advancing/maturing
Pivotal timelines (LYL314)Expect pivotal trial in 2025 3L mid‑2025; 2L early 2026 3L mid‑2025; 2L early 2026 reiterated Stable
Manufacturing readinessLyFE facility referenced broadly Tech transfer plans (integration of ImmPACT) LyFE now manufacturing clinical supply Achieved
Cash runway & OpEx disciplineFunded into 2027 Into 2027; net cash use $175–$185M in 2025 Into 2027 reiterated Stable
Macro/tariffs/interest rates––Macro risks (tariffs, rates, inflation) noted in FLS Ongoing caution

Management Commentary

  • “We are pleased with the progress we are making with our LYL314 clinical development strategy… remain on track to initiate two pivotal programs for LYL314… and [our] LyFE Manufacturing Center… is now manufacturing the LYL314 clinical supply…” — Lynn Seely, M.D., President & CEO .
  • “Cash, cash equivalents and marketable securities of $330.1 million as of March 31, 2025 support advancing pipeline into 2027 through multiple clinical milestones.” .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; investor communications were delivered via press release and accompanying 8‑K .
  • Guidance points and timeline clarity came through written disclosures: pivotal starts and manufacturing readiness emphasized without changes vs prior quarter .

Estimates Context

  • EPS modest beat: Actual diluted EPS $(3.54)* vs consensus $(3.60); revenue of $0.007M beat consensus $0.000M, though the absolute magnitude is not financially material for valuation. Values retrieved from S&P Global.
  • With limited revenue, estimate revisions likely focus on OpEx cadence and pivotal timelines rather than near-term P&L inflection .

Key Takeaways for Investors

  • Regulatory momentum: RMAT designation in 3L+ DLBCL plus Fast Track increases FDA engagement and can potentially streamline pivotal development discussions .
  • Execution milestone: LyFE manufacturing transfer completed; internal supply capability de‑risked for pivotal programs and potential scale‑up .
  • Near‑term catalyst: ICML oral presentation (June) will showcase more mature 3L data and initial 2L data—key for efficacy durability and expansion into earlier lines .
  • Cash runway to 2027: $330.1M EoQ cash/marketable securities provides visibility through multiple clinical milestones; the firm remains focused on expense discipline .
  • Pivotal timing unchanged: 3L initiation mid‑2025 and 2L early 2026 maintained—progress will be tracked closely for regulatory and competitive positioning in LBCL .
  • P&L context: GAAP net loss improved YoY with no impairment charges; non‑GAAP net loss rose due to personnel/severance and lower interest income—watch for OpEx trajectory as pivotal trials begin .
  • Trading lens: Stock likely sensitive to June ICML data readout, pivotal trial initiation announcements, and any RMAT‑related regulatory interactions or clarity on endpoints .

Values with asterisk retrieved from S&P Global.