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Lyell Immunopharma, Inc. (LYEL)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 net loss improved to $(38.8)M and diluted EPS of $(2.13), beating S&P Global consensus EPS of $(2.64); revenue was $15K versus consensus of $0, a small but positive surprise. Bold beats below. Values retrieved from S&P Global.*
  • Operating discipline drove a YoY reduction in R&D ($28.2M vs $39.5M) and modest G&A decline ($10.7M vs $11.8M), partly offset by a $(4.0)M loss on the SPA put/call asset tied to stock price moves.
  • Strategic momentum: acquired exclusive global rights to LYL273 (GCC CAR-T) with 67% ORR at highest dose; ronde‑cel (LYL314) received RMAT in 2L LBCL and PiNACLE–H2H Phase 3 is initiating sites ahead of first patient early 2026.
  • Liquidity remained strong with ~$320M cash, cash equivalents and marketable securities; cash runway into 2027 reaffirmed and 2025 net cash use guidance lowered to $155–$160M (ex-$40M upfront), a positive funding signal.

What Went Well and What Went Wrong

What Went Well

  • R&D efficiency: R&D fell $11.3M YoY on lower external R&D and headcount; “The decrease… was primarily due to… reduction in costs associated with… supplies… collaboration… and a decrease in personnel‑related expenses.”
  • Regulatory/designation wins: RMAT designation for ronde‑cel in 2L LBCL, complementing 3L+ RMAT/Fast Track, enabling increased FDA interactions.
  • Strategic asset acquisition: LYL273 license adds a solid tumor pipeline with dose-dependent activity (67% ORR at Dose Level 2) and Fast Track status; “We believe LYL273 has the potential to be a transformational advance in the treatment of colorectal cancer.”

What Went Wrong

  • Other income headwind: $(4.0)M loss recognized on the SPA put/call asset as a function of stock price changes, reducing the improvement in net loss.
  • Interest income down: Lower rates and balances reduced interest income to $3.3M from $6.0M YoY, creating a drag below the operating line.
  • Minimal revenue: Q3 revenue was $15K (vs $34K YoY), underscoring no commercial products yet and reliance on financing/partnerships.

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Thousands)$34 $7 $8 $15
Diluted EPS ($USD)$(3.48) $(3.54)*$(2.89) $(2.13)
Net Income ($USD Thousands)$(44,583) $(52,195) $(42,684) $(38,846)

Values with an asterisk retrieved from S&P Global.*

Operating Expenses ($USD Thousands)Q3 2024Q1 2025Q2 2025Q3 2025
Research & Development$39,500 $43,447 $34,857 $28,172
General & Administrative$11,769 $14,046 $9,786 $10,687
Other Operating (Income)/Loss$(730) $(119) $1,062 $(1,591)
KPIsMar 31, 2025Jun 30, 2025Sep 30, 2025
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)$330,126 $296,849 $319,624
Cash From Operations (YTD, $USD Thousands)$(54,738) $(89,196) $(117,773)

Note: Company reports one segment.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Cash Use (ex-$40M upfront)FY 2025$175–$185M $155–$160M Lowered
Cash RunwayThroughInto mid-2027 Into 2027 (post LYL273 upfront) Maintained/clarified
PiNACLE – H2H (2L LBCL)Trial startNAFirst patient by early 2026 New timing detail
PiNACLE (3L+ LBCL)Data/useProgress update late 2025; basis for BLA in 2027 Reaffirmed Maintained
ASH PresentationsDec 2025NATwo oral presentations accepted New event
LYL273 Phase 1 Update1H 2026NANext data update 1H 2026 New event

Earnings Call Themes & Trends

(No Q3 2025 transcript found.) Trends compiled from filings/press releases.

TopicPrevious Mentions (Q2 2025)Previous Mentions (Q1 2025)Current Period (Q3 2025)Trend
Manufacturing/LyFE capacityLyFE manufacturing ongoing; >1,200 doses capacity; West Hills closure impairment LyFE technology transfer complete; West Hills workforce reduction LyFE supports pivotal trials and potential commercial launch Strengthening, scale maintained
Regulatory designationsRMAT/Fast Track in 3L+ LBCL RMAT in 3L+ LBCL RMAT added for 2L LBCL Positive progression
R&D execution (ronde‑cel)PiNACLE underway; Phase 3 H2H by early 2026 Pivotal trials planned mid‑2025/early‑2026 Site initiation for H2H; ASH orals accepted Advancing to pivotal
Solid tumor pipelinePreclinical “fully‑armed” CAR T; IND in 2026 Preclinical tech stack; IND in 2026 LYL273 license; Fast Track; strong early ORR Major expansion
Macro/interest incomeInterest income down on rates/balances Interest income down Interest income $3.3M vs $6.0M YoY Ongoing headwind

Management Commentary

  • “Lyell is well positioned with two next-generation CAR T-cell product candidates, each with promising clinical data… focused on rapidly advancing the pivotal development of ronde‑cel through two pivotal programs.” — Lynn Seely, MD, President & CEO
  • “We believe LYL273 has the potential to be a transformational advance in the treatment of colorectal cancer, an area of tremendous unmet need.” — Lynn Seely, MD
  • CMO perspective on science: “CD62L-positive cell enrichment achieves greater memory phenotype expression and in vivo cell expansion compared to published data from FDA-approved CAR T-cell therapies for LBCL.” — David Shook, MD

Q&A Highlights

No Q3 2025 earnings call transcript was available; key clarifications emerged via press releases:

  • Timing: First patient in PiNACLE–H2H expected by early 2026; ASH oral presentations scheduled for December.
  • Cash runway and burn: Runway into 2027 reaffirmed; 2025 net cash use guidance lowered to $155–$160M (ex-$40M upfront for LYL273).
  • LYL273 safety management: Optimized diarrhea management protocol implemented; no Grade ≥3 diarrhea in last three patients at Dose Level 2.

Estimates Context

  • Consensus EPS (S&P Global) for Q3 2025: $(2.6425) vs actual $(2.13) — bold beat. Values retrieved from S&P Global.*
  • Consensus revenue (S&P Global) for Q3 2025: $0 vs actual $15K — bold beat on non-zero revenue. Values retrieved from S&P Global.*
Estimates vs ActualsQ3 2025
Primary EPS Consensus Mean$(2.6425)*
EPS Actual$(2.13)
EPS # of Estimates4*
Revenue Consensus Mean ($USD)$0*
Revenue Actual ($USD)$15,000
Revenue # of Estimates2*

Key Takeaways for Investors

  • EPS and revenue beats reflect disciplined opex: R&D down $11.3M YoY and G&A down $1.1M YoY; despite a $(4.0)M SPA put/call loss, overall loss narrowed. Potential near-term sentiment positive.
  • Clinical/regulatory momentum is strong: RMAT in 2L LBCL and PiNACLE–H2H site initiation underpin a clear path to pivotal outcomes; ASH December presentations are a near-term catalyst.
  • Portfolio expansion to solid tumors via LYL273 adds optionality and value; early U.S. Phase 1 data show compelling ORR/DCR with manageable safety and Fast Track designation, next update 1H 2026.
  • Liquidity and burn guidance de-risk funding: ~$320M cash and lowered 2025 net cash use support operations into 2027 without immediate financing pressure.
  • Trading focus: Watch ASH data (Dec 2025) and PiNACLE–H2H initiation milestones; any updates on SPA put/call mechanics or equity financing terms could affect non-operating items and sentiment.
  • Risk monitor: Interest income headwinds, non-cash SPA mark-to-model volatility, and minimal revenue until approvals; execution in pivotal programs remains the key value driver.
  • Medium-term thesis: Dual-targeting CAR T strategy (CD19/CD20) and CD62L enrichment aim to improve complete response rates and durability vs CD19-only therapies; if pivotal data confirm, 2027 BLA target is credible.

Bold beats/misses:

  • EPS: Beat vs $(2.64) consensus (actual $(2.13)).*
  • Revenue: Beat vs $0 consensus (actual $15K).*

All other quantitative data are cited in tables above from company filings and press releases.