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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
Values with an asterisk retrieved from S&P Global.*
Note: Company reports one segment.
Guidance Changes
Earnings Call Themes & Trends
(No Q3 2025 transcript found.) Trends compiled from filings/press releases.
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.*
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.