Lyell Immunopharma, Inc. (LYEL)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 was execution-heavy: Lyell initiated PiNACLE, the single‑arm pivotal trial of LYL314 in LBCL 3L+, and reiterated plans to start a 2L pivotal by early 2026 .
• Financials were stable-to-improving: net loss narrowed to $42.7M from $45.8M YoY and from $52.2M QoQ; R&D fell to $34.9M and G&A to $9.8M on lower stock-based comp and outside services .
• Balance sheet was strengthened via a private placement of up to $100M; initial $50M closed at $13.32/share, extending pro‑forma cash to ~$347M and runway into mid‑2027 .
• Clinical momentum continued: updated Phase 1/2 data showed 88% ORR and 72% CR in 3L+ and 91% ORR/64% CR in 2L, with manageable safety profile suitable for outpatient administration .
• EPS beat: primary EPS was -$2.89* vs consensus -$3.58, driven by disciplined OpEx and lower stock-based comp; revenue ($0.008M) was above a zero-consensus baseline but immaterial for valuation* .

What Went Well and What Went Wrong

What Went Well

• Initiated pivotal PiNACLE in 3L+ LBCL; pivotal 2L trial remains on track for early 2026, advancing LYL314 toward BLA in 2027 .
  “We have initiated the PiNACLE single-arm pivotal trial… and are on track to begin a second pivotal trial… by early 2026.” — Lynn Seely, President & CEO .
• Positive clinical durability and safety: 3L+ ORR 88%, CR 72% with 71% CR durability ≥6 months; safety profile appropriate for outpatient administration; similar strength in initial 2L cohort .
• Capital and runway enhanced: up to $100M private placement (initial $50M at $13.32) and pro‑forma cash ~$347M; runway into mid‑2027 supports pivotal programs and a solid tumor IND .

What Went Wrong

• Continuing losses and minimal revenue: net loss -$42.7M; revenue $0.008M; loss from operations -$47.1M reflects development stage and limited revenue contribution .
• Lower interest income YoY contributed to non‑GAAP net loss trajectory, reflecting lower rates and balances .
• Ongoing risk disclosures emphasize manufacturing complexity, regulatory uncertainty (RMAT/Fast Track do not assure approval), and macro/geopolitical/tariff risks that could affect timelines and costs .

Financial Results

Quarterly P&L and Balance Sheet (oldest → newest)

Year-over-Year (Q2 2025 vs Q2 2024)

Estimates Comparison (Q2 2025)

Source: S&P Global consensus and actuals for Q2 2025 (Revenue, EPS, target price)*.

Segment Breakdown

• Not applicable; Lyell does not report revenue by segment in Q2 2025 .

KPIs (Clinical Efficacy and Safety – LYL314)

Guidance Changes

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available in the document catalog; management commentary reflects the Q2 8‑K and associated press releases .

Management Commentary

• “We believe that our CD19/CD20 CAR T-cell therapy will disrupt the therapeutic landscape by delivering meaningfully increased complete response rates and improved durability over the currently approved CD19 CAR T-cell therapies.” — Lynn Seely, President & CEO .
• “Based on these robust data… we have initiated PiNACLE… and remain on track to initiate a pivotal trial… in the second-line setting by the beginning of 2026.” — Lynn Seely, President & CEO .
• “Our recent private placement… significantly derisks our business, extends our cash runway into mid-2027 and enables us to focus on rapidly advancing the clinical development of LYL314.” — Lynn Seely .

Q&A Highlights

• Q&A transcript for Q2 2025 was not available; the company did host a June 17 investor webcast to discuss clinical data, and reiterated pivotal timelines and manufacturing readiness in press materials .
• Areas where investors typically probed (inferences from disclosures): durability of CRs and outpatient feasibility (management emphasized favorable safety and durability) ; pivotal design, endpoints, and BLA timing (ORR primary endpoint; 2027 BLA target) .

Estimates Context

• Q2 2025 EPS beat: actual -$2.89* vs consensus -$3.58; revenue $0.008M vs $0.000M consensus, not economically meaningful*.
• Target price consensus stood at ~$15.67 (3 estimates)*; expense discipline and lower stock-based comp aided the EPS outcome against expectations .
• Implications: Consensus EPS for future quarters should reflect lower OpEx trajectory and capital structure post-financing; revenue remains non-driver until commercialization*.

Key Takeaways for Investors

• Pivotal inflection: PiNACLE initiated; 2L pivotal on track early 2026 — execution supports a 2027 BLA in 3L+ LBCL .
• Clinical differentiation: High CR rates with durable responses and outpatient-suitable safety profile may enable competitive positioning vs CD19-only CAR Ts .
• Balance sheet extended: Up to $100M private placement, pro‑forma cash ~$347M; runway into mid‑2027 covers pivotal programs and solid tumor IND .
• Operating discipline: R&D and G&A down YoY, contributing to narrowed GAAP and non‑GAAP net losses; reduced stock-based comp cited .
• Near-term catalysts: Late‑2025 PiNACLE update and more mature 2L data; potential milestone closing in the private placement structure contingent on clinical/corporate milestones .
• Risks to monitor: Manufacturing complexity, regulatory uncertainties despite RMAT/Fast Track, macro/tariff/geopolitical risks, and timeline execution .
• Trading angle: Momentum likely tied to durability/safety updates and pivotal enrollment progress; financing mitigates near-term dilution risk while enabling execution .

Values marked with * were retrieved from S&P Global.