Lyell Immunopharma — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $45.5 million for the third quarter ended September 30, 2026, compared to a net loss of $38.8 million for the same period in 2025.
• Revenue was $3,000 for the three months ended September 30, 2026, down from $15,000 in the same period in 2025; revenue was $9,000 for the nine months ended September 30, 2026, compared to $30,000 in the same period in 2025.
• Research and development (R&D) expenses increased to $40.9 million for the quarter ended September 30, 2026, from $28.2 million in the prior-year period, driven by a $12.2 million increase in research activities, collaborations, and outside services.
• General and administrative (G&A) expenses decreased to $9.3 million for the quarter ended September 30, 2026, from $10.7 million in the prior-year period, primarily due to lower professional services expenses.
• Non-GAAP net loss increased to $41.3 million for the quarter ended September 30, 2026, from $29.1 million in the prior-year period, primarily due to increased clinical trial activity and lower interest income.
• Cash, cash equivalents, and marketable securities totaled $194.0 million as of September 30, 2026, compared to $247.2 million as of December 31, 2025.
• Total operating expenses were $48.3 million for the quarter ended September 30, 2026, compared to $37.3 million in the prior-year period.
• Interest income, net, was $1.9 million for the quarter ended September 30, 2026, compared to $3.3 million in the prior-year period.

Guidance and Future Outlook:

• PiNACLE pivotal data disclosure is on track for mid-2027, with a Biologics License Application (BLA) submission expected in the second half of 2027.
• The PiNACLE trial is expected to complete enrollment by year-end 2026.
• Lyell expects its current cash balance of $194.0 million, together with net proceeds from the November 2026 private placement, to fund operations into 2028.
• Additional clinical data and an End-of-Phase 1 meeting with the FDA for LYL273 are expected in 2027.
• The company is focusing on preparation for commercialization of ronde-cel.

Business Segments and Product Lines:

• Ronde-cel: Updated clinical data from the PiNACLE pivotal trial (3L+ R/R LBCL) and Phase 1/2 trial 2L cohort were accepted for presentation at ASH 2026.
  • Among 44 efficacy-evaluable patients in the 3L+ PiNACLE trial, the overall response rate was 91% and the complete response rate was 77%.
  • Median duration of complete response and median progression-free survival were not reached; the estimated continued complete response rate was 92% at six months and 75% at 12 months.
  • No Grade ≥ 3 cytokine release syndrome (CRS) was observed, and Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 9% of patients.
  • The PiNACLE-H2H Phase 3 randomized controlled trial in the 2L setting continues to enroll patients.
• LYL273: Technology transfer to the LyFE Manufacturing Center™ was completed in September 2026 following FDA review of an improved manufacturing process.
  • The Phase 1/2 clinical trial for LYL273 in patients with R/R metastatic colorectal cancer (mCRC) continues to enroll patients, including dosing with the new manufacturing process.
  • The goal is to determine the recommended Phase 2 dose and optimize the safety management plan.
• Manufacturing: The LyFE Manufacturing Center™ has commercial launch capability and is expected to manufacture more than 3,000 CAR T-cell doses per year.

Market and Competitive Landscape:

• Ronde-cel targets B cells expressing CD19 or CD20 and is manufactured to enrich for CD62L-positive cells to enhance stemlike features and antitumor activity.
• The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the 3L+ setting and RMAT designation for the 2L setting.
• The FDA has granted LYL273 Fast Track designation for the treatment of mCRC.
• The company faces substantial competition in a rapidly changing industry.

Risks and Challenges:

• Risks include the potential for clinical trial results to not be predictive of future results, the complexity of manufacturing cellular therapies, and the possibility of delays in regulatory approvals.
• The company relies on the enrollment and retention of patients in clinical trials and faces risks related to intellectual property protection and dependence on third parties.
• Actual results may differ materially from forward-looking statements due to risks such as the need for additional capital and fluctuations in operating results.

Management Commentary and Tone:

• CEO Lynn Seely, M.D., stated that updated ronde-cel data strengthens conviction in the product's potential to improve outcomes for patients with large B-cell lymphoma.
• Management highlighted high rates of durable complete responses in both second- and third- or later-line settings, including in patients with high-risk primary refractory disease.
• The tone indicates a focus on advancing toward commercialization while continuing to develop the LYL273 program.

Other Key Points:

• Announced a private placement financing of $80.0 million in November 2026 with participation from existing and new investors.
• The company reported a prior-year loss on a securities purchase agreement put/call of $4.0 million that did not recur in the current quarter.
• Non-GAAP financial measures exclude non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the securities purchase agreement put/call, and success payment liabilities.