Lyell Immunopharma Q3 2024 Business and Financial Highlights

Lyell Immunopharma, Inc., headquartered in South San Francisco, California, has announced its financial performance and strategic advancements for the third quarter ending September 30, 2024. As a clinical-stage company focused on T-cell reprogramming to treat solid tumors and hematologic malignancies, Lyell has taken significant strides in its pipeline development and financial management.

The company has successfully acquired ImmPACT Bio, which has been instrumental in accelerating the development of IMPT-314. This dual-targeting CD19/CD20 CAR T-cell product candidate has shown promising Phase 1 clinical data for patients with aggressive, relapsed/refractory B-cell non-Hodgkin’s lymphoma. Dr. Lynn Seely, President and CEO of Lyell, emphasized the potential of IMPT-314 to offer higher complete response rates and prolonged response durations compared to current CD19 CAR T-cell therapies. Initial data from the Phase 1 trial of IMPT-314 will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2024, with plans to initiate a pivotal clinical trial in 2025.

Additionally, Lyell is progressing well with the Phase 1 trial of LYL119, a next-generation ROR1-targeted CAR T-cell product candidate. LYL119 incorporates four anti-exhaustion technologies aimed at enhancing T-cell resistance to exhaustion and improving their stem-like qualities. This trial is enrolling patients with ROR1-positive solid tumors, particularly focusing on platinum-resistant ovarian and endometrial cancers. A poster detailing the multiomic profiling of LYL119 will be presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting. Initial clinical data for LYL119 are anticipated in the latter half of 2025.

Financially, Lyell reported a net loss of $44.6 million for the third quarter of 2024, an improvement from the $50.9 million loss reported for the same period in 2023. The non-GAAP net loss, which excludes non-cash stock-based compensation and other non-cash expenses, was $37.1 million compared to $43.0 million in the previous year. Research and development (R&D) expenses decreased to $39.5 million from $43.8 million, largely due to reduced personnel-related costs following a workforce reduction in November 2023. Non-GAAP R&D expenses also fell to $35.9 million from $40.5 million for the same reasons.

General and administrative (G&A) expenses were $11.8 million, down from $15.5 million in the third quarter of 2023. The reduction in G&A expenses was primarily attributed to lower non-cash stock-based compensation. On a non-GAAP basis, G&A expenses were $7.8 million, compared to $9.5 million in the previous year, again reflecting the impact of the workforce reduction.

As of September 30, 2024, Lyell's cash, cash equivalents, and marketable securities totaled $460.7 million, ensuring the company is funded through multiple clinical milestones into 2027. This strong cash position enables Lyell to continue advancing its diverse pipeline of CAR T-cell therapies.

In summary, Lyell Immunopharma is making significant advancements in its clinical pipeline, particularly with the development of IMPT-314 and LYL119. With a robust financial position and strategic focus on innovative T-cell therapies, Lyell is well-positioned to meet its clinical and operational milestones in the coming years.