Lyell Immunopharma Q1 2024 Business Highlights and Financial Results

Lyell Immunopharma, Inc., a clinical-stage company specializing in T-cell reprogramming for cancer treatments, has reported its financial results and business highlights for the first quarter ending March 31, 2024. The South San Francisco-based firm focuses on developing cell therapies for solid tumors and is making significant strides in its clinical programs and research.

Dr. Lynn Seely, President and CEO, emphasized the importance of the upcoming data from the Phase 1 trial of LYL797, a ROR1-targeted CAR T-cell product. According to Dr. Seely, the initial data will offer crucial insights into their ability to reprogram CAR T cells to effectively target and eliminate cancer cells. Additionally, the company's robust financial position is expected to support ongoing operations through multiple milestones into 2027.

The company is currently advancing four wholly-owned product candidates. Among them, LYL797 and LYL845 are in Phase 1 clinical trials, while LYL119 and another unnamed TIL product candidate are in the preclinical development stage. Specifically, LYL797 is designed to target ROR1 and incorporates both genetic and epigenetic modifications to enhance its potency and durability. The Phase 1 trial for LYL797 is enrolling participants with relapsed or refractory triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). Initial data from at least 20 patients in this trial are expected this quarter.

LYL845, another product candidate, focuses on tumor infiltrating lymphocytes (TIL) and uses Lyell's proprietary Epi-R manufacturing protocol for enhanced efficacy and durability. The Phase 1 trial for LYL845 includes patients with relapsed or refractory metastatic or locally advanced melanoma, NSCLC, and colorectal cancer. Initial data from this trial are expected in the second half of 2024.

LYL119 aims to improve upon the first-generation ROR1-targeted CAR T-cell product, incorporating four novel reprogramming technologies designed to boost cytotoxicity. These technologies include c-Jun overexpression, NR4A3 knockout, the Epi-R manufacturing protocol, and Stim-R T-cell activation technology. Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 showed promising results, including reduced CAR T-cell exhaustion and sustained antitumor activity in preclinical models. An investigational new drug (IND) application for LYL119 is planned for submission this quarter.

Financially, Lyell reported a net loss of $60.7 million for the first quarter of 2024, slightly lower than the $67.0 million loss in the same period in 2023. Non-GAAP net loss, which excludes various non-cash expenses, was $37.5 million compared to $44.8 million in 2023. The company's research and development (R&D) expenses decreased marginally to $43.2 million from $44.6 million in the same quarter of the previous year. Non-GAAP R&D expenses also showed a decrease, primarily due to a reduction in personnel-related expenses following a workforce reduction in November 2023.

General and administrative (G&A) expenses were significantly lower at $13.5 million, down from $19.3 million in the same quarter of 2023. This decrease was also primarily driven by a reduction in non-cash stock-based compensation. Non-GAAP G&A expenses were $8.1 million, compared to $10.0 million in the same period in 2023.

As of March 31, 2024, Lyell had cash, cash equivalents, and marketable securities totaling $526.3 million. This strong financial footing is expected to support the company's development pipeline and operational needs well into 2027.

In summary, Lyell Immunopharma is making substantial progress in its clinical programs and has a solid financial base to support future developments. With multiple product candidates in various stages of clinical and preclinical development, the company is poised to make significant contributions to cancer treatment, particularly for patients with solid tumors.