Lyell Immunopharma Q2 2024 Business Highlights and Financial Results

Lyell Immunopharma, Inc., a clinical-stage T-cell reprogramming company, has announced significant advancements in its diverse pipeline of cell therapies targeting solid tumors and hematologic malignancies. The company, based in South San Francisco, California, reported its financial results and business highlights for the second quarter ending June 30, 2024.

One of the major highlights from Lyell's recent activities is the promising initial data from their Phase 1 trial of LYL797, a ROR1-targeted CAR T-cell product enhanced with anti-exhaustion technology. This product showed dose-dependent clinical activity in patients with relapsed/refractory triple-negative breast cancer (TNBC). At the highest dose tested (150 x 10^6 CAR T cells), the objective response rate (ORR) was 40%, and the clinical benefit rate (CBR) was 60%. Based on these results, Lyell has expanded the trial to include patients with platinum-resistant ovarian cancer, endometrial cancer, multiple myeloma, and chronic lymphocytic leukemia (CLL).

In addition, Lyell received clearance from the FDA for an Investigational New Drug (IND) application for LYL119, another ROR1-targeted CAR T-cell product. This next-generation candidate incorporates four proprietary technologies to enhance T-cell persistence and resistance to exhaustion. The initial clinical data from the Phase 1 trial for LYL119 are anticipated in the second half of 2025.

Financially, Lyell reported a net loss of $45.8 million for the second quarter of 2024, an improvement from the $63.9 million net loss in the same period of 2023. The company's cash, cash equivalents, and marketable securities stood at $491.1 million as of June 30, 2024, down from $562.7 million at the end of 2023. However, Lyell expects its cash reserves to support pipeline advancements through multiple clinical milestones into 2027.

Research and development (R&D) expenses decreased to $40.3 million for the second quarter of 2024 from $47.5 million in the same period of 2023. This reduction was mainly due to a decrease in personnel-related expenses following a workforce reduction in November 2023. General and administrative (G&A) expenses also saw a reduction to $12.3 million from $19 million in the same period in 2023, driven primarily by a decrease in non-cash stock-based compensation.

LYL797 continues to show promise as it progresses through its clinical trial stages. The trial, initially targeting patients with TNBC and non-small cell lung cancer (NSCLC), has expanded to include other cancer types based on the early data demonstrating its efficacy. Moreover, an IND is expected to be submitted later this year for a new Phase 1 trial of LYL797 in patients with multiple myeloma and CLL.

Lyell's pipeline also includes LYL845, a TIL (tumor infiltrating lymphocyte) product candidate undergoing Phase 1 clinical trials. LYL845 is designed using Lyell’s proprietary Epi-R manufacturing protocol to enhance potency and durability. This trial currently includes patients with advanced melanoma, NSCLC, and colorectal cancer, with initial data expected in the second half of 2024.

The company's strategy hinges on its proprietary ex vivo genetic and epigenetic reprogramming technology, aimed at overcoming T-cell exhaustion and enhancing the persistence and self-renewal capabilities of T-cells. This approach is designed to provide consistent and long-lasting responses to cell therapy in solid tumors.

In summary, Lyell Immunopharma is making significant strides in its clinical programs and financial management. With promising early data from its trials and a robust pipeline supported by substantial cash reserves, the company is well-positioned to advance its innovative cell therapies through several critical milestones in the coming years.