Lyell Immunopharma, Inc. reported a net loss of $342.99 million for the year ended December 31, 2024, compared to a net loss of $234.63 million in 2023. Revenue for 2024 was $61,000, a significant decrease from $130,000 in 2023. The company attributes the decrease in revenue to the termination of the GlaxoSmithKline (GSK) agreement in December 2022, which had previously generated substantial revenue. Research and development expenses decreased by $11.34 million to $171.6 million in 2024, primarily due to workforce reductions and lower software costs, partially offset by increased clinical trial activity. General and administrative expenses also decreased by $14.94 million to $52.04 million, mainly due to lower personnel costs.

A significant event in 2024 was the acquisition of ImmPACT Bio USA Inc. for a total consideration of $41.9 million in cash and 37.5 million shares of Lyell common stock. This acquisition included the transfer of ImmPACT's lead product candidate, IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy currently in Phase 1/2 clinical trials. Initial Phase 1/2 data for IMPT-314, presented at the American Society of Hematology (ASH) 2024 Annual Meeting, showed a 94% overall response rate and a 71% complete response rate in a subset of 17 patients. The company anticipates initiating two pivotal clinical trials for IMPT-314 in mid-2025 and early 2026, respectively.

Lyell also reported advancements in its preclinical pipeline, focusing on next-generation CAR T-cell therapies for solid tumors. The company expects to submit an Investigational New Drug (IND) application for a second CAR T-cell product candidate in 2026. Several presentations at the Society for Immunotherapy of Cancer (SITC) 2024 highlighted the company's proprietary anti-exhaustion and manufacturing technologies, showcasing their potential to improve T-cell function in solid tumors. The company's manufacturing strategy includes a technology transfer of IMPT-314 production from its Los Angeles facility to its LyFE Manufacturing Center in Bothell, Washington.

As of December 31, 2024, Lyell had 300 employees, with over 83% engaged in research and development, technical operations, and process sciences. The company reported that its employee turnover remained consistently below the average for the U.S. life sciences industry. Lyell also received certification as a Great Place to Work in 2024, based on employee feedback. The company's cash, cash equivalents, and marketable securities totaled approximately $383.5 million as of December 31, 2024, and the company believes this will be sufficient to fund operations into 2027. However, the company anticipates needing additional capital to complete clinical development and potential commercialization of its product candidates.

Lyell's 10-K filing included numerous risk factors, including the inherent uncertainties of clinical-stage drug development, the need for substantial additional funding, competition from established pharmaceutical companies, and the complexities of manufacturing and regulatory approval for cell therapies. The company also noted the potential for volatility in its stock price and the ongoing risks associated with complying with extensive regulatory requirements in the United States and internationally. The company stated that it intends to retain all future earnings for use in its business and does not currently plan to pay any cash dividends.

About Lyell Immunopharma, Inc.

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