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Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, reported its financial results and business highlights for the second quarter ended June 30, 2025. The company reported a net loss of $42.7 million, a decrease of $3.1 million compared to the same period in 2024. Non-GAAP net loss decreased to $37.8 million, primarily due to lower interest income and decreased cash balances. Research and development (R&D) expenses were $34.9 million, a decrease of $5.4 million from the previous year.
Lyell's lead clinical program, LYL314, a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate, continues to show promising results. The company presented new clinical data at the International Conference on Malignant Lymphoma in Lugano, Switzerland, in June, demonstrating high rates of durable complete responses in patients with aggressive large B-cell lymphoma (LBCL). The efficacy evaluable population consisted of 36 patients with Day 84 assessments or prior disease progression or death. The overall response rate was 88% in the 3L+ setting, with 72% achieving a complete response. In the 2L setting, the overall response rate was 91%, with 64% achieving a complete response.
The company has initiated the PiNACLE pivotal trial of LYL314 in patients with LBCL receiving treatment in the third- or later-line (3L+) setting and is on track to initiate a pivotal trial in the second-line (2L) setting by early 2026. The FDA has granted LYL314 Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of R/R diffuse LBCL in the 3L+ setting.
Lyell also entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million. The initial closing of approximately $50 million of common stock at a price of $13.32 per share occurred on July 25, 2025. The company expects to use the net proceeds from the private placement, together with its existing cash, cash equivalents, and marketable securities, to advance two pivotal-stage clinical trials of LYL314 as well as working capital for other general corporate purposes.
References:
[1] https://www.globenewswire.com/news-release/2025/08/12/3132110/0/en/Lyell-Immunopharma-Reports-Business-Highlights-and-Financial-Results-for-the-Second-Quarter-2025.html
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