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Lyell Immunopharma reports developments tied to its next-generation chimeric antigen receptor, or CAR T-cell, therapy pipeline for patients with cancer. The company’s recurring updates center on ronde-cel, an autologous dual-targeting CD19/CD20 CAR T-cell product candidate for large B-cell lymphoma, and LYL273, a GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer and other GCC-expressing cancers.
Company news also covers clinical-trial activity, FDA designation updates, manufacturing capabilities at the LyFE Manufacturing Center, quarterly financial results, equity financing activity, licensing transactions, investor-conference participation and executive or governance changes.
Lyell Immunopharma has received FDA clearance for its IND application to begin a Phase 1 clinical trial for LYL797, a novel CAR T-cell therapy targeting ROR1 in solid tumors. Expected to start screening patients by Q1 2022, LYL797 aims to tackle T-cell exhaustion and enhance durable stemness using Lyell's innovative technologies, Gen-R and Epi-R. The trial will initially focus on patients with relapsed/refractory triple-negative breast cancer (TNBC) and later include those with non-small cell lung cancer (NSCLC). Initial data is anticipated in 2023.
Lyell Immunopharma has announced the commissioning of its LyFE Manufacturing Center in Bothell, WA, complying with FDA's cGMP standards. The facility, operational since April 2021, is designed to produce cell products at scale for upcoming clinical trials, including CAR, TIL, and TCR programs. It incorporates advanced data analytics for real-time monitoring and process optimization, supported by a partnership with Amazon Web Services. This infrastructure is pivotal in Lyell's efforts to address challenges in T-cell therapy, aiming for effective treatments for solid tumors.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) announced that Dr. Rick Klausner has resumed his role as Chair of the Board after a temporary medical leave. CEO Liz Homans expressed gratitude for Klausner's health and his ongoing scientific guidance. Klausner emphasized the company's mission to develop curative cell therapies for solid tumors and acknowledged Cathy Friedman's leadership during his absence. The company utilizes its proprietary Gen-R and Epi-R platforms to address challenges in adoptive T cell therapy.
As of September 30, 2021, Lyell Immunopharma reported cash and investments totaling $936.4 million, bolstering its multi-modality cell therapy pipeline. The company anticipates submitting four IND applications by the end of 2022 and is actively expanding its research, development, and manufacturing capabilities.
In Q3 2021, research and development expenses rose to $31.4 million, up from $24.5 million in Q3 2020. General and administrative expenses also increased to $21.2 million from $13.6 million. The net loss widened to $48.9 million compared to $35.7 million in the prior year.
Lyell Immunopharma (LYEL) will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 15, 2021, at 2:00 PM ET. The event will focus on T cell reprogramming aimed at curing solid tumors. Interested parties can access a live webcast via the investor relations section of the company's website, with a replay available for 90 days afterward. Lyell is dedicated to overcoming major barriers in adoptive T cell therapy through its innovative Gen-R and Epi-R platforms.
Lyell Immunopharma (LYEL) reported significant advancements in operational capacity and financial health for the second quarter of 2021. The company achieved operational readiness at its LyFE manufacturing facility, crucial for upcoming clinical trials. As of June 30, 2021, cash, cash equivalents, and marketable securities reached $974.8 million, bolstered by $391.8 million from its IPO. While R&D expenses declined compared to 2020, G&A expenses rose due to increased stock-based compensation. The net loss decreased to $62.6 million for the quarter, indicating improved cost management.
Lyell Immunopharma, Inc. (Nasdaq: LYEL) has announced the pricing of its initial public offering (IPO) of 25,000,000 shares at $17.00 per share, aiming to raise approximately $425 million before expenses. The IPO is set to commence trading on Nasdaq on June 17, 2021, and is expected to close on June 21, 2021, pending customary conditions. Additionally, underwriters have a 30-day option to purchase up to 3,750,000 additional shares. Goldman Sachs & Co. LLC and others are leading the offering.