Lyell Immunopharma (LYEL) Stock News, Mar-Aug 2025

Lyell Immunopharma (Nasdaq: LYEL), a clinical-stage CAR T-cell therapy company, has secured a private placement agreement worth up to $100 million with institutional and accredited investors. The deal includes an initial $50 million closing at $13.32 per share, expected on July 25, 2025, with potential for an additional $50 million tied to clinical milestones.

The financing includes flexible terms with milestone-based pricing ranging from $10.41 to $25.61 per share and investor call options at $30.73 per share. The proceeds will fund two pivotal-stage trials of LYL314, including the PiNACLE trial for large B-cell lymphoma, and extend the company's cash runway into mid-2027.

Lyell Immunopharma (Nasdaq: LYEL) announced its participation in the H.C. Wainwright "HCW@Home" Series on June 25, 2025. The virtual fireside chat will feature CEO Lynn Seely and CFO Charlie Newton discussing their lead product LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma (LBCL).

The presentation will highlight recent positive clinical data presented at ICML and focus on next-generation CAR T-cell therapies. LYL314, which has received both RMAT and Fast Track designations from the FDA, aims to improve complete response rates and response duration compared to existing CD19-targeted therapies.

Lyell Immunopharma (LYEL) reported positive clinical data from their Phase 1/2 trial of LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. In third-line or later treatment settings (N=25), LYL314 achieved an 88% overall response rate and 72% complete response rate, with 71% of complete responders maintaining their response at 6+ months. The therapy demonstrated a manageable safety profile suitable for outpatient administration, with no Grade ≥3 cytokine release syndrome and low rates of severe ICANS. In second-line patients (N=11), the treatment showed a 91% overall response rate with 64% complete responses. The company has initiated the pivotal PiNACLE trial for third-line+ patients and plans to start a second-line trial by early 2026. LYL314 has received both RMAT and Fast Track designations from the FDA.

Lyell Immunopharma (LYEL), a clinical-stage company developing next-generation CAR T-cell therapies, has announced key appointments to strengthen its clinical and commercial capabilities. Mark J. Bachleda, PharmD, MBA joins as an independent Board member, bringing extensive cell therapy and commercial experience from roles at Eyconis, BMS, and Amgen. David Shook, MD, a cell therapy pioneer, becomes Chief Medical Officer after serving at Nkarta. Mark Meltz, JD joins as General Counsel and Corporate Secretary, bringing over 20 years of life sciences legal expertise. Jarrad Aguirre, MD, MBA was appointed as SVP of Medical Affairs. These appointments come as Lyell prepares to advance LYL314, their autologous CD19/CD20 CAR T-cell therapy, into pivotal trials for aggressive large B-cell lymphoma.

Lyell Immunopharma (NASDAQ: LYEL), a clinical-stage biotech company focused on developing next-generation CAR T-cell therapies for cancer patients, announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. The company's senior management team will deliver a presentation on Wednesday, June 11th, 2025, at 10:00 am ET. Investors and interested parties can access the live webcast through the Investors section of Lyell's website at www.lyell.com. A replay of the presentation will be made available on the company's website after the event.

Lyell Immunopharma (NASDAQ: LYEL) reported Q1 2025 financial results and key developments for its lead program LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. Key highlights include receiving RMAT designation from FDA for LYL314 in relapsed/refractory diffuse large B-cell lymphoma and successful manufacturing transfer to their LyFE Manufacturing Center. The company plans to initiate two pivotal trials: one in mid-2025 for third-line+ treatment and another in early 2026 for second-line treatment. Initial clinical data showed promising results with a 94% overall response rate and 71% complete response rate in 17 evaluable patients. Financially, Lyell reported a net loss of $52.2M for Q1 2025, with cash reserves of $330.1M expected to fund operations into 2027.

Lyell Immunopharma (NASDAQ: LYEL) announced that new clinical data from their Phase 1/2 trial of LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma, will be presented at the International Conference on Malignant Lymphoma (ICML) 2025. The presentation, scheduled for June 18, 2025, will showcase data on LYL314, which has received both Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA for treating relapsed/refractory diffuse large B-cell lymphoma in 3rd+ line settings. The therapy is enriched for CD62L+ stem-like cells and has shown promising results in achieving durable complete responses. Dr. Akil Merchant from Cedars-Sinai Medical Center will present the findings at ICML 2025 in Lugano, Switzerland.

Lyell Immunopharma (LYEL) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its LYL314 therapy, targeting relapsed/refractory large B-cell lymphoma. The designation was based on promising data from an ongoing Phase 1/2 trial.

Key clinical results include:

• 94% overall response rate (16/17 patients)
• 71% complete response rate (12/17 patients)
• 71% of patients maintaining response at last follow-up
• Median follow-up of 6.3 months
• No Grade 3+ cytokine release syndrome reported

LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates compared to existing treatments. The company plans to initiate two pivotal programs: one in mid-2025 for 3rd+ line treatment and another in early 2026 for 2nd line treatment. Additional clinical updates are expected throughout 2025.

Lyell Immunopharma (LYEL) reported its Q4 and full-year 2024 results, highlighting significant developments in its CAR T-cell therapy pipeline. The company's lead program, IMPT-314, showed promising Phase 1 data with a 94% overall response rate and 71% complete response rate in large B-cell lymphoma patients.

Key financial metrics include a net loss of $191.9M for Q4 and $343.0M for full-year 2024. Cash position stands at $383.5 million, expected to fund operations into 2027. The company plans to initiate pivotal trials for IMPT-314 in mid-2025 for 3rd line treatment and early 2026 for 2nd line treatment.

Research and development expenses were $48.7M in Q4 and $171.6M for the full year. The company acquired ImmPACT Bio, incurring $87.2M in IPR&D expenses, and recorded a $51.3M impairment charge on long-lived assets due to stock price decline.