Lyell Immunopharma will present new clinical data on LYL314 during the HCW@Home Series on June 25, 2025.
Quiver AI Summary
Lyell Immunopharma, Inc. announced that its senior management will participate in the H.C. Wainwright "HCW@Home" Series on June 25, 2025, where they will discuss promising clinical data for LYL314, its lead CAR T-cell therapy candidate aimed at treating large B-cell lymphoma (LBCL). This innovative autologous dual-targeting CD19/CD20 CAR T-cell product has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA and is currently in pivotal development for relapsed and/or refractory LBCL patients. The presentation will focus on the potential of LYL314 to enhance response rates and durability compared to existing treatments. After the live event, a replay will be available on Lyell’s website. The company is recognized for its next-generation CAR T-cell therapies and advanced manufacturing capabilities.
Potential Positives
- Lyell Immunopharma announced the presentation of positive new clinical data for its lead product candidate, LYL314, at a significant international oncology conference, indicating progress in its development and potential market interest.
- LYL314 has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, underscoring its potential therapeutic value and the company's commitment to expediting its development.
- The company's manufacturing facility, LyFE Manufacturing Center™, has commercial launch capability and can produce over 1,200 CAR T-cell doses, demonstrating readiness for scaling operations upon successful trial outcomes.
Potential Negatives
- Despite presenting new clinical data, the company may be facing significant risks and uncertainties regarding the future performance of its lead product candidate LYL314, as indicated by the emphasis on forward-looking statements and the potential for actual results to differ materially.
- The company has not provided specific details or timelines regarding the ongoing pivotal PiNACLE trial for LYL314, which could lead to uncertainty among investors and stakeholders about the development progress and potential market entry.
- Risks associated with the FDA designations and the competitive landscape for CAR T-cell therapies are acknowledged, suggesting potential hurdles in achieving expected therapeutic benefits and capturing market share.
FAQ
What is the purpose of the H.C. Wainwright “HCW@Home” Series?
The series will feature discussions on clinical data for Lyell's LYL314 and advancements in CAR T-cell therapy.
When will the Lyell Immunopharma presentation take place?
The presentation is scheduled for June 25, 2025, at 12:00 PM ET.
What is LYL314 and its significance?
LYL314 is a dual-targeting CAR T-cell therapy for relapsed/refractory large B-cell lymphoma, showing improved response rates.
How can I access the live webcast of the presentation?
The live webcast can be accessed through the Investors section on Lyell's website, www.lyell.com.
What unique capabilities does Lyell's LyFE Manufacturing Center™ offer?
The manufacturing center can produce over 1,200 CAR T-cell doses at full capacity for effective treatment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$LYEL Insider Trading Activity
$LYEL insiders have traded $LYEL stock on the open market 5 times in the past 6 months. Of those trades, 5 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $LYEL stock by insiders over the last 6 months:
- SUMANT RAMACHANDRA purchased 200,000 shares for an estimated $115,219
- CHARLES W. NEWTON (Chief Financial Officer) purchased 200,000 shares for an estimated $111,620
- LYNN SEELY (President and CEO) purchased 175,000 shares for an estimated $106,190
- RICHARD KLAUSNER purchased 158,000 shares for an estimated $94,942
- OTIS W BRAWLEY purchased 35,640 shares for an estimated $19,958
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$LYEL Hedge Fund Activity
We have seen 38 institutional investors add shares of $LYEL stock to their portfolio, and 76 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- FORESITE CAPITAL MANAGEMENT IV, LLC added 7,682,999 shares (+92.3%) to their portfolio in Q1 2025, for an estimated $4,133,453
- ORBIMED ADVISORS LLC removed 3,103,623 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $1,669,749
- ALMITAS CAPITAL LLC added 1,432,086 shares (+136.3%) to their portfolio in Q1 2025, for an estimated $770,462
- OPALEYE MANAGEMENT INC. removed 1,395,000 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $892,800
- BALYASNY ASSET MANAGEMENT L.P. removed 1,197,576 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $766,448
- MILLENNIUM MANAGEMENT LLC removed 914,550 shares (-95.5%) from their portfolio in Q1 2025, for an estimated $492,027
- D. E. SHAW & CO., INC. removed 889,087 shares (-92.0%) from their portfolio in Q1 2025, for an estimated $478,328
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
SOUTH SAN FRANCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will participate in the H.C. Wainwright “HCW@Home” Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET.
The discussion will highlight the positive new clinical data recently presented in an oral session at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on LYL314, Lyell’s lead product candidate, and the emerging landscape of next-generation dual targeting chimeric antigen receptor (CAR) T-cell therapy for patients with large B-cell lymphoma (LBCL). LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) that is in pivotal-stage development for patients with relapsed and/or refractory LBCL. LYL314 is designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL.
Fireside chat details are as follows:
- Lyell Speakers: Lynn Seely, MD, President and Chief Executive Officer and Charlie Newton, Chief Financial Officer
- Date and Time: Wednesday, June 25, 2025, 12:00 PM to 1:00 PM ET
-
Webcast Link: Register
here
A live webcast of the presentation can be accessed through the Investors section of the Company's website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company's website.
About Lyell Immunopharma, Inc.
Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. Lyell’s LyFE Manufacturing Center™ has commercial launch capability and can manufacture more than 1,200 CAR T-cell doses at full capacity. To learn more, please visit www.lyell.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell management’s attendance and presentation of clinical data on LYL314 at an investor conference; the potential clinical benefits and therapeutic potential of LYL314 for patients with relapsed and/or refractory LBCL; the potential benefits, if any, from the RMAT and Fast Track designations from the FDA for the treatment of patients with relapsed and/or refractory LBCL in the third- or later-line setting; and expectations around enrollment and timing of Lyell’s ongoing single-arm pivotal PiNACLE trial evaluating LYL314 in patients in the third- or later-line setting. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on May 13, 2025. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
[email protected]
