Lyell Immunopharma, Inc. (Nasdaq: LYEL) announced on July 25, 2025, that it has secured a private placement agreement with institutional and accredited investors for gross proceeds of up to approximately $100 million. The clinical-stage company is developing next-generation CAR T-cell therapies for cancer patients, with the funding specifically targeted to advance its lead candidate LYL314 through pivotal clinical trials.
Structured Financing with Milestone-Based Components
The private placement features a tiered structure beginning with an initial closing of approximately $50 million of common stock at $13.32 per share, expected to occur on July 25, 2025. The company retains the right to require investors to purchase an additional $50 million in common stock or pre-funded warrants upon achieving clinical milestones related to the ongoing LYL314 PiNACLE pivotal trial or other corporate milestones within 12 months of the initial closing.
The milestone closing would price shares at $25.61 each, unless the stock's closing price falls below $10.41 the day before the milestone closing, in which case the price would be set at $10.41 per share. Additionally, investors have the option to purchase their committed milestone shares at any time before the milestone closing at $30.73 per share through "Investor Call Closings."
Strategic Use of Proceeds for Pivotal Trials
After deducting offering expenses, Lyell plans to use the net proceeds alongside existing cash, cash equivalents, and marketable securities to fund two pivotal-stage clinical trials of LYL314. The company expects this financing to extend its cash runway into mid-2027, providing sufficient capital to reach several critical milestones including data from the LYL314 PiNACLE pivotal trial, from which Lyell intends to submit a Biologics License Application later in 2027.
The funding will support treatment development for patients with large B-cell lymphoma (LBCL) who have relapsed and/or are refractory to two or more lines of prior therapy. Additional planned milestones include a clinical trial data update from LYL314 at the end of 2025, initiation and conduct of a Phase 3 randomized controlled trial evaluating LYL314 in patients with relapsed or refractory LBCL in the second-line setting, and initiation of a clinical trial for a new fully-armed CAR T-cell therapy candidate targeting an undisclosed solid tumor indication.
Next-Generation CAR T Technology Platform
LYL314 represents Lyell's lead product candidate, designed as a next-generation dual-targeting CD19/CD20 CAR T-cell therapy. The treatment is engineered to increase complete response rates and prolong response duration compared to approved CD19-targeted CAR T-cell therapies for large B-cell lymphoma treatment. The PiNACLE trial is an ongoing single-arm pivotal trial evaluating LYL314 in patients with large B-cell lymphoma that has relapsed and/or been refractory to two or more lines of prior therapy.
Lyell's technology platform focuses on endowing CAR T cells with enhanced attributes needed for durable tumor cytotoxicity and consistent, long-lasting clinical responses. These include the ability to resist exhaustion, maintain qualities of durable stemness, and function effectively in hostile tumor microenvironments. The company's pipeline addresses both hematologic malignancies and solid tumors.
Manufacturing Capabilities and Commercial Readiness
The company operates the Lyell LyFE Manufacturing Center, which has commercial launch capability and can manufacture more than 1,200 CAR T-cell doses at full capacity. This manufacturing infrastructure positions Lyell to support potential commercial operations following regulatory approval of its lead candidates.
The private placement securities are being offered without public registration under the Securities Act of 1933, with investors receiving customary resale Form S-3 registration rights for the common stock issued in the financing.
