Key Highlights

• Lyell Immunopharma secured approximately $80 million through a private Placement of common stock at $10.77 per share

• Investors include ARCH Venture Partners, Adage Capital Management, Caligan Partners, RTW Investments, and other institutional investors

• The financing is expected to extend the company's cash runway into 2028, beyond a planned BLA submission for ronde-cel in H2 2027

• Ronde-cel, a dual-targeting CD19/CD20 CAR T-cell candidate, holds RMAT and Fast Track designations from the FDA

Lyell Immunopharma, Inc. (NASDAQ:LYEL), a late-stage clinical company developing next-generation chimeric antigen receptor (CAR) T-cell therapies, announced that it has entered into a securities purchase agreement for a private placement of approximately $80 million of its common stock. The financing brings together a syndicate of institutional investors, including ARCH Venture Partners, Adage Capital Management LP, Caligan Partners LP, RTW Investments, a leading mutual fund, and other new and existing shareholders.

Capital Allocation and Strategic Rationale

The proceeds from the private placement are intended to extend Lyell's cash runway into 2028, providing financial support through several anticipated clinical and regulatory milestones. The company plans to deploy the capital primarily toward the development of rondecabtagene autoleucel (ronde-cel), its lead CAR T-cell product candidate, which targets both CD19 and CD20 antigens in patients with relapsed or refractory large B-cell lymphoma (LBCL). The company sold 7,428,040 shares of common stock at a purchase price of $10.77 per share, matching the closing price on November 3, 2026.

Smital Shah, Chief Financial and Business Officer, noted that the financing positions Lyell to execute on its strategy as it approaches upcoming clinical and regulatory milestones. The company has described a significant clinical and commercial opportunity for ronde-cel, which is being developed as a one-time treatment that can be administered in an outpatient setting.

Ronde-Cel Development Timeline

Ronde-cel is currently being evaluated in two pivotal trials. The PiNACLE trial is a single-arm study in the third-line-or-later (3L+) LBCL setting, designed to support an initial Biologics License Application (BLA) for regular Marketing approval. The PiNACLE-H2H trial is a Phase 3 randomized controlled study comparing ronde-cel to an approved CD19-directed CAR T-cell therapy in the second-line (2L) setting. Ronde-cel has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for relapsed or refractory diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.

Lyell expects to present additional clinical data from the PiNACLE trial at the 68th American Society of Hematology (ASH) Annual Meeting in December 2026. The full pivotal dataset is anticipated in mid-2027, with a BLA submission to the FDA expected in the second half of 2027.

Broader Pipeline Progress

Beyond ronde-cel, Lyell is also advancing LYL273, a GCC-targeted CAR T-cell product candidate for patients with metastatic colorectal cancer. The program is progressing toward selection of a recommended Phase 2 dose, with additional clinical data and a planned End-of-Phase 1 meeting with the FDA expected in 2027.

The Path Forward

Lyell's $80 million capital raise provides funding continuity through the anticipated BLA filing for ronde-cel and positions the company to advance its broader oncology pipeline. With pivotal data expected at ASH 2026 and the full dataset anticipated by mid-2027, the coming months represent a defining period for the company's lead program. The participation of multiple institutional investors in the placement reflects ongoing interest in Lyell's approach to next-generation CAR T-cell therapy development.