On November 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that it has entered into a securities purchase agreement for a private placement of approximately $80 million of its common stock. The investors include ARCH Venture Partners, Adage Capital Management LP, Caligan Partners LP, RTW Investments, a leading mutual fund and other new and existing institutional investors.

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The financing is expected to extend Lyell’s cash runway into 2028, providing capital to support key clinical and regulatory milestones for rondecabtagene autoleucel (ronde-cel), its next-generation dual-targeting CD19/CD20 CAR T-cell product candidate being developed for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Lyell expects to present additional clinical data from the ongoing pivotal PiNACLE trial in the third-or later-line (3L+) LBCL setting at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2026, with the full pivotal dataset anticipated in mid-2027 and submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) expected to follow in the second half of 2027.

"This financing strengthens our financial position and supports the execution of our strategy as we approach several important clinical and regulatory milestones," said Smital Shah, Chief Financial and Business Officer of Lyell. "We see a significant clinical and commercial opportunity for ronde-cel, which has the potential to deliver durable responses with a one-time treatment that can be administered in the outpatient setting. We are pleased to have the strong support of our syndicate of high-quality existing and new investors as we advance toward these important milestones."

Ronde-cel is currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the second-line (2L) setting. Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.

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

Private Placement Details

Under the terms of the securities purchase agreement, Lyell has agreed to sell 7,428,040 shares of common stock at a purchase price of $10.77 per share, equal to the closing price of Lyell’s common stock on November 3, 2026. The financing is expected to generate gross proceeds of approximately $80 million before deducting placement agent fees and other offering expenses. The private placement is expected to close on or about November 4, 2026, subject to customary closing conditions.

Goldman Sachs and Leerink Partners acted as placement agents in connection with the financing.

Lyell intends to use the net proceeds from the private placement, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of ronde-cel, including its ongoing pivotal trials and planned regulatory submission activities, and the continued development of LYL273, as well as for working capital and other general corporate purposes.

Following the financing, Lyell expects its cash, cash equivalents and marketable securities to be sufficient to meet working capital and capital expenditure needs into 2028, including through the anticipated pivotal data and BLA submission for ronde-cel, as well as through the expected clinical data and regulatory update from the LYL273 development program in mCRC.

The offer and sale of the securities in the private placement are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued in the financing.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Lyell Immunopharma, NOV 4, 2026, View Source [SID1234674213])