On November 8, 2022 Lyell Immunopharma, Inc. (Lyell) (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, reported financial results for the third quarter of 2022 (Press release, Lyell Immunopharma, NOV 8, 2022, View Source [SID1234623404]).

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"In the past year we have advanced two product candidates into clinical development and have added LYL119, a second-generation CAR T-cell product candidate, to our pipeline of wholly owned novel cell therapies," said Liz Homans, CEO of Lyell. "As we continue to progress our pipeline, we are grateful for the support of physicians, clinical site staff, patients and their families and our dedicated and talented employees who enable our mission," said CEO Liz Homans. "Our strong financial position allows us to execute against our long-range plans with a cash runway into 2026, which takes us through important clinical milestones. These expected milestones include initial clinical data from both of our wholly owned product candidates, LYL797 and LYL845."

Recent Business Highlights

Announced FDA clearance of the IND for LYL845, a TIL product candidate enhanced with Lyell’s novel epigenetic reprogramming technology for solid tumors. LYL845 is an autologous TIL therapy enhanced with Lyell’s Epi-R reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function.
The Phase 1 trial is expected to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer.
Initial data presentation for LYL845 is expected in 2024.
Announced the presentation of five abstracts at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting preclinical data on Lyell’s product candidates and new genetic and epigenetic reprogramming technologies. The abstracts showcase compelling preclinical data underlying Lyell’s lead TIL product candidate, LYL845, as well as preclinical data on new stackable genetic and epigenetic reprogramming technologies being incorporated into LYL119, its second-generation investigational ROR1-targeting CAR T-cell product candidate.
Presented the first-in-human Phase 1 trial design for LYL797, Lyell’s ROR1-targeted CAR T-cell therapy enhanced with genetic and epigenetic reprogramming for the treatment of solid tumors, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris, France.
Patient screening in the Phase 1 trial of LYL797 was initiated in late March; however, clinical site activation was initially slower than anticipated. Lyell has undertaken several measures to accelerate administrative site activation activities and has also increased the number of sites that will participate in the trial. As a result, although site activations are now progressing well, enrollment has been slower than anticipated.
Despite the accelerated pace of site activations, in order to present a meaningful dataset in terms of both the number of patients and duration of response to therapy, the timing of presentation of initial data is now expected to occur in the first half of 2024.
Announced the appointment of Rahsaan W. Thompson, as Chief Legal Officer. Mr. Thompson is a biopharmaceutical industry veteran, with more than 20 years of experience with development stage and commercial companies.
Announced that GSK informed Lyell that, as part of a number of strategic actions it is taking, it is discontinuing its development of product candidates targeting NY-ESO-1, including the second-generation product candidates incorporating our genetic and epigenetic reprogramming technologies (LYL132 and LYL331). The termination of the collaboration agreement with Lyell will be effective December 24, 2022. Given the early stage of these second-generation programs, the decision is not based on any clinical efficacy or safety data from these programs.
Third Quarter 2022 Financial Results

Revenue

Revenue was approximately zero and $2.8 million for the three months ended September 30, 2022 and 2021, respectively. No additional research and development pursuant to the GSK Agreement was performed in the third quarter of 2022, which drove a decrease in revenue of $2.8 million.
GAAP and Non-GAAP Operating Expenses

Lyell reported a net loss of $70.3 million for the third quarter ended September 30, 2022, compared to a net loss of $48.9 million for the same period in 2021. Non-GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and non-cash impairment adjustment of other investments, was $43.7 million for the third quarter ended September 30, 2022 compared to $35.7 million for the same period in 2021.
Research and development (R&D) expenses were $41.6 million for the third quarter ended September 30, 2022, compared to $31.4 million for the same period in 2021. The increase in R&D expenses was primarily driven by increases in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the third quarter ended September 30, 2022, were $34.7 million, compared to $28.7 million for the same period in 2021.
General and administrative (G&A) expenses were $26.1 million for the third quarter ended September 30, 2022, compared to $21.2 million for the same period in 2021. The increase in G&A expenses was primarily due to a $4.3 million increase in stock-based compensation expense, primarily related to award modifications and new awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2022 were $11.4 million, compared to $10.9 million for the same period in 2021. The increase in non-GAAP G&A expenses was driven by public company operating costs.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2022 were $750.7 million, compared to $898.3 million as of December 31, 2021. Certain clinical trial expenses projected for 2022 are now expected to be incurred in 2023. As a result of expense timing, as well as diligent expense management, Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2026.