On March 29, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported fourth quarter and full year 2021 financial results and provided business highlights (Press release, Lyell Immunopharma, MAR 29, 2022, View Source [SID1234611113]).
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"With the recent FDA clearance of two INDs that incorporate our novel genetic and epigenetic reprogramming technologies, we are now a clinical stage-company advancing a pipeline of novel cell therapies for patients with solid tumors," said Liz Homans, CEO of Lyell Immunopharma. "During the past year, we’ve further strengthened our team with key executive and Board appointments and have grown the organization to focus on executing as a fully integrated clinical stage company. The coming year will be an exciting one for us as we initiate multiple clinical trials across our product pipeline. We are eager to clinically assess the impact of our innovative technologies designed to enable reprogrammed T cells to outlast and eradicate solid tumors in patients."
"We are embarking on what I believe to be among the most informative clinical trials in the field of oncology this year, as they will specifically evaluate the questions of exhaustion and durable stemness as key barriers to successful cell therapies for solid tumor cancers," stated Rick Klausner, MD, Chair of Lyell’s Board of Directors.
Full Year 2021, Recent Highlights, and Upcoming Milestones
LYL797, a chimeric antigen receptor (CAR) T-cell therapy targeting ROR1+ solid tumors that incorporates Gen-R and Epi-R reprogramming technologies
Announced FDA clearance of the IND for LYL797, a CAR T-cell therapy for patients with solid tumors expressing receptor tyrosine kinase-like orphan receptor 1 (ROR1).
The two Lyell technologies incorporated are designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with the properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.
Initiated screening for the Phase 1 open label dose escalation and expansion trial with relapsed/refractory triple-negative breast cancer or non-small cell lung cancer who have failed at least two lines of therapy, initial data expected in 2023.
LYL132, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Epi-R, being developed in collaboration with GSK for solid tumors
Announced FDA clearance of the IND for LYL132, a T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1).
LYL132 incorporates Epi-R and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development.
LYL845, a TIL therapy designed to target multiple solid tumor indications that incorporates Epi-R
On track to submit an IND in the second half of 2022 for LYL845, a tumor infiltrating lymphocyte (TIL) therapy.
Initially targeting melanoma, with plans to expand into other solid tumor indications, potentially including non‑small cell lung cancer (NSCLC), colon, head and neck, cervical, breast and pancreatic.
LYL331, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Gen-R, being developed in collaboration with GSK for solid tumors
GSK has communicated to Lyell that due to updated manufacturing timing, the IND for LYL331 is likely to be submitted in late 2022 / early 2023.
LYL331 is a TCR therapy for patients with solid tumors expressing NY-ESO-1.
LYL331 incorporates Gen-R and, along with LYL132, is under investigation as a potential next-generation enhancement to lete-cel.
Corporate and Operational
Lyell had the following corporate and operational highlights during 2021:
Announced cGMP qualification of LyFE, Lyell’s manufacturing facility designed to produce cell products at scale for upcoming clinical trials across its CAR, TIL and TCR products.
Completed an initial public offering with net proceeds of $391.8 million from the sale of 25 million shares of common stock.
Expanded executive management team with appointments of scientific and business leaders: Gary Lee, PhD appointed as Chief Scientific Officer and Charlie Newton appointed as Chief Financial Officer.
Expanded Board of Directors with appointments of industry and medical leaders: Otis Brawley, M.D., Elizabeth Nabel, M.D. and Lynn Seely, M.D.
Fourth Quarter and Full 2021 Financial Results
GAAP and Non-GAAP Operating Results
Lyell reported a net loss of $83.7 million and $250.2 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $38.9 million and $204.5 million for the same periods in 2020. 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 $41.7 million and $147.9 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $24.3 million and $165.9 million for the same periods in 2020.
Research and development (R&D) expenses were $19.3 million and $138.7 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $35.1 million and $182.2 million for the same periods in 2020. The quarterly decrease in R&D expense on a GAAP basis was primarily due to a decrease in success payment expense, which offset an increase in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. The annual decrease in R&D expense on a GAAP basis was primarily due to a decrease in collaboration and business development activity. 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 fourth quarter and year ended December 31, 2021 were $32.2 million and $119.7 million, respectively, compared to $27.6 million and $161.9 million for the same periods in 2020.
General and administrative (G&A) expenses were $31.9 million and $89.1 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $14.9 million and $46.9 million for the same periods in 2020. The increase in G&A expense on a GAAP basis was primarily due to an increase in personnel-related expenses, including stock-based compensation expense. Non-GAAP G&A expenses, which exclude non-cash stock-based compensation, for the fourth quarter and year ended December 31, 2021 were $13.4 million and $42.2 million, respectively, compared to $7.8 million and $28.6 million for the same periods in 2020.
Total other (loss) income, net was $(36.2) million and $(35.4) million for the fourth quarter and year ended December 31, 2021, respectively, compared to $0.7 million and $7.5 million for the same periods in 2020. The decrease in total other (loss) income, net was due primarily to the full impairment of our investment in PACT Pharma, Inc. Series C-1 convertible preferred stock valued at $36.4 million for the year ended December 31, 2021.
A discussion of these 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 December 31, 2021 were $898.3 million, compared to $692.6 million as of December 31, 2020, an increase of $205.7 million that supports the advancing of our multi-modality cell therapy pipeline. Lyell successfully completed its initial public offering in June 2021 with net proceeds of $391.8 million. Based on the current operating plan, Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2025.