LYEL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-11-04

• We are currently conducting two pivotal trials with ronde-cel in patients with relapsed/refractory (R/R) large B‑cell lymphoma (LBCL). The first, PiNACLE, is a single-arm clinical trial that is a seamless expansion of the third- or later-line (3L+) cohort in the Phase 1/2 trial. In November 2026, we…

• We were incorporated in June 2018. We wholly own and operate the LyFE Manufacturing CenterTM (LyFE) capable of providing clinical trial material for our ongoing clinical trials, as well as for commercial launch. We expect

• LyFE to have the capacity to manufacture more than 3,000 CAR T-cell doses/year. Our primary activities to date have included clinical development of investigational T‑cell therapies, conducting research and development, building and operating LyFE, acquiring technology, entering into strategic colla…

• chemotherapy prior to undergoing leukapheresis for CAR T-cell therapy. In a separate Medicare fee-for-service claims analysis, a similar percentage (57%) of patients with LBCL classified as receiving CAR T-cell therapy in the 2L had been administered a second chemotherapy regimen prior to CAR while …

• with a CD19 CAR T-cell therapy is only 50% to 60%. The median progression-free survival for the approved CD19 CAR T-cell therapies for patients in the 3L+-setting is 6 to 7 months.

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• We are currently conducting two pivotal trials with ronde-cel. The first, PiNACLE, is a single-arm clinical trial that is a seamless expansion of the third- or later line (3L+) cohort in the Phase 1/2 trial. This trial is expected to report additional data in the second half of 2026 and pivotal data…

• We were incorporated in June 2018. We wholly own and operate the LyFE Manufacturing CenterTM (LyFE) capable of providing clinical trial material for our ongoing clinical trials, as well as for commercial launch. We expect LyFE to have the capacity to manufacture more than 1,200 CAR T-cell doses/year…

• staffing the company, business planning, establishing and maintaining our intellectual property portfolio, regulatory submissions and other preparations to initiate and execute clinical trials, raising capital and providing general and administrative support for these activities.

• administered a second chemotherapy regimen prior to CAR while awaiting referral and/or scheduling for leukapheresis (Figure 2).

• Our ongoing Phase 1/2 trial of ronde-cel is a multi-cohort, multi-center, open-label dose-escalation and dose‑expansion clinical trial designed to evaluate the safety and clinical benefit of ronde-cel (NCT05826535). We presented positive data, detailed below, from the 3L+ and 2L cohorts from the ong…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rule 13a-15(f) of the Exchange Act. An evaluation was also performed under the supervision and with the participation of our management, including our Chief Ex…

• September 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rule 13a-15(f) of the Exchange Act. An evaluation was also performed under the supervision

• and with the participation of our management, including our Chief Executive Officer and our Chief Financial and Business Officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to m…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• Our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital to complete clinical development of any of our current programs.

• Until such time as we complete nonclinical and clinical development and receive regulatory approval of our product candidates and can generate significant revenue from product sales, if ever, we expect to finance our operations

• from the sale of additional equity or debt financings, or other capital that comes in the form of strategic collaborations, licensing, or other arrangements. Other than the Securities Purchase Agreement we entered into in November 2026, we do not have any committed external source of funds. Addition…

• In February 2024, we entered into the Sales Agreement with TD Cowen, acting as our sales agent, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $150.0 million from time to time in a series of one or more at‑the‑market equity offerings. N…

• Our revenues for any product for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the availability of other competing approved or

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• As a result of expense timing, as well as diligent expense management, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs into the third quarter of 2027. However, our future capital requirements a…

• We do not have any committed external source of funds. Additional funds may not be available when we need them on terms that are acceptable to us, or at all, and our ability to raise additional capital may be adversely impacted by potentially unfavorable global economic conditions or conditions in t…

• Our revenues for any product for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the availability of other competing approved or commonly used therapies in the indications for which we are approv…

• Under the Tax Cuts and Jobs Act of 2017 (the Tax Act), as modified by the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), our net operating losses (NOLs) generated in tax years beginning after

• December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of taxable income. There is variation in how states have responded and may continue to respond to the Tax Act and CARES Act. In addition, under Sections 382 and 383 of the U.S. Interna…