LYEL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• 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 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 in mid-2027, with subm…

• 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…

• Of the approximately 30,000 patients in the U.S. with LBCL, 40% to 50% are refractory to, or relapse following, first-line treatment and we estimate approximately 12,000 to 15,000 patients in the United States with LBCL progress to 2L treatment. We estimate the 3L+ patient population to be approxima…

• Figure 1: Ronde-cel is targeting the multi-billion dollar CD19 CAR T-cell market.

• In the 2L setting, the ZUMA-7 randomized controlled trial of axi-cel versus standard of care chemoimmunotherapy did not enroll patients above the age of 75 and the only bridging therapy allowed was steroids. In ZUMA-7, the complete response rate was 65% and the median progression-free survival in al…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We are currently conducting a pivotal clinical trial (PiNACLE) evaluating ronde-cel in patients with large B-cell lymphoma (LBCL) receiving treatment in the third- or later-line (3L+) setting and have announced the initiation of a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial (…

• Our research scientists are also developing next-generation CAR T-cell product candidates for additional solid tumor indications enhanced with our anti-exhaustion and additional arming technologies and manufactured with our proprietary protocols. These approaches are designed to endow CAR T cells wi…

• We were incorporated in June 2018. Our primary activities to date have included clinical development of T‑cell therapies, conducting research and development, acquiring technology, entering into strategic collaboration and license agreements, enabling and executing manufacturing activities in suppor…

• Approximately 40% to 50% of patients with LBCL are refractory to, or relapse following, first-line treatment and we estimate approximately 12,000 patients in the United States with LBCL progress to 2L treatment.

• Figure 1: NHL is comprised of over 90 distinct subtypes, of which DLBCL is the most common form accounting for ~30% of all patients diagnosed with NHL. We are initially focused on developing ronde-cel for the treatment of patients with NHL subtypes representing approximately 35% of the patients esti…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• 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 Ex…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• There has been no change in our internal control over financial reporting during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• •We will require substantial additional capital to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

• •We currently have no products approved for sale and have never generated revenue from product sales. We may never generate revenue from product sales or achieve profitability.

• •Our milestone, royalty and success payment obligations may result in dilution to our stockholders or may reduce the availability of our cash resources to satisfy the payment obligations, which could cause our operating results and financial condition to fluctuate significantly from quarter to quart…

• •If we are unable to successfully develop, manufacture and commercialize product candidates or experience significant delays in doing so, our business may be harmed.

• •Our product candidates and technologies are based on novel technologies that are unproven and may not result in approvable or marketable products, which expose us to unforeseen risks and make it difficult for us to predict the time and cost of product development and potential for regulatory approv…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• •We currently have no products approved for sale and have never generated revenue from product sales. We may never generate revenue from product sales or achieve profitability.

• •We will require substantial additional capital to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

• •Our milestone, royalty and success payment obligations may result in dilution to our stockholders or may reduce the availability of our cash resources to satisfy the payment obligations, which could cause our operating results and financial condition to fluctuate significantly from quarter to quart…

• •Our product candidates and technology platforms are based on novel technologies that are unproven and may not result in approvable or marketable products, which expose us to unforeseen risks and make it difficult for us to predict the time and cost of product development and potential for regulator…

• •We currently have no marketing, sales or distribution infrastructure, and we intend to either establish a sales and marketing infrastructure or outsource this function to a third party. Either of these commercialization strategies carries substantial risks to us.