Allogene Therapeutics is cutting back to stretch its cash runway into the second half of 2027, laying off 28% of its workforce and focusing its resources on getting two clinical programs to inflection points. The off-the-shelf CAR-T cell therapy specialist disclosed the changes alongside delays to two milestones.
California-based Allogene has three clinical programs. Tuesday, the company disclosed delays to updates on two of the candidates. Allogene has pushed back the lymphodepletion regimen selection and futility analysis milestone for its pivotal lymphoma trial to the first half of 2026. Zachary Roberts, M.D., Ph.D., chief medical officer at Allogene, explained why the company delayed the milestone by two quarters.
“Site-level operational constraints, including staffing shortages and administrative hurdles, led to slower-than-expected transitions from site activation to patient screening,” Roberts said on an earnings call. “Bifurcation of care between front-line lymphoma doctors and second-line cell therapy providers, even sometimes within institutions, required us to build bridges that had never been built before.”
The trial is now ticking over at the pace Allogene anticipated originally, but the unexpected, three- to four-month lag between site activation and patient screening has set the study back. Allogene previously said it would have primary event-free survival data from the trial around the end of 2026. The biotech backed away from that forecast Tuesday. Allogene will provide an updated timeline after the futility analysis.
Allogene is reevaluating which data will be appropriate to share as part of the lymphodepletion update. William Blair analysts said in a note to investors that “the update in the first half of 2026 could be more meaningful than the original mid-2025 update if the company is able to share additional data points, such as [minimal residual disease]-conversion rates.”
The company also delayed the timing of the first update from a phase 1 trial of its autoimmune CAR-T. Allogene plans to start the trial in mid-2025 and share an update in the first half of next year. Previously, the biotech was aiming to report proof-of-concept data around the end of 2025.
Allogene CEO David Chang, M.D., Ph.D., told analysts the revised timeline gives the company “little bit of buffer” and supports the inclusion of clinical response data in the first update. The biotech was originally planning to only include biomarker data in the first update, Chang said.
The changes pushed the next milestones for the pivotal lymphoma study and phase 1 autoimmune trial toward the end of Allogene’s cash runway, which was forecast to run into the second half of 2026 under the previous spending plan. Allogene has secured itself around another one year of runway by laying off around 28% of its workers. The cuts, which follow last year's 22% reduction in force, reflect a dialing back of manufacturing and the refocusing of resources on clinical programs.
“We recognize the challenges of the current macro-environment,” an Allogene spokesperson said via email. “Amid these headwinds, our top priority has been ensuring the resources needed to advance our trio of differentiated clinical programs. We are confident in what we are doing.”
Allogene can reduce its manufacturing operations because it calculates its cell therapy inventory is big enough to meet its near-term clinical needs. The supplies cover the pivotal trial of cemacabtagene ansegedleucel in large B-cell lymphoma, the phase 1 autoimmune program ALLO-329 and a study of solid tumor CAR-T ALLO-316.
The biotech has completed enrollment in the expansion cohort of a phase 1b trial of ALLO-316 in people with renal cell carcinoma, a type of kidney cancer. The Allogene spokesperson said the company is “preparing for FDA consultation on the registrational path, and assessing strategic options for ALLO-316, including potential partnership, to ensure that the right level of focus and resourcing can be dedicated to ensuring its success.”
Allogene is also open to partnering its autoimmune program. Chang said that, given the current market situation, the biotech is “very willing” to partner the program if a “reasonable deal” is available. The CEO said he would think differently in a better market environment, but the current economic situation for biotechs means “protecting the cash runway is the key.”
Editor's note: This story was updated at 10:30am E.T. on May 14 to correct the disease being targeted in the phase 1b ALLO-316 trial. It is renal cell carcinoma, not liver cancer.