Sara Nik

Sara Nik asked for more detail on the granularity of data to be presented at upcoming scientific conferences, specifically whether it would include subgroup analyses by age, region, or other preventative efficacy outcomes.

Answer

President and CEO Dr. Jeffrey Stein and CSO Dr. Les Tari confirmed that the types of subgroup analyses mentioned are included in the submitted abstracts. However, they clarified that specific details on what will be presented can only be provided after the abstracts are officially published by the respective conferences.

Sara Nik from H.C. Wainwright & Co., LLC asked for an update on enrollment progress for the next 30-40 patients in the Take-Aim Lymphoma study and whether new clinical sites were being added.

Answer

CEO James Dentzer reported that enrollment is steady and progressing as expected for an ultra-rare population. He reiterated the target of enrolling one patient per site per year across the 30+ existing sites and confirmed there is no current need to open additional sites to stay on track.

Sara Nik of H.C. Wainwright & Co. inquired about the implications of reducing the enrollment target for the second-line cholangiocarcinoma cohort in the BOLSTER trial, questioning its potential impact on the regulatory pathway and data requirements.

Answer

President and CEO Dr. David Mazzo clarified that as a Phase IIa proof-of-concept study, the BOLSTER trial aims to identify trends rather than meet a specific endpoint. He stated that 20 patients are sufficient for this purpose, and the decision to cap enrollment accelerates data availability for both trial arms and conserves capital in a challenging financial environment.

Asked for an update on the Qilu Pharmaceuticals Phase 2 trial in metastatic pancreatic cancer, specifically regarding enrollment progress, the number of patients treated, and the level of insight Lisata receives.

Answer

The executive stated that Qilu is a private company in China and does not publicly disclose trial progress. Lisata is aware the trial began in Q2 with a projected 18-month enrollment period. They receive high-level updates in quarterly meetings, such as whether the trial is 'on track', but do not get detailed enrollment numbers and are generally 'blind' to daily progress.

Sara Nik, on behalf of Joe from an undisclosed firm, asked for more details on the manufacturing delay for the BX004 program and whether it was a one-off circumstance.

Answer

CEO Jonathan Solomon explained that the delay was a one-time issue resulting from scaling up manufacturing volume from 10 liters to 50 liters for the larger Phase IIb study. He noted that the challenges in calibrating the system for the larger volume have been successfully resolved, and he expressed confidence in the revised timeline.