Chiara Montironi

Chiara Montironi asked about the expected impact of DANYELZA's inclusion in NCCN guidelines and the new COG-led trial on growth and clinician choice, and requested the trial's start timing.

Answer

DANYELZA Business Unit Head Doug Gentilcore explained the NCCN inclusion removes a headwind and puts DANYELZA on equal footing with competitors, creating a tailwind for clinical discussions. He reiterated the trial is expected to start in Q2, likely within 'days than weeks.' CEO Michael Rossi added that they expect the majority of trial enrollment to be completed during the remainder of 2025.

Chiara Montironi sought clarification on the clinical trial design for MP0712, asking if the Phase 0 imaging study and the Phase I therapeutic study would run in parallel, and if the start of Phase I was contingent on the Phase 0 results.

Answer

Michael Stumpp, EVP of Projects, clarified that the company has proposed to the FDA that the two studies run in parallel and not be contingent upon one another, based on supportive animal data. He noted that the final decision rests with the FDA, but the intent is to keep the studies closely staggered to facilitate patient treatment.

Chiara Montironi sought clarification on the clinical trial design for MP0712, asking if the Phase I start is contingent upon receiving positive data from the Phase 0 imaging study.

Answer

Michael Stumpp, EVP of Projects, clarified that the company's proposal to the FDA is to run the Phase 0 imaging and Phase I therapeutic studies in parallel to expedite the program. However, he noted that the final decision rests with the FDA. He assured that even if not fully parallel, the studies would be closely staggered for the benefit of patients awaiting treatment.