Katherine Dellorusso

Katherine Dellorusso inquired about expectations for initial data readout metrics and cohorts from the BRAVESST2 study, internal safety benchmarks, and how these relate to pursuing PRRT-naive versus experienced patient populations.

Answer

Dr. Scott Struthers, Founder and CEO, clarified that PRRT is not a prerequisite for CRN09682. Dr. Alan Krasner, Chief Endocrinologist, explained that phase I oncology trials typically enroll heavily pre-treated patients. He stated the primary endpoint for the dose escalation phase is safety and toleration, aiming for a well-tolerated therapy, with secondary measures including tumor size changes using RECIST criteria, noting that response data will take time to evolve.

Katherine Della Russo asked about expected metrics and cohorts for an initial data readout from the BRAVESST2 study, the safety benchmark, and implications for pursuing PRRT-naive versus experienced patient populations.

Answer

CEO Scott Struthers stated that PRRT is not a prerequisite for CRN09682. Chief Endocrinologist Alan Krasner added that Phase 1 oncology trials typically enroll heavily pre-treated patients. He explained that the primary endpoint for the dose escalation phase is safety and toleration, with tumor size changes assessed via RECIST criteria, acknowledging that response data will take time due to slow-growing tumors.

Katherine Dellorusso inquired about the potential launch trajectory for VYKAT XR in Europe compared to the U.S., asking if key learnings from the U.S. experience could accelerate uptake, and for comments on the estimated sales force size if Soleno were to commercialize independently in Europe.

Answer

Meredith Manning, Chief Commercial Officer, stated that the company is still evaluating the size of the field force, focusing initially on Germany and Austria. She highlighted that Europe has more concentrated centers of excellence, which differs from the U.S., and emphasized strong education for treaters and patient selection as key to launch success.