Shelby Hill

Shelby Hill inquired about the overall survival (OS) data for INT in adjuvant melanoma, noting the press release's silence on OS despite compelling initial separation of curves at ASCO 2024, and asked how this should be interpreted.

Answer

Stephen Hoge, President, stated that the OS curves for INT adjuvant melanoma will be shared at an upcoming medical meeting, implying that the data is being held for a full presentation. He noted that relapse-free survival holding consistent naturally includes survival, and all data from the five-year interim analysis will be presented.

Shelby Hill asked about the INT program, congratulating on the recent five-year data for melanoma and the consistent RFS hazard ratio. She inquired about the silence on OS in the press release, asking if it implies the OS curves are no longer separated or if details are being reserved for an upcoming medical meeting.

Answer

Stephen Hoge, President, stated that the OS curves for INT 5-year melanoma data will be shared at an upcoming medical meeting, implying that the data is being held for a full presentation rather than being negative. He noted that relapse-free survival holding consistent obviously includes survival.

On behalf of Luca Eci from RBC Capital Markets, Shelby Hill asked for more color on the Sanfilippo CRL, referencing prior comments about shipping validation and a stringent inspector, and questioned if the FDA was 'missing the forest for the trees.'

Answer

Emil Kakkis, Founder, President & CEO, responded that it is the FDA's job to scrutinize details ('check every tree') and that CMC rigor is essential. He emphasized that the company's focus is on methodically addressing all the issues raised in the CRL, which they believe are entirely manageable, rather than dwelling on the inspection process.