Ren Benjamin

Ren Benjamin asked if there was a strategy to combine Ruxolitinib XR with a pipeline product or in-license a product to mitigate LOE erosion. He also inquired about the registrational program for TGF-beta, asking about the study size, the required delta for a positive study, and the calculus given limited data.

Answer

CEO Bill Meury stated the current focus for XR is launching it for Jakafi indications, with no plans for combinations in development to fight LOE erosion. Chief Medical Officer Steven Stein explained the Phase 3 study for TGF-beta will be in first-line MSS colorectal cancer, combining with FOLFOX and BEV. The primary endpoint will be PFS, with benchmarks available for PFS and OS. The study size will be north of 500 patients and well-powered to show the desired PFS advantage.

Asked for details on the new direct-to-patient initiatives, their impact on SG&A, how their success is measured, and alternative strategies for market growth.

Answer

The company is investing in direct-to-patient campaigns to activate patients now that a prescriber base is established. The goal is to educate patients on what's possible beyond just coping with the disease, and hearing from other patients is a key part of this strategy to continue driving the launch.

Representing Ren Benjamin from Raymond James, an analyst asked what specific data from the NeuVax combination studies would be considered positive enough to warrant further development. He also questioned the development timelines for GALE-301 and GALE-302, considering the company's cash constraints and focus on anagrelide.

Answer

President and CEO Mark Schwartz responded that a clinically significant impact on disease-free survival (DFS) or recurrence rates would be very exciting. Regarding GALE-301 and GALE-302, he stated that the company aims to find a path forward for these earlier-stage programs that does not disrupt the higher-priority GALE-401, with development dependent on the company's future financial situation.