Clinical Efficacy And Population ExpansionA substantial reduction in breast cancer recurrence in patients without a common HLA marker, with similar immune response and safety across trial arms, suggests GLSI-100 could be effective in a broader patient population and materially increase the addressable market.
Regulatory MilestoneFDA approval of a commercial GP2 lot lowers regulatory risk and supports advancement toward a Biologics License Application for GLSI-100.
Supply Readiness And Funding FlexibilityCommercial GP2 vials available for storage or direct use in trials improve launch readiness, while continued use of ATM financing provides a bridge to non-dilutive funding options such as strategic partnerships or debt and royalty financing.