Greenwich LifeSciences is a single-asset biotech focused on GLSI-100, an immunotherapy for HER2-positive breast cancer, currently in Phase 3 trials. GLSI-100 demonstrated a 70-80% reduction in cancer recurrence in Phase 2b, outperforming approved therapies, with no serious adverse events reported. GLSI trades at a ~$279M market cap, below recent M&A comps, despite advanced clinical progress and a large addressable market in HER2/neu-positive breast cancer.
Greenwich LifeSciences (GLSI) remains a "Buy" as phase 3 FLAMINGO-01 advances in HER2-positive breast cancer with two major program updates. Open-label data from FLAMINGO-01 showed an 80% recurrence reduction in non-HLA-A*02 patients, supporting expanded protocol and potential market doubling. Company filed new patent claims based on statistically significant immune response and recurrence open-label data, potentially extending protection through 2045 if upheld.
Greenwich LifeSciences, Inc. approaches enrollment completion for the phase 3 Flamingo-01 study, using GLSI-100 for the treatment of patients with HER2/neu positive breast cancer, with full enrollment expected by the end of 2024. A prior phase 2b study indicated that patients, given GLSI-100 for HER2/neu positive breast cancer, were able to achieve a 100% recurrence free rate. The global breast cancer market size is expected to be worth $49.2 billion by 2032.