Greenwich LifeSciences (GLSI) Virtual Equity Conference summary

Clinical trial progress and design

• Phase III FLAMINGO-01 trial is underway, building on strong phase II results with minimal changes to protocol.

• Over 120 sites are open globally, including major U.S. and European centers, with about 600 patients screened per year.

• The trial includes both HLA-A2 and non-HLA-A2 patients, with plans to expand the HLA-A2 arm and add a control group.

• Interim analysis and enrollment updates are expected soon, with milestones anticipated in the next 12 months.

• No serious adverse events related to the treatment have been observed; safety profile is similar to vaccines.

Market opportunity and commercialization

• Target market for the initial indication is 40,000–80,000 new patients per year, with a potential to treat up to 44,000 HLA-A2 patients annually.

• Commercial opportunity estimated at $5–10 billion in annual revenue, with potential to double if non-HLA-A2 patients are included.

• Management holds 75–85% of shares, with a lockup through March 2026, and the company remains on the Russell 2000 index.

• Ongoing discussions with large pharma companies are expected to accelerate as more data becomes available.

• Low burn rate and use of ATM funding provide financial flexibility for future partnerships.

Scientific and clinical insights

• GP2 peptide, derived from HER2, is combined with GM-CSF to stimulate a targeted immune response post-surgery.

• Phase II data showed no metastatic recurrences in the treated group and substantial reduction in recurrence rates.

• Immune response peaks at six months, with 11 injections over three years aiming to prevent metastatic breast cancer.

• Mechanism involves T-cell activation against HER2-positive cancer cells, with ongoing research into T-cell sequencing.

• Potential future applications include other HER2-expressing cancers and combination therapies, pending phase III results.