Greenwich LifeSciences (GLSI) Noble Conference summary

Clinical trial overview and scientific rationale

• Conducting a phase III trial (FLAMINGO-01) to prevent metastatic breast cancer recurrence using a GP2 peptide vaccine targeting HER2-positive patients.

• The vaccine educates dendritic cells to generate T cells that kill residual cancer cells, aiming to prevent recurrence post-standard treatments.

• Phase II results showed very low to no recurrences and a strong immune response, justifying the large phase III trial.

• The trial involves 150 sites (140 active), with about 1,000 patients screened and plans to increase enrollment to 1,000–2,000.

• Immune responses and safety profiles in phase III are consistent with phase II, with ongoing plans for interim analyses and possible study resizing.

Patient selection, treatment protocol, and market potential

• Patient eligibility is based on HLA type, but early data suggest all patients may benefit, potentially expanding the target population.

• Standard care includes surgery, radiation, and antibody therapy; the vaccine is administered after these, with six initial doses and boosters every six months over three years.

• The addressable market is estimated at 44,000–88,000 patients per year in the US and Europe, with potential to save 4,000–5,000 lives annually.

• Preventing recurrence reduces long-term treatment costs and hospitalizations, offering significant healthcare savings.

• Future studies may move the vaccine earlier in the treatment timeline or expand to lower-risk groups.

Financials, operations, and strategic outlook

• Raised $40–$45 million since IPO; current burn rate is $7–$10 million per year, funded via an ATM facility with H.C. Wainwright.

• Four full-time employees manage global operations, supported by experienced consultants and clinical trial experts.

• Most trial costs are front-loaded; variable costs per patient will dominate going forward.

• Management and directors own about 80% of shares, with a lock-up through April 2026.

• Open to strategic partnerships with large pharma but focused on maximizing shareholder value and advancing the trial independently for now.