Greenwich LifeSciences (GLSI) Corporate presentation summary

Clinical development and trial design

• Phase III Flamingo-01 trial evaluates GP2 + GM-CSF immunotherapy for HER2/neu 3+, HLA-A2+ breast cancer patients post-surgery and adjuvant Herceptin or Kadcyla, with up to 150 sites in the US and EU.

• The trial aims to conservatively reproduce positive Phase IIb results, which showed substantial reduction in recurrence, peak immunity at 6 months, and minimal side effects.

• Interim analysis is planned after 12 prescribed events, with approximately 498 subjects enrolled and potential for multiple marketing approval pathways.

• The trial includes both HLA-A2+ and non-HLA-A2 arms, expanding potential patient reach.

• Steering committee includes leading oncologists from major US and EU cancer centers.

Efficacy and safety data

• Phase IIb trial demonstrated 100% disease-free survival in HER2/neu 3+ patients who completed immunization, compared to 89.4% for placebo.

• No serious adverse events attributable to GP2 were reported; most common side effects were mild injection site reactions.

• Immune response, measured by DTH skin test and injection site reactions, increased over time and correlated with reduced recurrence.

• Baseline immune response to GP2 may predict early recurrence risk.

• Safety and immune response trends in Phase III are consistent with prior trials.

Market opportunity and expansion

• GP2 addresses the unmet need for patients who do not respond to Herceptin or Kadcyla, potentially saving 4,000–5,000 lives per year in the US and EU.

• Market expansion possible to HER2/neu 1-2+ patients and other HLA types, increasing eligible population from 25% to up to 80–100%.

• Commercial opportunity in the US alone could reach 44k–210k new patients per year, with pricing comparable to existing HER2 therapies.

• GP2 may be developed for other HER2-expressing cancers and as a long-term treatment for survivors.

• Additional trials planned for neoadjuvant settings and combination with checkpoint inhibitors.