Hamlet BioPharma (HAMLET) investor relations material

Strategic progress and partnerships

• Transitioned from research to clinical success in three indications: bladder cancer, recurrent urinary tract infections, and bladder pain syndrome.

• Advanced to phase II clinical trials and initiated international partnering discussions, resulting in a non-exclusive letter of intent with a major player in bladder cancer.

• Ongoing constructive dialogue aims to finalize a commercial agreement for late-stage clinical and market development.

Clinical development and innovation

• Developed Alpha1H, a novel, low-toxicity compound for bladder cancer, showing selective tumor cell death and minimal impact on healthy tissue.

• Phase II studies demonstrated rapid tumor response, significant gene suppression, and immune activation, with approximately 80% tumor response rate.

• FDA fast track status obtained; phase III trial preparations completed, including regulatory, ethical, and manufacturing milestones.

Commercial and market outlook

• First-in-class therapy addresses a major unmet need in bladder cancer, the most expensive tumor type in the US due to high healthcare utilization.

• Strong patent protection and GMP-compliant production support commercial potential.