Hamlet BioPharma (HAMLET) investor relations material

Key achievements in June

• Received EMA approval for phase III clinical study, enabling trial initiation.

• Successfully produced and released the first batch of phase III drug for clinical trials.

• Published two significant papers on anti-infective therapies and cancer in leading journals.

• Established a new clinical collaboration with the University of Iowa, expanding geographic reach.

• Gained international recognition through media coverage and third-party validation.

Clinical and regulatory progress

• Achieved full GMP quality transition from phase II to phase III drug production.

• Conducted pre-initiation visit in Prague to ensure readiness for clinical trial.

• Maintained strong regulatory engagement with both FDA and EMA, leading to rapid approvals.

• Collaboration with key opinion leaders and international trial centers strengthens trial credibility.

Scientific and partnership highlights

• New anti-infective compound targets disease response, offering an alternative to antibiotics.

• Alpha1H drug candidate selectively targets tumor cells, providing a non-invasive biomarker.

• Partnership with University of Iowa led by renowned experts in bladder cancer.

• International consultants and CROs played a critical role in regulatory and clinical processes.