Hamlet BioPharma (HAMLET) Investor update summary

Key achievements in June

• EMA approval received for phase III clinical study, enabling trial initiation at the clinical level.

• Successful release and production of phase III drug batch, meeting complex regulatory and quality requirements.

• Two major publications in leading journals highlighted advances in anti-infective therapies and cancer research.

• Collaboration established with University of Iowa, expanding clinical trial reach and expertise.

• International recognition received, including positive coverage from BriefGlance and validation from key opinion leaders.

Clinical and regulatory progress

• Phase III neoadjuvant bladder cancer study prepared with in-person site visits and protocol submission.

• Approval from European regulatory authority (EMA) marks a significant milestone, equivalent to FDA approval.

• Drug production involved partnerships with Chinese and Swedish companies, ensuring GMP compliance.

• Pre-initiation visit in Prague confirmed readiness of clinical sites and personnel.

• Strong leadership and collaboration with international experts and CROs supported regulatory success.

Scientific and clinical innovation

• New anti-infective therapy targets disease response, offering an alternative to antibiotics, including for resistant strains.

• Alpha1H drug candidate selectively induces tumor cell apoptosis and provides a non-invasive biomarker.

• Dual mechanism of Alpha1H combines direct tumor cell killing with immune response activation.

• Third-party validation from University of Iowa and Professor O'Donnell underscores clinical potential.

• Advanced discovery platform and consultant network drive innovation and international attention.