Hamlet BioPharma (HAMLET) Investor Update summary

Key achievements and financial update

• Completed three successful phase 2 studies in cancer and infections, with Fast Track status from the FDA for the cancer project.

• Secured short- and long-term funding through two directed share issues, raising approximately 57 million SEK directly and up to 110 million SEK with full option coverage.

• Maintained a low development cost of around 250 million SEK for phase 2 studies, considered highly efficient for the sector.

• Expanded patent portfolio and ensured drug production readiness for phase 3 studies.

• Ongoing discussions with potential partners to accelerate project development.

Scientific and clinical progress

• Advanced non-antibiotic treatments for bacterial infections, including a major international study on infants with urinary tract infections.

• Developed four molecules, including NLPD, that effectively treat severe bacterial infections in animal models, matching antibiotic efficacy.

• NLPD, derived from symbiotic bacteria, modulates host immune response and shows rapid bacterial clearance, even against antibiotic-resistant strains.

• Mechanism of action studies utilize advanced AI and binding assays to understand protein targets.

Strategic outlook and organizational development

• Preparing for phase 3 studies with ongoing FDA dialogue and clinical site readiness.

• Open to expanding the team and forming partnerships to advance multiple key projects.

• Actively considering both independent and partnered paths for future development, with strong investor engagement.

• Funding strategy includes public grants and collaboration with Lund University, ensuring diversified support for research and development.