Hamlet BioPharma (HAMLET) investor relations material

Executive summary

• Achieved significant milestones in cancer therapy and anti-infective development, advancing multiple drug candidates to Phase III clinical trials and expanding the clinical pipeline in collaboration with leading institutions.

• Completed three controlled Phase II trials in cancer and infections, demonstrating successful treatment effects and strong commercial potential.

• Focused on translating innovation into clinical success with a robust pipeline targeting malignant tumors and antibiotic-resistant infections, and ongoing commercial partnerships and market access discussions for Phase III-ready assets.

• Strong collaborations with academic and industry partners, including Linnane Pharma, Lund University, University of Iowa, and ImmunoForge.

• Emphasis on commercial partnerships to bring new therapies to patients, with ongoing discussions with major pharmaceutical companies.

Segment performance

• Oncology: Alpha1H advanced to Phase III for bladder cancer, with regulatory approvals in Europe and the US, expanded studies for severe bladder cancer, and demonstrated strong tumor response rates (82% complete/partial response at higher dose).

• Infectious diseases: Non-antibiotic therapies demonstrated efficacy in Phase II trials for urinary tract infections and bladder pain syndrome; pipeline includes four non-antibiotic treatments showing efficacy against antibiotic-resistant infections.

• Pain: Anakinra showed significant reduction in pain and improved quality of life in bladder pain syndrome.

Significant events and developments

• IND application with FDA approved for Alpha1H, enabling multiple clinical trials, and secured European regulatory approval for Phase III Alpha1H study.

• Collaboration agreements signed with ImmunoForge (Korea) and University of Iowa for novel tuberculosis delivery technology and clinical advancements.

• Publication in The Journal of Infectious Diseases for new recombinant protein therapy.

• Expanded patent portfolio to 180 patents or patent families, with rapid approval of new candidates and new patents granted in multiple jurisdictions.

• Raised up to SEK 140 million through directed share issues and warrants, with further SEK 25.7 million post-period.