Hamlet BioPharma (HAMLET) Investor update summary

Progress in clinical and partnering activities

• Ongoing partnering discussions with a pharma company specializing in bladder cancer, with due diligence completed and further updates expected.

• Phase III study protocols and regulatory workup are finished; recruitment of new study centers is underway.

• Recent patent published for broader use of anticancer compounds, including systemic treatment.

• Clinical studies published in top journals, with strong clinical observations supporting efficacy.

• 180 patents now held, with active search for financing and partners to support market access.

Scientific and technological advancements

• Advanced omics platforms (proteomics, transcriptomics) enable detailed analysis of disease and treatment response.

• Proteomics via Luminex technology allows detection of over 100 proteins in a single assay, supporting biomarker discovery.

• Transcriptomics reveals broad inhibition of cancer-related genes and pathways after treatment, with dose-dependent effects.

• Imaging technologies provide high-resolution visualization of drug uptake and mechanism of action at the cellular level.

• Integration of computational tools (AlphaFold) and recombinant protein production accelerates drug discovery.

Clinical development and results

• Phase II studies show Alpha1H and IL-1RA treatments have comparable efficacy to antibiotics in infection models.

• Alpha1H treatment in bladder cancer patients leads to strong immuno response and significant downregulation of cancer genes.

• Over 80% response rate observed in higher dose groups, with some tumor disappearance.

• Phase III studies aim to establish complete response rates and longer follow-up endpoints.

• New patent data suggest systemic anticancer effects beyond local treatment.