Hamlet BioPharma (HAMLET) investor relations material

Clinical trial progress and regulatory milestones

• Phase III trial for non-muscle-invasive bladder cancer has officially started in Prague, with patient enrollment and treatment underway, following approvals from both European and FDA authorities.

• The Alpha1H drug for the trial was produced at phase III quality and successfully transported to the trial site, with strong collaboration from the Prague clinical team and regulatory support.

• The trial uses a stepwise, cost-effective protocol allowing ongoing assessment and potential protocol adjustments, with a 12-month patient follow-up and interim data expected before full completion.

• Recruitment pace is patient-dependent, and while timelines for milestones are uncertain, the team remains optimistic about progress.

• Partnering discussions are ongoing, with ambitions for a deal potentially in 2026, which could impact shareholder returns.

Financial strategy and partnering outlook

• Efficient operations and innovative trial design have enabled advancement to phase III with limited funding, but additional funding and partnerships are being actively pursued.

• Partnering is seen as a key mechanism for future funding, with international contacts and ongoing discussions to secure resources for parallel phase II and III studies.

• Shareholder dividends are considered, contingent on the magnitude of any partnership deal and continued cost-effective operations.

BAMLET research and commercialization

• Recent publication in a major journal highlights BAMLET's ability to reduce weight gain, blood glucose, and adipose tissue growth, and improve intestinal function in preclinical models.

• BAMLET acts via oral administration, targeting metabolic health, with effects on glucose transporters and hormones like adiponectin and leptin.

• No toxicity observed in animal studies, and BAMLET is being positioned for both nutritional and pharmaceutical development, with early commercialization in nutrition as a first step.

• Large-scale production capabilities have been established, and discussions with industry partners, including those mediated by Tetra Pak, are ongoing.