Hamlet BioPharma (HAMLET) BioStock Life Science Summit 2026 summary

Clinical pipeline and milestones

• Three positive phase II studies; phase III trial of intravesical Alpha1H for bladder cancer started, with enrollment completed in September.

• Phase III-quality drug manufacturing completed; European regulatory approval received, alongside prior FDA approval.

• Other bladder cancer opportunities include carcinoma in situ, adjuvant treatment after surgery, and advanced disease through a University of Iowa collaboration.

• University of Iowa collaboration expands U.S. clinical work; studies in more advanced bladder cancer are planned.

Alpha1H bladder cancer findings

• Alpha1H is a synthetic peptide biological derived from alpha-lactalbumin and alpha-oleate; reported effects include rapid tumor-cell shedding, reduced tumor size, apoptosis, and protective immune activation.

• After six instillations over one month, 82% of tumors treated at the highest dose showed reduced size.

• Cancer-related gene expression was reported down nearly 80%; effects on metabolism were also identified through a separate mechanism.

• Phase III protocol allows patients whose tumors clear with Alpha1H to avoid surgery; patients with partial response and control-group patients undergo surgery.

Host-directed infection program

• IL-1 receptor antagonist treatment targeted IL-1-dependent disease responses; recurrent bacterial infections and bladder pain were treated, with a phase II controlled study showing non-inferiority to antibiotics.

• Research targets disease mechanisms rather than bacteria; approaches include IRF7 siRNA, NlpD, LON, and anakinra, with reported symptom improvement and bacterial clearance.

• Three compounds cleared infections caused by antibiotic-resistant strains in the presented results, while the PBS cephalosporin comparator had no effect.

• Further studies are being considered in more severe bacterial infections, potentially including sepsis.