Hamlet BioPharma (HAMLET) Q3 2025 earnings summary

Executive summary

• Alpha1H achieved all primary safety and efficacy endpoints in Phase I/II bladder cancer trials, showing significant tumor reduction and no serious adverse events; advancing to Phase III with FDA Fast Track status.

• IL-1 receptor antagonist (anakinra) demonstrated efficacy comparable to antibiotics in recurrent cystitis and improved quality of life in bladder pain syndrome Phase II studies.

• Strategic focus remains on advancing clinical programs, securing partnerships, and global commercialization of late-stage assets.

Financial highlights

• Net sales were KSEK 0 for both the quarter and nine-month period; other operating income was KSEK 208 for both periods.

• Group loss before tax was KSEK -12,505 for the quarter and KSEK -37,157 for the nine months, compared to KSEK -12,296 and KSEK -30,278 year-over-year.

• Loss per share for the group was SEK -0.0704 for the quarter and SEK -0.2091 for the nine months.

• Cash and cash equivalents at quarter-end were KSEK 20,002 (parent) and KSEK 20,027 (group), down from KSEK 31,551 and KSEK 31,576 year-over-year.

Outlook and guidance

• Plans to complete Phase III trials for Alpha1H and seek market approval, with ongoing FDA discussions and GMP readiness for commercialization.

• Intends to partner late-stage assets and expand collaborations for preclinical and early discovery programs.

• Focus on global commercialization and strategic alliances to maximize asset value.