OncoZenge (ONCOZ) Q4 2025 earnings summary

Executive summary

• Submitted Clinical Trial Application (CTA) for pivotal Phase III trial of BupiZenge™ to EMA in Q4 2025, aiming for European approval and commercial launch.

• Secured strategic partnerships with Molteni Farmaceutici (Europe) and Avernus Pharma (GCC), and investment agreement with Sichuan Yangtian Bio-Pharmaceutical Co. Ltd for SEK 30.2 million.

• Manufacturing for Phase III trial established with Meribel Pharma Solutions; LINK Medical appointed as CRO for trial execution in Norway, Sweden, Denmark, and Germany.

• Key milestones include successful CTA submission, strengthened sponsor team, and completion of a UCLA patient engagement study informing trial design.

• Strategic focus on robust execution of European Phase III, expanding partnerships, and exploring market entry in China and the US.

Financial highlights

• Net sales for 2025: SEK 2,664 thousand (0 in 2024); Q4 net sales: SEK 0 thousand (0).

• Operating result for 2025: SEK -15,787 thousand (-8,685); Q4: SEK -9,748 thousand (-2,501).

• Earnings per share for 2025: SEK -1.31 (-0.74); Q4: SEK -0.78 (-0.21).

• Cash and cash equivalents at year-end: SEK 3,714 thousand (3,863).

• Equity ratio at year-end: 34.74% (87.02%).

Outlook and guidance

• CTA approval expected in late April or early May 2026, with first patient dosing in Q2 2026.

• Strategic priorities for 2026: execute European Phase III, secure further partnerships, refine China and US market strategies, and explore new indications.

• Projected funding from remaining investment tranches and convertible loans expected to finance operations through Q4 2026.