Oncopeptides (ONCO) CMD 2025 summary

Current business performance and market position

• Q3 2025 sales reached SEK 20 million, up 174% year over year, with four consecutive quarters of European commercialization growth.

• Pepaxti is available in Germany, Austria, Spain and Italy; profitability is targeted by end-2026.

• More than 550 patients have been treated across Europe; Pepaxti has positive clinical experience and inclusion in European guidelines.

• Partnerships are extending access to South Korea and MENA, with late-stage due diligence ongoing for Japan.

• Real-world data and clinical endorsements are supporting broader adoption and market confidence.

Product innovation and clinical differentiation

• Pepaxti (melflufen), the platform’s first peptide drug conjugate, has a unique, immune-independent mechanism of action.

• Demonstrates efficacy in triple-class refractory myeloma, including high-risk and elderly patients, and can serve as bridging therapy before immunotherapies.

• Once-monthly IV administration offers patient quality-of-life and logistical benefits; safety includes manageable hematologic toxicity and minimal non-hematologic side effects.

• Clinical and real-world data show durable benefit, manageable toxicity and applicability across patient subgroups.

Strategic pipeline and future growth opportunities

• Pipeline includes next-generation PDCs OPD5 and OPDC3, plus the SPiKEs platform for NK-cell engagement across oncology, hematology and autoimmune diseases.

• OPD5 has promising combination and glioblastoma potential, supported by preclinical data and blood-brain barrier penetration.

• SPiKEs is positioned as a differentiated, tolerable immunotherapy platform for cancer and autoimmune indications, including unique BCMA targeting.

• Preclinical assets are advancing toward IND readiness, with focus on scalable manufacturing and partnerships for clinical development.

• Grants, collaborations and licensing deals support pipeline advancement and global expansion.