Oncopeptides (ONCO) Investor update summary

Strategic rationale and market opportunity

• Plans to submit a Type II variation to expand Pepaxti's indication to third-line, less refractory multiple myeloma patients in Europe, aiming to double the addressable patient population and treatment cycles per patient.

• Decision is based on market expansion, extended exposure, clinical value, and improved pricing viability due to a more favorable pricing landscape compared to 2023.

• New immunotherapies and combination regimens have shifted third-line pricing from a single low-cost comparator to a basket of higher-priced drugs, enhancing commercial viability.

• Market potential could significantly increase, with current estimates at SEK 1.5 billion and further upside dependent on regulatory approval and successful price negotiations in each country.

• German pricing will serve as a benchmark for other European countries, supporting innovative price levels.

Clinical and scientific rationale

• Expansion is supported by robust Phase III OCEAN study data, showing significant improvement in progression-free survival (median 9.3 months vs. 4.6 months, hazard ratio 0.58) and overall response rate (42% vs. 26%) for Pepaxti plus dexamethasone versus standard care.

• Pepaxti's peptide drug conjugate (PDC) mode of action is independent of the immune system, offering a complementary approach for patients with exhausted immune systems.

• The target population for the new indication is less refractory, less frail, and can benefit from longer treatment duration.

• Removal of the "triple class refractory" requirement will facilitate earlier and more frequent patient identification.

Regulatory and financial outlook

• Type II variation submission to EMA is planned within months, with initial regulatory feedback expected in the second half of 2026 and a final European Commission decision in the first half of 2027.

• Market access and price negotiations will begin after regulatory approval, with processes varying by country.

• No change to the financial target of being cashflow positive in 2027; adjustments will be considered only after regulatory and pricing clarity.