First patient enrolled in Oncopeptides’ real-world evidence study MARINA in Germany

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STOCKHOLM — June 8, 2026 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company specializing in difficult-to-treat cancers, today announces that the first patient has been enrolled in the new real-world evidence study in Germany, named MARINA. The study, conducted by iOMEDICO, evaluates the use of Pepaxti (melflufen) in combination with dexamethasone for patients with relapsed, refractory multiple myeloma (RRMM), in routine clinical settings.

MARINA is an investigator-initiated, prospective, non-interventional study (NIS) designed to include 50 adult patients across approximately 25 clinical sites in Germany. The study population focuses on patients with relapsed, refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, directly reflecting the approved European indication of the medicine.

By tracking outcomes within everyday healthcare settings, the MARINA study aims to bridge the gap between controlled clinical trials and routine clinical practice. It provides a sophisticated approach to capturing the practical nuances of modern myeloma management in the real world, including critical parameters such as Disease Control Rate (DCR) and Pepaxti’s role as a bridging and sequencing option to immunotherapies like CAR-T cells and bispecific antibodies.

The initiation and first enrollment of the study align with the previously communicated timeline for the second quarter of 2026. The trial is operationally supported by the innovative SYNERGY platform, which utilizes an agile recruitment model that activates participating centers “just-in-time” once an eligible patient has been identified. Oncopeptides provides financial support for the study, while iOMEDICO serves as the formal sponsor and coordinator.

The results of the MARINA study will generate essential data to further strengthen the European real-world evidence base for Pepaxti, supporting continuous engagement with healthcare providers, clinical prescribers, and regulatory bodies.

For more information, including questions and answers for investors, please visit www.oncopeptides.com.

About Oncopeptides
Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers.

The company uses its proprietary Peptide Drug Conjugate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Its flagship drug is currently being commercialized in Europe with partnership agreements for South Korea, the Middle East and Africa and elsewhere.

Oncopeptides is also developing several new compounds based on its two proprietary technology platforms PDC and SPiKE.

The company was founded in 2000, has about 70 employees with operations in Sweden, Germany, Austria, Spain and Italy. Oncopeptides is listed on Nasdaq Stockholm with the ticker ONCO.

For more information see: www.oncopeptides.com

About Pepaxti
Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

First patient enrolled in Oncopeptides’ real-world evidence study MARINA in Germany

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It confirms that the study has successfully transitioned into its active data-collection phase, precisely on track with the Q2 2026 timeline previously communicated to the market. Operationally, it also validates the efficiency of the SYNERGY platform, demonstrating that centers can be dynamically activated the moment a matching patient journey is identified.

In oncology biotech, achieving regulatory approval is only the first step. Long-term commercial growth is driven by widespread market access and deep physician trust. Health authorities and insurance payers increasingly demand real-world data to maintain and justify reimbursement levels, while clinical doctors rely on it to guide daily, practical treatment choices. MARINA builds this essential clinical confidence in a non-trial setting.

Germany represents Oncopeptides’ largest and commercially most critical market. Documenting Pepaxti’s real-world efficacy and safety directly within the German healthcare environment strengthens the company’s core revenue foundation while validating its clinical utility to local decision-makers.

The study is intentionally designed to be operationally lean through the SYNERGY platform. Rather than incurring heavy upfront infrastructure costs to activate 25 centers simultaneously, the “just-in-time” model matches expenses directly to active patient enrollment. This controlled spending structure ensures the company can gather high-value scientific evidence while staying firmly on path toward reaching country-level profitability in Germany during 2026.

A key area of evaluation in MARINA is how physicians utilize Pepaxti as a “bridging therapy” to stabilize advanced patients before they receive immunotherapies like CAR-T or bispecific antibodies. This is a high-growth, highly relevant niche in modern myeloma treatment, and generating robust data here could expand Pepaxti’s defined role in the late line treatment cascade.

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First patient enrolled in Oncopeptides’ real-world evidence study MARINA in Germany

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