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May 11, 2026
Press release

Oncopeptides intends to submit type II variation to expand Pepaxti label to include third line treatment

InvestorScience
Regulatory

STOCKHOLM — May 11, 2026 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces its intention to submit a Type II variation application to the European Medicines Agency (EMA). The submission follows an updated assessment of the evolving therapeutic and regulatory landscape in Europe. An approved application for a broader indication would significantly expand the potential addressable market for Pepaxti.

A broader indication including third line patients would double the addressable patient population for Pepaxti in Europe. In addition, third line patients are also estimated to undergo, on average, double the number of treatment cycles compared to the current label. Oncopeptides has previously communicated a SEK 1.5 billion potential for Pepaxti in the European market, reflecting the current indication (fourth treatment cycle and onwards). Oncopeptides assesses that the potential regulatory approval followed by subsequent market access could unlock significant added potential for sales of Pepaxti in Europe.

“As more drugs have entered the markets across Europe, the treatment landscape has developed and now allows us to pursue an indication in earlier lines of therapy giving access to a broader population,” says Sofia Heigis, CEO of Oncopeptides. “Market experience from the use of Pepaxti has generated positive clinical experience confirming the unmet need for a PDC as a complement to immunotherapy.”

The submission is supported by clinical data from the Phase 3 study OCEAN and seeks to expand the therapeutic indication of Pepaxti (melflufen) to include adult patients with multiple myeloma who have received at least two prior lines of therapies (3L+), and whose disease is refractory to lenalidomide and the last line of therapy.

Oncopeptides intends to submit the application during the coming months and expects first regulatory feedback before end of this year with a subsequent final decision by the European Commission in H1 2027.

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

Webcast for investors
The company will host a webcast and Q&A session aimed at investors, analysts and media on May 11 at 12:00 CET.

If you wish to participate via webcast, please use the link below.
https://oncopeptides.events.inderes.com/investor-call-2026

If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/oncopeptides/investor-call-2026/dial-in

For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: ir@oncopeptides.com
Cell phone: +46 76 229 38 68

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-05-11 08:15 CEST.

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 80 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.

Attachments
Oncopeptides intends to submit type II variation to expand Pepaxti label to include third line treatment

Oncopeptides intends to submit type II variation to expand Pepaxti label to include third line treatment

Documents

Webcast presentation as PDF

Questions and answers

Oncopeptides intends to submit the application during the coming months and expects first regulatory feedback before the end of this year with a subsequent final decision by the European Commission in H1 2027. A positive decision by the Europan Commisson would be followed by market access processes including price negotiations. In general, first sales are possible once a new price is negotiated. In Germany, however, it is possible to start to sales immediately following the submission of a reimbursement dossier, which can be done after a positive EC decision.
In order to adjust our financial target, we would first need a successful regulatory process and clarity on all factors affecting the potential for Pepaxti. We already know that an approved application for a broader indication would double the current addressable patient population for Pepaxti in Europe and double the average number of treatment cycles per patient compared to the current label. What is unknown is the timeline and the outcome of the market access processes and price negotiations which are both important factors. Until that time, our previously communicated expectation remains: we expect to reach positive cash-flow during 2027.
Yes. As patients are now being exposed to all standard classes of drugs in the first two lines and immunotherapy is being approved from the second line, there is an unmet need for a PDC as a complement to immunotherapy. Market experience from the use of Pepaxti has generated positive clinical experience confirming this need in the third line.
There is a cost tied to both the regulatory and market access applications. The immediate submission cost is relatively low and mostly related to administration costs related to the regulatory and market access submissions distributed over 2026 and 2027. Because we already have an established commercial infrastructure in Germany and other key markets for the fourth line, the incremental cost of expanding in our key markets into third line is relatively low. We see this as a cost efficient way to scale our existing footprint. The primary risk, however, has in the past been price erosion in our current fourth line business. A new indication per definition triggers price negotiations which usually comes with a lower price if the patient population is expanded. A stronger competitive landscape has triggered a shift from a single comparator price anchor to a “basket” of drugs, meaning several different alternatives that are used today in the third line setting. This basket is a mix of different price levels and on average concludes a higher comparative price point than in 2023. Our assessment shows that the ‘basket’ approach will ensure that a renewed market access and pricing process will not compromise the innovative value of our drug.
In 2023, Oncopeptides opted to abandon a similar application despite a positive opinion from the European Medicine’s Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP). This was done to ensure optimal value for patients and shareholders following an analysis of the comparative pricing and competitive landscape at the time. The company has since concluded that the pricing landscape has evolved, supported by precedents set by other advanced myeloma therapies, confirming the commercial viability of a third-line indication. The 2023 decision was the correct one for that specific market access environment; had we proceeded, we would have locked in a generic-level price that would have diminished the drug’s value across Europe. In 2026, the German payer landscape has moved toward a “basket” approach for RRMM 3rd line patients. Precedents from other therapies have established that established that an average of several therapies is now the standard price anchor, allowing us to pursue this broader population without compromising the drug’s innovative price level.
Our previously communicated SEK 1.5 billion market potential reflects only the current indication—fourth treatment cycle and onwards—and does not account for the growth following an expanded label. An approved third-line indication would significantly expand our business case through a “multiplier effect”: First, moving to the third line would double our addressable patient population in Europe. Second, these patients are estimated to undergo, on average, double the number of treatment cycles compared to those treated under our current label. Finally, because the evolved pricing landscape now supports a “basket” approach, we can pursue this broader population assuming it will not compromise the drug’s innovative price level. Oncopeptides assesses that this regulatory approval, followed by market access, would unlock significant added potential for sales in Europe.
Yes. While BCMA-targeted therapies are moving earlier, the 2025 EHA-EMN guidelines continue to emphasize the need for diverse Mechanisms of Action (MoA). The evolving treatment landscape, with patients being exposed to all standard classes of drugs in the first two lines, concludes an unmet need for a PDC as a complement to immunotherapy. Market experience has confirmed that Pepaxti remains a highly competitive ‘ready-to-use’ option.

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