Oncopeptides publishes Q3 report 2026

“Oncopeptides delivered a quarter of commercial execution in line with expectations, while achieving clinical and regulatory milestones. Net sales of Pepaxti in Europe reached SEK 28.5 million in Q3, reflecting sustained growth compared to Q3 2025 (SEK 20.2 million). Net sales for the first nine months reached just under SEK 85 million, significantly ahead (+62%) of the SEK 52.6 million reported for the same period last year. Also, for the first time in Oncopeptides’ history, sales for the twelve last months exceeded SEK 100 million, reaching SEK 103.5 million,” says Sofia Heigis, CEO of Oncopeptides. “Strengthened by the CHMP recommendation to expand Pepaxti into the third line of treatment of multiple myeloma and the increased sales potential that a formal approval would bring, we continue to move toward our goal to reach positive cash flow for our commercialization of Pepaxti in 2027.”

Financial overview July-September

• Net sales amounted to SEK 28.5 (20.2) million
• Operating profit amounted to SEK -36.5 (-47.1) million
• Profit after tax amounted to SEK -44.0 (-60.9) million
• Earnings per share, before and after dilution -0.12 (-0.27) SEK
• Cash and cash equivalents at the end of the period amounted to SEK 116.8 (147.9) million

Significant events July-September

• CHMP issues positive opinion of label expansion of Pepaxti to third-line treatment in myeloma
• Oncopeptides highlights clinical progress and presents new data at the IMS Annual Meeting
• Preclinical and translational data presented at EANO 2026
• Oncopeptides receives list price for Pepaxti in Slovenia, first expansion milestone in Central and Eastern Europe

Events after the period

• Oncopeptides confirms blood-brain-barrier penetration based on data from first patients in glioblastoma WoO study
• Oncopeptides completes a directed share issue of approx. SEK 100 million
• Two independent European real-world studies (82 patients in Italy and Spain) accepted for presentation at ASH 2026

Financial overview of the group

*includes milestone payment of SEK 1.1 million from South Korea licensing deal

Conference call for investors, analysts and the media 
Investors, financial analysts, and media are invited to participate in a webcast and a subsequent Q&A session, at 09:00 CET today.

The presentation will be hosted by Sofia Heigis, CEO, together with Henrik Bergentoft, CFO. The webcast will be held in English and published on the website of Oncopeptides – www.oncopeptides.com/en – in conjunction with the start of the presentation.

Information for participants
If you wish to participate via webcast, please use the link below.
https://events.inderes.com/oncopeptides/q3-report-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/q3-report-2026/dial-in
 
CEO statement

Oncopeptides delivered a quarter of commercial execution in line with expectations, while achieving clinical and regulatory milestones. Net sales of Pepaxti in Europe reached SEK 28.5 million in Q3, reflecting sustained growth compared to Q3 2025 (SEK 20.2 million). Net sales for the first nine months reached just under SEK 85 million, significantly ahead (+62%) of the SEK 52.6 million reported for the same period last year. Also, for the first time in Oncopeptides’ history, sales for the twelve last months exceeded SEK 100 million, reaching SEK 103.5 million. Strengthened by the CHMP recommendation to expand Pepaxti into the third line of treatment of multiple myeloma and the increased sales potential that a formal approval would bring, we continue to move toward our goal to reach positive cash flow for our commercialization of Pepaxti in 2027.
 
Europe remains the core driver of our commercial value. Third-quarter sales reflected the European summer vacation period, with demand softer during August and September as observed in prior years. In Germany, commercial discipline and a sharpened business model continue to steer operations toward country-level profitability. Italy continues to outperform initial expectations, driven by established market access and a solid positive experience that is driving accurate patient identification and demand. In Spain, even though affected by the vacation period, sales continued at a higher level than the previous quarter.

A milestone for our European commercial business during Q3 was the CHMP recommendation for an approval to expand Pepaxti’s label into third-line multiple myeloma. An expanded label would move Pepaxti from the fourth-line to the third-line of treatment and remove the triple-class refractory requirement, effectively doubling our addressable patient population in Europe. We expect a decision from the European Commission in Q4.

Our European market footprint expanded further through our distribution collaboration with Salus Group in Central and Eastern Europe (CEE). In August, the Slovenian agency JAZMP approved a Maximum Allowed Price (MAP). As Slovenia serves as an important price reference across the CEE region, establishing this list price provides a solid foundation as Salus starts to submit reimbursement dossiers and then advance into formal reimbursement negotiations. In parallel, our partnership dialogues in Japan have continued through active engagements both remotely and in person, with multiple companies during Q3.

Phase 3 OCEAN data demonstrate that earlier intervention enables patients to stay on therapy longer, doubling the average number of treatment cycles per patient in third line, which would unlock commercial potential far beyond our current SEK 1.5 billion market estimate. Importantly, Germany’s modern ‘basket’ pricing framework establishes an attractive comparative price anchor that may protect Pepaxti’s innovative value. We plan to submit our German access dossier within approximately one month of a potential EC approval, permitting immediate commercial sales under the expanded indication while price negotiations proceed.

Pending a possible EC approval, we are also preparing for third line launches in Italy and Spain and stand ready to initiate the market access processes by submitting dossiers as soon as the local processes allow for it. As part of our third line pre-launch activities, we have also gathered insights from key opinion leaders on the positioning of Pepaxti in third line. Feedback is consistent and confirms the need for an option complementing immunotherapy. This is true also for countries outside of our current key markets and we are looking into different options, including partnerships, to ensure we over time can capture the full European potential.

Recently, we were pleased to also announce that two independent multicenter studies from Italy and Spain evaluating Pepaxti in a total of 82 heavily pretreated patients, including post-immunotherapy and bridging settings, have been accepted for presentation at the upcoming ASH annual meeting in December.

Beyond multiple myeloma, we announced a major step forward with our pipeline in October. Initial data from the first three patients in our clinical Window-of-Opportunity (WoO) study, OP-701 (INSULA), at Oslo University Hospital confirmed that our PDC platform successfully crosses the human blood-brain barrier (BBB) and achieves intra-tumoral drug concentrations in line with preclinical models. Lack of blood-brain barrier penetration causes more than 90 percent of systemic therapies to fail in brain tumors; confirming penetration and cytotoxic delivery in pharmacologically relevant concentrations in patients provides a strong clinical proof-of-concept for our platform in solid brain tumors. The treatment has been well tolerated, with the first patient receiving five monthly cycles in the study’s open-label extension without major drug-related toxicity.

In September, the first scientific presentations within glioblastoma with Oncopeptides’ data were held at the EANO Congress in Rome, where our translational glioblastoma research, demonstrating encouraging data in preclinical models, also was nominated for the EANO 2026 Poster Award.

To capitalize on this momentum, we recently completed a directed share issue of approximately SEK 100 million to Swedish and international institutional investors, with continued support from our largest owner HealthCap. These dedicated proceeds allow us to advance CMC manufacturing activities, complete study preparations, and finance the execution of the next clinical phase within glioblastoma without compromising our disciplined commercial operations.

With a potential third-line approval by the EC in the near future doubling our addressable multiple myeloma market, landmark clinical proof of blood-brain barrier penetration in glioblastoma, and dedicated funding secured to advance our clinical pipeline in glioblastoma, we hold powerful catalysts to accelerate our growth.

November 5, 2026
Sofia Heigis, CEO