Oncopeptides: Pivoting Toward a Broader European Franchise and a CNS Indication

Pepaxti grows 74% in H1 2026, the EMA submission could double its addressable population, and the first glioblastoma patient signals a platform beyond myeloma.

ONCO.ST · Earnings Call · 2026-08-27

A Transformative Label Expansion

Oncopeptides' Q2 2026 results are defined less by the 62% revenue growth and more by the strategic milestones achieved. The company now has a commercial product, Pepaxti, in several European countries, and it is taking steps to broaden that window. The most significant is the submission of a Type II variation to the EMA, which would expand Pepaxti's label from fourth-line to third-line multiple myeloma. In prepared remarks, CEO Sofia Heigis put it plainly: “Our submission to move from fourth line into third line represents a transformative opportunity.” — Sofia Heigis, Chief Executive Officer · 2026-08-27 Moving one line up and removing the triple-class refractory requirement could double the addressable patient population and increase the average treatment duration per patient, based on the OCEAN study data. The company has carefully positioned Pepaxti as an immunotherapy-sparing option, arguing that frail, elderly patients or those with infection concerns benefit from a non-cross-resistant mechanism. With over 1,000 patients treated across Europe, real-world evidence is building. In Germany, only experienced prescribers currently use Pepaxti in the late-fourth-line setting, but a third-line label would allow it to be used earlier, where longer treatment durations are common. Heigis acknowledged this potential when she described the need to "give clinicians the ability to identify and treat patients earlier."

Geographic Expansion and a Diplomatic Pivot

Beyond the label, Oncopeptides is accelerating its geographic reach. In Q2, the company signed a distribution agreement with Salus Group covering 11 countries in central and Eastern Europe—a region with an estimated SEK 150 million market potential under the current label. The first milestone was securing a list price in Slovenia in August, and first sales are expected in 2027. As Heigis noted, “first sales should come sometime in 2027.” — Sofia Heigis, Chief Executive Officer · 2026-08-27 This partnership is a cost-efficient way to scale without further diluting the lean organization. The company is also recalibrating its Japan strategy. Previously it had granted exclusivity to a single partner, but delays in that partner's decision-making have prompted parallel discussions. In the November 2025 call, Heigis was optimistic: “So like I mentioned, the discussions are advancing well.” — Sofia Heigis, CEO · 2025-11-05 Now, however, she concedes that "we see further delays based on their organization," and the company is actively engaging multiple potential partners. In a more marked shift, Oncopeptides has explicitly stepped back from the U.S. market. The FDA had revoked accelerated approval for Pepaxti because of a mismatch in target population. Heigis explained the rationale during the Q&A:

Currently, we are not focusing on the U.S. market. Maybe a bit of history here. We did have a quite lengthy process where we were in discussions with the FDA. At the end of the day, they concluded to pull the accelerated approval...
Sofia Heigis, Chief Executive Officer · 2026-08-27

Instead, management is prioritizing European commercialization and the pipeline, particularly the CNS program.

The Next Catalyst: Glioblastoma and the PDC Platform

The most striking development is the initiation of a glioblastoma window of opportunity study. The company dosed its first patient at Oslo University Hospital, using an approved PDC probe to demonstrate blood-brain barrier penetration in a cost-efficient, 10-patient study. This is a high-unmet-need indication where current standard-of-care temozolomide has limited efficacy. Heigis emphasized the scientific rationale: “The first major obstacle in brain cancer is crossing the blood-brain barrier. Based on preclinical data, we believe we can overcome this barrier.” — Sofia Heigis, Chief Executive Officer · 2026-08-27 The company's PDC platform is designed to penetrate 100% of the blood-brain barrier in preclinical models, and it has shown double-stranded DNA damage that may overcome resistance. If the study succeeds, it opens a multibillion-dollar opportunity beyond multiple myeloma. Financial discipline remains central to the narrative. Cash at the end of Q2 was SEK 158 million after a rights issue, and management reiterated that it expects positive cash flow in 2027—having previously guided for 2026. In the February 2026 call, Heigis explained the shift candidly: “we will not be able to reach the cash flow positive target in 2026, but we have pushed it to 2027.” — Sofia Heigis, CEO · 2026-02-19 In the current call, CFO Henrik Bergentoft added, “Key message is that the business is moving in the right direction with sales uptake, strong margins, and tight cost control.” — Henrik Bergentoft, Chief Financial Officer · 2026-08-27 The company reported a 98% gross margin in H1 and reduced operating expenses year-over-year, providing some confidence in its path to profitability. Oncopeptides is at a crucial inflection. The EMA decision on the Type II variation is expected between September and November 2026, and a positive opinion could transform its commercial scale. Meanwhile, the glioblastoma study provides optionality for the platform. With a lean cost base and a clear strategic focus, the company is positioning itself to become a sustainable European biotech—if the execution holds.