Oncopeptides Ab · OMXSTO:ONCO
Oncopeptides Ab — Type II application Investor conference (May 2026)
29 slides from Oncopeptides Ab's conference presentation, May 11, 2026
Slide 1: Type II application Investor conference
Type II application Investor conference May 11, 2026 1
Slide 2: Disclaimer
Disclaimer IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Oncopeptides AB (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows the oral
Slide 3: Presenters
Presenters Sofia Heigis Henrik Bergentoft Chief Executive Officer Chief Financial Officer 3
Slide 4: Today´s announcement
Today´s announcement • What are we announcing? • Oncopeptides intends 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 broad
Slide 5: Key takeaways
Key takeaways Market Extended Clinical value Pricing viability expansion exposure Built upon robust Assmessment shows Submission seeks to Average treatment Phase 3 OCEAN study evolved pricing get regulatory approval cycles are according to data previously landscape allows to at least double the clin
Slide 6: Background
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Slide 7: Looking back: 2023 – third line entry risk to Pepaxti value
Looking back: 2023 – third line entry risk to Pepaxti value “To move forward with an extension into earlier lines of treatment before fulfilling the higher unmet need in later lines could mean a new European price level for Pepaxti that does not reflect our innovation and ultimately risk the availab
Slide 8: Today: 2026 – a more favorable pricing landscape
Today: 2026 – a more favorable pricing landscape Strategic Factor 2023 Analysis 2026 Assessment Pricing anchor Cheapest comparator = generic “Basket" including advanced therapies Payer precedence Limited / single comparator Basket used in 2-3 line Commercial viability Unfavorable market access risk
Slide 9: Business impact
Business impact 9
Slide 10: Unlocking potential
Unlocking potential Oncopeptides’ communicated SEK 1.5 Billion market potential today reflects the current indication. A third line expansion could add potential based on three core multipliers: 2x Addressable Patients 2x Average no of Treatment Cycles Innovative Price Patients Treatment cycles Pric
Slide 11: Scientific rationale
»~ ~ > ‘‘ Scientific rationale © oncopeptides
Slide 12: Multiple Myeloma treatment course: A marathon – not a sprint
Multiple Myeloma treatment course A marathon – not a sprint Newly diagnosed Early relapse Late relapse Advanced disease Multiple Myeloma burden Tumor 2nd relapse Symptomatic Multiple Myeloma Current 1st relapse Rapid Initial therapy acceleration Pepaxti +/- Autologous of disease Indication Stem Cell
Slide 13: Multiple Myeloma treatment course: A marathon – not a sprint
Multiple Myeloma treatment course A marathon – not a sprint Newly diagnosed Early relapse Late relapse Advanced disease Multiple Myeloma burden Tumor Symptomatic Multiple Myeloma Potential 1st relapse Initial therapy Pepaxti +/- Autologous Indication Stem Cell Therapy Maintenance 1st line 2nd line 3
Slide 14: Mode of Action
Mode of Action PDCs enhance alkylation through enzymatic enrichment and dual targeting of both nuclear and mitochondrial DNA 1 2 Melflufen enters cells freely due to Peptidases and esterases are its lipophilicity, without the need of enzymes overexpressed in tumor transporter proteins. cells and imp
Slide 15: Multiple Myeloma treatment landscape
Multiple Myeloma treatment landscape 4th line and 1st line 2nd line 3rd line beyond Anti CD38 Proteasome monoclonal inhibitors Conventional Rechallenge antibodies therapy Immunomodula tors (IMIDs) Bispecific CAR T ADC*** Immuno- antibodies therapy Bispecific antibodies** PDC Nuclear export Nuclear e
Slide 16: Clinical positioning: where Pepaxti fits
Clinical positioning: where Pepaxti fits Unable to receive In-between Post-immunotherapy Immunotherapy immunotherapy failure Strategic option for patients Ideal "bridge" between RWD demonstrates Pepaxti can unable to receive immune-based therapies to be an alternative for patients immunotherapy due
Slide 17: Broadening the therapeutic reach
Broadening the therapeutic reach • Current indication • Future potential indication • 4th Line+ treatment • 3rd line+ treatment • Adult patients with RRMM who have • Adult patients with RRMM who have received at least 3 prior lines of therapies. received at least 2 prior lines of therapies. • Refrac
Slide 18: OCEAN study data
OCEAN study data 18
Slide 19: The OCEAN study
The OCEAN study A head-to-head study vs. previous standard of care and confirmed efficacy + safety in current label based on the HORIZON study HORIZON2 Pivotal Phase-2-study Efficacy & Safety DEFINITION1,3 of patients benefiting the most from melflufen CONFIRMATION3 CONFIRMATION of • Efficacy • Safe
Slide 20: A head-to-head comparison study
A head-to-head comparison study A phase 3, randomized, open-label, global study1 Patients with RRMMa Melflufen (40 mg IV, Day 1 of each cycle) • Aged ≥18 years Primary endpoints • 2-4 prior lines of therapy Dexamethasone • PFSd (40 mg PO weekly)b,c including lenalidomide and a PI Key Secondary 1:1 1
Slide 21: OCEAN: Patient characteristics
OCEAN: Patient characteristics Target population vs current label population: Characteristic OCEAN (n=145) Current label (n=52) Age, median (IQR), years 71 (46–91) 70 (42–86) Median time since diagnosis, years 3.5 (0.5-26.3) 7.4 (0.7-24.6) Previous lines of therapy, median (IQR) 2 (2–4) 5 (3-10) Pre
Slide 22: OCEAN: Efficacy – PFS and OS results
OCEAN: Efficacy – PFS and OS results Target population2,3 Events, Median PFS Progression-free Survival, % 100 n (%) (95% CI), months 80 Melflufen + d (n=145) 93 (64) 9.3 (7.2-11.8) Pomalidomide + d (n=148) 115 (78) 4.6 (3.6-6.3) 9.3 months Median PFS (Target Population) 60 40 HRc (95% CI): P value:b
Slide 23: OCEAN: Efficacy – Overall response (ORR)
OCEAN: Efficacy – Overall response (ORR) Statistical significance Melflufen + dex 42% p = 0.0046 Pomalidomide + dex 26% CR VGPR PR 23
Slide 24: Next steps
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Slide 25: Execution timeline and milestones
Execution timeline and milestones May-July 2026 H2 2026 H1 2027 2027 Type II Variation Initial Regulatory Feedback European Commission Market Access & Price Submission to EMA expected Final Decision negotiations 25
Slide 26: In conclusion
In conclusion 26
Slide 27: Bringing hope to patients
Bringing hope to patients Our commitment to innovation is driven by the desire to make a difference to patients. If approved and price negotiations are successful, this indication expansion represents a significant milestone for Oncopeptides, the patients we serve, and our shareholders. Third line a
Slide 28: Questions and answers
Questions and answers 28
Slide 29: Bringing hope through science
Bringing hope through science © oncopeptides
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