Slide 1: Focus on the Path Forward for Orviglance
ADVANCING ORPHAN ONCOLOGY Focus on the Path Forward for Orviglance® Ticker symbol: ACE Nasdaq Stockholm Conference call presentation on 20 August 2026, 10:00 CEST www.ascelia.com
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation, which includes all information and data on the following slides, any oral statements made when presenting these slides, and any other material distributed or statements made at, or in connection with, such presentation (the “Presentation”), relates to As
Slide 3: Quarterly Report Q2 2026 Investor Conference Call
QUARTERLY REPORT Q2 2026 INVESTOR CONFERENCE CALL Agenda Overview and recent key events Portfolio Financials and priorities ahead Presenters CEO - Magnus Corfitzen CSO – Andreas Norlin CFO – Anton Hansson 3
Slide 4: Global outlook and Nordic roots
At Ascelia Pharma, we identify, develop and commercialize novel drugs that address unmet needs of people with rare cancer conditions Global outlook and Nordic roots Based in Malmö (Sweden), US entity in New Jersey (US) Listed on NASDAQ Stockholm (Ticker: ACE) 4
Slide 5: Advanced Orphan Oncology Pipeline
ADVANCED ORPHAN ONCOLOGY PIPELINE Drug Indication Phase 1 Phase 2 Phase 3 Registration Market candidate Improved detection and visualization of focal liver lesions First-in-class contrast agent for use in liver MRI in Type A patients with severely impaired kidney function Completed meeting ORVIGLA
Slide 6: Q2 2026 Progress
Q2 2026 PROGRESS Key events in Q2 2026 Ascelia Pharma completes directed share issue of SEK 20 million before transaction costs Bulletin from the Annual General Meeting in Ascelia Pharma AB on May 4, 2026 Orviglance data presented at the European Society of Gastrointestinal and Abdominal Radio
Slide 7: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 7
Slide 8: Attractive Orviglance Opportunity
ATTRACTIVE ORVIGLANCE OPPORTUNITY A well-defined unmet need for liver imaging in cancer patients with impaired kidney function A global addressable market opportunity of USD 800 million Commercial scale manufacturing Clinical development completed with 9 studies and strong phase 3 results FDA Type A
Slide 9: Complete Response Letter Was Unexpected
COMPLETE RESPONSE LETTER WAS UNEXPECTED Ascelia Pharma was expecting an approval of Orviglance based on the NDA submission, regulatory interactions including prior meetings and outcome of audits The type A meeting on Sep 9, 2026 will provide an opportunity to understand the FDA decision and define t
Slide 10: Summary of FDA's Concerns in the Complete Response Letter
SUMMARY OF FDA’S CONCERNS IN THE COMPLETE RESPONSE LETTER Complete Response Letter issues: Clinical/Statistical • Justification of the re-read of images • Introduction of new bias in the training of new readers • The ability of the re-read to demonstrate added clinical utility versus standard of car
Slide 11: Ascelia Pharma Position
ASCELIA PHARMA POSITION Complete Response Letter issues: Ascelia Pharma position: Clinical/Statistical Clinical/Statistical • Justification of the re-read of images • Significant systematic biasa in lesion visualization • Introduction of new bias in the training of new scoring materially affected th
Slide 12: Path to Approval Focused on Interpretation of Clinical Imaging Data
PATH TO APPROVAL FOCUSED ON INTERPRETATION OF CLINICAL IMAGING DATA FDA inspections were completed without critical findings for the NDA Product quality issues have been addressed through alignment with FDA recommendations The remaining discussion is centered on the interpretation of the clinical im
Slide 13: Orviglance Milestones Ahead
ORVIGLANCE MILESTONES AHEAD US Regulatory path ahead Partnering Type A meeting with the FDA on Sep 9, 2026 Interest from potential partners has remained intact following Minutes expected no later than 30 days after the meeting the CRL Commercial opportunity Clarity on path to approval is Unmet
Slide 14: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 14
Slide 15: Improving Irinotecan Efficacy and Tolerability
IMPROVING IRINOTECAN EFFICACY AND TOLERABILITY Irinotecan intravenous bolus dosing irinotecan ONCORAL – irinotecan oral daily dosing High-dose IV infusion Oncoral low-dosing every 3 weeks daily tablet Serious side-effects Potential for improved efficacy limit efficacy with reduced side-effects Targe
Slide 16: Oncoral Unlocks the Potential of Low-Dose, Frequent Oral Irinotecan
ONCORAL UNLOCKS THE POTENTIAL OF LOW-DOSE, FREQUENT ORAL IRINOTECAN Conventional IV irinotecan Oncoral – Oral irinotecan Dosing regimen Established chemotherapy paradigm - High- Novel low-dose daily metronomic therapy dose intermittent therapy paradigm, enabled by proprietary novel oral drug deliver
Slide 17: Oncoral Aligned with Emerging Dose Optimization Paradigm in Oncology
ONCORAL IS ALIGNED WITH THE EMERGING DOSE OPTIMIZATION PARADIGM IN ONCOLOGY PLASMA EXPOSURE LEVELS OF SN-38 Oncoral is not simply an oral irinotecan formulation - It is a platform for optimizing how irinotecan is dosed Infrequent high-dose IV FDA's Project Optimusb reflects a paradigm shift from fin
Slide 18: Oncoral Phase 2 in Gastric Cancer
ONCORAL PHASE 2 IN GASTRIC CANCER STRONG RATIONALE FOR GASTRIC CANCER PHASE 2 STUDY OUTLINE • High unmet need and clinically demonstrated • ~100 patients with metastatic gastric cancer • Study arms: Oncoral + Lonsurf vs. Lonsurf • Potential for synergistic effect between Lonsurf and irinotecan • End
Slide 19: Multiple Opportunities Across Several Cancer Indications
MULTIPLE OPPORTUNITIES ACROSS SEVERAL CANCER INDICATIONS POTENTIAL FOR ORAL, DAILY DOSING OF IRINOTECAN3 Global 3 000 000 Annual A WELL-ESTABLISHED CHEMOTHERAPY Incidence with recognized anti-tumor effect in solid tumors 2 500 000 Lung Colorectal Current focus: Gastric cancer • Clinically demonstrat
Slide 20: Financials & Outlook
FINANCIALS & OUTLOOK 20
Slide 21: Operating Result – Low Operating Expenses
OPERATING RESULT– LOW OPERATING EXPENSES Operating loss of SEK 12 million in Q2 2026 Operating result (EBIT) (SEK million) SG&A costs R&D costs Quarterly costs lower than during 1H 2025 due to finalization of the NDA. -23.0 4.4 -15.8 -17.2 -15.3 3.0 4.4 4.2 -12.1 18.7 3.3 14.2 24.7 10.9 11.6 8.8 Q2
Slide 22: Liquidity - Cash Runway into Q2 2027
LIQUIDITY - CASH RUNWAY INTO Q2 2027 Liquid assets of SEK 38 million (30 Jun 2026) Liquid assets including marketable securities (SEK million) Directed issue raising SEK 20 million before transaction costs (Apr 2026) and cost saving initiatives extending the cash runway into Q2 2027 60 72 50 34 38 3
Slide 23: Ascelia Pharma Outlook
ASCELIA PHARMA OUTLOOK US Regulatory path ahead Type A meeting with the FDA on Sep 9, 2026 Minutes expected no later than 30 days after the meeting Partnering Interest from potential partners has remained intact following the CRL Clarity on path to approval is important for the partnering pr
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