Slide 1: Orviglance NDA Submitted to the FDA
ADVANCING ORPHAN ONCOLOGY Orviglance® NDA Submitted to the FDA Q3 Report 2025 Ticker symbol: ACE Nasdaq Stockholm Conference call presentation on 5 Nov 2025, 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 Q3 2025 Investor Conference Call
QUARTERLY REPORT Q3 2025 INVESTOR CONFERENCE CALL Agenda Recent key events Portfolio Financials and priorities ahead Presenters CEO - Magnus Corfitzen Deputy CEO - Julie Waras Brogren CSO – Andreas Norlin 3
Slide 4: At Ascelia Pharma, 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 Ongoing ▪ First-in-class contrast agent for use in liver MRI in NDA patients with severely impaired kidney function Completed submitted
Slide 6: Q3 2025 Progress
Q3 2025 PROGRESS Key events in Q3 2025 New Drug Application (NDA) for Orviglance submitted to the US Food and Drug Administration (FDA) Directed share issue of approximately SEK 30 million completed Fenja Capital II A/S converted all outstanding convertibles of SEK 7.5 Million Updated timeli
Slide 7: Substantial Orviglance Value Creation Opportunities
SUBSTANTIAL ORVIGLANCE VALUE CREATION OPPORTUNITIES Advance Orviglance to approval Secure partnering and commercialization readiness Timely approval by the US FDA as an orphan drug for the Focused launch for well-defined patient population with use in liver MRI for patients with severe renal impairm
Slide 8: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 8
Slide 9: 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 NDA submit
Slide 10: Orviglance – Filling an Unmet Need in Liver MRI
ORVIGLANCE – FILLING AN UNMET NEED IN LIVER MRI Patient Landscape Treatments Unmet Need Liver metastases are Contrast enhanced MRI A role for ORVIGLANCE critical in cancer care is the gold standard in patients with severe kidney impairment Patients with healthy kidneys ▪ Receive MRI with gadolinium-
Slide 11: Addressable Market of USD 800 Million Annually
ADDRESSABLE MARKET OF USD 800 MILLION ANNUALLY Japan Global addressable market of USD 800 million, Europe half of this in the US Focused launch for well-defined patient population in liver US imaging in cancer patients with severe kidney impairment Rest of Global commercialization through partners w
Slide 12: Attractive US Opportunity
ATTRACTIVE US OPPORTUNITY Abdominal imaging procedures in cancer patients ~100,000 with severe kidney impairment based on epidemiology and real-world data1 procedures annually Around 400 healthcare provider accounts serve ~400 accounts 75% of kidney impaired patients4 Pricing range benchmarks based
Slide 13: Unmet Need Recognized in Clinical Practice
UNMET NEED RECOGNIZED IN CLINICAL PRACTICE “Those of us who have seen NSF are frightened by it... you’ll get buy-in from a lot of nephrologists…”. - Head of Renal section at US university hospital NSF* risk (from Ascelia Pharma Advisory Board meeting) with warnings for target population +90% +16% of
Slide 14: Momentum for Change Also Beyond Renal Impairment
MOMENTUM FOR CHANGE ALSO BEYOND RENAL IMPAIRMENT Current challenges with gadolinium use A future with less gadolinium Black-box warning Risk of potentially fatal side effects of gadolinium, Manganese for use in renally impaired patients incl. nephrogenic systemic fibrosis, in patients with Orviglanc
Slide 15: Optimal Commercialization Through Partners
OPTIMAL COMMERCIALIZATION THROUGH PARTNERS Partner led commercialization Attractive partner opportunity Maximizes overall value of De-risked asset in registration phase Orviglance by leveraging established capabilities Unmet need with high value for payers – high value per patient Optimizes capital
Slide 16: Reimagine imaging for people with poor kidney function
Reimagine imaging for people with poor kidney Orviglance data accepted for function 4 oral and 5 poster presentations at major conferences since Phase 3 16
Slide 17: Orviglance NDA Submitted to the FDA
ORVIGLANCE NDA SUBMITTED TO THE FDA Obtain approval for Orviglance NDA submitted 3 September 2025 as a liver MRI contrast agent for ▪ Attractive benefit-risk profile patients with severe kidney ▪ Established commercial-scale manufacturing impairment or when gadolinium may be otherwise medically inad
Slide 18: NDA Supported by Robust Clinical Program
NDA SUPPORTED BY ROBUST CLINICAL PROGRAM Superior efficacy compared to unenhanced imaging 9 • Superior visualization of focal liver lesions • More lesions detected, in particular small lesions (< 1cm) • Consistent improvement of visualization across main patient groups • Efficacy further supported b
Slide 19: Superiority of Orviglance Demonstrated in Phase 3
SUPERIORITY OF ORVIGLANCE DEMONSTRATED IN PHASE 3 Improved visualization of focal liver lesions with Orviglance Without Orviglance (T1, Pre-contrast) With Orviglance (T1, post-contrast) Favors unenhanced Favors Orviglance Reader 1 Improved (n=61) visualization p<0.001 Improved visualization Reader 2
Slide 20: Orviglance Progresses Towards US Approval in 2026
ORVIGLANCE PROGRESSES TOWARDS US APPROVAL IN 2026 Objective: Timely approval by the US FDA as an orphan drug for the use in liver MRI for patients with severe renal impairment or when gadolinium may otherwise be medically inadvisable Milestones: 3 Sept 2025: NDA submission (review ongoing) November
Slide 21: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 21
Slide 22: 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 Tumor
Slide 23: Encouraging Safety Profile in Phase 1
ENCOURAGING SAFETY PROFILE IN PHASE 1 PLASMA LEVELS OF IRINOTECAN Frequent (metronomic) low-dose irinotecan • Several studies show potential for improved efficacy Infrequent high-dose IV and tolerability2-5 • Gastrointestinal and • Daily dosing – adjust quickly if acute toxicity SN-38 concentration
Slide 24: 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 25: High Value Opportunity in Gastric Cancer and Expansion
HIGH VALUE OPPORTUNITY IN GASTRIC CANCER AND EXPANSION 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 demonstrated
Slide 26: Financials & Outlook
FINANCIALS & OUTLOOK 26
Slide 27: Operating Result – Maintained Low Operating Expenses
OPERATING RESULT– MAINTAINED LOW OPERATING EXPENSES Operating loss of SEK 15 million in Q3 2025 Operating result (EBIT) (SEK million) SG&A costs Costs lower than Q2 due to finalization of R&D costs the NDA. -23.0 -21.9 -20.3 -17.8 3,6 4,4 4,6 -15.3 3,6 4,4 18,3 18,7 14,2 15,7 24.7 10,9 Q3 2024 Q4 20
Slide 28: Liquidity - Cash Runway into Q4 2026
LIQUIDITY - CASH RUNWAY INTO Q4 2026 Liquid assets of SEK 72 million (30 Sept 2025) Liquid assets including marketable securities (SEK million) Clean balance sheet following Fenja conversion of all outstanding convertibles of SEK 7.5 million (2 Sept 2025). 96 Directed issue raising SEK 30 million be
Slide 29: Substantial Orviglance Value Creation Opportunities
SUBSTANTIAL ORVIGLANCE VALUE CREATION OPPORTUNITIES Advance Orviglance to approval Secure partnering and commercialization readiness Timely approval by the US FDA as an orphan drug for the Focused launch for well-defined patient population with use in liver MRI for patients with severe renal impairm
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