Ascelia Pharma Ab · OMXSTO:ACE
Ascelia Pharma Ab — Q2 2025 Earnings Presentation
26 slides from Ascelia Pharma Ab's earnings presentation, Aug 22, 2025
Slide 1: Orviglance NDA Submission Approaching
ADVANCING ORPHAN ONCOLOGY Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com Orviglance® NDA Submission Approaching Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com Q2 and Half-Year Report 2025 Conference call presentation on 21 August 2025, 10:00 CEST
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 2025 Investor Conference Call
QUARTERLY REPORT Q2 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: Ascelia Pharma - Highlights
ASCELIA PHARMA - HIGHLIGHTS Pipeline ORVIGLANCE® – Registration phase ▪ First-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function ▪ FDA Orphan Drug Designation ▪ Global addressable market of USD 800 million ▪ Phase 3 study successful and clinical developme
Slide 5: Q2 2025 Progress
Q2 2025 PROGRESS Key events in Q2 2025 Study on Orviglance target patients accepted for presentation at the ISPOR 2025 conference Publication of scientific article on Orviglance in Investigative Radiology Ascelia Pharma receives gross proceeds of SEK 43 million from exercise of warrants series
Slide 6: Substantial Orviglance Value Creation Opportunities
SUBSTANTIAL ORVIGLANCE VALUE CREATION OPPORTUNITIES Advance to approval Secure partnering and commercialization readiness Timely submission and approval by the US FDA as an Focused launch for well-defined patient population with orphan drug with an optimal label for the use in the 800 MUSD annual ad
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 Clinical development completed with 9 studies and strong phase 3 results Commercial scale manufacturing Orviglance
Slide 9: 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 10: Clinical Development Completed
CLINICAL DEVELOPMENT COMPLETED Phase 3 study confirmed efficacy and safety in the target population 9 Pivotal study on visualization of focal liver lesions and safety in patients with severe kidney impairment (85 patients) Orviglance efficacy confirmed vs. gadolinium & unenhanced in re-evaluation Re
Slide 11: Advancing Orviglance Towards Approval
ADVANCING ORVIGLANCE TOWARDS APPROVAL Clinical US FDA Timely submission and approval by the US FDA as an orphan drug with an optimal label for Nonclinical use in the target population ✓ Full Clinical Study Report early Q4 2024 ✓ Conclusions from FDA meeting by Q1 CMC 2025 ▪ NDA submission by early S
Slide 12: 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 13: 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 14: 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 15: Momentum for an Alternative to Gadolinium
MOMENTUM FOR AN ALTERNATIVE TO GADOLINIUM Deposition in brain & organs concerns around safety for all patients New safety category recommended for Symptoms Associated with Gadolinium exposure (SAGE), by Am. College of Rad. (2022) Multiple-GBCA effect on body movement Water contamination scrutiny of
Slide 16: On Track for Optimal Commercialization
ON TRACK FOR OPTIMAL COMMERCIALIZATION Strategic objectives for commercialization Global commercialization through partners • Optimal balance between investment required and future revenues • Leverage established commercialization Secure launch readiness capabilities • Maximize value with global lau
Slide 17: Recognition in the Scientific Community
RECOGNITION IN THE SCIENTIFIC COMMUNITY Orviglance data accepted for 4 oral and 5 Publication in Investigative Radiology poster presentations at major conferences American Society of Nephrology (Kidney Week), Oct 2024 • SPARKLE primary results - oral presentation Radiological Society of North Americ
Slide 18: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 18
Slide 19: 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 20: Oncoral Phase 2 in Gastric Cancer
ONCORAL PHASE 2 IN GASTRIC CANCER STRONG RATIONALE FOR GASTRIC CANCER LONSURF AND IRINOTECAN COMBINATION • High unmet need and clinically demonstrated RANDOMIZED CONTROLLED PHASE 2 STUDY • ~100 patients with metastatic gastric cancer • Potential for synergistic effect between Lonsurf and irinotecan
Slide 21: 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 22: Financials & Outlook
FINANCIALS & OUTLOOK 22
Slide 23: Operating Result – Maintained Low Operating Expenses
OPERATING RESULT– MAINTAINED LOW OPERATING EXPENSES Operating loss of SEK 23.0 million in Q2 2025 Operating result (EBIT) (SEK million) SG&A costs Costs are at a similar level compared to R&D costs Q1 2025 with a continuous focus on NDA -21.9 -23.0 submission preparations. -20.3 -17.8 3,6 4,4 4,6 3,
Slide 24: Liquidity - Cash Runway to at Least End 2025
LIQUIDITY - CASH RUNWAY TO AT LEAST END 2025 Liquid assets of SEK 60 million (30 Jun 2025); Liquid assets including marketable securities (SEK million) Successful TO 1 warrants exercise with SEK 43 million additional financing before costs and a subscription rate of approximately 96 percent. SEK 20
Slide 25: Substantial Orviglance Value Creation Opportunities
SUBSTANTIAL ORVIGLANCE VALUE CREATION OPPORTUNITIES Advance to approval Secure partnering and commercialization readiness Timely submission and approval by the US FDA as an Focused launch for well-defined patient population with orphan drug with an optimal label for the use in the 800 MUSD annual ad
Slide 26: ascelia.com Follow Us on LinkedIn
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