Ascelia Pharma Ab · OMXSTO:ACE
Ascelia Pharma Ab — Q1 2025 Earnings Presentation
29 slides from Ascelia Pharma Ab's earnings presentation, May 16, 2025
Slide 1: Advancing Orphan Oncology
ADVANCING ORPHAN ONCOLOGY Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com Positive Outcome of Orviglance® FDA Meeting in Advance of the NDA Submission Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com First Quarter Report 2025 Conference call presentation on 16 May 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 Q1 2025 Investor Conference Call
QUARTERLY REPORT Q1 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: Q1 2025 Progress
Q1 2025 PROGRESS Key events in Q1 2025 Three scientific abstracts with SPARKLE Phase 3 data accepted for presentation at the ESGAR congress 2025 Extraordinary General Meeting on 25 February 2025 to adopt an employee stock option proposal Nomination Committee appointed for AGM 2025 in Ascelia P
Slide 6: 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 7: 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 8: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 8
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: Strong Superiority of Orviglance in Phase 3
STRONG SUPERIORITY OF ORVIGLANCE IN PHASE 3 Successful Phase 3 Study Favors unenhanced Favors Orviglance enhanced Phase 3 study demonstrated strong superiority in visualization Reader 1 of focal liver lesions with Orviglance (CMRI) compared to (n=61) unenhanced MRI p<0.001 Visualization scored signi
Slide 11: Clinical Development Completed
CLINICAL DEVELOPMENT COMPLETED Phase 1 studies demonstrated safety, absorption and signal intensity 9 Total 4 studies with 126 healthy volunteers Phase 2 studies demonstrated efficacy and safety in patients with known metastases Total 4 studies with 75 patients Nine studies with consistent positive
Slide 12: Positive FDA Meeting Confirms Path for NDA Filing
POSITIVE FDA MEETING CONFIRMS PATH FOR NDA FILING FDA meeting in advance of the NDA submission Ascelia presented the plan for the submission including: • How to analyze and present the clinical data • Finalization of Statistical Analysis Plan • Manufacturing documentation • Structure of the NDA The
Slide 13: 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 mid-2025 1
Slide 14: 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 15: 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 16: 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 17: 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 18: 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 19: Recognition in the Scientific Community
RECOGNITION IN THE SCIENTIFIC COMMUNITY Orviglance data accepted at major conferences so far with 4 oral presentations and 4 abstract presentations Radiological Society of North America (RSNA), Annual Meeting, December 2024 19
Slide 20: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 20
Slide 21: 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 22: 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 23: 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 24: Financials & Outlook
FINANCIALS & OUTLOOK 24
Slide 25: Successful Warrants Exercise Bring SEK 43 Million
SUCCESSFUL WARRANTS EXERCISE BRING 43 SEK MILLION Successful TO 1 warrants exercise • SEK 43 million additional financing before costs • Subscription rate of approximately 96 percent Cash runway to at least end 2025, well beyond the NDA submission • Includes repayment of the SEK 20 million loan to F
Slide 26: Operating Result – Maintained Low Operating Expenses
OPERATING RESULT– MAINTAINED LOW OPERATING EXPENSES Operating loss of SEK 20.3 million in Q1 2025 Operating result (EBIT) (SEK million) SG&A costs Costs are at a similar level compared to Q4 R&D costs 2024 with a continuous focus on NDA -21.9 submission preparations. -20.3 -17.8 3,6 -16.7 4,6 3,6 5,
Slide 27: Liquidity - Cash Runway to at Least End 2025
LIQUIDITY - CASH RUNWAY TO AT LEAST END 2025 Liquid assets including marketable securities (SEK million) Liquid assets of SEK 57 million (31 Mar 2025); excluding SEK 43 million gross proceeds from TO 1 warrants in April 2025. Cash runway now reaches at least end 2025; 96 75 with reserve for potentia
Slide 28: 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
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