Ascelia Pharma Ab · OMXSTO:ACE
Ascelia Pharma Ab — Q3 2024 Earnings Presentation
33 slides from Ascelia Pharma Ab's earnings presentation, Nov 7, 2024
Slide 1: Advancing Orphan Oncology
ADVANCING ORPHAN ONCOLOGY Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com SUCCESSFUL OUTCOME FROM RIGHTS ISSUE WITH SEK 105 MILLION EXTENDS RUNWAY UNTIL LATE 2025 Third Quarter Report 2024 Conference call presentation on 7 November 2024, 10:00 CET
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 2024 Investor Conference Call
QUARTERLY REPORT Q3 2024 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: Q3 2024 Progress
Q3 2024 PROGRESS Key events in Q3 2024 Ascelia Pharma carries out a rights issue of units of approximately SEK 105 million Notice of and bulletin from Extraordinary General Meeting on 14 August Announcement of outcome in fully subscribed SEK 105 million rights issue with runway extended to lat
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 Primary Endpoint Met Successfully Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) compared to unenhanced MRI Visualization scored significantly higher with Orviglance than without for all three r
Slide 11: Improved Visualization with Orviglance
IMPROVED VISUALIZATION WITH ORVIGLANCE Lesion Border Delineation 70% Orviglance enhanced* visualization of focal liver % of patients 60% lesions from “moderate” or “good” to “good” or 50% 40% “excellent” 30% UMRI 20% 10% CMRI • For unenhanced images, the median BD and LC 0% scores ranged from 2.1 to
Slide 12: Demonstrated Superiority of Orviglance
DEMONSTRATED SUPERIORITY OF ORVIGLANCE Orviglance improved visualization of focal liver lesions in Favors Favors Orviglance-enhanced* images compared to unenhanced UMRI CMRI images Reader 1 (n=61) p<0.001 • For all readers, the difference between Orviglance-enhanced images* compared to unenhanced im
Slide 13: Secondary Endpoints Reinforce SPARKLE Outcomes
SECONDARY ENDPOINTS REINFORCE SPARKLE OUTCOMES Secondary efficacy endpoints supports the positive The full safety analysis confirms that, consistent with primary analysis and confirms the robustness of the previous studies, common adverse drug reactions positive results were related to the gastroint
Slide 14: 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 15: 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 pre-submission CMC meeting by Q1 2025 • NDA submis
Slide 16: 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 17: 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 18: 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 19: Unenhanced MRI Preferred Today; 84% of US Physicians Likely to Use Orviglance
UNENHANCED MRI PREFERRED TODAY; 84% OF US PHYSICIANS LIKELY TO USE ORVIGLANCE 78% of physicians prefer MRI without or … even more for patients with Likelihood of Using Orviglance with partial dose contrast for patients acute kidney injury (AKI) for Target Patients with chronic kidney disease (CKD) 8
Slide 20: 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) Water contamination Multiple-GBCA effect on body movement scrutiny of
Slide 21: 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 22: SPARKLE Data Accepted at Major Conferences
SPARKLE DATA ACCEPTED AT MAJOR CONFERENCES 22
Slide 23: Reimagine imaging for people with poor kidney function
Reimagine imaging for people with poor kidney function. 23
Slide 24: Portfolio
ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy PORTFOLIO 24
Slide 25: 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 26: 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 27: 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 28: Financials & Outlook
FINANCIALS & OUTLOOK 28
Slide 29: Fully Subscribed Rights Issue of SEK 105 Million
FULLY SUBSCRIBED RIGHTS ISSUE OF SEK 105 MILLION Fully subscribed Rights Issue Use of proceeds • Fully subscribed financing of SEK 105 million • NDA submission to FDA • No guarantee commitments executed; ✓Phase 3 full Clinical Study Report, Q4 2024 guarantors compensated in cash • Conclusions from F
Slide 30: Operating Result - Maintained Low Operating Expenses
OPERATING RESULT– MAINTAINED LOW OPERATING EXPENSES Operating result (EBIT) (SEK million) SG&A costs Operating loss of SEK 17.8 million in Q3 2024 R&D costs Increased loss (costs) compared to Q2 2024 driven by NDA preparations -21.4 -16.7 -17.8 7,4 3,6 5,9 -11.3 -11.1 4,6 3,9 14 14,2 24.7 10,8 6,5 7
Slide 31: Liquidity - Cash Runway Extended to Late 2025
LIQUIDITY - CASH RUNWAY EXTENDED TO LATE 2025 Liquid assets including marketable securities (SEK million) Liquid assets of SEK 96 million (30 Sep 2024), including fully subscribed Rights Issue of SEK 105 million before costs 96 Runway to late 2025; well beyond NDA submission 39 27 30 22 30 Sep 31 De
Slide 32: 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 USD 800 million an
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