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ADVANCING ORPHAN ONCOLOGY Ticker symbol: ACE Nasdaq Stockholm www.ascelia.com Focus on the Path Forward for Orviglance® Conference call presentation on 20 August 2026, 10:00 CEST
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2 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 Ascelia Pharma AB (publ) (hereinafter, together with its subsidiaries, the “Company”) is furnished to you solely for your information and may not be reproduced or redistributed, in whole or in part, to any other person without the prior written consent of the Company. You should not rely upon it or use it to form the definitive basis for any decision, contract, commitment or action whatsoever, with respect to any transaction or otherwise. The information included in this Presentation may contain certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words “believes”, “expects”, “predicts”, “intends”, “projects”, “plans”, “estimates”, “aims”, “foresees”, “anticipates”, “targets”, and similar expressions. The forward-looking statements contained in this Presentation, including assumptions, opinions and views of the Company or cited from third party sources are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. Neither the Company nor any of its affiliates, directors, employees or advisors provides any assurance that the assumptions underlying such forward-looking statements are free from errors nor do any of them accept any responsibility for the future accuracy of the opinions expressed in this Presentation or the actual occurrence of the forecasted developments. This Presentation speaks as of the applicable reporting date, and there may have been changes in matters which affect the Company subsequent to the date of this Presentation. Neither the issue nor delivery of this Presentation shall under any circumstance create any implication that the information contained herein is correct as of any time subsequent to the date hereof or that the affairs of the Company have not since changed, and the Company does not intend, and does not assume any obligation, to update or correct any information included in this Presentation. Each person should make their own independent assessment of the merits of the Company and should consult their own professional advisors. By receiving this Presentation, you acknowledge that you will be solely responsible for your own assessment of the market and the market position of the Company and that you will conduct your own analysis and be solely responsible for forming your own opinion of the potential future performance of the Company’s business.
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3 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
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4 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)
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ADVANCED ORPHAN ONCOLOGY PIPELINE 5 Drug candidate Indication Phase 1 Phase 2 Phase 3 Registration Market ORVIGLANCE Improved detection and visualization of focal liver lesions 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 Completed Type A meeting Sep 9, 2026 ONCORAL Improved efficacy and safety of solid tumor treatment Daily, oral irinotecan chemotherapy Clinical collaboration with Taiho Oncology Opportunity in gastric cancer and other solid tumors Completed Ready
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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 Radiology (ESGAR) Ascelia Pharma Expands Orviglance IP Portfolio with new patent filing Key events after the period Ascelia provides Orviglance update after Complete Response Letter Ascelia announces Organizational changes and cost reductions Type A meeting with FDA scheduled for Sep 9, 2026 6 Q2 2026 PROGRESS
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ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy 7 PORTFOLIO
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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 8 FDA Type A meeting scheduled for Sep 9, 2026 ATTRACTIVE ORVIGLANCE OPPORTUNITY Commercialization with partner
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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 the path forward to bring Orviglance to patients Ascelia Pharma remains confident that the Orviglance NDA is supported by substantial evidence demonstrating the efficacy and safety of Orviglance in its intended patient population, and believes the totality of the clinical, safety, and imaging data generated across the development program supports approval 9
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SUMMARY OF FDA’S CONCERNS IN THE COMPLETE RESPONSE LETTER 10 Product quality • Issues related to specifications of drug product 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 care based (use of T1-WI only for visualization scoring) Product quality • Issues related to specifications of drug product
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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 care based (use of T1-WI only for visualization scoring) Ascelia Pharma position: Clinical/Statistical • Significant systematic biasa in lesion visualization scoring materially affected the reliability of the primary results, supporting the need for a re-read of the images • Training of new readers was appropriate • Orviglance is a T1-enhancing agent and therefore evaluating T1 images is appropriate for evaluating efficacy ASCELIA PHARMA POSITION 11a 2 out of the 3 readers evaluating the images showed a systematic shift in the scoring over time, The magnitude of this error was larger than the anticipated mean effect, which prevent reliable interpretation of data. Product quality • Issues related to specifications of drug product Product quality • Ascelia Pharma has aligned with FDA recommendations and implemented the actions requested by the FDA
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PATH TO APPROVAL FOCUSED ON INTERPRETATION OF CLINICAL IMAGING DATA FDA inspections were completed without critical findings for the NDA 12 Product quality issues have been addressed through alignment with FDA recommendations The remaining discussion is centered on the interpretation of the clinical imaging data The upcoming Type A meeting provides an opportunity to align with FDA on the path forward for Orviglance Ascelia continues to believe that the totality of the efficacy, safety, and imaging data supports approval
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ORVIGLANCE MILESTONES AHEAD 13 Partnering Interest from potential partners has remained intact following the CRL Clarity on path to approval is important for the partnering process US Regulatory path ahead Type A meeting with the FDA on Sep 9, 2026 Minutes expected no later than 30 days after the meeting Exclusivity and IP Orphan Drug Designation provides 7 years exclusivity Food effect and manufacturing patents filed in 2022, 2025 and 2026 to extend exclusivity Commercial opportunity Unmet medical need and global addressable market of $800m Market in the US represents almost half of global market
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14 PORTFOLIO ORVIGLANCE® Liver diagnostic imaging drug ONCORAL Daily, oral chemotherapy
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15 irinotecan Oncoral low-dosing daily tablet Serious side-effects limit efficacy Potential for improved efficacy with reduced side-effects High-dose IV infusion every 3 weeks Targeting tumor cells Targeting tumor cells and other cells in the tumor micro-environment IMPROVING IRINOTECAN EFFICACY AND TOLERABILITY Irinotecan intravenous bolus dosing ONCORAL – irinotecan oral daily dosing
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ONCORAL UNLOCKS THE POTENTIAL OF LOW-DOSE, FREQUENT ORAL IRINOTECAN Conventional IV irinotecan Oncoral – Oral irinotecan Dosing regimen Established chemotherapy paradigm - High- dose intermittent therapy Novel low-dose daily metronomic therapy paradigm, enabled by proprietary novel oral drug delivery technologya Drug exposure profile Exposure characterized by peak concentrations Designed for sustained drug exposure Primary treatment mechanism Direct cytotoxic effect on tumor cells Direct cytotoxic effect on tumor cells and potential added value through anti-angiogenic effectsb,c,d, immune-modulatione,f, and remodeling of the tumor micro-environmentg, which are distinct from direct tumor-cell cytotoxicity Safety and tolerability Safety often limiting to treatment effect Potential for improved tolerability and safety Treatment burden Requires IV administration and clinic visits Convenient oral administration, suitable for home administration 16 a Kümler et al. Cancer Chemother Pharmacol, 83:169-178, 2019. b Browder et al., Cancer Res 60:1878, 2000, c Kerbel & Kamen. Nature Rev Cancer 4:423, 2004, d Bocci et al., Br J Cancer 98:1619, 2008, e Ghiringhelli et al., Cancer Immunol Immunother 56: 641, 2007, f Peerebom et al., JCI Insight 4:1, 2019, g Chan et al., J Exp Med 213:2967, 2016, h Kümler et al., Cancer Chemother Pharmacol, 84:441, 2019
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Metronomic dose (Oncoral) Infrequent high-dose IV • Gastrointestinal and hematological side effects • ~30% severe or life- threatening (grade 3 or 4) a ONCORAL IS ALIGNED WITH THE EMERGING DOSE OPTIMIZATION PARADIGM IN ONCOLOGY 17 PLASMA EXPOSURE LEVELS OF SN-38 a Camptosar prescribing information, b https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus, c Kümler et al., Cancer Chemother Pharmacol 83:169, 2019 Oncoral is not simply an oral irinotecan formulation - It is a platform for optimizing how irinotecan is dosed FDA's Project Optimusb reflects a paradigm shift from finding the highest tolerable dose to identifying the optimal biological dose in oncology drug development. Oncoral's daily oral dosing design is inherently suited to this paradigm, creating opportunities to maintain efficacy while reducing treatment burden and improving tolerability Oncoral Phase 1 resultsc • Well tolerated, no unexpected side-effects • Hematological toxicities mild-moderate (grade 1 or 2) • 36% of patients with stable disease, in patients previously treated with IV irinotecan • Pharmacokinetic profile suitable for daily dosing SN-38 concentration (ng/mL) Time (days) Source: Simulation of Oncoral vs. IV Camptosar. Illustration of the principal differences in drug exposure for classical intravenous Maximum Tolerated Dose (MTD) dosing and metronomic dosing. Classical MTD dosing is characterized by high exposure peaks that may drive dose-limiting toxicity and treatment interruptions. Metronomic dosing aims to maintain biologically active drug levels over time, potentially optimizing the balance between efficacy, safety, and long-term treatment adherence.
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ONCORAL PHASE 2 IN GASTRIC CANCER 18 STRONG RATIONALE FOR GASTRIC CANCER • High unmet need and clinically demonstrated • Potential for synergistic effect between Lonsurf and irinotecan Control arm Lonsurf (TAS-102) IV irinotecan (CPT-11) Lonsurf + IV irinotecan Efficacy study in an animal model of gastric cancer1 (Relative Tumor Volume, RTV) 1) Nukatsuka et al, Anticancer Res 35:1437, 2015 PHASE 2 STUDY OUTLINE Clinical collaboration with LONSURF is approved for treatment of metastatic gastric cancer and metastatic colorectal cancer • ~100 patients with metastatic gastric cancer • Study arms: Oncoral + Lonsurf vs. Lonsurf • Endpoints: Progression Free Survival (Primary), Response Rate, PK, Safety (Secondary) and Overall Survival (follow-up) • IND approved in the US
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MULTIPLE OPPORTUNITIES ACROSS SEVERAL CANCER INDICATIONS 19 1) International Agency for Research on Cancer (IARC, 2021) 2) GlobalData - Gastric and Gastroesophageal Junction Adenocarcinoma – Global Drug Forecast and Market Analysis to 2024 3) Globocan 2020, WHO, Cancer Research UK • Clinically demonstrated • Guidelines recognized • 3rd highest cancer deaths1 • Orphan disease (US and EU) • $3-4bn market2 Colorectal Pancreatic Gastric Lung Esophagus Cervical Ovarian Liver NHL LeukemiaKidney - 500 000 1 000 000 1 500 000 2 000 000 2 500 000 3 000 000 0% 20% 40% 60% 80% 100% Indications where IV irinotecan are clinically demonstrated & guidelines recognized Indications where IV irinotecan are clinically demonstrated Approved indications for IV irinotecan Current focus: Gastric cancer POTENTIAL FOR ORAL, DAILY DOSING OF IRINOTECAN3 Global Annual Incidence Median 5-year Survival Rate A WELL-ESTABLISHED CHEMOTHERAPY with recognized anti-tumor effect in solid tumors
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20 FINANCIALS & OUTLOOK
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18.7 10.9 11.6 14.2 8.8 4.4 4.4 4.2 3.0 3.3 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 -23.0 -15.3 -15.8 -17.2 -12.1 Operating loss of SEK 12 million in Q2 2026 Quarterly costs lower than during 1H 2025 due to finalization of the NDA. Operating result (EBIT) (SEK million) Notes: Other operating income and other operating costs added to SG&A 24.7 SG&A costs R&D costs OPERATING RESULT– LOW OPERATING EXPENSES 21
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60 72 50 34 38 Liquid assets including marketable securities (SEK million) Liquid assets of SEK 38 million (30 Jun 2026) Directed issue raising SEK 20 million before transaction costs (Apr 2026) and cost saving initiatives extending the cash runway into Q2 2027 22 LIQUIDITY - CASH RUNWAY INTO Q2 2027 30 Jun 2025 30 Sep 2025 31 Dec 2025 31 Mar 2026 30 Jun 2026
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23 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 Financial outlook Cost reduction initiatives implemented Cash runway into Q2 2027 Partnering Interest from potential partners has remained intact following the CRL Clarity on path to approval is important for the partnering process
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