Ascelia Pharma Ab · OMXSTO:ACE
Ascelia Pharma Ab — Q4 2025 Earnings Presentation
23 slides from Ascelia Pharma Ab's earnings presentation, Feb 5, 2026
Slide 1: Full Year and Q4 Report 2025
Advancing Orphan Oncology Full Year and Q4 Report 2025 January – December 2025 FDA Accepts Orviglance® NDA for Review “ FDA's acceptance of the Orviglance NDA for review represents yet another significant step towards making Orviglance KEY EVENTS IN Q4 2025 available to patients. We look forward to
Slide 2: CEO Statement
Corporate overview CEO STATEMENT Following the Orviglance New Drug Application (NDA) submission in September 2025, we continued to make solid progress in Q4. In November, we received the US Food and Drug Administration (FDA) Day 74 letter, which formally accepted our NDA for review, aiming for a dec
Slide 3: Recognition in the scientific community
Corporate overview Recognition in the scientific community. We are pleased to see Orviglance is an attractive commercial opportunity for a partner. ”We have a cash runway into Q4 2026, the acceptances of Orviglance data for presentation at major We continue to advance the dialogues with potential co
Slide 4: Advancing Orphan Oncology
Corporate overview ADVANCING ORPHAN ONCOLOGY OUR VALUES OUR VISION OUR BASE FOCUS To be a leader in identifying, developing and Our headquarter is in Malmö, Sweden, We are devoted to improving the lives of patients commercializing novel drugs that address unmet and our US base is in New Jersey. and
Slide 5: Our Pipeline
Our pipeline products OUR PIPELINE ORVIGLANCE ONCORAL Diagnostic drug for liver MRI in registration phase Daily tablet chemotherapy ready for Phase 2 Orviglance is our first-in-class non-gadolinium diagnostic drug (contrast agent) to be used for Oncoral is our novel oral irinotecan chemotherapy tabl
Slide 6: Orviglance Addresses Unmet Need for Liver MRI in Patients With Kidney Impairment
Our pipeline products / ORVIGLANCE® ORVIGLANCE ADDRESSES UNMET NEED FOR LIVER MRI IN PATIENTS WITH KIDNEY IMPAIRMENT Orviglance aims to be the standard of care liver MRI contrast agent for patients also suffering from severe kidney impairment. These patients are at risk of severe side-effects from u
Slide 7: Orviglance Clinical Development Completed
Our pipeline products / ORVIGLANCE® ORVIGLANCE CLINICAL DEVELOPMENT COMPLETED Orphan liver MRI contrast agent in registration phase How Orviglance works Advanced to registration phase Orviglance is an orally administrated contrast agent developed for use with MRI of the liver. It is The NDA for Orvi
Slide 8: Phase 3 Successfully Completed
Our pipeline products / ORVIGLANCE® PHASE 3 SUCCESSFULLY COMPLETED Phase 3 primary endpoint met Designed to support regulatory approval Following an unacceptably high intra-reader variability in the The pivotal Phase 3 study, SPARKLE, successfully met the pri- The pivotal Phase 3 study (SPARKLE) is
Slide 9: Annual Addressable Market of USD 800 Million
Our pipeline products / ORVIGLANCE® ANNUAL ADDRESSABLE MARKET OF USD 800 MILLION Clear and attractive addressable market Unique opportunity to address an unmet need Partnering strategy Orviglance addresses a well-defined unmet medical Orviglance addresses an attractive market opportunity by offer- T
Slide 10: Oncoral Potential With Daily Dosing
Our pipeline products / ONCORAL ONCORAL POTENTIAL WITH DAILY DOSING Oncoral is a novel daily irinotecan chemotherapy in development. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily irinotecan tablet with the potential to offer better efficacy with improved saf
Slide 11: Phase 2 Study Design and Collaboration
Our pipeline products / ONCORAL PHASE 2 STUDY DESIGN AND COLLABORATION Phase 2 study design Clinical collaboration with Taiho Oncology Q Clinical Phase 2 collaboration with Taiho Oncology Inc. (part of Otsuka Group) Q Taiho Oncology Inc. will supply Lonsurf and provide scientific expertise Q The col
Slide 12: Financial Overview Q4 (Oct-Dec 2025)
Financial overview FINANCIAL OVERVIEW Q4 (OCT-DEC 2025) EARNINGS AND PROFITABILITY CASH FLOW AND FINANCIAL POSITION Cash flow from operating activities before changes in working capital amounted to SEK -13.8 Net sales and other operating income million (SEK -21.3 million). Changes in working capital
Slide 13: Financial Overview Full Year (Jan-Dec 2025)
Financial overview FINANCIAL OVERVIEW FULL YEAR (JAN-DEC 2025) EARNINGS AND PROFITABILITY CASH FLOW Cash flow from operating activities before changes in working approximately 96 percent. Ascelia Pharma received net pro- Net sales and other operating income capital amounted to SEK -70.2 million (SEK
Slide 14: Other Information
Other information OTHER INFORMATION Incentive programs Risks and uncertainties Significant events after the end of the reporting period Ascelia Pharma has has one outstanding employee option pro- Ascelia Pharma is exposed to a range of operational risks and un- On 21 January, Ascelia Pharma announce
Slide 15: Consolidated Income Statement
Financial information / Group Consolidated Income Statement Q4 (Oct-Dec) Full Year (Jan-Dec) SEK in thousands (unless otherwise stated)* 2025 2024 2025 2024 Net sales – – – – Gross profit/loss – – – – Administrative costs -4,117 -3,682 -17,314 -17,995 Research and development costs -11,611 -18,328 -
Slide 16: Consolidated Balance Sheet
Financial information / Group Consolidated Balance Sheet 31 Dec 31 Dec SEK in thousands* 2025 2024 ASSETS Non-current assets Intangible assets 57,070 57,078 Tangible assets - Equipment 52 15 Right-of-use assets 885 109 Total non-current assets 58,007 57,202 Current assets Advance payments to supplie
Slide 17: Consolidated Statements of Changes in Equity
Financial information / Group Consolidated Statements of Changes in Equity Full Year (Jan-Dec) SEK in thousands* 2025 2024 Equity at start of the period 78,944 74,328 Comprehensive income Profit/loss for the period -76,253 -80,029 Other comprehensive income 134 303 Total comprehensive income -76,119
Slide 18: Consolidated Cash Flow Statement
Financial information / Group Consolidated Cash Flow Statement Q4 (Oct-Dec) Full Year (Jan-Dec) SEK in thousands* 2025 2024 2025 2024 Operating activities Operating result -15,779 -21,929 -74,374 -67,766 Expensed share based remuneration not included in cash flow 1,000 51 4,164 4,340 Adjustment for
Slide 19: Parent Company – Income Statement
Financial information / Parent Parent Company – Income Statement Q4 (Oct-Dec) Full Year (Jan-Dec) SEK in thousands* 2025 2024 2025 2024 Net sales 250 55 482 214 Gross profit/loss 250 55 482 214 Administrative costs -4,061 -3,640 -17,135 -17,825 Research and development costs -11,539 -18,260 -55,112
Slide 20: Parent Company – Balance Sheet
Financial information / Parent Parent Company – Balance Sheet 31 Dec 31 Dec SEK in thousands* 2025 2024 ASSETS Non-current assets Tangible assets Equipment 52 15 Financial assets Shares in affiliated companies 58,068 58,068 Other long-term receivables from group companies 39,187 39,255 Total non-cur
Slide 21: Notes
Financial information / Notes Notes General information the management in order to assess the financial development of the largest impact on the value of the options, is the publicly This interim report for the Group has been prepared accord- the company. These financial key performance measures sho
Slide 22: Notes
Financial information / Notes Notes Definitions of alternative performance measures Alternative performance measures Definition Aim Operating results (TSEK) Profit before financial items and tax. The performance measure shows the company´s operational performance. Research and development costs/Oper
Slide 23: Financial Calendar Contact
Financial calendar Annual General Meeting 2026: 4 May 2026 Interim report Q1 2026 (Jan-Mar): 12 May 2026 Half-year report 2026 (Jan-Jun): 20 August 2026 Interim report 9M 2026 (Jan-Sep): 5 November 2026 Full-year report 2026 (Jan-Dec): 11 February 2027 Contact Magnus Corfitzen, CEO moc@ascelia.com |