Interim report
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Interim Report Q3 2025 January – September 2025 KEY RATIOS GROUP Submitting the Orviglance NDA to the FDA is a major achievement for us. We now look forward to advancing Orviglance through the FDA review process.” “ Advancing Orphan Oncology Orviglance® NDA Submitted to the FDA KEY EVENTS IN Q3 2025 New Drug Application (NDA) for Orviglance submitted to the US Food and Drug Administration (FDA) Directed share issue of approximately SEK 30 million completed Fenja Capital II A/S converted all outstanding convertibles of SEK 7.5 million Updated timeline for submission of the Orviglance NDA to take place early September 2025 Management changes to support future growth KEY EVENTS AFTER THE PERIOD Q3 (Jul-Sep) 9M (Jan-Sep) 2025 2024 2025 2024 OPERATING RESULT (SEKm) -15.3 -17.8 -58.6 -45.8 EARNINGS PER SHARE (SEK) -0.13 -0.42 -0.55 -1.30 CASH FLOW FROM OPERATIONS (SEKm) -15.7 -17.0 -50.6 -44.1 LIQUID ASSETS (SEKm) 72.3 95.7 72.3 95.7
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 2 Corporate overview Orviglance NDA submitted. The NDA for Orviglance has been submitted to the FDA. Ascelia Pharma seeks marketing approval for Orviglance as liver magnetic resonance imaging (MRI) con - trast agent for patients with severe kidney impairment. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the gadolinium-based contrast agents normally used today. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population and Orviglance has been granted an Orphan Drug Designation by the FDA. The standard FDA review timeline of the NDA file is 10 months. Mid November, 74 days after submission, the FDA will share the expected date for their review completion, i.e. the PDUFA date. Completion of Orviglance clinical development. The NDA submission is based on a successfully completed development program, including nine clinical studies with consistent positive efficacy and safety results. The program includes nine clinical studies with a total of 286 patients and healthy volunteers. 85 patients with known or suspected focal liver lesions and severely impaired kidney function were included in the global multi-cen - ter pivotal Phase 3 study, SPARKLE. As announced in 2024, the SPARKLE study successfully met the primary endpoint and demonstrated that our contrast agent Orviglance, significantly improved visualization of focal liver lesions compared to unenhanced MRI. The positive results had an acceptable level of variability and high statistical significance (P values <0.001) for all three independent readers, who scored study images according to the FDA agreed methodology. Common adverse events in the vulnerable patient population were in line with previous studies, such as mild- to moderate nausea. No serious adverse drug reactions were observed. Orviglance aims to give patients with impaired kidney function access to safe and effective liver imaging and the strong results from the clinical studies reinforce our confidence in the mar - ket potential and path to market for Orviglance. We are now focused on bringing Orviglance through the FDA review pro - cess. We submitted the NDA for Orviglance to the FDA in early September. This is a major achievement for us. Our focus is now on advancing Orviglance through the FDA review to obtain marketing authorization for Orviglance as a liver MRI contrast agent for patients with severe kidney impairment. We expect a standard 10 months review timeline with the FDA. The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. In our Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance for all three readers (<0.001). This quarter, we considerably strengthened our balance sheet. In September 2025, Fenja converted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue raising SEK 30 million before costs. With this fundraise, based on the inbound interest expressed by investors, we also broaden and anchor our investor base. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance. We are excited about our continued progress with Orviglance and the ongoing FDA review process. Partnership discussions for the commercialization of Orviglance continue and we look forward realizing the potential of Orviglance and provide better access to diagnosis and care for cancer patients with impaired kidney function. CEO STATEMENT
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 3 Corporate overview Recognition in the scientific community. We are pleased to see the acceptances of Orviglance data for presentation at major scientific conferences. In total four oral presentations and five abstract presentations have been accepted since the announce - ment of our Phase 3 results, und erscoring the interest in the medical and scientific community for an alternative to gadolini - um-based contrast agents. SPARKLE results have been presented as Cutting-Edge Research at the Radiological Society of North America conference (RSNA) in November 2024. Other key conferences have also welcomed SPARKLE data, such as the American Society of Nephrology Kidney Week, Society of Abdominal Radiology (SAR), and Eu - ropean Society of Gastrointestinal and Abdominal Radiology (ESGAR). In addition, a burden of illness real-world data analysis was presented at the Professional Society for Health Economics and Outcomes Research (ISPOR) Conference. In April 2025, an article in Investigative Radiology was published featuring Orviglance in a Phase 2 comparison study to unenhanced MRI and to gadolinium. The publication presents data utilizing the same independent reader methodology and approach as used in SPARKLE. Strategy to commercialize with partners. Orviglance address - es a well-defined unmet medical need representing an annual global addressable market of USD 800 million, with 100,000 annual procedures in the target patient population in the US alone. Our commercialization strategy is to launch Orviglance with commercialization partners. This strategy enables us to leverage established commercialization capabilities of a partner with a low investment from Ascelia Pharma required for launch. A focused, ambitious launch plan, built on advanced market in - sights, is in place. ”With our directed share issue of SEK 30 million before costs, we broaden our investor base and strengthen our balance sheet. We now have a cash runway into Q4 2026”. We continue to advance the dialogues with potential commer - cialization partners to make Orviglance available to patients who need high-quality liver imaging without the safety risks associ - ated with gadolinium. Strengthened financial position. This quarter, we considerably strengthened our balance sheet. In September 2025, Fenja con - verted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue raising SEK 30 million before costs. With this fundraise, based on the inbound interest expressed by investors, we also broaden and anchor our investor base. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance. Opportunities ahead into 2026 and beyond. With the NDA submission to the FDA, we are excited to advance Orviglance through the FDA review process and to advance the partnering process for the US launch of Orviglance. We look forward to con- tinuing our journey with opportunities for growing Ascelia Pharma into 2026 and beyond. Magnus Corfitzen CEO
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 4 Corporate overview ADVANCING ORPHAN ONCOLOGY Building Ascelia Pharma and building value ■ Orviglance market leader ■ Oncoral Phase 3 ■ Pipeline development ■ Pipeline further expanded ■ Orviglance revenue ■ Oncoral Phase 2 ■ Pipeline expansion ■ Orviglance in registration phase ■ Oncoral Phase 2 ready ESTABLISHED MARKET POSITION IN ORPHAN ONCOLOGY PRODUCT LAUNCH AND EXPANDING PIPELINE ADVANCING PIPELINE AND COMMERCIAL CAPABILITIES Our headquarter is in Malmö, Sweden, and our US base is in New Jersey. The shares in the company are listed on NASDAQ Stockholm (ticker: ACE). To be a leader in identifying, developing and commercializing novel drugs that address unmet needs of people with rare cancer conditions. FOCUS We are devoted to improving the lives of patients and creating values for our stakeholders. COURAGE We work tirelessly and follow our convictions even when it means changing status quo. INTEGRITY We build powerful relationship with mutual respect and adhere to the high ethical standards of our industry. OUR VALUES OUR VISION OUR BASE
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 55 OUR PIPELINE Our pipeline products Phase 2 results Orviglance Visualization of focal liver lesions (liver metastases, primary liver cancer) Market launch Market approval Phase 2 ready Oncoral Gastric cancer treatment with expansion potential to other cancer forms ORVIGLANCE Diagnostic drug for liver MRI in registration phase Orviglance is our first-in-class non-gadolinium diagnostic drug (contrast agent) to be used for magnetic resonance imaging (MRI) of the liver. Orviglance is developed to improve the visualiza - tion of focal liver lesions (liver metastases and primary liver cancer) in patients with impaired kidney function at risk of severe side-effects from the gadolinium contrast agents currently on the market. ■ First-in-class manganese-based diagnostic drug with FDA Orphan Drug Designation ■ USD 800 million global annual addressable market ■ Clinical development completed, incl. pivotal Phase 3, with consistent positive efficacy and safety data from nine clinical studies with 286 patients and healthy volunteers ■ NDA submitted to the FDA ONCORAL Daily tablet chemotherapy ready for Phase 2 Oncoral is our novel oral irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. The potential anti-tumor effect of irinotecan is well established. ■ Oral daily dosing of irinotecan chemotherapy ■ Potential for better efficacy and safety by frequent low dosing ■ Ready for Phase 2 in gastric cancer; potential to expand into other cancers
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 6 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 using gadolinium-based contrast agents. USD 800 million global annual addressable market The target group for Orviglance is patients who need liver imaging and have severely impaired kidney function. This patient group is at risk of serious, and potentially fatal, side effects from using the currently available gadolinium based contrast agents. These contrast agents, carry black box warnings for patients with severely reduced kidney function. The completed clinical studies show that Orviglance improves the diagnostic performance of MRI and offers a significantly better alternative than unenhanced MRI (i.e., MRI without con - trast agent). Consequently, Orviglance fills a significant unmet medical need to improve the diagnosis, and subsequently, the treat- ment of liver metastases and primary liver cancer for these patients. The immediate addressable market for Orviglance is estimated at USD 800 million yearly and Orviglance is expected to be the only gadolinium-free product on the market for this patient segment. Orphan Drug Designation Orviglance has received Orphan Drug Designation from the FDA. One major advantage of orphan drug status is, among other things, that orphan drugs can obtain longer market exclusivity after regulatory approval. Early detection of liver metastases is key Orviglance is a contrast agent used in MRIs to improve the detection and visualization of focal liver lesions (liver metasta - ses and primary tumors). The liver is the second most common organ for metastasis after the lymph nodes. Detecting liver metastases at an early stage is crucial for determining the right treatment method and for the patient’s chances of survival. Studies show that the five-year survival rate can increase from 6 percent to 46 percent if liver metastases can be removed sur - gically. An accurate MR scan using contrast agents is therefore critical to evaluate the possibilityfor surgical resection, but also for monitoring of treatment effect and surveillance for recur - rence of the disease. Suspected cancer in the liver Test kidney function Liver MRI scanMRI contrast agent decision MRI with gadolinium contrast agent Q All gadolinium contrast agents have regulatory Black Box warnings Q Risk of severe and potentially fatal side-effect (NSF - Nephrogenic Systemic Fibrosis) A) Healthy kidneys B) Poor kidneys Solution MRI with ORVIGLANCE
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 7 Our pipeline products / ORVIGLANCE ® How Orviglance works Orviglance is an orally administrated contrast agent developed for use with MRI of the liver. It is based on the chemical element manganese, which is a natural trace element in the body. Orviglance also contains L-alanine and vitamin D3 to enhance the function of manganese as a contrast agent. After having been absorbed from the small intestine, the manganese is transported to the liver where it is taken up by and retained in the normal liver cells. The high manganese uptake causes the normal liver tissue to appear bright on MR images. Metastases and tumor cells do not take up manganese to the same extent as normal liver tissue and therefore appear dark on MR images. Liver metastases are easier to identify due to this contrast effect by Orviglance. Successful clinical development Clinical development of Orviglance has been completed with consistent positive efficacy and safe- ty data from nine studies with 286 patients and healthy volunteers. The pivotal Phase 3 study for Orviglance, SPARKLE successfully met the primary endpoint and demonstrated that Orviglance significantly improved visualization of focal liver lesions compared to unenhanced MRI. The pos - itive results were strong and conclusive and had both an acceptable level of variability and high statistical significance (P values <0.001) for all three readers. Common adverse events in this vul- nerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were observed. Advanced to registration phase The NDA for Orviglance has been submitted to the FDA early September 2025. To reach this milestone, the Full Clinical Study Report from SPARKLE Phase 3 was completed in Q4 2024 and a pre-NDA meeting with the FDA was held in Q1 2025. The meeting provided clear and concrete guidance from the FDA for the finalization and submission of the NDA. The standard FDA review timeline of the NDA file is 10 months. Mid November, 74 days after submission, the FDA will share the expected date for their review completion, i.e. the PDUFA date. ORVIGLANCE CLINICAL DEVELOPMENT COMPLETED Orphan liver MRI contrast agent in registration phase Improved visualization Improved visualization Improved detection Example from a patient with metastases in the SPARKLE Phase 3 study Improved visualization of focal liver lesions with Orviglance Without Orviglance (T1, Pre-contrast) With Orviglance (T1, post-contrast) Without Orviglance (T1, Pre-contrast) With Orviglance (T1, post-contrast)
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 8 Strong positive Phase 3 results ■ For unenhanced images, the median BD and LC scores ranged from 2.1 to 3.0 across readers ■ For Orviglance-enhanced images, the median BD and LC scores increased to 3.0 and 4.0 across readers ■ Increases were statistically significant (p<0.001) for all three readers The results of secondary endpoints generally support the superiority of Orviglance compared to unenhanced MRI, e.g. with at least one additional lesion detected in 40-52% of patients with Orviglance across readers. No analysis favours unenhanced MRI, including in patient sub-group analysis. Superiority vs. unenhanced was demonstrated both when unenhanced was compared to images with Orviglance combined with unenhanced and for images with Orviglance alone. Phase 3 primary endpoint met The pivotal Phase 3 study, SPARKLE, successfully met the pri - mary endpoint and demonstrated that Orviglance significantly improved the visualization of focal liver lesions compared to MRI without contrast, unenhanced MRI. The results for all three readers were highly statistically significant (P values <0.001). Common adverse events in this vulnerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were ob - served. Designed to support regulatory approval The pivotal Phase 3 study (SPARKLE) is a global multicentre study, which was completed with 85 enrolled patients with sus - pected or known focal liver lesions and severely impaired kidney function. The evaluation of the primary endpoint was carried out by three blinded, independent radiologists (readers), in accordance with regulatory guidance to the industry. The readers assessed the changes in visualization of liver lesions with and without Orviglance, as well as other secondary eff icacy endpoints. Our pipeline products / ORVIGLANCE ® PHASE 3 SUCCESSFULLY COMPLETED Following an unacceptably high intra-reader variability in the first image scoring by readers mid-2023, a new evaluation of the images with new readers was successfully completed with the announced positive headline results and acceptable variability in May 2024, in line with the planned timeline. The full Phase 3 program was designed in accordance with in - dustry standards, regulatory guidance for imaging agent devel - opment and based on discussions with regulatory agencies. The program aims to support a regulatory filing and approval for use of Orviglance for liver imaging in patients where the use of gad - olinium may be medically inadvisable. -1,5 -1 -0,5 0 0,5 1 1,5 Mean paired difference in* LBD (●) and LC (●) score (CMRI - UMRI) Favors OrviglanceFavors unenhanced Reader 1 (n=61) p<0.001 Reader 2 (n=53) p<0.001 Reader 3 (n=61) p<0.001 *Visualization assessed by 3 independent readers as the improvement of Lesion border delineation (LBD) and Lesion contrast (LC) on combined Orviglance-enhanced + unenhanced (CMRI) images compared to unenhanced (UMRI) images for all matched lesions, using a 4-point scale (from 1 (“poor”) to 4 (“excellent”)). Data presented as mean paired differences for matched lesions per patient for CMRI and UMRI with 95% Confidence Intervals. One-sided paired t-test (α=0.025).Total N=85, n=number of patients with matched lesions (per reader). -1,5 -1 -0,5 0 0,5 1 1,5 Mean paired difference in* LBD (●) and LC (●) score (CMRI - UMRI) Favors OrviglanceFavors unenhanced Reader 1 (n=61) p<0.001 Reader 2 (n=53) p<0.001 Reader 3 (n=61) p<0.001
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 9 Clear and attractive addressable market Orviglance addresses a well-defined unmet medical need representing an attractive commercial potential with an annual global addressable market of USD 800 million. This estimate is based on: ■ Patients with primary liver cancer or liver metastases and severe kidney impairment (~4 percent) ■ Actual imaging procedures (real-world data) 1 ■ Payer and expert input (+75 stakeholders) 2 ANNUAL ADDRESSABLE MARKET OF USD 800 MILLION Our pipeline products / ORVIGLANCE ® US Europe Rest of World Japan Unique opportunity to address an unmet need Orviglance addresses an attractive market opportunity by offer - ing contrast enhanced liver imaging for cancer patients with poor kidney function ■ not associated with gadolinium safety risks for patients with poor kidney function ■ addressing the increasing demand for alternatives to toxic gadolinium 90 percent of health care professionals are concerned by safety issues related to gadolinium contrast agents including NSF. In fact, according to market research, 16 percent of healthcare providers have experienced gadolinium-induced NSF 3. In the US alone real-world data shows that 100,000 abdom - inal imaging procedures are performed every year in 50,000 patients that fall under the black-box warning for gadolinium con - trast agents, which is about 4 percent of the cancer patient popu - lation undergoing abdominal imaging. “Our commercialization strategy is to launch through partners, supporting our ambition to secure the optimal balance between future revenues and investment required. Our focus is therefore to continue the ongoing dialogue with potential partners and to ensure that Orviglance is ready for launch when approved”, says Julie Waras Brogren, Deputy CEO FOCUSED, AMBITIOUS STRATEGY Ensure OPTIMAL LABEL, timely SUPPLY and launch READINESS Drive EARLY ADOPTION AND PREFERENCE by decision makers with focused efforts and a strong value proposition Partnering strategy The go-to-market strategy for Orviglance is to launch with com - mercialization partners. This approach enables Ascelia Pharma to leverage established commercialization capabilities and maintain a low investment requirement for launch. The focus of Ascelia Pharma is to create value by ensuring launch readiness and collaboration with a partner by preparing for optimal adoption by key stakeholders at launch. UNIQUE OPPORTUNITY Give people with cancer in the liver and poor kidney function ACCESS TO SAFE AND EFFECTIVE IMAGING to live healthier and longer lives CLEAR AMBITION Be the STANDARD OF CARE liver imaging choice for cancer patients with poor kidney function 1) Ascelia Pharma market research on real-world volumes with DRG (2020) 2) Market access research and analyses with Charles River Associates (2020), Triangle (2022) and Trinity (2022), incl. 75 stakeholder and expert interactions. Final pricing and access strategy subject to Phase 3 data and payer evidence 3) Ascelia Pharma market research with Two Labs including 254 US HCPs (2022).
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 10 Our pipeline products / ONCORAL TODAY – Intravenous bolus infusionsONCORAL – a novel formulation of irinotecan Oral, daily dosingIntravenous New cancer indications Approved cancer indications TOMORROW – Oncoral oral daily dosing Gastric cancer ONCORAL Colorectal cancer Pancreatic cance r Proven anti-cancer effect The active substance in Oncoral is irinotecan, which has an established and proven effect in killing cancer cells. Irinotecan is a so-called antineoplastic agent that after meta - bolic activation inhibits the enzyme topoisomerase 1, there - by inducing cancer cell death via the prevention of their DNA replica tion. Irinotecan is converted by carboxylesterases, primarily in the liver, to the active metabolite SN-38 which is 100–1,000 more potent than irinotecan in killing tumor cells. Potential to be the first oral version of irinotecan Oncoral is a new patented oral tablet formulation of irinotecan, which enables a reliable release and efficient absorption of irino- tecan from the gastro intestinal tract after oral administration. With oral administration, irinotecan can be given with low daily doses. This is very different from the current standard of giving a high intravenous doses every third week. All-oral chemo combination Oncoral has the potential to be combined with other chemo - therapies and targeted cancer drugs and enable an all oral com - bination chemotherapy option with improved clinical outcomes. 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 safety following the daily dosing at home compared to intra- venous high-dose infusions at the hospital. Potential to expand Oncoral into other solid tumor indications Infrequent high-dose IV irinotecan ■ Gastrointestinal and hematological side effects ■ Dose limiting toxicity: 30 percent severe or life- threatening (grade 3 or 4) Potential – Frequent low-dose irinotecan ■ Improved efficacy driven by pharmacokinetic profile ■ Improved tolerability due to lower peak exposure with less severe side effects and manageable toxicity with flexible dosing ONCORAL POTENTIAL WITH DAILY DOSING
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 11 Our pipeline products / ONCORAL PHASE 2 STUDY DESIGN AND COLLABORATION Phase 2 study design Oncoral + Lonsurf vs. Lonsurf COMPARATOR Q Around 100 patients Q Metastatic gastric cancerPATIENTS Primary: Progression Free Survival Secondary: Response rate, Pharmacokinetics, Safety and Overall Survival data in a follow up analysis ENDPOINTS 2 - 2½ years, study start pendingSTUDY PERIOD 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 collaboration may be extended for further development Q Ascelia Pharma retains full development and commercialization rights LONSURF® is approved for treatment of metastatic gastric cancer and metastatic colorectal cancer
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 12 EARNINGS AND PROFITABILITY Net sales and other operating income The Group’s net sales in Q3 (Jul-Sep 2025) amounted to SEK 0 (SEK 0). Other operating income totalled SEK 0 (SEK 6 thousand). Administrative costs Administrative costs amounted to SEK 4.3 million (SEK 3.6 million). The cost increase compared to the same period last year is mainly driven by higher recognized costs for employee incentive programs. Research and development costs (R&D) R&D costs amounted to SEK 10.9 million (SEK 14.2 million). The cost decrease is related to the finalized NDA submission early September 2025. Commercial preparation costs No costs for commercial preparations were reported in the period. Operating results (EBIT) The operating result amounted to SEK -15.3 million (SEK -17.8 million). The cost decrease is related to the finalized NDA submission early September 2025. Net Profit/Loss for the period The Group’s net loss in Q3 2025 amounted to SEK -15.7 million (SEK -21.7 million). A net financial cost of SEK -0.5 million was recognized for convertibles based on accounting priniciples. These costs have no cash flow impact. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.13 (SEK -0.42). Financial overview FINANCIAL OVERVIEW Q3 (JUL -SEP 2025) Financial key ratios for the Group Q3 (July-September) 2025 2024 Operating result (SEK 000’) -15,252 -17,790 Net result (SEK 000’) -15,673 -21,732 Earnings per share (SEK) -0.13 -0.42 Weighted avg. number of shares 117,470,277 51,370,478 R&D costs/operating costs (%) 71% 80% Cash flow used in operating activities (SEK 000’) -15,658 -17,043 Equity (SEK 000’) 114,401 107,582 Liquid assets incl. marketable securities (SEK 000’) 72,275 95,718 CASH FLOW AND FINANCIAL POSITION Cash flow from operating activities before changes in working capital amounted to SEK -14.0 million (SEK -19.1 million). Changes in working capital for the quarter showed an outflow of SEK -1.7 million (SEK 2.0 million). The changes in working capital reflects a decrease in current liabilities. Cash flow from investing activities in amounted to SEK 0 (SEK 0) while cash flow from financing activities amounted to an inflow of SEK 27.5 million (inflow of SEK 83.1 million). In September 2025, a directed issue was completed generating proceeds of SEK 30 million before costs. On the closing date, equity amounted to SEK 114.4 million, compared with SEK 78.9 million per 31 December 2024 and SEK 107.6 million per 30 September 2024. The increase since 31 December 2024 and 30 September 2024 reflects the new share issue related to the warrants TO 1 in April 2025 as well as the directed new share issue carried out in Sepmteber 2025. Liquid assets amounted to SEK 72.3 million on the closing date, compared to SEK 75.3 million per 31 December 2024 and SEK 95.7 million per 30 September 2024.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 13 Financial overview FINANCIAL OVERVIEW 9M (JAN-SEP 2025) EARNINGS AND PROFITABILITY Net sales and other operating income The Group’s net sales during the period (Jan-Sep) amounted to SEK 0 (SEK 0). Other operating income totalled SEK 0.1 million (SEK 0.4 million). The income refers to exchange rate gains. Administrative costs Administrative costs in the period amounted to SEK 13.2 mil - lion (SEK 14.3 million). The cost decrease compared to the same quarter last year, is mainly driven by lower recognized costs for employee incentive programs. Research and development costs (R&D) R&D costs amounted to SEK 45.2 million (SEK 32.5 million). The cost increase of SEK 12.7 million mainly reflects the costs for NDA submission preparations. Commercial preparation costs No costs for commercial preparations were reported in the pe - riod. Operating results (EBIT) The operating result for the Group amounted to SEK -58.6 mil - lion (SEK -45.8 million). The increased loss mainly reflects the costs for NDA submission preparations. Net Profit/Loss for the period The Group’s net loss in he period amounted to SEK -60.4 million (SEK -51.7 million). A net financial loss of SEK -2.2 million was recognized, which mainly reflects interest and arrangement fee expenses related to loans. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.55 (SEK -1.30). CASH FLOW Cash flow from operating activities before changes in working ca- pital amounted to SEK -56.4 million (SEK -45.1 million). Changes in working capital for the period showed a positive impact of SEK 5.8 million (SEK 1.0 million). The changes in working capital reflects an increase in accounts payable, repayment of advances from suppliers and a decrease in credits on the tax account. Cash flow from investing activities amounted to an outflow of SEK -57 thousand (SEK 0). Cash flow from financing activities totalled an inflow of SEK 48.6 million (inflow of SEK 117.2 mil - lion). The inflow during the period is attributable to the net ef - fect of proceeds from the warrants series TO 1 and repayment of the loan to Fenja in April, and proceeds from the directed new share issue carried out in September. FINANCIAL POSITION The exercise period for warrants series TO 1 in Ascelia Pharma AB ended on 15 April 2025. The outcome shows that a total of 19,919,494 TO 1 were exercised for subscription of 19,919,494 new ordinary shares, corresponding to a subscription rate of approximately 96 percent. Ascelia Pharma received net pro - ceeds of SEK 41.5 million. In connection to the new share issu - ance a loan of SEK 20 million was repaid to Fenja. In September 2025, Fenja converted all outstanding convert - ibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue, raising SEK 30 million before costs. With this fundraise, we broaden our investor base and strengthen our balance sheet. On the balance sheet date, liquid assets amounted to SEK 72.3 million. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance. Financial key ratios for the Group 9M (January-September) 2025 2024 Operating result (SEK 000’) -58,595 -45,837 Net result (SEK 000’) -60,388 -51,697 Earnings per share (SEK) -0.55 -1.30 Weighted avg. number of shares 108,924,023 39,671,510 R&D costs/operating costs (%) 77% 70% Cash flow used in operating activities (SEK 000’) -50,560 -44,060 Equity (SEK 000’) 114,401 107,582 Liquid assets incl. marketable securities (SEK 000’) 72,275 95,718
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 14 Incentive programs Ascelia Pharma has has one outstanding employee option pro - gram as well as three share saving programs. If the terms of the option program are met at the time for utilization, the employ - ees has the right to purchase shares at a pre-determined price For the share- saving programs, employees are entitled to receive matching and performance shares according to the terms of the program. The Group recognizes share-based remuneration, which per - sonnel may receive. A personnel cost is recognized, together with a corresponding increase in equity, distributed over the vesting period. Social security costs are revalued at fair value. Further information about the incentive programs can be found in the Annual Report 2024 on pages 67-69. In case all outstanding incentive programs per 30 September 2025 are exercised in full, a total of 7.5 million common shares will be issued (including hedge for future payment of social se - curity charges). This corresponds to an aggregate maximum di - lution of approximately 5.6 percent of Ascelia Pharma’s share capital after full dilution (calculated on the number of common shares that will be added upon full exercise of all incentive pro - grams). Warrants TO 1 The warrants are valued at fair value based on the necessary variables using a Monte Carlo simulation. A first valuation was made after the Rights Issue in September 2024. A new fair value is calculated at each quarterly period. The new valuation gener - ates either a financial income or a financial cost which do not ef- fect the cash flow. In 2025 a financial income of SEK 2.1 million was recognizied related to TO 1. Information about risks and uncertainties for the Group and the parent company Ascelia Pharma continuously needs to secure financing to ensure continued development and growth. Market dynamics and financing needs create uncertainties regarding ongoing and future operations. To strengthen the balance sheet and ensure continued operations, the Company carried out a fully sub - scribed Rights Issue in September 2024 with warrants exercised in April 2025. The balance sheet was further strengthened with a directed new share issue in September 2025. From an operational perspective, the Company is exposed to a number of risks and uncertainties which impact, or could im - pact, it’s business, operations, financial position, and results. The risks and uncertainties considered to have the highest im - pact on results are within clinical drug development, regulatory conditions, commercialization and licensing, intellectual prop - erty rights and other forms of protection, financing conditions, macroeconomic conditions including impact from pandemics, geopolitical effects, inflation and foreign exchange exposure. The Group’s overall strategy for risk management is to limit un - desirable impact on its result and financial position, to the extent it is possible. The Group’s risks and uncertainties are described in more detail in the Annual Report 2024 on pages 35–37. Significant events after the end of the reporting period On 3 November, Ascelia Pharma announced management changes to support future growth. Auditor’s review This interim report has not been reviewed by the company’s auditor. This interim report has been prepared in both Swedish and English versions. In the event of any differences between the translations and the Swedish original, the Swedish version shall prevail. Malmö, 4 November 2025 Ascelia Pharma AB (publ) Magnus Corfitzen CEO Other information OTHER INFORMATION
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 15 Financial information / Group Consolidated Income Statement Consolidated Statement of Comprehensive Income Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands (unless otherwise stated)* 2025 2024 2025 2024 Net sales – – – – Gross profit/loss – – – – Administrative costs -4,308 -3,550 -13,197 -14,313 Research and development costs -10,887 -14,173 -45,205 -32,470 Commercial preparation costs – -31 – 669 Other operating income – 6 124 376 Other operating costs -57 -42 -316 -99 Operating result -15,252 -17,790 -58,595 -45,837 Finance income 427 168 2,974 1,161 Finance costs -898 -4,136 -5,168 -7,077 Net financial items -471 -3,968 -2,194 -5,916 Loss before tax -15,723 -21,758 -60,789 -51,753 Tax 50 26 401 55 Loss for the period -15,673 -21,732 -60,388 -51,697 Attributable to: Owners of the Parent Company -15,673 -21,732 -60,388 -51,697 Non-controlling interest – – – – Earnings per share Before and after dilution (SEK) -0.13 -0.42 -0.55 -1.30 Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands (unless otherwise stated)* 2025 2024 2025 2024 Profit/loss for the period -15,673 -21,732 -60,388 -51,697 Other comprehensive income Currency translation of subsidiaries** -1 32 92 -20 Other comprehensive income for the period -1 32 92 -20 T otal comprehensive income for the period -15,675 -21,700 -60,296 -51,717 * Some figures are rounded, so amounts might not always appear to match when added up. ** Will be classified to profit and loss when specific conditions are met
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 16 Consolidated Balance Sheet Financial information / Group 30 Sep 30 Sep 31 Dec SEK in thousands* 2025 2024 2024 ASSETS Non-current assets Intangible assets 57,073 57,076 57,078 Tangible assets - Equipment 57 34 15 Right-of-use assets 1,107 325 109 T otal non-current assets 58,236 57,434 57,202 Current assets Advance payments to suppliers 1,755 3,255 1,755 Current receivables Income tax receivables 1,539 1,688 632 Other receivables 1,572 913 5,054 Prepaid expenses and accrued income 1,038 2,401 1,022 Cash and bank balances 72,275 95,718 75,256 T otal current assets 78,179 103,975 83,718 T otal assets 136,415 161,409 140,920 EQUITY Share capital 127,903 97,193 97,193 Other paid-in capital 771,366 721,750 721,750 Reserve of exchange differences on translation 1,065 651 974 Loss brought forward (incl. net profit/loss for the period) -785,932 -712,012 -740,973 Equity attributable to Parent Company shareholders 114,401 107,582 78,944 T otal equity 114,401 107,582 78,944 LIABILITIES Long-term liabilities Long-term interest bearing liabilities – 26,215 – Lease liabilities 285 – – T otal long-term liabilities 285 26,215 – Current liabilities Accounts payable 7,245 2,596 4,733 Tax payable – 1 – Other liabilities 973 13,479 19,113 Interest bearing liabilities – – 25,225 Current lease liabilities 890 402 172 Accrued expenses and deferred income 12,621 11,133 12,733 T otal current liabilities 21,730 27,612 61,976 T otal liabilities 22,014 53,827 61,976 T otal equity and liabilities 136,415 161,409 140,920 * Some figures are rounded, so amounts might not always appear to match when added up.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 17 Consolidated Statements of Changes in Equity Financial information / Group 9M (Jan-Sep) Full Year (Jan-Dec) SEK in thousands* 2025 2024 2024 Equity at start of the period 78,944 74,328 74,328 Comprehensive income Profit/loss for the period -60,388 -51,498 -80,029 Other comprehensive income 92 -20 303 T otal comprehensive income -60,296 -51,518 -79,726 Transactions with shareholders New issue of common shares 80,325 105,324 105,324 Settlement of debt for warrants 16,100 -12,385 -12,385 New issue of C-shares – – – Common shares: Conversion from C-shares – – -26 C-shares: Resolution of C-shares – – 26 Issuance expenses -3,618 -14,452 -15,207 Call option premium in relation to loan facility – 2,165 2,165 Share based remuneration to employees 2,946 4,320 4,446 T otal transactions with shareholders 95,754 84,973 84,343 Equity at end of the period 114,401 107,782 78,944 * Some figures are rounded, so amounts might not always appear to match when added up.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 18 Consolidated Cash Flow Statement Financial information / Group Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands* 2025 2024 2025 2024 Operating activities Operating result -15,252 -17,790 -58,595 -45,837 Expensed share based remuneration 1,061 811 3,164 4,289 Adjustment for items not included in cash flow 195 -539 631 -69 Interest received 292 3 625 38 Interest paid -211 -1,425 -1,703 -3,857 Income tax paid/received -94 -147 -511 354 Cash flow from operating activities before changes in working capital -14,008 -19,087 -56,389 -45,084 Cash flow from changes in working capital Increase (-)/Decrease (+) of advance payments – 297 – 178 Increase (-)/Decrease (+) of operating receivables 805 -812 3,625 -2,121 Increase (+)/Decrease (-) of accounts payable 2,952 -73 2,516 1,069 Increase (+)/Decrease (-) of other liabilities -5,407 2,632 -312 1,898 Change in working capital -1,650 2,044 5,830 1,024 Cash flow used in operating activities -15,658 -17,043 -50,560 -44,060 Investing activities Investment in equipment – – -57 – Divestment of right-of-use assets – – – – Cash flow from investing activities – – -57 – Financing activities New share issue 29,999 105,324 72,825 105,324 Transaction costs for issuance -2,295 -14,023 -3,618 -14,452 Conversion from C-shares – – – – Resolution of C-shares – – – – Convertible bond issue – -700 – 733 New loans – 272 – 33,715 Amortisation of loan – -7,500 -20,000 7,500 Amortisation of lease liabilities -199 -224 -600 -658 Cash flow from financing activities 27,505 83,149 48,607 117,162 Cash flow for the period 11,847 66,106 -2,010 73,103 Cash and cash equivalents at start of period 60,443 29,775 75,256 21,855 Exchange rate differences in cash and cash equivalents -15 -163 -970 760 Cash and cash equivalents at end of period 72,275 95,718 72,275 95,718 * Some figures are rounded, so amounts might not always appear to match when added up.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 19 Parent Company – Income Statement Financial information / Parent Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands* 2025 2024 2025 2024 Net sales 96 21 233 159 Gross profit/loss 96 21 233 159 Administrative costs -4,259 -3,524 -13,074 -14,185 Research and development costs -10,766 -14,099 -43,573 -32,312 Commercial preparation costs – -31 – 669 Other operating income – 7 63 10 Other operating costs -31 -2 -85 -30 Operating result -14,962 -17,628 -56,436 -45,689 Finance income 1,443 167 5,765 1,037 Finance costs -856 -3,922 -5,066 -6,820 Result from other long-term receivables -475 773 -5,070 2,570 Net financial costs 112 -2,982 -4,371 -3,213 Loss before tax -14,849 -20,610 -60,807 -48,901 Tax – – – – Loss for the period -14,849 -20,610 -60,807 -48,901 * Some figures are rounded, so amounts might not always appear to match when added up.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 20 Parent Company – Balance Sheet Financial information / Parent 30 Sep 30 Sep 31 Dec SEK in thousands* 2025 2024 2024 ASSETS Non-current assets Tangible assets Equipment 57 34 15 Financial assets Shares in affiliated companies 58,068 58,068 58,068 Other long-term receivables from group companies 39,237 38,076 39,255 T otal non-current assets 97,361 96,178 97,338 Current assets Advance payments to suppliers 1,755 3,255 1,755 Current receivables Receivables from group companies 2,974 2,469 2,560 Income tax receivables 1,040 1,310 534 Other receivables 1,523 892 5,011 Prepaid expenses and accrued income 1,038 2,352 1,004 Cash and bank balances 70,976 95,223 74,440 T otal current assets 79,306 105,501 85,303 T otal assets 176,667 201,679 182,641 EQUITY Restricted equity Share capital 127,903 97,193 97,193 Non-restricted equity Other paid-in capital 771,366 721,750 721,750 Loss brought forward -682,526 -609,108 -622,123 Loss for the period -60,807 -48,901 -75,831 T otal equity 155,936 160,933 120,989 LIABILITIES Long-term liabilities Long-term interest bearing liabilities – 26,215 – T otal long-term liabilities – 26,215 – Current liabilities Accounts payable 7,181 2,587 4,632 Other liabilities 973 894 19,113 Interest bearing liabilities – – 25,225 Accrued expenses and deferred income 12,578 11,050 12,683 T otal current liabilities 20,731 14,531 61,652 T otal equity and liabilities 176,667 201,679 182,641 * Some figures are rounded, so amounts might not always appear to match when added up.
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 21 Notes General information This interim report for the Group has been prepared accord - ing to IAS 34 Interim Financial Reporting and applicable rules in the Swedish Annual Accounts Act (ÅRL). The interim report for the parent company has been prepared according to the Swedish Annual Accounts Act chapter 9, Interim Reporting. For the Group and the parent company, the same accounting princi - ples and basis for calculations have been applied as in the recent Annual Report. Fair value of financial instruments The recognized value for other receivables, cash and cash equiv- alents, trade payables and other liabilities constitutes a reason - able approximation of fair value. Interest bearing liabilities are recognized at amortized cost which is considered an approxima - tion of the fair value. Purchases from related parties No significant transactions with related parties have occurred during the period. Use of non-international financial reporting standards (IFRS) performance measures Reference is made in this interim report to alternative perfor - mance measures that are not defined according to IFRS. Ascelia Pharma considers these performance measures to be an import - ant complement since they enable a better evaluation of the company´s economic trends. The company believes that these alternative performance measures give a better understanding of the company´s financial development and that such key per - formance measures contain additional information to the inves - tors to those performance measures already defined by IFRS. Furthermore, the key performance measures are widely used by the management in order to assess the financial development of the company. These financial key performance measures should not be viewed in isolation or be considered to substitute the key performance measures prepared by IFRS. Furthermore, such key performance measures should not be compared to other key performance measures with similar names used by other companies. This is due to the fact that the above-mentioned key performance measures are not always defined identically by other companies. These alternative performance measures are described below. Important estimations and judgements Valuation of intangible assets The recognized research and development project in progress is subject to management’s impairment test. The most critical as - sumption, subject to evaluation by management, is whether the recognized intangible asset will generate future economic benefits that at a minimum correspond to the intangible asset’s carrying amount. Management’s assessment is that the expected future cash flows will be sufficient to cover the intangible asset’s carrying amount and accordingly no impairment loss has been recognized. Capitalization of development expenses In 9M 2025, the criteria for classifying R&D costs as an asset ac- cording to IAS 38 has not been met (capitalization of development expenses is normally done in connection with final regulatory ap- proval). Hence, all R&D costs related to the development of the product candidates have been expensed. Share-based incentive programs Employee option programs Ascelia Pharma has one onging employee option program which was implemented in February 2025. The parameter, which has the largest impact on the value of the options, is the publicly traded share price. The total recognized costs for the option program in 9M 2025 including social security charges were SEK 2.2 million. Share saving programs Ascelia Pharma has three active long-term incentive programs for employees in the form of performance-based share saving programs. The parameter, which has the largest impact on the value of the programs, is the publicly traded share price. The total recognized costs for the share saving programs including social security charges in 9M 2025 were SEK 1.0 million. Financial information / Notes
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Ascelia Pharma Interim Report Q3 (Jan–Sep 2025) 22 Notes Reconciliation table for alternative performance measures for the Group Definitions of alternative performance measures Alternative performance measures Operating results (TSEK) Research and development costs/Operating costs (%) Definition Profit before financial items and tax. The research and development expenses in relation to total operating costs (consisting of the sum of administrative expenses, R&D, costs for commercial prepara - tions and other operating expenses). Aim The performance measure shows the company´s operational performance. The performance measure is useful in order to understand how much of the operating costs that are related to research- and development expenses. Financial information / Notes Q3 (July-September) 9M (January-September) SEK in thousands* 2025 2024 2025 2024 Administrative costs -4,308 -3,550 -13,197 -14,313 R&D costs -10,887 -14,173 -45,205 -32,470 Commercial preparation costs – -31 – 669 Other operating costs -57 -42 -316 -99 T otal operating costs -15,252 -17,796 -58,718 -46,213 R&D costs/Operating costs (%) 71% 80% 77% 70%
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ASCELIA PHARMA AB (publ) Hyllie Boulevard 34 SE-215 32 Malmö, Sweden ascelia.com Financial calendar Full-year report 2025 (Jan-Dec): 5 February 2026 Annual General Meeting 2026: 4 May 2026 Interim report Q1 2026 (Jan-Mar): 14 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 | +46 735 179 118 Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial) jwb@ascelia.com | +46 735 179 116