Interim report
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Interim Report Q3 2026 January – September KEY RATIOS GROUP We remain confident in the strength of our data and in Orviglance's ability to offer an important solution for patients with severe kidney impairment.” “ Advancing Orphan Oncology Orviglance® update following FDA Type A meeting KEY EVENTS IN Q3 2026 Publication of Orviglance clinical study in Journal of Magnetic Resonance Imaging FDA Type A meeting completed on 9 September Ascelia Pharma receives a Complete Response Letter from the U.S. Food and Drug Administration CFO Anton Hansson is leaving the company, alongside measures to reduce the cost base Official minutes from Type A meeting with the FDA received KEY EVENTS AFTER THE PERIOD Q3 (Jul-Sep) 9M (Jan-Sep) 2026 2025 2026 2025 OPERATING RESULT (SEKm) -10.4 -15.3 -39.0 -58.6 EARNINGS PER SHARE (SEK) -0.08 -0.13 -0.30 -0.55 CASH FLOW FROM OPERATIONS (SEKm) -10.1 -15.7 -40.0 -50.6 LIQUID ASSETS (SEKm) 27.8 72.3 27.8 72.3
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2 Ascelia Pharma Interim Report January-September 2026 Corporate overview Regulatory status and next steps. In early July, the FDA com - pleted its review of the NDA for Orviglance and issued a CRL, indicating that the application cannot be approved in its present form. The FDA raised issues related to clinical data and product documentation. To drive the regulatory process forward, we re - quested a Type A meeting with the FDA to discuss the issues raised in the CRL. The Type A meeting was held on September 9, and in October, the official meeting minutes were received. The FDA maintains that approval requires additional clinical ev - idence from a new study. However, the agency indicated that such evidence could potentially be generated through a pro - spective reanalysis of Phase 3 SPARKLE images using a different primary endpoint. Th e FDA also acknowledged that Orviglance addresses a significant unmet medical need, has shown no se - rious safety concerns, and that existing clinical studies provide evidence supporting Orviglance technical performance as a con - trast-enhancing agent in T1-weighted MRI. We are now focused on evaluating the most efficient path for - ward for Orviglance in the U.S., focusing on alternatives that build on the existing SPARKLE dataset. Other key priorities for Ascelia Pharma will be to advance regulatory activities in Europe and continue the partnering process. In parallel, we continue to assess opportunities to advance Oncoral and create additional value from our broader development portfolio. Ascelia Pharma seeks marketing approval for Orviglance as a liv - er magnetic resonance imaging (MRI) contrast agent for patients with severe kidney impairment. These patients have the high - est risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the gad - olinium-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. Development program. Orviglance is supported by a compre - hensive clinical development program 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-center pivotal Phase 3 SPARKLE study. At the beginning of September, we completed a Type A meeting with the FDA following the receipt of a Complete Response Letter (CRL) regarding our New Drug Application (NDA) for Orviglance. The meeting provided an opportunity to discuss the issues raised by the FDA in the CRL and to gain further clarity on the regulatory path forward. In October, we received the official meeting minutes. FDA acknowledged both the unmet medical need and the positive safety profile, as well as Orviglance technical performance as a T1-enhancing contrast agent. Although the FDA maintains that approval requires additional clinical evidence from a new study, it acknowledged that such evidence could potentially be generated through a prospective analysis of Phase 3 SPARKLE images using a different primary endpoint. Based on the FDA’s feedback, we are currently evaluating the most efficient path forward for Orviglance in the U.S., focusing on alternatives that build on the existing SPARKLE dataset. We believe that the existing clinical data package provides a strong foundation for the continued pursuit of regulatory approval. Following the receipt of the CRL, we implemented cost-saving measures that have strengthened our cash position and increased our financial flexibility, enabling us to support the activities required to advance the regulatory process. Other key priorities ahead will be to advance regulatory activities in Europe and continue the partnering process.We believe that the commercial opportunity for Orviglance remains attractive and our partnering process continues to progress. We remain confident that the totality of evidence generated throughout the development program supports Orviglance’s efficacy and safety and remain fully committed to making Orviglance available to patients with severe kidney impairment. CEO STATEMENT
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3 Ascelia Pharma Interim Report January-September 2026 Corporate overview In 2024, the SPARKLE study successfully met the primary end - point, demonstrating that Orviglance significantly improved vi - sualization 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 inde - pendent 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 Orviglance's potential to address an important unmet medical need. Recognition in the scientific community. We are pleased to see the acceptance of Orviglance data for presentation at major scien- tific conferences. In total five oral presentations and six abstract presentations have been accepted since the announcement of our Phase 3 results, underscoring the interest in the medical and scientific community for an alternative to gadolinium-based con- trast agents. In addition, in September 2026 a peer-reviewed arti- cle related to Orviglance was published in the Journal of Magnet- ic Resonance Imaging (JMRI), one of the leading peer-reviewed journals in the field of magnetic resonance imaging. 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 strategy is to launch Orviglance with commercializa - tion partners. This strategy enables us to leverage established ” We are now focused on finding the most efficient path forward for Orviglance." commercialization capabilities of a partner with a low invest - ment from Ascelia Pharma required for launch. The Complete Response Letter has changed the timeline for ap - proval, which affects the partnering discussio ns; however, we believe that the commercial opportunity for Orviglance remains attractive and our partnering process continues to progress. Financial position. During the quarter, we implemented cost-saving measures to strengthen our financial position and improve liquidit y. This provides flexibility to support the work required to move forward in the regulatory process and gives us a cash runway extending into the second quarter of 2027. The path ahead. Following the clarity obtained through the di - alogue with the FDA, we are now focused on finding the most efficient way forward for Orviglance. We remain confident in the strength of our data and in Orviglance's ability to offer an important solution for patients with severe kidney impairment. Despite the prolonged regulatory process, our value-creating opportunities for Orviglance remain unchanged : advancing to - ward approval and establishing a partnership. Magnus Corfitzen CEO
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4 Ascelia Pharma Interim Report January-September 2026 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 value for our stakeholders. COURAGE We work tirelessly and follow our convictions even when it means changing the status quo. INTEGRITY We build powerful relationships with mutual respect and adhere to the high ethical standards of our industry. OUR VALUES OUR VISION OUR BASE
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5 Ascelia Pharma Interim Report January-September 20265 OUR PIPELINE Our pipeline products Phase 2 results Orviglance Liver MRI contrast agent for patients with severe kidney impairment Market launch Market approval Phase 2 ready Oncoral Gastric cancer treatment with expansion potential to other cancer types 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 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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6 Our pipeline products / ORVIGLANCE ® Ascelia Pharma Interim Report January-September 2026 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 possibility for 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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7 Ascelia Pharma Interim Report January-September 2026 Our pipeline products / ORVIGLANCE ® How Orviglance works Orviglance is an orally administered 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 was submitted to the FDA in early September 2025. To reach this milestone, the Full Clinical Study Report from the Phase 3 SPARKLE study was com - pleted in Q4 2024, and a pre-NDA meeting with the FDA was held in Q1 2025. In mid-November 2025, the FDA formally accepted the NDA filing in its Day 7 4 Letter. In July 2026, the FDA completed its review and issued a Complete Response Letter (CRL). Ascelia Pharma has subsequently requested a Type A meeting with the FDA to discuss the matters raised in the CRL and clarify the regulatory path forward. The meeting was held on September 9 and the offical meeting minutes were received in October. 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) In the Type A meeting, the FDA acknowledged that Orviglance addresses a significant unmet med- ical need, that no serious safety concerns have been identified, and that existing clinical studies provide evidence supporting its technical performance as a T1-weighted MRI contrast enhance - ment agent. While the FDA maintains that additional clinical evidence is required for approval, it also indicated that such evidence could potentially be generated through a prospective analysis of Phase 3 SPARKLE images using an alternative primary endpoint. Ascelia is now evaluating the most efficient path forward in the US, with a focus on options based on existing SPARKLE data.
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8 Ascelia Pharma Interim Report January-September 2026 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 multicenter 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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9 Ascelia Pharma Interim Report January-September 2026 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 gadolin - ium 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. 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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10 Ascelia Pharma Interim Report January-September 2026 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 chemother- apies and targeted cancer drugs and enables an all-oral combi - nation 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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11 Ascelia Pharma Interim Report January-September 2026 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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12 Ascelia Pharma Interim Report January-September 2026 EARNINGS AND PROFITABILITY Net sales and other operating income The Group’s net sales in Q3 (Jul-Sep 2026) amounted to SEK 0 (SEK 0). Other operating income totaled SEK 0.2 MSEK (SEK 0), attributable to positive foreign exchange effects. Administrative costs Administrative costs amounted to SEK 2.7 million (SEK 4.3 million). The decrease compared with the previous year was mainly attributable to lower personnel costs. Research and development costs (R&D) R&D costs amounted to SEK 7.8 million (SEK 10.9 million). Costs were lower than in the previous year as the NDA submission for Orviglance was completed in September 2025. Operating results (EBIT) The operating result amounted to SEK -10.4 million (SEK -15.3 million). The improvement compared with the previous year was mainly attributable to lower R&D expenses following the completion of the NDA submission, as well as reduced personnel costs. Net Profit/Loss for the period and financial items The Group’s net loss in Q3 2026 amounted to SEK -10.3 million (SEK -15.7 million). A net financial loss of SEK 0.1 million was recognized, primarily attributable to positive foreign exchange effects on USD cash balances. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.08 (SEK -0.13). Financial overview FINANCIAL OVERVIEW Q3 (JUL -SEP 2026) Financial key ratios for the Group Q3 (July-September) 2026 2025 Operating result (SEK 000’) -10,393 -15,252 Net result (SEK 000’) -10,293 -15,673 Earnings per share (SEK) -0.08 -0.13 Weighted avg. number of shares 133,535,460 117,470,277 R&D costs/operating costs (%) 74% 71% Cash flow used in operating activities (SEK 000’) -10,126 -15,658 Equity (SEK 000’) 79,691 114,401 Liquid assets incl. marketable securities (SEK 000’) 27,801 72,275 CASH FLOW During the period, cash flow from operating activities before changes in working capital amounted to SEK -10.2 million (SEK -14.0 million). Changes in working capital amounted to SEK 28 thousand (SEK -1.7 million). Receivables increased during the quarter, while other operating liabilities decreased. Cash flow from investing activities amounted to SEK 0 (SEK 0). Cash flow from financing activities amounted to an outflow of SEK -0.2 million (inflow: SEK 27.5 million) attributable to repayments of lease liabilities. FINANCIAL POSITION On the closing date, equity amounted to SEK 79.7 million, compared with SEK 114.4 million as of 30 September 2025 and SEK 99.5 million as of 31 December 2025. The decrease in equity compared with both the previous year and year-end 2025 was primarily attributable to the Group's reported losses. The Board of Directors continuously evaluates various alternatives of action to address the capital structure in light of the decreased equity in the Parent Company. Liquid assets amounted to SEK 27.8 million on the closing date, compared with SEK 72.3 million as of 30 September 2025 and SEK 49.9 million as of 31 December 2025.
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13 Financial overview Ascelia Pharma Interim Report January-September 2026 FINANCIAL OVERVIEW 9M (JAN-SEP 2026) EARNINGS AND PROFITABILITY Net sales and other operating income The Group’s net sales during the period amounted to SEK 0 (SEK 0). Other operating income amounted to SEK 0.4 million (SEK 0.1 million) and was attributable to foreign exchange rate gains and the redemption of a leased car. Administrative costs Administrative costs in the period amounted to SEK 9.3 million (SEK 13.2 million). The decrease in costs compared with the previous year was primarily attributable to lower personnel costs resul - ting from a reduced number of employees. Research and development costs (R&D) R&D costs amounted to SEK 30.1 million (SEK 45.2 million). Costs decreased compared with the previous year following the completion of the NDA submission in early September 2025. Operating results (EBIT) The operating result for the Group amounted to SEK -39.0 million (SEK -58.6 million). The im - provement compared with the previous year was primarily attributable to lower R&D expenses following the completion of the NDA submission for Orviglance, as well as lower personnel costs. Net Profit/Loss for the period The Group’s net loss for the period amounted to SEK -38.7 million (SEK -60.4 million). During the period, net financial income amounted to SEK 0.3 million, primarily reflecting a positive foreign exchange effect on USD cash balances. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.30 (SEK -0.55). CASH FLOW Cash flow from operating activities before changes in working capital amounted to SEK -38.2 million (SEK -56.4 million). Changes in working capital amounted to SEK -1.8 million (SEK 5.8 million) primarily attributable to a decrease in other operating liabilities. Cash flow from investing activities amounted to SEK 0 (SEK -57 thousand). Cash flow from financing activities amounted to an inflow of SEK 17.7 million (inflow of SEK 48.6 million). The inflow was attri- butable to the directed share issue of SEK 20 million completed in April 2026. FINANCIAL POSITION In April, a directed share issue was carried out. The share issue raised SEK 20 million before costs. On the balance sheet date, liquid assets amounted to SEK 27.8 million. The Company assesses that its existing cash resources are sufficient to finance operations into the second quarter of 2027. Financial key ratios for the Group 9M (January-September) 2026 2025 Operating result (SEK 000’) -39,015 -58,595 Net result (SEK 000’) -38,685 -60,388 Earnings per share (SEK) -0.30 -0.55 Weighted avg. number of shares 130,800,418 108,924,023 R&D costs/operating costs (%) 76% 77% Cash flow used in operating activities (SEK 000’) -39,969 -50,560 Equity (SEK 000’) 79,691 114,401 Liquid assets incl. marketable securities (SEK 000’) 27,801 72,275
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14 Ascelia Pharma Interim Report January-September 2026 Incentive programs Ascelia Pharma has two outstanding share saving programs. If the terms of the share saving programs are met, employees are enti- tled to receive matching and performance shares according to the terms of the program. The Group recognizes share-based remuner- ation, which personnel 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 and the liability is recognized on an ongoing basis. Further infor - mation can be found in the Annual Report 2025 on pages 68-70. In case all outstanding incentive programs per 30 September 2026 are exercised in full, a total of 3.6 million common shares will be issued (including hedge for future payment of social security charges). This corresponds to an aggregate maximum dilution of approximately 2.6 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 programs). Risks and uncertainties Ascelia Pharma is exposed to a range of operational risks and uncertainties that affect, or could affect, its business, operations, financial position, and results. The risks assessed as having the greatest potential impact relate to clinical drug development, reg- ulatory conditions, commercialization and licensing, intellectual property rights and other protective mechanisms, financing con- ditions, and broader macroeconomic factors. These include the effects of pandemics, geopolitical developments, inflation, and foreign exchange fluctuations. The Group’s overarching risk management approach is to mitigate and limit undesirable impacts on earnings and financial position. A detailed description of the Group’s risks and uncertainties is provided in the Annual Report 2025 on pages 37-39. Ascelia Pharma’s operations in R&D activities require continuous access to capital as the available liquidity is gradually consumed. The Group does not currently have a steady inflow of revenues; instead, revenues arise irregularly, for example through partner - ship agreements with pharmaceutical companies. As of the reporting date, Ascelia Pharma assesses that it does not have full financing for the coming twelve months but that Ascelia Pharma currently has a cash runway extending into Q2 2027. Be- yond that point, Ascelia Pharma will be dependent on revenues or other financing sources. There is a risk that such financing may not be available when needed or on favorable terms, which could have a material impact on the operations and create uncertainty regarding ongoing and future operations. Subsequent to the end of the quarter, the Company received the official meeting minutes from the Type A meeting with the FDA. The FDA maintains its position that approval would require addi- tional clinical evidence from a new clinical study. At the same time, the minutes indicate that clinical evidence supporting approval could potentially be generated through a prospective analysis of existing data. The company is now focused on identifying the most efficient regulatory path forward based on the existing data from the SPARKLE study. Depending on the regulatory path pursued, the Company's future capital requirements may vary significantly. If additional clinical studies are required, this would result in a substantially greater fi- nancing need than if sufficient clinical evidence can be generated through analysis of existing data. Accordingly, the scope, timing, and structure of future financing cannot currently be determined. At present, the Company is also unable to assess whether the FDA will accept the path that may subsequently be proposed. The partnering process for Orviglance is progressing. The timing and terms of any potential partnership could also have a material impact on the Company's financing needs, liquidity, and future fi- nancing opportunities. The Board of Directors continuously evaluates the various financ- ing alternatives and risks described above. However, these current circumstances indicate the existence of material uncertainties re- lated to the Company's future financing. The Board believes that there are reasonable grounds to secure financing and has conclud- ed that the interim report can be prepared on a going concern basis in accordance with IAS 8. Significant events after the end of the reporting period On 11 October, Ascelia Pharma provided updates following the FDA Type A meeting after receiveing the offical meeting minutes. Auditor’s review This interim report has been subject to a limited review 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 Nov 2026 Ascelia Pharma AB (publ) Magnus Corfitzen CEO Other information OTHER INFORMATION
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15 Financial overview Ascelia Pharma Interim Report January-September 2026 Introduction We have review ed the condensed interim financial information (interim report) of Ascelia Pharma AB (publ) as of 30 September 2026 and the nine-month period then ended. The board of di - rectors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our respon - sibility is to express a conclusion on this interim report based on our review. Scope of Review We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons respon - sible for financial and accounting matters, and applying analyti - cal and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted audi - ting standards in Sweden. The procedures performed in a re - view do not enable us to obtain assurance that we would beco - me aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion. Conclusion Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the Group, and with the Swedish Annual Accounts Act, regarding the Parent Company. Material uncertainty regarding the going concern assumption We would like to draw attention to page 3 and 14 of the quar - terly report, which shows that the company has a forecasted liquidity that extends into the second quarter of 2027. This si - tuation indicates that there is a material uncertainty that may lead to significant doubt about the company's ability to continue operations. We have not modified our statements. Malmö, 4 November Öhrlings PricewaterhouseCoopers AB Mikael Nilsson Authorized Public Accountant AUDITOR’S REPORT Ascelia Pharma AB (publ), corporate identity number 556571- 8797. To the Board of Directors of Ascelia Pharma AB (publ). This is a translation of the Swedish language original. In the event of any differences between this translation and the Swedish language original, the latter shall prevail.
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16 Ascelia Pharma Interim Report January-September 2026 Financial information / Group Consolidated Income Statement Consolidated Statement of Comprehensive Income Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands (unless otherwise stated)* 2026 2025 2026 2025 Net sales – – – – Gross profit/loss – – – – Administrative costs -2,714 -4,308 -9,262 -13,197 Research and development costs -7,783 -10,887 -30,094 -45,205 Commercial preparation costs – – – – Other operating income 155 – 408 124 Other operating costs -51 -57 -66 -316 Operating result -10,393 -15,252 -39,015 -58,595 Finance income 146 427 733 2,974 Finance costs -44 -898 -397 -5,168 Net financial items 101 -471 336 -2,194 Loss before tax -10,292 -15,723 -38,679 -60,789 Tax -1 50 -6 401 Loss for the period -10,293 -15,673 -38,685 -60,388 Attributable to: Owners of the Parent Company -10,293 -15,673 -38,685 -60,388 Non-controlling interest – – – – Earnings per share Before and after dilution (SEK) -0.08 -0.13 -0.30 -0.55 Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands (unless otherwise stated)* 2026 2025 2026 2025 Profit/loss for the period -10,293 -15,673 -38,685 -60,388 Other comprehensive income Currency translation of subsidiaries** -243 -1 -119 92 Other comprehensive income for the period -243 -1 -119 92 T otal comprehensive income for the period -10,536 -15,675 -38,804 -60,296 * 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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17 Ascelia Pharma Interim Report January-September 2026 Consolidated Balance Sheet Financial information / Group 30 Sep 30 Sep 31 Dec SEK in thousands* 2026 2025 2025 ASSETS Non-current assets Intangible assets 57,076 57,073 57,070 Tangible assets - Equipment 41 57 52 Right-of-use assets 253 1,107 885 T otal non-current assets 57,370 58,236 58,007 Current assets Advance payments to suppliers 145 1,755 145 Current receivables Income tax receivables 995 1,539 1,014 Other receivables 2,390 1,572 1,756 Prepaid expenses and accrued income 1,571 1,038 1,159 Cash and bank balances 27,801 72,275 49,861 T otal current assets 32,901 78,179 53,935 T otal assets 90,271 136,415 111,941 EQUITY Share capital 134,569 127,903 127,903 Other paid-in capital 784,699 771,366 771,366 Reserve of exchange differences on translation 989 1,065 1,108 Loss brought forward (incl. net profit/loss for the period) -840,566 -785,932 -800,904 Equity attributable to Parent Company shareholders 79,691 114,401 99,472 T otal equity 79,691 114,401 99,472 LIABILITIES Long-term liabilities Lease liabilities – 285 72 Other long-term liabilities 30 – – T otal long-term liabilities 30 285 72 Current liabilities Accounts payable 2,687 7,245 2,042 Tax payable – – – Other liabilities 886 973 973 Current lease liabilities 285 890 898 Accrued expenses and deferred income 6,692 12,621 8,484 T otal current liabilities 10,549 21,730 12,397 T otal liabilities 10,580 22,014 12,469 T otal equity and liabilities 90,271 136,415 111,941 * Some figures are rounded, so amounts might not always appear to match when added up.
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18 Ascelia Pharma Interim Report January-September 2026 Consolidated Statements of Changes in Equity Financial information / Group 9M (Jan-Sep) Full Year (Jan-Dec) SEK in thousands* 2026 2025 2025 Equity at start of the period 99,472 78,944 78,944 Comprehensive income Profit/loss for the period -38,685 -60,388 -76,253 Other comprehensive income -119 92 134 T otal comprehensive income -38,804 -60,296 -76,119 Transactions with shareholders New issue of common shares 20,000 80,325 80,325 Settlement of debt for warrants – 16,100 16,100 Common shares: Conversion from C-shares – – -53 C-shares: Resolution of C-shares – – 53 Issuance expenses -1,699 -3,618 -3,808 Share based remuneration to employees 721 2,946 4,030 T otal transactions with shareholders 19,022 95,754 96,647 Equity at end of the period 79,691 114,401 99,472 * Some figures are rounded, so amounts might not always appear to match when added up.
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19 Ascelia Pharma Interim Report January-September 2026 Consolidated Cash Flow Statement Financial information / Group Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands* 2026 2025 2026 2025 Operating activities Operating result -10,393 -15,252 -39,015 -58,595 Expensed share based remuneration not included in cash flow 165 1,061 526 3,164 Adjustment for other items not included in cash flow 212 195 600 631 Interest received 44 292 215 625 Interest paid -16 -211 -68 -1,703 Income tax paid/received -165 -94 -449 -511 Cash flow from operating activities before changes in working capital -10,153 -14,008 -38,191 -56,389 Cash flow from changes in working capital Increase (-)/Decrease (+) of advance payments – – – – Increase (-)/Decrease (+) of operating receivables -384 805 -754 3,625 Increase (+)/Decrease (-) of accounts payable 419 2,952 635 2,516 Increase (+)/Decrease (-) of other liabilities -7 -5,407 -1,660 -312 Change in working capital 28 -1,650 -1,778 5,830 Cash flow used in operating activities -10,126 -15,658 -39,969 -50,560 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 20,000 72,825 Transaction costs for issuance – -2,295 -1,699 -3,618 Amortisation of loan – – – -20,000 Amortisation of lease liabilities -206 -199 -615 -600 Cash flow from financing activities -206 27,505 17,686 48,607 Cash flow for the period -10,331 11,847 -22,283 -2,010 Cash and cash equivalents at start of period 38,046 60,443 49,861 75,256 Exchange rate differences in cash and cash equivalents 86 -15 223 -970 Cash and cash equivalents at end of period 27,801 72,275 27,801 72,275 * Some figures are rounded, so amounts might not always appear to match when added up.
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20 Ascelia Pharma Interim Report January-September 2026 Parent Company – Income Statement Financial information / Parent Q3 (Jul-Sep) 9M (Jan-Sep) SEK in thousands* 2026 2025 2026 2025 Net sales 95 96 729 233 Gross profit/loss 95 96 729 233 Administrative costs -2,677 -4,259 -9,142 -13,074 Research and development costs -7,502 -10,766 -26,941 -43,573 Commercial preparation costs – – – – Other operating income 65 – 200 63 Other operating costs -51 -31 -66 -85 Operating result -10,070 -14,962 -35,220 -56,436 Finance income 1,828 1,443 5,051 5,765 Finance costs -28 -856 -328 -5,066 Result from other long-term receivables 1,329 -475 3,556 -5,070 Net financial costs 3,128 112 8,278 -4,371 Loss before tax -6,941 -14,849 -26,942 -60,807 Tax – – – – Loss for the period -6,941 -14,849 -26,942 -60,807 * Some figures are rounded, so amounts might not always appear to match when added up.
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21 Ascelia Pharma Interim Report January-September 2026 Parent Company – Balance Sheet Financial information / Parent 30 Sep 30 Sep 31 Dec SEK in thousands* 2026 2025 2025 ASSETS Non-current assets Tangible assets Equipment 41 57 52 Financial assets Shares in affiliated companies 58,068 58,068 58,068 Other long-term receivables from group companies 49,408 39,237 39,187 T otal non-current assets 107,517 97,361 97,307 Current assets Advance payments to suppliers 145 1,755 145 Current receivables Receivables from group companies 4,132 2,974 3,229 Income tax receivables 995 1,040 551 Other receivables 1,419 1,523 1,702 Prepaid expenses and accrued income 1,559 1,038 1,151 Cash and bank balances 27,365 70,976 48,685 T otal current assets 35,614 79,306 55,462 T otal assets 143,131 176,667 152,769 EQUITY Restricted equity Share capital 134,569 127,903 127,903 Non-restricted equity Other paid-in capital 784,699 771,366 771,366 Loss brought forward -758,910 -682,526 -681,632 Loss for the period -26,942 -60,807 -76,300 T otal equity 133,417 155,936 141,336 LIABILITIES Long-term liabilities Other long-term liabilities 30 – – T otal long-term liabilities 30 – – Current liabilities Accounts payable 2,282 7,181 2,031 Other liabilities 886 973 973 Accrued expenses and deferred income 6,516 12,578 8,428 T otal current liabilities 9,684 20,731 11,432 T otal equity and liabilities 143,131 176,667 152,769 * Some figures are rounded, so amounts might not always appear to match when added up.
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22 Ascelia Pharma Interim Report January-September 2026 Notes General information This interim report for the Group has been prepared according 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 principles 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. 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 assumption, 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. Each year, the Group tests whether there is an impairment re - quirement with regards to intangible assets. For Ascelia Pharma, the recognized intangible assets refer to the R&D project in progress (Oncoral), which was acquired through the subsidiary Oncoral Pharma ApS. No impairment indicators for Oncoral have been identified as of the reporting date, but the impair - ment assessment is sensitive to underlying assumptions and val - uation is contingent on access to sufficient funding. In October 2026, the Board of Directors concluded that no impair- ment was required. The expected future cash flows are considered sufficient to support the carrying value of the intangible asset, and no indicators of impairment for Oncoral had been identified as of the reporting date. The assessment also included the receivables that the parent company has from its Danish subsidiary. However, the impairment assessment is sensitive to changes in the underlying assumptions, which by their nature are sub - ject to continuous change. The valuation is dependent on the Company’s ability to secure sufficient funding for the contin - ued development of the project. If Ascelia Pharma is unable to secure financing, the valuation of the asset may be adversely affected, including because the company could be forced to sell the asset under financially distressed circumstances, which would likely result in a lower sales value and consequently give rise to an impairment requirement. Further information can be found in the Annual Report 2025 on pages 74 and 75. Capitalization of development expenses In January-September 2026, the criteria for classifying R&D costs as an asset according to IAS 38 has not been met (capitalization of development expenses is normally done in connection with final regulatory approval). Hence, all R&D costs related to the develop- ment of the product candidates have been expensed. Share-based incentive programs Employee option programs Ascelia Pharma implemented an employee option program in February 2025. The program expired in June 2026 without any options being exercised. The parameter that had the greatest impact on the valuation of the options was the publicly traded share price. The total expense recognized during 2026 in relation to the share option program, including social security charges, amounted to SEK 0.4 million. Share saving programs Ascelia Pharma has two active long-term incentive programs for employees in the form of performance-based share saving pro - grams. 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 2026 were SEK 0.1 million. Financial information / Notes
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23 Ascelia Pharma Interim Report January-September 2026 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* 2026 2025 2026 2025 Administrative costs -2,714 -4,308 -9,262 -13,197 R&D costs -7,783 -10,887 -30,094 -45,205 Commercial preparation costs – – – – Other operating costs -51 -57 -66 -316 T otal operating costs -10,548 -15,252 -39,422 -58,718 R&D costs/Operating costs (%) 74% 71% 76% 77%
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ASCELIA PHARMA AB (publ) Hyllie Boulevard 34 SE-215 32 Malmö, Sweden ascelia.com Financial calendar Full-year report 2026 (Jan-Dec): 11 February 2027 Annual General Meeting 2027: 4 May 2027 Interim report Q1 2027 (Jan-Mar): 11 May 2027 Half-year report 2027 (Jan-Jun): 24 August 2027 Interim report 9M 2027 (Jan-Sep): 3 November 2027 Full-year report 2027 (Jan-Dec): 10 February 2028 Contact Magnus Corfitzen, CEO moc@ascelia.com | +46 735 179 118