New Risk • May 31
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 15% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr71m). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (kr412.6m market cap, or US$44.7m). Annuncio • Jan 27
Ascelia Pharma Announces Acceptance of Three Scientific Abstracts with SPARKLE Phase 3 Data at the European Society of Gastrointestinal and Abdominal Radiology Annual Meeting Ascelia Pharma AB (publ) announced that two oral presentations and one scientific poster with clinical data from the SPARKLE Phase 3 study with Orviglance have been accepted for presentation at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Annual Meeting, taking place 13-16 May in Amsterdam, Netherlands.
All three abstracts outline data and conclusions from the SPARKLE Phase 3 study with Orviglance. In the study, Orviglance was shown to enhance the detection of suspected or known focal liver lesions, including small-sized lesions, and consistently shows positive results in visualizing lesions in both patients with hepatocellular carcinoma (HCC, primary liver cancer) and those with liver metastases. The study includes patients with severe renal impairment who currently lack an alternative to gadolinium-based contrast MRI.
Ascelia Pharma expects to submit the New Drug Application (NDA) file for Orviglance to the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval. Annuncio • Oct 31
Ascelia Pharma AB (Publ) Announces Appointment of Marianne Kock as New Board Member Ascelia Pharma on 30 October 2024, at an extraordinary general meeting resolved, in accordance with the proposal from the Nomination Committee, to elect Marianne Kock as new board member for the time period up until the end of the next annual general meeting alongside the board members elected at the annual general meeting held on 6 May 2024. Annuncio • Oct 24
Ascelia Pharma AB (Publ) Presents Late-Breaking Abstract on Sparkle Data At the American Society of Nephrology Kidney Week Congress 2024 Ascelia Pharma AB (publ) announced that its latest scientific abstract, titled SPARKLE: A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of ACE-MBCA (Orviglance) in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment, has been accepted as part of the Late-Breaking Science Posters session at the prestigious American Society of Nephrology Kidney Week Congress 2024, taking place from 23-27 October in San Diego, US. The abstract highlights the significant findings from the SPARKLE study on the safety and efficacy of Orviglance and demonstrates that it improves diagnostic efficacy on suspected or known liver lesions (including liver cancer and metastasis) for patients with severe kidney impairment who currently lack alternatives to gadolinium-based contrast enhanced MRI. Annuncio • Sep 16
Ascelia Pharma AB (publ), Annual General Meeting, Apr 10, 2025 Ascelia Pharma AB (publ), Annual General Meeting, Apr 10, 2025. Annuncio • May 03
Ascelia Pharma AB (publ) Successfully Meets Primary Endpoint with Strong Headline Results in Orvigance Phase 3 Study Ascelia Pharma AB (publ) announced that liver imaging drug candidate, Orviglance®?, significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study SPARKLE. The Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) vs. unenhanced MRI with statistical significance for all three readers (<0.001) Orviglance is in development as a first-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function and has been granted FDA Orphan Drug Designation. Orviglance addresses a global USD 800 million market annually. The Phase 3 data marks the completion of Orviglance clinical development with nine studies in 286 patients and healthy volunteers. Submission of the New Drug Application (NDA) file to the US Food and Drug Administration (FDA) is expected by mid-2025. The pivotal Phase 3 study, SPARKLE, successfully met the primary endpoint and demonstrated that the company's magnetic resonance imaging (MRI) contrast agent, Orviglance significantly improved the visualization of focal liver lesions compared to unenhanced MRI. The Company expects to submit the New Drug Application (ND) file to the US Food & Drug Administration (FDA) by mid-2025 to obtain regulatory approval. Clinical development of Orviglance has now been completed with consistent positive efficacy and safety data from 286 patients and healthy volunteers in nine studies, of which the SPARKLE is the last and pivotal study. Patient enrollment in the global multi-center SPARKLE study was completed early 2023, with MRI data from 85 patients with known or suspected focal liver lesions and severely impaired kidney function. In accordance with regulatory requirements, the improvement of visualization of lesions was evaluated by three independent radiologist readers. In mid-2023, the unexpected discovery of high intra- reader variability in the study image scoring by the readers prevented the Company from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new readers was required. The company successfully completed the re-evaluation according to the planned timeline with the announcement today. Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration ("FDA") for liver MRI in patients with severely impairment kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the currently available class of gadolinium-based contrast agents. These patients are at risk of serious side effects from the currently available class of gadolium-based contrast agents. Orviglance, has been granted an Orphan drug Designation by the US Food & Drug Administration ("FDA"). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results. Oncoral. Oncoral, the Phase 3 study SPARKLE has successfully been completed with strong & consistent efficacy and safety results. Annuncio • Aug 10
Ascelia Pharma AB (publ) Announces Re-Evaluation Required After Intra-Reader Inconsistency in Scoring of Images from Phase 3 Study SPARKLE Ascelia Pharma AB (publ) reported the need for a re-evaluation of the collected images in the pivotal Phase 3 study SPARKLE with the liver imaging candidate drug Orviglance®. As per FDA guidance, a pre-defined number of patients were evaluated twice. This showed a high level of variability in the evaluation of images by some readers, which necessitates a re-evaluation of all images by a new group of independent radiology readers. Ascelia Pharma completed the global multi-center SPARKLE study in early March 2023 with MRI data from 85 completed patients. Since then, the MRI images have been read and evaluated by three independent radiologists as required by regulatory standards. During the evaluation of headline data, the company identified a high level of inconsistency in the image scoring by some individual readers, i.e., intra-reader variability. Intra-reader variability occurs when a reader reports different scores for the same image when seen at a different time point. This finding means that data from SPARKLE cannot be reported based on the performed reading. The patient recruitment and collection and transfer of MR images to the central database has been correctly performed and the company does not see a need for a new clinical study. Common adverse events in the SPARKLE study were in line with previous studies with Orviglance, such as mild to moderate nausea. No drug related serious adverse reactions were reported. Annuncio • Jan 28
Ascelia Pharma AB (publ) Announces 71 Patients Have Completed the SPARKLE Study Ascelia Pharma AB (publ) announced that by January 27, 2023, 71 patients have completed the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance. On December 29, 2022, Ascelia Pharma announced that 65 patients had completed the SPARKLE study, which will include 80 patients in total. Since that announcement, 6 more patients have completed the study. The company expects to complete patient enrollment by February/March 2023 with topline results by mid-2023. The SPARKLE study is the third and last of three clinical studies that form the Phase 3 programfor Orviglance, the company's orphan liver imaging agent. Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imagingdeveloped to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study. Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development. Annuncio • Dec 30
Ascelia Pharma AB (Publ) Announces 65 Patients Completes the Sparkle Study Ascelia Pharma AB (publ) announced that by December 29, 2022, 65 patients have completed the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance. On December 6, 2022, Ascelia Pharma announced that 58 patients had completed the SPARKLE study, which will include 80 patients in total. Since this announcement, 7 more patients have completed the study. The company expects to complete patient enrollment by February/March 2023 with topline results by mid-2023. The SPARKLE study is the third and last of three clinical studies that form the Phase 3 program for Orviglance, the company's orphan liver imaging agent. Annuncio • Dec 07
Ascelia Pharma AB (Publ) Announces New Data Show That the Pivotal Phase 3 Clinical Sparkle Study Ascelia Pharma AB (publ) announced that new data show that the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance can be completed with 80 patients, with a complete patient enrollment expected in Feb-Mar 2023 and a subsequent topline readout by mid-2023. New data with the same image reading methodology as in the SPARKLE study with Orviglance demonstrate a strong and statistically significant effect of two to three times the effect level previously expected in SPARKLE. Therefore, a statistically significant positive outcome is likely to be obtained with substantially fewer patients, while maintaining conservative assumptions. Ascelia Pharma has thoroughly analyzed the new data and original assumptions with statisticians and regulatory experts to validate this important finding. Ascelia Pharma has discussed the analysis with the US Food and Drug Administration (FDA) with the objective to decide on a smaller sample size in SPARKLE than initially planned. Based on these discussions, Ascelia Pharma has decided to change the patient enrollment target of SPARKLE to 80 patients. Years of pandemic impact on clinical trial activities at hospitals, a change of Clinical Research Organization following a bankruptcy, and the discontinuation of 13 clinical sites in Russia are all factors that have significantly influenced patient enrollment in SPARKLE. In recent months, patient enrollment has shown a positive trend based on the opening of additional study sites and a launch of patient enrollment initiatives. To date, 58 patients have completed the study. Ascelia Pharma expects to complete SPARKLE patient enrollment by February/March 2023 with topline results by mid-2023. are also committed to providing updates on SPARKLE patient enrollment after the last Friday every month. Two of the three clinical studies of the Phase 3 program for Orviglance are completed with successful results. The previously announced Food Effect study successfully concluded that Orviglance image enhancement was not impacted by a light meal. The Hepatic Impairment Study showed that Orviglance is well tolerated in patients with liver (hepatic) impairment. The completion of SPARKLE will finalize the Phase 3 program. Annuncio • Dec 03
Ascelia Pharma AB Announces That the Nomination Committee in Preparation for the Annual General Meeting on 4 May 2023 Has Been Appointed Ascelia Pharma AB announced that the Nomination Committee in preparation for the Annual General Meeting on 4 May 2023 has been appointed. In accordance with the instructions for the Nomination Committee in Ascelia Pharma, the Nomination Committee shall consist of four members representing the three largest shareholders together with the chairman of the board of directors. The "three largest shareholders" refer to the ownership grouped registered or in any other way known shareholders as per the end of September. The Nomination Committee in respect of the AGM that will be held in Malmö on 4 May 2023 has been established to consist of the following persons together representing approximately 27% of votes in the company: Jørgen Thorball, chairman of the Nomination Committee, appointed by Sunstone Life Science Ventures II K/S; Håkan Nelson, appointed by Øresund Healthcare Capital; Marianne Flink, appointed by The Fourth Swedish National Pension Fund (AP4); and Peter Benson, chairman of the board of directors. The Nomination Committee's proposals will be presented in the notice to the Annual General Meeting 2023. The duties of the Nomination Committee is to prepare and propose the following to the coming annual shareholders' meeting: election of chairman at the shareholders' meeting; election of chairman of the board of directors and other members of the board of directors; fees to the board of directors, divided between the chairman and other members, and any fees for committee work; election of auditor and fees to the auditor; and principles for appointment of the Nomination Committee. Annuncio • Dec 01
Ascelia Pharma Presents Results of Orviglance Food Effect Study At RSNA 2022 Showing Strong Liver Enhancement Both with Light Meal and in Fasting Condition Ascelia Pharma AB (publ) is presenting results from its Orviglance Food Effect study at the RSNA conference 2022- 27 November - 1 December Chicago, Illinois). The study evaluates the effect of food intake on the absorption and signal intensity of Orviglance, a manganese-based MRI contrast agent, and successfully concludes that image enhancement is not impacted by a light meal. The Food Effect Study results show that intake of a light meal within 30 min prior to Orviglance administration provides similar image MRI enhancement of the liver compared to a fasting condition. In line with previous studies, the data also confirms strong image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. In clinical practice, the results support administration of Orviglance both after fasting or after consumption of a light meal. The reporting of these final results for the Food Effect Study completes two of the three studies in Ascelia Pharma's ongoing Phase 3 clinical program for registration of Orviglance. As previously announced, the Hepatic Impairment Study successfully concluded that Orviglance is well tolerated in patients with liver (hepatic) impairment. The plan for the ongoing Phase 3 study, SPARKLE, required for regulatory submission, is to complete patient enrolment by the end of this year. Data from the Food Effect Study will be included in the marketing authorization application to health authorities, including FDA and EMA. Annuncio • Oct 06
Ascelia Pharma AB (Publ) Announces Resignation of Carl Bjartmar as CMO Ascelia Pharma AB (publ) announced that CMO, Dr Carl Bjartmar has decided to retire by the end of the year. Annuncio • Sep 29
Ascelia Pharma AB (publ) Announces Successful Final Results from Orviglance Hepatic Impairment Study Ascelia Pharma AB (publ) announced the final results of the Hepatic Impairment Study confirming that the company's lead drug candidate, the magnetic resonance imaging (MRI) contrast agent Orviglance®, is well tolerated in patients with hepatic impairment. The reporting of final results for the Hepatic Impairment Study marks the completion of the second of three studies in the ongoing Phase 3 clinical program for registration of Orviglance, Ascelia Pharma's investigational MR-imaging agent used in the visualization and detection of cancer in the liver in patients with reduced kidney function. The previously announced Food Effect study successfully concluded that Orviglance image enhancement was not impacted by a light meal. The plan for the ongoing Phase 3 study, SPARKLE, required for a subsequent regulatory submission, is to complete patient enrollment by the end of this year. Data from the Hepatic Impairment Study will be included in the marketing authorization application to health authorities, including FDA and EMA. As communicated earlier and in line with expectations, the results show that Orviglance is well tolerated in patients with liver (hepatic) impairment, with only mild to moderate transient, gastrointestinal adverse events reported, such as nausea. No new safety concerns were identified. The data confirmed there was no renal excretion of Orviglance, and that excretion is primarily occurring via the liver also in this subgroup of patients. The study was performed at the Texas Liver Institute in the US in patients with mild, moderate, or severe hepatic impairment, respectively, as defined by the Child-Pugh score. The volunteers were divided into three severity groups, each of which had 6 participants, who were matched to a control group with normal hepatic function. Annuncio • Jun 21
Ascelia Pharma AB (publ) Announces Change of CFO Ascelia Pharma AB (publ) announced that it has appointed Déspina Georgiadou Hedin as Chief Financial Officer. She has a strong background in finance, most recently as CFO and HR Manager at Bioglan. She will take up her new position at Ascelia Pharma in September and report to CEO Magnus Corfitzen. Déspina Georgiadou Hedin is 35 years old and holds a Master of Science in Business and Economics, from Linnaeus University, Växjö/Kalmar, Sweden. Most recently, she has been CFO and HR manager at Bioglan AB, and prior to that, she served as Chief Accountant and Senior Financial Specialist at Sol Voltaics AB. Déspina also has a background as auditor from the accounting firm BDO. She will take up her new position in September and succeeds Kristian Borbos who has been Ascelia Pharma's CFO since 2017. 
