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HC Andersen Capital: Release of new Ascelia Pharma investment case

HC Andersen Capital releases new Ascelia Pharma investment case. Ascelia Pharma’s Phase 3 pipeline product, Orviglance, addresses an unmet need in a market estimated to be USD 500-600m annually. Being a diagnostic product and supported by strong Phase 2 data, there is a solid foundation for obtaining market approval after Phase 3 (completion expected in 2022). The market, however, currently assesses a lower than 25 pct. chance it happens. This implies a large potential if approved. Read HC Andersen Capital's investment case here 

Notice of extraordinary general meeting in Ascelia Pharma

The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.   The shareholders in Ascelia Pharma AB, Reg. No. 556571-8797 (“Ascelia Pharma”), are hereby invited to the extraordinary general meeting to be held on Tuesday 13 April 2021.In light of the ongoing Covid-19 pandemic and in order to reduce the risk of infection spreading, the board of directors has decided that the meeting will be held only by advance voting (postal vote) in accordance with temporary legislation. This means

Ascelia Pharma has carried out a directed new share issue raising SEK 200 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA (THE “UNITED STATES”), AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE. Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma” or the “Company”) has successfully carried out a directed new share issue of 5,000,000 ordinary

Ascelia Pharma intends to carry out a directed new share issue

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA (THE “UNITED STATES”), AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma” or the “Company”) has mandated Danske Bank and Pareto Securities (the "Bookrunners”) to evaluate

Ascelia Pharma opens US office in preparation for Mangoral launch

Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has expanded its operations and established a US legal entity and office in Woodbridge, New Jersey, in preparation for US launch of its lead candidate drug, the liver contrast agent Mangoral. It is currently in pivotal clinical Phase 3 studies with market launch scheduled for Q4 2022 or H1 2023.The opening of a US office in Woodbridge, NJ, with an important proximity to the pharma and biotech community and competences in the area, including Princeton, is a central part of preparing for Ascelia Pharma’s market launch on the

Quarterly Report Q4 2020: Mangoral shows high diagnostic value in new study

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q4 2020 (October – December 2020), which is now available on the company’s website: https://www.ascelia.com/ir-media/reports-presentations/SIGNIFICANT EVENTS IN Q4 2020 · Upgraded estimate of the addressable market for Mangoral to $500-600 million annually (previously $350-500 million) · New study showing that Mangoral’s lesion visualization is as effective as gadolinium · US patent for second generation Mangoral SIGNIFICANT EVENTS AFTER THE PERIOD · Presentation of clinical

Information regarding transfer of shares in Ascelia Pharma AB from CMC SPV

Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma” or the “Company”) today announced that it has been informed of that CMC SPV of 3 April 2017 AB (“CMC SPV”) today has divested 687,606 shares in the Company in a private placement to institutional investors and distributed 2,250,000 shares in the Company to its shareholders, including Sunstone and certain members of the board of directors and management of Ascelia Pharma. Following the transaction, CMC SPV no longer holds any shares in the Company.As disclosed in the prospectus issued by Ascelia Pharma in connection with the listing on

Ascelia Pharma presents clinical development plan for Oncoral as a novel chemotherapy

Ascelia Pharma AB (publ) (ticker: ACE) today announced the clinical development plan for Oncoral. With Oncoral, Ascelia Pharma has the opportunity to develop a novel oral chemotherapy with the potential to offer both efficacy and safety benefits to cancer patients. The planned Phase 2 study, for the treatment of gastric cancer, is expected to start in H2 2021. Further details of the Oncoral development plan can be found on its dedicated website.Development plan – Phase 2 in gastric cancer With encouraging Phase 1 data, Ascelia Pharma has prepared the next steps of clinical development.

Ascelia Pharma gets US patent for second generation Mangoral

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the US Patent Office (USPTO) has issued a new patent covering a second-generation formulation of lead drug candidate Mangoral, currently in the pivotal Phase 3 study SPARKLE. The new patent further improves the unique value proposition of the Mangoral franchise and provides patent protection until year 2040 in the US.The opportunity to improve the Mangoral product and add patent protection rights add significant value to Ascelia Pharma’s Mangoral franchise. With the new patent, the protection rights are further strengthened until

New study shows Mangoral’s lesion visualization as effective as gadolinium contrast agent

Ascelia Pharma AB (publ) (ticker: ACE) today announced the results from an independent reader study where Mangoral was compared against a gadolinium-based liver specific contrast agent. The results showed that Mangoral was as effective as the gadolinium-based contrast agent gadobenate dimeglumine for visualization of focal liver lesions. The results also showed that Mangoral-enhanced MRI provides improved diagnostic efficacy compared to MRI without a contrast agent using identical endpoints as in Ascelia Pharma’s ongoing pivotal Phase 3 study SPARKLE.The blinded re-read study was performed

Quarterly Report Q3-2020: Raised market estimate for Mangoral and preparing for market launch

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q3-2020 (July – September 2020), which is now available on the company’s website: https://www.ascelia.com/ir-media/reports-presentations/SIGNIFICANT EVENTS IN Q3-2020 · First commercial scale manufacturing of Mangoral · Proceeds from directed share issue received in the beginning of July SIGNIFICANT EVENTS AFTER THE PERIOD · In October, the estimate of the addressable market for Mangoral was upgraded to $500-600 million annually (previously $350-500 million) · In November,

EMA confirms Mangoral eligible for the centralized regulatory procedure in the EU

Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has received confirmation from the European Medicines Agency (EMA) that a Marketing Authorization Application (MAA) for Mangoral is eligible to be submitted in the European Union (EU) under the Agency’s centralized procedure. Mangoral is Ascelia Pharma’s lead drug candidate, currently in Phase 3 development.The centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all EU member states, rather than requiring independent national procedures.

Upgraded estimate of addressable market for Mangoral to $500-600 million annually

Ascelia Pharma AB (publ) (ticker: ACE) today announced that its estimate of the addressable market in the US, EU and Japan for its lead candidate drug Mangoral has been increased to $500-600 million (previously $350-500 million). Preparations for launch are progressing well, with a strong case for own commercialization in the US. Investors, analysts and media are invited to today’s virtual Capital Markets Day where Mangoral’s market opportunity and commercial preparations are in focus.Upgraded estimate of addressable market The addressable market for Ascelia Pharma’s novel contrast agent

Invitation to Ascelia Pharma’s virtual Capital Markets Day

Ascelia Pharma AB (publ) (ticker: ACE) hereby invites analysts, investors and media to its virtual Capital Markets Day on Wednesday October 21, 2020. Focus of the day will be on Mangoral market opportunity and preparations for commercialization.Live Q&A webcastThe virtual event consists of presentations from Ascelia Pharma executives followed by a live Q&A webcast. The presentations will be available on Ascelia Pharma’s website www.ascelia.com on October 21 at 08:00 a.m. CET. The livestreamed Q&A webcast with will take place on October 21 from 14:00-15:00 CET. A recording of the Q&A

First commercial scale manufacturing of Mangoral

Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia”) today announced that the company has reached a key achievement with the first commercial scale manufacturing of its lead compound Mangoral, currently in pivotal Phase 3 development. The commercial scale manufacturing is an important step towards market launch.The milestone was reached in close collaboration with the manufacturing partner Cambrex, based in Whippany, New Jersey, US. All quality and manufacturability requirements were met and reproduced for this full-scale manufacture. High-quality manufacturing is key to patient safety and an

Quarterly Report Q2-2020: First participant in the hepatic study

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q2-2020 (April – June 2020), which is now available on the company’s website: https://www.ascelia.com/tag/reports-presentations/SIGNIFICANT EVENTS IN Q2-2020 · First participant enrolled in the clinical hepatic impairment study with Mangoral · Directed share issue to partly fund preparations for Mangoral market launch · Patent for Oncoral approved in Japan SIGNIFICANT EVENTS AFTER THE PERIOD · Proceeds from directed share issue received in the beginning of July FINANCIAL SUMMARY

Change in number of shares and votes in Ascelia Pharma AB

During July 2020, the number of shares and votes in Ascelia Pharma AB increased due to the directed new share issue, which was completed on 30 June 2020. Per 31 July 2020, the number of shares amounts 28,697,234, whereof 28,186,689 are ordinary shares with one vote per share and 510,545 are class C shares with one-tenth of a vote per share. The total number of votes in the company amounts to 28,237,743.5. For further information, please contact:Magnus Corfitzen, CEOEmail: moc@ascelia.comTel: +46 735 179 118Mikael Widell, Head of IR & CommunicationsEmail: mw@ascelia.com 

Ascelia Pharma completes a directed new share issue of 4,697,781 shares, raising approximately SEK 98.7 million

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, AUSTRALIA, SOUTH AFRICA, NEW ZEALAND, HONG KONG, SINGAPORE OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE MAY BE UNLAWFUL, WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma” or the “Company”) has, based on the authorisation granted by the annual general meeting on 6 May 2020, resolved on a directed new share issue to selected Swedish and international institutional

Vator Securities: Ascelia Pharma: A delay. Fundamentals for Mangoral remain unchanged.

Ascelia Pharma’s announcement of a three to six-month delay of the ongoing pivotal phase III SPARKLE study is not surprising given the circumstances with the ongoing covid-19 pandemic and its impact on clinical trials. While the delay does not affect our view of the commercial prospects of Ascelia’s lead project, we adjust our financial forecast in accordance with the new timeline. Provided that the company generates topline data in H2 2021, instead of in H1 2021, we expect filing to the FDA and EMA in late 2021/ early 2022 followed by approval in 2022 and launch in early 2023.In our

Updated SPARKLE timelines due to Covid-19 impact

Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma”) today announced updated timelines for the completion and top line results of the pivotal Phase 3 study SPARKLE with the lead compound Mangoral, which are now expected in H2 2021 instead of H1 2021 as previously communicated. The expected addition of three to six months reflects the impact of the Covid-19 pandemic.Ascelia Pharma is making good progress towards making Mangoral available to physicians and patients as a safe and effective imaging drug used in liver MRI for patients with severe kidney insufficiency or acute kidney injury.

Interim Financial Report Q1-2020: First patient enrolled in Phase 3 study SPARKLE

Ascelia Pharma AB (publ) (ticker: ACE) today published its interim financial report for Q1-2020 (January – March 2020), which is now available on the company’s website: https://www.ascelia.com/tag/reports-presentations/SIGNIFICANT EVENTS IN Q1-2020 · First patient enrolled in Mangoral’s Phase 3 study SPARKLE · Additional clinical sites opened for patient enrolment · Ascelia Pharma wins the award as the best Life Science company in Malmö, Sweden SIGNIFICANT EVENTS AFTER THE PERIOD · Patent for Oncoral approved in Japan · First participant enrolled in the clinical

Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2020

Today, on 6 May 2020, an annual general meeting was held in Ascelia Pharma AB. A summary of the adopted resolutions follows below. All resolutions were adopted with the required majority.The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.Resolution on adoption of accounts and allocation of the company's resultThe annual general meeting resolved to adopt the income statement and balance sheet as well as the consolidated income statement and consolidated balance sheet. The annual

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