Regulatory

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

2021-02-16
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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 development plan for Oncoral

FINANCIAL SUMMARY Q4 2020

  • Operating result of SEK -27.9M (SEK -22.9M)
  • Earnings per share of SEK -1.25 (SEK -1.16)
  • Cash flow from operations of SEK -27.6M (SEK -16.8M)
  • Cash and marketable securities of SEK 184.7M (SEK 184.2M)

“We are very pleased with the results of the blinded re-read study of Mangoral as it provides a robust evidence of the diagnostic value that Mangoral offers and the clear unmet medical need it fills. The re-read study further strengthens the data package to the regulatory authorities. We see a very attractive commercial opportunity for Mangoral and have raised our estimate of the addressable market to $500-600 million annually. Particularly in the US, we have an attractive opportunity to build our own commercial team to bring Mangoral to patients”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 16 February at 10:00am CET. The event will be hosted by the company’s CEO Magnus Corfitzen, CFO Kristian Borbos, CMO Carl Bjartmar and CCO Julie Waras Brogren. The presentation will be held in English. The presentation can be followed live via the link: https://tv.streamfabriken.com/ascelia-pharma-q4-2020

It will also be possible to take part of the audiocast afterwards at the same address or at Ascelia Pharma’s website: https://www.ascelia.com/ir-media/reports-presentations/

To participate in the telephone conference, please use the dial-in details shown below:
SE: +46 850 558 351
UK: +44 333 3009 270
US: +1 833 8230 587
DK: +45 787 232 52

For more information, please contact
Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118

Mikael Widell, IR & Communications Manager
Email: mw@ascelia.com
Tel: +46 703 11 99 60

The information was submitted for publication, through the agency of the contact person set out above, at 8.00 am CET on 16 February 2021.

About Ascelia Pharma
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Mangoral and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.

About Mangoral
Mangoral (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed 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. Mangoral, 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.

About Oncoral
Oncoral is a novel oral irinotecan chemotherapy tablet for the treatment of gastric cancer. Oncoral has the potential to offer a more patient friendly cancer drug regimen including a better safety profile following daily tablet dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, the Phase 2 for Oncoral is in preparation.

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Bulletin from the Annual General Meeting in Ascelia Pharma AB on 5 May 2021

Today, on 5 May 2021, the annual general meeting was held in Ascelia Pharma AB. In light of the ongoing Covid-19 pandemic and in order to reduce the risk of infection spreading, the annual general meeting was held only by advance voting (postal vote) in accordance with temporary legislation. A summary of the adopted resolutions follows below. All resolutions were adopted with the required majority of votes.
2021-04-30

Number of shares and votes in Ascelia Pharma AB