Regulatory

Phase III study of Mangoral to start in H2-2019

2019-08-22
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Ascelia Pharma AB (publ) (ticker: ACE) today announced that its full-year report for the period July 2018 – June 2019 is now available on the company’s website: https://www.ascelia.com/tag/reports-presentations/

SIGNIFICANT EVENTS IN Q4 (APRIL-JUNE 2019)

  • Encouraging results from Oncoral’s Phase I combination study with oral capecitabine
  • Supportive feedback from EMA on the Phase III program for Mangoral
  • New patent application filed for Mangoral with potential to extend IP rights to year 2040
  • IPO overallotment utilised raising SEK 22 million

FINANCIAL SUMMARY IN Q4 (APRIL – JUNE 2019)

  • Operating result of SEK -14.5M (SEK -8.2M)
  • Earnings per share of SEK -0.62 (SEK -0.62)
  • Cash flow from operations of SEK -14.4M (SEK -3.2M)
  • Cash and cash equivalents of SEK 225.0M (SEK 55.1M)

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

  • No significant events after the reporting period

“This fiscal year has been the most transformative period of Ascelia Pharma’s history so far. Apart from the scientific development with our lead candidates, we also made a successful and substantially oversubscribed listing on Nasdaq Stockholm which provided us with approximately SEK 222 million in gross proceeds. This means that we now have a fully financed Phase III study of Mangoral, which we plan to initiate later in 2019 with final results late 2020 or at the beginning of 2021”, said Magnus Corfitzen, CEO at Ascelia Pharma.”

A presentation for investors, analysts and media and will be held today 22 August at 09:00 CET. The event will be hosted by the company’s CEO Magnus Corfitzen, CFO Kristian Borbos and CMO Carl Bjartmar. The presentation will be held in English. The presentation can be followed live via the link:
https://tv.streamfabriken.com/ascelia-pharma-q4-2018-2019

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/tag/reports-presentations/

To participate in the telephone conference, please use the dial-in details shown below:
SE: +46 85 055 83 50

UK: +44 33 3300 9267

US: +1 833 823 0587


For more information, please contact:

Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel.
46 735 179 110

Mikael Widell, Head of IR & Communications
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 22 August 2019.

About Ascelia Pharma
Ascelia Pharma is an oncology-dedicated orphan drug development company located in Malmö, Sweden. The company’s strategy is to develop drugs, which target unmet medical needs, have an established mode of action and a relatively low development risk. Ascelia Pharma has two drug candidates – Mangoral® and Oncoral – currently under development.

Mangoral is a novel contrast agent for MR-scans and is ready for Phase III clinical studies. Mangoral is developed to improve the visualization of focal liver lesions (liver metastases) in patient with impaired kidneys that cannot tolerate current gadolinium contrast agents on the market. Oncoral is an oral chemotherapy tablet ready for Phase II for the treatment of gastric cancer. Ascelia Pharma is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.