Regulatory

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

2020-11-05
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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, confirmation was received from EMA that Mangoral is eligible for the centralized regulatory procedure in the EU

FINANCIAL SUMMARY Q3-2020

  • Operating result of SEK -16.3M (SEK -13.9M)
  • Earnings per share of SEK -0.51 (SEK -0.54)
  • Cash flow from operations of SEK -18.9M (SEK -20.1M)
  • Cash and marketable securities of SEK 220.7M (SEK 205.3M)


“Preparations for commercialization of Mangoral progress according to plan and during the third quarter we took yet another step towards market launch with the first commercial scale manufacturing. We see a very attractive commercial opportunity for Mangoral and have recently 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. We continue to monitor the development of the pandemic. We take every precaution to ensure both that everyone in our organization and those working on our Phase 3 trial SPARKLE are safe and well, and that the clinical program continues according to plans”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 5 November 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-q3-2020

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: +46 850 558 353
UK: +44 333 3009 265
US: +1 833 8230 590
DK: +45 781 501 07

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 5 November 2020.


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 http://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.

2020-11-13

Ascelia Pharma included in the global stock market index MSCI World Micro Cap

2020-11-05

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/
2020-11-03

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.