Regulatory

QUARTERLY REPORT Q3 2022: Successful completion of two out of three studies for regulatory submission

2022-11-04
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Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q3 2022(January – September 2022), which is now available on the company’s website:

https://www.ascelia.com/ir-media/financial-reports/

SIGNIFICANT EVENTS IN Q3 2022

  • Final results for the Hepatic Impairment Study marks the completion of the second study in the ongoing Phase 3 clinical program for registration of Orviglance.
  • Results from the Orviglance Food Effect Study have been accepted as an oral presentation at the world’s largest radiology conference, RSNA.

SIGNIFICANT EVENTS AFTER THE PERIOD

  • Leadership team expanded to seven members to prepare for expected growth.

FINANCIAL SUMMARY Q3 2022

  • Operating result of SEK -29.6M (SEK -32.7M)
  • Earnings per share of SEK -0.77 (SEK -0.82)
  • Cash flow from operations of SEK -32.5M (SEK -30.7M)
  • Cash and marketable securities of SEK 179.8M (SEK 291.0M)

FINANCIAL SUMMARY 9M 2022

  • Operating result of SEK -94.8M (SEK -98.8M)
  • Earnings per share of SEK -2.25 (SEK -2.80)
  • Cash flow from operations of SEK -96.6M (SEK -84.3)
  • Cash and marketable securities of SEK 179.8M (SEK 291.0M)

“Ascelia Pharma continued to make strong progress on our clinical projects in Q3 2022, particularly the important Phase 3 program with our investigational magnetic resonance imaging (MRI) contrast agent Orviglance®. We have successfully completed two clinical studies – Hepatic Impairment Study and Food Effect Study – that have run in parallel with the pivotal clinical study SPARKLE, which is a solid step forward in our preparations for regulatory submission and approval of Orviglance. Looking ahead. Our prime focus in 2022 is unchanged – to complete the clinical Phase 3 program for Orviglance and continue preparations for NDA filing and commercialization”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 4 November at 10:00am CET. The event will be hosted by the company’s CEO Magnus Corfitzen, Deputy CEO & CCO Julie Waras Brogren, CFO Déspina Georgiadou Hedin and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via the link: https://ir.financialhearings.com/ascelia-pharma-q3-2022

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/financial-reports/

To participate in the telephone conference, please use the dial-in details shown below:
DK: +45 781 501 08
SE: +46 8 505 583 75
UK: +44 333 3009 270
US: +1 646 7224 957