Regulatory

QUARTERLY REPORT Q4 2022: Orviglance phase 3 study, SPARKLE, expected to be completed in Q1 2023.

2023-02-10
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Ascelia Pharma AB (publ) (ticker: ACE) today published its Q4 financial report for 2022 (January – December 2022), which is now available on the company’s website:

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

SIGNIFICANT EVENTS IN Q4 2022

  • New strong Orviglance data support successful SPARKLE completion with substantially fewer patients.
  • Ascelia Pharma expands management team to prepare for commercialization.
  • Presentation at the RSNA congress of results from Orviglance food effect study showing strong liver enhancement both with light meal and in fasting condition.
  • 65 patients have completed SPARKLE at the end of 2022.

SIGNIFICANT EVENTS AFTER THE PERIOD

  • 71 patients have completed the SPARKLE study by January 27 2023.

FINANCIAL SUMMARY Q4 2022

  • Operating result of SEK -52.2M (SEK -39.2M)
  • Earnings per share of SEK -1.53 (SEK -1.01)
  • Cash flow from operations of SEK -28.7M (SEK -32.2M)
  • Cash and marketable securities of SEK 149.6M (SEK 261.6M)

FINANCIAL SUMMARY FY 2022

  • Operating result of SEK -147.0M (SEK -137.9M)
  • Earnings per share of SEK -3.77 (SEK -3.82)
  • Cash flow from operations of SEK -125.3M (SEK -116.6)
  • Cash and marketable securities of SEK 149.6M (SEK 261.6M)

“The fourth quarter of 2022 completed a very intense and productive year for Ascelia Pharma, with a particular focus on the important Phase 3 program with our investigational magnetic resonance imaging (MRI) contrast agent Orviglance®. In December, we presented an updated plan for the pivotal Phase 3 clinical SPARKLE study with Orviglance that will now be completed with 80 patients due to a significantly higher Orviglance effect than originally expected. Earlier in the year, we successfully completed the two other clinical studies which are part of our Phase 3 program for Orviglance – the Hepatic Impairment Study and the Food Effect Study. Our progress in the development of Orviglance in the fourth quarter sets us on course for a successful 2023. The entire Ascelia Pharma team is excited to bring Orviglance forward towards a successful 2023, with completion of patient enrollment, headline results and preparations of regulatory submission and launch.”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 10 February 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-q4-2022

To participate via teleconference, please register through the link below. After registration, you will be provided phone numbers and a conference ID to access the conference. https://conference.financialhearings.com/teleconference/?id=5009439

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/