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Ascelia Pharma

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

MARKN.

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/

Contacts

Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118

Déspina Georgiadou Hedin, CFO and Investor Relations
Email: despina.georgiadou@ascelia.com
Tel: +46 765 697 873

This information was submitted for publication, through the agency of the contact persons set out above.

About Us

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 – Orviglance (previously referred to as 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 Orviglance (previously referred to as Mangoral)
Orviglance (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. Orviglance, 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 irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.

Attachments

Ascelia Pharma Q4 Rapport 2022 EN

Datum 2023-02-10, kl 08:00
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Ascelia Pharma Q4 Rapport 2022 EN
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