Regulatory

QUARTERLY REPORT Q1 2023: Orviglance phase 3 study, SPARKLE, Last Patient Last Visit (LPLV) has been completed

2023-05-11
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Ascelia Pharma AB (publ) (ticker: ACE) today published its Q1 financial report for 2023 (January – March 2023), which is now available on the company’s website:

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

SIGNIFICANT EVENTS IN Q1 2023

  • Ascelia Pharma achieves last patient last visit (LPLV) in the Orviglance Phase 3 Sparkle study which now includes 85 completed patients
  • Investor update: Bringing Orviglance to market – Next steps towards launch
  • Third US Patent strengthens patent protection for Ascelia Pharma´s Oncoral (daily tablet irinotecan)
  • Ascelia Pharma resolves on conversion of series C shares into ordinary shares for delivery to participants in incentive program
  • Ascelia Pharma mourns the passing of board member René Spogárd

SIGNIFICANT EVENTS AFTER THE PERIOD

  • No significant events after the period

FINANCIAL SUMMARY Q1 2023

  • Operating result of SEK -36.7M (SEK -32.6M)
  • Earnings per share of SEK -1.07 (SEK -0.84)
  • Cash flow from operations of SEK -37.5M (SEK -31.4M)
  • Cash and marketable securities of SEK 111.4M (SEK 232.6M)

“ Following an intense and challenging 2022, we continued to make steady progress in the first quarter 2023, where the completion of patient enrollment for the phase 3 study with Orviglance, SPARKLE, puts us on course for a successful 2023.”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 11 May 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-q1-2023

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=200756

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, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A pivotal clinical program of nine studies, including the global Phase 3 study SPARKLE, have been completed. Headline results from the Phase 3 study are expected mid-2023.

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 Q1 2023 EN 2023 05 11

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