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Ascelia Pharma

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

MARKN.

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

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

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 – Orviglance® (Mangoral) and Oncoral – in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.

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.

About us

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 – Orviglance® (Mangoral) and Oncoral – in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit 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 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.

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Ascelia Pharma Q3 Report 2022 EN FINAL

Datum 2022-11-04, kl 08:00
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Ascelia Pharma Q3 Report 2022 EN FINAL
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