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Published: 2022-05-11 08:00:00 CEST
Ascelia Pharma AB
Interim report (Q1 and Q3)

Quarterly Report Q1 2022: Strong Orviglance support from healthcare professionals

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q1 2022 (January – March 2022), which is now available on the company’s website: https://www.ascelia.com/ir-media/financial-reports/

SIGNIFICANT EVENTS IN Q1 2022

  • Market research from healthcare professionals provides strong Orviglance support
  • Suspension of Russian clinical activities for Orviglance
  • Last patient visit completed in Orviglance Hepatic Impairment Study
  • Orviglance comparison study to gadolinium accepted for ESGAR conference
  • Issue and repurchase of series C shares for share saving program

 
SIGNIFICANT EVENTS AFTER THE PERIOD

  • New study positively shows that Orviglance MRI liver enhancement is not influenced by intake of a light meal
  • CFO Kristian Borbos resigns; search for successor ongoing

 
FINANCIAL SUMMARY Q1 2022

  • Operating result of SEK -32.6M (SEK -33.7M)
  • Earnings per share of SEK -0.84 (SEK -1.00)
  • Cash flow from operations of SEK -31.4M (SEK -22.9M)
  • Cash and marketable securities of SEK 232.6M (SEK 165.4M)

 
“In the first quarter, we continued to make progress with Orviglance. Most importantly, we completed patient recruitment in the Hepatic Impairment Study and announced the results from an extensive market research showing very strong support among healthcare professionals for a new contrast agent with a profile as Orviglance. After the period, we also reported results from our successful Food Effect Study which shows positively that Orviglance MRI liver enhancement is not influenced by intake of a light meal.
Because of the Russian invasion of Ukraine, we decided to suspend all clinical activities in Russia. Our expectation is to complete patient enrollment for the SPARKLE study in 2022. As our clinical development team is fully focused on SPARKLE, we will not de-focus them and hence postpone initiation of patient enrollment in the Oncoral Phase 2 study until we are able to do this without impacting SPARKLE”, 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, CFO Kristian Borbos, CMO Carl Bjartmar and CCO Julie Waras Brogren. The presentation will be held in English. The presentation can be followed live via the link: https://tv.streamfabriken.com/ascelia-pharma-q1-2022

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:
SE: +46 850 558 373
UK: +44 333 3009 269
US: +1 646 7224 903
DK: +45 787 232 52

Contacts

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

Mikael Widell, IR & Communications
Email: mw@ascelia.com
Tel: +46 703 11 99 60

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.


220511 Ascelia Pharma Q1 Report 2022 EN.pdf
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