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2021-11-04

Quarterly Report Q3 2021: Oncoral – entering clinical collaboration

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q3 2021 (July – September 2021), which is now available on the company’s website: https://www.ascelia.com/ir-media/reports-presentations/

SIGNIFICANT EVENTS IN Q3 2021

  • Clinical collaboration agreement with Taiho Oncology Inc. for the development of Oncoral in combination with LONSURF®
  • Abstract for Orviglance® comparison study to gadolinium accepted as an oral paper presentation at the world’s largest radiology conference RSNA
  • FDA conditionally accepted Orviglance as the brand name for Mangoral
  • Guidance for expected recruitment completion to the SPARLE trial was extended to H1 2022 (previously H2 2021)

 
SIGNIFICANT EVENTS AFTER THE PERIOD

  • Food Effect Study with Orviglance successfully completed

 
FINANCIAL SUMMARY Q3 2021

  • Operating result of SEK -32.7M (SEK -16.3M)
  • Earnings per share of SEK -0.82 (SEK -0.51)
  • Cash flow from operations of SEK -30.7M (SEK -18.9M)
  • Cash and marketable securities of SEK 291.0M (SEK 220.7M)

 
“We are making steady progress across our clinical portfolio. Particularly, for our novel chemotherapy tablet Oncoral, we signed in September an important clinical collaboration agreement with Taiho Oncology. The collaboration concerns the upcoming global Phase 2 clinical study in gastric cancer with Oncoral in combination with Taiho Oncology’s LONSURF (trifluridine and tipiracil). The agreement shows the potential for Oncoral to be part of a new all-oral treatment regimen for gastric cancer.

We also continued the clinical development program and the commercial preparations for Orviglance, our diagnostic drug currently in Phase 3. The progress continued after the quarter when we completed our food effect study with Orviglance in October”, 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, 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-q3-2021

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/reports-presentations/ 

To participate in the telephone conference, please use the dial-in details shown below:
SE: +46 8 505 583 74
UK: +44 333 3009 035
US: +1 833 5268 396
DK: +45 354 455 77 (DK-PIN: 84534526#)

Contacts


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

Mikael Widell, Head of 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.

Attachments


Ascelia Pharma Q3 Report 2021 EN

Författare MFN