Regulatory press release

Half-Year report 2023: Re-evaluation required after intra-reader inconsistency in scoring of images from phase 3 study SPARKLE

Ascelia Pharma AB (publ) (ticker: ACE) today published its half-year financial report for 2023 (January – June 2023), which is now available on the company’s website: https://www.ascelia.com/ir-media/financial-reports/

SIGNIFICANT EVENTS IN Q2 2023

Hepatic impairment study accepted for presentation at major radiology and liver conferences
Ascelia Pharma presented Orviglance hepatic impairment data and hosted a Q&A with liver imaging experts at the 2023 ESGAR annual meeting

SIGNIFICANT EVENTS AFTER THE PERIOD

Re-evaluation required after intra-reader inconsistency in scoring of images from phase 3 study SPARKLE
Clarification that the images were not read and scored properly

FINANCIAL SUMMARY Q2 2023

Operating result of SEK -41.8M (SEK -32.7M)
Earnings per share of SEK -1.19 (SEK -0.68)
Cash flow from operations of SEK -42.3M (SEK -32.7M)
Cash and marketable securities of SEK 70.5M (SEK 208.9M)

FINANCIAL SUMMARY H1 2023

Operating result of SEK -78.5M (SEK -65.2M)
Earnings per share of SEK -2.30 (SEK -1.54)
Cash flow from operations of SEK -79.8M (SEK -60.1M)
Cash and marketable securities of SEK 70.5M (SEK 208.9M)

“This year, our focus has been on completing SPARKLE, the pivotal Phase 3 study for our first-in class magnetic resonance imaging (MRI) contrast agent Orviglance®. We successfully completed patient enrollment in March. In early August, we found that a high “intra-reader variability” in the image scoring by independent radiologists prevented us from evaluating the efficacy data to generate results from the SPARKLE study. As per FDA guidance, intrareader variability is determined by the variance in ratings of a pre-defined number of patient images evaluated twice by the same reader at different time points. Due to this finding, we will unfortunately have to conduct a new evaluation of the images with independent readers before we can generate results from SPARKLE study. Although the planned re-evaluation does not require new or additional patient recruitment or clinical data, this is a regrettable setback for our timelines. Preparations for the re-evaluation are already underway, and we will communicate the timeline and financial implications for this mid-September. Most importantly, our confidence in the potential for Orviglance is unchanged and we are dedicated to making the product available for the patients in need of a gadolinium free liver imaging”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 18 August 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-q2-2023

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=5001498

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/

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 clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has been completed. Results from the Phase 3 study are not yet available.

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.