Ascelia Pharma

KEY EVENTS IN Q3 2023

• Re-evaluation required after intra-reader inconsistency in scoring of images from phase 3 study SPARKLE
• Ascelia Pharma significantly reduces organization to reach SPARKLE headline results
• Ascelia Pharma to reach headline results from SPARKLE re-evaluation by May 2024 with current funding

KEY EVENTS AFTER THE PERIOD

• Ascelia Pharma gets acceptance for publication of Orviglance® review article in Investigative Radiology
• Ascelia Pharma convenes an Extraordinary General Meeting on November 13, 2023 to vote on a proposal to introduce an employee stock option program 

FINANCIAL SUMMARY Q3 (Jul-Sept) 2023

• Operating result of SEK -21.4M (SEK -29.6M)
• Earnings per share of SEK -0.63 (SEK -0.77)
• Cash flow from operations of SEK -31.0M (SEK -32.2M)
• Cash and marketable securities of SEK 39.0M (SEK 179.8M)

FINANCIAL SUMMARY 9M (Jan-Sept) 2023

• Operating result of SEK -99.9M (SEK -94.8M)
• Earnings per share of SEK -2.93 (SEK -2.25)
• Cash flow from operations of SEK -110.0M (SEK -96.6M)
• Cash and marketable securities of SEK 39.0M (SEK 179.8M)

“This year, our focus has been on completing SPARKLE, the pivotal Phase 3 study for our orphan magnetic resonance imaging (MRI) contrast agent for liver imaging, Orviglance®. We successfully completed patient enrollment in March. In early August, it was discovered that high intra-reader variability in the study image scoring by independent radiologists prevented us from evaluating the efficacy data from SPARKLE. Due to this finding, we are now conducting a new evaluation of the images with new independent readers. With the aim of completing the re-evaluation with current funding, we have undergone significant cost-cutting initiatives and a reduction of the organization, as communicated end August. All our efforts and resources are now focused on the image reevaluation, and in September we communicated that we expect headline results from SPARKLE by May 2024, and that we can complete the re-evaluation with currently available funding. In addition, we expanded the commercialization strategy for Orviglance to also consider launching Orviglance in the US with a partner. While the re-evaluation is a regrettable setback on our timelines, our confidence in the potential of Orviglance is unchanged and we are dedicated to making the product available for patients in need of a gadolinium free liver imaging agent”, said Magnus Corfitzen, CEO at Ascelia Pharma.
 
A presentation for analysts, investors and media will be held today 8 November at 10:00am CET.

The event will be hosted by the company’s CEO Magnus Corfitzen, Deputy CEO Julie Waras Brogren, 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-report-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=5003498
 
It will also be possible to take part of the audiocast afterwards at the same address or on the website of Ascelia Pharma: 
https://www.ascelia.com/ir-media/