Ascelia Pharma

Ascelia Pharma AB (publ) (ticker: ACE) today published its Interim Report Q3 for 2024 (January – September), which is now available on the company’s website: https://www.ascelia.com/ir-media/financial-reports/

KEY EVENTS IN Q3 2024

• Ascelia Pharma carries out a Rights Issue of units of approximately SEK 105 million
• Notice of and bulletin from Extraordinary General Meeting on 14 August
• Announcement of outcome in fully subscribed SEK 105 million Rights Issue with runway extended to late 2025
• Ascelia Pharma resolves on a directed issue of convertibles of SEK 7.5 million
• Change in number of votes and shares in Ascelia Pharma AB

KEY EVENTS AFTER THE PERIOD

• Orviglance SPARKLE study primary results accepted as cutting-edge oral presentation at RSNA 2024
• Proposal for election of Marianne Kock as new member of the Board of Directors
• Notice of and bulletin from Extraordinary General Meeting on 30 October
• Orviglance SPARKLE data to be presented as late breaking abstract at Kidney Week 2024
• Completion of Full Study Report reinforces the successful outcomes of SPARKLE

FINANCIAL SUMMARY Q3 (Jul-Sep) 2024

• Operating result of SEK -17.8M (SEK -21.4M)
• Earnings per share of SEK -0.42 (SEK -0.63)
• Cash flow from operations of SEK -17.0M (SEK -31.0M)
• Liquid assets and marketable securities of SEK 95.7M (SEK 39.0M)

” We have met a major milestone this year with the successful headline results from our pivotal Phase 3 study, SPARKLE and hereby the completion of clinical development for Orviglance. The results showed that Orviglance significantly improved the visualization of focal liver lesions, successfully meeting the primary endpoint with statistical significance for all three readers (<0.001).

As communicated early November, the Full Study Report has also been completed and includes the results of secondary endpoints, which further reinforce the successful study outcomes and support the NDA process and potential clinical value of Orviglance.

The Rights Issue financing launched in July was completed early September with a fully subscribed SEK 105 million financing. With the full financing in place, the cash runway of the company extends until late 2025 well beyond the NDA submission.

With this financing in place we are in a strong position to deliver on our key priorities ahead; bringing Orviglance through the regulatory submission and approval process with a submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) expected by mid-2025 and continue. In parallel, we continue to advance the dialogue with potential commercialization partners to launch Orviglance and make it available to patients in need of a high-quality liver imaging option without gadolinium-related safety risks.”, said Magnus Corfitzen, CEO at Ascelia Pharma.
 
A presentation for analysts, investors and media will be held today 7 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: Ascelia Pharma Q3 Report 2024 (financialhearings.com)

To participate via teleconference, please register through the link below. After registration, you will be provided with phone numbers and a conference ID to access the conference. Call Access (finacialheraings.com)
 
It will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: https://www.ascelia.com/ir-media/