Ascelia Pharma

Ascelia Pharma AB (publ) (ticker: ACE) today published its Interim Report Q1 for 2024 (January – March), which is now available on the company’s website though this link.

KEY EVENTS IN Q1 2024

• Nomination Committee appointed for the Annual General Meeting 2024
• Orviglance review article is published in Investigative Radiology
• Ascelia Pharma secures financing of up to SEK 35 million

KEY EVENTS AFTER THE PERIOD

• SPARKLE image reading completed with expected headline results first half of May 2024
• Ascelia Pharma draws down SEK 15 million second tranche under existing loan
• Primary endpoint successfully met with strong headline results in Orviglance phase 3 study
• Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024
• Ascelia Pharma hosts Investor Update: Bringing Orviglance to Patients

FINANCIAL SUMMARY Q1 (Jan-Mar) 2024

• Operating result of SEK -16.7M (SEK -36.7M)
• Earnings per share of SEK -0.5 (SEK -1.1)
• Cash flow from operations of SEK -15.0M (SEK -37.5M)
• Liquid assets and marketable securities of SEK 26.5M (SEK 111.4M)

“On 2 May 2024, we announced positive headline results from our Phase 3 study with Orviglance. It was a day the entire team has been eagerly waiting for. The results were strong and showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study, SPARKLE with statistical significance for all three readers (<0.001). These strong results mark the completion of clinical development for Orviglance and reinforce our confidence in the regulatory and commercial path ahead for Orviglance.

We will now focus on bringing Orviglance through the regulatory submission and approval process. In parallel, we will continue to advance launch readiness and dialogue with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without gadolinium related safety risk. Submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) to obtain regulatory approval is expected by mid-2025.

We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond”, said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 16 May 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 this link.
To participate via teleconference, please register through this link. After registration, you will be provided with phone numbers and a conference ID to access the conference.
 
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/.