Ascelia Pharma: Wrap up from interview Deputy CEO and CFO Julie Waras Brogren

The Share Price Closed Up by 5,6% in SEK 3,02 Friday.

We hosted an event with Deputy CEO and CFO Julie W. Brogren in connection with the company’s full-year report. The focus of the event was a review of the financial results, key developments from 2024, and what investors should pay attention to in 2025.

Deputy CEO and CFO Julie W. Brogren presented the Phase 3 data from the SPARKLE study on Orviglance, highlighting the primary and secondary endpoints as well as the safety profile:

• “The Phase 3 study demonstrated strong superiority in the visualization of focal liver lesions with Orviglance (CMRI) compared to unenhanced MRI. Visualization scores were significantly higher with Orviglance across all three readers, achieving statistical significance.
• Secondary efficacy endpoints supported the primary analysis, confirming the robustness of the positive results, including lesion detection. Across all readers, at least one new lesion was detected in 40–52% of patients with Orviglance.
• In terms of common adverse events, they were consistent with previous studies, such as mild to moderate nausea, and no serious adverse drug reactions were observed.”

The study was conducted on 286 healthy individuals, demonstrating convincing efficacy and a strong safety profile for the target patient population.

The company’s current focus is on the next meeting with the FDA, scheduled for Q1 2025. During the event, Deputy CEO and CFO Julie W. Brogren elaborated on the process, noting that the meeting will cover both technical and strategic aspects. The company maintains its previous guidance, expecting to provide more information in Q1 2025. Additionally, she provided insights into the approval timeline and potential pathways with the FDA.

Another key topic was the timing of a potential partnership agreement for Orviglance. There has been ongoing speculation about when such an agreement might be finalized. Julie W. Brogren shared insights into what the company is looking for in a partner and confirmed that time is on their side. With strong headline data, a comprehensive study data package, secured financing to late 2025, and significant efforts invested in preparing for the FDA meeting, Ascelia Pharma is well-positioned for the next steps.

If you missed Friday’s event, you can watch it here: Ascelia Pharma interview

Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR/Corporate Visibility agreement.
Claus Thestrup, 8:15 AM, 10-02-2025