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Analyst Comment

Wrap-Up from Interview with Deputy CEO Julie Waras Brogren

By Claus ThestrupCEO, Sweden
Ascelia Pharma

We recently hosted an event in conjunction with the Q3 report and the announcement of the full data package completion for the Phase 3 Orviglance – SPARKLE study.

As Ascelia Pharma prepare for the pre-submission meeting with the FDA and the planned NDA filing for Orviglance in mid-2025, investors should anticipate an increase in costs. To support this, the company conducted a fully subscribed rights issue in Q3, raising SEK 105 million gross. Additionally, further funding is expected from the TO1 warrant in April 2025, which, if fully subscribed, could bring in another SEK 70 million. Beyond funding efforts, Ascelia Pharma is in active discussions with potential partners for the full commercialization of Orviglance. Terms have not yet been announced but are expected to include milestone payments and royalties.

Orviglance addresses an unmet need in liver imaging for cancer patients with severe kidney impairment, a market valued at approximately USD 800 million, with half of the potential in the U.S.

Deputy CEO Julie W. Brogren shared two highly insightful slides, presenting the primary and secondary endpoints from the full study report.

Primary endpoint:

Ascelia Primary

Secondary endpoint:

Ascelia Secondary

With strong data on both primary and secondary endpoints, a robust balance sheet, and promising partnership discussions, Ascelia Pharma is well-positioned to achieve its milestone objectives.

Listen to the interview here: Ascelia Pharma interview

Disclaimer: HC Andersen Capital receives payment from the Ascelia Pharma for a Digital IR/Corporate Visibility subscription agreement. Analyst Claus Thestrup 8:15 AM, 14.11.2024

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Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.

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