Wrap-Up from Interview with Deputy CEO Julie Waras Brogren
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:
Secondary endpoint:
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
Ascelia Pharma
Ascelia Pharma er et svensk biotek selskab med fokus på behandling af sjældne kræftsygedomme. De udvikler og markedsfører nye lægemidler, hvor der er behov for bedre behandlingsmuligheder eller hvor der ikke findes muligheder for behandling i dag, og de har en klar go-to-market strategi. Ascelia Pharma har to kandidater i pipelinen, Orviglance og Oncoral. Orviglance er et nyt kontrastmiddel til MR-scanning, og udviklet til at forbedre opdagelsen og visualiseringen af fokale leverlæsioner(Inklusiv levermetastaser – og primære tumorer) hos patienter med nedsat lever funktion. Oncoral er en tablet med en potent anti-tumor effekt, der indtages på daglig basis. Oncoral har vist god effekt ved kræftformer der er svære at behandle, og en bedre virkning/bivirkningsprofil for patienten sammenlignet med intravenøs behandlinger med høj dose udført på et hospital. Ascelia Pharma er noteret på Nasdaq Small Cap Stockholm med ticker ACE.
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