Release Date: August 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Ascelia Pharma AB (FRA:7ZA, Financial) completed the pivotal Phase 3 clinical study for Orviglance, marking a significant milestone in the company's history.
- Orviglance has orphan drug designation from the FDA and targets an $800 million annual market opportunity.
- The SPARKLE Phase 3 study demonstrated strong superior enhancement of liver lesion visualization with Orviglance compared to unenhanced MRI.
- The company has secured a rights issue to raise up to SEK105 million, with SEK70 million guaranteed, to finance key milestones.
- Oncoral, another drug in the pipeline, is ready to start Phase 2 trials for gastric cancer, showing promising results from Phase 1.
Negative Points
- Ascelia Pharma AB (FRA:7ZA) reported an operating loss of SEK11.3 million in Q2 2024.
- The company's share price has declined by 92% over the past three years, raising concerns among shareholders.
- There are potential risks and delays associated with the pre-submission meeting with the FDA for Orviglance.
- The company faces challenges in securing commercialization partnerships for Orviglance.
- Intra-reader variability issues during the first readout process could pose challenges in discussions with partners and the FDA.
Q & A Highlights
Q: Please provide more details regarding the critical steps towards submission, any risk and delays relating to the clinical protocol or delays and questions/changes as a result of the pre-submission meeting.
A: Andreas Norlin, Chief Scientific Officer: The critical steps include obtaining the full report from the pivotal study, which forms the basis for discussions with the FDA during the pre-submission meeting. This meeting is crucial to agree on the content of the application and the proposed label for the drug. While the FDA may provide feedback that could require adjustments, we consider the risk of significant delays to be low. We have maintained ongoing communication with the FDA throughout development, adhering to their recommendations to minimize unexpected feedback.
Q: What is the status of the partnering discussions?
A: Julie Waras Brogren, Deputy CEO and Chief Compliance Officer: Partnering discussions are ongoing, and the successful Phase III results have further reduced risks, aiding these dialogues. The rights issue financing is also crucial for maintaining a strong negotiating position. We will announce any partnership developments as they materialize.
Q: Is the issue with intra-reader variability during the first readout process last year a potential issue in discussions with partners or the FDA process?
A: Andreas Norlin, Chief Scientific Officer: We have a solid rationale for the re-evaluation due to data quality issues, and this is not expected to be a problem in the FDA process. Intra-reader variability is a common issue in the industry, and partners are familiar with it, so it should not impact partnering discussions.
Q: With the share price decline of 92% in three years, how are you working to regain the confidence from your shareholders?
A: Magnus Corfitzen, CEO: We understand the frustration and share the pain, as management and the Board have also invested in Ascelia. Despite past challenges, we have achieved successful Phase 3 data. Our focus is on achieving strong operational and strategic results, particularly in advancing the NDA process and securing commercialization partnerships, which are key value drivers for Ascelia.
Q: What sort of deal structures can be expected for partnerships?
A: Julie Waras Brogren, Deputy CEO and Chief Compliance Officer: Typical deal structures in the industry include a combination of upfront payments and royalties, often linked to milestones and sales progress. Our goal is to secure the best possible agreement to benefit Ascelia and create shareholder value.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
