Release Date: November 07, 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) successfully completed a pivotal phase three clinical study for Orby Gland, advancing it to the regulatory phase with an NDA submission planned for mid-2025.
- The company raised SEK105 million through a fully subscribed rights issue, providing a cash runway until late 2025.
- Orby Gland addresses a significant unmet medical need in liver MRI for patients with severe kidney impairment, targeting an $800 million global market.
- The Sparkle study demonstrated that Orby Gland provides superior imaging compared to unenhanced MRI, with statistically significant results.
- Ascelia Pharma AB (FRA:7ZA) is actively pursuing commercialization partnerships to optimize the launch and revenue potential of Orby Gland.
Negative Points
- The company faces a lengthy and complex NDA submission process, with a standard 10-month review period anticipated from the FDA.
- There is uncertainty regarding the potential for priority review by the FDA, which could impact the timeline for Orby Gland's approval.
- Ascelia Pharma AB (FRA:7ZA) has not yet secured a commercialization partner, which is crucial for the successful launch of Orby Gland.
- The company's operating loss increased to SEK17.8 million in Q3, driven by costs associated with NDA preparations.
- There is a risk associated with the reliance on external resources and CROs for the NDA submission process, which could affect timelines and costs.
Q & A Highlights
Q: Can you provide more details on the process leading up to the pre-NDA meetings with the FDA?
A: We are preparing for the pre-NDA meeting and expect to receive feedback in Q1 next year. The outcome will guide us towards the NDA submission in mid-2025. It's a detailed process, and we are ensuring it is done diligently. - Andreas Norlin, Chief Scientific Officer
Q: Should we expect external resources to be involved during the pre-submission meeting and up to the submission?
A: Yes, we are working with external resources, including CROs, to manage the extensive documentation and data required. This is accounted for in our current budget and cash runway. - Andreas Norlin, Chief Scientific Officer
Q: Can you provide context on the secondary endpoints, such as the mean size of the smallest lesion detected?
A: The mean size for unenhanced images was around 17-20 millimeters, and with Orviglance, it was approximately two millimeters smaller. In half of the patients, we found at least one more lesion with Orviglance. - Andreas Norlin, Chief Scientific Officer
Q: How are the partnering dialogues progressing, and what is the level of interest from potential partners?
A: The dialogues are progressing well. Conferences provide opportunities to meet potential partners, but the partnering process is independent. We confirm ongoing discussions and interest. - Julie Waras Brogren, Deputy CEO & Chief Compliance Officer
Q: What are your priorities in terms of deal economics when negotiating a potential licensing deal?
A: It's important that the agreement is attractive for both parties. We aim for a traditional transaction with upfront payments, milestones, and royalties, ensuring mutual success. - Magnus Corfitzen, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
