In This Article:
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Rights Issue: Fully subscribed to SEK105 million.
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Convertible Loan Repayment: SEK7.5 million repaid to Fenia Capital.
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Cash Position: SEK96 million at the end of September.
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Operating Loss: SEK17.8 million in Q3.
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Cash Runway: Extends to late 2025.
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Potential Additional Financing: Up to SEK70 million from warrant series T1 in April 2025.
Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Ascelia Pharma AB (FRA:7ZA) 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.
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The company raised SEK105 million through a fully subscribed rights issue, providing a cash runway until late 2025.
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Orby Gland addresses a significant unmet medical need in liver MRI for patients with severe kidney impairment, targeting an $800 million global market.
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The Sparkle study demonstrated that Orby Gland provides superior imaging compared to unenhanced MRI, with statistically significant results.
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Ascelia Pharma AB (FRA:7ZA) is actively pursuing commercialization partnerships to optimize the launch and revenue potential of Orby Gland.
Negative Points
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The company faces a lengthy and complex NDA submission process, with a standard 10-month review period anticipated from the FDA.
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There is uncertainty regarding the potential for priority review by the FDA, which could impact the timeline for Orby Gland's approval.
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Ascelia Pharma AB (FRA:7ZA) has not yet secured a commercialization partner, which is crucial for the successful launch of Orby Gland.
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The company's operating loss increased to SEK17.8 million in Q3, driven by costs associated with NDA preparations.
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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