In This Article:
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Annual Costs: SEK 136 million for the year.
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Cash Flow: SEK 20 million for the year, influenced by warrants and grants.
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Q4 Cash Position Change: SEK 8 million increase from the end of Q3.
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Cash Runway: Expected to last until the beginning of 2026.
Release Date: February 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Mendus AB (FRA:1YG0) presented positive long-term survival data from their advanced 2 trial in AML, indicating continued benefits for patients.
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The company received positive feedback from the FDA and EMA, confirming that their registration trial preparations for vididencel are on the right track.
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Mendus AB (FRA:1YG0) has established a large-scale manufacturing alliance with NorthX Biologics, which is crucial for pivotal stage readiness.
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The Alison phase 1 trial showed promising initial data for treating ovarian cancer with vididencel, indicating tumor-directed immune responses.
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The company has extended its cash runway until early 2026, supported by cost-saving measures and grant income, ensuring financial stability for ongoing projects.
Negative Points
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The clinical trial involving ilixadencel was halted due to the cessation of third-party funding, impacting the study of soft tissue sarcomas.
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The cadence trial is experiencing delays in opening centers and enrolling patients, which could impact the timeline for obtaining safety data.
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Mendus AB (FRA:1YG0) faces a challenging capital market environment, making it difficult to secure partnerships or additional funding.
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The company needs to treat a significant number of patients in the phase 3 trial for AML, requiring extensive resources and global site openings.
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There is uncertainty regarding potential accelerated approval for vididencel, as the company is taking a conservative approach to regulatory pathways.
Q & A Highlights
Q: Can you explain the cash runway extension to early 2026 and whether it includes preparation for the AML trial? A: The cash runway is based on our 2025 budget, which includes all preparation work for the pivotal stage of vididencel. The financing raised in 2023 and early 2024 was intended to reach this milestone. We are also focusing on cost-saving measures and grant income to extend the cash runway further. (Lotta Ferm, CFO; Erik Manting, CEO)
Q: How is the cadence trial progressing, and can we expect the first part of safety data soon? A: The cadence trial is taking longer than expected to open centers, but enthusiasm remains high. We are still waiting for the first patient to be treated. The trial is not necessary for phase 3 progress, as discussions with EMA and FDA are based on advanced 2 data. The cadence trial will provide additional safety data for the global registration dossier. (Erik Manting, CEO)