Q4 2024 Mendus AB (publ) Earnings Call Transcript
Key Points
- Mendus AB (FRA:1YG0) presented positive long-term survival data from their advanced 2 trial in AML, indicating continued benefits for patients.
- The company received positive feedback from the FDA and EMA, confirming that their registration trial preparations for vididencel are on the right track.
- Mendus AB (FRA:1YG0) has established a large-scale manufacturing alliance with NorthX Biologics, which is crucial for pivotal stage readiness.
- The Alison phase 1 trial showed promising initial data for treating ovarian cancer with vididencel, indicating tumor-directed immune responses.
- The company has extended its cash runway until early 2026, supported by cost-saving measures and grant income, ensuring financial stability for ongoing projects.
- The clinical trial involving ilixadencel was halted due to the cessation of third-party funding, impacting the study of soft tissue sarcomas.
- The cadence trial is experiencing delays in opening centers and enrolling patients, which could impact the timeline for obtaining safety data.
- Mendus AB (FRA:1YG0) faces a challenging capital market environment, making it difficult to secure partnerships or additional funding.
- The company needs to treat a significant number of patients in the phase 3 trial for AML, requiring extensive resources and global site openings.
- There is uncertainty regarding potential accelerated approval for vididencel, as the company is taking a conservative approach to regulatory pathways.
Welcome to the Mendus Q4 2024 report presentation. For the first part of the conference call, the participants will be in listen-only mode. (Operator Instructions). Now I will hand the conference over to the speaker's CEO, Erik Manting and CFO, Lotta Ferm. Please go ahead.
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Thanks, and welcome everybody to the Q4 and year-end webcast and business update of Mendus. My name is Erik Manting, CEO, and together with our CFO, Lotta Ferm.
As a summary of the main events of Q4, very importantly, we presented a survival update of our advanced 2 trial in AML at the American Society of Hematology conference at the end of last year, which demonstrated continued long-term survival in the majority of patients.
We also presented that as additional abstracts which support the broader positioning of vididencel in acute myeloid leukemia and also adjacent diseases such as chronic myeloid leukemia which may support the further broadening of the addressable patient population
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