Release Date: November 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mendus AB (STU:1YG0, Financial) has opened the first clinical centers for the AM LM 22 cadence trial, marking a significant step in their research efforts.
- The manufacturing alliance with North X for large-scale production of their lead product is on track, ensuring readiness for pivotal stage development.
- The collaboration with Insig Bonni allows Mendus AB (STU:1YG0) to reenter the clinic with their second clinical stage product, ELIXA Ensel, targeting soft tissue sarcomas.
- Mendus AB (STU:1YG0) has extended their cash runway, improving cost efficiencies and ensuring financial stability until mid-next year.
- The company is preparing for phase three readiness by mid-next year, with a focus on pivotal stage development for their lead product.
Negative Points
- The net result for Q3 was a loss of 23 million, indicating financial challenges.
- Cash flow from operating activities was lower than the net result, primarily due to prepaid costs for the manufacturing alliance.
- The cadence trial experienced delays in site activation, which could impact timelines for data readouts.
- Only a minority of patients respond to checkpoint inhibitors, highlighting challenges in improving efficacy.
- R&D expenses were notably lower in Q3, partly due to reduced activity during the vacation period, which may affect progress.
Q & A Highlights
Q: According to the Ash Abstract, it's encouraging to see only one additional death and the median overall survival not reached yet. For the survival update in December, will the new data cut-off be until November?
A: Yes, the update at Ash will be based on data collected from all hospitals, compiled for presentation. The abstract submitted earlier was based on data collected in May.
Q: I noticed three patients underwent stem cell transplants. How will you present this data in the next update?
A: We will censor the survival plots for transplanted patients to focus on monotherapy efficacy. Transplants were successful, indicating our product does not harm potential curative options.
Q: R&D expenses were notably lower in Q3 compared to Q1 and Q2. Is this due to the North X technology transfer nearing completion, and will this trend continue in Q4?
A: R&D costs fluctuate with activity levels. Q3 had lower activity due to the vacation period and maintenance stops at North X, so costs may not be directly comparable across quarters.
Q: Given AML is the strategic priority, what are the next steps in ovarian cancer following the Allison readout?
A: Ovarian cancer is a slower disease than AML, requiring more time to read out trials. We aim to identify survival benefits before deciding on further steps, which will take at least another 12 months.
Q: With the slight delay in the cadence trial site activation, does this influence the planned timelines for the registrational trial?
A: The cadence trial is independent of our phase three trial preparations. We are on track with trial design and large-scale GMP manufacturing, which are the key elements for phase three readiness.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
