Release Date: December 10, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vivoryon Therapeutics NV (STU:05Y, Financial) reported positive kidney function data from the VIVA-MIND Phase 2 study, showing significant improvement in eGFR versus placebo.
- The company presented kidney outcome results at ASN Kidney Week, receiving positive feedback from the nephrology community.
- Vivoryon hosted a virtual kidney disease KOL event, highlighting the potential of varoglutamstat in addressing key inflammatory and fibrotic pathways in kidney disease.
- The company plans to start a Phase 2 study in diabetic kidney disease (DKD) in 2025, leveraging strong data from VIVIAD and VIVA-MIND studies.
- Vivoryon has extended its financial guidance, expecting cash and cash equivalents to fund operations into the third quarter of 2025.
Negative Points
- Vivoryon reported a net loss of EUR17.4 million for the first nine months of 2024, consistent with the same period in 2023.
- The company's cash and cash equivalents decreased significantly from EUR28.6 million at the end of 2023 to EUR12.5 million as of September 30, 2024.
- The VIVA-MIND study was terminated early due to lack of efficacy in Alzheimer's disease, impacting the planned patient enrollment.
- There is a need for additional funding and partnerships to support future clinical studies and potential expansion into orphan kidney diseases.
- The company faces challenges in maintaining momentum in Alzheimer's research due to the shift in focus towards kidney disease.
Q & A Highlights
Q: Can we expect any additional sub-analysis from the VIVA-MIND study or any additional data on transforming levels or weight loss topic blood pressure?
A: We are at the beginning of the analysis of VIVA-MIND and will take our time to thoroughly analyze the data. We plan to publish and disclose additional findings in the next webcast or press release. Regarding diabetic kidney disease, we still need to conduct some analysis, but given the overall positive results, we expect similar outcomes.
Q: Are there any updates on kidney opportunities outside of diabetic kidney disease, such as Fabry disease?
A: Currently, there are no updates on opportunities outside of diabetic kidney disease. We are working on this, and updates will come in due course. These are partially academic collaborations, and we are waiting for further developments.
Q: How many patients in the VIVA-MIND study had diabetic kidney disease, and were any on concomitant SGLT2 or GLP-1s?
A: We are currently analyzing the data to determine the exact number of diabetic patients, which we expect to be between 10 and 20. We will disclose the concomitant medications once the data is fully mature, but some patients were on SGLT2s.
Q: What is driving confidence in extending the composition of matter IP for varoglutamstat?
A: Our confidence is high due to a good channel for patent applications, with several patents already granted. The process is ongoing, and we will provide updates once we have more information.
Q: Does the consistency of data between VIVA-MIND and VIVIAD change the plan for the Phase 2 DKD study?
A: The consistency of data will likely reduce the sample size needed for the Phase 2 DKD study. However, we aim to find a balance between evidence generation and statistical sample sizing to ensure a robust study.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
