Release Date: September 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vivoryon Therapeutics NV (FRA:05Y, Financial) reported compelling kidney function data from the VIVIAD Phase IIb study, showing a strong and consistent statistically significant improvement in kidney function with varoglutamstat.
- The company has successfully transitioned its strategy towards developing varoglutamstat in kidney disease, leveraging rigorous scientific research and intentional clinical study design.
- Vivoryon Therapeutics NV (FRA:05Y) observed a substantially higher treatment effect on eGFR with varoglutamstat in a post-op diabetes subgroup, indicating potential for targeted therapeutic applications.
- The company has advanced plans to initiate a Phase II study in advanced diabetic kidney disease, subject to additional funding or partnerships, demonstrating a clear path forward for clinical development.
- Vivoryon Therapeutics NV (FRA:05Y) has a strong scientific foundation and new PK/PD data that provide key information on the mechanism of action, demonstrating varoglutamstat as a robust molecule with potential in kidney disease.
Negative Points
- The VIVIAD results in early Alzheimer's disease (AD) were disappointing, highlighting a significant setback in this therapeutic area.
- The company reported a net loss of EUR 13.6 million for the first half of 2024, compared to EUR 10.7 million in the first half of 2023, indicating increased financial strain.
- Vivoryon Therapeutics NV (FRA:05Y) held EUR 15.3 million in cash and cash equivalents as of June 30, 2024, down from EUR 28.6 million as of December 31, 2023, reflecting substantial cash utilization.
- The company acknowledged that further funding or partnerships would be required to support a Phase II study in diabetic kidney disease and to extend its cash runway beyond the second quarter of 2025.
- The analysis of the VIVA-MIND study is still pending, and the company does not expect different outcomes in Alzheimer's disease compared to the VIVIAD study, potentially limiting future opportunities in AD.
Q & A Highlights
Q: Now that you have additional analysis from VIVIAD, what are you hoping to find out from the VIVA-MIND study?
A: We expect similar outcomes in VIVA-MIND as in VIVIAD for both Alzheimer's and kidney function. The VIVA-MIND study had a different outcome parameter for Alzheimer's assessment but used the same patient population and dose. We anticipate no different outcome in Alzheimer's disease and expect similar eGFR results, although the study is smaller and not powered for a p-value.
Q: How have partnership discussions progressed since disclosing additional data in diabetics?
A: We are in discussions with other pharma companies. The additional data and comprehensive analysis have strengthened our scientific position, making our case more convincing compared to earlier in the year. We feel confident in our unique position as leaders in anti-inflammatory research in kidney disease.
Q: Will patients in the diabetic kidney disease study be stratified by GLP-1 use?
A: Yes, patients will be stratified by standard of care, including GLP-1 and SGLT2 use. This is to avoid any mix-up of weight loss effects with the anti-inflammatory effects of varoglutamstat and because the penetration of these treatments is not homogeneous.
Q: Under which circumstances would you be able to extend the patent protection to 2044?
A: We have filed new composition of matter and indication patents about 1.5 years ago. We are in the review process and confident that these will be granted, extending our market exclusivity into the mid-2040s.
Q: What dose do you think would be needed to have a significant effect in reducing intracellular pyroGlu-Abeta?
A: We are still analyzing the data and cannot yet provide a specific dose. We need to complete our understanding and develop a PK/PD model. Technologies to improve blood-brain barrier penetration are also being considered, but it is too early to make definitive statements.
Q: Are the plans for exploring other kidney opportunities, such as Alport syndrome and Fabry disease, still on track?
A: Yes, these plans are still on track and within our budget. We expect research data to come in the next four to six months, which will justify potential clinical trials.
Q: What is the reasonable timeline to expect a decision on the new patents?
A: We are in the review process and cannot provide a specific granting and publication date. However, we are in Q&A with the patent reviewers, and it looks promising.
Q: What are the next steps for varoglutamstat in Alzheimer's disease?
A: We will conclude our next steps in Alzheimer's disease once we have the VIVA-MIND data and further analysis on biomarkers. We are still in the process of understanding the full potential and required doses.
Q: How do you plan to finance the Phase II study in diabetic kidney disease?
A: Further funding or partnerships will be required to support the Phase II study in diabetic kidney disease. We are actively seeking these opportunities to extend our cash runway beyond the second quarter of next year.
Q: What are the key takeaways from the first half of 2024 for Vivoryon?
A: We have made significant progress in understanding varoglutamstat's mechanism of action and its potential in kidney disease. The first half of 2024 was marked by continuous progress and a strategic shift towards kidney disease, driven by compelling data. We are well-positioned for future development in this area.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
