Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Immunic Inc (IMUX, Financial) reported promising preclinical and clinical data for vidofludimus calcium, highlighting its neuroprotective potential in multiple sclerosis (MS).
- The company published extended data from its Phase 2 EMPhASIS trial in a prestigious journal, reinforcing the strength of vidofludimus calcium's findings.
- Immunic Inc (IMUX) presented positive Phase 1b trial results for IMU-856, showing improvements in celiac disease symptoms and safety.
- The management team was strengthened with the addition of Jason Tardio as COO and President, bringing valuable experience in MS drug commercialization.
- The company has a solid cash position of $79.7 million, expected to fund operations into the third quarter of 2025.
Negative Points
- R&D expenses decreased due to reduced clinical development costs for IMU-856 and IMU-935, indicating potential delays or scaling back in these programs.
- G&A expenses increased, driven by higher personnel and legal costs, which could impact profitability.
- The net loss for the quarter was $21.4 million, reflecting ongoing financial challenges.
- The company is exploring additional financing or partnerships for the IMU-856 program, indicating potential funding gaps.
- Uncertainty remains regarding the outcome of Phase 3 ENSURE trials and potential need for sample size adjustments.
Q & A Highlights
Q: When designing the Phase 3 ENSURE studies, was a futility analysis always included, and is this standard for MS studies? What is the likelihood of needing a sample size adjustment?
A: Yes, the futility analysis was built into the study from the beginning, as it is an event-driven study. This ensures that resources are well-invested. The futility analysis has predefined questions, allowing only limited sample size adjustments, ensuring the study's success. - Daniel Vitt, CEO
Q: Regarding the CALLIPER trial, what are the expectations for brain volume change and key secondary endpoints?
A: The primary endpoint is brain volume change, with secondary endpoints including EDSS change and cognitive functions. The study aims to provide a comprehensive picture with 467 patients randomized. A 15% benefit on disability protection would be medically relevant, though any improvement would be significant given the lack of treatments for non-relapsing secondary progressive MS. - Daniel Vitt, CEO
Q: Why do the interim NFL changes in the CALLIPER study give confidence in the study's outcome?
A: The interim data showed a statistically significant 22% reduction in NFL levels, which is predictive of lower disability worsening. This correlation, supported by literature, makes us optimistic about the study's outcome in April. - Daniel Vitt, CEO
Q: Can you elaborate on the level of engagement with potential partners for vidofludimus calcium?
A: We are actively discussing partnerships to ensure the drug reaches patients quickly and increases company value. Options include regional out-licensing and profit-sharing. We are building in-house expertise to potentially launch the drug ourselves if needed. - Jason Tardio, COO
Q: What are the plans for the Phase 2 study of IMU-856, and what are the gating factors?
A: We are preparing for Phase 2 clinical testing in celiac disease and exploring other indications like osteoporosis and graft-versus-host disease. We are in discussions with experts and potential partners to ensure the right design and concept for the studies. - Daniel Vitt, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
