Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Immunic Inc (NASDAQ:IMUX) strengthened its management team with the addition of experienced executives, enhancing its leadership capabilities.
• The company achieved a positive outcome in the interim analysis of its phase three ensure program for relapsing multiple sclerosis, indicating progress in clinical trials.
• Immunic Inc (NASDAQ:IMUX) presented compelling data at the EAMS Congress, showcasing the potential of its drug candidate, vlu calcium, in treating multiple sclerosis.
• The company has a strong cash position, with $59.1 million in cash and cash equivalents, expected to fund operations into the third quarter of 2025.
• Immunic Inc (NASDAQ:IMUX) is actively pursuing partnerships with global and regional pharmaceutical companies, indicating potential for strategic collaborations.

Negative Points

• Research and development expenses increased to $21.4 million for the quarter, reflecting higher external development costs.
• The company reported a net loss of approximately $24.4 million for the quarter, indicating ongoing financial challenges.
• There is uncertainty regarding the speed of recruitment and data availability for the investigator-sponsored post-COVID trial in Germany.
• The company faces significant competition in the multiple sclerosis market, with over 20 approved therapies already available.
• Immunic Inc (NASDAQ:IMUX) has not yet secured a partnership for non-dilutive cash raises, which could impact future funding opportunities.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with IMUX.

Q: What level of detail should we expect in the topline readout of the Caliber study in progressive MS? Will it include subpopulation data? A: Dr. Daniel Fitt, CEO: We plan to release detailed data on both the general and sub forms tested during the study, similar to the interim analysis. This will include clinical endpoints like confirmed disability worsening, biomarkers such as NFL and GFA, and brain atrophy data. The data will be comprehensive and is expected in April next year.

Q: When might we expect data from the ongoing post-COVID investigator-led trial in Germany, and how might it relate to the Ensure trials? A: Dr. Daniel Fitt, CEO: As this is an investigator-sponsored trial, we can't provide guidance on recruitment speed. However, the role of fatigue is crucial in MS, and the overlap with EBV in both MS and post-COVID syndrome is significant. We aim to learn from this study to enhance treatment options. There is no predefined subanalysis for post-COVID syndrome in Ensure or Caliber trials, but we may extract relevant data later.

Q: What are your expectations for the hazard ratio for disability worsening in the Caliber study, and is there a potential for an accelerated approval path in PMS? A: Dr. Daniel Fitt, CEO: There is no predefined bar for the hazard ratio, but a 20% benefit would be a significant win. Regarding accelerated approval, it depends on the data and its distribution. If the data is strong, especially in nonactive secondary progressive patients, it could lead to discussions with the FDA about expedited approval.

Q: Can you discuss the unmet need in progressive MS and the potential impact of VLU calcium? A: Jason Tardio, President and COO: There is a significant unmet need, especially in nonactive secondary progressive MS, where no treatments are approved. VLU calcium's dual mechanism offers neuroprotective benefits without immunosuppression, potentially making it a gold standard in progressive MS treatment.

Q: Is Immunic in negotiations with big pharmaceutical companies for partnerships or nondilutive cash raises? A: Jason Tardio, President and COO: There is significant interest in VLU calcium from companies with interests in MS and neuroscience. While I can't provide specifics, discussions are ongoing, and interest has increased due to recent market dynamics, including BTK inhibitor failures.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.