Immunic (IMUX) 8 Aug 24 2024 Q2 Earnings call transcript

In the second quarter of 2024, Immunic presented its financial and operational highlights, clinical development programs, and anticipated upcoming milestones to investors and analysts. The company's executives, including Dr. Daniel Vitt, Glenn Whaley, and Jason Tardio, shared updates on Immunic's progress in various clinical trials and strategic partnerships, signaling a promising future for the company.

Clinical Highlights and Upcoming Milestones

The most notable update from the call was the ongoing clinical trials for Immunic's lead asset, vidofludimus calcium, in relapsing and progressive multiple sclerosis (MS). Immunic expects to report top-line data from its Phase II CALLIPER trial in April 2025, potentially positioning the drug as a first-oral treatment option for non-relapsing secondary progressive MS, a type with the highest unmet medical need and currently no approved therapeutics. Additionally, the company anticipates reporting interim results from its Phase III insurer trials in the second quarter of 2026.

Immunic's second clinical stage asset, IMU-856, also showed promise in the clinical trial results presented. The treatment, which has the potential to treat a broad range of serious gastrointestinal disorders, demonstrated significant improvements over placebo in key dimensions of celiac disease, including histology, disease symptoms, biomarkers, and nutrient absorption. Immunic plans to begin Phase II clinical testing of IMU-856, exploring potential applications in other gastrointestinal disorders where the renewal of the gut mucosa is important.

Management Team Enhancements

Immunic further strengthened its management team with the appointment of Jason Tardio as the Chief Operating Officer and President and Simona Skerjanec to the Board of Directors. Jason's extensive experience in launching and commercializing MS drugs for major biotechnology and pharmaceutical companies will be invaluable in preparing for the potential commercialization of vidofludimus calcium. Simona's track record in drug development and commercialization, including her role in achieving sustainable double-digit growth for Roche's neurological and rare diseases portfolio, will provide valuable insights as Immunic continues to advance its clinical programs.

Financial Overview and Outlook

Immunic reported a net loss for the second quarter of 2024 but maintained a strong cash position, with $79.7 million in cash and cash equivalents expected to fund operations into the third quarter of 2025. The company is actively seeking financing and partnerships to further fund its Phase II clinical development of IMU-856 and is preparing for a range of potential partnership outcomes for its pipeline assets.

Conclusion

Immunic's second quarter 2024 earnings call underscored the company's commitment to advancing its clinical programs and strategic partnerships. With top-line data from the Phase II CALLIPER trial expected in April 2025, Immunic is poised to make significant strides in addressing unmet needs in MS and gastrointestinal disorders. The addition of key executives, such as Jason Tardio and Simona Skerjanec, will further strengthen the company's capabilities and position it for success in the competitive pharmaceutical landscape.