Immunic (IMUX) Leerink’s Global Healthcare Conference 2025 summary

Key product and clinical development updates

• Lead product vidofludimus calcium is advancing in phase 3 for relapsing MS and phase 2 for progressive MS, with a key readout from the CALLIPER study expected in April 2025.

• The CALLIPER study targets 467 patients, focusing on non-active secondary progressive MS (SPMS) and primary progressive MS (PPMS), addressing high unmet needs.

• Only 6% of the non-active SPMS cohort had inflammatory activity, allowing for a clear assessment of neuroprotective effects.

• Success in the phase 2 study is defined as a 15–20% reduction in disability progression, with Ocrevus data serving as a key benchmark.

• Interim NfL biomarker analysis showed statistically significant results, boosting confidence in the upcoming clinical readout.

Competitive landscape and scientific context

• The study design allows for separation of anti-inflammatory and neuroprotective effects, a key scientific distinction.

• Ocrevus is the main approved therapy for PPMS, but has limitations due to B-cell depletion and infection risk.

• Tolebrutinib and other BTK inhibitors face safety concerns, particularly liver toxicity, and regulatory holds.

• The CALLIPER study is the first industry-sponsored phase 2 in progressive MS, providing a robust signal for future phase 3 design.

• Lower baseline NfL is a strong predictor of reduced future disability, supporting the study’s biomarker approach.

Strategic vision and partnership outlook

• The company is considering both independent commercialization and strategic partnerships, with ongoing discussions with potential partners.

• The asset is positioned as a unique, high-value opportunity in a $23 billion MS market, with significant unmet need in progressive MS.

• Recruitment for phase 3 ENSURE studies in relapsing MS is on track, with data expected next year.

• A partnership could accelerate commercialization and pipeline expansion, including development of a second molecule, IMU-856, for celiac disease and weight management.

• Financing is secured through a three-tranche PIPE deal up to $240 million, with future tranches linked to clinical milestones.