The Fly | IMUX

Advanced Clinical-Stage Pipeline: Immunic's lead therapeutic candidate, vidofludimus calcium (IMU-838), is in pivotal Phase 3 trials for multiple sclerosis, significantly de-risking its development and providing a clear path toward potential market approval.

Differentiated Mechanism of Action: IMU-838 is a selective oral DHODH inhibitor with a unique profile, offering a potentially favorable safety and tolerability advantage compared to some existing or developing therapies for chronic inflammatory and autoimmune diseases.

Oral Administration Convenience: All of Immunic's pipeline candidates are oral small molecules, providing patients with a convenient and generally preferred administration route over injectable treatments, which can enhance adherence and quality of life.

Clinical Trial Outcomes Risk: Failure or delays in ongoing and future clinical trials for their product candidates (e.g., imsidolimab, vidofludimab) could prevent regulatory approval and commercialization.

Regulatory Approval Risk: Immunic's product candidates may not receive necessary regulatory approvals from agencies like the FDA or EMA, despite positive clinical trial data, due to safety, efficacy, or manufacturing concerns.

Additional Capital Need Risk: Immunic has a history of losses and will require significant additional capital to fund its research, development, and commercialization activities, which may not be available on favorable terms or at all.