Immunic (NasdaqGS:IMUX) FY Conference Transcript

Summary of Immunic, Inc. Conference Call Company Overview - Company Name: Immunic, Inc. - Ticker: IMUX - Industry: Biotechnology - Focus: Developing small molecule therapies for chronic inflammatory and autoimmune diseases [1][2] Core Products - IMU-856: - Phase II-ready asset targeting SIRT6 to regenerate gut wall and barrier function in gastrointestinal diseases. - Proof-of-concept data in celiac disease showing a dose-dependent increase in endogenous GLP-1 [2][3]. - Vidofludimus Calcium: - Phase III molecule for relapsing forms of multiple sclerosis (MS). - Addresses both neuroinflammation and neurodegeneration, which are critical in MS progression [3][5]. Unmet Need in Multiple Sclerosis - MS leads to significant physical and cognitive disabilities. - Current therapies primarily address neuroinflammation but do not halt chronic disability accumulation. - Vidofludimus calcium aims to provide neuroprotective benefits alongside anti-inflammatory effects [3][4][5]. Mechanism of Action - Dual Mechanistic Approach: - Inhibits dihydroorotate dehydrogenase (DHODH) to reduce inflammation. - Activates nuclear receptor-related protein 1 (NRR-1) for neuroprotection [5][6]. - Epstein-Barr Virus: - Vidofludimus calcium may prevent reactivation of this virus, which is linked to MS symptoms [6][7]. Clinical Data - Phase II EMPhASIS Study: - 268 patients; significant reduction in cumulative active lesions (76%) and gadolinium-enhanced lesions (80%) at week 24 with 30 mg dose [11]. - Confirmed disability worsening was 1.6% for vidofludimus calcium vs. 3.7% for placebo, indicating over 50% benefit [11][12]. - Long-term follow-up showed less than 8% of patients reported confirmed disability worsening at week 144 [12]. - Significant reductions in serum neurofilament light chain, a biomarker for disability worsening [13]. - Safety Profile: - Low discontinuation rates (2.8%) compared to other therapies (e.g., Aubagio at 20%) [14]. - No increased risk of serious infections or hepatotoxicity observed [14]. Ongoing Studies - ENSURE I and ENSURE II: - Phase III studies fully enrolled with over 1,100 patients each, focusing on time to first relapse [16]. - Expected top-line data in late 2026 [16]. - CALIBRATE Study: - Exploratory Phase II study for progressive MS, showing a 31% reduction in disability worsening for primary progressive MS [17][18]. Market Opportunity - Market Size: - MS market valued at $23 billion, projected to grow to $30 billion [20]. - Vidofludimus calcium could capture a significant share as the first oral disease-modifying therapy for both relapsing and progressive MS [20][21]. - Potential Revenue: - Estimated $1 billion to $2 billion opportunity in relapsing MS and over $2 billion in progressive MS if successful [21]. Conclusion - Vidofludimus calcium represents a transformative opportunity in the MS market with its dual mechanism of action and favorable safety profile. - The company anticipates significant commercial potential if ongoing studies confirm its efficacy [21][22].