Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Clinical Trials and Pipeline Updates - The phase 3 ENSURE program for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) received a positive interim futility analysis, confirming the trials are not futile and should continue as planned without sample size adjustments [1][2] - Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) is expected in April 2025 [2][4] - The company is preparing for phase 2 clinical testing of IMU-856 in celiac disease, contingent on financing, licensing, or partnering [4] - Vidofludimus calcium demonstrated potential neuroprotective effects in PMS through Nurr1 activation, supported by interim data from the CALLIPER trial [2] - IMU-856 showed positive effects in phase 1b trials for celiac disease, including gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement [2] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $21.4 million, a $1.6 million increase from Q3 2023, driven by higher external development costs for vidofludimus calcium and IMU-856 [5] - For the nine months ended September 30, 2024, R&D expenses decreased by $5.5 million to $58.4 million, primarily due to deprioritizing the izumerogant program [6] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2024, up $0.6 million from Q3 2023, mainly due to higher personnel costs [7] - Net loss for Q3 2024 was $24.4 million, or $0.24 per share, compared to a net loss of $22.8 million, or $0.51 per share, in Q3 2023 [13] - Cash and cash equivalents as of September 30, 2024, were $59.1 million, expected to fund operations into Q3 2025 [15] Corporate and Strategic Developments - The company presented key data on vidofludimus calcium at the 40th Congress of ECTRIMS, highlighting its therapeutic potential in MS [3] - Immunic hosted an MS R&D Day in New York, featuring discussions on vidofludimus calcium's potential to become a leading treatment for relapsing and progressive MS [3] - The company appointed Simona Skerjanec to the Board of Directors and Jason Tardio as Chief Operating Officer and President to support the potential launch of vidofludimus calcium [3] - Immunic is exploring financing, licensing, or partnering opportunities to fund the IMU-856 clinical program [2] Market and Industry Context - Vidofludimus calcium combines neuroprotective, anti-inflammatory, and antiviral effects, positioning it as a unique treatment option for MS [2][17] - IMU-856 targets SIRT6, aiming to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in various gastrointestinal disorders [17] - The company's pipeline focuses on orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, addressing significant unmet medical needs [17]