Immunic Inc
NASDAQ:IMUX
Immunic Inc
Immunic, Inc. is a clinical-stage biopharmaceutical company, which develops a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases. The company is headquartered in New York City, New York and currently employs 55 full-time employees. The company went IPO on 2014-04-17. The firm is focused on developing oral therapies for the treatment of chronic inflammatory and autoimmune diseases. The firm is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORyt, and IMU-856 targets the restoration of the intestinal barrier function. The Company’s lead development program, IMU-838, is in Phase II clinical development for ulcerative colitis and relapsing-remitting multiple sclerosis, with an additional Phase II trial in Crohn’s disease.
Immunic, Inc. is a clinical-stage biopharmaceutical company, which develops a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases. The company is headquartered in New York City, New York and currently employs 55 full-time employees. The company went IPO on 2014-04-17. The firm is focused on developing oral therapies for the treatment of chronic inflammatory and autoimmune diseases. The firm is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORyt, and IMU-856 targets the restoration of the intestinal barrier function. The Company’s lead development program, IMU-838, is in Phase II clinical development for ulcerative colitis and relapsing-remitting multiple sclerosis, with an additional Phase II trial in Crohn’s disease.
Financial Position: Immunic ended Q3 2024 with $59.1 million in cash and cash equivalents, expected to fund operations into Q3 2025.
R&D Progress: The Phase III ENSURE trials in relapsing MS and Phase II CALLIPER trial in progressive MS are progressing as planned, with CALLIPER top-line data expected in April 2025.
Clinical Highlights: Interim analysis of the ENSURE trials received a positive IDMC recommendation to continue unchanged, supporting assumptions and sample size.
Commercial Readiness: Immunic strengthened its management and board, and is actively preparing for vidofludimus calcium's potential commercialization and partnership opportunities.
Unmet Need: Management emphasized a significant unmet need in progressive MS, especially non-relapsing secondary progressive MS, where no oral therapies are approved.
Financial Results: Net loss for Q3 2024 was $24.4 million ($0.24 per share), slightly higher than Q3 2023 due to increased trial expenses and personnel costs.
Partnership Discussions: Immunic is in active discussions with multiple potential pharmaceutical partners for vidofludimus calcium, citing increased interest after recent competitor setbacks.