Immunic Inc (NASDAQ:IMUX) ended the third quarter with over $59 million in cash to advance its key clinical programs, including its lead candidate, vidofludimus calcium (IMU-838), for multiple sclerosis (MS).
During the third quarter ended September 30, 2024, the firm advanced both its phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and a twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) looking at orally available lead asset, nuclear receptor related 1 (Nurr1) activator, IMU-838.
The biopharmaceutical company, focused on developing oral therapies for chronic inflammatory and autoimmune diseases, recently received a key recommendation from an Independent Data Monitoring Committee (IDMC) to continue its phase 3 ENSURE trials in RMS without increasing the sample size, following a non-binding futility analysis.
Immunic expects top-line data for the CALLIPER trial in PMS by April 2025 and aims to complete the ENSURE-1 and ENSURE-2 trials in 2026.
Interim data from the CALLIPER trial demonstrated a reduction in neurofilament light chain (NfL) levels compared to placebo, particularly significant for patients with non-relapsing secondary progressive MS.
“We continue to believe that, if approved, vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to the complex pathophysiology of MS,” Immunic CEO Daniel Vitt said in a statement.
The company also advanced preparations for its IMU-856 program, targeting gastrointestinal disorders, which demonstrated positive early-stage effects in celiac disease. Immunic is exploring financing, licensing, or partnership opportunities to fund further development of IMU-856, which aims to restore gut health by renewing the bowel wall.
Highlights from the balance sheet include research and development expenses of $21.4 million in the third quarter of 2024, largely due to ongoing clinical programs.
As of September 30, the company held $59.1 million in cash and cash equivalents, expected to fund operations through the third quarter of 2025.
The firm reported a third-quarter net loss of $24.4 million, or $0.24 per share, widening slightly from a $22.8 million loss a year earlier.