Immunic Inc (NASDAQ:IMUX) continued to advance its clinical programs for its lead drug asset during the first quarter of 2024 and paved its cash runway out to late 2025.
CEO Daniel Vitt highlighted progress in the company’s Phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin Phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) for its “potentially groundbreaking” therapy vidofludimus calcium.
"Just last month, we hosted a multiple sclerosis R&D Day, highlighting the latest developments in the MS landscape as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability-worsening associated with vidofludimus calcium, which represent important distinctions compared to currently available MS therapies,” Dr Vitt said in a statement.
“We also shared our strong belief that vidofludimus calcium could elevate today's standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all three components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects.”
He added that the company believes it may be able to position vidofludimus calcium as the first oral treatment option for non-relapsing secondary progressive multiple sclerosis.
“The clear separation from placebo in serum neurofilament light chain levels in patients with PMS and non-relapsing secondary progressive multiple sclerosis, which was observed in the recent interim analysis from our phase 2 CALLIPER trial, is significant,” he said.
Topline results from the CALLIPER trial are expected in April 2025. Additionally, data from the first Phase 3 ENSURE trial is expected in the second quarter of 2026 and from the second ENSURE trial in the second half of 2026.
During Q1, the company's balance sheet was bolstered through the first $80 million tranche of a $240 million private placement, which the company expects will be able to fund its operations into the third quarter of 2025.
Immunic exited March with cash and cash equivalents of $97.3 million after it invested $18.7 million in research and development during the period, compared to $22.9 million in the year-ago quarter.
The decrease reflected the deprioritization of the izumerogant program in psoriasis and castration-resistant prostate cancer and a $2.5 million decrease in external development costs related to the vidofludimus calcium and IMU-856 programs, offset by a $0.7 million increase in personnel costs.
The company's net loss was $29.6 million compared to $25.3 million in the same quarter of 2023.