Immunic, Inc. Announces Q3 2024 Financial Results and Corporate Update

Immunic, Inc., a biotechnology firm specializing in oral therapies for chronic inflammatory and autoimmune diseases, recently shared its third-quarter financial results and provided an update on its corporate advancements. The company is making significant progress with its lead drug candidate, vidofludimus calcium (IMU-838), which is currently in phase 2 and phase 3 trials for multiple sclerosis (MS).

During the third quarter, Immunic advanced its phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) and twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS). The unblinded Independent Data Monitoring Committee (IDMC) conducted an interim futility analysis for the ENSURE program, confirming that the trials were not futile and recommended they continue without changes. This milestone means that the ENSURE-1 trial is expected to conclude in the second quarter of 2026, and ENSURE-2 in the latter half of the same year.

The next significant milestone for Immunic is the release of top-line data from the phase 2 CALLIPER trial, anticipated in April 2025. Interim data from this trial suggested that vidofludimus calcium has potential efficacy in slowing disease progression for PMS patients and supports its neuroprotective properties due to Nurr1 activation. Should the trial meet its primary and key secondary endpoints, vidofludimus calcium could become the first oral treatment option for non-relapsing secondary progressive multiple sclerosis (SPMS).

In September, Immunic presented four posters at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), highlighting key aspects of vidofludimus calcium's profile. This included data on neurofilament light chain (NfL) levels, antiviral effects on fatigue reduction, neuroprotective potential through Nurr1 activation, and anti-inflammatory effects. These presentations followed Immunic's MS R&D Day, which featured discussions on vidofludimus calcium's safety, tolerability, and potential impact on the current standard of care.

Additionally, Immunic continued preparations for phase 2 clinical testing of IMU-856, a small molecule modulator targeting Sirtuin 6 (SIRT6) for gastrointestinal disorders. Initial phase 1b data indicated that IMU-856 could be a novel therapeutic approach for celiac disease by restoring gut health. The phase 2 trial is contingent on securing financing or partnerships.

The financial results for the third quarter of 2024 showed research and development (R&D) expenses of $21.4 million, an increase from $19.8 million the previous year. This rise was mainly due to higher external development costs for vidofludimus calcium and IMU-856, and increased personnel costs. For the nine months ended September 30, 2024, R&D expenses were $58.4 million, compared to $63.9 million in the prior year. This decrease was primarily due to a reduction in costs from deprioritized programs and phase 1 trial completions.

General and administrative (G&A) expenses for the quarter were $4.4 million, up from $3.8 million the previous year, primarily due to increased personnel expenses. For the nine months ended September 30, 2024, G&A expenses rose to $14.0 million from $11.9 million in the same period in 2023, driven by higher personnel and legal costs.

Interest income remained steady at $0.8 million for the three months ended September 30, 2024, and increased to $2.9 million for the nine months ended September 30, 2024, due to higher interest rates. Other income was $0.6 million for the quarter, largely due to increased R&D tax incentives in Australia. The net loss for the quarter was approximately $24.4 million, or $0.24 per share, compared to $22.8 million, or $0.51 per share, in the prior year. For the nine months, the net loss was $75.3 million, or $0.75 per share, compared to $72.0 million, or $1.63 per share, in the same period in 2023.

As of September 30, 2024, Immunic had $59.1 million in cash and cash equivalents, which is expected to fund operations into the third quarter of 2025.