Immunic, Inc. Q1 2024 Financial Results and Corporate Update

Immunic, Inc., a biotechnology firm listed on Nasdaq under the ticker IMUX, has released its financial results for the first quarter ending March 31, 2024, along with a corporate update. The company, specializing in developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, highlighted significant progress in its clinical programs and financial strategies.

During the quarter, Immunic continued to advance its phase 2 CALLIPER trial for progressive multiple sclerosis (PMS) and the twin phase 3 ENSURE trials for relapsing multiple sclerosis (RMS) using vidofludimus calcium (IMU-838). This oral therapy, a nuclear receptor related 1 (Nurr1) activator, shows promise in offering neuroprotective, anti-inflammatory, and antiviral benefits. CEO Daniel Vitt emphasized the potential of vidofludimus calcium to transform MS treatment by addressing diverse components of the disease. A significant finding was the separation from placebo in serum neurofilament light chain (NfL) levels in PMS and non-relapsing secondary progressive multiple sclerosis (SPMS) patients during an interim analysis from the CALLIPER trial. This evidence bolsters the possibility of positioning vidofludimus calcium as the first oral treatment for non-relapsing SPMS. The ENSURE phase 3 program is projected to yield initial results by the second quarter of 2026, with a complete readout by the second half of 2026.

Financially, Immunic significantly bolstered its balance sheet with a three-tranche private placement agreement totaling up to $240 million, securing an initial $80 million tranche in January 2024. This capital infusion from top-tier investors underscores the potential of Immunic's clinical programs. The company also strengthened its intellectual property portfolio, receiving a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a fourth patent, securing protection for vidofludimus calcium into 2041 in the U.S.

Immunic's second key program, IMU-856, targets the protein Sirtuin 6 (SIRT6) to restore intestinal barrier function and regenerate bowel epithelium. The phase 1b clinical trial in celiac disease patients showed promising results in gut protection, symptom improvement, biomarker response, and nutrient absorption. Preparations are underway for a phase 2 clinical trial in patients with ongoing active celiac disease (OACD) who continue to experience symptoms despite adhering to a gluten-free diet. The potential of IMU-856 extends to other gastrointestinal conditions as well.

In terms of financial performance, research and development (R&D) expenses decreased to $18.7 million for the first quarter of 2024, down from $22.9 million in the same period in 2023. This reduction was primarily due to deprioritizing the izumerogant program and reduced external development costs for vidofludimus calcium and IMU-856. General and administrative (G&A) expenses increased to $5.1 million, up from $4.2 million the previous year, reflecting higher personnel and legal costs.

Interest income rose to $1.2 million due to higher interest rates, while other income (expense) saw a significant decrease, primarily due to costs associated with the private placement deal and lower research and development tax incentives in Australia. The net loss for the quarter was approximately $29.6 million, or $0.30 per share, compared to a net loss of $25.3 million, or $0.58 per share, for the same period in 2023. Immunic reported $97.3 million in cash and cash equivalents as of March 31, 2024, providing a financial runway into the third quarter of 2025.

Immunic's strategic advancements in clinical trials and financial positioning reflect strong progress in its mission to develop innovative therapies for chronic inflammatory and autoimmune diseases. The company's robust pipeline and recent financial maneuvers position it well for future milestones and potential breakthroughs in multiple sclerosis and gastrointestinal disease treatments.