Immunic(IMUX) - 2024 Q4 - Annual Report

Financial Performance - Immunic has an accumulated deficit of approximately $511.4 million as of December 31, 2024, and$410.9 million as of December 31, 2023, with operating losses incurred each year since inception in 2016[28]. - The company incurred net losses of $100.5 million and$93.6 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $511.4 million as of December 31, 2024[160]. - The company has not generated any revenue from its current product candidates to date[165]. - The company anticipates continued significant and increasing losses for the foreseeable future[164]. - The independent auditor's report raises substantial doubt about the company's ability to continue as a "going concern" due to ongoing losses and negative cash flows[174]. - The company has consumed substantial cash resources since inception, indicating a high dependency on external funding for ongoing operations[169]. - The company has raised net cash of approximately$430.9 million from private and public offerings since inception, with cash and cash equivalents of approximately $35.7 million as of December 31, 2024[30]. - The company used net cash of$84.8 million and $70.8 million in operating activities for the years ended December 31, 2024, and December 31, 2023, respectively, primarily related to the development of current product candidates[169]. Clinical Trials and Development - The ongoing Phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and the Phase 2 CALLIPER clinical trial in progressive multiple sclerosis (PMS) are critical to the company's development pipeline[32]. - Positive interim data from the CALLIPER trial was announced on October 9, 2023, showing biomarker evidence of vidofludimus calcium's neuroprotective potential[18]. - The first patient was enrolled in a Phase 2 clinical trial of vidofludimus calcium for Post COVID Syndrome on September 4, 2024, sponsored by Goethe University Frankfurt[45]. - A positive interim analysis of the Phase 3 ENSURE program for vidofludimus calcium confirmed that predetermined futility criteria were not met, allowing the trials to continue without changes[48]. - The Phase 3 ENSURE program aims to enroll approximately 1,050 adult patients with active RMS across more than 100 sites in over 15 countries, with a primary endpoint of time to first relapse up to 72 weeks[86]. - The Phase 2 EMPhASIS trial of vidofludimus calcium demonstrated a 62% reduction in cumulative unique active MRI lesions at the 45 mg dose and a 70% reduction at the 30 mg dose compared to placebo[77]. - In the ongoing open-label extension phase of the EMPhASIS trial, 97.6% of patients were free from confirmed disability worsening after 48 weeks of treatment with vidofludimus calcium[81]. - The company has an ongoing Phase 3 clinical program for vidofludimus calcium in RMS, requiring two successful Phase 3 trials for marketing approval[105]. - The Phase 2 CALLIPER trial for vidofludimus calcium in PMS completed enrollment in August 2023, with top-line data expected in April 2025[90]. - The CALLIPER trial enrolled 467 patients across more than 70 sites, focusing on the annualized rate of percent brain volume change as the primary endpoint[93]. Product Candidates - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[21]. - The company is preparing for Phase 2 clinical testing of IMU-856 in patients with ongoing active celiac disease, contingent on financing[21]. - The company has selected IMU-381 as a development candidate for gastrointestinal diseases, currently in preclinical testing[22]. - IMU-856 is being developed as a treatment for gastrointestinal diseases, targeting the restoration of intestinal barrier function[112]. - Celiac disease affects approximately 1 in 100 people globally, with an estimated two million diagnosed in the United States alone[115]. - IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease pathophysiology, including protection of gut architecture and improvement of symptoms[125]. - The Phase 1 clinical trial of IMU-856 was found to be safe and well-tolerated, with no serious adverse events reported across all dose levels[120][122]. - The Phase 1b trial enrolled 43 patients, with doses of 80 mg or 160 mg of IMU-856 administered once daily over 28 days[124]. - IMU-856's formulation has been improved for Phase 2 clinical testing, enhancing stability and robustness[128]. - A patent covering the composition of IMU-856 is granted in the US and other jurisdictions, expected to provide protection until at least 2038[130]. Regulatory and Market Considerations - The FDA cleared the Investigational New Drug application for the Phase 3 ENSURE program on July 1, 2021, based on the promising results from the Phase 2 trial[85]. - The ongoing clinical trials are expected to provide a straightforward path towards potential regulatory approval of vidofludimus calcium in RMS[85]. - The marketing approval process for product candidates is lengthy and unpredictable, with no guarantee of success[181]. - The company may face delays and increased costs in clinical trials due to geopolitical factors, such as the invasion of Ukraine by Russia, which has disrupted clinical development programs[186]. - The approval process in foreign markets may require additional testing and compliance with varying regulatory requirements, which could delay commercialization[214]. - The company intends to market approved product candidates internationally, necessitating separate regulatory approvals in each market[214]. - Approved products will be subject to extensive ongoing regulatory requirements, which may lead to significant additional expenses and potential penalties for non-compliance[210]. - The FDA may require a Risk Evaluation and Mitigation Strategy for approved product candidates, which could include costly post-approval studies and safety monitoring[210]. Operational Challenges - Clinical trials have been delayed due to the ongoing military action by Russia in Ukraine, affecting over 60 planned sites[159]. - The company has limited marketing and sales experience, which may hinder revenue generation upon regulatory approval[157]. - The company may require additional funding sooner than planned, which could lead to dilution of stockholder equity or impose operational restrictions[170]. - The company has faced disruptions in operations due to disease outbreaks, epidemics, and pandemics, impacting clinical trial activities[156]. - The company has not completed all clinical trials required for the approval of its current product candidates, which may face delays or terminations due to various factors[187]. - Patient enrollment is critical for clinical trials and can be influenced by the size and nature of the patient population, eligibility criteria, and competing trials[188]. - The company is responsible for ensuring compliance with regulatory requirements during clinical trials, but cannot guarantee that clinical investigators will maintain such compliance[189]. - Delays or terminations of clinical trials can harm the commercial prospects of product candidates and increase costs, jeopardizing revenue generation[190]. - The company may face difficulties in enrolling patients for clinical trials due to the limited number of patients with the diseases being studied[207]. - The planned clinical trials may face challenges in identifying and enrolling eligible patients due to perceived risks and competing therapies, potentially delaying timelines for regulatory approval[208].