Immunic, Inc.

Good morning and welcome to Munich's third quarter 2024 earnings call. My name is Jessica Bru, Vice President Investor Relations and Communications at the Munich. I will also be the moderator today. Speaking on the call are Dr. Daniel Fitt, our Chief Executive Officer, Glenn Whaley, our Chief Financial Officer, as well as Jason Tardio, our President and Chief Operating Officer. Please note that all participants will be in listen-only mode and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. If you joined the webcast via the Zoom platform, there are two ways to submit questions. You can submit your questions in writing via the Q&A tool of the Zoom portal, or if you would like to speak with us directly, please use the raise hand function in the Zoom portal to queue your question. Before we begin, I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate, or words with a similar meaning. And such statements involve a number of risks and uncertainties that could cause Immunix's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunix's opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events. Please refer to Immunix's SEC filings for a more detailed description of the risk factors that may affect Immunix's results and these forward-looking statements. I would now like to turn the call over to our CEO, Dr. Daniel Fitt, to begin the presentation. Daniel?

Thank you, Jessica. I would also like to welcome everybody to today's Q3 2024 earnings call. Earlier this morning, we announced our financial results for the third quarter and nine months ended September 30, 2024. During the call today, we will walk through our third quarter 2024 achievements and subsequent highlights, financial and operating results, as well as our clinical development programs, including anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with a review of our third quarter 2024 and subsequent highlights. In July, our management team was strengthened with the addition of Jason Talio as President and Chief Operating Officer, bringing with him a wealth of experience launching and commercializing multiple sclerosis stocks for major biotechnology and pharmaceutical companies. Jason has already proven to be invaluable, leading internal efforts to prepare for the potential commercialization of VFK. Jason also has been collaborating closely with Patrick Walsh, our chief business officer, to prepare the company for a range of potential partnership outcomes for VFK, as well as our other drug candidates, where we are leveraging his extensive partnering experience. Additionally, Werner Gladiness was promoted to chief development officer. Werner joined Immunic in January of 2021 as head of IMU 838 program, and he has held positions of increasing responsibility since then. In his new role, he takes over additional strategic and operational responsibilities for Immunic's overall clinical operations functions. In July, we also strengthened our board of directors with the appointment of Simona Skerjanic, a thought leader in brain health with decades of experience in drug development and commercialization. Over a 30-year career in the United States and internationally, Simona has led research and development efforts, culminating in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, the medicines company, Eli Lilly, Pfizer, and Johnson & Johnson. It is worth pointing out that Simona led business and global corporate strategy for Roche's portfolio of neurological and rare diseases, achieving sustainable double-digit growth in sales, including with Ocrevus, which remains one of the most successful medicines for the treatment of MS today. Her success in this area really enhances our board as we work towards the potential commercial launch of Vida Fluidimus Calcium. In September, we hosted an in-person MS R&D Day, which featured two world-renowned industry experts, Dr. Francesca Monterolo, biologist and leading MS and No. 1 target expert from the Neuroscience Institute Cavalieri, Ottolenghi, and University of Turin, Italy, as well as Dr. Amit Baur, clinician, scientist, and one of the leading neuroimmunologists in MS from the University of Pennsylvania. These distinguished key opinion leaders, along with our management team, provided an in-depth overview of the MS landscape and our orally available lead acid, BD4-lumous calcium. The presentation highlighted its dual mode of action, which combines neuroprotective effects through its mechanism as a first-in-class nuclear receptor-related one, or NO-1 activator. with anti-inflammatory and anti-viral effects via VHODH inhibition. During the event, we also shared insights on our ongoing phase 3 insured trials in relapsing MS, our ongoing phase 2 caliper trial in progressive MS, and highlighted the commercial opportunity for Vitoflumus calcium in the MS market. In particular, we discussed our strong belief in the potential of VDF calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with relapsing and progressive forms of MS, where there are currently few options and there continues to be a huge unmet need. We continue to believe that VDF calcium has the potential to redefine the oral multiple sclerosis treatment landscape and elevate the standard of care for MS patients. In September, we enrolled the first patient in an investigator-sponsored Phase II clinical trial of Vitafluidimus calcium, the rapid revive trial, in post-COVID syndrome, for which Immunic is providing study medication. The trial is a randomized placebo-controlled double-blind parallel group trial led by Professor Maria Federschild and sponsored by the Goethe University of Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research. We are honored to have Vito Fluidimus Calcium chosen for this investigator-sponsored study run by such highly regarded investigators at esteemed institutions in Germany. We have already seen convincing data supporting Vito Fluidimus Calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our Phase II CalVIT-1 trial. Importantly, third-party researchers identified Epstein-Barr virus reactivation as a potential cause for fatigue, one of the most dominating symptoms for both post-COVID syndrome and MS patients, negatively impacting their quality of life and ability to participate in social activities. We also aim to confirm the ability of VFK to influence fatigue and Epstein-Barr virus reactivation in our ongoing MS trials and look forward to receiving additional data from the rapid-revive trial. It is our belief that this may create yet another differentiating feature for our drug candidate. In September, we also had the opportunity to present four posters at the prestigious 40th Congress of Actrims, showcasing data on key aspects of E. flutemus calcium's profile, illustrating the strength of the data generated today and its potential to become a new treatment option for MS. Jason, do you want to add a few words on the Congress?

Sure, and thank you, Daniel. The ECTRIMS Congress is the premier meeting of the year in the field of multiple sclerosis and brings together over 9,000 of the world's top clinicians, researchers, and healthcare professionals. We are particularly excited to have had the opportunity to present data at this meeting to further support the differentiation of beta-flutamase calcium as a potential treatment for both relapsing and progressive multiple sclerosis. More specifically, we shared additional data from the interim analysis of our ongoing phase two caliber trial in progressive multiple sclerosis that showed that Vitaflutimus calcium not only had a significant impact on reducing serum neurofilament light chain levels across the total study population, but also consistently reduces neurofilament light chain levels compared to baseline across different patient subgroups based on age and disability scores. These observations are important as neurofilament proteins are a marker of neuronal degeneration and serve as an important biomarker of disease activity in multiple sclerosis, with recent data showing that lower neurofilament light levels indicate a lower risk of future disability progression in progressive MS patients. We also prevented compelling data on fatigue from post hoc analysis of the CALVID-1 trial, which evaluated the safety and efficacy of beta-calcium 45 milligrams in patients hospitalized for COVID-19. As mentioned earlier, fatigue is the most frequent symptom reported by patients with multiple sclerosis. And for many patients, it is the most disabling and chronic symptom. Given the broad spectrum antiviral effects of Vitaflutamase calcium and its potential to prevent reactivation of the Epstein-Barr virus, or EBV, which has been linked to fatigue in multiple sclerosis, we sought to understand the impact of Vitaflutamase on fatigue in post-COVID syndrome patients. Results of this analysis show that 80% of patients who received placebo reported fatigue compared to only 50% of patients who received Vitaflutamase calcium. Fatigue was further decreased from weeks nine to 17 to 33% for patients on placebo and only 17% for patients on Vitaflutamase calcium, thus supporting the antiviral effects of Vitaflutamase and how it may contribute to lower fatigue levels. This hypothesis will be further assessed by determining effects on fatigue using patient questionnaires, as well as analysis of the anti-EBV effect in our ongoing caliber and insure trials. Lastly, we presented additional preclinical evidence supporting that Vitaformis calcium enhanced the expression of Nr1 target genes important for neuronal survival, further suggesting the neuroprotective benefit of this asset, and also reduced infiltrating T helper cells in the spinal cord and the number of pro-inflammatory T helper cells in the periphery in marine EAE models. In addition to these data presentations, Immunic also fielded an exhibitor booth for the first time at this important meeting. This served as a great opportunity to engage the MS community and further increase awareness of Vitaflutamase calcium as a potential treatment for MS. Back to you, Daniel.