Immunic, Inc.

Good morning and welcome to Munich's second quarter 2024 earnings call. My name is Jessica Brue, Vice President, Investor Relations and Communications at eMunich. 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 newly appointed Chief Operating Officer and President. 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 either 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 opinion 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 of future events. Please refer to Immunix SEC filings for a more detailed description of the risk factors that may affect Immunix 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 earnings call. Earlier this morning, we announced our financial results for the second quarter in six months and June 30th, 2024. During the call today, we will walk through our second quarter 2024 achievements and subsequent highlights, financial 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 second quarter 2024 and subsequent highlights. In April, we hosted a multiple sclerosis R&D day in San Francisco, highlighting the latest developments in the MS landscape, as well as our development program with the flumous calcium. We walked through our high-encouraging preclinical and clinical data generated so far, supporting the neuroprotective potential and reduced disability worsening associated with VFK, which represents a unique distinction compared with currently available MS therapies. We also shared our strong belief that Vitaflumib's calcium could potentially elevate today's standard of care by providing a comprehensive solution for the full spectrum of MS patients, given that it is designed to selectively address all three components of smoldering MS, with its neuroprotective, anti-inflammatory, and antiviral effects, in combination with its favorable safety and tolerability profile. I want to extend our thanks again to everyone who is able to join us for the event, both in person and those who listen to the recordings. Also in April, we announced that extended data from our Phase II Emphasis Trial of Vitae Fudimus Calcium in Patients with Relapsing Remitting Mitovascular RMS was published in the prestigious peer-reviewed journal Neuroimmunology and Neuroinflammation an official journal of the American Academy of Neurology. The paper, lead authored by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Calibre programs, included data for both study cohorts with an extended dose range. Inclusion in the publication represents further evidence of the strength of these findings for BFH calcium in RRMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences. First, the Newman data from our Phase 1B clinical trial of IMU856, our orally available and systemically acting small molecule modulator, the target 136 in patients with celiac disease, was presented in an oral presentation at Digestive Disease Week in Washington, D.C., The trial results gathered during periods of gluten-free diet and gluten challenge demonstrated meaningful improvements of a placebo in four key dimensions of celiac disease pathophysiology, specifically histology, disease symptoms, biomarkers, and nutrient absorption. IMU856 was also observed to be safe and well-tolerated in this trial. We continue to believe that this data provides initial proof of concept for a potential new oral therapy approach to a range of gastrointestinal disorders through the regeneration of bowel architecture. Additionally, we represented data from our Phase II caliper trial of VWL-MOS calcium in patients with progressive multiple sclerosis, or PMS, at two conferences, the 23rd National Congress of Neurology in Golden Sands, Bulgaria, and Consortium of Multiple Sclerosis Centers' 38th annual meeting in Nashville. We were pleased to have had the opportunity at both meetings to highlight the clear separation observed in serum neurofilament light chain, NFL, for vitoflutamase calcium over placebo in this PMS patient population, as it represents another significant step forward for what could potentially be a first-in-class NO1 activator for MS. This strong signal in NFL also makes us believe in a more likely positive outcome of the overall caliber trial, as well as clinically relevant endpoints like prevention of disability worsening. In July, we strengthened our management team with the addition of Jason Tardio in the newly created role of Chief Operating Officer and President. Jason's proven experience in launching and commercializing MS drugs for major biotechnology and pharmaceutical companies will be invaluable as he will lead internal efforts to prepare for the potential commercialization of B2 flumous calcium. Jason will also work closely with Patrick Walsh, our chief business officer, to prepare the company for a range of potential partnership outcomes for our pipeline assets, where we can leverage his extensive partnering experience. Additionally, Werner Gladines was promoted to Chief Development Officer. Werner joined Immunik in January 2021 and has held positions of increasing responsibility since then. In his new role, he will take over additional strategic and operational responsibilities for Immunik's overall clinical operational functions. I would like to take a moment to have Jason introduce himself and to say a few words regarding the recent appointment of Simona Skajanic as a board member of board of directors. Jason.

Thank you so much, Daniel. I'm delighted to be here this morning and truly excited to have joined the very talented team at Immunit during this pivotal time of the company's growth as we prepare for a number of important catalyst readouts for Vita Flutimus Calcium over the next six to nine months. Vitaflumine's calcium has the potential to address a number of key unmet needs that still exist for the more than 2 million individuals living with multiple sclerosis worldwide. And I look forward to applying my experiences in launching numerous multiple sclerosis drugs during the course of my career to support Immunic as we begin preparation plans. I was attracted to Immunic because I believe strongly in the potential of Vitaflutimib's calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with both relapsing and progressive forms of MS. This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first-in-class NIR1 activator with additional anti-inflammatory and antiviral effects by selectively inhibiting the enzyme DHODH. The data to date in both relapsing and progressive MS is encouraging. And combined with a favorable safety and tolerability profile, I believe that Vitaflumine's calcium has the potential to not only meaningfully enhance therapeutic options for individuals living with MS, but to capture significant share in the large global MS market. A market today that accounts for $23 billion in global sales and is forecast to grow to $33 billion by the year 2032. In addition to my work on helping to prepare for commercial readiness, I look forward to working closely with our chief business officer, Patrick Walsh, on a range of potential partnership opportunities for both Vita Flumimus Calcium and IMU 856, Immunix's orally available and systemically acting small molecule modulator that targets SIRT6 for celiac disease and other gastrointestinal disorders. As Daniel noted, late last month, we strengthened our board of directors with the appointment of Simona Skorjanic, a thought leader in brain health with decades of experience in drug development and commercialization. Over a nearly 30-year career in the United States and internationally, Simona has led research and development efforts, accumulating 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 or Ocalizumab, which remains one of the most successful medicines for the treatment of MS. I will now turn the call back over to Daniel. Yeah, thank you, Jason.