Immunic, Inc.

Good morning and welcome to Munich's first quarter 2023 earnings call. My name is Jessica Bru, Head of Investor Relations and Communications at the Munich. I will also be the moderator on today's call. Speaking on the call are Dr. Daniel Fitt, our Chief Executive Officer and President, as well as Glenn Whaley, our Chief Financial 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 join 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 Immunex's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect the Munich'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 Munich's SEC filings for a more detailed description of the risk factors that may affect the Munich's results and these forward-looking statements. I would now like to turn the webcast over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel?

Yeah, thank you, Jessica. I would like to welcome everybody to Immunix's first quarter 2023 earnings call. This morning, we announced our financial results for the first quarter ended March 31st, 2023, and provided an update on our clinical development progress and upcoming clinical milestones. During the webcast today, we will walk through our first quarter 2023 and subsequent highlights, financial and operating results, as well as anticipated clinical milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with the review of our first quarter 2023 and subsequent highlights. As a reminder, in February, we hosted a celiac disease R&D webcast, which included two renowned experts, namely Dr. Joseph Murray from Mayo Clinic in Rochester and Dr. Michael Schumann from the Charité Berlin. Topics discussed included the dynamics of this multifactorial complex autoimmune disease, including the characteristics of celiac disease, immune stimulation and its connection to clinical symptoms, the role of the epithelium barrier and the pathogenesis of the disease, as well as current and potential treatment options. The R&D webcast was intended to lay the groundwork of our clinical phase 1b readout of IMU856 in celiac disease patients. As most of you know, the data set published later on in May provided excellent clinical proof of concept data for IMU856, which I will get to in a few moments. Also of note, in February, Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Caliper programs in multiple sclerosis, presented data from the blinded and open-label extension parts of our Phase II emphasis trial of Vitoflutimus calcium in relapsing remitting MS at the prestigious Actrems Forum 2023. I would like to point out again that the data was favorable compared to historical data for current MS treatments and showed that long-term treatment with Vitoflutimus calcium was associated with a low rate of confirmed disability worsening over time. This data nicely underlined Vitoflutimus calcium's neuroprotective potential in addition to its already established anti-inflammatory and antiviral effects. Last month, we reported positive data from the maintenance phase of our Phase 2b CalDOS1 trial of BFHC in patients with moderate to severe ulcerative colitis, or UC. These results were extremely encouraging as they demonstrated statistically significant activity of BFHC as compared to placebo, while confirming the very favorable safety and probability profile observed in other trials. It is important to note that we believe the maintenance phase data confirms vitoflutimib's calcium activity in the absence of chronic corticosteroid co-administration. As previously announced, based on this encouraging outcome, we are exploring a variety of value-creating point options for the UC program and other inflammatory bowel disease indications. I also, once again, would like to welcome Dr. Richard Ruddick to our board of directors. Rick has a stellar background, including decades spent as a clinical expert in multiple sclerosis and as a clinical trialist who has overseen multiple successful pivotal studies. We are delighted to have Rick on our board and look forward to working with him as we continue to progress the development of edoflutimus calcium in multiple sclerosis, as well as our other pipeline programs. I also want to thank Dr. Vincent Osipov, who is stepping down from our board at the end of June for his dedication to Immunic and his valuable guidance over the past seven years. I speak for our entire team when I say we wish him well in his future endeavors. As many of you are aware, on May 4th, we announced highly positive results from the Part C portion of our Phase I clinical trial of IMU-856 in patients with celiac disease. This data significantly exceeded our expectations. IMU-856 demonstrated consistent and meaningful clinical improvements of placebo in four key dimensions of celiac disease pathophysiology, specifically protection of gut architecture, improvement of patient symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Most importantly, the observed protection of the lining of the gut and intestinal villi from gluten-induced destruction, independent of targeting immune mechanism involved specifically in celiac disease, appeals to be unique among proposed therapeutic approaches, which, for the first part, target either the immune response or antigen processing. We believe this impressive dataset provides first-in-little proof of concept that this oral, first-in-class molecule, INU856, represents an entirely new therapeutic approach which could be a game changer in the way we treat gastrointestinal disorders such as celiac disease, but also alternative colitis, Crohn's disease, or irritable bone syndrome with diarrhea. We are extremely enthusiastic about the potential for this program. Just last Saturday, we published additional news on our IMU856 program. In an e-poster presentation at Digestive Disease Week in Chicago, we were pleased to have unveiled, for the first time, IMU856 mode of action as a potent modulator of SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Through its effect on SIRT6, INO856 has shown the ability in animal and early clinical studies to restore intestinal barrier function and bowel wall architecture. That concludes our summary of the first quarter 2023 and recent subsequent highlights. I would now like to hand over to Glenn to provide a financial overview. Glenn?

Thank you, Daniel. I will now review the financial and operating results for the first quarter ended March 31st, 2023. Let me start with the cash overview. We ended the first quarter with $97.1 million in cash and investments, which we expect will be sufficient to fund operations into the fourth quarter of 2024. Regarding the operating results, research and development expenses were $23 million for the three months ended March 31st, 2023, as compared to $17.4 million for the three months ended March 31, 2022. The increase was mainly driven by external development costs related to the ongoing clinical trials of idiflutimus calcium and IMU856, and was partially offset by a decrease in external development costs related to the Phase II clinical trials of idiflutimus calcium and ulcerative colitis and the IMU935 program. General and administrative expenses were $4.3 million for the three months ended March 31, 2023, as compared to $4 million for the same period ended March 31, 2022. This slight increase was chiefly driven by travel expenses and was partially offset by a decrease in non-cash-based stock compensation. Other income was $2 million for the three months ended March 31st, 2023, as compared to $0.6 million for the same period ended March 31st, 2022. The increase was principally attributable to an increase in German tax incentives and the interest income and was partially offset by reductions in foreign exchange gains and R&D tax incentives for clinical trials in Australia. The net loss for the three months ended March 31st, 2023 was approximately 25.3 million or 58 cents per basic and diluted share based on 43.7 million weighted average common shares outstanding compared to a net loss of approximately 20.8 million or 74 cents per basic and diluted share based on approximately 28. 0.1 million weighted average common shares outstanding for the same period ended March 31st, 2022. With that, I'll turn the call back over to Daniel for an outlook on upcoming clinical milestones. Daniel?