Immunic, Inc.

Good morning and welcome to Munich's fourth quarter and year end 2022 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 of 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 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 presentation over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel?

Thank you, Jessica. I also would like to welcome everybody to Immunix Year-End 2022 Earnings Call. Earlier this morning, we announced our financial results for the fourth quarter and year ended December 31st, 2022, and highlighted recent activities as well as upcoming milestones related to our clinical development pipeline. During today's call, we will talk through our fourth quarter 2022 and subsequent highlights, year-end financial and operating results, as well as anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with the review of our fourth quarter 2022 and subsequent highlights. In October, we have bolstered our balance sheet with a closing of $60 million pipe financing, which extended our runway through several value inflection points into the fourth quarter of 2024. Also in October, we conducted a pre-planned interim analysis of our Phase 1B clinical trial of IMU935 in patients with moderate to severe psoriasis. Unfortunately, the group-level mean data did not show a benefit, of the two active doses tested compared to placebo, which both disappointed and surprised us. Although the active arms performed in line with OPERA expectations, the trial experienced a greater decrease than expected in PASI in the placebo arm. Administration of IMU95 and placebo were safe and well tolerated, and no new safety signals were observed. Even these were only the first two dose levels of IMU935 tested in psoriasis patients and also based on drugs very favorable pharmacogenetic safety and tolerability profile to date. We have the flexibility to explore different parameters in future clinical testing, including via dosing and longer treatment periods. We plan to provide further updates and guidance on potential next steps for this program towards the end of this quarter. Switching to our VFK program in multiple sclerosis. Throughout the year, we continued the development of our lead asset VFK in our ongoing MS program. In November, we hosted a virtual MS-R&D webcast, which featured three excellent renowned key opinion leaders. Dr. Fred Lublin from Eichen School of Medicine at Mount Sinai Hospital, Dr. Larry Steinman from Stanford University School of Medicine, as well as Dr. Heinz Wendel from the University of Münster in Germany. The experts discussed recent scientific findings and their effect on the MS treatment landscape. Additionally, IMUNIC provided an update on the scientific, preclinical, and clinical progress of viflutimus calcium in multiple sclerosis. In conjunction with the MS R&D webcast, we reported new data from the blinded and open label extension part of our Phase II emphasis trial of viflutimus calcium in relapsing remitting MS. The data was highly encouraging, showing that long-term treatment with Vitoflutimus calcium was associated with a low rate of confirmed disability worsening over time, which compares favorable to historical trial data for currently available MS medications. Overall, this data nicely underlines Vitoflutimus calcium's neuroprotective potential in addition to its already established anti-inflammatory and antiviral effects. In February of this year, we had a Celiac Disease R&D webcast, including two renowned experts to discuss the dynamics of this multifactorial complex autoimmune disease. Dr. Joseph Murray from the Mayo Clinic in Rochester, Dr. Michael Schuman from the Charité Berlin, as well as the Immunix management team focused on the characteristics of celiac disease immune stimulation and its connection to clinical symptoms, the role of the epithelial barrier, and the pathogenesis of the disease, as well as current and potential treatment options. We also touched on the preclinical and clinical development status of IMU856. There remains a continued unmet medical need for new, effective therapeutics for this disease, and we are excited about the potential of IMU856. As referred to a moment ago, in November of last year, we reported the promising new data from the blinded and open-level extension parts of our Phase II emphasis trial of ethudimus calcium in relapsing remitting MS. This data is being presented today at the prestigious Actrums Forum 2023 by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Caliper programs. 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 ridoflumous calcium was associated with a low rate of confirmed disability worsening over time. That concludes our summary for the fourth quarter of 2022 and reasons of subsequent highlights. I would now like to turn the call over to Glenn to provide financial overview. Glenn?

Thank you, Daniel. I will now review the financial and operating results for the year ended December 31st, 2022. Let me start with the cash overview. As Daniel mentioned, after raising $60 million during the fourth quarter, we ended the year with $116.4 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 71.3 million for the 12 months ended December 31st, 2022, as compared to 61.1 million for the 12 months ended December 31st, 2021. The increase was mainly driven by external development costs related to the ongoing clinical trials of vitiflutimous calcium, IMU935, and IMU856. It was partially offset by a decrease in external development costs related to the phase 2 clinical trials of vitiflutimous calcium and ulcerative colitis, relapsing remitting MS, and COVID-19. General administrative expenses were $15.3 million for the 12 months ended December 31, 2022, as compared to $13.3 million for the same period ended December 31, 2021. This increase was mainly driven by personnel expense, of which $0.6 million was related to non-cash stock compensations. We recorded a non-cash goodwill impairment charge of $33 million in the fourth quarter of 2022, which represents a full write-down of our previous goodwill balance. The impairment resulted from the announcement of the interim group level data of the Phase 1B clinical trial of IMU935 and psoriasis on October 20, 2022. Other expense was negative $0.9 million for the 12 months ended December 31st, 2022, as compared to negative $1.3 million for the same period ended December 31st, 2021. The decrease in expense was primarily attributable to increases in interest income and R&D tax incentives for clinical trials in Australia, which was partially offset by a decrease in grants. Net loss for the 12 months ended December 31st, 2022 was approximately 120.4 million or $3.78 per basic and diluted share based on approximately 31.8 million weighted average common shares outstanding. compared to a net loss of approximately $92.9 million, or $3.93 for basic and diluted share, based on approximately 23.7 million weighted average common shares outstanding for the same period ended December 31st, 2021. With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones. Daniel? Daniel?