Immunic, Inc.

Good morning and welcome to Munich's first quarter 2024 earnings call. My name is Jessica Bru, Vice President Investor Relations and Communications here at eMunich. I will also be the moderator today. 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 Immunix's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunix 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 call over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel.

Thank you, Jessica. I would also like to welcome everybody on today's earnings call. Earlier this morning, we announced our financial results for the first quarter and March 31st, 2024. in our press release. During the call today, we will walk through our first 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 the review of our first quarter 2024 and subsequent highlights. With our early January announcement of the completion of the three tranche private placement of up to $240 million, we are well capitalized into the third quarter of 2024. This nicely covers the readout of our phase two caliper trial of our potentially groundbreaking lead asset, Vidoflutimus calcium, in progressive multiple sclerosis, which is anticipated in April 2025. The round led by BVF partners included participation from a group of top tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Solios Capital, RTW Investments, and Adage Capital Partners. As a reminder, we received a total of $80 million in the first tranche, which closed on January 8th, 2024. The second tranche is a purchase of $80 million, which is conditioned on the announcement of the phase two top line data for the caliber trial. The third $80 million tranche is to occur no later than three years after the second tranche. All in all, this financing completed in a difficult capital market environment and with such a strong group of investors affirms the enormous potential inherent in our clinical programs. In February, Dr. Bob Fox from Cleveland Clinic, who is the coordinating investigator of our Ensure and Caliber programs, presented extremely positive data from an interim analysis of our Phase II Caliber trial of VF calcium at the Actroms Forum 2024. From the interim analysis, we saw a clear separation of VDF calcium from placebo in serum neurofilament light chain levels across all PMS patients as well as all subtypes. We believe that this data set provided biomarker evidence that VDF calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential, This strong signal also points to a more likely positive outcome for the overall CALIPR trial, as well as clinically relevant key secondary endpoints like prevention of disability worsening. Also at ACTRIMS Forum 2024, Dr. Alexandra Herrmann, Manager Translation Pharmacology at Immunic, presented a poster in our previous phase two, CALVIT-1 trial. Because of eduflutinibose calcium's broad spectrum antiviral activity and potential ability to prevent the reactivation of the Epstein-Barr virus, it may also contribute to the reduction of fatigue in MS patients. While fatigue is one of the most dominant symptoms among MS patients, greatly influencing the quality of life and ability to participate in social activities, it remains largely unsolved from the clinical perspective. Our clinical trial in COVID-19 patients showed an initial signal that patients treated with Viloferum with calcium exhibited the post-COVID symptom of fatigue less frequently than the patients in the placebo arm. Recent third-party data in post-COVID patients identified EBV reactivation as a potential cause for fatigue in this patient group. Our goal is to confirm the ability of endoflutamose calcium to influence fatigue and EBV reactivation in our ongoing Phase III insured trials in relapsing multiple sclerosis patients, as this could result in yet another key differentiating feature for this medication candidate. In March, we had the opportunity to further extend the visibility of our program with a presentation of data at both the annual meeting of the Society for Virology and Fungus in Medicine and Chemistry, highlighting Vitoflutimus calcium's potent activation of the neuroprotective transcription factor NO1, as well as its potent broad-spectrum antiviral activity in vitro. As a reminder, last year, we confirmed in preclinical testing that Vitoflutimose calcium acts as a potent NO1 activator, in addition to its known mode of action as an inhibitor of DHODH. We believe that the activation of NOAN could be responsible for the drug's postulated neuroprotective effects and may contribute to the reduction of confirmed disability worsening events in MS patients, as previously reported from our Phase II emphasis trial in patients with relapsing MS. Also in March, we received notice of allowance from the US Patent and Trademark Office for a patent covering the composition of matter of a specific polymorph of BFK and related method of production of the material. This patent provides another layer of proprietary intellectual property protection around our lead asset, Importantly, we currently have eight patent families protecting Heliophilumus calcium. We remain deeply committed to protecting the technology behind this phase three asset, which has been made that much stronger by the addition of this fourth US patent directed to the use of Heliophilumus calcium in multiple sclerosis. As a result, our extensive patent portfolio is expected to provide protection into at least 2041 in the United States and 2039 internationally unless extended further. Just last month, we hosted a multiple sclerosis R&D day, highlighting the latest developments in the MS landscape, as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability worsening associated with filofilmus calcium, which present important distinctions compared with currently available MS therapies. We also shared our strong belief that Vitoflumose Calcium could elevate today's standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all the three components of smoldering MS with its neuroprotective, anti-inflammatory, and antiviral effects. Thank you to everyone who was able to join us for this event in person or who were able to listen to the recording. That concludes our summary of the first quarter of 2024 and most recent highlights. I am very pleased with the scientific and clinical achievements we have made across our programs. As it relates to re-diplomus calcium, we continue to advance both our Phase II CalEPA trial in patients with progressive MS and our twin Phase III insured trials in relapsing myelodigastriosis. Based on the strong clinical evidence to date, we continue partnering discussions with both global and regional pharmaceutical companies. There's also a lot going on with our IMU 856 program, which could become a game changer for the treatment of a broad range of gastrointestinal disorders. I will provide more detail on this existing program later in this call. 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 first quarter ended March 31st, 2024. Let me start with a review of our cash position. We ended the first quarter of 2024 with $97.3 million in cash and cash equivalents. As Daniel noted, with these funds, we expect to be able to fund our operations in the third quarter of 2025. Regarding the operating results, R&D expenses were 18.7 million for the three months ended March 31st, 2024, as compared to 22.9 million for the three months ended March 31st, 2023. The decrease was mainly driven by reductions in clinical development costs. This was partially offset by an increase in personnel costs. G&A expenses were 5.1 million for the three months ended March 31st, 2024. as compared to 4.2 million for the same period ended March 31st, 2023. The slight increase was primarily related to personnel expenses. Interest income was 1.2 million for the three months ended March 31st, 2024, as compared to 0.8 million for the same period ended March 31st, 2023. This increase was due to higher interest rates. We also reported a change in the fair value of the tranche rights for the three months ended March 31st, 2024. The charge of $4.8 million was a non-cash charge related to the change of the value of the tranche rights associated with the future tranches two and three of our January 2024 financing. These tranches were initially classified as a liability upon the closing of tranche one on January 8, 2024, but were reclassified to equity on March 4, 2024, when shareholders approved an increase in the company's authorized shares from 130 million to 500 million shares of common stock. Therefore, the tranche two and tranche three rights needed to be revalued to fair value as of March 4, 2024 upon the reclassification to equity. Other income was negative $2.1 million for the three months ended March 31, 2024, as compared to $1.2 million for the same period ended March 31, 2023. The decrease was primarily attributable to a $1.7 million expense related to the portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche one, as well as the timing of recognizing the German Federal Ministry of Finance grant. The net loss for the three months ended March 31st, 2024 was approximately 29.6 million or 30 cents per basic and diluted share based on approximately 97.3 million weighted average common shares outstanding compared to a net loss of approximately 25.3 million or 58 cents per basic and diluted share based on approximately 43.7 million weighted average common shares outstanding for the same period ended March 31st, 2023. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?