Immunic, Inc.

Good morning to everybody on the line. I would like to welcome you to Immunix's fourth quarter and year-end 2023 earnings call. My name is Jessica Bru, Vice President Investor Relations and Communications at Immunix. 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 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 Immunex'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 and President, Dr. Daniel Fitt, to begin the presentation. Daniel?

Yeah, 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 fourth quarter and the year ended December 31st, 2023, in our press release and Form 10-K. During the call today, we will walk through our four quarters 2023 achievements 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 a review of our fourth quarter 2023 and subsequent highlights. Punctuating our remarkable progress throughout 2023 we announced a three-trunch private placement of up to $240 million last month. The round led by BDF partners included participation from a group of top-tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Solius Capital, RTW Investments, and Adage Capital Partners. We received a total of $75 million in net proceeds from the first tranche, which closed on January 8, 2024. The second and third tranches of $80 million each are conditioned on the announcement of Phase 2b top-line data for our Caliper trial, expected in April 2025. Volume-weighted average share price levels and minimum trading volumes. Any of these conditions in the second or third tranche can be waived by holders of the majority of the outstanding securities, including the lead investor. This financing completed in a challenging capital markets environment and with such a strong group of investors affirms the enormous value inherent in our two advanced technical programs. In October, we reported overwhelmingly positive internal data from the phase two caliber trial of our potentially groundbreaking lead asset, nuclear receptor-related 1,0-1 activator, Vitoflutimus calcium in progressive multiple sclerosis, or PMS. In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of PMS, saw a 22.4% improvement in serum neurofilament light chain, or NFL, for Vitoflutimus calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of Vitoflutimus calcium in this PMS population. Even a statistically significant difference was found for arithmetic mean serum NFL levels at week 24 between B. thutmose calcium and placebo with a p-value of 0.01. If you look at the subtypes of PMS to the right, you can appreciate that this difference in serum NFL at week 24 was consistently observed across all progressive MS subtypes. I would like to point out that we saw a 20.1% reduction of beta-flugimus calcium versus placebo in advanced SPMS, meaning patients with no focal inflammatory activity but continued disease progression. We believe this subtype is a segment of very high unmet need in MS with no relevant FDA-approved therapies available in the United States. This next slide puts our caliper interim data into the perspective of historical third-party studies and the same progressive MS subtypes. On the left, we display the data for PPMS compared to the oratorio study for orgylizumab, which showed a spread of NFL values between active and placebo at 24 weeks of 12.4%. In the caliber trial, we observed an 18.8% improvement of active drug over placebo in PPMS at week 24. You may recall that the results of the oratorio phase research led to the approval of ocrelizumab for treatment of PPMS. In the center of the slide, you see historical data for the secondary progressive MS, both for inflammatory, non-active, and active SPMS. In comparison, vena flutemus calcium was able to show a substantial reduction in NFL in both subpopulations. To our knowledge, this is the first time that such a substantial effect in NFL has been shown in non-active SPMS patients again, which is the PMS subtypes, which is the highest unmet medical need. The right side of the slide shows the comparison between our Phase II emphasis data for beta-plutonous calcium in RRMS versus historical relapsing MS studies to complete the picture. In summary, We believe the clear separation observed in serum-NFL for virefumous calcium over placebo in this PMS patient population, as well as its subtypes, represents another significant step forward for what could potentially be a first-in-class No-1 activator for MS. This strong signal also points to a more likely positive outcome of the overall caliber trial, as well as clinically relevant endpoints like prevention of disability worsening. Also in October, Dr. Bob Fox from Cleveland Clinic, who is the coordinating investigator of our Ensure and Caliper programs, presented data from our Phase II Emphasis Trial of Vitoflutimus calcium in RRMS in an e-poster at the Joint Actuums Meeting. It is important to reiterate that Vitoflutimus calcium showed an improvement on serum NFL in both treatment arms of 30 and 45 mg over placebo. In November, we were granted two fundamental new patents for VD-Fluidimus in the United States. The first covers a daily dose of about 10 mg to 45 mg of VD-Fluidimus calcium and other salt as well as free acid forms for the treatment of relapsing MS, including the 30 mg dosage used in our ongoing twin phase 3 insured trials. The second patent Granted, it covers the dosing regimen associated with phytofluidinous calcium and other salts, as well as the free acid forms for the treatment of MS, including all regimens tested in our MS clinical program. As a result, our extensive patent portfolio now provides protection into 2041 or even beyond in the United States. Turning to our second key program, IMU-816, an orally available and systemically acting small molecule modulator that targets SIRT6 protein. In October, we presented two abstracts at the United European Gastroenterology Week 2023. My colleague, Dr. Franziska Bojanek, Senior Medical Director at Immunik, presented data from our Phase 1b clinical trial of IMU856 in patients with celiac disease during a moderated poster session. The trial results gathered during periods of gluten-free diet and gluten challenge demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology, histology, disease symptoms, biomarkers, and nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Additionally, Dr. Geert de Haans from Amsterdam University Medical Center presented data from our Phase 2 CalDOS1 trial of BFHC in alternative colitis or UC. As a reminder, the maintenance phase results from the CalDOS1 trial demonstrated statistically significant activity of BFHC compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of VFCC in UC and other inflammatory bowel disease indications. In November, we were pleased that Dr. Bojanek had another opportunity to present the data from our Phase 1p clinical trial of IMU856 in patients with celiac disease in a virtual e-poster at the Association of European Celiac Society General Assembly Conference in Athens, Greece. That concludes our summary of the fourth quarter 2023 and most recent highlights. I'm very pleased with the scientific and clinical advancements we have made across our different programs, and we are leveraging this momentum going forward. As an example, for Vitaflumus calcium, the release of our overwhelmingly positive biomarker NFL data has been an impetus for partnering discussions and global and regional pharmaceutical companies. There's also a lot going on with our IMU 856 program, which we will update you as progress is made this year. I would now like to turn the call over to Glenn to provide a financial overview. Glenn.

Thank you, Daniel. I will now review the financial and operating results for the year ended December 31st, 2023. Let me start with a review of our cash position. We ended the year with $46.7 million in cash, cash equivalents. With these funds and the approximately $75 million in net proceeds raised in the first tranche of our January 2024 private placement, we expect to be able to fund operations into the third quarter of 2025. Regarding the operating results. R&D expenses were $83.2 million for the 12 months ended December 31, 2023, as compared to $71.2 million for the 12 months ended December 31, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials, the Vita Flutimus Calcium and IMU 856, as well as personnel expenses. This was partially offset by a decrease in external development costs related to the deprioritization of the IMU 935 program and a reduction in costs related to the Vita Flutimus Calcium program and ulcerative colitis. General administrative expenses were $16 million for the 12 months ended December 31, 2023, as compared to $15.3 million for the same period ended December 31, 2022. The slight increase was spread across numerous categories and was partially offset by a decrease in personnel expense. Other income was $5.6 million for the 12 months ended December 31, 2023, as compared to negative $0.9 million for the same period ended December 31, 2022. The increase was primarily attributable to a decrease in foreign exchange losses, a research allowance attributable to the 2021 and 2022 tax years from the German Ministry of Finance, and an increase in interest income as a result of higher interest rates. This was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia. The net loss for the 12 months ended December 31, 2023, was approximately $93.6 million, or $2.11 per basic and diluted share. based on approximately 44.3 million weighted average common shares outstanding, compared to a net loss of approximately 120.4 million, or $3.78 per basic and diluted share, based on approximately 31.8 million weighted average common shares outstanding for the same period ended December 31st, 2022. With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel?