Immunic, Inc.

Good morning and welcome to Munich's third 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 this nonly 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 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 of 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 third quarter ended September 30th, 2023 in our press release and form 10Q. During the call today, we will walk through our third quarter 2023 and subsequent highlights, 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 third quarter 2023 and subsequent highlights. I would like to begin with our Vitoflutimus calcium development program in multiple sclerosis. In August, we completed enrollment of our Phase II caliber trial of Vitoflutimus calcium in patients with progressive multiple sclerosis, or PMS. A total of 467 adult patients with primary MS or active or non-active secondary PMS were randomized to either 45 milligram daily doses of edofutamose calcium or placebo. Patients were enrolled at more than 70 sites in North America, Western, Central, and Eastern Europe. A few months later, in October, we reported overwhelmingly positive interim data from this Phase II caliber trial. In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of PMS, saw 22.4% improvement in serofilament 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 in this PMS population. A statistically significant difference was found for serum NFL at week 24 between and placebo with a P value of 0.01. If you look at the subtypes of progressive MS to the right, you can appreciate that this difference in NFL at week 24 was consistently shown throughout all subtypes of progressive MS. I would like to point out that we saw a 20% reduction for Vitaflumib's calcium versus placebo in SPMS, meaning the patients with no focal inflammation activity but disease progression. This subtype is a difficult to treat population with no relevant FDA approved therapies available. This slide puts our caliber interim data into the perspective of historical third-party studies in the same progressive MS subtypes. On the left, we display the data for PPMS compared to the oratorial study for oracalizumab, which showed a spread of NFL values between active and placebo at 24 weeks of 12.4%. In the Caliper trial, we observed an 18.8% improvement of active drug over placebo in PPMS at week 24. The results of this phase 3 study led to approval of Ocalizumab for treatment of PPMS. In the center of the slide, you see historical data for secondary progressive MS, both for non-active and active SPMS. In comparison, metaflutamase calcium was able to show a substantial reduction of NFL in both the active and non-active populations. 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 subtype with the highest unmet medical need. The right side of the slide shows comparison between our Phase II emphasis data for VF-C in RRMS versus our historical relapsing MS studies to complete the picture. In summary, we believe the clear separation observed for serum NFL for VF-C over placebo in this PMS patient population represents another major step forward for what potentially could be a first-in-class no-one activator for MS. This strong signal also points to a more likely positive outcome of the overall caliber trial, also on clinical relevant endpoints like prevention of disability worsening. In October, Dr. Robert J. Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Caliper programs, presented data from our Phase II emphasis trial of Vitafilmus calcium in RRMS in an e-poster at the joint Actums meeting. As a reminder, Vitafilmus calcium showed an improvement in serum NFL in both treatment arms of 30 and 45 mg over placebo. Just recently, we received a notice of a loan from the USPTO for patent covering the treatment of relapsing MS with a specific dose strength of VF-calcium. This includes a daily dose of about 10 milligram to 45 milligram of VF-calcium and other sorts, as well as the free acid form of the treatment for relapsing MS. Also covering the 30 milligram dosage used in our ongoing twin phase three insurance trials. The claims are expected to provide protection into 2041 unless extended further. This patent significantly bolstered the multi-layered proprietary IP position we have built around our late stage program for patients with MS. Moving to our IMU 856 program. In July, we hosted a virtual Celiac Disease Expert Roundtable to discuss ongoing active celiac disease, or OACD, a serious lifelong autoimmune disorder, and the substantial unmet need for therapeutic solutions. We were grateful and honored to have been joined for this event by the renowned thought leaders from Harvard Medical School, the Mayo Clinic, and Celiac Disease Foundation. During the round table, our chief medical officer, Andreas, also provided an overview of IMU 856 program, including our positive phase one trial results in celiac disease patients released earlier this year in May, which I will highlight again in just a moment. Also in October, we presented two abstracts at the United European Gastroenterology Week, UEGW 2023. My colleague, Dr. Franziska Bojanek, Senior Medical Director at Immunic, presented data from our positive phase 1B clinical trial of IMU856 in patients with celiac disease during a moderated poster session. IMU856 is an orally available and systemically acting small molecule modulator of the target SIRT6. The trial results gathered during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU856 over placebo in four key dimensions of celiac disease pathophysiology. Protection of the gut architecture, improvement of patient symptoms, biomarker response, and enhancement of nutrient absorption. IMU856 was also observed to be safe and well-tolerated in this trial. We believe that this highly encouraging data provides initial clinical proof of concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting the regeneration of bowel architecture. Additionally, Dr. Gerthe Hans from Amsterdam University Medical Center presented data from our Phase 2 CalDOS-1 trial of VFK in ulcerative colitis, or UC. As a reminder, the maintenance phase results from the Carlos I trial demonstrated statistically significant activity of VDL-calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of VDL-calcium in UC and other inflammatory bowel disease indications. Earlier this month, Dr. Bojanek had another opportunity to present the data from our Phase 1B clinical trial of IMUHF6 in patients with celiac disease in the virtual e-poster at the Association of European Celiac Society's General Assembly Conference in Athens, Greece. That concludes our summary for the third quarter 2022 industry and subsequent highlights. I am very happy that the scientific and clinical advancement and progress made across our different programs has been extremely positive during this year. Immunic is leveraging this momentum now in discussions with pharmaceutical companies. For IMU HF6, our goal is to identify a partner who is capable of performing several of their periodic phase two clinical trials. For Vita-Fluidomus calcium, the release of our very good biomarker NFL data has been an important trigger point for partnering discussions with global and regional pharma players. I would now like to hand over the call to Glenn to provide financial overview. Glenn?

Thank you, Daniel. I will now review the financial and operating results for the third quarter ended September 30th, 2023. Let me start a review of our cash position. We ended the quarter with 59.7 million in cash and cash equivalents. With these funds, we expect to be able to fund operations into September of 2024. Regarding the operating results. R&D expenses were $19.8 million for the three months ended September 30th, 2023, as compared to $16.5 million for the three months ended September 30th, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of beta flutamase calcium and personnel expenses. This was partially offset by a decrease in external development costs related to the IMU 935 and IMU 856 programs. The nine months ended September 30th, 2023. R&D expenses were 63.9 million as compared to 50.5 million for the same period ended September 30th, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of Vitaflumibus calcium, IMU-A56, and personnel expenses. This was partially offset by a decrease in external development costs related to the Phase II clinical trial of beta-fluidose calcium and ulcerative colitis, an IMU 935 program. G&A expenses were $3.8 million for the three months ended September 30, 2023, as compared to $3.6 million for the same period ended September 30, 2022. The slight increase was spread across numerous categories. For the nine months ended September 30, 2023, G&A expenses were $11.9 million as compared to $11.6 million for the same period ended September 30, 2022. The increase was related to an increase across numerous categories, which was partially offset by decrease in personnel expense related to stock compensation expense. Other income was 0.8 million for the three months ended September 30th, 2023, as compared to negative 1.1 million for the same period ended September 30th, 2022. The increase was primarily attributable to a decrease in foreign exchange losses 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. for the nine months ended September 30th, 2023. Other income was 3.8 million as compared to negative 1.8 million for the same period ended September 30th, 2022. The increase was primarily attributable to an increase in interest income as a result of higher interest rates, a decrease in foreign exchange losses, and the research allowance attributable for tax year 2021 from the German Federal Ministry of Finance that was received in 2023. The increase 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 three months ended September 30th, 2023 was approximately $22.8 million or $0.51 per basic and diluted share. Based on approximately $44.6 million, weighted average common share is outstanding. compared to a net loss of approximately 21.2 million or 69 cents per basic and diluted share based on approximately 30.6 million weighted average common shares outstanding. The same period ended September 30th, 2022. Net loss for the nine months ended September 30th, 2023 was approximately 72 million or $1.63 per basic and diluted share based on 44.2 million weighted average common shares outstanding. compared to a net loss of approximately $63.9 million, or $2.16 per basic and diluted share, based on 29.7 million weighted average common shares outstanding for the same period ended September 30, 2022. With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel?