Immunic, Inc.

Good morning and welcome to Munich's second 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 listening 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 your questions. You can either submit 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 findings 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.

Yeah, thank you, Jessica. I would also like to welcome everybody to Immunix second quarter 2023 earnings call. Earlier this morning, we announced our financial results for the second quarter ended June 30th, 2023, and highlighted recent activities as well as upcoming milestones. During today's call, we will walk through our second quarter 2023 and subsequent highlights, financial and operating results, as well as anticipated upcoming milestones. After the presentation, as Jessica noted, we will open the line to give the audience an opportunity to ask questions. Let's start with a review of our second quarter 2023 and subsequent highlights. In April, we reported positive data from the maintenance phase of our Phase 2b CalDOS-1 trial of BFHC in patients with moderate to severe ulcerative colitis. These results were extremely encouraging as they demonstrated statistically significant activity of E. coli as compared to placebo, while confirming the very favorable safety and tolerability profile for the drug already observed in other trials. As illustrated on the slide, data showed a dose linear increase in clinical remission as compared to placebo at week 50. An exploratory statistical analysis showed a p-value of 0.0358 confirmed the 30 milligram dose of VDF calcium to be statistically superior in achieving clinical remission and week 50 with a 33.7% absolute improvement over placebo. Overall, we believe the maintenance phase data confirms VDF calcium's activity in alternative colitis patients. Also in April, we welcomed Dr. Richard Rudick to our board of directors. Rick has spent decades as a clinical expert in multiple sclerosis and as a clinical trialist, overseeing multiple successful pivotal studies. His insights are already proving valuable as we continue to progress the development of Vitoflutimus calcium in multiple sclerosis, as well as in our earlier programs. In May, we reported stronger than expected positive results from the Part C portion of our phase one clinical trial of IMU 856 in patients with celiac disease during periods of gluten-free diet and gluten challenge. The data set shows the first clinical evidence of its ability, as observed preclinically, to regenerate the gut bone. In particular, the Phase Ib data showed that IMU856 was effective compared to placebo in improving four crucial aspects of celiac disease pathophysiology. Protection of gut architecture, improvement and reversal of patients' gluten-induced symptoms, biomarker response, and enhancement of nutrient absorption, such as vitamin B12. IMU 856 was also observed to be safe and well-treated 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 mechanisms involved specifically in celiac disease, appears to be unique among proposed therapeutic approaches. We believe this data provides initial proof of concept that this oral first-in-class molecule may represent an entirely new therapeutic approach, which could be a game changer in the way we treat gastrointestinal disorders, such as celiac disease, but also, for example, ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea. We are extremely enthusiastic about the potential for our IMU 856 program. On the heels of these results, was our announcement at the Digestive Disease Week in Chicago of clinical and preclinical data for INU856, including its molecular mode of action as a potent and highly selective modulator of SIRT6, a protein which serves as a transcription regulator of intestinal barrier function and regeneration of bowel epithelium. Through its effect on SIRT6, IMU856 has shown the ability in preclinical models to restore intestinal barrier function and regenerate bowel wall architecture. Importantly, in May, we also announced publication in the Journal of Medicine Chemistry of preclinical evidence showing that Vitoflutimus calcium acts as a potent NO1 activator. in addition to its known mode of action as a DHO-DH inhibitor. We believe that the activation of NO1 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 remitting MS. That said, these findings could be relevant not just in multiple sclerosis, but also in other neurological indications. As a reminder, the potential neuroprotective properties of VF calcium were already identified in our emphasis trial, where the trial data showed encouraging clinical signals regarding prevention of confirmed disability worsening, as well as a remarkable reduction of the biomarker neurofilament-like chain, NFL. Most recently, last month, we hosted a virtual Celiac Disease Expert Roundtable to discuss ongoing active celiac disease, or ACD, a serious lifelong autoimmune disorder, and the substantial unmet medical need for therapeutic solutions. We were honored to have been joined for this event by three renowned thought leaders from Harvard Medical School, Mayo Clinic, and the Celiac Disease Foundation. we could not be more grateful for their participation. During the call, our chief medical officer, Andreas Müller, also provided an overview of our IMU856 program, including our positive phase 1b trial results in celiac disease patients, which we discussed a little earlier this call. That concludes our summary of the second quarter 2023 and subsequent highlights. 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 second quarter ended June 30th, 2023. Let me start with the cash overview. We ended the quarter with $77.3 million in cash, which we expect will be sufficient to fund operations into the fourth quarter of 2024. Regarding the operating results, R&D expenses were $21.2 million for the three months ended June 30, 2023, as compared to $16.5 million for the three months ended June 30, 2022. These costs were mainly driven by external development costs related to ongoing clinical trials of Vita flutimus calcium and IMU 856, and partially offset by a decrease in external development costs related to the Phase II clinical trial of Vita flutimus calcium and ulcerative colitis and IMU 935 program. For the six months ended June 30, 2023, R&D expenses were $44.1 million, as compared to $34 million for the same period ended June 30, 2022. These costs also were mainly driven by external development costs related to the ongoing clinical trials in vitoflutinous calcium and IMU-A56, and were partially offset by a decrease in external development costs related to the Phase II clinical trial of beta-fluidinous calcium and ulcerative colitis in the IMU935 program. General administrative expenses were $3.8 million for the three months ended June 30, 2023, as compared to $4.1 million for the same period ended June 30, 2022. The slight decrease was chiefly driven by a decrease in non-cash based stock compensation partially offset by increased costs across a number of categories. For the six months ended June 30th, 2023, G&A expenses were $8.1 million as compared to $8 million for the same period ended June 30th, 2022. The nominal increase was related to an increase across a number of categories, which was partially offset by a decrease in personnel expense in G&A, primarily due to non-cash-based stock compensation decrease. Other income was $1 million for the three months ended June 30, 2023, as compared to negative $1.3 million for the same period ended June 30, 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 for clinical trials in Australia. With the six months ended June 30, 2023, other income was $3 million, as compared to negative $0.7 million for the same period ended June 30, 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 a research allowance attributable for the tax year 2021 from the German Federal Ministry of Finance. The increase was partially offset by a decrease in R&D tax incentives for clinical trials in Australia. The net loss for the three months ended June 30th, 2023 was approximately 24 million or 54 cents per basic and diluted share based on 44.4 million weighted average common shares outstanding compared to a net loss were approximately 21.9 million or 72 cents per basic and diluted share based on 30.2 million weighted average common shares outstanding for the same period ended June 30th, 2022. net loss for the six months ended June 30, 2023, was approximately $49.3 million, or $1.12 per basic and diluted share, based on 44 million weighted average common shares outstanding, compared to a net loss of approximately $42.7 million, or $1.49 per basic and diluted share, based on 28.7 million weighted average common shares outstanding, for the same period ended June 30, 2022. With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel?