Immunic, Inc.

good morning everybody and welcome to munich's second quarter 2022 earnings call my name is jessica brew 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 fit our chief executive officer and president as well as glenn whaley our chief financial officer for the q a section of today's webcast we also have with us our chief scientific officer dr hella kohlhof 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 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 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 webcast over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel, up to you.

Thank you, Jessica. I would like to welcome everybody to Immunix second quarter 2022 earnings call. Earlier today, we announced our financial results for the quarter ended June 30th, 2022, and highlighted recent activities as well as upcoming milestones related to our clinical development pipeline. During today's call, we will walk through our second quarter 2022 and subsequent highlights, additional clinical updates we provided in the filings this morning, financial and operating results, as well as anticipated milestones. As Jessica noted before we close the call, you will have the opportunity to ask questions. The second quarter of 2022 was a period of continued progress in our clinical programs, which we believe set the stage for important data readouts during the second half of this year. In particular, we look forward to reporting first clinical activity data for our selective oral IL-17 inhibitor IMU935 in psoriasis, and first in human healthy volunteer data from IMU856, our orally available and systemically acting small molecule that has shown preclinically to regulate intestinal barrier function and regenerate bowel epithelium. But let me move to a more detailed review of our second quarter updates. In May, we announced the start of the patient cohort in our ongoing phase one clinical trial of IMU856 in patients with celiac disease. This represents the first time patients are being treated with this small molecule, oral epigenetic regulator that appears to influence the tightly regulated network of genes and proteins associated with intestinal epithelial cell interaction and adhesion. With respect to videofluidimus calcium, our selective OLDH-ODH inhibitor, in June, we reported top-line data from our Phase II CALDOS-1 trial in patients with moderate to severe UC. The data revealed a previously unknown interaction with chronic concurrent steroid use, resulting in the trial missing its primary endpoint. As a consequence, we decided not to continue our development of videofluidimus calcium for inflammatory bowel disease indications without a partner. Consistent with prior data sets in other patient populations, administration of BDF calcium in this trial was observed to be safe and well tolerated. Also in June, the data from cohort one of our phase two emphasis trial in RRMS comprising 30 and 45 milligram of BDF calcium and placebo was published in the peer-reviewed journal, Annals of Clinical and Translational Neurology. The publication underlines the importance of our excellent phase two findings for Vitoflutimus calcium in patients with RMS. I would like to express my thanks to the lead author and coordinating investigator Robert Fox from Cleveland Clinic and to the entire team involved in preparing this article. In other corporate news, last month we announced the appointment of Maria Thunsen, an industry executive with 20 years of global commercial expertise and experience in US and ex-US markets, to our board of directors, and the resignation of Jan van der Bosche from the board, both of which were effective on July 5th, 2022. Before I hand over to Glenn for the financial summary, I would like to highlight some other interesting clinical updates we provided in our earnings filing this morning. Based on the observation, On the observed interaction between Vitoflutibus calcium and chronic steroid use in the CalDOS1 trial in UC patients, we performed the post-hoc analysis of our Phase II emphasis data in RMS patients to explore the potential influence of steroids on these study results. As anticipated, steroid use was rare, and among those IMS patients who received any steroid, the majority received only short steroid courses following relapse events or acute neurological events. Most of these patients only had one short course of steroids, and the average duration of steroid treatment in these patients was 4.4 days. This underlines that steroids are rarely used in MS patients and mostly for very short duration. In conclusion, comparing patients who received at least one dose of corticosteroids with those who did not, we neither see differences in clinical parameters nor evidence that the rare short-term use of steroids in our MS patients has any influence on the effectiveness of riloflutemus calcium in this patient population. With respect to IMU935, we are progressing well in our development program. In this context, we already completed an exploratory phase one study in 15 available healthy human subjects to assess the drug-drug interaction potential for the drug. No relevant signals for DDI potential were observed, and the treatment in this trial was safe and well tolerated. Finally, the first two dose cohorts of all phase one clinical trial of IMU925 in metastatic castration-resistant prostate cancer have been fully recruited, with six patients enrolled in the 300 milligram cohort and six patients enrolled in the 600 milligram cohort. Of these patients, all have completed the 28-day dose-limiting toxicity observation period. The third 900 milligram cohort is expected to start dosing soon. Initial safety data available so far show a promising safety profile of IMU935 in metastatic CRPC with only benign adverse events and no dose-limiting toxicities. We plan to provide a more comprehensive update on safety and also on potential signs of anti-tumor activity of IMU935 in this trial as soon as data from the planned dose expansion part are available. That concludes our summary of the second quarter 2022 and subsequent highlights, as well as our clinical updates. I'd like to turn the call over to Glenn, who will provide the financial overview.

Glenn? Thank you, Daniel. I will now review the financial and operating results for the quarter ended June 30th, 2022. Let me start with the cash overview. We ended the second quarter with $88.1 million in cash and cash equivalents, which we expect to be sufficient to fund our operations into the fourth quarter of 2023. Regarding the operating results, research and development expenses were $16.5 million for the three months ended June 30th, 2022, as compared to $15.7 million for the three months ended June 30th, 2021. These costs are mainly driven by external development costs related to the ongoing clinical trials of it if you lose calcium and I am you 935. The six months ended June 30 2022 r&d expenses were $34 million as compared to $27.3 million for the same period last year. These expenses were also mainly driven by external development costs of our three clinical development programs. General administrative expenses were $4.1 million for the three months ended June 30, 2022, as compared to $3.4 million for the same period ended June 30, 2021. The increase is mainly driven by personnel expenses, including non-cash stock compensation related to headcount. For the six months ended June 30, 2022, G&A expenses were $8.1 million, as compared to $7.1 million for the same period in 2021. The increase was driven primarily by personnel expenses, including non-cash stock compensation related to headcount. Other expense was negative $1.3 million for the three months ended June 30, 2022, as compared to other income of $1.2 million for the same period ended June 30, 2021. The decrease was primarily attributable to an increase in the loss on intercompany loan between Immunic Inc. and Immunic AG as a result of changes in currency exchange rates. For the six months ended June 30th, 2022, other expense was negative $0.7 million as compared to negative $0.9 million for the same period last year. Net loss for the three months ended June 30th, 2022 was approximately $21.9 million or 72 cents per basic and diluted share. based on approximately 30.2 million weighted average common shares outstanding compared to a net loss of approximately $17.9 million or 82 cents per basic and diluted share based on 21.7 million weighted average common shares outstanding for the same period ended June 30th, 2021. Net loss for the six months ended June 30th, 2022 was approximately $42.7 million or $1.49 per basic and diluted share based on approximately 28.7 million weighted average common shares outstanding compared to a net loss of approximately $52.5 million or $2.44 for basic and diluted share based on 21.5 million weighted average common shares outstanding for the period ended June 30th, 2021. With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones. Daniel?