Immunic, Inc.

Good morning and welcome to Munich's third quarter 2021 earnings call. My name is Jessica Brue, Head of Investor Relations and Communications at the Munich. I will also be the moderator on today's call. Please note, all participants will be in listen-only mode and this event is being recorded. Speaking on today's call are Dr. Daniel Fitt, our Chief Executive Officer and President, as well as Glenn Whaley, our Vice President of Finance and Principal Financial and Accounting Officer. After today's presentation, there will be an opportunity to ask questions. If you join the webcast via the Zoom client, there are two ways to submit your 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. If you join today's webcast by phone, please press star nine 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 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 now would like to turn the call over to our CEO and President, Dr. Daniel Fitt, to start with the presentation. Daniel, please go ahead.

Yeah, thank you, Jessica, for opening the call. I also would like to welcome everybody on Immunix third quarter 2021 earnings call. Earlier this morning, we announced our financial results from the third quarter of 2021 and highlighted recent milestones as well as upcoming updates to our clinical development pipeline. During today's call, we will talk through our third quarter 2021 and subsequent highlights, financial and operating results, as well as anticipated milestones. Before we close the call, you will have the opportunity to ask questions. During the third quarter, we continue to make great progress in advancing our three product candidates through the clinic. setting the stage for several important data readouts in the fourth quarter of 2021 and 2022. Most importantly, we expect to start patient enrollment in our Phase III program in relapsing multiple sclerosis still this quarter. Another major milestone will be the top-line data from our Phase II trial in ulcerative colitis, which we anticipate in the second quarter of 2022. We just recently announced completion of patient recruitment with 263 patients randomized in total. For our second program, IMU-935, we expect unblinded safety data from the single and multiple ascending dose parts of the phase one trial later this year. Additionally, we just have started part C of the phase one trial in psoriasis patients and expect initial human data from this patient population in the second quarter of next year. Finally, we also hope to see first clinical data from the ongoing phase one trial of INU856 in the third quarter of next year. But let me walk through the third quarter 2021 and subsequent highlights in more detail first. In July, we hosted a virtual R&D day to provide an update on the preclinical and clinical development of our raw gamma T inverse agonist, IMU935. We presented very encouraging preclinical data showing that IMU95 may inhibit both the generation of TH17 cells and the production of IL-17 cytokines that are responsible for the development of autoimmune diseases without impairing thymocyte development. We think that this may avoid a potential risk for lymphoma that has complicated third-party programs in this space. At the R&D day, we also presented further new preclinical data highlighting the potential of IMU95 for the treatment of metastatic castration-resistant prostate cancer. Based on the strength of this data, we expect to initiate an open-label phase one dose escalation trial in CRPC during the fourth quarter of this year. Also in July, we successfully completed a $45 million follow-on offering, which extended our cash runway through multiple value inflection points into 2023. In September, we signed an in-license agreement with University Medical Center Göttingen in Germany, covering the combination of DHO-DH inhibitors and nucleoside analogs to treat viral infections. At the same time, we published remarkable preclinical data showing that certain DHO-DH inhibitors, including IMU828, strongly synergize with selected nucleoside analogs to inhibit SARS-CoV-2 replication in vitro. This powerful reduction was demonstrated across multiple SARS-CoV-2 variants, including alpha, beta, and delta, and thereby highlighting the independence of this approach to mutant virus forms. I once again would like to thank our research partners at the University Medical Center, Göttingen, Ruhr University, Bochum, Universitätsklinikum Erlangen, Utah State University, and MBM Science Bridge for their tremendous work. In September, we enrolled the first patient in our Phase II Caliper Trial of IMU828 in patients with progressive MS. The trial will run concurrently with our twin Phase III Ensure Trials in relapsing MS and is thought to be a supportive trial to underline IMU828's neuroprotective potential. We believe that if the trial is successful in showing a beneficial neuroprotective effect of IMU828, We may be able to clearly differentiate IMU 838 versus other oral MS medications and carve out a very attractive commercial positioning in the MS landscape. In October, we are very pleased to welcome Patrick Walsh as our new chief business officer. Patrick is a seasoned BD executive, and I very much look forward to leveraging his experience here at Immunik. In October, we also dosed the first psoriasis patient in Part C of our ongoing Phase I trial of IMU9C5. This represents the first time patients are treated with our oral IL-17 inhibitor, IMU9C5. We expect initial psoriasis data in the second quarter of next year. October was a month of clinical milestones for Immunic. We also completed patient randomization in our phase two trial of IMU838 in moderate to severe ulcerative colitis. In total, 263 patients were randomized. We now eagerly await the top line data of the trial in the second quarter of next year. For the next part of our presentation, I would like to hand over to Glenn for the financial overview.

Thank you, Daniel. We will now review the financial and operating results for the third quarter of 2021. Let me start with the cash overview. We ended the quarter with $110 million in cash and cash equivalents, which we anticipate to be sufficient to fund operations into 2023. Now let's review the operating results. Research and development expenses in the third quarter were $15.5 million, as compared to $11 million for the same period in 2020. For the nine months ended September 30th, R&D expenses were 42.7 million, as compared to 27.5 million for the same period in 2020. The increase in costs for both periods reflect a continued ramp up of our clinical expenses related to our three clinical programs, as well as increased personnel expenses as a result of hiring more people to support the company's growth. The increases were partially offset by decreased costs related to our phase two clinical trial in COVID-19 that was finished in the first quarter of 2021 and decreases in drug supply costs for IMU 856. General and administrative expenses were 2.9 million for the three months ended September 30th, as compared to 2.5 million for the same period last year. For the nine months ended September 30th, GNA expenses were 10 million, as compared to 7.3 million for the same period in 2020. The increase in costs for both periods was primarily due to non-cash stock compensation expense, as well as smaller increases in costs across numerous categories. Net loss for the third quarter 2021 was approximately 19.3 million, or 76 cents per share, based on 25.3 million weighted average common shares outstanding. compared to a net loss of approximately 12.9 million, or 70 cents per share, based on 18.4 million weighted average common shares outstanding for the same period in 2020. Net loss for the nine months ended September 30th was approximately 71.8 million, or $3.33 per share, based on 21.6 million weighted average common shares outstanding, compared to a net loss of 32.9 million, or $2.35 per share based on 14 million weighted average common shares outstanding for the same period in 2020. I would like to remind everybody that our year-to-date net loss was impacted by the settlement agreement of our subsidiary, Immunic AG, signed with 4SC AG in March of 2021. Immunic AG settled this remaining obligation of a 4.4% royalty on net sales of IMU 838 for 17.25 million. The payment was made 50% in cash, 50% in shares of Immunix common stock. No further payment obligations remain between Immunix and Forest CAG. With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones. Daniel.