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Good morning, and welcome to Immunic’s Third Quarter 2024 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer, Glenn Whaley, our Chief Financial Officer; as well as Jason Tardio, our President and Chief Operating 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. [Operator Instructions] 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 in Immunic’s actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunic’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 Immunic’s SEC filings for a more detailed description of the risk factors that may affect Immunic’s results and these forward-looking statements. I would now like to turn the call over to our CEO, Dr. Daniel Vitt, to begin the presentation. Daniel?

Thank you, Jessica. I would also like to welcome everybody to today’s Q3 2024 earnings call. Earlier this morning, we announced our financial results for the third quarter and nine months ended September 30, 2024. During the call today, we will walk through our third quarter 2024 achievements and subsequent highlights, financial and operating results as well as our clinical development programs, including anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let’s start with the review of our third quarter 2024 and subsequent highlights. In July, our management team was strengthened with the addition of Jason Tardio, as President and Chief Operating Officer, bringing with him a wealth of experience launching and commercializing multiple sclerosis drugs for major biotechnology and pharmaceutical companies. Jason has already proven to be invaluable, leading internal efforts to prepare for the potential commercialization of vidofludimus calcium. Jason also has been collaborating closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for vidofludimus calcium as well as our other drug candidates, where we are leveraging his extensive partnering experience. Additionally, Werner Gladdines was promoted to Chief Development Officer. Werner joined Immunic in January of 2021 as Head of IMU-838 Program, and he has held positions of increasing responsibility since then. In his new role, he takes over additional strategic and operational responsibilities for Immunic’s overall clinical operations functions. In July, we also strengthened our Board of Directors with the appointment of Simona Skerjanec, a thought-leader in brain health with decades of experience in drug development and commercialization. Over a 30-year career in the United States and internationally, Simona has led research and development efforts, culminating in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, The Medicines Company, Eli Lilly, Pfizer and Johnson & Johnson. It is worth pointing out that Simona led business and global corporate strategy for Roche portfolio of neurological and rare diseases, achieving sustainable double-digit growth in sales, including with Ocrevus, which remains one of the most successful medicines for the treatment of MS today. Her success in this area really enhances our Board as we work towards the potential commercial launch of vidofludimus calcium. In September, we hosted an in person MS R&D day, which featured two world renowned industry experts, Dr. Francesca Montarolo, Biologist and Leading MS and Nurr1 Target Expert from the Neuroscience Institute Cavalieri Ottolenghi and University of Turin, Italy; as well as doctor Amit Bar, Clinician, Scientist and one of the leading neuroimmunologist in MS from University of Pennsylvania. These distinguished key opinion leaders, along with our management team, provided an in-depth overview of the MS landscape and our orally available lead asset, vidofludimus calcium. The presentation highlighted its dual mode of action, which combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 or Nurr1 activator, with anti-inflammatory and anti-viral effects via DHODH inhibition. During the event, we also shared insights on our ongoing Phase 3 ENSURE Trials in relapsing MS, our ongoing Phase 2 CALLIPER trial in progressive MS and highlighted the commercial opportunity for vidofludimus calcium in the MS market. In particular, we discussed our strong belief in the potential of vidofludimus calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with relapsing and progressive forms of MS, where there are currently few options and there continues to be a huge unmet need. We continue to believe that vidofludimus calcium has the potential to redefine the oral multiple sclerosis treatment landscape and elevate the standard of care for these patients. In September, we enrolled the first patient in an investigator-sponsored Phase 2 clinical trial of vidofludimus calcium, the RAPID_REVIVE trial, in Post COVID Syndrome, for which Immunic is providing study medication. The trial is a randomized, placebo-controlled, double-blind, parallel-group trial led by Professor Maria Vehreschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research. We are honored to have vidofludimus calcium chosen for this investigative sponsored study run by such highly regarded investigators at esteemed institutions in Germany. We have already seen convincing data supporting beta vidofludimus calcium’s antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our Phase 2 CALVID-1 trial. Importantly, third-party researchers identified Epstein-Barr virus reactivation as a potential cause for fatigue, one of the most dominating symptoms for both Post COVID syndrome and MS patients, negatively impacting their quality of life and ability to participate in social activities. We also aim to confirm the ability of vidofludimus calcium to influence fatigue and Epstein-Barr virus reactivation in our ongoing MS trials, and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for our drug candidate. In September, we also had the opportunity to present four posters at the prestigious 40th Congress of ECTRIMS, showcasing data on key aspects of vidofludimus calcium profile, illustrating the strength of the data generated today and its potential to become a new treatment option for MS. Jason, do you want to add a few words on the Congress?

Sure. And thank you, Daniel. The ECTRIMS Congress is the premier meeting of the year in the field of multiple sclerosis and brings together over 9,000 of the world’s top clinicians, researchers, and healthcare professionals. We are particularly excited to have had the opportunity to present data at this meeting to further support the differentiation of vidofludimus calcium as a potential treatment for both relapsing and progressive multiple sclerosis. More specifically, we shared additional data from the interim analysis of our ongoing Phase 2 CALLIPER trial in progressive multiple sclerosis that showed that vidofludimus calcium not only had a significant impact on reducing serum neurofilament light chain across the total study population, but also consistently reduces neurofilament light chain levels compared to baseline across different patient subgroups based on age and disability scores. These observations are important as neurofilament proteins are a marker of neuronal degeneration and serve as an important biomarker of disease activity in multiple sclerosis. With recent data showing that lower neurofilament light levels indicate a lower risk of future disability progression in progressive MS patients. We also prevented compelling data on fatigue from post-hoc analysis of the CALVID-1 trial, which evaluated the safety and efficacy of vidofludimus calcium 45 milligrams in patients hospitalized for COVID-19. As mentioned earlier, fatigue is the most frequent symptom reported by patients with multiple sclerosis. And for many patients, it is the most disabling and chronic symptom. Given the broad spectrum antiviral effects of vidofludimus calcium and its potential to prevent reactivation of the Epstein-Barr virus or EBV, which has been linked to fatigue in multiple sclerosis, we sought to understand the impact of vidofludimus on fatigue in Post COVID syndrome patients. Results of this analysis show that 80% of patients who received placebo reported fatigue compared to only 50% of patients who received vidofludimus calcium. Fatigue was further decreased from weeks 9 to 17 to 33% for patients on placebo and only 17% for patients on vidofludimus calcium, thus supporting the antiviral effects of vidofludimus and how it may contribute to lower fatigue levels. This hypothesis we further assess by determining effects on fatigue using patient questionnaires as well as analysis of the anti-EBV effect in our ongoing CALLIPER and ENSURE trials. Lastly, we presented additional preclinical evidence supporting that vidofludimus calcium enhanced the expression of Nurr1 target genes, important for neuronal survival, further suggesting the neuroprotective benefit of this assay. And, also reduce infiltrating T helper cells in the spinal cord and the number of pro-inflammatory T helper cells in the peripheral in marine EAE models. In addition to these data presentations, Immunic also filled an exhibitor booth for the first time at this important meeting. This served as a great opportunity to engage the MS community and further increase awareness of vidofludimus calcium as a potential treatment for MS. Back to you, Daniel.

Yes. Thank you, Jason. In October, we announced a positive outcome of the interim analysis of our Phase 3 ENSURE program of vidofludimus calcium in relapsing multiple sclerosis or RMS. An Independent Data Monitoring Committee, IDMC, reviewed unblinded data and based on this, recommended that the trials are not futile and should continue as planned without any changes, marking the successful achievement of a critical milestone for the program. While Immunic remain blinded to our data, the IDMC favorable recommendations corroborate our initial assumptions of the design, powering and relapse rate of the twin Phase III trials and to suggest that they are in-line with the data observed so far. In particular, the plan sample size seems appropriate to address the statistical assumptions for the primary endpoint of time to first relapse. We are confident in vidofludimus calcium’s potential to transform the RMS market and continue to believe that the Phase III program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. That concludes our summary of the third quarter 2024 and most recent highlights. I am very pleased with the scientific and clinical achievements we have made across our programs. As it relates to vidofludimus calcium, we continue to advance both our twin Phase 3 ENSURE trials in patients with relapsing MS and our Phase 2 CALLIPER trial in progressive MS. We are very excited to read out the topline data of the CALLIPER trial in just a couple of months from now expected in April 2025. Based on the strong clinical evidence today, we continue to pursue partnering discussions with global and regional pharmaceutical companies. Our team has also been busy advancing our IMU-856 Program, which has the potential to become a game changer for the treatment of a broad range of gastrointestinal disorders. 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 third quarter and nine months ended September 30, 2024. Let me start with a review of our cash position. We ended the third quarter of 2024 with $59.1 million in cash and cash equivalents, which we expect to be able to fund our operations into the third quarter of 2025. Regarding the operating results, R&D expenses were $21.4 million for the three months ended September 30, 2024, as compared to $19.8 million for the three months ended September 30, 2023. The increase was mainly driven by increases in external development costs related to our clinical trials, which was partly offset by a decrease from the deprioritization of the izumerogant program in psoriasis and castration-resistant prostate cancer last year. For the nine months ended September 30, 2024, R&D expenses were $58.4 million as compared to $63.9 million for the nine months ended September 30, 2023. The decrease was mainly driven by the deprioritization of the izumerogant program in psoriasis and castration-resistant prostate cancer and the completion of the Phase 1 clinical trial of IMU-856 in celiac disease last year. This was partially offset by an increase in external development costs related to the vidofludimus calcium program as well as an increase in personnel expenses. G&A expenses were $4.4 million for the three months ended September 30, 2024 as compared to $3.8 million for the same period ended September 30, 2023. The increase was primarily related to personnel expenses. For the nine months ended September 30, 2024, G&A expenses were $14 million as compared to $11.9 million for the same period ended September 30, 2023. The increase was primarily related to personnel expenses, legal and consultancy expenses and other across numerous categories. Interest income remained unchanged at $0.8 million during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. For the nine months ended September 30, 2024, interest income was $3 million as compared to $2.5 million for the nine months ended September 30, 2023. The $0.5 million increase was due to higher interest rates. We also reported a change in fair value of the tranche rights for the nine months ended September 30, 2024. The change of $4.8 million was a non-cash charge related to the change in value of the tranche rights associated with the future tranches 2 and 3 of the January 2024 private placement. Other income was $600,000 for the three months ended September 30, 2024 as compared to $35,000 for the same period ended September 30, 2023. The increase was primarily attributable to R&D tax incentives for the clinical trials in Australia. For the nine months ended September 30, 2024, other income was negative $1.1 million as compared to $1.3 million for the same period ended September 30, 2023. The decrease was primarily attributable to an expense related to the portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche 1. The timing of recognizing the German Federal Ministry of Finance grant, as well as a decrease in R&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. The decrease was partially offset by an increase in foreign exchange gains. The net loss for the three months ended September 30, 2024, was approximately $24.4 million or $0.24 per basic and diluted share based on 101.3 million weighted average common shares outstanding compared to a net loss of approximately $22.8 million or $0.51 per basic and diluted share based on approximately 44.6 million weighted average common shares outstanding for the same period ended September 30, 2023. Net loss for the nine months ended September 30, 2024 was approximately $75.3 million or $0.75 per basic and diluted share based on approximately 100 million weighted average common shares outstanding compared to a net loss of approximately $72 million or $1.63 per basic and diluted share based on 44.2 million weighted average common shares outstanding for the same period ended September 30, 2023. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?

Thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming milestones. Our next important clinical readout, which we are eagerly anticipating, will be the topline data from our Phase 2 CALLIPER trial of vidofludimus calcium in progressive MS in April of next year. In addition to the overall PMS population, the data would also deliver insights on its sub-forms, including non-relapsing secondary progressive MS, a subtype with the highest unmet medical need. Should the topline data continue to show a neuroprotective effect and the Phase 2 trial meets its primary and key secondary endpoints, we may also be able to position the drug as the first oral treatment option for non-relapsing secondary progressive MS. Additionally, we are progressing as planned with our Phase 3 ENSURE program of vidofludimus calcium in relapsing MS and expect to complete the first of our identical twin Phase 3 ENSURE trials in the second quarter of 2026. The completion of the second ENSURE trial is expected in the second half of 2026. As it relates to our second clinical program, IMU-856, we remain very enthusiastic and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders by targeting physiological intestinal epithelium regeneration, resulting in gut wall healing with the absence of broad immunosuppression seen in many currently available gastrointestinal drugs in use today. It bears repeating that data from our Phase 1b clinical proof-of-concept trial of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge demonstrated significant improvements over placebo in four key dimensions of clinical outcomes in celiac disease: protection of the gut architecture, improvement of patients’ symptoms, enhancement of nutrient absorption and a strong biomarker response. As previously reported, we have begun preparing for Phase 2 clinical testing of IMU-856. And, in addition to celiac disease, we are also exploring a number of other clinical applications for other gastrointestinal disorders, where the renewal of the gut wall is important. We are currently exploring options to separately fund this unique asset and are openly considering different avenues. Let me hand over to Jason, at this point again to emphasize vidofludimus calcium’s unique profile.

Thank you, Daniel. Now, part of the reason I joined Immunic, just a few months ago was because of what I see as a tremendous opportunity and a tremendous potential for vidofludimus to transform the MS market and to potentially become the leading therapeutic within the oral disease modifying therapy segment. The profile of this drug candidate is unique given its first-in-class dual mode of action approach designed to address the full spectrum of multiple sclerosis from stages of relapses and focal inflammation through the progressive stages where neurodegeneration takes hold. As a first-in-class Nurr1 activator, vidofludimus calcium goes beyond inflammation, providing direct neuroprotective effects and thereby offering potential benefits for both relapsing, progressive MS patients. In addition, vidofludimus is also a highly selective DHODH inhibitor associated with potent anti-inflammatory effects, which we know plays a key part in the relapsing forms of multiple sclerosis. We believe this mode of action combine with an exceptional safety and tolerability profile and the convenience of once-daily oral administration gives vidofludimus calcium a potentially best-in-class benefit risk profile within the oral class of medicines. Initially, it’s worth highlight that we do not believe there is going to be any first dose or on-treatment monitoring necessary, which means this will be an easy medicine to start newly diagnosed patients on and also a very easy medicine to switch patients to, remembering that about 65% of the market today is a switch category. We also do not anticipate any safety concerns or black box warnings specific to the vidofludimus calcium. Given this profile and if approved across the vast indications of multiple sclerosis, we believe vidofludimus calcium has the potential to transform the oral disease modifying therapy market with expected peak sales of this product ranging from US$2 billion to US$6 billion. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.

Yes. Thank you, Jason and Daniel and Glenn, for walking us through the third quarter and subsequent highlights, as well as our clinical development pipeline and upcoming value inflection points. We will now begin the question-and-answer session. As a reminder, 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. Our first guest today is William Wood from B. Riley. William, welcome, and please unmute yourself.

Thank you so much. We really appreciate you, taking our questions, and congrats on another successful quarter. We have a couple of questions, on our end. So the first is, just thinking about your CALLIPER study, coming up readout in April. This is in PMS, so SPMS including active and non-active as well as PBMS. What level of detail should we expect a topline readout across these populations for both your primary as well as your secondary endpoints presented, possibly CDW, NfL, and or GFAB? Essentially, I’m trying to, are we going to just get an overall population data, or should we expect some of these subpopulation data also? And then, I have a follow-up. Thank you.

Yes. Thank you, William, for that wonderful question. And, I have good news. So, we plan to really, come out with detailed data on the general and the subforms, tested during the study, as we did for the interim analysis a year ago. And also, we really tried to have everything possible available at the readout, including the very important clinical endpoint, so confirmed disability worsening, the biomarker, NfL, but also GFAB, given that the duration of the study allows to also evaluate that exploratory biomarker, and also the brain atrophy data, of course. So, it will be quite comprehensive data we’re expecting in April next year.

Excellent. It’s great to hear. And then, just a quick second one. You also have as you noted, you have your ongoing Post COVID investigator-led trial, going on in Germany. You’re looking to enroll, looks like, about 376 patients. It’s got a 56 day timeline, and it’s obviously evaluating fatigue, a key issue in multiple sclerosis. Maybe you could remind me when we might expect the data here possibly before ENSURE’s readout in 2026? And if so, how should we think about the results in this Post COVID trial, how it might highlight your dual-MOA and success in ENSURE? And then, remind me if there’s any type of subtype analysis or earmarking of patients in either ENSURE or CALLIPER that are diagnosed with Post COVID syndrome? Thank you. I’ll hop back into queue.

Okay. I hope I remember everything from the questions. So, starting with the Post COVID study, this is an investigator-sponsored trial. And therefore, we really can’t give any guidance on the speed of recruitment. I know that the study kicked off and they have patients in, but we are not a sponsor. We provide here the drug. But, we’re excited about the specific analysis here. The role of fatigue is super important in multiple sclerosis. And, it’s interesting to see the overlap and the role of EBV, expected in both in MS, but also in Post COVID syndrome. Therefore, it could be scientifically and medically very meaningful thing, even if it’s an investigator-sponsored trial. So, we want to learn, and we want to use that knowledge for the patients, to have a better treatment option, also to understand why and to what extent vidofludimus calcium can really make a difference here on preventing fatigue. And then, there was a second part of the question. I forgot what that was.

Yes. Just if you’re earmarking, or making note of or any type of sub-analysis going on in ENSURE or CALLIPER for these Post COVID syndrome patients, just to sort of understand how that might translate, their data might translate to these larger trials?

Yes. That’s a good point. It’s not predefined, in the study, as far as I know. But, we will see if that shows up in the general safety monitoring of the study.

Yes.

And, if we have data, we will likely also extract that, maybe not at a topline data readout, but maybe at a later time point then.

Great. Makes sense. Thank you again, and I’ll hop back in the queue. Congrats again on a very nice quarter.

Thank you, William.

Thank you, William. The next one I have in the queue here is Yasmeen Rahimi with Piper Sandler. Yas, please unmute yourself and go ahead.

Hey. Good morning, team. This is [Jungkook] (ph) on for Yas.

Hi, Jungkook.

Thanks for taking our questions. First, to the extent, can you comment on what do you see on a blinded basis for CALLIPER, in regards to safety and efficacy? And secondly, given that CALLIPER has different PMS subpopulations for disability worsening, can you detail which subgroup is most likely experienced the biggest treatment effect?

Thank you. Let me start with the first thing. We see blinded data. We can’t conclude anything from that. So and, therefore, we should not speculate on anything on the blinded data for CALLIPER. So far, what I hear from the clinical team, the study is progressing as expected. So, that’s all I can say. On the sub-indications, that’s a good point. I think there is clearly, there are three sub-indications predefined in CALLIPER, the Active Secondary Progressive, Non-Active Secondary Progressive and Primary Progressive MS. And, I think the Non-Active Secondary Progressive and Primary Progressive populations are kind of similar, on the issue that they don’t have relapses, that we you don’t measure lesions in the brain, no inflammatory lesions, but they still progress on disability. And, given that we have certain inclusion criteria for baseline EDSS score, so we think those should be in the same ballpark of placebo disease activity in those patients. It’s a little bit different, I think, for the active SPMS patients, given that there are still some inflammatory activity. And therefore, we expect that to be a little bit, generally, I think, a little bit higher. But also, the number of those patients, it’s a smaller subgroup in the study. It’s 9% of the patients in the study.

I got it. Thank you.

Thank you, Jungkook. Next one in the queue here is Faisal Khurshid from Leerink Partners. Faisal, please unmute yourself, and good morning.

Hey, guys. Good morning. This is, Matt Cowper on for Faisal Khurshid. Thanks for taking my question. A couple from me. What hazard ratio for disability worsening will you be looking for in CALLIPER to feel good about vidofludimus’ potential in PMS? And then, pending positive data, in CALLIPER, is there any opportunity for an accelerated registrational path in PMS, or would you have to run a trial similar to what we see with the BTKs in PMS? Thank you.

Yes. Thank you, Matt. Hazard ratio assumptions. I think there is no predefined bar right now, of what you need to show, of course, but there is a little of a perception of KOLs, what they perceive as medically meaningful. And, we asked the questions of the medical team. There was, we had a meeting with some of our KOLs not too long ago, and my colleague Andreas asked the team, what do you expect? And, the discussion more or less came around, okay, if it’s a 15% benefit on disability protection that is something. At 20%, I think everybody agreed that, that’s a real signal. So, we think that there’s no hard line, but a 20% benefit would be a big win for the molecule. And, then the better, the higher the difference, the better for the drug, of course. And, on accelerated approval, that’s definitely an opportunity. But, again, it depends on the data, on the one hand and the distribution of the data. And there, for example, how similar are things between the subgroups and so forth. And then, and the signal strength, for example, in the biggest population in the study, and in non-active secondary progressive patients. And, that may qualify for having at least a discussion with the FDA on any kind of expedited way forward. However, we can’t guarantee that this is an opportunity, but definitely worth a try.

Great. Thanks for the insight and taking my questions.

Thank you.

Thank you, Matt. Just for full transparency here, we also had the question on accelerated or expedited approval two times in the chat. So, I guess this is answered now. Next one in the queue here is Matt Kaplan from Ladenburg. Matt, please unmute yourself and go ahead.

Hey. Good morning, guys. Just wanted to stay on the CALLIPER study a little bit in progressive MS. Can you talk a little bit about the unmet need, in PMS and specifically also the subgroups of PMS as well?

Oh, yes. Good that you asked. I think this is so super important, and I think we can’t say often enough that this is really one of the areas where there is the highest need. And specifically, for non-active secondary progressive MS, there’s currently not a single treatment approved. So, that clearly is a huge unmet need. Maybe, Jason, you have a little bit of comments also on the number of patients affected there, answering that question. And, just to complete it for the same, it’s not the same, but similar in primary progressive where you currently, we only have approved as an infusion. There’s no oral drug approved. And also, I think on the effect size, it’s good to have another option as well for PPMS patients. But maybe, Jason, you can add a little bit more color on that.

Sure. Happy to do so, Daniel and Matt. Thank you for the question. So clearly, look, there’s a huge unmet need in the progressive side of this disease, specifically, and the non-relapsing secondary progressive MS, phenotype or subtype. As Daniel mentioned, there’s no currently approved medicines. We know that in across the seven major markets, there’s approximately a 175,000 patients diagnosed with non-relapsing secondary progressive MS. So, it’s a big opportunity, represents about 15% of the total, MS population. Also, on the primary progressive side, we know that there’s approximately a 120,000 or so patients diagnosed across the major markets, representing about 10% of the total population. There is only one treatment approved to-date, in primary progressive MS and that is Ocrelizumab or Ocrevus. But, I also think it’s important to note that, as patients progress, as they, get into these more neurodegenerative forms of the disease, they’re normally a little bit older in age. They normally have more, accumulation of disability, both physical and cognitive disability. And just as patients age, you have a normal breakdown or wear down of the body’s natural immune system. And so, in these primary progressive patients, though Ocrevus is currently approved, there is some reluctance about putting these type of patients on immunosuppressant, right, broad B cell depleting, therapies. And so, again, the uniqueness of vidofludimus calcium given its dual mechanism of both the neuron activation and highly selective inhibition of DHODH, is that we think it’s going to have a very, very strong neuroprotective play. It’s not immunosuppressant. So, if approved and we show a good signal here, we believe it could become a gold standard-of-care in the progressive forms of the disease.

Thank you.

Thank you, Matt. And maybe a follow-up, question for Jason here in the chat. Can you share more details on the calculation of the peak sales mentioned, regarding market share?

Yes. I mean, I’m not going to get into the intricacies of total market capture. What I can tell you is that we’ve done a lot of work to understand both the bottoms up and the top down of forecast and opportunity for this respective medicine. It’s quite clear even with 20 approved, 20 plus approved therapies in the relapsing forms of the disease, there continues to be a huge unmet need. A couple of data points that I think are worth mentioning. Of the roughly 900,000 patients that are currently diagnosed with relapsing forms of multiple sclerosis across the major markets today, only about 525,000 of them are currently on a disease modifying therapy. So, there’s a huge delta between the number of patients diagnosed and those currently on therapy. And, there’s a lot of reasons as to why patients are not on therapy. But many of the most common reasons are patients had a poor experience with an initial therapy, meaning that the tolerability associated with the medicine, was worse than the disease itself. There are many patients, especially early in their diagnosis, that have concerns about some of the safety signals of the available therapies and it’s not surprising. These are young, people in the prime of their life. They have a long life ahead of them. And of course, if you have a medicine that potentially causes severe and serious opportunistic infections or potentially increases the risk of malignancies, that could certainly be a concern to many of these young patients. Again, there’s also an unmet need for medicines that have a unique mechanism to stop this continued disability progression even in the relapsing forms of the disease. Vidofludimus calcium is going to address all these concerns. And so, we believe that it is a wonderful option and will fill a need in the relapsing forms of the market. And therefore, all of the research that we’ve done to-date supports significant uptake of this potential medicine, right? And, I’ve discussed without, NOSIUM here a little bit about the progressive side, but it goes without saying again. Clearly, if this medicine shows signals in the progressive side, it ultimately becomes approved. We think that the efficacy, the uniqueness of this mechanism, the Nurr1 activation that clearly provides neuroprotective benefits and the balance of all of this with a great safety and tolerability profile really will differentiate this medicine. And again, we think it has the potential to disrupt the oral disease modifying therapy category, and that’s why we’re so hopeful.

Thank you, Jason. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. And, we actually have one more on the Q&A tool. Is Immunic in any negotiations to partner with big pharmaceutical at this moment, or are you still looking for a partner for non-dilutive cash raises?

So, Daniel, why don’t I take that? So, as you would imagine, there is significant interest in vidofludimus calcium. There are very few late-stage, there’s little to no late-stage therapies in development for multiple sclerosis and even in neuroscience in general. So certainly, companies that have an existing interest in MS and companies that have an existing interest in neurology or neuroscience, we are talking to just about every single one of them. I will not get into specifics around where we are at in those negotiations, but I can tell you that, again, there’s significant interest. I think the interest has even increased over the course of the last couple of months, given some of the market dynamics specific to the recent failures of the BTK inhibitors and the relapsing forms of the disease. Again, I think that you have many companies taking a fresh and different look at the potential for vidofludimus calcium. So, we’re in ongoing discussions, but nothing more specific to provide at this point.

Thank you, Jason, and thank you for all the questions. This concludes our question-and-answer session today. I would like to turn the conference back over to Daniel, for any closing remarks.

Yes. Thank you, Jessica. And, thanks to everyone on the call today for your always insightful questions and good discussion here. I would like to end the call by reiterating how excited we are about the potential for our advanced clinical pipeline programs, especially lead asset vidofludimus calcium, which is targeted to elevate the standard-of-care for the full spectrum of MS patients. We are pleased with the milestones we have achieved with this program and look forward to reporting topline data from our Phase 2 CALLIPER trial as expected in April of next year, while continuing the enrollment in our Phase 3 ENSURE trials. Additionally, as progress is made, we expect to also provide an update in our preparations for Phase 2 clinical trial of IMU-856 and its unique potential for the treatment of a broad array of serious gastrointestinal disorders and beyond. With that, I would like to close today’s call. Thank you again for joining, and we are very happy to answer any additional questions one-on-one. So, please do not hesitate to reach out.

Thank you for joining Immunic’s third quarter 2024 earnings call. The call has now concluded. You may now disconnect.

Good morning, and welcome to Immunic's First Quarter 2024 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications here at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer and President; as well as Glenn Whaley, our Chief Financial Officer. [Operator Instructions] This event is being recorded. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] 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 Immunic's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunic'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 Immunic's SEC filings for a more detailed description of the risk factors that may affect Immunic's results and these forward-looking statements. I would now like to turn the call over to our CEO and President, Dr. Daniel Vitt, to begin the presentation. Daniel?

Yes, thank you, Jessica. I would also like to welcome everybody on today's earnings call. Earlier this morning, we announced our financial results for the first quarter ended March 31, 2024, in our press release. During the call today, we will walk through our first quarter 2024 achievements and subsequent highlights, financial and operating results as well as our clinical development programs, including 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 first quarter 2024 and subsequent highlights. With our early January announcement of the completion of the three-tranche private placement of up to $240 million, we are well capitalized into the third quarter of 2024. This nicely covers the read-out of our Phase II CALLIPER trial of our potentially groundbreaking lead asset, vidofludimus calcium, in progressive multiple sclerosis, which is anticipated in April 2025. The round, led by BVF Partners, included participation from a group of top-tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. As a reminder, we received a total of $80 million in the first tranche, which closed on January 8, 2024. The second tranche is a purchase of $80 million, which is conditioned on the announcement of the Phase II top line data for the CALLIPER trial. The third $80 million tranche is to occur no later than 3 years after the second tranche. All in all, this financing, completed in a difficult capital market environment and with such a strong group of investors, affirms the enormous potential inherent in our clinical programs. In February, Dr. Bob Fox from Cleveland Clinic, who is the coordinating investigator of our ENSURE and CALLIPER programs, presented extremely positive data from an interim analysis of our Phase II CALLIPER trial of vidofludimus calcium at the ACTRIMS Forum 2024. From the interim analysis, we saw a clear separation of vidofludimus calcium from placebo in serum neurofilament light chain levels across all PMS patients as well as all subtypes. We believe that this dataset provide biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory impacts, further reinforcing its neuroprotective potential. This [ strong cycle ] also points to a more likely positive outcome for all -- for the overall CALLIPER trial as well as clinically relevant key secondary end points like prevention of disability worsening. Also at the ACTRIMS Forum 2024, Dr. Alexandra Hermann, Manager of Translation Pharmacology at Immunic, presented a poster on our previous Phase II CALVID-1 trial. Because of vidofludimus calcium's broad-spectrum antiviral activity and potential ability to prevent the reactivation of the Epstein-Barr virus, it may also contribute to the reduction of fatigue in MS patients. While fatigue is one of the most dominant symptoms among MS patients, greatly influencing the quality of life and ability to participate in social activities, it remains largely unsolved from the clinical perspective. Our clinical trial in COVID-19 patients showed an initial signal that patients treated with vidofludimus calcium exhibited the post-COVID symptom of fatigue less frequently than the patients in the placebo arm. Recent third-party data in post-COVID patients identified EBV reactivation as a potential cause for fatigue in this patient group. Our goal is to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing Phase III ENSURE trials in relapsing multiple sclerosis patients as this could result in yet another key differentiating feature for this medication candidate. In March, we had the opportunity to further extend the visibility of our program with the presentation of data at both the Annual Meeting of the Society for Virology and Frontiers in Medicinal Chemistry, highlighting vidofludimus calcium's potent activation of a neuroprotective transcription factor, Nurr1, as well as its potent broad-spectrum antiviral activity in vitro. As a reminder, last year, we confirmed in preclinical testing that vidofludimus calcium acts as a potent Nurr1 activator in addition to its known mode of action as inhibitor of DHODH. We believe that the activation of Nurr1 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 MS. Also in March, we received Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition-of-matter of a specific polymorph of vidofludimus calcium and related method of production of the material. This patent provides another layer of proprietary intellectual property protection around our lead asset. Importantly, we currently have 8 patent families protecting vidofludimus calcium. We remain deeply committed to protecting the technology behind this Phase III asset, which has been made that much stronger by the addition of this U.S. patent directed to the use of vidofludimus calcium in multiple sclerosis. As a result, our extensive patent portfolio is expected to provide protection into at least 2041 in the United States and 2039 internationally unless extended further. Just last month, we hosted a Multiple Sclerosis R&D Day, highlighting the latest developments in the MS landscape as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability worsening associated with vidofludimus calcium, which presents important distinctions compared with currently available MS therapies. We also shared our strong belief that vidofludimus calcium could elevate today's standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all the 3 components of smoldering MS with its neuroprotective anti-inflammatory and antiviral effects. Thank you to everyone who was able to join us for this event in person or who were able to listen to the recording. That concludes our summary of the first quarter of 2024 and most recent highlights. I am very pleased with the scientific and clinical achievements we have made across our programs. As it relates to vidofludimus calcium, we continue to advance both our Phase II CALLIPER trial in patients with progressive MS and our twin Phase III ENSURE trials in relapsing multiple sclerosis. Based on the strong clinical evidence to date, we continue partnering discussions with both global and regional pharmaceutical companies. There's also a lot going on with our IMU-856 program, which could become a game changer for the treatment of a broad range of gastrointestinal disorders. I will provide more detail on this existing program later in this call. I would now like to turn the call over to Glenn to provide financial overview. Glenn?

Thank you, Daniel. I will now review the financial and operating results for the first quarter ended March 31, 2024. Let me start with a review of our cash position. We ended the first quarter of 2024 with $97.3 million in cash and cash equivalents. As Daniel noted, with these funds, we expect to be able to fund our operations in the third quarter of 2025. Regarding the operating results. R&D expenses were $18.7 million for the 3 months ended March 31, 2024, as compared to $22.9 million for the 3 months ended March 31, 2023. The decrease was mainly driven by reductions in clinical development costs. This was partially offset by an increase in personnel costs. G&A expenses were $5.1 million for the 3 months ended March 31, 2024, as compared to $4.2 million for the same period ended March 31, 2023. This slight increase was primarily related to personnel expenses. Interest income was $1.2 million for the 3 months ended March 31, 2024, as compared to $0.8 million for the same period ended March 31, 2023. This increase was due to higher interest rates. We also reported a change in the fair value of the tranche rights for the 3 months ended March 31, 2024. The charge of $4.8 million was a noncash charge related to the change of the value of the tranche rights associated with the future tranches 2 and 3 of our January 2024 financing. These tranches were initially classified as a liability on the closing of tranche 1 on January 2024, but were reclassified to equity on March 4, 2024, when shareholders approved an increase in the company's authorized shares from 130 million to 500 million shares of common stock. Therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value as of March 4, 2024, upon the reclassification to equity. Other income was negative $2.1 million for the 3 months ended March 31, 2024, as compared to $1.2 million for the same period ended March 31, 2023. The decrease was primarily attributable to a $1.7 million expense related to the portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche 1 as well as the timing of recognizing the German Federal Ministry of Finance grant. The net loss for the 3 months ended March 31, 2024, was approximately $29.6 million or $0.30 per basic and diluted share based on approximately 97.3 million weighted average common shares outstanding compared to a net loss of approximately $25.3 million or $0.58 per basic and diluted share based on approximately 43.7 million weighted average common shares outstanding for the same period ended March 31, 2023. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?

Thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming milestones. We very much look forward to reporting top line data from our Phase II CALLIPER trial in progressive MS in April 2025. This read-out could be a transforming value inflection point for Immunic. Additionally, we expect to report an interim futility analysis of our Phase III ENSURE program later this year and to read-out the first of our identical twin Phase III ENSURE trials in relapsing MS in the second quarter of 2026, with the read-out of the second ENSURE trial expected in the second half of 2026. [ It bears repeating ], based on the strong clinical evidence observed thus far, the vidofludimus calcium's unrivaled safety and tolerability profile observed in multiple clinical trials. We believe that the design of our Phase III ENSURE program will provide a straightforward path to potential regulatory approval in relapsing MS. On top of this, if the top line CALLIPER data continues to show a neuroprotective effect in PMS patients, we may be able to position vidofludimus calcium as the first oral treatment for non-relapsing secondary progressive MS as well. The progressive MS subtypes were the highest unmet medical need. We also expect that the drug's potential first-in-class ability to activate Nurr1 will meaningfully benefit the ongoing clinical trials in MS. As we have noted before, [indiscernible], we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of MS based on its combined neuroprotective, anti-inflammatory and antiviral effects. Turning to our second program, IMU-856, an orally available and systemically acting first-in-class small molecule modulator of Sirtuin 6, we are very excited about this program and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders by targeting physiological intestinal epithelial regeneration, achieving gut wall healing with the absence of broad immunosuppression. As a reminder, data from our Phase Ib clinical proof-of-concept trial of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge demonstrated meaningful improvements over placebo in 4 key dimensions of clinical outcomes in celiac disease: protection of architecture, protection of patients regarding celiac disease symptoms, enhancement of nutrient absorption and also a strong biomarker response. We believe this data provides initial clinical proof-of-concept for a potentially new oral therapy approach to a multitude of gastrointestinal disorders through the physiological regeneration of gut wall barrier function, utilizing a new innovative targeted mechanism while avoiding the immunosuppression seen in many gastrointestinal medications today. As previously reported, we have begun preparing our Phase II clinical testing of IMU-856. Based on its potential paradigm-shifting potential for the treatment of GI diseases in addition to celiac disease, we are also exploring multiple additional clinical applications where the renewal of the gut wall is important, including, for example, inflammatory bowel disease or short bowel syndrome. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.

Yes. Thank you, Glenn and Daniel for walking us through the first quarter and subsequent highlights as well as our clinical development pipeline and upcoming value inflection points. [Operator Instructions] Our first guest today is Matt Kaplan from Ladenburg Thalmann.

Congrats on the progress. A few questions on the vidofludimus program. I guess how was the impact on the NfL that you observed in the CALLIPER study interim analysis? How was that received at the ACTRIMS meeting when you presented that?

Yes. Thank you, Matt. I'm happy to share some feedback here. Generally, I would say what we have seen here is very much appreciated from experts broadly, I would say, because I think so far, we are not aware of any other comparable data with such a strong reduction on NfL reduction. And so we take that as a positive feedback here from all the conferences we attended.

Okay. That's helpful. And then in terms of the interim futility analysis for the ENSURE program, what are the potential read-outs from this analysis that you're expecting to announce later this year?

Yes. Good that you asked, because this is really -- since this is really a Phase III program, we will rarely get any data. We will get just a response to the questions to the -- coming from the committee, from the Safety Monitoring Committee, basically on either to go ahead as planned or to suggest some sample size adjustment. That's all we can read-out there. So we will not see any medical results or any biomarkers from that futility analysis. So it's really more reconfirming our estimates when we started the study. And since this trial is an event-driven trial, it's important to have an eye on do we have enough events based on our statistical assumptions we made initially.

Thank you, Matt. The next one in the queue here is Yasmeen Rahimi with Piper Sandler.

This is Jun-Goo on for Yas. The first question we had was if you could comment if you had any visibility on a blinded basis to event rates across ENSURE trials. If you do, are these like event rates in line with expectations? And secondly, have you had a chance to meet with the agency in regards to 856? Could you provide any color where you are in terms of Phase II prep and study design?

Okay. Thank you for the questions. Let me first start with the ongoing studies. No, we don't have the current event rates on disability worsening so far, so I can't comment on that. What I can tell is so far, the study is on track. And we may have an eye on that may be coming closer to the futility analysis time, also to have some blinded data updates we can share with the public. Regarding 856 further plans and regulatory interactions, we are working on those. We are planning for a meeting with the U.S. regulators. We are preparing several Phase II studies, so indications, as I said in the presentation. So it's, of course, given the very good proof-of-concept in celiac disease, that's the #1 indication we're looking at. But I mentioned also that -- also looking on the preclinical data, we think this drug makes a lot of sense beyond celiac disease and other indications, and the team here is actively working on a couple of different concepts. And we will look how -- what is the best way to develop it further and also to get the appropriate funding for all of the ideas we have with that wonderful molecule.

Thank you. [Operator Instructions] The next one here is Mayank Mamtani with B. Riley.

Congrats on the updates. Just quickly on the Phase II CALLIPER study, could you talk to the functional end points being evaluated there, and which ones you think can be attributed to vidofludimus' dual Nurr1 DHODH mechanism based on what you've seen in the [ plan ] Phase II? And then secondly, remind us of the brain volume changes schematics noted relative to NfL, [ with that ] maybe other studies that are out there of, say, in B-cell depleting agents. And then I have a quick follow-up.

Yes. Thank you for the questions. So the CALLIPER study is an important study, and since this is really limited to non-relapsing patients, we think that the mentioned functional analysis make a lot of sense here and that the data -- the set of patients here can really give good answers to all of or a lot of these questions. So the first thing, of course, is that the classical established EDSS scores [indiscernible] and change in confirmed disability worsening is the key secondary end point of the study, I think the most important medical secondary end point. On top of this, and this also was also seen from other studies and other companies, that functional read-out's playing a more important role, and they're not completely covered in EDSS. So one thing is the 25-foot walk test, which is pretty established; cognition testing; and the nine-hole peg test specifically. So those three are the established tests which are also recorded during the study. So we will also expect data on those end points on top of just the EDSS clinical read-out.

Got it. And any comment on the brain volume changes schematics relative to NfL, given your interim at 24-week and then obviously, the final analysis at 72-week?

Yes. I think brain volume change is believed to be a robust and sensitive measure of neurodegeneration in MS patients. Specifically, if it comes to the long time line, we have a 120-week full uptime in the CALLIPER study. So brain volume change should be a strong signal here. And we know that this is -- they are traditionally is expected to correlate with disability and also then with NfL changes. There is, to my knowledge, not too many publications on the direct correlation between brain volume change and NfL, but they all refer usually to disability change in the patients. And specifically, I think in the recent months, I think there were a couple of good publications where the office nicely separated inflammatory for noninflammatory patients, which is, I think, very important to quantify any signal on NfL in progressive MS in contrast to relapsing, because as we all know, if there is an overlying relapse activities from the NfL side, usually has a high risk of overlay the signal of NfL.

Yes. Makes sense. And then on the Phase III sample size reassessment or futility for ENSURE later in the year, could you just remind us of the different scenarios in terms of how high you have to increase the patient number or vice versa? Could you -- given what you're seeing versus placebo, because you don't have an active competitor here, could you also -- maybe a good -- if you're seeing the event rates that you expect or better than that? Is there a positive scenario where you could expedite the program? So maybe just loop in the scenarios there from the reassessment.

Yes. Thank you for that question. It's important that you asked that, I think. We need to repeat these things a couple of times. The FDA does not allow any acceleration of the program for the stopping for early response signals because that is -- due to the statistical planning of such a study, they exclude this option, so we can't do that. What we did is we -- so it's a futility analysis, so we can most likely or we hope to get a proceed as planned feedback from the committee. What could also be -- we will have a couple of scenarios of sample size adjustment, but only if such ones which makes sense. I think it doesn't make sense to make sample size adjustment if it's getting a huge number of patients to that. So only these viable approaches could be an answer to that analysis. And else, we will maybe then have an answer that we should stop the study.

Thank you, Mayank. We have one more in the queue, Tom Smith with Leerink Partners.

Just a couple on our end. I guess, first, for the Phase II CALLIPER study, can you -- and this extends I guess, across your entire MS program, but can you just remind us how you're measuring neurofilament light chain, what assay you're using and how much variability there is with measuring of marker? And then with respect to life cycle management, can you comment on whether you're working on any additional IP for vidofludimus calcium or preclinical Nurr1 activator compounds that could help extend the franchise?

Yes. Thank you, Tom, for the good questions. First of all, I think we -- in the past, we commented a lot on the technologies here. I think what we are using is more or less state-of-the-art Simoa technology by Quanterix. We use also the newest dual-antibody test system there for this technology. So that is, I think, really with the goal to reduce the signal/noise ratio as much as possible. Another thing is that we do -- we measure all the batches in parallel in one. So we really try to avoid any operational variability in testing that. So I think this -- the data on NfL will be as precise as possible from a technology point of view right now. But to remind you, I think every technology has its own absolute level. So we just need to look always on relative changes on NfL at the read-out. So that's on the technology side. On more on the strategic side on IP and life cycle management, we don't talk too much about, but of course, we're doing that. And if you'll read between the lines what we are telling you, I think what we -- last year, when we identified that vidofludimus calcium is a potent activator of Nurr1, and this is importantly means also we see in the gene regulation, an up to 500% increase of gene regulation. This is really at the upper end of what you can get at all, and to my knowledge, really the only molecule in the clinics [ to test on ] something like that. This makes it an attractive platform. So it's not only that vidofludimus has another trick, which is wonderful, because this opens up the avenue towards neuroprotection, it also gives us at Immunic [ a platform ] of Nurr1 modulation. And we are working here internally, but also in collaboration with researchers at different universities on the one hand, on the biology, and on the other hand, also on the chemistry, to broaden what we're doing here. We have some IP filed on this. We have some interesting derivatives of vidofludimus calcium in research. Yes, I think -- absolutely, so we think this is a great platform. And just think about the great biology which was published and where a lot of work was done on Parkinson's disease and other neurodegenerative diseases where Nurr1 is believed to play a major role. And this opens up a lot of potential for further preclinical and clinical work later.

Thank you, Tom. This concludes our question-and-answer session. I would like to turn the conference back over to Daniel for any closing remarks.

Yes. Thank you, Jessica, and thank you to today's attendees for your insightful questions today. To summarize, we have a well-differentiated advanced clinical pipeline in various stages of development. With top line data from our Phase II CALLIPER trial executed in April of next year and the ongoing enrollment of our Phase III ENSURE trials, we continue to make meaningful progress on the clinical development of vidofludimus calcium. We also continue to strengthen our intellectual property position and remain committed to that effort. Further, the successful three-tranche PIPE financing earlier this year means that we are well capitalized to execute, with $97.3 million on our balance sheet, which is expected to fund the company into the third quarter of 2025. As progress is made, we expect to also provide an update on our preparations for a Phase II clinical trial of IMU-856 and its potential for the treatment of a broad array of serious gastrointestinal disorders. With that, I would like to close today's call. Thank you very much for joining, and we're very happy to answer any additional questions one-on-one.

Thank you for joining Immunic's first quarter 2024 earnings call. The call has now concluded. You may now disconnect.

Good morning to everybody on the line. I would like to welcome you to Immunic's Fourth Quarter and Year End 2023 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Vitt, 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. [Operator Instructions] 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 Immunic's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunic'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 Immunic's SEC filings for a more detailed description of the risk factors that may affect Immunic's results and these forward-looking statements. I would now like to turn the call over to our CEO and President, Dr. Daniel Vitt, to begin the presentation. Daniel?

Yes. 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 fourth quarter's 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-tranche private placement of up to $240 million last month. The round, led by BVF Partners, included participation from a group of top tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Soleus 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 8th, 2024. The second and third tranches of $80 million each are conditioned on the announcement of Phase IIb top line data for our CALLIPER 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 a 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 confirms the enormous value inherent in our two advanced clinical programs. In October, we reported overwhelmingly positive interim data from the Phase II CALLIPER trial of our potentially groundbreaking lead asset, nuclear receptor-related one over one activator, vidofludimus 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 vidofludimus calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of vidofludimus calcium in this PMS population. Even a statistically significant difference was found for arithmetic mean serum NfL levels at week 24 between vidofludimus 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 vidofludimus calcium versus placebo in advanced SPMS, meaning the patients with no focal inflammatory activity, but continued to cease 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 CALLIPER interim data into this perspective of historical third-party studies in the same progressive MS subtypes. On the left, we displayed the data for PPMS compared to the ORATORIO study for ocrelizumab, which showed a spread of NfL values between active and placebo at 24 weeks of 12.4%. In the CALLIPER 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 III study led to the approval of ocrelizumab for treatment of PPMS. In the center of this slide, you see historical data for the secondary progressive MS, both for inflammatory, non-active and active SPMS. In comparison, vidofludimus 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 vidofludimus calcium in RRMS versus historical relapsing MS studies to complete the picture. In summary, we believe the clear separation observed in serum NfL for vidofludimus calcium over placebo in this PMS patient population as well as its subtypes represent another significant step forward for what could potentially be a first-in-class Nurr1 activator for MS. This strong signal also points to a more likely positive outcome of the overall CALLIPER 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 CALLIPER programs, presented data from our Phase II EMPhASIS trial of vidofludimus calcium in RRMS in an e-poster at the Joint ECTRIMS-ACTRIMS Meeting. It is important to reiterate that vidofludimus calcium showed an improvement on serum NfL in both treatment arms of 30 and 45 milligrams over placebo. In November, we were granted two fundamental new patents for vidofludimus calcium in the United States. The first covers a daily dose of about 10 milligram to 45 milligram of vidofludimus calcium and other salt as well as free acid forms for the treatment of relapsing MS, including the 30 milligram dosage used in our ongoing twin Phase III ENSURE trails. The second patent granted covers the dosing regimen associated with vidofludimus 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-856, 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 Burianek, Senior Medical Director at Immunic, presented data from our Phase Ib clinical trial of IMU-856 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 improvement over placebo in four key dimensions of celiac disease of the physiology. Histology, disease symptoms, biomarkers and nutrient absorption. IMU-856 was also observed to be safe and well tolerated in this trial. Additionally, Dr. Geert R. D'Haens from Amsterdam University Medical Center, presented data from our Phase II CALDOSE-1 trial of vidofludimus calcium in ulcerative colitis, or UC. As a reminder, the maintenance phase results from the CALDOSE-1 trial demonstrated statistically significant activity of vidofludimus calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of vidofludimus calcium in UC and other inflammatory bowel disease indications. In November, we were pleased that Dr. Burianek had another opportunity to present the data from our Phase Ib clinical trial of IMU-856 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 vidofludimus calcium, the release of our overwhelmingly positive biomarker NfL data has been an impetus for partnering discussions and global and regional pharmaceutical companies. There is 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 31st, 2023, as compared to $71.2 million for the 12 months ended December 31st, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials, vidofludimus 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 vidofludimus calcium program in ulcerative colitis. General and administrative expenses were $16 million for the 12 months ended December 31st, 2023, as compared to $15.3 million for the same period ended December 31st, 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 31st, 2023, as compared to negative $0.9 million for the same period ended December 31st, 2022. The increase was primarily attributable to a decrease in foreign exchange losses, our 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 31st, 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?

Thank you, Glenn. I would now like to provide an update on the anticipated upcoming milestones for our clinical development programs. We eagerly anticipate reporting top line data from our Phase II CALLIPER trial of vidofludimus calcium in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase III ENSURE program late this year, and to read out the first of our identical twin Phase III ENSURE trials in relapsing MS in the second quarter of 2026. As stated before, based on the strong clinical activity observed thus far, vidofludimus calcium solidly established safety and tolerability profile to date, we believe that the design of our Phase III ESNURE program will provide a straightforward path to potential regulatory approval in relapsing MS. If the top line CALLIPER data continues to show a neuroprotective effect for PMS patients, we may be able to position vidofludimus calcium as the first oral treatment for advanced secondary progressive MS as well. We also expect that the drug's potential first-in-class ability to activate Nurr1 will meaningfully benefit the ongoing clinical trials in multiple sclerosis. We are particularly excited about our MS program in light of the recent developments in the MS market. As we have noted before, if approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of multiple sclerosis based on its combined neuroprotective, anti-inflammatory and antiviral effects. With regard to our IMU-856 program, as previously reported, we have begun preparing for a Phase II clinical trial in ongoing active celiac disease patients. At the same time, based on the drug's broad therapeutic potential by targeting physiological epithelial regeneration, we are also considering additional clinical applications in other GI disorders. We are very excited about this program and believe IMU-856 could present an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of old architecture without the serious consequences associated with immunosuppressive therapies. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.

Thank you, Daniel, and also Glenn for walking us through the fourth quarter 2023 and subsequent highlights as well as our upcoming value inflection points. We will now begin the question-and-answer session. [Operator Instructions] Our first guest today is Caroline Pocher from Wedbush. Caroline, please unmute yourself and go ahead.

Hi. Good morning. This is Caroline on for Andreas. Just two questions from us. So if the data from CALLIPER are positive, can you discuss what the regulatory path forward looks like in advanced SPMS? And then since the last quarterly update, it looks like the times were slightly shifted for the readout from the first ENSURE trial from the end of 2025 to Q2 2026. Just any clarity as to why the slight change and just enrollment progression in both of those trials?

Yes. Thank you, Caroline, for the question. Let me start with CALLIPER. So I think it's a difficult question to answer. I think the normal process in such an indication -- let us pick non-active secondary progressive as the most likely indication where there is nothing approved, basically, or nothing available for patients. That of course may offer an accelerated pathway forward towards approval. But that requires a discussion with the regulators in the different countries. What we know is that likely a Phase III study would only require one study. So we think it will be a pretty lean package we expect after a positive readout of that study. On ENSURE, I think we didn't change the timelines from our last projection. I think this was already updated some weeks ago. That is reflecting the current speed of recruitment and our estimation. We always need to make and continuously explore how quick things are going forward, and therefore, we made an adaption to the timelines. But we are okay. We are on track on the current recruitment right now.

Great. Thank you so much.

Thank you, Caroline.

Thank you, Caroline. The next one I have in the queue here is Nat Charoensook from Leerink. Nat, please unmute yourself and go ahead. Nat, can you hear us?

Hi. Can you hear me all right?

Yes. Hello. Good morning.

Hi, there. This is Nat Charoensook on for Tom Smith. So congrats on all the progress, and we have couple of questions. So the first one like what are the biomarker results that we can expect from the interim analysis for the ESNURE study expected in late 2024, and what you need to see to continue the development of vidofludimus calcium in RMS.

Yes. Thank you, Nat, for the question. And that's good that you asked because I want to clarify that. This is, as we have written, this will be just a futility analysis. Since this is a Phase III study, we can't read out biomarkers or other clinical data at this time point. So it will just be a futility analysis, and we would get feedback from the Data Safety Monitoring Board about progression of the study. It may allow us for sample size adjustment. So this is maybe the only outcome which could happen. Either continue as planned or sample size adjustment recommendations from the Data Safety Monitoring Board.

Got it. That's very helpful. So the next one is, so what are the gating factors to start a Phase II study in ongoing active celiac disease? And can you please go over a potential trial size for the Phase II study? I think you plan to look into like additional doses other than the 80 mg or 160 mg that you looked at in the Phase Ib study. And what are the potential endpoints as well as exploratory biomarkers you plan to include in the study?

Yes, also a good question. As you know, we are heavily working and involved in a celiac disease committee in the space, given our wonderful readout from the proof-of-concept study last year, of course, that drove a lot of interest. And that is influencing our very active preparation time of a potential Phase II study in celiac disease. And also for potential other indications, as I said before. The more -- the proof-of-concept we achieved in the Phase I is not only limited to celiac disease, because we have, for example, seen a very nice improvement of enterocyte function by increased uptake of nutrients like vitamin B12, for example. But also, this is also more or less proving that the drug may work in other situations where you want to increase the viability and the function of those cells. With respect to Phase II, as we have said before, the Phase II study currently is not in our budget. So we are preparing a study. We have talks ongoing with potential partners and also looking for other ways to finance a full blown Phase II study. And we will keep the market informed as we progress on these discussions and the way forward. That may also mean that it's not finally limited to celiac disease. Maybe one thing I need to clearly say here, it could really go beyond celiac disease as indication in that context.

Got it. That's very helpful. Thank you so much.

Thank you, Nat. We have a question that came in via the Q&A tool in writing, and it nicely fits to IMU-856, so I will read it. Can you provide any high level description of how potential partners view the drug and if completion of Phase II is prerequisite for them?

As of my little bit subjective conclusion on perception of the drug is that people really think it's cool stuff. It's a new target. I think this has the potential really to address the GI disorders in a very different way. So lacking immunosuppressive effects is really a unique benefit we see here, and therefore, I think it is an attractive thing. On the other hand, typically, new targets need to demonstrate that they work. And to our favor, I think we have already achieved this clinical proof-of-concept in the celiac disease patients. So I think generally, the perception is very positive, and people are very excited about a completely new approach for those diseases.

Thank you, Daniel. The next one in the queue here is Matt Kaplan from Ladenburg. Matt, welcome. Please unmute yourself.

Hi. Good morning, guys. Can you hear me?

Good morning. Yes. Good morning.

Great. Well, congrats on the progress. I mean, I just wanted to kind of zero in on the data that you've gotten so far with vidofludimus in terms of the impact on NfL. I guess, what's been the feedback so far you've received from the MS community KOLs with that observed pronounced reduction in the CALLIPER and EMPhASIS studies?

Thank you. Good morning, Matt, and thank you for that question. I think this is unique and people see that. And given that recently, if you look on a couple of key publications in that space, there are very nice data showing that NfL is in progressive MS specifically, in an isolated way, if you really separate the activity of NfL from focal inflammation and relapses, on the one hand from the new regenerative contributions like you can do in progressive MS patients, there is clearly a nice predictive power of NfL for future disability outcome. And it was shown in a couple of recent papers. Specifically in the second half of last year, there were some papers really pointing to that. And that also drives excitement. And I think it's -- it's a scientific progress. Of course, at the end, we want to and we need to demonstrate clinical benefit as well, which is the goal of the Phase II study. And we're not too far from that, I think, April 25. Not too far from now. And given the, as I said before, the huge unmet medical need in all forms of progressive MS, namely the non-inflammatory advanced secondary progressive MS population, we think that vidofludimus calcium is really the opportunity to change the way we treat these diseases.

Okay. That's helpful. And then you mentioned business development plans or partnering plans. What are your plans for the MS indications for vidofludimus in terms of partnering?

Yes. I think given that some people we are talking to, I mean they're also on the line here, I tend to be careful on projections and the status on BD discussions. But I think we do what we always do. We establish collaborations. We establish trust relationships to potential partners. And progressing towards the readout, I think, clearly paves the way also for partnerships. If the Phase II PMS data is positive, this is certainly something which has a relevance for the whole treatment landscape of multiple sclerosis, even beyond PMS, because that may also be of benefit for and support scientifically the ENSURE RMS Phase III studies which are ongoing as well. So I think this is something we have really some activity on we, but we are not in a situation that we say we need to do something now. I think we have the funding available to read out the Phase II study in a good way and then to look what is the best way forward here.

Okay. Great. Thanks for the added detail.

Yeah. Thank you, Matt.

Thank you, Matt. [Operator Instructions] And the next one here is Jun-Goo Kwak from Piper Sandler. Jun-Goo, please unmute yourself and go ahead.

Hi. Good morning, team. This is Jun-Goo on for Yas. Thanks for taking our questions. We have two. For the futility analysis later this year for ENSURE, how should we think about its implications upon readout? And what would be considered a win? And second, for the Phase II celiac study, where are you with finalizing the design? And could you provide more color on your interactions with the regulatory agencies so far?

Give me a second. Yeah, thank you for the question. To the first question, I think, the nature of futility analysis is that you just want to get a proceed as planned answer from the committee. Or and this is one of the reasons, given that we have an event-driven endpoint, we would allow a reasonable sample size adjustment. That's all we can get and then we then will implement into further development. So it's a more binary thing, honestly, there. But we don't expect any surprises given based on the Phase II data we obtained from the EMPhASIS studies in relapsing MS, we are very confident that this trial will also deliver comparable results. And I think all the calculations and assumptions were based on the Phase II EMPhASIS data. And the second question, maybe you can repeat it, was on regulatory interactions for PMS?

Celiac.

For celiac. Yes, that's work in progress right now. And also we are still working on the project on a clinical Phase II study design. There are a couple of thoughts which we're running through. So as soon as there is something to report on, we will disclose that.

Right. Got it. Thank you so much.

Thank you. Bye-bye.

Thank you. Next one in the queue here is William Wood from B. Riley. William, welcome. Please unmute yourself.

Yes. Can you hear me?

Yes. Hello.

Awesome. Thanks so much and congratulations on the quarter and thank you for taking our questions. Just thinking about your Phase III ENSURE, when should we expect to see the baseline characteristics for that trial and actually I'll just leave it there.

Good question. I don't know exactly when we can disclose that and even we can get that because it's a Phase III study. I think likely we need to wait for integrity of the study reasons until we unblind the study in 2026. So that's the most likely case there, because quality first, and you don't want to end up in difficult discussions with regulators just because we are -- we want to know too early these kind of things. But we will have an eye on this and maybe more in the future if there is a way to get this information earlier.

Got it. And actually, I do have two more. You also have two presentations at ACTRIMS forums coming up next week. Should we be expecting any additional data on your EMPhASIS interim results which have already been presented? And how should we view sort of the blocking of that EBV reactivation as being an important strategy in improving patient symptomology overall and what that can mean for your Phase II study in PMS? And I have one more.

Yes. I think the second one is really the talking point from one of those posters, the EBV reactivation. This is something we got a little bit quiet the last couple of months regarding that because we were so excited about Nurr1, but it's still true that vidofludimus calcium is a blocker of reactivation of EBV. And I think it's still not fully understood how that could have a positive impact on disability, for example, prevention of disability, and how the full indication disease progression is influenced by reactivation of EBV in patients. There are a lot of hints for this. There's a lot of work done by really great scientists here around the world, but also here, collaborators of ourselves. So I think that's an interesting scientific flashlight on the third aspect of activity of vidofludimus calcium on one poster. And the second one is more dedicated to CALLIPER and to trial design and NfL, but no really new data. But it's important to put that in context. We figured out that the market is maybe not fully up to speed on the link between NfL and future disability progression. And we therefore think we want to come into this casual with doctors on this more specifically and to also talk about Nurr1 activation and the way this has the neuroprotective potentially. Because this could really change the way we treat the disease and could be a major, major impact for the whole MS market if the data reads out in a positive way next April.

Got it. And thank you for correcting me there. It definitely is CALLIPER interim results. And then lastly, just if I may, could you discuss how or possibly what the current learnings for vidofludimus calcium, the differentiated MOA position it in relation to other anti-CD20, or actually just anti-CD20 antibodies, and even emerging excitement sort of in regards to the CD19 CAR-T space?

I think the bigger difference is that Nurr1 is not targeting focal classical inflammation signals, which is different from basically all of the other approaches. And that makes it unique in a way that it may -- and we've seen that in the NfL data, but we may see also this in clinical outcomes, starting with the CALLIPER study, that vidofludimus calcium can have a beneficial effect in patients which are not benefiting or not enough benefiting from immunosuppressive therapies like anti-CD20s, anti-CD19 or whatever you use there because it is just something different, an orthogonal mode of action to these. The good thing about vidofludimus is that on the other hand, we also inhibit DHODH which also, on top of this potential neuroprotective effect, also is anti-inflammatory. So then we -- if you're focused on the key unmet medical need, which is really preventing and slowing down disability worsening in MS patients of all kind, that we target both. So the more relapse-related and the relapse-independent worsening of progression in the patients. And that would be I think the best differentiator you can have and also the best news for patients suffering from these indications like primary progressive and secondary progressive MS specifically.

Got it. Very helpful. And thank you for taking our questions and congratulations again.

Yes. Thank you, William.

Thank you, William. I actually have another question here on the Nurr1 target in the Q&A tool. In case of Nurr1 activation confirmation, do you see further benefits of vidofludimus in the future for other neuromuscular disorders such as Parkinson's disease or even Alzheimer's?

A simple answer, yes. So, very clear, this is something, it was a breakthrough finding when we, together with our collaborators at University here in Munich around Daniel Murak, found that vidofludimus calcium is such a good activator of Nurr1. And most of the historic research on therapeutic use of Nurr1 has been performed in the area of Parkinson's disease. So this was the original main focus of researchers in the world. And I think Nurr1 still is on the top of the list of hope for potential targets for Parkinson's disease. Therefore, this primes, of course, our vidofludimus to be tested there. But we have more molecules. We have a bunch of derivatives. We have molecules with different properties, maybe priming molecules for different, for example, CMS penetration and so forth. So there may be the potential to start other independent developments with our molecules in such indications with very specific target profiles. So we see a huge potential there. But once again, currently, the focus is delivering data for MS. And therefore, we will not use huge amounts of our budget for these highly innovative new things. But we are also considering collaborations there as well to boost things in parallel to our current MS activities.

I have another question here in writing. Are there any plans for the vidofludimus UC program, given the stronger maintenance phase data?

Yes, that's the money question right now again. So I would love to continue with the Phase III directly in that indication. Once again and that was the reason why we kicked off a new program called IMU-381. We have molecules which are maybe from their tissue distribution profile better suited for GI penetration, but using our mode of action and our proof-of-concept from the CALLIPER studies. So yes, in principle, yes. But once again, something we would likely more likely separate in a different development track.

Thanks, Daniel. Final question I currently have may be a good chance for you to summarize the status quo and upcoming milestones for vido. What are the updates regarding IMU-856 -- IMU-838, I'm sorry.

Well, more or less the summary of what we spoke about. I think we were intrigued by the data of last year, specifically the NfL data giving us a very nice signal and really increasing the likelihood of success for the clinical outcomes of the CALLIPER study with a readout in April 25. This would make the drug a very huge also commercial opportunity, I think. This is a very huge potential for vidofludimus calcium. That's I think maybe the main driving force here right now. In parallel, we have that rock solid ENSURE program in relapsing MS ongoing, which is more or less just based on our very good Phase II data for that molecule we obtained from the EMPhASIS study, which allows us a low risk way forward towards approval and data readout in 2026. So these are the key driving forces for the vidofludimus program. But to reiterate -- I don't want to talk too long here, but to reiterate, we also had this positive readout on GI, on UC study on the maintenance data, which is more or less boosting other molecule developments in that space. And also the Nurr1 potential beyond just multiple sclerosis and other related neurological indications, also something where we think this has another huge potential. And we will definitely also look into these things.

Very good. This concludes our question-and-answer session today. I would like to turn the conference back over to Daniel for any closing remarks.

Thanks, Jessica, and thank you to today's attendees for your insightful questions. To summarize, with the positive interim data from our Phase II CALLIPER trial as well as the continuation of enrollment of our Phase III ENSURE trials, we continue to make tangible progress on the clinical development of vidofludimus calcium. As progress is made, we also expect to provide an update on our preparations for further Phase II clinical development of IMU-856. With our funds at the end of the fourth quarter and the recent closing of the first tranche of our three-tranche private placement, we remain well funded, providing us runway through multiple clinical milestones into the third quarter of 2025. With that, I would like to close today's call. Thank you very much for joining, and we are very happy to answer any additional questions one-on-one.

Thank you, Daniel, and thank you for joining Immunic Fourth Quarter and Year End 2023 Earnings Call. The call has now concluded. You may now disconnect.