Immunic, Inc. Q3 FY2024 Earnings Call

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. 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, 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 the 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’s 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 Dr. Amit Bar, Clinician, Scientist and one of the leading neuroimmunologists in MS from the 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 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 to date 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 presented 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, we also reduced 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 remains blinded to our data, the IDMC's favorable recommendations corroborate our initial assumptions of the design, powering, and relapse rate of the twin Phase III trials and suggest that they are in line with the data observed so far. In particular, the planned 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 will 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 the 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 and 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 combined 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 highlighting 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 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 $2 billion to $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 understand, 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 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 us 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, 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 the sponsor. We provide 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 MS and also in Post COVID syndrome. Therefore, it could be scientifically and medically very meaningful, 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.

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 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 to experience the biggest treatment effect?

Thank you. Let me start with the first thing. We see blinded data. We can’t conclude anything from that. 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 are three sub-indications predefined in CALLIPER: the Active Secondary Progressive, Non-Active Secondary Progressive, and Primary Progressive MS. 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 don’t measure lesions in the brain, no inflammatory lesions, but they still progress on disability. Given that we have certain inclusion criteria for baseline EDSS score, 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 is still some inflammatory activity. 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. We asked the questions of the medical team. There was a meeting with some of our KOLs not too long ago, and my colleague Andreas asked the team, what do you expect? 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’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. The better and the higher the difference, the better for the drug, of course. Regarding accelerated approval, that’s definitely an opportunity. But, again, it depends on the data and the distribution of the data. For example, how similar are things between the subgroups and so forth, and the signal strength, particularly in the biggest population in the study and in non-active secondary progressive patients. 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. 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 only have approved as an infusion. There’s no oral drug approved. I think on the effect size, it’s good to have another option 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. Clearly, look, there’s a huge unmet need in the progressive side of this disease, specifically in the non-relapsing secondary progressive MS phenotype or subtype. As Daniel mentioned, there’s no currently approved medicines. We know that across the seven major markets, there are approximately 175,000 patients diagnosed with non-relapsing secondary progressive MS. So, it’s a big opportunity representing about 15% of the total MS population. Also, on the primary progressive side, we know that there are approximately 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, and that is Ocrelizumab or Ocrevus. It’s important to note that as patients progress and 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. As patients age, you have a normal breakdown or wear down of the body’s natural immune system. In these primary progressive patients, though Ocrevus is currently approved, there is some reluctance about putting these types of patients on immunosuppressants and broad B cell depleting therapies. The uniqueness of vidofludimus calcium, given its dual mechanism of both 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 immunosuppressive. If approved and we show a good signal here, we believe it could become the 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 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 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. Many of the most common reasons patients are not on therapy are due to poor experience with an initial therapy, meaning the tolerability associated with the medicine was worse than the disease itself. Many patients, especially early in their diagnosis, have concerns about some of the safety signals of the available therapies. It’s not surprising; these are young people in the prime of their life with a long life ahead of them. If you have a medicine that potentially causes severe and serious opportunistic infections or increases the risk of malignancies, that could certainly be a concern to many of these young patients. 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. We believe it is a wonderful option and will fill a need in the relapsing forms of the market. All of the research we’ve done to date supports significant uptake of this potential medicine. I’ve discussed without, from the progressive side, but it goes without saying again. If this medicine shows signals in the progressive side and 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 this with a great safety and tolerability profile really will differentiate this medicine. 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. 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? As you would imagine, there is significant interest in vidofludimus calcium. There are very few late-stage therapies in development for multiple sclerosis and even in neuroscience in general. 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 there is 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. Many companies are taking a fresh and different look at the potential for vidofludimus calcium. 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. Thanks to everyone on the call today for your always insightful questions and good discussion. I would like to end the call by reiterating how excited we are about the potential for our advanced clinical pipeline programs, especially our 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.