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Earnings call: Immunic reports strong Q4 and annual financials, positive trial data

EditorEmilio Ghigini
Published 02/23/2024, 06:54 PM
Updated 02/23/2024, 06:54 PM
© Reuters.

Immunic, Inc. (ticker: NASDAQ:IMUX) reported robust financial results for the fourth quarter and full year of 2023, showcasing strong progress in its clinical development programs, particularly for its lead drug candidate, vidofludimus calcium. The company highlighted significant advancements in its Phase II CALLIPER trial for progressive multiple sclerosis (MS) and is well-funded into the third quarter of 2025, following a successful private placement.

Key Takeaways

  • Immunic announced a private placement of up to $240 million, with $75 million in net proceeds received in January 2024.
  • Positive interim data from the Phase II CALLIPER trial for vidofludimus calcium in progressive MS indicated a significant improvement in serum neurofilament light chain levels.
  • The company reported a net loss of $93.6 million for 2023, which is an improvement from the $120.4 million net loss in 2022.
  • Top line data from the Phase II CALLIPER trial is expected in April 2025, and an interim futility analysis of the Phase III ENSURE program will occur later in 2024.
  • Immunic is exploring potential partnerships and business development plans for MS indications and other neuromuscular disorders, including Parkinson's disease.

Company Outlook

  • Immunic is optimistic about its clinical development programs, with a focus on vidofludimus calcium for MS and IMU-856 for gastrointestinal disorders.
  • The company is progressing towards clinical milestones and remains well-funded through Q3 2025, with plans to continue the Phase III UC program for vidofludimus and develop new programs like IMU-381.

Bearish Highlights

  • The company faced increased expenses over the 12 months ended December 31, 2023, contributing to a net loss of $93.6 million.

Bullish Highlights

  • Immunic has received positive interim data from its clinical trials and is actively considering collaborations to enhance its MS program.
  • The company is well-capitalized following the recent private placement, which bolsters its financial position.

Misses

  • Despite the positive interim data, Immunic still reported a substantial net loss for the year 2023.

Q&A Highlights

  • Discussions are ongoing regarding potential partnerships for Immunic's clinical programs.
  • The company is considering additional clinical applications for IMU-856 in gastrointestinal disorders and is exploring the potential of vidofludimus in other neuromuscular disorders.
  • Immunic plans to report further data from ongoing trials, including the Phase II CALLIPER trial and the Phase III ENSURE program.

Immunic's financial results and positive clinical trial data reflect a pivotal period for the company as it advances its lead drug candidates through critical stages of development. With a strategic focus on progressive MS and gastrointestinal disorders, coupled with a solid financial foundation, Immunic is positioned to continue its path toward potential commercialization and therapeutic breakthroughs. The anticipation of data readouts in the coming years will be crucial milestones for the company and its stakeholders.

InvestingPro Insights

Immunic, Inc. (IMUX) has shown a promising trajectory with its clinical development programs and financial strategies, as evidenced by the recent financial results and clinical trial advancements. To further understand the company's financial health and market performance, let's delve into some key metrics and InvestingPro Tips:

InvestingPro Data:

  • The company's Market Cap stands at $109.71 million, reflecting its current valuation in the market.
  • With a Price to Book (P/B) ratio of 2.27 as of the last twelve months ending Q3 2023, Immunic's stock is valued above its book value, which can indicate investor expectations for future growth.
  • The stock has experienced a strong return over the last three months, with a price total return of 16.19%.

InvestingPro Tips:

  • Immunic holds more cash than debt on its balance sheet, which is a positive sign of financial stability and may provide flexibility in funding its clinical trials and operations.
  • Despite the positive outlook, analysts do not anticipate the company will be profitable this year, which aligns with the reported net loss for 2023. This is an important consideration for investors assessing the company's near-term financial prospects.

For investors looking for a deeper dive into Immunic's financials and market performance, InvestingPro offers additional insights. There are 9 more InvestingPro Tips available, which can be accessed at https://www.investing.com/pro/IMUX. These tips can provide a comprehensive view of the company's financial health and market position. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription and unlock the full potential of InvestingPro's analytics.

Full transcript - Vital Thera (IMUX) Q4 2023:

Jessica Breu: 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?

Daniel Vitt: 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?

Glenn Whaley: 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?

Daniel Vitt: 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.

A - Jessica Breu: 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.

Caroline Pocher: 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?

Daniel Vitt: 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.

Caroline Pocher: Great. Thank you so much.

Daniel Vitt: Thank you, Caroline.

Jessica Breu: 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?

Nat Charoensook: Hi. Can you hear me all right?

Jessica Breu: Yes. Hello. Good morning.

Nat Charoensook: 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.

Daniel Vitt: 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.

Nat Charoensook: 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?

Daniel Vitt: 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.

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

Jessica Breu: 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?

Daniel Vitt: 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.

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

Matthew Kaplan: Hi. Good morning, guys. Can you hear me?

Jessica Breu: Good morning. Yes. Good morning.

Matthew Kaplan: 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?

Daniel Vitt: 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.

Matthew Kaplan: 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?

Daniel Vitt: 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.

Matthew Kaplan: Okay. Great. Thanks for the added detail.

Daniel Vitt: Yeah. Thank you, Matt.

Jessica Breu: 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.

Jun-Goo Kwak: 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?

Daniel Vitt: 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?

Jun-Goo Kwak: Celiac.

Daniel Vitt: 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.

Jun-Goo Kwak: Right. Got it. Thank you so much.

Daniel Vitt: Thank you. Bye-bye.

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

William Wood: Yes. Can you hear me?

Jessica Breu: Yes. Hello.

William Wood: 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.

Daniel Vitt: 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.

William Wood: 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.

Daniel Vitt: 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.

William Wood: 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?

Daniel Vitt: 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.

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

Daniel Vitt: Yes. Thank you, William.

Jessica Breu: 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?

Daniel Vitt: 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.

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

Daniel Vitt: 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.

Jessica Breu: 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.

Daniel Vitt: 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.

Jessica Breu: 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.

Daniel Vitt: 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.

Jessica Breu: 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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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