Immunic Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 22, 2024

There are 8 speakers on the call.

Operator

Good morning to everybody on the line. I would like to welcome you to Munich's 4th quarter year end 2023 earnings call. My name is Jessica Brew, Vice President Investor Relations and Communications at Munich. I will also be the moderator today. Speaking on the call are Doctor.

Operator

Daniel Fitt, our Chief Executive Officer and President as well as Glen 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. If you join the webcast via the Zoom platform there are 2 ways to submit questions. You can either submit your questions in writing via the Q and A tool of the Zoom portal.

Operator

Or if you would like to speak with us directly, please use the raise hand function in the Zoom portal to queue your question. Before we begin, I would like to remind you that this presentation may contain forward looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate or words with a similar meaning. And such statements involve a number of risks and uncertainties that could cause immunics actual results to differ materially from those discussed here. Please note that these forward looking statements reflect immunix 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.

Operator

Please refer to Munich's SEC filings for a more detailed description of the risk factors that may affect the Munich's results and these forward looking statements. I would now like to turn the call over to our CEO and President, Doctor. Daniel Firth, to begin the presentation. Daniel?

Speaker 1

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 Q4 and the year ended December 31, 2023, in our press release and Form 10 ks. During the call today, we will walk through our 4th quarter's 2023 achievements and subsequent highlights, year end financial and operating results as well as anticipated upcoming milestones.

Speaker 1

As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with a review of our Q4 2023 and subsequent highlights. Punctuating our remarkable progress throughout 2023, we announced a 3 tranche private placement of up to $240,000,000 last month. The round led by VDF Partners included participation from a group of top tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Solius Capital, RTW Investments and Adedge Capital Partners. We received a total of $75,000,000 in net proceeds from the 1st tranche, which closed on January 8, 2024.

Speaker 1

The second and third tranches of $80,000,000 each are conditioned on the announcement of Phase 2b top line data for our CALIDPR trial expected in April 2025, volume weighted average share price levels and minimum trading volumes. Any of these conditions in the 2nd or 3rd tranche can be waived by holders of 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 affirms the enormous value inherent in our 2 advanced clinical programs. In October, we reported overwhelmingly positive interim data from the Phase 2 TELIPA trial of our potentially groundbreaking lead acid nuclear receptor related 1nerone activator, beta thalassemia, in progressive multiple sclerosis, or PMS. In total, 203 patients were included in this analysis.

Speaker 1

The overall population, which includes all subtypes of PMS, saw a 22.4% improvement in serum neurofilament light chain or NfL for vedofructures calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of vinoflavinumus calcium in this PMS population. Even a statistically significant difference was found for arithmetic mean serum NfL levels at week 24 between B duveitimus 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% of B.

Speaker 1

Diffusing less calcium versus placebo in advanced SPMS, meaning the patients with no focal inflammatory activity but continued disease progression. We believe this subtypes 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 Caliper interim data into the perspective of historical third party studies and the same progressive MS subtypes. On the left, we display the data for PPMS compared to the our editorial study for ocrelizumab, which showed a spread of NfL values between active and placebo at 24 weeks or 12.4 percent. In the CALIBRE trial, we observed an 18.8% improvement of active drug over placebo in PPMS at week 24.

Speaker 1

You may recall that the results of the oratorial Phase 3 led to the approval of ocrelizumab for treatment of PPMS. In the center of the slide, you see historical data for the secondary progressive MS, both for inflammatory non active and active SPMS. In comparison, viniliflutiniluzcalcium 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 with the highest unmet medical need. The right side of the slide shows the comparison between our Phase II Mphasis data for beta pruditus calcium in RRMS versus historical relapsing MS studies to complete the picture.

Speaker 1

In summary, we believe the clear separation observed in serum NfL for vedoflumus calcium over placebo in this PMS patient population as well as its subtypes represents another significant step forward for what could potentially be a 1st in class NOVAN activator for MS. This strong signal also points to a more likely positive outcome of the overall CALIBOR trial as well as clinically relevant endpoints like prevention of disability worsening. Also in October, Doctor. Bob Fox from Cleveland Clinic, who is the coordinating investigator of our ENSURE and CALIBOR programs, presented data from our Phase II emphasis trial of vidofolimus calcium in RRMS in an e posted at the joint ACTROMS meeting. It is important to reiterate that vidofoluis calcium shortened an improvement on serum in both treatment arms of 30 45 milligrams over placebo.

Speaker 1

In November, we were granted 2 fundamental new patents for vedifugimos in the United States. The first covers a daily dose of about 10 milligram to 45 milligram of V. DeFruidimus calcium and other salt as well as free acid forms for the treatment of relapsed LMS, including the 30 milligram dosage used in our ongoing twin Phase III INSULET trials. The second patent granted covers the dosing regimen associated with Friedofluorimous 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 2,041 or even beyond in the United States.

Speaker 1

Turning to our 2nd key program, IMU856, an orally available and systemically acting small molecule modulator that targets CIRD6 protein. In October, we presented 2 abstracts at the United European gastroenterology week 2023. My colleague, Doctor. Franziska Bojanik, Senior Medical Director at Immunic, presented data from our Phase 1b clinical trial of IMU856 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 improvements placebo in 4 key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrients absorption.

Speaker 1

IMU856 was also observed to be safe and well tolerated in this trial. Additionally, Doctor. Gerd de Hans from Amsterdam University Medical Center presented data from our Phase 2 CALDOSE 1 trial of fetal thrombus calcium in ulcerative colitis, OUC. As a reminder, the maintenance phase results from the COLRS-one trial demonstrated statistically significant activity of beta fluting with calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of beta fluidumus calcium NUC and other inflammatory bowel disease indications.

Speaker 1

In November, we were pleased that Doctor. Borjanec had another opportunity to present the data from our Phase 1b 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 Q4 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 beta thalamus calcium, the release of our overwhelmingly positive biomarker NfL data has been an impetus for partnering discussions and global and regional pharmaceutical companies.

Speaker 1

There is also a lot going on with our IMU-eight fifty six program, which we will update you as progress is made this year. I would now like to turn the call over to Glen to provide a financial overview. Glen?

Speaker 2

Thank you, Daniel. I will now review the financial and operating results for the year ended December 31, 2023. Let me start with a review of our cash position. We ended the year with $46,700,000 in cash, cash equivalents. With these funds and the approximately $75,000,000 in net proceeds raised in the first tranche of our January 2024 private placement, we expect to be able to fund operations into the Q3 of 2025.

Speaker 2

Regarding the operating results, R and D expenses were $83,200,000 for the 12 months ended December 31, 2023, as compared to $71,200,000 for the 12 months ended December 31, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of vitaflutimus calcium and IMU856 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 vita fluidumab calcium program in ulcerative colitis. General and administrative expenses were $16,000,000 for the 12 months ended December 31, 2023 as compared to 15 point $3,000,000 for the same period ended December 31, 2022. The slight increase was spread across numerous categories and was partially offset by a decrease in personnel expense.

Speaker 2

Other income was $5,600,000 for the 12 months ended December 31, 2023, as compared to negative $900,000 for the same period ended December 31, 2022. The increase was primarily attributable to a decrease in foreign exchange losses, a research allowance attributable to the 2021 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 and D tax incentives as a result of less spend for clinical trials in Australia. The net loss for the 12 months ended December 31, 2023 was approximately 93,600,000 dollars or $2.11 per basic and diluted share based on approximately 44,300,000 weighted average common shares outstanding compared to a net loss of approximately $120,400,000 or $3.78 per basic and diluted share based on approximately 31,800,000 weighted average common shares outstanding for the same period ended December 31, 2022. With that, I will turn the call back over to Daniel for a view of our upcoming clinical milestones.

Speaker 2

Daniel?

Speaker 1

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 2 CARIBER trial of venofludimus in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase 3 INSURE program late this year and to read out the first of our identical twin Phase III INSUUR trials in relapsing MS in the Q2 of 2020 6. As stated before, based on the strong clinical activity observed thus far and vidofilamux calcium solidly established safety and tolerability profile to date, we believe that the design of our Phase 3 InSure program will provide a straightforward path to potential regulatory approval in relapsing MS.

Speaker 1

If the top line CALIBER data continues to show a neuroprotective effect for PMS patients, we may be able to position medullumus 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 NO1 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 beta thalassemia calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of mitralospirosis based on its combined neuroprotective anti inflammatory and antiviral effects. With regard to our IMU856 program, as previously reported, we have begun preparing for Phase 2 clinical trial in ongoing active celiac disease patients.

Speaker 1

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 bowel 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 and A session.

Operator

Thank you, Daniel, and also Glenn, for walking us through the Q4 2023 and subsequent highlights as well as our 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 2 ways to submit questions. You can either submit your questions in writing via the Q and 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.

Operator

Our first guest today is Caroline Pocha from Wedbush. Caroline, please unmute yourself and go ahead.

Speaker 3

Hi, good morning. This is Caroline on for Andreas. Just two questions from us. So if the data from CALIFR 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 insurer trial from the end of 2025 to Q22226.

Speaker 3

Just any clarity as to why the slight change, and just enrollment progression in both of those trials?

Speaker 1

Yeah, thank you, Caroline for the question. Let me start with caliber. So I think this is 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.

Speaker 1

But that requires a discussion with the regulators in the different countries. What we know is that likely, if 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 projections. I think this was already updated some weeks ago. That is reflecting the current speed of recruitment and our estimation.

Speaker 1

We always need to make and continue to explore how quick things are going forward. And therefore, we made an adduction to the timelines. But we are okay. We are on track on the current recruitment right now.

Speaker 3

Okay, great. Thank you so much.

Operator

Thank you, Caroline.

Speaker 1

Thank you, Caroline.

Operator

The next one I have in the queue here is Ned Chevarensuk from Leerink. Ned, please unmute yourself and go ahead.

Speaker 4

Yes, so congrats on all the progress and we have a couple of questions. So the first one, like what are the biomarker results that we can expect from the interim analysis for the INSURA study expected in LAD24 and what you need to see to continue the development of

Speaker 1

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 will get feedback from the Data Safety Monitoring Board about progression of the study. It may allow us for sample size adjustment.

Speaker 1

So this is maybe the only outcome which could happen, either continuous planned or sample size adjustment recommendations from the Data Safety Monitoring Board.

Speaker 4

Got it. That's very helpful. So the next one is, so what are the getting factors to start a Phase 2 study in ongoing active CRTCs? And can you please go over a potential trial decide for the Phase 2 study? Do you plan to look into additional doses other than the 80 mg or 160 mg that you looked at in the Phase 1b study?

Speaker 4

And what are the potential endpoints as well as exploratory biomarkers you plan to include in this study?

Speaker 1

Yes. Also a good question. As you know, we are heavily working and involved in a celiac disease community 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 2 study in celiac disease and also for potential other indications.

Speaker 1

As I said before, the more the proof of concept be achieved in the phase 1 is not only limited to a celiac disease, because we have, for example, seen a very nice improvement of endocyte function by increased uptake of nutrients like Y2B12, for example. So that would 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 on with potential partners and also looking for other ways to finance a full blown Phase 2 study.

Speaker 1

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 an indication in that context.

Speaker 4

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

Operator

Thank you, Nat. We have a question that came in via the Q and 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 2 is prerequisite for them?

Speaker 1

As my little bit subjective conclusion on perception of that 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.

Speaker 1

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 cancer in 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.

Operator

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

Speaker 5

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

Operator

Good morning. Yes, morning. Great. Great.

Speaker 5

Well, congrats on the progress. I mean, I just wanted to kind of 0 in on the data that you've gotten so far in with the Fluminous 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 caliper and emphasis studies?

Speaker 1

Thank you. Good morning, Matt. Yes, 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.

Speaker 1

If you really separate the activity of NfL from focal inflammation and relapses, On one hand, from the neurodegenerative contributions like you can do in progressive MS patients, There's clearly a nice predictive power of NFL for future disability outcome. And that 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. I think it's a scientific progress.

Speaker 1

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. And I think April 25, so 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 really fructimos calcium has really the opportunity to change the way we treat these diseases.

Speaker 5

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

Speaker 1

Yes, I think given that some people we are talking to are maybe also on the line here tend to be careful on projects and the status on BD discussions. But I think we do what we always do. We establish collaborations. We establish trustful relationships to potential partners. And progressing towards the readout, I think, clearly paves the way also for partnerships.

Speaker 1

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 2 study in a good way and then to look what is the best way forward here.

Speaker 5

Okay, great. Thanks for the added detail.

Operator

Yeah, thank you, Matt. Thank you, Matt. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q and A tool. And the next one here is Youngeo Kwak from Piper Sandler. Youngeo, please unmute yourself and go ahead.

Speaker 6

Hi. Good morning, team. This is Yongle on for Yas. Thanks for taking our questions. We have 2.

Speaker 6

For the futility analysis later this year for insurer, how should we think about its implications upon readout? And what would be considered a win? And second, for the Phase 2 celiac study, where are you with finalizing the design? And could you provide more color on your interactions with the regulatory agency so far?

Speaker 1

Give me a second. Yes, thank you for the question. To the first question, I think the nature of utility analysis is that you just want to get a procedures planned answer from the committee. Or and this is one of the reasons, given that we have a eventual endpoint, we would allow a reasonable sample size adjustment. That's all we can get.

Speaker 1

And then we all we then will implement into further development. So it's a more binary thing, honestly. We 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 AMPASIS data. And the second question, maybe you can repeat this, was on regulatory interactions for celiac.

Speaker 1

For celiac. Yes, that's work in progress right now. And also, we are still working on the project on the clinical Phase 2 study design. There are a couple of thoughts, which we are running through. So as soon as there is something to report on, we will disclose that.

Speaker 6

I got it. Thank you so much.

Speaker 1

Thank you. Bye bye.

Operator

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

Speaker 7

Yes. Can you hear me?

Operator

Yes. Hello.

Speaker 7

Awesome. Thanks so much and congratulations on the quarter and thank you for taking our questions. Just thinking about your Phase 3 IN SHORE, when should we expect to see the baseline characteristics for that trial? And you know, I'll just leave it there.

Speaker 1

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 'twenty six. 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 you know more in the future if there is a way to get this information earlier.

Speaker 7

Got it. And actually, I do have 2 more. You also have 2 presentations at ACTRIM's forums coming up next week. Should we be expecting any additional data on your emphasis in 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 2 study in PMS and I have one more.

Speaker 1

Yes. I think the second one is really the talking point from one of those posts is the EVV reactivation. This is something where it got a little bit quiet in last couple of months regarding that because we were so excited about new one, but it's still true that fetal fluid muscalciton 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.

Speaker 1

There's a lot of work done by really great scientists here in around the world, but also here, collaborators of our cells. So, I think that's an interesting scientific flashlight on the third aspect of activity of and the second one is more dedicated to CALIPR and to trial design and NFL and but no really new data. But it's important to put that into 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 discussion with doctors on this and more specifically and to also talk about new one activation and the way this has the neuroprotective potential here 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.

Speaker 7

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

Speaker 1

I think the biggest difference is that NOV1 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 CALIPR study, that beta thrombus 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 autogonal mode of action to these. The good thing about is that on the other hand, we also inhibit DHODH, which also and on top of this potential neuroprotective effect also is anti inflammatory. So that we if you focus 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.

Speaker 1

And that would be, I think, the best differentiated you can have and also the best news for patients suffering from these indications like primary progressive or secondhand progressive MS specifically.

Speaker 7

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

Speaker 1

Yes. Thank you, William.

Operator

Thank you, William. I actually have another question here on the NEUR1 target in the Q and A tool. In case of NEUR1 activation confirmation, do you see further benefits of idofludimos in the future or other neuromuscular disorders, such as Parkinson's disease or even Alzheimer's?

Speaker 1

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 Merck found that Lithothelial calcium is such a good activator of NO1. And most of the historic research on therapeutic use of NO1 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 still NOVAN still is on the top of the list of hope for potential targets for Parkinson's disease.

Speaker 1

Therefore, this primes, of course, our 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, CNS 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.

Speaker 1

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.

Operator

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

Speaker 1

Yes. That's a money question right now again. So I would love to continue with the Phase 3 directly in that indication. Once again, and that was the reason why we kicked off a new program called IMU-three eighty one. We have molecules which are maybe from their tissue distribution profile better suited for GI penetration by using our mode of action and our proof of concept, from the CALDOT studies.

Speaker 1

So yes, in principle, yes. But once again, something we would likely more likely separate in a different development track.

Operator

Thanks, Daniel. Final question I currently have, maybe a good chance for you to summarize the status quo and upcoming milestones for Mido. What are the updates regarding IMU-eight fifty six IMU-eight thirty eight? I'm sorry.

Speaker 1

Well, more or less the summary of what we spoke about. I think we were intrigued by the data of last year, specifically NFL data, giving us a very nice signal and, really increasing the likelihood of success for the clinical outcomes of the CALIBRE study with the readout in April 25. This would make the drug a huge also commercial opportunity. I think this is a very huge potential for venous fluid in schizophrenia. That's, I think, maybe the main driving force here right now.

Speaker 1

In parallel, we have that rock solid ensured 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 Mphasis 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 fetal food loss 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 your C study, on the maintenance data, which is more or less boosting other molecule developments in that space. And also, the No one potential beyond just mitigprosclerosis and other, related, neurological indications, also something where, we think this has another huge potential. And we will definitely also look into these things.

Operator

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.

Speaker 1

Thanks, Jessica, and thank you to today's attendees for your insightful questions. To summarize, with the positive interim data from our Phase 2 CALIBOR trial as well as the continuation of enrollment of our Phase 3 ENSURE trials, we continue to make tangible progress on the clinical development of filial fluidimus calcium. As progress is made, we also expect to provide an update on our preparations for further Phase 2 clinical development of IMU856. With our funds at the end of the Q4 and the recent closing of the first tranche of our 3 tranche private placement, we remain well funded providing us runway through multiple clinical milestones into the Q3 of 2025. With that, I would like to close today's call.

Speaker 1

Thank you very much for joining, and we are very happy to answer any additional questions 1 on 1.

Operator

Thank you, Daniel. And thank you for joining Munich's Q4 year end 2023 earnings call. The call has now concluded. You may now disconnect.

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Key Takeaways

  • Secured up to $240 million in a 3-tranche private placement led by VDF Partners, with the first $75 million tranche closed and remaining tranches tied to Phase 2b CALIBER top-line data expected in April 2025, funding operations into Q3 2025.
  • Interim Phase 2 CALIBER data for vedofludimus calcium in progressive MS showed a 22.4% reduction in serum neurofilament light chain at week 24 versus placebo and a 20.1% decrease in nonactive SPMS, outperforming historical benchmarks such as ocrelizumab’s 12.4% in PPMS.
  • Granted two new U.S. patents covering vedofludimus calcium dosing regimens and formulations extend the company’s intellectual property protection into 2041 and beyond.
  • Phase 1b trial of IMU856 in celiac disease demonstrated meaningful improvements over placebo in histology, symptoms, biomarkers and nutrient absorption with a favorable safety profile, and Phase 2 planning is underway for active celiac and other GI disorders.
  • Key upcoming milestones include Phase 2 CALIBER top-line readout in April 2025, an interim futility analysis of the Phase 3 INSURE program in late 2024, and initial Phase 3 ENSURE data in Q2 2026.
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Earnings Conference Call
Immunic Q4 2023
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