Immunic Q3 2023 Earnings Call Transcript

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November 14, 2023

Key Takeaways

  • Phase 2 CALIBRE interim data showed a 22.4% improvement in serum NfL versus placebo at week 24 and consistent NfL reductions across all PMS subtypes, including a 20% reduction in non-active SPMS, indicating a potential first-in-class neuroprotective oral therapy.
  • USPTO patent allowance for vedafludimus calcium in relapsing MS covering 10–45 mg doses and the 30 mg formulation extends exclusivity into 2041, bolstering the company’s IP position.
  • As of September 30, 2023, Munich reported $59.7 million in cash and equivalents, providing runway into September 2024, but incurred a Q3 net loss of $22.8 million ($0.51 per share), driven by increased R&D expenses.
  • Key upcoming milestones include top-line Phase 2 CALIBRE data in April 2025, an interim futility analysis of the Phase III Ensure program late next year, Phase III readouts end of 2025, and initiation of the Phase 2 IMU 856 celiac trial.
  • IMU 856 Phase 1b results in celiac disease showed gut architecture protection, symptom improvement, favorable biomarker responses, enhanced nutrient absorption, and good tolerability, supporting a novel GI therapy approach.
AI Generated. May Contain Errors.
Earnings Conference Call
Immunic Q3 2023
00:00 / 00:00

There are 8 speakers on the call.

Operator

Good morning and welcome to Munich's Q3 2023 earnings call. My name is Jessica Bru, Head of Investor Relations and Communications at the Munich. I will also be the moderator on today's call. Speaking on the call are Doctor. Daniel Fitt, our Chief Executive Officer and President, as well as Glenn Whaley, our Chief Financial Officer.

Operator

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 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 in the Zoom portal Munich.

Operator

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 Munich's actual results to differ materially from those discussed here. Please note that these forward looking statements Munich. Munich'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.

Operator

Please refer to Imunich's SEC filings for a more detailed description of the risk factors that may affect Imbunik's results and these forward looking statements. I would now like to turn the call over to our CEO and President, Doctor. Daniel Fitt, 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 Q3 ended September 30, 2023 in our press release and Form 10Q. During the call today, we will walk through our Q3 2023 and subsequent highlights, financial and operating results As well as anticipated upcoming milestones.

Speaker 1

As Jessica noted, after the presentation, you will have the opportunity Our vedafludimus calcium development program in multiple sclerosis. In August, we completed enrollment of our Phase 2 CALIBRE trial of idiopulmonary calcium in patients with progressive multiple sclerosis or PMS. A total of 467 adult patients with primary MS or active or non active secondary PMS We're randomized to either 45 milligram daily doses of idioplutimus calcium or placebo. Patients were enrolled at more than 70 sites in North America, Western, Central and Eastern Europe. A few months later in October we reported Overwhelmingly positive interim data from this Phase 2 CALIBRE trial.

Speaker 1

In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of PMS, saw a 22.4% improvement in serofilament light chain of NFL, or NFL, for beta threudinous calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of editholimus calcium in this PMS population. A statistically significant difference was found for serum NfL at week 24 between Metoflumus calcium and placebo with a p value of 0.01. If you look at our sub of the if you look at the subtypes of progressive MS to the right, You can appreciate that this difference in NfL at week 24 was consistently shown throughout all subtypes of progressive MS.

Speaker 1

I would like to point out that we saw a 20% reduction for beta thrombus calcium versus placebo in SPMS, Meaning the patients with no focal inflammation activity, but disease progression. This subtype is a difficult to treat population with no relevant FDA approved therapies available. This slide puts our CALIBRE interim data into the perspective of IMMUNIC. On the left, we display the data for PPMS compared to the oratorio study for Orkanizumab, which showed a spread of NfL measures between active and placebo at 24 weeks of 12.4%. In the CALIBET trial, we observed an 18.8% improvement of active drug over placebo in PPMS at week 24.

Speaker 1

The results of this Phase 3 study led to approval of ocrelizumab for treatment of PPMS. In the center of the slide you see historical data for secondary progressive MS, both for non active and active SPMS. In comparison, Metaflutimus calcium was able to show a substantial reduction of NfL in both the active and non active populations. 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 subtype with the highest unmet medical need. The right side of the slide shows comparison between our Phase II emphasis data for veutrolumus calcium in RRMS versus our historical relapsing MS studies to complete the picture.

Speaker 1

In summary, we believe the clear separation observed for serum NfL for beta thalamus calcium over placebo in this PMS patient population Represents another major step forward for what potentially could be a 1st in class, no one activator for MS. The strong signal also points to a more likely positive outcome of the overall CALIBRE trial, also in clinical relevant endpoints like prevention of disability worsening. In October, Doctor. Robert J. Fox from HUPLAIN Clinics, Who is also the coordinating investigator of our INSUURE and CALIPA programs, presented data from our Phase 2 EMFISIS trial of beta thalamus calcium in RRMS in an e poster at the Joint ACTROMS meeting.

Speaker 1

As a reminder, beta filamentous calcium showed an improvement in serum NfL in both treatment arms of 30 45 milligram oral placebo. Just recently, we received a notice of a loan from the USPTO for a patent covering the treatment of relapsing MS with a specific dose track of VDFLUMOUS calcium. This includes a daily dose of about 10 milligram to 45 milligram of VDFLUMOUS calcium and other source as well as the free asset form of the treatment for lip synch MS, also covering the 30 milligram dosage used in our ongoing twin and Phase III insurance trials. The claims are expected to provide protection into 2,041 unless extended further. This patent significantly bolstered the multilayered proprietary IP position we have built around our late stage program for patients with MS.

Speaker 1

Moving to our IMU 856 program. In July, we hosted a virtual select disease Expert Roundtable to discuss ongoing active celiac disease or OACD, a serious lifelong autoimmune disorder And the substantial unmet need for therapeutic solutions. We were grateful and honored to have been joined for this event By the renowned thought leaders from Harvard Medical School, the Mayo Clinic and Celiac Disease Foundation. During their own time, our Chief Medical Officer Andreas Also provided an overview of IMU 856 program, including our positive Phase 1 trial results in celiac disease patients released earlier this year in May, which I will highlight again in just a moment. Also in October, we presented 2 abstracts at the United European Gastroenterology Week, UEGW 2023.

Speaker 1

My colleague, Doctor. Franziska Vujhanig, Senior Medical Director at IMMUNIC presented data from our positive Phase 1b clinical trial of IMU856 in patients with celiac disease during a moderated poster session. IMU 856 is an orally available and systemically acting small molecule modulator of the target SIRT6. The trial results gathered during periods of gluten free diet and gluten challenge demonstrated positive effects For IMUH56 over placebo in 4 key dimensions of celiac disease pathophysiology: Protection of the gut architecture, Improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption. IMUH Class VI was also observed to be safe and well tolerated in this trial.

Speaker 1

We believe that this highly encouraging data provides initial clinical proof of concept for an entirely new therapeutic approach to gastrointestinal disorders By promoting the regeneration of bowel architecture. Additionally, Doctor. Geert de Hans From the Amsterdam University Medical Center presented data from our Phase 2 Caldos 1 trial of renal thalamus calcium in ulcerative colitis or UC. As a reminder, the maintenance phase results from the CALOS-one trial demonstrated statistically significant activity Offedophilus calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of eduflumer's calcium in UC and other inflammatory bowel disease indications.

Speaker 1

Earlier this month, Doctor. Borjanik had another opportunity to present the data from our Phase 1b clinical trial of IMB-eight hundred and twenty six in patients with celiac disease in the virtual e poster at the Association of European Celiac Society's General Assembly Conference in Athens, Greece. That concludes our summary for the Q3 EMUNIC. I am very happy that the scientific and clinical advancement and progress made across our different programs has been extremely positive during this year. IMMUNIC is leveraging this momentum now in discussions with pharmaceutical companies.

Speaker 1

For IMU 856, our goal is to identify a partner who is capable of performing several therapeutic Phase 2 clinical trials. For media for the most calcium, the release of Our very good biomarker NfL data has been an important trigger point for partnering discussions with global and regional pharma players. I would now like to hand over the call to Glenn to provide financial overview. Glenn?

Speaker 2

Thank you, Daniel. I will now review the financial and operating results for the Q3 ended September 30, 2023. Let me start a review of our cash position. We ended the quarter with $59,700,000 in cash and cash equivalents. With these funds, we expect to be able to fund operations into September of 2024.

Speaker 2

Regarding the operating results, R and D expenses were $19,800,000 for the 3 months ended September 30, 2023, as compared to $16,500,000 for the 3 months ended September 30, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of beta flutinous Emunich. This was partially offset by a decrease in external development costs related to the IMU 935 and IMU 856 programs. For the 9 months ended September 30, 2023, R and D expenses were $63,900,000 as compared to $50,500,000 for the same period ended September 30, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of beta fluidumabas calcium, IMU A56 and personnel expenses.

Speaker 2

This was partially offset by a decrease in external development costs related to the Phase 2 clinical trial of beta fluidus calcium and ulcerative colitis and IMU 935 program. G and A expenses were $3,800,000 for the 3 months ended September 30, 2023, As compared to $3,600,000 for the same period ended September 30, 2022. The slight increase was spread across numerous categories. For the 9 months ended September 30, 2023, G and A expenses were $11,900,000 as compared to $11,600,000 for the same period ended September 30, 2022. The increase was related to an increase across numerous categories, which was partially offset by a decrease in personnel expense related to stock compensation expense.

Speaker 2

Other income $800,000 for the 3 months ended September 30, 2023, as compared to negative $1,100,000 for the same period ended September 30, 2022. The increase was primarily attributable to a decrease in foreign exchange losses and an increase in interest income as a result of higher interest rates. This was partially offset by decrease in R and D tax incentives as a result of less spend for clinical trials in Australia. For the 9 months ended September 30, 2023, other income was $3,800,000 as compared to negative $1,800,000 for the same period ended September 30, 2022. The increase was primarily attributable to an increase in interest income As a result of higher interest rates, a decrease in foreign exchange losses and the research allowance attributable for tax year 2021 from the German Federal Ministry of Finance that was received in 2023.

Speaker 2

The increase 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 3 months ended September 30, 2023 Was approximately $22,800,000 or $0.51 per basic and diluted share based on approximately 44,600,000 weighted average common shares Emunich. Compared to a net loss of approximately $21,200,000 or $0.69 per basic and diluted share Based on approximately 30,600,000 weighted average common shares outstanding in the same period ended September 30, 2022. Net loss for the 9 months ended September 30, 2023 was approximately $72,000,000 or $1.63 per basic and diluted share based on 44,200,000 weighted average common shares outstanding. Compared to a net loss of approximately 63,900,000 for $2.16 per basic and diluted share based on 29,700,000 weighted average common shares outstanding for the same period ended September 30, 20 With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones.

Speaker 2

Daniel?

Speaker 1

Yes. Thank you, Glenn. I would like to provide an update on the anticipated upcoming milestones for our clinical development programs. Our current expectation is to report top line data from our Phase 2 CALIBRE trial in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase III insured program late next year to read out the first of our identical twin Phase III insured trials in relapsing MS at the end of 2025.

Speaker 1

As stated before, based on the strong clinical activity observed so far, Envidefruzumos calcium solidly established safety and tolerability the Munich. We believe that the design of the Phase III Insure program will provide a straightforward path to a potential regulatory approval in relapsing MS. If top line HADAPA data continues to show neuroprotective effects for PMS patients, You may be able to position Metaflumis calcium as the first oral treatment for non active secondary progressive MS as well. We also expect the drug's potential first in class ability to activate NUR1 to meaningfully benefit the ongoing Phase III insured trials in relapsing MS. With regard to our IMD846 program, as previously reported, We have begun preparing for a Phase 2 clinical trial in ongoing active celiac disease patients.

Speaker 1

We are very excited about this data and believe IMU 856 We present an entirely new therapeutic approach for gastrointestinal disorders by promoting the 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

Yes. Thank you, Daniel and also Glenn, for walking us through the Q3 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 Munich. You can either submit your questions in writing via the Q and A tool of the SUM portal.

Operator

Or if you would like to speak with us directly, Please use the raise hand function of the Zoom product to queue your question. And our first guest today is Caroline Pocha from Wedbush Pecrow. Caroline, please unmute yourself and go ahead.

Speaker 3

Hi, good morning. This is Caroline on for Andreas. Thank you for taking our questions. Just a few from us. Can you provide any insight into where you are in terms of preparing for the Phase 2 trial for 856 in celiac disease?

Speaker 3

What do you anticipate the trial design would look like and the timelines for when you think you would initiate the trial?

Speaker 1

Yeah. I think as we have stated before, we have fully evaluated the data, done our homework on completion of the data packages. So this is work in progress right now. And maybe some thoughts on the trial design. And so likely this will be should be a treatment phase of 3 months of treatment in ongoing active celiac disease patients.

Speaker 1

So a trial which also make it possible to really conclude data for Further testing down the road in pivotal trials. More than I said, that's where we are right now. We're still in the preparation process.

Speaker 3

Okay. Great. And then just one follow-up From us, can you talk about how enrollment is progressing in the Insure program and what your target timeline is to complete enrollment?

Speaker 1

Yes, I think, as you know, we usually don't give a rolling update on the recruitment status. But we keep currently our guidance of completion of enrollment in the way that we are able to read out the first of the insured studies end of 2025 And the second one a couple of months later. So that's all I can say.

Speaker 3

Okay. Great. Thank you so much and congrats on the progress.

Operator

Thank you, Caroline. Our next guest is Liam Heaster from Piper Sandler. Liam, please unmute yourself and go ahead.

Speaker 4

Hi. I'm calling I'm asking a question on behalf of Yasmeen Rahimi. Just two questions. So my first one is related to the CALIFR trial. So what type of data are you expecting to report in April 2025?

Speaker 4

And what's the bar of success expected for the readout?

Speaker 1

Yeah. That's a good question. Because I think we have spoken a lot about this really strong NFL data. So of course, we will I also report NFL as a secondary readout from the study. But I think the most Interesting endpoints will be the primary endpoint, which is brain volume change in patients comparing ACTIVE with placebo As a primary endpoint, brain atrophy, maybe that's the right word for that.

Speaker 1

And another maybe the most important secondary endpoint or key secondary endpoint Is confirmed disability worsening, so a change in EDSS score in a confirmed way. So that also will give us and that's, I think, important the ability to correlate the changes in biomarkers and clinical endpoints as well at Same time. So that's all planned to be able to be released in April 25.

Speaker 4

Great. And is there a specific bar of success that you're looking for?

Speaker 1

Well, if you look on what's currently on the market, I think the bar is not super high here. I think We want to see a benefit on all of those endpoints. But if we more or less translate what we have seen And the NFL data set into the full data readout, that

Speaker 5

would be

Speaker 1

wonderful. And also a meaningful medical difference And disability prevention would be maybe the best thing, best win here. Specifically looking on those untreatable patient populations, so Looking specifically on the secondary progressive patients without focal inflammation, without relapses, So the non active secondary progressive population, I think any benefit here would be great. And I can't give you really hard numbers here at that point. It will I think the study was designed to be powered for brain atrophy benefit.

Speaker 1

So that That is something we want to achieve on a statistical readout here.

Speaker 4

Thank you. And then just one more question, just to build off of the previous one. Well, actually, in relation to that, IMU 856. Have you spoken with the FDA at all with Phase 2 design? Or is it still just in the preliminary

Speaker 1

Page. This is a process which is ongoing right now. So Usually what we do is we submit our IND filing and then you have written communication with the regulators For example, protocol design and so forth.

Speaker 4

Great. Thank you.

Operator

Thank you, Liam. The next one here in the queue is Matt Kaplan from Ladenburg Thalmann. Matt, please unmute yourself and go ahead.

Speaker 6

Hey, good morning guys. And thanks for taking the questions. Just wanted to focus a little bit on your business development goals. You mentioned during the prepared remarks. Can you talk a little bit more about that for 856 and Also 858.

Speaker 1

Yes. Thank you, Matt, and thank you for the question. Of course, here we have several good assets and good data. So you remember this year was full of good data readouts With the celiac data, with the cal dose maintenance data and now with the caliper data. And all of these Data typically are good points to intensify discussions with companies.

Speaker 1

It's difficult to really say exactly what comes First, what is the best option? But I think what we are trying is to make sure we use the data in our active discussions To really build a level of trust and a good discussion with potential partners and based on that then to execute the one or the other deal. So I think the best description would be that we are building more optionality on that and to Have also access to some non dilutive financing sources to fuel the rest of the pipeline based on that.

Speaker 6

Okay. Thanks. And then you mentioned in terms of some new IP, what is that the new IP that was Allowed, what does that get you in terms of exclusivity period?

Speaker 1

Yes, I think that's a good point. So that patent runs until 38. So that's a patent which covers the dose strength and the treatment of relapsing MS. And it is covered with the certain dose strengths here and would protect us into 38 Plus, there's a potential for a pandemic extension there, which would then protect us until 41. No, no, sorry.

Speaker 1

I mixed that up. No, I think this panel goes

Operator

No, 41 is correct.

Speaker 1

41 is correct. Yes. Sorry. So 41 is the right number here. But we have more things in the making, so that's why.

Speaker 6

And then, and then

Speaker 1

report later.

Speaker 6

Okay. Great. And then the you've been characterizing The venetlumas as well in terms of its ability to be a neuro1 activator, What does that mean from the point of view of the drug as well?

Speaker 1

Yeah, I'm very thankful for this question because that's maybe the elephant in the room on the MS treatment landscape, I think. The thing is that So far in MS, we have good options to treat relapses on the one hand. And we have very good drugs on doing that And reducing inflammation. What is maybe the missing piece is really to protect from impairment from cell death by triggers and signals which are independent of focal inflammation. So something which, for example, is happening patients once they progress from relapsing MS into secondary progressive MS, where relaps is skewed down, but still disability is there.

Speaker 1

And with the data we have obtained and in combination with literature data and work other groups have done in the scientific community, We believe that NO1 is a target which may give us here a signal, a protective signal for neurons In a way, which is independent of that focal inflammation. And combining the NuVon activation now with our known and well reported DHODH inhibition, I think this drug has a kind of like a double strike on the 2 important pieces for treating relapsing MS here on inflammation and Direct neuroprotection, whereas it also offers now, and this was, I think, the conclusion we draw from the NFL reduction, Also offers a treatment option for those so far untreatable patients of PMS, specifically Primary progressive and more active secondary progressive in this.

Speaker 6

And just to be clear, this is something That's totally separate from the DHOD inhibiting effects and not unique To put a few minutes and not characteristic of other DH

Speaker 1

OZ inhibitors? Exactly. It's not linked to DH OTH. It's something which is A property of the molecule and its binding ability to both, to DHODH on the one hand and to NO1 on the other hand. And we have published a paper earlier this year together with our academic collaborators around Daniel Merck, showing that the drug directly There's an ICT data there in this paper showing that the molecule is directly binding to NO1 as a protein.

Speaker 6

Perfect. Great. Thanks. Thanks, Daniel.

Operator

Pleasure. Thank you, Matt. Yes, maybe to follow-up on Matt's Question regarding BD. We received 2 questions here in writing via the Q and A tool, which go into a similar direction. The first one, Please describe your strategy for maintaining adequate liquidity to see these opportunities through to fruition.

Operator

And the second one, great Clinical results, what's the plan to raise cash? Maybe Daniel you can give your strategic thoughts here again.

Speaker 1

Yeah, of course. That's an important piece to make sure we earn the fruits at the end of the day. And therefore, we think it's worth to follow different ways To fund the company for the next years. And as I said, one of the important pieces could be business development activity partnering On one of the assets or maybe even on 2 or some territorial partnerships could also be an option. Another option is kind of non dilutive financing, for example, coming from project financing.

Speaker 1

And the third one could be Any kind of equity financing. So I think we keep those options on the table, but also considering what's going on in the capital markets.

Operator

Yes. Thank you, Daniel. Our next live guest here is Tom Smith from Leerink Partners. Tom, please unmute yourself and go ahead.

Speaker 7

Great. Hey, guys. Good morning. Thanks for taking the questions. Good morning.

Speaker 7

I was just wondering if there's any update on the early Munich. Pipeline programs like IMU-three eighty one. And do you have any visibility on timing for advancing this program into the clinic or when we can expect to learn more on this asset?

Speaker 1

Yeah. Thank you, Tom, for the question. I think the program was initiated based on positive data we generated from the Data we generated from the CauldOS trial. But clearly, the company is prioritizing now the clinical programs right now for time and resource reasons. So We have the all the preparation work ongoing, part of that completed.

Speaker 1

But clearly, The resource focus and the progress of the company is focusing on performing next steps and continuing the trials Munich.

Speaker 7

Got it. That's helpful. And if I could just follow-up on an earlier question. Just on the 856 Gilead study, are there any specific Gaining factors, Daniel, that you would call out, I guess, in terms of getting that program off the ground and getting the IND cleared and starting to Enroll patients

Speaker 1

there? No. As mentioned, we are preparing the trial. That means also physically preparing the trial on the material side, So production of material for the trials and so forth. And we have also stated that our priority will be celiac disease That's first indication that we're trying to look at.

Speaker 1

But it's also a little bit related to the other question we have answered already Today is that we also think about partnering could make sense to also broaden development beyond celiac disease. So this is something which is Also an important aspect to consider in any priorities, speed going forward and so forth with the program. So, so far this is still all in preparation, also the interaction of the regulators. And this is not just limited To the U. S, it goes also into European regulators, to really make sure we have a good trial prepared.

Speaker 1

Also discussing with the with our KOL network on the different aspects of Having a good trial set up to make sure we read out proper data, we don't hold on our own feet here. You can learn a lot from other trials in in that world of celiac disease treatments. So I think it's going forward. And as soon as we are making the next steps, I think we will update the market on that.

Speaker 7

Understood. That makes sense. All right. Thanks for taking the questions.

Speaker 1

Thank you, Tom.

Operator

Thank you, Tom. Just as a reminder, if you have EMUNIC. And we have one more here who wants To be with us live, which is Mayank Mamtani from B. Riley. Mayank, please unmute yourself.

Speaker 5

Hi, this is actually William on for Mayank today. Congratulations on the really nice Q3 results. I think just one from us on your NFL data from Caliper. Hey, it looks really, really nice. You've got, it's really nice data across all subpopulations, including this, the broader PMS population.

Speaker 5

I'm curious slightly about the active SPMS, got a pretty low end there. And I'm just kind of curious how we should think about the sort of the smaller number there. But then also when we're doing when we get to the final readout,

Speaker 1

Will you

Speaker 5

be looking at these subpopulations and trying to figure out exactly your path forward potentially choosing one subset Over the other for then going into the Phase 3 or potentially for partnering activities, are you really trying to keep this as A PMS, more of a broader drug. Just trying to sort of figure out your path forward there. Appreciate it.

Speaker 1

Thank you for that question. I think it's something important we should touch on, because I think this is more what is the track towards Any regulatory approval later? And how do we prioritize things? I think we have been very excited specifically on the data for the, As I mentioned, for the non active population, which is really the one in the PPMS population and the non active secondary progressive populations. The active populations had responded very nicely to NFL.

Speaker 1

But I think in the U. S, in the space of the FDA regulated Treatments, they fall into RMS, basically. So therefore, if you focus on US treatments, This is covered by our INSUURE study, basically. And therefore, if we focus on PMS, we will mainly discuss And go forward with those patients where there is little or no relapsal activity remaining. By the way, this was the you mentioned the subpopulation of active patients, but also reconfirms what we have seen in the EMFASIS Phase 2 study On those patients, so I think it's also a nice confirmation of the RMS population that you have generated earlier.

Speaker 1

But if it's if it comes to the best indication going forward, I think, we definitely need to and want to pick the best Choice for regulatory approval. And I think this is more or less dictated by 2 things, by our data and the unmet need. And I think this clearly is In non active secondary progressive, there is no real treatment available right now for patients. And our data was So good there as well on the NFL side that we think it is likely the indication of choice. Of course, we first want to look on the data In April 25 to see if we see the same clinical signals as we have seen on the NFL, we don't.

Speaker 5

I appreciate that. It's very helpful and congratulations again.

Operator

Thank you, Will.

Speaker 1

Thank you.

Operator

Yeah, this actually concludes our question and answer I would like to turn the conference back over to Daniel for any closing remarks.

Speaker 1

Yes. Thanks, Jessica. And thank you, today's attendees, for your insightful questions. In summary, With the completion of enrollment of our Phase 2 CALIBRE trial, the positive interim data from the CALIBRE trial as well as the continuation of enrollment Of the ENSURE Phase III trial, we have continued to make tangible progress on the clinical development of idifilumus calcium during this past quarter. As progresses meet, we also expect to provide an update on our preparations for a Phase 2 clinical trial IMMUNIC.

Speaker 1

With that, I would like to close today's call. Thank you very much for joining. And we are happy to answer any additional questions 1 on 1.

Operator

Thank you for joining EMUNIC's Q3 2023 earnings call. The call has now concluded. You may now disconnect.

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