Immunic Q2 2024 Earnings Call Transcript

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August 8, 2024

There are 9 speakers on the call.

Operator

Communications at the munich I will also be the moderator today speaking on the call are Doctor. Daniel Fitt our Chief Executive Officer Glen Whaley our Chief Financial Officer as well as Jason Tardio our newly appointed Chief Operating Officer and President. 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 to queue your question. Before we begin, I would like to remind you that this presentation may contain forward looking statements.

Operator

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 EMURIC's actual results to differ materially from those discussed here. Please note that these forward looking statements reflect ImmuneX opinion 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 Munich's SEC filings for a more detailed description of the risk factors that may affect the Munich's results in these forward looking statements. I would now like to turn the call over to our CEO, Doctor.

Operator

Daniel Fitt to begin the presentation. Daniel?

Speaker 1

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 Q2 in 6 months ended June 30, 2024. During call today, we will walk through our Q2 2024 achievements and subsequent highlights, financial and operating results as well as our clinical development programs, including anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions.

Speaker 1

Let's start with a review of our Q2 2020 4 and subsequent highlights. In April, we hosted a multiple sclerosis R and D Day in San Francisco, highlighting the latest developments in the MS landscape as well as our development program, MediFLUMUS CAR TION. We walked through our highly encouraging preclinical and clinical data generated so far, supporting the neuroprotective potential and reduce disability worsening associated with Metofilamis calcium, which represents unique distinction compared with currently available MS therapies. We also shared our strong belief that MediaPharmacylcus Calcium could potentially elevate today's standard of care by providing a comprehensive solution for the full spectrum of MS patients, given that it is designed to selectively address all three components of smoldering MS with its neuroprotective, anti inflammatory, and antiviral effects in combination with its favorable safety and tolerability profile. I want to extend our thanks again to everyone who was able to join us for the event, both in person and those who listen to the recordings.

Speaker 1

Also in April, we announced that extended data from our Phase 2 EMFISIS trial of fedafilumabiscalcium in patients with relapsing remitting mitibosclerosis, or RMS, was published in the prestigious peer reviewed journal, Neurology and Neuroinflammation, an official journal of the American Academy of Neurology. The paper lead authored by Doctor. Bob Fox from Cleveland Clinic who is also the coordinating investigator of our INSure and CALIBRE programs, included data for both study cohorts with an extended dose range. Inclusion in the publication represents further evidence of the strength of these findings for ritofluenced calcium in RRMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences.

Speaker 1

First in human data from our Phase 1b clinical trial of IMU-eight fifty six, our orally available and systemically acting small molecule modulator that target 13 6 in patients with celiac disease was presented in an oral presentation at Digestive Disease Week in Washington, D. C. The trial results gathered during periods of Gluten Free Diet and Gluten Challenge demonstrated meaningful improvements over placebo in 4 key dimensions of celiac disease pathophysiology, specifically histology, disease symptoms, biomarkers and nutrient absorption. IMU AFF6 was also observed to be safe and well tolerated in this trial. We continue to believe that this data provides initial proof of concept for a potential new or therapy approach to a range of gastrointestinal disorders through the regeneration of bowel architecture.

Speaker 1

Additionally, we represented data from our Phase 2 CALIPRE trial of VWO plus calcium in patients with progressive multiple sclerosis or PMS at 2 conferences: the 23rd National Congress of Neurology in Golden Sands, Bulgaria and Consortium of Multiple Sclerosis Center's 38th Annual Meeting in Nashville. We were pleased to have had the opportunity at both meetings to highlight the clear separation observed in serum neurofilament light chain, NfL, for beta thrombus calcium over placebo in this PMS patient population as it represents another significant step forward for what could potentially be a 1st in class NO-one activator for MS. This strong signal in NfL also makes us believe in a more likely positive outcome of the overall CALIBOR trial as well as clinically relevant endpoints like prevention of disability worsening. In July, we strengthened our management team with the addition of Jason Tadeo in the newly created role of Chief Operating Officer and President. Jason's proven experience in launching and commercializing MS drugs for major biotechnology and pharmaceutical companies will be invaluable as he will lead internal efforts to prepare for the potential commercialization of B.

Speaker 1

Diffluenced calcium. Jason will also work closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for our pipeline assets, where we can leverage his extensive partnering experience. Additionally, Werner Gladines was promoted to Chief Development Officer. Werner joined Munich in January 2021 and has held positions of increasing responsibility since then. In his new role, he will take over additional strategic and operational responsibilities for Immunix's overall clinical operational functions.

Speaker 1

I would like to take a moment to have Jason introduce himself and to say a few words regarding the recent appointment of Simona Svejanic as a Board of Directors. Jason?

Speaker 2

Thank you so much, Daniel. I'm delighted to be here this morning and truly excited to have joined the very talented team at Immunet during this pivotal time of the company's growth. As we prepare for a number of important catalyst readouts for VITAFLUNAV's calcium over the next 6 to 9 months. VITAFLUNAVOUS calcium has the potential to address a number of key unmet needs that still exists for the more than 2,000,000 individuals living with multiple sclerosis worldwide, and I look forward to applying my experiences in launching numerous multiple sclerosis drugs during the course of my career to support Immunic as we begin preparation plans. I was attracted to Immunic because I believe strongly in the potential of vutaflutimus calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with both relapsing and progressive forms of MS.

Speaker 2

This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a 1st in class neuro1 activator with additional anti inflammatory and antiviral effects by selectively inhibiting the enzyme DHODH. The data to date in both relapsing and progressive MS is encouraging, and combined with a favorable safety and tolerability profile, I believe that vidafolumab is calcium has the potential to not only meaningfully enhance therapeutic options for individuals living with MS, but to capture significant share in the large global MS market, a market today that accounts for 23,000,000,000 in global sales and is forecasted to grow to 33,000,000,000 by the year 2,032. In addition to my work on helping to prepare for commercial readiness, I look forward to working closely with our Chief Business Officer, Patrick Walsh, on a range of potential partnership opportunities for both vita fluunimus calcium and IMU 856, Immunic's orally available and systemically acting small molecule modulator that targets SIRT6 for celiac disease and other gastrointestinal disorders. As Daniel noted, late last month, we strengthened our board of directors with the appointment of Simona Skorjanik, a thought leader in brain health with decades of experience in drug development and commercialization.

Speaker 2

Over a nearly 30 year career in the United States and internationally, Sonoma Simona has led research and development efforts, cumulating in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, The Medicines Company, Eli Lilly, Pfizer and Johnson and Johnson. It is worth pointing out that Simona led business and global corporate strategy for Roche's portfolio of neurological and rare diseases, achieving sustainable double digit growth in sales, including with OCREVUS or ocalizumab, which remains one of the most successful medicines for the treatment of MS. I will now turn the call back over to Daniel.

Speaker 1

Yes. Thank you, Jason. We are very proud and excited that both you and Simona joined the Immunic team. Simona's track record in drug development and commercialization, combined with Jason's experience in launching and commercializing MS drugs really strengthens Immuniq as we work towards the potential commercial launch of beta fumonis calcium in MS. That concludes our summary of the Q2 2024 and most recent highlights.

Speaker 1

We remain pleased with the clinical and operational advancements we are making across all programs. As it relates to our lead asset, video fluid combustion, we are advancing both our Phase 2 CALIPRE trial in patients with progressive MS and our twin Phase 3 INSURE trials with relapsing MS. Based on the strong clinical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies. Our team has also been busy advancing our IMU H56 program, which has the potential to become a game changer for the treatment of a broad range of GI disorders. As mentioned in our previous calls already, we are currently exploring different options to further fund Phase 2 clinical development of IMU856 in celiac disease and potentially other GI indications.

Speaker 1

I would now like to turn the call over to Glenn to provide financial overview. Glen?

Speaker 3

Thank you, Daniel. I will now review the financial and operating results for the Q2 6 months ended June 30, 2024. Let me start with a review of our cash position. We ended the Q2 of 'twenty four with $79,700,000 in cash and cash equivalents, which we expect to be able to fund our operations into the Q3 of 2025. Regarding the operating results.

Speaker 3

R and D expenses were $18,300,000 for the 3 months ended June 30, 2020 4 as compared to $21,200,000 for the 3 months ended June 30, 2023. The decrease was mainly driven by reductions in clinical development costs for the IMU 856 and IMU 935 programs. This was partially offset by an increase in external development costs related to the vita fluidumus calcium program. The 6 months ended June 30, 2024, R and D expenses were $37,000,000 as compared to $44,100,000 for the 6 months ended June 30, 2023. The decrease was mainly driven by reductions in clinical development costs for the IMU 856 and IMU 935 programs, which was partially offset by an increase in personnel expenses.

Speaker 3

G and A expenses were $4,500,000 for the 3 months ended June 30, 2020 4 as compared to $3,800,000 for the same period ended June 30, 2023. The increase was primarily related to personnel and legal and consultancy expenses. For the 6 months ended June 30, 2024, G and A expenses were $9,600,000 as compared to $8,100,000 for the same period ended June 30, 2023. The increase was primarily related to personnel, legal and consultancy expenses. Interest income remained unchanged at $1,000,000 for the 3 months ended June 30, 2024, as compared to the 3 months ended June 30, 2023.

Speaker 3

For the 6 months ended June 30, 2024, interest income was 2 point $2,000,000 as compared to $1,800,000 for the same period ended June 30, 2023. The $400,000 increase was due to higher interest rates. We also reported a change in fair value of the tranche rights for the 6 months ended June 30, 2024. The change of $4,800,000 was a non cash charge related to the change in the value of the tranche rights associated with the future tranches 23 of the January 2024 private placement. Other income was $400,000 for the 3 months ended June 30, 2024 as compared to $100,000 for the same period ended June 30, 2023.

Speaker 3

The increase was primarily attributable to an increase in foreign exchange gains, which was partially offset by a decrease in other grants received and a decrease in R and D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. For the 6 months ended June 30, 2024, other income expense was negative $1,700,000 as compared to $1,200,000 for the same period ended June 30, 2023. The decrease was primarily attributable to a $1,700,000 expense related to a portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche 1 in the timing of recognizing the German Federal Ministry of Finance Grant as well as a decrease in R and D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. The decrease was partially offset by an increase in foreign exchange gains. The net loss for the 3 months ended June 30, 2024 was approximately 21,400,000 or $0.21 per basic and diluted share based on 101,300,000 weighted average common shares outstanding compared to a net loss of approximately $24,000,000 or $0.54 per basic and diluted share based on approximately 44 point 4,000,000 weighted average common shares outstanding for the same period ended June 30, 2023.

Speaker 3

Net loss for the 6 months ended June 30, 2024, so approximately $51,000,000 or $0.51 per basic and diluted share based on approximately 99,600,000 weighted average common shares outstanding compared to a net loss of approximately 49,300,000 dollars or $1.12 per basic and diluted share based on 44,000,000 weighted average common shares outstanding for the same period ended June 30, 2023. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?

Speaker 1

Thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming milestones. We eagerly anticipate reporting top line data from our Phase 2 CALAPA trial of medial flumus calcium in progress FMS in April of next year. If the top line data continues to show neuroprotective effects, we may be able to position the drug as the first oral treatment option for non relapsing secondary progressive MS, the progressive MS subtype with the highest unmet medical need and currently no approved therapeutics available for patients. Additionally, we expect to report an interim futility analysis of our Phase III Insure program in the Q4 of this year after approximately half of the events have occurred in the double blind treatment periods.

Speaker 1

This analysis will allow for a non binding futility analysis and inform potential sample size adjustments. We further expect to complete the first of our identical twin Phase III insured trials in relapsing MS in the Q2 of 2026 and the 2nd INSURE trial in the second half of twenty twenty six. We plan to provide detailed insights on our MS development program at our next MS R and D Day, which we will host in New York City on September 10. We plan to discuss the unique profile of idiofridimous calcium and its potential to become a groundbreaking treatment of choice for both RMS and PMS patients. As I noted earlier in this call, we believe that video feederimous calcium could meaningfully improve today's standard of care by providing a holistic solution for the full range of MS patients.

Speaker 1

The event will also feature 2 top notch industry experts, Doctor. Francesca Monterola from University Hospital Turin in Italy, who is one of the leading experts for the Nur1 target protein, as well as Doctor. Amit Bahor from University of Pennsylvania, who is one of the leading neuroimmunologists and well known MS expert. We very much look forward to having such excellent speakers at our MS R and D Day. As it relates to our 2nd clinical stage asset, IMU856, we remain very enthusiastic about this program and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders such as celiac disease, inflammatory bowel disease or graft versus host disease.

Speaker 1

By targeting the physiological intestinal epithelial regeneration, we believe IMUH5-six treatment results in gut wall healing and the absence of broad immunosuppression. It bears repeating the data from our Phase 1b clinical proof of concept trial of IMU-eight fifty six in patients with celiac disease during periods of gluten free diet and gluten challenge demonstrated significant improvements over placebo and for key dimensions of clinical outcomes of celiac disease, protection of gut architecture, improvement of patient symptoms, enhancement of nutrient absorption and strong biomarker response. As previously reported, we have begun preparing for Phase 2 clinical testing of MU856. And in addition to celiac disease, we are also exploring a number of other clinical applications for other gastrointestinal disorders, where the renewal of the gut mold is important, contingent on further financing, licensing or partnering of the asset. This brings us to the end of our formal presentation.

Speaker 1

Jessica, please open the call for Q and A session.

Operator

Yes. Thank you, Daniel, and also Glenn and Jason for walking us through the Q2 and subsequent highlights as well as our clinical development pipeline. 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 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 of the Zoom portal to queue your question. Our first guest today is Yasmeen Rahimi from Piper Sandler. Yas please unmute yourself and go ahead.

Speaker 4

Good morning team. Thank you so much for all the great updates. Few questions for you. I guess, one of the questions is when you design your current Phase III studies, ensure studies, was there always a futility built in? Is that standard protocol for MS studies, if you could talk about that?

Speaker 4

And also kind of dissect out what are the possible what is the likelihood that there will need to be a sample size adjustment? So I would love for you to sort of tackle that. And then I have a follow-up in regards to Calibre.

Speaker 1

Yeah. Thank you, Yasmeen. And very clear, yes, it was from the very beginning, the futility was built into that study. One of the main reasons is it's an event driven study, and we just wanted to make sure that not for just random things, we run short on a couple of patients. And as you know, with futility analysis, you need to predefine the questions.

Speaker 1

And therefore, we have only a limited small number of sample size adjustment options where the committee can say yes or no. So it's a very straight and important thing. And I think it really makes just ensures that the money of those Phase 3 studies really well invested and we succeed in the overall program.

Speaker 4

Okay. Thank you. And then in regards to Calibre, obviously, you know, the primary endpoint is looking at the brain volume change. I think in the past, you have talked about sort of a 15% change would be sort of reflective. I would love for you to kind of go back as we go into April.

Speaker 4

What do you hope to see in analyst volume rate? And also some of the key secondaries, right? Like, what are at once that we should be able to maybe pick up statistical differences, maybe a reminder of what are considered clinically meaningful differences. Obviously, you guys are measuring nicely a number of key secondaries from the EDSS scores to the 25 foot walk tests, etcetera. So would love for you to kind of talk about that as well.

Speaker 4

Then I'll jump back into the queue.

Speaker 1

Yeah. I'm very happy that you asked question because I think CALIBR is really could be a major transformative study for MS patients and also for the company. And as you said, the primary endpoint of the study is brain volume change between placebo and the 45,000,000 active dose. And but as you said, I think there are secondary endpoints, which are medically also very meaningful. And you mentioned the EDSS change, so confirmed disability worsening, so that the official secondary key secondary endpoint is 24, we confirm disability worsening, which we will also report in April.

Speaker 1

And on top of that, there are other parameters, which could help us to understand to what extent video photomus calcium has neuroprotective effects. And part of that, Argo, as you mentioned, cognitive functions. We have the 9 hole pack test. We have the 25 foot walk test and these standard things implemented in the study and we also will report on those. And all of those are meaningful, I think.

Speaker 1

The study was really designed to give a full picture. We have randomized 467 patients overall in the study. It's a big study and we have high expectations of what we can see here. What I can't tell you and others right now is what is the exact threshold of activity here. As you mentioned, a 15% benefit on disability protection would be something medically relevant, I think, but there is no official number what is here meaningful and what not.

Speaker 1

But in the absence of any treatment, for example, for non relapsing, secondary and progressive, every step forward would be perceived as a success, I think.

Speaker 4

Got it. Thank you so much.

Speaker 1

Yeah. Thank you, Yasmeen.

Operator

Thank you, Yasmeen. Next one in the queue here is Matt Kaplan from Landmark Thalmann. Matt, please unmute yourself and welcome to the call.

Speaker 5

Hi, good morning, guys, and thanks for taking the questions. Just a follow-up to Yasmeen's question on Caliper. Just give us a sense in terms of why the interim NFL changes that you observed in the study make you confident or give you confidence in the outcome of the study that we'll see in April?

Speaker 1

Yeah. Thank you. And good morning, Matt. That's a very good question because we spent a lot of work on really understanding the role and the relevance of NFL for predicting disability outcome. And I think the most of the hints why that is believed to be relevant is coming from the newer literature of other studies.

Speaker 1

I think one of the most important maybe the most important in that context was a very good paper published last year with the main author Amit Bahor as I said, who will join us for the MSR and D Day in September. And he was the main author of the paper on ocralizumab study, the oratorial study in primary progressive MS. And they clearly have shown that if you, if you really focus on those patients, which don't show real absence and don't show inflammation, and they did it by re baseline in the study population, then the lower NfL level at baseline is predictive of future disability of a lower rate of disability worsening for the patients at low NfL. So that's why it's a pretty big data set and I think was really nice that they have shown that there is this correlation which was statistically significant. There are other hints from noninventional studies, interventional studies, where also this relation was shown.

Speaker 1

The point is that we think that NfL is a very good tool, but we need to be very careful on really separating inflammatory for non inflammatory patients at the evaluation. And therefore, looking back on the interim data we reported last October for CALIBUR with a statistical significant 22% reduction of NFL compared with the active plus between active and placebo. We think that makes us very optimistic on a readout on the disability protection in next April after the full 120 week data.

Speaker 5

Thanks, Daniel. That's very helpful.

Speaker 1

Yeah. Thank you, Matt.

Operator

Thank you, Matt. Next one in the queue here is Tom Smith from Leerink Partners. Tom, please unmute yourself and welcome.

Speaker 6

Hey, guys. Good morning. Thanks for taking the questions. Just one on VITAFLU DIMIS. I mean, you mentioned you continue to partnership and other business development opportunities.

Speaker 6

Can you just elaborate on the level of engagement with pharma now? I guess how that's evolved over the last 12 months and what you're looking for in a potential partner?

Speaker 1

Yeah, happy. Maybe, Jason, would you like to take over that question?

Speaker 2

Sure. So look, when we think about partnerships, clearly, you know, our goal is if this medicine is successful, would be to ensure that we can get it to as many patients as quickly as possible. Right? And therefore, not only help patients that continue to have unmet need, but also to increase value for the company and for shareholders. And so we're exploring a variety of different potential partnerships, that is not limited to just full out licensing.

Speaker 2

It could be regional out licensing. It could be partnerships around profit share and others. Again, we're building expertise in house as Daniel has mentioned. It's a big reason why I've joined the company. We believe that if necessary and if needed, we will go forward ourselves and begin to build commercial plans to launch these drugs ourselves.

Speaker 2

But we have a responsibility as well to look at partnerships. And so we are in active discussions with a variety of different companies. I obviously will not mention specifics at this time for both large global but also regional potential partnerships. And we look forward to sharing additional information in the future.

Speaker 6

Got it. That makes sense. And then just one on 856. Yeah, I was just wondering if you could provide a little bit more color on where you stand with the Phase 2 plans. Have you engaged with or received feedback from the FDA?

Speaker 6

And then, I guess, what are the gating factors to starting the celiac study?

Speaker 1

Yeah, I think as I said, the focus of the company is really right now to ensure the full performance and speed of the MS programs. Therefore, we are looking for independent additional financing INFAS 6 programs and we want to do that in a hopefully broad way to not just bet on one indication but also hopefully being able to do more than one clinical application here. And the 3 options we have on the table and we are working on in the preparation of protocols, and discussing with experts exploring potential sites and so forth that's actively ongoing. So these are, of course, celiac disease as the indication where we have already received very good proof of concept data. But also in ulcerative colitis.

Speaker 1

And as a third indication, which is interesting, specifically, it's a smaller niche indication, but the mode of action perfectly fits there is graft versus host disease. So these are the three things we are looking at. And in that context, we have some regulatory discussions and we think we have a clear plan forward. And currently, most work is done in discussions with investors and potential partners to make sure we have the right design and the right concept together to go the next big steps into Phase 2 studies.

Speaker 6

Got it. That makes sense. Thanks for taking the questions.

Speaker 1

Thank you, Tom.

Operator

Thank you, Tom. Once again, if you have a question, please use the raise hand function of the Zoom portal or the Q and A tool. And I see some more here in the queue. I would like to welcome next Tyler Busian from Brookline. Tyler, please unmute yourself and go ahead.

Speaker 7

Hi, Jessica and Daniel. Thanks for taking the time. Quick question on the potential data readouts from CALIFR. Obviously, since you designed the trial, you have a large amount of data talking about the neuroprotective effects and kind of secondary mechanisms compared to traditional DHRVH inhibition. I just kind of wanted to get a sense of if a lot of those neuroprotective readouts come through, are there any possibilities for expedited review, fast track designation from the FDA?

Speaker 7

What's, I guess, kind of, is that a possibility? And what type of results would you need to see for something like that?

Speaker 1

Yeah. Thank you for the question, Tyler. Of course, it depends on the data. That's the answer you always get with such questions. But I think you're right.

Speaker 1

Given the absence of real treatments for non relapsing secondary progressive and also considering that 60% of the 467 patients in the study have a non relapsing secondary progressive MS. This is an area of huge unmet need. And I think also the regulators are aware of this around the world. So if the data is good and good means showing a relevant medically meaningful protective effect, for example, on disability worsening, on brain volume change and maybe also other cognitive parameters. We, of course, will try to discuss with the regulators to what extent we are able to expedite the track towards approval.

Speaker 1

That could in a positive case, it could really be a very much quicker way to get the drug to the patients. And I think it's something we'd really be happy to do.

Speaker 7

Great. Thank you for your time.

Operator

Thank you, Tyler.

Speaker 1

Thank you.

Operator

Next one here is Madison Alzadi from B. Riley. Madison, good morning. Please unmute yourself.

Speaker 8

Hey, guys. Hey, guys.

Operator

Good morning. We can hear you, but we have a feedback.

Speaker 8

Yes, I think it's fixed now.

Operator

Yes, that's better. Thank you.

Speaker 8

Thanks for taking our question. So a couple from me kind of starting the highlights. So given the missteps we've seen with the BTK class, I'm just kind of wondering your expectations for this class. Do you think we've already seen the ceiling of efficacy in kind of the floor of safety for this class? And maybe if there's a scenario where you become you're able to kind of leapfrog this drug class and become the oral therapy of

Speaker 1

choice? Yeah, I think, of course, the evobrutinib data was a disappointment for the patients. And we need to all we all need to admit that the industry tried really a lot to develop that class of BTK inhibitors as a next option for RMS and PMS. And there I think there's still some in development and I think the market is expecting data for example from Sanofi soon on the tolebrutinib data. I think already my perception is that the evobrutinib data really opened doors for us because they more or less recognize that there is a good alternative, an interesting molecule with a new mode of action, 1st in class, the 1 activator, which could fill into here, potentially, lower number of other alternative development candidates in the BTK pipeline.

Speaker 1

So we are yes, we clearly think that we see already that the market has that impression. But it's still open, I think, despite the clinical holds in the U. S. For some of the BTK inhibitors, they are still in development, and we will see what's coming out of the studies there.

Speaker 8

Okay, great. Thank you. And then secondly, so assuming the Phase 2 caliber is positive, is it too early to talk about next steps if you'll go straight to kind of Phase 3? And if so, would that be in a PPM or active or non active SPMS population? Or are you thinking kind of a wider population targeting all of PMS?

Speaker 1

Yeah. Should we be doing that? I think this is our duty. We need to think about it. We already the clinical team is working on the protocol for Phase 3 in PMS.

Speaker 1

And regardless if we get expedited approval or not, the Phase 3 will be needed. We know that one Phase 3 should be sufficient for progressive MS. And also clearly the focus is likely and also looking on the interim data, the focus will likely be first on non relapsing, secondary progressive MS given absence of any other treatments there that makes it medically the quickest and the high demand indication and therefore and the drug seems to work in this difficult to treat population, at least based on the biomarker side. So, yeah, I think that that's the way forward from our point of view. However, as Jason said, this is also and you ought to be seen in the global strategy.

Speaker 1

It could be a piece of a global partnership. So there are other ways. Let's look at the data. We're doing the homework. We are prepared for different options.

Speaker 1

But I think the most important piece is to get the data and to see how strong are they and what options do we have on the table then in the Q2 of next year.

Speaker 8

Got it. Thank you.

Speaker 1

Thank you.

Operator

Great. Thank you, Madison. All right. 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

Thank you, Jessica. And thanks to all of today's attendees for your always insightful questions. I would like to end the call by reiterating how excited we are about the potential of our advanced delicate pipeline programs. With top line data from our Phase 2 CALEPO trial expected in April of next year and the ongoing enrollment of our Phase 3 INSURE trials, we continue to make tangible progress with our lead program, B. Diffilumus calcium.

Speaker 1

Importantly, with €79,700,000 on our balance sheet, which is expected to fund the company into the Q3 of next year, we are capitalized even a couple of months beyond the Calibre readout. Additionally, as progress is made and contingent on financing, licensing or partnering, we expect to also provide an update on our preparations for a Phase 2 clinical trial of IMUH56 and its unique potential for the treatment of a broad array of serious gastrointestinal disorders. With that, I would like to close today's call. Thank you again for joining, and we are very happy to answer any additional questions 1 by 1. So please do not hesitate to reach out.

Operator

Thank you for joining Munich's Q2 2024 Earnings Call. The call has now concluded. You may now disconnect.

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Key Takeaways

  • As of June 30, 2024 the company held $79.7 million in cash and equivalents, extending its runway into Q3 2025, while net losses narrowed year-over-year as R&D spending shifted toward key programs.
  • The lead asset, vidaflutimus calcium, demonstrated a 22% reduction in serum NfL versus placebo in its Phase 2 CALIPRE trial for progressive MS, with topline data expected in April 2025 and interim futility readout from the twin Phase 3 INSURE trials due in Q4 2024.
  • Oral small molecule IMU-856 showed proof-of-concept in celiac disease—improving histology, symptoms, biomarkers and nutrient absorption with a favorable safety profile—and Phase 2 plans in celiac disease, ulcerative colitis and graft-versus-host disease are underway pending financing or partnerships.
  • Management was bolstered by appointing Jason Tadeo as COO & President to lead commercialization and partnering for MS assets, promoting Werner Gladines to Chief Development Officer, and adding neuroscience veteran Simona Skorjanic to the Board to accelerate drug development and market preparation.
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Earnings Conference Call
Immunic Q2 2024
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