Immunic, Inc. (NASDAQ:IMUX) Q2 2024 Earnings Conference Call August 8, 2024 8:00 AM ET
Company Participants
Jessica Breu – VP, IR & Communications
Daniel Vitt – CEO
Glenn Whaley – CFO
Jason Tardio – COO
Conference Call Participants
Yasmeen Rahimi – Piper Sandler
Matt Kaplan – Ladenburg Thalmann
Tom Smith – Leerink Partners
Tyler Bussian – Brookline
Madison El-Saadi – B. Riley
Jessica Breu
Good morning, and welcome to Immunic’s Second Quarter 2024 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today.
Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer; Glenn Whaley, our Chief Financial Officer; as well as Jason Tardio, our newly appointed Chief Operating Officer and President. [Operator Instructions] This event is being recorded. [Operator Instructions]
Before we begin, I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate or words with similar meaning. And such statements involve a number of risks and uncertainties that could cause Immunic’s actual results to differ materially from those discussed here.
Please note that these forward-looking statements reflect in Immunic’s 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 Immunic’s SEC filings for a more detailed description of the risk factors that may affect Immunic’s results and these forward-looking statements.
I would now like to turn the call over to our CEO, Dr. Daniel Vitt, to begin the presentation. Daniel?
Daniel Vitt
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 second quarter and six months ended June 30, 2024. During the call today, we will walk through our second quarter 2024 achievements and subsequent highlights, financial and operating results as well as our clinical development programs, including anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions.
Let’s start with a review of our second quarter 2024 and subsequent highlights. In April, we hosted the multiple sclerosis IT Day in San Francisco, highlighting the latest developments in the MS landscape as well as our development program vidofludimus calcium.
We walked through our highly encouraging preclinical and clinical data generated so far supporting the neuroprotective potential and reduced disability worsening associated with vidofludimus calcium, which represent unique distinction compared with currently available MS therapies.
We also shared our strong belief that vidofludimus 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 is able to join us for the event both in person and those who listen to the recording. Also in April, we announced that extended data from our Phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing remitting multiple sclerosis, RRMS was published in the prestigious peer-reviewed journal Neurology, Neuroimmunology & Neuroinflammation and official journal of the American Academy of Neurology.
The paper leads off by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our insurer and CALLIPER 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 vidofludimus calcium in RRMS.
In May, we had the opportunity to present data from our clinical programs at various scientific conferences. First in human data from our Phase 1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator that targets Sirtuin 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 four key dimensions of celiac disease pathophysiology, specifically histology, disease symptoms, biomarkers and nutrient absorption.
IMU-856 was also observed safe and well tolerated in this trial. We continue to believe that this data provides initial proof-of-concept for a potential new oral therapy, the approach to a range of gastrointestinal disorders through the regeneration of bowel architecture.
Additionally, we represented data from our Phase 2 CALLIPER trial of vidofludimus 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 National.
We were pleased to have had the opportunity at both meetings to highlight a clear separation observed in serum neurofilament light chain, NFL, for vidofludimus calcium over placebo in this PMS patient population. As it represents another significant step forward for what could potentially be a first-in-class Nurr1 activator for MS. This strong signal in NFL also makes us believe in a more likely positive outcome of the overall CALLIPER trial as well as clinically relevant endpoints like prevention of disability worsening.
In July, we strengthened our management team with the addition of Jason Tardio, 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 vidofludimus 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 Gladdines was promoted to Chief Development Officer. Werner Immunic 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 Immunic’s overall clinical operational functions.
I would like to take a moment to have Jason introduce himself and to say a few words regarding the recent appointment of Simona Skerjanec as a Board Member of Board of Directors, Jason.
Jason Tardio
Thank you so much, Daniel.
I’m delighted to be here this morning and truly excited to have joined the very talented team at Immunic during this pivotal time of the company’s growth as we prepare for a number of important catalyst readouts for vidofludimus calcium over the next six to nine months. vidofludimus calcium has the potential to address a number of key unmet needs that still exist for the more than two million 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 vidofludimus calcium and then the prospect of bringing such a groundbreaking and much-needed oral treatment option to patients with both relapsing and progressive forms of MS.
This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first-in-class Nurr1 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 vidofludimus 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 billion in global sales and is forecasted to grow to $33 billion by the year 2032.
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 vidofludimus 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 Skerjanec, a thought leader in brain health with decades of experience in drug development and commercialization. Over a nearly 30-year career in the United States and internationally, Simona has led research and development efforts accumulating in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, the Medicines Company, Eli Lilly, Pfizer and Johnson & Johnson.
It is worth pointing out that Simona led business and global corporate strategy for Roche’s portfolio of neurological and rare diseases, achieving sustainable double-digit growth in sales, including with OCREVUS or ocrelizumab, which remains one of the most successful medicines for the treatment of MS.
I will now turn the call back over to Danny.
Daniel Vitt
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 Immunic as we work towards the potential commercial launch of vidofludimus calcium in MS.
That concludes our summary of the second quarter 2024 and most recent highlights. We remain pleased with the clinical and operational advancements we are making across all programs. As it relates to our lead asset, vidofludimus calcium, we’re advancing both our Phase 2 CALLIPER trial in patients with progressive MS and there were three Phase 3 ENSURE trials with relapsing MS.
Based on the strong technical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies. Our team has also been busy in advancing our IMU-856 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 IMU-856, in celiac disease and potentially other GI indications.
I would now like to turn the call over to Glenn to provide financial overview. Glenn?
Glenn Whaley
Thank you, Daniel.
I will now review the financial and operating results for the second quarter and six months ended June 30, 2024. Let me start with a review of our cash position. We ended the second quarter of ’24 with $79.7 million in cash and cash equivalents, which we expect to be able to fund our operations into the third quarter of 2025. Regarding the operating results.
R&D expenses were $18.3 million for the three months ended June 30, 2024, as compared to $21.2 million for the three 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 vidofludimus calcium program.
For the six months ended June 30, 2024, R&D expenses were $37 million as compared to $44.1 million for the six 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.
G&A expenses were $4.5 million for the three months ended June 30, 2024, as compared to $3.8 million for the same period ended June 30, 2023. The increase was primarily related to personnel and legal and consultancy expenses.
For the six months ended June 30, 2024, G&A expenses were $9.6 million as compared to $8.1 million 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 million for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023.
For the six months ended June 30, 2024, interest income was $2.2 million as compared to $1.8 million 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 six months ended June 30, 2024. The change of $4.8 million was a noncash charge related to the change in the value of the tranche rights associated with the future tranches two and three of the January 2024 private placement.
Other income was $0.4 million for the three months ended June 30, 2024, as compared to $0.1 million for the same period ended June 30, 2023. 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&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country.
For the six months ended June 30, 2024, other income expense was negative $1.7 million as compared to $1.2 million for the same period ended June 30, 2023. The decrease was primarily attributable to a $1.7 million 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 one in the timing of recognizing the German Federal Ministry of Finance Grant as well as a decrease in R&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. The decrease was partially offset by an increase in foreign exchange gains.
The net loss for the three months ended June 30, 2024, was approximately $21.4 million or $0.21 per basic and diluted share based on 101.3 million weighted average common shares outstanding compared to a net loss of approximately $24 million or $0.54 per basic and diluted share based on approximately 44.4 million weighted average common shares outstanding for the same period ended June 30, 2023.
Net loss for the six months ended June 30, 2024, was approximately $51 million or $0.51 per basic and diluted share based on approximately 99.6 million weighted average common shares outstanding compared to a net loss of approximately $49.3 million or $1.12 per basic and diluted share based on 44 million 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?
Daniel Vitt
Yes. 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 CALLIPER trial of vidofludimus calcium and progress MS 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 3 ENSURE program in the fourth quarter of this year after approximately half of the events have occurred in the double-blind treatment periods. This analysis will allow for a nonbinding futility analysis and inform potential sample size adjustment.
We further expect to complete the first of our identical twin ] Phase 3 ENSURE trials in relapsing MS in the second quarter of 2026 and the second ENSURE trial in the second half of 2026.
We plan to provide detailed insights on our MS development program at our next MS R&D Day, which we will host in New York City on September 10. We plan to discuss the unique profile of vidofludimus 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 vidofludimus calcium could meaningfully improve today’s standard of care by providing a holistic solution for the full range of MS patients. The event will also feature two top-notch industry experts. Dr. Francesca Montarolo from University Hospital Turin in Italy, who is one of the leading experts for the neuron target protein as well as Dr. Amit Bar-Or 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&D Day.
As it relates to our second clinical stage asset, IMU-856, 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. By targeting the physiological intestinal epithelial regeneration, we believe IMU-856 treatment results in gut wall healing and the absence of broad immunosuppression.
It bears repeating that data from our Phase 1b clinical proof-of-concept trial of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge demonstrated significant improvements over placebo in four key dimensions of clinical outcome in 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 IMU-856, and in addition to celiac disease, we are also exploring a number of other clinical applications for other gastrointestinal disorders where the renewal of the gut mall is important, contingent on further financing, licensing or partnering of the asset.
This brings us to the end of our formal presentation. Jessica, please open the call for a Q&A session.
Question-and-Answer Session
A – Jessica Breu
Yes. Thank you, Daniel, and also Glenn and Jason, for walking us through the second quarter and subsequent highlights as well as our clinical development pipeline.
[Operator Instructions] Our first guest today is Yasmeen Rahimi from Piper Sandler. Please unmute yourself and go ahead.
Yasmeen Rahimi
Good morning team, thank you so much for all the great updates. A few questions for you. I guess, One of the questions is, when you design your current Phase 3 studies, insure studies, was there always a futility built in? Is that standard protocol for MS studies, if you could talk about that? 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 CALLIPER.
Daniel Vitt
Yes. Thank you, Yasmeen. And very clear, yes, it was — from the very beginning, the utility 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. 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.
Yasmeen Rahimi
Okay. Thank you. And then in regards to CALLIPER, obviously, 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, what do you hope to see in analyzed volume rate and also some of the key secondaries, right? Like what are ones that we should be able to maybe pick up statistical differences, maybe a reminder of what I’ll consider clinically meaningful differences. Obviously, you guys are measuring nicely in a number of key secondaries from the EDSS scores, so that 25 but walk test, et cetera. So I would love for you to kind of talk about that as well, then I’ll jump back into the queue.
Daniel Vitt
Yes, I’m very happy that you asked the question because I think CALLIPER really could be a major transformative study for MS patients and also for the company. And as I said, the primary endpoint of the study is brain volume change. between placebo and the 45-milligram 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 the official secondary — key secondary end point is 24, we confirm disability worsening. We will also report in April. And on top of that, there are other parameters which could help us to understand to what extent vidofludimus calcium has neuroprotective effects. And part of that, as you mentioned, cognitive functions, we have the 9-hole peg test, we have the 25-foot walk test and the standard things implemented in the study, and we also will report on those.
And all of those are meaningful. I think 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 whatnot. But in the absence of any treatment, for example, for non-relapsing secondary progressive, every step forward would be perceived as a success, I think.
Yasmeen Rahimi
Got it. Thank you so much.
Daniel Vitt
Thank you, Yasmeen.
Jessica Breu
Thank you, Yasmeen. Next one in the queue here is Matt Kaplan from Ladenburg Thalmann. Matt, please unmute yourself and welcome to the call.
Matt Kaplan
Hi, good morning, guys. Thanks for taking the questions. Just a follow-up to Yasmeen’s question on CALLIPER. 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?
Daniel Vitt
Yes. Thank you, Matt. That’s a very good question because we spent a lot of work on really understanding the role the relevance of NFL for predicting disability outcome. And I think most of the hints why that is believed to be rather than is coming from the newer literature of other studies. I think one of the most important or maybe the most important in that context was a very good paper published last year with the main author Amit Bar-Or.
As I said, he will join us for the MS R&D Day, in September. And he was the main author of the paper on ocrelizumab 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 relapses and don’t show inflammation, and they did it by rebaselining 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 it was really nice that they have shown that there is this correlation which was statistically significant. There are other hints from non inventional studies — interventional studies, where also this relation was shown — 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 nonimplementary patients at the evaluation.
And therefore, looking back on the interim data we reported last October for CALLIPER, with a statistical significant 22% reduction of NFL compared with 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.
Matt Kaplan
Thanks Daniel, that’s very helpful.
Daniel Vitt
Yes. Thank you, Matt.
Jessica Breu
Thank you, Matt. Next one in the queue here is Tom Smith from Leerink Partners. Please unmute yourself and welcome.
Tom Smith
Hi guys, good morning. Thanks for taking the questions. Just one on to vidofludimus. I mean you mentioned you continue to explore partnership and other business development opportunities. 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?
Daniel Vitt
Yes, happy. Maybe Jason, would you like to take over that question.
Jason Tardio
Sure. So look, when we think about partnerships, clearly, 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 a full-out licensing. It could be regional out-licensing. It could 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. 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.
Tom Smith
Got it. That makes sense. And then just one on 856. I was just wondering if you could provide a little bit more color on where you stand with the Phase 2 plans to be engaged with or receive feedback from the FDA? And then I guess, what are the gating factors to starting the celiac study?
Daniel Vitt
Yes. I think as I said, the focus of the company is really right now ensure the full performance and speed of MS programs. Therefore, we are looking for independent edition of financing for 856 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 there are three options we have on the table that we are working on in the preparation of protocols, discussing with experts, exploring potential sites and so forth, it’s actively ongoing.
So these are all for celiac disease as the indication where we have already received very good proof-of-concept data, but also in [indiscernible] 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 kind of 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.
Tom Smith
Got it. That makes sense. Thanks for taking the questions.
Daniel Vitt
Thank you, Tom.
Jessica Breu
Thank you, Tom. [Operator Instructions] I would like to welcome next Tyler Bussian from Brookline. Tyler, please unmute yourself and go ahead.
Tyler Bussian
Thanks Daniel, thanks for taking the time. A quick question on the potential data readouts in CALLIPER. Obviously, since you designed the trial, you have a large amount of data talking about the neuroprotective effect some kind of secondary mechanisms compared to traditional DHODH 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? What’s, I guess, kind of — is that a possibility? And what type of results would you need to see for something like that?
Daniel Vitt
Thank you for the question, Tyler. Of course, that depends on the data, that’s the answer you always get with such questions. Well, I think you’re right. Given the absence of real treatment for non-relapsing secondary progressive and also considering that 60% of the 467 patients in the study have nonrelapsing 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 regulator to what extent are able to expedite the track towards approval. 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.
Tyler Bussian
Great, thanks very much.
Jessica Breu
Thank you, Tyler.
Daniel Vitt
Thank you.
Jessica Breu
The next one here is Madison El-Saadi from B. Riley. Madison, good morning. Please unmute yourself.
Madison El-Saadi
Hi, guys.
Jessica Breu
Good morning. We can hear you but we have a feedback.
Madison El-Saadi
Yes, I think it’s fixed now.
Jessica Breu
That’s better. Thank you.
Madison El-Saadi
Thank you for taking my question. So a couple from me kind of starting the — so given the stuff we’ve seen with the BTK class, I’m just — and I’m wondering your expectations for this class. Do you think you’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 then come the oral therapy of choice?
Daniel Vitt
Yes. I think, of course, the evobrutinib data was a disappointment for the patients. And we need to — 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 plate.
I think already, my perception is that the evobrutinib data really opened doors for us because they more or less — it’s recognized that there is a good alternative and an interesting molecule with a new mode of action, first-in-class for activator, which could fill into here potentially lower number of other alternative development candidates in the BTK pipeline.
So we — yes, we clearly think that we see already that the market has that impression, but it’s still open, I think, despite the clinical loads 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.
Madison El-Saadi
Okay. Great. Thank you. And then secondly, so assuming the Phase 2 CALLIPER 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 a PPE or active or nonactive SPMS population? Or are you thinking kind of a wider population targeting all of PMS?
Daniel Vitt
Yes. It’s true we’re doing that. I think this is our duty. We need to think about it. We already — the clinical team is working on a protocol for Phase 3 in PMS. And regardless if we get expedited approval or not the Phase 3 will be needed. So we know that one in Phase 3 should be sufficient for progressive MS.
And also, clearly, the focus is likely — and also looking on the interim focus will likely be first on non-relapsing secondary progressive MS given absence of any other treatments there, that makes sense medically the quickest and the high demand indication and therefore, and the drugs work in this difficult-to-treat population, at least based on the biomarker side. So yes, I think that, that’s the way forward from our point of view.
However, as Jason said, this is also be seen in the global strategy. 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. 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 than in the second quarter of next year.
Madison El-Saadi
Got it. Thank you.
Daniel Vitt
Thank you.
Jessica Breu
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.
Daniel Vitt
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 clinical pipeline programs. with top line data from our Phase 2 CALLIPER trial expected in April of next year and the ongoing enrollment of our Phase 3 ENSURE trials, we continue to make tangible progress with our lead program vidofludimus calcium.
Importantly, with $79.7 million on our balance sheet which is expected to fund the company into the third quarter of next year, we are capitalized even a couple of months beyond the CALLIPER readout. Additionally, as progress is made and contingent on financing, licensing or partnering, we expect to also provide an update on our preparations for our Phase 2 clinical trial of IMU-856 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 one by one, so please do not hesitate to reach out.
Jessica Breu
Thank you for joining our Immunic’s second quarter 2024 earnings call. The call has now concluded. You may now disconnect.
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