Immunic Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 7, 2024

There are 8 speakers on the call.

Operator

Good morning, and welcome to Munich's Third Quarter 2024 Earnings Call. My name is Jessica Brew, Vice President, Investor Relations and Communications at Munich. I will also be the moderator today. Speaking on the call are Doctor. Daniel Fitt, our Chief Executive Officer Glen Whaley, our Chief Financial Officer as well as Jason Tardio, our President and Chief Operating 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 submit your questions in writing via the Q and A tool of the Zoom portal. Or if you would like to

Speaker 1

Zoom portal. Or if you would like to speak with us directly, please use raise hand

Operator

function in the Zoom portal to queue your question. Before we begin, I would like to remind you that this presentation may contain forward looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate or words with a similar meaning. And such statements involve a number of risks and uncertainties that could cause Munich's actual results to differ materially from those discussed here. Please note that these forward looking statements reflect Immunics' 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 Immunics' SEC filings for a more detailed description of the risk factors that may affect Immunics' results and these forward looking statements. I would now like to turn the call over to our CEO, Doctor. Daniel Fitt, to begin the presentation. Daniel?

Speaker 1

Thank you, Jessica. I would also like to welcome everybody to today's Q3 2024 earnings call. Earlier this morning, we announced our financial results for the Q3 9 months ended September 30, 2024. During the call today, we will walk through our Q3 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 Q3 2024 and subsequent highlights. In July, our management team was strengthened with the addition of Jason Talio as President and Chief Operating Officer, bringing with him a wealth of experience launching and commercializing multiple sclerosis drugs for major biotechnology and pharmaceutical companies. Jason has already proven to be invaluable, leading internal efforts to prepare for the potential commercialization of idafolimus calcium. Jason also has been collaborating closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for idioplutimus calcium as well as our other drug candidates, where we are leveraging his extensive partnering experience. Additionally, Werner Gladinez was promoted to Chief Development Officer.

Speaker 1

Werner joined Immunic in January of 2021 as Head of RU838 program, and he has held positions of increasing responsibility since then. In his new role, he takes over additional strategic and operational responsibilities for Immunics' overall clinical operations functions. In July, we also strengthened our Board of Directors with the appointment of Simona Skjerianic, a thought leader in brain health with decades of experience in drug development and commercialization. Over a 30 year career in the United States and internationally, Simona has led research and development efforts, culminating 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 portfolio of neurological and rare diseases, achieving sustainable double digit growth in sales, including with vocribus, which remains one of the most successful medicines for the treatment of MS today.

Speaker 1

Her success in this area really enhances our board as we work towards the potential commercial launch of fetal fluridinibuscardium. In September, we hosted an in person MS R and D Day, which featured 2 world renowned industry experts, Doctor. Francesca Monterolo, biologist and leading MS and L1 target expert from the Neuroscience Institute, Cavalieri, Autolengi and University of Turin, Italy as well as Doctor. Amit Baor, clinician, scientist and one of the leading neuroimmunologists in MS from University of Pennsylvania. These distinguished key opinion leaders, along with our management team, provided an in-depth overview of the MS landscape and our orally available lead acid, idiopludimus calcium.

Speaker 1

The presentation highlighted its dual mode of action, which combines neuroprotective effects through its mechanism as a 1st in class nuclear receptor related 1 or NO1 activator with anti inflammatory and antiviral effects via DHODH inhibition. During the event, we also shared insights on our ongoing Phase III insured trials in relapsing MS, our ongoing Phase II CALIBER trial in progressive MS and highlighted the commercial opportunity for vidoflumus calcium in the MS market. In particular, we discussed our strong belief in the potential of vidofluinous calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with relapsing and progressive forms of MS, where there are currently few options and there continues to be a huge unmet need. We continue to believe that vidafudinous calcium has the potential to redefine the oral multiple sclerosis treatment landscape and elevate the standard of care from these patients. In September, we enrolled the 1st patient in an investigator sponsored Phase II clinical trial of fetal fluidum with calcium, the RAPID REVIVE trial in post COVID syndrome, for which Immunic is providing study medication.

Speaker 1

The trial is a randomized, placebo controlled, double blind, parallel group trial led by Professor Maria Federschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research. We are honored to have bitofinumab calcium chosen for this investigator sponsored study run by such highly regarded investigators at esteemed institutions in Germany. We have already seen convincing data supporting venofludimus calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our Phase II CALVID-one trial. Importantly, 3rd party research has identified Epstein Barr virus reactivation as a potential cause for fatigue, one of the most dominating symptoms for both post COVID syndrome and MS patients, negatively impacting their quality of life and ability to participate in social activities. We also aim to confirm the ability of belifullumus creatium to influence fatigue and Epstein Barr virus reactivation or ongoing MS trials and look forward to receiving additional data from the rapid revive trial.

Speaker 1

It is our belief that this may create yet another differentiating feature for our drug candidate. In September, we also had the opportunity to present 4 posters at the prestigious 40th Congress of Actuums, showcasing data on key aspects of B. Diffusing calcium's profile, illustrating the strength of the data generated today and its potential to become a new treatment option for MS. Jason, do you want to add a few words on the Congress?

Speaker 2

Sure. And thank you, Daniel. The Acton's Congress is the premier meeting of the year in the field of multiple sclerosis and brings together over 9,000 of the world's top clinicians, researchers and healthcare professionals. We are particularly excited to have had the opportunity to present data at this meeting to further support the differentiation of beta plutimus calcium as a potential treatment for both relapsing and progressive multiple sclerosis. More specifically, we shared additional data from the interim analysis of our ongoing Phase 2 CALIBER trial in progressive multiple sclerosis that showed that beta plebiscalcium not only had a significant impact on reducing serum neurofilament light chain levels across the total study population, but also consistently reduces neurofilament light chain levels compared to baseline across different patient subgroups based on age and disability scores.

Speaker 2

These observations are important as neurofilament proteins are a marker of neuronal degeneration and serve as an important biomarker of disease activity in multiple sclerosis with recent data showing that lower neurofilament light levels indicate a lower risk of future disability progression in progressive MS patients. We also prevented compelling data on fatigue from post hoc analysis of the CALVID-one trial, which evaluated the safety and efficacy of beta chromis calcium 45 milligrams in patients hospitalized for COVID-nineteen. As mentioned earlier, fatigue is the most frequent symptom reported by patients with multiple sclerosis and for many patients, it is the most disabling and chronic symptom. Given the broad spectrum antiviral effects of vita fluormus calcium and its potential to prevent reactivation of the Epstein Barr virus or EBV, which has been linked to fatigue in multiple sclerosis, we sought to understand the impact of vita fullemiss on fatigue in post COVID syndrome patients. Results of this analysis show that 80% of patients who received placebo reported fatigue compared to only 50% of patients who received vita fullemiss calcium.

Speaker 2

Fatigue was further decreased from weeks 9 to 17 to 33% for patients on placebo and only 17% for patients on vtafludamis calcium, thus supporting the antiviral effects of vtafludamis and how it may contribute to lower fatigue levels. This hypothesis we further assess by determining effects on fatigue using patient questionnaires as well as analysis of the anti EBV effect in our ongoing CALIBER and INSUURE trials. Lastly, we presented additional preclinical evidence supporting that vedipronomist calcium enhanced the expression of NER1 target genes important for neuronal survival, further suggesting the neuroprotective benefit of this assay and also reduce infiltrating T helper cells in the spinal cord and the number of pro inflammatory T helper cells in the periphery in marine EAE models. In addition to these data presentations, Iminic also filled an exhibitor booth for the first time at this important meeting. This served as a great opportunity to engage the MS community and further increase awareness of beautiful miss calcium as a potential treatment for MS.

Speaker 2

Back to you, Daniel.

Speaker 1

Yes. Thank you, Jason. In October, we announced a positive outcome of the interim analysis of our Phase III IN SHOPE program of eduflumer's calcium in relapsing mitralcosclerosis or RMS. An independent data monitoring committee, IDMC, reviewed unblinded data and based on this, recommended that the trials are not futile and should continue as planned without any changes, marking the successful achievement of a critical milestone for the program. While immune link remained blinded to our data, the IDMC favorable recommendations corroborate our initial assumptions of the design, powering and relapse rate of the twin Phase III trials and suggest that they are in line with the data observed so far.

Speaker 1

In particular, the planned sample size seems appropriate to address the statistical assumptions for the primary endpoint of time to first relapse. We are confident in beta fluidimod calcium's potential to transform the RNMS market and continue to believe that the Phase III program provides a clear and straightforward path towards seeking potential regulatory approval in RMENCE. That concludes our summary of the Q3 2024 and most recent highlights. I am very pleased with the scientific and clinical achievements we have made across our programs. As it relates to the results from this call team, we continue to advance both our twin Phase III INSURED trials in patients with relapsing MS and our Phase II CALIPRE trial in progressive MS.

Speaker 1

We are very excited to read out the top line data of the CALIPRE trial in just a couple of months from now expected in April 2025. Based on the strong clinical evidence today, we continue to pursue partnering discussions with global and regional pharmaceutical companies. Our team has also been busy advancing our IMU-eight fifty six program, which has the potential to become a game changer for the treatment of a broad range of gastrointestinal disorders. I would now like to turn the call over to Glenn to provide a financial overview. Glenn?

Speaker 3

Thank you, Daniel. I will now review the financial and operating results for the Q3 9 months ended September 30, 2024. Let me start with a review of our cash position. We ended the Q3 of 2024 with $59,100,000 in cash and cash equivalents, which we expect to be able to fund our operations into the Q3 of 2025. Regarding the operating results, R and D expenses were $21,400,000 for the 3 months ended September 30, 2024, as compared to $19,800,000 for the 3 months ended September 30, 2023.

Speaker 3

The increase was mainly driven by increases in external development costs related to our clinical trials, which was partly offset by a decrease from the deprioritization of the Azumorogant program in psoriasis and castration resistant prostate cancer last year. For the 9 months ended September 30, 2024, R and D expenses were $58,400,000 as compared to $63,900,000 for the 9 months ended September 30, 2023. The decrease was mainly driven by the deprioritization of the Azumab Grant program in psoriasis and castration resistant prostate cancer and the completion of the Phase 1 clinical trial of IMU-eight fifty six in celiac disease last year. This was partially offset by an increase in external development costs related to the vita fluidum as calcium program as well as an increase in personnel expenses. G and A expenses were $4,400,000 for the 3 months ended September 30, 2024, as compared to $3,800,000 for the same period ended September 30, 2023.

Speaker 3

The increase was primarily related to personnel expenses. For the 9 months ended September 30, 2024, G and A expenses were $14,000,000 as compared to $11,900,000 for the same period ended September 30, 2023. The increase was primarily related to personnel expenses, legal and consultancy expenses and other across numerous categories. Interest income remained unchanged at $800,000 during the 3 months ended September 30, 2024 as compared to the 3 months ended September 30, 2023. For the 9 months ended September 30, 2024, interest income was $3,000,000 as compared to $2,500,000 for the 9 months ended September 30, 2023.

Speaker 3

The $500,000 increase was due to higher interest rates. We also reported a change in fair value of the tranche rights for the 9 months ended September 30, 2024. The change of $4,800,000 was a non cash charge related to the change in value of the tranche rights associated with the future tranches 23 of the January 2024 private placement. Other income was $600,000 for the 3 months ended September 30, 2024 as compared to $35,000 for the same period ended September 30, 2023. The increase was primarily attributable to R and D tax incentives for the clinical trials in Australia.

Speaker 3

For the 9 months ended September 30, 2024, other income was negative $1,100,000 as compared to $1,300,000 for the same period ended September 30, 2023. The decrease was primarily attributable to an expense related to the 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. 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 September 30, 2024 was approximately $24,400,000 or $0.24 per basic and diluted share dollars per basic and diluted share based on 101,300,000 weighted average common shares outstanding compared to a net loss of approximately $22,800,000 or $0.51 per basic and diluted share based on approximately 44 point 6,000,000 weighted average common shares outstanding for the same period ended September 30, 2023.

Speaker 3

Net loss for the 9 months ended September 30, 2024 was approximately $75,300,000 or $0.75 per basic and diluted share based on approximately 100,000,000 weighted average common shares outstanding compared to a net loss of approximately $72,000,000 or $1.63 per basic and diluted share based on 44,200,000 weighted average common shares outstanding for the same period ended September 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. Our next important clinical readout, which we are eagerly anticipating, will be the top line data from our Phase II CALIBOR trial of beta fluid musculature in progressive MS in April of next year. In addition to the overall PMS population, the data will also deliver insights on its subforms, including nonrelapsing secondary progressive MS, a subtype with the highest unmet medical need. Should the top line data continue to show a neuroprotective effect and the Phase II trial meets its primary and key secondary endpoints, we may also be able to position the drug as the first oral treatment option for non relapsing secondary progressive MS.

Speaker 1

Additionally, we are progressing as planned with our Phase III INSURE program of edufirnomus calcium in relapsing MS and expect to complete the first of our identical twin Phase III INSURE trials in the Q2 of 2026. The completion of the second INSURE trial is expected in the second half of twenty twenty six. As it relates to our second clinical program, IMUHF6, we remain very enthusiastic and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders by targeting physiological intestinal epithelial regeneration, resulting in gut wall healing with the absence of broad immunosuppression seen in many currently available gastrointestinal drugs in use today. It bears repeating that data from our Phase 1b clinical proof of concept trial of IMU A56 in patients with celiac disease during periods of gluten free diet and gluten challenge demonstrated significant improvements over placebo in 4 key dimensions of clinical outcomes in celiac disease: protection of the gut architecture, improvement of patient symptoms, enhancement of nutrient absorption and a strong biomarker response. As previously reported, we have begun preparing for Phase II clinical testing of IMU-eight fifty six.

Speaker 1

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 wall is important. We are currently exploring options to separately fund this unique asset and are openly considering different avenues. Let me hand over to Jason at this point again to emphasize Vinodafudimus calcium's unique profile.

Speaker 2

Thank you, Daniel. Part of the reason I joined IMNIC just a few months ago was because of what I see as a tremendous opportunity and a tremendous potential for vivofludimus to transform the MS market and to potentially become the leading therapeutic within the oral disease modifying therapy segment. The profile of this drug candidate is unique given its 1st in class dual mode of action approach designed to address the full spectrum of multiple sclerosis from stages of relapses and focal inflammation through the progressive stages where neurodegeneration takes hold. As a 1st in class NEAR-one activator, vutaflimus calcium goes beyond inflammation, providing direct neuroprotective effects and thereby offering potential benefits for both relapsing progressive MS patients. In addition, betaflunamis is also a highly selective DHODH inhibitor associated with potent anti inflammatory effects, which we know plays a key part in the relapsing forms of multiple sclerosis.

Speaker 2

We believe this mode of action combined with an exceptional safety and tolerability profile and the convenience of once daily oral administration gives vita fluvamis calcium a potentially best in class benefit risk profile within the oral class of medicines. Initially, it's worth highlight that we do not believe there is going to be any first dose or on treatment monitoring necessary, which means this will be an easy medicine to start newly diagnosed patients on and also a very easy medicine to switch patients to. Remembering that about 65% of the market today is a switch category. We also do not anticipate any safety concerns or black box warnings specific to the beta glutinous calcium. Given this profile and if approved across the vast indications of multiple sclerosis, we believe vitaplutimus calcium has the potential to transform the oral disease modifying therapy market with expected peak sales of this product ranging from US2 $1,000,000,000 to US6 $1,000,000,000 This brings us to the end of our formal presentation.

Speaker 2

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

Operator

Yes. Thank you, Jason and Daniel and Glenn for walking us through the Q3 and subsequent highlights as well as our clinical development pipeline and upcoming value inflection points. We will now begin the question and answer session. As a reminder, if you joined the webcast via the Zoom platform, there are 2 ways to submit questions. You can either submit your questions in writing via the Q and A tool of the Zoom portal.

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 William Wood from B. Riley. William, welcome, and please unmute yourself.

Speaker 4

Thank you so much. We really appreciate you taking our questions, and congrats on another successful quarter. So we have a couple of questions on our end. So the first is thinking just thinking about your CALIPR study coming up readout in April. This is in PMS, so SPMS including active and non active as well as PBMS.

Speaker 4

What level of detail should we expect a top line readout across these populations for both your primary as well as your secondary endpoints presented, possibly CDW, NFL and or GFAB. Essentially, I'm trying to are we going to just get an overall population data? Or should we expect some of these subpopulation data also? And then I have a follow-up. Thank you.

Speaker 1

Yes. Thank you, William, for that wonderful question. And I have good news. So we plan to really come out with detailed data on the general and the subforms tested during the study as we did for the interim analysis a year ago. And also, we really tried to have everything possible available at the readout, including the very important clinical endpoint, so confirmed disability worsening, the biomarker NfL, but also GFAB, given that the duration of the study allows to also evaluate that exploratory biomarker and also the brain atrophy data, of course.

Speaker 1

So it will be quite comprehensive data we're expecting in April next year.

Speaker 4

Excellent. It's great to hear. And then just a quick second one. You also have, as you noted, you have your ongoing post COVID investigator led trial going on in Germany. You're looking to enroll, it looks like about 3 76 patients, got a 56 day timeline, and it's obviously evaluating fatigue, a key issue in multiple sclerosis.

Speaker 4

Maybe you could remind me when we might expect the data here possibly before insurers read out in 2026? And if so, how should we think about the results in this post COVID trial? How it might highlight your dual MOA and success in Ensure? And then remind me if there's any type of subtype analysis or earmarking of patients in either Ensure or CALIBR that are diagnosed with post COVID syndrome? Thank you.

Speaker 4

I'll hop back into queue.

Speaker 1

Okay. I hope I remember everything from the questions. So starting with the post COVID study, this is an investigator sponsored trial. And therefore, we really can't give any guidance on the speed of recoupment. I know that the study kicked off and they have patients in, but we are not a sponsor.

Speaker 1

We provide here the drug. But we're excited about the specific analysis here. The role of fatigue is super important in multiple sclerosis. And it's interesting to see the overlap and the role of EBV expected in both in MS, but also in post COVID syndrome. Therefore, it could be scientifically and medically very meaningful thing, even if it's an investigator sponsored trial.

Speaker 1

So we want to learn and we want to use that knowledge for the patients to have a better treatment option, also to understand why and to what extent beta thalamus calcium can really make a difference here on preventing fatigue. And then there was a second part of the question, I forgot what that was.

Speaker 4

Yes. Just if you're earmarking or making note of or any type of sub analysis going on in Ensure or Caliper for these post COVID syndrome patients just to sort of understand how that might translate their data might translate to these larger trials?

Speaker 1

Yes, that's a good point. It's not predefined in the study as far as I know, but we will see if that shows up in the general safety monitoring of the study. And if we have data, we will likely also extract that, maybe not at a top line data readout, but maybe at a later time point.

Speaker 4

Great. Makes sense. Thank you, and I'll hop back in the queue. And congrats again on a very nice quarter.

Operator

Thank you, William. Thank you, William. The next one I have in the queue here is Yasmeen Rahimi from Piper Sandler. Yas, please unmute yourself and go ahead.

Speaker 5

Hey, good morning team. This is Jung Woo on for Yas.

Operator

Hi, Jung Woo.

Speaker 5

First, to the extent you can, can you comment on what do you see on a blinded basis for CALOPR in regards to safety and efficacy? And secondly, given that CALOPR has different PMS subpopulations for disability worsening, can you detail which subgroup is most likely experienced the biggest treatment effect?

Speaker 1

Thank you. Let me start with the first thing. We see blinded data, we can't conclude anything from that. So therefore, we should not speculate on anything on the blinded data for Caniper. So far, what I hear from the clinical team, the study is progressing as expected.

Speaker 1

So that's all I can say. On the sub indications, that's a good point. I think there is clearly there are 3 sub indications predefined in Caliper, the active secondary progressive, non active secondary progressive and primary progressive MS. And I think the non active secondary progressive and primary progressive populations are kind of similar on the issue that they don't have relapses, that you don't measure lesions in the brain, no inflammatory lesions, but they still progress on disability. And given that we have certain inclusion criteria for baseline EDSS score.

Speaker 1

So we think those should be in the same ballpark of placebo disease activity in those patients. It's a little bit different, I think, for the active SPMS patients given that there are still some inflammatory activity. And therefore, we expect that to be a little bit generally, I think, a little bit higher, but also the number of those patients, it's a smaller subgroup in the study. It's 9% of the patients in the study.

Operator

Next one in the queue here is Faiza Khorshid from Leerink Partners. Faiza, please unmute yourself and good morning.

Speaker 6

Hey, guys. Good morning. This is Matt Kalper on for Wesselcrashid. Thanks for taking my question. A couple from me.

Speaker 6

What hazard ratio for disability worsening will you be looking for in Kalper to feel good about bifludinous' potential in PMS? And then pending positive data in CALIPR, is there any opportunity for an accelerated registrational FAP in PMS? Or would you have to run a trial similar to what we see with the BTKs in PMS? Thank you.

Speaker 1

Yes. Thank you, Matt. Hazard ratio assumptions, I think there is no predefined bar right now of what you need to show. Of course, there is a little of a perception of KOLs, what they perceive as medically meaningful. And we asked the questions of the medical team.

Speaker 1

There was a we had a meeting with some of our KOLs not too long ago. And my colleague Andreas asked the team, what do you expect? And the discussion more or less came around, okay, if it's a 15% benefit on disability protection, that is something. At 20%, I think everybody agreed that that's a real signal. So we think that there is no hard line, but a 20% benefit would be a big win for the molecule.

Speaker 1

And then the better the higher the difference, the better for the drug, of course. And on accelerated approval, that's definitely an opportunity. But again, it depends on the data on the one hand and the distribution of the data. And there, for example, how similar are things between the subgroups and so forth. And the signal strength, for example, in the biggest population in the study and in non active secondary progressive patients.

Speaker 1

And that may qualify for having at least a discussion with the FDA on any kind of expedited way forward. However, we can't guarantee that this is an opportunity, but definitely worth a try.

Speaker 6

Great. Thanks for the insight and taking my questions.

Speaker 1

Thank you.

Operator

Thank you, Matt. Just for full transparency here, we also had the question on accelerated or expedited approval 2 times in the chat. So I guess this is answered now. Next one in the queue here is Matt Kaplan from Ladenburg. Matt, please unmute yourself and go ahead.

Speaker 7

Hey, good morning, guys. Just wanted to stay on the CALOPR study a little bit in progressive MS. Can you talk a little bit about the unmet need in PMS and specifically also the subgroups of PMS as well?

Speaker 1

Yes. Good that you asked. I think this is so super important. And then I think we can't say often enough that this is really one of the areas where there is the highest need. And specifically for non active secondary progressive MS, there's currently not a single treatment approved.

Speaker 1

So that clearly is a huge unmet need. Maybe, Jason, you have a little bit of comment also on the number of patients affected there answering that question. And just to complete that for the same it's not the same, but similar in primary progressive where you currently, we only have Opryvos approved as an infusion. There is no oral drug approved. And also, I think on the effect size, it's good to have another option as well for PPMS patients.

Speaker 1

But maybe, Jason, you can add a little bit more color on that.

Speaker 2

Sure. Happy to do so, Daniel and Matt. Thank you for the question. So clearly, look, there's a huge unmet need in the progressive side of this disease. Specifically, on the of side of this disease, specifically on the non relapsing secondary progressive MS phenotype or subtype.

Speaker 2

As Daniel mentioned, there's no currently approved medicines. We know that across the 7 major markets, there's approximately 175,000 patients diagnosed with non relapsing secondary progressive MS. So, it's a big opportunity, represents about 15% of the total MS population. Also on the primary progressive side, we know that there's approximately 120,000 or so patients diagnosed across the major markets, representing about 10% of the total population. There is only one treatment approved to date in primary progressive MS and that is ocalizumab or OCREVUS.

Speaker 2

But I also think it's important to note that as patients progress, as they get into these more neurodegenerative forms of the disease, they're normally a little bit older in age. They normally have more accumulation of disability, both physical and cognitive disability. And just as patients age, you have a normal breakdown or wear down of the body's natural immune system. And so in these primary progressive patients, though ACREVIS is currently approved, there is some reluctance about putting these type of patients on immunosuppressant, right, broad B cell depleting therapies. And so again, the uniqueness of bupiquidomus calcium given its dual mechanism of both the neuron activation and highly selective innovation of DHODH is that we think it's going to have a very, very strong neuroprotective play.

Speaker 2

It's not immunosuppressant. So if approved and we show a good signal here, we believe it could become the gold standard of care in the progressive forms of the disease.

Speaker 7

Thank you.

Operator

Thank you, Matt. And maybe a follow-up question for Jason here in the chat. Can you share more details on the calculation of the peak sales mentioned regarding market share?

Speaker 2

Yes. I mean, I'm not going to get into the intricacies of total market capture. What I can tell you is that we've done a lot of work to understand both the bottoms up and the top down forecast and opportunity for this respective medicine. It's quite clear even with 20 approved, 20 plus approved therapies in the relapsing forms of the disease, there continues to be a huge unmet need. A couple of data points that I think are worth mentioning.

Speaker 2

Of the roughly 900,000 patients that are currently diagnosed with relapsing forms of multiple sclerosis across the major markets today, only about 525,000 of them are currently on a disease modifying therapy. So, there's a huge delta between the number of patients diagnosed and those currently on therapy. And there's a lot of reasons as to why patients are not on therapy. But many of the most common reasons are patients had a poor experience with an initial therapy, meaning that the tolerability associated with the medicine was worse than the disease itself. There are many patients, especially early in their diagnosis that have concerns about

Speaker 1

some

Speaker 2

of the safety signals of the available therapies. And it's not surprising. These are young people in the prime of their life. They have a long life ahead of them. And of course, if you have a medicine that potentially causes severe and serious opportunistic infections or potentially increases the risk of malignancies that could certainly be a concern to many of these young patients.

Speaker 2

Again, there's also an unmet need for medicines that have a unique mechanism to stop this continued disability progression even in the relapsing forms of the disease. Vidaformis calcium is going to address all these concerns. And so we believe that it is a wonderful option and will fill a need in the relapsing forms of the market. And therefore, all of the research that we've done to date supports significant uptake of this potential medicine, right? And I've discussed without in nauseam here a little bit about that the progressive side, but it goes without saying again, clearly if this medicine shows signals in the progressive side, it ultimately becomes approved.

Speaker 2

We think that the efficacy, the uniqueness of this mechanism, the neuro-one activation that clearly provides neuroprotective benefits and the balance of all of this with a great safety and tolerability profile really will differentiate this medicine. And again, we think it has the potential to disrupt the oral disease modifying therapy category. And that's why we're so hopeful.

Operator

Thank you, Jason. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q and A tool. And we actually have one more in the Q and A tool. Is in Munich in any negotiations to partner with BIG Pharmaceutical at this moment? Or are you still looking for a partner for non dilutive cash raises?

Speaker 2

So Daniel, why don't I take that? So as you would imagine, there is significant interest in vitafulumas calcium. There are very few late stage there's little to no late stage therapies in development for multiple sclerosis and even in neuroscience in general. So certainly companies that have an existing interest in MS and companies that have an existing interest in neurology or neuroscience, we are talking to just about every single one of them. I will not get into specifics around where we are at in those negotiations, but I can tell you that again there's significant interest.

Speaker 2

I think the interest has even increased over the course of the last couple of months given some of the market dynamics specific to the recent failures of the BTK inhibitors and the relapsing forms of the disease. Again, I think that you have many companies taking a fresh and different look at the potential for beta polymerase calcium. So we're in ongoing discussions, but nothing more specific to provide at this point.

Operator

Thank you, Jason, and thank you for all the questions. 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 everyone on the call today for your always insightful questions and good discussion here. I would like to end the call by reiterating how excited we are about the potential for our advanced clinical pipeline programs, especially lead acid video thrombus calcium, which is targeted to elevate the standard of care for the full spectrum of MS patients. We are pleased with the milestones we have achieved with this program and look forward to reporting top line data from our Phase II CALIBRE trial as expected in April of next year, while continuing the enrollment in our Phase III INSUUR trials. Additionally, as progress is made, we expect to also provide an update on our operations for Phase II clinical trial of IMUHAP6 and its unique potential for the treatment of a broad array of serious gastrointestinal disorders and beyond. With that, I would like to close today's call.

Speaker 1

Thank you again for joining, and we are very happy to answer any additional questions 1 on 1, so please do not hesitate to reach out.

Operator

Thank you for joining Munich's Q3 2024 Earnings Call. The call is now concluded. You may now disconnect.

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Key Takeaways

  • Jason Tardio was appointed President and COO and Werner Gladinez was promoted to Chief Development Officer to bolster commercialization readiness and clinical operations, while Simona Skjerianic joined the Board to enhance neurological strategy.
  • Lead candidate vidoflumus calcium features a dual mechanism—NR1 activation for neuroprotection and selective DHODH inhibition for anti-inflammatory/antiviral effects—with compelling preclinical, clinical, and ACTRIMS poster data.
  • Phase III INSURE trials in relapsing MS received a positive interim IDMC review to continue as planned, and the Phase II CALIBER study in progressive MS remains on track for a detailed top-line readout in April 2025, including subpopulation efficacy analyses.
  • An investigator-sponsored Phase II RAPID-REVIVE trial in post-COVID syndrome has enrolled its first patient, assessing vidoflumus calcium’s impact on fatigue and EBV reactivation as potential differentiators.
  • As of September 30, 2024, Munich held $59.1 million in cash (funding into Q3 2025), recorded Q3 R&D expenses of $21.4 million, and reported a net loss of $24.4 million ($0.24 per share).
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Earnings Conference Call
Immunic Q3 2024
00:00 / 00:00