Q3 2024 Immunic Inc Earnings Call
Good morning and welcome to Munich's third quarter 2024 earnings call. My name is Jessica Breu, Vice President Investor Relations and Communications at the Munich. 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 President and Chief Operating Officer. Please note that all participants will be in listen-only mode, and this event is being recorded.
After today's presentation, there will be an opportunity to ask questions. If you joined the webcast via the Zoom platform, there are two ways to submit questions. You can submit your questions in writing via the Q&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 questions.
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 Immunix Actual results to differ materially from those discussed here.
Please note that these forward-looking statements reflect Immunix opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information of future events.
Please refer to Immunix SEC filings for more detailed description of the risk factors that may affect Immunix results and these forward-looking statements.
Speaker Change: 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 Q3 2024 earnings call.
Daniel Vitt: Earlier this morning, we announced our financial results for the third quarter and nine months ended September 30, 2024.
During the call today, we will walk through our third 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 third quarter 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 growth stocks for major biotechnology and pharmaceutical companies.
Days have already proven to be invaluable, leading internal efforts to prepare for the potential commercialization of dilifidumus 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 Redefining with Calcium, as well as our other drug candidates, where we are leveraging his extensive partnering experience.
Daniel Vitt: Additionally, Werner Gladiness was promoted to Chief Development Officer. Werner joined Munich in January of 2021 as head of IMU 838 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 Skrjanic, 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
Daniel Vitt: culminating in numerous regulatory drug approvals and successful commercial launches, working with companies such as Roche, the medicines company, L.L. Lilly, Pfizer, and Johnson & Johnson.
Daniel Vitt: It is worth pointing out that Simone led business and global corporate strategy for Roche's portfolio of neurological and rare diseases, achieving sustainable double-digit growth in sales.
Including with Boquevus, which remains one of the most successful medicines for the treatment of MS today.
Daniel Vitt: Her success in this area really enhances our board as we work towards the potential commercial launch of Betafluid Mascarpion.
Unknown Speaker
In September, we hosted an in-person MS R&D Day.
which featured two world-renowned industry experts, Dr. Francesca Monterolo, biologist and leading MS and NOVANT target expert.
from the Neuroscience Institute, Cavalieri, Ottolenghi, and University of Turin, Italy, as well as Dr. Amit Baor, clinician, scientist, and one of the leading neuroimmunologists in MS from the University of Pennsylvania.
Daniel Vitt: These distinguished key opinion leaders, along with our management team, provided an in-depth overview of the MS landscape and our already available lead-acid-videofluvium as calcium.
The presentation highlighted its dual mode of action, which combines neuroprotective effects through its mechanism as a first-in-class nuclear receptor-related one, or NUR1 activator, with anti-inflammatory and antiviral effects via DHODH inhibition.
On our ongoing quiz re-ensure trials in relapsing MS.
Our ongoing phase 2 caliper trial in progressive MS and highlighted the commercial opportunity for Vitaflumas calcium in the MS market.
Daniel Vitt: In particular, we discuss our strong belief in the potential of bilifidimus 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.
Daniel Vitt: where there are currently few options and there continues to be a huge unmet need.
Daniel Vitt: We continue to believe that vitifluvimus calcium has the potential to redefine the oral mitoposclerosis treatment landscape and elevate the standard of care for these patients.
Daniel Vitt: In September, we enrolled the first patient in an investigator-sponsored Phase II clinical trial of beta-fluoridamide calcium, the RAPID-REVIVE trial.
and Post-COVID Syndrome for which Immunic is providing study medication.
Daniel Vitt: The trial is a randomized placebo-controlled, double-blind, parallel-group trial led by Professor Maria Federschild and sponsored by the Goethe-University of Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research.
Daniel Vitt: We are honored to have Vito Philippus Carlsen chosen for this investigators funded study run by such a highly regarded investigators and at esteemed institutions in Germany.
Speaker Change: We have already seen convincing data supporting beta-flu-limose calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our Phase II Calvigruen trial.
Daniel Vitt: Importantly, third-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.
Daniel Vitt: Negatively impacting the quality of life and ability to participate in social activities.
Daniel Vitt: We also aim to confirm the ability of B.difidumus keratium to influence fatigue and Epstein-Barr virus reactivation in our ongoing MS trials and look forward to receiving additional data from the rapid-revive trial.
Daniel Vitt: It is our belief that this may create yet another differentiating feature for our drug candidates.
Daniel Vitt: In September, we also had the opportunity to present four posters at the prestigious 40th Congress of Actors, showcasing data on key aspects of beta-flurinose calcium's profile, illustrating the strength of the data generated today and its potential to become a new treatment option for MS.
Speaker Change: Jason, do you want to add a few words on the call web?
Sure, and thank you, Daniel.
Daniel Vitt: The EdTerms 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.
Daniel Vitt: We are particularly excited to have had the opportunity to present data at this meeting to further support the differentiation of beta-polymerase calcium as a potential treatment for both relapsing and progressive multiple sclerosis.
Daniel Vitt: More specifically, we shared additional data from the income analysis of our ongoing Phase II Caliber trial in progressive multiple sclerosis.
Daniel Vitt: That showed that beta-polymerase calcium not only had a significant impact on reducing serum neurofilament light chain levels across the total study population,
Daniel Vitt: But also consistently reduces neurofilament light chain levels compared to baseline across different patient subgroups based on age and disability scores.
Daniel Vitt: 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.
Daniel Vitt: With recent data showing that lower noroformin light levels indicate a lower risk of future disability progression in progressive MS patients.
Speaker Change: We also prevented compelling data on fatigue from post hoc analysis of the CalVid-1 trial, which evaluated the safety and efficacy of butylcholamines calcium 45 milligrams in patients hospitalized for COVID-19.
Daniel Vitt: 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.
Daniel Vitt: Given the broad-spectrum antiviral effects of VF calcium and its potential to prevent reactivation of the Epstein-Barr virus, or EBV, which has been linked to fatigue and multiple sclerosis, we sought to understand the impact of VF on fatigue in post-COVID syndrome patients.
Daniel Vitt: Fatigue was further decreased from weeks 9 to 17 to 33% for patients on placebo and only 17% for patients on betafluoromus calcium, thus supporting the antiviral effects of betafluoromus
and how it may contribute to lower fatigue levels.
Speaker Change: 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 Ensure trials.
Daniel Vitt: Lastly, we presented additional preclinical evidence supporting that Vitaformas calcium enhanced the expression of Nr1 target genes important for neuronal survival, further suggesting the neuroprotective benefit of this acid.
Daniel Vitt: 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.
Daniel Vitt: In addition to these data presentations, it may also feel like an exhibitor booth for the first time at this important meeting.
Daniel Vitt: This served as a great opportunity to engage the MS community and further increase awareness of butyphlegmous calcium as a potential treatment for MS.
Back to you, Dan. Yeah.
Thank you, Jason.
Daniel Vitt: In October, we announced a positive outcome on the interim analysis of our Phase III Insure Program of EDVMS calcium and relapsing microsclerosis, or RMS.
Daniel Vitt: 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
Daniel Vitt: While Immunics remain blind to all data, the IDLC's favorable recommendations corroborate our initial assumptions of design, powering, and relapsing.
Daniel Vitt: rate of the twin phase 3 trials and suggests that they are in line with the data observed so far. In particular, the plant sample size seems appropriate to address the statistical assumptions for the primary endpoint of time to first relapse.
Daniel Vitt: We are confident in VitaFluidiMost Calcium's potential to transform the oil and gas market and continue to believe that the Phase III program provides a clear and straightforward path towards seeking potential regulatory approval in RMS.
That concludes our summary of the
Daniel Vitt: Third quarter 2024 and most recent highlights. I am very pleased with the scientific and clinical achievements we have made across our programs.
Daniel Vitt: As it relates to B-difference calcium, we continue to advance both our twin phase 3 ensured trials in patients with relapsing MS and our phase 2 caliper trial in progressive MS.
Daniel Vitt: We are very excited to read out the top line data of the CALIPER trial in just a couple of months from now, expected in April 2025.
Daniel Vitt: Based on the strong clinical evidence today, we continue to pursue partnering discussions with global and regional pharmaceutical companies.
Daniel Vitt: Our team has also been busy advancing our new HF6 program, which has the potential to become a game changer for the treatment of a broad range of gastrointestinal disorders.
Speaker Change: I would now like to turn the call over to Glenn to provide a financial overview. Glenn?
Glenn Whaley: Thank you, Daniel. I will now review the financial and operating results for the third quarter and nine months ended September 30, 2024.
Glenn Whaley: Let me start with a review of our cash position. We ended the third quarter of 2024 with $59.1 million in cash and cash equivalents.
Glenn Whaley: which we expect to be able to fund our operations into the third quarter of 2025.
Glenn Whaley: Regarding the operating results, R&D expenses were $21.4 million for the three months ended September 30, 2024, as compared to $19.8 million for the three months ended September 30, 2023.
Glenn Whaley: The increase was mainly driven by increases in external development costs related to our clinical trials, which was partly offset by a decrease in the deprioritization of the Azumarogam program in psoriasis and castration-resistant prostate cancer last year.
Glenn Whaley: For the nine months ended September 30, 2024, R&D expenses were $58.4 million as compared to $63.9 million for the nine months ended September 30, 2023.
Glenn Whaley: The decrease was mainly driven by the depriorization of the Zuma grant program in psoriasis and castration-resistant prostate cancer, and the completion of the Phase I clinical trial of IMU-856 in celiac disease last year.
Glenn Whaley: This was partially offset by an increase in external development costs related to the VitaFluidomast calcium program, as well as an increase in personnel expenses.
Glenn Whaley: G&A expenses were $4.4 million for the three months ended September 30, 2024, as compared to $3.8 million for the same period ended September 30, 2023.
The increase was primarily related to personnel expenses.
Glenn Whaley: For the nine months ended September 30th, 2024, G&A expenses were $14 million, as compared to $11.9 million for the same period ended September 30th, 2023.
Glenn Whaley: The increase was primarily related to personnel expenses, legal and consultancy expenses, and other costs across numerous categories.
Glenn Whaley: Interest income remained unchanged at $0.8 million during the three months ended September 3, 2024, as compared to the three months ended September 3, 2023.
Glenn Whaley: For the nine months ended September 3, 2024, interest income was $3 million, as compared to $2.5 million for the nine months ended September 3, 2023. The $0.5 million increase was due to higher interest rates.
Glenn Whaley: We also reported a change in fare value of the tranche rights for the nine months ended September 30th, 2024.
Glenn Whaley: The change of $4.8 million was a non-cash charge related to the change in value of the tranche rights associated with the future tranches 2 and 3 of the January 2024 private placement.
Glenn Whaley: Other income was $600,000 for the three months ended September 30, 2024, as compared to $35,000 for the same period ended September 30, 2023.
Glenn Whaley: The increase was primarily attributable to R&D tax incentives for the clinical trials in Australia.
Glenn Whaley: The nine months ended September 30th, 2024, other income was negative 1.1 million, as compared to 1.3 million for the same period ended September 30th, 2023.
Glenn Whaley: The decrease was primarily attributable to an expense related to the portion of cost from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche one.
Glenn Whaley: 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.
Glenn Whaley: The decrease was partially offset by an increase in foreign exchange gains.
Glenn Whaley: The net loss for the three months ended September 30, 2024, was approximately $24.4 million, or 24 cents per basic and diluted share, based on 101.3 million weighted average common share is outstanding.
Glenn Whaley: Compared to a net loss of approximately 22.8 million or 51 cents per basic and diluted share based on approximately 44.6 million weighted average common shares outstanding for the same period ended September 30, 2023.
Glenn Whaley: Compared to a net loss of approximately $72 million, or $1.63 per basic and diluted share, based on 44.2 million weighted average common shares outstanding, the same period ended September 30, 2023.
Speaker Change: With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?
Daniel Vitt: Thank you Glenn. I would now like to provide an update on our clinical development programs and anticipate upcoming masters.
Speaker Change: Our next important clinical readout, which we are eagerly anticipating, will be the top-line data from our Phase II caliper trial of B. calcium in progressive MS in April of next year.
Speaker Change: In addition to the overall PMS population, the data will also deliver insights on the subforms, including non-relapsing secondary progressive MS, a subtype with the highest unmet medical need.
Speaker Change: Should the top-line data continue to show a neuroprotective effect and the phase 2 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 or progressive MS.
Speaker Change: Additionally, we are progressing as planned with our Phase III Ensure Program of V. calcium in relapsing MS and expect to complete the first of our identical twin Phase III Ensure Trials in the second quarter of 2026.
Speaker Change: The completion of the second ensured trial is expected in the second half of 2026.
As it relates to our second clinical program, IU-HF6,
Speaker Change: We remain very enthusiastic and believe that this 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.
Speaker Change: It bears repeating that data from our Phase 1B clinical proof-of-concept trial of IMU-856 in patients
Speaker Change: with celiac disease during periods of gluten-free diet and gluten challenge demonstrated significant improvement of a placebo in four key dimensions of clinical outcomes in celiac disease.
Speaker Change: Protection of the Gut Architecture, Improvement of Patient Symptoms, Enhancement of Nutrient Absorption, and a Strong Biomarker Response.
Speaker Change: As previously reported, we have begun preparing for Phase 2 clinical testing of IMU-856.
Speaker Change: 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.
Speaker Change: Let me hand over to Jason at this point again to emphasize with a little bit calcium unique profile.
Thank you, Daniel.
Jason: You know, part of the reason I joined Immunic just a few months ago was because of what I see as a tremendous
Speaker Change: Opportunity and a tremendous potential for beautiful to miss to transform the MS market and to potentially become the leading therapeutic within the oral disease modifying therapy segment
Speaker Change: The profile of this drug candidate is unique, given its first-in-class dual mode-of-action approach, designed to address the full spectrum of multiple sclerosis.
Speaker Change: from stages of relapses and focal inflammation through the progressive stages where neurodegeneration takes hold.
Speaker Change: As a first-in-class neuroinactivator, Vitaful Miss Calcium goes beyond inflammation, providing direct neuroprotective effects, and thereby offering potential benefits for both relapsing progressive MS patients.
Speaker Change: In addition, butyl polonimus 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 Change: We believe this mode of action, combined with an exceptional safety and tolerability profile, and the convenience of once-daily oral administration, gives VitaFluidimus Calcium a potentially best-in-class benefit-risk profile within the oral class of medicines.
Speaker Change: 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.
Speaker Change: Remembering that about 65% of the market today is a switch category.
Speaker Change: We also do not anticipate any safety concerns or black box warnings specific to Vita Plutonus Calcium.
Speaker Change: Given this profile and if approved across the vast indications of multiple sclerosis, we believe beta-flutamose calcium has the potential to transform the oral disease modifying therapy market with expected peak sales of this product ranging from 2 to 6 billion USD.
Speaker Change: This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.
Jessica Breu: Yeah, thank you Jason and Daniel Glenn for walking us through the third quarter and subsequent highlights as well as our clinical development pipeline and upcoming value inflection point.
Jessica Breu: We will now begin the question and answer session. As a reminder, if you joined the webcast via the Zoom platform, there are two ways to submit questions. You can either submit your questions in writing via the Q&A tool of the Zoom portal, or if you would like to speak with us directly, please use the raise hand function of the Zoom portal to queue your question.
Speaker Change: Our first guest today is William Wood from Be Riley. William, welcome and please unmute yourself.
William Wood: Thank you so much. We really appreciate you taking our questions and congrats on another successful quarter. We have a couple of questions on our end. So, the 1st is thinking, just thinking about your caliper study coming up read out in April, you're.
That was a bust.
William Wood: This is in PMS, so SPMS, including active and non-active, as well as PPMS.
Speaker Change: What level of detail should we expect at top line readout across these populations for both your primary as well as your secondary endpoints presented, you know, possibly CDW, NFL, and or GFAB? Essentially, I'm trying to
Speaker Change: 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 Change: Yeah thank you William for that wonderful question and I have good news. So we 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.
Speaker Change: And also, we really tried to have everything possible available at the resort, including
Speaker Change: The very important clinical endpoint, so confirmed disability reasoning, the biomarker NFL, but also GFAP, given that the duration of the study allows
Speaker Change: to also evaluate that exploratory biomarker and also the brain atrophy data of course. So it will be quite comprehensive data we're expecting in April next year.
Speaker Change: 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 a role, it looks like about 376 patients, it's got a 56-day timeline, and it's obviously evaluating fatigue, a key issue in multiple sclerosis.
Speaker Change: Maybe you could remind me when we might expect the data here, possibly before insurer's readout in 2026, and if so,
Speaker Change: How should we think about the results in this post-COVID trial, how it might highlight your dual MOA and success in, and should, and
Speaker Change: in Ensure, and then remind me if there's any type of subtype analysis or earmarking of patients in either Ensure or Caliper that are diagnosed with post-COVID syndrome. Thank you. I'll hop back into Q.
Speaker Change: Okay, I hope I remember everything from the question. 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 recruitment. I know that this study kicked off and they have patients in, but we are not a sponsor. We provide here the drug.
Speaker Change: 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.
Speaker Change: and expected in both in MS but also in post-COVID syndrome. Therefore, it could be scientifically and medically a very meaningful thing, even if it's an investigative sponsored trial. So we want to learn and we want to...
Speaker Change: use that knowledge for the patients to have a better treatment options, also to understand why and to what extent beta thalimbus calcium can really make a difference here on preventing fatigue.
Speaker Change: And then there was a second part of the question, I forgot what that was.
Speaker Change: Yeah, just if you're earmarking or making note of or any type of sub analysis going on in Insure 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 Change: Yeah, 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 in the general safety monitoring of the study.
Speaker Change: 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 Change: Great. Makes sense. Thank you. And I'll hop back into queue and congrats again on a very nice quarter. Thank you, William. Thank you, William. The next one I have in the queue here is Yasmin Rahimi from Piper Sanchez. Yas, please unmute yourself and go ahead.
Speaker Change: Hey, good morning team. This is Jungu on for Yas. Hi Jungu. Thanks for taking our questions.
Speaker Change: First, to the extent you can, can you comment on what do you see on a blinded basis for Caliper in regards to safety and efficacy? And secondly, given that Caliper has different PMS subpopulations, for disability worsening, can you detail which subgroup is most likely to experience the biggest treatment effect?
Thank you. Let me tell you the first thing.
We, we see blinded.
Speaker Change: data, we can't conclude anything from that. So therefore, we should not speculate on anything on the blinded data for caliber.
Speaker Change: So far what I hear from the clinical team is that the study is progressing as expected. So that's all I can say.
Speaker Change: On the sub-indications, that's a good point. I think there is clearly, there are three sub-indications predefined in Caliper. The active secondary progressive, non-active secondary progressive, and primary progressive MS.
Speaker Change: And I think the non-active secondary progressive and primary progressive populations are kind of similar on the
Speaker Change: 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.
Speaker Change: And given that we have certain inclusion criteria for baseline EDSS score. So we think.
Speaker Change: Those should be in the same ballpark of placebo disease activity in those patients.
Speaker Change: It's a little bit different, I think, for the active SPMS patients, given that there are still some inflammatory activity. Therefore, we expect that to be a little bit different.
Speaker Change: Generally, I think a 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.
Thank you.
Speaker Change: Thank you, Django. Next one in the queue here is Faisal Khurshid from Learning Partners. Faisal, please unmute yourself and good morning.
Speaker Change: Hey guys, good morning. This is Matt Kalper on for Festival Crusade. Thanks for taking my question. A couple for me. What hazard ratio for disability worsening will you be looking for in Caliber to feel good about the flutimus' potential in PMS?
Speaker Change: And then pending positive data in Caliper, is there any opportunity for an accelerated registrational path in PMS? Or would you have to run a trial similar to what we see with the BTKs in PMS? Thank you.
Yeah, thank you, Matt.
Hesitant Ratio Assumptions, I think there is no, no predefined.
Bar right now of what you need to show
Speaker Change: Of course, there is a level of perception of KOLs, what they perceive as medically meaningful. And we asked the questions of the medical team, we had a meeting with some of our KOLs not too long ago, and my colleague Andreas asked the team,
Speaker Change: What do you expect? And the discussion more or less came around, okay, if it's a 15% benefit on
Speaker Change: on disability protection. That is something. At 20%, I think everybody agreed that that's a real signal. So we think that's...
Speaker Change: There's no hard line, but a 20% benefit would be a big win for the molecule. And then the better, the higher the difference, the better for the drug, of course.
Speaker Change: and Unaccelerated Approval, that's definitely an opportunity, but again, it depends on
Speaker Change: On the data, on the one hand, and the distribution of the data, 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 Change: 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.
Great. Thanks for the insight and taking my questions.
Speaker Change: Thank you. Thank you, Matt. Just for full transparency here, we also had the question on accelerated or expedited approval two times in the chat, so I guess this is answered now. Next one in the queue here is Matt Kaplan from Leidenblock. Matt, please unmute yourself and go ahead.
Matt Kaplan: Hey, good morning, guys. Just wanted to stay on on the CalPERS 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?
Good that you asked. I think this is
Speaker Change: This is so super important, and 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 Change: So that clearly is a huge unmet need. Maybe Jason, you have a little bit of comments also on the number of patients affected there answering that question.
Speaker Change: as an infusion, there's no oral drug approved. And also, I think on the effect size, it's good to have another option as well for PPMF patients. But maybe Jason, you can add a little more color on that.
Jason: We know that across the seven 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.
Jason: Also on the primary progressive side, we know that there's approximately 120,000 or so patients diagnosed across the major markets.
Jason: 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.
Jason: But I also think it's important to note that, you know, as patients progress, as they, as they
Jason: As they get into these more neurodegenerative forms of the disease.
Jason: They're normally a little bit older in age, they normally have more
Accumulation of disability, both physical and cognitive disability.
Jason: And just as patients age, you have a normal breakdown or wear down of the of the body's natural immune system. And so in these primary progressive patients, they'll accrue this is currently approved.
Jason: There is some reluctance about putting these types of patients on immunosuppressant, right, broad B cell depleting therapies. And so again,
Speaker Change: The uniqueness of beta-colonized calcine given its dual mechanism of both the NIR1 activation and highly selective inhibition of DHRDH.
Jason: is that we think it's going to have a very, very strong neuroprotective play. 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.
Thank you.
Speaker Change: 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 Change: Yeah, 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 in a top down
Speaker Change: 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 Change: Of the roughly 900,000 patients that are currently diagnosed with relapsing forms of multiple sclerosis across the major markets today,
Speaker Change: 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.
Speaker Change: But many of the most common reasons are patients had a poor experience with an initial therapy, meaning that the tolerability associated with that medicine was worse than the disease itself. There are many patients, especially early in their diagnosis, that have concerns.
Jason: severe and serious opportunistic infections or potentially increases the risk of malignancies, that could certainly be a concern to many of these young patients.
Jason: 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.
Jason: 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, of, of the market. And therefore all of the research that we've done to date supports
Jason: significant uptake of this potential medicine, right? And I've discussed without, you know, in nauseam here a little bit about the progressive side, but it goes without saying again, clearly, if this medicine shows signals in the progressive side, it ultimately becomes approved.
Jason: We think that the efficacy, the uniqueness of this mechanism, the NIR1 activation that clearly provides neuroprotective benefits
Jason: 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.
Speaker Change: Thank you, Jason. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. We actually have one more in the Q&A tool. Is in Munich and any negotiations to partner with big pharmaceutical at this moment or are you still looking for a partner for non-dilutive cash raises?
Speaker Change: So Daniel, why don't I take that. So as you would imagine, there is significant interest in VitaFlumis calcium.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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. I think the interest has
Speaker Change: has has even increased over the course of the last couple of months given
Speaker Change: Some of the market dynamics specific to the recent failures of the BTK inhibitors and the relapsing forms of the disease.
Speaker Change: Again, I think that you have many companies taking a fresh and different look at the potential for Vitaform as calcium. So we're in ongoing discussions, but nothing more specific to provide at this point.
Speaker Change: 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. Yeah, thank you, Jessica. And thanks to everyone on the call today for your always insightful questions and good discussion here.
Daniel: I would like to end the call by reiterating how excited we are about the potential for our Advanced Clinical Pipeline Program, especially Lead Acid Velocitomers Calcium, which is targeted to elevate the standard of care for the full spectrum of MS patients.
Speaker Change: We are pleased with the milestones we have achieved with this program and look forward to reporting top-line data from our Phase 2 CALIPER trial as expected in April of next year while continuing the enrollment in our Phase 3 INSURE trials.
Speaker Change: Additionally, as progress is made, we expect to also provide an update on our preparations for Phase II clinical trial of IMU-HF6 and its unique potential for the treatment of a broad array of serious gastrointestinal disorders and beyond.
Speaker Change: 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-on-one, so please do not hesitate to reach out.
Speaker Change: Thank you for joining in Munich's third quarter 2024 earnings call. The call has now concluded. You may now disconnect.