Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| But we don't expect any surprises given based on the Phase II data we obtained from the EMPhASIS studies in relapsing MS, we are very confident that this trial will also deliver comparable results |
| This financing completed in a challenging capital markets environment and with such a strong group of investors confirms the enormous value inherent in our two advanced clinical programs |
| We also expect that the drug's potential first-in-class ability to activate Nurr1 will meaningfully benefit the ongoing clinical trials in multiple sclerosis |
| I'm very pleased with the scientific and clinical advancements we have made across our different programs, and we are leveraging this momentum going forward |
| As a reminder, the maintenance phase results from the CALDOSE-1 trial demonstrated statistically significant activity of vidofludimus calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile |
| So lacking immunosuppressive effects is really a unique benefit we see here, and therefore, I think it is an attractive thing |
| So I think generally, the perception is very positive, and people are very excited about a completely new approach for those diseases |
| I think we were intrigued by the data of last year, specifically the NfL data giving us a very nice signal and really increasing the likelihood of success for the clinical outcomes of the CALLIPER study with a readout in April 25 |
| And that would be I think the best differentiator you can have and also the best news for patients suffering from these indications like primary progressive and secondary progressive MS specifically |
| This strong signal also points to a more likely positive outcome of the overall CALLIPER trial as well as clinically relevant endpoints like prevention of disability worsening |
| In parallel, we have that rock solid ENSURE program in relapsing MS ongoing, which is more or less just based on our very good Phase II data for that molecule we obtained from the EMPhASIS study, which allows us a low risk way forward towards approval and data readout in 2026 |
| And given that recently, if you look on a couple of key publications in that space, there are very nice data showing that NfL is in progressive MS specifically, in an isolated way, if you really separate the activity of NfL from focal inflammation and relapses, on the one hand from the new regenerative contributions like you can do in progressive MS patients, there is clearly a nice predictive power of NfL for future disability outcome |
| As stated before, based on the strong clinical activity observed thus far, vidofludimus calcium solidly established safety and tolerability profile to date, we believe that the design of our Phase III ESNURE program will provide a straightforward path to potential regulatory approval in relapsing MS |
| But to reiterate -- I don't want to talk too long here, but to reiterate, we also had this positive readout on GI, on UC study on the maintenance data, which is more or less boosting other molecule developments in that space |
| In November, we were pleased that Dr |
| And also the Nurr1 potential beyond just multiple sclerosis and other related neurological indications, also something where we think this has another huge potential |
| We are particularly excited about our MS program in light of the recent developments in the MS market |
| This would make the drug a very huge also commercial opportunity, I think |
| The more -- the proof-of-concept we achieved in the Phase I is not only limited to celiac disease, because we have, for example, seen a very nice improvement of enterocyte function by increased uptake of nutrients like vitamin B12, for example |
| In October, we reported overwhelmingly positive interim data from the Phase II CALLIPER trial of our potentially groundbreaking lead asset, nuclear receptor-related one over one activator, vidofludimus calcium, in progressive multiple sclerosis, or PMS |
| As an example, for vidofludimus calcium, the release of our overwhelmingly positive biomarker NfL data has been an impetus for partnering discussions and global and regional pharmaceutical companies |
| We are very excited about this program and believe IMU-856 could present an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of old architecture without the serious consequences associated with immunosuppressive therapies |
| If the Phase II PMS data is positive, this is certainly something which has a relevance for the whole treatment landscape of multiple sclerosis, even beyond PMS, because that may also be of benefit for and support scientifically the ENSURE RMS Phase III studies which are ongoing as well |
| This is a very huge potential for vidofludimus calcium |
| IMU-856 was also observed to be safe and well tolerated in this trial |
| To summarize, with the positive interim data from our Phase II CALLIPER trial as well as the continuation of enrollment of our Phase III ENSURE trials, we continue to make tangible progress on the clinical development of vidofludimus calcium |
| I think this is unique and people see that |
| With our funds at the end of the fourth quarter and the recent closing of the first tranche of our three-tranche private placement, we remain well funded, providing us runway through multiple clinical milestones into the third quarter of 2025 |
| The trial results gathered during periods of gluten-free diet and gluten challenge demonstrated meaningful improvement over placebo in four key dimensions of celiac disease of the physiology |
| So we see a huge potential there |
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| So I think it's a difficult question to answer |
| Just two questions from us |
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