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spk06: Good morning and welcome to Munich's third quarter 2023 earnings call. My name is Jessica Bru, head of investor relations and communications at the Munich. I will also be the moderator on today's call. Speaking on the call are Dr. Daniel Fitt, our chief executive officer and president, as well as Glenn Whaley, our chief financial officer. Please note that all participants will be in this nonly mode and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. If you join 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 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 Immunex's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunix's 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's SEC filings for a more detailed description of the risk factors that may affect Immunix's results and these forward-looking statements. I would now like to turn the call over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel?
spk02: Yeah, 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 third quarter ended September 30th, 2023 in our press release and form 10Q. During the call today, we will walk through our third quarter 2023 and subsequent highlights, financial and operating results, as well as 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 2023 and subsequent highlights. I would like to begin with our Vitoflutimus calcium development program in multiple sclerosis. In August, we completed enrollment of our Phase II caliber trial of Vitoflutimus calcium in patients with progressive multiple sclerosis, or PMS. A total of 467 adult patients with primary MS or active or non-active secondary PMS were randomized to either 45 milligram daily doses of edofutamose calcium or placebo. Patients were enrolled at more than 70 sites in North America, Western, Central, and Eastern Europe. A few months later, in October, we reported overwhelmingly positive interim data from this Phase II caliber trial. In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of PMS, saw 22.4% improvement in serofilament light chain or NFL for Vitoflutimus calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of in this PMS population. A statistically significant difference was found for serum NFL at week 24 between and placebo with a P value of 0.01. If you look at the subtypes of progressive MS to the right, you can appreciate that this difference in NFL at week 24 was consistently shown throughout all subtypes of progressive MS. I would like to point out that we saw a 20% reduction for Vitaflumib's calcium versus placebo in SPMS, meaning the patients with no focal inflammation activity but disease progression. This subtype is a difficult to treat population with no relevant FDA approved therapies available. This slide puts our caliber interim data into the perspective of historical third-party studies in the same progressive MS subtypes. On the left, we display the data for PPMS compared to the oratorial study for oracalizumab, which showed a spread of NFL values between active and placebo at 24 weeks of 12.4%. In the Caliper trial, we observed an 18.8% improvement of active drug over placebo in PPMS at week 24. The results of this phase 3 study led to approval of Ocalizumab for treatment of PPMS. In the center of the slide, you see historical data for secondary progressive MS, both for non-active and active SPMS. In comparison, metaflutamase calcium was able to show a substantial reduction of NFL in both the active and non-active populations. To our knowledge, this is the first time that such a substantial effect in NFL has been shown in non-active SPMS patients, again, which is the PMS subtype with the highest unmet medical need. The right side of the slide shows comparison between our Phase II emphasis data for VF-C in RRMS versus our historical relapsing MS studies to complete the picture. In summary, we believe the clear separation observed for serum NFL for VF-C over placebo in this PMS patient population represents another major step forward for what potentially could be a first-in-class no-one activator for MS. This strong signal also points to a more likely positive outcome of the overall caliber trial, also on clinical relevant endpoints like prevention of disability worsening. In October, Dr. Robert J. Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Caliper programs, presented data from our Phase II emphasis trial of Vitafilmus calcium in RRMS in an e-poster at the joint Actums meeting. As a reminder, Vitafilmus calcium showed an improvement in serum NFL in both treatment arms of 30 and 45 mg over placebo. Just recently, we received a notice of a loan from the USPTO for patent covering the treatment of relapsing MS with a specific dose strength of VF-calcium. This includes a daily dose of about 10 milligram to 45 milligram of VF-calcium and other sorts, as well as the free acid form of the treatment for relapsing MS. Also covering the 30 milligram dosage used in our ongoing twin phase three insurance trials. The claims are expected to provide protection into 2041 unless extended further. This patent significantly bolstered the multi-layered proprietary IP position we have built around our late stage program for patients with MS. Moving to our IMU 856 program. In July, we hosted a virtual Celiac Disease Expert Roundtable to discuss ongoing active celiac disease, or OACD, a serious lifelong autoimmune disorder, and the substantial unmet need for therapeutic solutions. We were grateful and honored to have been joined for this event by the renowned thought leaders from Harvard Medical School, the Mayo Clinic, and Celiac Disease Foundation. During the round table, our chief medical officer, Andreas, also provided an overview of IMU 856 program, including our positive phase one trial results in celiac disease patients released earlier this year in May, which I will highlight again in just a moment. Also in October, we presented two abstracts at the United European Gastroenterology Week, UEGW 2023. My colleague, Dr. Franziska Bojanek, Senior Medical Director at Immunic, presented data from our positive phase 1B clinical trial of IMU856 in patients with celiac disease during a moderated poster session. IMU856 is an orally available and systemically acting small molecule modulator of the target SIRT6. The trial results gathered during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU856 over placebo in four key dimensions of celiac disease pathophysiology. Protection of the gut architecture, improvement of patient symptoms, biomarker response, and enhancement of nutrient absorption. IMU856 was also observed to be safe and well-tolerated in this trial. We believe that this highly encouraging data provides initial clinical proof of concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting the regeneration of bowel architecture. Additionally, Dr. Gerthe Hans from Amsterdam University Medical Center presented data from our Phase 2 CalDOS-1 trial of VFK in ulcerative colitis, or UC. As a reminder, the maintenance phase results from the Carlos I trial demonstrated statistically significant activity of VDL-calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of VDL-calcium in UC and other inflammatory bowel disease indications. Earlier this month, Dr. Bojanek had another opportunity to present the data from our Phase 1B clinical trial of IMUHF6 in patients with celiac disease in the virtual e-poster at the Association of European Celiac Society's General Assembly Conference in Athens, Greece. That concludes our summary for the third quarter 2022 industry and subsequent highlights. I am very happy that the scientific and clinical advancement and progress made across our different programs has been extremely positive during this year. Immunic is leveraging this momentum now in discussions with pharmaceutical companies. For IMU HF6, our goal is to identify a partner who is capable of performing several of their periodic phase two clinical trials. For Vita-Fluidomus calcium, the release of our very good biomarker NFL data has been an important trigger point for partnering discussions with global and regional pharma players. I would now like to hand over the call to Glenn to provide financial overview. Glenn?
spk07: Thank you, Daniel. I will now review the financial and operating results for the third quarter ended September 30th, 2023. Let me start a review of our cash position. We ended the quarter with 59.7 million in cash and cash equivalents. With these funds, we expect to be able to fund operations into September of 2024. Regarding the operating results. R&D expenses were $19.8 million for the three months ended September 30th, 2023, as compared to $16.5 million for the three months ended September 30th, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of beta flutamase calcium and personnel expenses. This was partially offset by a decrease in external development costs related to the IMU 935 and IMU 856 programs. The nine months ended September 30th, 2023. R&D expenses were 63.9 million as compared to 50.5 million for the same period ended September 30th, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of Vitaflumibus calcium, IMU-A56, and personnel expenses. This was partially offset by a decrease in external development costs related to the Phase II clinical trial of beta-fluidose calcium and ulcerative colitis, an IMU 935 program. G&A expenses were $3.8 million for the three months ended September 30, 2023, as compared to $3.6 million for the same period ended September 30, 2022. The slight increase was spread across numerous categories. For the nine months ended September 30, 2023, G&A expenses were $11.9 million as compared to $11.6 million for the same period ended September 30, 2022. The increase was related to an increase across numerous categories, which was partially offset by decrease in personnel expense related to stock compensation expense. Other income was 0.8 million for the three months ended September 30th, 2023, as compared to negative 1.1 million for the same period ended September 30th, 2022. The increase was primarily attributable to a decrease in foreign exchange losses and an increase in interest income as a result of higher interest rates. This was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia. for the nine months ended September 30th, 2023. Other income was 3.8 million as compared to negative 1.8 million for the same period ended September 30th, 2022. The increase was primarily attributable to an increase in interest income as a result of higher interest rates, a decrease in foreign exchange losses, and the research allowance attributable for tax year 2021 from the German Federal Ministry of Finance that was received in 2023. The increase was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia. The net loss for the three months ended September 30th, 2023 was approximately $22.8 million or $0.51 per basic and diluted share. Based on approximately $44.6 million, weighted average common share is outstanding. compared to a net loss of approximately 21.2 million or 69 cents per basic and diluted share based on approximately 30.6 million weighted average common shares outstanding. The same period ended September 30th, 2022. Net loss for the nine months ended September 30th, 2023 was approximately 72 million or $1.63 per basic and diluted share based on 44.2 million weighted average common shares outstanding. compared to a net loss of approximately $63.9 million, or $2.16 per basic and diluted share, based on 29.7 million weighted average common shares outstanding for the same period ended September 30, 2022. With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel?
spk02: Yeah, thank you. Um, thank you. I would like to provide an update on the anticipated upcoming milestones for our clinical development programs. Our current expectation is to report top-line data from our Phase II caliber trial in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase III insure program late next year to read out the first of our identical twin Phase III insure trials in relapsing MS at the end of 2025. As stated before, based on the strong clinical activity of SERPs so far, and VFK solidly established safety and durability profile to date, we believe that the design of the Phase III INSURE program will provide a straightforward path to potential regulatory approval in relapsing MS. If top-line caliper data continues to show neuroprotective effects for PMS patients, we may be able to position VFK as the first oral treatment for non-active secondary progressive MS as well. We also expect the drug's potential first-in-class ability to activate NUR1 to meaningfully benefit the ongoing phase III insured trials in relapsing MS. With regard to our IMU8126 program, as previously reported, we have begun preparing for a phase two clinical trial in ongoing active celiac disease patients. We are very excited about this data and believe IMU8126 could represent an entirely new therapeutic approach to gastrointestinal disorders by promoting the regeneration of bowel architecture without the serious consequences associated with immunosuppressive therapies. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.
spk06: Yeah, thank you, Daniel, and also Glenn for walking us through the third quarter and subsequent highlights, as well as our 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 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. And our first guest today is Caroline Pocher from Wetbush Pack Raw. Caroline, please unmute yourself and go ahead.
spk03: Hi, good morning. This is Caroline on for Andreas. Thank you for taking our questions. Just a few from us. Can you provide any insight into where you are in terms of preparing for the phase two trial for 856 and celiac disease? What do you anticipate the trial design would look like and the timelines for when you think you would initiate the trial?
spk02: Yeah, I think as we have stated before, we have fully evaluated the data, done our homework on completion, the data packages. So this is work in progress right now. maybe some thoughts on the trial design. So likely this will be, should be a treatment phase of three months of treatment in ongoing active celiac disease patients. So try to also make it possible to really conclude data for further testing down the road in pivotal trials. Yeah. More than that, that's where we are right now. We're still in the preparation process.
spk03: Okay, great. And then just one follow up from us. Can you talk about how enrollment is progressing in the insure program and what your target timeline is to complete enrollment?
spk02: Yeah, I think as you know, we usually don't give a a rolling update on the recruitment status, but we keep currently our guidance of completion of enrollment in the way that we are able to read out the first of the insurer studies end of 25 and the second one a couple of months later. So that's all I can say.
spk03: Okay, great. Thank you so much and congrats on the progress. Thank you.
spk06: Our next guest is Liam Heaster from Piper Center. Liam, please unmute yourself and go ahead.
spk04: Hi, I'm calling, I'm asking a question on behalf of Yasmin Rahimi. Just two questions. So my first one is related to the Caliper trial. So what type of data are you expecting to report in April 2025? And what's the bar of success expected for the readout?
spk02: Yeah, that's a good question because I think we have, spoken a lot about this really strong NFL data. So, of course, we will also report NFL as a secondary readout from the study. But I think the most interesting endpoints will be the primary endpoint, which is brain volume change in patients comparing active with placebo as a primary endpoint, or brain atrophy, maybe that's the right word for that. And another, maybe the most important secondary endpoint or key secondary endpoint is confirmed disability worsening. So a change in EDSS score in a confirmed way. So that also will give us, and that's, I think, important, the ability to correlate the changes in biomarkers and clinical endpoints as well at the same time. And so that's all planned to be able to be released in April 25th.
spk04: Great. And is there a specific bar of success that you're looking for
spk02: Well, if you look at what's currently on the market, I think the bar is not super high here. I think we want to see a benefit on all of those endpoints. But if we more or less translate what we have seen in the NFL data set into the full data readout, that would be wonderful. And also a meaningful medical difference in disability prevention would be maybe the best thing, the best win here. specifically looking on those untreatable patient populations, so looking specifically on the secondary progressive patients without focal inflammation, without relapses, so the non-active secondary progressive population, I think any benefit here would be great. And I can't give you really hard numbers here at that point. I think the study was designed to be powered for brain atrophy benefit, so that is something we want to achieve on a statistical readout here.
spk04: Thank you. And then just one more question, just to build off of the previous one, well, actually related to that IMU 856. Have you spoken with the FDA at all with Phase 2 design, or is it still just in the preliminary stage?
spk02: this is an this is a process which is ongoing right now um so usually what we do is we submit um our ing filing and then you have written communication with the regulators on for example protocol design and so forth great thank you thank you liam um the next one here in the queue is matt kaplan from ladenburg tellman matt please unmute yourself and go ahead
spk05: Hey, good morning, guys, and thanks for taking the questions. Just wanted to focus a little bit on your business development goals you mentioned during the prepared remarks. Can you talk a little bit more about that for 856 and also 858?
spk02: Yeah, thank you, Matt. And thank you for that question. Of course, here we have several good assets and good data. So you remember this year was full of good data readouts with the Celiac data, with the CalDOS maintenance data, and now with the Caliper data. And all of these data typically are good data. good points to intensify discussions with companies. It's difficult to really say exactly what comes first, what is the best option, but I think what we're trying is to make sure we use the data in our active discussions to really build a level of trust and a good discussion with potential partners, and based on that then to execute the one or the other deal. So I think the best description would be that we are building more optionality on that and to have also access to some non-dilutive financing sources to fuel the rest of the pipeline based on that.
spk05: Okay, thanks. And then you mentioned in terms of some new IP, what is the new IP that was allowed? What does that get you in terms of exclusivity period?
spk02: Yeah, I think that's a good point. So that patent runs until 38. So it's a patent which covers the dose strength and the treatment of relapsing MS. And it's covered the certain dose strengths here and would protect us until 38 plus patent time extension. But there's a potential to patent time extension there, which would then protect us until 41. No, no, sorry, I mixed that up. No, I think this pan goes to... No, 41 is correct. 41 is correct, yeah. Sorry. So 41 is the right number here. But we have more things in the making, so that's why. And then...
spk05: Okay, great. And then the, you've been, you know, characterizing the, the vitifluminous as well in terms of its, its ability to be a neuro one activator. What does, what does that mean from the point of view of the, the drug as well?
spk02: Yeah, I'm very thankful for this question, because that's maybe the elephant in the room on the MS treatment landscape. I think the thing is that so far in MS, we have good options to treat relapses on the one hand, and we have very good drugs on doing that and reducing inflammation. What is maybe the missing piece is really to protect neurons from. Impairment from cell death by triggers and signals, which are independent of focal information. So, something which, for example, is happening patients once they progress from relapsing MS into secondary progressive MS, where relapses go down, but still disability is there and. With the data we have obtained and in combination with literature data and other groups have done in the scientific community. We believe that no 1 is a target, which may give us here a signal, a protective signal for neurons in a way, which is independent of that focal information. And combining the new 1 activation now with our known and reported inhibition. I think the strike has a kind of like a double strike on the 2 important pieces for treating relapses relapsing MS here on inflammation and direct neuroprotection. Whereas the in it also offers now, and this was, I think the conclusion we draw from the NFL. reduction also offers a treatment option for those so far untreatable patients of PMS, specifically primary progressive and non-active secondary progressive MS.
spk05: And just to be clear, this is something that's totally separate from the DHO-DH inhibiting effects and unique to glutathiaminase and not characteristic of other DHO-DH inhibitors.
spk02: Exactly. It's not linked to DHO-DH. It's something which is a property of the molecule and its binding ability to both, to DHO-DH on one hand and to NO-1 on the other hand. We have published a paper earlier this year together with our academic collaborators around Daniel Merck showing that the drug directly binds. There's an ICT data there in this paper showing that the molecule is directly binding to NO1 as a protein.
spk05: Perfect. Great. Thanks, Daniel. Pleasure.
spk06: Thank you, Matt. yeah maybe to follow up on matt's question regarding bd we received two questions here in writing via the q a tool which go into a similar direction and the first one please describe your strategy for maintaining adequate liquidity to see these opportunities through to fruition and the second one create clinical results what's the plan to raise cash maybe then you can give your strategic Thoughts here again?
spk02: Yeah, of course, that's an important piece to make sure we earn the fruits at the end of the day. And therefore, we think it's worth to follow different ways to fund the company for the next years. And as I said, one of the important pieces could be business development activity partnering on one of the assets or maybe even on two or some territorial partnerships could also be an option. Another option is kind of non-dilutive financing, for example, for project financing. And the third one could be any kind of equity financing. So I think we keep those options on the table, but also considering what's going on in the capital markets.
spk06: Yeah, thank you, Daniel. Our next live guest here is Tom Smith from Lering Partners. Tom, please unmute yourself and go ahead.
spk00: Great. Hey, guys, good morning. Thanks for taking the questions. Good morning. I was just wondering if there's any update on the early pipeline programs like IMU381, and do you have any visibility on timing for advancing this program into the clinic or when we can expect to learn more on this asset?
spk02: Yeah, thank you, Tom, for the question. I think the program was initiated based on positive data we generated from the CALDOS trial. But clearly the company is prioritizing now the clinical programs right now for time and resource reasons. So we have all the preparation work ongoing, part of that completed. But clearly the resource focus and the progress
spk00: Got it. That's helpful. And if I could just follow up on an earlier question, just on the 856 DLAX study, are there any specific gating factors, Daniel, that you would call out, I guess, in terms of getting that program off the ground and getting the IND cleared and starting to enroll patients there?
spk02: Now, as mentioned, we are preparing a trial that means also physically preparing the trial on material side. So production of material for the trials and so forth. And we have also stated that our priority will be celiac disease as first indication in trying to look at. But it's also a little bit related to the other question we have answered already today is that we also think about partnering could make sense to also broaden development beyond celiac disease. So this is something which is also an important aspect to consider in any priorities, speed going forward and so forth with the program. So, so far, this is still all in preparation, also the interaction with the regulators. And this is not just limited to the US, it goes also into European regulators to really make sure we have a good trial prepared. Also discussing with our KOL network on the different aspects of having a good trial set up to make sure we read out proper data, we don't, over our own feet here. You can learn a lot from other trials in that world of celiac disease treatment. So I think it's going forward. And as soon as we are making the next steps, I think we will update the market on that.
spk00: Understood. That makes sense. All right. Thanks for taking the question. Thank you, Tom.
spk06: Thank you, Tom. Just as a reminder, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. And we have one more here who wants to be with us live, which is Mayank Mamthani from B. Riley. Mayank, please unmute yourself.
spk01: Hi, this is actually William from Mayank today. Congratulations on the really nice third quarter results. I think just one from us on your NFL data from Caliper, you know, A, it looks really, really nice. You've got really nice data across all subpopulations, including the broader PMS population. I'm curious slightly about the active SPMS. It's got a pretty low end there. And I'm just kind of curious how we should think about the sort of the smaller number there. But then also, when we're doing, when we get to the final readout, Will you be looking at these subpopulations and trying to figure out exactly your path forward, potentially choosing one subset over the other for then going into the phase three or potentially for partnering activities? Are you really trying to keep this as a PMS, more of a broader drug, just trying to sort of figure out your path forward there? Appreciate it.
spk02: Thank you for that question. I think it's something important we should touch on because I think this is more what is the track towards any regulatory approval and how do we prioritize things? I think we would have been very excited specifically on the data for the, as I mentioned for the non active population, which is really the 1 in the population and the non active secondary progressive populations. The active populations had responded very nicely to NFL, but I think in the, in the US, in the, in the space of the regulated treatments, they fall into basically. So, therefore. If we focus on US treatments, this is covered by our insure study basically. And therefore, if we focus on PMS, we will mainly discuss and go forward with those patients where there is little or no relapse activity remaining. By the way, this was the, you mentioned the subpopulation of active patients, but also reconfirms what we have seen in the emphasis phase two study on those patients. So, I think it's also a nice confirmation of the RMS population that you have generated earlier. Um, but if it's, if it comes to the, to the, to the best indication going forward, I think we definitely need to and want to pick the best choice. For regulatory approval, and I think this is more or less dictated by 2 things by our data and the, and I think this clearly is in non active secondary progressive. There is no, no real treatment available right now for patients and our data was. so good there as well on the NFL side that we think it is likely the indication of choice. Of course, we first want to look on the data in April 25 to see if we see the same clinical signals as we have seen on the NFL.
spk01: We don't. I appreciate that. It's very helpful and congratulations again.
spk06: Thank you, Will.
spk01: Thank you.
spk06: Yeah, this actually concludes our question and answer session. I would like to turn the conference back over to Daniel for any closing remarks.
spk02: Yeah, thanks, Jessica. And thank you to today's attendees for your insightful questions. In summary, with the completion of enrollment of our phase 2 caliber trial, the positive intern data from the caliber trial, as well as the continuation of enrollment of the ensure phase 3 trial. We have continued to make tangible progress. On the clinical development of calcium during this past quarter as progress is made. We also expect. to provide an update on our preparations for a Phase II clinical trial of IMUHF6 in patients with ongoing active celiac disease. With that, I would like to close today's call. Thank you very much for joining, and we are happy to answer any additional questions one-on-one.
spk06: Thank you for joining in the next third quarter 2023 earnings call. The call has now concluded. You may now disconnect.
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