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spk05: Good morning and welcome to Munich's first 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 listen-only 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 the Munich'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 or future events. Please refer to Munich's SEC filings for a more detailed description of the risk factors that may affect the Munich's results and these forward-looking statements. I would now like to turn the webcast over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel?
spk03: Yeah, thank you, Jessica. I would like to welcome everybody to Immunix's first quarter 2023 earnings call. This morning, we announced our financial results for the first quarter ended March 31st, 2023, and provided an update on our clinical development progress and upcoming clinical milestones. During the webcast today, we will walk through our first quarter 2023 and subsequent highlights, financial and operating results, as well as anticipated clinical milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with the review of our first quarter 2023 and subsequent highlights. As a reminder, in February, we hosted a celiac disease R&D webcast, which included two renowned experts, namely Dr. Joseph Murray from Mayo Clinic in Rochester and Dr. Michael Schumann from the Charité Berlin. Topics discussed included the dynamics of this multifactorial complex autoimmune disease, including the characteristics of celiac disease, immune stimulation and its connection to clinical symptoms, the role of the epithelium barrier and the pathogenesis of the disease, as well as current and potential treatment options. The R&D webcast was intended to lay the groundwork of our clinical phase 1b readout of IMU856 in celiac disease patients. As most of you know, the data set published later on in May provided excellent clinical proof of concept data for IMU856, which I will get to in a few moments. Also of note, in February, Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our Ensure and Caliper programs in multiple sclerosis, presented data from the blinded and open-label extension parts of our Phase II emphasis trial of Vitoflutimus calcium in relapsing remitting MS at the prestigious Actrems Forum 2023. I would like to point out again that the data was favorable compared to historical data for current MS treatments and showed that long-term treatment with Vitoflutimus calcium was associated with a low rate of confirmed disability worsening over time. This data nicely underlined Vitoflutimus calcium's neuroprotective potential in addition to its already established anti-inflammatory and antiviral effects. Last month, we reported positive data from the maintenance phase of our Phase 2b CalDOS1 trial of BFHC in patients with moderate to severe ulcerative colitis, or UC. These results were extremely encouraging as they demonstrated statistically significant activity of BFHC as compared to placebo, while confirming the very favorable safety and probability profile observed in other trials. It is important to note that we believe the maintenance phase data confirms vitoflutimib's calcium activity in the absence of chronic corticosteroid co-administration. As previously announced, based on this encouraging outcome, we are exploring a variety of value-creating point options for the UC program and other inflammatory bowel disease indications. I also, once again, would like to welcome Dr. Richard Ruddick to our board of directors. Rick has a stellar background, including decades spent as a clinical expert in multiple sclerosis and as a clinical trialist who has overseen multiple successful pivotal studies. We are delighted to have Rick on our board and look forward to working with him as we continue to progress the development of edoflutimus calcium in multiple sclerosis, as well as our other pipeline programs. I also want to thank Dr. Vincent Osipov, who is stepping down from our board at the end of June for his dedication to Immunic and his valuable guidance over the past seven years. I speak for our entire team when I say we wish him well in his future endeavors. As many of you are aware, on May 4th, we announced highly positive results from the Part C portion of our Phase I clinical trial of IMU-856 in patients with celiac disease. This data significantly exceeded our expectations. IMU-856 demonstrated consistent and meaningful clinical improvements of placebo in four key dimensions of celiac disease pathophysiology, specifically protection of gut architecture, improvement of patient symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Most importantly, the observed protection of the lining of the gut and intestinal villi from gluten-induced destruction, independent of targeting immune mechanism involved specifically in celiac disease, appeals to be unique among proposed therapeutic approaches, which, for the first part, target either the immune response or antigen processing. We believe this impressive dataset provides first-in-little proof of concept that this oral, first-in-class molecule, INU856, represents an entirely new therapeutic approach which could be a game changer in the way we treat gastrointestinal disorders such as celiac disease, but also alternative colitis, Crohn's disease, or irritable bone syndrome with diarrhea. We are extremely enthusiastic about the potential for this program. Just last Saturday, we published additional news on our IMU856 program. In an e-poster presentation at Digestive Disease Week in Chicago, we were pleased to have unveiled, for the first time, IMU856 mode of action as a potent modulator of SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Through its effect on SIRT6, INO856 has shown the ability in animal and early clinical studies to restore intestinal barrier function and bowel wall architecture. That concludes our summary of the first quarter 2023 and recent subsequent highlights. I would now like to hand over to Glenn to provide a financial overview. Glenn?
spk00: Thank you, Daniel. I will now review the financial and operating results for the first quarter ended March 31st, 2023. Let me start with the cash overview. We ended the first quarter with $97.1 million in cash and investments, which we expect will be sufficient to fund operations into the fourth quarter of 2024. Regarding the operating results, research and development expenses were $23 million for the three months ended March 31st, 2023, as compared to $17.4 million for the three months ended March 31, 2022. The increase was mainly driven by external development costs related to the ongoing clinical trials of idiflutimus calcium and IMU856, and was partially offset by a decrease in external development costs related to the Phase II clinical trials of idiflutimus calcium and ulcerative colitis and the IMU935 program. General and administrative expenses were $4.3 million for the three months ended March 31, 2023, as compared to $4 million for the same period ended March 31, 2022. This slight increase was chiefly driven by travel expenses and was partially offset by a decrease in non-cash-based stock compensation. Other income was $2 million for the three months ended March 31st, 2023, as compared to $0.6 million for the same period ended March 31st, 2022. The increase was principally attributable to an increase in German tax incentives and the interest income and was partially offset by reductions in foreign exchange gains and R&D tax incentives for clinical trials in Australia. The net loss for the three months ended March 31st, 2023 was approximately 25.3 million or 58 cents per basic and diluted share based on 43.7 million weighted average common shares outstanding compared to a net loss of approximately 20.8 million or 74 cents per basic and diluted share based on approximately 28. 0.1 million weighted average common shares outstanding for the same period ended March 31st, 2022. With that, I'll turn the call back over to Daniel for an outlook on upcoming clinical milestones. Daniel?
spk03: Yeah, thank you, Glenn. Let me provide an update on our anticipated upcoming clinical milestones. During the first quarter, we continued to progress for the treatment of multiple sclerosis. Our ongoing studies include the identical twin phase three insured trials in relapsing MS and the phase two caliber trial in progressive MS. Our current expectation Is to report data from the interim by market analysis of the caliber trial in progressive and the 2nd, half of 2023 and to read our top line data at the end of 2024. The caliber trial is designed to corroborate the neuroprotective potential of calcium in a progressive patient population. And if successful could be an important additional differentiator, but if we definitely miss calcium in this market. Additionally, we look forward to reporting data from the interim analysis of our phase three insured program late next year and to read out the first of our phase three insured trials in relapsing MS at the end of 2025. As we have stated before, based on the strong clinical activity observed thus far, the solidly established safety and tolerability profile to date, and with the flutemus calcium combined anti-inflammatory, antiviral, and neuroprotective effects, we continue to believe that it has the potential to be a unique treatment option targeted the complex pathophysiology of mitobosclerosis. With regards to our IMU856 program, as a result of the overwhelmingly positive data generated from our Phase 1B clinical trial in patients with celiac disease, we have begun preparing for a Phase 2B clinical trial of IMU856 in ongoing active celiac disease patients. We are at the same time considering additional potential clinical applications for this oral first-in-class molecule in other gastrointestinal disorders. As stated earlier, we are very excited about this program and believe that INU856 could present an entirely new and innovative oral treatment approach for a number of gastrointestinal diseases without the serious consequences associated with immunosuppressive therapies. This brings us to the end of our first quarter 2023 overview. Jessica, please open the webcast for the Q&A session.
spk05: Thank you, Daniel and Glenn, for walking us through the first quarter 2023 and the subsequent highlights and also our upcoming clinical milestones. 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, please use the raise hand function of the Zoom portal to queue your question. Our first question today comes from Andreas Agiridis at Wetbush. Andreas, hello and please unmute yourself.
spk02: hello and good morning and thanks for taking our questions um we'll just ask uh two here so uh to our knowledge uh this is the first drug uh targeting uh SART6 can you just provide additional insight into what gives you confidence uh 856 could work in this indication and along the same lines do you see 856 being beneficial and other indications if so which ones thanks
spk03: Yeah, sure. Thank you. Andreas for for that question. I'm not unexpected. Yeah, this is if you're a 1st mover in an interesting area. Of course, the challenge is, does it work or not? And I'm very glad that the clinical trial really more or less exactly showed what we have seen in preclinical works of before. So. Looking on the phase 1B data we have recently shown, it's exactly what we have seen. So we have seen, for example, protection of villi. We have even seen increase in villi size in some of the patients, despite the gluten challenge design of that study. So pretty impressive data on the histology and the functions as well. So just to remind you that we have seen an increase in vitamin B12, for example. already, despite being a short trial. So that is a wonderful confirmation of what we have seen preclinically. And on top of that, as I said, we have done a lot of preclinical work, including the SS model and so forth, where we have exactly seen those findings. And this is, I think, the nice thing on this mode of action. It's very different from what else is there, and it's not including any kind of immunosuppression. So we think This really could start could be the start of a very broad activity. The 2nd question for other indications we have done most of the work in colitis models. So, we believe that the holistic view of the data we have really. Crohn's disease and ulcerative colitis are indications where clearly patients should benefit as well from such a treatment. And given that it's a completely different approach from everything out there, it could really be a very nice synergistically effect for patients to achieve higher rates of remission and protecting patients from relapses down the road.
spk02: Okay, great. Thanks for taking our question. We'll hop back in the queue. Yeah, thank you, Andreas.
spk05: Thank you, Andreas. Our next guest today is Yasmin Rahimi from Piper Sandler. Yas, please unmute yourself and welcome.
spk04: Hi, guys. This is Lauren on for Yas. A few questions from us. First, when are you planning or if you are planning to tighten the guidance to the interim caliber and 2H23? And can you remind us of the utility of this key data? And then our second question, when do you expect to have the meeting with the FDA for the phase 2B design details? And do you think that 2024 will be an opportunity to share data from this study? And then what work is being done in regards to evaluating 856 and other GI diseases? Thanks.
spk03: Thank you. I need to remember the first question.
spk05: The first one was the interim caliber.
spk03: All right. So we gave guidance for a second half of this year. We keep it as it is right now. If we have more knowledge about precise timing, we will come out with that.
spk05: And what is included and what is included?
spk03: Okay. Yeah. So, clearly the focus of this interim is on biomarkers. And I think we stated that in some of the calls earlier. That, I think the key readouts were, which we have planned in the, for the interim were. looking on NFL and GFAP levels for the patients just to have the state-of-the-art pair of biomarkers, which should give us a little bit of an insight to what extent patients on the treatment groups benefit more than patients on placebo, and also looking on potential differences in the subset of patients with primary and secondary progressive MS. So that's what we so far have mentioned in the public. Then on the FDA, of course, that's an important point. I think the team is currently working on, so we just recently got the data. So we try to be very quick, you know, in including the findings in the phase two protocol and design. And then as quickly as possible, submit our IND filing in the S. and use that as a starting point for the discussion with the regulators. And because we think we really want to make sure we have some proper feedback on design of the trial, you may be familiar that the FDA released a draft guideline for celiac disease phase three studies last year. And I think that that's a good starting point for any discussions between the company and the regulators.
spk05: And the 3rd question was other GI diseases.
spk03: Yeah, I think that's more in the making. I think we definitely for time and resource reasons. We'll definitely focus 1st on given the. I think outstanding data we got from this very small. Part C of the phase 1 study, encouraging us to fill that space. And also, I think. The medical need is very high in Celiac. There is no treatment approved. So this is all forces driving excitement here towards Celiac as a first indication. But of course, the value gets much bigger if you consider Crohn's and colitis, for example, as indications. But I think I don't want to make a pre-decision on what we will do as the next indication. But from the biology point of view, for example, Crohn's should be one of those prioritized indications in the future.
spk04: Great. Thank you so much, guys. Thank you, Loren.
spk03: Thank you.
spk05: Just as a reminder, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. Our next guest is Matt Kaplan from Leidenberg. Matt, please unmute yourself, and hello.
spk06: Hi, good morning. Thanks for taking the questions. Just continuing on 856 a little bit, I guess based on the recently announced mode of action, mechanism of action for 856, and combined with the positive data that you had in Celiac, And what are your thoughts, I guess, given the results for 838 in ulcerative colitis on how you're thinking about moving these two programs forward in the clinic, given kind of their overlap and potential indications, ulcerative colitis, Crohn's disease, et cetera?
spk03: Well, I think there's a synergy between the concepts. As I said, 856 is not just another shot on the same goal. It's really an article on all of action. And if you look on what the current treatment landscapes delivered and how patients are treated, for example, if you look on UC, how often patients switch therapies, what they run through, how still low the clinical remission rates for induction trials are. Despite all success, it looks like a little bit of a ceiling of effects. There is a demand for new mode of actions on the inflammation side. But 856 really comes from a very different place. So I think we can add more than just another approach. It's something which can fundamentally, my thought is can be combined with all of the current treatments. Of course, it makes more sense to combine something like HF6 in UC and Crohn's with maybe the safest treatments which are currently available. So there's a lot of potential. I think in the perfect world, I would just combine it both. That's more a funding and resource question. You can't do every trial. So maybe first delivering single agent activity and then looking beyond makes a lot of sense. But look, just as I said, coming just from Chicago, from DDW, I see that we have something really important here, which goes beyond the normal piece of innovation and stepwise approach. 856 can really be a game changer. And this is not just over-optimistic CEO statement here. It's something where I feel really excitement among the experts we talk to, for example.
spk06: Okay, that's helpful. And then you spoke about the interim look on the Caliper study. How could the interim results impact the conduct of the Caliper study going forward?
spk03: Yeah, I think, as I said, we have two different kind of populations in it. So secondary, progressive, and they're active and non-active. The majority is non-active, secondary progressive, and primary progressive patients. And We don't know what we see there, what we will see there, because they all, all these diseases are a little bit different and the history of patients is different. So we will, as I said, we will compare placebo with the active ones, but also between the different active ones that we see more effects on one or the other subpopulation. And therefore we, for example, may prioritize specific set of some indications during completion of the trial to increase the information content of the study for the full readout.
spk06: Okay. Thanks. Thanks for taking the questions. Thank you, Matt.
spk05: Thank you, Matt. We have two more which came in from an anonymous attendee in writing. The first one, 4856, will you continue to follow the Phase 1b patients and provide a subsequent update?
spk03: Actually, this is not planned. A good point. I would love to have that. But when we planned this trial, it was just intended to demonstrate proof of concept. So as you know, all of the phase two studies we are running, we have these follow-ups here. In this phase one, we don't have that.
spk05: okay thank you and the second one also i think the target disclosure was a nice surprise to a lot of folks it does seem quite novel so can you talk a bit more about the target and there and are there other companies working on this target yeah yeah um thanks for this this is really a new target therefore there's a lot a lot uh ongoing there there is to my knowledge one other company in israel um working on the target but in a different context
spk03: here this our work really originated from um from scientific observations of phenotypes and it's an epigenetic regulator and it looks like that the molecule 856 binds in a way to to 36 as a protein which is causing a couple of different things which then lead to a specific phenotype and the specific phenotype is really renewal of intestinal lining You may know that the renewal is a normal physiological process. So in a healthy human, intestinal stem cells are replicating once a day in average. And this is a normal process. But in patients with these GI disorders, this process is not sufficient enough to heal the gut and to renew it. and therefore damage goes on. So it's more a structural effect which we achieve by repairing that mode of action. Yeah, and I think the key is here really that intestinal renewal leads them to restore barrier function and therefore as a consequence also should lead to less symptoms and ongoing disease. And this was nicely shown in this phase one study. Yeah.
spk05: Thank you. We have one more in the queue here. Tom Smith from SVB Securities. Hey, Tom, please unmute yourself.
spk01: Hey, guys. Good morning. Thanks for taking the questions. Just a couple on our end. Yep. First on business development. Can you comment on whether there's been any uptick in inbound interest on the celiac disease data? And can you just remind us how you're thinking about partnership opportunities broadly across 838 and 856? and then um secondly we noticed on the pipeline side that you've added a new program this uh imu 381 for gi diseases what can you tell us about this program how do you think about development timelines and uh when can we expect to hear more on this thanks yeah i think um thank you john for the question and as i said i had the pleasure that close to the data reload and release of the model of action data we have attended
spk03: um ddw and also took the opportunity to speak to players in industry and academia kls but also companies i i think With the concept of 856, my feeling is we hit the sweet spot of what is missing there. It's something which is not another solution for the same problem, but a different way to approach it. And my feeling is this is appreciated among industry and the players we talk to. Of course, we can't tell you more details here publicly about discussions with any pharma companies, but my feeling is that That is really resonating. Well, maybe you get the same feedback if you have the opportunity to speak to some of those. And from the general perspective, I think, as I always said, we on that end, we are open minded people. We are executing trials because at the end. BD is driven by data and the potential of molecules and how they fit into the company's strategy and maybe also needs on the commercial side. Therefore, we are open on both ends. And decisions here will be based on what is available, what's on the table, and what is attractive on the value perspective for the company. It's maybe too early to give more details on that, but I think this is something where I feel personally very excited about. Then on the 351, you mentioned this is. This is the newest thing, newest addition to the pipeline and as, you know, we are working broadly in and we have also achieved quite positive data here in the maintenance study from. Or, um, and we think. It dissolves more resources, um, and. Yeah, focus for preclinical work to come up with something where we have maybe make benefit of all the learnings and our. technical capacities here to optimize molecules and we have developed a series of very important molecules and just decided that one of those should now be brought into a preclinical development process. No guidance on that, how quickly that goes. This is preclinical work and we need some time to complete the package, but it's something which nicely will complement the portfolio in the GIA space.
spk01: Okay, got it. That's helpful. Yeah, thanks for taking the questions. Thank you, Tom.
spk05: Thank you, Tom. Good. Thank you to all the questions. This concludes our question and answer session. I would like to turn the webcast back over to Daniel for any closing remarks.
spk03: Yeah, thanks, Jessica. And thank you to today's participants for your great questions and good discussion. In summary, we look forward to reporting data in the second half of this year from the interim analysis of our Phase II caliper trial of VF calcium in progressive MS. We also look forward to providing an update on our MU HF6 program, hopefully very soon. We remain well-funded with $97.1 million in our balance sheet providing us runway into the fourth quarter of 2024. With that, I would like to close today's call. Again, thank you very much for joining. And as always, we are more than happy to answer any additional questions one-on-one.
spk05: Thank you for joining in Munich's first quarter 2023 earnings call. The webcast has now concluded. You may now disconnect.
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