Q1 2023 Immunic Inc Earnings Call
Speaker 1: of targeting immune mechanism involved specifically in Cedar disease, appears to be unique among proposed therapeutic approaches, which, for the first part, target either the immune response or antigen processing. We believe this impressive data set provides first-to-middle proof of concept that this oral, first-to-close molecule, INA-8.6 represents an entirely new therapeutic approach, which could be a game changer in the way we treat gastrointestinal disorder such as celiac disease, but also adept colitis, Crohn's disease or erotomyibond syndrome with diarrhea. We are extremely enthusiastic about the potential for this program. Just last Saturday, we published additional news on our ANG-8.6 program. In the E-Post-to-Presentation at the Adjustive Disease Week in Chicago, we were pleased to have ambiot.
Speaker 1: For the first time, I'm the ASS-6 mode of action as a potent modulator of CERC-6, a protein which serves as a transcriptional regulator of intestinal variabfunction and regeneration of back and bowel epithelial. Through its effect on CERC-6, I'm the ASS-6 has shown the ability in animal and clinical studies to restore intestinal variabfunction and bowel wall architecture. That concludes our summary of the first quarter of 2023 and the reasons of frequent highlights. I would now like to hand over to Glenn to provide a financial overview. Glenn, thank you, Daniel.
Speaker 2: I will now review the financial operating results for the first quarter-ended March 31, 2021-23.
Speaker 2: on operating results for the first quarter-ended March 31, 2023. Let me start with the cash overview.
Speaker 2: 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.
Speaker 2: Regarding the operating results.
Speaker 2: Research and development expenses were $23 million for the three months ended March 31, 2023, as compared to $17.4 million for the three months ended March 31, 2022.
Speaker 2: The increase was mainly driven by external development costs related to the ongoing clinical trials of VD fluidimus calcium and IMU-856. It was partially offset by decrease in external development costs related to the phase 2 clinical trials, the VD fluidimus calcium and also of colias, and the IMU-935 program.
Speaker 2: General and administrative expenses were 4.3 million for the three months ended March 31st, 2023, as compared to 4 million for the same period ended March 31st, 2022.
Speaker 2: The slight increase was chiefly driven by travel expenses, and was partially offset by a decrease in non-cash-based stock compensation.
Speaker 2: 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.
Speaker 2: 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.
Speaker 2: The net loss for the three months said in March 31, 2023 was approximately 25.3 million or 58 cents for basic and diluted share. Based on 43.7 million weighted average common shares outstanding compared to a net loss of approximately 20.8 million.
Speaker 2: or 74 cents per basic and deluded share, based on approximately 28.1 million weighted average common shares outstanding for the same period and did March 31st, 2022.
Speaker 2: With that, I'll turn the call back over to Daniel for an outlook on upcoming clinical milestones. Daniel.
Speaker 1: Yeah, thank you Glenn. Let me provide an update on our anticipated upcoming clinical milestones.
Speaker 1: During the first quarter, we continued to progress with the Phyllis calcium for the treatment of myobasturosis. Our ongoing studies include the at an antico-20 phase 3 in short trials in relapsing MS and the phase 2 calipers trial in progressive MS.
Speaker 1: Our current expectation is to report data from the interim by market analysis of the Calibertron in progressive MS and the second model of 2023 and to read our top line data at the end of 2024. The Calibertron is designed to corroborate the neuroprotective potential of the Vlumus Calcium.
Speaker 1: in a progressive patient population and it's successful could be an important additional differentiator for the beautiful miscalculation in this market. Additionally, we look forward to reporting data from the interim analysis of our Phase 3 insure program late next year and to read out the first of our Phase 3 insured trials in Lexi-MS at the end of 2025. As we have stated before, based on the strong clinical activity observed thus far.
Speaker 1: The solidly established safety and vulnerability profile to date, and we just want to must cut some combined anti-inflammatory, anti-viral, and your protective effects, we continue to believe that it has the potential to be a unique treatment option targeted the complex pathophysiology of multiple scurroses.
Speaker 1: With regards to our IMA-ASA 6-Brow, as a result of the overwhelming positive data generated from all phase on B-canico-trial mutations with CDAC disease, we have begun preparing for phase 2 B-canico-trial of IMA-ASA 6 in ongoing active CDAC disease patients.
Speaker 1: We are at the same time considering additional potential chemical applications for this oral first-ing-dark molecule in other gastro-testarital disorders. As stated earlier, we are very excited about this program and believe that I mean 8.6 could present an entirely new and innovative or achievement approach for a number of.
Speaker 1: Master in test of this illness.
Speaker 1: with all the serious consequences associated with immune suppressive therapies.
Speaker 3: Let's bring those to the end of our first quarter 2023 overview. Jessica, please open the webcast for the Q&A session. Thank you Daniel and Glenn for working 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 join the webcast via the Zoom platform, there are two ways to submit.
Speaker 2: Hello, good morning, things for taking our questions. We'll just ask to here. So to our knowledge, this is the first drug targeting start six. Can you just provide additional insight to what gives you confidence?
Speaker 4: A56 to work in this indication and along the same lines, do you see A56 being beneficial in other indications if so which ones? Thanks.
Speaker 1: Yeah, sure. Thank you Andreas for that question. I'm not unexpected. Yeah, this is if you are first mover in an interesting area, of course the challenges doesn't work or not. And I'm very glad that the filmicot file really more or less exactly showed what we have seen in Prokernikov work so before it sold.
Speaker 1: Looking on the phase 1 B data, we have recently shown it's exactly what we have seen. We have seen, for example, protection of villibef even seen increasing the size and some of the patients, despite the two to challenge design of that study.
Speaker 1: pretty impressive data only is told to and the functions as well. So just to remind you that we have seen an increase in vitamin B12 for example. Already despite being short. So that is the wonderful confirmation of what we have seen frequently. I don't talk of it as that we have done a lot of critical work including.
Speaker 1: the SS model and so forth where we have exactly seen those findings. And this is, I think, the nice thing on this model of action is 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.
Speaker 1: So the second question for other indications we have done also the privilege of the work in colitis models. So we believe that the holistic view of the data we have really.
Speaker 1: makes us believe that.
Speaker 1: Crohn's disease and a lot of colliders are indications that 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 and logistically effect for patients to achieve fair rates of offer mission and protecting patients from relaxation on the road.
Speaker 4: Okay, great. Thanks for taking that question. We'll hop back in the queue.
Speaker 3: Yeah, thank you Andreas. Thank you Andreas. So our next guest today is Yasmin Rahimi from Piper Sandler. Yas, please admit yourself and welcome. Hi guys, this is Lauren on for you. A few questions from us first. When are you planning or if you are planning to tighten the guidance to the interim falliper and to age two?
Speaker 5: And then what work is being done in regards to evaluating A56 and other GI diseases? Thanks. Thank you.
Speaker 1: And you need to remember the first one what the interim Calabar no. All right, so we get guidance for 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 on with that.
Speaker 1: And what is included? And what is included? 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 results were which we have planned in the for the interim were looking on NFL and G fabulous for the patients, especially have the state of the out pair off biomarkers.
Speaker 1: which should give us a little of an insight to what extent patients on the treatment group benefit more in patients than placebo and also looking on potential differences in the subcell of patients with primary and secondary progress as a mess.
Speaker 1: So that's what we so far have mentioned in the public.
Speaker 1: Then on the FDA, of course that's an important point, I think the team is currently working on and so we just recently got the data so we try to be very quick now in including the findings in the Phase II protocol and design and then as quick as possible.
Speaker 1: .
Speaker 1: And you use that as a starting point for the discussion with your regulators. And because we think we really want to make sure we have some proper feedback on the line of the trial. You may be familiar with that the FDA released the draft guideline for a CDAC disease phase three studies.
Speaker 1: last year and I think that that's a good starting point for any discussions between the company and the regulators. And the third question was the other GID series 8.5.6? Yeah, I think that's more in the making. I think we definitely for time and resource reasons was definitely focused first.
Speaker 1: on celiac given the I think outstanding data we got from the very small part C of the phase one study encouraging us really to fill that space and also I think the medical need is very high in celiac. There is no treatment approved.
Speaker 1: So this is the all forces driving and excited to watch to the first indication. But of course, the value gets much bigger if you consider Crohn's and Collide's for example as indication. But I think we don't want to make it a pre.
Speaker 1: decision on what we will do as an ex-in-occasion. But from the biology point of view, for example, Krone should be one of those prioritized indications of the future.
Speaker 5: Thank you so much, guys. Thank you, Lauren. Thank you.
Speaker 3: Just as a reminder, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool.
Speaker 6: Our next guest is Matt Katlin from the Laguevork. Matt, please honor to yourselves. Until then. Good morning. Thanks for taking the questions. Just continuing on 8.56 a little bit. I guess based on their recently announced, you know, mode of action, mechanism of action for 8.56.
Speaker 6: you know, combined with the positive data that you had in Syliac. What do you, and what are your thoughts, I guess, given the results for 838 in also ?
Speaker 6: on how you're thinking about moving these two programs forward in the clinic given kind of their overlap in potential indications also the Clyde's, Crohn's disease, et cetera.
Speaker 1: Well, I think there's a synergy between the conscious, as I said, 8-5-6 is not just another shop on the same goal. It's really an optical non-haul of action. And if you look on what the current treatment landscape is delivered and how patients are treated, for example, if you look on your seat, how often patients switch them, please, what they run through. Power.
Speaker 1: Still, the older clinical remission rates for induction trials are. Despite all success, it looks like a little bit of a ceiling of effects.
Speaker 1: There is 80 months for new motorbikes on the inflammation site.
Speaker 1: But HF6 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.
Speaker 1: Of course, it makes no sense to combine something or interest in your CMC and Crohn's worth, maybe the safety 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 funding and resource correction you can't do every trial. So maybe first delivering single-ation activity and then looking beyond makes a lot of sense.
Speaker 1: But I look at, just as I said coming from Chicago from the DW, I see that we have something really important here and which goes beyond the normal piece of innovation and stepwise approach. E5.6 can really be a game changer and this is majestic.
Speaker 1: over optimistic CEO statement here at something where I feel really excitement among the experts we talk to for example.
Speaker 6: 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? Yeah, I think as I said, we have two.
Speaker 1: two different kind of populations in it. So secondary progressives, and they're active and nonactive. The majority is a nonactive, secondary progressives, and primary progressives 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
Speaker 1: through completion of the trial to increase the information content of the study for the full result.
Speaker 7: Okay.
Speaker 6: Thanks. Thanks for taking the questions.
Speaker 3: Thank you, Matt. Thank you, Matt. We have two more, which came in from an anonymous attendee in writing. The first one for 856 will you continue to follow the Phase 1D patients and provide a subsequent update?
Speaker 1: Actually, this is not planned. A good point, I would love to have that, but when we planned this try, 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.
Speaker 3: 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 noble, so can you talk a bit more about the target and that?
Speaker 1: And are there other companies working on this target? Yeah, thanks for this. This is really a new target, therefore there's not a lot ongoing there. There is, to my knowledge, one other company in Israel working on the target but in a different context.
Speaker 1: This all over again originated from scientific observations or phenotypes.
Speaker 1: And it's an epigenetic regulator and it looks like that the molecule 856 binds in a way to 36 as a protein which is causing a couple of different things which then lead to a specific phenotype. The specific phenotype is really renewal of intestinal lining.
Speaker 1: What is the really this process is not sufficient enough to heal the gut and to renew it?
Speaker 1: And therefore damage goes on so it's more a structure effect.
Speaker 1: which we achieved by repairing that model of action.
Speaker 1: Yeah, and it's I think the key is here really that.
Speaker 8: In just a renewal of leads then 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 case one study.
Speaker 9: leads then to restore barrier function and therefore as a consequence also should lead to less these symptoms and ongoing disease and this was nicely shown in this phase one study.
Speaker 10: Thank you. We have one more on the queue here. Tom Smith from SBB Securities. Hey Tom, please I'm in just self.
Speaker 11: Hey guys, good morning. Thanks for taking the questions. The couple on our end. Yeah, first on business development. Can you comment on whether there's been any uptick in the uninterest following the Celiac disease data? And can you just remind us how you're thinking about partnership opportunities broadly across 838 and 856? And then...
Speaker 12: Secondly, we noticed on the pipeline slide that you've added a new program, this IMU 381 for GI diseases. What can you tell us about this program? How are you thinking about development timelines? And when can we expect to hear more on this? Thanks.
Speaker 13: Yeah, I think thank you John for the question. As I said, I had to pledge that close to the data readout and release of the model of action they have attended.
Speaker 14: DDW and also took the opportunity to speak to players in industry and academia, KRLs, but also companies. I think with the concept of 856...
Speaker 15: We somehow my feeling is we hit the sweet spot of what is missing there and something which is not another solution for the same problem but a different way to approach it and my feeling is this is appreciated. I'm in industry and the players we talk to. Of course we can't tell you more details here, but we are probably able to discuss some of the things that we have found in companies.
Speaker 16: My feeling is that that is really resonating well. Maybe you've got the same feedback if you have the opportunity to speak to some of those.
Speaker 17: And from the general BD perspective, I think as I always said, we are open-minded people. We are executing trials because at the end.
Speaker 18: 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 a value perspective for the company.
Speaker 19: And maybe to go 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 the newest thing in the newest addition to the pipeline and as you know we're working broadly in the eye and we have also achieved quite positive data here in the maintenance study from.
Speaker 20: for HBA and we think it is also more resources and we have focused for pre-penicure work to come up with something where we have maybe make benefit of all the learnings and our technical capacity here to optimize molecules and we have...
Speaker 21: developed a series of very potent molecules and just decided that one of those should not be brought into a pre-pinnacle development process. No guidance on that or quickly that goes. This is pretty much a work and we need some time to complete the package. But it's something which nicely will compliment the portfolio and the GI space.
Speaker 22: Okay, got it. That's helpful. Yeah, thanks for taking the questions. Thank you. Thank you, Tom.
Speaker 23: 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. 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 internal analysis of our Phase II Caliper trial of V development calcium in progress In the next
Speaker 24: We also look forward to providing an update on our MU856 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.
Speaker 25: And as always, we are more than happy to answer any additional questions, one-on-one.
Speaker 26: Thank you for joining me in the first quarter 2023 earnings call. The webcast has not concluded. You may now disconnect.