Immunic Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 11, 2023

There are 7 speakers on the call.

Operator

Good morning, and welcome to Munich's Q1 2023 Earnings Call. My name is Jessica Brew, Head of Investor Relations and Communications at the Munich. I will also be the moderator on today's call. Speaking on the call are Doctor. Daniel Fitt, our Chief Executive Officer and President as well as Glenn Whaley, our Chief Financial Officer.

Operator

Call. 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 2 ways to submit questions. You can either submit your questions in writing via the Q and A tool of the Zoom portal.

Operator

Call. Before we begin, I would like to remind you call. 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 debt could cause Munich's actual results to differ materially from those discussed here.

Operator

Please note that these forward looking statements reflect Munich's opinions only as of 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. Call. Please refer to Munich's SEC filings for a more detailed description of the risk factors that may affect Munich's results and these forward looking statements. Call. I would now like to turn the webcast over to our CEO and President, Doctor.

Operator

Daniel Firth, to begin the presentation. Daniel? Call.

Speaker 1

Yes. Thank you, Jessica. I would like to welcome everybody to EM Munich's Q1 2023 earnings call. Call. This morning, we announced our financial results for the Q1 ended March 31, 2023 and provided an update on our clinical development progress and upcoming clinical milestones.

Speaker 1

During the webcast today, we will walk through our Q1 2023 and subsequent highlights, financial and operating results as well as anticipated clinical milestones. As Jessica noted, call. After the presentation, you will have the opportunity to ask questions. Let's start with a review of our Q1 2023 and subsequent adds. Call.

Speaker 1

As a reminder, in February, we hosted a senior disease R and D webcast, which included 2 renowned experts, namely Doctor. Joseph Murray from Mayo Clinic in Rochester call. And Doctor. Michael Schumann from the Charite T. Berlin.

Speaker 1

Topics discussed included the dynamics of this multifactor complex autoimmune disease, including the characteristics of celiac disease, immune stimulation and its connection to clinical symptoms, The role of the epithelium barrier in the pathogenesis of the disease as well as current and potential treatment options. Call. The R and D webcast was intended to lay the groundwork of our clinical Phase Ib readout of annual HFAM6 in celiac disease patients. Call. As most of you know, the data set later on in May provided excellent clinical proof of concept data for Hanger 856, which I will get call.

Speaker 1

Also of note, in February, Doctor. Bob Fox from Cleveland Clinic, Who is also the coordinating investigator of our ENSURE and CALIBOR product, amyloidosclerosis, presented data from the blinded and open label extension part of our Phase II EMFISIS trial of idofludimus calcium in relapsing remitting MS. At the prestigious ACTRIMS 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 erythematous calcium was associated with a low rate of infant disability worsening over time. This data nicely underlined the Plutimus calcium's neuroprotective potential in addition to its already established anti inflammatory and antiviral effects.

Speaker 1

Call. Last month, we reported positive data from the maintenance phase of our Phase 2b CALDOSE I trial of vedofolimus calcium call. In patients with moderate to severe ulcerative colitis or NUC. These results were extremely encouraging as they demonstrated statistically significant activity of leproludus calcium as compared to placebo, while confirming the very favorable safety and probability profile of certain other trials. Call.

Speaker 1

It is important to note that we believe the maintenance phase data contributes to the calcium's activity in the absence of corticosteroid coadministration. Call. As previously announced, based on this encouraging outcome, we are exploring a variety of validating points options call for the UC program and other inflammatory bowel disease indications. I also once again would like to welcome Doctor. Richard Reich call to our Board of Directors.

Speaker 1

Rick has a stellar background, including DK's brand as an expert in multiple sclerosis call as we continue to progress the development of idiofruidimus calcium in mitral sclerosis as well as our other pipeline programs. Call. I also want to thank Doctor. Vincent Ossipoff, who is stepping down from our Board at the end of June for his dedication to Munich and his valuable guidance over the past 7 years. I speak for our entire team when I say, wish him well in his future endeavors.

Speaker 1

Results from the Part C portion of our Phase 1 clinical trial of IMU-eight fifty six in patients with celiac disease. This data significantly exceeded our expectations. IMBL 856 demonstrated consistent And meaningful clinical improvements of placebo in 4 key dimensions of celiac disease pathophysiology, question. IMU856 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 appears to be unique among proposed therapeutic approaches, call, which for the first part target either the immune response or antigen processing.

Speaker 1

We believe this impressive data set provides first clinical proof of concept that this oral 1st in class molecule, IMU-eight fifty six, represents an entirely new therapeutic approach, call, which could be a game changer in the way we treat gastrointestinal disorders such as celiac disease, but also ulcerative colitis, Crohn's disease or irritable bowel syndrome with diarrhea. We are extremely enthusiastic about the potential for this program. Call. Just lastly, we published additional news on our AMU856 program. In the e poster presentation call.

Speaker 1

At Digestive Disease Week in Chicago, we were pleased to have unveiled for the first time IMO APAV6 mode of action as a potent modulator of cirrhosis, Through its effect on 76, IMO-eight fifty six has shown the ability in animal and allergic displays to restore intestinal barrier function and bowel wall architecture. That concludes our summary of the Q1 2023 and recent subsequent highlights. Call. I would now like to hand over to Glenn to provide a financial overview. Glenn?

Speaker 2

Thank you, Daniel. Call. I will now review the financial and operating results for the Q1 ended March 31, 2023. Let me start with the cash overview. Call.

Speaker 2

In the Q1, we generated $96,100,000 in cash and investments, which we expect will be sufficient to fund operations into the Q4 of 2024. Call. Regarding the operating results, research and development expenses were $23,000,000 for the 3 months ended March 31, 2023, call as compared to $17,400,000 for the 3 months ended March 31, 2022. The increase was mainly driven by external development costs related to the ongoing clinical trials of vidifludimus calcium and IMU-eight fifty six and was partially offset call. By decrease in external development costs related to the Phase 2 clinical trials of edifelucamis calcium and ulcerative colitis and the IMU-nine thirty five program.

Speaker 2

General and administrative expenses were $4,300,000 for the 3 months ended March 31, 2023, call as compared to $4,000,000 for the same period ended March 31, 2022. The slight increase was chiefly driven by travel expenses, It was partially offset by a decrease in non cash based stock compensation. Other income was $2,000,000 for the 3 months ended March 31, 2023 as compared to $600,000 for the same period ended March 31, 2022. Call. The increase was principally attributable to an increase in German tax incentives and the interest income call.

Speaker 2

And was partially offset by reductions in foreign exchange gains and R and D tax incentives for clinical trials in Australia. Call. The net loss for the 3 months ended March 31, 2023 was approximately $25,300,000 or $0.58 per basic and diluted share. Call. Based on 43,700,000 weighted average common shares outstanding compared to a net loss of approximately 20,800,000 Our $0.74 per basic and diluted share based on approximately 28,100,000 weighted average common shares outstanding for the same period ended March 31, 2022.

Speaker 2

With that, I'll turn the call back over to Daniel for an outlook upcoming clinical milestones. Daniel?

Speaker 1

Yes. Thank you, Glenn. Let me provide an update on our anticipated upcoming clinical milestones. Call. During the Q1, we continued to progress VDFLIMUS calcium for the treatment of multiple sclerosis.

Speaker 1

Our ongoing studies include The Atlantica Twin Phase III's INSURE trials in lapsing MS and the Phase II CALIBOR trial in progressive MS. Call. Our current expectation is to report data from the interim biomarker analysis of the KELA-twelve progressive MS in the second half of twenty twenty three and to read our top line data at the end of 2024. The CATALIPA trial is designed to corroborate the neuroprotective potential call of beta blue blood glucose calcium in a progressive patient population and if successful, could be an important additional differentiator quarterly results. Additionally, we look forward to reporting data from the interim analysis of our Phase III insured program call later next year and to read out the first of our Phase III's insured trials in relapsing MS at the end of 2025.

Speaker 1

Call. As we have stated before, based on the strong clinical activity observed thus far, the solidly established safety and tolerability profile to date. And vidofilumascarsum combined anti inflammatory antiviral and neuroprotective effects, call. We continue to believe that it has the potential to be a unique treatment option targeted at the complex pathophysiology of mitraloposclerosis. Call.

Speaker 1

With regards to our NHF6 program, as a result of the overwhelmingly positive data generated from our Phase Ib clinical trial in patients with celiac disease, We have begun preparing for Phase IIb clinical trial of IMU-eight fifty six in ongoing active celiac disease patients. Call. We are at the same time considering additional potential clinical applications for this oral first in class molecule in other gastrointestinal disorders. Call. As stated earlier, we are very excited about this program and believe that IMU-eight fifty six could present an entirely new and innovative oral treatment approach for a number of gastrointestinal diseases without the serious consequences associated with immunosuppressive therapies.

Speaker 1

Call. This brings us to the end of our Q1 2023 overview. Jessica, please open the webcast for the Q and A session.

Operator

Call. Thank you, Daniel and Glenn, for walking us through the Q1 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 2 ways to submit questions. Call.

Operator

Our first question today comes from Andreas Arderidis at Wedbush. Andreas, hello, and please unmute yourselves.

Speaker 3

Hello and good morning. Thanks for taking our questions. We'll just ask 2 here. So to our knowledge, This is the first drug targeting SARS-six. Can you just provide additional insight into what gives you confidence 856 could work in this indication.

Speaker 3

And along the same lines, do you see 856 being beneficial in other indications? If so, which ones? Thanks.

Speaker 1

Yes, sure. Thank you, Andreas, for that question. I'm not unexpected. Yes, this is if you're a first mover in an interesting area, of course, it tells us does it work or not. Call.

Speaker 1

And I'm very glad that the clinical trial really more or less exactly showed what we have seen in preclinical workflow before. So Looking on the Phase Ib data, we have recently shown it's exactly what we have seen. So we have seen, for example, Protection of VILI. We have even seen increasing VILI size in some of the patients flighty glucan challenge design of that study. So pretty impressive data on the histology and the functions as well.

Speaker 1

So just to remind you that we have We've 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. Call. And on top of that, as I said, we have done a lot of preclinical work, including DSS model and so forth, where we have exactly seen Those findings. And this is, I think, the nice thing on this mode of action.

Speaker 1

It's very different from what else is there, and it's not call, including any kind of immunosuppression. So we think this really good start could be the start of a very broad activity. The second question for other indications, we have done also the preview of the work in colitis models. So we believe that The holistic view of the data we have really makes us believe that 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 be really be a very nice and logistical effect for patients to achieve higher rates of remission and protecting patients from relapses down the

Speaker 3

road. Call. Okay, great. Thanks for taking our question. We'll hop back in the queue.

Speaker 1

Thank you, Andreas.

Operator

Thank you, Andreas. So our next guest today is Vadim Alimi from Piper Yes, please, amortize yourself and welcome.

Speaker 4

Hi, guys. This is Lauren on for you guys. A few questions from us. First, when you're planning call. If you are planning to tighten the guidance to the interim caliber in 2H23, can you remind us of the utility of this key data?

Speaker 4

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 shared data from the study and then what work is being done in regards to evaluating 5 0 6 and other GI diseases? Thanks.

Speaker 1

Call. Thank you. And did you remember the first I gave guidance for Sanddex here as it is right now. If you have more knowledge about precise timing, we will come out on that. Call.

Speaker 1

I think the key readouts where which we have planned for the interim were looking on NfL and Gfabs for the patients thus to have the state of the art payer of biomarkers, call. We should give a little insight to what extent opinions on the treatment of expanded modifications on placebo and also involve potential differences in the subset of patients With primary and secondary progressive. So that's what we so far have mentioned in the public. Then on the SGA process, an important point I think we've got the data. So we Let me be very quickly now in including the findings in the Phase II protocol and design.

Speaker 1

Then as quickly as possible, submit or IND filing in the U. 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 with that.

Speaker 1

The FDA released a draft guideline for selected disease Phase III studies 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?

Operator

Was other GI diseases. Page 46?

Speaker 1

Yes. I think that's more in the making. I think we Definitely, for time and resource reasons, we'll definitely focus first on celiac. Given the, I think outstanding data we got from this very small Part C of the Phase I study encouraging Australia to fill that space. And also, I think The medical need is very high in celiac.

Speaker 1

There is no treatment approved. So this is these are, of course, is 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 more, I think we I don't want to make here a pre decision on what we will do as next indication. But from the biology point of view, for example, Crohn should be one of those prioritized indications in the future.

Speaker 1

Call.

Speaker 4

Great. Thanks so much, guys.

Operator

Thank you, Oren.

Speaker 1

Thank you.

Operator

Call. Our next guest is Matt Kaplan from Ladenburg. Matt, please unmute yourself and tell.

Speaker 5

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, what are your thoughts, I guess, given the results for 838 in ulcerative colitis on how you're thinking about moving these 2 programs forward in the clinic Given kind of their overlap in potential indications also colitis, Crohn's disease, etcetera.

Speaker 1

Call. Well, I think there is a synergy between the concepts. As I said, 856 is not just another shot on the same goal. It's It's really an article on all 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 UC, How often patients switch therapies, what they run through, how still low clinical remission rates for maculinumetrials are.

Speaker 1

Call. 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 HF6 really is comes from a very different place. So we I think we can add more than just another approach.

Speaker 1

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 your CE and Krones With maybe the safest treatments, which are currently available. So there is a lot of potential. I think in a perfect world, I would just combine it both. That's more a funding and resource question.

Speaker 1

You can't do every trial. So maybe first, delivering single agent activity and then looking beyond makes A lot of sense. But I look at you, just as I said, coming from 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. IFRS 6 can really be a game changer. And this is not just overoptimistic CEO statement here.

Speaker 1

It's something where I feel really excitement among the experts we talk to, for example. Call.

Speaker 5

Okay. That's helpful. And then you spoke about the interim look on the CALIFAR study. How could the interim results impact the conduct of the CALIFAR study going forward?

Speaker 1

Yes. I think, as I said, we have 2 different kind of populations. So secondary progressive and non active, the majority is active, secondary progressive patient. We don't know, obviously, I would have seen. This is to say they all all these decisions are a little bit different and it's different.

Speaker 1

So we will as I said, we will compare this with the active ones, but also between the different active ones to see more effects on one of the other subpopulation. And therefore, we, for example, may prioritize specific set of certifications during completion of the trial To increase the information content of the study for the full readout.

Speaker 5

Okay. Call. Thanks. Thanks for taking my questions.

Speaker 1

Thank you, Matt. Thank you, Matt.

Operator

We have 2 more which came in from a Numis attendee in writing. Call. The first one, for 856, will you continue to follow the Phase Ib 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, I was just intended to demonstrate with the onset. So As you know, we all of the Phase II studies we are running, we have these follow ups here in this Phase I, we don't have that.

Operator

Okay. And the second one also, I think the target slide disclosure. It was a nice surprise to a lot of folks. It does seem quite novel. So can you talk a bit more about the target?

Operator

And are there other companies working on this target?

Speaker 1

Call. Yes. Thanks for this. This is really a new target. Therefore, there's not a lot ongoing there.

Speaker 1

There's finally one other company in Israel working on the topic, but in a different context. Here, in this, our work, we originated from scientific observations of phenotypes. And it's an epigenetic regulator. And it looks like that the molecule 856 finds a way to SIRT6 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 call of intestinal lining.

Speaker 1

You may know that the renewal is a normal physiological process. So in a healthy human, intestinal sensors are replicating once a day on average. And it's a new process. But in patients with these GI disorders, they really this process is not sufficient enough to heal the gut and to renew it. And therefore, damage goes on.

Speaker 1

So it's more a structural effect, Which we achieved by repairing that mode of action. Yes. And it's I think the key is here really that intestinal renewal needs then to restore barrier function question. And therefore, as a consequence, also should lead to less symptoms and ongoing disease. And this was nicely shown in this Phase I study.

Operator

Yes. Thank you. We have one more in the queue here. Tom Smith from SEB Securities.

Speaker 6

Just a couple Our end. Yes. 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 If you think about partnership opportunities broadly across 838 and 856. And then secondly, we noticed on the pipeline side, you've added a new program, IMU-three eighty one for GI diseases.

Speaker 6

What can you tell us program? How are you thinking about development time lines? And when can we expect to hear more on this? Thanks.

Speaker 1

Yes. I think to jump on for the question. I mean, as I said, I had the pleasure that close to the data we had and release of the model of action data was intended GDW and also to be already muted to speak to players in industry and academia care also, but also companies. I think the concept of 856, we somehow my feeling is we have to spot up what is missing there. It's something which is Not an absolute solution for the same problem, but a different way to approach it.

Speaker 1

And my feeling is this is appreciated among the 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 BD perspective, I think, as I always said, we're on that end, we are open minded people.

Speaker 1

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. And therefore, we are open to 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. And maybe to give more details on that one, I think This is something where I feel personally very excited about. Then on the 351, you mentioned This is the newest thing, newest addition to the pipeline.

Speaker 1

And as you know, we are working broadly in the eye and we have also achieved quite positive data here in the maintenance study for A3A. And we think It deserves more resources and, yes, focus for preclinical work to come up with something where we have where we 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 particularly to work and we need some time to complete the package.

Speaker 1

But it's something which nicely will complement the portfolio in the GI space.

Operator

Call. 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.

Speaker 1

Yes. Thanks, Jessica, and thank you, Today's participants for the right questions and good discussion. In summary, we look forward to revealing data in the second half of this year From the interim analysis of our Phase II CALIBRE trial of edutifilin musculosum in progressive MS. We also look forward to providing an update on our MU H56 program, hopefully very call. We remain well funded with €97,100,000 in our balance sheet providing us runway into the Q4 of 2024.

Speaker 1

Call. 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 1 on 1.

Operator

Call. Thank you for joining Munich's Q1 2023 earnings call. The webcast has now concluded. You may now disconnect.

Powered by Quartr
Earnings Conference Call
Immunic Q1 2023
00:00 / 00:00