Q4 2022 Immunic Inc Earnings Call
Today at the prestigious actions from 2023.
Dr. Bob Fox from Cleveland Clinic, with also the coordinating investigator of our insurer in telecom programs.
I'd like to point out again that the data was favorable compared to historical data for current MFS treatments and showed that long term treatment with a diffluence calcium was associated with a low rate of confirmed disability worsening over time.
Yeah.
That concludes our summary for the fourth quarter of 2022 and recent subsequent highlights I would like.
I would now like to turn the call over to Glenn to provide financial overview.
<unk>.
Thank you Daniel I will now review the financial and operating results for the year ended December 31 2022.
Let me start with the cash overview.
As Daniel mentioned after raising $60 million during the fourth quarter. We ended the year with $116 4 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 $71 3 million for the 12 months ended December 31 2022.
As compared to $61 1 million for the 12 months ended December 31 2021.
The increase was mainly driven by external development costs related to the ongoing clinical trials of the Definitiveness calcium IME and 935, and <unk> 56, and was partially offset by a decrease in external development cost related to the phase III clinical trials of <unk> calcium and ulcerative colitis relapsing remitting.
MFS and COVID-19.
General and administrative expenses were $15 3 million for the 12 months ended December 31 2022.
As compared to $13 3 million for the same period ended December 31 2021.
This increase was mainly driven by personnel expense of which <unk> 6 million was related to noncash stock compensation.
We recorded a noncash goodwill impairment charge of $33 million in the fourth quarter of 2022, which represents a full write down of our previous goodwill balance.
The impairment resulted from the announcement of the interim group level data of the phase <unk> clinical trial of <unk> 935 in psoriasis on October 22022.
Other expense was negative <unk> 9 million for the 12 months ended December 31, 2022, as compared to negative $1 3 million for the same period ended December 31 2021 the.
The decrease in expense was primarily attributable to interest increases in interest income and R&D tax incentives for clinical trials in Australia, which was partially offset by a decrease in grants.
Net loss for the 12 months ended December 31, 2022 was approximately $120 4 million or $3 78 per basic and diluted share based on approximately $31 8 million weighted average common shares outstanding.
Compared to a net loss of approximately $92 9 million or $3 93 per basic and diluted share based on approximately $23 7 million weighted average common shares outstanding for the same period ended December 31 2021.
With that I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones Daniel.
Okay.
Okay.
Thank you Glenn I would now like to provide an update on our anticipated upcoming data readouts.
Our phase two clinical trial in progressive Ms and other phase III ensure trials in relapsing Ms continue to enroll patients our current expectation.
Is to report data from the interim biomarker analysis of the caliber of Australia in the second half of 2020 three and to record topline data at the end of 2024.
So all the insured program, we added new guidance that we expect to report data from the aims of analysis in late 2024.
And as previously announced to read out the first of the insured trial and of 2025.
As we have noted previously based on the strong clinical activity observed so far.
Peter Flaherty, Ms calcium placebo like safety and Tolerability profile, we believe that the design of the insurer program gives us a donald Trump towards potential regulatory approval in relapsing Ms. Keller trial S additional potential and progressive illness to Artemis program beyond our Lewis.
We just really must cuts and could represent a unique treatment option targeted to the complex pathophysiology of M. S.
<unk> by its combined anti inflammatory anti viral and potentially in your protective business.
As already mentioned earlier, we plan to provide an update on potential expense of onion 95 development in psoriasis towards the end of this quarter.
Of note annualized five recently received the proposed international local Cartage name is Americans from the World Health organization.
Our next clinical milestone will be mid this year, where we plan to report top line data from the double blind randomized placebo controlled part C of our phase one clinical trial of <unk> six in celiac disease patients.
He is designed to assess safety and Tolerability of audiotapes on six during 28 days of treatment with 80, and 160 milligram of mining rates of six or placebo once daily during periods of gluten free diet and to challenge.
Secondary objectives include chemical kinetics, as well as acute and chronic disease markers, including those evaluating acute outcomes on the biomarker by attune and gastrointestinal architecture and celiac disease symptoms.
Monday April six as an orally available and systemically acting small molecule modulator from preclinical lead to regulate intestinal barrier function and original and regenerate boldly precision.
It appears to influence a tightly regulated network of genes and proteins associated with intestinal you could see yourself into action and adhesion restoring intestinal barrier function, while maintaining immuno competency.
These characteristics indicate that <unk> could represent an entirely new and innovative approach for the treatment of a number of I'm, sorry to ask those diseases, including CLEC disease, IBD or Ibs D with global serious consequences associated with immunosuppressive therapies.
This brings us to the end of our formal presentation. Jessica. Please open the call for Q&A session. Thank you Danielle plan for walking us through the fourth quarter 2022, and subsequent highlights as well as upcoming value inflection points. We will now begin the question and answer session as a reminder.
If you join the webcast by Edison platform that you'll wait to submit questions. You can either submit your questions in writing by Atico and HR at some quarter or if you would like to speak with us directly eight years rates and function of the same product to kill a question.
Our first question today comes from Jack Meehan Rahimi at Piper Sandler.
Welcome and please on mute yourself.
Good morning team and thank you so much for all the great updates few questions Danielle.
<unk> team, where I am very excited to look at the fall data problem 93, five as you're going to be of appointing Ikea and Nokia and sorry end of this quarter could you maybe help us understand again Mike.
Why has it taken quite a bit of time to really gather the data and.
Helpful. Tom is that data really is gonna be for hot so that we could actually step and decide you know what the opportunity is and when you say next steps that kind of makes us think that there is a next step involved and that the data or the analysis looks encouraging something you could provide.
Provide some color around there and then I have some questions on it sure.
Sure. Thank you yes.
That's an important question and let me some of the time, Florida for data analysis. This is still ongoing.
It's a big package of Biomarkers, we are looking at collecting tissue samples and so for US I can't remember what we reported was group level unblinded data. So this was really much before database lock and so forth. So these things take time.
Sorry for that but it's the nature of what we're doing here.
With expect regarding expectations of that I think.
We want to really deliver the rationale for decision, making and make appropriate decision at that time point.
But we have things in the right way together at the end of the quarter and to give direct guidance on that end and as you know we always try to be very mindful of the science behind it the data and then based on that make smart decisions to go forward.
And maybe a clarification question for you Danielle given that you guys have been very thoughtful around really analyzing the dead animals comprehensive plan on taking right now after next steps does that can we conclude that you're staying very encouraging signals that more forward or is that does that.
And not copper that's one and then the second question I had it.
A lot of investors will be looking very eagerly into the interim analysis of insurer in late 2020 or are you starting to see sort of the advance rates and progression of disease.
As you expected so that you know like on a confidence level basis like how should.
How confident are we that that data is going to fall until late 2024, and does not slip into 2025 and thank you so much and I'll jump back into the queue is that.
So.
So first of all.
Once again, the landscape I think I know that everybody wants to learn and worried about and I would like everybody to us to be patient until the end of the quarter to give the update there.
Is it just a thorough job to decide was.
What should we do and it has a couple of implications for example, if we continue to trial what is the right design for that what would be the right design for them.
As I said in the presentation and duration of treatment is one thing that one should look at.
On those trends and so forth. So there are a lot lot lot of things too.
To really take into account for for decision making.
While the timing of the interim of insurer.
Pretty confident we can we can deliver an interim analysis of 24.
But of course I don't see.
On the data coming out from his ongoing trial. So this is really just the reset of the path as an event driven readout.
But would be no. So far we should be able to have two interim data available.
Around the end of 'twenty four.
As we said in the crude.
Alright, Thank you yes.
Our next guest is Thomas Smith from SBB Security Securities Tom Please Emilio yourself and go ahead.
Good morning. This is <unk> ARPA consciousness, Oh, Hey, Nat gas congrats on the progress during the quarter every half of your question.
The first one with the initial phase one data at <unk> expected in May 23, what are your expectations for the data and when do you plan to review the MLA up I am new Asics.
Do you have a follow up.
Yeah good.
Good question, so expectations I think we had this this R&D day, one that everybody on this line here you had a chance to listen to that so far even though it's available as a recording on the homepage my way.
We think that.
And that design, we operate with treated for four weeks in half of the time without with insurers.
And then we follow in the second half of the trial for another 14 days worth of gluten challenge.
I think the most robust expected readout would be to look whether to what extent, we can we can block the IL two signaling after starting the <unk> insurance and this is totally done so hours after starting diluted sales you'll measure than the series two levels and if you if we were able to restore very functional.
Block basically discipline of gluten and <unk> to the immune system, then we should see a reduced amount of violent too. So that's the first piece.
Similarly, non MLA.
<unk>, Yes, there was a second question the moh.
As you know we have been very quiet on that and just to make sure. We deliver we maintain core advantage over potential competitors on our knowledge of the target and how it works.
And but we plan to disclose the target during this year.
But of course, we would like to do that in the context of a scientific presentation or conference. So that it has the rights around there of a scientific environment. So.
Likely after the release of the data we will.
Not too long after that would come out with the with the target and maybe more details on the mono Vinci. Despite we have I think shown some some aspects of the mono vaccine for example, gene regulation affecting lauded proteins.
Set of Houston ended tier as a system, where we have shown that the drug is able to restore barrier function and client importantly meet your models.
Got it that makes sense.
And then what's the interim data from the caliper in Pms expecting second half like what would a great data set look like in your perspective, and what their occupancy would have lost confidence in the potential of different much calcium or indication.
Yes, I think it's important to thank you for that question. It's important to know what are you reading the order I think the focus of this retailers clearly on Biomarkers, we will have a couple of those and as you know progressive and mask. Some of the we are not a lot of things works.
For them, it's a huge unmet need so seeing a difference between placebo and the different subsets of Pms.
In this trial would be a success from my point of view.
This is not a into announces which is towards the end of statistical readout since really just looking to we see a signal here and as a typical more.
Important question is here is it medically meaningful cigna, we see there.
But the focus is clearly here on the Biomarkers.
To remind you the primary endpoint of the trial will be.
Change in brain atrophy between placebo and active matters, then expected to be read out.
24 so.
All of the pieces.
<unk> are important to opinion judge about to what extent the potential of <unk> goes beyond.
The RMS phase III program, which were running.
Got it thank you and congrats again on the progress I'll hop in.
Thank you Dave Thank you.
The next one as Matt Kaplan from Ladenburg Thalmann met this unmet yourself unwelcome.
Hey, good morning, Thanks for taking the questions just some follow ups on your kind of near term milestones.
Clinical milestones.
First one with 93 five as you analyze that data there from that psoriasis cohort or.
What are your expectations in terms of looking at the drugs impact on IL 17 in production there.
That would get you excited about moving the drug forward.
And I think it's not only IL seventeens also looking on overall.
Markers impact on <unk>.
<unk> regulations, we are we are looking at.
What I would like to.
CE is.
Kind of like a difference between the groups to guide us forward and to be able to conclude some some ideas on potential dosing unions of risk going forward. So that would be that would be my expectation.
Yes that is.
That's all I can tell or not I think become dig into more details on the ongoing broke here sorry.
Sorry for that.
The fact that that's helpful. Thank you and then and then in terms of just a follow up on the insurer interim analysis.
Are the potential outcomes of the interim analysis is this a futility analysis or what type of analysis says it will go on there.
Net net it's not not not per se a futility analysis.
Looking on what do we see when we reached half of the events.
Giving us the ability to do sample size adjustment at that time point, so that's that.
The pre planned.
<unk>.
The plan here.
So.
It will.
And we will not be handled as a as a termination reason or something that is really loading arms.
Yes.
More of a powering our sizing analysis okay.
Okay very helpful. Now I think some of the other questions have been covered already but perfect and congrats on the progress.
Thank you Matt Thank you Matt.
Just to remind everybody. Please use the raise hand function of to assume Paula origins to Q&A I'll take your question.
The next one is <unk> <unk> from Wedbush unrest.
Scientists and make yourself.
Good morning, and thanks for taking our question, we've actually more or less all gonna ask at this point.
Maybe a quick follow up on just 93 five.
Do you see any potential to dose higher on the phase one or extend the treatment period.
And are there going to be any changes to the patient population that can be implemented in terms of modifying exclusion inclusion criteria. Thank.
Thank you.
Yes. Thank.
Thank you, yes all of those.
<unk> on the team so.
When we started this trial for the first two dose strengths. We were limited on the dosing for 28 days because of the preclinical package. We Meanwhile, completed three months safety package and are able to in principle able to prolong the treatment.
To 12 weeks, which is something which we would consider.
Duane.
And as it once again with the automotive side embedded some of some of the options on the table second thing is dosing <unk> of course that is something we can do which we have the ability to increase doses.
And on the other parameters of course, that's an important exercise to understand what is what was the reason for the high placebo activity, we have seen and that of course is something we need to look on the on.
Patient characteristic of a baseline what is different.
And where our potential risks.
On getting a bias in or around placebo activity and that's something we are looking at every stone and flipping in every stone that we have here.
And then also as part of the reason why the team needs to spend some time on really carefully evaluating all of these things.
Okay, great. Congrats on all the progress. Thank you. Thank you Andreas.
And we have one more person in the queue with just <unk> from B Riley My uncle case, a major Socgen go ahead.
Hi, This is we're more around Vermont requirement today.
Really nice.
And the.
Great work there.
Graph on everything I've got a couple of questions on more follow up on what others are that on.
The interim look.
Mmm.
No for some you haven't been by Americans have been added to the <unk> a package for example, <unk> and others.
And of course I think in this driving may look on some uhm functional readers, but that will not be the uhm bumped set of data at that time I think it's <unk> has done will be done when.
50% of the patients have reached 24 week treatment services.
Already in the treatment and therefore, we think of Biomarkers are the best suited for <unk>.
For such an instrument nurses and somebody just to check do we see a difference here between the accident and the placebo patients.
Just as a reminder, we have two different kinds of placebos with primary and secondary progressive patients.
Patients in this trial.
And.
Of course also and information you want to <unk>.
For example is one subgroup benefiting.
Substantially better than any other.
Which may give us the opportunity in that area.
Completion of the try to consider that until maybe enrich more patients from the one or the other.
That'd be and then what.
<unk> when we get the same data the same biomarkers et cetera at the end of the crowd also yeah, Yeah sure sure I forgot to mention that yes of course be this is an important part of the story to also look on the on the evolving biomarkers over time and the changes there and.
That may be a very interesting read out.
All of the different parameters overtime right.
Yeah excellent and then.
Taken out of step Friday following.
You just mentioned that there might be some wiggle room or some some <unk> based on P. B M. S. At the end that do you have any plans to meet with the F. D. A on how they may receive it the biomarkers and then.
So essentially adjust or both ensure caliber if you're if needed and I'm just trying to understand the path. While we're following attention read out.
Notice this law for internal decision, making and I think there is no plan right not to talk with the <unk> on the interim analysis, but of course that will influence our strategy going forward and just ended discussions. We will then have with the complete data sibling.
So.
It's more down to formerly of looking longest it's lost its really important too.
To to understand the signs and that's why we're doing these things.
As interim renounced.
I I think we are all excited to see what's coming out there because it's.
It's a totally underserved area and I'm not so many things worth so far so as well.
Low hanging fruit here uhm.
Okay makes sense.
And then one last one if I may.
You've mentioned that the insurer in Germany. It out it is currently a little.
The Department is gonna be based on your then primarily at Walmart could you just give us any details on how enrollment is proceeding furniture, but also for caliber may be commenting on if anything thanks long, it down or or even eating it up.
Yeah, I think as you know in the Pond Street.
Really <unk>.
Never gave guidance.
On enrollment data is because if you stop and raised and it's something we are we have every every week other questions on them. So we stick to our current guidance on the results. So that means we assault simple satisfied with what we see.
On recruitment and both trends and as soon as we figure out that expectations are changing we need to get an update on that of course and be willing to bet.
Excellent. Thank you so much that's it we're gonna include congratulations again, yeah. Thank you so much.
Thank you William and also thank you too alright, I guess today. This concludes our question and answer session I would like to turn the conference back over to Daniel's for any closing remarks, yeah. Thanks, Jessica and thank you to today's attendees for your insight.
Questions.
To summarize.
The very much look forward to reporting clinical data from <unk> and <unk> six programs. This year data from the currency portion of our phase one clinical trial.
Six in celiac disease patients is expected to be available mid tier. Moreover, we expect to report data from the interim analysis of our phase two clinical trial will be defeated Wisconsin and progressive a mess in the second half of this year.
We remain bill funded by 116.4 million on our balance sheet, providing <unk>.
One way through multiple clinical milestones into the fourth quarter of 2024.
With that I would like to close today's call again. Thank you very much for joining and we are very happy to answer any additional questions. One one.
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