Q2 2023 Immunic Inc Earnings Call
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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 I'll watch with a similar meeting and such statements involve a number of risks and uncertainties that could cause immune its actual results to differ materially.
From those discussed here.
Please note that these forward looking statements reflect immune opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release. The result of any revisions to these forward looking statements in light of new information or future events. Please refer to it makes at the SEC filings for more detailed description of the risk factors that may affect.
And your next results and these forward looking statements.
I would now like to turn the call over to our CEO and President after Daniel set to begin the presentation.
Thank you Jessica.
I would also like to welcome everybody to even in the second quarter of 2023 earnings call.
Earlier this morning, we announced our financial results for the second quarter ended June 32023, and highlighted recent activities as well as upcoming milestones.
During today's call, we will walk through our second quarter 'twenty two to three years and subsequent highlights financial and operating results as well as anticipated upcoming milestones. After the presentation. That's just you can notice we will open the line to give the audience an opportunity to ask questions.
Let's start with a review of our second quarter towards through the three and subsequent highlights.
In April we reported positive data from the maintenance phase of our phase <unk> trial of <unk> in patients with moderate to severe ulcerative colitis.
These results were extremely encouraging as they demonstrated statistically significant activity of redevelopments calcium as compared to placebo why confirming the very favorable safety and tolerability profile for the drug already observed in other trials.
As illustrated on the slide data showed a dose related increase in clinical remission as compared to placebo at week 50.
And exploratory statistical analysis showed a P value of 0.0358.
Confirmed the 30 milligram dose I'll be there for them as calcium to be statistically superior in achieving clinical remission at week 50, with a 33, 7% absolute improvement over placebo.
Overall, we believe the maintenance phase data confirms beautifully Wisconsin activity in ulcerative colitis patients.
Also in April we welcomed Dr. Richard <unk> to our board of Directors, Rick has spent decades as a clinical expert in multiple sclerosis.
And as a clinical trial is overseeing module towards successful pivotal studies.
His insights are already approved.
Proving valuable as we continue to progress the development of Peter Foodie, Ms calcium in multiple sclerosis, as well as in our earlier programs.
In May we reported stronger than expected positive results from the part C portion of our phase one clinical trial of <unk> 856 in patients with celiac disease.
In periods of gluten free items and took some challenge.
The data set shows the first clinical evidence office ability as observed pre clinically to regenerate the calf born in.
In particular, the phase <unk> data showed that <unk> six was effective compared to placebo in improving four crews with aspects of celiac disease pathophysiology.
Prospect protection of got architecture.
Improvement and diverse pool of patients who ultimately induced symptoms.
Biomarker response.
And in advancement of nutrient absorption such as vitamin D 12.
I'm New APAC six was also observed to be safe and reiterated in this trial.
Most importantly, the observed protection of the lining of the gut and in technical ability from gluten induced destruction.
Pendant or targeting immune kennan Mackay missions.
Involved specifically in celiac disease.
He has to be unique and micro posted a pudic approaches.
We believe this data provide initial proof of concept.
This first in class molecule may represent an entirely new therapeutic approach, which could be a game changer in the way, we treat gastrointestinal disorders, such as celiac disease, but also for example, ulcerative colitis, crohn's disease or irritable bowel syndrome with diarrhea.
We are extremely enthusiastic about the potential for our <unk> six.
Six program.
On the heels of these results.
Whilst our announcement at the digestive disease week in Chicago of clinical and preclinical data for <unk> at eight six including its molecular mode of action is a potent and highly selective modulator of <unk>, a protein which serves as the inscription regulator of intestinal barrier function and <unk>.
Regeneration of ball epithelium.
Through its effect on slide six I'm with 806 has shown the ability in preclinical models to restore intestinal barrier function and regenerate followed world architecture.
Importantly in May we also.
Announced publication in the journal of medical chemistry of preclinical evidence showing that <unk> calcium X as a potent <unk> activator in.
In addition to its known modes of action as a D. H O D H <unk> inhibitor.
We believe that the activation of new one quick responsible for the drive costs.
In Europe protective effects and may contribute to the reduction of confirmed disability worsening events in MF patients as previously reported from our phase II emphasis trial in patients with relapsing Remitting Ms.
That said these findings could be relevant not just in multiple sclerosis, but also in other neurological indications.
As a reminder, the potential in your protective properties off of your fluids calcium but already identified in our emphasis to try it.
We have Australia data showed encouraging clinical signals regarding prevention of confirmed disability worsening as well as a remarkable reduction of the biomarker and euro <unk> light chain NFL.
Most recently last month, we hosted a virtual celiac disease extra grand table to discuss ongoing active celiac disease or ACD.
Serious lifelong auto immune disorder, and the substantial unmet medical need for a therapeutic solutions.
We were honored to have been joined for disadvantaged by three renowned.
Leaders from Harvard Medical School Mayo clinic, and the Celiac disease Foundation.
We could not be more grateful for their participation.
During the call our Chief Medical Officer, Andreas Mueller also provided an overview of our <unk> program, including our positive phase one B trial results in celiac disease patients, which were just a little early on this call.
That concludes our summary of the second quarter 2023, and subsequent highlights I would now like to turn the call over to Glenn to provide a financial overview.
Thank you Daniel I will now review the financial and operating results for the second quarter ended June 32023.
Let me start with the cash our view we.
We ended the quarter with $77 3 million in cash, which we expect will be sufficient to fund operations into the fourth quarter of 2024.
Regarding the operating results R&D expenses were $21 2 million for the three months ended June 32023.
As compared to $16 5 million for the three months ended June 32022.
These costs were mainly driven by external development costs related to ongoing clinical trials of <unk> calcium and I am <unk> and partially offset by a decrease in external development costs related to the phase two clinical trial of a beautiful calcium in ulcerative colitis and <unk> ninth refi program.
For the six months ended June 32023, R&D expenses were $44 1 million as compared to $34 million for the same period ended June 32022. These.
These costs also were mainly driven by external development costs related to the ongoing clinical trials and beautifully and as calcium and <unk> five six and were partially offset by a decrease in external development cost related to the phase two clinical trial of <unk> calcium in ulcerative colitis.
And then not immune 93 five program.
General and administrative expenses were $3 8 million for the three months ended June 32023, as compared to $4 1 million for the same period ended June 32022.
The slight decrease was chiefly driven by a decrease in noncash based stock compensation, partially offset by increased costs across a number of categories.
For the six months ended June 30 of 2023, G&A expenses were $8 1 million as compared to $8 million for the same period ended June 32022, and.
<unk> increase was related to an increase across a number of categories, which was partially offset by a decrease in personnel expense and G&A, primarily due to noncash based stock compensation decrease.
Other income was 1 million for the three months ended June 32023, as compared to negative $1 3 million for the same period ended June 32022.
The increase was primarily attributable to a decrease in foreign exchange losses, and an increase in interest income as a result of higher interest rates.
This was partially offset by a decrease in R&D tax in SaaS for clinical trials in Australia.
For the six months ended June 30th trying 23, other income was $3 million as compared to negative <unk> 7 million for the same period ended June 30 of 2022.
The increase was primarily attributable to an increase in interest income as a result of higher interest rates.
Decrease in foreign exchange losses, and a research allowance attributable for the tax year 2021 from the German Federal Ministry of Finance.
The increase was partially offset by a decrease in R&D tax incentives for clinical trials in Australia.
The net loss for the three months ended June 30 of 2023 was approximately $24 million or <unk> 54 per basic and diluted share.
Based on $44 4 million weighted average common shares outstanding compared to a net loss of approximately $21 9 million or <unk> 72 per basic and diluted share.
Mmm Neurofilament lighting N F L and the fall of this year.
There's no more precise time now provide <unk> compared to our previous guidance on the second of March 2023.
We expect to read off this trial at the end of 2024.
Additionally, we look forward to reporting data from the interim analysis of our phase III insure program late next year and to read all of the first of our identical twin phase III insure trust in relaxing M. S. At the end of 2025.
As we have stated before.
From the strong clinic connectivity absurd, that's far and beautiful castle solidly established safety and Tolerability Proactivity. We continue to believe that the design of the phase III insure program bird provide straightforward path to potential regulatory approval in relapsing M. S.
As I noted earlier the phase II <unk> is designed to corroborate the neuroprotective potential of the deployment calcium and progressive M. S and could therefore be an additional differentiator for the drug in the market.
With a pretty much calcium with its combined anti-inflammatory antiviral and direct neuroprotective effects may represent an important and unique treatment options targeting the complex pathophysiology of M. S.
With regards to our Andrew April six program as a result of the overwhelmingly positive data generated from the final portion of Gore a phase one clinical trials in celiac disease patients. We have begun preparing for phase two clinical trials and ongoing active celiac disease patients.
Once again, we are very excited about this program and believe that I knew 856 could represent an entirely new and innovative oral treatment option.
Approach for a number of gastrointestinal diseases without the serious consequences associated with immunosuppressive therapies.
This brings us to the end of all formal presentation, Jessica police opened the call for the Q&A session. Yeah. Thank you Daniella and I also think that you're Daniel and plan for working after the first half of 2023 and subsequent highlights as well as our upcoming dial inflection point.
We will now begin the question and answer session. As a reminder, if you joined the web.
Platform. There are two ways to submit questions you can either submit your questions in writing via the cure natural up to <unk> or if you would like to speak with us directly <unk> function of <unk> Your question.
And we jumped right into it with <unk> from Piper Sandler Jazmine. Please amateur Sir go ahead.
Hi, guys. This is lauren on for years, Congrats file the pipeline progress two questions from us. So first and then you guys have historically sad that for <unk> separation placebo, maybe could you taken a little bit and is there any type of magazine that you want to see to be considered a strong signal.
And with that what do we know about the separation in regard to how it well <unk> two per cent brain volume change on the primary an appointment and then the second question have you had your end of phase two meeting with the F D. A.
Prior to the phase two and celiac and when can you come back and communicate at your next steps for the face too. Thanks.
Yeah. Thank you <unk>.
Uhm.
Coming to N F L I think.
As you as you were N F L is.
Morris temperature Margaret compared to <unk>.
<unk> <unk> lots of about other studies effects in and NFL changes in progressive M. S and therefore, it's difficult to really.
Give guidance for what we see I think the goal is here.
To look for a signal and specifically and this may be the main purpose of this trial is to look whether the indications. So it's up to us is really indications.
We are testing so we have patients with primary progressive active in Omaha secondary progressive to see whether there is a specific indication patients benefit more based on the on the the biomarker signal.
Everything else I think would be limited over over interpretation risk just that is is done.
Uhm.
And for the coordination with a Rainbow I don't think that's established I think that's something when you when you need one.
To observe a neutral observer and finally also underlined with other endpoints more from the technical side for example, confirm disability worsening, which I believe.
Is it a very important to reach out for for the progressive in a study for the kind of your study.
Uhm coming to the eight six question.
Yeah. So this.
This was a <unk> study. So there is no end of his too meeting plan I think or a regulatory interactions are currently focusing on I envy submission.
And based on that I think there is an active dialogue with the F. D. A so that's that's ongoing there and it's a more reliable timeline I think.
The main reason why we think this is the right direction.
For the regulatory in Texas right now.
Perfect. Thank you guys. Thank.
Thank you so much. Thank you Lauren and we have a follow up question on the <unk> that came in by it in writing from Thomas Smith at nearing can you elaborate on what data you expect to report the incident biomarker analysis from the Caliper trial analysis and the fall what are your expectations for the split up.
Yeah, that's that's it and maybe I need to repeat myself a little bit here. So it's really <unk>.
So to see a difference here fees for example, a C in the treatment groups.
A more benign.
N F. L change effects for example, a reduction there that would be great, but I think the main purpose is really to identifying southern.
<unk> indications, where we believe what is what is the most promising pop over in the progressive M. S space for for the treatments here and I I really I I.
<unk> 25 year give any guidance on the amount be expected to forefront of research and I would say there's.
There's not too much of historic comparison available here, so, let's let's keep fingers crossed for for for two a differentiation between active and placebo in the study.
Thank you Daniel and thank you for the question.
Next one we have life here in the queue and draft aggravated from Wedbush, Andrea Chris Amish yourself into that.
Good morning, and thanks for taking our questions.
For the sorry, you're having a nice time of my questions. So can you quickly also provide.
A French or is it progressing according to your expectations I.
When do you expect the trial to be fully enrolled.
And then quick one.
<unk> and ulcerative colitis.
Somewhere to programs and then if you look for a partner for the program.
Gotcha.
Yeah first of all I think to ensure enrollment goes whether I'd be home, we have the two studies extra wanting to ensure to running and the boat.
Are on track compared to the plan to enrollment right now so I think it's pretty.
Pretty pretty good situation there.
Uhm <unk>, yes, that's an ongoing discussion we're having that's also important to also an important thing is here that we are as you may have seen we also have the 381 added to the <unk>, which is a program, which is dedicated to G. I indications and May also benefit.
The data we have obtained from the.
From the Kello study from the maintenance phase two two potentially also come up with another molecule, which.
May be effected their <unk> can leverage the.
The proof of considered have generated for you just put them as calcium.
In order to provide us so there's more potential <unk> I strongly believe that.
The modem actually here, we have <unk> I think it's pretty interesting development going forward.
In that space with both.
Alright, and just one quick follow up.
Just also remind us what gives you confidence that the marijuana activator would work at progressive multiple sclerosis.
Thanks.
Yeah I think.
It's it's more of the general <unk> biology on that coming from literature.
And so far it uhm also <unk> on the <unk>.
Confirm disability worsening and our our conclusion that.
<unk> may have any effect on on relapse independent disability worsening.
And therefore it May then also work and and Progressiveness, but that's I think the objective of the clinical study I think we really need to prove that in this study.
Great Thanks, and congrats on all the progress.
Take your Andreas again, if you have a question. Please use the redhead function of the <unk>.
And we also have <unk> cabinet and the line from Ladenburg, Netflix and make yourself and go ahead.
Thanks, Thanks, Jessica Uhm in the morning, just just a follow up uhm. Thanks, just to follow up on 856 in Celiac I guess <unk> in preparation for the <unk>. What are you what are your current thoughts on the design of the face too as as you move it interfaced him.
Yeah. Thank you <unk>.
That is of course, an important thing right now here Uhm as you see from our presentation or excitement about the program and we believe it really deserves to continue as quick as possible into celiac disease, and therefore, we aligned with a couple of global experts.
A number of good meetings discussed what is the right design also carefully looked on the F. T. A.
Draft guideline for fees.
Three in celiac disease, with which was published mm mm.
Second last year.
And based on that B and maybe some some things are thoughts uhm. This is not set as stolen. So this is an ongoing discussion, but I'm happy to share some of the thoughts.
So.
We think we should.
Patient population should be really.
B.
It was equivalent to what the F. T egg I've answered so will you be able to look and we will look specifically on onto an active cilic disease patients.
Here and and points are alright things tested will it be for example, histological changes symptomatic changes.
And also some biomarkers and functional changes and improvements.
The I think the F D. A guidelines state that they want to see for phase three studies.
You've been off of symptomatic and histological improvement here.
Which also should be tested <unk>, what do you want to define the right dose.
And and the right design for the first few studies.
Duration of maybe one comment here.
S. S N not finally decided but like the the study will mainly look on in another three months uhm timeline for improvement on on those scores.
And what what I can say right now what's the exact size of the trial and that's work in progress.
Two to determine.
Sides of each group of the trial, but maybe one remark on the doses we are located on.
On a on the spread of doses, which would clearly to be solid than an identification of this best suited the dose for it at a phase three study going forward.
That's very helpful. Ma'am, what one follow up on that I guess given the.
The potential utility of 856 out side of celiac disease, and and also ulcerative colitis. How are you thinking internally about the development of 856 and 838, an ulcerative colitis.
Both are interesting.
Yeah, I think the challenge with with H eight is that we are in a very important.
M. S study at the same time so.
Therefore, I think M O R. G I focus right now with a fresh results from the phase one being a study on 856.
And clearly I think H F. Six has some something very special.
Modern immunosuppressive and therefore, I think the drug could really add something new to the to the treatment landscape injure items orders and if you look on the front of treatments and things in development for for indications like Crohn's and colitis, clearly a nanometer suppressive rock.
Which is able to restore the proper healthy <unk>.
Good at something substantial and I think that's the beauty of that concept could easily combined with other treatments a swell down the road and.
<unk> and there for maybe the first choice to overcome the so called <unk> ceiling received with just give me a suppressive therapy.
So I I think I see a very bright future for 846 in the broader G ice pays really beyond celiac disease as well.
Uhm, it's it's your right to say what indications exactly where we need to focus to air Bud Nike IBD is of course, that's a coffee in further detail.
Thanks, Daniel that's that's very helpful.
Thank you, Matt and thank you to all our guests today. This concludes our question and answer session I would like to turn the conference back over to Daniel's by any closing remarks gatherings, Jessica and thank you.
Days attendees for your insightful questions.
In summary, we remain about funded with 77.3 million on our balance sheet, providing expected run right through multiple value for any political milestones into the fourth quarter of 2024.
Looking ahead as noted we'd expect to report data from the insurance <unk> phase two clinical trials of.
Mischarged some in progressive a mess in the fall of this year.
As progress is made we expect to also provide an update in our preparation politics too.
What's wrong with you H M 16 patients with ongoing active celiac disease.
With that I would like to close today's call. Thank you very much for joining we're very happy to answer any additional questions. One on one.
Thank you all set from my side and joining emailing second quarter 2023 earnings call. The webcast has has now concluded you may now disconnect.
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