Q3 2021 Immunic Inc Earnings Call

Jessica Breu: Good morning, and welcome to Immune.

So.

Good morning, and welcome to third quarter 2021 earnings call. My name is Jessica <unk> head of Investor Relations and communications at the Munich I will also be the moderator on today's call.

Jessica Breu: third quarter 2021 earnings call. My name is Jessica Brew, head of

Jessica Breu: Group, Head of Investor Relations and Communications at Munich. I will also be the moderator on today's call.

Jessica Breu: Please note, all participants will be in listen-only mode and this event is being recorded. Speaking on today's call are Dr. Daniel Fitt, our chief executive officer and president, as well as Glenn Whaley, our vice president of finance and principal financial account.

Please note all participants will be in listen only mode and this event is being recorded.

Speaking on today's call adopt it and it fits our chief Executive Officer, and President as well as Glenn <unk>, Our Vice President Finance and principal financial and accounting officer.

Glenn Whaley: and accounting officer.

Jessica Breu: After today's presentation, there will be an opportunity to ask questions. If you joined the webcast via the Zoom client, there are two ways to submit your questions. You can either submit your questions in writing via the Q&A tool of the Zoom Portal, or if you would like to speak with us directly, please use the raised hand function of the Zoom portal to queue your questions. If you join today's webcast by phone, please press

After todays presentation, there will be an opportunity to ask questions.

If you join the webcast by I'd assume clients there are two ways to submit your questions.

You can either submit your questions in writing via the Q&A tool after some portal.

Or if you would like to speak with US directly. Please use the right hand function of the <unk> to <unk> your question.

If you joined today's webcast by phone. Please press star nine to clear your question.

Jessica Breu: Then, please press star 9 to ask pure questions.

Jessica Breu: Before we begin, I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate, or words with a similar meaning.

Before we begin I would like to remind you that this presentation may contain forward looking statements.

Such statements can be identified by words, such as May will expect anticipate estimate or words with similar meaning and such statements involve a number of risks and uncertainties that could cause <unk> actual results to differ materially from those discussed here.

Jessica Breu: And such statements involve a number of risks and uncertainties that could cause the Munich's

Jessica Breu: results to differ materially from those discussed here. Please note that these forward-looking statements reflect

Note that these forward looking statements reflect in Munich opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events.

Jessica Breu: in Munich's opinions only as of the date of this presentation, and it undertakes no obligation

Jessica Breu: undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events. Please refer to Immunix SEC filings for a more detailed description of the risk factors that may affect Munich's results and these forward-looking statements.

Please refer to <unk> SEC filings for a more detailed description of the risk factors that may affect immune <unk> results in these forward looking statements.

Jessica Breu: I now would like to turn the call over to our CEO, president.

I now would like to turn the call over to our CEO and president Dr. <unk> <unk> to start with the presentation. Daniel. Please go ahead. Thank you Jessica for opening the call also.

Jessica Breu: President Dr. Daniel Fitt to start with the presentation. Daniel, please go ahead. Yeah, thank you, Jessica for

Daniel Vitt: Yeah, thank you, Jessica, for opening the call. I also would like to welcome everybody to Immunics' third quarter 2021 earnings. Earnings, Earlier this morning, we announced our financial results from the third quarter of 2021 and highlighted recent milestones as well as upcoming updates to our clinical development pipeline. During today's call, we will talk through our third quarter 2021 and subsequent highlights, financial and operating results, as well as anticipated milestones.

So would like to welcome everybody on immune <unk> third quarter 2021 earnings call.

Earlier this morning, we announced our financial results from the third quarter of 2021, and highlighted recent milestones as well as upcoming updates to our clinical development pipeline.

During today's call, we will talk through our third quarter 2021, and subsequent highlights financial and operating results as well as anticipated milestones.

Daniel Vitt: Before we close the call, you will have the opportunity to ask, During the third quarter, we continued to make great progress in advancing our three product candidates through the clinic, setting the stage for several important data results in the fourth quarter of 2021 and 22. Most importantly, we expect to start patient enrollment in our phase 3 program in relaxing multibuscarosis stilda's core. Another major milestone will be the top line data from our phase two trial in Altad of colitis, which we anticipate in the second quarter of 2022. We just recently announced the completion of patient recruitment with 263 patients randomized in total. For our second program, I'm UN35.

Before we close the call you will have the opportunity to ask questions.

During the third quarter, we continued to make great progress in advancing all three product candidates toward the clinic.

In this stage for several important data readouts in the fourth quarter of 2021 and 22.

Most importantly, we expect to start patient enrollment in our phase III program in relapsing multiple sclerosis.

This quarter.

Another major milestone will be the top line data from our phase II trial in ulcerative colitis, which we anticipate in the second quarter of 2022.

We just recently announced completion of patient recruitment with 263 patients randomized in total.

For our second program <unk> 95, we expect unblinded safety data from the single and multiple ascending dose part of the phase <unk> trial later this year.

Daniel Vitt: We expect unblinded safety data from the single and multiple ascending dose parts of the phase one trial later this year. Additionally, we have just started Part C of the Phase 1 trial in psoriasis patients and expect initial human data from this patient population in the second quarter of next year. Finally, we also hope to see first clinical data from the ongoing phase one trial of INA8-6 in the third quarter of next year.

Additionally, we just have started part C of the phase one trial in psoriasis patients and expect initial human data from this patient population in the second quarter of next year.

Finally, we also hope to see first clinical data from the ongoing phase one trial of annual <unk> six in the third quarter of next year.

Okay.

Daniel Vitt: But let me walk through the third quarter of 2021 and subsequent highlights in more detail. In July, we hosted a virtual R&D day to provide an update on the preclinical and clinical development of our raw gamma-t inverse agonist. I'm U.N. 55.

But let me walk through the third quarter 2021, and subsequent highlights.

In more detail first.

In July we hosted a virtual R&D day to provide an update on the preclinical and clinical development of Ror Gamma T inverse agonist.

905.

Daniel Vitt: We presented very encouraging preclinical data showing that IME 95 may inhibit both the generation of CH17 cells and the production of IL-17 cytokines that are responsible for the development of autoimmune diseases without impairing the time of site development. We think that this may avoid a potential risk for lymphoma that has complicated third-party programs in this. At the R&D day, we also presented further new preclinical data highlighting the potential of IMEU 95 for the treatment of metastatic castration-resistant prostate cancer.

We presented very encouraging preclinical data showing that annual Nine-to-five may inhibit both the generation of th 17 cells and the production of IL 17 cytokines that are responsible for the development of autoimmune diseases without impairing time on site development with.

We think that this may avoid a potential risk for lymphoma that is complicated third party programs in this space.

At the R&D day, we also presented further new preclinical data highlighting the potential of <unk> 95 for the treatment of metastatic castration resistant prostate cancer.

Daniel Vitt: Based on the strength of this data, we expect to initiate an open-label phase one dose escalation trial in CRPC during the fourth quarter of this year. Also, in July, we successfully completed a $45 million for one offering, which extended our cash runway through multiple value inflection points into 2023. In September, we signed an in-licensed agreement with University Medical Center Göttingen in Germany covering the combination of HODH inhibitors and nucleosite analogs to treat viral infectors.

Based on the strength of this data we expect to initiate an open label phase one dose escalation trial and CFO during.

During the fourth quarter of this year.

Okay.

Also in July we successfully completed a $45 million follow on offering which extended our cash runway through multiple value inflection points into 2023.

Yeah.

In September we signed on in license agreement with University Medical Center getting in in Germany, covering the combination of th OTH inhibitors, and nucleoside analogs to treat viral infections.

Daniel Vitt: At the same time, we published remarkable preclinical data showing that certain DH-ODH inhibitors, including IMU8-28, strongly synergized with selected nucleoset analogs to inhibit SARS-CoV2 replication in vitro. This powerful reduction was demonstrated across multiple SARS-CoV-2 variants, including alpha, beta, and delta, thereby highlighting the independence of this approach to mutant viruses.

At the same time, we published remarkable preclinical data showing that certain ph OTH inhibitors, including annual <unk> strongly synergize with selected nucleoside analogs to inhibit Sars COVID-19 two replication in vitro.

This powerful reduction was demonstrated across multiple SaaS Cobra two variants include.

Including all of our better than Delta and thereby highlighting that independent of this approach to mute and virus firms.

Daniel Vitt: I once again would like to thank our research partners at the University Medical Center, Goettingen, Rue University, Bohum, Universities Clinicum, Erlangen, Utah State University, and MBM Science Bridge for their tremendous work. In September, we enrolled the first patient in our Phase 2 caliber trial of IMU8-2A-2A2A in patients with progressive MS. The trial will run concurrently with our twin phase three ensure trials in relapsing MS and is thought to be a supportive trial to underline IMU8's neuroprotective potential.

I once again would like to thank our research partners at the University Medical Center good thing in <unk>.

<unk> University boom, when you visit tests clinical Erlanger, Utah State University, and MBM Science bridge for their tremendous work.

Okay.

In September we enrolled the first patient in our phase II Calliper trial of <unk> in patients with Progressive Ms.

The trial will run concurrently with our twin phase III ensure trials in relapsing, Ms and is thought to be <unk>.

<unk> tried to underlying annual <unk> neuroprotective potential with.

Daniel Vitt: We believe that if the trial is successful in showing a beneficial neuroprotective effect of IMEA to 8, we may be able to clearly differentiate IMEA to 8 versus other oral MS medications and carve out a very attractive commercial position in the MS market. In October, we are very pleased to welcome Patrick Vultz, our new chief business officer. Patrick is a seasoned business development executive, and I very much look forward to leveraging his experience here in Munich.

We believe that if the trial is successful in showing a beneficial neuroprotective effect of annual <unk> III, we may be able to clearly differentiate I'm your hit rate versus other oral MFS medications and carve out a very attractive commercial positioning and the EMS landscape.

In October we are very pleased to welcome Patrick Walsh as our new Chief business Officer, Patrick is a seasoned executive and I very much look forward to leveraging his experience here in Munich.

Yeah.

Daniel Vitt: In October, we also dosed the first Rises patient in Part C of our ongoing phase one trial of IME-95. This represents the first time patients are treated with our oral IL-17 inhibitor, I'm U-9-5. We expect initial results from the rises trial in the second quarter of next year.

In October we also dosed the first <unk> patients in part C of our ongoing phase one trial of <unk> 95.

This represents the first time patients are treated with our oral IL 17 inhibitor immune nine-to-five.

We expect initial psoriasis data in the second quarter of next year.

Daniel Vitt: October was a month of clinical milestones for us in Munich. We also completed patient randomization in our phase two trial of IMA8 in moderate to severe altidicolitis. In total, 263 patients were randomized.

Yeah.

Yeah.

October was the month of clinical milestones for immunity. We also completed patient randomization in our phase II trial of <unk> in moderate to severe ulcerative colitis.

In total 263 patients were randomized we now eagerly await the top line data of the trial in the second quarter of next year.

Glenn Whaley: We now eagerly await the top line data from the trial in the second quarter of next year. For the next part of our presentation, I would like to hand over to Glenn for the financial overview. Thank you, Daniel.

For the next part of our presentation I would like to hand over to Glenn for.

For the financial overview.

Thank you Daniel.

Glenn Whaley: We will now review the financial and operating results for the third quarter of 2020. Let me start with a cash overview. We ended the quarter with 110 million in cash and cash equivalence, which we anticipate to be sufficient to fund operations into 2023. Now, let's review the operating review. Research and development expenses in the third quarter were 15.5 million, as compared to 11 million for the same period in 2020. For the nine months ended September 30th, R&D expenses were 42.7 million, as compared to 27.5 million for the same period in 20.

We will now review the financial and operating results for the third quarter of 2021.

Let me start with the cash overview.

We ended the quarter with $110 million in cash and cash equivalents, which we anticipate to be sufficient to fund operations into 2023.

Now, let's review the operating results reset.

Research and development expenses in the third quarter were $15 5 million as compared to $11 million from the same period in 2020.

For the nine months ended September 30, R&D expenses were $42 7 million as compared to $27 5 million for the same period in 2020.

Glenn Whaley: The increase in cost for both periods reflects a continued ramp-up of our clinical expenses related to our three clinical programs, as well as increased personnel expenses as a result of hiring more people to support the company. The increases were partially offset by decreased costs related to our phase two clinical trial in COVID-19 that was finished in the first quarter of 2021 and decreases in drug supply costs for IMU 85. General and Administrative expenses were 2.9 million for the three months ended September, as compared to 2.59 for the same period. For the nine months ended September 30th, G&A expenses were 10 million, as compared to 7.3 million for the same period in 20. The increase in cost for both periods was primarily due to non-cash stock compensation expense, as well as smaller increases in costs across the numerous categories.

The increase in costs for both periods reflect the continued ramp up of our clinical expenses related to our three clinical programs as well as increased personnel expenses.

As a result of hiring more people to support the company's growth.

The increases were partially offset by decreased costs related to our phase II clinical trial in COVID-19 that was finished in the first quarter of 2021 and decreases and drug supply costs for <unk> five six.

General and administrative expenses were $2 9 million for the three months ended September 30, as compared to $2 5 million for the same period last year.

For the nine months ended September 30th G&A expenses were $10 million as compared to $7 3 million for the same period in 2020.

The increase in costs for both periods was primarily due to noncash stock compensation expense as well as smaller increases in costs across numerous categories.

Glenn Whaley: Net loss for the third quarter, 2021, was approximately 19.3 million or 76 cents per share, based on 25.3 million weighted average common shares outside, compared to a net loss of approximately 12.9 million, or 70 cents per share, based on 18.4 million weighted average common shares outstanding for the same period in, Net loss for the nine months ended September 30th was approximately 71.8 million or $3.33 per share based on 21.6 million weighted average common share is outstanding, compared to a net loss of $32.9 million, or $2.35 per share based on 14 million weighted average common shares outstanding for the same period in $20. I would like to remind everybody that a year-to-date net loss was impacted by the settlement agreement of our subsidiary in Munich AG, signed with 4 SC AG in March of 2021.

Net loss for the third quarter 2021 was approximately $19 3 million or <unk> 76 per share.

Based on $25 3 million weighted average common shares outstanding.

Compared to a net loss of approximately $12 9 million or <unk> 70 per share based on $18 4 million weighted average common shares outstanding for the same period in 2020.

Net loss for the nine months ended September 30 was approximately $71 8 million or $3 33 per share based on $21 6 million weighted average common shares outstanding.

Compared to a net loss of $32 9 million or $2 35 per share based on 14 million weighted average common shares outstanding for the same period in 2020.

I would like to remind everybody that our year to date net loss was impacted by the settlement agreement of our subsidiary in Munich AG signed with four SCE AG in March of 2021.

Glenn Whaley: Munich Agee settled this remaining obligation of a 4.4% royalty on net sales of IMU 838 for 17.25 million. The payment was made 50% in cash, 50% in shares of immunix common stock. No further payment obligations remain between Munich and Forestry.

Munich AG settled this remaining obligation of four 4% royalty on net sales of <unk> three eight for $17 $2 5 million dependent.

The payment was made 50% cash 50% in shares of <unk> common stock.

No further payment obligations remain between our Munich and for our CAGR.

Daniel Vitt: With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones. Daniel? Yeah, thank you, Glenn. As mentioned at the beginning of the call, we have a wealth of milestones coming up in the next couple of months, and I'm happy to walk you through these.

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

Okay.

Yeah. Thank you Glen as mentioned in the beginning of the call. We have a wealth of milestones coming up in next couple of months and I'm happy to walk you through these.

Daniel Vitt: Still, in the fourth quarter of this year, we anticipate advancing IMEA to 8 into active phase three development, where the first relapsing MS patients are expected to be dosed very soon. The ensure program comprises twin phase three designed to evaluate the efficacy, safety, and tolerability of IMEA-2-8 in RMS patients. We have targeted an enrollment of approximately 1,050 patients in each trial, and dosing will be either 30 milligrams daily dose of IMJ-838 or placebo.

Still in the fourth quarter of this year, we anticipate advancing <unk>.

Right into access phase III development with our first relapsing Ms patients expected to be dosed very soon.

They ensure program comprises twin phase III design.

To evaluate the efficacy safety and Tolerability of <unk> hundred eight in RMS patients.

We have targeted an enrollment of approximately $1 50 patients in each trial.

Dosing will be either 30 milligram daily dose of either <unk> or placebo. The primary endpoint for both trials at this time to first relapse after 72 weeks.

Daniel Vitt: The primary endpoint for both trials is time to first relapse up to 72 weeks. One of our biggest milestones in 2022 will be the readout of our phase two trial in patients with moderate to severe alternative colitis. We currently expect the top line results of the induction phase to be available in the second quarter.

One of our biggest milestones in 2022 will be the readout of our phase II trial in patients with moderate to severe ulcerative colitis. We currently expect the top line results of the induction phase to be available in the second quarter.

For our phase one trial of <unk> 95, we recently completed the extra mental phase of the multiple ascending dose part and <unk> in healthy volunteers.

Daniel Vitt: For our phase one trial of IMU 95, we recently completed the experimental phase of the multiple ascending dose part in 15 healthy volunteers. We anticipate to receive unbended safety, pharmacodynamic, and pharmacokinetic data from both the single and multiple ascending parts still in the fourth quarter of 2021. Also, for IMN 95, we expect initial patient data from the third portion of the phase one trial in moderate to severe psoriasis to be available in the second quarter of 2020.

Anticipate to receive unblinded safety Pharmacodynamic and pharmacokinetic data from both the single and multiple ascending dose parts still in the fourth quarter of 2021.

Also for <unk> five we expect initial patient data from the third portion of the phase one trial in moderate to severe psoriasis to be available in the second quarter of 2022.

595, we will be there.

This will be a major value inflection point at the data will provide us the first time hint about timing 90, five's safety and efficacy profile and the patient population.

Daniel Vitt: For 1095, we will be, This will be a major value inflection point, as the data will provide us with the first time hearing about IME 95's safety and efficacy profile in a patient population. Staying a little bit with our IMEU 95 program. In July, we announced that we anticipate to begin an open-label, phase one, dose escalation trial of IMU 95 in patients with progressive metastatic castration-resistant prostate cancer. The trial is designed to establish a recommended phase two dose and to assess safety, probability, and tumor activity, biomarkers, and some microkinetics of IMD-95 in CRPC.

They are a little bit with our <unk> program in July we announced that we anticipate to begin an open label phase one dose escalation trial of <unk> five in patients with progressive metastatic castration resistant prostate cancer.

The trial is designed to establish a recommended phase II dose and to assess safety tolerability and tumor activity Biomarkers and pharmacokinetics of <unk> 95 <unk>.

We were very honored that professor Johann de Bono from Royal Marsden Hospital in London agreed to be the principal investigator of the trial.

Daniel Vitt: We were very honored that Professor Johan de Bono from Royal Marston Hospital in London agreed to be the principal investigator of the trial. We have just recently received approval by the relevant authorities in the UK to conduct the trial, which we expect to start in the fourth quarter of this year. Finally, we anticipate unblinding safety data from the single and multiple descending parts of IMU856 and healthy volunteers in the third quarter of 2022, and initiating patient part of the phase one trial in intestinal barrier function-related diseases as expected in the first half of 2022.

Most recently, we received approval by the relevant authorities and the U K to conduct the trial, which we expect to start in the fourth quarter of this year.

Finally, we anticipate unblinded safety data from the single and multiple ascending dose part of 806 in healthy volunteers in the third quarter of 2022.

Initiation of patient part of the phase one trial in intestinal barrier function associated diseases is expected in the first half of 'twenty to 'twenty two.

This brings me to the end of the presentation Jessica please.

Please open the call for the Q&A session.

Thank you Daniel Glenn for walking us through the third quarter 2021 earnings presentation. We will now begin the question and answer session.

Jessica Breu: This brings me to the end of the presentation, Desica. Please open the call for the Q&A. Thank you, Dania and Glenn, for working up through the third quarter 2021 earnings presentation. We will now begin the question and answer session.

A reminder, if you joined the webcast via the <unk> clients. There are two ways to submit a question you can submit your questions in writing via the Q&A tool opportune portal or if you would like to speak with US directly. Please use the raise hand function of the same products or to your question.

Jessica Breu: As a reminder, if you joined the webcast via the Zoom client, there are two ways to submit questions. You can either submit your questions in writing via the Q&A tool of the Zoom portal, or if you would like to speak with us directly, please use the raised hand function of the Zoom portal to queue your questions.

If you joined today's webcast by phone. Please press star nine two to your question.

For the Q&A session. We also have our broader management team on the call. In addition to Danielle Glenn we have Dr. Andreas Mueller, our Chief Medical Officer, Patrick Walsh, our newly appointed Chief business Officer, and in Nepal thing Our General counsel.

Jessica Breu: If you join today's webcast by phone, please press star 9 to queue a question.

At this time, we will pause momentarily to assemble our roster.

Yeah.

Yeah.

The first question comes from Yasmin Rahimi at Piper Sandler.

Jessica Breu: For the Q&A session, we also have our broader management team on the call. In addition to Dania and Glenn, we have Dr. Andreas Müller, our chief medical officer, Patrick Walsh, our newly appointed chief business officer, and Nepal Singh, our general counsel. At this time, we will pause momentarily to assemble our rules.

He has me please <unk> yourself and go ahead.

Okay.

Oh.

Hi, good morning team. Thank you so much for taking my question I have a number for them, maybe we would like I would like to start off as we think about that Caldolor study that is upcoming so I think a frequent question that we're getting from our clients is to understand how we should be thinking about the composite endpoint in my chest antibiotic called.

Jessica Breu: The first question comes from Yasmin Rahimi at Piper Sandler. Yeshmeen, please unmute yourself and go ahead.

Yasmin Rahimi: Good morning, team. Thank you so much for taking the time to answer my questions. I have a number for them. Maybe we would like I would like to start off as we think about the Caldo study that is upcoming. So I think a frequent question that we get from our clients is to understand how we should be thinking about the composite endpoint, which is symptomatic remission and endoscopy healing. If you could provide us with some color on what bar in your view is concerned,

Michigan Endoscopy healing and he could provide us some color on.

Bar in your view is considered SaaS and then second I would love to also learn a little bit more in terms of the clinical execution.

Pointing needs histological Edmonton Endoscopy reading and then I have a follow up.

Very good thank.

Thank you you asked for the crushing this is Andreas <unk> Chief Medical Officer.

Andreas Müller: Very good. Thank you, yes, for the question. This is Andreas, the chief medical officer. Regarding our Caldose 1 trial in a moderated severe ulcerative patient, yes, I think you're absolutely right. I think we use a composite endpoint that entails both symptomatic remission and endoscopic remission to be achieved at the same time at week 10. So when we designed the study, both regulators and also international clinical experts that we work with really indicated that we needed to find an endpoint that reduces the variability of the outcomes in placebo. It is known from the history of trials in IBD that there is some variability between trials in the placebo response, and patients can actually get better even under placebo, no treatment in this indication.

<unk>.

Regarding our condos one trial in <unk>.

Moderate to severe asthma glider person, yes, I think you're absolutely right I think we used the composite endpoint that entails both symptomatic remission and endoscopic remission to be achieved at the same time at weeks week 10, So when we designed the studies.

Both regulators and also international clinical experts that we work with.

<unk> has really indicated that we needed to find an endpoint that.

Reduces the variability of the outcomes in placebo. It is known from the history of trials in IBD that there is some variability between trials and in the placebo response in patients actually can get better even on the placebo no treatments.

In this indication and this variability has contributed to some of the failures of clinical trials in the past of drugs that we know to be active so when we designed this trial. This composite endpoint was designed to minimize any placebo response. So we do expect a very.

Andreas Müller: And this variability has contributed to some of the failures of clinical trials in the past of drugs that we know to be So, when we designed this trial, this composite endpoint was designed to minimize any placebo response. So we do expect a very low treatment response in the placebo group. But also, I think we will influence this and know what to expect in terms of the response in the active dose groups for IMUA-3-8 when we have three dose groups, 10, 30, and 45 milligrams in this trial. So I think there should be an expectation.

Low treatment response in the placebo group.

But also I think we are.

This will.

Have influence on what to expect in terms of the response in the active dose groups.

<unk> will be a three dose groups 10, 30% and 45 milligrams in the in this trial.

So I think there should be the expectation thats very similar to very recent trials. They are also used.

Andreas Müller: That's very similar to very recent trials that have also used composite endpoints, or very similar, even identical composite endpoints, where you see that the placebo response is below 10% or much below 10%, and the active treatment arms of these drugs that we know are active have been found somewhere in the range of 15, 20, 25% for the active treatment arms. And I think that's also our expectation that this would be a desired outcome and a good outcome for this kind of trial where we use this very stringent and a composite endpoint in order to reduce the variability of placebo. So that's your first question; yes.

The <unk>.

Composite endpoints are very similar even identical composite endpoints.

Where do you see that the placebo responses below 10%.

Our much below 10% and the active treatment arms of these drugs that we know are active been found somewhere in the range of 15 20, 25%.

<unk> for the active treatment arms and I think that's that's also our expectation that this would be a desired outcome and a good outcome for this kind of trial, where we use this very stringent composite endpoints in order to reduce the variability of placebo.

That's the first question, yes, and the second question the clinical execution of of Endoscopy in histology. So as with many other trials I think it's now state of the art Deb D endoscopy discrete.

Andreas Müller: And the second question, the clinical execution of endoscopy and histology. So as with many other trials, I think it's now a state of the art that the endoscopy, the endoscopy, but also we have endoscopies, of course, at week 10 for the primary endpoint, and we have an endoscopy at week 50 at the end of the double blind maintenance period after the induction, after remission was achieved, that all of those endoscopies are done by a central blinded reader.

The screening endoscopy, but also we have endoscopies of course, a return for the primary endpoint and we have an endoscopy at week 50 at the end of the double blind maintenance periods. After the induction.

The remission was achieved.

Is that all of those Endoscopies are done.

By the central blinded reader. So this is not done locally by the sum of our central buying a reader and the.

Andreas Müller: So this is not done locally, but this is done by a central blinded reader. And there was also an adjudication of the week 10 endoscopy, which means that they have been read at least twice. And if they're not concurred, then an adjudication is done. So I think this is what we've done, I believe, is really state of the art compared to what's currently done in IBD trials. In terms of histology, we have a histology assessment at screening at week 10 and at week 50 that will allow us to do a Guita score.

There was also an adjudication of the week 10, endoscopy that means that they have been red at least twice and if theyre not concurrent than an adjudication goes down. So I think this is what we've done I believe is is really state of the art two to whats currently done in IBD trials in <unk>.

Histology.

We havent histology assessments at screening and at week 10 out of the 50 that will.

We will allow us to do it a ddos score. That's also the histology store. That's the views that of course is also done in a blinded fashion, which is of course much easier because it's done often by eight.

Andreas Müller: That's also the histology store that's used. That, of course, is also done in a blinded fashion, which is, of course, much easier because it's often done by a, it has to be done by a central lab that is completely independent of the execution of the trial.

It has to be done by a central lab that is completely independent of the execution of the trial hopefully yes.

Andreas Müller: Hopefully, Yes, I have addressed your questions.

Addressed your questions.

Yasmin Rahimi: No, that was perfect. Thank you, Andres.

No that was perfect. Thank you Andre.

Yasmin Rahimi: And maybe one more follow-up question for you would be, will you also be reporting a top line and just the individual rates for clinical remission? And then the second question is, as we are awaiting the data from the satin-map portion of 935, should we be looking at certain biomarkers that will help us sort of provide translation into the 1B psoriasis cohort? And thank you again for taking my long list of questions.

And maybe one more follow up criteria would be what will you be reporting of top line also just the individual rates of our clinical progression and then the second question is as we are awaiting the data from.

The fat at map portion of nine three buy should we be looking at Cherokee biomarker. It that it will help I sort of provide translation into that one piece or <unk> cohort and thank you again for taking my long list of questions that no. That's fine yes, So I think.

Andreas Müller: Yeah, no, no, that's fine, yes. So I think for the UC trial, the Caldose 1 trial, the top line data will not only include the primary data but also include the individual rates of clinical, clinical remission, clinical improvement, endoscopic improvement, and endoscopic remission. So I think there will be individual data as well, not just the composite data. I think because it also provides a better understanding of comparability to other UC drugs and phase two trials. So I think that for us, it was important as well to be part of the top line data. In terms of 935, that's a very good question.

Four.

We rebuilt for the UC trial condos, one trial, we will of course the top line data will not only include the primary data but also includes.

The individual rates of clinical submit clinical remission clinical improvements and endoscopic improvement endoscopic.

Hum.

<unk>. So I think that will be there will be these individual data. So not just the composite data I think because also I think it provides a better understanding of comparability to other UC drugs in phase III trials. So I think that process was important as well to be part of the top line data.

In terms of 93 five.

David.

That's a very good question do we have indeed part A&P that that includes healthy volunteers any chance to have.

Yasmin Rahimi: Do we have in part A and B, that includes healthy volunteers, any chance to have biomarkers that will hint at efficacy or activity in the psoriasis part later on? I have to say that's very difficult. We have thought about this quite a lot, and it's very difficult to do because you wouldn't have to look at, for example, cytokines or some other biomarkers that are not elevated in these healthy volunteers because they're very carefully selected to be really healthy volunteers and have no medical history and so forth.

Biomarkers that will hinge on efficacy or activity in.

And the psoriasis part later on I have to say is that is very difficult. We have thought about this quite a lot and it's very difficult to do because.

You wouldn't have to look at.

For example, cytokines or some other biomarkers that are not elevated in these healthy volunteers because thats the very carefully selected to be really healthy volunteers and have no medical history and so on.

Yasmin Rahimi: So I unfortunately have to say, I don't think with the data that we will present to you before the end of the year, in terms of safety, pharmacokinetics, undblinded, laboratory findings, and so forth, I don't think that we'll give too much credence to efficacy activity readouts. So I don't think that it's possible with this healthy volunteer population.

Unfortunately, I have to say I don't think with the data that we will present to you before the end of the year in terms of the safety pharmacokinetics unblinded.

Laboratory findings and so forth I don't think that will give.

Too much credence on.

On efficacy activity readout, so I don't think thats possible with this healthy volunteer population.

Yasmin Rahimi: Thank you so much for taking my questions.

Thank you so much for taking my question.

Gobind Singh: Thank you, Yas. Our next question comes from Gobind Singh at JMP. Gobind, please unmute yourself and go ahead.

Okay.

Thank you, yes, and our next question comes from Goldman saying at JMP.

Kelvin please on mute yourself and go ahead.

Gobind Singh: Hi, is this working? Yes. wonderful, thanks.

Is this a working yes.

Wonderful. Thanks, So two from me first on I am you 838 in Progressive Ms are.

Andreas Müller: So two from me, first on IMU838 in Progressive MS. Wondering if there's, do you have any comments about the recent hype from Large Farma to kind of develop their own BTK in this space, also RMS, of course, but why BTK is in MS now and why not, and is there any relation to neurofilaments and what we have seen there? And is there any way to kind of use that as a bar for what could be coming from the interim readout from the caliber trial? And then one follow-up from... Hi, Govind, thanks for the question.

Wondering if there's do.

Do you have any comments about the recent hype from our trauma to kind of develop their own PTK in the space.

Also Rms of course, but.

If y <unk> and MFS and now and is there any relation to neuro filaments and what are we seeing there and is there any way to kind of use that as a bar for what could be coming from the interim readout from the Calliper trial and then one follow up for me.

Hydro hydro Vince Thanks for the question. This is Andre Africa, Chief Medical Officer, So I think in terms of the <unk> work.

Andreas Müller: This is Andrea S again, Chief Medical Officer. So I think in terms of BTK, we're carefully looking, of course, at the BTK inhibitors and how they present themselves in this space, especially in progressive MS, but also in general in the MS space. And to be quite honest, I think I've seen the presentations by the companies developing it, and at the moment, they are focusing very much on. still the immune component of their reaction and the upregulation of the BTK in immune-related cells in the brain, which surprised me a little bit because I think if you have to, if you want to develop this for secondary progressive, you have to, in my mind or in our mind, address also mechanisms of disability worsening that are unrelated to, primarily unrelated to, the immune system.

Carefully looking of course at at the <unk> inhibitors.

And how they present themselves.

In this space, especially in progressive Ms, but also in general in Dms space.

But to be quite honest I think I've seen the two presentations bye bye.

The company is developing it and at the moment they are focusing very much on.

Still the immune component of that reaction.

And the Upregulation of of the BT U K.

Andreas Müller: So I think the BTK inhibitors have focused on microblea, for example. However, we believe that the mechanism of action of IMUA38 is much broader than that and can address different things that, of course, involve, for example, antiviral effects. It also involves having an effect on, which is known for other DHA or DH inhibitors, the metabolic status, especially mitochondrial stress, in actually neuronal cells, so non-immune related cells, which I think, and we believe is contributing to, efficacy in a phase of MS that's not primarily driven by immune mechanisms.

Andreas Müller: So in that respect, I see clear differences in the way that IMEU838 can act in secondary progressive MS or in primary progressive MS compared to BTK inhibitors. On the other hand, I also feel very strongly about our safety profile that we have shown in phase two, in the relapsing remitting phase, and also that we see now in the continued open label phase of this phase two study. And we have more than 200 patients in this phase two trial still on the drug, still on treatment in this open label portion.

In.

The way the <unk> connect in secondary Progressive Ms are in primary progressive Ms. <unk> inhibitors on the other thing I also feel very strongly that our safety profile that we have shown in phase II.

And the relapsing remitting.

And also that we see now and the continued open label phase of this phase III study and we have more than 200 patients of this phase II trial still on drug still on treatment in this open label portion of it we see very little.

Gobind Singh: And we see very little drop-off in basically patients on treatment, which we take as a very good sign in terms of the general tolerability profile for this drug. So I think we feel very strongly that we can achieve a very good differentiation versus BTK inhibitors, even in this progressive MS population. One follow-up on that.

Dropoff in basically patients on treatment, which we take as a very good sign in terms of the general Tolerability profile for this drug. So I think we feel very strongly that we can achieve a very good differentiation versus PTK inhibitors, even in this progressive Ms population.

One follow up on that have you seen.

Gobind Singh: Have we seen with any of the BTKs what it's doing to neurofilament? And then, on the open label part of the trial, might we see any updated data, longer term, perhaps improvements in neurofilament? I believe the last results you guys presented there were almost, you know, about 20% reduction compared to placebo. Why do we see an update in the open label this year? And then one follow-up on COVID-19, you know, with everything going around Merck and the excitement there and the data that you guys have presented in the combo setting, XVo for the potentially improved reduction in SarkoVi, is there anything there that you can comment on at this point about maybe resuming clinical development or otherwise? Yeah, Gobind, so just the question for you, basically, in your filament.

With any of the V. Teekay is what it's doing on your filament.

And then on the open label part of the trial.

Might we see any updated data longer term, perhaps improvements and eurozone that ive I believe the last.

Results you guys presented there was almost about a 20% reduction.

Compared to placebo you can see an update in the open label. This year and then one follow up on COVID-19, without everything going around with Merck and their excitement there.

And the data that you guys have presented in the combo setting ex vivo for the potentially improved reduction in SAR Covey. Two is there anything there that you are you can comment on that at this point about maybe resuming clinical development or otherwise.

Yes.

Just a question for you basically into a filament.

Daniel Vitt: I have to hear in public present ignorance on my part that I don't really have a good understanding of what the newer filament is doing in PTK inhibitors. So I know you're very interested in it, and I'll do my best to update myself a little bit better next time. And maybe for the question about the synergistic effect between DHAD and other drugs in the COVID setting, I would hand over to Daniel. Yeah, I think we just recently announced, you have seen, we signed this collaboration or a licensing agreement with University Götting, and it was based on exactly that synergy observed.

I have two here in public.

Presents ignorance on my part.

Don't really have a good understanding of what <unk> is doing and PTK inhibitors. So I know youre very interested in it and I'll do my best to update myself, a little bit better next time.

And maybe for the question about the synergistic effect between Th OTH.

This with other drugs.

And the Covid setting I would hand over to Daniel I think we just recently announced.

You have seen we signed.

Collaborations or a licensing agreement with University of good thing and it was based on exactly that synergy observed.

Daniel Vitt: We think the potential is broad and goes differently beyond COVID-19. So I think this principle should be used on a broader level on targeting antivirals or having new antivirals, very potent antiviral treatments. However, we've clearly said in the past already that we are not planning to go ahead with phase three with 8 to 8 in COVID-19, and we haven't changed our plans here. I think we are focusing the company really on the important things.

We think the potential is broad and it goes beyond COVID-19. So I think this is principally should be used on a broader level targeting antiviral.

Having a new antiviral very potent antiviral treatments.

However, clearly we.

We clearly said in the past already that we are not.

Planning to go ahead into phase III.

With 8% to eight and COVID-19, and we didn't change our plans I think we are focusing the company really on the important things here.

Daniel Vitt: important things here. We are still interested in the combination and in the antiviral properties, but that should be done in a collaboration or in an independent way. And I'm not in a position to give more details on the status of the discussion here, but I think clearly there is an interest in this world for potent antivirals, and there will be a way forward for that molecule, but it's unlikely that we will start clinical trials soon.

We are still interested in the combination antiviral properties, but that should be done in a collaboration or in an independent way forward.

Not in a position to give more details on the discussion status here, but.

Clearly there is an interest in this world.

In Poland, Antivirals, and there will be a way forward for that molecule, but.

It's unlikely that we started clinical trials soon.

Gobind Singh: Thank you. Thank you, Gobind. Our next question comes from Thomas Smith at SBB Learning.

Thank you.

Yeah.

Yeah.

Thank you Gordon and our next question comes from Thomas Smith, SVP Leerink Thomas Please on mute yourself and go ahead.

Thomas Jonathan Smith: Thomas, please unmute yourself and go ahead.

Mike: Hi everyone, this is Mike on behalf of Tom. Can you hear me?

Hi, everyone. This is Mike on for Tom can you hear me Alright, Yes, Hi, Mike sure.

Mike: Yes, hi, Mike. Sure. Hi there. We have two questions on our end. The first is just, can you provide some color on how you think about the overall competitive landscape and IVD, and specifically what kind of impact you see the recent labeling updates for the jack inhibitors having, and I have to follow up.

Thanks for taking our questions two on our end the first one just to provide some color on how you're thinking the overall competitive landscape in IBD and specifically what kind of impact do you see the recent labeling updates for the JAK inhibitors have them or not is all up.

Okay.

Mike: That was, well, it's a mixture of questions for Anderson myself. Of course, it's an interesting time in that space, and specifically given that, and it's not a secret that the FDA had some questions around the safety and durability of jack inhibitors recently. So that's, of course, impacting the whole set of therapy developments in that space, and for us, it underlines that there is a high unmet medical need. we nicely fit in, and just to repeat, and I mentioned that in our company presentations a couple of times.

That was well it's a mixture of question for Andrew or myself.

Of course, it's an interesting time in that space and specifically given that.

And that is not a secret that the FDA had some some question Chris is around safety and Tolerability of JAK inhibitors recently.

So that of course impacting the whole setup.

<unk> therapy development in that space.

For us it underlines that there's a high unmet medical need we nicely fit in that to repeat and I mentioned that in our company presentation couple of time.

Daniel Vitt: A2A provides something, promoter action point of it is something new for patients' alternative colitis, which is, on the one hand, being a selective immune regulator and targeting specifically hyperactivated immune cells. On the other hand, having antiviral properties protecting patients from via reactivations. I think these are two features which are urgently needed from patients in that phase. Um, not sure, and does if you want to add some, some more color on this, on the competitive landscape from your point, just from the medical point of view, they know, yes, and of course, I, when we started the phase two program for, for IMUA38, um, there was, when we, then we talked to our medical advisors and, and experts, there was cause, they had a lot of focus on the jack inhibitors because they had an advantage to the market, um, to, um, in establishing this new category of these novel immune modulators that are between the traditional immune modulators and the biologics.

<unk> hundred to provide something for.

Promoter vectren pointing to something new for patients as it is.

Colitis, which is on the one hand.

Selective immune regulator and targeting.

Targeting specifically hyper activated immune cells on the other hand, having antiviral properties protecting patients from viral reactivation I think these are two features.

Which are urgently needed from from patients in that space.

I'm not sure if that's if you want to add some more color on this.

On the competitive landscape from your point of view just from a medical point of view not that yes and of course.

When we started the phase II program for <unk> hundred eight.

There was when we when we talk to our medical advisors and experts there was cause they had a lot of focus on the JAK inhibitors, because they had a.

An advantage to the market.

In establishing this new category of this these.

Novel immune modulators that are between the traditional immune modulators in the biologics and what I've seen now is really I think that there's more and more drugs coming down.

Daniel Vitt: And what I've seen now is really, I think that there's more and more drugs coming, there was the hope that what's called more selective jack inhibitors would behave differently or would have less challenges, which I think in general didn't materialize. And so I think the whole class of drugs. really has to certain the different degrees of course the different drugs but have the same I think reputational problem then also for the medical community we also have seen that that was especially about the jack inhibitors a lot of discussions about the increases of infections during treatment and virus reactivations especially Zuster reactivations and I think we clearly see here that that our antiviral properties really has helped us that we have in our clinical trials never seen an increase of infections and pestations versus placebo.

The hope that the what's called more selective JAK inhibitors would behave differently or would have less challenges, which I think in general Didnt materialize and so I think the whole class of drugs really has.

So certain that the different degrees of course, a different drugs, but have the same.

I think reputation a program that also for the medical community.

We also have seen that was especially about the JAK inhibitors, a lot of discussions about the increases of infections during treatment.

Virus reactivation.

Especially zoster reactivation.

And.

I think we clearly see here that our anti viral properties.

It really has helped us that we have in our clinical trials never seen an increase of infections in patients versus placebo. We have not seen these viral reactivation and in that respect we feel very strongly that.

Daniel Vitt: We have not seen these viral reactivations. And in that respect, we feel very strongly that the time advantage that these jack and headers had coming into the market will not play out well for them. In my mind, we have a very good chance with IMA-38 to create a very successful drug in authoritative colitis.

The time advantage that these JAK inhibitors have coming into the market.

We will not play out well for them to my mind that we have a a very good chance to with <unk> hundred eight to create a very successful drug in ulcerative colitis.

Got it that's very helpful. Thanks, and then just quickly with respect to the MS program has anything changed recently in the Phase III trial assessment and how do you plan on mitigating potential impact of Covid in the study.

Andreas Müller: That's very helpful, thanks. And then just quickly, with respect to the MS program, has anything changed recently in the phase three trial assessment, and how do you plan on mitigating the potential impact of COVID on the industry? So, I'm not sure if anything has changed, no, I don't. I'm just thinking what you could mean because I, we are just executing as quickly as possible the plans that we had. And so I think it's a very big problem.

So.

I'm not sure anything has changed no.

I'm, just thinking what it could mean because I.

We are just executing as quickly as possible.

Plants that we had.

And so I think it's a very large form. It's also these phase III programs are very complex in terms of the different assessments with different vendors that you have to do so I think.

Andreas Müller: It's also these phase three problems are very complex in terms of the different assessments with different vendors that you have to do. So I think our team does extremely good work in terms of preparing these phase three trials, but nothing has changed in the execution of the phase three trials. Yeah, maybe just on COVID, I think we talked about it, given that we have seen antiviral properties of 8 to 8.8, we clearly see not a big issue with the ongoing COVID pandemic in recruitment.

Our team does Xtra do is extremely good work in terms of preparing these phase III trials, but nothing has changed.

And the execution of the phase III trials and.

Maybe just some color I think.

You talked about it given that we have seen antiviral properties of.

Of <unk>.

We see not a big issue with the ongoing COVID-19 pandemic on recruitment that's priced in basically in our estimates.

Andreas Müller: That's priced in basically in our, I think we have the experience from the Caldose trial, the IMEA-3-8 trial in Alzheimer's Colitis, that of course had a lot of activity during the whole COVID period. And yes, there are usually a few sites that make monitoring harder and also that we have accessibility problems for patients.

I think we have the experience from the from the condos trial. The <unk> trial in ulcerative colitis that of course had.

A lot of activity during the whole COVID-19 period, and yes. There are a few sites usually that makes monitoring harder and also.

We have excess ability problems for patients.

Daniel Vitt: But this was really, I think, very minimal on our part, the COVID impact on IMA 388 because we have been in very close contact with all of the investigators during the COVID period, highlighting the broad antiviral property. At the time when we didn't know that we had activity in COVID-19, as we found out later on with the Calvert trial, we focused on this does not put patients at risk, like many other immunomodulators, but it actually puts patients at risk, which is very well known now for a more severe course of the COVID-19 disease.

But this was really I think very minimal in our part D. The COVID-19 impact on <unk>, because we had been in very close contact with all of the investigators during the Covid period, highlighting the broad antiviral property.

At the time, when we didn't know that.

We had actually activity and COVID-19, as we found out later on this call. The trial, we focus that does not put patients at risk like many other immune modulators, but thats actually put patients at risk, which is very well known now for a more severe course after of the COVID-19 disease.

Daniel Vitt: And once we had the Calvert data in COVID patients, we actually also informed them that we had seen some activity in this trial that would support that we actually might be helpful for these patients in case they get infected. So I think this all gave very good, I think, assurance to the investigators that they should continue this trial. That's what you had seen, at least in the Caldo trial.

And once we have to call that.

Data and cohorts patients, we actually also informed them that.

That we've seen.

Some activity in this trial that would support that we actually might be helpful. For these patients in case, they get infected so I think thats all have.

Very good.

I think assurance to the investigator said that they should continue to trial and Thats why you have seen at least in the call those trial.

Mike: We, of course, take preventive measures, especially in terms of providing study drugs to patients when they're not allowed to access the site. But in terms of enrollment, I don't think we see a significant impact, even with maybe more robust infection numbers in the future here this winter for COVID-19. Great, thanks very much and congrats on the progress. Thank you, Thomas. Mike. Mike, sorry.

Of course take preventative measures.

Especially in terms of providing study drug to patients when they're not allowed to to access the sites but.

In terms of enrollment.

We see a significant impact even with.

Maybe.

More robust infection numbers in the future here and this winter.

Before COVID-19.

Great. Thanks, very much and congrats on the progress thank.

Thank you Thomas.

Mike Mike Sorry, Mike.

So our next two questions come from the Gela at Roth capital and I would actually with them because they came in via the Q&A tool.

Jessica Breu: So our next two questions come from Zach Bejala at Roth Capital, and I will actually read them because they came in via the Q&A tool. First question: most indications being pursued by Munich, including MS, UC, psoriasis, etc. And even your investigator-sponsored studies like MCRPC are all indications for which there are multiple competing drugs. You've shown success in MS. How are you thinking about the competitiveness of your programs in UC and psoriasis?

First question North of indications being pursued by Munich, including <unk>, <unk> horizon et cetera, and even your investigator sponsored studies like M. CRP C. All blockbuster indication. However, they also indications for which there are multiple competing trucks, you've shown success and M. Ed how are you thinking about.

The competitiveness of your programs and you'll see in psoriasis.

Jessica Breu: But this is a very important strategic question for the company. And first of all, I agree with the success in the MS space; that's a good problem to have. They are big indications, and I think the company is addressing high unmet medical needs. We may not be in a position to continue with all the programs through phase three, our own.

But this is a very important strategic question for the company and first of all.

I agree with the success in the EMS space. That's a good problem to have they are big indications and I think the company is addressing unmet medical needs.

We may not be not be in a position to continue with all the programs through phase III our own so it's likely something where we are.

Daniel Vitt: So it's likely something where we are open to partnering. And in that context, you can also see that we just recently strengthened the team with Patrick Walsh joining us in October as chief business officer to balance the exposure here and also strengthen our discussions here with potential farmers for the future. But of course, these are big markets, and they are driven by big unmet needs.

Opened for partnering and in that context, you can also see that we just recently strengthened the team with Patrick Walsh, joining us in October as Chief business officer to balance the exposure here and also strengthening our discussions here with potential pharma.

For the future.

But of course these are big markets and they are driven by unmet medical need.

Patrick Walsh: The second question is about our interest in partnerships, and are you likely to also independently take your UC and SORIS programs into phase three, like you have with the MS program, or are you open to partnering ahead of the initiation of pivotal studies? Patrick, would you like to comment on that? Yes, happy to, and good morning everyone. Patrick Walsh.

The second question is about our interest in partnerships and are you likely to also independently take care you see in psoriasis program into phase III like you haven't been there in that program or are you open to partnering ahead of the initiation of pivotal studies.

Patrick would you like to.

To comment on that.

Yes happy to.

Good morning, everyone Patrick Walsh.

Patrick Walsh: I'll summarize it this way: we are actively exploring many options across the portfolio, and we have not made any decisions with respect to the types of arrangements that we will or won't consider, but certainly excited about the evolution of the data for all of our programs here. Looking forward to that. Thank you, Patrick. Just as a reminder, if you have a question, please use the right-hand function of the Zoom portal, or if you joined by phone, please press star 9. Our next question comes from Matt Kaplan at Laydenberg-Talman. Matt, please unmute yourselves and go ahead.

I'll summarize it this way and that we are actively exploring many options across the portfolio and we have not made any decisions with respect to the types of arrangements that we will or won't consider.

But certainly excited about the evolution of the data for all of our programs here. So.

Looking forward to that.

Thank you Patrick.

As a reminder, if you have a question. Please use the right hand function. After some part of our if you joined by phone. Please press star nine.

Our next question comes from Matt Kaplan at Ladenburg Chairman, Matt Please Amit yourself and go ahead.

Jessica Breu: Unmute yourself and go ahead.

Matthew Lee Kaplan: Hi, good morning; can you hear me?

Hi, Good morning can you hear me, yes, hey minutes.

Matthew Lee Kaplan: Yes, hey Matt.

Matthew Lee Kaplan: Thanks for taking the questions. Just one, a couple of questions.

Thanks for taking the questions I just want a couple a couple of questions first a follow up on <unk> question.

Matthew Lee Kaplan: First, follow-up on Yasmin's question in terms of sad and mad data for 935. I guess we're not looking for a read-through to psoriasis, but can you describe the PD data that we should be looking for as that comes out later this year? So Matt, are you meaning what's in part A and B that we're... Just from a pharmacodynamic point of view, what are some of the things you're looking for, not really beyond PK, I guess, in the Sadnad data?

In terms of the sad and Mad data for 935 I guess.

Not that it's not that we're looking for a read through to the psoriasis, but can you describe the PD data that we should be looking for as that has that reads out later this year.

Yeah.

So I've met you.

Meaning what's in the part A&D that Deborah.

From a pharmacodynamic point of view.

What are some of the things you're looking for not not really beyond T. K I guess.

Got it.

Matthew Lee Kaplan: So pharmacokinetic, of course, data we will have extensively because, of course, in this part A and B, we did a single dose pharmacokinetic. We have... We had multiple dose pharmacokinetic over 14 days in these patients. And these were healthy volunteers; sorry. We also explored different dosing options, once daily versus twice daily. I think it would be good to see how they address certain needs, for example, or how they would allow us certain configurations for these patients. So both are done. And we also, in parts A and B, did evaluation of food effects, for example, on pharmacokinetics. So that's what you should expect all to come.

The pharmacokinetic of course data we will have.

And thirdly because of course in this part A&D we did.

Single dose pharmacokinetic, we had multiple dose pharmacokinetic over 14 days in these patients.

Healthy volunteers.

We also explored different dosing options.

Once daily versus twice daily I think to see how they address.

<unk>.

Certain needs for example, or how they would allow us certain configurations for these patients. So overdone and we also in this part a and b.

Valuation of food effect for example on the pharmacokinetic. So that's what you should expect all to come.

Andreas Müller: And I think I just have to stress what I told you, yes, I think the amount of pharmacodynamic data that you can get that is relevant to our indication and that exceeds what we had done in vitro because we had done the in vitro data with human lymphocytes and release based on different concentrations of IME-935. So this was done in vitro, and we felt that there's very little that you can do in healthy volunteers that would really exceed the value of in vitro experiments that we had done with human lymphocytes.

And I think I.

I have to stress what I told you, yes, I think the amount of.

Pharmacodynamic data that you can get that is relevant to really our indications and that exceeds what we had done in vitro because we had done the in vitro data are as human lymphocytes and release based on.

Difference.

Concentrations of 93, 5%.

So this was done in vitro.

Felt that.

There's very little that you can do in healthy volunteers that would exceed the value of it.

In vitro.

Experiments that we have done with the human lymphocytes.

Andreas Müller: Okay, that's very helpful, thank you. And then a second question, just wanted to focus a little bit on your other program, IMU-856, which targets the intestinal barrier function. Can you give us a sense in terms of what role this molecule could play and what indications you're excited about potentially pursuing after the year?

Okay. That's very helpful. Thank you and then second question just wanted to focus a little bit on Europe.

There are other program <unk> 856, which targets the intestinal barrier function can you give us a sense in terms of.

What this what role this molecule could play and what indications youre excited about potentially pursuing after here.

Andreas Müller: after you announced the sad and mad data, I guess, in the third quarter of Nick

You announced.

Announced the sad and Mad data, yes third quarter of next year.

Matthew Lee Kaplan: Yeah, I think Matt, these are very good questions. So the thing with the, and you know this as well as I do, that we, that the mechanism of action addresses the, the basic, the barrier dysfunction in the gut, that is responsible for so many diseases, symptoms, and pathophysiology for different diseases, yes, and that's, As much as good news as bad news, yes, because I think the company has to focus to find its indication where we believe we can show proof of concept relatively quickly with the 28-day dosing, similar to psoriasis, where you have a medical need, and where you also have the ability to execute quickly towards with endpoints that are accepted by the FDA.

Yes, I think Matt Mathison.

Very good questions.

The thing with the and you know this as well as I do that.

The mechanism of action of dresses.

The basic the barrier dysfunction.

And the gaps that is responsible for so many diseases symptom.

And pathophysiology for different diseases.

The deaths.

As much as good news as bad news, because I think the company has to focus to find its indication where we believe we can show proof of concept.

Relatively quickly with a 28 day dosing similar to psoriasis.

Where you have a medical need.

And where you also have the ability to execute quickly towards.

With endpoints that are accepted by the FDA and with this this discussion is ongoing but I think.

Matthew Lee Kaplan: And this discussion is ongoing, but I think we're going to, I can promise you, we have a lot of these interesting discussions, and we will relatively soon present our plans for that, but at the moment, we haven't fully been able to make this public. Fair enough. Well, thanks for taking the questions and congratulations on all the progress.

I can promise you we have a lot of these interesting discussions in vivo.

Relatively soon present our plans.

Plans for that but at the moment.

We haven't fully.

<unk> been able to make this public yet.

Okay fair enough.

Well, thanks for taking my questions and congrats on all the products.

Matthew Lee Kaplan: Thank you, Matt. The next question comes from Buba Lan Pachayapan at H2 Rainwright. Well, please unmute yourself and go ahead. Hi, can you hear me? Yes, hi. Okay, awesome. So just a few, thanks for taking my question, just a few from our end.

Okay.

Thank you Matt.

Next question comes from Google Anthos shy upon at H C Wainwright.

Well unclear unmet yourself and go ahead.

Hi can you hear me, yes, hi.

Okay Awesome. So just thanks for taking my question just feel from our end. So just curious to hear your thoughts on NFL, especially these two questions. So firstly, how do NFL levels.

Buba Lan Pachayapan: So, just curious to hear your thoughts on NFL, especially these two questions. First of all, how do NFL levels in RRMS patients compare with healthy adults? And secondly, do you think utilizing NFL as a biomarker may streamline patient recruitment for your upcoming inshoot trial and maybe future pivotal trials in advanced MS patients? Thank you.

Our MF patients compared with healthy others.

Secondly, do you think utilizing NFL as a biomarker made streamlined patient recruitment for your upcoming <unk> trial, and maybe a future pivotal trials in advance of MF patients.

Yeah.

Buba Lan Pachayapan: Hi Bublan, this is Andreas again, the chief medical officer. So I think this goes way beyond Munich, yes?

Hydro Flask is Andre Africa, the Chief Medical Officer, So I think.

This goes way beyond immune against because I think.

Andreas Müller: Because I think the, not only the MS community but the community doing clinical research on neurodegenerative diseases, this is beyond MS. I've really found that the biomarker neurofilament correlates to the amount of damage to neurons and independent of the disease process that's involved. And we have seen this in several diseases. And in MS, also, we've seen a very good correlation, not just in our trial but also in other trials in the last year, that the treatment effect of preventing the damage to neurons and neurons dying and having less lesions and having less relapse activity always translates into neurofilment so that And we have shown the stress with the XRMS poster, I think two months ago, last month, that But you're also asking a good question because I think there's predictability.

Not only the MS community, but the community of doing clinical research on <unk> and Euro degenerative diseases.

This is beyond <unk> had really found that the biomarker in euro filament correlates to the amount of damage to eurobonds and independent necessary.

Independent of the disease process, that's involved and we have seen is in several diseases and in <unk> also we've seen a very good correlation not just in our trial, but also in.

Other trials in the last year.

D a.

The treatment effect and preventing the damage to the neurons and Duran Duran, staying and having less lesions and having less rehab activity.

Always translates into.

<unk> so.

And we've shown this just with the <unk> poster.

I think two months ago, one last month.

That is correlated very relevant to patients who had relapsed for example in our phase two trial had more of a.

More resistance to NFL decreased in patients who didn't have a relapse.

But you're also asking a good question because I think there's a predictability doesn't mean that.

Andreas Müller: It doesn't mean that there's not overlap in individual patients. So I think NFL is a good marker for groups in terms of, or populations in terms of, therapy control or a therapy relation to success of therapy. But we have also seen that, and we have also published in this Act Jim's poster, those patients who at baseline, for example, at the start of therapy, have a relatively high neurofilament tend to have more activity in a trial. They tend to have more activity.

There is not overlap in the individual patients.

NFL is it is a good marker for groups in terms of.

Our populations in terms of.

Therapy control or a therapy relation to success of therapy, but we've also seen that we have also published and as <unk> said.

Those patients who at baseline for example that startup therapy have.

The rest of the highest euro filament that Dara.

Sure.

Having more activity and a trial date that tend to be have more activity, but it's also a little bit more. This is a prediction may not help you on the individual patient level, but on a population that's true.

Andreas Müller: But it's also a little bit more; this is a prediction, and may not help you. On the individual patient level, but on the population level, that's true. We will not use a stratification or an inclusion exclusion criteria for neurofilament in phase three because we believe, I think, also, that what we have seen from the phase two data, and that was part of the post as well, part of the poster as well, that the treatment effect of IMU-A-38 is independent of what baseline your filament level you have. But so I think it would unnecessarily diminish our phase-free population

We will not use a stratification or a inclusion extrusion Cartier four euro filament into phase III, because we believe I think also that.

What we have seen from the phase II data.

And that was part of the part of the poster as well.

The treatment effect.

100, <unk> independent of what baseline your filament level you have.

But so I think it would unnecessarily diminish our phase III population.

Andreas Müller: And also we don't need to basically enrich a more active or a more in a population that is expected to have more relapses for this trial, we believe. So it's something that is a very good marker for damage to neurons. And especially to you come back to your last question in terms of progressive MS. There are over the last one or two years, and this actrooms again last month was also no exception, more data because I think the markers started with relapsing MS data, but we have no more data in progressive MS and they absolutely mirror what we know from relapsing MS that neurofilament also is a very good treatment predictor and correlates with activity of drugs in secondary, progressive, and patients who have a more aggressive form of progressive MS, have a higher neurofilament in serum than those patients who have a less severe disability progression or brain atrophy.

And also we don't read too basically.

Enrich and.

A more active or more.

Yes.

In a population that is expected to have more relapses for this trial, we believe so.

It's something that is a very good marker for damaged neurons and especially when you come back to your last question in terms of Progressive Emmis there aren't over the last one or two years I mean <unk> again last month was also no exception there now.

More data because I think the market started with relapsing Ms data, but we have no more data in progressive Ms and they absolutely mirror, what we know from relapsing Ms asset.

<unk> also has a very good.

Treatment predictor.

And correlates with activity.

If trucks in and secondary progressive Ms and patients to have a more aggressive form of progressive MF have a higher newer filaments and theorem than than those patients who have.

A less severe disability progression of brain atrophy, and this has been shown over and over again.

Andreas Müller: And this has been shown over and over again, so I think this is a real effect. And that's why we're also using neurofilament as part of our interim analysis for our Caliber trial. And we believe that this could be predictive in terms of the overall results to expect at the end of the trial.

It's I think this is a real effect and that's why we're also using euro filament as part of our interim analysis for our caliber trial and we believe that this could be predictive in terms of the overall results to expect at the end of the trial.

Buba Lan Pachayapan: Hi Sanja, that's really, really helpful. So the Caldose 1 study has completed enrollment. So what are your baseline expectations for this trial? And what would be the minimum placebo-adjusted clinical remission rate you'd like to see to carry the program forward? And do you think the Caldose 1 results will impact the upcoming Crohn's disease trial?

Thanks, Sanjay that's really really helpful. So catalyst one study has completed enrollment so what are your baseline expectations for this trial as well what would be the minimum placebo adjusted clinical remission rate you'd like to see to carry the program forward and do you think the catalyst one results impact.

Upcoming Crohn's disease trial.

Andreas Müller: So I think I know that's a very good question in terms of whether you have a hard threshold or a hard parameter on which to decide whether to go forward in phase three. Usually, I think these phase three decisions are not related to statistical significance or to a certain outcome; I think you need to justify it on the entirety of the data because I think there's also some benefit risk that you have to consider, where you have to balance the safety versus the gain and efficacy or activity that you see. So I personally think that you need to look at the entirety of the data.

So I think.

I know that's a very good question in terms of whether you have a a.

A hard threshold or our hearts.

Parameters on which to decide whether to go forward to phase III.

Usually I think these phase III decisions or not.

Related to statistical significance or to a certain outcome or I think you need to justify it on the on the.

Entirety of the data because I think thats also.

Some benefit risk that you have to consider.

You have to put the safety versus the gain in efficacy or activity that you see so I personally.

Things that you need to look at the entirety of the data for example, I just want to remind you of the phase II trial in towards dividend. So it took us by.

Andreas Müller: For example, I just want to remind you of the phase two trial with topopacidivin, like Pfizer, that there was really, I think, as far as I remember, there was no statistically significant outcome in the primary or key secondary outcomes. And clearly, it's an active drug, and you see. And Pfizer took it forward.

By Pfizer.

Really I think as far as I remember there was no statistically significant outcome in the primary or key secondary outcome and.

And clearly it's an active drug in UC.

And it took us forward. So I think the expectation should be really to look at the entirety of the data and make an assessment of benefit risk and also what the dosing level that is supported by activity and the safety and so far what <unk> seen I think we have that.

Andreas Müller: So I think the expectation should really be to look at the entirety of the data and make an assessment of benefit risk and also what the dosing level is that is supported by activity and safety. And so far, what we have seen, I think we have, and that was true for the phase two study in MS, that we could have taken any of our doses forward that we had in phase two in terms of safety.

This was true for the phase III study in MF that we could have taken any of our doses forward that we had in phase II in terms of safety, but then after the site.

Andreas Müller: But yeah, then you have to decide what's the lowest effective dose that should go into phase three. And that's how we chose the 30 milligram dose. It was not an assessment of a certain statistical outcome from phase two, to be quite honest. So I think more considerations should be given, but I think the outcome, of course, in the main efficacy endpoints, of course, have a huge effect on how this benefit risk is, but I think it's wrong to have a, it's not advised to have a very hard criterion for that, in my mind.

The.

The lowest effective dose that should be going into phase III and thats. How we chose the 30 milligram dose it was not.

Assessment of a certain statistical outcome from the phase III to be quite honest.

I think more consideration spend but I think.

The outcome of course in the main efficacy endpoints of course have a huge effect on how this benefit risk is but I think it's wrong to have a well it's not advice to have a.

A very hard criteria and for that to my mind.

Buba Lan Pachayapan: Okay, awesome. One last one from me. So what are some of the gain items remaining to initiate the GBS program, Gianbury Syndrome, and where do you see opportunities for value creation, given there are multiple players in the clinical development space? Thank you.

Okay Awesome and one last one from me so what are sort of the gating items remaining.

The GBS program.

<unk> syndrome that do you see opportunities for value creation, given there are multiple players in the clinical development space. Thank you.

Daniel Vitt: So maybe this is more an overall question for the pipeline, the balance, and we decided to park it for a little bit because we have identified CRPC as a very attractive indication and prioritized CRPC a little bit over GPS. And given that we will see data from the SAV, the MAD safety part, and at the end of the year and first thing, first efficacy hints from the psoriasis patient cohort in the second quarter next year coming from surasis, I think this will help us to get the full picture and also will help us to support going forward, for example, in GBS as well.

So maybe this is more of an overall question for the pipeline and the bonds and we decided to pocket for a little bit.

Because we have.

Identified.

<unk> is a very attractive indication.

[laughter] prioritize see RPC, a little bit over all the GBS and given that we will see data from the sad and Mad safety part towards the end of the year.

First thing for us to think of the hands from psoriasis patient cohort in the second quarter next year coming from Horizon. I think this will this will help us to get the full picture and also will help us.

Supporting going forward.

For example in the.

Buba Lan Pachayapan: Okay, thanks so much for taking my question. Great, I appreciate it time. Thank you. Thank you, Gubalan. Our next question comes from Andreas Aguridis at Webbush. Andreas, please unmute yourself and go ahead.

GBS as well.

Okay. Thanks, so much for taking my question, Greg I appreciate the time.

Thank you.

Thanks, Tim for Milan.

Our next question comes from Andreas I read it at Wedbush Andreas Please make yourself and go ahead.

Andreas Argyrides: Yes, hi, Andreas. I think it was a little bit lower volume, I think, then the rest. So I just say, repeat the question for if somebody had a hard time hearing the question. So you want a little bit more color on how this study will be done in CRPC for IMU 935. So this.

Alright, good morning, and thank you for taking our questions just a quick one.

Right.

The prostate cancer program might be five.

We provided additional color on the study.

As such as how many doses will be assessed at the start of a trial with Biomarkers do you plan on measuring.

Yes, Hi, Andreas.

I think of us.

Good.

Lower volume I think the rest of this so I just.

Repeat the question for if somebody had a hard time hearing the question.

One's a little bit more color how does study will be done in <unk> for <unk> hundred five.

Andreas Müller: First of all, in general, this study will have a dose escalation part. That means that we have several cohorts where we try to escalate the dose and potentially find a dose limit of toxicity. This is something that we have not done in the phase one trial in the general phase one trial for IMEU-935 because we know that the dose limiting toxicity is way beyond the therapeutic doses for immunologic diseases. So in that respect, this will be different, of course, before the oncology indication where you have to try to dose up to the dose limiting toxicity. So this will be done with several courts. We don't know how many.

So this <unk>.

First of all in general.

The study will have a dose escalation part that means that we have several cohorts, where we tried to escalate.

The dose.

And potentially find a dose limiting toxicity.

This is something that we have not done in the.

Phase one trial and the general Phase one trial for <unk> hundred 90, <unk> five because we know that the dose limiting toxicity is way beyond the the therapeutic necessary doses for immunology diseases. So in that respect.

This will be different of course support oncology indications, where you have to try to dose up to the dose limiting toxicity.

This will be done with this several court, we don't know how many.

Andreas Müller: So it depends a little bit, of course, how quickly you find that dose number because of whether or not you find it. We have a maximum dose also identified where we will stop because it's, we believe that you don't need to go beyond that. And then we have a second part, that's an expansion part, where we take one or two doses that we identified as potential phase two doses or that basically are where we have seen maybe some hint of activity.

So it depends a little bit of of course.

How quickly you find that those lines could be or whether you would not find that we have a maximum dose also identified where we will stop because.

We believe that.

You don't need to go beyond that and then we have a second part.

A expansion part where we take one or two doses that we identified as potential phase II doses are the basically are.

Wherever you have seen maybe some hint of activity in the dose escalation part.

Andreas Müller: in the dose escalation part to expand cohorts to allow a more thorough assessment of activities in these those parts. The study will look at biochemical markers, of course, PSA, yes, as a biochemical output. We are looking at imaging. We're looking at circulating tumor cells. So everything that you know about prostate cancer, and especially about cancer-resistant prostate cancer from the prostate cancer working group, now recommendation three, I think we have implemented.

To expand.

Our courts.

Allow a more thorough assessment of activities and these those parts.

This study will look.

Ed.

Biochemical markers of course PSA yes.

The biochemical output.

Andreas Müller: So I think when you read the prostate cancer working group document, you basically find the biomarker that we're also looking for. We're following the recommendations as you on the Bono as one of the authors of this prospect cancer working group documents and really had set the guidelines. I think you more or less have to follow these guidelines then. Thank you, Andreas. Thank you, Andreas. This concludes our question and answer session.

Jessica Breu: This concludes our question and answer session. I would like to turn the call back over to Daniel for any closing remarks.

Daniel Vitt: Yeah, thank you, Jessica, and thank you all for the great questions and the lively discussion today here. I very much enjoyed that. I hope you can feel our excitement about the operational progress Immunic has made this year and the multiple catalysts to come in the next couple of months. We very much look forward to seeing clinical data from our clinical programs next year, in particular the phase two data of IMEA8 in alternative colitis and the initial patient data from IMEU 95, both in the second quarter of next year. With that, I would like to close today's call. Thank you very much for joining us, and we are very happy to answer any additional questions one-on-one.

Field or excitement about the operation of progress you mean, the case made this year and the muscle catalysts to come in the next couple of months.

We very much look forward to seeing clinical data from allergenic of programs next year in particular, the phase two data I'm in a trade and onto the colitis and the initial patient data from I'm in 95, both in the second quarter of next year with this I would like to close today's call. Thank.

Thank you very much for joining and we are very happy to answer any additional questions and one on one.

Jessica Breu: Also, from my side, thank you for joining in Munich's third quarter 2021 earnings call today. The conference has now concluded.

Awesome for my site. Thank you for joining in your <unk> third quarter 2021 earnings call. Today. The conference has now concluded you may now disconnect.