Q1 2022 Immunic Inc Earnings Call
Jessica Breu: My name is Jessica Breu, Head of Investor Relations and Communications at Immunic. I will also be the moderator on today's call. Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer and President, as well as Glenn Whaley, our recently promoted Chief Financial Officer. Please note that all participants will be in listen-only mode, and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. If you joined the webcast via the Zoom platform, there are two ways to submit questions.
My name is Jessica Brew head of Investor Relations and communications at the Munich I would also be the moderator on today's call.
Speaking on the call. Our Doctor then if it's our chief Executive Officer, and President as well as Glenn Wailea, Our recently promoted Chief Financial Officer.
Please note all participants will be in listen only mode and this event is being recorded.
After todays presentation, there will be an opportunity to ask questions.
He joined the webcast by the swim platform, they're two way to submit questions. You can submit your question in writing via the Q&A till after soon portal or if you would like to speak with US directly. Please use the raise hand function in the same quarter to pure question. If you joined today's webcast by phone. Please press star.
Jessica Breu: You can either submit your question in writing via the Q&A tool of the Zoom portal, or if you would like to speak with us directly, please use the raise hand function in the Zoom portal to queue your question.
Jessica Breu: If you joined today's webcast by phone, please press star 9 to queue a question. 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.
Two quick questions.
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 all works with a similar meaning and such statements involve a number of risks and uncertainties that could cause immune if extra.
Jessica Breu: And such statements involve a number of risks and uncertainties that could cause Immunics' actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunics' opinions only as of the date of this presentation and that Anna takes 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. Please refer to Immunics' SEC filings for a more detailed description of the risk factors that may affect Immunics results and these forward-looking statements. I would now like to turn the call over to Dr. Daniel Vitt, our CEO and president, to begin the presentation. Daniel, please go ahead.
Our results to differ materially from those discussed here. Please note that these forward looking statements reflect immunity 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.
Please refer to immune <unk> SEC filings for a more detailed description of the risk factors that may affect <unk> results in these forward looking statements.
I would now like to turn the call over to Dr. Daniel <unk>, our CEO and president to begin with the presentation. Daniel Please go ahead.
Daniel Vitt: Yeah, thank you, Jessica. I would like to welcome everybody to Immunics' first quarter 2022 earnings call. Earlier this morning, we announced our financial results for the quarter ended March 31, 2022 and highlighted recent activities as well as upcoming milestones related to our clinical development pipeline. During today's call, we will talk through our first quarter of 2022 and subsequent highlights, financial and operating results, as well as anticipated milestones. As Jessica noted, before we close the call, you will have the opportunity to ask, "The first quarter of 2022 was marked by a continued decline in COVID-19 cases. My apologies, Daniel.
Yes, Thank you Jessica.
I would like to welcome everybody.
First quarter 2022 earnings call.
Earlier this morning, we announced our financial results for the quarter ended March 31st 2022.
Highlights of recent activities as well as upcoming milestones related to our clinical development pipeline.
During today's call, we will talk through our first quarter 2022 and subsequent highlights.
Mentioned operating results as well as anticipated milestones.
As Jessica noted before we close the call.
You would have the opportunity to ask questions.
Yeah.
The first quarter of 2022 was marked by continued advanced node design with advanced with advanced with advanced cirrhosis bonds with advanced nodes advance.
So with advanced with advanced.
So with advanced cirrhosis bonds.
With advanced with advanced with advanced with advanced with advanced nodes advanced cirrhosis.
Two at advanced nodes.
So with advanced with advanced with advanced payments.
So with advanced.
With advanced with advanced nodes advanced cirrhosis.
So with advanced nodes advanced with advanced.
With advanced with advanced with advanced Ron Stewart, advancing with advanced with advanced with advanced with advanced with advanced nodes advanced nodes advanced nodes advance it with advanced <unk>.
So with advanced <unk>.
So with advanced nodes advanced with advanced <unk>.
Advanced nodes advanced cirrhosis bonds with advanced nodes advance it with advanced with advanced users.
So with advanced <unk> with advanced nodes advanced with advanced cirrhosis cirrhosis monsoon advance it with advanced here with advanced nodes advanced with advanced users.
Jessica Breu: I had to mute you for a second. It seems like the audio had a little problem. Maybe you can restart with the review of the quarter, please. 1, 2, 3, to 1, 2, 3, to 1, 2, 3, to 1, 2, 3, to 1, 2, 3, to 1, 2, 3, to 1. Now, still, still a technical issue with the line. My apologies to the audience. Bond, Judith Bond, Judith Bond, Judith Bond.
My apologies Daniela I had to mute you for a second and it seems like the audio had another problem, maybe you can restart with the.
With the review of the quarter. Please.
I'm, sorry, with advanced nodes advanced use advanced use advanced you at this time.
Now still still a technical issue with the line my apologies to the audience.
Okay.
Ron Stewart advanced use advanced yield advanced Stuart <unk>.
Now networking M not sure maybe Glen would you like to take over.
Sure, we'll do Jessica.
Yeah.
So.
Glenn Whaley: No, not working. I'm not sure. Maybe Glenn, would you like to take over? Sure, will do, Jessica. So, earlier this morning, we announced our financial results for the quarter ended March 31st, 2022 and highlighted recent activities as well as upcoming milestones related to our clinical development pipeline. During today's call, we will walk through our first quarter of 2022 and subsequent highlights, financial and operating results, as well as anticipated miles. As Jessica noted, before we close the call, you have the opportunity to ask, "The first quarter of 2022 was marked by continued progress across the business, including financially and within our key pipeline program."
Earlier this morning, we announced our financial results for the quarter ended March 31, 2022, and highlight our recent activities as well upcoming milestones related to our clinical development pipeline.
During today's call, we will walk through our first quarter 2022, and subsequent highlights financial and operating results as well as anticipated milestones.
Jessica noted before we close the call you'll have the opportunity to ask questions.
The first quarter of 2022 was marked by continued advancement across the business, including financially and within our key pipeline programs. The progress. We have made as I stated last quarter is clearing the way for several important data readouts. This year that could be transformative for a minute.
Glenn Whaley: The progress we have made, as I stated last quarter, is clearing the way for several important data readouts this year that could be transformative for a minute. Let me walk through the first quarter 22 and subsequent events in more detail. In February, we presented the preclinical data for the potent anti-inflammatory activity of additional miscalcium at the 17th Congress of ECO. Highlights included First, beta-fetal calcium reduces pro-inflammatory immune cell responses by inducing regulatory macrophages, reducing pro-inflammatory cytokine secretion, and reducing T cell proliferation.
Let me walk through the first quarter 'twenty, two and subsequent events in more detail.
In February we presented preclinical data at the potent anti inflammatory activity of beautiful boneless calcium at the 17th Congress of igo.
Highlights included <unk>.
The Vida food almost calcium reduces provost clamatorial immune cell responses by inducing regulatory macrophages, reducing pro inflammatory cytokine secretion and reducing T cell proliferation.
Glenn Whaley: Second, dibutofluvimalis calcium shows additive to synergistic effects with anti-TNF antibodies. And finally, DHODH is important in the fraction of cells that receive a strong immune stimulus and are highly metabolically active. In conjunction with the ECO Congress, as you may recall, we also announced the blind and baseline characteristics of our Phase 2 CalDose 1 trial of beta-fumarose calcium in UC. Patients in the trial had active to moderate severe disease. And, as we noted, we were pleased to see that only 17 percent of the patients were pre-treated with a biologic. The trial utilized a central independent reader to evaluate the endoscopic eligibility criteria. At baseline, 55% of patients had a modified Mayo endoscopic score of 3, and 45% of patients had a score of 2.
Second.
The beautiful numerous calcium shows additive to synergistic effect with anti TNF antibodies and.
And finally, the D. H O D. H is important in the fraction cell.
That receive a strong immune stimulus and our highly metabolically active.
Yes.
In conjunction with the Eco Congress as you May recall, we also announced the blinded baseline characteristics of our phase II Cal dose one trial, a beautiful boneless calcium and UC.
Patients in the trial had active to moderate severe diseases and as we noted we were pleased to see that only 17% of the patients were pre treated with biologics.
<unk> utilized our central independent reader to evaluate the endoscopic eligibility criteria at baseline 55% of patients had a modified Mayo endoscopic score of 345% of patients had a score of two.
Okay.
Glenn Whaley: As previously noted, we firmly believe that the randomized patient data and the methodology regarding endoscopic assessments used in the trial will contribute to ensuring optimized study readout. We continue to believe that the results of the interim analysis, along with Vitifumo's calciums, which already have strong safety and tolerability profiles, suggest that the drug could become a preferred oral treatment option for patients suffering from ulcerative colitis and obvious alternatives to biologics. Moving to our second asset, IMU935, our potentially best-in-class oral IL-17 inhibitor.
As previously noted we firmly believe that the randomized patient data and the methodology regarding endoscopic assessments using the trial to contribute to ensuring optimized study readout.
We continue to believe that the results of the interim analysis, along with it a few months calcium who's already established strong safety and Tolerability profile.
Suggests that the drug can become a preferred oral treatment option for patients suffering from all sort of colitis and obvious alternatives to biologics.
Yes.
Moving to our second asset by immune 935, our potentially best in class oral IL 17 inhibitor and.
Glenn Whaley: In February, we significantly bolstered our intellectual property protection for IMU-935 with the receipt of notice of allowances for composition of matter patents in the U.S., Europe, and Australia. These patents provide protection at least to 2038 with further extension possible through the potential PTE in the U.S., or SPC in your perspective. In March, we promoted Glenn Whaley to our Chief Financial Officer. He's done an outstanding job in
In February we significantly bolstered our intellectual property protection for eye immune 93, five with a receipt of notice of allowances for composition of matter patents in the U S Europe and Australia.
These patents provide protection at least to 2038 with further extension possible through the potential pte in the U S. R.
Our SBC and Europe , respectively.
Okay.
And March will be promoted Glenn rally to our Chief Financial Officer. He has done an outstanding job in 2019, please to our pipeline in this position.
Glenn Whaley: We are pleased to have Glenn in this position. Most recently, we announced the start of patient cohorts and our ongoing phase one clinical trial of IMU-856, our third clinical asset in patients with celiac disease. Marking the first time patients will be treated with this early available small molecule, which targets restoration of the intestinal barrier function and regeneration of the bowel epithelium. This is an important milestone in the clinical development of this program as data from preclinical studies have suggested to us that IMU-AID5's IMU-A56 can restore barrier function in the gastrointestinal tract and regenerate intestinal architecture while maintaining immunocompetency.
Most recently, we announced the start of the patient cohorts in our ongoing phase one clinical trial of I am you 856, our third clinical asset in patients with celiac disease.
Marking the first time patients can be treated with this early available small molecule, which targets restoration of the intestinal barrier function and regeneration of bowel epithelium.
This is an important milestone in the clinical development of this program as data from preclinical studies have suggested to us that I am you eight five.
I am you a five six can restore barrier function in the gastrointestinal tract and regenerate intestinal architecture, while maintaining immuno competency.
Okay.
Moving on.
Glenn Whaley: Moving on, to the financial results. Let me start with the cash overview. We ended the first quarter with $95.7 million in cash and cash equivalents, and then, subsequently, in April, we raised an additional $10 million through our at-the-market facility.
Two to financial results.
Let me start with the cash overview.
We ended the first quarter with $95 7 million in cash and cash equivalents and then subsequently in April we raised an additional 10 million through our at the market facility.
We anticipate this cash balance.
Glenn Whaley: We anticipate this cash bang. We anticipate this cash balance to be sufficient to fund operations into the third quarter of 2022, based on operating results. Research and development expenses for the quarter ended March 34, 2022 were $17.4 million, as compared to $11.5 million for the same period in 2021. The increasing costs for the quarter reflect a continued ramp-up of clinical expenses related to our three clinical programs, as well as increased personnel expenses related to the hiring of more people to support the company's growth.
We anticipate this cash balance will be sufficient to fund operations into the third quarter of 2023.
Regarding the operating results.
Research and development expenses for the quarter ended March 30 for 2022 were $17 4 million as compared to $11 5 million for the same period in 2021.
The increase in costs for the quarter reflect the continued ramp up of clinical expenses related to our three clinical programs as well as increased personnel expenses related to the hiring of more people to support the company's growth.
The increases were partially offset by decreased costs related to our phase two clinical trials in COVID-19, and ulcerative colitis and a decrease in drug supply cost per visit from one of those calcium.
Glenn Whaley: The increases were partially offset by decreased costs related to our Phase 2 clinical trials in COVID-19 and ulcerative colitis and a decrease in drug supply costs for vitifluoroscal. General Administrative Expenses were $4 million for the quarter ended March 31, 2022, as compared to $3.6 million for the same period last year.
General and administrative expenses were 4 million for the quarter ended March 31, 2022, as compared to $3 6 million for the same period last year.
Glenn Whaley: The increase in costs was primarily due to personnel expenses as well as smaller increases in costs across numerous categories. The loss for the three months ended March 31, 2022, was approximately $20.8 million, or $0.74 per share, based on approximately 28.1 million weighted average common shares outstanding. Compared to a net loss of approximately $34.5 million, or $1.63 per share, based on 21.2 million weighted average common shares outstanding for the same period in 2021.
The increase in cost was primarily due to personnel expenses as well as smaller increase in costs across numerous categories.
Net loss for the three months ended March 31, 2022 was approximately $20 8 million or <unk> 74 per share based on approximately $28 1 million weighted average common shares outstanding.
Compared to a net loss of approximately $34 5 million or $1 63 per share based on $21 2 million weighted average common shares outstanding for the same period in 2021.
Okay.
Yeah.
Yeah.
Sure.
Glenn Whaley: Moving on, Notably, one of our most important upcoming value inflection points will be the highly anticipated readout of our Phase 2 CalDOS-1 trial of beta-fluminous calcium in patients with moderate to severe UC, which we previously reported having completed enrollment during the fourth quarter of last year. As a reminder, At the completion of patient recruitment, the trial had randomized a total of 263 patients into four hours, three active dosing arms of 10, 30, and 45 milligrams, as well as placebo.
Moving on to.
Notably one of our most important upcoming value inflection points will be the highly anticipated readout of our phase III <unk>, one trial, a vida fluminous calcium in patients with moderate to severe UC.
Which we previously reported having completed enrollment during the fourth quarter of last year.
As a reminder.
At the completion of patient recruitment the trial had randomized a total of 263 patients into for ARX <unk>.
Reactive dosing arms of 10, 30, and 45 milligram as well as placebo.
Yeah.
Glenn Whaley: As for IMU-935, after having previously reported positive unblinded safety, PK, and PT data from healthy volunteer portions of our ongoing phase one trial of IMU-935, as planned, we expanded the trial in Q421 to include a third portion to treat patients with moderate to severe psoriasis. This was a key milestone for us as it represents the first time patients are being treated with this compound.
As for IMMU 935, after having previously reported positive unblinded safety PK and PD data from healthy volunteers portions of our ongoing phase one trial of IME and 93 five as planned we.
We expanded the trial in Q4 'twenty one to include a third portion to treat patients with moderate to severe psoriasis.
This was a key milestone for us as it represents the first time patients are being treated with this compound.
Glenn Whaley: As mentioned in our fourth-quarter call, in order to address the COVID-19 related limitations in Australia and New Zealand, where this trial has been exclusively conducted, we have now submitted the required documentation to regulatory authorities in Bulgaria and North Macedonia in order to press forward rapidly with patient randomization. We expect initial results from this third portion of the trial to be available in the second half of this year. The initial data will provide us with a first important look at IMU935's safety and efficacy profile in this patient population.
As mentioned in our fourth quarter call in order to address the COVID-19 related limitations in Australia, and New Zealand.
Where this trial has been exclusively conducted we have now submitted the required documentation to regulatory authorities in Bulgaria, and north Macedonia in order to press forward rapidly with patient randomization we.
We expect initial results from this third portion of the trial to be available in the second half of this year.
The initial data will provide us with a first important look at IME 935 safety and efficacy profile in this patient population.
Okay.
Glenn Whaley: In addition, enrollment in the Phase 1 dose escalation trial of IMU-935 in progressive metastatic castration-resistant prostate cancer, which was initiated in late Q4 of 2021, has been ongoing. The trial is led by Principal Investigator Dr. Johan Sebastian de Bono, one of the world's foremost experts on the subject of CRPC.
In addition, enrollment in the phase one dose escalation trial of IV, and 935, and progressive metastatic castration resistant prostate cancer, which was initiated in late Q4 of 2021 has been ongoing.
The trial is led by principal investigator Dr. Johann Sebastian de Bono, one of the world's foremost experts on the subject of C. R. P C.
Glenn Whaley: We are grateful to have Dr. DeBono at the helm of this trial and anticipate that initial safety data will be available in the third quarter. As a reminder, the trial is designed to establish a recommended phase two dose and to assess safety, tolerability, anti-tumor activity, biomarkers, and pharmaconetics of IME-935 in this indication. With regard to our ongoing phase one clinical trial of IMU-856, with the single ascending dose partly part already completed and the multiple ascending dose currently ongoing, we eagerly anticipate reporting the unblinded safety data from these healthy volunteer participants in the third quarter of 2020.
We are grateful to have Dr de bono at the helm of this trial and anticipate that initial safety data will be available in the third quarter of this year.
As a reminder, the trial is designed to establish a recommended phase II dose and to assess safety Tolerability antitumor activity Biomarkers and pharmacokinetics of irony of 93 five in this indication.
With regards to our ongoing phase one clinical trial of IMMU 856.
With the single ascending dose, partly part already completed and multiple ascending dose currently ongoing we eagerly anticipate reporting the unblinded safety data from these healthy volunteer parts in the third quarter of 2022.
Glenn Whaley: It is also important to note that our twin phase three trials for litifluminous calcium ensure one and two in patients with relapsing multiple sclerosis are progressing. As a reminder, we have targeted enrollment of approximately 1,050 patients in each group. Dosing is either 30 milligrams once daily, a bit of calcium, or placebo.
It is also important to note that our twin phase III trials for litter frivolous calcium ensure one and two in patients with relapsing multiple sclerosis are progressing.
As a reminder, we have targeted an enrollment of approximately 1050 patients in each trial.
Dosing is either 30 milligram once daily of seamless calcium or a placebo.
Glenn Whaley: The primary endpoint for both trials is time to first relapse, up to 72 weeks. Also ongoing is our supportive Phase II Caliper trial in progressive multiple sclerosis, designed to demonstrate beta-fluminous calcium's potential for neuroprotective activity. This trial is expected to enroll approximately 450 patients, randomized to either 45 milligrams once daily, a bit of flummoxed calcium, or placebo. The primary endpoint is the annualized rate of percent brain volume change up to 120 weeks.
The primary endpoint for both trials is time to first relapse up to 72 weeks.
Also ongoing as are supportive phase III caliber trial and progressive multiple sclerosis designed to demonstrate <unk> potential for neuro protective activity.
This trial is expected to enroll approximately 450 patients randomized to either 45 milligram once daily of Cumulus calcium or placebo.
The primary endpoint is the annualized rate of brain per.
Percent brain volume change up to a 120 weeks.
Glenn Whaley: We remain highly enthusiastic about the potential of deuteronomous calcium to become a best-in-class therapeutic for this patient population, given its demonstrated activity in preventing lesion formation, as shown in our Phase II episys and RMS, and its exceptionally safe and tolerability profile thus far. Despite the limitations of currently approved therapies, the global MS market exceeds $23 billion, and British Women's Counseling is uniquely positioned to address the unmet needs of MS patients.
We remain highly enthusiastic about the potential of directionless calcium to become a best in class therapeutic for this patient population given its demonstrated activity in preventing lesion formation as shown in our phase two emphasis in our rns.
And as exceptionally safety and Tolerability profile.
Thus far despite the limitations of currently approved therapies, the global <unk> market exceeds 23 billion and beautiful and MS. Calcium is uniquely positioned to address the unmet needs for MF patients.
Jessica Breu: That brings us to the end of this formal presentation. Jessica, please open the call for Q&A. Thank you, Glenn.
That brings us to the end of this formal presentation Jessica Please open the call for Q&A.
Jessica Breu: Thank you very much for jumping in here. And apologies again to the audience for the technical issues. That's what sometimes happens in the digital world.
Yes. Thank you Glenn Thank you very much for jumping in here and apologies again for the audience for any technical issues. That's what sometimes happens in a digital world Danielle do you want to say some closing remarks here for the formal part of the presentation, where I just want to.
Daniel Vitt: Daniel, do you want to make some closing remarks here for the formal part of the presentation? Well, I just want to say thank you to Glenn and you for managing that despite the challenges here in Texas. I hope that works now for the Q&A session. I think what I wanted to add to the end of the presentation is that we're really pleased that we will be reading out this number of important clinical trials very soon. And we can do that with a strong financial base, decent cash reach, as well as having raised more than $40 million since the beginning of this year through our AGM facility.
Just to say, thank you to Atlanta, and Youtube to manage that despite the challenges the Olympics a readout.
I hope that works now for the Q&A session.
Yeah, I think what I, what I wanted to add on to the end of the presentations that were really pleased.
Then we will be reading out this number of important clinical trials very soon and we can do that with a strengthened financial base.
Decent cash reach as well as they have raised and addition of more than 40 million since beginning of this year through our ATM facility.
Jessica Breu: And with that, maybe, Jessica, you can open the Q&A session. Yeah, sure. I'm more than happy to do that. Just as a reminder, if you joined the webcast via the Zoom platform, 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, please use the raise your hand function of the Zoom portal to queue your question.
And with that maybe Jessica you can you can open the Q&A session.
Yes, sure I'm more than happy to do this and just as a reminder, if you join the webcast by Edison platform. There are two ways to submit a question you can submit your questions in writing via the Q&A tool of Hudson portal or if you would like.
Please use the raise hand function after assumed portal to Korea question.
Jessica Breu: At this time, we will pause momentarily to assemble our rooster. All right, our first question comes from Thomas Smith at SVB Lehring. Thomas, please unmute yourself and go ahead.
At this time, we will pause momentarily to assemble our own stock.
Okay.
Thomas Smith: Great. Thanks, guys. Thanks for taking the questions. Just a couple on our end.
All right. Our first question comes from Thomas Smith at SBB Leerink, Thomas Please and let yourself in go ahead.
Great. Thanks, guys. Thanks for taking the questions just a couple on our end I guess first on the <unk> trial in ulcerative colitis, you know we've seen a number of phase two readouts over the last few weeks when you're looking at some of these results can you just help put your study with beautiful unum us into context.
Daniel Vitt: I guess first on the beta-flutimus trial and ulcerative colitis. You know, we've seen a number of phase two readouts over the last few weeks. When you're looking at some of these results, can you just help put your study with beta-flutimus into context and remind us what's driving your confidence and success at the top line here in June? You're happy to do that.
And remind us what's driving your confidence and success of the pipeline here in June .
Daniel Vitt: I think we really prepared intensively with KOLs, the design of the trial, inclusion criteria, and we tried to really make sure that the trial is well designed, looking at baseline purposes, as mentioned, also making sure that we technically have a good trial ongoing. So far, we are satisfied with what we have seen technically from the trial, so we are very confident that this trial will read out properly. Our confidence in the data, in positive data, comes from a couple of other findings in the past.
Sure happy to do that I think we I mean really.
Payouts intensively with Kols the design of the trial inclusion criteria and we tried to really make sure.
The trial is well designed looking on baseline characteristics as mentioned.
Also making making sure that we would technically have a.
A good trial ongoing so far we are satisfied with what we have seen them.
Technically from the trial. So we are very confident that this trial will read out properly.
Our confidence on the data on positive data comes from a couple of hours.
Daniel Vitt: First of all, you may remember that there was a small interim analysis done after 25% of the patients had completed the 10-week induction phase, and the data review committee at that time suggested continuing with all active doses because none of the doses was expected to be. In fact, if compared with placebo, this was not done on a statistical assessment, but just from a data review committee perspective. Also, there was prior data from an open label, small proof of concept trial, the entrance trial in the past, showing that the drug may have activity in these indications. So we're quite optimistic and confident that it will. Okay, great. That's helpful. And then just a couple on IMU-935.
Other findings in the past first of all you may remember that there was a small interim analysis done after a 25% of the patients.
<unk> been have completed the 10 week induction phase.
And the data review committee at that time as suggested to continue with all active doses because none of the dose was expected to be.
Ineffective compared with placebo.
This woman and done on a statistical assessment, but just from there from a data review Committee perspective.
Also there was prior data from open.
From an open label small proof of concept trial. The entrants tried in the past showing that the drug may have activity in these indications. So we are we're quite optimistic and confident that it works.
Daniel Vitt: I guess first, can you just clarify if you started dosing psoriasis patients in the Part C portion of the study? And then as you look to expand enrollment here into Eastern Europe, and you're opening up the trial sites in Bulgaria and Macedonia, how are you thinking about regional enrollment? Do you expect more patients to come from the Australia and New Zealand region or the Eastern European region?
Okay, Great that's helpful and then.
Just a couple on immune 93, five I guess first can you just clarify if you started dosing psoriasis patients in the part C portion of the study and then as you look to expand enrollment here in the eastern Europe , and you're you're opening up the trial sites in Bulgaria and in Macedonia. How are you thinking about regional enrollment do you.
Got more patients to come from the Australia, and New Zealand region or the Eastern European region, and then just.
Daniel Vitt: And then just a final question on how you're thinking about the overall study population. Have you considered opening enrollment to mild to moderate patients, maybe as a way to bolster enrollment in the short term? Thanks for taking the questions, guys. Yeah, thank you once again. I think that's a good point. So we, yes, we are recruiting patients right now in the psoriasis portion of the county. We have active recruitment in the LODOS cohort, which is 150 mg once daily. That's what's going on in Australia and New Zealand.
A final question on how you're thinking about the overall study population have you considered opening enrollment to mild to moderate patients maybe as a way to to <unk>.
Ulster enrollment in the short term thanks for taking the questions.
Yes. Thank you once again I think good point. So yes, we are recruiting patients right now in the psoriasis portion in the economy.
We have active recruitment of the.
The low dose cohort, which is 150 milligram once daily.
That's going on in Australia, and New Zealand.
Daniel Vitt: As we said, we are in the process of getting Bulgaria and Macedonia up and running. So we submitted the documents, so that's work in progress. We hope that...
As we said we are in the process of getting Bulgaria, Macedonia are up and running so we submitted the documents. So that's work in progress and hope that.
Daniel Vitt: These countries and centers will be active soon and will be coming to the study population, I think. If you look at other trials, you should not spread it too widely because a reasonable good activity of psoriasis is required to see a real delta between placebo and active, and therefore, we keep it from moderate to severe, which requires, for example, a policy score of 10 minimum, just to make sure we don't get too much noise in such a trial. So it may be easier to recruit if you include my patients. But it may destroy your results because of potential placebo activity from mild patients. Okay, I got it.
Yes.
Countries and centers will be active sooner.
And coming to the study population I think.
If you look on other trials.
You should not.
Spread it to why because a.
A reasonable good activity of psoriasis is required to see a.
The real delta between placebo and active and therefore, we keep it for moderate to severe which required for example pilot score of 10 minimum just to make sure we don't get too much noise things ought to try and so it may be easier to recruit if you include my patients.
It's it may destroy your results.
Because of potential placebo activity for from the mild patients.
Okay got it that's helpful. Thanks for taking the question.
Okay.
Thank you Tom.
Thomas Smith: That's helpful. Thanks for taking the question. Thank you, Tom. Our next guest in our line here today is Yasmeen Rahimi from Piper Sandler. Yas, please unmute yourself and go ahead.
Next guests and are aligning it today is yes mean rahimi of Piper Sandler Yes. Please I'm gonna just thoughts on go ahead.
Yasmeen Rahimi: Good morning, team. Thank you so much for taking my questions. I have a number for you.
Good morning team. Thank you so much for taking my questions I have a number of Franke you maybe in the first place to start office.
Yasmeen Rahimi: Maybe the first place to start off is, Recently, we saw another competitor program who missed on their primary endpoint, driven by losing maybe some patients due to the European conflict. So maybe you could kindly ensure us that the number of samples that were analyzed specifically for clinical remission are exactly as you predicted. There are no lost follow-ups.
Recently, we saw another competitor program until missed on that primary endpoint.
Driven by losing maybe some patients due to the European conflict. So maybe kind of can you kindly ensure us that the number of.
Sam pulse, our annualized specifically for clinical information.
Or exactly as you predicted there are no last follow up so let's start there and I have a few more.
Daniel Vitt: So let's start there, then I have a few more. Sure, I think the good thing is that the 10-week phase, which is the primary endpoint, was completed before the war started in Ukraine, so yes. Okay, okay, great. The second question for you is, you know, we did also notice that there are quite a lot of sponsors who have lots of sites ongoing, and there's quite a bit of heterogeneity that could influence the placebo. So given the CALDO study has a very large number of, you know, clinical sites up and running, how can we get confident that there's not going to be an introduction of site heterogeneity? So just any commentary you could provide us as we head into the top line would be helpful. That's true.
Sure I think the good thing is that.
The 10 week phase, which is the primary endpoint was completed before.
The war started in Ukraine, So yes, okay.
Okay, Okay great.
Second question for you is you know we did also notice that there is quite a bit of.
Sponsors who have lots of sites ongoing theres quite a bit of heterogeneity that could influence the placebo. So given the Caldolor study has a very large clinical sites up and running how can we get confident that theres not going to be an introduction on state heterogeneity.
Any commentary you could provide us as we head into the top line could be helpful.
Daniel Vitt: And I think this is a challenge, and you see charts for a decade, basically, and we try to really address it by, for example, doing eligibility assessment based on baseline endoscopy screening. So we do that in an essential unbiased fashion, just to make sure there's no site bias and no country bias in these things. And I think that's good. Also, another part of that is to ensure data integrity.
That is true and I think there's lots of this is is it Samson and youll see types for our core decay basically and we try to really address it by for example doing.
Eligibility assessment based on baseline endoscopy screening so we make that in the central unbiased fashion just to make sure Theres no SIFI is and what country bias in these things so I think that's it.
Also another part of that is to ensure data integrity. We also implemented a two plus one reading skiing for 40 endoscopy.
Daniel Vitt: We also implemented a two plus one reading scheme for the endoscopy. So it's done in a sense of fashion, in a double blind fashion. And the two independent readers are looking at the endoscopies, and if they don't come to the same conclusion, there's a third adjudicator taking care of that.
So it's fun in the sense of session in a double blind fashion.
And the two independent readers are looking on the Endoscopies and if they don't come to the same conclusion necessarily Judy theater, taking care of that that's also.
Daniel Vitt: That's also, interestingly, now a recommendation from the FDA in the new draft paper for UC guidance for phase three. So I think we did what we could to make sure there was not unwanted noise. Also, we are stratifying for prior therapies, also stratifying for steroid use, for example, so everything in place to make sure there are no statistical issues here from there. Thank you, Daniel. And then where are we as, obviously, we have what, maybe two and a half, maybe three weeks left in June.
Interestingly, our recommendation from the FDA and a new draft paper for for UC.
Guidance for phase three so I think we did what we can do to make sure there's definitely.
They are not an unwanted noise also we are Australia filing for <unk>.
Prior therapies.
Source ready frame for.
Steroid use for example.
Everything in place to make sure there's no.
No.
Statistical issues here from there.
Yasmeen Rahimi: Can you just give us a quick snapshot of, you know, has the data been unblinded yet? What is it going to be, you know, what's left to do between now and reporting top-line data? And if you feel comfortable to narrow down, you know, when in June, whether it's early June or mid June or late June, that could be really helpful for us. So, and thank you again for my very detailed questions, Steve. Yes, I would love to give you a date, but I can't do that.
Thank you Daniel and then where are we as obviously, we have what maybe two and a half maybe three weeks left in to June can you just give us a quick snapshot on has the data in an unblinded. Yeah. What is what is going to be you know what what's left to do between now and reporting top line data.
And if you feel comfortable to narrow down in a win in June whether it's early June or mid June or late June that could be really helpful for us.
Thank you again my hasn't had detailed questions here.
Daniel Vitt: So, and we are still blinded. So I should not have this call if I were unblinded. No, I think it's June, it's maybe more, more likely the first half of June, but we keep the guidance for June. The data database is still not locked.
Yes, I would love to give you a date, but I can't do that so and we are still blinded so.
That's what's in the blinded data I should not have this call if that would be unblinded.
No I think it's June it's maybe more.
The first half, but we keep the guidance for June .
Data data basis still not locked so that's work in progress. It's a final final signature hung themes and cannot work on the database ongoing right now.
Daniel Vitt: So that's work in progress. It's the final, final signature hunting and do not work from the database ongoing right now. Okay, great. Thank you. I'll jump back in the queue.
Okay, great. Thank you I'll jump back in the queue.
Yeah.
Thank you yes.
Yasmeen Rahimi: Thank you, y'all. Our next guest is Andreas Agouridis of Wetbush. Andreas, please unmute yourself and go ahead.
Our next guest is Andreas Aggregators of Wedbush Andreas Please I'll, let yourself in go ahead.
Andreas Agouridis: All right, good morning. Thanks for taking our question. Just a quick one from us here, also on CalDOS-1. So the study is powered for an 8 to 12% improvement in clinical remission based on an expected placebo response of five. Can you just talk about how you planned to mitigate the placebo response some other trials have seen hire 5-10% in their trials.
Alright, good morning, and thanks for taking our question just a quick one from US here also on <unk>. One. So the study is powered for an 8% to 12% improvement in clinical remission based on an expected placebo response of 5% to 10% can you just talk about.
How you plan to mitigate the placebo response, some other trials, we've seen are higher than a 5% to 10% in their trials I appreciate that thank you.
Daniel Vitt: I think there are endless discussions about that, and I know there may be a lot of reasons why in some trials placebo rates are higher. But what we see as the biggest risk, and I think that was also repeated by KRLs recently, is if you allow too much co-medication, which sometimes has an unpredictable activity on placebo patients. So we don't allow immunosuppressants as co-therapies, for example. That was seen with some other trials in the past, and they were coronated with a higher risk of placebo rates.
I think that endless discussions on that I didn't know there maybe.
Enough reasons why in some trials placebo rates are higher when we see as the biggest risk and I think that was also reputed by Kols recently, if you will.
Too much communication, which sometimes has some unpredicted activity on placebo patients.
So we don't allow any immunosuppressants as core therapies for example, like we've seen with some other trials in the past and daiwa correlated with a higher risk of placebo rates.
Daniel Vitt: The other thing we're doing is just to make sure we have stringent inclusion criteria and we follow our own principles here, and then I think the trial should be comparable to other successful trials. Thank you. Right. Thank you, Andrea. Next one is Matt Kaplan from Ladenburg-Talman. Matt, please unmute yourself and go ahead.
The other thing we're doing assess and make sure we have stringent inclusion criteria and we followed our own principles here.
Then I think the trial should be comparable to the two other successful trials.
Okay.
Great. Thank you I'll jump in the queue.
Alright, Thank you Andreas.
Next one is Matt Kaplan of Ladenburg Thalmann met this unmet yourself and go ahead.
Matt Kaplan: Hi, good morning. Thanks for taking the questions. I just wanted to kind of stay with the CalDOS study a little bit. I guess given the interim analysis results that you saw, can you talk a little bit about how you are going to be analyzing the different doses in the study? And, and should we expect a dose response given given the, I guess, interim dose that, that said, continue all of those?
Hi, good morning, Thanks for taking my questions I, just wanted to kind of stay with the Caldolor study a little bit I guess, given the interim analysis results that you saw.
Can you talk about a little bit about kind of the.
How are you going to be analyzing the different doses in the study and should we expect a dose response.
Given given the I guess interim dose.
It said continue all Texas.
Matt Kaplan: Yeah, thank you, Matt. Thank you for asking what the call is about. On the doses, I think I had a very strong opinion on that when we started the trial and, in between, read out our wonderful MS data in 2020, where I think 30 and 45 milligrams, the two high dose groups came on almost at the same good activity level. So, Hi. I can't really tell you if I believe 45 is the highest active dose.
Yeah. Thank you, Matt Thank you for asking weapons to call them.
On the doses I think I had a very strong opinion on that when we started the trial and in between rent out our wonderful and S data and.
In 2020, where I think 30 and 45 minutes from the two high dose groups came on almost at the same <unk>.
Activity levels so I.
I can tell you really if I, if I believe 45 50.
Highest active dose.
I'm, a little bit careful on that and let me what we I think can deliver here is to identify.
Daniel Vitt: I'm a little bit careful on that end. What we can deliver here is to identify a suitable dose for phase three. And we are very lucky that we have three active doses in the trial and placebo. So this trial is designed to deliver the answer to the question, what is a suitable dose for phase three? I think that's the purpose and that we likely will deliver. Yeah, so those responses would be wonderful. But if you look at other tribes, it sometimes follows interesting, interesting curves.
Suitable dose for phase III, and we are very lucky that we have three active doses in the Tri net zero. So this trial is designed to deliver.
Answer to the question what is suitable dose for phase III I think that's the purpose and Becky likely will deliver.
Yeah, so dose responses.
Would be wonderful, but if you look on other tribes, it's sometimes photos interesting interesting curve.
Matt Kaplan: And then in terms of 856 and the phase one program, it said you're expanding into colitis patients. Can you, sorry, celiac patients, can you give us a sense in terms of what to look for there as the potential data reads out, I guess, from the SADMAD grouping in the third quarter? I think that's it.
Alright, great and then in terms of.
856, the phase one program that said you're expanding into colitis pay.
Patients.
Can you sorry, celiac patients can you give us a sense in terms of what what to look for there is as the data potential data reads out I guess in the sad Mad.
Grouping in the third quarter.
Daniel Vitt: Thank you once again. So this is, of course, a big step because the third program is currently actively recruiting patients in the MAT portion of the healthy volunteer part, so 14-day treatment and healthy volunteers. And this data, together with that for the single ascending dose part, is expected to be available in the third quarter of this year. So not too far from now, we should have safety and PK data for that.
Yes, I think that I. Thank you once again. So this is of course, the big step because the third program is is currently actively recruiting patients and the mad portion of the of the health of the landscape high. It's a 14 day treatment in the healthy volunteers and this data together with us with the single ascending dose part as expected.
To be available in them.
The third quarter of this year, so not too far from now we should have a safety and PK data for that and in parallel now and that was the message.
Matt Kaplan: And in parallel now, and that was the message here on celiac disease, is that we think celiac disease is a good proof of concept indication for a drug which, without impacting directly the immune system, is able to restore the barrier function. And therefore, we believe that this is a very good indication for people to come. Thanks. Thanks, Daniel. Thank you, Matt.
Here on the celiac disease, as we think of severe diseases.
As a good proof of concept in any occasion for a drug which is without impacting directed immune system.
But to really sort of area of sanction.
And therefore, we believe that this is.
A very good indication for proof of concept.
Right.
Thanks, Jamie.
Jessica Breu: Just as a reminder, if you have a question, please use the raise hand function of the zoom portal. Next question comes from Bubalan Pachapayan at HG Wainwright. Bubalan, please unmute yourself and go ahead. Hi, can you hear me OK?
Thank you Matt just as a reminder, if you have a question. Please use the raise hand function of the <unk> portal.
And our next question comes from Google and <unk> at H C. Wainwright.
Well on please and let yourself in go ahead.
Bubalan Pachapayan: Yes. Hi. Awesome. So just to follow up on 856. I'm trying to get an understanding of the biomarkers that you might be evaluating down the road. So are you planning to investigate some histological biomarkers that might require deodorant biopsy or some less invasive peripheral blood cell and cytokine biomarkers?
Hi can you hear me, Okay, Yes, hi, good afternoon.
Awesome. So just a follow up on 856.
Daniel Vitt: And also, if these biomarkers were de-risked in any of the prior competitor trials? Yeah, I think that, thank you for the question, Gubalan. I think, yeah, sure, we will also measure biomarkers in that part of the trial. We will also give more updates on the trial itself in the next couple of months when we progress through the trial. The idea is really to have an indication where you really have a more synchronized process of barrier function modulation and to use that strength model to demonstrate that 856 has the potential to restore barrier function and maybe also, and this brings us to the histology question, restore the proper structure here in the gut wall.
I'm trying to get an understanding of the Biomarkers that you might be evaluating down. The road. So are you planning to investigation histological biomarkers that might require a biopsy or some less invasive peripheral blood cells cytokines Biomarkers and also if these biomarkers or dentist in any.
Of the prior year compare.
Competitors trials.
Yeah, I think that.
Thank you for the question Bob I think yes sure were you able to measure also by end markets and that's part of the trial.
We will also give more updates on the trial.
The next couple of months to come.
When we progress to the trial.
The idea is really to have an indication where you you really have more synchronized.
Process of barrier function modulation and to use that strength and also to demonstrate that 806 has the potential to restore barrier function and maybe also on the breakfast to these policy question.
Your store.
The proper structure here.
In the golf ball.
Bubalan Pachapayan: Okay, and one more on this. You mentioned that the drug will be evaluated in 28 days. So just curious whether that period is sufficient to gain initial evidence for drug activity. Specifically, can intestine barrier function normalize, and bowel epithelium regenerate in 28 days?
Okay, that's fine.
And one more on this so you mentioned that about you'll.
You'll be the drug will be evaluated in 28 days. So just curious whether that period is sufficient to gain initial evidence for drug activity.
Specifically.
Ken interesting barrier function normalizing bowel epithelium regenerated in 28 days.
Yeah, I think based on the discussions we're having with the experts and our team did a very intense work there we believe that should be.
Daniel Vitt: Yeah, I think based on the discussions we've had with the experts and our team did very intense work there, we believe that should be possible in the 28th time frame. Okay, that's it for me. Thanks so much.
Possible into 2008.
And time frame.
Okay. That's it from me thanks, so much.
Bubalan Pachapayan: Thank you. Great. Thank you, Boubalan. The last one I currently have on the line here is Brendan Hawley of Roth Capital. Please unmute yourself and go ahead. Hi, this is Zegba.
Thank you Greg.
Great. Thank you Milan.
The last one I currently have in our line yeah, It's Brendan Holly of Roth capital. Please I'm not yes, I think go ahead.
Yeah.
Brendan Hawley: I'm actually on the line, thought I wasn't going to make it, but a couple of quick questions. I'm looking at the blinded baseline characteristics for the CALDOS study. Is there anything unique about this patient population that we need to be aware of before making any cross-trial comparisons? And are you also going to be stratifying based on baseline disease severity, meaning moderate versus severe, in addition to what you mentioned about stratifying based on steroid use or other factors?
Hi, This is Zach Bob actually on the line that I wasn't going to make it bad Jonathan.
A couple of quick questions I was looking at the blinded baseline characteristics, but the Cal does that is there anything unique about this patient population that we need to be aware of before making any cross trial comparisons.
We're also going to be stratified based on baseline disease severity, meaning a moderate to severe in addition to what you mentioned that Bosch stratified based on staring to use or other factors.
Daniel Vitt: Yes, thank you for that question. I looked around, or the team looked around at other trials, and we found that, based on the baseline characteristics, maybe the best comparable trial would be the Ozani Mod Phase II trial, which had the same level of pre-treated patients, and severity was comparable. I think that this maybe did, from what I have seen as parameters, the best comparison.
Yes, I think your assessment for that question I looked around are we the team looked around on other trials and viewpoint on the baseline characteristics may be the best comparator trial would be deals any more phase III trial, which was had the same level of pre treated patients also severity was comparable I think that that's maybe did come from what <unk>.
Afcs promises the best comparator.
Okay.
Brendan Hawley: Thank you. And then the next one here is just, again, as we prepare for the first look at clinical data for psoriasis patients treated with IMU-935, you know, again, what should we be keeping in mind as we think about kind of benchmarking the data that's coming out again? And then have you begun active conversations with regulatory bodies in the US and Europe?
Okay. Thank you and then the next one year. It's just again as we prepare for the first look at clinical data for the psoriasis patients treated with <unk> 95, you know again, what should we be keeping in mind as we think about kind of benchmarking and the data that's coming out again, and then have you begun active.
Conversations with them.
Right.
Excuse me regulatory bodies, and the U S and Europe .
Daniel Vitt: With respect to 935 and psoriasis specifically, yeah, I think they thank you for asking the question. And 95 is a wonderful molecule with a very unique potent. inhibition of IL-17 as an oral drug.
With respect to <unk>, sorry, a secret to us with respect to the 95 or <unk> 95 in psoriasis specifically.
Yes, I think.
Thank you for for that question.
95 is a wonderful molecule with.
Very unique proteins.
Daniel Vitt: So we believe the drug is poised to be a successful drug between currently used oral treatments, namely premilast as a dominant player there, and the broadly very successfully used IL-17 pathway antibodies. So if you ask me regarding what we can expect, the treatment is limited to four weeks. Therefore, we can only show four-week data. And therefore, we said we look at a reduction of the PAL-E score. So we will not look at PAL-E50 or PAL-E75.
Inhibition of IL 17 is an oral drug so we believe the drug is.
Is poised to be a successful black between currently used orla treatments, namely our prime elasticity I think are the dominant player there.
And the broadly very successfully used.
IL 17 pathway antibodies.
So if you asked me regarding what can we expect so.
The treatment is limited to four weeks. Therefore, we can only show a four week data and therefore, we said and we look on redact.
The reduction of the pilot scores. So we will not look on how the 50 probably.
75.
That is something we would do in phase III.
Daniel Vitt: That is something we will do in phase two. But for the phase one proof of concept, basically, what we're doing here, we are looking at poly reduction. But the good thing is there's so much data out on other drugs where you can actually compare this. Typically, if you look at historic trials there, the placebo rates are ranging between 10, 15, sometimes up to 20%. That's it.
Five four for the phase one proof of concept basically what we're doing here. We are looking on the part of the risk reduction, but the good thing is there is so much data on some of the drugs anyway, you can nicely compared is.
Typically if you look on the historic trials there are the placebo rates are ranging between 10 and 15, sometimes up to 20%.
Daniel Vitt: So we think we should see quite a good differentiation already after four weeks if we compare the two active doses with a placebo group. And therefore, this trial is really designed to deliver a very strong, A rational thing for a face to do. Which is now bridging to the next question on regulatory discussions; we are currently working on packages for discussions with the FDA and also with other regulatory bodies, but it's not yet done.
And that's it so.
We think we should see a quite good differentiation of already after four weeks.
If we.
If you compare your active the two active doses with a placebo group and therefore this trial it.
It was really designed to deliver a very strong.
Our rationale for for a phase II trial.
Which is not bridging to the next question on on regulatory discussion. We are currently working on packages.
For discussions with the FDA and also with other regulatory bodies.
But it is not yet done so that's work in progress.
Daniel Vitt: So that's working. Thanks, Daniel. And then the last one year, with so many catalysts coming up, it's easy to forget about the ensuring caliper studies, but we're just wondering if you can provide any additional progress there with enrollment or site activation. Well, yeah, as you know, we usually don't give any guidance on updates on enrollment of the trials. We give guidance on how we believe they're running. And given that Ensure and Caliper started not too long ago, they are still in the startup mode and phase.
Thanks, Daniel and then the last one year with with so many catalysts coming up.
It's easy to forget about the insurer and caliber studies, but I was just wondering if you can provide any additional color on progress there.
On the NOI side Activations.
Daniel Vitt: They're actively recruiting in several countries; we're adding more countries, more sites, step by step. So that's how it's progressing. Also, I think, and you're right, we have so many other things we're currently focusing on and readouts for the next couple of months that we don't talk too much about that. But it's, as you know, it's a good opportunity to remind everybody that the drug has shown, A2A has shown wonderful, good activity in a very big phase two trial in relapsing MS, and therefore, we think, or we continue to believe, that it's going to be a very successful phase two trial.
Well, yes, as you know, we usually don't give any guidance on update on enrollment of the trials.
When we give guidance on how we believe they're running so.
Given that ensure and caliper started not too long ago. They are still in the startup mode in phase they're actively recruiting in several countries, we're adding more countries more science step by step so that that's progressing.
Also I think.
And.
And you're right we have so many other things we're currently focusing on and read outs for the next couple of months that we don't talk too much about that but as you know it's a good opportunity to remind everybody that the drug has shown a trade has shown wonderful good activity in a very big phase II trials in relapsing Ms.
And therefore, we think or we continue believing that.
Daniel Vitt: We continue believing that the drug is likely to be successful in the phase 3 RMS phase trials, the ensured trials. But we were also quite thrilled about the potential and progressive MS, and that's usually not covered too much in the press and everywhere. But we think that the mode of action and the features we have seen, and to add some data in the context of R10K, findings from our second cohort, the 10 milligram dose cohort, we see a lot of hints that the drug is really neuroprotective and may have.
The drug is is likely.
Successful in the phase III Rms.
Tries to ensure trials.
But we were also quite thrilled about the the potential and progressive a mess and that's usually not snow covered too much in the press and everywhere, but we think that the mode of action and the features we have seen recently and also some data in the context of our and 10-K.
Findings.
From a second cohort of 10 milligram dose cohort that we we see a lot of things that the drag is really not neuroprotective and may have.
Daniel Vitt: A very strong benefit also for progressive patients with PMS there, and so that's also an important piece we're working on. Thank you and look forward to the update. Thank you, Sector. All right. I think this was all the questions I had on my list here.
A very strong benefit also forward for paid for progressive patients.
With Pms, there and so that's also an important piece we're working on.
Okay.
Thank you looking forward to the optics.
Jessica Breu: So this concludes our question and answer session. I would like to turn the conference back over to Daniel for any closing remarks. Thank you, Jessica.
Thank you effect there.
Right I think this was all the questions I have are in the list here. So this concludes our question and answer session I would like to turn the conference back over to Daniel for any closing remarks.
Thank you Jessica.
Just need to find them.
Daniel Vitt: Yeah, thank you, Jessica. And thanks to today's attendees for your insightful questions. We are highly enthusiastic about the progress we achieved recently and the important upcoming milestones we anticipate this year, including the phase two UC data for beta-fluidimus calcium in June and the initial psoriasis patient data for IMU-925 in the second half of. With that, I would like to close today's call. Thank you very much for joining, and we are very happy to answer any additional questions in one-on-ones Thank you, Daniel. Also, from my side, thank you for joining Immunics' first quarter 2022 earnings call today. The conference has now concluded. You may now disconnect.
Yeah. Thank you Jessica and thanks to today's attendees for your insightful questions. We are highly enthusiastic about the progress with <unk> recently and the important upcoming milestones we anticipate this year, including the phase III UC data computer for the most cuts in June .
And the initial psoriasis patient data for <unk> hundred five in the second half this year.
With that I would like to close today's call. Thank you very much for joining.
And we are very happy to answer any additional questions and one of those months and once again I apologize for the technical issues. We had during this call.
Thank you Daniele also from my side. Thank you for joining <unk> first quarter 2022 earnings call. Today. The conference has now concluded you may now disconnect.
Yeah.
Okay.
Okay.
Okay.