Q4 2023 Immunic Inc Earnings Call
Jessica Brou: Good morning to everybody on the line. I would like to welcome you to Immunic's fourth quarter and year-end 2023 earnings call. My name is Jessica Brou, Vice President of Investor Relations and Communications at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Fitts, our Chief Executive Officer and President, as well as Glenn Whaley, our 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. 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 raise hand function in the Zoom portal to queue your questions.
Good morning to everybody on the line I would like to welcome you to the immune its fourth quarter and year end 2023 earnings call. My name is Jessica Brew, Vice President Investor Relations and communications at the Munich I will also be the moderator today.
Speaking on the call are adopted in your fit our Chief Executive Officer, and President as well as Glenn Williams, our Chief Financial Officer.
Please note that 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. If you join the webcast by Edison platform. They had to wait to submit questions. You can submit your questions in writing via the Q&A 12 to some puddle or if you would like to speak with US directly. Please use the right time, right hand function and assume quota to Korea question.
Jessica Brou: 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, and such statements involve a number of risks and uncertainties that could cause Immunix's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunix's opinions only as of the date of this presentation, and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events. 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 our CEO and President, Dr. Daniel Fitts, to begin the presentation.
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 actual results to differ materially from those discussed here.
Please note that these forward looking statements reflect in Unix opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release. The result of any revisions to these forward looking statements in light of new information or future events.
He's referred to a minute SEC filings for more detailed description of the risk factors that may affect the unit's results in these forward looking statements.
I would now like to turn the call over to our CEO and president of fit to begin the presentation Daniel.
Dr. Daniel Fitts: Thank you, Jessica. I would also like to welcome everybody to today's earnings call. Earlier this morning, we announced our financial results for the fourth quarter and the year ended December 31st, 2023 in our press release and form 10-K. During the call today, we will walk through our four quarters of 2023 achievements and subsequent highlights, year-end financial and operating results, as well as anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions.
Thank you Jessica.
I would also like to welcome everybody to todays earnings call.
Earlier this morning, we announced our financial results for the fourth quarter and the year ended December 31 2023.
Our press release and Form 10-Q.
During the call today, we will walk through our fourth quarter 2023 achievements.
Subsequent highlights and financial and operating results as well as anticipated upcoming milestones as Jessica noted after the presentation you will have the opportunity to ask questions.
Dr. Daniel Fitts: Let's start with a review of our fourth quarter 2023 and subsequent highlights. Punctuating our remarkable progress throughout 2023, we announced a three-tranch private placement of up to $240 million last month. The round led by VDF Partners included participation from a group of top T&U and existing investors, including Vidity Partners, Janus Henderson Investors, Sirius Capital, RTW Investments, and LH Capital Partners.
Let's start with a review of our fourth quarter 2023, and subsequent highlights.
Okay.
Penetrating our remarkable progress throughout 2023.
We announced a three tranche private placement of up to $240 million last month.
But round led by media partners included participation from a group of top tier new and existing investors, including avidity partner Genesis centers and investors. So he knows capital aren't you doubled your investment in energy capital partners.
Dr. Daniel Fitts: We received a total of $75 million in net proceeds from the first tranche, which closed on January 8, 2020. The second and third tranches of $80 million each are conditioned on the announcement of Phase IIb top-line data for our CALIPER trial, expected in April 2025. Volume-Mated Average Share Price Levels and Minimum Trading Volume; Any of these conditions in the second or third tranche can be waived by holders of a majority of the outstanding securities, including the lead investor.
We received a total of <unk>.
$75 million in net proceeds from the first tranche, which closed on January eight 2024.
The second and third tranches of 20 of $80 million each are conditioned on the announcement of phase <unk> top line data for our kind of per trial.
Spectrum in April 2025.
Volume weighted average share price levels and minimum trading volumes.
Any of these conditions in the second or third tranche.
Can be raised by the holders of a majority of the outstanding securities, including the lead Investor.
Dr. Daniel Fitts: This financing completed in a challenging capital market environment and with such a strong group of investors affirms the enormous value inherent in our two advanced clinical programs. In October, we reported overwhelmingly positive internal data from the Phase 2 Caliper trial of our potentially groundbreaking lead-acid nuclear receptor-related 1,0,1 activator, beta-fluoridylmuth-calcium, in progressive multiple sclerosis or PMS. In total, 203 patients were included in this analysis.
This financing completed in the challenging capital markets environment, and with such a strong group of investors affirms the enormous value inherent in our two advanced clinical programs.
In October we reported overwhelmingly positive interim data from the phase III <unk> trial of our potentially groundbreaking lead acid nuclear receptor related one through <unk> activator redeployed with calcium in progressive multiple sclerosis or <unk>.
In total 203 patients were included in this analysis. The overall population, which includes all subtypes of Pms slow at 22, 4% improvement in general <unk> light chain or NFL for video photos calcium or placebo at week 24.
Dr. Daniel Fitts: The overall population, which includes all subtypes of PMS, saw a 22.4% improvement in serum narcosine neurofilament light chain, or NFL, for beta-fluidized calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of Isofutamose calcium in this PMS population. Even a statistically significant difference was found for arithmetic mean serum NFL levels at V24 between V. calcium and placebo with a p-value of 0.01. If you look at the subtypes of PMS, to the right, you can appreciate that this difference in serum NSL at week 24 was consistently observed across all progressive MS subtypes.
We believe that this is a substantial and meaningful difference in favor of even through the most counts and this PFS population.
Even a statistically significant difference with Holland forever metric mean serum NFL levels at week 24 between video for the Ms calcium and placebo with a P value of 0.01.
If you look at the subtypes of Pms to the right. You can appreciate that this difference in serum Nf L. At week 24 was consistently observed across all progressive met sometimes.
Dr. Daniel Fitts: I would like to point out that we saw a 20.1% reduction of beta-fluorinus calcium versus placebo in advanced SPMS, meaning patients with no focal inflammatory activity but continue to see progression. We believe this subtype is a segment of very high unmet need in MS with no relevant FDA-approved therapies available in the United States. This next slide puts our caliper interim data into this perspective of historical third-party studies and the same progressive MS subtype. On the left, we display the data for PPMS compared to the oratorial study for Ocrelizumab, which showed a spread of NFL values between active and placebo at 24 weeks or 12.4%. In the Caliber trial, we observed an 18.8% improvement in active glucose placebo in TPMS at week 24. You may recall that the results of the Oratorio phase response led to the approval of Orkutizumab for treatment of PPMS. In the center of the slide, you see historical data for the secondary or progressive MS, both for implementary, non-active, and active SPMS. In comparison, medial glutamate calcium was able to show a substantial reduction in NFL in both subpopulations.
I would like to point out that we saw a 21% reduction opportunities many months calcium versus placebo in advanced as pms, meaning patients with no focus inflammatory activity.
But continued disease progression.
We believe this subtypes as a segment of very high unmet need in MFS with no relevant FDA approved therapies available in the United States.
This next slide puts our caliper interim data into this perspective on terrific third party studies and the same progressive Ms. Sometimes on the left we displayed a data four P. P. M S compared to our target was partly for predict some up which showed a spread of NN.
I guess between active and placebo at 24 weeks or 12, 4%.
And the kind of a try we observed an 18.8% improvement of active drug or placebo in ppm at week 24.
You may recall that the results of the <unk>.
Oratorio phase III pointed out to the approval of accreted sum up for treatment of deep Tms.
In the center of the slide you'll see historical data for the secondary progressive Ms.
Both for Implementors monarch and excess Sps.
In comparison, we do floating with calcium was able to show a substantial reduction in Nf L. In both sub populations to our knowledge. This is the first time that such a substantial effect and it has been shown in an active SPM S. Patients again, which is the pms subtypes, which has the highest unmet medical need.
Dr. Daniel Fitts: To our knowledge, this is the first time that such a substantial effect in NFL has been shown in non-active SPMS patients again, which is the PMS subclass with the highest unmet medical need. The right side of the slide shows the comparison between our phase 2 emphasis data for beta-plutonus calcium in rRMS versus historical relapsing MS studies to complete the picture. In summary, we believe the clear separation observed in serum NFL for VFMOS calcium over placebo in this PMS patient population, as well as its subtypes, represents another significant step forward for what could potentially be a first-in-class Novant activator for MS patients.
The right side of the slide shows the comparison between our phase II emphasis data for me to put them as calcium in arguments.
Versus historical relapsing Ms studies to complete the picture.
In summary, we believe the clear separation observed in serum Nf L for video from Us accounts over placebo and this pms patient population.
As well as at subtypes represent another significant step forward for what could potentially be a first in class <unk> activations for I Miss.
Dr. Daniel Fitts: This strong signal also points to a more likely positive outcome of the overall CALIPER trial as well as clinically relevant endpoints like prevention of disability versus. Also, in October, Dr. Bob Fox from Cleveland Clinic, who is the coordinating investigator of our Insure and Caliper programs, presented data from our Phase II emphasis trial of B.difidimus calcium in RRMS in an e-poster at the joint ACTRMS It is important to reiterate that VF calcium showed an improvement in serum NFL in both treatment arms of 30 and 45 mg over placebo. In November, we were granted two fundamental new patents for B.diflurimus in the United States. The first covers a daily dose of about 10mg to 45mg of B.diflurimus quiatium and other salts as well as free acid foams for the treatment of relapsing MS, including the 30 milligram dosage used in our ongoing twin phase 3 insure trial.
This strong signal also points to a more likely positive outcome of the overall caliber trial as well as clinically relevant endpoints like prevention of disability worsening.
Also in October talked about Fox from Cleveland Clinic, who is the coordinating investigator of our insured and chemical programs presented data from our phase two emphasis trial will be the famous calcium in our RMS and an E poster at the joined <unk> meeting.
It is important to reiterate that <unk> calcium shortly and improvement on serum NFL in both treatment arms of 30, and 45 milligram over placebo.
In November we were granted two fundamental new patents so easily months in the United States. The first covers a daily dose of about 10 minutes to 45 milligram opioid free months calcium.
And other support as well as free acid forms for treatment offered at CMS, including a 30 milligram dose used in our ongoing <unk> phase III <unk> trials.
Dr. Daniel Fitts: The second patent granted covers the dosing regimen associated with philofluvimus calcium and other sorts, as well as the free acid forms for the treatment of MS, including all regimens tested in our MS clinical program. As a result, our extensive patent portfolio now provides protection into 2041 or even beyond in the United States. Turning to our second key program, IMU-8256, an orally available and systemically acting small molecule modulator that targets 36 proteins. In October, we presented two abstracts at the United European Gastroenterology Week 2023. My colleague, Dr. Franziska Bojanic, Senior Medical Director at Immunics, presented data from our Phase 1b clinical trial of IMU-HF6 in patients with celiac disease during a moderated post-assay. The trial results gathered during periods of a gluten-free diet and gluten challenge demonstrated meaningful improvement of placebo in four key dimensions of celiac disease pathophysiology, histology, disease symptoms, biomark
The second patent granted covers the dosing regimen associated with three years to fully Ms calcium and other thoughts as well as the free acid forms for the treatment of imas, including all regimens tested in our EMS clinical program.
As a result, our.
Extensive patent portfolio now provides protection into 2041 or even beyond in the United States.
Turning to our second key program and your 86, an orally available and to systemically acting small blocks of modulator that targets six protein.
In October we presented two abstracts at the United European Gastroenterology Week 2023, My colleague total Francisco embryonic senior medical director Chris.
Presented data from our phase one clinical trial of IV <unk> in patients with celiac disease during a moderated poster session.
The trial resides gathered during periods of gluten free diet and gluten challenge demonstrated meaningful improvement over placebo in four key dimension of celiac disease pathophysiology.
Histology D C symptoms biomarkers at new tunes absorption.
Dr. Daniel Fitts: 856 was also observed to be safe and well-tolerated in this, Additionally, Dr. Gerhard de Hans from Amsterdam University Medical Center presented data from our Phase II-CALDOS-1 trial of beta-fluidimus calcium in ulcerative colitis. As a reminder, the maintenance phase results from the CALLOS-1 trial demonstrated statistically significant activity of beta-fluorochemous calcium compared to placebo and reaffirmed the drug's favorable The data validated the potential of B.difidimus calcium for NUC and other inflammatory bowel disease indications.
And the 806 was also observed to be safe in both tolerated in this trial.
Additionally, Dr. <unk> from anthem Dumb University Medical Center presented data from our phase II <unk> trial of <unk>.
Ms calcium in ulcerative colitis or UC.
As a reminder, the maintenance phase results from the colors, one trial demonstrated statistically significant activity of projects with numerous calcium compared to placebo and reaffirm the drugs favorable safety and Tolerability profile.
Data validated the potential if we defer them as characters and Youll see and other inflammatory bowel disease indications.
Glenn Whaley: In November, we were pleased that Dr. Boryanek had another opportunity to present the data from our Phase 1b clinical trial of IMU-856 in patients with celiac disease as a virtual e-poster at the Association of European Celiac Society General Assembly Conference in Athens, Greece. That concludes our summary of the fourth quarter of 2023 and most recent highlights. I'm very pleased with the scientific and clinical advancements we have made across our different programs, and we are leveraging this momentum going forward. As an example, for beta-filaments calcium, the release of our overwhelmingly positive biomarker NFL data has been an impetus for partnering discussions with global and regional pharmaceutical companies. There's also a lot going on with our IMU-856 program, which we will update you on as progress is made this year. I would now like to turn the call over to Glenn to provide a financial overview. Blanton.
In November we were pleased that Dr. <unk> had another opportunity to present the data from our phase <unk> clinical trial of <unk> in patients with celiac disease and a virtual E poster at the association of European Celiac Society General Assembly Conference in essence, Greece.
Okay.
That concludes our summary of the fourth quarter of 2000 tons to three and most recent highlights.
I am very pleased with the scientific and clinical advancements we have made across our different programs and we are leveraging this momentum going forward.
As an example for redeployments calcium the release of our overwhelmingly positive biomarker NFL data has been an impetus for it.
Partnering discussions and global and regional pharmaceutical companies.
That's also a lot going on with our I mean, it's a fixed program, which we will update you as progress is made this year.
I would now like to turn the call over to Glenn.
To provide a financial overview.
Glenn.
Glenn Whaley: Thank you, Daniel. I will now review the financial and operating results for the year ended December 31st, 2023. Let me start with a review of our cash position. We ended the year with $46.7 million in cash and cash equivalents.
Thank you Daniel I will now review the financial and operating results for the year ended December 31 2023.
Let me start with a review of our cash position.
We ended the year with $46 7 million in cash cash equivalents.
Glenn Whaley: With these funds and the approximately $75 million in net proceeds raised in the first tranche of our January 2024 private placement, we expect to be able to fund operations into the third quarter of 2025. Regarding operating results, R&D expenses were $83.2 million for the 12 months ending December 31, 2023. As compared to 71.2 million for the 12 months ended December 31st, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials, Vitaflutimus Calcium, and IMU-856. There is a role for personnel expenses. This is partially offset by a decrease in external development costs related to the deprioritization of the IMU-935 program and a reduction in costs related to the beta thalidomide calcium program and ulcerative colitis. General administrative expenses were $16 million for the 12 months ended December 31, 2023.
With these funds in the approximately $75 million in net proceeds raised in the first tranche of our January 2024, private placement, we expect to be able to fund operations into the third quarter of 2025.
Regarding the operating results R&D expenses were $83 2 million for the 12 months ended December 31 2023.
As compared to $71 2 million for the 12 months ended December 31 2022.
These costs were mainly driven by external development costs related to the ongoing clinical trials.
<unk> calcium and <unk> six as.
As well as personnel expenses.
This was partially offset by a decrease in external development costs related to the de prioritization of the IMU 93, five program and a reduction in costs related to the video for the risk calcium program in ulcerative colitis.
General and administrative expenses were $16 million for the 12 months ended December 31 2023.
Glenn Whaley: That's compared to 15.3 million for the same period ended December 31st, 2020. The slight increase was spread across numerous categories and was partially offset by a decrease in personality. Other income was $5.6 million for the 12 months ended December 31st, 2023, as compared to negative $0.9 million for the same period ended December 31st, 2023. The increase was primarily attributable to a decrease in foreign exchange losses, a research allowance attributable to the 2021 and 2022 tax years from the German Ministry of Finance, and an increase in interest income as a result of higher interest. This is partially offset by a decrease in R&D tax incentives as a result of less spending on clinical trials in Australia. The net loss for the 12 months ended December 31st, 2023 was approximately $93.6 million, or $2.11 per basic and diluted share. Based on approximately 44.3 million weighted average common shares outstanding. Compared to a net loss of approximately $120.4 million, or $3.78 per basic and diluted share, based on approximately 31.8 million weighted average common shares outstanding for the same period ended December 31, 2020.
As compared to $15 3 million for the same period ended December 31 2022.
The slight increase was spread across numerous categories and was partially offset by a decrease in personnel expense.
Other income was $5 6 million for the 12 months ended December 31, 2023, as compared to negative <unk> 9 million for the same period ended December 31 2022.
The increase was primarily attributable to a decrease in foreign exchange losses.
Our research allowance attributable to the 2021 and 2022 tax years from the German Ministry of Finance and an increase in interest income as a result of higher interest rates.
This was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia.
The net loss for the 12 months ended December 31, 2023 was approximately $93 6 million or $2 11 per basic and diluted share base.
Based on approximately $44 3 million weighted average common shares outstanding.
Compared to a net loss of approximately $124 million or $3 78 per.
Our basic and diluted share.
Based on approximately $31 8 million weighted average common shares outstanding for the same period ended December 31 2022.
With that I will turn the call back over to Daniel for a review of our upcoming clinical milestones Daniel.
Dr. Daniel Fitts: With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel? Thank you, Glenn. I would now like to provide an update on the anticipated upcoming milestones for our clinical development program. We eagerly anticipate reporting top-line data from our Phase 2 CARIPA trial of B. f. calcium in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase 3 Insure program late this year and to read out the first of our identical twin phase three ensure trials in relapsing MS in the second quarter of 2020. As stated before, based on the strong clinical activity observed thus far, and via Fudemuth's calcium-solidly established safety and solubility profile to date, we believe that the design of our Phase III inshore program will provide a straightforward path to potential regulatory approval in relapsing MS. If the top-line data continues to show a neuroprotective effect for PMS patients, we may be able to position rediflumos calcium as the first oral treatment for advanced secondary progressive MS as well.
Thank you Glenn I would now like to provide an update on the anticipated upcoming milestones for our clinical development programs.
We eagerly anticipate reporting topline data from our phase II <unk> trial, a video for Bemis calcium in progressive in April 2025. Additionally.
Additionally, we expect to report interim futility analysis of our phase III <unk> program.
Late this year.
And to read out the first of oriented and enter code 20 phase III ensure trials in relapsing Ms. In the second quarter of 2026.
As stated before based on the strong clinical activity observed thus far and media for the most calcium solidly established safety and Tolerability profile to date, we believe that the design of our phase III <unk> program will provide a straightforward path to potential regulatory approval in relapsed AML.
If the topline candidate data continues to show a neuroprotective effect for Pms patients, we may be able to position to be the theme of calcium is the first ever treatment for advanced secondary progressive Ms. As well. We also expect that the drug's potential first in class ability to activate <unk> where.
Meaningfully benefit the ongoing clinical trials in multiple sclerosis.
We are particularly excited about our MS program in light of the recent developments in the Ms market.
As we have noted before if approved we believe that video segments calcium has the potential to be unique treatment option targeted to the complex pathophysiology of multiple sclerosis based on its combined near protective anti inflammatory and anti viral effects.
Dr. Daniel Fitts: We also expect that the drug's potential first-in-class ability to activate NO1 will meaningfully benefit the ongoing clinical trials in multiple sclerosis. We are particularly excited about our MS program in light of the recent developments in the MS market. As we have noted before, it's proof that we believe that beta-fugose calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of multiple sclerosis based on its combined neuroprotective, anti-inflammatory, and antiviral effect. With regard to our INUID HF6 program, as previously reported, we have begun preparing for a two-clinical trial in ongoing active celiac disease At the same time, based on the drug's broad therapeutic potential by targeting physiological epithelial regeneration, we are also considering additional clinical applications in other GI disorders.
With regard to our <unk> hundred six program as previously reported we have begun preparing for a phase two clinical trial, an ongoing active selected these patients at the same time based on the drug's broad therapeutic potential by targeting Hematological epithelium regeneration. We are also considering additional clinic.
Applications, an upper Gi disorders.
We are very excited about this program and believe our new eight 6% in entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of our architecture with Altice Europe consequences associated with immunosuppressive therapies.
Okay.
This brings us to the end of our formal presentation. Jessica Please open the call for the Q&A session.
Thank you Danielle and also blend for walking us through the fourth quarter of 2023, and subsequent highlights as well as our upcoming value inflection points. We will now begin the question and answer session. As a reminder, as he joined to wrap customer Edison platform that two ways to submit questions. You can submit your questions in writing via the Q&A till after some collateral or if you would.
Jessica Brou: We are very excited about this program and believe IMU856 could present an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture without the serious consequences associated with immunosuppressive therapies. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session. Thank you, Daniel, and also Glenn for walking us through the fourth quarter 2023 and subsequent highlights, as well as our upcoming value inflection points. We will now begin the question and answer session. 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 speak with us directly, please use the raise your hand function of the Zoom portal to queue your question.
I'd like to speak with US directly please use the raise hand function of the <unk> question.
Our first guest today is Caroline <unk> from Wedbush, Caroline unmet yourselves and go ahead.
Hi, Good morning. This is Caroline on Brian just two questions from Alex.
So if the data from caliper are positive can you discuss what the regulatory path forward looks like an advance S. Pms.
And then just the last quarterly update it looks like the titles were slightly shifted for the readout from the first ensure trial from the end of 2025 Q2 'twenty six.
Jessica Brou: Our first guest today is Caroline Popper from Wetbush. Caroline, please unmute yourself and go ahead. Hi, good morning, this is Caroline Omper-Andreas. We have just two questions from you. So, if the data from Taliper are positive, can you discuss what the regulatory path forward looks like for advanced SPMS? And then, since the last quarterly update, it looks like the times were slightly shifted for the readout from the first insured trial from the end of 2025 to Q2, 26, just any clarity as to why the slight change and just enrollment progression in both of those trials. Yeah, thank you, Caroline, for the question. Let me start with Jennifer.
Any clarity as to why the slight change.
Enrollment progression in both of those trials.
Yes, Thank you Caroline for the question.
Let me start with <unk>. So I think this is a difficult question to answer I think the normal process in such an indication.
Pik.
Non active secondary progressive.
Most likely an indication where there is nothing approved graveyard nothing available for patients that of course, it may offer an accelerated pathway forward.
Towards approval.
That requires a discussion with the regulators and the different countries.
What we know is that likely.
Jessica Brou: So I think it's a difficult question to answer. I think the normal process in such an indication that lets us pick non-active secondary progressives as the most likely indication where there is basically nothing approved, basically, or nothing available for patients. That, of course, may offer an accelerated pathway forward toward approval, but that requires a discussion with the regulators in the different countries. What we know is that, likely, a phase three study would only require one study, so we think it will be a pretty lean package we expect after a positive readout of that study. I want to ensure that we didn't change the timelines from our last projections. I think this was already updated from some weeks ago, that is reflecting the current speed of recruitment and our estimation. We always need to make and continue to explore how quick things are going forward, and therefore, we have made an adaptation to the timelines, but we are okay. We are on track with the current recruitment. Okay, great. Thank you so much.
Phase three study would only require one Ah study.
So we think it will be a pretty lean.
Package, we expect after a positive readout of that study.
I'm sure I think we didn't change the timeline.
From our last projections I think this was already to update some some weeks ago, Dennis reflecting declined.
Speed of recruitment in our estimation, we always need to make and continue to explore how quick things are going forward and therefore, we made an adoption to it.
Two.
And the timelines by relocate beyond track them on the current recruitment right now.
Okay, great. Thank you so much.
Thank you Caroline Thank you Caroline.
The next one I have in the queue here is a net <unk> from Leerink net Amit just seven go ahead.
Yeah.
<unk>, yes.
Hi can you hear me alright.
Yes, Hello, good morning.
Yes, it's a snapshot isotonic next.
Yes, so congrats on audit progress and we have a couple of questions.
First one like what R&D biomarker, we felt that we can expect from the.
Jessica Brou: Thank you, Caroline. Thank you, Caroline. The next one I have in the queue here is Nat Chavaranzuk from Leering. Nat, please unmute yourself and go ahead.
Interim analysis for the insurance study expected in late 'twenty four.
Jessica Brou: Nat, can you hear us? Hi. Can you hear me all right? Yes, morning. Yeah, this is Snatcher, and it's for Tom Smith.
And what you need to see to continue the development.
We definitely we definitely met calcium in Rms.
Yes, thank you and that sort of other question. Then that's good that you asked because I wanted to clarify that this is as we have written that there will be just the futility analysis. Since this is a phase III study.
Dr. Daniel Fitts: Yeah, so congratulations on all the progress, and we have a couple of questions. So the first one, like, what are the biomarker results that we can expect from the interim analysis for the insurance study expected in late 24 and what you need to see to continue the development of radiofumic calcium in RMS. Okay, yeah, thank you, Ned, for the question.
We can't read at Biomarkers and other clinical data at this time points that it would just be a futility analysis and we will get.
Feedback from the data safety monitoring board about.
Progression of the study it may allow us for sample size adjustment. So this is maybe the only outcome which could happen.
Dr. Daniel Fitts: And it's good that you asked, because as we have written, this will be just a futility analysis. Since this is a phase 3 study, we can't read out biomarkers or other clinical data at this time point. So it would just be a futility analysis, and we will get feedback from the Data Safety Monitoring Board about the progression of the study. It may allow for sample size adjustment. So this is maybe the only outcome which could happen, either continue as planned or receive sample size adjustment recommendations from the Data Safety Monitoring Board. Got it.
Either continuous planned or sample size adjustment recommendations from the data safety monitoring board.
Got it Thats very helpful.
So the next one as I saw what are the gating factor to start a phase III study in five active selling season can you just go over it potential travel side for effective steady Eddie you plan to look into late doses at that data and make all 160, Meg that you have looked at in the phase <unk> study and what audience potential.
Dr. Daniel Fitts: That's very helpful. So the next one is, so what are the getting factors to start a phase two study on the ongoing active CFTC? Can you please go over a potential trial design for the Phase 2 study? Do you plan to look into additional doses other than the 80 mg or 160 mg that you looked at in the Phase 1b study? And what are the potential endpoints as well as exploratory biomarkers you plan to include in the study?
Endpoints Sos exploratory biomarker or do you plan to create a steady.
Yeah and also a good question as you know we are heavily working and then Ballston celiac disease commute CDN space, given our wonderful readout from the proof of concept study last year end of.
<unk> core that drove a lot of interest in that is influencing our very active preparation time of a potential phase two study in <unk> disease.
Dr. Daniel Fitts: Yeah. Also, a quick question. As you know, we are heavily working and involved in the celiac disease community and the space. Given our wonderful readout from the proof of concept study last year, of course, that drove a lot of interest. And that is affecting our very active preparation time for a potential phase two study on celiac disease. And also, for potential other indications, as I said before, the proof of concept we have achieved in phase one is not only limited to celiac disease. Because we have, for example, seen a very nice improvement of endocrine side function by increased uptake of nutrients like vitamin B12, for example. So this is also more or less proving that the drug may work in other situations where you want to increase the viability and the function of those cells.
And also for potential other indications.
As I said before the <unk>.
The proof of concept.
<unk> in the phase one is not only limited to celiac disease, because we have for example seen a very nice improvement of.
And home side function by increased uptake of neutral language, maybe 12 for example, so that would also.
This is also more or less proving that the drug may work in other situations, where you want to increase the viability and the fine tuning.
I'll go cells.
With respect to phase II.
As we have said before the phase II study currently is not in our budget. So we we are preparing a sunny we have talks ongoing with potential partners and also looking for other ways too.
To finance a full blown phase III study and we will keep the market informed as we progress on these discussions underway to forward that may also mean that it's it's it's months finally limited two celiac diseases, maybe one thing I need to clearly say here it could really go beyond.
Dr. Daniel Fitts: With respect to Phase 2, as we have said before, the Phase 2 study currently is not in our budget. So we are preparing a study, we have talks ongoing with potential partners, and we are also looking for other ways to finance a full-blown Phase 2 study, and we will keep the market informed as we progress with these discussions and the way forward. That may also mean that it's not fully limited to celiac disease. Maybe one thing I need to clearly say here: it could really go beyond celiac disease as an indication in that context.
Celiac disease as indication in that context.
Got it got it.
Helpful. Thank you so much.
Thank you Matt.
And we have a question that came in by Abbvie Q&A to underwriting and of Nike sits to plastic. So I will read it can you provide any high level description of how potential partners, who view the drug and if complete in our phase III prerequisite for them.
As of my age my limit subject us.
Dr. Daniel Fitts: Got it. That's very helpful. Thank you so much.
Loosen on perception of their drug is that people really think it's cool stuff.
Dr. Daniel Fitts: Thank you, Nat. We have a question that came in via the Q&A tool in writing, and it nicely fits into IMU856, so I will read it. Can you provide any high-level description of how potential partners view the drug and if completion of phase two is a prerequisite for them? As my little subjective conclusion on perception of the drug is that people really think it's cool stuff.
It's a new target I think this has the potential really.
To address the Gi disorders and in very different ways. So lacking the immunosuppressive effects is really.
Unique benefit we've seen here.
And therefore, I think it is an attractive thing.
Dr. Daniel Fitts: It's a new target. I think this has the potential to really address EGI disorders in a very different way. So, lacking immunosuppressive effects is really a unique benefit we see here. And therefore, I think it is an attractive thing.
On the other hand typically.
New targets need to demonstrate that they work to.
Our favor I think we have already achieved this clinical proof of concept in the celiac disease patients.
Dr. Daniel Fitts: On the other hand, typically, new targets need to demonstrate that they work. And, to our favor, I think we have already achieved this clinical proof of concept in celiac disease patients. So I think, generally, the perception is very positive, and people are very excited about a completely new approach to those diseases. Thank you, Daniel. The next one in the queue here is Matt Kaplan from Laneberg. Matt, welcome. Please unmute yourself. Hi, good morning, guys. Can you hear me?
So I think generally the.
The perception of this.
I'm very positive and people are very excited about it.
A completely new approach for dose diseases.
Okay.
Thank you Danielle and the next one in the queue here is Matt Kaplan from Ladenburg, Matt Latam, Keith Anoint yourself.
Hi, Good morning, guys can you hear me, yes morning, great great well congrats on the progress I mean, I just wanted to kind of zero.
Zero.
The data that you've gotten so far and with Vodafone with us in terms of.
Jessica Brou: Morning? Yes. Morning. Great. Great. Well, congrats on the progress. I mean, I just wanted to kind of zero in on the data that you've gotten so far and with the luminous in terms of the impact on NFL. I guess what's been the feedback so far you've received from the MS community, KOLs, with that observed, you know, pronounced reduction in the caliper and at the, Thank you. Good morning, Matt.
Impact on Nf L.
I guess, what's the what's been the feedback so far you are seeing from the MS community Kols with with that observed.
Announced reduction in California, and emphasis studies.
Thank you good morning.
And thank you for that question I think this is unique.
People see that.
And given that recently.
If you look on a couple of key publications in that space there are.
Dr. Daniel Fitts: Yeah. And thank you for that question. I think this is unique. People see that.
Very nice data showing that Nf L.
Dr. Daniel Fitts: And given that recently, if you look at a couple of key publications in that space, there are very nice data showing that NFL is in progressive MS specifically in an isolated way, if you really separate the activity of NFL from focal inflammation and relapses, on the one hand from the neurodegenerative contributions, like you can do in progressive MS patients, there's clearly a nice predictive power of NFL for future disability outcomes. And that was shown in a couple of recent papers, specifically the second half of last year; there were some papers really pointing to that. And that also drives excitement.
In progressive Ms. Specifically in an isolated if you really separate the activities NFL from.
<unk> inflammation and relapses.
On the one hand.
From the newer degenerative contributions.
Like you can do in progressive Ms patients.
There is clearly a nice predictive power of Nf L.
For future disability I want to come on that was shown in a couple of.
On a recent paper specific to our second half of last year. There were some papers really pointing to them and that also drives excitement I think it is.
Dr. Daniel Fitts: I think it's scientific progress. Of course, at the end, we want to, and we need to demonstrate clinical benefit as well, which is the goal of the phase two study. And we're not too far from that. I think April 25th, we're not too far from now.
Yes.
It's a scientific progress of course at the end, we want to and we need to demonstrate.
Clinical benefit as well, which is the goal of the phase III study and we're not too far from that I think April 25, so that too far from now adding time.
Given.
Dr. Daniel Fitts: And given the, as I said before, the huge unmet medical need in all forms of progressive MS, namely the non-inflammatory advanced secondary and progressive MS population, we think that really for people with calcium, it's really the opportunity to change the way we treat these diseases. It's helpful. And then, and then you mentioned business development plans or partnering plans.
As I said before the huge unmet medical needs.
In all forms of progressive Ms, namely to monetize inventory advanced secondary progressive Ms population.
We think that beautiful Khartoum is really the opportunity to change the way we treat these diseases.
Okay. That's helpful. And then and then you mentioned business development plans are partnering plans what are your what are your plans for.
Dr. Daniel Fitts: What are your plans for the MS indication? Yeah, I think given that some people we are talking to are maybe also on the line here, I tend to be careful about projections and status in BD discussions, but I think we will do what we always do. Establish collaborations, we establish trustful relationships with potential partners, and progressing towards the readout, I think clearly paves the way also for partners. If the phase 2 PMS data is positive, this is certainly something which has a relevance for the whole treatment landscape of multiple sclerosis, even beyond PMS, because that may also be of benefit for and support scientifically the ensure RMS phase 3 studies which are ongoing as well. So I think this is something we have really some activity on, but we're not in a situation where we say we need to do something now.
On the MFS indications.
Fair enough.
Some of the partners.
I think given that some people were talking to are mainly also on the line here.
It tends to be careful on projects in the state of the <unk> discussions.
I think that.
We do what we always do we are we.
Establishing collaborations we have established customer relationships to potential partners.
And progressing towards the read at all I think clearly paves the way also for partnerships.
If the phase II Pms data is positive. This is certainly something which has the relevance for the whole.
Treatment landscape.
Multiple sclerosis, EBIT, even beyond Pms because.
That may also.
Be of benefit for and support.
Scientific can be the insurer of RMS phase III studies, which are ongoing as well. So I think this is something that we have some activity on <unk>.
But we are not in a situation that was hey, we need to do something now I think we have the funding available to read out the phase II study and in a good way and then to look what is the best way forward here.
Dr. Daniel Fitts: I think we have the funding available to read all the phase two studies in a good way and then to look at what is the best way forward. Great. Thanks for the edit, DT. Yeah, thank you, Matt. Thank you, Matt. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. And the next one here is Jungo Clark from Piper Sandler. Jungo, please unmute yourself and go ahead. Hi, good morning, team. This is Jungu. I'm for Yaz.
Okay, great. Thanks for the added detail.
Yes. Thank you Matt Thank you Matt.
Again, if you have a question. Please use the raytheon functional consumed or the Q&A tool and the next one year younger Clark from Piper Sandler <unk> Keith It yourself on go ahead.
Hi, Good morning team. This is Jamie on for Adam Thanks for taking our questions we have to.
Jessica Brou: Thanks for taking our questions. We have two. For the futility analysis later this year for Ensure, how should we think about implications upon readout and what would be considered a win? And second, for the Phase 2 celiac study, where are you with finalizing the design, and could you provide more color on your interactions with the regulatory agency so far? Give me a second.
For the futility analysis later on the payer front sure how should we think about implications upon readout and what would be considered a win.
The second part of that Phase two celiac study, where are you with finalizing the design and could you provide more color on your interactions with the regulatory agencies so far.
Give me a second thank you for the question.
Dr. Daniel Fitts: Yeah, thank you for the question, um, To the first question, I think the nature of utility analysis is that you just want to get a preferred plant answer from the committee, or, and this is one of the reasons, given that we have an event-driven endpoint, we would allow a reasonable sample size adjustment. That's all we can get, and we will implement it for further development. Um, so it's a more binary thing, honestly there. So we don't expect any surprises given based on the phase two data we obtained from the emphasis studies in relaxing MS, we are very confident that this trial will also deliver comparable results. And I think all the calculations and assumptions were based on the phase two emphasis.
To the first question I think the nature of utility analysis that you just want to get any preceded plant answering from the committee.
Or and this is the model given that we have a event driven endpoint.
We would allow a reason amount of bulk sample size adjustment.
That's all we can get them to be on.
With annual implemented into further development.
So.
It's a more binding everything.
Honesty, there. So we don't expect any surprises given based on the phase II data, we obtained from the emphasis studies in relapsing Ms. We are.
I'm very confident that this.
This trial will also deliver a comparable restaurants and I think all the calculations and assumptions that are based on the phase III emphasis data.
Dr. Daniel Fitts: And the second question, maybe you can repeat this, was on regulatory interactions for PILOT and CELIA. Yeah, that's work in progress right now, and also we're still working on the project, Clinical Phase II Study Design. There are a couple of thoughts which we're running through, so as soon as there is something to report on, we will disclose it. I got it. Thank you so much.
And the second question, maybe if you could kind of repeat this was on our regulatory interactions for pellets Kip for celiac.
Yes, that's that's work in progress right now and also we are still working on the project.
On the clinical Phase II study design there.
Couple of thoughts, which were running through so as soon as there is something towards Florida unbelievable, we would disclose that.
Got it thank you so much.
Dr. Daniel Fitts: Thank you. Bye-bye. Thank you. Next one in the queue here is William Wood from the Riley. William, welcome. Please unmute yourself. Hi, can you hear me?
Thank you.
Thank you.
Next one into acuity is William what from B Riley.
Welcome please on mute yourself.
Hi can you hear me, yes, Hello, awesome, thanks, very much and congratulations on a quarter and thank you for taking our questions.
Jessica Brou: Yes, hello. Awesome. Thanks so much.
Dr. Daniel Fitts: And congratulations on the quarter. And thank you for taking our questions. Um, just thinking about your phase three ensure. When should we expect to see the baseline characteristics for that trial? And, you know, Thank you. I'll just leave it there. Good question.
And.
Just thinking about your phase III ensure when should we expect to see the baseline characteristics for that trial and.
<unk> leave it there.
Yeah.
Good question.
Dr. Daniel Fitts: I don't know exactly when we can disclose that, and even if we can get that because it's a phase three study. I think, likely, we need to wait for Integrity of the Study reasons until we unblind the study in 2016. So that's the most likely case there.
I don't know exactly when we can disclose that and even if we can get that because it's a phase III study I think likely we need to wait.
For our integrity of the study.
Isn't until we unblinded study in 26.
That's the most likely case, there because quality assurance and you don't want to end up and difficult discussions with regulators.
Dr. Daniel Fitts: Because quality first, and you don't want to end up in difficult discussions with regulators just because we want to know these kinds of things too early. But we will have an eye on this, and maybe more in the future, if there is a way to get this information. Got it. And actually, I do have two more.
Just because we are at war.
Want to know to already these kind of things, but we will we won't we won't have an eye on this and maybe you know more in the future.
As a way to get this information earlier got.
Got it and actually I do have a.
Two more you also have to presentation that accurate forms coming up next week should we should we be expecting any additional data on your on your emphasis in our interim results on which you've already been presented and how should we view sort of the blocking of that EBV reactivation as being an important strategy and improving.
Dr. Daniel Fitts: You also have two presentations at Actrooms forums coming up next week. Should we be expecting any additional data on your emphasis on interim results, which have already been presented? And how should we view sort of the blocking of that EVV reactivation as being an important strategy in improving patient symptomology overall and what that can mean for your phase two study in PMS and at one point? Yeah, I think the second one is really the talking point from one of those posts, EDV reactivation. This is something that got a little quiet in the last couple of months regarding that because we were so excited about the new one. But it's still true that we do food with calcium. A blocker of reactivation of EBV, and I think it's still not fully understood how that could have a positive impact on disability, for example, prevention of disability. Indication Disease Progression as Influenced by Reactivation of EBV in Patients. There are a lot of hints to do this.
Patient Symptomology overall, and what that can mean for your phase II study in Pms and I have one more.
Yes, I think the second one is really the talking point from one of those parts of the EV reactivation. This is something called live with quiet the last couple of months and regarding that because we were so excited about <unk>, but it's still true that the Eagle Ford in Wisconsin is.
At block or a reactivation of EBV and.
I think it's still not fully understood how that.
Could have a positive impact.
On on disability for example prevention of visibility.
And how the fall.
Indication in disease progression as influenced by reactivation of EBV and patients. There are lot of pins for it is theres a lot of work done by really great scientists here and around the world and also here.
Dr. Daniel Fitts: There's a lot of work done by really great scientists here and around the world, but also here, as collaborators of ourselves. So I think that that's an interesting scientific Flashlight on the third aspect of activity of video fluid muscle calcium on the one poster, and the second one is more dedicated to caliper um, and to trial design and NFL, but no, no really new data, but it's important to put that in the context. We figured out that the market is maybe not fully up to speed on the link between NFL and future disability progression. And we therefore think... We want to come into the discussion with doctors about this more specifically and also talk about NUVAN activation and the way this affects the neuroprotectors potentially because this could really change the way we treat the disease and could be a major, major impact for the whole MS market if the data reads out in a positive way next April. Yeah, and thank you for correcting me there.
Colorado of ourselves.
So I think that's an interesting scientific.
Flashlight on August 3rd aspect of activity all figures with MS accounts from on the one posted in the second one is more dedicated to caliber.
And the trial design, and NFL, and but no no really new data, but it's important to put that into context, we figured out that the market is.
Is maybe not fully up to speed on the link between Nf L and future disability progression.
I mean, therefore I think.
We want to come into those casual with doctors.
More specifically and to also talk about move on activation and <unk> has the the near protected potentially because.
Could we could change the way, we treat the disease and could be a major major impact political EMS market.
If the data reads out in a positive way next.
The next April.
Got it and thank you for correcting me there it definitely is a caliber in term our results and then lastly, just.
Dr. Daniel Fitts: It definitely is a caliber interim result. And then lastly, if I may, Could you discuss how or possibly what the current learnings for glutamate calcium differentiated MOA position it in relation to other anti-CD20 or actually just anti-CD20 antibodies and even emerging excitement sort of in regards to the CD19 CAR-T space? I think the biggest difference is that NOAA-1 is not targeting focal classical inflammation signals, which is different from basically all of the other approaches, and that makes it unique in a way that it,
I may.
Could you discuss hour or possibly what the current learnings for.
<unk> calcium differentiated MLA position it in relation to.
Anti other anti CD 20, or actually just anti CD, 20, antibodies and and even emerging excitement sort of in regards to the CD 19 car T space.
I think the biggest difference is that no. One is not toggled TV bulk <unk> classic of inflammation signals, which is different from basically all of the other approaches.
And that makes it unique in a way that and.
Maybe.
Dr. Daniel Fitts: And we will see that in the NFL data, but we may also see it in clinical outcomes, starting with the CALIPER study, that V-deflutimase calcium can have a beneficial effect in patients who are not benefiting or not benefiting enough from immunosuppressive therapies like anti-CD20s, anti-CD19, or whatever you use there because it is just something different, an autogenal mode of action to these. The good thing about V-deflutimase is that, on the other hand, we also inhibit DHODH, which is, on top of this potential neuroprotective, also anti-inflammatory. So that we, if you focus on the key unmet medical need, which is really preventing and slowing down disability worsening in MS patients of all kinds, we target both. So the more relapse-related and relapse-independent worsening of progression in the patients. And that would be, I think, the best differentiator you can have and also the best news for patients suffering from these indications, like primary progressive or secondary progressive MS specifically. Very helpful, and thank you for taking our questions and congratulations again. Yeah, thank you, William. Thank you, William.
And we've seen that in the NFL data, but we may see also this in clinical outcomes, starting with the catheter study.
That would be different in Wisconsin cannot be beneficially impacting patients, which are not benefiting or not enough benefiting from it you need a suppressive therapy like anticipated twenties until 2019 or whatever you'd use there because it is just something different and entrepreneur mode of action <unk>. The good thing about where you're putting on.
On the other hand, we also inhibit the adjoining acreage which also.
On top of that as potential Neuroprotective, you think also its anti inflammatory so that we if you'll focus on the key unmet medical need which is really preventing and slowing down disability worsening in MF patients of all kind.
But if we target both semi to more.
So an extra maintenance and diminished independent worsening operation and the patients and that would be I think the best differentiated you can have and also the best thing for patients suffering from from these indications like primarily for myself from secondary progressive Ms. Specifically.
Got it very helpful and thank you for taking our questions and congratulations again.
Yes. Thank you. Thank you William and I actually have a another question here on the new London target into Q&A tool.
Dr. Daniel Fitts: I actually have another question here on the NeurO1 target in the Q&A tool. In the case of NeurO1 activation confirmation, do you see further benefits of vidoflutimus in the future or other neuromuscular disorders such as Parkinson's disease or even Alzheimer's? A simple answer, yes.
No one activation confirmation do you see further benefits of including those in the future or other neuromuscular disorders, such as parkinsons disease, or even alzheimers and.
Simple answer yes.
Dr. Daniel Fitts: So very clear, this was a breakthrough finding when we, together with our collaborators at the university here in Munich, around Daniel Merck, found that vidoflutimus calcium is such a good activator of NeurO1. And most of the historic research on the use of NeurO1 has been performed in the area of Parkinson's disease. So this was the original main focus of researchers in the world. I think it still is, on top of the list of hope for potential targets for Parkinson's disease. Therefore, this primes, of course, our beta-fluidinase to be tested there. But we have more molecules. We have a bunch of derivatives. We have molecules with different properties, maybe finding molecules for different purposes, for example, CNF penetration and so forth.
So very clear distance something it was a breakthrough finding when we blend and we together with our collaborators of the junior varsity giving Munich.
Iran Daniel Mark.
Holland that either through the most calcium is such a good activator of new one and most of the historic research on.
On the receptor that use of Milan.
And it has been performed and the area of Parkinson's disease. So this won't be original main focus of researchers in the world.
I think so.
No one is still is.
On the top of the list of whole potential targets for Parkinson's disease, and therefore at this price.
Our.
Need a floating must to be tested there.
We have more markets, we have a bunch of chocolate chips, we have.
Molecules with different properties, maybe finding molecules for different for example, TNF penetration and so forth.
Dr. Daniel Fitts: So there may be the potential to start other independent developments with our molecules in such indications with very specific target profiles. So we see huge potential there. But once again, currently, the focus is on delivering data for MS, and therefore, we will not use huge amounts of our budget for these highly innovative new things.
Maybe the potential to start either independent developments with our molecules and such indications, but a very specific target profiles.
So we see a huge potential there.
But once again pardon me the focus is to never indeed, all formats.
And therefore, we will not use a huge amount of our budget for Florida East highly innovative new things.
Dr. Daniel Fitts: But we are also considering collaborations there as well to boost things in parallel to our current MS activities. I have another question here in writing. Are there any plans for the Vidoflutimus UC program, given the stronger maintenance phase data? Yeah, that's the money question right now again.
But we are also considering collaborations there as well to boost things in parallel to our domestic.
S activity.
Yes.
I have another question in writing are there any plans for the Mito floating most you'll see program given the stronger maintenance they stayed up.
Yeah, that's the money question right now.
Dr. Daniel Fitts: So I would love to continue with phase three directly in that indication. Once again, and this was the reason why we kicked off a new program called IMU381. We have molecules which are maybe from their tissue distribution profile better suited for GI penetration, but using our mode of action and our proof of concept from the Caldo studies.
So I would love to continue with the phase III directly.
Indications.
Once again.
And that was the reason why we kicked off a new program called <unk>.
One.
We have a molecule, which may be found at tissue distribution profile better suited for four Gi penetration by using our mode of action and our proof of concept.
From the condo studies.
Dr. Daniel Fitts: Yes, in principle, yes. But once again, something we would likely, more likely separate on a different development track. Thanks, Daniel. Final question I currently have, maybe a good chance for you to summarize the status quo and upcoming milestones for METO. What are the updates regarding IMU-848? I'm sorry.
Yes in principle, yes.
But once again.
Something we would likely more likely separate in a different development trunk.
Thanks, Danielle final question I cant do you have maybe a good chance to you to summarize the status quo and upcoming milestones for <unk> what are the updates regarding on your end plastics and <unk> I'm sorry.
Dr. Daniel Fitts: Well, more or less the summary of what we spoke about. I think we were intrigued by the data from last year, specifically the NFL data giving us a very nice signal, and we're increasing the likelihood of success for the clinical outcomes of the Caliper study with the readout on April 25. This would make the drug a huge commercial opportunity. I think this is a very huge potential for venous fluid miscarriage. That's, I think, the driving force here right now. In parallel, we have that rock solid. Ensure Program in Relapsing MS, ongoing, which is more or less just based on our very good phase two data for that molecule we obtained from the emphasis study, which allows us a low-risk way forward toward approval and data readout in 2026. So these are the key driving forces for the Beautifulness Program.
Morning, guys to summary of what we spoke about it I think we were intrigued by the data of last year's specific again, it's another daytime giving us.
Hey.
Very nice signal and.
We are increasing the likelihood of successful clinical outcomes, all the kind of a study.
What's the readout in April 25.
This would make the drop.
Huge also commercial opportunity I think this is.
Very huge potential for <unk>.
From Wisconsin.
I think the driving force here right now.
In parallel we have that broke some of it.
In short program in relapsing, Ms ongoing which is more or less just based on our very good phase two data for that molecule. We obtained from the emphasis study.
Which allows us and low risk way forward.
Towards approval.
And data read out in 2026. So these are the key driving forces for the Ms program.
But to reiterate, I don't want to talk too long here, but to reiterate, we also have this positive on GI, on your C-study, on the maintenance data, which is more or less boosting other molecule developments in that space, and also the No. 1 potential beyond just mitoposterolosis and other related neurological indications, also something where we think this has another huge potential, and we will definitely also look into those. Tent Very good. This concludes our question and answer session today. I would like to turn the conference back over to Daniel for any closing remarks. Thanks, Jessica, and thank you to today's attendees for your insightful questions. To summarize, with a positive interpreter from our Phase II CALIPER trial, as well as the continuation of enrollment in all Phase III ENSURE trials, we continue to make tangible progress in the clinical development of B. fluidimus calcium.
But to reiterate and don't want to talk too long here, but to reiterate.
To reiterate we also had this positive result.
On GI online you see study of the maintenance data, which is more or less what we are seeing other molecule developments in that space.
And also the no one potential beyond just multiple sclerosis, and other related neurological indications also something where we think this has huge potential and we will we will.
Definitely also look into these things.
Okay.
Very good.
This concludes our question and answer session today, I would like to turn the conference back over to Daniel for any closing remarks.
Thanks, Jessica and thank you to today's attendees for your insightful questions.
To summarize some of the positive interim data from our phase II <unk> trial as well as the continuation of enrollment of our phase III <unk> trials, we continue to make tangible progress on the clinical development of BDO 40 months calcium.
As progress is made, we also expect to provide an update on our preparations for further phase 2 clinical development of IMU-AID fast-tracking. With our funds at the end of the fourth quarter and the recent closing of the first tranche of our three-tranche private placement, we remain well funded, providing us runway through multiple clinical milestones into the third quarter of 2025. 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. Thank you, Daniel, and thank you for joining Immunics' fourth quarter and year-end 2023 earnings call. The call has now concluded. You may now disconnect. Goodbye.
As progress is made we also expect to provide an update on our preparations for the phase II clinical development of our new age plastics with our funds at the end of the fourth quarter and the recent closing of the first tranche of our three tranche private placement, we remain well funded providing us runway through multiple.
The next milestones into the third quarter of 2025.
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. One on one.
Thank you Danielle and thank you for joining <unk> fourth quarter and year end 2020 earnings calls the call has now concluded you may now disconnect.