Q2 2022 Immunic Inc Earnings Call
Unknown Executive: Second Quarter 2022 Earnings Call.
You've called my name is Jessica <unk> head of Investor Relations and communications at the Munich.
Jessica Breu: My name is Jessica Breu,
Jessica Breu: Head of Investor Relations and Communications at Immunic.
Jessica Breu: I will also be the moderator on today's call.
We'll also be the moderator on today's call.
Jessica Breu: Speaking on the call are Dr. Daniel Vitt,
Speaking on the call our Doctor Daniels fit our Chief Executive Officer, and President as well as Glenn <unk>, Our Chief Financial Officer for the Q&A section of today's web cast. We also have with US our chief Scientific officer, Dr. Pamela Quibble.
Jessica Breu: our Chief Executive Officer and President,
Jessica Breu: as well as Glenn Whaley, our Chief Financial Officer.
Jessica Breu: For the Q&A section of today's webcast,
Jessica Breu: we also have with us our Chief Scientific Officer,
Jessica Breu: Dr. Hella Kohlhof.
Jessica Breu: 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.
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 cut off questions. If you joined the webcast via the zoom platform. There are two ways to submit a question to.
Jessica Breu: If you joined the webcast via the Zoom platform, there are two ways to submit questions.
Jessica Breu: 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 of the Zoom portal to queue your question.
You can either submit your questions in writing via the Q&A till after soon portal or if you would like to speak with US directly. Please use the right hand function of the June quarter to clear your question.
Jessica Breu: Before we begin, I would like to remind you, that this presentation may contain forward-looking statements.
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 what.
Jessica Breu: 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.
With similar meaning and such statements and got a number of risks and uncertainties that could cause a units actual results to differ materially from those discussed here. Please note that these forward looking statements reflect in units opinion only as of the date of this presentation and it undertakes no obligations to revise or publicly release the results of.
Jessica Breu: 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 results of any revision to these forward-looking statements.
Any revision to these forward looking statements in light of new information or future events.
Jessica Breu: In light of new information of future events, please refer to Immunix SEC filings for a more detailed description of the risk factors that may affect Immunix results and these forward-looking statements.
Please refer to <unk> SEC filings for a more detailed description of the risk factors that may affect in Unix results in these forward looking statements.
Jessica Breu: I would now like to turn the webcast over
I would now like to turn the webcast over to our CEO and president of the Dania sets to begin the presentation Daniel up to you yeah. Thank you Jessica.
Jessica Breu: to our CEO and President, Dr. Daniel Fitts,
Jessica Breu: to begin the presentation.
Jessica Breu: Daniel, up to you.
Daniel Vitt: Yeah, thank you, Jessica.
Daniel Vitt: I would like to welcome everybody, to Immunix's second quarter 2022 earnings call. Earlier today, we announced our financial results, for the quarter ended June 30th, 2022, and highlighted recent activities as well as upcoming milestones related to our clinical development pipeline.
I would like to welcome everybody to <unk> second quarter 2022 earnings call.
You should review our financial results for the quarter.
Sure.
So a new 22 highlighted recent activities as well as upcoming milestones related to our clinical development pipeline.
Daniel Vitt: During today's call, we will walk through our second quarter 2022 and subsequent highlights, additional clinical updates we provided in the filings this morning, financial and operating results, as well as anticipated milestones.
During today's call, we will walk through our second quarter 2022, and subsequent highlights additional clinical updates, which we provided in the filings this morning financial and operating results.
Well as anticipated milestones as.
Jessica Breu: As Jessica noted before we closed the call, you will have the opportunity to ask questions.
As Jessica noted before we close the call you will have the opportunity to ask questions.
Daniel Vitt: The second quarter of 2022, was a period of continued progress in our clinical programs, which we believe set the stage for important data readouts during the second half of this year. In particular, we look forward, to reporting first clinical activity data for our selected oral IL-17 inhibitor, IMU-965 in psoriasis.
The second quarter of 2000 towards excuse was a period of continued progress in our clinical programs, which we believe surplus stage for important data readouts during the second half of this year.
In particular.
We look forward to reporting first clinical activity data for our selected.
17 inhibitor <unk> in psoriasis and first in human healthy volunteer data from our new eight from six are already available and systemically acting small molecule that has shown pretty clearly can lead to regulate intestinal barrier function and regenerate power epithelium.
Daniel Vitt: And first, the new mental health volunteer data, from IMU-856 are already available and systemically acting small molecule that has shown pretty clinically to regulate intestinal barrier function and regenerate bowel epithelium.
Daniel Vitt: But let me move to a more detailed review, of our second quarter updates.
But let me move to a more detailed review of our second quarter updates.
Daniel Vitt: In May, we announced the start of the patient cohort, in our ongoing phase one clinical trial of IMU-856 in patients with celiac disease. This represents the first time patients, are being treated with this small molecule, oral epigenetic regulator that appears to influence the tightly regulated network of genes and proteins associated with intestinal epithelial cell interaction and adhesion.
In May we announced the start of the patient cohort in our ongoing phase one clinical trial of <unk> in patients with celiac disease. This represents the first time patients are being treated with this small molecule.
Epigenetic regulator that appears to influence the tight tightly regulated network of genes and proteins associated with intestinal PTO sell into action in the tissue.
Daniel Vitt: With respect to VFM, our selective OLDH inhibitor, in June we reported top-line data from our, Phase II CALDOS-1 trial in patients with moderate to severe UC. The data revealed a previously unknown interaction with chronic concurrent steroid use, resulting, in the trial missing its primary endpoint. As a consequence, we decided not to continue our development of VFM for inflammatory bowel, disease indications without a partner.
With respect to be recouped in Wisconsin, our selective for OTH O'dea reach inhibitor in June we reported topline data from our phase II Carlos one trial in patients with moderate to severe UC.
The data reveals that previously unknown into action with chronic concurrent steroid use resulting in the trial missing its primary endpoint.
As a consequence, we decided not to continue our development of beautiful muscocho for inflammatory bowel disease indications without a partner.
Daniel Vitt: Consistent with prior data sets in other patient populations, administration of VFM in this, trial was observed to be safe and well-tolerated.
Consistent with prior data sets and other patient populations administration, a bigger fluid most couch some industry wide was observed to be safe and well tolerated.
Daniel Vitt: Also in June, the data from Cohort 1 of our Phase II EMPHASIS trial in RRMS, comprising, 30 and 45 mg of VFM and placebo, was published in the peer-reviewed journal, Annals of Clinical and Translational Neurology. The publication underlines the importance of our excellent Phase II findings for VFM, in patients with RRMS.
Also in June the data from cohort one of our phase II emphasis driving our RMS comprising $30 and 45 milligram of fruit in Wisconsin and placebo was published in the peer reviewed journal Annals of clinical and translational neurology.
The publication underlines the importance of our excellent phase II timings for food in Wisconsin in patients with RMS.
Daniel Vitt: I would like to express my thanks to the lead author and coordinating investigator, Robert, Fox, from Cleveland Clinic, and to the entire team involved in preparing this article.
I would like to express my thanks to believe ultimately and coordinating investigator Robert Fox from Cleveland Clinic and to the entire team involved in preparing this article.
Daniel Vitt: In other corporate news, last month we announced the appointment of Maria Tönschen, an industry, executive with 20 years of global commercial expertise and experience in U.S. and ex-U.S, markets, to our Board of Directors, and the resignation of Jan van der Bosche from the, Board, both of which were effective on July 5, 2022.
In other corporate news last month, we announced the appointment of Maria Thompson and.
And industry executive with 20 years of global commercial expertise and experience in U S and X U S markets to our board of directors and the resignation of the unfunded portion from the board both of which were effective on July five 2022.
Daniel Vitt: Before I hand over to Glenn for the financial summary, I would like to highlight some other
Before I hand over to Glenn for the financial summary, I would like to highlight some other interesting clinical updates we provided in our earnings filings. This morning.
Daniel Vitt: interesting clinical updates we provided in our earnings filing this morning.
Daniel Vitt: Based on the observation, on the observed interaction between VFM and chronic steroid, use in the CALDOS1 trial in UC patients, we performed a post-hoc analysis of our Phase II EMPHASIS data in RRMS patients to explore the potential influence of steroids on these, study results. As anticipated, steroid use was rare, and among those RRMS patients who received any, steroid, the majority received only short steroid courses following relapse events or acute neurological events.
Based on the observation of the observed interaction between leader for the Wisconsin and clinics to reduce and Carlos <unk> in UC patients. We performed a post hoc analysis of our phase II emphasis data in RMS patients to explore the potential influence austerity on these study results.
Daniel Vitt: Most of these patients only had one short course of steroids, and the average duration, of steroid treatment in these patients was 4.4 days. This underlines that steroids are rarely used in RRMS patients, and mostly for very, short duration.
As anticipated steroid use was ram and among those RMS patients who received any serious.
The majority received only short stay Recourses following relapse events are acute neurological events.
Most of these patients only had once short course of series and the average duration of treatment in these patients was four days.
This underlines its too its a reality used in MF patients and mostly for very short duration.
Daniel Vitt: In conclusion, comparing patients who received at least one dose of corticosteroids with, those who did not, we neither see differences in clinical parameters nor evidence that the rare short-term use of steroids in RRMS patients has any influence on the effectiveness of phytofluidinose calcium in this patient population.
In conclusion, comparative patients who received at least one dose of corticosteroids with those who did not we need to see differences in clinical parameters, nor evidence that the Ria short term use of service in RMS patients has any influence on the effectiveness of feed or food in Wisconsin and this patient pop.
Elevation.
Daniel Vitt: With respect to IMU-95, we are progressing well in our development program. In this context, we've already completed an exploratory Phase I study in 15 evaluable, healthy human subjects to assess the drug-drug interaction potential for the drug. No relevant signals for DDI potential were observed, and the treatment in this trial, was safe and well tolerated.
With respect to <unk> 95, we are progressing well in our development program in this context, we've already completed an exploratory phase <unk> study in <unk>, we have good healthy human subjects to assess.
Assess the drug drug interaction potential for the drug.
All relevant signaled for Adi potential were observed in the treatment in this trial was safe and well tolerated.
Daniel Vitt: Finally, the first two dose cohorts of all Phase I clinical trials of IMUNE-965 in metastatic, castration-resistant prostate cancer have been fully recruited, with six patients enrolled in the 300mg cohort and six patients enrolled in the 600mg cohort. Of these patients, all have completed the 28-day dose-limiting toxicity observation period.
Finally, the first two dose cohorts of our phase one clinical trial of <unk> five.
In metastatic castration resistant prostate cancer have been fully recruited with six patients enrolled in the 300 milligram cohort and six patients enrolled in the 600 milligram cohort.
These patients all have completed the 28 day dose limiting toxicity observation period.
Daniel Vitt: The third, 900mg cohort is expected to start dosing soon. Initial safety data available so far show a, promising safety profile of IMUNE-965 in metastatic CRPC, with only benign adverse events and no dose-limiting toxicities.
<unk> 900 milligram cohort is expected to start dosing soon.
Initial safety data available so far show a promising safety profile of <unk> in metastatic CRC with only benign adverse events and no dose limiting toxicities.
We plan to provide a more comprehensive update on safety and also on potential signs of antitumor activity of <unk> in this trial as soon as data from the planned dose expansion part automated.
Daniel Vitt: We plan to provide a more comprehensive update on safety and also on potential signs of antitumor activity of IMUNE-965 in this trial as soon as data from the planned dose expansion part are available.
Daniel Vitt: That concludes our summary of the second quarter
That concludes our summary of our second quarter 2022, and subsequent highlights as well as our clinical updates I would like to turn the call over to Glenn.
Daniel Vitt: 2022 and subsequent highlights as well as our clinical updates.
Daniel Vitt: I'd like to turn the call over
Provide a financial overview.
Thank you Daniel I will now review the financial and operating results for the quarter ended June 32022.
Daniel Vitt: to Glenn, who will provide the financial overview.
Let me start with the cash overview.
Glenn Whaley: Glenn?
We ended the second quarter with $88 $1 million in cash and cash equivalents, which we expect to be sufficient to fund our operations into the fourth quarter of 2023.
Glenn Whaley: Thank you, Daniel.
Glenn Whaley: I will now review the
Regarding the operating results research and development expenses were $16 5 million for the three months ended June 32022 as.
Glenn Whaley: financial and operating results for the quarter ending June 30, 2022.
As compared to $15 7 million for the three months ended June 32021.
Glenn Whaley: Let me start with the cash overview. We ended the second quarter with $88.1 million in cash and cash equivalents, which we expect to be sufficient to fund our operations into the fourth quarter of 2023.
These costs were mainly driven by external development costs related to the ongoing clinical trials of the distributor must calcium and IMU 93 five.
Glenn Whaley: Regarding the operating results, research and development expenses were $16.5 million for the three months ended June 30, 2022, as compared to $15.7 million for the three months ended June 30, 2021. These costs were mainly driven by external development costs related to the ongoing, clinical trials of vitifluvimus calcium and IMUNE-935. For the six months ended June 30, 2022, R&D expenses were $34 million, as compared to $27.3 million for the same period last year. These expenses were also mainly driven by external development costs of our three clinical, development programs.
For the six months ended June 32022, R&D expenses were $34 million.
As compared to $27 3 million for the same period last year.
These expenses were also mainly driven by external development costs of our three clinical development programs.
Glenn Whaley: General administrative expenses were $4.1 million for the three months ended June 30, 2022, as compared to $3.4 million for the same period ended June 30, 2021. The increase is mainly driven by personnel expenses, including non-cash stock compensation, related to headcount.
General and administrative expenses were $4 1 million for the three months ended June 32022 as.
As compared to $3 4 million for the same period ended June 32021.
The increase was mainly driven by personnel expenses, including noncash stock compensation related to head count.
Glenn Whaley: For the six months ended June 30, 2022, G&A expenses were $8.1 million, as compared to $7.1 million for the same period in 2021. The increase is driven primarily by personnel expenses, including non-cash stock compensation related to headcount.
For the six months ended June 32022, G&A expenses were $8 1 million.
As compared to $7 $1 million for the same period in 2021.
The increase was driven primarily by personnel expenses, including noncash stock compensation related to head count.
Glenn Whaley: Other expense was negative $1.3 million for the three months ended June 30, 2022, as compared to other income of $1.2 million for the same period ended June 30, 2021. The decrease was primarily attributable to an increase in the loss on intercompany loan, between Immunic Bank and Immunic AG as a result of changes in currency exchange.
Other expense was negative $1 3 million for the three months ended June 32022, as compared to other income of $1 $2 million for the same period ended June 32021.
The decrease was primarily attributable to an increase in the loss on intercompany loan between Munich ink in the Munich AG as a result of changes in currency exchange rates.
Glenn Whaley: For the six months ended June 30, 2022, other expense was negative $0.7 million, as compared, to negative $0.9 million for the same period last year.
For the six months ended June 32022, other expense was negative seven zero point $7 million as compared to negative <unk> 9 million for the same period last year.
Glenn Whaley: Net loss for the three months ended June 30, 2022, was approximately $21.9 million or $0.72, per basic and diluted share, based on approximately 30.2 million weighted average common shares outstanding, compared to a net loss of approximately $17.9 million or $0.82 per basic and diluted share, based on 21.7 million weighted average common shares outstanding for the same period ended June 30, 2021.
Net loss for the three months ended June 32022 was approximately $21 9 million or <unk> 72.
Our basic and diluted share.
Based on approximately 32 million weighted average common shares outstanding.
Compared to a net loss of approximately $17 9 million or <unk> 82 per basic and diluted share.
Based on $21 7 million weighted average common shares outstanding for the same period ended June 32021.
Glenn Whaley: Net loss for the six months ended June 30, 2022, was approximately $42.7 million or $1.49, per basic and diluted share, based on approximately 28.7 million weighted average common shares outstanding, compared to a net loss of approximately $52.5 million or $2.44 per basic and diluted share, based on 21.5 million weighted average common shares outstanding for the period ended, June 30, 2021.
Net loss for the six months ended June 32022 was approximately $42 7 million or $1 49 per basic and diluted share based on approximately $28 7 million weighted average common shares outstanding.
Compared to a net loss of approximately $52 5 billion.
Our $2 44.
Our basic and diluted share.
Based on $21 5 million weighted average common shares outstanding for the period ended June 32021.
Glenn Whaley: With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical
With that I will turn the call back over to Daniel for an outlook on our upcoming clinical milestones Daniel.
Daniel Vitt: milestones.
Daniel Vitt: Daniel?
Daniel Vitt: Yeah, thank you, Glenn.
Daniel Vitt: As Matt mentioned in the beginning of the call, we have several important data readouts, coming up.
Yes, Thank you Glenn.
And at the beginning of the call we have several important data readouts coming up.
Daniel Vitt: Our Phase III program, Obedient Fulminous Calcium in RMS, is progressing based on the, excellent clinical data package obtained in our emphasis Phase II trial. It's interesting to see that new third-party data clearly highlights the unmet need of, preventing disability progression, which is seen across the spectrum of patients with MS.
Our phase III program, albeit from Wisconsin in RMS is progressing based on the excellent clinical data package obtained in our emphasis phase II trial, it's interesting to see the new third party data clearly highlights the unmet need of preventing disability progression, which is seen across the spectrum of patients with Ms.
Daniel Vitt: The understanding of MS has evolved with evidence showing a smoldering disease that is connected, to Epstein-Barr virus infections and subsequent inflammation and associated with neurodegeneration in the MS patients.
The understanding of NSS evolved with evidence showing this motoring disease that is connected to Epstein Barr virus infections, and subsequent inflammation and associated with annuity generation in Ms patients.
Daniel Vitt: With its antiviral, anti-inflammatory, and potential neuroprotective effects, beta-Fulminous, Calcium is aiming to quell smoldering, multiple sclerosis, and is uniquely positioned to address this high unmet medical need.
With an antiviral anti inflammatory and potential neuroprotective effects, we did.
William Roscosmos aiming to grow smoldering multiple sclerosis, and is uniquely positioned to address this high unmet medical need.
Daniel Vitt: As mentioned, several recent new findings from clinical research are underlining this, concept and the relevance for a next-generation MS therapy.
As mentioned several recent new findings from clinical research underlining this concept and the relevance for our next generation Ms therapy.
Daniel Vitt: An important epidemiologic study published by Bjornvik et al. in Science early this year, showed a clear association between EBV infection and occurrence of MS with a 32-fold increased risk of EBV in EBV-infected patients with serum levels of neurofilament light chain increased.
An important epidemiologic study published by <unk> in the us.
And signs early this year. So that's a clear association between EBV infection and a current offer matched with a 32 fold increased risk of ABB in EBV infected patients with serum levels of new equipment light chain increase.
Daniel Vitt: Another study published by Lantz et al.
Another study published by nonsense all in nature. This year revealed that cross reactive antibodies between the EBV antigens from Taiwan, and the CNS proteins, Leila, Kim where font industry through it of MF patients.
Daniel Vitt: in Nature this year revealed that cross-reactive, antibodies between the EBV antigen, EPNA1, and the CNS protein, Gliricam, were found in the cerebral fluid of MS patients, basically linking EBV infections and neurodegeneration.
<unk> linking EBV infection, and you were to generation.
Daniel Vitt: Using the anti-CD20-directed therapies to deplete B-cells, but not to deplete the progeny, antibody-producing plasma cells, which are CD20-negatives, and therefore unlikely are able to reduce EBV, those cross-reactive antibodies.
Interesting.
Antecedent 'twenty directed therapies deplete b cells, but the market lead approach any antibody producing plasma cells, which are <unk> 20 negative and therefore unlikely are able to reduce.
Those cross reactive.
Antibodies.
Daniel Vitt: One update that probably many of us have been waiting for is our first-time public guidance, of timelines for our ongoing clinical MS programs in SURE and CALIBRE.
One of the probably many of US have been waiting for is our first time public guidance of timelines for our ongoing clinical EMS programs ensure and caliber we have carefully analyzed the impact that the current events in the Ukraine, and Russia may have an ongoing clinical programs.
Daniel Vitt: We have carefully analyzed the impact that the current events in the Ukraine and Russia may have on our ongoing clinical programs.
Daniel Vitt: Based on this assessment, our current goal is to report data from the interim analysis of our phase 2 CALIBRE trial of beta-flutimose calcium in progressive MS patients in the second half of 2023 and to read our top-line data at the end of 2024.
Based on this assessment of our current goal is to report data from the interim analysis of our phase II trial will be fully most calcium and progressive Ms patients in the second half of 2023 into reading our topline data at the end of 'twenty 'twenty four but.
Read out of the first of our phase III and short trying to figure out the most council in relapsing multiple sclerosis is currently targeted for the end of 2025.
Daniel Vitt: The readout of the first of our phase 3 and SURE trials of beta-flutimose calcium in relapsing multiple sclerosis is currently targeted, for the end of 2025. We plan to periodically review this assessment and provide updates of material changes as appropriate.
We plan to periodically review this assessment and provide updates of maturity just as appropriate.
Daniel Vitt: We believe that the design of the two SURE trials provided a straightforward path towards potential regulatory approval of beta-flutimose calcium in RMS, which should be further supported by the data from the CALIBRE trial focusing on beta-flutimose calcium's potential neuroprotective effects.
We believe that the design of the two ensure trials provided a straightforward path towards potential regulatory approval all video for the Wisconsin in Rms.
Which shouldnt be further supported by the data from the clinical trial, focusing on video <unk> costumes potential neuroprotective protective effects.
We remain highly enthusiastic about the potential for you to remove calcium to become a highly differentiated and uniquely valuable treatment option for this RMS patient population.
Daniel Vitt: We remain highly enthusiastic about the potential of beta-flutimose calcium to become a highly differentiated and uniquely valuable treatment option for this RMS patient population.
We chosen.
<unk> of our phase one clinical trial of <unk> nine to five in patients with moderate to severe psoriasis is ongoing in Australia, and New Zealand and Bulgaria initial.
Daniel Vitt: Recruitment of part C of our phase 1 clinical trial of IMU-95 in patients with moderate to severe psoriasis is ongoing in Australia, New Zealand, and Bulgaria. Initial results are expected to be available in the fourth quarter of this year.
Initial results are expected to be available in the fourth quarter of this year.
Daniel Vitt: Additionally, we expect unblinded safety data from the single and multiple ascending dose part, of our phase 1 clinical trial of IMU-856 in healthy human subjects to be available in the third quarter of 2020.
Additionally, we expect unblinded safety data from the single and multiple ascending dose part of our phase one clinical trial.
I'm with 806 in healthy human subjects to be available in the third quarter of 2020.
Daniel Vitt: This brings us to the end of our formal presentation, and Jessica,
This brings us to the end of our formal presentation and Jessica Please open the call for the Q&A session.
Jessica Breu: please open the call for the Q&A session.
Yes. Thank you Danielle and also plan for walking us through the second quarter update we will now be in the question and answer session. As a reminder, if you joined the webcast Madison platforms. There are two ways to submit questions. You can eat that submit your questions in writing via the Q&A, 12% quarter or if you would like to speak with us directly is used.
Jessica Breu: Yeah, thank you Daniel and also Glenn for walking us
Jessica Breu: through the second quarter updates.
Jessica Breu: We will now begin the question and answer session.
Jessica Breu: As a reminder, if you joined the webcast via the Zoom platform, there are two ways to submit questions.
The rate of return assumption.
<unk> two chemo question.
Our first guest today is Andreas <unk> of Wedbush pet growth.
Okay.
Sorry.
Okay.
Yeah.
We need a minute to switch here.
Jessica Breu: 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 of the Zoom portal to queue your question.
My apologies Andreas please limit yourself and go ahead.
Jessica Breu: Our first guest today is Andreas Argiridis of WebPushPackro.
Yes, Thank you no worries.
Morning, and thanks for taking my question.
Jessica Breu: Sorry.
Just two quick ones from us. So can you just described.
The baseline characteristics of the celiac patients enrolled in the phase one trial and what are your expectations for the readout and then.
Perhaps you could just provide a little bit more color on the insurer readout.
According to our timeline it seems like it got pushed out a bit.
I mean I have that correctly you saw any impact.
From Ukraine conflict or other factors would be a great. Thank you.
Jessica Breu: We need a minute to switch here.
Yes, I will try my best to answer the questions. So regarding the CLEC disease trial I think this trial is really proof of concept. So the goal is to really demonstrate that we somewhat confirm the impact of $85 six on the barrier function. So we said, okay, let's do it in patients where it's proven that their refunds.
Jessica Breu: My apologies.
<unk> plays an important role so that was the reason why we picked celiac disease and it's a four week treatment then we start.
<unk> for two weeks.
In a randomized fashion between active and placebo and then after 14 days, we trigger a tutor challenge and therefore patients and that's maybe the most important based on characteristics need to be on proper diet before inclusion and the size of gluten free diet before acuity notice.
Study.
And there are two base to two endpoints you're looking at the one is the inflammatory and pencil we measure IL two and the second one has been histological assessment of Italy, and the patient so.
Two quite important one structural <unk> implements white parameters to be read out.
And to give us an impression whether we have an effect of the drug.
In these patients.
Yeah.
Switching to the second question I think that maybe we were a little bit misunderstood here in our presentation diesel diesel the adjusted numbers. So we have more or less in our current guidance for the duration of the insured try it and also clipper. There is now priced in that we have not access to patients in Ukraine and in Russia.
Sure.
And so we I think there is no price Dan and this is the new guidance, we are giving here on our way forward now of course that compared with our initial plans that of course this.
Has slowed down a little bit, but I think we are very happy that the team was very successful in managing this challenge in finding new sites and also including new countries too.
Get the best possible recruitment.
In this challenging environment. So affected by this way I would also think our internal team for all of these efforts.
To managing.
That in this challenging situation.
Great. Thanks, I'll jump back in the queue.
Thank you Andreas.
Andreas Argiridis: Andreas, please unmute yourself and go ahead.
Our next speaker, our guest is yes mean rahimi of Piper Sandler.
Yes, please make yourself and go ahead.
Good morning, Tim and thank you so much for taking my question.
Andreas Argiridis: Yes, thank you.
<unk> you're on mute.
Yeah.
Okay. Good morning, Tim can you hear me.
Andreas Argiridis: No worries.
Yes, sorry.
For some reason [laughter] nowadays.
Thank you so much for taking my question. The first question that's directed T O S.
Andreas Argiridis: Good morning, and thanks for taking our question.
Is there an opportunity to go to into the caliber and the emphasis trial and exclude or make it clear that Cherokee is should not be present, and then can you comment on if and the analysis that you presented this morning at the doses and the duration of steroid use and that math with.
Andreas Argiridis: Just two quick ones from us.
Andreas Argiridis: So, can you just describe the baseline characteristics of the, celiac patients enrolled in the phase 1 trial, and what are your expectations for the readout?
Andreas Argiridis: And then, perhaps you could just provide a little bit more color on the insurer readout.
Andreas Argiridis: According, to our timelines, it seems like it got pushed out a bit.
Andreas Argiridis: We may not have that correctly.
Andreas Argiridis: So, any impact?
Andreas Argiridis: from Ukraine conflict or other factors would be great.
Daniel Vitt: Thank you.
Daniel Vitt: Yes, I will try my best to answer the questions.
Similar to what we had seen in the Crown study and that data.
Daniel Vitt: And we start treating for two weeks in a randomized fashion between active and placebo. And then after 14 days, we trigger a gluten challenge. And therefore patients, and that's maybe the most important basic characteristic, need to really be on proper diet before inclusion in the study, so a gluten-free diet before inclusion in the study.
Daniel Vitt: So regarding the CELAC disease trial, I think, this trial is really proof of concept. So the goal is to really demonstrate that we somewhat confirm the impact of 856 on the barrier function. So we said, okay, let's do that in patients where it's proven that barrier function plays an important role. So that was the reason why we picked CELAC disease.
Daniel Vitt: And it's a four-week treatment.
I have a follow up question.
Daniel Vitt: And there are two endpoints we're looking at.
Daniel Vitt: One is an inflammatory endpoint, so we measure IL-2.
Daniel Vitt: And the second one is then a histological assessment of the ability and the patient.
David I can't really be very clear on that answer.
I mentioned in the call and this was I think that the goal was to show that.
Basically corticosteroid treatment does not play a role in MS therapy. So I mentioned that we had only less than 20% of patients.
With any steroid treatment during the trial at all and the average duration was $4 four days.
And Yossi try on those.
50% of the patients from a steroid treatment and it had an average treatment duration of 300 days. So that's of course, a huge different totally different it does not play a role in the Theres no chronic steroid use in EMS. It's only in the case of <unk> mentioned that.
In the case of an acute relapse that patients get an infusion for a couple of days and then that's it. So we think and then also we look back on the data as I said in the presentation. When we look back on the data for the phase two and there is no difference. So we see really no hint that this is at all a charge. It was seems to be really AUC limited problem, we have identity at five four.
The steroids interaction.
Daniel Vitt: So two quite important, one structural and one inflammatory parameter to be read out and to give us an impression whether we have an effect of the drug in these patients.
Thank you and then Tim could you maybe comment on onto this exploratory DDI study what prompted the idea of measuring to run the study with I Am 90, 935, and then maybe what are some of the findings of the study.
Daniel Vitt: Switching to the second question, I think that maybe we were a little bit misunderstood here in our presentation.
Daniel Vitt: These were the adjusted numbers. So we have more or less in our current guidance for the duration of the Ensure trial and also CLIPR, there's now priced in that we have not access to patients in Ukraine and in Russia.
Although the finding I mentioned theres no finding that goes to gold cyclic to see that there is no DDI actress and advanced what prompted this study is clearly new OE forward, we are preparing for phase II.
And of course.
Yeah, the support package to be done and this is an important piece.
Going forward and ultimately syndicate to make sure you don't have a DDI problem and therefore, we said okay. Let's.
Get that done early and mirrored with heavy debt.
This trial was done it was really showing the <unk>, obviously has no adi risky.
Thank you and sorry for one last question can you just give us a little bit more color in terms of how enrollment is progressing into that once this crisis cohort.
I know you tend to give us a little bit more detail.
[laughter], it's going well.
I mentioned in the last call I mentioned that.
Some of it was challenging in Australia, and science to get more patients active that seems I think I'm.
I'm very happy and maybe that's also because our team was visiting the sites and have good discussions with art.
Investigators.
I think even though even the Australia New Zealand sites.
Up to speed right now and with the additional growth area. I think we are we are optimistic to really keep our time lines.
Daniel Vitt: And so I think there's now priced in and this is the new guidance we are giving here on a way forward.
Daniel Vitt: Of course, compared with our initial plans, that of course is slowed down a little bit, but I think we are very happy that the team was very successful in managing this challenge and finding new sites and also including new countries to get the best as possible recruitment in this challenging environment.
Daniel Vitt: So I think by this way, I would also thank our internal team for all these efforts to managing that in this challenging situation.
Just more precise on the guidance.
Andreas Argiridis: Great, thanks.
It's still the second half, but it's a fourth quarter and we expect the data.
Okay. Thank you Daniel.
Jessica Breu: I'll jump back in the queue.
Pleasure.
Thank you yes.
Next question comes from Matt Kaplan at landmark not place amongst yourselves and go ahead.
Jessica Breu: Thank you, Andreas.
Morning, Thanks, Thanks for taking the questions.
Yasmin Rahimi: Our next speaker or guest is Yasmin Rahimi of Piper Sandler. Yas, please unmute yourself and go ahead.
Just wanted to dig into a little bit more to the phase three studies for <unk> and <unk>.
Yasmin Rahimi: Good morning, team, and thank you so much for taking my question.
And asked are you given given the recent publications on <unk> are you monitoring for ADP activity in the study and what what could you.
<unk>, Kevin given the activity.
I can say ADP potentially.
And of course, we have preclinical data that we inhibit the react or prevent the reactivation of Epstein Barr virus infection that was passed again follow up testing and we will monitor our base as well in the phase III clinical study because we will take them.
Put them samples and really check for shedding of.
Pirates.
So that's implemented.
And I would say by the way it was implemented before the paper mills.
I'm very glad that our clinical team was forward looking on that and we did the team.
It was believing into EBV relevance already before the science paper came out.
And in parallel to base to this shedding investigation level, there will be an antibody distribution as well.
Anti <unk> antibody.
Great Great and then a second question in terms of 19, five that Suraj cohort.
What what what should we be looking for when we see the data.
Fourth quarter.
It turns out of that activity.
As you know, Matt we are very bullish about the program itself and we think this is something that's a big thing or the other.
This is a phase one trial so we.
We are aiming to get run about 40 patients treated <unk> two dose groups. So what we want to see is a clear signal of activity.
<unk>.
I'm I think it's maybe not.
Not fair to say, okay based on that percent of success its successes with theirs and medically meaningful cyclical activity and I think that's what we're aiming for that will be a success.
As signaled before really getting full speed.
Two phase two also in our partnering discussions for it and I think the whole team is really excited about the progress right. Now next couple of weeks are really really busy year, and we will do everything to to get the data as quickly as possible.
Great. Thanks, Thanks for that detail.
Thank you Matt.
Yasmin Rahimi: Oh, Yasmin, you're on mute.
Again, if you have a question please use the rate assumption after assuming prana.
We currently have one more which is Tom Smith.
SPD Securities.
Yasmin Rahimi: Yeah.
Please I'm Gonna just doesn't go ahead.
Yasmin Rahimi: Oh, okay.
Yasmin Rahimi: Good morning, team.
Hi, everyone. This is Mike on for Tom Thanks for taking our questions I guess, a quick follow up to the last one in terms of what <unk> is a winning scenario in the upcoming 93 five readout in.
I'm curious if you'd give any additional details on what kind of efficacy signals you are looking for.
Yeah, Okay, I see I need to tell me more.
Of course at the end if you look on the on the current market situation.
What is perceived as a success of course, the goal would be to be better than a primary loss to come closer to the probably of what we're seeing with them.
Other TNF antibodies and 17 antibodies and the patient situation and just want to reemphasize. The phase one we have two doses and there is another fluids phase III.
And the business model for <unk>.
Phase II trial with the broad coverage of exposure so.
Therefore, we want to see activity, but we're not looking only on a percent policy reduction, which is the main read out for efficacy.
Percent reduction after four weeks basically that's what they're looking for into prepared with other.
<unk> published we will also look for example for something like <unk>, 15 reduction, which may be something worth after four weeks to look at.
Also we'll look on itch and other parameters.
The plan is to publish year.
Whatever we have at that reading out in the fourth quarter and give as much insight as possible at that time point.
Just to give a bit of a hats off on the details.
Full unblinded all the trial is expected them to happen a little bit later than then.
The first top line readout and.
And then including also for example, the.
Histological assessment of skin punches for example, we can look on cytokines and inflammatory subset and so forth that would be give us much more insight.
Second.
A portion of our results.
Yeah.
Yeah, but I think.
I don't want to.
Make it a small its a big REIT audience, an important step for the company.
Going forward.
Got it that's really helpful. Additional color. So I appreciate it and then I guess just one last follow up is in terms of partnership discussions that you've mentioned previously curious if theres any progress you can provide there and when you might be able to do you expect to reach some kind of agreement.
So with it.
Mr <unk>.
<unk> partnership with <unk>.
I think this is this a good point.
Of course, there is always.
There are different ways to progress.
And what we do is basically we try to be open.
To communicate.
A full set of data.
To shareholders and investors, but also to.
Our friends at pharma companies and of course, we have.
Activated to discussions on basically an obviously programs with pharma and biotech companies.
And going forward of course data is also driving.
It's also driving these discussions.
Maybe one remark on X gene mutations here, we think that.
<unk> hundred five is really uniquely positioned here.
As the first.
2017 17 selective.
Broadband <unk> agonist and we know that this is an outstanding future and we have high expectations on the value of the program the broadness of development and any partnership shifts should reflect.
<unk> that value we see in there.
That asset so we will likely not do.
That credit should the deal.
So.
We really want to make sure that value is also covered if we if it would go.
For a licensing <unk>.
<unk> something like that.
Understood. Thanks, very much for the color.
Thank you Mike Alright, given we have no more questions in the queue. We conclude our Q&A session I would like to turn the conference back over to Daniel for any closing remarks, yes, thanks, Jessica and thank you.
Yasmin Rahimi: Can you hear me?
Today's attendees for your interesting questions.
Otherwise we are highly enthusiastic about the progress we have achieved so far in 2022 as well as the important upcoming milestones from our earlier clinical programs we anticipate.
Later this year.
Include the unblinded safety data from both single and multiple ascending dose parts of our phase one clinical trial of <unk> hundred six in healthy human subjects expected in the third quarter as well as the initial clinical activity results from part C of our phase one clinical trial of <unk>, two five and mortgage.
<unk> psoriasis patients expected in the fourth quarter.
With that I would like to close the call.
Again, thank you very much for joining our webcast today and we are very happy to answer any additional questions and long lengths.
Yasmin Rahimi: Yes, sorry.
Yasmin Rahimi: We lost you for some reason.
Great. Thank you for joining <unk> second quarter 2022 earnings call today at the conference is now concluded you may now disconnect.
Yasmin Rahimi: No worries.
Yasmin Rahimi: Thank you so much for taking my question.
Yasmin Rahimi: The first question that's directed to you is, is there an opportunity to go to into the caliber and the emphasis trial and exclude or make it clear that steroid use should not be present?
Yasmin Rahimi: And then can you comment on if, in the analysis that you presented this morning, if the doses and the duration of steroid use and MS were similar to what we had seen in the
Yasmin Rahimi: Crohn's study?
Unknown Executive: The conference, was now concluded. You may now disconnect.
Yasmin Rahimi: And then I have a follow-up question.
Daniel Vitt: I can really be very clear on that answer.
Daniel Vitt: I mentioned in the call, and this was, I think, the goal was to show that basically cortical serotreatment does not play a role in MS therapy. So I mentioned that we had only less than 20% of patients with any serotreatment during, the trial at all.
Daniel Vitt: And the average duration was 4.4 days in the UC trial.
Okay.
Daniel Vitt: We had 50% of the patients for our serotreatment, and they had an average treatment duration of 300 days.
Daniel Vitt: So that's, of course, a huge difference.
Daniel Vitt: It's totally different.
Daniel Vitt: It does not play a role, in the, there's no chronic steroid use in MS.
Daniel Vitt: It's only in a case of, and I mentioned that, in the case of an acute relapse that patients get an infusion for a couple of days, and then that's it.
Daniel Vitt: So we think, and also we look back on the data, as I said in the presentation, we look back on the data for the phase two, and there's no difference.
Daniel Vitt: So we see really no hint that this is at all a challenge.
Daniel Vitt: It seems to be really a UC-limited, problem we have identified here for the steroids interaction.
Yasmin Rahimi: Thank you.
Daniel Vitt: And then team, could you maybe comment on, onto this exploratory DDI study?
Yasmin Rahimi: What prompted the idea of measuring to run the study with IM-935, and maybe what are, some of the findings of the study?
Daniel Vitt: Oh, the finding I mentioned, there is no finding.
Daniel Vitt: That was the goal, basically, to see that there is no DDI risk.
Daniel Vitt: And what prompted the study is clearly a way forward.
Daniel Vitt: We are preparing phase two, and of course, there's a broad package to be done, and there's an important piece going forward in all these indications to make sure you don't have a DDI problem.
Daniel Vitt: And therefore, we said, okay, let's get that done early, and we're very happy that the trial was done and was really showing the drug obviously has no DDI risk.
Yasmin Rahimi: Thank you, and sorry for one last question.
Daniel Vitt: Can you just give us a little bit more color in terms of how enrollment is progressing, into the 1C psoriasis cohort?
Daniel Vitt: I know you tend to give us a little bit of more details.
Daniel Vitt: It's going well, and I think I mentioned in the, I think in the last call I mentioned, that somehow it was challenging in all Australian sites to get more patients active.
Daniel Vitt: That changed, I think.
Daniel Vitt: I'm very happy, and maybe that's also because our team was visiting the sites, and had good discussions with our investigators.
Daniel Vitt: I think even the Australian and New Zealand sites are up to speed right now, and with the addition of Bulgaria, I think we are optimistic to really keep our timelines up.
Daniel Vitt: And we're just more precise on the guidance.
Daniel Vitt: It's still a second half, but it's the fourth quarter.
Daniel Vitt: We expect the data.
Daniel Vitt: Okay.
Yasmin Rahimi: Thank you, Daniel.
Daniel Vitt: Pleasure.
Jessica Breu: Thank you.
Jessica Breu: Yes.
Jessica Breu: Next question comes from Matt Catlin at Landmark.
Matt Catlin: Matt,
Matt Catlin: please unmute yourself and go ahead.
Matt Catlin: Good morning.
Matt Catlin: Thanks.
Matt Catlin: Thanks for taking the questions.
Matt Catlin: Just wanted to dig in a little bit more to the phase three study for photoluminescence and MS.
Matt Catlin: Are you, given the recent publications on EBV, are you monitoring for EBV activity in the study,
Matt Catlin: and what could you see given the activity against EBV?
Matt Catlin: So yes, of course, we have preclinical data that we inhibit the react or prevent the reactivation of Epsom bar virus infection that was tested in cellular testing.
Daniel Vitt: And we will monitor this as well in the phase three clinical study because we will take, sputum samples and really check for shedding of virus.
Daniel Vitt: So that's implemented.
Daniel Vitt: And by the way, it was implemented before the paper came out, so I'm very glad that, our clinical team was forward looking on that and the team was believing in the EBV relevance already before the science paper came out.
Daniel Vitt: And in parallel to this, to the shedding investigation, we will do the antibody distribution as well. Anti-EBV antibodies.
Daniel Vitt: Great, great.
Matt Catlin: And then a second question in terms of 935, the psoriasis cohort, what should we be looking, for when we see the data in the fourth quarter in terms of activity?
Daniel Vitt: As you know, Matt, we are very bullish about the program.
Daniel Vitt: So we think this is a big thing.
Daniel Vitt: On the other hand, this is a phase one trial.
Daniel Vitt: So we are aiming to get around about 40 patients treated in these two dose groups.
Daniel Vitt: So what we want to see is a clear signal of activity.
Daniel Vitt: And I think it's maybe not fair to say, okay, this and that present a success.
Daniel Vitt: A success is if there's a medically meaningful signal for activity.
Daniel Vitt: And I think that's what we're aiming for, that will be a success and a signal for really, getting full speed to phase two, also in our partnering discussions for it.
Daniel Vitt: And I think the whole team is really excited about the progress right now.
Daniel Vitt: The next couple of weeks are really, really busy here and we will do everything to get, the data as quickly as possible.
Matt Catlin: Great.
Matt Catlin: Thanks.
Jessica Breu: Thanks for that detail.
Jessica Breu: Thank you, Matt.
Jessica Breu: Again, if you have a question, please use the raise hand function of the Zoom portal.
Jessica Breu: We currently have one more, which is Tom Smith of SBB Securities.
Tom Smith: Tom, please unmute yourself and go ahead.
Mike: Hi, everyone.
Mike: This is Mike on for Tom.
Mike: Thanks for taking our questions.
Mike: I guess just a quick follow up to the last one.
Mike: In terms of what you kind of see as a winning scenario in the upcoming 9.35 readout, I'm, curious if you'd give any additional details just on what kind of efficacy signals you're looking for.
Mike: Yeah.
Daniel Vitt: Okay.
Daniel Vitt: I see.
Daniel Vitt: I need to tell more.
Daniel Vitt: Of course, at the end, if you look on the current market situation and what is perceived, as a success, of course, the goal would be to be better than a premier last, to come closer to what was seen with anti-GNF antibodies and IL-17 antibodies in the patient situation.
Daniel Vitt: I just want to reemphasize as a phase one, we have two doses and this is not a full phase, two.
Daniel Vitt: This is not a full phase two trial with the broad coverage of exposure.
Daniel Vitt: Therefore, we want to see activity here.
Daniel Vitt: But we're not looking only on the percent PASI reduction, which is the main readout, for efficacy. Percent reduction after four weeks, basically, that's what we're looking for and to compare, it with other drugs published.
Daniel Vitt: We will also look, for example, for something like PASI 50 reduction, which may be something, worth after four weeks to look at.
Daniel Vitt: We also will look on itch and other parameters.
Daniel Vitt: The plan is to publish here whatever we have at that readout in the fourth quarter and, give as much insight as possible at that time point.
Daniel Vitt: Just to give a bit of heads up on the details, the full unblinding of the trial is expected, then to happen a little bit later than the first top line readout.
Daniel Vitt: Then including also, for example, the histological assessment of skin punches, for example, where, we can look on cytokines and inflammatory subsets and so forth.
Daniel Vitt: That would give us much more insight than in the second portion of readout.
Daniel Vitt: Yeah, but I think, I don't want to make it small, it's a big readout and it's an important, step for the company going forward here.
Mike: Got it, that's really helpful additional color, so I appreciate it.
Mike: And then I guess just one last follow up is, you know, in terms of partnership discussions, that you mentioned previously, curious if there's any progress you can provide there and when you might be able to expect to reach some kind of agreement.
Daniel Vitt: So what, sorry, I missed the first one, the partnership, okay, good.
Daniel Vitt: Yeah, I think this is a good point.
Daniel Vitt: Of course, there's always, there are different ways to progress.
Daniel Vitt: And what we do is basically we try to be open to communicate a full set of data, not only, to shareholders and investors, but also to our friends at pharma companies.
Daniel Vitt: And of course, we have activated discussions on basically in all of the programs with pharma, and biotech companies.
Daniel Vitt: And going forward, of course, data is also driving these discussions.
Daniel Vitt: And just really one remark on expectations here.
Daniel Vitt: We think that 9.5 is really uniquely positioned here as the first TH17, 9.17 Selective Broad, MRT Interest Agonist. And we know that this is an outstanding feature and we have high expectations on the value, of the program, the broadness of development, and any partnership should reflect that value we see in that asset.
Daniel Vitt: So we will likely not do a quick cheap deal.
Mike: So we really want to make sure that value is also covered if we would go for a licensing, transaction, something like that.
Mike: Understood.
Mike: Thanks very much, Ms. Keller.
Jessica Breu: Thank you, Mike.
Jessica Breu: All right.
Jessica Breu: Given we have no more questions in the queue, we conclude our Q&A session.
Daniel Vitt: I would like to turn the conference back over to Daniel for any closing remarks.
Daniel Vitt: Yeah, thanks, Jessica.
Daniel Vitt: And thank you to today's attendees for your interesting questions.
Daniel Vitt: To summarize, we are highly enthusiastic about the progress we have achieved so far in 2022.
Daniel Vitt: As well as the important upcoming milestones for our earlier clinical programs we anticipate, later this year. These include the unblinded safety data from both single and multiple sending dose parts, of our Phase I clinical trial of IMU-856 in healthy human subjects expected in the third quarter, as well as the initial clinical activity results from Part C of our Phase I clinical trial of IMU-856 in moderate to severe psoriasis patients expected in the fourth quarter.
Daniel Vitt: With that, I would like to close the call.
Daniel Vitt: Again, thank you very much for joining our webcast today.
Daniel Vitt: And we are very happy to answer any additional questions in one-on-one.
Jessica Breu: Great.
Jessica Breu: Thank you for joining Immunic's second quarter 2022 earnings call today.