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spk08: good morning everybody and welcome to munich's second quarter 2022 earnings call my name is jessica brew head of investor relations and communications at the munich i will also be the moderator on today's call speaking on the call are dr daniel fit our chief executive officer and president as well as glenn whaley our chief financial officer for the q a section of today's webcast we also have with us our chief scientific officer dr hella kohlhof 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 of the Zoom portal to queue your question. Before we begin, I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate, or words with a similar meaning. 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 of future events. Please refer to Immunix's SEC filings for a more detailed description of the risk factors that may affect Immunix's results and these forward-looking statements. I would now like to turn the webcast over to our CEO and President, Dr. Daniel Fitt, to begin the presentation. Daniel, up to you.
spk03: Thank you, Jessica. I would like to welcome everybody to Immunix 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. 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. As Jessica noted before we close the call, you will have the opportunity to ask questions. 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 selective oral IL-17 inhibitor IMU935 in psoriasis, and first in human healthy volunteer data from IMU856, our orally available and systemically acting small molecule that has shown preclinically to regulate intestinal barrier function and regenerate bowel epithelium. But let me move to a more detailed review of our second quarter updates. In May, we announced the start of the patient cohort in our ongoing phase one clinical trial of IMU856 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. With respect to videofluidimus calcium, our selective OLDH-ODH 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 videofluidimus calcium for inflammatory bowel disease indications without a partner. Consistent with prior data sets in other patient populations, administration of BDF calcium in this trial was observed to be safe and well tolerated. Also in June, the data from cohort one of our phase two emphasis trial in RRMS comprising 30 and 45 milligram of BDF calcium and placebo was published in the peer-reviewed journal, Annals of Clinical and Translational Neurology. The publication underlines the importance of our excellent phase two findings for Vitoflutimus calcium in patients with RMS. 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. In other corporate news, last month we announced the appointment of Maria Thunsen, an industry executive with 20 years of global commercial expertise and experience in US and ex-US markets, to our board of directors, and the resignation of Jan van der Bosche from the board, both of which were effective on July 5th, 2022. 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 filing this morning. Based on the observation, On the observed interaction between Vitoflutibus calcium and chronic steroid use in the CalDOS1 trial in UC patients, we performed the post-hoc analysis of our Phase II emphasis data in RMS patients to explore the potential influence of steroids on these study results. As anticipated, steroid use was rare, and among those IMS patients who received any steroid, the majority received only short steroid courses following relapse events or acute neurological events. 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 MS patients and mostly for very short duration. 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 our MS patients has any influence on the effectiveness of riloflutemus calcium in this patient population. With respect to IMU935, we are progressing well in our development program. In this context, we already completed an exploratory phase one study in 15 available 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. Finally, the first two dose cohorts of all phase one clinical trial of IMU925 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. Of these patients, all have completed the 28-day dose-limiting toxicity observation period. The third 900 milligram cohort is expected to start dosing soon. Initial safety data available so far show a promising safety profile of IMU935 in metastatic CRPC 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 anti-tumor activity of IMU935 in this trial as soon as data from the planned dose expansion part are available. That concludes our summary of the second quarter 2022 and subsequent highlights, as well as our clinical updates. I'd like to turn the call over to Glenn, who will provide the financial overview.
spk01: Glenn? Thank you, Daniel. I will now review the financial and operating results for the quarter ended June 30th, 2022. 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. Regarding the operating results, research and development expenses were $16.5 million for the three months ended June 30th, 2022, as compared to $15.7 million for the three months ended June 30th, 2021. These costs are mainly driven by external development costs related to the ongoing clinical trials of it if you lose calcium and I am you 935. 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. 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. 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 was driven primarily by personnel expenses, including non-cash stock compensation related to headcount. 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 Inc. and Immunic AG as a result of changes in currency exchange rates. For the six months ended June 30th, 2022, other expense was negative $0.7 million as compared to negative $0.9 million for the same period last year. Net loss for the three months ended June 30th, 2022 was approximately $21.9 million or 72 cents 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 82 cents per basic and diluted share based on 21.7 million weighted average common shares outstanding for the same period ended June 30th, 2021. Net loss for the six months ended June 30th, 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 for basic and diluted share based on 21.5 million weighted average common shares outstanding for the period ended June 30th, 2021. With that, I'll turn the call back over to Daniel for an outlook on our upcoming clinical milestones. Daniel?
spk03: Yeah, thank you, Glenn. As mentioned in the beginning of the call, we have several important data readouts coming up. Our phase three program of video for the most calcium in RMS is progressing based on the excellent clinical data package obtained in our emphasis phase two 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. 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 newer degeneration in the MS patients. With its antiviral, anti-inflammatory, and potential neuroprotective effects, Vitofolibus calcium is aiming to quell smoldering multiple sclerosis and is uniquely positioned to address this high unmet medical need. As mentioned, several recent new findings from clinical research are underlining this concept and the relevance for a next-generation MS therapy. An important epidemiologic study published by Bjornvik et al. in Science earlier 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-like chain increased. Another study published by Lancet All in Nature this year revealed that cross-reactive antibodies between the EBV antigen Ebna1 and the CNS protein Gliocam were found in the cerebral fluid of MS patients, basically linking EBV infections and neurodegeneration. Interestingly, anti-CD20 directed therapies deplete B cells, but do not deplete the progeny antibody-reducing plasma cells, which are CD20 negative, and therefore unlikely are able to reduce those cross-reactive antibodies. 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 CALIPER. We have carefully analyzed the impact that the current events in the Ukraine and Russia may have on our ongoing clinical programs. Based on this assessment, our current goal is to report data from the interim analysis of our Phase II CALIPER trial of Vitoflutimus calcium in progressive MS patients in the second half of 2023, and to read our top-line data at the end of 2024. The readout of the first of our phase three ensured trials of videoflutimus calcum 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 believe that the design of the two INSURE trials provided a straightforward path towards potential regulatory approval of VFK in RMS, which should be further supported by the data from the CALEPPA trial focusing on VFK's potential neuroprotective effects. We remain highly enthusiastic about the potential of edufluidimus calcium to become a highly differentiated and uniquely valuable treatment option for this RMS patient population. Recruitment of Part C of our Phase I clinical trial of IMU935 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. Additionally, we expect unblinded safety data from the single and multiple descending dose part of our phase one clinical trial of IMU 856 in healthy human subjects to be available in the third quarter of 2022. This brings us to the end of our formal presentation. And Jessica, please open the call for the Q&A session.
spk08: Yeah, thank you, Daniel and also Glenn for walking us through the second quarter updates. 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 hand function of the Zoom portal to queue your question.
spk07: Our first guest today is Andreas Agiridis of Wet Push Pack Row. Sorry. We need a minute to switch here. My apologies. Andreas, please unmute yourself and go ahead.
spk00: Yes, thank you. No worries. Good morning and thanks for taking our question. Just two quick ones from us. So can you just describe 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 timelines, it seems like it got pushed out a bit. We may not have that correctly. So any impact from the Ukraine conflict or other factors would be great. Thank you.
spk03: Yeah, sure. I will try my best to answer the question. So regarding the C-Lag disease trial, I think this trial is really proof of concept. So the goal is to really demonstrate that we somehow confirm the impact of 856 on 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 C-Lag disease. And it's a four-week treatment, 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 gluten-free diet before inclusion in the study. And there are two endpoints we're looking at. One is the inflammatory endpoints, so we'll measure IL-2, and the second one is then histological assessment of the villiite in the patient. 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. Switching to the second question, I think that maybe we were a little misunderstood here in our presentation. These were the adjusted numbers. So we have more or less in our current guidance for the duration of the Ensure trial and also Caliper, we have now priced in that we have not access to patients in Ukraine and in Russia. And so I think that's now priced in and this is the new guidance we are giving here on our way forward. 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. So thanks by this way. I would also thank our internal team for all these efforts to managing that in this challenging situation.
spk06: Great, thanks. I'll jump back in the queue.
spk07: Thank you, Andreas.
spk08: Our next speaker or guest is Yasmin Rahimi of Piper Sandler.
spk02: Yes, please unmute yourself and go ahead. Good morning, team, and thank you so much for taking my question.
spk07: Oh, Yasmin, you're on mute.
spk02: Yeah. Okay. Good morning, team. Can you hear me? Yes, sorry. We lost you for some reason. No worries. Thank you so much for taking my question. The first question that's directed to you is, is there an opportunity to go into the caliber and the emphasis trial and exclude or make it clear that steroid use should not be present? 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 Crohn study? And then I have a follow-up question.
spk03: I can really be very clear on that answer. I mentioned in the call, and this was I think 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 4.4 days in the UC trial. We had 50% of the patients for a steroid treatment, and it had an average treatment duration of 300 days. So that's, of course, a huge difference. It's totally different. It does not play a role in the – there's no chronic steroid use in MS. It's only in the case of – and I mentioned that – In the case of an acute relapse, the patients get an infusion for a couple of days, and then that's it. 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. So we see, we know hint that this is at all a challenge. It seems to be really a UC limited problem. We have identified here for the steroid interaction.
spk02: Thank you. And then team. Could you maybe comment on onto this exploratory DDI study? What prompted the idea of measuring to run the study with IM9935? And maybe what are some of the findings of the study?
spk03: Oh, the finding I mentioned, there is no finding. That was the goal, basically, to see that there is no DDI. And what prompted the study is clearly the OA forward. We are preparing phase two. And of course, there's a broad package to be done. And this is an important piece going forward in all these indications to make sure you don't have a DDI problem. And therefore we said, okay, let's get that done early. And we're very happy that this trial was done and was really showing the drug obviously has no DDI risk.
spk02: 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 the One Seas Horizon cohort? I know you tend to give us a little bit of more details on each call.
spk03: It's going well. And I think I mentioned in the last call, I mentioned that somehow it was challenging in all Australian sites to get new patients active. That changed, I think. I'm very happy. And maybe that's also because our team was visiting the sites and had good discussions with our investigators. I think... even even the Australian New Zealand sites um are up to speed right now and with the addition of Bulgaria I think we are we are optimistic to really keep our timelines now and we're just more precise on the guidance it's it's it's still a second how it's it but it's a fourth quarter we expect the data okay thank you Daniel pleasure
spk08: Thank you. Yes. Next question comes from Matt Kaplan at Landmark. Matt, please unmute yourself and go ahead.
spk06: Good morning. Thanks. Thanks for taking the questions. Just wanted to dig in a little bit more to the phase three study for beta-luminous and MS. Are you, given the recent publications on EBV, Are you monitoring for EBV activity in the study and what could you see given the activity against EBV potentially?
spk04: So yes, of course, we have preclinical data that we inhibit the react or prevent the reactivation of Epstein-Barr virus infection that was tested in cellular testing. 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. So that's implemented.
spk03: 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.
spk04: And in parallel to this, to the shedding investigation, we will do the antibody distribution as well. Anti-EBV antibodies.
spk06: Great, great. 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?
spk03: As you know, Matt, we are very bullish about the programs. We think this is a big thing. On the other hand, this is a phase one trial. So we are aiming to get around about 40 patients treated in these two dose groups. So what we want to see is a clear signal of activity. And I think it's maybe not not fair to say, okay, this and that present a success. A success is if there's a medically meaningful signal for activity. 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. And I think the whole team is really excited about the progress right now. Next couple of weeks are really, really busy here and we will do everything to get the data as quickly as possible.
spk06: Great. Thanks. Thanks for that detail.
spk08: Thank you, Matt. Again, if you have a question, please use the raise hand function of the Zoom portal. We currently have one more, which is Tom Smith of SBB Securities. Tom, please unmute yourself and go ahead.
spk05: Hi, everyone. This is Mike on for Tom. In terms of, you know, what you kind of see as a winning scenario in the upcoming 935 readout, you know, curious if you have any additional details just on what, you know, kind of efficacy signals you're looking for.
spk03: Yeah. Okay. I see. I need to tell more. All right. 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-TNF antibodies and IL-17 antibodies in the patient situation. I just want to re-emphasize, this is phase one, we have two doses and it's not a full phase two. And this is not a full phase two trial with the broad coverage of exposure. So therefore we want to see activity here, but we're not looking only on the percent palsy reduction, which is the main readout for efficacy. So, percent reduction after 4 weeks, basically, that's what we're looking for and to compare it with other drugs published. We will also look, for example, for something like 50 reduction, which may be something worth after 4 weeks to look at. We also will look on itch and other parameters. 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. Just to give a bit of a heads up on the details. the full unblinding of the trial is expected then to happen a little bit later than than um the the first top line readout and then including also for example the histological assessments of skin punches for example where we can look on cytokines and inflammatory subsets and so forth that would be give us much more insights than in a second uh portion of readouts um yeah but i think I don't want to make it small. It's a big read-on. It's an important step for the company going forward here.
spk05: Got it. That's really helpful additional color, so I appreciate it. 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.
spk03: Sorry, I missed the first part. Partnership. Okay, good. Yeah, I think this is a good point. Of course, there's always different ways to progress. 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. And of course, we have activated discussions on basically in all the three programs with pharma and biotech companies. And going forward, of course, data is also driving these discussions. Maybe one remark on expectations here. We think that 935 is really uniquely positioned here as the first TH17, IL-17 selective raw gamma T inverse 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. So we will likely not do a quick, cheap deal. So we really want to make sure that value is also covered if we would go for a licensing transaction, something like that.
spk07: Understood. Thanks very much for the call.
spk08: 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.
spk03: Thanks, Jessica, and thank you to today's attendees for your interesting questions. To summarize, we are highly enthusiastic about the progress we have achieved so far in 2022, 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 the single and multiple ascending dose parts of our phase one clinical trial of IMU856 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 IMU935 in moderate to severe 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 in one-on-ones.
spk08: Great. Thank you for joining in Munich's second quarter 2022 earnings call today. The conference is now concluded. You may now disconnect.
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