Earnings call transcript: Cantargia AB outlines strategic plans amid market challenges in Q1 2025

Cantargia AB, a biotech firm with a market capitalization of $40 million, recently held its Q1 2025 earnings call, highlighting strategic developments and financial performance amid challenging market conditions. The company’s stock saw a notable decline of 6.02%, reflecting investor sentiment regarding its financial losses and future prospects. According to InvestingPro analysis, the company currently appears undervalued based on its Fair Value assessment.

Key Takeaways

• Cantargia AB’s stock decreased by 6.02%, trading between its 52-week high and low.
• The company reported an operating loss of SEK 45 million and a reporting loss of SEK 47 million.
• Phase one studies for CAN10 have been successfully completed, demonstrating full receptor occupancy.
• Nadunolumab trials show progress with completed recruitment and new patient enrollments.

Company Performance

Cantargia AB reported an operating loss of SEK 45 million for Q1 2025, with a reporting loss of SEK 47 million. The company’s financial performance reflects increased R&D expenses, which rose by 6% compared to the same quarter last year. Despite these challenges, Cantargia maintains a strong cash position of SEK 104 million, expected to support operations until Q4 2025.

Financial Highlights

• Operating Loss: SEK 45 million
• Reporting Loss: SEK 47 million
• R&D Expenses: SEK 45-41 million, up 6% YoY
• Cash Position: SEK 104 million

Market Reaction

Cantargia AB’s stock experienced a decline of 6.02% following the earnings call. The stock is currently trading between its 52-week high of $0.53 and low of $0.12, with analyst price targets ranging from $0.51 to $0.69. InvestingPro analysis indicates the stock has shown significant volatility, with a beta of 1.9, though it has demonstrated a strong return over the last month. This movement may be attributed to the company’s financial losses and ongoing need for financing, despite positive developments in its product pipeline. Access detailed valuation metrics and expert analysis through InvestingPro’s comprehensive research reports.

Outlook & Guidance

Cantargia plans to initiate phase two studies for CAN10 in Hidradenitis Suppurativa and Atopic Dermatitis by the end of 2025. The company is also progressing with Nadunolumab trials, with results expected in mid-2025. Cantargia is actively seeking additional financing to support these ongoing programs.

Executive Commentary

Interim CEO Damian Marron expressed confidence in the company’s strategic direction, stating, "We remain as confident as we can be in the current circumstances." Chief Medical Officer Morten Lin Jensen highlighted the potential of CAN10, noting, "Our broad mode of action is really what makes it super suitable for HS."

Risks and Challenges

• The company faces financial losses and increased R&D expenses.
• There is a need for additional financing to sustain operations beyond Q4 2025.
• The competitive landscape in inflammatory and oncology treatments presents challenges.
• Macroeconomic pressures may impact the biotech sector’s growth.

Q&A

During the earnings call, analysts inquired about the design of CAN10’s phase two study and the development of a diagnostic test for Nadunolumab. The company also addressed its financing strategies and potential market positioning, providing insights into its future plans. With an EPS forecast of -$0.07 for FY2025 and current analyst consensus recommendations available on InvestingPro, investors can access comprehensive analysis and future projections to make more informed decisions.

Full transcript - Cantargia AB (CANTA) Q1 2025:

Damian Marron, Interim Chief Executive Officer, Cantasia: everybody to today’s interim report of our first quarter twenty twenty five. On this, next slide, you see our safe harbor statement, which, of course, its main effect is to make everybody aware that any forward looking statements that we make, should be taken, with great care and not relied on or taken as guarantees of future performance. So as we’ve just introduced, I’m Damian Marron. I’m the interim, chief executive officer. I’ll be taking the first few slides for you and then handing over to Mortal Lynn Jensen, our chief medical officer, and, we also have Patrick Remblad, our chief financial officer, who will take us through the financial section of today’s presentation.

So it’s been a busy first quarter and, actually, a busy few weeks since the end of that quarter as well. So just quickly, here are the significant events that occurred in the first quarter of twenty twenty five. I was appointed, as the interim CEO following the resignation of Jorgen Forsberg, our long standing, prior CEO. We then presented promising phase one data from our, Canton First multi dose cohort as well as feedback from the FDA and the clinical experts. We finished recruitment in the randomized phase two trifor study in triple negative breast cancer with nadunolumab, and we enrolled the first patient in a new investigator initiated study of nadunolumab in leukemia that is taking place in The US, and we published two abstracts, on IL-one wrap ADC and on nadinolumab’s potential to reduce chemotherapy induced neuropathy.

We announced they will be presented at AACR, which has just taken place. Significant results, since the reporting period are obviously, the appointment of, Morton Lingensen as chief medical officer, and he will be speaking with you today. We selected treatment resistant atopic dermatitis as our second indication for Kanten, for Kanten’s phase two program, and Morton will talk to you more about that. And we have also just announced that pharmacokinetic modeling, which used data from both the single ascending dose groups, but also the full data from the first multiple dose cohort in our, Kanten phase one study has confirmed our choice of every four week dosing in phase two, which we can see as potentially quite a significant competitive advantage, and we’ll talk we’ll show you some of that data in a few minutes. So moving to focus, first of all, on can ten, and on the, data we’ve been announcing since the start of the year.

So just to quickly, remind people, this is the, design of our phase one first in human study, our single ascending dose, multiple ascending dose study. So we started with cohorts, 10 cohorts of healthy volunteers who received single doses of Canton, and at each cohort we increased the dose, and each cohort had six subjects who received Canton and two who received placebo. That has been completed and finalized as we’ve already reported. We then moved into the multiple ascending dose healthy subject cohorts, and here we have two dose cohorts again, six can 10 to two placebo. These dose cohorts will allow us to move into phase two.

So we anticipate finishing this study in q two and being able to start phase two towards the end of ’4 this year. We also have some psoriasis subjects that we are studying separately, which will enable us to look to undertake some exploratory mechanistic studies. And what we’ve shown to date is full receptor occupancy on immune cells, I’ll show you that in a second, full blocking of IL-one family cytokines, and very importantly we have seen no safety concerns in either the single ascending dose or the completed multiple, first multiple ascending dose cohort. So what have we seen as results? As I mentioned there, we have documented full receptor occupancy, in the study, and you can see on the bottom left here for two different immune cell types, classical monocytes and neutrophils, that as we increase the dose in the single ascending dose part of the study, we reached full receptor occupancy on both of those cell types.

And you can see right on the right hand side that we also achieved this full receptor occupancy with the multiple ascending dose fourteen days after the last dose, was taken. So this is very encouraging data for us. On the right, you see, an inhibition assay in whole blood taken from the subjects, and on here on the right you were looking at the ability of IL-thirty six, one of the IL-one superfamily that way block, to induce IL-six release. And this is either at day one with the SAD or day 40 in the multiple ascending dose, and on the right hand side day eight, on the single ascending dose, so eight days after that single dose, or again, towards the end of the multiple ascending dose treatment. And again, what you see here is that we get, as we got full receptor occupancy, we also get full inhibition of IL-thirty six.

As we increase the SAD or we have we look at the, multiple ascending dose of three hundred milligrams, you can see that we completely block, IL-thirty six. There is no more IL-six release induced by applying IL-thirty six here. And if we go to the next slide, we also looked at the ability of I l one beta to induce I l six release. And, again, we see a similar pattern, that we can completely, block the ability of I l one beta to induce I l six release either after single doses or with the multiple ascending dose at three hundred milligrams. This data is very important because it highlights the unique functions of Kanten that we can block all of the IL one superfamily.

So IL-one, IL-thirty three, and IL-thirty six. This is unique function of an IL-one rep antibody like Canton and differentiates us from both approved treatments, but also treatments that are in development at the moment such as the IL-one alpha beta blocker lutekizumab, the IL-thirty six blocker spisolumab, or indeed the IL-one beta blocker that is in development by the US biotech of Arlo. And the importance of this is that we then made the immune cells non responsive to IL-one and IL-thirty six. So these are the immune cells that migrate into the tissues and actually cause the damage that we see with h in HS patients, hidradenitis suppurativa. Finally, I spoke just before about the fact that we our data now supports that we can use every four week dosing or q four w as it is shortened to.

We have seen excellent PK results. We have a linear PK profile. We have a higher bioavailability of Kanten. This model that we’re showing here is being developed by Sattara using the data from all the subjects in the study, both single ascending dose and multiple ascending dose. And the results from these simulations, as you can see, support the feasibility of q four weekly dosing.

Along the bottom of the slide, you can see, at each four week interval that we have, 95% confidence we do not have the drug level in the patient’s blood dropping below the, what we call the c trough level, which is the lowest estimated level that we need for efficacy, which has been set based on the results I just showed you of the inhibition of the cytokines and the receptor occupancy. So our combined results so far suggest, we have great potential for efficacy, we have good safety, and we have certainly great convenience for the use in HS and other future applications. And with this, I’ll pass you over to Morten to take you through the next few slides.

Morten Lin Jensen, Chief Medical Officer, Cantasia: Yes. Hello. My name is Morten Lin Jensen, and I’m CMO in Cantasia. First of all, what we have been looking at is to how do we best utilize the very broad mode of action of this molecule? We know that, the IL-one family is broadly associated with both acute and chronic inflammation, and we know that that there is a strong involvement of the multiple inflammatory cascades that that we impact, and therefore, it also impacts multiple inflammatory diseases.

So this, broader mechanism, where we both target inflammation and fibrotic elements is really something that can be used in many different indications. So we contracted with Lumenity and explored where could such a molecule have a relevance and identified both respiratory indication indications with the bones and joints, indications in the gastrointestinal tract, and other, systemic indication. And we did identify skin as, as as one of the first indications for us to move into with the hidradenitis suppurativa as the primary indication, but also atopic dermatitis since it has such a broad involvement of both Th one and Th two inflammatory pathways has been identified as something that is highly relevant. And in particular, since, we now know that dupilumab is very broadly prescribed when there is a need for biologic treatment. But but but there are people who don’t benefit from dupilumab, and, of course, they should have an adequate treatment as well.

But in HS, our primary derm indication, the treatment landscape really looks like there is adalimumab and the I l seventeen block has

Speaker 2: been a

Morten Lin Jensen, Chief Medical Officer, Cantasia: kisumumab and sirokinumab. And those medicines are reasonably effective. They’re administered every week or every second week. But what we believe we can really obtain with this broader mode of action is a higher efficacy and a less frequent dosing for the convenience of the patients and also for the adherence to treatment. So we we do want to look at the harder to achieve endpoints.

We want to use high score 75 because it’s more relevant for the patients compared to high score 50. It’s really about looking at abscesses and inflammatory nodules and and tunnels in this disease, and it’s super painful for them. So the pain, those lesions, this is what we want to go for, and we believe that we can get higher efficacy with a with a less frequent dosing. So we really target the every second week dosing regimen in ATS. And then and and similar to to ATS, when we looked at atopic dermatitis, it’s clear that there is this very broad activation of the inflammatory pathways.

And in particular, when when when AD becomes more chronic, then there seems to be a shift from the t h two driven pathways towards t h one, t h twenty two and seventeen where it’s also clear that dupilumab is not relevant. It’s IL-four and IL-thirteen. Right? So so our our exploration of this indication really also looked at the indicators from other single cytokine monoclonals where it looks like there is an effect, but it also looks like there’s a requirement for broader target of the inflammatory cascades. So in the green boxes here, when where there have been, relevant, individual cytokine studies and where we think there’s potential if we target broader.

And targeting broader is exactly what, what we do. So if we look at the nonclinical data we have and also the ex vivo human data from the phase one study and from biopsies, it’s clear that we do target multiple pathways. We have both data from from, from animal peritonitis, animal cardiac inflammation, animal skin inflammation, and lung and skin fibrosis models. And we have the ex vivo human, human whole blood, study and the biopsies. And if we look at it cumulatively, all these pieces of information, it’s clear that we do target much broader, and we also target at different levels in the inflammatory cascade.

So we have canten that blocks thirty three and thirty six as as we have talked about and also IL-one, alpha and beta as we have already talked about. But we also have in our heat maps clear indicators that we reduce IL-seventeen. We reduce IL-five. We reduce the infiltration of monocytes, neutrophils, eosinophils and T cells. We also reduce activation and permeability of the endothelial cells, and we reduce the activation of of mast cells.

So, really, all these things with a broad inflammatory involvement in the disease, which gives rise to the itch and the scratching and all the skin lesions, this molecule will really be good for that even in patients who do not respond to dupilumab. So so, this is one of the other indications where this molecule has a great promise. I think this was my last slide. Should I advance?

Damian Marron, Interim Chief Executive Officer, Cantasia: That’s great. No. Thanks, Morton. Thank you for that very, clear run through of, approach to HS and our newly chosen second indication there of AD. So I hope everybody, has seen that, you know, this the, the first quarter of this year and the subsequent few weeks have been really rich in data strongly supporting the development of Cam ten, in the serious skin conditions as Morton has just explained there with the the rationale for both HS and AD.

And, obviously, there are phase one single ascending, multiple ascending dose study has really produced all the data that we could have hoped for, but absolutely back up why we have gone into these indications and demonstrate that we can block these cytokines, we can block these immune cells, and we do have great hope of delivering new level levels of efficacy, safety, and convenience to patients with these inflammatory immune skin conditions, and then later, as Martin showed on into other conditions as well. So that’s where we will, finish the focus on can ten, and we will now move to talk to nadunolumab, of course, or CANO4, IL-one wrap antibody, that we’ve been developing in oncology for, quite a long time now, but for which we have now developed, quite some substantial data, and we continue to move forward. So in terms of the nadinolumab clinical development, we have announced obviously that we have the diagnostic test in development. This is a diagnostic test to be able to identify patients who have, different levels of IL-one wrap, in their tumors at the start of treatment. What that will enable us to do is to select as we go forward or enrich, if you like, the studies, that we are going to do, certainly in PDAC, pancreatic cancer.

Select those patients who have a high IL-one RAP level so we can treat that subgroup, and that is the subgroup, as I’m sure you will recall, that showed, very, very encouraging overall survival data in our previous, clinical studies. We’ll move that forward and we’re planning for regulatory interactions during 2025. The development of this test does take some time, and so that will be the major active activity in the PDAC program for 2025. Of course, PDAC is not the only indication, that we have looked at with nadunolumab. And indeed, we were very pleased to announce, in March that we have completed the recruitment in what is our first randomized controlled phase two study with nadunolumab, the trifor study in triple negative breast cancer.

The patients are, now the last patients are now, under treatment, and we estimate to be able to release the initial results, which will be on the, overall response of the patients after three months of treatment. We expect to have to release that in mid twenty twenty five, so that’s obviously going to be exciting news, for the company at that point. And of course separately, we have announced that we have recruited the first patient in a leukemia study, in acute myeloid leukemia and in early myelodysplastic syndromes. This is a study that is taking place at the University of Texas MD Anderson Cancer Center and is sponsored by the US Department of Defense. This is a very interesting study in a lot of ways because, IL-one wrap itself was first identified actually, here at the University of Lund, as being present on leukemic, precursor cells.

So this is in a way a little bit of a full circle, for the IL-one wrap story and the development, of nadginolimab. Of course, we’re not full circle because we still have a way to go before we can bring this treatment to patients, but this is very exciting point, in the development of nadunolumab now. We have treated overall over 300 patients and we have, as you can see here, different, oncology indications and opportunities for nadunolumab to become a new treatment for patients who need these new oncology treatments and to become a multimillion dollar product and develop value for our shareholders. We also have been, presenting, posters and, having publications published around, nadinolumab, work and IL-one wrap work. So we presented a very interesting poster just recently at the American Association of Cancer Research conference of linking clinical data with higher doses of nadunolumab to a reduced instance, and the delayed onset of chemotherapy induced neutropenia, neuropathy, I beg your pardon, because chemotherapy induced neuropathy, which is a exceedingly troublesome side effect of a number of chemotherapy regimes, which leads to patients discontinuing treatment, or leads to patients having to reduce their dose or prolong the interval between treatments, and all in all means that patients are very poorly and are also not receiving their optimal anti cancer treatment.

So this data is very interesting and we backed this up with supporting preclinical data from mouse models looking at the mechanism of action, and which indicate together that targeting IL-one wrap with naduenumab not only has good antitumor activity as we’ve shown, but also can significantly reduce this chemotherapy induced neuropathy. And actually we’ve also shown that can do that in the, context of antibody drug conjugates as well, which, are also known to significantly induce these neuropathy. So this is, another very interesting set of data to support the development of nadunolumab as we go forward. We also had a publication in cancer discovery by Hanahan Atal, followed up actually by a presentation by professor Hanahan at AACR where he highlighted, the data, our preclinical and translational data identifying the IL-one family, and its signaling as a key driver of cancer related systemic immune suppression. And these findings really do provide strong support for us in our development of nadunolumab and its potential to counteract tumor driven immune suppression, and therefore enhance its own activity, but also that of immunotherapy and potentially cancer vaccines also.

So all in all, some very, very interesting and strong data around Naginolumab as well since the start of this year. Finally, I want to say a few words to you about our CANXX program. This is based on our library, of over 200 IL one wrap antibodies, which we can tune to have different properties, which offer us a number of pathways to value creation as we go forward. And in particular, we have actually published data, a poster at the AACR also about an anti IL one wrap ADC. So IL one wrap is overexpressed in many tumors and also in the tumor microenvironment and in the stroma, around the, the supporting tissue, if you like, around the tumor and then and through the tumor.

And what we’re able to show was, our anti IL-one wrap ADC, so an anti IL-one wrap antibody conjugated through a linker to a tumor killing toxin, but a toxin which you normally cannot deliver because it is too toxic for the body, but if you can make it locate in the tumor through a targeting mechanism, in this case IL-one wrap, then you have very strong potential for, treating, the cancer. And what we were able to demonstrate was very strong tumor growth inhibition in tumor models expressing both high and relatively low levels of IL-one wrap in their tumors. The ADC was also well tolerated in preclinical models, and we showed that adding the ADC function did not reduce the IR one wrap binding, that we would love to see. So very exciting data in and of itself, but also illustrating the strength of this platform. So we have, as I said, numerous antibodies with different properties that we can bake, develop into new IL one wrap based therapies.

So not just ADC, but we could look at bi specifics in oncology, but also in immunology along where we have content, we can look just to develop other of our antibodies targeting different indications. You saw the very large number of indications that the IL-one wrap and the IL-one superfamily are implicated in, in immunology and autoimmune inflammatory diseases, and we could develop antibodies which are more suited for certain of those diseases than others, for instance. So not only do we have Canton and Najunolumab, but now we have also in early stages of mitolivre anti r one wrap ADC and the possibility to continue to develop other very interesting molecules as we go forward. Finally, from me, before handing over to Patrick to talk you through the financial figures, are our milestones for this year. So we’ve already, in q one, been able to publish, the very exciting initial phase one data with Kanten SAD and MAD.

We have completed the recruitment of the nadinolumab trifor study, and we’ve started the investigator initiated trial at MD Anderson in AML and MDS. As we move through the year, for can ’10, we will complete fully complete the phase one study, later in the year we will look to file our IND and subject to financing start our study. For PDAC, we will provide a regulatory update later in the year, and obviously, as I said in around mid year, we will have to try for initial results. And then for Canton around the end of the year, we’ll have the phase two start in HS and AD as I just mentioned. So we have an extensive news flow expected during 2025, and this can also be backed up with additional new preclinical and translational results as well of the type that I’ve just shown you.

So with that, I will hand over to Patrick, to take you through our financial results. Thank you, Patrick.

Patrick Remblad, Chief Financial Officer, Cantasia: Thank you very much, Damian. And we announced this morning our financial report, which is actually the topic of why we are here today for the first quarter of twenty twenty five. And we started out with R and D expenses at about SEK 45,000,000 SEK 40 1 million, which is slightly higher than we have been trending in the previous quarters, and it’s 6% higher than than q one last year. And that increase is driven and and reflecting somewhat higher activity in the clinical programs, both can ten as well as Trifor in in adenoma, but also that we have decided to produce more of of can ten antibodies in order to to have that for the phase two programs. We have already finished the drug products so that we can start the studies according to plan, but we are proactively looking at making sure that we have a buffer of stocks there.

On the G and A side, we saw costs of 4 plus million in the quarter. We have implemented relatively tight cost control, but we saw an increase compared to the same period last year, mainly due to organizational changes. So all in all, our operating loss was at SEK 45,000,000 and the reporting loss at SEK 47,000,000. And the difference there is reflecting impact on currency fluctuations, which has a negative effect on our currency hedging currency accounts. All in all, we also ended the quarter with a cash position of 104,000,000.

We started at SEK 33,000,000 by the turn of the year. We received SEK 107,000,000 in the in net proceeds from the rights issue that we conducted back in the end of twenty twenty four. And we had a net outflow of SEK 36,000,000, which consisted of SEK 34,000,000 in operating cash flow and SEK 2,000,000 in currency adjustments. And that sort of took us to SEK 104,000,000. Now we estimate that this will take us into Q4 this year in terms of our financial position, but we have flagged that it’s not sufficient to fund operations throughout the entire year.

And we are actively, together with the board, working on various tracks and various transactions, potential transactions aiming at strengthening our financial position and making sure that we are stronger funded. And those activities include, but not limit that but not limited to BD discussions, potential equity raises and other financial alternatives. And with that, I hand over to you Damian for closing remarks.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thank you very much, Patrick. Yeah. So so just in closing remarks, I’d you know, it has obviously been a very active and very exciting first quarter and subsequent few weeks for the company. All of this is taking place against the background, macroeconomic and geopolitical background, which is exceedingly disfavorable for the whole biotech industry. You know, I think anybody who is invested in in biotech companies would be aware of that right now.

This doesn’t make, you know, our job of creating value any easier, but nevertheless, we are working exceedingly hard. We have a number of different tracks ongoing. This is development as Patrick referenced there, also corporate transactions that we are looking at and other ways to make sure that we can be in a position where we can finance the company and take the company forward. It’s always a difficult area to talk about because we cannot give any detail for very obvious reasons of confidentiality with the parties with whom we’re in discussion, but, you know, we continue to move forward. We remain as confident as we can be in the current circumstances, and of course, with no guarantees that we are will be able to close a value creating transaction for the company in the relatively, near term.

And so, they are my, you know, final remarks for today. I want to thank you and to thank all of our shareholders, for their support. We don’t take it lightly and, you know, we’re all working very hard to create value for you, but also we’re all driven by the desire to develop new medicines for patients, in serious need. And I think you can see that we’re making strong progress on that as well and that is how we will develop value for everybody. So now, we can move across to q and a.

Thank you.

Speaker 4: You.

Speaker 5: The next question comes from Luisa Morgado from Van Lanchet Kempen. Please go ahead.

Speaker 6: Hi, team. Thank you for taking my questions. Maybe to start out with Kenten, I was wondering since you’re now, starting the cohort in healthy volunteers and the one with in psoriasis continues with recruitment. I was wondering when will you share more data if this will just happen throughout h one of this year. And then also for CAN 10, in terms of the pilot study in atopic dermatitis, could you provide any more details here in terms of trial design, timelines, duration, that sort of thing?

Damian Marron, Interim Chief Executive Officer, Cantasia: Thanks, Louisa, for your questions. I’ll take the first one, and then I’ll hand you over to Martin to to talk about, you know, our first ideas about what our a an AD study could look like. But, yes, our second, multiple ascending dose cohort is fully recruited, and is on the study right now and running forward. So we’ll expect to, be able to announce the data from that before, the end of this quarter or around the end of this quarter. Psoriasis is a little more, difficult to predict.

The the enrollment of patients has been stop go, or subjects I should say, but these subjects with psoriasis, it’s been stop go, and it I’ll be quite honest, it’s not been that easy. It’s asking a lot of a of a person with psoriasis to take part in a study where they need to be, staying in a clinic, overnight, where they’re having skin biopsies taken and so on, but we continue to move, that forward and hopeful that we may get another subject or two, into that shortly. So I can’t give you a moment a time at this point when we can talk about the psoriasis data, but I would just remind that that is not on our path to being able to file an IND and move to phase two. It really is exploratory, for mechanistic purposes. So that’s the, the content phase one.

So, Morton, over to you about the AD study.

Morten Lin Jensen, Chief Medical Officer, Cantasia: Yes. On the question to the AD pilot study, I think it’s the the question was about, timing and trial design and so on. So so what is really important for us is to understand if this, nonclinical, you could say, clearly, mode of action fit to to AD translates into clinical effect. And and and therefore, our first step at it is a small pilot study. So so what we really aim to do is to expose around thirty patients with AD for around sixteen weeks and then enrich the study with an with inadequate dupilumab responders so that we clearly understand whether whether this translation holds true.

And also, the the place we are at right now is that we have engaged with a handful of different CROs, which are highly experienced within both HS and atopic dermatitis. And we do right now interact with them on the right study design because the recent years, atopic dermatitis has become, increasingly hard to to recruit in and conduct good studies where we don’t get too impacted by the placebo response. So it’s critical to understand how we can collaborate with the CROs to make sure that we actually deliver on this small pilot study while we, at the same time, execute on the bigger HS study. So what we really hope to be able to do is to start the recruitment or start the study at the end of this year, both in terms of the AD study, the small pilot study in AD and the ATS study.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thanks, Morten. I hope that answered your question, Louisa.

Speaker 6: Thank you. Yes, very clear. Thank you. And nice to meet you, Morten. Maybe just one final question from my side then.

In terms so you mentioned the regulatory interactions that you will that you are planning for this year for nadunolumab. Could you just elaborate in terms of what do you expect together in terms of conclusions here? And this is not only relative to just the diagnostics test. Right? This is also just for the trial design of CDAC.

Damian Marron, Interim Chief Executive Officer, Cantasia: Yeah. Initially, we are looking at, discussions around the, the path to being able to get the diagnostic, to a position where it is able to support, you know, advanced phase two stroke phase three, you know, registrational type studies. That’s very important to make sure that we advance that in a way that will be acceptable to regulatory agencies and the, you know, at the end of the year. And then, yes, of course, as we go further on, we would expect to have some further discussions with the agency around design. We’ve already had some in the past.

Some, of course, which came back with answers relevant to project optimus, which has made us have to change our plans more than once as we’ve gone along. And so, yes, we’ll be having those very important discussions as well in due course.

Speaker 6: Okay. Thank you so much. That’s all from my side.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thanks, Luisa.

Speaker 5: The next question comes from Richard Romanius from Redeye. Please go ahead.

Speaker 2: Good afternoon. I had some questions relating to the clinical study, phase two study of Cam ten. So I guess that’s for Morten. Could you say something more about the design of this study? What line of patients should we use refractory for, let’s say, patients who haven’t undergone treatment before.

You mentioned in your presentation that you would use the high score 75. So what you said something about your expectations in this since I know, like, solar solar came up from Moonlight. They’ve made a lot about their I think it was high score 75 from if I remember correctly, which was superior in their Phase II study. So what relative performance would you expect? And also as a I may ask you straightaway really.

There have been issues with Phase two studies not translating perfectly into Phase three in HSN, I think, in psoriasis as well. Are you taking that into account in the design of the phase two study?

Morten Lin Jensen, Chief Medical Officer, Cantasia: Can I should I start answering maybe on the yes? And so, Richard, what this thing about the high score, it’s it’s sort of an artificial construct because the regulatory requirement in particular from the FDA is to use high score 50 in phase three studies. But what it really is is that it’s a reduction in inflammatory nodules and abscesses of more than fifty percent if it’s high score 50 or more than seventy five percent if it’s high score 75 without an increase in either abscesses or fistulas. And, the thing is that when we explore the efficacy is the delta between the placebo and the active that is important. And it is so in the different trials that it’s harder to get a high placebo response in high score 75 because if you improve with to a higher degree, then it really requires efficient treatment.

So that’s the rationale for selecting high score 75. It’s really to to, to see less of of a placebo response. But in terms of interpretation, it’s the delta between the placebo and the active arm we would be looking for. And in terms of moving forward in phase three at a later stage, we would maybe have to change to high score 50. But for phase two, the FDA has accepted high score 75 because it is essentially the same construct.

Then about the translation ability, I think, yeah, it really you would always be concerned about whether it translate into the right effect when you expose the right patients. But I think the best thing we can do in this situation is to understand the disease, and HS is is something that really broadly involves inflammatory cascades. And then in the more progressed disease stages where you get a lot of tissue destruction, it gets even worse. So in in my opinion, I think the broad mode of action is really what makes it super suitable for ATS. So I wouldn’t be particularly concerned that we that we don’t translate.

And in particular, if we can administer the drug every four weeks, then I think we have then we are at a good place with this molecule. And then, Richard, you had a third element, I think, but I forgot what that was.

Speaker 2: Yeah. What line of treat patient treatment naive or if they’re refractory?

Morten Lin Jensen, Chief Medical Officer, Cantasia: Yeah. So we would want to include both, and we have proposed around thirty percent who is treated with prior biologics, either TNF alpha or IL seventeen, and then seventy percent who are naive to make sure that we, in the phase two study, get data indicating effect on both whether they have been treated with prior biologics or or whether they are biologics naive. Oh, yeah. And then your your last question was to the expected level of of effect in the high score 75 of this drug, I would say that at least forty percent, if we look at, if we look at an expected placebo of of 20. So we would have at least the the double the number of responders.

Speaker 2: Yeah. Alright. Yeah. So do And

Damian Marron, Interim Chief Executive Officer, Cantasia: if I could just add if I could just add there, Richard, you know, our our ambition sorry, Richard. I could say our ambition, you know, clearly is to get high school 70 five’s at a higher than the existing treatments, and we think the mechanism of action that we have, this broader mechanism of action, gives us every chance because we hit more of the pathological processes of HS than the single pathway blockers do. So, yeah, you know, that is the minimum that we expect to see as Morten has just said, but our ambition is to be, you know, certainly better than existing treatments.

Speaker 2: So let’s say if you if you achieve these results, how would that translate into product placement? I guess it would be difficult to get it in the second line in that case. If you get a really good great score, wouldn’t that would that be possible?

Damian Marron, Interim Chief Executive Officer, Cantasia: That that’s a really good question, Richard. You know, it crosses over into, you know, a whole number of subjects such as, you know, reimbursement, which is which is, you know, different in different in different countries and, you know, pharmacy benefit management and hospital formularies and so on. But the general expectation is that, you know, a lot of patients, unless unless, you know, your data is absolutely incredible, a lot of patients will, first of all, get, you know, generic biologics, so TNFs, before they move on to the newer biologic afterwards. And that is just simply a case of cost control. What the indication would that we will go for, obviously, depending on the data.

But given the population that we’re planning to use in phase two, if we use that in phase three, the indication would be to be able to treat both biologic naive and refractory patients down the line.

Speaker 2: Interesting. Let’s see. I had some more questions pertaining to nadunolumab. What phase two activities remain before you can or let’s say preparatory activities remain before you can start a phase two study? You mentioned you have produced enough substance.

Are you doing long term toxicology studies and or other activities?

Damian Marron, Interim Chief Executive Officer, Cantasia: Yeah. There is a, toxicology study which, needs to be completed and reported out, and that’s on the same time frame as the phase one study. So that is the other key activity, you know, and then as we continue to move forward, there will be, you know, continued drug product and drug substance and drug product manufacturing, but in terms of the actual activities to get to the trial, it is getting the, you know, the relative amount the relevant amount of drug product in place to get underway and to ensure we can have continued continuity of supply. And for the IND, it’s to complete the phase one study and wrap up and report the, toxicology study, and that is a prerequisite. Yeah.

Sorry. And I think as we can tell, did you actually ask about nadirinolumab? Sorry.

Speaker 2: No. No. Sorry. I may no. No.

You’re right. It was this was about, yeah. This was about Canton. No. I’m Okay.

My mistake. But, yeah, you gave the right right answer. Now my question in in adrenolumab was sorry. I misplaced my notes. My question about adrenolumab was when do you expect the results from the leukemia study?

Damian Marron, Interim Chief Executive Officer, Cantasia: Well, you know, that’s an investigator initiated trial, so it is not under our, direct control. But we are expecting it is gonna take around about two years for that study, to produce results.

Speaker 2: Okay. Thanks. That’s all my questions.

Damian Marron, Interim Chief Executive Officer, Cantasia: Okay. Thank you, Richard. Appreciate it.

Speaker 5: The next question comes from Sten Westerberg from Annalisgaiden. Please go ahead.

Speaker 4: Okay. Congratulations to a very productive quarter. Two questions on Kanten. First, if you can break up the expansion of the Phase I trial a little bit more. If originally estimated at enrolling 80 patients and now enrolling up to 116, it’s a quite big expansion for a Phase I study in my mind.

Is this entirely related to the SAD group, or have you made changes in the other groups as well? That’s my first one. And and also on on the pharmacokinetics of of the molecule, will you have to give a loading dose of Kanten in phase two, or will you directly move into a four week dosing schedule?

Speaker 2: These are my two questions.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thank you, Stan, and, thank you for your kind remarks at the start. In terms of the, the phase one study and the the enlargement of that study, That was undertaken mainly to add single ascending dose groups to the studies that we could go higher in concentration or higher in dosing, I should say. Because, you know, eventually we want to have the highest therapeutic window we can and make sure that we can deliver fully effective doses to patients. So given how very good the tolerability was, we added more groups to the study. I might ask Patrick as he has more corporate memory than both Yep.

Morton and myself who are recent arrivals, if he has any extra detail to add.

Patrick Remblad, Chief Financial Officer, Cantasia: No. I I we that’s absolutely true, but we also added MAD cohorts to to to exactly as as Damian said, to explore higher doses. And that’s particularly because we we we saw that in general, other competitors were were actually dosing higher in HS than in other diseases. So So we wanted to have the freedom to put give the right dose levels in phase two to patients in HS.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thanks, Patrick. As you can hear, Stan, our our chief financial officer has, has a much wider view on the company than many chief financial officers do. Absolutely. And I’m sorry, Stan, if you could remind me of your your second question.

Speaker 4: Yes. It would be interesting if you will need a loading dose of ten ten in the future studies or if you can move directly into the four week dosing schedule.

Damian Marron, Interim Chief Executive Officer, Cantasia: Yeah. To ensure that we, get as quickly as possible to the steady state, pharmacokinetics and making sure that we’re always above that, c trough level that I referred to, we will use one loading dose, at the start, of treatment in phase two.

Speaker 4: Alright. One loading dose. Okay.

Damian Marron, Interim Chief Executive Officer, Cantasia: Yeah. So to be clear, that would mean patients who get a initial dose, a two week dose, a four week dose, and then afterwards, every dose would be every four weeks in the in a q four w arm. Yeah.

Speaker 4: Okay. Understood. Yes. So I understand there will be a loading phase in in the study.

Damian Marron, Interim Chief Executive Officer, Cantasia: Yeah. But yes. Exactly. Yeah. One one loading dose.

Yes.

Speaker 4: Let’s see. In the mhmm. In the in the ADC field, where there appears to be a lot of activities from all parties involved in in oncology drug development. Will you can you provide us with any more future plans or directions of your own preclinical programs? Will you be able to come up with a CD anytime soon?

Speaker 2: Or or

Speaker 4: which are your plans in this interesting field?

Damian Marron, Interim Chief Executive Officer, Cantasia: At the moment, we have, you know, we have we’re at very early stages. You know, we have just done, you know, done this early work that we’ve just published. So, you know, we’re some time yet from designating the clinical candidate and then moving forward into pre IND studies. So, you know, but on the other hand, you know, the program has attracted some attention. You may you may also be aware that Pfizer published an IL-one wrap ADC poster at the at the AACR at the same time as we did our paper.

So you can see that, you know, there is industry interest in this area, and and we would be very happy, you know, to have a collaboration with somebody around this for sure.

Speaker 4: Thank you. That concludes my questions.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thank you Stan.

Speaker 5: No more phone questions at this time. So I hand the conference back to the speakers for any written questions or closing comments.

Speaker 7: Yeah. The first written question is, how does the blocking of IL-one beta relate to the blocking of IL-one alpha?

Damian Marron, Interim Chief Executive Officer, Cantasia: Morten, do you want to take that one?

Morten Lin Jensen, Chief Medical Officer, Cantasia: Yes. But maybe I don’t know if we could show the slides again. There is one which really explains it quite well, slide number eight. No. Well, anyway,

Patrick Remblad, Chief Financial Officer, Cantasia: if It’s It’s showing there more to now. Right? Yeah.

Morten Lin Jensen, Chief Medical Officer, Cantasia: Oh, yeah. It is. Okay. Cool. Yeah.

So, obviously, our our nonclinical team and and the CMC guys are much better at explaining the science of this. But if you look at the small yellow thing in the middle of the two, parts of the IL-one receptor complex and also thirty three and thirty six, then the thing is that putting it there blocks both alpha and beta in terms of the IL-one. So you could say, how does it relate? It relates in this way that it blocks both IL one beta and IL one alpha.

Damian Marron, Interim Chief Executive Officer, Cantasia: Exactly, Morton. And and also, you know, as you as you said briefly there, it blocks IL 33, and it blocks all of the IL 36 isotypes as well. The only reason we don’t have data is that there isn’t an a whole blood ex vivo inhibition assay for IL-one alpha, and that’s what we haven’t actually, got data that we can show you. But that is the way mechanistically that this works.

Speaker 7: Thank you. And the last question is related to the can 10 program. How will you finance the next phase for that program?

Damian Marron, Interim Chief Executive Officer, Cantasia: As we, as I hope I discussed about earlier, now we are looking Patrick discussed as well, we’re looking at a whole range of ways of getting finance into the company principally through business development and corporate transactions. But we are also looking at all other options as well. It’s quite clear at the moment that we can’t finance it, but we, you know, we are as confident, as I said, as confident as we can be in the current circumstances and with no guarantees that we will, be able to close a transaction that will allow us to move our programs forward.

Speaker 7: Thank you. And that were all questions coming in from the web.

Damian Marron, Interim Chief Executive Officer, Cantasia: Thank you, Jonas. So on behalf of Patrick Morton and myself, I’d like to thank everybody who’s dialed in and listened today. I hope we’ve given you a good update about where we are and where we’re going. We thank you very much indeed for your interest and your support, and we hope to repay that to you as soon as we can. Thank you very much.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.