OSE Immunotherapeutics SA (OSE.PA) Earnings Call Transcript & Summary

Good evening, and welcome to the webcast of OSE Immunotherapeutics. This evening, we're going to talk about the strategic plan that we announced yesterday. My name is Fiona Olivier. I'm Chief Corporate Affairs and Investor Relations Officer at OSE. And it's my pleasure to have Marc Le Bozec, our CEO; and Thomas Gidoin, who is our CFO. This discussion will be in French. There are a simultaneous translation into English. So feel free to choose the language you prefer. I'm going to start by asking a few questions to Marc and Thomas. And then we'll answer your questions. You can see on your screen at the bottom left, a system to ask questions, and we'll try to answer as many questions as possible. I'm going to start off with you, Marc. You are the CEO and have been so for only 2 months. First, you were elected to the Board of Directors at the shareholder meeting on the 30th of September. And then 10 days -- 2 days later, you were appointed CEO. What have you been doing since then?

Well, since then, we conducted an audit, which is best practice, when you tied up in a company, and we did this in a group because I believe a lot in teamwork, I don't believe in Providence. Now it's a little tiring, but communication is repetition. So I say this every day. We had a scientific, so labor and financial order. And on the basis of that, we developed together a strategy, which meant going quite deeply into the company, not just the management board, a lot of people in the company were involved, and we interacted a lot with the new Board of Directors. We finally adopted this strategy or had this strategy adopted a few days ago. And all this was done in only 6 weeks, which is very fast. Now we're in the communication phase of the strategy. The next sequence will be the implementation phase where we will launch programs, launch investor relations activities intended for both professional investors and private investors as well in France and in the U.S. Yesterday, we announced that with 4 levers for opportunities for value creation.

Can you tell us a bit more about that?

Yes, I can. The general idea of this plan is that for many people, and I was one of them. I was a professional investor myself. I've had -- always had a lot of affection for OSE, but it was sometimes hard to read I think it was one of the problems with the former management team. They were so enthusiastic, but they wanted to reveal as many people as possible, everything was going on inside the company. Now that was nice. It was friendly. It was enthusiastic. But at times, it could come to the detriment of the ease of reading of this company now with Thomas, as we're quite experienced here and I in this, we said we should take a step back and try and think in terms of a stock market time frame. We are listed on the stock market. We have to meet their requirements and report and be accountable to our shareholders. The challenge of this or the stakes of this plan is to reveal value creation factors over a short period that is compatible with the stock market. It means over a few months, medium term, it's 18 months and long term is 2, 3 years. So we've developed a plan with that idea to generate as much value as possible for our main assets, which are Tedopi and Lusvertikimab. That doesn't mean everything else is going of stop. There'll be other things, but for the time being, at least, will try and explain repeatedly, just those 2 assets have so much value, latent value. There are 4 factors. First of all, to take Tedopi into the end, it is second Phase III. We're in the middle of the end of Phase III. The last patient to be included will be at the end of 2026 and for a marginal cost, which is quite modest. No questions to be asked there, irrespective of the market it will be hundreds of millions of euros or even billions of euros that we have to understand this. So we talk about 50,000, 100,000 patients at a sales price at EUR 100,000 do the math. No one does it. But 50 times, EUR 100,000 is in the billions. That's the reality of Tedopi. I'm not saying the clinical trials will be positive. I'm saying that if they are, then the company will be worth. We know a lot more money. Second pillar is to develop and devise a subcutaneous form of Lusvertikimab, this has succeeded brilliantly, it's Phase II in ulcerative colitis, but in an intravenous format. Now this format is a bit dated now because competition has provided new solutions in subcutaneous and also an oral format. And clearly, patients will want to go preferably into those forms. So we have to develop this new format of Lusvertikimab then what will happen, it will take between 18 and 24 months. And then third pillar -- we will launch studies or 1 or 2 on small indications without going as far as ulcerative colitis, which require so much a lot of money. But with smaller indications, we think we can create value. And we're working today on choices of indications because we shouldn't get it wrong either. But we're aiming at trials compatible with that stock market time frame of the end of 2028. The final pillar, our research team, an excellent team in OSE, you should appreciate we have a research team that generates products that goes into clinics all trials that developed by development teams and that are then licensed early or late by our business development team. And that team will strive to enhance the profile of Lusvertikimab working on combinations, and there are quite a lot of principal actives as well in medication, in drugs that are there for UC, which will combine with that to see if there's a synergy. That's the first set of work. And then a second set, which is to work on the biomarker, which is a super promise, but which is also still quite early. And we have preliminary results that comes from the CoTikiS study, Phase II something in Ulcerative Colitis, but there's not enough there for us to be able to launch a clinical trial even with a partner. What is that? A biomarker basically is a set of parameters. It could be a protein in blood, the result of a histological biopsy or cut. It could be medical imagery. All these things will qualify a population that will respond well to Lusvertikimab. That would be fantastic if we can confirm this. But at the moment, we're still at the early stage. And the research team, which is basically not, will focus a lot of its effort in the months and years to come, working on ex-plans, biopsies of patients to confirm this where applicable.

Thank you Marc, in the press release that we released yesterday, we issued yesterday, Thomas, we said there were 4 drivers for value creation. We talked about balanced financing. Can you explain this how you see things in terms of financing and financing therefore?

Yes, absolutely. Now we would be able to answer in very specific terms to that question today, firstly, in terms of the amount because it will depend on new indications that Marc has just indicated, by the way, that whether we continue to pursue with Lusvertikimab, it will also depend on market conditions when we'll get there. But what we can say already is that the cash -- the operational cash burn on average that we plan for the next 3 years for the implementation of that plan, we're presenting will be in the region of EUR 30 million per year. Depending on the time frame we want to finance you've got an idea of the order of magnitude we'll need in all cases. What that means is that we're not talking about EUR 150 million or EUR 200 million that are very significant. We're on much more modest amounts. Also, in terms of structure, what we can say is that, yes, today, we do plan for an equity increase that will serve as a backbone for this financing. But around that capital increase or the equity increase, we've got a whole range of tools available to us. They are complementary. For example, we can restructure our current debt -- we have a loan with the European Investment Bank for which we still have EUR 17 million in capital to reimburse over the next 2 years to consider. We could restructure that debt. We could also imagine add a reasonable amount of debt -- new debt that would be made possible, thanks to market operations in equity, which once again will be used as a backbone. And we've also got multiple milestones with our current partnerships that could be involved in the next 3-year time frame. We also -- I could mention the second part of the payment of the asset purchased by Boehringer last year, where there's EUR 17.5 million written receivables. It is possible or probable that we will get this within the next 3 years. And in a more marginal terms, we've also got Tedopi marginal revenue through a compassionate access market where we've got doctors, cancer oncologists that can prescribe Tedopi to their patients to treat lung cancer, and we will invoice the hospital and it will be 100% reimbursed by the social security system. It's a more peripheral approach, but we can imagine a few million euros in the next 2, 3 years. And that shows the interest of the scientific and medical communities in others. Yes, indeed, over and beyond the economic aspects, it gives a very positive message in that it shows that there's a medical requirement that hasn't been satisfied and at least the French doctors, but other French doctors to prescribe Tedopi, although the product has not been released. I'd like to go back to partnerships. It's difficult to do this with the [indiscernible]. We talked about the announcement made on Monday about the [ AbbVie ] amendment.

Can you talk about that?

Yes, it's quite traditional in this type of partnership. There's a shuttle. Sometimes when a large group can have a change in governance, there will be portfolios coming back that are halted, deprioritized. And that's relatively conventional, but there's additional work to be done in 2030 that will be post clinical, and that's our expertise. And there we're taking back the active, the asset for a while and then send it back to IV and the economic conditions remain the same.

I'm going to start taking some questions. We've got a few already, before taking question. We got a question about DJ. Where are we with that in recruiting a new CEO? Can you explain what's going on? Well, what's going on?

Well, we've had a time under the responsibility of our Chairman, Markus Cappel, who's Chairman of the Board. He did an overview of the various head hunting firms that could help us. We selected one. We retained one that's already had some candidates, and we're going to start interviews. After that, which can vary in time, we're talking about a few months. Here are some summarized points before we take the questions. In the press release, we said that the indications in terms of rare specialist diseases, where now would be announced into the early 2026, and Thomas will give us a bit more visibility on financial terms about that later on. Let's start off with some questions.

The first one that I received from Roland. Are you going to publish the conclusions, the finding of the audit? Or how did the audit, in fact, inform the strategy?

Well, yes, as we are listed company unveil all our secrets, in fact, or reveal them, but especially in the scientific part, there are things that we want to keep secret or confidential. We have a portfolio of patents that are very broad. We have IP activity that is very significant, but it doesn't mean that we're going to unveil reveal everything. in financial terms, if we've got something relevant to say, of course, we will say so. But then there are technical aspects typically in social terms and labor terms, the forms of job contracts and what have you and things that are being questioned to be able to move forward toward more greater efficiency. But once again, for a listed company, publishing internal audit reports, I'm not sure it would be a very good idea. A question from Regis that I'd like to thank, by the way, because he's always here to share and he always comments -- makes comments on our LinkedIn posts. Here's a question. Are there plans to include an institutional investor or fund such as Sofinova for this AK? Thomas, over to you.

Well, the answer, the easy one is yes. One of the objectives of our capital increase or market operation, you can call it what you like, is, of course, to raise financing and finance our activities, but also to bring in key shareholders into our capital. Today, we realize it's something that's lacking, and that's something we're working on. And now will that mean that it's going to be our friends from Sofinova? Maybe. Well, we'll meet them like we'll meet all health players in Europe and U.S., and we'll be doing this in the weeks to come with Mark. But the answer is yes. It's our intention to include key investors, shareholders, specializing in health in Europe and America, and it will give credibility to what our narrative, and they will be there over the long term. And that's something we'll be looking at absolutely. Just a quick thing I want to say, just to [indiscernible] what he said, so we understand clearly. So far, the company has raised very little money in capital, about EUR 50 million over a decade, which is very little. But it's in Phase III. It concluded the Phase II with ulcerative colitis. That's remarkable as a performance. What's fantastic is the capital has lots of individual shareholders that like the company very sincerely, like me.

And yet for the next steps, I mean, this sequence is absolutely great. We are entering a new phase now where we're going to finalize our work, our studies. And I suppose we will consider the state of the company or the transactions that could be considered. Now having institutional benchmark, institutional investors is a real plus point in this context. It's not just [indiscernible]. Everything we do is for the benefit of the company and shareholders. So clearly, when we want to carry out a transaction, for example, taking over a company or selling a license, if we have shareholders who we know will support us, people we can contact who can invest more, this will be extremely effective as opposed to a situation where we would have to find new investors or new shareholders every time. Just concluding remarks on this very briefly. In the biotech community, people usually think that on the day following the release or people thought that we would -- we were going to sell the company for several billions euros after the release of the Phase III result. But it doesn't work like this. After the release of Phase III results, you spent some time with on community pharmaceutical companies and big biotech companies. And if your cash position is low, you are in a much less comfortable position than if you had reserves. And remember, we are a listed company and all our figures are public. So the people who we negotiate with are also aware of this.

Thank you very much, Marc. So as I was saying, we are a listed company and our partners also are -- and we don't always have control over communication in our partnerships. It's a recurrent question from our shareholders. Why don't you communicate on some partnerships on some of these clinical trials or on the latest of our partners? We cannot answer. Well, we cannot because we are bound by NDAs, nondisclosure agreements. And it's always the same thing. People would like to have their cake and sell it. We license product to a third party. They pay us in return. But over that period of time, the product is theirs. They do what they want with it. And again, we are bound by nondisclosure agreements. So that's one of the reasons why we don't communicate a lot on this. And we don't include in our forecast the revenues from these partnerships that could be paid and strengthen our cash position in a less dilutive way has happened throughout the history of the company.

Now a question about Tedopi, which is one of our products from -- a question from Nick, it's in English. So I'll try. So the question is about Tedopi, as I was saying, and about the Artemia clinical trial. Is it possible to complete this Phase III trial with the resources we currently have? Are we going to reduce the scope of the trial? Are we going to slow down enrollment? And is there a risk of delaying the readout?

Well, this is quite a surprising question, but let's try and answer it. Why not? We have additional funding needs, but it's quite moderate relative to the needs of the company. So we're not too worried about this. And funding, as described by Thomas earlier on, will -- all this funding will allow us to carry out all our activities, not only the Phase III of Tedopi. Now the idea is not to reduce our capabilities and only focus on a handful of assets and pray that will come to our help. No, we made different choices compared with the previous management team on Lusvertikimab. And we want to create value within the next 3 years. We do not want to change the clinical protocol at all. Maybe some had considered this option, but it can actually distort your trial. It can distort data and considerably also the perception of doctors and patients. So it's a very, very bad idea indeed. The enrollment pace is satisfactory. We're not at liberty to communicate more specifically on the enrollment pace because, again, this might influence data. It's very important to understand this. We live in a highly regulated world, and we cannot do everything we want on the one hand. And on the other hand, it's all based on statistics. And if for some reason, a doctor is going to replace a patient X or Y, it may change everything in depth. So the last patient should be included at the end of 2026. In between, there will be a futility analysis. This futility analysis is about whether it makes sense to pursue these trials considering the cost-benefit ratio for patients.

Nick has asked another question. Let me carry on with this on the ABBV-230.

On ABBV-230, the amendment says OSE will finance this work. So it will -- Thomas will explain this further.

But can you maybe explain what is going to happen? Do we have resources? Will we allocate resources to this program? Yes, absolutely, we will. It's part of the plan. Again, we communicate on -- during the sequence, which is starting with the Tedopi Phase III and Lusvertikimab because these are the most advanced assets, and they are the ones that are likely to create value for stock markets. Yes, that doesn't mean we're going to halt other projects. The answer is yes, we'll fund some of this work. Right. I would urge our participants to ask questions. We still have some time to answer them.

We have 2 questions here again on Lusvertikimab. The first one is from [indiscernible]? So the first question, hello, if you carry out Phase IIb of Lusvertikimab, so I think we need to be more specific on this. So if you carry out the Phase IIb of Lusvertikimab, according to the former management team, it would cost EUR 50 million. But then this asset would yield a value of EUR 500 million, possibly more. So let's maybe rework the question. Maybe I can ask this -- I can ask Thomas. Maybe it's about how we can finance this and what's the cost of studies for small indications will be for? Small indications with Lusvertikimab?

The question was about -- specifically about Lusvertikimab Phase IIb. This study that we will not conduct ourselves and that we will entrust with a partner in the second stage once we have the subcutaneous formulation that has been approved and more data generated on the biomarker that Marc mentioned earlier on. So regardless of the cost and the cost will be quite high. Well, this question, we hear EUR 50 million, it's really the minimal price tag, and it's probably more expensive than this. And I suppose we can discuss the protocol and number of patients for quite some time, and it's probably more expensive than this. We won't do this. This will be for one of our partners. However, as Mark has said, we will embark upon 1 or 2 complementary studies for smaller indications, rare or specialty disease indications. And well, the ballpark figure for these studies would be between EUR 10 million and EUR 15 million for each study. So the amounts are completely different from a Phase IIb trial study. That's the whole point.

Another question about Lusvertikimab. This time about the subcutaneous formulation. Mark, you already mentioned this. You gave us some feedback about patient comfort and also feedback from pharmaceutical companies that are looking more for this type of formulation. So could you comment this? So have they -- did they refuse to license an IV formulation -- and well, maybe you could answer this first question, I'll try to translate the second part for you.

Well, I shall not make any further comments on this. However, evidently, considering what's starting now sort of foresight or prospective studies in our discussions with pharmaceutical companies, it will be either an oral or subcutaneous formulation. Today, there are very few options just to enroll patients in clinical trials for IV subcutaneous formulation, it's much more complicated. And again, if we had wanted to go down this road, the enrollment times and the entire time for the full clinical trial would have been much longer. And we're not talking about 3 years here. So it's because of the market reality, they are subcutaneous oral formulations. [indiscernible] for example, is an oral formulation. So we just try to adapt to the market. It is an investment worth several millions that will stretch over 18 to 24 months, and it has started.

Okay. The second part of this question is, does this mean that a deal -- a partnership deal is on the table as long as we haven't developed this formulation?

Yes. Well, it's -- there are always lots of discussions underway. We have a team led by Jean-Jacques Mention that's very active, very dynamic that's really connected to the market that talks to a lot of players in the market on our advanced products, Tedopi and Lusvertikimab, the most advanced products, but also on products that come out of our research. Particularly lately, we had some active discussions on one of our products, which is very attractive, which is still at an early stage, but it's -- we are constantly in talks. It's quite surprising.

A question from Sylvie. I'd like to -- hello Sylvie, who facilitates a group of shareholders on Facebook. Question by Sylvie. When could the first of the 2 new IIa phases start? I wanted to underscore here that it could be 1 or 2 studies. So when could the first phase start?

Right. We need to properly choose our indications. This is work underway with a lot of people involved in-house. And I'm quite struck to see that they are quite only a few external consultants because we have a lot of skills in-house, very complementary skills. that's quite outstanding. Now we would like to start this at the beginning of 2026, so this first study. And depending on our financial resources, depending on the indications that we have selected, we will decide on the -- although it is opportune to launch a second study in 2026. But again, we just took our position. We've been in our position for only 2 months. Everybody has stepped up to the plate. And we still have about a month's work before we can adjudicate on this, before it's really crystal clear in our mind. So we need to look at all the arguments, regulation, action mechanism, target population, et cetera. We're going at every -- we're looking at every single dimension. And eventually, we'll choose the indications and we'll decide at the start of the year whether we'll do 1 or 2 and which one.

An interview was published in [indiscernible] is also placed this afternoon. And you said that OSE was one of the greatest biotech companies in Europe. Can you tell us about your first impressions? You've made the team in not. You're talking about teams that do great work in-house. Can you tell us about your first impressions on the company?

I've known this company for quite some time because I know some of the founders for about 10 years, I was a professional investor. So I would meet those executives across the table as it were. And I always very much appreciated this company and the quality of their scientific work. Now for me, this company was maybe too humble. I wouldn't say shy or maybe shy or humble, I am. I don't know how to put it. And I think that their Investor Relations work was maybe not commensurate with the quality of its scientific work. So we're going to remedy this with Thomas and other members of the management team are going to go out there and meet investors, private investors, institutional investors in France, Europe and in the U.S. much more often. There's no secret. I mean, you experienced this in other companies, so did I. There's no secret. We need to go and meet investors. We need to talk to them because they have millions of offers made to them. If you don't go to them, they forget about you. Now what is OSE? OSE is a company that has raised only EUR 50 million approximately in capital, which is in the medium end of Phase III for a cancer study for 2L. It's a market that can turn out to be worth for billions of euros. We have secured results in UC. We have very good positive results in the Phase II. So just that for a market cap of EUR 110 million, EUR 120 million. So there's a huge opportunity here to make money.

One last question that will be for you, Thomas. And then Mark, I will ask you to say concluding remarks. This is a question from Michael. Thomas, you already mentioned this, but maybe it would be worthwhile to revert to this. What's the amount of AK that you are targeting?

Well, indeed, just to go back to what I was saying briefly before, the capital increase is the backbone of our financing. We consider this financing for the next 3 years to be in the region of EUR 30 million on average per year. It doesn't mean we're going to raise EUR 90 million in a capital increase. It means over 30 years, we'll need a sum similar or close to EUR 90 million. We'll raise an amount to be defined for this. And around all of this, we have a range of tools restructure our current debt, additional debt or milestones in partnerships that may be their derivative of new fundings from Tedopi things. All of this cumulatively should come to over 3 years to a figure close to EUR 90 million. But once again, AK, it's written AK. It's diabolical for individual shareholders. It's not at all the case. It's probably the form of financing that's the healthiest and the most long-lasting for a company that doesn't generate turnover that must be financed through equity. And once again, over and beyond the amounts that we raise, it means we get key shareholders in, which is something we really want to have. It really is the backbone of our financing. And I think we can safely bet on the fact that today, the share price impact by the fact that we don't have any financial visibility over 12 months. We financed up to the beginning of the fourth quarter of next year. And if we turn up tomorrow with a capital increase that brings in key investors and shareholders that makes it possible to supplement with other mechanisms to actually finance that roadmap over the next 3 years. I think it's excellent news, and I think the market will acknowledge this. NASDAQ, yes or no. Yes or no to NASDAQ. NASDAQ, yes, if it's at the right time for the right reasons. It's not an end in itself. It's not a specific target for us. It's something we have in mind, but we need parameters, and they're not there today. Now we're getting to the end of our webcast. Thank you all for having joined us and for your support and interest in OSE Immunotherapeutics. The replay of this will be available immediately on the same links on which you are looking now. And you will have a second newsletter in early 2026, which intends to go into current news in involve, not to unveil new things, but perhaps better explain things. So we'll have a second newsletter in early 2026. The first one, of course, can be found on our website. And to conclude, Mark, do you have a final word?

Yes, I repeat. I'd like to hammer this my enthusiasm in heading up this company in supporting it because I sincerely believe it's one of the finest companies in France and in Europe in biotechnology that once again, with the economy of means has managed to be in the middle of Phase III in lung cancer in Non-Small Cell and achieve results in UC that have -- are quite demonstrative. The new approach that we have developed together will make it possible for you to capitalize on 4 factors to create value. And we mentioned only those where we are really in control right now. There may be others that you may have understood through this discussion that might turn up such as partnerships, current ones that could change, but also new partnerships that we might sign.

With that value, with the current value of the company, we're far from the reality of the richness, the value latent that is in the portfolio of OSE Immunotherapeutics. So please follow this company in the weeks and months to come. Thank you, Mark. Thank you, Thomas. Thank you all. [Statements in English on this transcript were spoken by an interpreter present on the live call.]