Good afternoon, good evening or good morning depending on where you are based. Thank you for joining us. Today marks a significant milestone for MaaT Pharma and I'm proud to share a transformative update on our commercial strategy we are executing on our roadmap. Today I will walk you through how our partnership with Clinigen marks a critical step toward commercialization for the arbitrary. Today I'm going to be presenting most of the presentation myself together with Eric for the financial part, our CFO, but I'm also with Frédéric Fasano, our Deputy CEO, and Jonathan Chriqui, Chief Business Officer. All of us, we have participated intensively in the discussion around the deal and we will be happy to take your questions at the end of the meeting. The first slide on slide number four, the first slide I want to share with you.
It's about our journey since the IPO. We have delivered on our roadmap and I would like to focus today on the past 12 months as they marked a significant inflection point on the company direction. The first item is that we have delivered the pivotal phase III data in GVHD in the so-called ARES clinical trial. The second pillar of the strategy was to submit as fast as we can, the marketing authorization in Europe. And this marketing authorization has been accepted by the EMA recently in June 2025. As a conclusion of this very intense segment of the journey, we are now announcing our partnership with Clinigen. Of course, that will ensure the scalability and make the company commercially ready for the next step of the development of the company.
Regarding the partnership, we have signed an exclusive licensing agreement in Europe with Clinigen for Xervyteg. That is the scope of the agreement. Xervyteg was known as MaaT013 in the past and that has been branded recently. Clinigen's track record in critical care and hematology oncology was very important in terms of the selection of the partner. Clinigen also has a strong reputation in early access program and that makes them the ideal commercial partner to scale our innovation. We feel a strong continuum on what we have achieved since the inception of the company in 2014 and now we are in a position to maximize the reach to patients. They bring the market expertise and we continue to drive innovation in our field. Continuing on Clinigen, that is a global pharmaceutical company with a significant activity in services.
They have deep, deep roots, sorry, in rare disease and hospital-based commercialization. On our side, we also had a very good relationship with a team of clinicians, which was an important criteria when settling this long-term partnership. They are active in 130 countries and bring trusted relationships with prescribers but also payers. Their focus on hematology oncology perfectly aligns with the needs of Xervyteg patient population. You have more detail in the slide, including the products that they are already commercializing, focusing on the product in hematology oncology. In terms of responsibilities, the partnership that we have settled, I think it's fair to say it's a smart deal and a lean model, where Clinigen will take over the early access program in Europe as well as the commercialization. Of course, MaaT remains manufacturing and market authorization holder.
Clinigen will also handle the market access and the promotion of the product. The coverage of this agreement covers the 27 European countries plus Iceland, Norway, Liechtenstein, and the U.K.. This approach will allow us to focus on clinical and regulatory milestones so that we can delegate everything which is related to the connection with the hospitals to Clinigen. We will be focusing on where we are good at, meaning the clinical and regulatory developments. There are many synergies within this collaboration. That is not only supply and distribution. It is mutual strength that we share together. MaaT drives discovery, development, and manufacturing, as I said, and Clinigen brings market access, prescriber reach, and the infrastructure. In terms of the supply chain, we are aligned on our mission: patient access faster and broader.
What you see a little bit on the early access program, you see here the trend of the demand and you can see that from 2023 to 2024 the demand of early access program has increased significantly with an increase of 75%. Difficult to say in 2025, but if we look at what happened on the first semester, we see that 2025 is scheduled to be a better year as compared to 2024 today. We do report plus 25% in terms of the increase. That's an important element. As a reminder as well, Xervyteg when it used to in compassionate use is important to get data. We recently presented during EHA, that was in June in Italy, we reported data on 173 GVHD patients. I want to reinforce the following message.
We have reported an overall response rate of 57% as part of this data set and overall survival of 51%. What I want to recall is that those data, they are very similar to what we have achieved on the pivotal RS study. These early access data set comes in confirmation of what we have generated in terms of the pivotal study, which makes us very confident and that is also one of the value of this early access program. We want to expand and continue this program so that we can continue to confirm the performance of the product. As I said also earlier, because we are planning for this program to continue to expand, that is also for us important to delegate it to a partner who can support the workload.
We want also to free our internal resources to clinical development and scale operations through Clinigen. I think that's a moment everybody is waiting for. That's the deal terms and for that I'm gonna give the mic to Eric. Thank you, Eric.
Thank you. Thank you Hervé. Hello everyone. I'm now indeed taking a few minutes on the financial terms of this partnership between MaaT Pharma and Clinigen. The closing of the agreement comes with an upfront payment to MaaT Pharma of EUR 10.5 million and then regulatory and sales milestones up to EUR 18 million. Most of those will be upon approval in Europe and then a steady stream of revenues in the form of royalties on net sales in a bit 30%. By the way, note that royalties are stable over the duration of the agreement, they are not tiered and the direct supply agreements on Xervyteg at a fixed price. Just to quickly recap the business opportunity for Xervyteg in acute graft-versus-host disease, GVHD, we estimate incidence of third line GVHD of approximately 1,900 patients in Europe.
We believe market penetration for Xervyteg could be between 1,200-1,600 patients at peak and that would translate into peak sales for Xervyteg around EUR 75 million-EUR 100 million if approved mid- year next year. Commercialization could commence in certain countries before the end of next year. Taking a step back and looking at the entirety of this partnership agreement, I see personally a number of very positive points. One, financial terms are very well balanced between the two partners taking into account both royalties on net sales and drug supply. It is a well balanced split of revenues aligning both partners' interests on optimizing commercial and industrial performance. Second, the upfront payment upon closing extends runway into early 2026 in a non-dilutive manner and that gives us time to execute on other ongoing financial initiatives and more is to come on that front.
Third, this first commercial agreement in Europe sends a benchmark for MaaT Pharma on many accounts. One, we knew since ARES data and the real life results from the early access program, as Hervé has recalled, that Xervyteg is clinically promising. This partnership now shows that Xervyteg is also commercially credible. Also, the balanced economics of the deal draw a steady stream of revenue and margin for MaaT Pharma once commercialization starts and the sustainable business case. In other words, these agreements de-risk the company while retaining the marketing authorization, controlling the manufacturing, and preserving upside on the commercialization with royalties and milestone payments. We believe this is indeed a benchmark that we may replicate in due course with other assets or in different geographies. Finally, that brings MaaT Pharma into a new biotech league.
With not that many crossing that line, raising the company profile and making it fit for a new array of funding opportunities. Moving to the next slide, a quick word to remind that MaaT Pharma had already invested in a dedicated biomanufacturing CGMP grade site in partnership with French CDMO Skyepharma. Actually also in Lyon. You can see the picture. It's brand new, it's beautiful. With a capacity set for hematology commercial volumes, this site has been an invaluable asset to develop a proprietary process and it is now ready to supply your partner with no significant scale costs. I am now leaving the floor back to Hervé for concluding remarks and then we'll of course open the call for questions. Hervé, back to you.
Yeah, thank you. We start to converge to the conclusion. This deal has really very strong strategic significance for us. Would like to tell you why. With a structure of three main items. The first one, the deal structure, that's an exclusive agreement so that Clinigen is free to distribute and commercialize the product. They are free to do that. There are already questions on the chat regarding how we will launch and everything. I suggest we address that as part of the Q & A. We can retain the manufacturing. We will continue to retain the manufacturing. You know, this is a new class of therapeutics. It is super important that you can control the manufacturing so that you have control on the development of the processes, but also on the cost of goods sold. That is super important.
We remain, regarding the deal structure, really in control about producing the product. For us, it's very important to ensure the consistency of what we do. Also, as part of the deal structure, the early access program is important because that will ensure a smooth transition toward commercialization. We have already a very intensive early access program with more than 100 patients treated in 2024 under the EAP, for example. That will continue to grow as you have seen from the graphics. It's a little bit like, without the authorization and everything and without the caveat, but it's a little bit like the supply chain has to be prepared because of the high level of demand. The infrastructure has to be prepared. We are commercial, so that will be really an ideal transition for us.
That was relevant to transition the early access program to Clinigen as well. Because of that, the financial terms, I think they are just well balanced. I think they are very respectful of the added value of each partner. The upfront is in line. The upfronts, they are in line with the size of the market. For us it is really acceptable. The mid-30s is also reflecting the high added value of the product. We are very pleased with that. The fact that we are in a long term supply agreement was also important for us. As a reminder, we have created the company in 2014. The IP we have generated is our IP. The first patents are from 2015.
Now we have a very long duration in terms of the coverage and that was also for a long-term supply agreement. Regarding the financial updates, it's also important to mention that we are now moving the cash runway into January 2026. More importantly, this deal now provides way more optionalities for MaaT Pharma because we have set a benchmark. It's not stupid, I would say, to think that we could replicate this kind of model in other regions. That's an important element. Now we have showed that we can monetize the innovation that we are developing at MaaT Pharma and that will provide MaaT Pharma with more optionalities. Sorry for that. I want also to conclude on the fact that Xervyteg will be the first approved microbiome therapy if guaranteed by the EMA. It's only a cornerstone toward next steps.
The next step they will be around MaaT0 33 which remain unpartnered as we speak today. So we have additional optionalities for the refinancing of the company, but also the MEDC pipeline. The MaaT0 34 in immuno- oncology is progressing well. We have recently presented non clinical data that's progressing pretty well and that will provide long term growth engine for the company as well. This positions us to expand into new geographies and indication in the future. With that I will maybe just summarize and then go to the questions. This is a capital, efficient, balanced value, creative partnership. It validates our clinical and commercial strategy. Our cash runway is extended and we are very pleased that in the morning, we have seen that two brochures have increased their target price consistently. They were at EUR 15.5. They have increased for one at EUR 17, the other one EUR 16.5.
Now we are between 16 and 19 in terms of the target price, which offers a lot of potential. When you think about the share price, which is, even if today it's trading very well, we are close to, we are navigating between 5 and 6, which is the latest price of the latest capital increase. There is huge potential. We are proud to lead the field with the first potential microbiome to organization. With that I will invite my colleagues, of course, and Frédéric and Jonathan to join me for the Q & A sessions. We have the first questions in the chat. I'll take them as they come. Sorry if it will be maybe not consistent for you. The first question is for you, Frédéric.
What is the planned commercial strategy for launching MaaT013 in Europe? Will it be a country by country launch?
Yeah. Thank you, Hervé, and happy to be with all of you this afternoon or this morning for certain of you.
Yes. About the commercial strategy, there is two parts here, of course. Number one point, sorry, that I have to mention is that it will be under Clinigen, our partner responsibility to define the commercial strategy. It is necessarily a country by country launches, since launches will take place in different ways according also to the pricing question. Some countries are more quick at defining pricing for reimbursement than others. Necessarily we have to plan the launching sequence in different ways. To the second part of the question, the answer is yes. Again, we will be happy to review the commercial plan of Clinigen. Again, this will take place under their responsibility.
Of course we know the product, we know the disease, and we will be sharing that in different working groups and starting as soon as we get the marketing authorization.
Thank you, Frédéric. The second one is for you, Jonathan. Can you tell us a bit more about how this deal came about and why Clinigen was selected over other parties?
Thank you, Hervé. We have gone through an extensive search and went through, with the help of some advisors, a competing process whereby we had different stages and different offers on the table. The reason why we chose Clinigen is for their capabilities in, of course, hospital rare disease. One of the key also was the fit with the team because for us it's important. We're a biotech and we need to make sure that we have the same values and see the endpoint of treating the patients as soon as possible as a major driver of this. Of course, the financials were on the table, they were adequate to what we were looking for, and finally we made it happen.
Thank you, Jonathan. There is a series of questions that I'll start to answer. The first one is regarding the governance. Could you share a little bit more about the planned governance structure with Clinigen? And to which extent MaaT will be involved in decision making regarding MaaT commercial plan in Europe going forward. Everything regarding the governance has not been settled. We just signed the deal this week. I can just tell that I'll be on the committee together with Jerome Charton, who is the CEO of Clinigen, who I think I thank for the constructive spirit he has put into the discussion. It's too early to say regarding the governance exactly. There is a question regarding the commercial plan. What we want Clinigen to do is to sell the product as much as they can.
We will ourselves, we are committed ourselves to deliver the products so that they are not limited with the supply. There is going to be regular meeting we will have together. We have already agreed on a business plan as we speak today and it could evolve over time. That would indeed be through the governance that we can make some adjustment. Too early to say but I see that as being led by the commercial plan, led by Clinigen but with strong inputs from MaaT Pharma. Especially when you think about the experience we have developed with the early access program where we know all the centers. For example, if you look at France, we have already with the early access program penetrated 30% of the available market. We are very knowledgeable on that and I believe Clinigen will want to leverage on that.
We will be consulted, I believe. There is also a question: will there be additional deals with Clinigen going forward? Why not? I mean, we are invested in a relationship together with Clinigen, so we will be pragmatic. Changing for changing does not make sense. We need to continue with Clinigen if it makes sense, on the other hand. We are investing into the relationship. We are going to train the team, the people from Clinigen and everything. If everything goes well, we are super happy to continue. If things could be better, of course we will continue to seek for the best partner. Today I have absolutely no reason to think it will be the case. There is a question for Eric. Have you explained about tenants? Can you explain about—so that is probably a shareholder. Can you explain about the tendency of the action?
Why is it going down?
Yes, it's true that MaaT Pharma has been delivering very good news steadily since the start of the year. The IRIS data, the European submission, now this partnership with Clinigen, definitely good news which is de-risking the company. It's true that it has not been fully reflected in the market price to say the least and it can be kind of frustrating. I share that frustration. I believe also it's not unprecedented that for biotech like us where you had some investors who've been investing in the company for many years and for a number of reasons different from one case to the other, they may have t o shift the position.
Taking advantage of the volumes that are created and triggered by the good news is certainly a reason to see this selling pressure that we may have seen from time to time in the recent days. We're addressing this point, I can tell you, and I believe that the market will finally realize the good news that we are delivering on plan on a steady pace. I'm quite confident that it should finally reflect in the market price.
Thank you, Eric. I have two questions that would merge and that is for you. The first one is regarding our financing strategy. Knowing that we are announcing the end of cash is early 2026, and how do you bridge up to the marketing authorization in Europe?
Yeah.
I think they said a few minutes ago that this partnership, first partnership agreement for MaaT Pharma, is a benchmark. It is indeed a benchmark again on many accounts, including in terms of financial strategy. First, it shifts MaaT Pharma to a new biotech league. That's for sure. Again, a company with a positive phase III under registration process in Europe with commercial activities and market access getting ready, it's not that often, and I think now that we are in that league, it will open a new array of funding opportunities and we're actually working on a number of them.
Those funding opportunities are not necessarily getting back to the market and that's a good thing because as you know financial markets are very challenging these days and we have shown starting with that deal that we're able to fully fund, well, to further fund the company with other options, non-deal dev options. As I said earlier, this first partnership that we've just closed in Europe can be the first of other potential partnerships, other assets, other geographies that we may be contemplating in the coming months. I think indeed we have a number of funding options. This new step is opening new opportunities also in terms of financing strategy for the company. We intend to leverage on those many fronts.
Thank you, Eric. There's also a request to update on the U.S. plan. In the U.S. we are in active discussion with the FDA. What we have announced in June is that after having communicated with the FDA, we know the European data by themselves will not be sufficient. We will need a clinical trial. Where we are now is that we are discussing what the clinical trial in the U.S. will be. As you know, we have an IND open in the U.S. for a pivotal study that was already authorized by the FDA. However, we need to adjust it because now we have the full package of data from the European data. What we have seen in Europe requires small adjustment within the U.S. clinical trial. That is typically what we will be discussing with the FDA.
We do plan to start a clinical trial in the U.S. in 2026. There's also a request on other regions, especially Asia. Do you have any plan in Asia? That's the question. Thus far we have been concentrating ourselves indeed in Europe and in the U.S. We see more and more demand coming from Asia. I know there are Asian people connected today in the call. I just can confirm that now we are also opening the potential of the company to Asia as well. That's something we would clearly consider. We are already adjusting the organization at MaaT Pharma to make that possible, to understand, at least to have a readiness phase to understand if the potential is confirmed. If you take China only, it's the same number of allogeneic HSCT as compared to Europe.
In total, that's roughly 50,000 allo-HSCT in China performed every year. They use corticosteroids, they use ruxolitinib. It's the same setting. There is a huge potential there and we are in a readiness phase to understand if we will go there or not. There are other questions coming. One is for Frédéric, does the current capacity cover the demand for European countries? I think it's the manufacturing capacity. Or do you have to—yeah, that's—or do you have to extend the manufacturing site? Can you elaborate a little bit more?
Yes, of course. It is a very good point. You will recall that actually MaaT did a lot of effort to be manufacturing by itself. We have today a plant that is already supporting all the supply for clinical but also for the EAP. Importantly, the sum up is that no more CapEx is required to supply the market, the European market for commercial products. Everything is in place, the plant is up and running and what will be done now in the scale-up program is adopting all the process and starting material and collection of material actually to support the commercial supply. Again, it is about OpEx and not anymore CapEx.
We will be at the end of the day very happy to have an important scale up as the sales are rising because it will mean that the launch actually is successful. Of course, it's a long term and just to remember, it's a long term agreement of supply as well and we are well equipped to start as soon as the product will be launched.
Thank you, Frédéric. There is a question for Jonathan. It has been said that the microbiome therapeutics, they are new. How have you seen the reaction from the pharmaceutical company during the selection of the partner? Maybe you can share also that we had a process.
I would say yes, exactly. We had the process but we reached out to a number of potential partners at the beginning. I have seen a lot of evolution. I started in the company about one and a half years ago and reached two partners at that time. From a year and a half to now where we are, things have changed. The vision of the product has changed for several reasons. The first one being that we are actively developing a drug, not a probiotic, not anything like that. We're actively moving a drug to the market through a centralized procedure, which is something that now is standard. Whether you look at, I do not know, a small molecule, you never ask yourself what you're dealing with. Here it's the same.
The vision of the partners has evolved over time and it is way better understood now. Especially since the data are so good and we save patients' lives, this has been, let's say, gathering a lot of interest from the different partners. Yes, there has been a change in the way people have looked at the product and I think we are pioneering that in our ecosystem, which is extremely exciting and bringing a lot of innovation to the market.
Thank you, Jonathan. There is a question which I will take. There is a question about the kind of changes we would need for the U.S. regarding the clinical trial. What I said is more adjustment than changes. For example, the calculation of the power of the trial will be different because of the strength of the signal. I would also say that that is not only MaaT Pharma that has changed. There is a lot of evolution within the administration, within the FDA, and there is a new leader at the CBER, the biologic division, and they have their also own views on how we should be developing drugs in rare diseases. We need also to accommodate with that. The world is not exactly the same as it was a year ago or even when we had the authorization for the Apollo trial, the twin protocol as compared to ARES.
We need also to make sure that what we are doing is also compliant with the most recent regulatory policy. It is not. I think it is prudent to go that way as well. On our side, it is more about adjustment based on what we have learned in Europe. There is also another question. Do you expect to continue the early access program in EU? If yes, can you describe the benefit, how you choose the suitable candidates? And will Clinigen be involved in this strategy until drug approval? Clinigen will be running the show. There will be, I would say, three steps: EAP up to the point that we get an approval. Then you enter the second phase where you have an approval but you do not have a price reimbursed, and then you have a reimbursement.
I think it's clear for everyone that from the reimbursement step, Clinigen will commercialize. In between the marketing authorization and the reimbursement, there's an opportunity to sell the product under what we call unlicensed product. That's a product which is in between. Each country has its own framework. Before we get the approval, we will continue with the compassionate use with Clinigen. Why? Very simply, because there's patients. I'll take an example. We received this week a request for a patient of 18 years old, two allo-HSCT, 5 line of treatment for GVHD. If there's no drug that works for this patient, if we don't come with Xervyteg, we might not save the patient. If we don't try, we will never know. We want to continue to provide the product to the patients just because they are severe patients and they have no option.
There's also a question for you, Eric. What do you mean by long term supply agreement? Minimum purchase per year per clinician. More detail on what do you mean by long term supply agreement?
Yes, thank you, Hervé. It is indeed long term because it is over the duration of the agreement, which is for 14 years in line with the duration of our intellectual property. It is an agreement on supply, meaning that we have agreed together with our partner on minimum purchase per year, which is in line with the shared commercial plan. In terms of revenue, it is like a marriage. We are fully aligned on the plan and it does translate into some minimum requirements. That is why I was speaking about a steady stream of revenue. We have now this better clarity on the plan going forward. With this stream of financial resources for the company, of course we need to bridge that gap to the start of commercial sales, which is about 18 months from now.
As I said earlier, with this agreement, we have new funding opportunities that are now open, that were not accessible before that deal and that are now getting real and accessible. Because again, when you have a stream of revenue, you have some additional options that are suddenly getting possible.
There's also another question which has nothing to do with the topic today, but I think it's also relevant that's regarding the use of MaaT013, now Xervyteg, in other indications such as in immuno-oncology. That probably refers to the phase II clinical trial for which we are expecting the results for the second part of 2025. That makes sense. It's relevant also because it's part of the value creation of the company. Indeed, we are expecting the results for the PICASSO trial, that's metastatic melanoma patients where we want to improve the response to immune checkpoint inhibitors by modulating the microbiome. This trial is also the first randomized control trial, multi-centers, which could show that a microbiome modality could improve the efficacy of immune checkpoint inhibitors.
That will be the first time in the world that we can demonstrate such a result with a very strong methodology being on RCT. That is also something we do expect in H2. If it is successful, we will continue, of course, the IO program, the immuno-oncology program. You could expect the next development phase mid 2026, which will even further fuel the value creation within the company. With that, I am looking at the chat, and please, on the back office, let me know if I am wrong, but I do not see any other questions. Yeah, I have a beep, so that means I have a response. No. I think we are good. There are no other questions. Thank you very much for your attention. Once again, we are very, very happy to be in front of you today.
We are super proud to lead the field with the first potential microbiome drug in hematology oncology. I will let you with that, that's really what we are proud of. We will continue to deliver as per plan and connect with you again in the near future. Thank you very much and talk to you soon. Thank you.
Bye bye.
Thank you.
Bye.