Philogen S.p.A. (PHIL) Earnings Call Transcript & Summary

Welcome, everybody. Today, we want to take the opportunity to provide an update on our recent scientific and industrial developments of the company. As always, on the call, we have our CEO and CFO, Professor Dr. Dario Neri and myself, who will guide you through the slides. The slides today focus on science. We'll have a financial update around the end of September, together with the release of the half year report. The presentation is being recorded as always and will be followed by a Q&A session, which is not recorded. [Operator Instructions] Without further ado, I hand over the stage to Dario Neri, who will start off with the presentation.

Thanks a lot, Emanuele, and it's always a pleasure to share at regular intervals information about the progress of the company. We'll see many updates. If we go to the next slide, we see the disclosure statement and Philogen still a Swiss Italian biotech company. These colors will come up over and over again. When you see green, we refer to the antibody part of the pipeline, the Philogen part of the pipeline. The Philogen Group has a fully owned daughter company based in Switzerland called Philochem that focuses on small molecule therapeutics and you will see good progress, both with the green and with the blue part of the pipeline. The next slide summarizes as always the strategy of the company. We use payloads of proven pharmaceutical benefit. And these payloads are not only cytokines but also drugs and radionuclides and we make them better by fusion to ligands, which delivered these payloads to the site of disease. We rely on excellence, on encoded library technologies, namely antibody phage display and DNA-encoded chemical libraries. We'll see clinical examples of activity in all three sectors. Now this is the problem that we want to solve and I think we are solving. In this slide, you see 4 patients with cancer. These 4 patients received 4 different types of drugs from conventional chemotherapy through the targeted therapies of Philogen and these products were radiolabeled up so that you can see them in the body. Wherever you see a black grain, this means that's where the drug went and if we start at the very left, we would have a patient with mesothelioma, so the tumor would be somewhere around the lungs. And basically, you see that the drug goes everywhere in the body except to the tumor. You have an uptake in liver, spleen, feces, urine, but there is no preferential uptake in the tumor. So you understand that this is really a tragedy of 70 years of conventional chemotherapy where we give poisonous compounds to the patient, but these compounds do not go to the tumor. Antibodies in IgG format are better but they're not as good as the antibody fragments that we deliver to the tumor; you see one of our patients with liver metastasis of breast cancer imaged one day after administration of the L19 antibody. And basically, you see a tumor-to-organ ratio of about 10:1. This is what can be accomplished with antibodies. With small organic ligands that bind to tumor antigens with antibody like Affinity, we do even better and this is probably the world record of tumor targeting. You see a patient with metastatic breast cancer, this black spots tell you where the primary tumor was located. The bone metastasis unfortunately, many bone metastasis, the liver metastasis and you see that the rest of the body is very clean. So basically, the mission of Philogen is to turn therapies like the ones at the very left to targeted therapies that we see at the right. Now if we go to the next slide, basically, you see that for the antibody products, we mainly focus on a high-value target called the Extra Domain B of fibronectin. It's a splice variant of fibronectin and it's a dream antigen. In the bottom left panel, you see that the antigen is almost undetectable in the normal adult body. You find the placenta, you find around some vessels in the ovary, but otherwise, you don't find the antigen, whereas the panel on the right, and that was a publication together with our colleagues at Pfizer shows 5 main tumor types, 5 patients for each tumor type. You see brown everywhere, which means antigen is strongly expressed in the majority of solid tumors and also aggressive lymphoma. So it's a dream antigen because it's clean in normal organs, and it's strongly expressed in cancer. This is our pipeline, again, green and blue. I will start with Nidlegy. Emanuele, our Chief Operating Officer, will continue with SOTERNEC. This is the trademark name of fibromun, and I will finish up with chemistry. So let's start with Nidlegy, which is dermato-oncology drug, you will see not only that have made progress in melanoma, but also in non-melanoma skin conditions. Indeed, we are going for the main types of skin cancer, which are depicted in the slide; melanoma, locally advanced basal cell carcinoma, squamous cell carcinoma of the skin. You see the incidence in the U.S. and indeed, the melanoma is actually the smallest indications because there are more patients with BCC and SCC and we believe that we are providing benefit to all 3 indications, as you will see from the next slide. Basically, Nidlegy consists of 2 active ingredients. The L19 bodies fused to interleukin-2 and the L19 antibody fused to tumor necrosis factor. In Europe, we enjoy a combi pack authorization from the European Medicinal Agency. And this is the only product that we give intralesionally because we are treating skin conditions even though we have shown that we can inject locally and achieve a benefit also in non-injected lesions. And let's start with the melanoma program. We have focused in locally advanced melanoma. We give the product in the neoadjuvant setting that these patients are all candidate to surgery, but basically, we give Nidlegy before surgery to shrink the tumor and activate the immune system. Patients are allowed to receive adjuvant treatment even like PD-1 blockade, if they want. And the next slide shows the design of the European Phase III trial, which has successfully concluded. We had a one-to-one randomization, patients received surgery in the control arm followed within 4 weeks. And in the treatment arm, 4 injections of Nidlegy followed by surgery, again, before 4 weeks and recurrence-free survival was the primary endpoint. 256 patients, 22 clinical sites in Europe, I'll tell you about the U.S. in a split second. The baseline characteristics were well balanced in the 2 arms for all relevant parameters. Importantly, more than 90% of patients had received prior treatments on average, we were 25 months after the first treatment. So really a heavily pretreated patient population and 35% of patients have received the systemic treatment. And this patient population has obviously a worse prognosis compared to, let's say, other melanoma trials with basically patients at first detection. The slide here is the slide that was presented at ASCO by Professor Hauschild in representation of all the clinical teams. In yellow, you see the recurrence-free survival for the control group. We have bet on a medium RFS of 7 months based on the German Melanoma Registry, we observed the 6.8 months. So we expect -- we had exactly what we were expecting and Nidlegy did much better. So we had more than doubling of this time-dependent end-point going from 6.8 to 16.7 months with a statistically significant and clinically relevant results. If we look at distant metastasis-free survival, and this is typically what matters because the disease, when it kills, it kills because of metastatic spread. Again, there is a very nice separation of the blue and yellow curve with a statistically significant improvement of distant metastasis-free survival. The next slide shows a subgroup analysis on the role of adjuvants. The adjuvants played against Nidlegy, so to say, because 40.5% of patients in the control arm got adjuvants and only 29% in the experimental arm, so in the Nidlegy arm. But basically, you see that the recurrence-free survival with surgery alone was 5.3 months. With adjuvant, it improves as expected to 11.7 months, Nidlegy is at least as good, 13.8 months with, I would say, a better tolerability profile, substantially better profile. And when you use Nidlegy and adjuvants, then you have the maximum benefit and RFS becomes 22.8 months. So no matter how you look at this data, Nidlegy is providing a benefit to patients. We are running a twin study in the United States, same design. We have already treated more than 100 of the 186 patients, which are foreseen in the trial. And for the FDA, we have to stratify for adjuvant treatment. And the difference is that in the United States, about 70% of patients received a PD-1 blockade as adjuvant treatment. So the study is well underway. Now the developments in Europe have been important in the sense that, yes, we have presented the data at the international meetings, including ASCO. We have filed the marketing authorization application with EMA on June 3, as planned, and we have received from the EMA confirmation that the dossier has been validated. The next interactions will be at the end of September with the dialogue with authorities. Now in the United States, we are preparing a pre-BLA meeting to discuss with FDA whether the European data can be used as a basis for conditional approval and the U.S. trial is meant to be a registrational trial for full approval. After the EMA decision, we can use the decision to submit in an accelerated process marketing authorizations in other countries and especially Australia, New Zealand, U.K., Switzerland are very important to us. We have made progress also in basal cell carcinoma. You know that we are treating patients in 2 Phase II clinical trials in Europe. Soon, we will be in the United States in the Duncan trial, which is the most advanced one. We have already treated 56 out of 72 patients. So we have, by now, a good clinical experience on drug. About 50%, a little bit more than 50% of patients with Nidlegy enjoy a pathological complete response and this is depicted in the slides and in the biopsies that really show how the tumor goes away and patients who enjoy a complete response typically never come back with the disease, which is a very nice observation. Same story, and this is the next slide, for squamous cell carcinoma, where we report 47% complete response rate. Please remember that squamous cell carcinoma is a disease that kills more than melanoma. So we are encouraged by these results. And the good news, at least for the drug is that in addition to the company-sponsored trials, we are receiving now more and more requests from qualified clinical centers who also want to use the drug either in early access programs or in compassionate treatment. So the doctors believe that the drug is providing a benefit to patients, and we are glad to facilitate the transition. So the results are promising. We have just completed an International Advisory Board meeting in Rome with U.S. and European investigators. And they see a positioning and benefit in multiple lines, even though at this moment in time, the fastest way to the market may be a third-line approval in BCC and the second line approval in squamous cell carcinoma. These trials are small. But this does not exclude multiple execution of trials, and this we will discuss if you want at discussion time. With this, I hand over to Emanuele, who will guide us through the SOTERNEC developments, which are, I would say, equally promising.

Thank you very much, Dario. You remember that SOTERNEC is developed in glioblastoma and soft tissue sarcoma. And in total, we have 6 ongoing trials with registration potential. So glioblastoma, the most malignant primary brain tumor, kills patients with recurring disease in about 8 months. Soft tissue sarcomas arise from muscles, fat, nerves and other soft tissues. When they become metastatic, they are very aggressive. The median overall survival for these patients is about 12 months. So with SOTERNEC, we're addressing really 2 huge unmet medical needs, for which, unfortunately, no drugs cures the disease. Here, it's the molecular structure is one of the 2 active ingredients of Nidlegy. We have orphan drug status for SOTERNEC in soft tissue sarcoma and glioblastoma, both in Europe and in the U.S. When given systemically by intravenous infusion, the drug goes to the tumor, sparing healthy tissues, which is exactly what we want achieve to have maximum activity at the site of disease and minimizing toxicities. The programs in glioblastoma are progressing very fast. The Gliosun study in newly diagnosed patient is almost completing Phase I. We'll be able probably to show some data around the end of the year. The Gliostar study is the most advanced one in recurrent setting, and we'll expand in one second. We started, as you remember, another trial in the U.S. that we call GLIOSTELLA in patients with recurring diseases. We really have 4 patients with one center. Now we're expanding the number of clinical sites that would be involved in the trial. Also for this, we'll be able to show probably data in about few months. Regarding the Gliostar trial, we opened 15 centers in different European geographies. We completed Phase I clinical trial. We launched the Phase II part of the study where patients receive lomustine or the combination with L19 and TNF, SOTERNEC and the primary endpoint is overall survival. You see on the right there, enrollment projection. The first one we made at the beginning of the study are depicted in blue, we thought to finish the enrollment by the end of December 2025. But now you see we're already at 83 patients out of 158, and we had to revise the predictions. We expect now to complete the enrollment around first half 2025 and to complete the study around the end of 2025. So we really are going very fast, and we also have yet other centers to open. So there is a lot of excitement in the field from the key opinion leaders in glioblastoma for these trials. In soft tissue sarcomas, we have this Phase III European study in combination with doxorubicin in first-line patients. A Phase IIb study still in first-line, but metastatic leiomyosarcoma patients. Now the Phase II randomized study in last line patients. The study has a random [ high-order ] potential. Here, the standard of care is another chemotherapy called Dacarbazine. See the first line and the third line studies in Europe are open up many size, 25 and 19, respectively. Here on the bottom, you see the enrollment rates. In first line, the Phase III trial has passed the interim analysis that we announced in February 2024. There was a data and safety monitoring board that looked at safety and efficacy and recommended to go on with the completion of the study. This is quite exciting because it means that the statistical assumptions made at the beginning was pretty correct at the beginning of the study. So now we have 116 patients out of 118. So 2 patients are missing and we will announce with the press release when we reach the 118 patients, which would come in the next few days. The trial is an event-driven trial, so a PFS to expect to reach the event needed for the readout of the study around the end of the year or beginning of next year. In the third-line setting, we're also making good progress. We're missing 14 patients to complete the study that we should expect around September and since the patients have much more aggressive disease, they progress fast, we also expect to record the events necessary to read out the study enough with faster time lines. So we expect also this one to be completed very soon after the enrollment. So after the completion, the successful completion of Nidlegy Phase III trial, the sarcoma trial will be the next one on the line for our company that could bring a second product to the market. With this, I hand over the stage to Dario again, we will finish off the presentation with the chemistry part of the pipeline.

So we are excited about the antibody part with the melanoma data post Phase III, but also with opportunities in BCC, in SCC, in glioblastoma first line, in glioblastoma second line, in soft tissue sarcoma first line, soft tissue sarcoma third line but you will see that also the chemistry pipeline is doing very well. Next slide, please. The vision is always the same that I mentioned at the beginning. To be better at targeting not only macroscopically, that's what you see by nuclear medicine, but also at the microscopic level. You see tumor sections where in green, you see the pharmaceutical agent, antibodies in conventional IgG format only limit themselves to perivascular structures, whereas small molecules can penetrate deep into tumors, and this is good for the delivery of drugs and radionuclides. It doesn't matter for cytokines, but it matters for drugs and radionuclides. Now you can see that when we go from our DNA-encoded chemical libraries, I feel that we have helped develop and we discover high-affinity ligands, then we have several opportunities, the delivery of radionuclides for imaging or for therapy. The delivery of drugs or other modalities that we are exploring at the preclinical level that I will not show today. So let's focus on radionuclides first. We have 5 targets with ligands at the level of nuclear medicine validation. And for the sake of time, I will focus on the first one, FAP and on the last one, ACP-3. Let's start with FAP, Fibroblast Activation Protein. And let's focus on radionuclide delivery. We have licensed our OncoFAP platform to Bracco for imaging applications. We have studied together with our centers more than 200 patients. We have successfully completed our Phase I clinical trial and the product is now with Bracco, which has the right and duty to run the pivotal program. Now you see here 5 representative patients from this more than 200 patients that were imaged and all images were acquired at 1 hour, and they are just wonderful. You see the metastatic disease in esophageal, sarcoma breast, pancreas cancer, and you see that the normal organs are very, very clean. So a typical patient who receives such an image wants also therapies. They not only want information about where the metastatic disease is located. That's why next slide, we kept the rights for therapy within Philogen. All we can do is to use a therapeutic radionuclide like Lutetium 177. We used a slightly different product for therapy called OncoFAP-23. We have implemented GMP manufacturing at the central facility in Austria and then we offer the product both in a Phase I clinical trial that should start soon but also for compassionate treatment, which has already started. The first patient was already treated twice in Minster in Germany, and now a number of patients have requested access to the drug. They are typically young patients who don't have a therapeutic alternative and we are very happy to offer this experimental medication to them. We have also explored the possibility to deliver drug conjugates. In this case, the class of compounds is small molecule drug conjugates. And the next slide shows you top half right of the slide, you see the chemical structures in blue, the OncoFAP moiety that goes to the tumor. FAP is also protease, so it will cleave the [indiscernible] curve in green, liberating a very potent drug called monomethyl auristatin E. We can cure mice, we have published it in clinical cancer research, and then we have decided to execute Phase I clinical trial in animal patients, namely dogs with spontaneous tumors. The first dog to be treated, Coco, received 3 mg per meter square once a week, and the CT scan shows how the lesion already was shrinking more than 50% with this treatment. The next slide shows you Coco basically 9 months after the beginning of treatment, a 14-year-old dog enjoying a clear benefit from the treatment. Second patient, Ezie, you see the primary tumor in a tonsil. You see a huge lymph node metastasis in the throat that was basically obstructing the digestive tract. The dog could not eat anymore. We observed the benefit also in this case. You see the patient at presentation and the patient after administration of 5 mg per meter square of drug. And the next slide shows this dog Ezie that started eating again as a result of the treatment. We have now many more patients with objective responses observed in this very natural setting. And as a company, we have now made the commitment to offer the drug also to human patients. So we have reached a recommended dose in the dog. The next slide shows ACP-3, a superior target for prostate cancer and the beautiful story. Basically, in prostate cancer, there is already a successful radiopharmaceutical for therapy. It's Novartis Pluvicto. It's a ligand of a target called PSMA, labeled with lutetium-177, a beta-emitting radionuclide. The benefit to patients was proven in a Phase III trial. You can see that the blue curve in terms of PFS is better than the standard of care but basically, all patients progress by 20 months. And these patients are typically not cured also because the doctors cannot increase the dose as Pluvicto has 2 clear liabilities, very clearly visible in nuclear medicine; the product goes and stays in the kidneys, the product goes and stays in salivary glands. If you give too much radiation, you will burn the salivary glands and you will burn the kidneys. So in order to outperform PSMA, we decided to go for a different target, an acidic phosphatase called ACP-3. In this slide, you see consecutive sections from the same patient. You see, for example, for the second patient, both PSMA and ACP-3 are good. You see a strong brown staining. But for many patients, you see that ACP-3 is strongly present, whereas the antigen of Pluvicto-PSMA is weekly expressed or even negative. And so ACP-3 is always expressed in prostate cancer, whereas in normal organs, PSMA is dirty, the brown staining, for example, shows you that there is strong expression in kidneys and no surprise that Pluvicto goes and stays in the kidney, whereas ACP-3 is completely clean in normal organs, exception made for prostate which is not an issue in prostate cancer because it's [indiscernible] in patients. So based on immunohistochemistry, ACP-3 is a better target. Thanks, next slide, through the DNA-encoded chemical libraries, we could discover a 100 picomolar ligand called OncoACP-3. This is a high affinity ligand that basically goes to the tumor efficiently. You see percentage of dose per gram on the tumor and the normal organs from 2 hours to 72 hours. So strong uptake in the tumor, negligible uptake in kidney and salivary glands, we are able to cure mice with this drug. Already 2 centers in Germany have asked for this drug for experimental treatment of patients that have already received OncoACP-3 and we have filed for a clinical trial in -- so we are filing for clinical trials in Europe that will start around November. This is our estimate at this moment in time. So the last slide summarizes everything that Emanuele and I have told you. We think that all 3 areas are enjoying a very good momentum. We are proud of having submitted our first marketing authorization application according to the time lines that we had announced. The developments in BCC and SCC are very exciting, and we really like to see the doctors and patients like the treatment. We believe, and we have previously communicated that BCC and the SCC will represent even larger market opportunities than melanoma, which is already per se an important indication, both medically and commercially. SOTERNEC, we have chosen this commercial name, has very good developments in soft tissue sarcoma and glioblastoma. The readout in soft tissue sarcoma, first line and third line, is expected around the end of 2024. So these are exciting times. And the readout in second line glioblastoma is expected around December 2025. In the next webinar, we will show you also the first-line developments in glioblastoma, which as mentioned by Emanuele, are promising, but we like to show data when the Phase I part is complete. In terms of chemistry, both FAP and ACP-3 are good targets, but be reassured that we are going for additional targets. We have high affinity ligands, and we see the possibility to really change the way radionuclides and drugs are delivered to the tumors. With this, we thank you for having followed us in this day and afternoon. We stop here. I see that Clemence has already a question. So we open the discussion session, which will not be recorded.

Can you hear me? I just wanted to get back on the BCC setting because last time you said that you were moving from second line to first line because of the efficacy that you observed and now you're talking about launching a pivotal trial in third line. What's happening there?

Well, what we are reflecting very transparently is one of the consensus of this meeting with key opinion leaders from the United States and from Europe that took place in presence in Rome on the 3rd of July. The investigators are very clear that in basal cell carcinoma, there is a need both in first line and in third line and they are actually pushing for clinical trials in both directions, but they want to give more granularity to the statement. A registration in third line will be fast and will require approximately 60 to 100 patients. And these patients are not real, because typically, patients discontinue [ JAK ] inhibitors very rapidly. You'll get very sick, you get pain, you lose your hair. And typically, the disease doesn't go away. Okay? So you are very sick. The disease doesn't go away. Patients have strong motivation to stop taking [ JAK ] inhibitors. PD-1 blockers, not everybody wants to take them again for the risk of mortality and lifelong autoimmunity. So the doctors who are telling us, you will see a stream of patients, like we have already now in the trial, that want to take Nidlegy. This is the fastest route to the market with about 60 to 80 patients in a noncontrolled trial. And I can tell you as a company we are committed to executing that development. The doctors are pushing us also to study the patient frontline. We have received scientific advice from EMA that in first line, we have to demonstrate superiority over a [ JAK ] inhibitor. So this will be the controlled trial and we still have to discuss the matter with the U.S. FDA, which will happen shortly. So what I can tell you now is really the outcome of this key opinion leader meeting. We have a commitment as a company to go in third line. Largely, we have the data and by focusing on a subset of patients post a [ JAK ] inhibitor post PD-1. We think this is the fastest avenue to registration. It is possible but not yet decided that we will go in first line because once the product is available on the market, we believe that the patients will choose this product because it's efficacious and it's very well tolerated. So I can only tell you the outcome of a very recent meeting. I'll pause here in case you have additional questions or in case Emanuele wants to add something.

Okay. Very well understood. When you say faster, how long do you expect the trial to last. You're probably going to launch it as soon as possible? Or are we looking at like 1 year, 1.5 years? Just a guess?

I think realistically, what will happen is the following. By the end of the year, we will already have close to 100 patients treated, which is important because it's a good data set, but not all patients are third line. So this will be useful information, but per se, probably not sufficient. Our operational plan is to launch the trial by the end of the year. We estimate that it will probably take 1 year to recruit these patients and the follow-up in third line is -- does not have to be very long. Doctors were recommending follow-up time of pursue; follow up as long as you can, but relevant follow-up for approval is 3 to 6 months. So if you factor it into a model, you have to consider a trial that should start by the end of the year will recruit in 2025 and we will have a readout in real time. It's an open-label trial. In 2026, basically, the trial should read out and should allow us, hopefully, to ask for an additional indication on top of melanoma. This is the thought process, and this is the fastest process. It's possible but not yet decided whether we will go in first line or whether we'll take the registration in third line to let then doctors and patients choose their option. Clemence, let me mention also that the interest in squamous cell carcinoma is as high as in BCC. The doctors and the patients see this as a medical need. If you have really disfiguring disease and you need disfiguring impairing surgery. They don't want surgery. They don't want it. They want the injection and they want that the disease goes away.

Makes sense. And if I can squeeze a last question just on OncoFAP on the trial, so you treated the first patient. Could you just remind the size of the trial. When will we see the results?

And yes. I went very fast, but I tried to be precise. We have 2 types of activities, exactly like we did for imaging. I told you that for imaging we run a Phase I clinical trial, a company sponsored trial. But we also allowed compassionate treatment. So to give you the numbers for imaging, it was 18 patients for Phase I and it was more than 200 patients for compassionate treatment. For therapy, it's the same story. You know that both Lutathera and Pluvicto have largely been developed with compassionate treatments and company-sponsored trials. And the same is happening here. The compassionate treatments are allowed in certain German countries, namely Germany has been always very active for this life-saving opportunities when patients have no alternative. And to give you an idea, we have already treated the first 2 patients. They are typically very young patients. They were both with metastatic colorectal cancer, heavily metastatic disease, strong uptake and basically, they go for 200 millicuries of Lutetium-177 on OncoFAP and this is an opportunity to learn. But of course, what matters is also the registration trial. We have filed an application for a clinical trial Europe-wide and the trial for these 2 arms. One is the dose escalation arm monotherapy and you can imagine that with radiolabeled compounds, you don't have to go through, I don't know, 5, 10 cohorts. You do 3 cohorts, 150 million to 100 millicuries, by the way we already know the 200 millicuries are well tolerated, and you look at activity in monotherapy. The other arm features OncoFAP Lutetium-177 plus L19-IL2 because we have published in the Journal of Nuclear Medicine that these 2 agents are strongly synergistic in the preclinical setting. So you have to imagine that the company-sponsored trial will start in November this year. The compassionate treatments will continue. The Phase I part of the study will be finished in 2025 but then the dose expansion will certainly continue in 2026. But you have to imagine something that by the end of 2026, we'll have a substantial body of patients, both from the dose escalation arms and from the compassionate treatment. So I think it's fair to say that already by the end of this year, 2024, we will be able to make a statement about activity in compassionate patients, but only next year, we will be able to make a statement in the company-sponsored trial. I can already make the statement that the imaging looks very good and that this therapy makes sense based on what we have seen in patients.

We will wait additional 30 seconds.

Isacco?

Everybody. Hope you can hear me well. A couple of questions from my side. The first one is on the U.S. trial of Nidlegy. After some calls in which it looked like things were moving a bit slow, my impression is that your tone is a bit more confident. So if you can update us on, say, an idea of the timing to complete the trial, say, in terms of lag to the European trial for instance?

With pleasure. So the -- what is happening is the following. First of all, the ASCO presentation and also the meeting in Chicago, the U.S. investigators were very positive. The doctors liked the data that were presented, and we have been able to take onboard additional quality centers. For example, today and yesterday, we had in Siena representative of the Dermato-Oncology Group of MD Anderson, and it makes a difference to have this type of persons and centers on board for quality and also for recruitment. So in terms of recruitment and in terms of regulatory activities, the time lines are as follows: we are filing for a pre-BLA meeting with the FDA. This is a Type B meeting in which basically we go to the FDA, we present the European data, and we ask whether the FDA would be comfortable allowing an application for accelerated approval. This is the name in the U.S. for conditional approval. So this yes or no answer will happen in the second half of 2024. And we are optimistic because we have an orphan drug designation in the United States, and we are also treating a heavily pretreated patient population. So this is the regulatory work with the European data towards a possible but not certain conditional approval in the United States. Now regarding the Neo-DREAM trial. So the registration trial in the United States, the Phase III trial in the United States, we have more than 100 patients treated. We -- our projections show that the trial should read out sometime in 2026. And I think from the next presentations, we will start adding also the U.S. charts so that you can see the evolution of the trial in real time. So the projections have not changed. We expect a readout sometimes in 2026, and we will have more granularity in the coming months.

Second question is on more generally speaking, on the commercial strategy. You had some important clinical meetings. You mentioned ASCO. Just wondering if there has been any change, any additional interest on either the U.S. part of Nidlegy or Fibromun?

I'm very delighted to add, and I'm happy if Emanuele complements. So for Nidlegy, I can tell you, we are extremely pleased with our collaboration with Sun Pharma. Sun Pharma is a dream partner. At this moment in time, the commercial agreement is focused on Europe, Australia and New Zealand, but it's no surprise that we have a broad mind about possible extensions of commercial activities. And what is happening, and we had mentioned it in the past, but now we can be more explicit. SOTERNEC is really approaching the moment of truth in the sense you have seen in soft tissue sarcoma, we have already 116 out of 118 patients and 2 patients have already announced that they want to receive treatment. So this study will complete enrollment by the end of July. So this is the moment to find a commercial partner. We have concrete dialogue on this topic. And I think we have the opportunity to have good commercialization strategy also for SOTERNEC. But as always, in business, you announce the results if and when contracts are signed. So we are delighted to see interest for SOTERNEC both at the medical and at the commercial level. We are very actively working on this program, and maybe Emanuele wants to expand.

It's very clear. The focus is to define the strategy and the partner for the SOTERNEC and this is what make our days very busy.

It is clear that if we finalize a commercial agreement, a good distribution agreement, in the second half of 2024, then we have perfect timing for the preparation of early access programs and the submission of regulatory applications. This type of agreements make sense on a global basis. You understand that for skin conditions, the incidence is uneven because patients with fair skin have a higher probability of developing skin cancer compared to other patient population. For glioblastoma and for soft tissue sarcoma, skin color doesn't matter because the incidence is basically very similar globally and also ethically you need to be able to provide the drug on a global basis. We are receiving requests globally, both for soft tissue sarcoma and glioblastoma. So it's very, very important to make sure that with whatever partner we work, that the partner has the track record and capability to offer the drug on a global basis, and we are very active in this field.

Wait 30 seconds, and then we can close the event.

As always, we care very much for our dialogue with interested parties and with investors. So if and when you want also to request a one-to-one meeting with Emanuele and with me, needless to say, we are always at your disposal.

Thank you all very much. I think the next webinar will be around end of September, beginning of October. We will keep you updated with the new press releases, especially when now the 118 patients in the [indiscernible] trial would be enrolled. Thank you very much. Have a nice day.