Welcome everybody to our new webinar. Today, as always, we will give an update on the latest financial and industrial results. We'll focus on the first half of 2025. We have very good news also to provide, that we have also enclosed in the recent press releases about the new licensing agreement with Racebio. That brings a lot of new resources for the company. We will tell you also how we will think to invest these new resources. As always, we have Dario Neri, our CEO and CSO, Laura Baldi, our CFO. We'll split the presentation among the three of us. The presentation is being recorded. It will be followed by a Q&A session, which is not recorded. I will start off with the presentation and then hand it over to Dario. I will alternate. For those who are the first time attending these webinars, Philogen is a Swiss-Italian biotech company. The Philogen mother company focuses on antibody therapeutics based in Siena, while Philochem, the fully owned subsidiary of the Philogen group, based in Zurich in Switzerland, focuses on small molecule therapeutics. You will see over and over during the presentation the split between these two colors: green antibodies and blue small molecule therapeutics. The group is listed on the Italian Stock Exchange since 2021 and enjoys collaborations with different pharmaceutical companies. As a company, we discover and develop drugs which target mostly tumors. You see that normally the feature is ligand. That can be either an antibody or a small molecule ligand that we discover in-house through and co-elaborate technologies that we've been practicing for the last 25 years. Plus, once we discover a ligand, then we couple it to payloads that can be, let's say, cytotoxics, radionuclides. If the ligand is small, the payloads are small as well. While with cytokines, we mostly focus on antibody-cytokine fusion. You also see here the color matching between green antibodies and blue small molecules. Why ligands are important, you see it from this slide. If you just inject a chemotherapy here on the left, this goes everywhere except to the tumor. This is a patient, for example, with mesothelioma. You expect the tumor around the lung, but the chemotherapy goes to the liver, the intestine, but never goes to the tumor. If you use IgG antibodies, those are better, but they're very big. They take forever to extravasate from the bloodstream. You may start getting a decent tumor-to-organ ratio at seven days post-injection. You normally also see a steady uptake in the liver for a long period of time. You can do much better using antibody fragments, which are smaller than conventional IgG. You have a very good tumor-to-organ ratio already at one day post the intravenous injection. You see, as an example, a patient with liver mets of breast cancer. Of course, the world record can be achieved using small molecules with ultra-high affinity to tumor-associated antigen. This is an example of OncoFAP. You get excellent tumor-to-organ ratio in 20 to 1 already one hour after the injection. In June, we announced a new deal with Racebio on our new ligand called OncoCP3, that has been cleared by the Antitrust also in August, so recently. The partner is Racebio. It's a BMS company with a big focus on radiopharmaceuticals for oncology. The product is a small molecule ligand targeting ACP3 with ultra-high affinity and specificity. As disclosed also in the press release, we have an ongoing phase I clinical trial, company-sponsored, on the diagnostic agent. There are ongoing IND-enabling activities for a therapeutic agent based on actinium-225 that are ongoing. We launched also phase I clinical trials for a therapeutic agent. This is what we've disclosed in terms of key economic terms: $350 million upfront plus, let's say, $1 billion in development, regulatory, and commercial milestones that we expect, and up to $1 billion. Also, mid-single to low double-digit royalties on global net sales. We have received also many questions on what do you do with all these resources. It's very simple. We'll invest in late-stage products, like Nidlegy and Fibromun. We have also just launched three additional global trials in non-melanoma skin cancers, on which Dario will expand. On Fibromun, we launched also the phase IIb part of Gliosan, the first line trial. We will bring a new pipeline. For example, we start a new phase I with L19IL2 with arleukin. We will start also the dose expansion of Dorikin. This is L19IL12. We expect additional four programs to start phase I that we've discovered also recently here in Zurich. We expect the phase I to start in the near future. For the small molecules, we will present here for the first time excellent data from the phase I clinical trial of OncoCA9, Gallium-68, a new imaging agent that we are investigating in the clinic. We are now already planning the launch of a phase III. We also are planning the launch of a phase I of the SMDC, OncoFAP-GliproMMA. It's the non-radioactive derivative of OncoFAP targeting fibroblast activation protein that also showed very good data in dogs with spontaneous tumor. Lastly, we're also expanding the clinical team to new Milan offices. We have revamped the facility of Monteriggioni that has been operational since 2004. It was very important for all clinical trials that have been conducted so far. We are expanding the research activities here in Zurich, so Otelfingen, that have been instrumental, for example, for all new molecules that they've discovered so far. With this, Dario will start off with Nidlegy. I will take over for Fibromun. I will hand over to Dario again for the small molecule therapeutics. Laura will finish off with one slide on financials. Thanks a lot, Emanuele. I'm delighted to give you an update about Nidlegy, our advanced dermatology drug. You remember that it's a combination of two active principles, two immunocytokines, L19IL2 and L19TNF, mixed together in a combination pack approved by EMA. This is given intralesionally to patients with melanoma and other types of skin cancer. In melanoma, we are actively working towards the resubmission of the marketing authorization application. We are diligently doing activities that have been discussed with EMA. We are also seeking regulatory advice from authorities, which means we are busy and we think we know what we are doing. The sister trial, which is the NeoDream trial in the United States, is making progress. We are devoting a lot of energy to the activation of additional sites in multiple geographies, including the U.S., Canada, and within Europe. I would like to focus more on non-melanoma skin cancer because these are activities where we can draw some conclusions from the completed phase II clinical trials, but also we can look at the registration trials that have just been launched. As presented in the past, we had two phase II clinical trials in basal cell carcinoma and squamous cell carcinoma. The Duncan trial enrolled 94 patients, two more than the planned 92 patients, and has been completed. It will be presented at ESMO next month. The Intrinsic trial is also well advanced, with 50 patients treated out of 70 which are planned. I think we have a good understanding of how the drug works in basal cell carcinoma and squamous cell carcinoma. I'd like to show you three examples here in this slide with basal cell carcinoma in the nose, in the cheek, in the scalp. Usually, these tumors are frequent and they occur at light-exposed parts of the body. If you treat them by surgery, the outcome can be really disfiguring. You see a lady with a lesion in the nose, which really disappears completely, and you have a complete response at week 52. A quite diffuse lesion in the cheek, and you see the response to treatment, and progressively, the lesion goes away. Again, you see a complete response by biopsy analysis at week 52. Here, you see an ultra-large lesion in the scalp. It's one of the largest tumors that we have treated. We were delighted to see a complete response, even for a lesion of this size, at week 52. These are results that, of course, fill us with pride and also with motivation to do well in the future. A couple of additional examples, a young patient and a 94-year-old patient, again, to show that the treatment is well tolerated and can be administered to different patients. You go here from a situation, you would say this is a small lesion. It's a BCC that would have required the surgical amputation of 2 centimeters of lip, which means it's horrible. It's disfiguring for the rest of the life. You can see with, again, one-year follow-up that the outcome is perfect. This was a 94-year-old lady with squamous cell carcinoma in the cheek. Again, very large lesion. You can see the week 52 photograph confirming a durable complete response. We are proud of these results, which triggered the launch of new trials. Namely, we have submitted three trials with registration potential. One in cutaneous squamous cell carcinoma, second line, phase II, which means last line, single arm, 92 patients. Similar trial in BCC, third line, single arm, 92 patients. A trial which could treat anything between 60 and 180 patients in earlier BCC patients. The protocols have been approved by the U.S. FDA. The expansion to Europe is ongoing, demonstrating our commitment to a global registration program. A head-to-head first line trial in BCC is in planning. We will update you when the data mature. With this, I hand over to Emanuele, who will drive us through the Fibromun programs. Yeah, thank you. You remember that we have three programs in soft tissue sarcoma and three programs in glioblastoma. The product is partnered with Sun Pharma. This is a global deal, whereas the partnership with Sun Pharma Nidlegy is focused on Europe, Australia, and New Zealand for skin cancer applications. Glioblastoma is the most malignant and deadly primary brain tumor. There are at least 15,000 patients in the U.S. every year that are diagnosed with the disease. Unfortunately, virtually all of them succumb at some stage within 14 months. Soft tissue sarcoma, the situation is not much better. There are 13,600 new cases, according to the numbers of the United States. Around 40% to 50% of them are metastatic. All these metastatic patients, unfortunately, also succumb to the disease. What is TNF? Nidlegy TNF, which is Fibromun, is still an antibody cytokine fusion protein. This time it's given systemically by intravenous infusion. We've shown in several publications that it goes through the tumor, sparing healthy tissues, which is exactly what we want to achieve with the targeted therapies. In soft tissue sarcoma, with regards to the three programs, the one in first line, in combination with doxorubicin, we have completed enrollment exactly matching our expected industrial timelines. We have treated a bit more patients than the one foreseen by the protocol, which is allowed from the protocol. The primary endpoint is progression-free survival. We've reached all the events. It's in 92 out of 92. We are finishing the analysis of the data that will be communicated in the coming weeks. In the third line setting, also we have completed enrollment matching our internal timelines. We treated also here a bit more patients than one expected from the protocol, which is allowed. Here we're missing four PFS events for the final readout of the trial. In the coming weeks, we will communicate the results of the first line trial. In glioblastoma, also we are running three trials. The Gliosan is in first line, so newly diagnosed patients. We have completed the phase I. We are now also seeking regulatory advice, also in collaboration with Sun Pharma, with FDA, and EMA, to directly transition from phase I to phase IIb. This regulatory advice will happen in the coming months. We will be able to update you as soon as we have this information. For Gliostar, it's the second line trial, so glioblastoma at first progression. Remember, we have enrolled patients much faster than expected. Those are the updated predicted, let's say, timelines with actually observed enrollment rate of patients, which match with the updated prediction. We have also here completed enrollment with 163 patients out of 158 foreseen by the protocol. We expect the OS events here, because the primary endpoint is overall survival, in early 2026. Of course, we don't have a control on when patients have an event. I think based on our, let's say, internal projections, we expect that to happen in early 2026. With regards to the other study, the so-called Gliostella, which enrolls patients with a second or later or more progressions, those are more advanced patients compared to the Gliostar. Also here, we have enrolled patients faster than expected. We have enrolled all patients, so the 90th patient was enrolled this month out of 90. I think we need to wait for the OS events to mature, and we'll be able to communicate the results somewhere in 2026. With this, and as promised, we finish this with some information on the blue part of the pipeline, namely the chemicals. This is a part which has grown very rapidly over the last few years. I think last year, probably we took three new molecules to the clinic. We, I think, are very excited about the results which are emerging. The potential is the one that Emanuele had already explained before. These are two patients with FAP-positive tumors. In the first case, the patient had received the radiolabeled antibody. In the second case, the patient had received our radiolabeled OncoFAP. It's clear that, at least for this target, small molecules work better for targeting. This is true at the macroscopic level. We have extensively published also on the fact that at the microscopic level, small molecules may be better delivery agents than antibodies, more homogeneous. We want to give you an impression of what we are doing. Once we discover our ligands by the encoded chemistry, many different opportunities can, in principle, be performed. I will focus on radionuclide delivery and drug delivery. First, I'll give you an update about FAP, fibroblast activation protein. The update is that basically we have the program for imaging partnered with Bracco. We have our own therapeutic product, which is still owned. It's attractive to show you what we can do in terms of drug delivery, where OncoFAP basically, and this becomes explicit in the next slide, you see in blue the OncoFAP portion of the moiety, then a cleavable linker here depicted in green. The payload is monomethyl auristatin E, which is a highly cytotoxic payload. The logic is very simple: to deliver MMAE to the site of disease, helping spare normal tissues. This is twice selective, so to say, because we enjoy the selectivity of ligand-based pharmacodelivery. We also enjoy the selectivity that we have chosen as cleavable linker GliproMMA, which is the substrate of FAP. FAP is both the target and the enzyme which liberates the drug at the site of disease. We have previously reported on the really exciting results observed in spontaneous tumors in the veterinary setting. You see a sarcoma in the mouse with 3 centimeters of diameter responding rapidly to the treatment with drug conjugate. This is the caliper measurement. The same animal at some stage relapsed because we were not allowed to treat more than four times. When the tumor relapsed one year later, it was very big. You see 15 centimeters in diameter and again responded nicely to four injections of the drug. We are running GMP manufacturing. Safety tox activities are also ongoing with the goal to be in the clinic next year. This is very exciting. I think it will be a small molecule drug conjugate that hopefully has the potential to show activity. If we look at carbonic anhydrase 9, this is a target where we have probably been the first group in the world to show that small ligands can be used for targeting. I'll show you data with our second-generation product. We had a first-generation product in the clinic, which was good. It's published but had some accumulation in normal organs, including the kidney. We wanted something more specific. We used the encoded chemical libraries. This is the work of Sebastian Euler and colleagues to discover molecules here represented as dots that bind very specifically to carbonic anhydrase 9, but not to other carbonic anhydrase isoforms. You see BIACORE profiles here for carbonic anhydrase 9, the intended target, and no binding, for example, to carbonic anhydrase 2 in a logarithmic plot. You can see how the new generation molecule in blue is extremely selective for carbonic anhydrase 9, whereas the old generation products were not selective. Many other competitors in the clinic lack this selectivity. The question is, OK, what can we expect? We have published that in animals, the molecule looks very nice. OncoCA9, radiolabeled, has a good accumulation in the tumor% injected dose per gram, which is saturated only at about 1 micromole per cubic meter, with an excellent tumor-to-organ ratio. It is a durable accumulation in the tumor. Here you see a PET image in mice showing, again, this beautiful selectivity. We moved the molecule to the clinic in collaboration with clinical centers in Northern Italy. I would like to highlight here the collaboration, acknowledge the collaboration in particular with Arturo Chitti. The three patients which are indicated in the slide come from his clinic. You see with the green arrow a very strong accumulation in kidney tumors. The normal kidney is completely clean at one hour. There is an uptake in stomach and in the small intestine, which is expected because carbonic anhydrase 9 is completely clean in the rest of the body, but is present in stomach and small intestine. For diagnostic reasons, this is not an issue at all because the intended use of this molecule is to show if there are masses in the kidney which are clear cell renal cell carcinoma and plan adequate management of the patients. The data are so good. We show you only three, but they are so good that as a company, we are considering moving directly from phase I to phase III. We know that there is a medical need in the field of radiopharmaceuticals. Telix has just completed phase III clinical trials with a radiolabeled antibody called Girentuximab. They showed good sensitivity and specificity. We feel that we can get to the tumor much more rapidly and with less radiation burden compared to an antibody which needs several days for adequate imaging. We are really working towards hopefully making this product a reality in the market. With this, I give you an impression of what we are doing, again, continuing to do with small molecules, taking them to the clinic. With this, I hand over to Laura, Laura Baldi, our Chief Financial Officer, for the last slide that summarizes the breakdown of the net financial position at the end of first half 2025. Laura. Thank you, Dario. Only one slide on financial to show in a graph the cash burn of first half 2025. The year opened with a cash and cash equivalent of €110.7 million, increased by €5.3 million of new proceeds from a contract with a client we have in place. Operating costs absorbed cash for approximately €17 million, CapEx €1.7 million, and €1.4 million is the payback program that the group is going on. All these amounts are compensated in part of approximately €1 million of positive financial items. The first half of the year closed with cash and cash equivalent of €100 million. As Dario and Emanuele said before, after the clearance of Antitrust, the contract with Racebio is effective. The upfront payment of $370 million has been cashed in September. Now the financial position, cash and cash equivalent, is more than €350 million. The group enters in this second part of the year with a very ample liquidity and solid long-term financing capacity. From my side, that's all. Thank you. Thanks a lot, Laura. I think now we will stop the recording. If there are any questions, we'll be glad to discuss with you. We can do it online now, or otherwise, of course, as always, we are available to interested parties and investors and analysts in dedicated calls, some of which have been scheduled. Rajan. I should be able to speak. Hi. Can you hear me? Great. Thanks. Thanks for taking the question. I just was wondering if we could get an update on the EMA refiling process for Nidlegy, please. We know that there were two issues that needed to be resolved, which was the CMC and then also the additional data analysis. I was just wondering if you could provide an update on progress on either or both of those. On the data piece in particular, you mentioned that you needed additional EFS analysis and longer OS data. Do you have those now? Yes, we are working on both activities. The GMP activities de facto involved additional characterization and validation activities that have been performed. In addition, we are anyway continuing to manufacture our product because we need it for our trials. We have arranged a meeting with the Paul-Ehrlich Institute, the German authority, in November. This is the authority of the rapporteur for our product. We look forward to this meeting because it will allow us to discuss technical issues again in preparation for the resubmission. At the clinical level, we were very explicit mentioning that on one hand, we need additional evaluations. As time goes by, overall survival data matures and will allow us to resubmit the dossier with more mature data and adding data to the submission. We are pleased with the process. If there are news from the interaction with the Paul-Ehrlich Institute or other authorities, we will update you at the next webinar. Yeah, the timelines are kept also compared to the last time we spoke about. We still plan to resubmit mid-next year. Of course, we will keep you updated as the dialogue with the authorities continues. OK, thank you. Thank you. Other questions, Rajan? Zacco also has this. Yeah. Hi, Zacco. Hi, everybody. Hope you can hear me well. Three quick questions from my side. The first one is on the initiatives you mentioned, if you can help us quantify the CapEx associated to investment, to revamping in Monteriggioni and investments in Zurich, and how hiring in the clinical section should impact your overall cost base, annual cost base. Second question is on your strategy for the U.S. route to market. Does the cash in from the recent agreement on OncoCP3 change your ambitions to go direct in the U.S. for Nidlegy? Last question is on the multiple non-melanoma trials you mentioned, if you can share a bit more color on sort of indicative timetable to complete these trials. With pleasure. The first topic. The cost of the revamping. Cost of revamping. I can tell you that the revamping of Monteriggioni was about €1 million of investments. We have really a very nice facility. We will seek now the confirmation of our license up to phase III clinical trials. The facility is really nice. We had separation between pre-viral and post-viral processes that we didn't have before. We have presented it at least in a dedicated teleconference to authorities. The formal procedure is to submit now the documentation asking for the re-approval of the facility. We expect it to happen in the coming months. With respect to. So Milano. Yes. Now, with respect to Milan, this is an important decision for the company because you know until now, we have operated in Zurich and Siena. Sometimes, especially for clinical activities, it's extremely important to be able to rely on skilled persons. It is a fact that it's easier to find these professionals in the Milan area. Not to say that actually Milan is halfway between Zurich and Siena, which again, makes interactions and meetings easier. We have already offices in Milan, but the new headquarters will open in January. This is an important step forward for the clinic. In terms of Otelfingen, it's really seeing how productive Philogen has been. We have the intention to expand further the laboratories. We want to build a dedicated biosafety level two lab. These are technicalities, but these are activities that probably don't need to go into a financial plan because we are not speaking about huge figures. The core of the labs has been built and it's operational and will continue to be operational. When we speak about the route to the market for the U.S., yes, this is certainly, we are very pleased with our financial position. We expect it to continue to be good also for the future because we are very pleased with the various activities of the group. It's nice. We are a company in a good financial position. I think we have shown our ability to generate technologies. We don't have products on the market yet. As you have seen, this is our ambition and we try very hard. At this moment in time, our focus is more on getting our programs always as global registration programs. The partnership with Sun Pharma is very good. At least from our side, we are very pleased with Sun Pharma as a partner. For this reason, I confirm what we said before. I think the most logical development would be to have Sun Pharma as a distribution partner for the U.S. Again, this is something which we will have to see. We have the option to do it ourselves for the dermatology product. This is something which is not yet decided. Now, for the non-melanoma skin cancer, I can be more specific because this is an area which we consider to be very attractive. It's a high, high incidence market, both for basal cell carcinoma and squamous cell carcinoma. Basal cell carcinomas, for example, are the most common tumors on Earth, about 4 million new cases per year in the United States. Luckily, most of them you can cut away. About, let's say, 1% to 2% are high-risk tumors. Even 5% are tumors that you can cut, but then you pay consequence in terms of disfiguration. There are opportunities. What has been our thought process and what are the time to development? The thought process was that the product is probably going to help patients both in BCC and SCC, but you need to run dedicated trials, hence the dedicated programs. When we asked authorities, you know, can we do it with single-arm trials? Should we do it with controlled randomized trials? I think the answer was very clear, which means that if there is a standard of care, you have to be the standard of care in a controlled trial. If you are in last line, you go with single-arm trials. For the third line BCC and second line SCC, there is no standard of care. We go with single-arm trials. We are working very hard now to launch also a first-line trial in BCC because we believe that our product has what it takes to offer a benefit to patients. I don't want to make forward-looking statements, and I will not make them. I will state a few facts that were presented in the slides. For example, in the slides of Emanuele, he showed that we were able to run complex trials in glioblastoma. Running trials in glioblastoma is much more difficult than running trials in basal cell carcinoma. Basically, the Gliostar trial was recruited in two years. The Gliostella trial was recruited in about one year. These were trials respectively of 160 plus patients and 90 patients for Gliostella. This gives you an idea of the type of recruitment rate that we have shown in the recent past. Of course, for BCC, it's easier because the typical patient who has a lesion receives four injections once a week and then is in follow-up. Also, the time to follow up is faster. Typically, the responses come up in two to three months, and they're durable. I see, Zacco, maybe you have follow-up questions on this. No, I guess that's enough. Thanks, Dario. Very clear. Thanks a lot. Are there additional questions? If this is not the case, we would like to thank all participants, of course, all patients, all clinical centers that worked with us, and also, of course, our partners. Thank you very much. Have a nice day. Thank you. Bye-bye.