Philogen S.p.A. ($PHIL)

Okay. Welcome, everybody, to this new event. Today, we focus on the full year results of 2025 both from a scientific and financial perspective. As always, on. The call, we have Professor Dario Neri, our CEO and CFO, and Dr. Laura Baldi, our Chief Financial Officer; and myself, here as the Head of Investor Relator. And we're happy to guide you through the presentation lasting about 30 minutes, which is recorded and will be followed by Q&A session, which is not recorded. Without further ado, I hand over the stage to Dario Neri to guide you through the slides.

Thanks a lot Manuela. And basically, the first slides are the ones that we always use, but there may be new persons in the call -- the Philogen Group focuses on antibody therapeutics -- and it also owns a fully owned data company called Philochem, that deals with small molecule therapeutics. We will show examples from both types of technologies -- and the Milano site, which is really halfway between Zurich and Ciena is gaining momentum. We are expanding clinical activities in this new clinical site, mainly devoted to clinical science and also to data science. As always, the strategy of the company focuses on the use of payloads proven therapeutic activity, cytotoxic drugs, radio cytokines that we deliver to the site of disease by fusing them to ligands that bind to tumor-associated antigens. In other words, we take payloads and we try to make them better by delivery to the site of disease. And these ligands are discovered in-house from very large encoded combinatorial libraries. They may be antibody fragments, they may be small organic molecules and we'll give you in the final part of the presentation some update about our ability to discover these delivery vehicles. Now the promise of the technology is a quest for more selectivity. We know from nuclear medicine studies. These are 4 patients with cancer that if they receive chemotherapy, or if they receive conventional antibodies specific to tumors, these conventional methodologies are not particularly selective in tumor uptake, Indeed, chemotherapy usually does not show a preferential uptake in tumors, while IgGs may preferentially accumulate in tumor, but without outstanding sellectivity with our our antibody fragments or with our small molecule specific to tumor-associated antigens, we get good preferential uptake in lesions -- and these are experimental images observed at one day with one of our antibody fragments or at 1 hour with 1 of our small molecule ligand. So it's a gradient of selectivity. This is the pipeline when the company was listed 5 years ago. So in March 2021, you see molecules that we will present in more detail later today. And basically, in green, you see the antibody-based products in blue, you see the small organic molecule products. And we compare it to the pipeline today, we see a richer pipeline with many more trials in blue we indicate trials which have been completed. In red, we show trials that have been submitted in 2026, and we will go slowly through the pipeline so that you get a detailed really presentation on what is happening for the various programs. So it's better to go really product by product and focus on the different indications, but let me state that we have made progress with the pipeline and at least in 2026, we have launched many new trials. Let's start with Nidlegy. Nidlegy is a dermato-oncology product. It's a combination of 2 active ingredients, which are called LIL2andBL19-TNF. It's given in traditionally, and it's used for dermato-oncology indications, and we will focus both on melanoma and in non-melanoma skin cancer. The melanoma programs are focused on Stage 3 BC melanoma, which means locally advanced resectable melanoma. The design, both for the European trial and for the confirmatory American trial features a 1:1 randomization of patients who may receive surgery for midline the neoadjuvant setting followed by surgery and then recurrence-free survival is the primary endpoint in both studies. We have agreed with the FDA to include event-free survival also as an important endpoint for the study. And we are expanding the American trial to be a truly global trial reaching 40 sites, and these activities are ongoing. On top of that, together with our partners and Pharma, we have an expanded access program, which actually has allowed many patients in need of the drug to receive it and to be treated with Nidlegy agent. Now the data that we published last year in terms of recurrence-free survival over time, show a superiority of Nidlegy Daromun, is the other names on idle over the standard of care surgery. And this is the RFS curve for the whole population -- and this is the RFS for the patients that were pretreated that account almost for 90% of the whole population. So you see that there is a benefit compared to the surgical control group. And these are new data with longer follow-up time that basically nicely confirms what we have done. And these are event free survival data per Dina. So -- these are the type of data that EMA wants to see when we submit applications. So I toggle back and forth, RFS and DFS, we are pleased with the data that we will present. Now where do we stand? In November, we aligned with Polar Institute, which is a German authority about the work with the industrial manufacturing of the drug. And we are very pleased with where we stand and with the feedback that we received from the Polar institute. Also as promised, we had the Type C scientific advice session with which we were able to present the European data and get alignment on the regulatory path for a future approval based on both European and U.S. trials. So we are pleased also with this interaction. We are at the presubmission meeting with reporters aiming for a submission in July 2026 for the European Marketing Authorization and sometimes next year, there will be a decision. We are also committed to finishing the U.S. trial as soon as possible so that the data that have been discussed with the FDA can hopefully form the basis for an application for marketing authorization also in the United States in non-melanoma skin cancer Duncan is a Phase II trial in BCC and CD with 94 patients, which is completed, whereas intrinsic, the second Phase II trial is almost finished. We have already rolled 65 out of the target 70 patients. And the data have been presented desmofor basal cell carcinoma and the squamous cell carcinoma data will be presented in 2026. Here, some of key collaborators are shown in the slide. We have shown these pictures before, patients really enjoying a durable complete response in basal cell carcinomas that would have required relating surgery. And of course, we are very pleased with this data, which have been published. And -- these are 3 patients with business circurcinoma that would have required disfiguring surgery -- in all cases, you see the 52-week follow-up. So the 1-year follow-up documenting a durable benefit with very clear functional benefit and durable complete response and also smaller regions, but they would have required disfiguring surgery with durable benefit in a younger patient and in an elderly patient. So these are some of the data that we continue to accumulate in support for the registration programs. So where do we stand? We have the ambition to launch 4 trials with registration potential three, the first 3 here depicted in green are in squamous cell carcinoma second-line BCC third line, BCC first line, these 3 trials are already approved by the FDA, and they are at a good stage of expansion to Europe, all the interaction until now has not shown any red flag. So basically, this will be global trials for which we indicate the target number of patients, the estimated completion of enrollment and the interaction with authorities has been satisfactory. There is a fourth indication in a controlled trial in which we run Nidlegy against inhibitors in the first-line setting, -- we have successfully completed the Type C meeting with the FDA in which we have reached clarity about the rules of the game to have this as a registration trial. And we are now going ahead with the submission of the application for this pivotal trial, Phase III trial. With this, I hand over to Emanuele, who will guide us through the Fibromun program and also other immunocytokine programs and I will take over for the chemistry and for the financial summary.

Thank you, Dario. Remember, Fibromun is the second most advanced asset in our pipeline, is also licensed to Sun Pharma, who is our commercial partner, we're very heavy about the collaboration. We're focusing on 2 big indications, let's say, challenging called the Soft Tissue Sarcoma and glioblastoma and as [indiscernible] in blue, you see the trial as that have been completed. In black, you see the trials that are ongoing and in red, the new trials that we are launching now. Just as a quick reminder, glioblastoma is the most aggressive primary brain tumor, kills more than 10,000 patients every year only in the U.S. Soft Tissue Sarcoma is also a very aggressive indication, especially when it becomes metastatic and it feels more than 5,000 patients every year in the U.S. only. Fibromun is one of the 2 active ingredients of Nidlegy, you see the antibody in green fused to TNF. In red, this red part is really by active payload of the pharmaceutical. Fibromun itself is given systemically by intravenous infusion. We have orphan drug status for both indications for both Europe and the U.S., and we've shown that the drug goes to the tumor sparing healthy issues. We completed the most, so the Phase II trial interline setting in which film is combined with the carbazine which treated all patients, 94 patients for by protocol. I mean, it is allowed to treat a bit more than what expected. And we reached all the events for the without of the study. We also completed the Phase III trial in first-line setting, where the combination agent here is doxorubicin. And also here, we reached all the events for the without of the study. And in both cases, the progression-free survival was the primary endpoint. Here in the Phase III, as I announced also earlier, last year. Let's say, we -- despite we didn't meet the primary endpoint, there was a strong signal in overall survival in a subgroup of patients, representing 67% of the overall trial population and consisting of liposarcoma plus other subtypes, which are indicated at the bottom of the slide. And you see that the medium overall survival here went from 13.6 months to 21 months in red. And on that basis, we're basically planning the next steps. So the next steps will focus on the first-line setting where we have approximately 20,000 patients addressable every year in the U.S. plus Europe. And beyond the overall survival signal, we also saw a complete response in the Fibromun study. In this patient with metastatic mix of fibrosarcoma, 1 of the most aggressive SCS subtype, see this patient at [indiscernible] here that the combination regimen, which is something unprecedented very rare to see in this setting. And on that basis, we also are launching the so-called FIBROSARC Phase III study in this subgroup of patients of the FIBROSARC trial. And we have already requested our parallel scientific advice, both with FDA and EMA to align on the protocol that will take place around [indiscernible] this year. After that, we launched the study in the clinical trial application, so the submission of the clinical trial application is expected in 2026. In parallel, we are ongoing -- we are progressing with the FIBROSARC U.S. study, Phase IIb study in metastatic leiomyosarcoma in which we treated 83 out of 158 patients. And in the third line setting, where the patient population, which are addressable, which is addressable by a drug in that setting would have been 2,500 every year in U.S. plus Europe. In that case, the flash Phase II trial did not meet primary endpoint. So on glioblastoma, so here, we have also 3 studies, Gliosan in the Nolans setting. We have completed the dose escalation part, and we launched the dose expansion part of the study. which will be run and conduct will be conducted before launching the Phase IIb randomized part of BioSun. Then with regards to gliostar which is be conducting glioblastoma first progression -- so second line, we've completed enrollment and reached there was events that we present in the next slide, while gliostela, which is conducted in glioblastoma first or later progression in the U.S. We also enrolled all patients faster than what expected by our internal time lines. And you will expand those on time lines of the readout in the next slide. So to summarize the glioblastoma program GeoStar is 2 clinical trial conducted in patients with first progression. Here, we were speaking about 15,000 addressable patients. in the U.S. plus Europe every year. The trial did not meet the primary end point, as mentioned in the press release on Friday, but there was an improvement in terms of overall survival a group of patients had a limited exposure to alkylating agent, and this is similar to what we have also in Giosan. And for this indication is setting, so first progression remains a very challenging disease. We're not the only 1 that failed to improve survival, but also very successfully commercial drugs like VEGF blockers antibody drug conjugates or anti-PD-1 antibodies have failed to improve the survivor compared to the historical controls. The Gliostilla trial ongoing in the U.S. I said, this is in a later setting compared to GLIOSTAR and we expect the readout, which is the OS 12 months in September 2026. So on this will keep updated. And with regards to the GLIOSNUN -- we have that represents also the biggest market with 30,000 addressable patients every year in Europe plus in Europe plus U.S. We've completed those escalation and we launched the dose expansion part. So on this, I finished the Fibromun part. In general, we have announced a dotcom of GLIOSTAR and flash of soft cell Sarcoma will focus on the first line, most of the biggest market potential. And on glioblastoma we're committed to continuing the [indiscernible] GLIOSUN which are ongoing in a different line of treatment compared to the GLIOSTAR. A very quick update on the Intraco technology that we have mentioned also last time. This is just to say that we continue improving our assets. And 1 way to do it is to have strategies to improve and enhance the interpret index of our drugs, meaning that we can give more without toxicity by masking the activity of the payload initially after the injection on the concentration of the cytogenic -- and we do that by giving intracellular signaling inhibitor called ruxolitinib that masks the activity of the sarin the beginning without having an impact on Nitor activity. This is something that -- the update is that we've launched the first study, and we will keep you updated on the results from the clinical trial that we look very much forward to.

With this, I now move to the blue part of the pipeline, the chemistry component of the pipeline with different targets and also with new trials launched in 2026. I -- the promise, as mentioned before, is that if you target the same target, the same molecular target, the same tumor-associated target with a conventional antibody or with a small organic league and usually the small organic leg and wins. These are 2 patients with FAP positive tumors. I think it's quite obvious that with OncoFAP, we get better picture compared to the antibody. Now once we have a ligand typically discovered from our DNA code chemical libraries that recognizes the target of interest, one can use it to deliver regional clients, drugs or other modalities. Today, I will focus on clinical programs with this drug or radionuclide conjugates, but I'll also mention one example in the immunomodulatory field. So let's start with fibroblast activation protein, which is one of the targets on which we work. Here you see fact targets, but in reality, our list is rapidly expanding. By now, both in company-sponsored trial and also in compassionate treatments. More than 500 patients have been imaged using Gallium 68 on cap -- you see a few examples with really excellent selectivity at 60 minutes, heavily metastatic disease. This is the foundation for everything that follows. For Imaging, the product is licensed to the Bracco group, which is in charge of the development. We have retained the therapeutic rights. So OncoFap labeled with Lutetium-177 clinical trial has started. Here, you see the very first 2 patients that were treated and you see really already at 1 hour of fantastic selectivity in the tumor compared to normal organs. You see in the left a patient with triple-negative breast cancer and the right patient with colorectal cancer with metastasis deliver. And really, this is the basis for everything we are doing. We are excited by the dosimetry that has been measured by the centers and also the combination of opportunity with L9 IL-2. You remember that we have also a nonradioactive therapeutic program in which OncoFAP here depicted in blue is linked to a very potent anti-cancer drug called mono material statin, thanks to acrivable linker, which is cleaved at the level of this glycine proline structure -- so it's a small molecule drug conjugate, which has the potential to rival the performance of antibody drug conjugates, again because OncoFap goes to the tumor very efficiently. I had shown this picture before the first dog that was treated in a veterinary Phase I clinical trial, first at low dose, 3.5 mg per meter square. You see the tumor shrinking in just 28 days and then you see a bigger lesion also shrinking at a higher dose, 10 mg per meter square I just want to report that we are committed to the translation to clinical trials in humans, the industrial manufacturing and the safety tox studies are approaching completion. -- expect submission by the end of the year. And we continue to have good results in better in trials. This is a picture from one of the animal patients, which is still alive and in good shape more than one year after the recruitment into the trial. When we move to a second target called Carbon and [indiscernible] this is the best market by POX and also the best market for clear cell renal cell carci which accounts for about 80% of kidney cancers, namely the most aggressive type conventional imaging does not distinguish between malignant and benign kidney lesions and the result is that about 30% of masses in the kidney are removed, for example, by kidney removal, whereas the lesion will be benign if one would have known the surgery could be speed. So an accurate detection of clear cell renal circarcinoma promises to distinguish malignant from benign lesions and to spare unnecessary surgery. We have completed a Phase I trial with 20 patients with our gallium labeled Onco C9 product with really excellent results already at 1 hour, we can clearly see the tumor with excellent tumor to organ ratio as highlighted by the green arrow -- and by comparison, this is a competing product of Telix based on an antibody called Girentuximab labor with zirconium 189, and you know that antibodies have longer circulation times. So the imaging results have delayed possibly exposing patients to too much radioactivity. We are committed to the development of Onco C&I, and we have been very fast to go from the discovery of the molecule in 2024 to the Phase I trial executed in 2025 to the preparation activities for the pivotal trial, GMP manufacturing called Kit interaction with authorities. -- with the estimate to execute the Phase III trial in 2027, 2028. The incidence of renal circurcinoma in United States and in Europe are reported here based on literature data, -- and this incidence is expected to double in the coming years. So there is a clear unmet medical need, and we believe also market opportunity -- in reality, Carbonic Anhydrase IX is relevant not only for renal cell carcinoma, but also for other hypoxic tumors, including colorectal cancer. The last example, ACP 3 is relevant in the field of prostate cancer radiopharmaceuticals, which until today, have been dominated by ligands, small organic ligands, targeting the prostate-specific membrane antigen, PSMA, -- there are products for imaging. You see, for example, a product label with gallium 68, you see the very nice progression of sales or label with fluorine-18 for imaging, again and for therapy, one uses therapeutic radials like Lutetium-177. So the real pharmaceutical market for prostate cancer is dominated by PSMA. The cumulative sales of imaging plus therapy in 2024 were more than EUR 3 billion, and they're now approaching billion in 2025. So there is clearly a performance and a need for these products and the opportunity is to see whether can beat PSMA. This was a slide that was presented by the organizers of the European Association for nuclear medicine Congress in Barcelona, with an angry PSMA and smiling CP3. We did not draw this slide, but we were pleased to see the reaction of the scientific community had announced last year that we have licensed the global rights for imaging and for therapy to raise Bao, which is part of the Bristol-Myers-Squibb company. The product has as described in the press release potential for imaging and for therapy and as Bio has, of course, a commitment for alpha meters like actinium 225. The financials are repeated in this slide, and they were also disclosed in the press release, but very good upfront milestone and also royalties for the 10. We continue to do innovation because OncoCP3 was discovered using the encoded chemical library technology, and our technology continues to improve you can imagine that with very large libraries at hand, we have continued to isolate ligands against targets of high pharmaceutical value, and we feel that we have the potential to follow on what we have successfully done in the past and discover and valorize ligands for other important conditions. And this is work in progress. We hope already at the next meeting to be able to show you tangible performance results. The last slide is to summarize actually the penultimate slide is to summarize that we finished 2025 with a good net profit of about EUR 230 million -- we have, by the end of December 2025 cash and cash equivalents, approximately EUR 380 million. And because of the good result of 2025, there has been then the decision to issue a dividend of EUR 0.70 per share -- and with this, I hand over to the last slide before the discussion, a summary slide, which is also an outlook with idle, the work towards the marketing authorization application is on track. And importantly, we have a good alignment with the FDA following Type C interaction. The early access program adoption has been good in Europe. And importantly, we have trials with registration potential in non-melanoma skin cancer -- and we are excited by the results observed in more than 150 patients with non-melanoma skin cancer that are being treated. In Fibromun, Emanuele indicated that we like the promising signal observed in first line of tissue sarcoma -- and we aim at confirming this with the FIBROSARC trial. Patients are benefiting from this treatment, and we want to offer it to patients. While GLIOSTAR did not meet the primary endpoint in second-line glioblastoma, we remain committed to the bigger indication, which is Gleason in first line glioblastoma and third-line soft tissue sarcoma FLASH Phase II trial did not meet the primary end point. With small molecule pharmaceuticals, the FAP, C9 and the CP programs are progressing. But importantly, we have their technology to continue discovering and valorizing hits against valuable pharmaceutical targets. So the future life of the company will be a texture of all products now at advanced stage and new products that we continue to discover and bring to the clinic. With this, we stopped the recorded part of the session and open to the questions and answers that will not be recorded. As always, persons can announced their wish to ask a question.

The first one is Clemence from Stifel and the floor is yours.

All right. Thank you, and thank you for the presentation. Just first question, can you confirm that you will not pursue third line STS and second-line GBM, just to make sure I understood.

I can only tell you that in third-line STS, the Phase II trial did not show did not meet the primary endpoint. So if you want my personal opinion, it's unlikely that we push third-line STS. In second line or second line plus glioblastoma we are still analyzing the data that will be presented at major international congresses and the GLIOSTAR data need to be complemented by the GLIOSTELLA trial, which is fully American trial. And this will also be presented at the International Congress is -- so all I can tell you is what Emanuele presented is that there is a signal in patients who have larger lesions and also patients who were actually not exposed to alkylating agents. So we need to digest the data, and we will need to see in time which subset of patients benefit from the drug only a posteriory, you can make a decision. And the situation is exactly the same that we have seen with FIBROSARC. With FIBROSARC we announced that we had not met the primary endpoint, but we announced that we had a signal in that case, a survival signal in a population of patients, which is still considerable population. And so this is a situation which evolves while we were not pleased with GLIOSTAR results didn't need to be digested and the strategy follows.

Okay. Very clear. And maybe a bit touch that did those readout had any impact on your relationship with Snam on the Fibromun side? Are you working together for a development path? Or are you digesting the data, as you say, and then present potentially a new path to to how does it work between the 2 of you?

Well, I can only say we think that Sun is a fantastic company. We are very Pleased to have Sun Pharma's partner. As you have seen, we work on multiple programs with Sun, and we have launched new trials. So -- from our perspective, you should ask Sun. But from our perspective, the relation is very good, and we are committed to offering the drugs to patients as rapidly as possible and for indications in which patients have benefit. The dermato-oncology situation is very clear. So I don't think that this deserves much discussion. The Fibromun situation really requires a careful analysis for did patients that benefit from the drug and also the patients that do not benefit from the treatment so that we can have confirmatory trials. FIBROSARC is one such example. And typically, authorities are happy to see confirmed results. You have also seen that we go and ask authorities before executing these large trials, and that's what we have done in skin, and that's what we are doing now with soft tissue sarcoma and possibly this is what we will do actually, not possibly. This is what we will also do in glioblastoma. But it's really a sequence of getting the data, evaluating the data discussing with authorities and if appropriate, taking the next action. .

Perfect. And just one last very quick and I'll freeze the floor. Is 67% liposarcoma and other STS types something a ratio you would find in real life.

think it's higher, honestly, in real life, [indiscernible] is 25% to 30% of tumor types in soft tissue sarcoma, which is a basket of many different indications. So my number would be 70%. These are very well-documented proportions. So I think this certainly corresponds to the majority of soft tissue sarcomas and having a survival signal with a few patients really enjoy very long benefit is a good starting point. And of course, this needs to be confirmed. Isacco, Please go ahead.

I hope you can hear me well. The first one is on the expected cost and cash burn profile of 2026. 6 months ago, we were talking about with costs very well covered. In the meanwhile, we see Philogen launching a larger number of trials, maybe some negative readouts, which you are I don't know, building expectations in terms of mine stores. Just wondering whether the comment on expected no cash burn or a positive cash generation is confirmed for this year?

First of all, it's a complex question which touches on many points, and I'll try to go slowly through the many points. The first point is that as you see, we start from a very good cash position. You remember the cash position that was announced after the third quarter, and you see that basically, it's not changed. You also know that clinical trials have a different impact depending on the number of patients and also the type of trial design I can tell you that we can afford the trials that we are launching -- and as communicated in the past, we will not have an explosion of cost. Then I look at the revenues in a split second. But basically, we will not have an explosion of cost. We go into certain programs with very pragmatic attitude. First of all, if we can afford it, -- and if we have a reasonable expectation of hopefully getting a good result. So costs will not explode, and we always extrapolated a moderate increase of clinical cost, and this is confirmed now. As far as the revenues are concerned, you can imagine that I can say what I've always said that our revenues are a mixture of different items. There may be milestones received based on contracts that we have already signed. They may be service activities such as discovery of manufacturing that we continue to do well. And actually, that we are expanding our manufacturing business is expanding. And then there are the events that you have seen also in the recent past in which a newly discovered product attracts a pharmaceutical interest and may attract substantial payments. So as it would have been difficult to make estimates at the beginning of 2025, and we didn't do it at the time we are not making precise estimates at the beginning of 2026. We are only telling that our ability to execute programs and also to discover new products remains unchanged. If anything, it has improved. I think the company will have a good balance, a good financial balance, but we discover it over time. This is a personal judgment and time will show how the numbers look like. I just want to say we are financially very cash strong, and our spending is in check. I don't know if Laura wants to complement what I said, but this is the statement that I want to deposit.

Yes, yes, I fully agree, as you can see in the net financial position, we had for 2025, spending around EUR 4 million per month, so in a range of EUR 50 million in a year. and we expect to increase EBITDA, but not too much or probably to stay in the same range for the next year. We -- that you say, we don't expect to increase a lot. It depends on our program development.

And revenues will be communicated as they come along. As CEO, I I'm proud of where Philogen stands and what Philogen can execute.

A follow-up on 1 of the points you touched under a strategic standpoint, you are now dealing with a lot of things between, say, legacy Nidlegy new trials to be given to be launched in non-melanoma new triers for Fibromun, a lot of new discovery also in small molecules, which is generally speaking, the appetite on your side for doing things stand-alone rather than scout new potential collaborations going forward?

In terms of how we run the company, we are a fully integrated company from discovery to Phase III clinical trials, and we continue to do so. So we are very proud of our discovery capabilities, if you want, the CPI was a good example. And as mentioned, we continue to discover ligans against pharmaceutical targets of high value. What is changing, and I think this is a positive evolution is we are constantly trying to improve the performance of our company. And this is an area in which machine learning and artificial intelligence has already helped us a lot. So we have committed to setting up a data science team, which is now quite substantial, operating at all 3 sites. So in Siena in Milano, especially, but also in Zurich, we have actually data science specialists that help us be more efficient -- and you can imagine that the processing of clinical data, source data verification the integration of clinical activity with financial activities. These are all areas which can benefit from artificial intelligence and so does also discovery. So this is something which has already started to happen in the past few years, and it's now bringing fruits. And so you may say we run many programs. Yes, we run many programs, but we are structured to run these programs, and we are investing in technologies that make it more and more feasible to execute programs with good -- at the highest regulatory standards.

[indiscernible] , please go ahead.

Can you hear me? I have 3 on my side. The first 1 is basically on what you call Philochem. So I was wondering if you can share with us a little bit more on what are the expectations on the sales from this division? Because if I remember correctly, you do still have some contracts with Bracco that you find an agreement in the past. So my question is, do you find that the possibility in the near future to have something like more relating to some kind of milestone payments for revenues coming from that. And the second one is on ACP 3. I read from the news that you shared with us during the full year financial that there was the first patient treated. Can you share with us a little bit more on what is the process from now to the testing, if you have any idea when this testing will start with the Phase I trial, everything also on the potential milestone attached to the process could be helpful for the year. And I noted this was the first one. It was very long, sorry. And the second one is on the pharmaceutical part. So regret from how the glio project went in the past. So we hope that the new study will bring fruits -- but my question was mostly on Nedlegy and Nedlegy resubmission. So I hear that the GMP question that the FDA and EMA made under the process of making the pharmaceutical and treating the risk is being addressed -- so my point is where we are in the process of submitting the Nedlegy file to the EMA if there's anything that you want to share with us on what are your expectation on that? And lastly, it's mostly on the financial side. So we is the third year in a row, if I'm not wrong, that you approve or propose to the shareholder buyback. We saw that there was some kind of targets and in the last 2 years, the targets were not met because if I look and correct me if I'm wrong, in last year, there was just a buyback of 0.5% of the total why you were asking us the ability to buy up to 6%. So -- what are your view on the share value. And if you're guiding the process, if there's anything that you think that has to happen in order to be able to buy more on the market.

Thanks a lot. So the first question is about the chemistry collaborations. Philochem certainly is a very important part of the Philogen Group -- and you have seen our presentations on FAP on carbonic anhydrase 9 on ACPIII. And you've also seen my statement that we have actually already discovered leans against important pharmaceutical targets. So certainly, Philochem remains an important and healthy part of the group. Now when we license a product, and this is the case for OncoFAP to the Bracco group or OncoCP3 we have a press release in which we disclosed the starting conditions of the collaboration, but the product then has a new owner. And what is communicated is what is in the public domain other pieces of information may be sought from the partner who is the new owner. For example, -- we have communicated that the Phase I trial that was responsibility of Philogen has been successfully completed for OncoFAP has also been published and presented at the international congresses. And -- then the new owner, of course, is a specialist in the field of radiopharmaceuticals and we are very pleased with the collaboration with Bracco Group. Similarly, for OncoCP3 the results of the Phase I clinical trial have been presented at the international congresses, but any future communication will be performed by Bristol-Myers Squibb -- and while I understand that it may be interesting to know what they do. I mean they are the new owner, and we have to respect these contractual agreements. Now -- regarding your second point, which means where do we stand with the resubmission process. It's very simple. The authorities made both CMC requests, but also certain clinical requests. And we took them very seriously. And since we knew that this request would have required time, -- we withdrew the marketing authorization application. We did our homeworks and we are ready for resubmission. Specifically, what have we done? The authorities wanted basically. I oversimplify, but this is the sense. They wanted to see more industrial manufacturing activities performed -- and these activities have been performed also according to certain modalities that were indicated by EMA -- and in November, we checked with the ind institute to make sure that the indications of the reporter were well received and implemented by us. We have minutes for this meeting. And while this is work in progress that actually will keep us busy until June, everything that has been done until now is on track and according to the quality standards that we have discussed and agreed. On top of that, there was a clear indication also in terms of clinical results that we would not only present recurrence free survival data, but also event-free survival data at resubmission. Today, we have shown you one such analysis, and this will be part of the resubmission package. So the short answer is we resubmit in July because this is the time that we needed to perform something like 10 additional industrial manufacturing activities, which take time. Now regarding the third point, which....

Just in as we elaborate. So if I understand correctly, so the procedure to check whatever it has been asked from the FDA and the IFA will be performed up to July of this year.

You have -- you perform certain activities, okay, which means you have for certain manufacturing. You have to monitor these activities analytically over time because you have -- we have to deliver analytical data -- so that's why I call it work in progress. You perform manufacturing you perform your analytics, you keep performing the analytics according to a plan which has been discussed and agreed -- and this is where we stand now. We are almost at the end of these activities once everything has been done you package it in the resubmission and you resubmit. That's why we target July and not May or not November.

Okay. But when -- if I understand sorry if double check on this. So if and when on July, we'll have the data ready to be packed -- the process to restudy the case and resubmit to the EMA or I don't know if there will be the opportunity to resubmit also to the FDA in that case. But would be shorter versus the first time that we did it or will be similar. If you have to guide the way we have to think about this process.

So the resubmission is scheduled for July 2026, which means the ECT, this is the name of the document that we have to submit. We plan to submit it in July 2026. And this is based on a body of data, especially manufacturing data which continues to expand because this additional industrial manufacturing activities are monitored analytically according to a plan which has been discussed and approved. So I think there is no confusion that we finish certain analytics -- and we don't have to wait 6 months, 12 months to assemble the data. The data are assembled in real time and they constitute a large body of industrial preparations at the highest regulatory standards with additional analytical techniques which have been agreed with authorities. I give you an example. It's highly technical, but hopefully, it gives the picture. [indiscernible] concurred on the fact that certain preparations should be characterized by a technique, which is called peptide mapping, okay? And -- or charge of firms have to be characterized. These are duties that we have accepted, and we are executing according to procedures that have been agreed, and this is exactly what we are doing.

But once you submit that the process is similar to last time, I think also indicated with the slide, I think then I think we'll have something like 1 year or a bit less for the CMP to take the decision. .

And this is in one of the slides, and we were showing submission in July and decision expected mid-2027.

And sorry, just to close on this point. The the body that we'll have to judge on the this Nedlegy data pack. Data pack is the same of the first time or will be rechoosing.

So the body -- the decision is made by CHMP members, which are basically the representatives of the member states in Europe. The assessors the reporter or porters may change but the final vote is a vote, it's a collision vote, it's a majority vote, which is made by CHMP members. And the last topic, and I hand over again if you want to ask more questions, the buyback, I think every year, we ask the Board for the permission to buy back shares up to what is allowed by regulations. We have typically bought back shares, and we were pleased to buy them back because we think that the company is a good company. We are biased, of course, but we think that the company is a good company in good Health, including good financial health. And I could imagine that this continues because it's an opportunity that we don't want to miss, and we are pleased if the Board gives us the authorization to buy, then Yes.

Yes. Maybe my point was that, basically, if I look the approval that we gave each year to the Board and the number of shares that have been bought during the year there is a huge gap between what you can do and what you actually do. So my question is, -- is it something that is guided from you? Or is made by -- I see that Mediobanca is running the buyback activity. So it's decided by third party. So my question right now is how we should see this activity and potentially seeing that the company in the last 2 years have changed the risk profile. So there is your ability also from the comments that you give to Isacco a a few minutes ago, there is a full sustainability of financial of this company. So also seeing some kind of buyback and helping this company to perform versus...

I will hand over to Laura, but we want to have the freedom to buy -- and the comment with Isacco, which I'm glad to repeat is that we have, I think, technologically, strong company with a rich pipeline and a very good ratio between the cash in the bank spending and expected revenues. This is where I derive my statement of satisfaction for where we are. But of course, as a company, I hand over to Laura for the buyback programs.

And Walter, as you know, it is allowed by the CBS code, the maximum amount of 20% and the company is still under this limit. Our program is approved to reach 3%, 5% of share capital. Of course, the authorization of the Board of Directors first and the assembly after it's a signal of strong confidence flexibility in the group and the buyback program, a way to finance some plan -- internal plan, for example, the incentive plan or just to sustain the trend of the share, especially in a period of market very -- with very ability as it was in the last year. And what you asked is, you have an amount, but you don't reach this amount because we gave a broker contract to Mediobanca, as you know. And they have to act by law in the respect of the mar -- so the market, the market abuse regulation, so they can't buy amount with an internal rule. This is why we have still pro in place but we don't reach the high amount because the amount of share fluctuated in the market, not only they are purchasable in the respect of this law. I don't know if I was pretty clear on technical aspect you require it.

Okay. I will look into the definition of the Board in order to better understand what are the prices allowed in the volumes -- because if I look at the cons of regulation, you should be able to do a little bit more than what was actually done in the last year. But again, we can...

Yes, as you know, the company is independent on the buyback program because you can decide to do it yourself, but it is not our case. In case you engage an external partner in this case, Mediobanca acting with a broker contract, brokery contract, and they have some strict rule required by the mar. So, I said is to make a double check, but if you want, we can discuss on this separate part.

Yes, please, maybe we can organize a call just to better understand how it has been designed just to understand clearly what does this mean for all the shareholders?

Of course, when you want just write me or call me.

There is -- thanks, Walter. There is a last question, Mustafa Kilitch and then we have to close, but we are very glad to go through your questions.

Thank you very much for the nice presentation and showing the data. I'm very interested in the scientific part the nice principle of key and lock that you show with or EMA and coded diaries is really nice and have so much protein that I was interested in how do you select them? And what -- how do you decide which is the best target -- and if you have this principle and the million supply risk, how can it be that you have only -- I mean this is like a question that you have sold less products because you can screen for a lot like in the pipeline, how is it possible to have not much more projects. And yes, that's the question. And also the second question is, are all of these proteins have been common that there are tumor associated antigens. So more like antigens that are not neoantigens. Is this what you see in your libraries? Is it more like an approach which is chart between different tumors and their shell between the healthy tissues.

Okay. These are good questions, and I have to break it in parts. The first part is that certainly our libraries, both antibody libraries, but we have, for example, also libraries of chemically modified peptides comprising more than 200 billion members, are very rich source of target specificity. So this is a good news. We have the library, the freezer when we need a little and we know how to disclose. The second part of your question is how do you choose the target. And this is, of course, structure process. You start from the unmet medical need. You see if the unmet medical need has a target, which deserves to be targeted. You have seen it in our recent past. I mean we went for targets that were maybe not considered by competition, but we were able to discover the good ligands to do the job. And so this is what continues. We start with unmet medical need. We use many technologies, including proteomic technologies to identify targets, which deserve being drugged, and then we execute at the live level. Then the second part of the question is in cancer, do we focus on tumor-associated antigens or on stromal antigens on new antigens -- we typically work on tumor-associated antigens that can be either on the cell surface or stroma. So FAP and DDB would be a good example of stromal antigens -- and I've given you examples also of cellular antigens. This will continue. And actually, this has continued. The last point is we are mainly active in concept, but not only in cancer. We have a trial, for example, in rheumatoid arthritis. We have undisclosed research activities in osteo trades. So we are very interested in this leg and this pharmaco deliveries also beyond oncology, but the biggest part of our pipeline is in oncology. Please go ahead. .

Wonderful. That was already what I wondered, but also can we say then and can be generalized that neoantigens are not patent targets on tumors. So why don't you focus on neoantigens of your library, is this most possible?

So the problem with neoantigens if you take the definition of new antigens that would be mutations mutations that happen sporadically on individual patients. Then basically, you cannot run a clinical trial because I may have the risk mutation Emanuele may not have it. So you can use it with personalized vaccines. This is an approach which some companies are pursuing having personalized vaccines in the context of a clinical trial. I personally feel that there are enough validated targets that cover a sufficiently broad portion of population, which are simply in search for good ligands. And this is, I think, what we can deliver. The identification of good targets the discovery of the ligands and then the implementation. Of course, we could do more, but at some stage, there is a funnel and the funnel is given by the performance in preclinical models, the industrial preparation, which is expensive, the safety tox studies and the execution of clinical trials. So if you look at the breadth of our pipeline while you say we could do more. And I think I agree with you, but in reality, I think it's a good mixture between having a broad pipeline but at the same time, a structure which has a sound financial basis.

So thank you very much, and apologies that we go -- we went a bit over time, but we had a discussion -- so if you have any questions, you can send an email to us, and we're happy to reply. Thank you very much.

Thank you very much, bye-bye.