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 CSO; Dr. Laura Baldi, our Chief Financial Officer; and myself here with a hat of Investor Relations.

We're happy to guide you through the presentation lasting about 30 minutes, which is recorded and will be followed by a 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, Emanuele. 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 daughter company called Philochem that deals with small molecule therapeutics. We will show examples from both types of technologies.

The Milano site, which is really halfway between Zurich and Siena, 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 of proven therapeutic activity—cytotoxic drugs, radionuclides, 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.

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 four 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 preferential accumulate in the tumor, but without a stunning selectivity. With our antibody fragments or with our small molecules specific to tumor-associated antigens, we get a good preferential uptake in lesions.

These are experimental images observed at 1 day with one of our antibody fragments or at 1 hour with one of our small molecule ligands. It's a gradient of selectivity.

This is the pipeline when the company was listed 5 years ago, in March 2021. You see molecules that we will present in more detail later today.

Basically, in green, you see the antibody-based products. In blue, you see the small organic molecule products.

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.

We will go slowly through that pipeline so that you get a detailed, really presentation on what is happening for the various programs. 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 two active ingredients, which are called L19-IL2 and L19-TNF. It's given intralesionally, and it's used for dermato-oncology indications.

We will focus both on melanoma and in non-melanoma skin cancer. The melanoma programs are focused on stage IIIB/C melanoma, which means locally advanced, resectable melanoma.

The design both for the European trial and for the confirmatory American trial features a 1-to-1 randomization of patients who may receive surgery or Nidlegy in the neoadjuvant setting, followed by surgery. 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. 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 partner, Sun 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. 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 name for Nidlegy—over the standard-of-care surgery.

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. You see that there is a benefit compared to the surgical control group.

These are new data with a longer follow-up time that basically nicely confirms what we had done. These are event-free survival data per Nadina.

These are the type of data that EMA wants to see when we resubmit the application. I toggled back and forth RFS and EFS.

We are pleased with the data that we will present. Now, where do we stand?

In November, we aligned with the Paul-Ehrlich-Institut, which is the German authority, about the work with the industrial manufacturing of the drug. We are very pleased with where we stand and with the feedback that we received from the Paul-Ehrlich-Institut.

Also as promised, we had a Type C scientific advice session with the FDA, 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 US trial. We are pleased also with this interaction.

We are at the presubmission meeting with rapporteurs aiming for a submission in July 2026 for the European marketing authorization. Sometimes next year, there will be a decision.

We are also committed to finishing the US 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 2 trial in BCC and cSCC with 94 patients, which is completed, whereas INTRINSIC, the second Phase 2 trial, is almost finished.

We have already enrolled 65 out of the target 70 patients. The data have been presented at ESMO for basal cell carcinoma, and the squamous cell carcinoma data will be presented at the ADO in 2026.

Here, some of key collaborators are shown in the slide. We had shown these pictures before.

Patients really enjoying a durable complete response in basal cell carcinomas that would have required mutilating surgery. Of course, we are very pleased with these data, which have been published.

These are three patients with basal cell carcinoma that would have required disfiguring surgery. In all cases, you see the 52-week follow-up, the 1-year follow-up documenting a durable benefit with very clear functional benefit and durable complete response.

Also smaller lesions, but still they would have required disfiguring surgery with a durable benefit in a younger patient and in an elderly patient. These are some of the data that we continue to accumulate in support for the registration programs.

Where do we stand? We have the ambition to launch four trials with registration potential: three—the first three here depicted in green—are in squamous cell carcinoma second-line, BCC third-line, BCC first-line.

These three 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.

Basically, these 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 hedgehog inhibitors in the first-line setting.

We have successfully completed a 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. We are now going ahead with the submission of the application for this pivotal trial, Phase 3 trial.

With this, I hand over to Emanuele, who will guide us through the Fibromun program and also other immunocytokine programs. 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.

It's also licensed to Sun Pharma, who is our commercial partner. We're very happy about the collaboration.

We're focusing on two big indications, let's say, challenging, called soft tissue sarcoma and glioblastoma. As mentioned by Dario before, in blue, you see the trials that have been completed, in black, you see the trials that are ongoing, and in red, the new trials that we're 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 US. Soft tissue sarcoma is also very aggressive indication, especially when it becomes metastatic, and it kills more than 5,000 patients every year in the US only.

Fibromun is one of the two active ingredients of Nidlegy. You see the L19 antibody in green fused to TNF in red.

This red part is really the bioactive 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 US. We have shown that the drug goes to the tumor, sparing healthy tissues.

The programs—an update on the programs in soft tissue sarcoma. We have completed the most advanced ones in Europe, the Phase 2 trial in third-line setting in which Fibromun is combined with dacarbazine.

We treated all patients, 94 patients, foreseen also by protocol. It's allowed to treat a bit more than what expected.

We reached all the events for the readout of the study. We also completed the Phase 3 trial in first-line setting, where the combination agent here is doxorubicin.

Also here, we reached all the events for the readout of the study. In both cases, the progression-free survival was the primary endpoint.

Here in the Phase 3, as announced also earlier last year, let's say, 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 this leiomyosarcoma plus other subtypes, which are indicated at the bottom of the slide. You see that the medium overall survival here went from 13.6 months to 21 months, you see in red, and on that basis, we're basically planning the next steps.

The next steps will focus on the first-line setting, where we have approximately 20,000 patients addressable every year in the US plus Europe. Beyond the overall survival signal, we also saw a complete response in the FIBROSARC study in this patient with metastatic myxofibrosarcoma, one of the most aggressive STS subtype.

See, this patient had three lesions here that vanished during the combination regimen, which is something unprecedented, very rare to see in this setting. On that basis, we also are launching the so-called FIBROSARC-2 Phase 3 study in this subgroup of patients of the FIBROSARC trial.

We have already requested a parallel scientific advice both with FDA and EMA to align on the protocol that will take place around mid of this year. After that, we will launch the study and the clinical trial application, the submission of the clinical trial application is expected in Q3 2026.

In parallel, we're progressing with the FIBROSARC US study, a Phase 2b study in metastatic leiomyosarcoma, in which we treated 83 out of 158 patients. In the third-line setting, where the patient population which is addressable by the drug in that setting, would have been 2.5k every year in US plus Europe.

In that case, FLASH, a Phase 2 trial, did not meet the primary endpoint. In glioblastoma, here, we have also three studies.

GLIOSUN in the newly diagnosed setting, we have completed the dose-escalation part, and we launched the dose-expansion part of the study, which will be run and conducted before launching the Phase 2b randomized part of GLIOSUN. Then with regards to GLIOSTAR, which has been conducted in glioblastoma at first progression, second-line, we've completed enrollment and reached the OS events that will be presented in next slide, while the GLIOSTELLA, which is conducted in glioblastoma at first or later progression in the US, we're also enrolled all patients faster than what expected by our internal timelines.

We will expand also on timelines of the readout in the next slide. To summarize the glioblastoma programs, GLIOSTAR Phase 2 clinical trial conducted in patients at first progression—here, we were speaking about 15,000 addressable patients in the US plus Europe every year—the trial did not meet the primary endpoint, as mentioned in the press release on Friday, but there was an improvement in terms of overall survival in a subgroup of patients that had a limited exposure to alkylating agent, and this is similar to what we have also in GLIOSUN.

Overall, this indication, this setting, at first progression, remains a very challenging disease. We're not the only one 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 survival compared to the historical controls.

The GLIOSTELLA trial, ongoing in US, as I said, is in a later setting compared to GLIOSTAR. We expect the readout, which is the OS at 12 months, in September 2026.

On this, we'll keep you updated. With regards to GLIOSUN, we have that represent also the biggest market with 30,000 addressable patients every year in Europe plus US.

We've completed the dose escalation, and now we launched the dose-expansion part. On this, I finished the Fibromun part.

In general, we have announced the outcome of GLIOSTAR and FLASH. On soft tissue sarcoma, we'll focus on the first-line, also the biggest market potential.

On glioblastoma, we're committed to continuing the GLIOSTELLA and the GLIOSUN, which are ongoing in a different lines of treatment compared to GLIOSTAR. A very quick update on the Intracokine technology that we have mentioned also last time.

This is just to say that we continue improving our assets. One way to do it is to have strategies to improve and enhance the therapeutic index of our drugs, meaning that we can give more without toxicity by masking the activity of the payload initially after the injection when the concentration of the cytokine is high.

We do that by giving an intracellular signaling inhibitor called ruxolitinib that masks the activity of the cytokine at the beginning without having an impact on antitumor activity. This is something that we've launched the first study, and we will keep you updated on the results from that 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. 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 ligand, usually the small organic ligand wins.

These are two 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-encoded chemical libraries that recognizes the target of interest, one can use it to deliver radionuclides, 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.

Let's start with fibroblast activation protein, which is one of the targets on which we work. Here, you see five 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 OncoFAP. 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. OncoFAP labeled with lutetium-177 clinical trial has started.

Here, you see the very first two patients that were treated, and you see really already at 1 hour a fantastic selectivity in the tumor compared to normal organs. You see in left a patient with triple-negative breast cancer, in the right a patient with colorectal cancer with metastases to the liver.

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 opportunity with L19-IL2.

You remember that we have also a non-radioactive therapeutic program in which OncoFAP, here depicted in blue, is linked to a very potent anticancer drug called monomethyl auristatin E thanks to a cleavable linker, which is cleaved at the level of this Gly-Pro structure. 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 1 clinical trial, first at low dose, 3.5 mg/m², you see the tumor shrinking in just 28 days, and then you see a bigger lesion also shrinking at a higher dose, 10 mg/m². 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. We expect submission by the end of the year, and we continue to have good results in veterinary trials.

This is a picture from one of the animal patients, which is still alive and in good shape more than 1 year after the recruitment into the trial. When we move to a second target called carbonic anhydrase IX, this is the best marker of hypoxia and also the best marker for clear cell renal cell carcinoma, which accounts for about 80% of kidney cancers, namely the most aggressive subtype.

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 would be benign and if one would have known, the surgery could have been spared. An accurate detection of clear cell renal cell carcinoma promises to distinguish malignant from benign lesions and to spare unnecessary surgery.

We have completed a Phase 1 trial with 20 patients with our gallium-labeled OncoCAIX product with really excellent results. Already at 1 hour, we can clearly see the tumor with excellent tumor-to-organ ratio, as highlighted by this green arrow.

By comparison, this is a competing product of Telix based on an antibody called girentuximab labeled with zirconium-89, and you know that antibodies have longer circulation times, the imaging results are delayed, possibly exposing patients to too much radioactivity. We are committed to the development of OncoCAIX, and we have been very fast to go from the discovery of the molecule in 2024 to the Phase 1 trial executed in 2025 to the preparation activities for the pivotal trial: GMP manufacturing, cold kit, interaction with authorities, with the estimate to execute the Phase 3 trial in 2027, 2028.

The incidence of renal cell carcinoma in United States and in Europe are reported here based on literature data, and this incidence is expected to double in the coming years. 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, ACP3, 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 labeled with gallium-68, you see the very nice progression of sales, or labeled with fluorine-18 for imaging again—and for therapy, one uses therapeutic radionuclides like lutetium-177. The radiopharmaceutical market for prostate cancer is dominated by PSMA.

The cumulative sales of imaging plus therapy in 2024 were more than $3 billion, and they're now approaching $4 billion in 2025. There is clearly a performance and a need for these products, and the opportunity is to see whether ACP3 can beat PSMA.

This was a slide that was presented by the organizers of the European Association of Nuclear Medicine Congress in Barcelona with an angry PSMA and a smiling ACP3. We did not draw this slide, but we were pleased to see the reaction of the scientific community.

We had announced last year that we have licensed the global rights for imaging and for therapy to RayzeBio, 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 RayzeBio has, of course, a commitment for alpha emitters 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 term. We continue to do innovation because OncoACP3 was discovered using DNA-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. 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.

This is work in progress. We hope already at the next meeting to be able to show you tangible performance results.

The penultimate slide is to summarize that we finished 2025 with a good net profit of about €230 million. We have, by the end of December 2025, cash and cash equivalents approximately €380 million.

Because of the good result of 2025, there has been then the decision to issue a dividend of €0.70 per share. With this, I hand over to the last slide before the discussion, a summary slide, which is also an outlook.

Nidlegy, the work towards the marketing authorization application is on track. Importantly, we have a good alignment with the FDA following Type C interaction.

The early access program adoption has been good in Europe. 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 have been treated.

In Fibromun, Emanuele indicated that we like the promising signal observed in first-line soft tissue sarcoma, and we aim at confirming this with the FIBROSARC-2 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 GLIOSUN in first-line glioblastoma, and third-line soft tissue sarcoma, FLASH, a Phase 2 trial, did not meet the primary endpoint. With small molecule pharmaceuticals, the FAP, CAIX, and ACP programs are progressing, but importantly, we have the technology to continue discovering and valorizing hits against valuable pharmaceutical targets.

The future life of the company will be a mixture of older products now at advanced stage and new products that we continue to discover and bring to the clinic. With this, we stop the recorded part of the session and open to the questions and answers that will not be recorded.

As always, persons can announce their wish to ask a question. The first one is Clémence from Stifel, and the floor is yours.

Hi. 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 2 trial did not meet the primary endpoint. 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. The GLIOSTAR data need to be complemented by the GLIOSTELLA trial, which is a fully American trial, and this will also be presented at international congresses.

All I can tell you is what Emanuele presented, is that there is a signal in patients who had larger lesions and also patients who were actually not exposed to alkylating agents. We need to digest the data, and we will need to see in time which subset of patients benefits from the drug.

Only a posteriori you can make a decision. 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 a considerable population. This is situation which evolves.

While we were not pleased with the GLIOSTAR results, data need to be digested, and the strategy follows.

Okay. Thank you.

Very clear. Maybe a bit touchy, but did those readouts had any impact on your relationship with Sun Pharma on the Fibromun side?

Are you working together for a development path, or are you digesting the data, as you say, and then presenting potentially a new path to Sun? How does it work between the two of you?

I can only say we think that Sun is a fantastic company. We are very pleased to have Sun Pharma as a partner.

As you have seen, we work on multiple programs with Sun, and we have launched new trials. You should ask Sun, but from our perspective, the relation is very good.

We are committed to offering the drugs to patients as rapidly as possible and for indications in which patients have a benefit. The dermato-oncology situation is very clear, I don't think that this deserves much discussion.

The Fibromun situation really requires a careful analysis for the 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-2 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. That's what we have done in skin, and that's what we are doing now with soft tissue sarcoma, and this is what we will also do in glioblastoma.

It's really a sequence of getting the data, evaluating the data, discussing with authorities, and if appropriate, taking the next action.

Perfect. Thank you, Dario.

Just one last very quick, and I'll freeze the floor. Is the 67% leiomyosarcoma and other STS types a ratio you would find in real life?

I think it's higher, honestly. In real life, LMS is 25% to 30% of tumor types in soft tissue sarcoma, which is a basket of many different indications.

My number would be 70%. These are very well documented proportions, I think this certainly corresponds to the majority of soft tissue sarcomas.

Having a survival signal with a few patients really enjoying very long benefit is a good starting point, and of course, this needs to be confirmed.

Okay. Perfect.

Thank you.

Thank you.

Thank you. Next,

we have Isacco. Isacco, please go ahead.

Hi, all. Hope you can hear me well.

Yes.

Hi, two questions from my side. The first one is on the expected cost and cash burn profile of 2026.

6 months ago, we were talking about a year with costs very well covered. In the meanwhile, we see Philogen launching a larger number of trials, maybe some negative readouts of which you were, I don't know, building expectations in terms of milestones.

Just wondering whether the comment on expected no cash burn or positive cash generation is confirmed for this year.

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. As communicated in the past, we will not have an explosion of costs.

Then I look at revenues in a split second, but basically we will not have an explosion of costs. 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.

Costs will not explode, and we always extrapolated a moderate increase of clinical costs, and this is confirmed now. As far as revenues are concerned, you can imagine that I can say what I've always said, that our revenues are a mixture of different items.

They 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. Then there are the events that you have seen also in the recent past in which a newly discovered product attracts pharmaceutical interest and may attract substantial payments.

As it would have been difficult to make estimates at 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 you 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,

I fully agree. As you can see in the net financial position, we had for 2025 a spending around €4 million per month, in a range of €50 million in a year.

We expect to increase a bit, but not too much, or probably to stay in the same range for the next year. As Dario say, we don't expect to increase a lot.

It depends on our program development.

Revenues will be communicated as they come along, but—

Yes.

I'm proud of where Philogen stands and what Philogen can execute.

Thanks, Dario. Thanks, Laura.

A follow-up on one of the points you touched, Dario. Under a strategic standpoint, you are now dealing with a lot of things between, say, legacy Nidlegy and Fibromun, new trials to be launched in non-melanoma, new trials for Fibromun, a lot of new discovery also in small molecules.

Which is, generally speaking, the appetite on your side for doing things standalone 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 3 clinical trials, and we continue to do so. We are very proud of our discovery capabilities.

If you want, ACP3 was a good example, and as mentioned, we continue to discover ligands 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.

This is an area in which machine learning and artificial intelligence has already helped us a lot. We have committed to setting up a data science team, which is now quite substantial, operating at all three sites.

In Siena, in Milano especially, but also in Zurich, we have actually data science specialists that help us be more efficient. 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.

This is something which has already started to happen in the past few years, and it's now bringing fruits. 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 at the highest regulatory standards.

All clear. Thanks, Dario.

Thank you. Thank you, Isacco.

Valter, please go ahead.

Hello, can you hear me?

Yes.

Okay. Thank you for taking my question.

I have three on my side. The first one is basically on what you called Philochem.

I was wondering if you can share with us a little bit more on what are the expectation on the sales from this division, because if I remember correctly, you still have some contract with Bracco that you signed an agreement in the past. My question is do you find that this possibility in the near future to have something more relating to some kind of milestone payments or revenues coming from that?

The second one is on ACP3. I read from the news that you shared with us during the full-year '25 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 1 trial, everything also on potential milestone attached to the process could be helpful for the year? I know that this was the first one, it was very long story.

The second one is on the pharmaceutical part. Regret from how the glio project went in the past, we hope that the new study will bring fruits.

My question was mostly on Nidlegy and Nidlegy resubmission. I heard that the GMP question that the FDA and EMA made on the process of making the pharmaceutical and treating the risk is being addressed.

My point is where we are in the process of resubmitting the Nidlegy file to the EMA, if there's anything that you want to share with us on what are your expectation on that? Lastly, it's mostly on the financial side.

It's the third year in a row, if I'm not wrong, that you approve or propose to the shareholder a buyback. We saw that there was some kind of targets, and in the last 2 years, the target 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, while you were asking as the ability to buy up to 6%.

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? Thank you very much.

Thanks a lot. 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 IX, on ACP3, and you have also seen my statement that we have actually already discovered ligands against important pharmaceutical targets. 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 OncoACP3—we have a press release in which we disclose the starting conditions of the collaboration, but the product then has a new owner. 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 1 trial that was responsibility of Philogen has been successfully completed for OncoFAP, has also been published and presented at international congresses.

Then the new owner, of course, is a specialist in the field of radiopharmaceuticals, and we are very pleased with the collaboration with the Bracco Group. Similarly, for OncoACP3, the results of the Phase 1 clinical trial have been presented at international congresses, but any future communication will be performed by Bristol Myers Squibb, RayzeBio, and while I understand that it may be interesting to know what they do, they are the new owner, and we have to respect this 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.

We took them very seriously. Since we knew that this request would have required time, we withdrew the marketing authorization application, we did our homework, 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.

In November, we checked with the Paul-Ehrlich-Institut to make sure that the indications of the rapporteur were well received and implemented by us. We have minutes for this meeting.

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. 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—

Sorry. Just on this to elaborate, if I understand correctly, the procedure to check whatever has been asked from the FDA and AIFA will be performed up to July of this year, but—

You perform certain activities, okay, which means you perform certain manufacturing. You have to monitor these activities analytically over time because we have to deliver analytical data.

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. When, if I understand—sorry if I 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 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?

The resubmission is scheduled for July 2026, which means the eCTD—this is the name of the document that we have to submit—we plan to submit it in July 2026. This is based on a body of data, especially manufacturing data, which continues to expand because these additional industrial manufacturing activities are monitored analytically according to a plan which has been discussed and approved.

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.

EMA and also the Paul-Ehrlich-Institut concurred on the fact that certain preparations should be characterized by a technique which is called peptide mapping, okay, and or charge isoforms 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.

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

This is in one of the slides in which we were showing submission in July and decision expected mid-2027.

Sorry, just to close on this point, the body that will have to judge on these data pack, is the same of the first time or will be re-chosen?

The decision is made by CHMP members, which are basically the representatives of the member states in Europe. The assessors, the rapporteur, co-rapporteurs may change, but the final vote is a vote, it's a collegial vote, is a majority vote, which is made by CHMP members.

Okay. Passing on the buyback.

The last topic, and I hand over it 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 limit 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,

yeah. 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.

My question is is it something that is guided from you, or I see that Mediobanca is running the buyback activity, is decided by third party? My question right now is how we should see this activity and potentially seeing that the company in the last 2 years changed, there is profile, there is your ability also from the comments that you give to Isacco a few minutes ago, there is full sustainability of financial of this company.

Also seeing some kind of buyback and helping this company to perform versus a sector. If you want

I will hand over to Laura,

but

we want to have the freedom to buy. The comment to Isacco, which I am glad to repeat, is that we have a 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. Valter,

as it is allowed by the Civil 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 director first and the assembly after is a sign of strong confidence and flexibility in the group. The buyback program, it's a way to finance some internal plan, for example, the incentive plan, or just to sustain the trend of the share, especially in a period of market with very volatility, as it was in the last year.

What you ask, it is you have an amount, but you don't reach this amount because we gave a broker contract to Mediobanca, as and they have to act by law in the respect of the MAR. The MAR, it's the Market Abuse Regulation, they can't buy amounts with an internal rule.

This is why we have still program in place, but we don't reach the high amount, because the amount of share fluctuated in the market, not all they are purchasable in the respect of this law. I don't know if I was pretty clear on technical aspect you required.

I will look into the definition of the board in order to better understand what are the prices allowed and volumes, because if I look at the concept of regulation, you should be able to do a little bit more than what was actually done in the last year. Again, we can take it separately.

As 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, they are acting with a brokerage contract, and they have some strict rule required by the MAR.

I suggest to make a double-check, but if you want, we can discuss on this

in

a 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 shareholder.

Okay.

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

Thanks a lot. Thanks, Valter.

There is a last question: Mustafa Afkiliç. 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 showed with your DNA-encoded libraries is really nice, and you have so much proteins. I was interested in how do you select them, and how do you decide which is the best target?

If you have this principle and a billion of libraries, how can it be that this is a question that you have so less products, because you can screen for a lot in the pipeline. How is it possible to have not much more products?

That's the question. Also, the second question is are all of these proteins have in common that they are tumor-associated antigens, more like antigens that are not neoantigens?

Is this what you see in your libraries? Is it more like an approach which is shared between different tumors and shared between the healthy tissues?

These are good questions, and I have to break it in parts. The first part is that certainly our libraries, both antibody libraries, DNA-encoded chemical 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.

This is the good news. We have the libraries in the freezer.

When we need a ligand, we know how to discover it. The second part of your question is how do you choose the target?

This is, of course, a structured 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.

We went for targets that were maybe not considered by competition, but we were able to discover the good ligands to do the job. 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 library level.

Then the second part of the question is in cancer, do we focus on tumor-associated antigens or on stromal antigens, on neoantigens? We typically work on tumor-associated antigens that can be either on the cell surface or stromal.

FAP and EDB would be 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 cancer, but not only in cancer. We have a trial, for example, in rheumatoid arthritis.

We have undisclosed research activities in osteoarthritis. We are very interested in this ligand-based pharmacodeliveries also beyond oncology, but the biggest part of our pipeline is in oncology.

Please go ahead.

Wonderful. Thank you very much.

That was already what I wanted, but also, can we say then and can we generalize that neoantigens are not really the targets on tumors? Why don't you focus on neoantigens with your library?

Is this not possible?

The problem with neoantigens, if you take the definition of neoantigens, that would be mutations, okay, mutations that happen sporadically on individual patients. Then basically, you cannot run a clinical trial because I may have this mutation, Emanuele may not have it.

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. 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. 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 sound a financial basis.

Awesome. Thank you very much.

Okay. Thank you very much, and apologies that we went a bit over time, but we enjoyed the discussion.

If you have any questions, you can send an email to us, and we'll be happy to reply. Thank you very much.

Thanks a lot. Bye-bye.