Earnings call transcript: Philogen’s H2 2025 highlights strong financials and product innovation

Philogen SpA, an Italian biotechnology company, concluded its earnings call for the second half of 2025, showcasing robust financial performance and significant advancements in its product pipeline. The company reported a net profit of approximately EUR 230 million for the full year 2025, underlining its financial strength with cash reserves of EUR 380 million. Despite the absence of specific earnings forecasts, Philogen’s strategic initiatives and product development efforts were emphasized as key drivers of future growth.

Key Takeaways

• Philogen reported a net profit of EUR 230 million for 2025, supported by diversified revenue streams.
• The company approved a dividend of EUR 0.70 per share, reflecting confidence in its financial position.
• Philogen’s product pipeline, including Nidlegy and Fibromun, showed promising clinical progress.
• Strategic partnerships, such as the OncoACP3 deal with Bristol Myers Squibb/RayzeBio, are expected to bolster revenue.

Company Performance

Philogen demonstrated strong financial performance in 2025, with a net profit of EUR 230 million and substantial cash reserves of EUR 380 million. The company’s financial health allowed it to approve a dividend distribution while maintaining operational flexibility. Philogen’s revenue streams are well-diversified, including milestone payments, service activities, and potential new partnerships.

Financial Highlights

• Net Profit: EUR 230 million for 2025
• Cash and Cash Equivalents: EUR 380 million as of December 31, 2025
• Dividend: EUR 0.70 per share approved

- Share Buyback: Authorization requested for up to 35% of share capital

Investors seeking deeper insights into Philogen’s financial metrics and strategic positioning can access comprehensive analysis through InvestingPro, which offers one of over 1,400 detailed Pro Research Reports that transform complex financial data into clear, actionable intelligence for smarter investment decisions.

Outlook & Guidance

Philogen anticipates a modest increase in spending for 2026, maintaining a monthly rate of EUR 4-5 million. The company remains confident in its ability to sustain a good financial balance, with revenue sources expected to remain diversified. Management emphasized a pragmatic approach to program execution, focusing on financially viable trials with reasonable expectations of positive outcomes.

Executive Commentary

Philogen’s management expressed confidence in the company’s financial stability and growth prospects. They highlighted the company’s "very cash strong" position and the strategic importance of maintaining spending "in check." The management’s focus on diversified revenue streams and strategic partnerships was underscored as key to Philogen’s continued success.

Risks and Challenges

• Regulatory Challenges: Navigating complex regulatory requirements for product approvals.
• Clinical Trial Risks: Potential setbacks in clinical trials could impact product development timelines.
• Market Competition: Intense competition in the biotechnology sector may affect market share.
• Economic Conditions: Macroeconomic factors could influence funding and investment opportunities.

Philogen’s earnings call for H2 2025 highlighted its strong financial position and strategic focus on innovation and partnerships. The company’s robust net profit, substantial cash reserves, and diversified revenue streams position it well for future growth, despite potential risks and challenges in the biotechnology landscape.

Full transcript - Philogen SpA (PHIL) H2 2025:

Dario Neri, Chief Executive Officer, Philogen: 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.

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 for 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 good preferential uptake in lesions, and these are experimental images observed at one day with one of our antibody fragments or at one 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, so 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 the pipeline so that you get a detailed up 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 IL-2 and L19 TNF. It’s given intralesionally, 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 III BC melanoma, which means locally advanced, resectable melanoma.

The design both for the European trial and for the confirmatory American trial features a one-to-one randomization of patients who may receive surgery or Nidlegy in 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. 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, so 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 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 the Paul-Ehrlich-Institut, which is a German authority, about the work with the industrial manufacturing of the drug. We are very pleased where we stand and with the feedback that we received from the Paul-Ehrlich-Institut. Also, as promised, we had the Type C scientific advice session with 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 U.S. trial. We are pleased also with this interaction. We are at the pre-submission meeting with rapporteurs aiming for a submission in July 2026 for the European marketing authorization, and sometime 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 SCC with 94 patients, which is completed, whereas INTRINSIC, the second phase II trial, is almost finished. We have already enrolled 65 out of the target 70 patients, and 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 the 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 this data, which have been published. These are three patients with basal cell carcinoma that would have required the disfiguring surgery. In all cases, you see the 52-week follow-up, so the one-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 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 the JAK 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 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.

Emanuele Vignati, Executive (Fibromun Program Lead), Philogen: 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. 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 U.S. 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 U.S. 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 U.S., and we have shown that the drug goes through the tumor, sparing healthy tissues. An update on the programs in soft tissue sarcoma. We have completed the most advanced ones in Europe. The phase II trial in third line setting in which Fibromun is combined with Dacarbazine. We treated all patients, 94 patients, as foreseen also by a protocol.

I mean, it is allowed to treat a bit more than what expected, and we reach all the events for the read out of the study. We also completed the phase III trial in first-line setting, where the combination agent here is Doxorubicin. We also here reached all the events for the read out of the study. In both cases, the progression-free survival was a primary endpoint. Here in the phase III, as announced also earlier last year, 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 liposarcoma plus other subtypes which are indicated at the bottom of the slide.

You see that the median overall survival here went from 13.6 months to 21 months, you see in red. On that basis, we’re basically planning the next steps. The next steps will focus on the first-line setting, where we have approximately 20K patients addressable every year in the U.S. 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. You see this patient had three lesions here that vanished during the combination regimen, which is something unprecedented or very rare to see in this setting. On that basis, we also are launching the so-called FIBROSARC-2, phase III 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-May this year. After that, we launch the study and the clinical trial application, so the submission of the clinical trial application is expected in Q3 2026. In parallel, we are ongoing progressing with the FIBROSARC US study, a phase IIb 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 U.S. plus Europe. In that case, the FLASH phase II 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’ve launched the dose expansion part of the study, which will be conducted before launching the phase II B randomized part of GLIOSUN. With regards to GLIOSTAR, which has been conducted in glioblastoma at first progression, so second line. We’ve completed enrollment and reached the OS events that we present in the next slide. While the GLIOSTELLA, which is conducted in glioblastoma at first or later progression in the U.S., we’ve also enrolled all patients faster than what was expected by our internal timelines. We will expand on those timelines of the readout in the next slide.

To summarize the glioblastoma programs, GLIOSTAR, the GLIOSTAR phase II clinical trial conducted in patients at 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 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. Apart from 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 commercialized 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 the U.S., I said, is this in a later setting compared to GLIOSTAR, and we expect the readout, which is the OS at 12 months in September 2026. We’ll keep you updated. With regards to the GLIOSUN, we have that represent also the biggest market with 30,000 addressable patients every year in Europe plus U.S. We’ve completed dose escalation, and now we launched the dose expansion part. I finished the Fibromun part. In general, we have announced the outcome of GLIOSTAR and FLASH on Fibromun in soft tissue sarcoma. We’ll focus on the first line, also the biggest market potential.

On the glioblastoma, we’re committed to continuing the GLIOSTELLA and the GLIOSUN, which are ongoing in a different line of treatment compared to the GLIOSTAR. A very quick update on the IntraCork technology, that we have mentioned also last time. This is just to say that we continue improving our assets, and 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 a intracellular signaling inhibitor called ruxolitinib that masks the activity of the cytokine at the beginning without having impact on antitumor 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 that clinical trial that we look very much forward to.

Dario Neri, Chief Executive Officer, Philogen: 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 5 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, so OncoFAP labeled with lutetium-177. A clinical trial has started. Here you see the very first 2 patients that were treated, and you see really already at 1 hour a fantastic selectivity in the tumor compared to normal organs.

You see on the left a patient with triple-negative breast cancer, on the right a patient with colorectal cancer with metastasis 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 L19IL2. 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 glycine proline 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 I 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 one year after their 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 I trial with 20 patients with our gallium-labeled OncoCAIX product with really excellent results.

Already at one 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, so the imaging results are delayed, you know, 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 I 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 III trial in 2027, 2028.

The incidence of renal cell carcinoma in the United States and in Europe is 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 a market opportunity. In reality, carbonic anhydrase nine 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 EUR 3 billion, and they’re now approaching EUR 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, 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. 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. Because of the good result of 2025, there has been then the decision to issue a dividend of EUR 0.70 per share. With this, I hand over to the last slide before the discussion.

A summary slide, which is also an outlook, with Nidlegy, 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 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 II trial, did not meet the primary endpoint. With small molecule pharmaceuticals, the FAP, CA9, and the 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 old 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.

Clémence, Analyst, Stifel: Hi. Thank you. 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.

Dario Neri, Chief Executive Officer, Philogen: I can only tell you that in third line STS, the phase II trial did not show, you know, 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, you know, 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.

Clémence, Analyst, Stifel: Mm.

Dario Neri, Chief Executive Officer, Philogen: a fully American trial, and this will also be presented at the 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 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.

Clémence, Analyst, Stifel: Okay. Thank you. Very clear. Maybe a bit touchy, but did those readout 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?

Dario Neri, Chief Executive Officer, Philogen: Well, 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. 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 a benefit. The dermatologic oncology situation is very clear, so 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, 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. It’s really a sequence of getting the data, evaluating the data, discussing with authorities, and if appropriate, taking the next action.

Clémence, Analyst, Stifel: Perfect. Thank you, Dario. 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?

Dario Neri, Chief Executive Officer, Philogen: I think it’s higher, honestly. In real life, leiomyosarcoma is 25%-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, so 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.

Clémence, Analyst, Stifel: Okay. Perfect. Thank you.

Dario Neri, Chief Executive Officer, Philogen: Thank you. Thank you very much. We have Isacco. Isacco, please go ahead.

Isacco, Analyst, Unknown: Hi, all. I hope you can hear me well.

Dario Neri, Chief Executive Officer, Philogen: Yes.

Isacco, Analyst, Unknown: I have two questions from my side. The first one is on the expected cost and cash burn profile of 2026. Six 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 results 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.

Dario Neri, Chief Executive Officer, Philogen: 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, you know, 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 cost. I look at the revenues in a split second. 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. Costs will not explode, and we always extrapolated a moderate increase of clinical cost, 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.

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. As it would have been difficult to make, you know, 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.

Laura, Chief Financial Officer, Philogen: Yes. Yes. I fully agree. As you can see in the net financial position, we had for 2025 a spending around EUR 4 million per month, so in a range of EUR 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. We, as Dario say, we don’t expect to increase a lot. It depends on our program development.

Dario Neri, Chief Executive Officer, Philogen: Revenues will be communicated as they come along.

Laura, Chief Financial Officer, Philogen: Yes

Dario Neri, Chief Executive Officer, Philogen: ... as CEO, I’m, you know, proud of where Philogen stands and what Philogen can execute.

Isacco, Analyst, Unknown: 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 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.

Dario Neri, Chief Executive Officer, Philogen: 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. We are very proud of our discovery capabilities. If you want, the 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, and 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.

Isacco, Analyst, Unknown: All clear. Thanks, Dario.

Emanuele Vignati, Executive (Fibromun Program Lead), Philogen: Thank you. Thank you, Isacco. One second. Walter, please go ahead.

Walter, Analyst, Unknown: Hello. Can you hear me?

Emanuele Vignati, Executive (Fibromun Program Lead), Philogen: Yes.

Walter, Analyst, Unknown: Okay. Thank you for taking my question. I have three on my side. The first one is basically on what you call the 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 do still have some contracts with Bracco that you found an agreement in the past. My question is, do you find that there is possibility in the near future to have something like 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 share with us during the full year 2025 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. I know that this was the first one. It was very long, sorry. The second one is on the pharmaceutical part. We read 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 the Nidlegy resubmission. I hear 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 re-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, is mostly on the financial side. Is 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 two years, the buyback targets were not met because if I look, and correct me if I’m wrong, in last year, it was just a buyback of 0.5% of the total, while you were asking us 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.

Dario Neri, Chief Executive Officer, Philogen: 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 nine, 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 I 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 I clinical trial have been presented at the international congresses, but any future communication will be performed by Bristol Myers Squibb or RayzeBio. 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, you know, 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. 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, which is-

Walter, Analyst, Unknown: Sorry. Just on this, to elaborate. If I understand correctly, the procedure to check whatever has been asked from the FDA and the EMA will be performed up to July of this year. But

Dario Neri, Chief Executive Officer, Philogen: 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.

Walter, Analyst, Unknown: Okay. If I understand, sorry if I double-check on this. If and when on July 1, 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. 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.

Dario Neri, Chief Executive Officer, Philogen: 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, and 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, you know, we finish certain analytics and, you know, we don’t have to wait six months, twelve 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. You know, 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.

Emanuele Vignati, Executive (Fibromun Program Lead), Philogen: Walter, once you submit, the process is similar to last time, I think, also as indicated in the slide. I think then we’ll have something like one year or a bit less for the CHMP to take the decision.

Dario Neri, Chief Executive Officer, Philogen: Yeah. This is in one of the slides in which we were showing submission in July and decision expected mid-2027.

Walter, Analyst, Unknown: Sorry, just on to close on this point. The body that will judge on this Nidlegy data pack is the same as the first time or will be re-chosen? Could be-

Dario Neri, Chief Executive Officer, Philogen: The body, 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. It’s a majority vote, which is made by CHMP members.

Walter, Analyst, Unknown: Okay. That’s more better.

Dario Neri, Chief Executive Officer, Philogen: The last topic, 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 the 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. You know, 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.

Walter, Analyst, Unknown: Yeah. Maybe my point was that basically if I look at 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 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. My question right now is, how we should see this activity and potentially seeing that the company in the last two years had changed the risk profile. Your ability also from the comments that you give to Isacco few minutes ago, there is full financial sustainability of this company.

also seeing some kind of buyback and helping this company to perform versus a sec-

Dario Neri, Chief Executive Officer, Philogen: If you want, I will hand over to Laura.

Laura, Chief Financial Officer, Philogen: Sure.

Dario Neri, Chief Executive Officer, Philogen: We want to have the freedom to buy, and the comment to Isacco, which I’m glad to repeat, is that we have, I think, a 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.

Laura, Chief Financial Officer, Philogen: Walter, as you know, 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 35% of share capital. Of course, the authorization of the board of director first and the assembly after is a signal of a strong confidence of 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 very with variability as it was in the last year.

What you ask is this, 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 respect of the MAR. The MAR, it’s the Market Abuse Regulation, so they can’t buy amount with an internal rule. This is why we still have program in place, but we don’t reach the high amount because the amount of shares fluctuated in the market, not all days are purchasable in respect of this law. I don’t know if I was pretty clear on technical aspect you required.

Walter, Analyst, Unknown: Okay. I will look into the definition of the board in order to better understand what are the prices allowed and the volumes. Because if I look at the Consob 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.

Laura, Chief Financial Officer, Philogen: 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, they are acting with a broker contract, a brokerage contract, and they have some strict rule required by the MAR.

Walter, Analyst, Unknown: Okay. Maybe

Laura, Chief Financial Officer, Philogen: I suggest to make a double check, but if you want, we can discuss on this.

Walter, Analyst, Unknown: Yeah, yeah.

Laura, Chief Financial Officer, Philogen: separate part.

Walter, Analyst, Unknown: Yes, please. Maybe we can organize a call or just to better understand how it has been designed. Just to understand clearly what does this mean for all the shareholders. Okay.

Laura, Chief Financial Officer, Philogen: Of course. When you want, just write me or call me.

Dario Neri, Chief Executive Officer, Philogen: Thank you.

Walter, Analyst, Unknown: Thank you so much.

Dario Neri, Chief Executive Officer, Philogen: Thanks, Walter. There is a last question, Mustafa Kilic, and then we have to close, but we are very glad to go through your questions.

Mustafa Kilic, Analyst, Unknown: Thank you very much for the nice presentation and showing the data. I’m very interested in the scientific part. I mean, the nice principle of key and lock that you show with your DNA-encoded libraries is really nice, and you have so much proteins. I was interested in how do you select them and what. How do you decide which is the best target? If you have this principle and there are millions of libraries, how can it be that you have only. I mean, this is like a question that you have so less products because you can screen for a lot, like in the pipeline. How is it possible to have not much more products. Yeah, 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 they are, shared between the healthy tissues?

Dario Neri, Chief Executive Officer, Philogen: Okay, these are good questions. I have to break it in parts. The first part is that certainly our libraries, both antibody libraries, the encoded, the chemical libraries. 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.

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. 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. 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. I’ve given you examples also of cellular antigens. This will continue, and actually this has continued.

Mustafa Kilic, Analyst, Unknown: It-

Dario Neri, Chief Executive Officer, Philogen: 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 pharmacodelivery also beyond oncology. The biggest part of our pipeline is in oncology. Please go ahead.

Mustafa Kilic, Analyst, Unknown: Wonderful. Thank you very much. That was already what I wanted. 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?

Dario Neri, Chief Executive Officer, Philogen: The problem with neoantigens, if you take the definition of neoantigens, that would be mutations. Okay? Mutations that happen sporadically on individual patients. Basically, you cannot run a clinical trial because I may have this mutation and Manuel 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 financial basis.

Mustafa Kilic, Analyst, Unknown: Awesome. Thank you very much.

Emanuele Vignati, Executive (Fibromun Program Lead), Philogen: Okay. Thank you very much, and apologies that we went a bit over time. We enjoyed the discussion. If you have any questions, you can send an email to us and we’re happy to reply. Thank you very much.

Dario Neri, Chief Executive Officer, Philogen: Thank you so much. Bye-bye.

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