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

So welcome, everybody, to this new webinar and thank you for joining us today. As always, we have our CEO, Dario Neri; and our CFO, Laura Baldi and myself will provide an update on our latest clinical development and financial results. as of first half 2026. The presentation is being recorded and will be followed by a Q&A session, which is not recorded. As we have a busy agenda with 48 slides, without further ado I hand over the stage to Dario Neri to start the presentation. Over to you.

Thanks a lot, Emmanuel. The first slides are very well known to you. We are a Swiss Italian biotech company listed on the stock exchange in Italy, and you see that the 3 locations in Siena in Milan and in Zurich, they're all important for the company, and we are indeed expanding them. Today, I'm calling from the Zurich operations. We continue to be active in ligand-based pharmaco delivery. We have at present clinical operations with drugs, with radionuclide with immunological modulators, we are expanding beyond cytokines and this payloads are delivered to the site of disease by means of targeting agents, which are nothing but molecules that bind to markers of pathology and these ligands can be antibody fragments or small organic molecules. The quest is a quest for selectivity. We see really a gradient of selectivity from left to right, looking at patients with cancer that receive radioactive drugs, we see that conventional chemotherapy, for example, docetaxel goes everywhere except to the tumor in this mesothelioma patient liver spleen feces, urine but no preferential uptake in the mesothelioma with monoclonal antibodies, the situation doesn't get much better. We get much better with antibody fragments. This is one of our patients with liver mets or breast cancer, and when we have small ligans with antibody-like affinity to accessible targets. This is really the world record of targeting. You see 60 minutes post injection, a patient with metastatic breast cancer every region. So the primary tumor, the bone and liver mets are clearly visible. Our pipeline has grown both horizontally and vertically. We have more products, more indications, more studies, the studies which have been completed are indicated in blue, the new studies launched in 2026 are indicated in red. And as always, we'll go through the products and tell you what's relevant for late stage and for early-stage products. And I will give the presentation together with Emanuele as usual. So Nidlegy is our most advanced product. It's a cocktail of 2 immuno cytokines, with an EMA combi Park authorization. We give it in traditionally because we treat so far, mainly skin cancer patients, and we have focused both in melanoma and non-melanoma skin cancer. We had previously presented the European data of the pivotal trial 256 patients in locally advanced melanoma. 2 arms are receiving surgery as standard of care and our treatment arm with Nidlegy in the new advanced setting followed by surgery with recurrence-free survival as primary endpoint. I'll show you the updated data that have just been published in the journey of clinical oncology, but it's nice to mention that an expanded access programs managed by our partner, Sun Pharma, has treated some 330 patients in about 2 years in France and in Germany, and we are very delighted to see the adoption of the product. This is the primary endpoint of the study, recurrence-free survival as a function of time. We have just published in the Journal of Clinical Oncology, the 36 months basically monitoring of the data that confirmed the very nice separation of the Nidlegy arm from the control arm with good assertation P value. In terms of company operations, you see that we have done everything we promised to do. We had scientific advice with the German authority scientific advice with the FDA, which has defined a very clear path for a possible approval in the U.S. pending a successful outcome of the U.S. trial, pre-submission meeting with Rupert submission at the EMA on July 23, and we are awaiting the first feedbacks from Europe that may come in November or December this year with a procedure that hopefully will be completed next year. And in 2028, we expect the completion of the U.S. trial, and I'll tell you more about it. It's really a sister trial compared to the pivotal trial. It's called new dream, and we have agreed with American authorities that we would treat 240 patients. And you see we have already treated 184 patients. So we are approaching the completion of the trial. And this speed up in the trial has been possible because we really dedicated a lot of energy to activate new sites in the U.S. and in Europe, you see the situation in 2024, and you see the situation in with involved centers and sites in activation are indicated in red and here a big thank to our team. You remember that we are as passionate for melanoma as for non-melanoma skin cancer. Also the non-melanoma skin cancer data being published in 2025, a first report and now really the complete set for the Phase II trial called Duncan has just been accepted and it's impressed in the journey of clinical oncology in which we document this beauty for complete durable responses observed in patients with busier carcinoma and also in squamous cell carcinoma. These are pictures of patients who enjoy a durable benefit. You see 52 weeks follow-up for different types of BCC in different parts of the body. And this last slide is again to remind us that the benefit extends to other tumor, for example, Mercer carcinoma, you see a big reason here in the that is converted into a necrotic cap within 2 weeks. And then the skin is perfect by week 12 for a patient with squamous cell carcinoma and even smaller lesions like this lesion in the lip that would have required disfiguring surgery with amputation of about 2 centimeters of LIPA. You see a perfect cosmetical functional outcome at week 52. So we like the product very much. And we have a vision also in non-melanoma skin cancer. We have launched 3 global trials with registration potential and there is fourth one, which has just been submitted, again with a global intent, Europe and U.S. If I go slowly, we are going in squamous carcinoma in second line, so post PD-1 failure, 92 patients in last-line basic cell carcinoma, again, 92 patients trial, which has been asked by the U.S. FDA in which we will treat between 60 and 180 patients with BCC depending on different steps of the protocol. And and we have submitted the Duncan 2 trial that is a head-to-head competition against the current standard of care, which is a hedgehog inhibitor. And again, we go in a randomized trial, first-line BCC patients with the plan to treat 80 patients. So in short, we continue to believe that Nidlegy has transformational potential as a broadly applicable dermato-oncology drug, and we are making progress with our trials. With this, I hand over to Emanuele, who yes, there is a last slide that, of course, is also important. It's something we know, but it's good to repeat it. These are indications, unfortunately, with many, many patients. If we look at Europe and U.S. for locally advanced melanoma, we are talking about around 23,000 new cases per year whereas if we look at locally advanced buses cell carcinoma and locally advanced squamous carcinoma numbers are even greater. So we see from the many requests for compassionate treatment and also from the early access program that there is a need for efficacious drugs that treat patients locally and so are also better tolerated. And with this, I hand over to Emmanuel, who will guide us through [indiscernible] and also a very exciting results for do decking and antibody cytokine fusion that we have not described in the recent past, but on which we have made considerable clinical progress.

Thank you, Dario. So we started with Fibron, that is partnered with Sun Pharma that is currently investigated for the treatment of soft tissue sarcoma and glioblastoma. Board indications targeted with Fibron represent areas of huge unmet medical needs. In the United States, we have about 15,000 new cases per year. In terms of glioblastoma with more than 10,000 reported debts annually. For soft tissue sarcoma, we have about 13,600 new cases every year with more than 5,000 deaths annually. And in the past, unfortunately, for neither indications have been really big progresses in the pharmaceutical field. Fibron is based on TNF anti targets [indiscernible] a well-characterized marker of the tumor extracellular matrix. And when fused to TNF we aim at selectively delivering the payload at the start of disease, limiting exposure to healthy organs. TNF is a very important cytokins with immunostimulatory in cytotoxic properties that we're not exploiting via the targeted delivery approach that also Dario mentioned before. And [ Lantintenev ] is given by intravenous infusion. And at this moment, is meant fully treatment of solid tumors such as sarcomas and glioblastomas. In one slide, here, we provide a concise update on the developments in both indications. Starting with soft tissue sarcoma first line. We have completed the first Phase III study called Fibrosarc. The primary endpoint was progression-free survival what we had observed is a strong signal in terms of overall survival in a subgroup of patients, representing approximately 70% of the patient population of the study. And if you look at the graph, we went from 13.6 months in blue in the control arm to 21 months, you see in red, in the treatment arm with a hazard ratio of indiscernible] based on these findings, we're now devising new potential Phase III studies called Fribrosarc II with overall survival as a primary endpoint in that group of patients, where we saw the signal in Fibrosarc and now there is a current alignment with both FDA and EMA. In parallel, we also have a start in the U.S. called Fibrosis is a Phase IIb clinical trial in which we enrolled 87 out of 158 patients with metastatic leiomyosarcoma. So this is slightly different compared to the one in the in these [indiscernible] studies. And the primary end point is progression-free survival. On the right, you see that this on glioblastoma, we're active boarding first and last line setting. [ Gliosan ] running in first line. We have a Phase I/IIb study, we have completed the first part with 18 patients and launched in the last few months, the Part 2 that foresees 30 patients -- and this was aligned with the FDA. Part 2 is expected to be completed in 2027 after which we will reach out again to FDA before launching the Phase IIb part. So really keeping constant dialogue with authorities. In the last-line setting, you remember the [indiscernible] Phase II study. The primary points were actually safety plus the 12-month overall survival rate. The last patient was enrolled in September 2025. For the 12 months rate end this September so this month. We'll now need a few weeks to clean the data and run the analysis in order to be presented at the upcoming webinars. Moving back to the [indiscernible] to the pipeline. I'd like now to focus on [indiscernible] which is another important component of our antibody portfolio, which is being investigated for the treatment of viral solid tumors. For [indiscernible] in this case, the payload that is [indiscernible] to also called directly simply IL-12, a key mediator of antitumor immunity and that has been for long regarded as a very promising cytokine for cancer immunotherapy. Here, IL-12 is still use 2019, the lenti antibody targeting EDP, which is expressed in virus solid tumors. You see 5 different examples of of cancers from breast to pancreas in 5 different patients. You see ADB expressions you always find it in brown and the pan-tumor expression of the antigen gives also a very broad applicability of [indiscernible] in across different indications. The interest in IL-12 is also reflected in the recent very substantial transactions that have been reported over the last years. He report 2 of them 1 between Bristol-Myers Squibb and Dragonfly and the other between Gilead and Silo in which you see a significant upfront and milestone payments that were foreseen in these agreements. And so [indiscernible] is now investigating a Phase I clinical trial. We have completed the dose escalation part. We went from 0.1 microgram per kg all over to 12 micrograms per kg. And this is the dose that's been selected for the dose expansion part currently ongoing in 20 patients with virosolid tumors. The clinical results, which are emerging are promising. We have seen, for example, a patient with heavily pretreated disease. So metastatic mucosal melanoma. You see here a liver metastasis. These are FDG scan. The lesion here eats a lot of glucose. That's why it lights up so much. But after 2 months or 4 months of treatment, you see that the tumor is basically dead, and that's why it doesn't eat any glucose anymore. So in that case, we saw a strong metabolic complete response. As a next step, what we want to do is based on our experience with [indiscernible] is that -- this drug has a dose-dependent antitumor effect. So we want to go higher than 12-microgram per kg by applying our patented technology called [ Intracork. ] In this slide, we have a simplified explanation of how this Intracork technology works, but is much more detailed in the papers that you see at the bottom of the slide. This is a classical, let's say, PK profile in blood in tumor of of our immuno cytokines. You see the concentration of the drug as a function of the time. Normally, the concentration of the drug in blood is highest soon after the infusion, and it drops quite rapidly while thanks to the LNT antibody, we have a built up over time in the tumor. With immunocytokines, the toxicity and normally is observed shortly after infusions and are reversible. And as soon as the concentrations in blood drop below a certain threshold, you indicated a toxicity threshold the adverse events fade away. So what we want to do is to use an intracellular signaling inhibitor, namely [ fuxolintinib ] to constantly mask the activity of IL-12 for only a short time, when its blood concentrations are the highest without impacting on antitumor efficacy as the inhibitor gets cleared. And this only works with ligand-based delivery if you have a nontargeted approach, like the one described below of Dragon Flight, this wouldn't work because you wouldn't see a build-out in the tumor. The first clinical trial has just been just started also with another anti-infusion called [indiscernible] We're now planning the second study also with [indiscernible] replenish submission in the coming weeks.

And so the vision is, as you see, is to continue to innovate antibody cytokine infusions with a couple of twists. First of all, the observation that FDG PET is a very good methodology to detect early responses, especially when you are then left only with a necrotic scab which no longer it's obviously tumor because it's no longer live tumor and also the implementation of our patented [indiscernible] technology. So we will present updates also in the upcoming webinars. Now when we come to the small molecule pipeline depicted in blue because it corresponds to the fully owned Filo Chem daughter company of Filo Gen, we go again, through the principle that for certain targeting applications, small ligands are even more efficient than antibodies, both macroscopically in terms of their ability to localize to the tumor and also microscopical in terms of their ability to reach every single tumor cell here depicted with a green ex vivo fluorescence microscopy study. The pipeline starts with discovery of ligands typically from our denoted chemical libraries, we confirm the targeting ability of the best molecules. And then we functionalize them by attaching radionuclide or a cytotoxic drug or even immunostimulatory agents. And we have all these programs in the clinic at this moment in time. So today, we focus on 3 targets called FAP fibroblast activation protein, C9, carbonic erase 9 and the CP III acidic phosphatase, and we'll show you clinical data, but we have as you will see more radiopharmaceuticals moving to the clinic in 2027, and I have a dedicated slide later today. You see already from these pictures, not only the structures of our molecules, but also the fantastic selectivity observed in patients just 60 minutes after intravenous administration. Let's start with FAP. You know that the product is partnered with Blue at diagnostic company of the [ Bracco ] Group. We have already treated more than 500 patients. Bed has now started Phase II clinical trial. Here, you see the number. And again, information on this trial are provided by the [ Bracco Group ] because they hold an exclusive license for imaging applications. We have kept all rights for radionuclide therapy applications. We have launched Philogen sponsored Phase I clinical trial. Again, those patients not only want to know that they have lesions, but they want to receive therapeutic nucleates like lutetium 177, the trial started and from exemplary patients that we show, I think you can see the exquisite selectivity of Onco FAP reaching the metastatic tumor lesions in different indications. We have also a promising nonradioactive fab-based therapeutic called Onco FAB [indiscernible] MMAE or [indiscernible] You see the modular structure of this product. You see the Onco FAP in blue that targets FAP FAP is not only a target, but also proteins that cliffs after proglycin and proline. So you see that we have put glycine and proline in the linker -- and then we have monomethyl restarting as a very well-established potent cytotoxic pilot. We had previously reported on the nice experience in animal patients clinical trial in animal patients, namely dogs with spontaneous tumors. This is one of these patients with a 15-centimeter sarcoma that received 4 injections of the product, and you see that 28 days later, the mass of the tumor has sufficiently shrunk substantially shrunk and you look at the hematology of all the treated patients, the treatment is really very well tolerated with really no sign of hematological toxicity or other types of toxicities in the investigated dose depicted here to the left. The beauty is that the data are published. And if you go to the publication, you see a one-to-one correspondence between performance and immunostochemistry in patients with high fab expression you see this type of performance. If the tumors are negative for the antigen, then the performance is worse. We have completed the GMP production of the active pharmaceutical ingredient. We have completed safety tox studies and first in human studies are expected in 2027. We are obviously very excited because Fab is a good target for many tumors with nuclear medicine validation, and this data in animal patients are a good basis for the clinic. The second target that we would like to describe is carbon and ads 9, and we have, again, a ligand called Kidney cancer is actually an important type of oncological disease. In this graph, you see the incidence and the mortality of different cancer types. And you see that actually kidney cancer is unfortunately pretty high in terms of mortality per 100,000 persons per year. And among kidney cancers, clear cell renal cell carcinoma accounts for about 80% of renal cell carcinoma cases and it's really unfortunately, in many cases, daily disease. There is a need to distinguish between clear cell renal cell carcinoma and benign key lesions because about 30% of renal masses are surgically removed in a way, even though they may not be aggressive tumors. And so in a way, we want to avoid this unnecessary surgery and also provide a reliable diagnosis to the clinical centers, C&I is the target for clear cell carcinoma. Telix has already published a Phase III clinical trial with 300 patients showing good results, but since they used an antibody to image patients with kidney cancer. They had to observe patients for several days and possibly this methodology delivers a high amount of radio activity because antibodies circulate in vivo very long. Our onco CNI gives a very confident detection of kidney masses already after one hour with excellent discrimination against the normal kidney you see residual uptake also in stomach and in testing, but this has no impact on the diagnostic performance. And when you have a patient with heavily metastatic disease like this third patient that you see in this slide, you can really appreciate the potential of the drug, not only for the detection of the primary tumor but also for staging applications. The Phase I clinical trial has been run in Italy and coordinated by [indiscernible] and data being presented. It's nice to confirm these 2 situations, a patient with mass in the kidney, which was C-positive clear cell renal cell carcinoma indicated by this red arrow already after 10 minutes, you see very confidently the presence of the region and the negative control, if you want a patient with a benign kidney mass and at no moment in time, you see the yellow arrow detection of a mass in the pet experiment. So we like the product very much. and we are committed to moving the product towards Phase III clinical trials. We have completed Phase I testing. We are making progress with GMP manufacturing and coal kit development by the end of the year, we will have a meeting with the U.S. FDA to discuss the registration path for the product that is expected to start in 2027. And you know that imaging trials are faster than therapy trials. Of course, we have a CPI that we will discuss in a split second and, of course, more products coming to the clinical next year. If we look at the PSMA market of radiopharmaceuticals in prostate cancer, you see imaging products like [indiscernible] and you see therapy products like Pluvicto, there were cumulative sales in 2025, greater than USD 3.5 billion, probably around USD 4 billion growing. As you can see, and there is an opportunity to do better than PSMA. We always like to show the slide that the European Association of Nuclear Medicine chose to the Congress with the smiling ACPI and maybe an angry PSMA. We think that ACP III is an interesting contribution. And you know that we announced last year the licensing of Onco ACP III to race Bio, a company of Bristol-Myers Squibb both for imaging and for therapeutic applications and the -- if we use the new Bristol-Myers Squibb names, which are indicated here, these products are being developed therapeutic and as a diagnostic agent. And of course, if you have more questions, you should address them to Race Bio, which is the new owner of the product, the financials for the deal with upfront payment, milestone payments and also royalties are indicated in this slot. We will bring new products to the clinic next year, but there is a dedicated slide. I want to show 2 last slides on science to say that all these developments are possible because we invest in discovery technologies. Everything starts with the ability to discover ligands. You know that we have practiced antibody face display technology for more than 3 decades by now. And also, we mentioned how Dell Technology has delivered products for the targeting of FAP, CN, ACPI and more targets we have established by now very large Fitch display libraries complaining libraries of cyclic peptides containing more than 200 billion candidates. We have recently established successfully mRNA display of cyclic peptides and modified peptides, and we have been successful also in applying artificial intelligence tools for the discovery of other types of protein binders. So different methodologies give us the binders with which we implement our discovery platform. And again, in addition to the late-stage trials that were mentioned before, I am pleased that to confirm that in 2027, we expect the start of at least 4 new molecules in the clinic. Onco FAP [indiscernible] for various F-positive tumor types, so a small molecule drug conjugate that has been tested in dogs until now. Two new radiopharmaceuticals, which are not disclosed today, but we will present them when they yield the first clinical data, the preclinical data are very, very promising. And we have a second-generation IL-2-based immuno cytokine called FA IL-2 with Intra-Core technology that we believe will move us ahead in the field of cytokine-based therapeutics. The last slide is really a comparison of important financial figures in 2024, 2025, 2026, always looking at the first half of the year. If we look at the cash, we went from EUR 64 million in 2024, EUR 100 million in 2025 to more than EUR 300 million in 2026. We have a very good cash position. As you can see, -- and the operating costs have grown moderately. So to a stage that we can afford and there, of course, will be future revenues from contracts that we have in place and when they come, of course, we will communicate them. So with this the presentation finishes. It's basically almost 3:40. We stopped the recording, and we can start the Q&A session, which is not recorded.

So we see that Clemence and Issaco have questions. So maybe Clemence, you want to start?

Yes. Congrats on the progress. Two questions on my side. The first 1 is on BCC com. Could you clarify the development strategy? Because he described the study as pivotal, but unlike the other 3 studies, the pipeline slide do not live at having registrational potential. So just wondering whether it could support a regulatory filing or if it's more like a dose component sales and study? That's the first.

It's good. It's a good question. It's an important trial for the following reason. In squamous cell carcinoma, we have the second line trial in BCC. We have the third line trial -- but the difference between the U.S. FDA and the European situation is the following one. In Europe, we have a combi park authorization, which means European EMA has accepted that the combination of L9 IL-2 and 19 TNF, the dose that we use is one product and this 100 as 1 product. The U.S. FDA formally requires that whenever you go with combinations, you have to demonstrate the contribution of each agent. So it's not a dose-finding study, but it's a contribution of each component. So the trial foresees that we treat patients with [indiscernible] with the cocktail of the 2 side. [indiscernible] can stop at different stages depending on the signals which are generated I consider it of registration potential because we treat many patients with BCC that are underserved by other modalities. So as always, when we have data, we go back to the FDA, not only for the confirmation that the combination of the 2 active ingredients is better, but also to show the data that we have. On top, in first-line the race is against hedge Hock inhibitors, and that's why we are launching Duncan 2.

Okay. That's very clear. And just maybe a broader question because across all your program, there are several ongoing regulatory interactions. Could you maybe give us some idea of where you would say you have clear alignment with the agency and where there is maybe more regulatory uncertainty?

Yes, it's a very fair question. So I will give a long answer because we have gone through many different meetings. So if I look at needles in melanoma. In Europe, we are at the marketing authorization application. So the next one to speak will be EMA. But in the U.S., we have aligned about the number of patients, the statistical design, the endpoints for the NEODRIM trials, so the Phase III clinical trial. So I feel that we have complete alignment with the FDA about the design of the trial and the requirements for registration. For non-melanoma skin cancer, we have formally asked for a scientific advice on the different indications. And I think that, again, we have clouded in first, second and third line. When we go to Fibron, the soft tissue sarcoma results that have emerged from the [indiscernible] study have been discussed and have been presented and we, in a harmonized parallel scientific advice procedure with Europe and U.S. authorities. And it has been clear that registration will require a second trial with overall survival as endpoint. In parallel, the glioblastoma programs we have in writing the outcome of parallel harmonized scientific advice procedure with Europe and the United States. When we go to do decking, this is new stuff. This is really emerging potent data of activity and so [indiscernible] has not yet been discussed with authorities in terms of path to registration when it comes to the radiopharmaceuticals, again, the Bracco Group will speak for FAP. The BMS Group will speak for on Onco[indiscernible], we have submitted the request and the documentation for a Type C meeting. And by December, we should hopefully have the blessing on our development plan for the Phase III trial. So I've covered a lot of ground, and I stop here in this

Thank you lot, Clemence and Isacco? I see the hand raised is a we can...

Apologies for the issue. So 3 questions on my side. I will go one by one if it's okay for you. First question is on non-melanoma times. Just if you can share a bit more color on the timetable you have in mind for the completion of the different registrational guidance?

Yes. the 3 trials, which are ongoing are -- they have to be considered 1 by one. The squamous cell carcinoma trial, second line is the easiest to execute because it's 92 patients and basically after PD-1 blockade, there is no other agent. At this moment in time, we expect to be able to recruit it by 2028, but time will tell. So as always, you know that you have seen it for Neo Dream. When we make progress, we tell you really webinar after webinar, where we stand. But our time lines are so for the third line business carcinoma, we will see unfortunately because in third line patients are more difficult to treat. And we are never really focused on third line so far. So I don't like to make a prediction. I can only tell you that we watch the recruitment and having opened good centers like MD Anderson in the U.S. and also many European centers I think we will be able to recruit by 2028, 2029, but we can be more specific ones the trial has made sufficient progress. For BCC come, this is something where we will have the answer very, very soon. But as indicated, the trial could stop already after 60 patients that would be 20 per arm or depending on the protocol, it could go all the way up to 180 patients. And the last one is a first-line trial Duncan that we have submitted Duncan 2. The trial will start in 2027 with Odonto as comparator -- and we need to treat 180 patients. I believe that we may need between 2 and 3 years to finish that particular trial.

Thanks Dario. Second question is on -- more on strategy on your side with Onco ACP III, you opted for an early-stage partnership from the presentation on ONCO CA9 looks to me, you look confident to go alone? Is it a correct understanding? Or?

Okay. No, maybe I'll be more specific. I think ONCO CA9 is really a good imaging agent. I'm biased, of course, and you have to judge with your own brain, but I think the pictures speak for themselves and also the data presented by the [ Citi ] Group are very nice. So I can say that we have companies, multiple companies that have actually approached us for a possible in-licensing of the product, and so never seen ever. But what I've learned is that it's extremely important at least for the -- moving the product to development for kid development a little by little, we have gained these capabilities and then when we have them in-house, we like to move product with Philogen quality, [indiscernible] quality and also with Philogen Speed. And so this is something that will certainly enter the clinic very soon. And then we will be -- we will decide really based on the offer, if it's worth partnering or if it's worth thinking of bringing the product all the way to the market ourselves. Sorry, long answer. I know you have more questions.

No, no. Makes sense. similar comment maybe on [indiscernible] just curious to know if you're keen to go alone or maybe a partnership would make...

Honestly think whenever you bring these products and you see activity you dream to have the next immuno-oncology drug. We feel that the road to interleukin 12 therapeutics has been a difficult road. Some 30 years ago, actually, Interleukin 12 was first brought to the clinic as a non targeted agent, Roche and other company studied it. They saw some responses, but also they didn't manage toxicity and site looking [indiscernible] was sort of forgotten. We were the first group to publish that you can deliver interleukin-12 with antibodies nature by technology 2002, and we have really spent 20 years perfecting the molecule. We have seen molecules go to the clinic and fill. We mentioned some of them so at this moment in time, we really go one step at the time. The goal of the Phase I trial was to see if we could see activity and also pharmacodynamic evidence of activity in patients, and this evidence is here. We have a technology intracork to go up to the dose. And we know from animal studies that the more you give, the better it is. So your question is what do we do next? What we do certainly is we want to establish very clear evidence of efficacy in the clinic with Intra-Core technology. And this will happen within the next 18 months. So the plan for the next 18 months is to collect the documentation of solid evidence of durable activity in last-line patients. Then, of course, it's always the same decision. If we find good partnering opportunities, we will partner. If we think that the development of the company allows us to go further ourselves possibly all the way to the market. I think we know that we can do it because we have brought other products to the completion of Phase I so we are not in a hurry to partner because actually, we are doing very well with money. But we are in a hard to provide a clinical proof of principle which is solid. Until now, no company could show solidly that they could exploit Interleukin-12 therapeutics. We believe we will be the first actually to formally prove this.