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Edited Transcript of PCIB.OL earnings conference call or presentation 27-Nov-19 7:30am GMT

Q3 2019 PCI Biotech Holding ASA Earnings Call

Dec 10, 2019 (Thomson StreetEvents) -- Edited Transcript of PCI Biotech Holding ASA earnings conference call or presentation Wednesday, November 27, 2019 at 7:30:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Per Walday

PCI Biotech Holding ASA - CEO

* Ronny Skuggedal

PCI Biotech Holding ASA - CFO

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Conference Call Participants

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* Pal Falck

Arctic Securities AS, Research Division - Research Analyst

* Esben Eriksen

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Presentation

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Per Walday, PCI Biotech Holding ASA - CEO [1]

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Good morning, everyone, and welcome to PCI Biotech's Third Quarter Presentation 2019. My name is Per Walday. I'm the CEO of PCI Biotech, and I have with me also Ronny Skuggedal who is the CFO of PCI Biotech.

So we will start with going through a bit around the background and technology of the company, then moving into the highlights. And after that, going more into details in the 3 different programs before we end up with talking about the outlook.

So to start a bit with the company. So PCI Biotech is developing a platform technology, the platform technology is called Photochemical Internalization. It has been invented here at the Radium Hospital in the building next to where we are today. And we are developing this specific technology in 3 different programs. We call them fimaCHEM, fimaVACC and fimaNAc. It's all based on the same platform technology, but it addresses 3 different areas of unmet medical need.

The first one is to enhance locally the effect of chemotherapeutics that are already approved. And this is the lead program that we have, which we are developing in bile duct cancer. And we are now in the pivotal development, a study for registration of Amphinex, which is the agent here for treatment of inoperable bile duct cancer.

The second program we call fimaVACC. It's a vaccination technology, where we use the same technology to enhance, specifically, T-cell cellular immune responses from therapeutic vaccines or from vaccines in general, but specifically needed in therapeutic use of vaccines.

And the third program we call fimaNAc and NAc stands for nucleic acid therapeutics. And these are large molecules that have difficulties coming into cells, but need to get in that work. And we have -- we are using PCI as a delivery technology to get those efficiently into cells.

Now how do we do this? What is the platform technology? It is a triggered endosomal release technology. A number of molecules or medicines have problems getting into cells. And if then they have targets within the cell, they then have also problems in reaching the target and thereby exerting the therapeutic effect. Now many of these drugs are taken up anyway into cells through a process called endocytosis. With endocytosis, it's like a way that cells eat and take in nutrition. They invaginate the cell membrane and form small capsules and take in that way in what is on the outside of the cell into the inside of the cell, but it is then trapped inside the small endosomes, the capsules. And what we can do is to release what has been taken up into cells through the Photochemical Internalization technology. We have a photosensitizer, which is called fimaporfin. It is designed so that it accumulates on the inside of these membranes of the endosomes. And then when we illuminate an area or a tissue, an organ, where we have this fimaporfin in the endosomes, it will activate the fimaporfin who reacts with amongst other oxygen, produces singlet oxygen, which reacts with the components in this endosomal membrane and destabilizes the integrity of that membrane, which means it becomes leaky. So whatever then the cell has eaten up through this endocytosis mechanism and have in those capsules can leak out into the cell and reach its target. So it's a way of delivering stuff into cells that is not easily getting into cells by themselves.

We are, as I said, developing this in 3 different technologies, whether -- this is really a challenge to realize the huge therapeutic potential that are in these technologies sufficiently.

So fimaCHEM enabling approved drugs to fulfill unmet local treatment needs. We can enhance the effect of chemotherapies where we illuminate, specifically where we illuminate, and by doing this address unmet local treatment need. For fimaVACC, to enhance the cellular immune response that is important for the therapeutic effect of vaccines, so enhancing T-cell responses. And for fimaNAc to provide efficient delivery, intracellular delivery solution for nucleic acid therapeutics.

So this is the technology on the background of the company. And now I'm going to go over to talk about the highlights for the third quarter.

So the pivotal study in the fimaCHEM program that I talked about is called RELEASE, the RELEASE study. The first patient was enrolled in May this year. And we now have regulatory and ethics approvals in 10 of the 11 EU countries that we are aiming to open up sites and in the U.S.A. We have opened a total of 23 of the planned 40 sites for this study. And we have also now opened the first U.S. site, and that opened just recently. And knowing that this is a rare disease, enrollment of the first U.S. patient are likely to slide into 2020 since it just opened recently. It takes normally some time before they find the first patient. So we're not sure we're going to get it this year.

We are approximately 10 sites behind what we had in the schedule. So we are a little bit lagging on site opening, but we are, according to our projections, expecting to catch up early in 2020, approximately in the first months of 2020. And we are -- we have site selection ongoing in Asia, with the aim to include sites in 2020 in Asia, which will enhance the recruitment projections, as this is a more prevalent disease in Asia.

Now for fimaVACC, we have got acceptance for presentation of our Phase I study, the proof-of-concept study at the ESMO Immuno-Oncology Congress, a global congress, which is very important within the immuno-oncology area. We have, in this study that was going to be presented, showed proof-of-concept for the technology in healthy volunteers. We can see enhanced immune responses and the immune responses we're looking for the T-cells. We also have now recently had a publication of some promising preclinical results in Frontiers of Immunology, which is a high-impact immunology journal. And what we're doing now with this is to have parallel development strategies with direct partnering efforts for this technology with companies that are developing vaccines as well as looking to whether we can start a clinical proof of concept in a disease setting ourselves.

For fimaNAc, we have now, with the top 10 pharma collaboration, which is AstraZeneca, expanded this to other disease areas. We have some very encouraging results with and such synergies shown with our technology within oncology in this collaboration. And now there was a wish to enhance or expand the scope to look also at other disease areas. This collaboration is now valid and open for experimental studies until the end of the year. So it's a limited time, but there's a clear plan for what should be done within this time before the end of the year. And then in the agreement, there is a 6-month time period afterwards for discussion on potential next steps based on what we achieved during this last half year of the collaboration.

We have also had a promising early response on a patent application for mRNA delivery, which is highly relevant for a number of these -- several of these collaboration partners or partnerships that we have established with fimaNAc.

So with that, I would like to go into the different programs a bit more in detail and talk about where we are and what we're doing. So as I mentioned, fimaCHEM, we're using the PCI technology to enhance locally the effect of systemically-distributed or systemically-used chemotherapies. So when you use a chemotherapy, you normally give that intravenously or per orally, and it goes out throughout the body. Now what we can do is we can enhance the effect of that established treatment locally by combining it with our technology. And we've shown that we can do that approximately in 20% of all relevant cytotoxics. Now what we are focusing on initially is bile duct cancer. This is the program that we're going -- that we now have taken into pivotal development. And for that, we are using gemcitabine, enhancing the effect of gemcitabine, which is the standard of care in this patient population.

So why bile duct cancer then? And it's really -- it's a subgroup of this as well as extrahepatic inoperable bile duct cancer. Well, there is an excellent fit between the medical need here and the technology in this patient population and existing treatments and PCI, so if we look at the unmet need, to start with, it's only 11 to 12 months average survival of these patients when they are inoperable, and most of them are inoperable. Actually, less than 1/3 of the tumors are resectable at presentation. So normally what happens with these patients is that they get stents to open up the bile duct and they get chemotherapy. There is nothing approved though of chemotherapies. So what is used as a standard of care is a combination of gemcitabine and cisplatin. They are actively used and they are recommended in guidelines, but they are not approved by the regulatory authorities. And in addition, as I said, one uses endoscopes, scopes you put in through the mouth, down the esophagus, through the stomach and into the bile duct to put in stents, take biopsies and so on. That's standard procedure in these patients. And normally what's done then is to put stents for palliative biliary drainage.

Now the advantages of fimaCHEM here is that we've done a Phase I study and the highest dose cohort had more than 20 months overall survival. Now it's early days in few patients, but there was a clear link between tumor response and apparently clear link at least between tumor response and survival. So it then also potentially offers a clear benefit for a majority of the target patient population for this study. It enhances the recommended first-line chemotherapy, which is gemcitabine. And most of these patients die from the local effect of the tumor, the effect of the tumor in the bile duct. So what you need to establish is a better local regional control of the tumor. And this is what we do. We can boost the effect of the chemotherapy where it is most needed. And this can be done quite easily through what's used standard in these patients when they use the endoscopy to stent or take biopsies, all of those different technologies. We can just use the same technology to put a light optic fiber through the endoscope into the bile duct and illuminate the tumor from the inside of the lumen of the bile duct.

So what we're developing this for is actually a first-line treatment for newly diagnosed patients with inoperable extrahepatic bile duct cancer, and we're including also patients with liver metastasis in this study. What we have agreed with the authorities is that we are going to do a one-to-one randomized study in a total of 186 patients. And it's then a control arm with 93 patients, which gets the standard of care gemcitabine plus cisplatin up to 8 cycles and then an experimental arm where we add, in addition to this, up to 2 doses of fimaCHEM with the standard of care to enhance it locally.

And at the bottom of this slide, you can see how this is done. It just depicts the treatment from the start of the cycling to second treatment also at cycle 5. And the specific treatment procedure for fimaCHEM, you can see at the down right corner, lower right corner, which is a 3-step procedure, where we first give Amphinex, the fimaporfin sensitizer, we wait 4 days for this to localize into the endosomal compartments and then we give gemcitabine and then just a few hours afterwards, we illuminate the bile duct.

It is a rare disease. It's approximately 1 to 2 cases per 100,000 in EU and U.S. It's more, it's higher generally in Asia. And what we are going to open here is approximately 40 sites. That's what we told and in 11 European countries and U.S., but we are now doing site selection in Asia. And we're initially focusing on South Korea and Taiwan, based on the feasibility that we've done.

We have now, for this study, regulatory approval and ethics approval. So everything that we need of approval to be able to start the study in 10 of 11 European countries. The one missing is U.K. And also, we have approval in the U.S. As mentioned, we have opened 23, and 1 of those is in the U.S. of 40 sites for patient enrollment. And you can see here a map on the right-hand side on where we have approval currently -- full approval currently. As I said, the first U.S. site just opened now recently. So the first patient in the U.S. is likely to slide into 2020.

And we have then a current lag, as I mentioned, approximately 10 sites behind what we had in our plan, but that is not going to affect the main milestones. We retain the main milestone of actually having the interim read after 36 months. And site selection is going -- ongoing for startup in Asia in 2020. Bile duct cancer is more prevalent there, and that will enhance -- our expectation is that, that will enhance the recruitment of patients.

So a bit about the study. This is a study -- a single pivotal study, which is done based on the interactions that we have done with the authorities. And it has an interim analysis for where we can get accelerated approval, if we reach the endpoints. The primary endpoint for the interim analysis is progression-free survival and the secondary important endpoint is objective response rate.

We have orphan drug designation, both in Europe and U.S. already. And this potentially accelerated conditional approval is, of course, very positive and important for us.

The final analysis is also progression-free survival and the secondary -- key secondary here is actually my fault, so this is wrong, it should read overall survival as the final analysis. A key secondary is overall survival, not objective response rate for the final analysis. So apologies for that.

So milestones and timelines for this. The first patient was enrolled in Europe in May, and the first patient then we are expecting to have in the first half of 2020. We have established, what we call, an IDMC, an Independent Data Monitoring Committee. As a company, we are blinded to the study and the study results, but they will, at certain points, get the results so they can review it. It's a small group of experts, a statistician and 2 clinicians, and provide recommendations to the company. They will also be the first ones to look at the interim analysis when that happens. It is an event-driven interim analysis. So it's progression-free survival, PFS events, that is progression events, really. And the interim analysis is, as I mentioned, expected 36 months, 3 years after first patient included, which was in May this year.

And then the timing and the format for the study conclusion, the end of this will depend on what comes out of the interim analysis, of course. But the final analysis, if the study runs on, is expected approximately 50 months after inclusion of the first patient.

Now this has all been designed based on -- and agreed with the authorities based on some promising results that we saw in the Phase I. We saw a tumor response that was dominated by significant target tumor reduction in the first 6 months. And all the reductions that we saw that are reassessed valid reductions locally are at the highest dose levels of fimaporfin through these different cohorts. We also see an encouraging link between tumor response and overall survival. So the median overall survival at the highest dose cohort in the dose escalation was 21.7 months. If you look at the full dose escalation study, it was 14.4 months. And that is the dose, the Cohort IV dose, that was selected for the pivotal RELEASE study and half of the patients there, it's only 6, but half of the patients in Cohort IV survived more than 30 months. And actually, we have 1 patient still alive now by mid-November, which is then 44 months after treatment. And that was actually a patient not only with local disease, but also lymph node involving disease, so a quite advanced patient.

So these encouraging results paved the way for a pivotal trial. And because of this, we also were allowed to have an interim analysis for potential accelerated approval. And we have also then done an extension study where we've shown that it's safe to do this to repeat this treatment to do it twice. So we do up to 2 treatments in the pivotal study.

So let's move over to fimaVACC, the vaccination technology. It's the same triggered endosomal release, but it's used in a different way. Here, we take a vaccine, a protein or peptide-based vaccine, we mix it with fimaporfin, our photosensitizer, and we inject it into the skin. When you inject vaccines, they are taken up by something called dendritic cells, which are a specific cell in the immune system that sort of guard the body and looks at everything that comes into the body to see if there is anything that is harmful. So those are the cells we're looking for when we are vaccinating people. Now what normally happens then is that they take up these vaccines through this process of endocytosis that I mentioned early on in the presentation and they are presenting this on a specific presentation molecule called MHC Class II. And MHC Class II provides a response of antibodies and helper T-cells, very useful and very good when you want to protect the body against a virus or a bacteria or something that you can catch in the blood.

Now if you really want the immune system to kill the cells of your own body that are sick, you need to have cytotoxic T-cells, and those are induced primarily through a different route, presentation on MHC Class I. And to get access to that route, we can use our technology to illuminate the area where we injected the vaccine and then what's been taken up into dendritic cells. These immune cells will be released out of the endosomes and will come into the cytosol. And when it comes into the cytosol, it will be processed by proteasomes there and the presentation route is different than the presentation is on MHC Class I. And by doing this, we can generate then more disease-specific cytotoxic T-cells, which can attack cancer and virus-infected cells more effectively. We have a lot of preclinical data showing that this is a very efficient technology to enhance the cytotoxic T-cells. And our aim then was to translate those over also to the clinical setting to man to see whether the same effect can be achieved in man.

So we did then a Phase I study in healthy volunteers. And this Safe I study -- Phase I study provided successful clinical proof of concept of fimaVACC in this population. The overall objective here was to look at safety, tolerability and the immune responses that we could achieve by including fimaVACC to small peptide and large proteins. And we, by this, got proof of concept and efficacy in terms of intradermal dosing, so using it in the skin and -- as well as a positive overall characterization of tolerability. And we know that then from this study that we can see efficacy across a relatively wide tolerable dose span. So all looking very good.

Looking at a snapshot of results here. We can induce a substantial increase in the number of T-cell responders. So looking at the different healthy volunteers that got this, the left panel here, you can see the control and increasing fimaVACC doses and the percent of responders when using this technology. We also saw that we get clearly enhanced overall T-cell responses. So not only in more responders, but also stronger responses in those responding. And we also saw that we had more robust CD8 T-cell responses. What we induced the effect here with was an HPV peptide from the protein -- oncogenic protein E7. So one of the proteins that drives cancer that are induced from HPV infection. And this peptides from E7 is very, very difficult to induce CD8-positive T-cells with, but we could nevertheless do this in healthy volunteers, as you can see in the middle here, control versus 2 fimaVACC doses.

So we also then when looking at these specific CD8 T-cells, we could see an increased functionality of the induced CD8 T-cells, which means that they are better in attacking cancer, better in doing what they're supposed to do. And all of these are highly sought-after features, especially for therapeutic vaccination, where you need a good T-cell response and a specifically good cytotoxic functional T-cell response. So we -- fimaVACC can provide increased number of responses, enhanced responses and better functionality, all very good.

Now these results are going to be presented in more detail at the ESMO Immuno-Oncology Congress in December this year. And we are also working on a publication for a scientific journal of the more detailed results. And we're now using these results. When we have published and have the details, we will go out and use these results to ensure that we get interest from companies that are developing these kinds of drugs, these kinds of vaccines. But we also look at doing a clinical proof of concept in a disease setting ourselves. So it's a two-pronged approach here, looking at both internally how can we develop this further and also reaching out to potential partners.

And talking about partners, I will go into the fimaNAc technology, nucleic acid therapeutics. This is then developing, or delivering I mean, nucleic acid therapeutics very efficiently into cells. Nucleic acid therapeutics or gene therapies or different kinds of therapies related to gene therapy are all very large molecules, and they utilize the machinery that are inside cells to do the work they are supposed to do. They can either go in and knock down genes to stop production of a harmful protein, for example, where you can give something as you can do with siRNA or microRNA or you can use mRNA or DNA to place in this to enhance the production of something beneficial that you want to induce a protein that you want to increase the production of. So therapeutic protein production. So instead of doing these productions, which is very cumbersome outside or in a factory, where you need to have a biological manufacturing and you get a product that is not as well-defined as normally small molecules are, and it's very expensive and quality control of it is quite cumbersome. What you can do is to give something that actually makes your own cells producing the same protein. And by this, you use the body as the manufacturing process for that specific protein. So it's a very smart way of using it.

Now the only problem with this is that they are large molecules, very large molecules and they need to get into cells to use the machinery inside cells to get this done. And we have a technology to deliver them efficiently into cells. And we do this because all of these are taken up through endocytosis, but then they're trapped in endosomes and broken down in lysosomes. But with our technology, we can release them from the endosome so they get into the cytosol and can exert the therapeutic effect.

For this specific program, we are using a collaborative approach. We don't have nucleic acid therapeutics ourselves. So we go out to companies that are developing this very promising new class of drugs, telling them that we have a very efficient way of delivering these. And we have established collaborations with -- currently with 6 companies that are key players in this field, all from big pharma like AstraZeneca, down to small biotechs like eTheRNA. And several of these are actually working with mRNA, which relates to the promising response that we have now on a patent application for mRNA delivery, highly relevant for several of these collaborations.

Now the collaboration with AstraZeneca has been ongoing for quite a while since 2015. And it's now been extended to the end of 2019. And we just recently now also expanded the scope because we see good synergies in oncology. And what AstraZeneca wants to do then is to see whether they can see the same kind of synergies in other disease areas. So now there's a time window until the end of the year, where they can do research to -- with this technology to see what else can they use this technology for. And then we have an additional 6 months in the agreement to discuss the next steps for a potential collaboration.

With this, I will leave the floor to Ronny to talk a little bit about the finances.

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Ronny Skuggedal, PCI Biotech Holding ASA - CFO [2]

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Yes. Thank you, Per. You said a little bit, and I'll try to not be too quick. The financial figures, other income, meaning public grants, are aligned with previous years. Public grants means SkatteFUNN and BR from -- [first thing to know that] related to the fimaVACC program.

Operating results impacted by the planned start-up activities and the RELEASE study, and the increased costs are according to plan. So at the end of the quarter, we have a cash position of NOK 284,000 meaning that we are, as previously communicated, expected to have a financial runway through the interim read of the fimaCHEM RELEASE study. That was fairly quick.

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Per Walday, PCI Biotech Holding ASA - CEO [3]

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So I will end this presentation by just talking quickly about the key achievements and near-term milestones. So first half 2019, we completed the fimaVACC study. We achieved proof-of-concept for fimaVACC by showing in man, by showing this in healthy volunteers. We also confirmed that we had safety of repeated treatment of fimaCHEM. So we can include up to 2 treatments in the pivotal study. We also, in first half, had the first patient enrolled into the RELEASE study. And now in second half 2019, we will have the Phase I results from fimaVACC presented at the key conference. And first half next year, published in a scientific journal. First half next year also, we have now expectations that the first U.S. patient will not come this year, but probably slide into next year because of that we just recently opened the first site and we are slightly behind on the site activations, which get this effect. But we expect, as I said, to be back on the site (inaudible) track again as planned early in the next year. And then we expect to have in the second half of 2020, the first Asian patient enrolled in the RELEASE study.

So thank you for the attention during this presentation. We will now open up the floor for questions. We also have an opportunity to submit questions through the webcast. And we will take those in the end also, if there are relevant questions that have come in through the webcast that has not been covered by the questions from the audience.

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Questions and Answers

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Unidentified Analyst, [1]

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I guess, I can start again, (inaudible). The nucleic acid area is probably one of the hottest, I guess, area within medicine today, maybe the hottest one. You have revealed in the press release yesterday that you have been cooperating with AstraZeneca since 2015. Can you say a little bit about AstraZeneca's position within that market there?

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Per Walday, PCI Biotech Holding ASA - CEO [2]

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So yes, AstraZeneca is a big player in that market. They have a collaboration with Moderna, which is one of the important players in mRNA, specifically, and one of the pioneers within mRNA. And what they have of other -- we have a confidential agreement. So I'm not sure what's in the public domain of what I know. So I will be a bit difficult -- a bit careful, I mean, with what I say here. But clearly, they are an important player in this field. And I think several of the big pharma companies are now putting some quite big bets on these kind of nucleic acids for the future because it's a completely new area that opens up a plethora of opportunities where you probably before didn't have the same kind of opportunities at all. I think that's all I can say. They are absolutely into this.

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Unidentified Analyst, [3]

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AstraZeneca is going to test out, I guess, your product in different area also. You have given them just 1.5 months to do this. Realistically, what can they do in such a short time frame?

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Per Walday, PCI Biotech Holding ASA - CEO [4]

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They can do studies -- initial studies to see whether things that we've seen in oncology is transferred over to other tissues by using other models. They can't do very extensive and large studies, but this is the time they have with the agreement we have. So we've said that this is the -- we've already communicated that this is the final experimental period. And after that, we need to sit down and discuss next steps. And now they have realized that they would like to see -- look at the other disease areas as well to see whether the good results we have seen also are transferred over there. So they will do as much as they can.

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Unidentified Analyst, [5]

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You said that you have seen synergies within the oncology, I guess, area. So I guess, based on that, I guess, you're quite optimistic about what will happen, I guess, with the cooperation you already have with AstraZeneca in the future. I think about the discussions you're going to have next year. It's quite interesting, promising, I would think.

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Per Walday, PCI Biotech Holding ASA - CEO [6]

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So yes, I would say that the results are quite encouraging, I would say, quite good results. And we hope that those are -- and there shouldn't be no reason why they shouldn't be transferable to other areas as well. So from a pure research results perspective, I am quite optimistic, absolutely. But then there are all sorts of strategic evaluations on the other side of here, and we don't control our partners. So that's the way it is.

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Unidentified Analyst, [7]

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Of course, yes. You're going to present the result -- the final result from the fimaVACC study at ESMO in Geneva in December. This is going to be a poster as far as I understand.

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Per Walday, PCI Biotech Holding ASA - CEO [8]

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Yes.

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Unidentified Analyst, [9]

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Is it just going to be a poster? Or could there be a presentation also?

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Per Walday, PCI Biotech Holding ASA - CEO [10]

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No, it's just a poster.

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Unidentified Analyst, [11]

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So it's not going to be a late-breaking abstract or something like that?

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Per Walday, PCI Biotech Holding ASA - CEO [12]

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I don't think you will get a late-breaking abstract on an oncology conference with the study in healthy volunteers. That would be unheard of, to put it mildly. I think it's quite encouraging that we are accepted to present these at an oncology at a big and important immuno-oncology conference when we only have results in healthy volunteers. That speaks to itself about the results, I think.

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Unidentified Analyst, [13]

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Yes. So I was just wondering why is the name of your big pharma company revealed 6 weeks before this agreement ends.

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Per Walday, PCI Biotech Holding ASA - CEO [14]

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So it's not like we have said that we don't want to reveal it before because I know there's been always a lot of speculation who is this and so on, and we've been working overtime to get this revealed. And now was the time where we were able to persuade them that this needs to be done. I think that's the simple answer.

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Unidentified Analyst, [15]

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I have a question regarding also this AstraZeneca story. It seems to me that they are expanding and trying on other diseases, means that they have a pretty big interest in the fimaNAc technology in all, if you can say so. So they are actually looking for -- if they can have the NAc technology for using it in actually all the platforms they have, is that the correct assumption or...

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Per Walday, PCI Biotech Holding ASA - CEO [16]

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I wouldn't say all the platforms because I don't know whether they have what all other platforms are, to be honest. But in several disease areas, they are interested to look at whether they can get an enhancement. And of course, it needs to be enhanced deliveries with this technology where it fits because it happens where you illuminate, but only where you illuminate. So it's a benefit and a limitation. And so it needs to fit with the use that they have. So they have -- from what they've looked at of different programs, they have interest in certain areas where this is most usable to put it that way. And that's what they are looking into now in those different disease areas.

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Unidentified Analyst, [17]

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Have they also shown interest for fimaVACC?

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Per Walday, PCI Biotech Holding ASA - CEO [18]

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We haven't discussed fimaVACC with them.

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Esben Eriksen, [19]

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Yes, Esben Eriksen. I was just wondering about the patient population. You always said that 3,000 is eligible for the fimaCHEM treatment in U.S. and E.U. Some literature says that it's almost 18,000 that get the disease in the U.S. alone. And now that you are opening in Asia, are you going to increase -- I guess, you're actually going to increase the number of patients, but have you any idea of how many you think now is eligible?

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Per Walday, PCI Biotech Holding ASA - CEO [20]

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We haven't. If you do that calculation, you need to look at what Asian countries are you including, and we haven't gone into that specifics to look at that. There are 2 important factors driving inclusion of Asia. One is that it's a big market with a high prevalence. But also, this is a rare disease, so it can enhance patient recruitment. So it's also to make sure that you get studied on as quickly as possible. We have not yet gone into details on the -- on how this will increase, sort of define the market and see how much this will increase the patient population, but it's a significant increase, of course, it is. Absolutely. And it is -- with epidemiology, it depends on what sources you use. Some sources may say, 18,000 is very, very high. I'm not sure where you got that number from. But we are basing ours on what has been published before and the outcome of discussions that we have had with -- in market assessments that we've done when discussing this with key opinion leaders.

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Unidentified Analyst, [21]

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(inaudible). Can you tell us about any sites you are planning to include in Asia?

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Per Walday, PCI Biotech Holding ASA - CEO [22]

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So it's -- it might be in 10 to 15 sites, approximately, I think. But it's still not yet -- all of this goes through first in the feasibility with a large number of sites and then you look at who are qualified to actually take part in this study, who has the best number of patients and so on. And then you do pre-qualification. We sit on all of these different sites to see whether they have everything that is needed to take part in a GCP study like this. Can they do the study according to requirements we have? So we don't invalidate the study by including sites that are violating GCP regulations and things like that. So there's a number of steps in this site selection process, but I would think around 10 to 15 sites.

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Unidentified Analyst, [23]

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And also, you mentioned you could also go into other countries other than South Korea and Taiwan. Is that a possibility?

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Per Walday, PCI Biotech Holding ASA - CEO [24]

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That is a possibility. But right now, we are focusing on South Korea and Taiwan to start with.

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Unidentified Analyst, [25]

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Do you want to mention any of those countries that could be of interest for you?

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Per Walday, PCI Biotech Holding ASA - CEO [26]

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Of course, Japan is always of interest, but then you need to have a discussion with the authorities around whether it's possible to do it. And in Japan, everything takes time. So this is something we are evaluating and looking into, but it's too early to say anything about that. And Thailand is not a country that is interesting in the sense that it has a large number of patients. China is a big country. So that's also a potential country to look at. But we are right now focusing on South Korea and Taiwan. So we'll have to come back to whether we include further countries. And if so, which countries.

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Unidentified Analyst, [27]

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You have presented the high-level results from the fimaVACC study. Can you say a little bit about interest in the industry so far?

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Per Walday, PCI Biotech Holding ASA - CEO [28]

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There is clearly an interest around these results. That's what I can say, I think. But I think, the hurdle to actually write the CDA with someone is quite high, at least in the bigger pharmaceutical companies. And they know that we are going to present this fairly soon. So there are some sitting on the fence as well.

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Unidentified Analyst, [29]

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It has taken a long time to get approval from U.K. authorities. Why is it taking that long time?

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Per Walday, PCI Biotech Holding ASA - CEO [30]

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It's a mistake, really. There was a deadline that was not reached by us or really by our CRO. It's our CRO, so it's really us, and which means that it needs to be resubmitted, the whole fine. So it was just a mistake, really, in the submission process. So it's nothing about they being negative to the study or anything like that. It's just a procedural glitch, really.

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Unidentified Analyst, [31]

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You have mentioned earlier that you have had discussion with companies in Asia about the partner agreement, but it took a long time this discussion there. So I guess you stopped them discussing at that time here. I guess, ideally, we probably like to have a partner agreement in Asia for this country or at least for some of these countries that are starting up and planning to start up in. Do you have any partner discussion going on in Asia these days?

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Per Walday, PCI Biotech Holding ASA - CEO [32]

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No, not concrete partner discussions going on at this stage.

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Unidentified Analyst, [33]

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But this is something you would get more into later on?

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Per Walday, PCI Biotech Holding ASA - CEO [34]

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Yes, of course. We haven't stopped looking for that, but we don't have any specific going on right now.

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Unidentified Analyst, [35]

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You've mentioned that you plan to include South Korea and Taiwan in the RELEASE study. What type of additional work do you think you have to do before you can start marketing the product? I guess potentially there will be some additional work you need to do to get approval?

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Per Walday, PCI Biotech Holding ASA - CEO [36]

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Ideally, in these 2 countries, I think it's possible to actually get approval based on the RELEASE study if you have a sufficient amount of population from these 2 countries included in the study and using the Phase I safety dose escalation study. This remains to be confirmed through discussions with the authorities, but I think the likelihood is quite high.

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Unidentified Analyst, [37]

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I have a question regarding this patent you received positive feedback on. Do you expect to have this patent or how is that -- you said it's just a positive feedback. So first time it was submitted, there were some small issues. Are they resolved or...

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Per Walday, PCI Biotech Holding ASA - CEO [38]

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Yes, yes. They seem to be -- this is the early feedback that you get from sort of the first committee. So I think it is quite promising. There will be some -- there is always some modifications in the patents, and there will be some modifications around this as well. But in general, it's quite positive. So it will give a good protection. Now I don't have -- I have to go back to my patent guide to -- if you want more details on that because I don't have all the details.

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Unidentified Analyst, [39]

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I just wanted to know that it gave very good protection for the technology.

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Per Walday, PCI Biotech Holding ASA - CEO [40]

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It does. That's my understanding. That's what we mean with promising feedback. But it needs -- that's the first step, as you know. It needs to go out to examiners in all the different countries, and there will be discussions with all of those around this, but it's at least a promising first sign that this is grantable, if that's a word, possible to get granted.

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Unidentified Analyst, [41]

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Yes, just in the same area, which time frame do you see for this patent to be finally decided or granted? When do you think it will be?

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Per Walday, PCI Biotech Holding ASA - CEO [42]

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Well, that is very different from country to country. So it depends on what you mean with granted, first country or biggest country or -- because this is a process that it goes on with all the different countries and you get granted in the different countries over time. But I'm not really sure, to be honest. It can take a very long time in some. In Japan, we've had examples that we got it granted -- the patents granted just a few years before they expire. So it's in some areas, in some countries, it can take very long.

So some last questions now before we have a look at the web to see whether there's anything from there.

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Unidentified Analyst, [43]

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You have some open positions. Can you say a little bit about how the hiring process is going?

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Per Walday, PCI Biotech Holding ASA - CEO [44]

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Good.

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Unidentified Analyst, [45]

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Anything else?

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Per Walday, PCI Biotech Holding ASA - CEO [46]

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I think we have some good candidates for -- and we're in the interviewing process. So that's -- I'm not coming out with any names of candidates or anything if you think that.

So Pal, maybe we can end up with Pal as the last question from the audience and then we can look at the webcast before we wrap up.

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Pal Falck, Arctic Securities AS, Research Division - Research Analyst [47]

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There's been a lot of good questions here. So the last one for me. Obviously, great news about expanding the study RELEASE into Asia. Have you thought about the commercial aspects of it, meaning it will be a pretty expensive drug, sort of the market penetration, how much are they willing to pay from new innovative expensive medicine? Have you sort of come into that phase that you started considering that aspect?

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Per Walday, PCI Biotech Holding ASA - CEO [48]

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That is an important question when you look at this because you need to do -- South Korea and Japan are the other countries where we would very much like to have this drug approved and marketed because they are paying quite well. And it's a bit more difficult if you go to Thailand or other countries. So it's -- we have done an initial assessment around this and focusing then on South Korea and Japan. But we haven't really done a proper thorough assessment of the whole Asian region. That's not been done yet.

Anything from the web?

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Ronny Skuggedal, PCI Biotech Holding ASA - CFO [49]

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Yes, there are some very detailed questions on the web, which is not suitable for this session, but there is one question regarding publication of the AstraZeneca collaboration. If you can comment anything about that?

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Per Walday, PCI Biotech Holding ASA - CEO [50]

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Yes. So we have agreed with AstraZeneca that we will publish the results. They are open to do that. So the results that have been achieved this far will be published. But I can't really tell you when because it's something that needs to be done in collaboration, and we haven't determined any time lines for it. But we have agreed to publish the results. And I think that's also important and good news for us to get those results out.

Anything else?

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Ronny Skuggedal, PCI Biotech Holding ASA - CFO [51]

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There are...

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Per Walday, PCI Biotech Holding ASA - CEO [52]

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Not too detailed.

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Ronny Skuggedal, PCI Biotech Holding ASA - CFO [53]

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Not -- there is another not too detailed question, and that is regarding the presentation at the ESMO Conference, if or who will be the presenter of the poster at the ESMO Conference?

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Per Walday, PCI Biotech Holding ASA - CEO [54]

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So we can't, as a company, present at the ESMO. So it needs to be an academic that does -- do the presentation. Unfortunately, Sjoerd van der Burg is not going to that conference this year, and it's not possible for him to do it. So he can't do it. So there will be one of our researchers that we have at the Radium Hospital here that are involved in all of these studies that we do. The Radium Hospital have done the T-cell analysis with ELISPOT in this study that will do the presentation. And our CSO will be present as well at the meeting.

So we have 5 minutes left. So a last question I can allow for, if there is anything. If not -- oh, just one last question.

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Unidentified Analyst, [55]

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It's about the head and neck study. So there's been some quite interesting information coming out from other Norwegian company on the head and neck lately. Also very interesting to see that compared to the results you had, which I think it was about 80% of response rate compares very well to the checkpoint inhibitor results so far achieved. Can you comment on how close -- if you see any prospects for opening up that study or -- in a setting that you can come back to the head and neck in the future?

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Per Walday, PCI Biotech Holding ASA - CEO [56]

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I would not disregard that completely. I would say that we would not go back to do the head and neck study the way we did it, which was quite complicated study where you tried to ablate the whole tumor. But it is possible to do something in head and neck with this technology and combine it, for example, with checkpoint inhibitors, or actually using maybe even the fimaVACC technology and do intratumor vaccination, which we have very good preclinical results with and combining that with checkpoint inhibitors. So there are possibilities there that we can pursue, but we don't have any plans currently to do it, and we don't have funding to do it currently. So we're right now focusing on achieving the bile duct cancer study and making sure that we have progress in that study and taking that to completion. And in parallel, we are assessing what other things it's possible to do in the area.

Okay. Thank you very much for your attention and your time.