PCI Biotech Holding ASA

Welcome to PCI Biotech's Q3 presentation. Today in Norwegian, after a comment from our listeners. My name is Ronny Skugedal, I am the CEO. And with me today is Anders Haugset, CSO, and Morten Lur, BD Manager. At the end of the presentation, it will be possible to call in questions. You can find the details here. It is also possible to send written questions via the webcast console. Please note our disclaimer. So the agenda for today, first some highlights from my side, then Anders and Morten will take us through the operational review, then a little about finance and questions and answers at the end. So first some highlights. We reported in August that the company will not carry out a company-sponsored phase 2 study with our vaccine technology, Fimavac. This was due to the lack of funding for such a study in the recommended market. This decision also meant that we had to de-escalate our clinical team. This is now done and will have a full cost reduction effect from Q1 next year. Today's cash position is 67 million Norwegian kroner, and that will give us a financial runway into 2024. This period we now use to focus on mainly three fields for FIMA NAK, which are skin applications and bioprocess, production of biological drugs. and Fimavac with intratumoral immunotherapy. The company has been and is in a challenging situation with respect to restructuring and neuromagnetism. Despite this, we have held up momentum and progressed in our focus areas. This has materialized within our skin application. We have signed an external preclinical study where we will demonstrate the delivery of mRNA with the help of PCI technology in a cancer model. We expect the results of this study to be available in the first half of next year. Anders will give you more details about this later in the presentation. For the bioprocess project, we have now continued to work on our internal evaluation, and we are now focusing on the use of FIMA NAC for the production of gene therapy. Morten will give you more details on this. When it comes to Fimavac, this intratumoral immunotherapy project is an early phase project that will mainly be continued through a PhD program supported by the research department. But we continue to build on the data we have generated within our vaccine program earlier. Here we focus on a local application with a systemic effect, thereby increasing the effect of immunotherapy. PCI technology is very well suited for local application in this community. Our collaboration. We recently, in November, ended the collaboration with Mendes. This is based on the results of the project and an internal prioritization from both companies. Because of that, we agreed to end the collaboration recently. In August, we started a new collaboration with a company called MyMetix. Anders will come back with some comments about that later. So for FIMA-CAM release. Release was as known decided to be terminated in Q1, and the company has since worked towards an effective and cost-effective ending of the program. A lot has been done, and we expect that all essential closing actions will be completed before Christmas. We have already published the results, the so-called synopsis, in the European clinical database. And we expect that the same publication in the US is soon to arrive, but still not in place due to some formalities. The results we collected through this study were unfortunately not sufficient to draw conclusions about the effect. This is in line with what we have previously reported. The remaining cash effect of the study is expected to be up to NOK 3 million from 1 October. Then we will move on to the operational review, and I give the floor to Anders Haugset, CSO.

Hi, and good morning. I'm going to talk a little bit about what we are planning to do, mainly within FIMA NAC and FIMA VAC, and also a little bit about some other things. As Ronja has been talking about, when it comes to FIMA NAC, we are now focusing on to use the technology within dermatology, or rather things that are on the surface of the skin. The goal is to develop a platform technology to use the PCI technology to deliver nucleic acid on the surface of the skin. There are several reasons why we are investing in this. Obviously, since we use light, it is very easy to shine on the surface of the skin. I will come back to this on the next slide. There are also many interesting diseases that are well suited for nucleic acid and PCI therapy on the surface of the skin. So the goal here is to develop what we call a topical formulation to deliver things to the skin. We have previously shown, as you can see on the left side of the slide, that we can use the PCI technology to deliver nucleic acids into the skin. If we look at these mice, we see that inside the red squares, we have used PCI to deliver an mRNA. Inside the black ones, there is a control where we have not used PCI. So we see that PCI has a very good strengthening effect on nucleic acid delivery in the skin. But what we have done here is to inject nucleic acid into the skin. If you are going to treat skin diseases, it is a much better approach to make, for example, a cream or a gel that you can just smear on the skin and light afterwards. And that is what we want to focus on now, to develop a formulation that can be used to deliver both Femaporphine and nucleic acids. We have done some preliminary tests here, as you can see on the right side, where we have taken Femaporphine in a simple formulation and rubbed it on the skin, and measured how much penetrates into the skin. These columns show how much has penetrated down to the layers we are interested in treating, and the red line shows the level we know is necessary to get nucleic acid delivery. So what you can see here is that this shows that we are fully capable of delivering enough Fimaporphine down to the deeper skin layers to achieve the effect we want. And what we want to do further within this project is to carry out experiments together with a company that is an expert on this type of experiments, where we want to show that we are able to use the PCI technology to improve the effects of mRNA delivery in a wound model. This model is simply that you get skin from healthy volunteers, typically people who have had fetal operations and such, and you can stretch out this skin on a surface and create an artificial wound, and then the skin is treated. They can keep this human skin alive for about 14 days afterwards, so this is a very relevant model for what happens in human skin. The goal here is to show that with a simple formulation, we are able to improve the effect of mRNA delivery. We want this to be a platform technology that can be used to deliver many types of nucleic acids to many types of lesions or diseases in the skin. We think we have a very good technological fit here, because... It is easy to shine on the skin, and creams and light are used today in extreme degree in skin treatment already, so this is technology that is well tested and commonly used. And as you can still see, patients can use it at home. You can apply a cream to the skin and shine yourself. One thing we want to focus on is the treatment of chronic wounds. For example, diabetes is an indication where there is a very large unmet medical need. Many of these conditions have a complex biology that is very well designed for nucleic acid therapy. What you need here is not usually a single drug that does one thing, but you need drugs that are capable of reprogramming what happens in the wound. change the environment in the wound so that you get healing instead of keeping it as an open chronic wound. Nucleic acid is very well used for this because it can be used to reprogram cells to do new things. We believe that both in diabetes and in many other skin applications, nucleic acid therapy will have a very big future. In the meantime, the delivery of such lesions has been a big problem. You can inject it, but it is limited to how large areas you can inject nucleic acids over, so developing a cream that can be used in larger areas and get an effective delivery of nucleic acids will be very attractive. for many companies. We are not trying to make PcBiotech develop its own nuclear power plants. What we want to create is a platform technology that we want to develop in collaboration with other companies. I give the floor to Morten, who will continue with the bioprocess.

Thank you. We have previously communicated that there are specifically three areas within the bioprocess where there are interesting opportunities for Fimanac. These are cell culture, cell and gene therapy, and virus production. We are talking about using Fimanac in the production of biological medicines. We have recently conducted internal studies, in addition to hearing about our interest in technology at conferences with external actors. We can also say that we will focus on the production of virus vectors in the future. Viral manufacturing in English. In this context, we would like to tell you a little more about how virus production works. The process starts with cell lines in culture, from a few hundred milliliters up to several thousand liters. The cells are manipulated to get certain characteristics, for example by gene modification, or by the addition of enzymes or growth factors in the media the cells are absorbed into. Cells produce virus vectors over several days, where the goal is to produce as many viruses as possible at the end of the process. It is important to note that today's production methods have a great need for improvements to be able to produce enough viruses to treat new diseases and reach larger patient groups. Finally, for the virus vectors to be able to be given to patients, extensive cleansing and characterization must be performed. The virus is used in several areas, including cancer treatment, general vaccination and gene therapy. We are particularly interested in the production of gene therapy. One example of a gene therapy is Solgensma from Novartis, which is used against spinal muscular atrophy to replace a defective gene. We are now working internally to develop one or more prototypes for use in the production of viruses. In the first round, the results are used to secure relevant patents. They also develop the basis for future early phase testing of prototypes for potential customers, so-called alpha testing, where the goal is to get feedback on how the prototypes work. It is important to emphasize that to get to that stage, more data must be generated. But the feedback we get from such a test is used to improve the prototypes, so that by late-phase testing, so-called beta testing, with potential customers, we are safe in that we are relatively close to a commercial product, without having to make expensive and time-consuming changes. And then I would like to give the floor back to Anders.