PCI Biotech Holding ASA

Good morning, and welcome to PCI Biotech's Q1 2023 presentation. My name is Ronny Skogedal, and with me today are Anders Haugset and Morten Lur. First of all, let's take a look at our important notice and disclaimer. This is the agenda for today. In the end, we will have a Q&A session. You can send questions via the web console. You can start with that now. First, some highlights from QN. Bioprocess for the use of Fimanac for the production of gene therapy. We applied for the first patent in the fall of 2022. In QN 2023, we used it to generate data that supplemented the initial application. What does your external world say about the customer value of our application? We get positive feedback, and we also get feedback that potential future customers may want to test our application, as long as we can show data that proves our idea. That is what we will focus on in the future, generating data that can trigger external testing of Fimanac for bioproduction. Regarding dermatology, where we want to demonstrate the delivery of nucleic acids to wounds with the help of Fimanac. The first step in this early phase project is planned in a wound model. The run-in phase of these experiments is ongoing, and we expect to be able to report this by next quarter's presentation. Positive results from such a study will of course be used to generate cooperation. Then, Fimavac, where we want to use the technology in connection with intratumoral immunotherapy, and this can make it possible for new treatment combinations. The first patent was also applied in Q1, and this is also a project that is supported by the Research Council by a PhD candidate for three years in the future, now from Q1. Corporate, we have now, as previously communicated, a financial runway towards the end of 2024. This gives us a space to show the commercial potential of the PCI platform. We work hard for this every day. Anders and Morten will talk a bit more about dermatology and bioprocess, so I'll hand it over to Anders.

Good morning. Anders Haukseth, Chief Scientific Officer. I'll talk a bit about where we stand when it comes to the use of PSI for the treatment of skin diseases. with nucleic acids. There are many types of diseases where there is a great need for new treatments, and many of these can potentially be treated with nucleic acid-based therapies such as mRNA, oligonucleotides and so on. There are many types of diseases that are graded from very serious, for example chronic sores, which have an survival that is in line with cancer, down to less serious skin diseases. The system we develop can be used for many types of these diseases, but we initially focus on the treatment of wounds. In a wound, the biology goes wrong, that is, the cells in the wound are in a state that makes the wound not heal. The idea with nucleic acid therapy is to be able to reprogram cells in the wound to go from a state where it does not heal to a state where it heals. This is a principle that is known to work in animal models, but it is, as with other nucleic acid therapies, always a problem to get the nucleic acids delivered effectively to the target area to be treated. It is a system to do this that we want to develop. This will be a simple, user-friendly system consisting of a cream or gel containing a therapeutic nucleic acid and our photosensitizer, which can be smeared on a wound and this is illuminated with a single light sign. Such a light sign is already on the market today and is used in the treatment of wounds, so this is a concept that is very easy to implement and where most of the components, apart from what we are developing, already exist. The status, as Ronny has already mentioned, is that we have started a study to look at the delivery of mRNA to wounds. This is human skin, where a wound has been made, taken out of the human skin and stretched out on a small membrane. Then you can see if we have delivered the nucleic acid to this wound, and if Fimanac can improve this delivery. There we have done a run-in phase, and we are now going to start the main study soon. And as Ronny said, we expect to be able to report the results from this in the report for the second quarter. Thank you. I'll pass the floor to Morten.

Good morning. In the bioprocess program, we use FIMA NAC to expand the production of gene therapy. Gene therapy is biological medicine with great potential, but it is limited to complex and time-consuming production methods. In order to reach new and larger patient groups with gene therapy, there is a need for innovative technologies that can solve bottlenecks in these processes. In the second half of 2022, a patent was submitted for use of FIMANAC in the production of gene therapy. In Q1, new data has been generated that broadens this patent. Submitting a patent takes 12 months to supply the applicant with new data to strengthen the patent. This period is called the Priority Period. Until the Priority Period has expired, we cannot publicly say how we want to use FIMANAC to improve the production of gene therapy. But we expect to be able to share more details about this in the Q3 report. In Q1, we have also had several interactions with potential customers that continue to show interest in the technology we are developing. The focus in Q2 will be further strengthening of IP and work with generating data that enables testing with potential customers. Thank you. I give the floor back to Ronny.

Yes, thanks, Anders and Morten. Then a little bit about finance. At the end of Q1, we have 51 million kroner in the bank, which gives us a runway to the end of 2024. Because of the restructuring we went through in 2022, it is not reasonable to compare the numbers from Q1 this year to Q1 last year. The only line I can comment on is Other Income, where we had a tax fund project that ran out in 2022, but we have searched for a new one from 2023 and out in 2025, but we have not received a response yet. Therefore, there is a decline in the order income in 2023. Regarding our pipeline, we have three projects. Dermatology, intratumoral immunotherapy and bioprocess. Regarding the status of our milestones for the first half of 2023, Then we have two that we have drawn out green, that we have submitted a patent on intratumoral immunotherapy. We have also submitted a patent on the fight against Lachshulis, where we have cooperation with the Sea Research Institute. The last two are marked in yellow. We will further develop FIMA-NAC for the production of gene therapy against potential testing with external partners, as Morten talked about. We also want, as Anders mentioned, eller forvente å rapportere ut denne studien med topikal levering med FIMANAK i neste kvartalspresentasjon. Da er vi gjennom vår presentasjon, så da hadde vi tenkt å ha en spørsmål- og svarrunde til slutt. And then I'll just see here on the internet if we have any questions. Then we have two questions here that I can take. The following is, cooperation with Olyx has now been on hold for a long time. Is this the result of a dermatology you are waiting for? In general, we can say that none of our collaborations is in active mode right now. No research is being conducted on this. Our goal with this study on dermatology with the delivery of nucleic acid in a cell model is of course to generate partner interests. OLIX is a candidate there like everyone else, but we don't have any special agreements with them around this particular study. So we work broadly on all fronts. I don't know if there is anything else to comment on, Anders?

No, I can just say that Olix has expressed interest in the type of product we want to make here. They want, like many others, to be a good candidate for partners, and we already have an interaction with them.

We have one more question. The previous partner who recommended the bioprocess, is this one relevant as a new partner if the law is in effect? And again, I have to say that this is a candidate like all the others. We want to develop an application and prove our idea with data, and then we spread it out to all candidates, but we don't want to comment on anything more than that. Then... Those were the two questions that came in via the web. I thank you for your attention and wish you a good day. Thank you.