PCI Biotech Holding ASA

Good morning, and welcome to PCI Biotech's first half-year 2023 presentation. My name is Ronny Skugeral, and with me today are Anders Haugset, our CSO, and Morten Lur, responsible for BD. Please take a look at our important notice and disclaimer. This will be an opportunity to ask questions along the way, and it is now open to send in questions via our web solution. I encourage you to send in questions already now, and we will try to answer them at the end of today's session. Then we go straight to the operational review and hand over the floor to Morten.

Good morning. PCI Biotech is working on the use of FIMA NAC to dissolve flasks inside the production of gene therapy. These are biological drugs with great potential, but are limited by complex and expensive production methods. While the details around this technology are still confidential by IP view, we expect to be able to share more information about this in the second half of 2023, when the patent is completed. We have continued to strengthen IP by generating new data on a small scale, and we are looking forward to a broad and robust patent. Furthermore, we are now working towards early phase testing with potential customers, where the goal is to get feedback, which means that we can improve and develop a market-leading technology that solves bottlenecks in the production of gene therapy. Then I pass the floor to Anders Haugset.

Good morning. I will give a short update on the status of what we do within dermatology, i.e. skin diseases. As you may remember from previous presentations, our goal is to develop an effective and simple technology to deliver nucleic acids to the skin. with regard to using this in therapy together with partners who have nucleic acid. We focus here on wound treatment, but we also want to deliver to other types of skin diseases. To start studying this, we have made some experiments together with a company that is an expert on skin models, to see if the PCI technology has an effect on the delivery of mRNA, which is what we have chosen to deliver in this regard, which is a nucleic acid that is relatively difficult to deliver compared to many others. We have tested this in two different models. The first was a single model where you have human skin cells growing on a plate. The delivery of mRNA increased about 10 times compared to what we got with a very used other delivery technology. So these were very positive results. In the meantime, when we tried to transfer this to a more complex model, where you have, you can call it a full-scale model, where what you do is to take human skin, skin from healthy, voluntary people, stretch it out, make a wound and try to deliver something to this wound. What we saw here was that we did not receive any signals from what we delivered at all, nor what was supposed to be a positive control, so it was impossible in this case to draw conclusions, but we could of course not say that PCI gave an improvement of delivery in this case. It has to be said that what we tested here was a rather difficult model. We delivered the so-called naked mRNA, which is not protected against degradation, to a wound. There are many possible reasons why this did not work. So we would like to move on and evaluate these initial results and also make contact with commercial possible cooperation partners within the area. Thank you.

Thank you, Morten and Anders. Then we will talk a little about finance. The company has a financial running track until the end of 2024. No change in those estimates. We had a balance of 45 million kroner by the end of June. The total change in the balance for the first six months was minus 11 million kroner. Regarding Other Income Public Grants, there has been a decline towards last year, and that is because we had a tax fund project that ran out in 2022. We have applied for a new project now for 2023-2025, but have not received any answers from the Research Board on it, so therefore there is a decline under Other Income. When it comes to the other revenue streams, it is not sensible to compare them to previous periods. because of the restructuring we went through last year. Financial calendar. We want full focus on research and development. We have therefore decided to go over to the obligatory reporting rules with half-year reporting. That means that the next reporting will be for the whole of 2023. In time, it will happen in mid-February next year. We will of course update the market on other news and important things along the way. This is our pipeline. For FIMAVAC, we mainly work with intramural immunotherapy through a PhD program supported by the Research Council with up to 50% coverage for over three years, starting in January this year. As far as our collaborations are concerned, we have several collaborations that have been terminated this year, including the collaboration we had with the Sea Research Institute. It was terminated as planned on the 30th of June this year. Unfortunately, the results generated in that collaboration did not provide the basis for further collaboration around that project. Regarding dermatology, as Anders mentioned, with the data we have, we are now looking for contacts with commercial actors within the field of nuclear sensors, and are interested in testing the PCI technology around that in a preclinical setting in the first round. For Bioprosess, our new investment, where we sent the first patent in the second half of last year, we are working hard, as Martin mentioned, to generate data on a small scale that can generate file testing, alpha testing, with commercial partners within a prototype setting. We get repetitive positive feedback on our solution and curiosity for this, so this is something we are working hard towards, as I said, generating small-scale data that will be able to convert the interest into actual cooperation. Then, Have we gone through what we wanted to say today? I will check if there are any questions on the web. The first questions here are about the collaboration we had with the Sea Research Institute and the LAXELUS project, which was an early phase project. As I said, it ended as planned on June 30. This was a project that was 100 percent external support, public funding, but the results generated did not lay the foundation for further collaboration. We have a question here. When and how do you expect PSI Biotech to increase revenues? That is, of course, through cooperation as a first step, and then a commercial phase with cooperation partners within the bioprocess, dermatology and intramural immunotherapy. If we are to talk about where These could possibly be in the timeline. Intratemoral immunotherapy is the earliest phase, but we must not forget that we applied for the first patent in the bioprocess last year, but here the timeline is shorter, up to a possible commercialization by a partner. So there are possibilities for the company, but we must first generate the data that can trigger us to enter such a setting.

Let's see.

I think most of the other questions are about the Laxey Luz project. I think we have covered that. There is also a question at the end. What timeline do you see on bioprocess and possible collaboration? We can't say anything concrete about the timeline there, but what we can say, or what I can repeat, is that we have an external interest and curiosity in our solution. This is in an early phase, but as I said, we are working on generating data on a small scale that will trigger the possibility to test this together with large, recognized international companies. in a so-called pilot phase. Such a pilot phase does not necessarily mean that there will be commercial terms for PcBiotech in such a setting in the first place. I think we have gone through the questions that have come in here. I say thank you for your attention and thank you for today.