PCI Biotech Holding ASA

Good morning, and welcome to PCI Biotech's first half year 2025 presentation. My name is Ronny Skukedal, and with me today is Morten Lur, CSO. Let's take a look at our important notice and disclaimer. First, Morten will take a look at the operational part. Then there will be some finance and status, and then we have a question and answer round at the end. It is possible to send in questions via webcast to the console, and I encourage you to start sending in questions now, so that we have them in place until we get there. Then I give the floor to Morten.

Good morning. PC Biotech has worked on developing new technology to increase productivity in the production of AAV gene therapy to make these treatments more accessible. AAV gene therapy builds on an adeno-associated virus that has been modified to deliver genetic medicine to patients. In this context, the virus is called a viral vector. The typical target group for AAV gene therapy is people who have a rare mutated mutation that causes serious illness. Here you can see the process for the production of AAV gene therapy. AAV is produced by living cells in a biovector. In the upstream process, the viral vectors are produced and are pumped up into the cells. to be able to separate the virus vectors from the cells, the cells must be opened up with the help of a process called cellolysis. Cellolysis opens up the cells so that the virus vectors are freed, shown in the figure to the right. The difficult balance is to get the AAV out without the AAV itself being destroyed, and that it does not follow too many irregularities from the production cells. Today's solutions do not reach this balance in a good way. In the downstream process, the virus vectors are cleaned in several steps, where 70% loss of gene therapy is common. Injuries from the production cells are one of the causes of this loss. Pesci Biotech has developed a new type of cellulosis, called photochemical lysis, short for PCL. When previously shown these upstream results from a small bioactor, it will show that PCL can be more than double the release of AAV, with about half the amount of impurities compared to industrial standards. Despite increased power yield, this was not converted to increased yield after cleaning, i.e. no increased netto yield. This was described as high durability and the challenges we had in the cleaning process. Since then, we have reproduced the promised flow results in small bioreactors. Unfortunately, these results have not been transferred to increased net yield or other convincing cost savings in a more robust cleaning process. What is especially challenging is the high variability in the results between different laboratories. Because of this variability, there must be very large effects to get through this mess in the hermitage and draw clear conclusions. At the same time, we do not let go of the fact that we have not been able to show increased net yield in small bioactors. To show this is an important risk-mitigating step before we move on with the escalation to the clinical production scale. When we have not achieved this, the need for resources in the project increases, and the time line is extended, and the risk increases to an unacceptable level. We therefore decided to put down this program. Thank you. I give the floor back to Ronny.

Da skal vi kort innom finans og status på corporate-siden. Så da er det vesentlig usikkerhet rundt selskapets evne for fortsatt drift. The company had at the beginning of the quarter, at the end of June, 13.6 million kroner in the bank, and this maintenance is estimated to support the operation into Q4. The stop of the PCL program was reported on August 18. As Morten said, our work with external partners did not carry out good enough results. We had deficient progress in small bioreactors. This increased the risk to a level that caused the program to be stopped. We have, as I said, a financial runway in Q4. It is essential uncertainty around continued operation and the company's ability to create new capital. So the focus now is to secure values and evaluate alternative strategic opportunities for the company. This process is in an early stage, but we will come back with more information when we have something concrete to report. Then we move on to a question and answer round. So I will see if any questions come in here and encourage you to send in questions now. Det er lange sekunder å stå her og vente på noen spørsmål, og da når det ikke er noen spørsmål som kommer inn her, så velger vi å si takk for oppmerksomheten og takk for oss.