PCI Biotech Holding ASA

second quarter presentation. I am Hans-Peter Bøhn. I'm the chairman of the board. And with me here today, I have Ronny Skugedal, our CEO. And I have Morten Lur, our strategic alliance manager and business development manager. 2022, to say the least, has been a difficult year for PCI Biotech. At the beginning of the year, we were forced to abandon our lead project with FEMA Chem in bile duct cancer, as you know. And later now, we discovered that we found that there was not sufficient interest among our shareholders and the finance community to finance our backup project with the FEMA VAC in Hedeneck Council. As a result, we decided to close down and wind down the part of the company that is capable of running clinical trials. As a result, we now have an organization, or we will get an organization with approximately half the number of employees as we had at the beginning of the year. Needless to say this has been difficult for employees as well as for shareholders as well and also our partners and collaborators around the world. For this I apologize. Yet, I believe the restructured and realigned PCI biotech is our best option going forward. It is now time to lift our heads and look forward into the future with renewed enthusiasm and energy. With this, I pass the word to Ronny.

Thank you.

Sorry for that, some technical issues here at the start. Please pay attention here to the information about the Q&A session, which we will have towards the end of the presentation, where we open up for questions through a telephone conference facility. And you can also send in questions through the webcast console. Please also pay attention to our important notice and disclaimer. So the agenda for today, I will first take you through some highlights. Morten will take you through our operational review and then key financials and outlook at the end before we have the Q&A. So then highlights for first half 2022 on the corporate side. We reported efforts, sorry, the reported efforts to finance phase two clinical trial did not under the current market condition result in a feasible way forward. And the company will not conduct a company sponsored phase two trial with the FEMAVAC technology. I will give you some background information about the considerations made before this decision was taken. We managed to establish a scientific sound and interesting project and supported by the preclinical data and the phase one data, we generated clinical expert interest and we attracted KOLs in the field of head and neck cancer. We also aimed high for a checkpoint inhibitor supply agreement for the tribe. We did not succeed with this. We had interactions with several ICI owners. It is widely acknowledged that ICI owners have clinical data as a prerequisite for a supply agreement. But nevertheless, we had interactions with them, but in this setting, we did not manage to attract sufficient interest from their end for a supply agreement. Even though we had the phase one data, it was not enough at this stage due to being a healthy subject study. On the investor side, we aimed high to attract healthcare competent investors to be a lead investor for the financing round. The project was viewed upon by these investors as a project with a financing need of up to 150 million Norwegian crowns. And in the current market environment, with very high competition for funds and the reduced risk willingness in the market, we did not succeed in attracting such a competent healthcare investor as a lead or cornerstone investor. Without such a cornerstone investor, we did not manage to attract sufficient commitment for a financing round of the indicated size. And on the back of this, we then took the decision not to pursue this further in the current market. So now we focus efforts and resources on non-clinical research, developing further the current pipeline opportunities, while exploring new fields of use for the PCI timing. For FEMA-VAC, it's intratumoral immunotherapy. And for FEMA-NAC, it's dermatology and bioprocessing. And bioprocessing is a new field of use, which we disclose for the first time today. And Morten will revert with more details around this under the operational review. As Hans-Peter said, this year has been challenging and difficult for the company. And as we no longer run clinical projects, there has been a need for consolidation of the organization, including downsizing in several steps during the year. And we now also need to take a complete downsizing of the clinical team. And this will be enacted during this second half year. Downsizing is a tough exercise, but necessary under the current circumstances. I would like to thank all employees for their efforts over the years and for their understanding and cooperation in this difficult process. I'm also honored by the opportunity to lead PCI Biotech as a CEO going forward from tomorrow, and to further build upon our opportunity for future progress. Taking into account the recent changes, the company has now a financial runway into 2024 with the current plans. We continue to explore financing and strategic opportunities as the non-clinical pipeline matures. These strategic opportunities are primarily based upon scientific rationales, but corporate actions are also included in these. in these efforts to keep all options open. But first of all it will be scientifically motivated. The results from preclinical studies done in collaboration with our partners in Zurich strengthened our understanding of the immunological effects of the PCR treatment and the potential for its use in intratumoral immunotherapy. And this immunotherapy focus area is supported by a PhD grant received by the Research Council of Norway and under this project we are exploring intertumoral immunotherapy aiming to identify novel treatment combinations to increase the response rate of checkpoint inhibitors. For FEMA-NAC, the focus development for applications specifically suited to the strengths of the technology is determined to be dermatology and bioprocessing. And as I said, bioprocessing is a new field of use for PCI biotech. The platform technology for use in the exciting field of mRNA therapies was presented by the CSO Anders Högseth on-site in the US in May. As you know, the release trial was terminated in the beginning of the year due to the competitive changes in the competitive landscape rendered the trial challenging to complete and potentially inadequate for approval. The available data have been reviewed and are insufficient to draw conclusions regarding the efficacy and safety of the treatment. It has been a swift wind-down closure process for the trial and all major study closure activities are expected to be completed during Q3. Collaborations. In January, we established a new collaboration with a South Korean company named MD Immune. And very recently, now in August, we initiated a collaboration with a European company named Mimetics. All our collaborations have the same motivation, scientific enthusiasm from both sides to explore technical synergies in preclinical settings. Considerations for further expansion of partnerships are impacted by many factors, not only the generated data, but also internal priorities, status of other internal projects, strategic decisions, and so on. Based on such reviews by both parties, the Etherna and Apposense collaborations are closed during this year. Regarding the Etherna collaboration, it is a disappointment that the collaboration is closed, but the data was not convincing enough to generate enthusiasm from their end for further partnership. Then we move on to the operational review. And I'll leave, we'll ask Morten to go through that.