Good morning, welcome to PCI Biotech first quarter 2022 presentation. My name is Per Walday. I'm the CEO of PCI Biotech, and I have with me today also Ronny Skuggedal, who is the CFO, and Amir Snapir, who is the CMO. After the presentation, we will have a Q&A session, which will be through both the teleconference and the webcast console. Please pay attention to the details here. If you want to ask a question, you need to call in and do this if you want to do it verbally. Otherwise, please use the webcast. Also, please pay attention to this important notice and disclaimer. What we are going to review today, first to start with the highlights of the first quarter 2022, and then an operational review, the clinical and preclinical programs, and then ending it with key financials and outlook before we have the question and answer session afterwards. Let me start by going through the highlights. fimaVacc is our lead program now, and this is progressing towards initiation of a phase 2 clinical proof of concept study. This study has a very good project readiness. We have established a group of international clinical experts that have helped us in designing the study and will provide clinical guidance and support the development and performance of the trial going forward. We are working on the preparation of a clinical trial application and also sourcing of all the study treatments. The selection of clinical sites in the main countries in EU has started. We will come back to much more details about this, and, specifically, Amir will go through a lot of the details around this study in the presentation later. With regard to fimaNAc, we are progressing a focused preclinical development plan. We are targeting this specific application, which is delivery of nucleic acid therapeutics into cells, to applications that are suited to the specific strength of this PCI technology. We have in the first quarter also established a preclinical collaboration with the South Korean company MDimune, who are developing innovative drug delivery technologies for modifying cellular and disease processes. We'll come back to this program also, with some further details. As you know, in first quarter, we had to close RELEASE, our lead program. It was closed to recruitment in January 2022 due to changes in the competitive situation, with results that was announced at the ASCO GI meeting in January. The new information that came out at ASCO GI will render this trial challenging to complete and potentially also inadequate for approval. We had no other choice than to stop the trial. Now we have collected all the data, and reviewed the data, and there is not sufficient data here to show differences between the different treatment arms. Therefore, we are now terminating the whole study as quickly as possible, and we are not going to follow up patients any further. The last patient will leave the study in this month. Now, closing Release as quickly as possible also means that we will not spend much more money on this, and we expect the future cash effect of up to NOK 10 million to close the study. On the corporate side, I will step down as CEO at the end of this month, and Ronny Skuggedal will take over as interim CEO effective first of June. The CBO, Ludovic Robin, will leave the company in May, also this month. The whole organization after Release was closed for recruitment has been reduced by 4 full-time equivalents. We have notice periods of those ending during second quarter. This means that the financial runway with current commitment is now estimated to be towards the end of 2023. I'm happy to announce that we have strengthened the scientific advisory committee. We have now included Professor Ernst Wagner at the Ludwig-Maximilians-Universität München and the Center for NanoScience in Munich, which has had a long experience in delivery of nucleic acid therapeutics. He also have some experience in working with the PCI technology. He's a luminary in this area, and it will be important for us and for the progress of the fimaNAc program to have him in the scientific advisory committee. I would also like to thank Kjetil Taskén, who will leave the scientific advisory committee. He's been with the company both as board of the board of directors and the scientific advisory committee after that for a number of years and has contributed significantly to what we have achieved in PCI Biotech. Just an overview of where we are now then. We have two development programs that are based on the PCI technology platform. We call these fimaVacc, which is a vaccination technology for therapeutic cancer vaccines, and fimaNAc, which is a delivery technology for nucleic acid therapeutics, drugs that needs to get into cells to be effective but have a real barrier of actually getting into cells. fimaVacc is a clinical stage program. We have completed a healthy volunteer study, a phase 1 study, and we are now moving towards a clinical phase 2 study, a proof of concept study for this specific program. While fimaVacc is a preclinical program where we have established a number of collaborations and more of a collaborative program. Although we now also have quite some internal research and development at the preclinical stage to target specific applications. Those were the highlights. With this, we are going into the operational review, and I will hand over to Amir, who will lead the presentation on fimaChem and fimaVacc, the clinical parts. Amir. Thank you, Per. Well, next, please. There is not much to add on what Per mentioned earlier in the highlights about RELEASE. The clinical team is working hard to close the RELEASE as effective as possible to reduce costs and to complete the transfer of the focus to the planned fimaVacc proof of concept study. All these facts that are listed here have been mentioned. Shifting to fimaVacc program, I want to start with a recap of the science behind the technology before talking about the planned proof of concept study in more details. The planned fimaVacc proof of concept study is based on the demonstrated capability of the technology to enhance the cytotoxic effect of the immune system, which is essential for effectiveness of therapeutic cancer vaccines. CD8 cells, also called cytotoxic T cells, are the preferred immune cells for targeting cancer, and they require MHC class I antigen presentation to be induced, which is a major hurdle in cancer vaccination. fimaVacc platform overcomes this challenge by strongly enhancing MHC class I antigen presentation, activating and inducing infiltration of these cytotoxic T cells in tumors, leading to tumor cell killing. Following intradermal injection of the PCI vaccine, which is now depicted as PCIV-01, step one, fimaporfin and the vaccine antigens are taken by antigen-presenting cells and colocalized to endosomes and lysosomes. With light activation of fimaporfin, it triggers permeabilization of the endosomal and lysosomal membranes, releasing vaccine antigens into the cell cytosol, which is a critical step because the next step of enhanced access to antigens result in increased MHC class I antigen presentation, a critical step in the therapeutic vaccination of cancer. If you go next, please. The antigen-presenting cells then carry the vaccine antigen and migrate to lymph nodes where they activate cytotoxic T cells, which then migrate to the tumor and infiltrate it. This is now depicted by 5, 6, 7, and 8 steps. The activated cytotoxic T cells are able to recognize and attack the tumor cells. Next, please. The effectiveness of the PCI vaccination principle has been demonstrated in preclinical models. Here we show one where we use an HPV tumor model with TC-1 cells that are rapidly growing tumor cells. In this study, TC-1 cells were inoculated in an animal where they're either not treated or treated with fimaporfin and HPV peptide antigens with the addition of poly-IC adjuvant. This was done on day 8, 13, and 22 after the tumor was established. The tumor in the untreated animal kept growing, as seen here, very quickly. The experiment had to be stopped before day 30. In the animal treated with a PCI vaccination, which is seen on the right, the tumor did not grow, and the animals finally became tumor-free, as seen by the 0 volume of the tumor cells. The animal became immune to re-challenge with these tumor cells, meaning that the immune system has developed a way to recognize these cancer cells and kill them before they establish a tumor. Next, please. The fimaVacc technology was further investigated in humans in a phase 1 study where healthy subjects were given fimaVacc vaccination. Subjects who received fimaporfin in a dose of 12.5 microgram or higher had a significantly higher rate of immune response. The fimaporfin dose of 12.5 microgram given intradermally with the vaccine components, which were the antigen and the adjuvant, showed a good safety profile and was very well tolerated. The dose of fimaporfin was identified as a recommended phase II dose. The dose of 12.5 microgram was recommended as phase II dose. This is the dose that we take forward to our proof of concept study. Recognizing the power of the fimaVacc platform to increase immune response primarily by enhancing cytotoxic T-cell activation, we believe that fimaVacc can improve the effectiveness of the immune system to fight tumor. If you go to next slide, please. The basic idea is that immune checkpoint inhibitors are effective treating "hot" tumors. But it means tumors that the immune system can see in a way. Unfortunately, most patients have tumors that are hidden or partially hidden from the immune system, so-called "cold" tumors. These are then characterized by few T cells and lower infiltration of T cells into the tumor, immunosuppressive cells present in the tumor, and poor response to immune checkpoint inhibitors. We believe that PCI vaccination is going to significantly increase cytotoxic T-cell activation and infiltration into tumor. By combining the vaccine with additional immunomodulation that aims to reduce suppressive immune cells and inhibit immune checkpoint, we can achieve a significantly better response treatment. Next, please. When we initiated the plans for the proof of concept study, we evaluated the building blocks of success of the fimaVacc platform scientifically, clinically, and commercially. We recognized that a big challenge with the dominating immunotherapy market, many patients have limited response to checkpoint inhibitor. We recognize that this is an attractive opportunity space to leverage the fimaVacc platform. We talked about the capability of fimaVacc to sensitize what we believe is non-responding tumor to checkpoint inhibitors. We evaluated which indication. We evaluated several indications, and we looked for a high unmet medical need, commercial opportunity, and scientific rationale for studying this specific indication. We reviewed and evaluated different trial designs that can maximize the cost benefit from expensive clinical trials. We engaged early in the process a top-level group of key opinion leaders to evaluate with us the plans, the clinical plans. We wanted that we develop a treatment concept that can be taken forward and is more ready, not just to demonstrate proof of mechanism, but go and show clinical efficacy. We wanted also that there is a way to expand the value that the platform can grow from this initial proof of concept study. Next, please. Following a thorough evaluation of several different cancer indications, we consider that recurrent or metastatic head and neck squamous cell carcinoma is the best entry indication for evaluating the effectiveness and safety of the PCI vaccination. The reason is that the treatment with immune checkpoint inhibitor is established, and most patients would get this treatment. However, many patients are not going to respond to this treatment. It depends on the history of treatment and what they are combined with, and what the stage of the disease, but it is about 60%-70% of patients that receive these anti-PD-1 therapy, they will progress within six months. There is high unmet medical need to convert these patients that progress and resensitize them for checkpoint inhibitors. The design we ended up with is optimized to explore efficacy combined of the PCI vaccination that is combined with immunomodulation in this target population. We believe that we ended up with a study that is most cost-effective for the purpose or for the aim of the development. Next, please. The treatment in the study has been following much discussion. We plan to combine the PCI vaccine with an adjuvant like we have done in the past, in past studies, but this time we want to add additional treatment that can take the response to a higher level, to maximize the response. The PCI treatments in this study are planned to include the PCIV-01, which is the PCI vaccine, which has fimaporfin and a mix of peptide antigens that are relevant. These antigens are tumor-associated antigen presented on cancer cell surface. We are going to include in it also a CD4 helper T cell stimulator peptide. To this vaccine, we are going to add a vaccine adjuvant, Hiltonol, which is poly IC. We have much data generated in combination with Hiltonol showing strong synergism between the two. To these two treatments, we are going to add immune checkpoint inhibitor, and this is to modulate the system, helping the T cells attacking cancer cells. On top of this, at the beginning of the treatment, we plan to add additional immunomodulator. It is planned to be a specific chemotherapy to decrease immunosuppressive cells to enhance immunotherapy efficacy during the initial treatment cycle. This is not going to be the treatment throughout the treatment period, but only through the priming period when we initiate the immune response to the vaccine, to the study vaccine. Next, please. This is just to bring all together what we plan to do. The patient population are recurrent or metastatic head and neck squamous cell carcinoma patients progressing on pembrolizumab or nivolumab within six months of treatment. This is called primary progression, and this suggests that the patient have one of the reason they progress or in many of the patient is that the tumor is just not seen by the immune system. We consider that primary progression is a better starting point for the PCI vaccine. This patient can have history of pembrolizumab or nivolumab as monotherapy or with chemotherapy. We also chose to have the HPV negative type of tumors. The reason behind it is that there is greater unmet need. Also for the HPV positive type of tumors, there are already several treatments in late stage development, and we believe that it's a much more difficult indication to get into at this point. We plan to study up to 20 patients, and the treatment like was described in the previous slide. Because there are some combination of treatment, we had to design the schedule in a way that we maximize the effect and we minimize the potential negative interaction, for example, with regard to safety or use of corticosteroids that are associated with other treatments that can potentially affect the vaccination, the effect of vaccination. This has been carefully considered and designed, and we aim to follow on radiographic progression, immune response in tissue and in blood, and of course, on safety. This is open study, and data are going to be accumulated as more and more patients are treated, and we will have, of course, a way to look into the safety and efficacy and immune response data. We are able to discuss this internally and externally. This is international multicenter study planned in 8-12 clinical sites. We need to assess recruitment rate in different sites and based on this and other factors, select these sites, and after this, we will know better how many sites are going to be involved in the study. We are very happy with the core clinical investigators and external expert that we engaged into this program. They endorsed the study. They were actively involved in the planning and some of them are going to be also investigators in the study, which helps in the engagement of the investigators. We hope that this is translated into better recruitment and better execution overall of the study because they've been part of planning the protocol, so there is a better streamline between the clinical sites and the protocol. We plan to start the study in 2023. Next, please. This is now where we are in the project readiness. Ongoing activities focusing on preparation of the clinical trial application. This is a big job involving several major documents that is under work currently. We are working on the CMC aspect. This is a study with several treatments, so there are much considerations and efforts need to be done to source the study treatments and first to manufacture and then sourcing the rest. The study operations in a way started when we look or we evaluate clinical CROs to be involved in the study and starting to plan for the start of the study. Like I said, we are very happy with the group of international experts that were engaged in this program, and they are truly engaged and very responsive. We had very good meetings to evaluate the outline of the study, and we are in very good progress working with them. Selection of clinical sites for the study started in Europe, major countries or bigger countries. Next, please. To summarize, this proof of concept study is a focused opportunity that is scientifically solid. The planned study design, the treatment endorsed by top experts and is well-positioned to drive value we believe. Solid foundation and scientific rationale, we have preclinical and clinical data supporting the antitumor activity in animal models and increased immune response in humans. Broad IP portfolio covers protection of the vaccine technology in combination with immune checkpoint inhibitors for years. Entry indication has high unmet medical need and is perceived to have high likelihood of response to treatment. It, again, dedicated group of top-level clinical expert has been engaged, which we consider one of the biggest advantages where we are to the success of the study. Next, please. We plan to submit the clinical trial application in Q4 this year and enroll the first patient in Q1 2023 with top-line results available in first half of 2024. We are actively seeking partnership for the program, and as data accumulate in the study, good results are going to support this process. I think that, with this, Per Walday, Ronny Skuggedal, I completed the cover of fimaVacc program. Thank you so much, Amir. I will take over and move into the fimaNAc. First, before I do that, I would like to just say that the groundwork that Amir and the clinical team has done on this fimaVacc is really outstanding, really, really good work laid a very good foundation to move this fimaVacc technology into a solid clinical proof of concept study and, hopefully, show the value in the clinical setting of this technology. Thank you, Amir. fimaNAc. For fimaNAc, we have a technology where we help nucleic acid therapeutics getting into cells because that is a real barrier. We have some really compelling preclinical results with strong data from oligonucleotides, smaller nucleotides to large molecules like mRNA. As I said, we are addressing what is considered a major hurdle for this class of drugs to get sufficient of the amount of the nucleic acid therapeutics into cells for them to give the therapeutic advantage they are meant to give. We are now focusing the development with targeting applications that are suited to the strength of the platform. The strategy is then to build partnership in key areas. We are still opportunistic and open with this. Whenever there is interest from the outside in our technology, we are open to collaborate to see whether there is any synergies that can be found and further development that can come out of those kind of collaborations. We have most recently now in Q1 2022 established a collaboration with MDimune, which is a South Korean biotech company, who are developing other types of innovative drug delivery technologies that potentially can be combined with PCI to really produce good synergy and even better effects. We have determined now that the area we want to put focus on is dermatology. There's an excellent technological fit with dermatological diseases. We have seen substantial enhancement of intracellular nucleic acid delivery in skin with the studies that we have done preclinically. We also know that fimaNAc provides excellent spatial specificity of nucleotides. It means that you don't have leakage to other to other areas to off-target areas. You can actually restrict the entry to the specific area where you want this to happen. We know that of course with dermatology, it's easy illumination access, and also it's possible to have topical applications and topical formulations done, which means that you can use this without being very invasive at all. There's a large market and large opportunity space, a lot of companies developing nucleic acid therapeutics for dermatological applications. We have currently also one collaboration in place with a company who is doing exactly this. This is another South Korean company called OliX. This is a very good fit with the fimaNAc technology. What we are then going to focus on is to develop a user-friendly and integrated and suitable application for dermatological diseases. Then the intent is we intend then to initiate the collaborative development of these integrated solutions, developing a topical formulation of fimaNAc and also a specific skin illumination device. This can be applied across a number of different dermatology applications, which will expand the collaborative opportunity space within this focused area. That is our plans for fimaNAc going forward. We are still having a collaborative strategy on this, but we are focusing some internal work to more mature some specific applications to ready-to-use solutions in specific areas where we think it's best suited for our technology. Then we're done with the operational review. We move over to corporate key financials and outlook before we go into the Q&A. I will hand over to Ronny Skuggedal to take over at this stage to do the rest of the presentation. Thank you, Per. First corporate organizational changes. Clinical team reduced as a direct effect of the RELEASE trial. The CBO will leave in May and the CBO's main objective was to commercialize the fimaChem program based on RELEASE. As Per mentioned earlier, he has decided to pursue new opportunities and he will step down by the end of the month and myself is appointed by the board as interim CEO effective 1st of June. The research and development team is fit for purpose. Now when RELEASE is put behind us soon and we will push hard for fimaVacc. We have a highly skilled team with a diversified experience and they are highly motivated to achieve our objectives. Here is a list of conferences we are attending in short term. LSX World Congress in London, a combined BD and investor conference where we are in person as we speak. The CSO Anders Høgset is in Boston in person at TIDES, a fimaVacc, sorry, fimaNAc focused event where we also have a poster and we will have a virtual company presentation later in the month at ABG Sundal Collier's Life Science Summit. Key financial figures. With the changes, we have now an estimated financial runway towards the end of next year. RELEASE closure, estimated future cash effect of up to NOK 10 million in cash for closure of the program. Here I would like to give credit to the clinical team for all the hard efforts to make sure that we have a swift and cost-effective wind down of the study, balancing our need or our wishes to gain results out of the study. Now since the follow-up of patients are to be ceased in May with the last patient leaving the study in May, we are pushing hard and looking into even further efficiencies in the closure of the RELEASE trial. Hopefully we are able to reduce the cash effect as well. Organizational changes will impact in full from Q3 and preparations for the fimaVacc study will continue while financing opportunities are being explored. Regarding the figures, public grants in the quarter, slight decrease from last year due to the BIA program ending in the summer 2021. Net financial result fluctuates with exchange rate effects on bank deposits in euros. We have a cash position of around NOK 93 million at the end of the quarter. Q1 cash flow has been on the same average level as 2021. This is due to RELEASE being close to a normal operational month for Q1. Also remember that we had very good recruitment into the trial in Q4, also impacting the Q1 costs. Outlook. Of course, now fimaVacc is our lead program, so we are pushing hard to progress towards an initiation of a phase two, where we aim to convert cold tumors to hot, improve the response of ICIs, and thereby generate value. We have good project readiness. The clinical expert group, as Amir reviewed, and through this network, we have been able to select or to recruit sites in major countries in Europe. The objective now is to show the real value of our versatile vaccination technology and generate partnering opportunities. For fimaNAc, as Per reviewed, we are focusing on applications well suited for the PCI technology strengths, and we are starting with dermatology, and we are of course pursuing new collaborative opportunities and also work hard to convert the existing ones into more into next steps. For fimaChem, swift and cost-effective closing of course, and I can assure you that the team, clinical team and the whole company still push hard on this to put RELEASE behind us and minimize the costs. We are over to the Q&A session, and we can start with opening up for verbal questions. Monitor, please open up for any questions. Yep, then we will start with some questions from the web. Here is a question for you, Amir. Can you elaborate a bit on the results seen from RELEASE? Is there not any differences between the treatment arms? Yeah, I will answer this. First, the first thing to consider is the size of the valuable data that we look at. We enrolled 41 patients and 34 patients have been treated, so we include 34 patients in the analysis. Now, not all of these patients provided radiographic progression data. They were included in the analysis, but the data set that actually provided information on progression-free survival and objective response rate is smaller than this. This represents less than 20% of what was planned, 20% of patients or events that were planned to provide power to assess difference between the arms. Now, we did look whether there are some differences. Overall, in the two populations, the effect was similar. When we looked at the patients who received the PCI treatment, on average, there was a numerically greater effect in the biliary tract tumors that were exposed to illumination. Meaning that because we allowed patients to enroll into the study with lesions that are measurable, that we can measure radiographically, also the lesion could be in the liver, in the lungs, lymph nodes in the abdomen, everywhere. What we looked at, we looked at those patients that had the lesion next to the bile duct that we treated and compare it to lesions in the same treatment arm that were further away, and there was numerically rather big difference between the effect on the lesion itself. Lesions that were exposed to illumination, all lesions were exposed to the same treatment because fimaporfin and chemotherapy were given intravenously. Those that were exposed to the light, this is where fimaporfin was activated, and these lesions that were exposed to light shrink more, numerically significantly more than other lesions. This is a small look further into the data, and this is not something that we can in any way stand behind and build because the study was designed with effect between the arms on these endpoints, and this is only scientific interest whether the illumination shrink tumors more than without illumination. Hope this answered the question. Thank you. We are over to fimaVacc related questions. Here is one very specific one. What kind of chemotherapy are you planning to use? More information will be provided later. We are now finalizing the last steps of putting the protocol together, and we are not going to give this information at this point, but it's going to be provided at an earlier point. There are several considerations behind when we reveal what data, but at this point, we do not tell about the specific chemotherapy. Okay. Here is another one, specific. What are the therapeutic peptides included in the PCIV-01 vaccine? This falls under exactly the same response that I gave regarding the chemotherapy, and the specific peptides, you know, like, the sequence of the peptides is going to be revealed later from the same consideration. I can only say, as we said in the presentation, that these are tumor antigens, and they are expressed commonly, very commonly in head and neck cancer, in recurrent and metastatic head and neck cancers. We expect these antigens to be relevant to all the patients that are enrolled into the study. Thank you. Here is a question maybe for you, Per. Will initiation of the new fimaVacc study need to be proceeded by an equity issue, or do you expect to initiate the start with the current funds? You do never initiate patient treatment from ethical considerations until you have ensured that you have sufficient funds to actually complete the study. We will not start treating patients until we know that we have funding to complete the study. We can complete and do all the preparations towards initiation of the study at this stage. Very good. It's more a general question here. How is the eTheRNA collaboration going, and do you see any interests in the fimaVacc and/or fimaNAc program? Yes. I think we can clearly say that we see interest in both fimaNAc and fimaVacc program, absolutely. The eTheRNA collaboration is progressing. As these are confidential, the results that come out of this, we can't talk very specific about these collaborations and what we're doing in them, but it is progressing well, and it is absolutely something that we are still focusing on. Specifically, intra-tumor treatment with the PCI technology, which is where we're collaborating with eTheRNA, is a very interesting area for PCI. Although it wasn't mentioned now specifically in this because we focused on the dermatology and the fimaVacc opportunity for clinical for this quarterly presentation, it is still part of the focus of what we are doing pre-clinically in PCI. Very good. Maybe we can go back to the moderator to see if there are any questions from the telephone conference. Okay. I think we have covered all questions from the web, and I will then take this opportunity to say thank you to Per for all your efforts for PCI Biotech over the years. It's been a pleasure. Good luck with your new opportunities. Thank you. I would also like to say thank you to all the hard work done by our PCI colleagues and also say good luck to those who are also seeking new opportunities outside of PCI Biotech. With that, I think we will say have a good day. Thank you.