Welcome to the Vivesto audiocast with teleconference Q1 2022. For the first part of this call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. May I present to you today CEO François Martelet. Please begin your meeting. Thank you and good morning, everyone. This morning we released our Q1 2022 results, which we will be going through this presentation. As usual, we will run through the highlights and the financials and then take any questions at the end of this presentation. I'm now on slide one, which is a forward-looking statement that you should be aware. Slide two, I have with me Fredrik Järrsten, our CFO. Let's move to slide three. The first quarter of 2022 has seen us delivering sustained operational progress. Specific highlights include a successful rights issue, raising SEK 151 million to drive the development of our current business and programs. We also, I know that Freddie will go through that. We continue to reduce our operating expenses. We have announced a manufacturing agreement with Lonza for clinical trial material for the Cantrixil phase 2 study. At the same time, an upgrade to the Uppsala Research and Development facility to support Cantrixil development, especially for the IV formulation. I am also pleased to report that the phase 1b docetaxel micellar study recruitment is on track. Even more importantly, the Apealea launches in Europe are expected to happen during 2022. More about this a bit later. Elevar is also reviewing an optimal development strategy for the US markets. We've made progress with the development of our drug delivery technology, XR-18. A novel candidate has been identified. A research agreement has been signed off with Visikol, which is a US CRO. We have appointed Daniel Tesfa as our Chief Medical Officer, and Kai Wilkinson as our Chief Technical Officer. There will be a new chairman and board members that have also been proposed post-period end. We continue to focus on our string- of- pearls strategy in order to expand our oncology portfolio. Slide four. In a very difficult financial market conditions, we've been able to successfully raise SEK 151 million through a rights issue, therefore strengthening significantly our financial position to drive the development and value of our existing pipeline. This is absolutely a key step towards building a Nordic oncology powerhouse focused on how to treat a late-stage cancer. Let me take here the opportunity to thank our shareholders, our current shareholders, our new shareholders, for their support, which is greatly appreciated. Slide five, please. T his is a reminder, Cantrixil is the first of our string of pearls in license from Kazia last year. As a reminder, this is a tubulin binding small molecule with potent cytotoxicity against CD44 ovarian cancer stem cell and ovarian somatic cancer cell, which are both resistant to standard chemotherapies, which is why it has an orphan drug designation status in the US. I have to emphasize the capability of the drug, the potentiality of the drug against stem cell. Positive phase 1 data was presented at the AACR conference in 2021 and published later on in the Journal of Cancer. We are now working and planning a phase 2 for the US and also in Europe as well. As a reminder, the incidence of ovarian cancer continues to grow. In 2020, there were about 314,000 new cases of ovarian cancer worldwide. The global ovarian cancer market is therefore expected to grow at a compound annual growth rate of close to 20% until 2025. Slide 6. As I said, we have ambitious plan for Cantrixil over the next year as we prepare to go into the phase two in advanced ovarian cancer. That includes we continue the interactions with our experts, scientific advisory boards, which are made up of key opinion leaders in Europe, Australia, and in the US, in order to guide us on the design of the phase two. We also plans to hold talks with regulators to discuss endpoints and appropriate data for submission. These early interactions with the regulators are absolutely key and should help and will help to de-risk the program. Cantrixil at the same time is a complex drug to make, which is of course on the positive side, a high barrier to entry. During the quarter, we signed off a contract manufacturing agreement with Lonza for a large scale production of main drug, intermediate material for the phase 2 clinical study. As I said earlier as well, we expanded our research and development lab capabilities in Uppsala, especially for Cantrixil. Cantrixil is very exciting. W e believe this is a pipeline in a product. It has really a great potential in other CD44-positive cancer as well. Slide seven. Another promising in-house project is docetaxel micellar, which targets advanced prostate cancer. This is an IV formulation of the widely used cancer drug docetaxel, also known under the brand name of Taxotere. By using our XR-17 delivery technology, we therefore aim at eliminating the need for solubility enhancers, potentially therefore improving the side effect profile and eliminating the need for additional drugs for many patients, such as corticosteroids. Our Swiss partner, SAKK, is running the phase 1b study in three major hospitals in Switzerland with the aim of recruiting 18 chemotherapy naive patients. SAKK has a target of completing this trial by the end of 2022. We're also working on expanding the IP around docetaxel micellar, and we are evaluating a formulation using our improved drug delivery platform XR-18. During the quarter, we have announced that the first patient had fully completed the study. Furthermore, the first two of three dosing groups in the trial had been successfully recruited, and the first patient in dose group 3 is in the screening phase. Obviously, we look forward to updating you as the trial progresses. Slide 8. As I mentioned to you earlier we are also excited about the potential of our drug solubilization platform. With regard to XR-18, our scientists in Uppsala have identified and synthesized a promising novel drug candidate for use in the platform, and this is already being tested in combination with a widely used oncology compound. Now, we unfortunately cannot disclose more information about it at that stage for obvious competitive and commercial reasons. During the quarter, we were pleased to announce a significant expansion of our IP portfolio linked to XR-17. Building on these advances, post period end, we announced the signing of a research agreement with Visikol Inc. to evaluate the cellular effects of new and existing anti-cancer drug formulations developed using Vivesto XR-17 and XR-18 technologies. As a result of this research, we will be able to assess anti-cancer compounds formulated with our XR-17 drug delivery platform, as well as line extensions formulated with our XR-18 technology. Slide nine. I know that you are all expecting the launch of Apealea in Europe. Now it's coming and Inceptua is planning to launch Apealea first in two key markets in Europe, which are the largest markets: U.K. and Germany. The Apealea U.K. launch is perfectly on track and packs will be available before end of June of this year. Inceptua has secured a list price with the Department of Health and Social Care of the U.K. The German launch is slightly delayed versus original plans and is now expected to happen at the early time frame of H2 2022. Still on track fundamentally. Inceptua is also evaluating launches in other European markets, and therefore, we believe that we will receive our first European royalties this year. In the U.S., Elevar is reviewing an optimal development strategy for Apealea, and also for competitive reasons, I cannot disclose the precise clinical design. Slide 10. You will certainly have seen that our nomination committee have proposed some changes to streamline the board to 4 members without any deputies. In addition, the nomination committee proposed the re-election of board members Hege Hellström and Peter Zetterberg, and the new election of Pål Ryfors and Roger Tell as board members. Peter Zetterberg, representing Vivesto main shareholder, is proposed as the new chairman. Anders Härfstrand, Andrea Buscaglia, and Birgit Stattin Norinder have declined re-election to the boards. These proposed changes will be voted at our AGM later today. During the quarter, we also announced that Dr. Daniel Tesfa will be joining us as our Chief Medical Officer in July at the latest. Kai Wilkinson has been promoted to the management team as Chief Technology Officer. Slide 11, and I'm turning to Fredrik to comment this slide. Thank you, François. I'm turning to our finances. A few key numbers on page 11 give you a snapshot of our performance in Q1. We have continued our cost savings efforts and we show operating costs totaling SEK 21 million. That is a significant reduction since Q1 2021 when we had SEK 34.5 million in operating costs. It's also a reduction since Q4 when we had SEK 31 million in costs. We're very pleased with that continued development. We reported an operating loss of SEK 26.3 million. Now, that is also an improvement since Q1 2021 when we had loss of SEK 41 million. We had operating cash flow of SEK -22 million, so that's equivalent to burn rate of approximately SEK 7.3 million per month, which is also well below our previous target of SEK 10 million per month. We had cash and cash equivalents at the end of the quarter of SEK 74 million. That does not include the net proceeds from the rights issue and which we received after the end of the quarter. If we include that of SEK 135 million, the cash position would be SEK 208 million. Further on the rights issue, that was completed in Q1. We raised gross SEK 151 million before issue expenses of SEK 16 million. With that, we strengthened equity with SEK 135 million. We have a very solid financial position, with an equity asset ratio of 94%, and we can also conclude that we have no debt on the balance sheet. A very solid financial position, going forward. Thank you, François. I think that is my space. Thank you, Fredrik. Slide twelve. On this slide, you can see that we continue focusing on building our proven capabilities to make us a more attractive partner for innovative assets. Our core capabilities include product, clinical development, business development, and regulatory affairs. Therefore, we have all the functions of a small pharmaceutical company. Ultimately, we are aiming at building our pipeline with new late-stage oncology assets using different mode of actions in order to spread the risk. Once this development process will be completed, we always will have the option to commercialize our product through global collaboration or in some cases to undertake direct commercialization ourselves for certain niche products in Europe. Slide thirteen. This is an important slide. Looking ahead, we have multiple catalysts to drive near and midterm value. Apealea initial launches in Europe which is happening now as we speak in the UK and very quickly afterwards in Germany. Further partnering with Elevar, obviously there will be the Chinese partner is in sight. Potential initial revenue from royalties as well. This is absolutely key and we will therefore belong to the limited club of biotech companies having royalties coming from an approved product. Docetaxel micellar, the phase 1b completion of the enrollment and the initiation of another trial with XR-18 constitutes certainly another set of milestones to achieve. Cantrixil intraperitoneal injection preparation of the phase 2a as we speak, and we will be also working on preclinical and proof of concept work on a new formulation, the IV formulation, which also constitutes a number of different catalysts compared to Apealea and docetaxel micellar. Of course, above all, we are planning to extend our technology platform through our internal in-house developments, XR18 in particular. I n summary, this is slide 14, we have now completed fully the turnaround of the company. The last step was to change the name of the company, which has been done. With the recent fundraising, Vivesto is well capitalized to fund existing operations over the course of the next 18-24 months, which is also something very significant if we look at the biotech market in Sweden. We do have capabilities in place to build a diversified pipeline of programs by executing our string- of- pearls strategy through in-licensing and/or M&A. Ultimately, we are aiming at building and developing a diverse pipeline, creating multiple shots on goal in order to decrease the level of risk linked to clinical development in oncology. We've built a strong platform to attract innovative partners and also obviously, we hope to attract new specialist institutional investors to help us to grow this business. This is my last slide. At this point in time, I will pass the floor to the moderator for questions. Thank you. We will now begin the question and answer session. If you wish to ask a question, please press zero and one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero and two to cancel. Please limit yourselves to two questions at a time. There will be a brief pause while questions are being registered. The first question comes from Joseph Sheridan, Rx Securities. Your line is now open. Please go ahead. Good morning. Thanks for taking my questions. First one on Cantrixil. You've established part of the manufacturing process with this deal with Lonza. Can you just remind us how many steps are left to secure the full manufacturing chain? And are you looking at agreements with different companies, or could this also be done with Lonza? And what do you think the timeline to completion of that is? Secondly, on Apealea, you mentioned that Inceptua has secured a US, UK list price. Could you tell us what that is, please? Thank you. On your first question about the Cantrixil manufacturing process. Cantrixil, yes, is indeed a difficult product to manufacture, which is actually quite great because of course it is a significant barrier to entry for any other compounds in a similar class. Having said that, as I said we have signed off a great agreement with Lonza for drug substance. We will be also involving two other manufacturers in order to complete the drug substance process. Then we are in a stage of working for drug products. We hope to simplify as much as we can the manufacturing chain. That is obviously our objective. W e will update you at the next quarterly conference about this progress. W e were actually very pleased to have been able to sign off this agreement with Lonza, which is a very solid, well-known manufacturer. On Apealea, this is run through Inceptua. W e are pleased that launches are now happening. The UK will be first, and it's imminent. Okay. With regard to Germany, there were administrative issue that did produce a very slight delay, but not really significant overall. Inceptua, we will obviously announce that through a press release when the first packs will be indeed launched. With regard to other markets in Europe, this is the next step for Inceptua. They are evaluating a number of other key European markets in which Apealea can be and will be launched. W e will be updating you as soon as possible. Okay, thanks. Just anything on the U.K. price? I don't have any authority to disclose that at this point in time for obvious competitive reasons given the Taxol being generic in the U.K. Okay, thanks very much. You're welcome. The next question comes from Per Andersson, Private Investor. Your line is open. Please go ahead. Yes, thank you. I was wondering regarding the timeline that you presented now. On your webpage, you have a similar timeline presented from the AngloNordic Life Science Conference, the presentation there. In that, you presented a more precise timeline for the US phase, FDA trial initiation. Then you stated late 2023 in that presentation. Has that changed? W e are in constant discussion with our partner Elevar in the U.S. Recently, I don't know if you are aware, but there is a significant change in management at Elevar. I actually even discussed last night the matter with the CEO of Elevar. And really, they absolutely are reluctant to disclose any precise information on the U.S. strategy for competitive reasons. It's not that we are hiding anything. It's that this is a very competitive field in ovarian cancer. That's the reason. T here is obviously some frustration also on your side. I understand that. It is as it is. It is an extremely competitive situation. The information in that presentation, late 2023, where did that information come from then? Yeah, yeah, absolutely, yes. Yeah. That was the indication you had at that time, that it could be at the end of next year the trial would be initiated. W e will release any information related to the start of the study from Elevar. This is in the hands of Elevar. The information. I cannot comment any further. That information was not reliable, that it's stated late 2023. That was incorrect. It's no. T he planning process is still ongoing, and therefore, we give you information when we get it. A fterwards, planning may change. There is an absolute commitment of Elevar to pursue a US registration strategy with Apealea, which is the most important thing. Could it be delayed indefinitely by Elevar again and again? Could we be sitting here, in June next year and you just giving the same statement that you're giving now? I cannot comment on that one. T hat every year there is a conference call together with the Elevar CEO. That hasn't happened this year because of the change of the management. That will be the topic of a conversation that will be held with Elevar at the right time. I cannot comment any further. I'm sorry for that. Regarding Cantrixil, if you look at the same slide with the time frame, should we interpret that planning as though Cantrixil phase 2 will be initiated late 2023, almost at the beginning of 2024? For Cantrixil, as I said earlier, we are in a process to finalize the drug substance manufacturing process. At the same time, we are working on the drug product process. Now, as of today, the timeline that you refer to is correct. Obviously, it all depends on the way we will be able to manage the drug product process through another manufacturer or the same one that we are using for drug substance. This is where we are. What is important is not necessarily if there is a delay of one or three months. It is important to secure a proper, very professional manufacturing chain for Cantrixil. This is the key issue. Yes. At the present time, you predict end of 2023. At the present time, I am telling you that we continue to secure the drug substance manufacturing chain together with the drug product, and we will come back to you with a more precise time frame when I will know it. Okay, my next question is regarding the collaboration with Karolinska Institutet. Last June, you said that results of that collaboration regarding the potential of the platform would be communicated before the end of last year. What has happened with that? We have decided to continue working with Karolinska. At the same time we have signed an agreement with Visikol, which is a U.S. CRO, in order to look for the cellular mechanism of the platform. Then based on those results, we will continue to work with Karolinska, and we will report the progress at that time. But there is nothing wrong with the work with Karolinska. T his is a two-step process actually. Do you have a time frame you could give on that when there will be a communicated update? During the next year that we will communicate that. Yes, we will communicate the reports on both the work from Visikol and KI as well. Your list regarding potential value drivers, you have removed divestment of AdvaVet. Does that mean that a divestment is highly unlikely to ever take place? No. We continue to pursue the best strategy with regard to animal health portfolio. We have actually we continue to work with U.S. experts in this area, U.S. people who have a lot of expertise in the vet business. We'll update you at the right time. Okay. My final question, can you comment at all for the reasons for the board members leaving? N o. T his is a decision made by shareholders, so I cannot comment on this one. What I can tell you is that management will be looking forward to working with the new boards. Okay. Thank you. Welcome. The next question comes from Frederick Hagen Private. Your line is open. Please go ahead. Thank you and good morning. Morning. I would like to ask, do you have any expectations of a milestone within coming from the Elevar agreement within 2022? Yes. C ertainly, there are milestones that are in the making for Apealea. Whether I would make a formal commitment on a time frame, no, because it's not in my hands. It's actually in the hands of Elevar and the authorities as well. I can tell you that we will update you as soon as we have that to happen. Yes D on't even think that Elevar doesn't work on that. There is some work ongoing on that. All right. I interpret you as that there could be a milestone within 2022, but nothing is for sure. Is that what you're saying? You see, milestones are in this licensing agreement depends on geography approval, essentially. Okay. On indication approval, okay? Unfortunately, indication or geography approval does not depend on me. It depends on regulatory bodies. Right. We work on that through Elevar. I see. Next question. Do you expect to get any sales estimate from Inceptua for the- Ah. Um- Apealea. That Inceptua is a privately held pharmaceutical company, and they don't provide any guidance on that. There won't be any public guidance on Apealea sales at all. Okay. All right. Thank you very much, and good luck. You're welcome. There are no further questions. I hand back to you, speakers. Thank you. L et me conclude this quarterly call that if I look at the Swedish biotech market we are in a fortunate situation. Why? Because we have money in the bank in order to pursue our operations. This is really a significant point that I would like to emphasize. Two, we are launching Apealea. The first royalties will be expected by year-end on the UK and German launches. Which is something that is also very significant if I compare to any other biotech company in Sweden. With these two strong points, I would like to thank you for attending this call, for your confidence in us delivering milestones and royalties through our partners. Thank you. Ladies and gentlemen, thank you for your attendance. This call has been concluded.