Technologies who just released its Q1 report today. With me today, I have the CFO and the CEO of the company who will take you through a presentation of the Q1 results and milestones. I will give the word to both Keith and Bent and take us through the presentation. Thank you, Frank, for allowing us to present to our investors here at HC Andersen Capital's digital investor relations platform. My name is Bent Frandsen. I'm CEO of ExpreS2ion Biotechnologies. I'll go through a few introductory slides about the company and important milestones achieved in the first quarter of 2021, before handing over to Keith Alexander, our CFO, who will talk financials in connection with today's release. You'll notice Keith is American, [audio distortion]. Next slide please, Frank. First, the usual forward-looking statement and disclaimer that we'll let you study in order to undertake your own informed decision of the trading in our share. Next slide, please. ExpreS2ion Biotechnologies is a Scandinavian biotechnology company with operational activities in Denmark and public business in Sweden with a clinical stage development pipeline of high-value vaccine product candidates. Our vision is clear. We want to be leader in the oncology and infectious disease fields. With our current pipeline assets, we believe we have a fair chance of fulfilling this vision. We've been listed at NASDAQ First North Growth Market since 2016 and have been able to increase our market capitalization since public inception from SEK 33 million to about SEK 1.3 billion. Most of this growth is coming from our recent focus on pipeline development. ExpreS2ion holds a 34% ownership in the joint venture partner, AdaptVac, which holds the unique virus-like particle technology or the VLP system, one slide back here, Frank, which is a proprietary vaccine efficacy-boosting technology that complements our S2 insect cell-based protein production really well. Both on the S2 insect cell system and the cVLP system, the IP protection by issued patents extends well into the 2030s. For the S2 insect cell system, we have pending patents even until 2040. Our development pipeline, which I will cover after this slide, is very robust, and collectively the pipeline projects address some of the most grave and widespread diseases where the world regretfully see numerous deaths. COVID-19, we have seen more than 3 million deaths by now. breast cancer, where more than 600,000 die each year. influenza that kills more than 300,000 each year, and malaria, where about half a million lives are killed every year. At the company, we are proud to have unique vaccine solutions to address these disease areas. Finally, our cash position is very sound due to recent raising of SEK 131 million in the rights issue in Q4 2020, as well as the successful raising of another SEK 39 million in our recent exercise of warrants that were associated with the autumn capitalization. Next slide, please. As mentioned, our development pipeline is very robust and covers clinical-stage projects too. Most recently, we've been able to progress significantly on two lead projects within COVID-19 and breast cancer. In COVID-19, the ExpreS2ion developed the SARS-CoV-2 antigens are decorated on the surface of a virus-like particle using AdaptVac's technology. This project was initiated shortly after the identification of the genomic sequence of the Wuhan coronavirus in January 2020. This project got funding early on from an E.U. Horizon 2020 grant. Very quickly caught the attention of commercial licensing partners. Through a licensing agreement between AdaptVac and Bavarian Nordic, Bavarian Nordic has obtained exclusive rights to commercialize this vaccine opportunity. Furthermore, ExpreS2ion and AdaptVac have a licensing agreement which allows for the use of ExpreS2ion's technology in the final COVID-19 product. This vaccine opportunity have in preclinical animal testing settings demonstrated some of the most promising, if not the best data at all. The data sustains the front profile that it may be a one shot only, long-term protecting and strong immune-inducing vaccine. On top of this, with a stability allowing storage in ambient temperatures and handling even at temperatures up to 49 degrees Celsius. In breast cancer, the ExpreS2ion developed HER2 antigen are decorated on the surface of the VLP. This is fully licensed from AdaptVac to ExpreS2ion, and here we developed the vaccine product onwards based on very promising preclinical data, which have shown in transgenic mice that spontaneously develops HER2 tumors and has shown ability to modify the disease progression and possibly even break intolerance. We have given this project the project code ES2B-C001. It has now in our hands shown to have a solid biophysical profile, and we just last week announced our selection of a lead candidate that we'll now focus on in our development work going forward. In influenza, ExpreS2ion is part of an E.U.-sponsored consortium called INDIGO, where ExpreS2ion manufactured hemagglutinin proteins will be tested in a novel adjuvant system to develop new-generation influenza vaccines. The emphasis here is on making products that are cost competitive to be able to distribute also to developing countries. The cost-friendly element is an important notion also within malaria. Here we are involved in a handful of different vaccine projects. While COVID-19 has actually had a slowing effect on the development of these projects, we are very pleased about the recently published clinical phase I/IIa data for the University of Oxford-sponsored malaria vaccine project, where ExpreS2ion's technology is applied to make the complex protein RH5. These data concluded that the RH5 vaccine, in combination with the so-called AS01 Adjuvant vaccine, is safe, well-tolerated, and immunogenic in healthy adults. A significantly reduced blood-stage parasite growth rate was observed in the vaccinated population following controlled human malaria infections, which is a defining milestone for the blood-stage malaria vaccine field. Next slide, please. Through most of our pipeline, we've seen really important news here during the first quarter of 2021. Let me highlight them here. First of all, we have communicated in early January the clinical trial application that was sent for the Dutch authorities for the COVID-19 vaccine. It took two months for this CTA file to be approved. The approval came in March and allowed us to initiate dosing in the first healthy volunteers within the first quarter. On 12th of April, we announced that the safety profile of dosing of the first 18 healthy volunteers. So far, the vaccine has been very well-tolerated, and first immunological investigations are ongoing. Within breast cancer, we obtained and communicated on the granting of the exclusive license from AdaptVac to ExpreS2ion on the 2nd of February. In the same month, we announced the research collaboration with University of Bologna. University of Bologna hosts a state-of-the-art animal models that will help us develop this project onwards. It's the same models that were used as basis for the research in the 2018 Paladini paper, where the previously mentioned proof of concept in animals was documented. In May, we announced the selection of the lead candidate, which now makes the breast cancer vaccine project more tangible as we look for testing a specific construct that we have developed with unique biophysical properties that look very promising. Finally, within malaria, it was pleasing last month to announce the publication of the clinical phase I/IIa data in a scientific journal, as I just referred to. All in all, at ExpreS2ion, we are very excited of these accomplishments during the first quarter. Now, Keith will take over and describe the financials during the quarter. Perfect. Thank you, Bent, and thank you, Frank. As been mentioned, I'm the Chief Financial Officer of ExpreS2ion Biotechnologies, and I'm located in Hørsholm, Denmark, despite my accent. I'll present a few prepared remarks about the financials. Frank, do you mind moving forward two slides? During the first quarter of 2021, we laid the foundation for our future with investments in equipment, personnel, and facilities needed for the development of ES2B-C001, which is our breast cancer vaccine candidate, as well as the scale-up of the ABNCoV2 COVID-19 vaccine for further clinical development. Let us tell you a few of the key figures. Here you can see the summary for the first quarter along with comparisons to the first quarter of 2020 and the full year of 2020 results. Our net loss increased from -SEK 5.2 million to -SEK 11.2 million, primarily as a result of the investments in pipeline projects and lower grant income. We'll go into more detail on this in the coming slides. The net loss per share was SEK 0.40 in the first quarter of 2021, compared with SEK 0.37 in the first quarter of 2020. We concluded the quarter with SEK 82.8 million in cash, which is approximately DKK 61 million. Our cash position was reduced in the quarter, primarily as a result of the operating loss and a one-off reduction in current liabilities related to the COVID-19 project. After the close of the quarter on April 28th, we announced the outcome of the exercise of the Series T04 warrants, through which we raised an additional SEK 39 million in an offering which was 97.6% subscribed. Given the share price development in the quarter, it is not surprising that the subscription level was so high. Still, it's something we're quite happy about. Frank, do you mind moving to the next slide? We'd like to focus on a few developments in the quarter. First, our operating income was significantly lower in Q1 than in the preceding quarters. This is because we've realized the full grant income from the E.U. Horizon 2020 grant related to the COVID-19 vaccine development project, and the CRO business remains impacted by COVID-19 itself. On the positive side, income from the CRO business was stronger than it had been for the last three quarters. Both operating and net profit are impacted by the one-time payment for the ES2B-C001 license of SEK 3.4 million, which is equivalent to DKK 2.5 million, as well as higher costs associated with pipeline projects and personnel. These are partially offset by lower interest expense due to changes in our capital structure. Frank, do you mind moving to the next slide? Moving to the group income statement, we'd like to spend some time discussing our operating costs, focusing on the largest figures. You'll note that raw materials and consumables and other external costs have both increased significantly. These are both driven by investments in our pipeline business and most notably, the preclinical development of ES2B-C001. Our personnel costs have also increased. Our headcount today is now 25, with recent additions adding strong competencies in clinical development, oncology, project management, and quality, as well as in administrative functions. Frank, would you mind moving to the last slide? The final comment that I'd like to make is on the change in our investor mix we experienced during the quarter. First, the chart on the left-hand side shows the turnover experienced in the first quarter by healthcare companies listed on the NASDAQ First North Growth Market. Note that the turnover is calculated as the number of shares traded by, divided by the market capitalization of the company. It's a reflection of share liquidity. ExpreS2ion Biotech AB had the highest turnover of the group in the first quarter and 2x the level of the second company in the group. The chart on the right is based on data from Euroclear, and it shows how the number of investors by country changed during the quarter. We have removed the actual numbers since nominee-registered investors are not broken out by country. In the first quarter, the number of Danish investors increased almost fourfold, and the number of Swedish investors increased by approximately 1/3. In total, the number of investors approximately doubled from 6,000 -1 2,000. Finally, ExpreS2ion Biotech Holding AB will be added to the MSCI World Micro Cap on May 27th, 2021. We look forward to welcoming additional index investors. With that, I'll pass the mic back to Bent to comment on the key milestones for the rest of the year and closing remarks. I'll stick around for any questions after his comments. Thank you. Thanks, Keith. Taking a look at our outlook for the near future, they will show it as we have also described it in our newly issued annual report. I'm very pleased that we are already in the first quarter of 2021, see some successful completions of the milestones. That's shown here with the green tick marks. Going forward for the COVID-19 vaccine, we rely on the Bavarian Nordic continuing the development of it efforts now. They are deeply committed and involved in this project now, and it was also very pleasing to notice their successful test rates in monkeys right after the approval to conduct the first clinical trial. Their announcement of further monkey study data showing that the COVID-19 vaccine has strong immune protection even against variants of concern like the U.K. and South African variants, is also extremely encouraging. Bavarian Nordic has conveyed dedicating DKK 200 million to develop the clinical phase III supply and manufacturing set up for the COVID-19 project. Furthermore, they continuously seek new funding for the clinical phase III trial, which, provided they obtain funding, could initiate in the second half of 2021 and possibly start distributing commercially during 2022. For ES2B-C001 in breast cancer, we have the funding in place and a clear road plan for bringing us towards clinical testing in May in 2023. By the end of this year, we hope to obtain new animal proof-of-concept data through the collaboration with University of Bologna. Based on this, we will in parallel develop the GMP manufacturing processes and scale up and perform toxicology studies later in 2022. That will form part of our clinical trial application for submission in the first half of 2023. Within influenza, we expect to move into preclinical animal studies later this year. We continue to perform research and development in this field to establish development of new influenza vaccine candidates. Finally, within malaria, we hope to move into an additional clinical trial with our collaborators at Oxford University. All in all, we have a great future ahead of us. Keep on working to maximizing the value of the company to the benefit of the shareholders, and at the end of the day, to all the community in need of effective vaccines against some of the most deadly diseases in our lifetime. Thank you. I'll hand over the word now to Frank, and Keith and I are available for any questions. Yes. Thank you, Bent. Thank you, Keith. We will now welcome questions, and I encourage you to be brief in your questions. I see a lot already came in, but please be brief. That will add the opportunity for many to answer the questions. We'll start out, Bent, and ask you a little into the COVID-19 vaccine. We see that also Lars Christensen from Bavarian Nordic had some mention about the possibilities for financing a phase III study. Is there any news regarding that, state financing of a potential phase III study or something that you would like to share with us? Can you elaborate just a little bit more also on the upcoming news flow from the COVID vaccine. Sure. First of all, I think it should be clear by now that Bavarian Nordic, they have the exclusive license to the COVID-19 vaccine product. In essence, they are committed to developing this onwards and will continue to seek funding. What they convey is, of course, something that is ExpreS2ion Biotechnologies support. In essence, Bavarian Nordic, they're doing the job, and I trust they will get the funding in place for this. We have a question about the pipeline. Have you any consideration of adding on more projects to the pipeline going forward? We have a vision of being a leader within oncology and infectious diseases. There are many unmet needs within these areas, and we have the technologies to address a unique vaccine within this field. If the right opportunity comes up, then for sure we would be interested in looking at this in detail. I'm sure we can contribute in such an opportunity and gain even further value by potentially expanding our pipeline. We're constantly working within our business development to look at various opportunities. That's the name of the game here in this line of business. Of course, we have to focus on the pipeline projects that we have, but we're always open to discuss other projects and collaborations which fit with our pipeline focus. Thank you. With respect to the breast cancer vaccine, will you need additional financial resources to progress this project, or how do you see that? For the time being, we are well-funded. That was the whole purpose with the cash raising transaction that we did in the autumn 2020. We are well-funded and can progress the breast cancer vaccine project into the 1st clinical stage in early 2023. That's the aim. We are fine on the financing with respect to that project. Another question regarding the phase III study of the COVID-19 vaccine. Are you aware of whether part of the phase III study will be in Denmark? I don't know the plans of Bavarian Nordic with respect to the design of the phase III of the locations of the phase III trial. Okay. There also is a question regarding the COVID-19, that if you choose to test it, whether you see if they will test it as a booster? Is that also something that we should address to Bavarian Nordic? That's been conveyed from Bavarian that it would have a product profile as a booster vaccine. Again, yes, Bavarian Nordic, they are really the best to answer these questions, I think. Of course, I have a constant dialogue with our partners there at Bavarian Nordic. I think Bavarian Nordic, they should handle the communication on this themselves. Okay. There is a question also again regarding the COVID-19 vaccine, and the question is how a positive outcome of the study will affect your work with your breast cancer vaccine? The good thing about the COVID-19 project and the fact that it's been so accelerated, we're already at a clinical stage with this project, is that it uses both the technologies that we also use in the breast cancer vaccine candidate, meaning that we produce the SARS-CoV-2 antigens and decorate them on the surface on the VLP. That principle is exactly the same that we use in the breast cancer vaccine, where we make the HER2 antigens in the ExpreS2 VLP's production system and decorate them on the VLP. It's great that COVID-19 progresses along clinically and regulatory-wise, not least. That will be a benefit for the HER2 project, no doubt about it. There's some rumors out of the Netherlands that some of your test persons have developed a large number of antigens, even being exposed to only smaller doses of your COVID-19 vaccine. Is this something that you can tell us a little bit more about? I can't comment on the ongoing trial at the moment, except that it's running as planned, and we have conveyed that we will provide the data when we have the full outcome of the study in July. By then we have run the study through all 42 healthy volunteers in all the study groups. Then it will be exciting to get the full overview of the study outcome. We're looking forward to that, of course. Okay. There's a question also with respect to ExpreS2ion will be listed in the MSCI index in the near future. What do you expect from this? Keith, perhaps that's a question you can address. I can, but I want to say upfront that we don't have any clear expectations there. Just the understanding that when a company is added to an index, then the managers of index products will typically allocate part of their portfolio to that company. Perhaps we could see additional investment associated with that. You'd have to ask MSCI and the index providers for more information about the timing and scale of that. Thank you. Also maybe a question for Keith. When do you expect to have a profit or a positive figure? I think the question is when you expect to be cash flow positive. Sure. I think our investors know that we are a biotech company, and as such, we make significant capital investments early in the development process and throughout the development process. Doing clinical trials is not an inexpensive process. It could be some time until we are cash flow positive. However, depending on how things go with the COVID-19 vaccine, that can accelerate it dramatically. Another question also goes to the COVID-19 vaccines, and it goes like, "Since Bavarian Nordic handles the commercial part of the COVID-19 vaccine, how do you benefit financially? Well, there's a licensing agreement between AdaptVac and Bavarian Nordic that provides some milestone payments and royalties to AdaptVac. AdaptVac and ExpreS2ion also has a licensing agreement because ExpreS2ion's S2 technology is in the final product. There's a channel of proceeds from the Nordic that will pay royalties to AdaptVac, which will then pay royalties to ExpreS2ion, actually. We have conveyed that the royalties in these licensing agreements can be in the two-digit percentage level. Bent, can you remind us how is ExpreS2ion's ownership in relation to the vaccines? Of course, that's important to state as well. On top of this, we own 34% of AdaptVac. In addition to the proceeds through these licensing agreements, there's also a 34% ownership of AdaptVac. That's a very nice value object there. Maybe perhaps as a final question, looking forward to the rest of 2021, what is it that you encourage investors to look for at your company? It will, of course, be extremely exciting to see the clinical data coming out of the COVID-19 vaccine trial, both here in July and also the subsequent clinical trials. Furthermore, on the HER2 project, the breast cancer vaccine project, we expect proof of concept in animals by the end of the year. A very important milestone also for the company as we proceed with this project. Those are the two primary goals here this year. Of course, we progress on our influenza and malaria projects as well. We expect a continued journey that is very exciting over the year. Okay. I think let that with the exciting news flow coming up be the last question because time flies, and we have to cut off for today. I'll say thank you to both Keith and Bent for joining us and answer all the questions and for the presentation of the Q1 results. Thank you, both of you. Thank you very much. Yeah. Thank you.
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