Yes. Welcome to this event with ExpreS2ion Biotech. My name is Henrik Ekman, Equity Analyst from HC Andersen Capital. I'll be hosting this event. With me today is CEO from ExpreS2ion, Bent Frandsen, and CFO, Keith Alexander. Welcome to you both. We have talked about that we will do the format for today. Today's event will be that you will be speaking of the highlights for the second quarter and first half of the year, then after for about 15 or 20 minutes, afterwards we will take Q&A from the chat room. With that, welcome. The floor is yours. Thank you very much, Henrik, and thank you for inviting us to this event with HC Andersen Capital. First, the forward-looking statement disclaimer. I'll quickly move into a description of our company then highlight some of our achievements here in the second quarter before I hand over the mic to Keith. ExpreS2ion Biotechnologies, we are a leader in advanced protein sciences, we have a valuable pipeline which address a 45 billion EUR market. We produce complex proteins using our patented ExpreS2 technology. We've been doing that for more than 10 years, having had more than 100 clients and collaborators around the world. Our production technology has been very useful for making therapeutics, vaccines, and diagnostics. AdaptVac is a joint venture that we established in 2017, they have a virus-like particle technology. We own 34% of this joint venture, the combination of our ExpreS2 production technology and the vaccine technology, the VLP vaccine technology, make some really highly immunogenic and cost-effective vaccines and therapeutics. Now we have embarked on a new strategy since the beginning of 2020 with a pipeline of novel therapeutics and vaccines addressing high unmet needs and in a more than EUR 45 billion market. We have a nice revenue stream from our services business using our production technology of around SEK 15 million annually, and it's growing nicely. On top of this, we are listed, as it says, and we have experienced more than 12x increase in our share price since January 2020, which reflects the transition from a service-based to a more pipeline-driven business. Next slide, please. We have a broad clinical stage pipeline. Our two primary product candidates are our corona vaccine project, the first line, and the second line is our breast cancer vaccine candidate. During the second quarter, we have progressed on our coronavirus vaccine candidate. It has moved into the first clinical phase I, phase II trial, and we have actually just released the headline results from these trials last week. They are extremely exciting because this study shows that it's a very safe and highly effective coronavirus vaccine candidate. I'll speak more about this later. The breast cancer vaccine is a vaccine candidate we have in-licensed from AdaptVac, and it's 100% controlled by ExpreS2ion now, and we're progressing on our preclinical activities, and have done that very nicely also during the second quarter. Furthermore, we have development activities within influenza and in malaria. I should highlight here also in malaria, we have just here in July announced the initiation of another clinical trial in Tanzania, the first on-site malaria trial with this exciting malaria vaccine candidate. Next slide, please. As mentioned during the second quarter here, we have progressed with the coronavirus vaccine. We started the trial in March and announced the first safety data with the first 18 human test persons April 12th, and we have then finalized the testing in the 45 humans, and got the first results out here last week. They look really great. As I said, it's a safe and tolerable vaccine, and the efficacy shows high antibody titers, and more importantly, also high neutralization antibody levels, meaning that we can induce a long-term response and get efficacy that is durable as well as strong. This allows this particular vaccine to be either a strong standalone coronavirus vaccine or a booster vaccine, which is highly needed at the moment, of course. Secondly, within our breast cancer, as mentioned, we initiated this project in February and already selected a lead candidate in May and have progressed on establishing the proof-of-concept animal models that need to take place here in the autumn, and expect to dose the first mice here very soon. The aim is here to obtain proof of concept in animals around the year, and probably around January or February 2022. Furthermore, in influenza, we have also progressed on our work here. We have worked on a number of constructs within this consortium, EU-sponsored project. We are discussing within the consortium which candidate to continue with in in vivo studies later on this year. As mentioned, in malaria, we just got the news that we started a new clinical trial with the lead candidate here. Next slide, please. Just a word on our breast cancer vaccine efforts. It's an area which continues to have high unmet needs. More than 500,000 women die every year. We know that the currently available treatments have some drawbacks in terms of patients developing resistance to these monoclonal antibodies, and there's even risk of heart-related serious side effects. Also the administration and the dosing is very costly. All of these drawbacks we address with our vaccine-like approach. We are very thrilled that we have already proof of concept in animals with a previous version of this that was released in the "Nature" paper a couple of years ago. Now we have a novel lead candidate that we are using in this project, and are excited about continuing with this. Next slide, please. With respect to the COVID-19 project, I think it's important to address the economics about this. As described before, the project is actually licensed from our joint venture partner at AdaptVac to Bavarian Nordic. Bavarian Nordic, they hold a global exclusive commercialization license around this COVID-19 vaccine candidate. You can see to the left, the economics revolving this licensing deal. Now, ExpreS2ion owns 34% of AdaptVac, so that's obviously a very important value driver for ExpreS2ion here going forward. On top of this, we have a licensing deal with AdaptVac there, because there's also ExpreS2ion technology in the vaccine that's being tested. You can see that's some minor milestone payments, and also some royalties. By far, the 34% ownership of AdaptVac is quite important for us going forward. As we have just recently seen the headline result of the first clinical trial, and thereby minimizing some of the risk we've had in this project so far, this becomes very valuable for us naturally. Next slide, please. Sorry, I think you jumped one. Okay. That's it for my side. Sorry. Over to you, Keith. Sure. Thank you, Bent, and thank you, Henrik. Henrik, if you don't mind going back one slide, that'd be great. During the second quarter of 2021, we continued to invest in the preclinical development of ES2B-C001, our wholly-owned breast cancer vaccine candidate, and achieved the second highest level of quarterly revenues since our 2016 IPO on the Nasdaq First North Growth Market. This was partially driven by scale-up projects related to the COVID-19 vaccine candidate. Let us tell you a few key figures. Now, Henrik, do you mind going to the next slide? Here you can see a summary of the second quarter, along with comparisons to the second quarter of 2020, and similar comparisons for the first half of the year. Our quarterly operating income of SEK 4.8 million was the second highest since our 2016 IPO. Our operating loss of SEK 9.1 million was more than double that of the same period last year. We concluded the quarter with SEK 108 million in cash after raising SEK 39 million through a warrants subscription, which was 97.6% subscribed. We're looking forward to the next warrants subscription period, which will be from September 6th- 20th. Brochures will be sent to warrant holders shortly. Next slide. We'd like to focus on a few developments in the quarter. First, our operating income growth was driven by the combination of COVID-19 scale-up projects, royalty fees, and a diverse mix of CRO projects. Grant income was de minimis. Our operating loss of SEK 10.4 million was further driven by investments in the pipeline and changes to non-cash personnel cost accounting, which I'll go into more detail on, partially offset by a one-time dividend paid by AdaptVac. Cash increased by SEK 25 million to SEK 108 million, primarily reflecting the SEK 39 million raised in the TO4 warrants subscription. Moving to the group income statement on the next slide, 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 continue to be driven by investment in our pipeline business, and most notably, the preclinical development of ES2B-C001, which is our wholly owned breast cancer vaccine candidate. Our personnel costs have also increased. It's very important to note what is driving that increase. We have increased headcount, but the key driver is a change in the accounting treatment of incentive compensation. Most importantly, this is a non-cash charge. You can see it reversed on the cash flow statement in the line adjustments for items not included in the cash flow. Also of note, we received a one-time dividend from AdaptVac of SEK 463,000, which was reflected in result in jointly governed companies. Moving to the next slide. The final comment I'd like to make is about our research coverage and investor meetings. As the company grows, we have endeavored to expand our research coverage and broaden and diversify our investor marketing. Pareto Securities initiated sponsored coverage research of ExpreS2ion in June and raised its price target to SEK 66 per share after the publication of the headline phase I and II results for the ABNCoV2 COVID-19 vaccine candidate. More broadly, we've noted that there is significant investor dialogue occurring on a variety of social media platforms. We have been participating in various conferences, including the LifeSci conference in June, and we'll be present at several conferences in September. We encourage you to meet us there and learn more about ExpreS2ion. 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. Yes, just to finalize with some outlook comments. You can see our pipeline here. With respect to coronavirus, of course, having more or less completed the first phase I, phase II trial within ExpreS2ion and the PREVENT-nCoV consortium, we are now handing over this project to Bavarian Nordic, who will develop this onwards. They have already filed a clinical trial application with the German authorities for initiating a phase II study in 210 people, and have communicated that this will start already very, very soon, perhaps here in August. Furthermore, with respect to a phase III trial, they continue to look for funding and, as far as we know, are in discussions with a range of all types of relevant funding opportunities. Hopefully, all this will lead that into the vaccine becoming available here later in 2022. With respect to the breast cancer vaccine project, as I said, we have continued on the preclinical activities. We will work closely on this in the autumn with the aim of getting the first proof of concept animal data early next year. That will enable us to continue on production scale-up during 2022 and clinical preparations, with the aim of filing the first clinical trial application before the end of 2022 and starting the clinical trial in early 2023. Afterwards, we expect to be much active in the partnering with respects to ongoing development on this opportunity. With influenza, we continue to work on the various constructs within the INDIGO consortium. On malaria, as I just said, we have the first clinical trial with the new construct, with the new novel adjuvant, starting in Africa here this year. The headline results of that will come in 2023. That's how it looks at the moment. Based on this, we are available here for another 15 minutes for a round of Q&A. Yes. Thank you for that, Bent, and thank you for that, Keith. Yes, there's already coming in a lot of questions from the audience. If you take the bigger picture, there's one concerning as the short-term focus is to fund the progressing pipeline. On a longer-term basis, when do we actually expect this development to result in a positive profit outlook? When will the company be profitable? What's the longer-term picture here? Sure. That is, of course, related to our pipeline projects. Within the coronavirus, if that is successful during 2022, some of the proceeds getting into AdaptVac will naturally also spill over to ExpreS2ion due to our 34% ownership of that joint venture. That's really a near-term potential cash flow coming there. As I've said earlier, we have actually not really calculated with this income, but having the first clinical phase I/II trial announced here last week that looks so good, we see a better likelihood of that revenue stream coming in a year's time. With the breast cancer, as I said, we need to do our homework. Right now it's in a preclinical stage, and we want those proof of concept data to be good, which I'm sure they will be, but we'll see. We'll progress on this and getting this into a clinical phase I in 2023. Then when in the clinical stage, we'll request partnering discussions, not necessarily to do a co-development deal before the end of the phase I trial or even before the end of a phase II trial, but we need to start promoting that this is a fantastic breast cancer vaccine opportunity. You mentioned in the statement that the corona vaccine will ultimately either be a vaccine on its own or a booster vaccine. What's the difference from a regulatory timeline, financial perspective of this? That's a good question. Some of these questions related to this vaccine going onwards, I would like Bavarian Nordic also to comment on those. It's exclusively their product now, and all the interaction with regulatory authorities are now being handled by Bavarian Nordic going forward. When we say it's a standalone or a booster vaccine, that's definitely also Bavarian Nordic's communicated strategy around this. There is, as far as I understand, a question from the audience regarding the VLP substance from a competitor that has reported 10x the effectivity on their update. How is that different from this substance, from Medicago's VLP substance? We reported last week a 12-fold. Yeah. a 12x higher level of neutralizing antibodies compared with human convalescent sera from infected COVID-19 patients. That's better. On top of this, our VLP approach, as we've seen, it's a very, very stable vaccine, and it can be handled in up to +49 degrees Celsius temperature. Administering this in storage and transportation-wise, a lot of advantages there. The VLP itself is based on a bacteriophage molecular structure, and the antigens that we have been making are in ExpreS2ion's insect cells here for this vaccine candidate. As far as I know, Medicago's vaccine is based on some plant-based technology. From scientific literature, at least we know that in terms of stability, it's not easy to assemble proteins based on plant-based technologies. That's the only thing I can comment on. The preliminary data from last week suggested that it also has a good effect relating to the Delta virus. Will you provide further, more complete data on this, the effect on, or what can you say about it? Yes. Actually, the analysis of neutralizing data is not a trivial matter because we need secure laboratories, and it takes time. That's why we said we will detail the complete neutralization data here before the end of the year, when we actually also have the full analysis done. The headline results are based on some of the data we have so far, and they look good. We have no reason to believe that anything should change based on this. That's the clear communication we have from our science people in this project. Okay. Yes. The mentioning in the financial part of the report is that there has been a major change in revenue mix, because COVID is now reducing or is not affecting your revenue as much. Is it back to a normal now that you can meet clients and have further revenue from clients instead of just grants? Sure. Maybe both Keith and I can comment. Keith, if you'd like to start with how the mix looks of the top line. Yeah, sure. I'm happy to do that. Henrik, just as you mentioned, the mix has changed drastically, but it's a reversal of the mix shift we saw last year where most of the revenues went from CRO business to grant-driven revenues. A lot of that was driven by, one, people couldn't travel anymore, so the ability to do sales of the CRO business were impacted. Two, we had very big success in raising grant revenue for the COVID vaccine and other vaccines we're working on. Now our grant revenue from the COVID vaccine has been fully earned, so we don't expect to have any more of that. We're seeing an uptick in our CRO business as we have some time to work on that outside of the pipeline development efforts. Bent, do you want to take it from there? Sure. We can see here in the first half, we also have some revenue that is actually driven from the Bavarian Nordic and AdaptVac because we have been asked to do some additional protein work on the project, which was outside the scope of the PREVENT-nCoV grant project. That's of course nice that we can even invoice some of that work in that respect. The pipeline regarding the malaria projects, the market potential, how can you elaborate on that? It differs when you talk to experts, it differs a lot. What can you say? It's an area, of course, which first of all, the disease takes place in Africa primarily, and there's been various assessments of the market potential. When it says EUR 0.4 billion here, it's actually based on old data from Boston Consulting Group, which assessed the market value to be of this size. I'm pleased that the technologies that we work with actually allow for a potentially very cheap vaccine, and that means that we have a place in the market to address the disease in these markets which are based on more poorer countries. Okay. There is, of course, since you reduced the ownership of AdaptVac, there is, of course, question relating to the joint venture in that regard. What can you say about the overall longer-term relationship in terms of how we should see the cooperation with AdaptVac going forward? Well, it's been a very nice collaboration since the establishment, and we are very thrilled that we have been allowed to in-license the breast cancer vaccine project from the scientists who invented the VLP technology and are part of the ownership in the 66% owned NextGen Vaccines. The divestment from 50%- 36% was based on the in-licensing of the breast cancer vaccine candidate. We cannot say for sure that anything like that should happen if there's a new candidate coming from AdaptVac's internal efforts that they can see that ExpreS2ion could be a licensee to. So far, it's 34% and we are very happy with that. As we can hear, you are very thrilled with the preliminary results from the COVID-19 vaccine study last week. The market doesn't seem to agree. What are your thoughts about the adaption or the assessment of the news? I understand from you that you think these results are as good as they could get, and that was why you actually made the announcement. What are your thoughts on the market direction, if any? Absolutely. It's super thrilling with the data, and we really believe that there's a marketplace here for Bavarian Nordic with this exciting vaccine candidate, for sure. Pareto has issued a report saying a share price of DKK 66, and I'm not really the one to comment on share prices. That would not really be prudent. Of course, I think we have de-risked the COVID-19 vaccine project somewhat with this nice data. That's for sure. That's my comment to this. Of course. You touched upon the funding timeline in terms of the ONE program probably being accepted in September. Keith, trying to take us through the sort of the longer-term funding structure. I know this is very much also part of Bavarian's decisions to do things. Can you still sort of take us more detail through the timeline of the funding structure after this ONE program? Sure. I can touch briefly, but there's not much that I can actually say about that. Our fundraising plans are private until they become public. I would just say that we are a biotech company that is using cash, and at some point, we will want to raise more capital. It makes sense to time capital raises with times when the market is open. We're watching that closely. We talk to our advisors, and when the timing is right, we'll proceed as we need to. Okay. Thank you. Bent Frandsen and Keith Alexander, thank you for taking this time to discuss your latest results. We will speak to you soon and hear more from you soon when there are more results to be published. Thank you so much for this. Thank you, Henrik. Yeah. Thank you all.
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