Welcome to this digital event with BioPorto. Following the announcement earlier today that they are going to raise some capital. My name is Henrik Ekman. I'm Equity Analyst here at Saxo Bank Capital. With me today is Tony Pare, CEO from BioPorto, and CFO, Neil Goldman. Before we start, the format is as always will be a introduction from the company. They will go through some slides describing the conditions for the rights issue. After that, we will take some questions. Feel free to forward your questions, and I will do my best to forward them to the management. With that, I will give the word to you, Tony Pare. Welcome.
Okay. Thank you, Henrik, and good afternoon to everyone that's online. I am Tony Pare. I'm the CEO of BioPorto. I am joined by Neil Goldman, our CFO. Both Neil and I joined BioPorto almost four months ago after being presented with this very exciting opportunity to get a very impactful diagnostic tool into the hands of clinicians. I'm actually joining this presentation from a hotel room at the AKI CRRT conference in San Diego, and Neil is at our headquarters in Copenhagen. In attending this conference and meeting with clinicians that are influencing the diagnosis and treatment of the acute kidney injury, I'm more excited now than when I started the company that BioPorto can make a big difference.
As announced earlier today, we have started a rights offering for new shares in BioPorto to raise between DKK 74 million and DKK 100 million. The capital will be used to fund working capital and ensure that we complete our clinical trials and FDA submissions and invest into our systems and commercialization so that we can quickly drive market adoption once the approval is granted. Let's take a quick view of the company. If we could change the slide, please, to the number four. Okay. BioPorto is an in vitro diagnostics company that has a diverse antibody library at its core.
Antibodies are developed into reagents that can bind to whatever protein you target, and we have multiple methodologies to perform this binding and identification. Our flagship product and the focus of the capital that we are raising in the immediate future is a very specific biomarker called the NGAL test. NGAL is a protein that is expressed when injury occurs to your kidney. To diagnose this kidney injury called acute kidney injury, AKI, the standard of care is to measure serum creatinine in urine, which lags the expression of NGAL as a biomarker by several hours or days, and often after a timeframe where a good interventional therapy could have been applied, like renal replacement therapy.
When your kidney is injured, you have to act fast, otherwise dialysis might be required and the chance for morbidity and mortality increases. Early detection of NGAL levels help prevent these events and that's what you know that's why we're excited about joining this company. If we change the slide, please. We've had the two big changes in leadership at BioPorto with the addition of Neil and myself. I have led medical device and diagnostic organizations for over 25 years. I've also executed on several acquisitions, and I have an eye for companies with significant potential, and I definitely see this with BioPorto.
The other important thing to note in my background is I've successfully led companies through regulatory approval and product launch of several FDA-cleared and CE mark devices. I'm a commercial-oriented leader, and you know, have a lot of familiarity with getting new products, new diagnostics onto the market. With that, I'll let Neil introduce himself very quickly and talk about the terms that we announced today.
Thanks, Tony, and good afternoon, everyone. Thank you for joining us. As Tony said, we just joined BioPorto about four months ago. I come here after spending four years at a Nasdaq-listed diagnostics company called Chembio Diagnostics, where we launched a number of products in the US with FDA approval and elsewhere around the world. I come here along with having many, many years with global manufacturing companies. Early on, I started my career at Ernst & Young for many years there as a CPA. The common theme through all of that has been companies that have been rapidly growing, and certainly that's what we look forward to doing here at BioPorto. If you wanna advance to the next slide, please. I'll give just a very brief overview of the offering structure. Don't worry, I will not be reading this entire slide.
Many of the details are in the press release announcements that we issued today and certainly along with the prospectus, which we do encourage you to read. Just in summary fashion, this is a preemptive rights offering, which means it's going to existing shareholders, and that's an offering of up to 66.9 million new shares with gross proceeds of up to a little over DKK 100 million. If it were fully subscribed, that would result in net proceeds of about DKK 93.3 million. The subscription price is DKK 1.50 per share, and the ratio is four to one. Which means for every share that you hold as of the record date, you'll receive one subscription right and four subscription rights plus DKK 1.50 will provide one new share in the company.
You can see the dates listed there for the record date of March 10th, the rights trading period from March 9th to the 22nd, and the subscription period from March 11th to the 24th. We expect to announce the outcome of the offering on March 28th. Tony talked about the use of proceeds. With that, I'll turn it back to Tony.
All right. Thank you. Advance one more, Henrik. Okay. My focus and Neil's focus over the last four months has been to review, revise, and communicate our strategy internally and externally on a consistent basis. Our strategy is simple, as you know, the best strategies are, especially with a company our size, and it's as much as about what you're not gonna do as about what you are going to do. As we look at this year and into next year, we will have a very high level of focus to launch the NGAL test in the U.S. That is not to say that we will shut down or expand other existing revenue streams, but to continue a pipeline of new, and continue a pipeline with new product potentials.
It does mean that those other activities will never take priority over the focus of launching NGAL, taking it through the FDA approval and launching NGAL. There's a lot more detail behind what is listed here, but let me focus on the three pillars of our strategy. First pillar is exactly what I just talked about, drive NGAL test market adoption, which is you know, our big first step is to get the approval from the FDA. In the meantime, you know, we can generate NGAL awareness by promoting its use to the rest of the world through our distributor network. We will focus on providing them the education and tools to do this effectively, while recruiting KOLs to promote on our behalf. One of the reasons that I'm here in San Diego at this conference.
As we get closer to launch, and we get a sense of likelihood and timing of clearance, we'll invest in the U.S. commercial team and you know, basically, pre-market to key target accounts. Our second pillar is to strengthen the company, to scale and execute. This means getting our quality and documentation systems so that they are FDA audit ready. It also means investments into core business operations and financing the company, which we have started today. Our third and very important pillar is to attract, develop, and retain the best and brightest employees aligned with our values. As we build our team, we need to recruit the very best. As you may know, COVID has driven a lot of employee turnover in businesses globally.
Employees are more selective than ever on where they will be employed. Our goal is to have BioPorto be the company that they are motivated to hire onto and to stay with. If we can move that down. A little bit about our regulatory strategy. When you submit for an FDA clearance to market a product, you have to be very specific on your indication for use. The IFU means the indication for use means what patients are you gonna target with the diagnostic test? What is the intent of the test? And what devices are you gonna run the diagnostic? Our first submission will be to assess acute kidney injury, AKI, in pediatric patients in the ICU. This is based on the direct advice that we received from the FDA.
In fact, the FDA provided us with a breakthrough designation on our submission. What this means is that we get a priority review once we perform the submission. The FDA basically outlines step by step what we have to do to get a successful submission, and we are basically making sure that all those T's are crossed and I's are dotted, you know, following those steps very succinctly. Once we submit, well, let me take a step back. Our goal is to complete our clinical trial, which basically will be done, we believe, in the first half of this year. We can complete the package, the submission package, and actually get it to the FDA.
Once you submit it to the FDA, the time clock starts. It's basically 150 days for the FDA to respond to us in one fashion or another. We would love for them to provide us an approval right off the bat. That's not necessarily you know the standard. Most of the times they do come back with questions or ask for additional data. When they do that, the clock stops, right? The actual approval process can take some time. If we change to the next slide. Acute kidney injury is a big issue.
It's usually brought on by another sickness or disease state, like recovering from cardiac surgery, sepsis, administration of drugs that are harmful to the kidney, nephrotoxins, the use of ventilators, and of course, the most recently, COVID has brought on a significant occurrence of AKI. It can affect one in four hospitalized pediatric patients and one in five adults. It increases the chance for mortality for critical care patients by 25%. In terms of our enrollment, as I just discussed, we you know we're in line to get the enrollment done for the first half of 2022. We're on track for that. It'll allow us to submit for FDA approval after the data has been analyzed and packaged. If we go to the next slide.
As I just described, there's a lot of patients that get AKIs. As such, the opportunity is significant. We estimate the market opportunity for the NGAL test to be about $3 billion, of which, you know, $1.2 billion comes from the U.S. This is not a small market opportunity. This affects a lot of patients. If we go to the next slide. Obviously, at this point in time with this offering, we are approaching the Danish capital markets. Historically, the company has had very good success and support from these investors. Our intention, however, and when the timing is right, for us as a company and of course the capital markets, is to raise money from other capital markets.
That could occur, you know, as early as Q4 this next year or going into next year. With this raise that we are doing today, we anticipate that we will be well-funded, you know, for the next 12 months. You know, we will look at other markets when we go to raise money. Again, like I said, when the timing is right, not only from a capital market standpoint, but from a where we are in the FDA submission process and what do we anticipate in terms of getting our approvals. With that, I'm gonna turn it back to Neil to talk about the transaction.
Great. Thanks, Tony. This is really a slide to illustrate what I talked about earlier for how the preemptive rights will work. Preemptive, of course, means that current shareholders get the, if you will, first dibs because they will receive the rights from the company. Those rights are tradable on Nasdaq Copenhagen, so they can be both sold and purchased, of course. As I said earlier, holders of existing shares will each receive one preemptive right for each share that they hold, and that with a conversion ratio of four to one, if, for example, as you can see in the chart on the bottom, if you hold 40 shares, you'll also receive 40 rights, and together with DKK 1.50 per share, you would get 10 new shares in with the offering.
That's something you handle through your local bank. That's who you wanna coordinate with to undertake these. Next slide, please. Here's, again, a summary of the important dates with the rights issue. These are all listed in the releases as well as the prospectus that went out today. I guess the takeaway from this is, this is something that is gonna be completed over the next few weeks, and we sincerely appreciate our shareholders' support in this undertaking for the important next steps for the business. Of course, there's a wide range of risk factors, again, outlined in a prospectus as well as here, which we encourage you to read.
Okay. I think that is the end of our formal presentation, Henrik, and we are ready and willing to take questions.
Yes. Okay. Well, thank you very much, Tony and Neil. Of course, it's on a relatively short notice from when the announcement was made and until this meeting. Just to let the audience know and those who look at the event later on, there will be other events following this one in the coming weeks. Now I was just as a start, in the latest report, it was mentioned that there was actually a prolonged period of cash in the company. Now, you still need to raise capital or you feel it's necessary to raise capital.
Also the market timing, as the S&P Biotech Index is down 25% this year and risk is massively off, especially towards biotech and life science company. What has been your considerations in that regard, both to the need for capital and for the market timing perspective?
Yeah. I'll start with that, Henrik, thanks and for the question, and I'll pass it over to Tony if he has anything he wants to add. It's actually really straightforward, and it's everything we've been talking about. Our priority is to sustain the momentum in the business on the submission process for the NGAL test, sustain the momentum for the submission of the NGAL test. With this offering, we're doing exactly that. The markets are volatile, and I think we all understand well that it reflects a very sad situation in Europe. The board's decision in terms of how and when to proceed with this offering reflects our collective belief in the business, and that's why we're proceeding now.
There could also be the consideration I know from some investors suggesting that why not wait for the NGAL test studies until the data to be official. Perhaps that is a better time to raise capital. What has been your consideration as to wait for these data?
Well, the answer is a great question, and timing is always a very, very important consideration with these in every situation. As you saw from the chart with the series of bars going across related to timing, we need to be in a position to execute on the strategy to complete the clinical trials. Yeah, thank you. That's exactly it. To complete the clinical trials, analyze the data collection, compile the results, and submit them to the FDA. The time to do that with where our balance sheet ended the year and where we continue to now is we believe now is the best time to go do that and be well-positioned. No one has a crystal ball and knows exactly what the future will bring.
What we know is that the shareholders who've put their faith in this business in the past, and we hope to as we go forward and approach the finish line and then the launching point for this product in the U.S., will be there in support of our ability to go do exactly that.
If we take this slide, Neil or Tony, for that matter, the bar for the compiling of the results is very narrow. Is that? Does that reflect that as soon as the enrollment has been finished, the collection of data and the analyzing of the data and the submission to FDA will be very swift and almost only take a month or so? Or how should we interpret this way that it's illustrated?
Yeah. We know exactly what the FDA wants, right? And it's really all about getting the data that they require and then, you know, putting it into a package. They also require analytical data, right, to make sure that our instrument accurately measures NGAL. They require us to have the set of technical files that's required to, you know, support a medical device, a medical diagnostic. A lot of that activity can be done in advance, and obviously, we are doing that, right? We are not taking a serial fashion to this. We're trying to do as much in parallel as possible, so that once we have that final data, that final adjudication, it's a matter of a couple of months, a month to two months, to actually perform the submission.
You know, that's why it reflects such a short time. It's just a lot of preparation in advance coming into this timeframe.
Taking this illustration into account, it looks as if the latter part of 2023 or in the beginning of 2024. How should we interpret that?
The chart is intentionally somewhat fluid in terms of where they line up. They are not vertical lines. That's intentional. There are things that we can control, and there are things that we can't control. Of course, many of those are outlined in the prospectus, and you've certainly heard us talk about those as well. For example, we can't control how patients come and show up in the ICU and the ER, who could be potential candidates for the trial. What we can control is to make sure that the clinicians at the 15 leading hospitals across the United States with whom we are working are there ready to enroll them in the trial so we can use that information to advance precisely what we're trying to do here.
Once we get through that, our team will very critically evaluate that information. While we're not putting a specific timeline for how that's gonna work, you can rest assured that we're all of us aligned to get that in, but to get it done right.
I guess it's also intentional that the U.S. Nasdaq listing is also not associated with any timeframe. How can you comment on that, the potential U.S. listing?
Yeah. I think we have to drive some, you know, some more value in the business, right? The way we drive more value is by getting the clinical trials done and actually performing the submissions. Then at that point in time, I think we will be in a very good position. We will have taken some more risk out of the business, right? I mean, all businesses have risk, but we'll take and we'll be able to take more risk out of the business, and I think that'll invite a, you know, different types of shareholders once we get to that particular point.
Okay. As far as you can see, of course, it's impossible to guess so long in advance. Still, do you expect the current raising of capital to be sufficient to bring you to that potential point of a dual listing, which would, I guess, be accompanied by also some raising capital at that point? Is that sufficient, the current raise of capital announced today?
Yeah. Let me answer it a little bit more precisely, and that is in the prospectus, we make it very clear that this equity offering, this rights offering, will allow the company to run for another 12 months beyond the prospectus date, which of course is today. As for when and how we go about undertaking, whether it's a targeted cross-border offering and/or a dual listing or listing in Nasdaq, how that comes together, we're gonna be working on that to make sure that it's well-positioned to drive shareholder value and increase value in the company, as Tony said.
Okay. Let's go back to the usage of the proceeds or the likely usage. There's this mentioning of general corporate purposes. What is that? What is it that needs to be built now that you've been there for four months? What have you witnessed, and what have been your thoughts regarding this comment?
I mean, we have witnessed a strong team that we're adding to get this across the finish line, right? There were some vacancies that they needed to be filled, obviously. The one that you know, both Neil and I took, as well as some vacancies in our development organization that you know, we are still in the process of filling in our commercial organization as well. You know, there are investments that we need to make as we prepare to you know, get this approval and those investments in systems that you need to make you know, months in advance of approval, so that when you basically get the approval, you can hit the ground running.
We're starting to look at those systems like our quality systems and our production systems and so forth, to make sure that we are ready.
The good news is the people who are doing that have done it before.
Yes.
That's why they're here at BioPorto to do it again.
Okay. You're also mentioning these strategic priorities and in particular, the build-up of some sort of sales force in U.S., on condition on the approval of the NGAL test. Just to better understand, is this the start of build-up of the sales force, or is this the more or less the sales force needed to ramp for production and sales, if you get the approval?
Yeah. It'll be the start of a build of the sales force, right? You know, this is an area that I have a lot of experience in in terms of building a sales force at the right pace so that you're not you know, over-hiring when you shouldn't over-hire. It'll be the start of the build and that may start to occur at the end of 2022. Assuming we get approval early in 2023, you know, we'll start to ramp from that. The sales force is a combination of sales reps and what we call medical science liaisons that basically communicate the clinical value of the test.
Okay. Now, a few months ago, when we made a video of as an introduction to the two of you, and you were very explicit about speaking about the NGAL test being the focus of the company and for the both of you. You do have other businesses, a whole portfolio of businesses. You have the ELISA product, the antibody sales, and the gRAD technology platform. Any changes now that you've been there for four months, any changes as to how we should look at this portfolio from a portfolio perspective?
Yes. No changes in terms of the portfolio, right? We have antibody customers that we service today and will continue to service in the future, and the same thing with our ELISA kits. The only difference is that you know, the focus of our investments will be on the NGAL test, not necessarily growing the antibody business or the ELISA business. It's a good revenue stream, good cash flow. I think we have good products and, you know, we'll continue to service our customers and distributors with those products.
Yes. Exactly. As Tony said, this is about focus. It's about the allocation of resources in the areas that we've described as a matter of priorities, to get this product submitted, approved and hopefully launched in the U.S.
Okay. Time is running, so with that, I think we are more or less through. One last comment from you, Tony.
Yeah. Thank you for giving us the time this afternoon. As I indicated before, the more time that I spend with the company, and I think Neil can share the same sentiment that I get more and more excited about this business and the potential for this business. I appreciate our current shareholders and you know appreciate any new shareholders that want to invest in, I think, a company that's going to grow very, very well in the future.
Okay. Well, with that.
Thank you. I wanna thank you as well, Henrik. It occurs to me one last point is that the offering is about just nearly 75% subscribed with the support of our three largest shareholders, which includes Arbejdernes Landsbank, as well as other new institutional investors as guarantors.
Mm-hmm.
We appreciate that support and what it says about their belief in the business as Tony has described today as well.
As I understood, we should expect that the prospectus is available online from today?
Yes. It's on our website.
Okay.
That is correct. It's on our website.
Yeah. Okay. Good. With that, thank you very much. Thank you for the audience, and we will be hosting some more events in the coming weeks, I'm sure. Thank you for now.
Thank you.