Welcome, welcome to today's event featuring SoftOx Solutions. We are pleased to have upcoming Chairman Ulrik Spork, upcoming CEO Thomas Bjarnsholt, and upcoming CFO Ingrid Juven with us. They will provide a market update in connection with the ongoing rights issue, rights issue. This session, this session will begin with a slide presentation by the upcoming management team, and following the presentation, we will open the floor for a live Q&A session. So if you have any questions during the event, please feel free to submit them on the SoftOx Solutions profile at investorweb.no. So you can go to investorweb.no, search for SoftOx Solutions profile, and submit questions there.
If you submit your questions through Facebook or any Facebook group or Facebook pages, you have to submit them on investorweb.no for us in order to answer them. And by that, I give the word to Chairman Ulrik Spork.
Hello, everyone, thanks for listening in. As you just heard, my name is Ulrik Spork. I'm a Danish national. I actually understand Norwegian very well, but we agreed that I would address you in English. I hope everyone can follow that. Later on, we come to questions. I'm happy to answer them, even if you post them in Norwegian. But anyway, I'm pleased to be presenting this. I've been asked to get involved in this discussion ahead of me entering as chairman by the end of the month, when the issue is concluded. The plan is on the request of the current shareholders, that I will step into the chairman role of the company.
And what we prepared today is a slide that gives you highlights of what is the focus that we would take, a bit about our background, and a chance for you to say, what will our focus be, how will we conduct our business, once we step formally into position? So, if we advance one slide... There was two, but there's a disclaimer first. So, and which I will not go through, and I'm sure you're all happy about that. So, this slide gives you a picture of what will be the new management team in SoftOx. Going forward, we will be a much more, much smaller organization, much more focused organization.
And I've been asked to speak a little bit about my own background, and why I'm here and why I think this is a really fascinating and interesting story. By education, I have engineering background. I have a master's degree from the Technical University in Copenhagen, and I also have a business degree, also from Copenhagen. I spent my entire professional career in the life sciences industry. I ended up being more than 25 years in the Novo Group of companies, and I was involved in corporate business development, venture capital, and private equity investments. I have been doing deals and raising capital and deploying venture capital and private equity into emerging life science companies, almost throughout my career.
Last 10 years, I've acted as a professional board member, chairing boards, advising companies, and sitting on boards. And in total, I think I've been in more than 30 sort of emerging companies in the U.S. and Canada, France, U.K., Sweden, Denmark. This will be my first Norwegian company, and I look forward to be part of that. So, what I bring with me is sort of an understanding of how you advance especially pre-revenue companies, which is certainly in the current funding climate challenging to raise capital. So it's really important that you have a focus on the next value inflection point, sort of where you have created value to allow you to either raise additional capital or seek partners to help you advance your technology.
So that's a bit of my background. I'm new to SoftOx. I didn't know of the technology before, but a colleague of Thomas actually reached out to me a couple of months ago, and introduced me to the technology, and I find that the platform technology really has interesting potential. Eventually, it is deployed in many different aspects. But I think the current focus that we will talk more about, I think is particularly relevant, and I think the company has come to a point where we need to focus very narrowly on that, and I'll come back to a bit about that.
So, talking about Thomas, we have a common acquaintance that introduced me, and Thomas will be the incoming CEO in the company. Thomas, perhaps a few words about yourself before we advance. You're muted, Thomas.
Yeah, sorry. Yes. Thank you, Ulrik. My name is Thomas Bjarnsholt, and, in Denmark, I'm a professor at University of Copenhagen and also at the Copenhagen University Hospital, Rigshospitalet. I have, an engineering background as Ulrik, and I'm also a doctor of medicine from University of Copenhagen. I spent the last 15-20 years on understanding, especially-
... difficult to treat bacterial infections in airways, but also in wounds. And due to the wounds, I was involved with SoftOx as a consultant around seven years ago, but two years ago, I became the Chief Scientific Officer of SoftOx. I have primarily driven the inhalation arm of SoftOx, how to inhale the solution and what to do about it, conducting all the preclinical trials leading up to the Phase II trial that we are raising money for in the next round of financing rounds. I initiated the project in the beginning of the COVID pandemic and I know very well how the product behaves and the pitfalls of it.
But also I have a great confidence that if we can show a proof of concept in this model that we present, we also can have great future of the company. Thank you.
Okay. Part of the team as well is Ingrid. I'm very pleased that Ingrid is joining us. I think it's essential we, with two new individuals in the management team, Thomas and myself, we will also have additional new members coming into the board. So it's essential that we have Ingrid, who's also part of the past in a transition role. Perhaps, Ingrid, you can speak a little bit to your own background. You're muted as well, I think. No, now it's...
It's Ingrid Juven. Can you hear me?
Yes.
Yeah, probably something with the picture. I don't know. Okay, try again. My name is Ingrid Juven. I'm acting as the CFO in the company right now. I have a background, educationally, I have a Master of Business Administration degree and has over 25 years' experience from management consulting, project management, restructuring, finance processes, and so on. I've been responsible for the finance area since the restructuring of the company started in 2023, February approximately. So that was a short introduction.
Very good. So let's, let's move on. So, in the course of the last few months, the company have prepared a refocusing, and, and basically a restructuring. There's a lot of efforts that went on in the spring of rearranging past debt. And this is some of the pillars that the future will be built on. So the focus strategy that we will be implementing will be a very narrow focus on a single area in the inhalation space. A technology that I believe has really strong merit, as Thomas just said. And we have found an indication, and a way to do that, that means we can get to a very meaningful value inflection point with a reasonably reduced budget.
We'll come back to that. So financial restructuring and cost reduction sounds boring, but it's totally essential in the current market condition and also where the company is. So we will be having a very tight ship, and we have a very strong focus on activities and cost preservation and cash preservation. And basically, of course, we are a company, but we will be more like a project. So we have a project team. We will conduct a clinical trial that really is a proof of concept trial to hopefully, with good success, prove that we can make a difference for patient with this particular challenge of pneumonia. So that will be the focus for what we would do.
Then we are bringing in competencies to supplement what is already installed in the company. So, professionalism sounds a little arrogant when you talk about yourself, but I think when some of the shareholders reached out to me, I think it was their assessment that I could bring some experience and some network and some past knowledge into this, and we will complement the team that you see today with additional competencies also in the board. So hopefully we can, around this project, have a lot of insight, and knowledge that we can deploy. So that really is the foundation that we will be working from. So if we go to the next slides, clearly, what is the investment case?
Clearly, at the current valuation level, we are at a level that is not attractive for those investors who have been with the company for long. But we really believe that there is an interesting future ahead. Once we have completed this rights issue, we will be able to pay back some positions of debt that is still valid in or actually in the company. We have and will continue to bring in competencies around the company. And as I said, we will have a very lean and project oriented organization.
We also have a runway, which is not far, but it will be enough, hopefully, for us to successfully raise capital for the VAP Phase II project that we will talk to you a little more about. But the highlights of that is that we are addressing a large unmet medical need. It has very high cost for hospitals, and those patients who are getting exposed to this problem has a very high mortality rate. They're quite sick to begin with, and when they get pneumonia on top of that, it really is a challenging situation. We believe that what Thomas have put together is really a very well-defined clinical development plan that first of all builds on very strong data from what we have learned already.
Thomas has been intimately involved in all the activities associated with this indication, and we have a very solid basis for this. We also have a very well-defined mode of action, which I think we can claim gives us hope of having a high probability of success. When you do clinical trial with real patients in real challenging situations, there's no guarantee of where it'll come out, but I think we certainly have moved ourselves in a position where I think we have a good chance of being successful based on what we've seen and the way that we designed this.
So I really believe that once we can get these results, we get to a very tangible value inflection point, a point where we clearly have proved that we have a valuable technology, and we can do it in a sort of pharmaceutical settings with rather modest funding. We come back to that, but it's NOK 60-80 million that we need to run this study over the next two and a half years. Once we have the results, the overall plan is to target industrial partnerships, and find partners who can help us take the product further on and onto the market, and those data should be available in early 2027. So that basically is the plan that we intend to pursue.
If we go to the next slide, in terms of the cooperation today, I think those of you who've been with the company for long, which I haven't, but I tried to read up on that, there's been a number of different plans, and what I've committed to do and been asked to do is to focus on what is on the right-hand side of the slide. It really is the inhalation activities. We already have, and I think you're aware of that, there is a defense activity going on, which Thomas will talk a bit more to in a little while.
But again, the VAP opportunity, ventilator-associated pneumonia opportunity, which will be our main focus and which I just talked about, that will be the focus of our activities. That is where we will deploy our activities in the next six months, and once we raise the capital, we will go on and do the clinical trials going forward in a very focused project mindset kind of way. We also have some assets within the company in the skin and wound care area. They also have potential for value generation, but in the short term, we will be focusing on the other inhalation sides. There will be no current activity in the wound side, but once the opportunity arise, it, it, it...
The intent is to spin it out. It needs management, it needs funding to enable that, but I will make sure that our focus will primarily be on the inhalation sides, while we keep an open eye on what opportunities may arise for the skin and wound side. If we advance once more, this will be the segue for Thomas to tell us why ventilator-associated pneumonia is a relevant area. So, Thomas, on to you. Thomas, you're muted.
Sorry. I was so focused on talking. To keep SoftOx focused, as Ulrik was talking about, and to really, for the first time, generating a real proof of concept to show that our solution, the hypochlorous acid, has a antibacterial, antimicrobial effect in human beings, we need to perform a study which is easy, not too complicated, and cheap. That's why, together with the intensive care units in the university, Copenhagen University Hospital has chosen to focus on ventilator-associated pneumonia. It's a very severe type of pneumonia affecting patients who are admitted to the intensive care units. Currently, there's limited effective treatments, there's high mortality rates, but we, from our previous animal studies, we know that we can get the solution into the lungs of the patients.
We know that we can treat and kill the bacteria associated with these infections, and we have a very well-defined group of patients. So, yeah, and also we'll be working with very dedicated staff at the intensive care units in Copenhagen, which all not ensures, but raise the probability of success of this proof of concept study. When, hopefully, when we show that SoftOx can eradicate the bacteria in these ventilated patients and hopefully prevent some death of the patients and prevent extraordinarily long stays in hospitals, there will be also an economic benefit. One thing is that we can alleviate the patients, but there's also a large market potential. So I think it's a good case for a small company like SoftOx. Advance, please.
Yeah, and those of you who have been following, SoftOx, then you've also seen these slides that the infection happens when patients have, difficulties, breathing or are put in comas, then they're intubated and, artificially, ventilated. This tube, which is inserted into the, trachea and in the lungs of the patients, are prone to be, infected with bacteria. And when that happens, for some reason, antibiotics do not really work anymore. But we know that our solution work on bacteria in what we also term as biofilms, in these very, very difficult to treat settings of bacteria. So we have a very, focused, group of patients which are very prone to die from this, and we do not really have a treatment.
But we think, despite of this, we actually think that we will make a difference in these patients. Advance, please. Our project plan so far is, of course, SoftOx has been developing this technology. For the inhalation part of SoftOx, we have also conducted, performed all the right preclinical investigations and tests. We've conducted, I'll show a slide later, all the necessary toxicology, and also we've been in humans already. So we have shown that it is safe to inhale, and there's no immediate side effects. And we've also shown in animals and in vitro that there is a preclinical efficacy. What we really need is to show proof of concept and then, of course, take it to Phase III and possible market adoption. Advance, please.
In this slide, if you download the slide deck from the web, you can go into depth with this. But this is to show that all the necessary toxicology, all the necessary testing for being able to enter a Phase II human trial has been conducted. And advance, please. And as I said before, we also tested it in human beings. Actually, before we tested it in the real Phase I trial, I also tried it myself, and I'm still here, so that was pleasant. It wasn't unpleasant at all. But also our subjects that were exposed to this for 5 minutes, up to 4 x daily for 5 days, showed no adverse events, no serious adverse events.
And, it showed that there was a great tolerability, and also it was easy to use. And that also indicates that we're ready to go into sick patients. Advance, please. And this is to show that we have this pan-antimicrobial effect of SoftOx. It's not an antibiotic. It's not a classical antimicrobial agent. It will target any organic molecule. That is why we can inactivate virus, we can kill bacteria, we can kill fungi, we can basically kill all microorganisms. But it's also something that our body, our white blood cells makes themself. So our body is used to hypochlorous acid, the main component of SoftOx. So we can kill all the microbes, but we do not kill the patients in the concentrations that we're planning to use in the trials.
Advance, please. We tested it in several mouse models, and we can show that if you infect mice with a mouse strain of influenza, we can lower the amount of virus in the lungs of the mice. And if you take the next slide... Advance, please. Yeah. We also see that we can also prevent infections. So I think this is a quite cool experiment we conducted, where we infected one mouse, the black mouse, and then put this black mouse together with seven healthy mice, and then we saw if the virus would spread from the black mouse to the white mice. And if the mice were just treated with saltwater saline, then seven out of the eight mice actually became infected with the virus.
But if we treat it with the SoftOx solution, we could prevent 6 out of 8 mice from getting infected. So I think it's a really strong signal, even though it's preclinical, that our solution works in a real biological model. Advance, please. Our developmental plan is that we'll spend the next year or so, first of all, of course, to raise the capital needed for the Phase II trial, but also to prepare the trial. We need to submit the application to the medical authorities and also really carefully plan the trial. We will perform the trial together with a platform unit called InCEPT, incept.dk, you can look it up. And they are extremely experienced in conducting clinical trials in intensive care unit patients.
So far, the plan is to have the first patient treated by the end of 2025, and then the Phase II trial will run for 12-18 months. It's an adaptive trial design, so we also have a readout of data as we go along, which means also we can adapt the trial, but also we can potentially adapt it into also a Phase III trial if funding is available. Next slide, please. Yeah. And this slide is to show that there's a huge unmet need. There's 130,000 patients succumbing to ventilator-associated pneumonia in the E.U. and U.S. per year.
If you're admitted to the intensive care unit, there is a 10%-30% risk of developing VAP, and up to 50% of these will die from the infection. As I said in the beginning, antibiotics, the gold standard of treatment, is difficult to get to work, so the hospitals really need a new solution. We think we can give it to them, and that also means that the hospitals, if this works, if we show proof of concept, they will be eager to purchase this, and then there's, of course, a market potential. Advance, please. You also heard about our European Defence Fund project, which has been funded through the European Defence Fund.
SoftOx received approximately NOK 35 million, but the entire work package of the inhalation part of this COUNTERACT project was NOK 90 million. But SoftOx has not received more than NOK 35 million of these, and this we've been using and will be used until end of 2026, approximately, to update the solution, but also to prepare and partner up with CMOs, manufacturers of the drugs to be used in clinical trials. And also within the EDF project, we will do a second Phase I study. It will still be in healthy volunteers, but we aim to go somewhat higher than we did in our first project.
The EDF project is not a prerequisite for going into our Phase II trial, but it's an add-on, and there's great synergies between the two projects. Advance, please. This is also what we see here, that we still have the VAP timeline that we will go forward with, but the GMP production of the drug to be used in patients is being generated and produced and tested within the EDF, and we also do more preclinical work and optimization of the solution. Then, of course, we make this Phase II, Phase one B, and the Phase II in VAP and the Phase one B within EDF. Both, if successful, will open doors much wider than what we see here. Advance, please. Then back to you, Ulrik.
Thank you, Thomas. And then this is a concluding slide, and we try to list some of the key takeaways. So, as you heard, once we get through the restructuring, and we get the money from the rights issue in place, we can pay back the debt positions, and we are a debt-free company with a very well-defined and very promising and quite cost-effective clinical development plan in place. Obviously, we need, as Thomas just said, we need to spend the rest of the year raising that amount of capital from new and/or existing investors. We also have a new board and a management team in place, and we have good experiences we think are relevant for being successful in conducting this further on.
As you just heard from Thomas, the VAP, which is our target, represents a very significant value potential. Our study costs are unusually low for a Phase II study, and if successful, as Thomas just said, it means that we will be able to develop additional indications based on those results. So until we get there, we will have a very narrow focus. There are very strong synergies with the EU-funded EDF project, which you just heard about. And the approach that we would take as a leadership team will be one to maintain sort of a venture style, very sharp focus on how we spend money, and only do things that are really mission-critical to get us to the next value inflection point.
For me, this is what I've been doing for the last 20 years or so in venture capital companies. Being very appreciative of doing things that adds value or decreases risk so you could get on. Obviously, if you have more money, you can do more things in parallel, but what we will have to do is be very focused on how we spend money, and being very sure that we are not losing the chance to actually meet our goals in time. That will be the primary focus for us in the new management team. We will not be spending time or efforts on skin and wound care business. It will be spun out at the right point in time.
Obviously, if the opportunity arise, you know, the board will consider that, but that will be our focus. And as I said before, once we are advancing and we get data, we will seek industrial partners to take the company, this product further on towards the market. So those were the words that we planned to share with you today.
Again, on the incoming, I don't have a formal role, but based on the feedback that I've gotten from shareholders, I'm confident that we will see the new management team take position in the company, and I look very much forward to be spending more time within the company, running the project together with the team that you just seen. So I think from here, we will open up for questions. So what would you... Do you have something already we can address?
Yeah. Thank you very much, Ulrik and Thomas, for the slide presentation. What I meant, forgot to mention during the live introduction was that, if you are watching this webcast as a recording, you can still submit questions SoftOx Solutions profile on the Investorweb, and the management will give a written answer there in the next few days. Please take the chance to ask your questions if you have any kind of follow-up questions. I have some pre-submitted questions already, so I can start with them, maybe.
Yeah.
Okay, so the questions, they are in Norwegian, so I will read out loud in Norwegian and you can answer them.
Yeah.
Can you elaborate more on the relationship with NATO and the Norwegian Armed Forces? How will these partnerships affect SoftOx's strategy and revenue streams going forward?
Okay, I can take that. So we, as you just heard from Thomas, we currently have sole funding for this project until Phase Ib , which will be in about a year and a half from now. We hope that these results will be so good, so it yields a continued interest in advancing this together with the authorities and the military organization, and thereby providing an additional sort of funding. If so, it would be very synergistic with our other development plans, and over time, if we are continued to be successful, obviously could lead to revenue to us.
At this point in time, it's not possible to quantify it further, but we would be very interested in continuing very good collaborations that we have had in the past years.
Thank you. The next question is: What is the plan to ensure continuous funding through the different Phases of clinical development?
Yeah, I talked about advancing to a value inflection point. Value inflection points have been a buzzword in the venture capital, but it means you get to a point where you have demonstrated success or reduced risk, and therefore you should be more valuable. When you conduct a trial, it's essential that you have the funds available to go through. So the intent is that we raise the capital needed, and as you saw on Thomas's slides, it's in the NOK 60 million-NOK 80 million to run the project. It's both the cost to run the project externally and to keep the organization going. We have a very small and narrow organization, probably only for company.
But our intent is to raise that amount of money over the next six months, so we can, without delay, initiate the Phase II trial and run it all the way forward without having management being concerned about, you know, do we have enough money to go through this? So that is the intent, and of course, subject to the results of the Phase II, we will have a strategic discussion, should we continue to do it in our own right, or should we seek partners?
As we said before, we think that time will be relevant because Phase II are really critical, pivotal information, and in the indication we are in, if we're successful in Phase II, I think we have a very good chance of convincing potential partners that we have something that could be a real product in the marketplace.
Thank you very much. The next question: Referring to the goal of seeking industrial partnerships or exit after the Phase II study, what are the primary criteria you evaluate in potential partners, and what happens if the company is not able to find partners?
Yeah, it's... That's a very relevant question. Perhaps I should back up and say how do I see partnerships in the pharma, pharmaceutical industry? You know, as we said, we intend to take those discussion based on the study results that we think we will have in early 2027. And we intend to engage with partners at the time. The fact is that in the pharmaceutical industry, certainly over the last 20 years, a very large proportion, far more than 50% of all innovation comes from small companies like SoftOx. Now, that's why there's a biotech industry in the US and many other places of the world.
So the pharma industry is used to looking for interesting technology and innovations from small companies, and we hope to be in a position that we can open those discussions with, hopefully, a number of potential pharmaceutical companies who can be impressed by the clinical results we have generated and be convinced of the commercial value of this. If we are lucky to have a choice, we will be looking at, you know, how committed is the partners to the space already? What are the assets and capabilities they have that can help increase the chance that we get a successful launch of the product? And obviously, the financial terms.
At that time, we will have a discussion with the partner, how much of the value should be allocated to the current owners of SoftOx, and what should the partner get? So of course, the financial terms will be relevant as well. At the current time, there's no point in guessing what it will be. My view is, if we have strong data, I think we will be an attractive partner, and hopefully we will have a chance to have multiple discussions. It's not something that we just start, you know, in, you know, once we have the data, but we need to have good data to have those kind of interesting dialogues with potential partners. And you also ask, so what happens if we can't find a partner?
Obviously, we also have the option to, you know, do a standalone, maybe not on a global basis, but in a selected region. So I think we will be, we in the board will be considering the options we have at the time. Obviously, we could take it to the market ourselves, but to me, it's quite obvious for a small company to try to build a commercial organization is a challenge, both from a cash deployment and a capability point of view. And there are very strong synergies at that point, with organization who already have a commercial organization. And there's a whole industry who is waiting for this point, interesting technology, they will buy a small company to get in the hands of a larger organization.
So I think we have a good chance of having very interesting dialogues at the time. It was a very long-winded answer. I hope it answers your question. You're muted.
Thank you very much. That was the pre-submitted questions. We haven't got any question during the webcast, so we can give another 34 seconds to see if we get any questions. As I mentioned earlier, if you're watching this presentation as a recording, you can still submit questions at SoftOx Solutions profile at investorweb.no. Is there anything else Ulrik, Thomas, or Ingrid want to add before we turn off?
I don't think so, but I look forward to come back and, in due time.
Mm-hmm.
and hear more about what we've been up to.
Yeah. Perfect. Thank you very much to the viewers. Thank you very much to the SoftOx's upcoming management team, and we look forward to follow the journey and see you next time.
Thank you.
Thank you very much.