Good morning, everyone. I'd like to wish everyone welcome to the EXACT Therapeutics webcast. This is set up in preparation for the annual general assembly. I'm Anders Wold, I'm the Chairman of the Board, and I will take you through some of this. I will come back to the agenda. Maybe go to the next page. The intent of this is really, as I said, preparing for the general assembly. Also, we have received some questions related to that particular agenda. The focus on this one is really to focus on the delist from Euronext Growth. This is the main topic. All other topics, clinical, et cetera, may be deferred directly to the company following this. First of all, make certain that all shareholders are receiving the opportunity to participate and get the streaming version of this.
We will also make certain that we'll follow this agenda here. First of all, we'll give a company status and update where we are. The key topic is the rationale for delisting from Euronext Growth, and the process related to that. At the end, we will have a Q&A. In this case, you will have Slido link where you can ask the questions. Please use that, and that's the process here. To support this activity today, I'll do some of the presentation, but also Per Walday, who's the Chief Executive Officer will be there, and John Edminson, the Chief Financial Officer, will conduct this one. That's the plan for today. Again, thank you very much for joining. With that, let's proceed to the next step. Per.
Thank you, Anders. Thanks for the introduction. To the company status and update, where are we today? I'm just going to go through very quickly with you what it is that we are about, what is the technology, and where are we currently, and what's happening in the field of locally advanced pancreatic cancer where our focus is. Next slide. We are really with this building a biotech company that are using ultrasound and our proprietary agent, PS101, a platform kind of agent, to enhance the delivery of drug into solid tumors. It is difficult to get drugs into solid tumors, and our technology can enhance across a number of different cancers and across a number of different drugs, the uptake into solid tumors. Our focus is on pancreatic cancer, which is a disease with severe delivery problems into these solid primary tumors.
Our ambition then is to win in locally advanced, because that is a disease where you can do a real impact by increasing the local delivery into the tumor. We focus now on the phase II study. That's our current focus, which we are doing in locally advanced pancreatic cancer. That study reads out with an interim read towards the end of this year and first half next year for the key readout. If we go to the next slide, our focus is locally advanced pancreatic cancer. The reason for this is by enhancing the uptake of drugs into specifically locally advanced pancreatic tumors, you may be able to take these patients over to a curative setting.
From just a life-extending treatment to a potential curative treatment by making them resectable. What we want to do is to really substantially enhance the tumor shrinkage in these tumors, and thereby convert patients from only life-extending treatment to a potentially curative treatment and a tumor resection. This patient population represents approximately 30%-40% of all the newly diagnosed pancreatic cancer patients. Sizable population of patients. On the next slide, we're just going to repeat what we have provided previously of data when we had the first safety readout from this technology, which was in February this year. We saw some really encouraging tumor responses, very good safety, and some really encouraging tumor responses in the first patients here.
The only approved biomarker that shows what kind of effect you get out of treatment of pancreatic cancer is CA19-9, we saw a really strong enhanced decrease in this biomarker and sort of telling that the tumor burden of the patients had decreased significantly. Actually, the patient, just to repeat this, were transferred over to curative treatment, what we want to achieve, and went through a complete clean resection without any tumors left in the body that were visible in the tumor margin or in the lymph nodes. A very positive outcome and a very positive start to this study. On the next slide, just giving you a quick status on where we are. All sites that we have, seven in the U.S. and three in the U.K., are open for enrollment.
We have now, after this previous TMC where we cleared the 40 mL/ kg dose of PS101, we increased the dose on the basis of the recommendation of the trial monitoring committee up to 60. Now we have a safety cohort where two of the patients have passed the safety window, and we're waiting for the third to pass the safety window. If that happens and that patient is not withdrawn, we will have our second TMC at the end of June. After that, we can open up for unrestricted enrollment at the selected dose early in July.
What we think that we can achieve with this, depending on the recruitment we have, but we have a really good activity across all the different sites, is an interim analysis towards the end of this year and the final analysis in the first half of 2027. Really nice progress, some very encouraging early results, and this is really our focus to take this forward. Next slide just shows something about what happened in this field, because there has been some really positive movement in the field. These tumors are primarily driven by a mutation which is called KRAS, and this has been very difficult to drug. A company in the U.S., Revolution Medicines, recently came out with phase III results in metastatic patients.
Not our patient population, but a different patient population, but the same disease, showing that their drug really works well in those kind of patients. This means that we've had a breakthrough in metastatic pancreatic cancer disease, which validates that this now can also be treated with targeted drugs. There's been a renewed confidence that the RAS biology can really drive a good effect in this cancer. There are a number of companies that are working with RAS agents, and there is real enthusiasm in the field around this. The next wave, this is not yet a complete solution, because locally advanced have a different problem, not just extending life, but actually making patients resectable. Next wave goes on combinations, early-stage interventions. This was second line that the phase III reported out on.
Of course, also important for us, better delivery. As mentioned previously, we are a platform technology. We can deliver different kind of drugs to different kind of tumors. There is no reason to believe that we wouldn't be able to also enhance the delivery of these new targeted agents. We are now very well positioned with our clinical momentum in pancreatic cancer to capture this shift and take advantage of the recent findings with RAS-targeted agents in locally advanced pancreatic cancer. That is the status right now. With this, I take it back to Anders to talk a bit about the process and the rationale for delisting from Euronext Growth.
Yeah. Thanks, Per. Let's dive into the main topic of today. Let me first start a little bit by the business situation here and the bigger picture and EXACT Therapeutics has come a long way, and people maybe even remember it as Phoenix Solutions. What has happened in the last three years has been very exciting. First of all, the listing first, we started to get partners. We started to get a focus in the company and focusing on pancreatic, first of all, because that seems to be a very unmet need situation. We started to get traction from preclinical to clinical and phase I and now phase II. All of that has brought a lot of momentum in the work and traction in the marketplace.
On top of that, like Per was saying, there is even new dynamics in the marketplace with RAS and things like that. Our position as a drug delivery enhancing therapy is a very nice sweet spot at the moment. We are very encouraged by this. It looks promising. We are already thinking beyond the phase II and assuming this is going well as it looks like today. Preparing for phase III means we have to have a strong capital platform to do that. We go to the next page. We will depend on the marketplace that works for EXACT. Today, actually, Euronext Growth does not work well. First of all, just look at these points here. I mean, 50% of the trading days in the last five years have been without any trades. It's not a lot of liquidity.
There's not a lot of activity here. The listing may not contribute to reasonable pricing of shares. We have seen that even though we come with new and great results, there is really no result. In fact, nothing really happens to the valuation of the company. That is very frustrating for the company and for the shareholders, of course. We are here to protect the shareholders and making certain that we build value to the company. There is no connection between those, say, value built and the share price and the trading volume or the valuation of the company. We have seen a steady decline, and you also see today even there is almost nothing. It's a single-digit total share trade year-to-date. Basically, this is a major issue.
If you go to the next page, another component of this discussion is really the shareholders composition today almost looks like a private company, because there's a large percentage of the company shares held by few shareholders. That's a result of, say, the last few years where there's really no trade, and we still needed to fund the company, et cetera. The largest shareholder holds 39%, as you can see. We have, out of the 10, 20 largest, hold approximately 75% and 87% shares. That's another challenge in the cap table, so to speak. All the rest 400 plus shareholders hold a very small ticket. This structure of the shareholders is really not helping much in terms of liquidity and building the same valuation for the company. It doesn't look like this is going to change.
We have seen this has been over the last couple of years, it's the same. We are a little bit stuck given the plan that in the next phase III, which will commence sometimes in the later part of 2027, we will have to take the next step for the company. That forces us to think differently. If we go to the next page, it will talk a little bit about that, because it's all about getting access to capital. For instance, one idea could be to have international VCs involved, and our advisory, and we have had several meetings with advisors on this topic. Of course, as part of capital planning for the company, we looked at all different avenues, including delisting or stay listed, or other ways. We have seen what has happened in the last few years.
We had a bigger shareholders that has been believing in helping the company, et cetera. Given this situation, it suggests that the private setting is a more likely way to or potentially even be a prerequisite for successful financing. That's number one. Of course, the lower liquidity and the high volatility of EXACT shares on Euronext Growth really prohibits the investment for most international funds. That's another direct feedback we got, and we have a lot of statistics on this that points in this direction. In many ways, this is forcing the board to propose a delisting, which is on the agenda for the general assembly. Today we wanted to share as much information we can about this.
That's kind of the position of both the management and the board has supported this into the best to build a future valuation and value for the company, but also to prepare really for phase III, which really is maybe one and a half years away. We just have limited time to even to do this. With that, I'll hand it over to John for going through the process itself, and what it potentially could be. John.
Thank you, Anders . The potential process for delisting of the shares from Euronext Growth is regulated in the legal framework. If you skip to the next slide, please. There is a legal framework regarding this with the Securities Trading Act, of course, and Euronext Growth has their own rule book, which we obviously apply to. There are the MiFID II regulations as well. Following the coming practical process now is that it is the general assembly that makes the decision to authorize the board to apply for a delisting of the shares from the Euronext Growth. To be approved at the general assembly, a resolution must pass with at least two-third majority of both the votes cast and the share capital represented at the general assembly.
If the resolution is passed at the general assembly, a formal application will be sent to Oslo Stock Exchange submitted by the board of directors. Oslo Stock Exchange is to consider this application in an estimated three weeks processing time here, but it depends a little bit on the complexity of the application that is sent. If Oslo Stock Exchange approve the application, a last day of trading will be announced, and the company will then propose that the last trading date is given reasonably time ahead so that the investors, including minority shareholders, will have some time and opportunity to adjust to the new situation as a private company. Shares will be available to trade through the Oslo Stock Exchange until the last day listed.
The next slide, please. In terms of timing, we have sent the call for the general assembly, which is on June 12. As mentioned, following that, in a few days time after that, if the resolution is passed, an application will be sent, estimated around June 18. If there is about three weeks application processing time at the stock exchange, early July will be a decision by Oslo Stock Exchange. They will announce the last day of trading. We estimate that, based on previous cases, to be three months ahead of time. In the first part of October, that is when the company will most likely, if it's been passed and the process is followed, that will be the last day of trading. If we go to the next slide, please. This is, of course, important.
What does this mean for the minority shareholders? Obviously, all your rights as the shareholders remain unchanged. You continue to own the same number of shares that you have today. Voting rights remain unchanged as well. One share equals one vote in EXACT Therapeutics. There is a minority protection in the Norwegian company's law that they will, of course, remain in place. In terms of trading and buying and selling of shares, these must be made through alternative channels since the shares are no longer listed at the stock exchange. The buyer and seller must agree upon a price. There will be no observable market price in that regards on the shares. Reporting and information, we will continue to provide the relevant updates on the clinical developments and financial status to the shareholders through our website and other communication channels.
An exit offer, I know this is something that some of the minority shareholders have been concerned about. At this point in time, there has not been an exit offer that has been established from the shareholders, the larger shareholders of the company. In terms of how the assessment goes from Oslo Stock Exchange, they will consider whether or not this will cause significant detriment to the investors' interest, especially in terms of the minority interest. They will make a proper assessment on what rights and protection the minority shareholders have. This has been, of course, discussed by the board of directors in this process as well. The next slide, the key takeaways. In terms of the key takeaways that we have talked about here today, and we will continue with the focused oncology strategy for the company.
We have positive clinical proof of concept for PS101. The phase II ENACT trial is on to a positive start with the 40 mL dose as well as the 60 mL dose, which is well underway. We are planning for success. This new capital market strategy will facilitate future potential VC funding for the company. Of course, this is to be put up for vote at the general assembly on June 12th, 2026, and this is the fora for the shareholders to support or have their voice heard. Anders?
Okay. With this, thank you, John. That's the process for delisting and all questions around or, say, considerations around this, and hopefully that addresses some of the questions. I see there is some questions coming in already. That's great. Thank you. We'll turn into the Q&A session right now. There is a list of questions that have been submitted, and if you haven't, there is an opportunity to do that right now. Let me just maybe start off here a little bit. There is a few questions related to the board, which I represent, of course. One question is the question of whether the board is aligned with 2/3 of the share capital with this proposal, and the answer to that is yes. It's actually 100% the support for the proposal, which was first recommended by the management, but also the board.
That is one component. I believe John has addressed the other question, how has the minority shareholders been evaluated, their interest in this, and have you considered the down listing, for instance, OTC, et cetera? That was addressed by John. It has been, of course, considered. The Board has an obligation to represent everyone, including majority. We feel that is detrimental to the proposal. Both the management and the Board don't think that's a good idea at all, and actually will further continue issues because don't forget, the main rationale here is to be in position to fund the company and raise capital for phase III, and that work needs to be done, so we can't just have another Euronext Growth situation on our hands. That's the background for that part. Maybe, John, if you could address the following question.
What exit opportunities will the minority shareholders have related to the delisting and before or after rather?
As mentioned, the shares will be available for trading up until the last day listed if the resolution is passed by the general assembly and approved by the Stock Exchange. None of the larger shareholders have indicated that they will provide an exit offer. For the time being, we do not see an exit offer as a likely scenario in this process.
Maybe, Per, there's a question here. There has been a discussion here. Here is the question. After the last emission was done, what has changed in the evaluation to offer the shareholders liquidity through a listing? What has been the consideration around this question?
Yes. Maybe just to quickly comment on your answer as well. As you said, we own the 2/3 of the shareholders or share capital that are aligned, and you said 100%. I think 100% of the board, I think is the right to say, and not 100% of the shareholding. That's not a confusion. What has changed since the last funding that we had? I would say that two different things have changed. One, we had the warrants exercise, which we thought was something that really, to some extent, put a weight on the trading in the share, because there was a discount on these warrants on 20% from the three months average volume weighted price. We were hoping to see that after that, we would see an effect of actually increased real increased trading and real increased value, which has not really materialized at all.
That's one part of it. Another part of it is that we, in May, had workshops with financial advisors, international financial advisors with VC background and have raised a large amount of money, where we went through our plans, the amount of money we need to actually get to the next stage, fund next stage, which is significantly more than what our market cap is on Euronext Growth today. It was a very clear message from that workshop that you have to delist the company. You can't be unlisted on the Euronext Growth like this. You can't be in the situation that you are today if you are to attract VC interest and get the kind of money that you need to take the company to the next stage.
I think on the basis of that advice, we went back to the board and had a discussion in the board, a very thorough discussion around this, the pros and cons, and what does it mean for minority shareholders as well, and what are the options for this that really could build value of the company going forward. This was seen, taking the company off in a delisting process was absolutely seen as the best for the company and for all the shareholders. That's the best option we have right now. Then the decision was made relatively quickly that we need to act because it takes time to raise funds, and it takes time to do this with VC. That's really what has happened since the last funding.
Yeah. Okay, thanks, Per. Some we can answer. Some obviously is not in the house or either management or the board. It's the shareholders and the general assembly. There's a question here which was a little bit what you talked about. More information about the new capital market strategy to facilitate future VC funding, for instance, what are the amounts, et cetera. Just to repeat Per's question here, the amount needed will depend very much on where we stand. I mean, we are not through phase II. Number one, we have to make certain that phase II, if it's successful, that will give us a guidance what kind of next step studies are being there. Next step studies will qualify the capital need and define the amount.
I think from a ballpark point of view, it's more than the value of the company today. I think it's the best guideline we can give. Given that is exactly what Per said, we will have to take a different route. That's the conviction of the management and the board and the alignment with the majority of the shareholders. That's where it is, and we can't say more about that. Obviously, we need to get through the delisting discussion first and the decision on that. There are many questions on pricing. Of course, we have no idea about the pricing.
The only thing we know that we feel, we think the rationale here is that the company is completely undervalued given where we are at the Euronext Growth. Of course, we had to prove what we are doing today, and we had to go through the studies and so forth. Our convictions and the excitement and the belief here by most of the people involved in this is very positive. Gives us an idea that this will go one direction, and that's north. We cannot say more about the pricing and that. Obviously, we are here to build value for shareholders. The valuation is a number one driver for the company. That's the main objective. I think, Per, if there is anything else on the question list, I think we covered many of these right now. Yes. Yeah. Go on.
There is a question on this. What exit opportunities or availability is it for minority shareholders? Is it available after delisting? There's really nothing the way it's proposed right now. Of course, general assembly may address that. That's what John was responding to earlier on. I would say basically, if we think the funding for the company is over the next two years, getting into Phase III, that's probably whatever time that will take, that will be the next step for the company, following if it's delisted privately held. That will be the phase where really nothing will happen. There's been other questions around what we will obviously share information on the same level that we have done as a listed company, so there'll be regular updates for shareholders and so forth.
That will keep you abreast, but to exit in this phase will depend very much on the investors. There is nothing we can say more about that right now. Okay. Looks like we ran out of questions here. I think we'll try to close it here. First of all, thank you all for participating, your interest in EXACT. We remain extremely positive and encouraged by our results. That's the most important part. We have to navigate through the capital part. That is a little bit challenging, but I hope there's a full understanding here, and the general assembly is on the 12th of June, and that's where the next step will be for the company. Thanks again, and we'll close the call. Bye-bye.