Good afternoon, everyone, and welcome to today's investor webinar featuring CHOSA Oncology. My name is Björn Andersson. I work at Västra Hamnen Corporate Finance, and I will be your host for today's session. Before we get started, just a quick note: we will have a Q&A session at the end of the presentation. You're welcome to submit your questions at any time during the webinar using the Q&A button at the bottom of your screen. Today's presentation will give you deeper insight into CHOSA Oncology's platform, clinical development plans, and strategic outlook. Joining us today is CHOSA Oncology's CEO, Peter Buhl Jensen, and CCO, Claus Frisenberg. They will walk us through the company's strategy, current status, and upcoming milestones. With that, I'll hand over the floor to Peter and Claus. Please go ahead. Thank you. Thank you, Björn. Thank you. A little bit of background about CHOSA. Myself, I'm a previous professor at Rigshospitalet in Copenhagen. In CHOSA, we have a very small team, but we have experience and have been working on drug development before. We actually have in our team two products approved by the FDA and also one by the European Medicines Agency. I think we have fantastic timing with what we're doing right now, and I look forward to present that today. I will now share the presentation. Just a second. What we have in CHOSA is—no, what's happened? Now it's here. Yeah. What we have in CHOSA is a technology that can increase the efficacy of a very important anti-cancer drug by more than 80%. I'll just give the word now to Claus. Okay, thank you, Peter, and welcome, everyone. Just a few words on my background. I am not a scientist by training, but as Peter, he usually claims that I should know a little after having worked together with Peter and the team for more than 10 years. I have a finance and strategy background, and I'm involved in our commercial activities towards partners, potential partners, and also towards investors. I will kick off this presentation, and then there will be an exchange on the way between Peter and I, so we get a little dynamics into the presentation. Peter, next slide. The first one is the disclaimer. Whatever Peter and I will say, you cannot use it against us. This is just a formality that we need to go on. If we continue to the next slide here for all of you, this is—if you forget what we are saying on the way, then please remember this slide or what we have here. CHOSA Oncology, we are a precision medicine company. We have our own proprietary solution that can more than double the efficacy rate of patient or the chemotherapy given to patients where platinum is involved. In particular, it is relevant in combination with PD-L1 products, one of the most significant areas of cancer treatment right now in the market, and we are relevant in multiple indications. What is about this PD-L1 immune therapy market is that it is growing significantly. Last year, it had a value of more than $50 billion, and it is expected to grow to more than $150 billion in annual revenue by 2032. Also, the most known drug in this area, that's Keytruda, which is actually the most valuable drug across all disease areas. It is even more valuable than some of the drugs targeted at obesity. We have a number of upcoming milestones. Peter will talk more about this a little down this presentation. We have some very interesting inflection points over the next six to 12 months, and we can do so with very limited capital. We are also having a lot of partnering activities going on, both with key opinion leaders. This is the influences of the medical industry. We are working together with large research groups, both in Europe and the U.S., and we also have dialogues with big pharma. In total, we could say that we are on a very good road or track towards guideline introduction and potentially also FDA approval. Yes, next slide. One of the reasons why we are here today and why we are presenting here together with Västra Hamnen is that we have initiated a hybrid issue. We have conducted a directed issue that went on in the beginning of June. Alongside this, we are proposing or we are offering a rights issue to all existing shareholders on equal terms to what was given to the directed issue. In total, we are aiming at SEK 20 million. We already got close to SEK 4 million in the directed issue. We also got some commitments to the rights issue, which is currently going on. It started on the 12th of June and is running until the 26th. What is the structure of our offering? For every eight shares that you are currently holding in the company, you will get three units. One unit consists of three shares and three warrants. The price for this unit is SEK 1.86, which is equal to SEK 1.62 or SEK 0.62 per share, which includes also the warrant, which is there for free. The exercise of the warrant can take place next July, July 26. It is having a strike price, which is equal to 20% off from the current offering price. It is SEK 0.78 per warrant compared to the SEK 0.62 that we are offering for the ones that are being issued right now. It is also important to state that we have a runway with this offering that will be significantly prolonged if we are succeeding with a full subscription. Currently, we have a burn rate of close to SEK 7 million per year. The majority of our proceeds will be used on KOL studies. That is studies that we will be doing together with key opinion leaders in Europe and in the U.S.. The rest will go to our normal working capital. That is our normal operation that will also be secured from these proceeds. We have a number of inflection points, as mentioned. We are at the end here of Q2. Maybe it will go a little into Q3, but we have a lung cancer study that we are working on. We will get back to that. In Q3 this autumn, we will hopefully be able to announce new partnerships with research groups in Europe and the U.S.. Also later this year, we will include new indications of our study portfolio. Early next year, so early January, February 26, we will have a new study published in lung cancer where we are looking into the combination treatment of PD-1 and chemotherapy. This will actually also be leading, if successful, it will lead into an initiation of an FDA process. That is short about the offering. Peter, over to you. Thank you. Let me see. Basically, we all hear about sort of advantages in lung cancer and in other cancers' treatment, but in essence, it's still very, very difficult to treat cancer. In effect, what you see is that only 25% of products actually give the sort of the results when given to cancer patients that we hope for. So 75% of all cancer treatments actually have some or no effect on the tumor. You could say patients certainly suffer the side effects, and it can be very serious, but it can also just be delaying outcome, and it can cost the healthcare system also. What we have is a product that is actually a little bit more effective than most of them. It's working in 40% of patients. It's a platinum. There are two drugs, cisplatin and carboplatin. Around a number of cancers, platinum, either cisplatin or carboplatin, is quite effective. We also see a situation now where we can stop treating patients like they were all the same. We can benefit on our response prediction. Cisplatin was the first product on the market, and it was actually very, very early on. It is like 50 years ago that one of our Danish traveling cyclists, he was cured for his testicular cancer. Later, Lance Armstrong was also cured for testicular cancer. It is a dangerous sport, you could say, but it is definitely a very, very important product. Before that, people died of testicular cancer. It kind of works in 90% of the cases. This is not how it is in many other cases, in lung cancer and other cancers. It's basically used in 16 different cancers, but in testicular cancer, it's exceptionally active. It's been there for 50 years, and its mechanism of action is complex. Also, what happens when it doesn't work is complex. It's not been possible to identify who would actually benefit and who would not. That's where we have a technology. Going to lung cancer, where there's been some sort of huge developments within the last couple of years, it used to be that cisplatin was the only drug for lung cancer. There came the understanding of our own immune system, and it was possible to get the immune system activated. What we see was there was a synergy with cisplatin. When given the immune therapy together with platinum, there was a sort of more than additive effect. Alone, you could say if you have a lung tumor and you want to kill all the tumor cells in this patient, it's very—I mean, cisplatin can only do that in 5% of the patients. It may benefit more, but only sort of getting rid of all the tumor cells, you're talking about 5%. And immune therapy alone, that can kill all the tumor cells. It's also demonstrated in sort of 8% of the patients. Together, so the 5% of cisplatin and the 8% immune therapy is more than additive when we give it together. We're now having a 24% success rate killing all tumor cells. This is, of course, the best ever. This is the gold standard today and excellent. It's also obvious that still, you could say synergy is only in 25%. If patients should not have platinum, there are other alternatives if synergy is not there. That is basically where we are. With our response predictor, we can demonstrate this synergy. I'll ask Claus to explain this situation. Yeah, I'm building on Peter's comments on the previous slide here. We have tried to put up an illustration on the efficacy improvement that we deliver with our solution, our ability to identify those that will benefit and those that are not likely to benefit from the combination treatment. If you look on the right-hand side, our illustration, and follow the arrow, here we are having the example of Nivolumab. That's one of the key immune therapy drugs. As you can see, it's departing from a 24% efficacy rate, as Peter mentioned on the previous slide. If we then use our technology and our solution, and we look into the tumors of the individual patients, and then we measure the likelihood of response to the combination treatment, we actually then decide, okay, we will only treat one in three. We will measure three patients, but we will actually only treat the ones that are having the highest likelihood of response. By using that or doing this methodology, we will actually be able, for those that are actually being treated, to increase the pathological complete remission, which is what Peter says, is where the cancer is completely gone from the patient. We are able to increase the pCR rate from the 24% without any solution to 44% pCR rate for those that are included in our process and using our solution. That is why we put up that we are able to increase the efficacy rate by plus more than 80%. Yes, it is correct that we will also deduct the number of patients by two-thirds. If you are a newcomer to the market, this is also a very high market that you can actually approach, and you will be having a significantly better market offering, and you will differentiate your product compared to what is already golden standard in the market. Peter? Okay. What is the PD-1 market? Yes, as I mentioned before, it is a market that is expected to grow into $150 billion in annual revenue by 2032. It is growing by more than 15% per year. We already have 11 drugs approved and more than 20 are in development. This is an area that is taking up very much attention from both smaller pharma companies and biotech, but also the big pharma companies. What is interesting about all these plus 30 drugs is that all of them, they look very much the same. They have, as we say, they have the same mechanism of action or mechanism of action, which means that they work within the body and towards the tumor in a very similar way. That is why it is so important to differentiate because all of these plus 30, they have more or less the same efficacy when they are given as a standalone. Keytruda and Opdivo, they are the ones that take up the majority of the market. Keytruda, they have more than half of the market, and Opdivo is also taking up a big chunk. In total, the top three products, they are taking more than 90% of the total market of immune therapy. Peter? Yeah. This is not only something that's happening in lung cancer. Platinum and immune therapy is today the new gold standard of treatment. It's changed the treatment of lung cancer, bladder cancer, certain types of breast cancer, head and neck cancer, endometrial cancer, and esophageal cancer, also what we call MADSTOP cancer. It's like you can say, in all cases, there is a very nice benefit of the combo, but there is also a large fraction of the patients who really don't have any benefit, which shouldn't be treated with platinum in this setting. Just a bit what we, basically what we are working on is that we need a biopsy to come up with our prediction. As you know, I mean, the biopsy is the start of the whole cancer diagnose. You diagnose always, you need to have a sample of the tumor to the pathologist. That is also that sample that we actually can read from. It is, yeah, you can say rocket science, but it is actually clearly solved now and very simple. We use our analysis and look at the biopsy as the pathologist also do. The oncologist selects a standard treatment. The patients undergo treatment, and you, of course, evaluate the effectiveness through follow-ups and imaging. What we are looking at is what we have is that you basically, we now know that we know something about the biology, and it should not be guesswork whether patients should have platinum or not. Our response DRP, drug response predictor, is a sort of really utilizing 205 genes. We have, you can say, tried here to embrace the complexity. This was actually invented by Professor Steen Knudsen together with his colleague Thomas Jensen. They came up with this concept of looking at how the genes were actually being used instead of trying to come up with one gene that would be actually predicting. It is human intelligence. It is not artificial intelligence, but there is no doubt that artificial intelligence is going to give us more of those options for the future. It is also important that we have a pattern on those 205 genes. We are protected until 2038 with this. It gives us a test that gives the oncologist an evidence-based result that allows, you could say, individual oncology treatment plans. We have shown in lung cancer, this is before the immune therapy where you basically give chemotherapy with platinum after surgery. When you think you've removed, when the surgeon thinks you've removed everything, you give platinum because very often there's still some tumor cells there. When we look at the response predictor, our DRP, when we look at those biopsies, and when we say this patient has a score of 90, the patient has a 90% three-year survival. If the patient has a DRP of very low in 10, they show only a 40% three-year survival. That's clearly defining, you can say, the value of the platinum and also the predictor here to identify who responds. We've also done a study in breast cancer that we published in 2023 at ASCO. We have seen that we're now talking about the patients that are sort of heavily pretreated breast cancer patients with metastatic disease. The ones that were in the highest levels, in the top 20 or more than 80% of the DRP, they were the ones that had benefit. The tumors shrunk, and they also had progression-free survival that was significantly longer than the ones at lower scores. We've shown in basically, we've shown in two lung cancer studies and in two breast cancer studies, and we have the first and only, you can say, predictor of cisplatin and carboplatin efficacy out there. It's a situation where I'd like to ask Claus to say, how are we going to sort of monetize that opportunity? Of course, that's a question that we often get from particular investors. How are you going to commercialize this? What we have intentions to do is that we would like to partner with one of the PD-1 owners or one of the biosimilar owners. The biosimilar owners are coming into the market by 2028 when Keytruda is going out of patent. As I mentioned, the three major PD-1 owners share more than 90% of the market. That means that all the remaining, they will gain significantly from a partnership from us because they will be able to differentiate their offering towards the market. Having a differentiation from 24% to 44% or even to 34% is of great importance when you are making an offering to hospitals or to social security globally. We are proposing to the ones that we talk to that we actually make a solution that is based on subscription, meaning that they actually give a royalty payment based on the revenue gain that they have by using our solution. The partners, they will be responsible for the regulatory and the commercial activities. CHOSA, we will actually be insisting at the back end of the value chain by assisting with the logistics and also delivery and analysis of the results for each patient. The dialogues that we have so far on a modest and very conservative level, they give an indication of 5% royalty of the revenue gain. For example, just in lung, I think it was lung or bladder, Peter, but it is not very unlikely that a player here will have a $1 billion gain in revenue by using the PD-1 in combination with platinum and in combination with our solution. A $1 billion gain will actually be equal to $50 million per year in royalty payment to CHOSA. We think that is a very good way to look at the potential here. It is a $150 billion market. By changing or improving for one of the players in this industry, just improving their business with $1 billion, we will have a $50 million revenue. Compared to our current market cap, that signifies the significant potential for our company of getting ahead here. Peter? Yes. You can say what we aim for is to stop treating patients like they were all the same. We can see that we can identify the patients that benefit from platinum. We have now initiated, and we're also basically in the middle of a collaboration with a study with a world-recognized research organization, ETOP in Switzerland, with two key opinion leaders, Solange Peters and Rolf Stahel. We are working with them and basically going into a large study that they have already performed, but where we can get access to the archived biopsies. There we can validate both carboplatin and cisplatin and also methods of measuring. We see a readout here, as Claus also said, around Q2, very soon here. It's the first collaboration with the large key opinion leader group. This is, yeah, I mean, this is actually what Claus talked about before. The opportunities are, there's a lot of opportunities for collaboration with companies, giving them exclusivity to our opportunity here. So what we have, just you could say the inflection points of what's happening in the next 12 months. I mean, we also added here that we came up with a readout in breast cancer study in Q1 here in 2025, showing that carboplatin in breast is working for us. The readout that we expect to come here around mid-year is with cisplatin and carboplatin in lung cancer. What we now are using our procedures for is for going into biopsies where patients have actually received a PD-1 or a PD-1 and cisplatin or carboplatin and reading out, we can predict who's actually getting the, what you call the pathological complete remission, who's getting the benefit, who's not. This is a collaboration that we would do with our key opinion leaders, and we expect to have a readout in Q1 of 2026 on biopsies similar to what we're doing now in Switzerland. As Claus said, this is also going to initiate the FDA process. We are working with other studies with key opinion leaders in both breast and bladder and endometrial in addition to the lung cancer. We have, I think, very nice support from some of the most influential oncologists in this world. We have Fred Hirsch on our board. He's the director for lung cancer at Mount Sinai in New York and previously was the CEO of International Association for the Study of Lung Cancer with more than 15,000 members. Solange Peters, Rolf Stahel, and Giuseppe Curigliano are lung cancer experts. Josh Sosman and Martin e Piccart are breast cancer experts, Dr. Mirza in gynecological cancer, and Galsky in bladder cancer. They all support the concept of if we can identify the patients who benefit, we can bring oncology forward to more success. Stop treating the patients like they're all the same. Summary is back to Claus. Yeah. As we started out, we believe we have a unique company here with a unique offering. We have our own proprietary solution that can significantly improve the response rate and differentiation in the biggest medical or drug market in the world globally across all diseases, so the immune therapy. We are the only one who can provide this opportunity to the players who we believe that we will be or we are attractive to a lot of companies out there. We have, as Peter just mentioned, some upcoming milestones that will have a possible inflection, be inflection points to our share price. It will also be an inflection point in attracting interest from the big pharma companies. We do so by a relatively limited capital need. We already have the dialogues with key opinion leaders. We have worked with research groups and pharma. We have a road going towards guideline introduction and FDA approval. Just finally, revisiting the offering, we are looking to raise SEK 20 million. We already have the SEK 4 million from our direct issue. For every eight shares you have in the company today, you will get one unit. This unit consists of three shares and three warrants. The warrants are given for free. For this unit, you pay SEK 1.86, which is equal to SEK 0.62 per share. The strike price for the warrants is 120% of the price per share in the subscription, so it is SEK 0.78. We have the subscription period, which runs for another week. If we succeed, we will have a good prolongation of our runway as we are only taking up or spending around SEK 7 million per year. Oh yeah, per year. I think that was it. Okay. Thanks a lot. Thank you, Peter and Claus, for that insightful presentation. We'll now move on to the Q&A session. We've received several interesting questions from the audience. Number one, Peter, could you tell us more about your background and what you have accomplished? Oh, yes. So yeah, basically, I've been doing translational research since I was a young boy, and that's a long time ago. At Rigshospitalet, I was able to form the company or the group of a laboratory, sort of a laboratory of experiments of medical oncology. That gave us, you can say, the information that started our company, TopoTarget, where we had two products approved by the FDA and one by EMA. Also the contact to Steen Knudsen, which has actually been, you can say, pivotal for giving us those very nice signals for who will respond to platinum and who will not. I've been working on the translational research since, and you can say I'm now what you call a serial entrepreneur. I think the timing here has been surprisingly good. We worked with this platinum prediction for some years, but in 2023, we had this sort of very, also for us, very surprising synergy seen with the immune therapies. Suddenly, the whole timing of a response predictor for such an old product makes a lot of sense, more sense. I mean, it made sense before, but now it's really, really hot. Peter, probably it's also worth mentioning that you have already gotten two products approved by the FDA, so you know about this process and what it takes to bring towards approval and also commercialization. Yeah, I mean, we've been teams on that, and I think we know the hurdles or some of the hurdles, and also the things that are needed on quality. Good. Could you just elaborate on why you have chosen to focus on an old product? What are the advantages with that? That's a good question. The old product is relevant because it's still relevant. That means that, yes, you can say it's not a very costly product. I mean, it's not like platinum is not very expensive. Now we have the new immune therapies. They're suddenly costing more than $100,000 per year because they have patent coverage and they're difficult to produce. Platinum as such is not. The fact is that NCI, the National Cancer Institute in the us, can actually estimate that more than 10% of cancer patients will be at some time point in their cancer treatment be sort of receiving one type of platinum. It's hugely used, although it's still 50 years ago. I do think that the efficacy, what platinum is doing is something no other drugs can do. We see some new products where you have antibodies that are linked to chemotherapies, what's called those ADCs that are coming in now. They do not have platinum. They do not have this particular cell-killing mechanism. Basically, you have to kill, you have to have the most effective cancer drugs to be able to win over the cancer. There is no foreseeable future. There is no way that cisplatin is going up. Good. How much clinical data supports DRP today? Yeah, I think the data we have is two very nice studies in lung cancer. One was from a sort of public published study where we had access, Steen Knudsen had access to data from that published data, including how the genes were performing. There he demonstrated that his technology was very nice in predicting who benefited. We repeated that study at Rigshospitalet, here in Copenhagen, with 100 patients, biopsies, and could show that this was exactly the same data as he found. We've been working with breast cancer where we've been into a, you can say, prospective. That means that you basically treat patients based on the response predictor. That's where you could see that we were able to identify very precisely that 20% of this patient population was the ones that were benefiting. We also have in another study we just published that carboplatin works very nicely in breast cancer, also metastatic to setting. I think we got four sort of independent studies demonstrating that this is actually working in lung and breast. We do not know if it works in all cancers, but we have seen lung and breast as very nice. We move into other cancers to see if it also translates. This is also, as you know, very, very big indications, and being able to cover that is exceptional. Peter, isn't it worthwhile also mentioning that the development of the DRP is based on, is it 4,000-5,000 patient data that we have been using to kind of develop before it was finalized? Yes, that's correct. So many thousand patients have been included. Yeah, so that's the fine-tuning or making the response predictor clinically relevant has required 5,000 patients, yeah. Good. Here is a question. What does the test cost? The cost of the test is around, with everything. That's the cost for us, you can say, if we are running it. Today, it's a $1,500 per test. We can see that it's also about quantum. I mean, more will get the price down. It's a lot of money. If we are saying that we will be testing three patients for taking a decision to treat one patient with lung cancer, that would be almost $5,000. The other part of the equation is immune therapy, and that is always more than $100,000. You can say for every $5,000 spent, a partner would be able to sell their product for $100,000 for an exclusivity. It's an expensive test, but not expensive compared to the price of the immune therapy. When we compare to clinical trials, we have been used to actually, when you're doing clinical trials, you have to expect that you're paying maybe $150,000 per patient going into a clinical trial. We do not need to do a real clinical trial as such. We need to do a test on the biopsy. That is only costing us $1,500. I'm not saying what we will be charging for, but this is the cost of running the test. Thank you. Are there ongoing partnership discussions around DRP? That is a yes. There are discussions with pharma, and we cannot promise when you will see a deal. I have done that previously, and you have to be very careful of that because of the market expectations. We do think that we already have an interest from pharma. We also think that when we are getting the next level of data this summer, but also next winter, when we are getting the combination with PD-1, that we will create a situation where there will be what you call a fear of missing out, where pharma companies will be looking at it and say, "Okay, should we see if we could get exclusivity for this opportunity for differentiation and a market dominance in those platinum-sensitive patients? Great. I think we only have one last question, and that is, what are the key value-driving milestones we can expect in the next six to 12 months? No, that's a good question. I think this summer's results in lung cancer will be the first where we're doing with external collaboration with key opinion leaders is going to be very important. I do think that the most important is what we are raising money for right now is to get the PD-1 and the platinum biopsies and come up with those data at the beginning of next year. That's really an inflection point as I see it. Of course, a deal. Of course. With that, I think we will end today's session. Thank you to everyone who joined us today, and a special thanks to Peter and Claus for sharing your exciting journey with us. Thanks a lot. Before we end this session, I also want to stress that it is, of course, possible to also subscribe for units without unit rights. You can get more information either by reaching out to me at Västra Hamnen or at Nordic Issuing, which is the issuing agent in the transaction. You could also talk to your own bank of how to accomplish this. If you have any follow-up questions or would like to learn more, feel free to reach out to us at Västra Hamnen Corporate Finance or directly to the company. This concludes today's webinar. Have a great day.
Loading workspace