Thank you. Good afternoon, everyone. I'm very pleased to hear that we are over 100 participants on this webcast. Really thank you for that. This morning we announced the acquisition of global development and commercialization rights for Cantrixil, a clinical stage ovarian cancer program, building therefore critical mass in our oncology pipeline. Over the course of the next hour or so, I'm looking forward to sharing with you the strategic rationale for this move and our excitement about it as we believe it marks an important milestone in Oasmia transformation. As usual, we will be hosting a Q&A session at the end of this presentation. Slide two, that I will not ask you to read. Slide three. Today I am joined by Dr. Reinhard Koenig, who is our Acting Chief Scientific Officer, who has been working for quite some time for Oasmia. Since this is the first time that you hear Reinhard, I would kindly ask him to present himself in a few words. Reinhard, the floor is yours. Yeah. Thank you very much, Francois. Hi everybody. I'm Reinhard Koenig, and I'm a medical doctor by training and a pharma and life sciences professional. I have about more than 25 years of experience in the U. S. and Europe in the field. All of my career, I've been developing products from early stages to approval international in several indications, and I've held positions with companies in the U.S. and Europe in various capacities, mainly in product development, regulatory, and general management. Back to you, Francois. Thank you, Reinhard. Let's move to the slide number four. Today, as I said earlier, we took really a bold step forward by announcing the acquisition of the global rights of Cantrixil, our drug candidate from Kazia Therapeutics Limited, an Australian biotechnology company. This licensing has been very carefully considered, and really it builds on our proven development and regulatory expertise in ovarian cancer. As you all know that we have been able to register successfully Apealea in Europe. Furthermore, we plan to evaluate the potential of Cantrixil for synergy with Apealea and with our technology platform XR-17, down the road 18, which is also, in some other words, a double shot at once. We are really particularly excited by this licensing agreement as it is a part of a wider strategy to transform Oasmia into a sustainable specialty pharma company. This is the first of several envisioned product compound acquisitions aiming at beefing up our pipeline. This is really the first step of our, what I would call our string of pearls strategy. Having said that, I will pass the floor now on to Reinhard on slide five, please. Okay. In the next few slides, I will be discussing some of the scientific background of Cantrixil and will paint a picture of its properties. On slide five, let's talk about Cantrixil, a broader overview. Cantrixil is a first-in-class, third generation benzopyran targeting CD44+ cancers, initially ovarian cancer. As you know already, Oasmia already has considerable experience in ovarian cancer through the development of our lead program, Apealea. Cantrixil has shown promising results in pre-clinical development, and those are activity against ovarian cancer stem cells as a key driver of chemotherapy resistance. It's been shown that Cantrixil monotherapy inhibits tumor growth in a model of aggressive ovarian cancer, and it has been shown that Cantrixil and standard chemotherapy combine effectively against chemo-resistant cancers in vitro and in animal experiments. Most recently, top line results were published from a clinical study, a phase I clinical study. The highlights of the study were intraperitoneal I.P. application. The study objectives by and large were achieved. The maximum tolerated dose was determined, a partial response and a complete response were observed. Generally, the compound was well-tolerated. Since this was only a top line disclosure, we're waiting for a peer-reviewed publication that will discuss the entirety of the results. Next slide, please. Let's talk a little bit about the market case for ovarian cancer. As we all know, it's a major medical unmet need with a high rate of recurrence. From a business perspective, this is a market that is growing globally. About 295,000 women are diagnosed or were diagnosed with ovarian cancer in 2018, which makes it the eighth most common cancer in women. Many of those women, probably more than 70%, have a relapse within three years from diagnosis. The market size, according to the measures that we looked at, are considerable, about $6.7 billion. Now, how does Cantrixil work? In order to discuss that, I want to give you a little bit of background on ovarian cancer. Broad strokes, of course, no scientific minutia. Overall, the cancer stem cells play a key role in tumor recurrence and resistance. Cancer stem cells are able to self-renew, differentiate, and initiate and maintain tumor growth. Very often, cancer stem cells are drug-resistant, leading to tumor recurrence and metastasis. In the indication, the standard of care is still platinum and taxane-based therapies, with a significant occurrence of drug resistance after first use. That makes it a very difficult disease to treat, among others. Cantrixil has shown potent anti-cancer activity. Sorry, let's go to slide number eight, please. Slide number eight talks about the pre-clinical results that Cantrixil has achieved so far. Cantrixil has shown anti-cancer activity in some of those experiments, it has been shown that Cantrixil destroys cancer stem cells, that under monotherapy, it inhibits tumor growth in aggressive ovarian cancer model, that there is a effect on the basis of Cantrixil with a combination of cisplatin, in vitro and in vivo. There has been an anti-cancer activity demonstrated across a panel of ovarian cancer cell lines across different histotypes. The IND-enabling profile was favorable for the compound. Next slide. How does Cantrixil work? It may be, and this is still an emerging area of inquiry, that Cantrixil exhibits a multifactorial mechanism of action in combating those cancer cells. One of them is the mitotic arrest that directly inhibits tubulin polymerization. Another effect is the activation of pro-death apoptosis pathways, and other effects are the inhibition of pro-survival pathways. Those targets will need to be fully validated going forward. Next slide. In this slide, I'm going to briefly discuss the phase I safety and PK results. I don't want this to be too technical, so I just want to state that the maximum tolerated dose in this clinical study was established as 5 mg per kg, and that adverse events were assessed, of course, in this study. There was an incidence of abdominal pain, fatigue, vomiting, and nausea. All of those data, please keep in mind, are very early. They are from a phase I study and cannot be extrapolated at this point. Overall, the pharmacokinetic profile is predictable and there is no accumulation of the compound. Next page. Next slide. In the phase I study that I referred to earlier, it was also reported as a top-line report late last year. Cantrixil showed positive efficacy and safety signals. Again, very early signals, not final results. It was shown that out of 16 patients that were evaluable for efficacy, one patient showed a complete response, and two patients showed a partial response. Generally, the compound was well-tolerated with the mentioned GI toxicities, abdominal pain, vomiting, nausea. This is an overview over the data of Cantrixil, both clinical and pre-clinical. With that said, I'm passing on back to you, Francois. Thank you, Reinhard. Thank you for this explanation. Let's move to slide 12 now. With the addition of Cantrixil to our product portfolio, we are building our critical mass in our oncology pipeline. You all know that Apealea has been approved in Europe for adult patients for relapsed platinum-sensitive epithelial ovarian cancer, but also primary peritoneal cancer and fallopian tube cancer. You also know that a commercialization deal has been now announced with Inceptua from Elevar, and commercialization will start this year. You also know that Elevar is making significant progress with regard to their registration in the U.S. Now, we are about to enter the clinics with docetaxel micellar in metastatic prostate cancer. Obviously, we continue to work hard on adding new candidates to this pipeline through in-licensing, initially focused on oncology. The transaction today is certainly the first of a planned series of string of pearls acquisitions and licensing-in deals. Let's move at the slide 13. I'm very happy to report that we have secured a favorable agreement terms for this transaction. With an upfront consideration of $4 million. Development and milestones up to $42 million for ovarian. We have not disclosed the royalties. They are sales based, as you would expect, in line with the standards in the biotech industry. The next steps that you're going to see over the next few weeks and months. First of all, as Reinhard alluded to, there will be a peer review publication of the full phase I results, not only the top line, but the full phase I. We are planning to initiate the phase II next year. Why? We, first of all, need to secure an international drug supply this year for Cantrixil. We will be building up an advisory board. We have already started to talk to most of the leaders in the intraperitoneal fields, also in the U.S. We obviously would need to talk to the regulatory agencies in Europe, but also in the U.S. in order to disclose and validate our clinical plan, which is an essential part of our strategy. Let's move to slide number 14. To sum up, we're really excited about Cantrixil. It's an exciting opportunity with the potential platform synergies. First-in-class tubulin binding small molecule and with a potent cytotoxicity against CD44+ ovarian cancer, but not only ovarian cancer. Potentially bladder and colorectal cancer as well. This drug has the potential to improve the outcome in relapsed ovarian cancer. Reinhard showed the safety profile in I.P. use, as well as a favorable PK profile as well. That work has got an orphan drug designation with the U.S. FDA that is always a plus. From a patent standpoint, we are in a safe position with the composition of the matter patent protection up to 2035. Again, there is other opportunities with this compound in other indications than bladder. As I said earlier, there will be an evaluation of the potential synergy with Apealea. Let's see what we can. I meant here IV formulation and also with our technology platform XR-17/18. On to slide 15. I'd like to say that clearly, this transaction demonstrates our ability to deliver. This is the first step of a string of pearls acquisition and licensing deals. We have a strong cash position of SEK 287 million that was disclosed by year-end. Many of you have been made familiar with our four-pillar strategy for growth. With this transaction, we've made progress against two of those four pillars. The pillar two in red and the pillar four as well. Thank you for listening to this presentation. I hope you share with us our excitement regarding to this compound. I would like to open up to Q&A at this point in time. Back to you, operator. Thank you. If you wish to ask a question, please dial zero one on your telephone keypad now to enter the queue. Once your name is announced, you can ask your question. If you find it is answered before it is your turn to speak, you can dial zero two to cancel. Our first question comes from the line of John Priestley at Edison Investment Research. Please go ahead. Your line is open. Hi there, Francois, and thank you. I have couple of questions, probably ask them one at a time. My first question really is, so why was Cantrixil the best fit for Oasmia, and are there any current limitations that you believe the XR-17 platform is best suited to address? Okay. I mean, first of all, we believe a decent level of expertise in ovarian cancer. That's one point. The other thing is that, of course, for a company of our size, Kazia was happy to give us this compound because it will be a very important product for Oasmia. That's the rationale. Now, in terms of limitations, I'm not sure that I really understand your question. Sorry. If you could repeat it, please. Yeah. I was just wondering if there are any kind of current limitations that you believe the XR-17 platform is best suited to address in terms of using them in combination together? Not really. Well, first of all, of course, the development program of Cantrixil will be an I.P., intraperitoneal. At the same time, we will be testing, evaluating in vitro through the IV formulation, what we could do with our platform. I mean we would need to work on this. Okay. That's great. With the phase II set to start in 2022, we can assume that'll be for the unmodified Cantrixil. I was just wondering if you could provide any details on really the clinical protocol, in terms of maybe number of patients or whether there'll be a combination arm in the phase II trial set to start. Okay. Reinhard, you would like to address this one, please? Yeah. Thank you for the question. It's too early to make any kind of comments or commitments on design and locations. We'll evaluate that in the next few months, and then we'll get back to the market on this. Okay. That's great. Just a final question, if I may. This is obviously a very exciting announcement and really, how many assets do you think will allow Oasmia to reach this critical mass, and when do you expect these additional announcements to come? Right. That's a good question. A challenging one. Well in principle, you know that we are not a one-trick pony. This is the first comment I would say, and what we've done today demonstrate that even more. Now, to your question on how many assets do we need to have in order to have a decent portfolio, well, I would refer to ultimately companies like Genmab, you have the answer. We will need to acquire a couple of more, broaden our scope of activities, broaden the scope of immunology candidates and mechanism of action, in order to have this critical mass that is needed to survive in the biotech world. That's great. Thank you very much for taking my questions. You're welcome, John. Thank you. Our next question comes from the line of Joseph Hedden of Rx Securities. Please go ahead. Your line is open. Good afternoon. Thanks for taking my questions. Congrats on this deal. Certainly makes a lot of sense with your expertise in ovarian cancer and the complementarity with Apealea. Just some questions on the phase I study. Appreciate that there's not a lot more that you can say about data that's not been reported. In terms of this publication, could you confirm whether the full 14 patients are going to be evaluable for efficacy in that publication? Reinhard, please. That's a very good question. The overall dataset will be submitted for the manuscript, of course. I can't make a firm commitment whether or not 14 or 16 will be evaluable. Obviously, we'll do our best. Okay. Thanks. Then staying on the phase I study, we saw the progression-free survival after the dose escalation, and it suggested encouraging in comparison to historic chemotherapy rate for that particular last line patient group. Can you say whether or not you had a chance to see the PFS data before you signed this deal? Appreciate it's not public, but did you see the PFS? I'd rather not comment on that. The answer is no. I'm referring you to the published data on this study. There is an abstract that is available on the web, and there is some other information, previous press releases. At this point, we don't want to discuss those specifics. Okay, sure. Then just on the phase II, you announced that you expect that in 2022, so that implies a fair time period until we get to the start of the study. Is there anything that needs to be done, any additional work you envisage before you get to that trial? Is that why there's a little bit of a delay? In general, there is technology transfer from our partner that takes time, and in addition to that, we want to initiate an authority consultation process and want to get prepared for manufacturing-related issues. That's going to take a little bit of time that we will need in order to initiate a clinical study. Okay. That makes sense. Given the mechanism of action, conceptually, it seems to me that this drug is best suited as a first-line therapy or at least in an early line of therapy. Is that in line with your views? Is the phase II a first-line trial or at least not in such a refractory population as this, where presumably there's already so much resistance that the drug doesn't have as good a chance to work as it would maybe in first line? Right. This is a good observation. This is obviously a very difficult indication with many limitations from a study design enrollment perspective. What we are going to do is, we'll consult with our Key Opinion Leaders, and we will find the best population and protocol to run a phase II study. We're not there yet, but that's an ongoing process. Okay, great. I realize I've taken a few questions here, but just on the financial side of the deal, I appreciate you're not going to disclose very specific details about milestones and royalties. Just wanted to get an idea of the split between development and commercial milestones and whether there is a milestone tied to the phase II start. Yes. Well, as you would expect, we will not be disclosing any details of the agreement. That is industry standards from a royalties standpoint, and I cannot say more about the milestones. Okay. Fair enough. Thank you, Francois. Thanks, Reinhard. You're welcome. Thank you. Thank you. We currently have one further question in the queue. Just as a reminder to participants, if you do wish to ask a question, please dial zero one on your telephone keypads now. Our next question comes from the line of Klas Palin of Erik Penser Bank. Please go ahead. Your line is open. Thank you very much. Thanks for taking my questions. I just wonder if you could elaborate a little bit about possible cost that will be added to Oasmia in 2021 for Cantrixil. Also perhaps, I guess you will not disclose that much about the milestone package, but maybe you can say if there will also be a milestone payment when starting the phase II trial. Okay. We disclosed by year-end close to SEK 300 million in cash, in SEK, and you know that we have reduced our burn rate significantly, so we have plenty of financial muscles to execute on our plan with Cantrixil, and I cannot comment any further. With regard to milestones/royalties, unfortunately, I cannot disclose anything on that, and which is not probably surprising to you, Klas. Sorry for that. No. Okay. Also, there's a lot of pre-clinical work done with this compound. I just wonder if the previous owners have perhaps been looking into combination with mTOR inhibitor. Reinhard, please. Yeah. I can't comment on what previous owners did, but this is certainly an area where we would be interested in getting input from our KOLs and see what the possibilities are. The answer is yes, it's interesting, and we'll evaluate it. Then my last question is about, you also mentioned that you want to evaluate an IV solution with your platform. Is that regulated in the deal that you have now signed with Kazia? Well, no. This is not. This is, let's say, an added benefit for us, for the compound, for Oasmia, for our investors, to evaluate further any individual work with regard to the IV formulation and potentially whether we could improve it with our technology platform. This is totally independent from the deal with Kazia. Okay, great. Thank you very much. You're welcome, Klas. Thank you. We've had a couple more questions come through. The next is from the line of Tony Olsen, our private investor. Please go ahead. Your line is open. Yes, hello. Thank you. Could you just clarify that this is in fact the XR-17 and new API that you have referred prior? Yeah. We have initiated some work with the technology platform in an upgrade manner. Okay? I don't want to be necessarily specific. We will be using our technology platform and potentially the upgraded one, in order to perform the necessary in vitro work with Cantrixil. I think this is the answer to your question. I understand. You have previously said that you will announce a new API and XR-17, and I just wanted to clarify that this is in fact that combination. Well, this does serve that purpose as well. Whether this is a new API, I cannot comment on that. We are still working on another API as well, as we speak. Okay. Thank you for that. From what I understand, this is not chemo and it is not intravenous. It seems, from what I could read, there wasn't any toxic issues. What could be the advantages of combining it with XR-17? It's not the typical advantages that you would have from Apealea or other chemo combination. I think there are two things. First of all, the phase I has been performed intraperitoneal. Okay? The phase II program will be intraperitoneal. At the same time, we will be evaluating whether the IV formulation could be exploitable, and whether, at the same time, we could potentially improve it with our technology platform. This is two different things. Okay. Thank you. You also mentioned that you will be looking into combination therapy and not just monotherapy. If you would combine it successfully with Apealea and it would be addressing first line rather than relapse, when that is all finished and done, how would that affect and synchronize with your current deal with Elevar? Considering it would include Apealea and Cantrixil. Okay. Reinhard, would you like to address this one? Yes. Great questions, but the last question specifically is obviously speculative and looking far out. We are driven by research. We will take the next steps. We will find out if there is any synergy with our therapeutic regimens, then we'll explore them. We haven't really thought about potential business-related transactions or interactions based on the Apealea situation. It is more a scientific possibility that needs to be validated. At this point, we can't really comment on that in more specific fashions. I understand. I just figure it would be a game changer for Apealea if it also moved Apealea into first line and not just relapse. I just figure it would have something to do with Elevar as well. Yes. That's a great thought. Yeah. Okay. Thank you. My last question is considering the report you had recently, you disclosed that there is $ 30 million worth of inventory and finished cost of goods. What are those $3 0 million worth of inventory? Well, I cannot comment specifically on that. This is part of our relationship with Elevar, and we are addressing that as well. Okay. Thank you. You're welcome. Thank you. We've got one further question in the queue at this time. That's from the line of Joseph Hedden at Rx Securities. Please go ahead. Your line is open. Thanks for taking my follow-up. It was just on pre-clinical data in terms of now that you've licensed this product, how quickly do you think you could do some pre-clinical work testing the synergy, the potential synergy with Apealea? Would it be possible to see pre-clinical data from such studies over the next year? That is a great question, and it's one of our priorities. We're assessing the timing and will then plan appropriate pre-clinical work and get back to the market on this. Okay, thanks. Well, congrats again. Thank you. Thank you. Once again, if there are any final questions, please dial zero one on your telephone keypads now. Okay, there seems to be no further questions at this time. I'll hand back to our speakers for the closing comments. Thank you very much for listening to this presentation and asking those questions. I hope you are sharing with us our excitement with regard to this transaction, the first step in our string of pearls strategy. We will continue to work hard behind the scenes to evaluate all the opportunities such as today's news. Not all of them will get to the market, will get to the finish line, let's say. I appreciate your patience, your commitment to Oasmia, and I'm sure that we will have another opportunity to speak pretty soon. Thank you very much to you all.
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