Vivesto AB (VIVE.ST) Earnings Call Transcript & Summary

Please go ahead.

Thank you very much, and good morning, everyone. I'm very pleased to be here today, although I've got a strong cold. So I do apologize for some of the tones of my voice, but very pleased to be with you to update you on our progress of the last quarter. So Slide 2 please, which is a forward-looking statement. Slide 3 shows Fredrik, that's together with me, we'll go through this Q3 report presentation. Let's go to Slide 4. So I thought it will be important to recap very quickly what has been done over the last 18 months. Since March 2020, when I joined Oasmia, I've been focusing all my efforts together with my colleagues to transform the business. We've been taking a number of important steps to get the company ready for the future. That means, first, streamlining our activities to focus on growth opportunities; two, strengthening our balance sheet and getting the best value from our standing; three, and this is very important, building our in-house capabilities to make us a partner of choice in oncology. And of course, the last piece is also very important, we've been able to reduce the risk by sorting out many of the problems we have inherited and most recently, settling in outstanding legal issues. Slide 5, please. This is our mission statement, which really sum up where the business is now heading, building a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanism of actions. Slide 6, right, so all this hard work will now enable us to look ahead rather than backwards. Going forwards, we have 2 areas for future growth. First, oncology R&D builds around our wholly-owned development-stage assets like Cantrixil and docetaxel micellar, which will start to drive value as they progress through the clinical development stages. We are working hard to add innovative new programs that will give us a diversified oncology pipeline through M&A and in-licensing. Second, this is what I would call the business line. This is the maximization of our existing assets Apealea with our commercial partner, through our commercial partner and we anticipate revenues that will start to flow in 2022 generating certainly cash for future reinvestment in our company. At the same time, we continue to refocusing on the underlying science for our proprietary drug delivery technology to optimize its potential in cancer. Slide 7 now, which really emphasize and outlines the progress that we have done during the third quarter of this year. Well, we have continued to build a first-rate team with the skills to take innovative new products from early-stage development through business development and late-stage partnering. Then we've made the final move in outsourcing the commercialization of Apealea, signing a license agreement with a Swiss company called FarmaMondo to commercialize the product in Russia and Commonwealth of Independent States called CIS. With regard to Inceptua, which is the -- as you know, the Elevar chosen commercial partner for Apealea in Europe. Clearly, Inceptua is planning to launch in Europe to start with Germany and the U.K. because those countries are free pricing. Therefore, we need to maximize this opportunity and Inceptua is telling us that those launches will start during H1 next year, therefore, generating revenues for us as well. At the same time, we are watching closely the Elevar plan in the U.S. market regarding the clinical development. I have to say that Elevar continues to evaluate the best clinical and regulatory pathway to deliver the maximum impact for the patients, for the clinicians, and we will update you when we learn more from Elevar on the finalization of those plans. In our growing pipeline of therapy for hard-to-treat cancer, we held our first scientific advisory board meeting of key opinion leaders to guide the preparation for the Cantrixil Phase II initiation. At the same time, we have started to negotiate complex drug supply agreements and the timetable for the start of that study has moved back slightly to reflect those and I will come back to that once I have more certainty on the finalization of the agreement with regard to the manufacturing. Docetaxel micellar Phase Ib is on track to be completed late 2022. That means the enrollment with our 3 Swiss centers that are now open. As I mentioned earlier, we are accelerating our work on adding new products, working with leading investment banks on licensing and M&A. Finally, we've been able to reduce our business risk. This is very important. Most recently, we have announced a global settlement of several outstanding legal disputes that we have inherited. Slide 8, please. So over the past 1.5 years, we have completely transformed the team that will take us into the future, bringing in senior-level executives with first-rate experience in our industry. And in particular, we've been able to recruit people with the capability and experience that have -- in order to build and develop a diversified oncology pipeline and this is important. So we have now industry leaders with us that are coming from Roche, Eli Lily, Novartis, GSK, Genentech and other first-rate companies. As I mentioned earlier, during this quarter, we welcome Kia Bengtsson as our Head of Clinical Development who is joining us from the Nanologica and -- who previously worked at AstraZeneca and Ipsen; and Johanna Röstin as our Head of Clinical Development, who has an excessive experience from Sobi, Pharmacia, and Biovitrum, sorry, Head of Regulatory. I have to also to say that -- I'm sorry to say that Peter Selin has decided to leave Oasmia. Peter will remain in his role while we have already initiated the search for a successor as Head of Business Development and M&A. Very grateful to him for his contribution to our company. Slide 9, please. There were a number of developments around Apealea in the last quarter. Our global license partner, Elevar Therapeutics has sub-licensed the product to Inceptua in Europe. I think I mentioned that, including the Nordics. Inceptua is a well-established European pharmaceutical company focused on rare diseases and specialty products. They have a special capability in market access in the hospital segment and that's the reason why we are confident that the launch that is foreseen for H1 2022 in Germany and in the U.K. will be successful. In September, we completed the out-licensing of Apealea globally with an agreement with FarmaMondo, the Swiss-based company for Russia and CIS and that was a territory where Elevar did not acquire the rights from us. On the clinical development side, in the U.S., it is absolutely certain that Elevar is committed to make it a success and clearly, there will be some adjustments in the time lines of the regulatory and clinical development plan for Apealea in the U.S., and we will let you know once we get some information from Elevar when final decisions will be made on how best to proceed in order to reduce the time to market. That is absolutely essential goal that Elevar has in mind. Right, let's move to Slide 10. With regard to Cantrixil, we've made some good progress in our -- with regard to this first acquisition of our string-of-pearls strategy. This small molecule has a very potent cytotoxicity against specific ovarian cancer stem cells and ovarian somatic cancer cells that are resistant to current standard chemotherapies. We have appointed a first-class expert advisory board, including key opinion leaders on a global scale such as Professor Jim Coward, who is our Principal Investigator from Australia. They met for the first time in September to give us guidance on the structure and on the design of the Phase II program and we will be consulting them regularly throughout this process. This is obviously a multiple-stage process. We've been also starting to work and renegotiate with different suppliers for the drug needed for the trial and this is quite a complex operation that does involve several parties. To manufacture Cantrixil, you need a couple of suppliers. So we also, here, we are trying to reduce the time to market. We're trying to simplify as well and at the same time, secure an excellent manufacturing chain because as you know very well, without any product, there is no business. We are also planning next year to initiate the interactions with the regulatory bodies in order to validate our design of our Phase II and I think this is extremely important for us. Without proper validation, you run into the fog and this is exactly what we want to avoid. We want to drive in a very clear sky. Let's move to the Slide 11, please. So this is docetaxel micellar. There is good progress made by our Swiss partner, SAKK with regard to the progress in terms of enrollments. This study is now underway at major hospitals in Switzerland. The goal is to recruit 18 chemotherapy-naive patients and the target of completing the enrollment of this study is on track to be expected by the end of 2022. Right, next slide, Slide 12 relates to our project with Karolinska Institutet. This project is to explore the full potential of XR-17 drug, the solubilization technology platform and we are really on track to report the results of this first stage. This is mainly an in vitro work in this stage in order to have a better understanding of the cellular mechanisms and it is, as I said, nearly completed. I will be happy to report that next time we speak. Slide 13, becoming an attractive partner for innovative oncology assets and companies require a number of things and the work we have done over the past 18 months has had a clear goal, which means to put in place all the internal pieces that will make us a compelling development partner for innovative oncology assets and companies. We now have expert capabilities from early-stage development through commercial and partnering. And obviously, with the help of specialist banks, we are able to focus on the final piece of this puzzle and that piece is building a diversified cancer portfolio with multiple mechanism of action and offering multiple shots on goal to increase chance of success. Let me go through a little bit more into details on this on Slide 14. We are working hard on business development and licensing to deliver on the potential of our string-of-pearls strategy to build that critical mass. We are seeing more and more as an attractive partner for promising assets, leverage our internal development, regulatory and partnering scales. We are seeking to in-license oncology product from pre-clinical to late Phase III. I have to say that we have performed around 8 full due diligence on a number of target oncology companies and/or assets with several projects ongoing. And of course, as you know, it's always a matter of fit from a science and from a finance perspective. We are confident that one of them will materialize relatively soon. I will now hand it over to our CFO, Fredrik Jarrsten, to share with you some of the recent legal updates. Fredrik, the floor is yours.

Thank you, Francois. So on Page 15, we, as Francois mentioned, 1 key development announced after the end of Q3 was settling the inherited range of complex legal disputes. So this global settlement addresses all disputes with MGC Capital, former Board members of Oasmia as well as members of former management. And the settlement results in a negative cash flow impact of SEK 24.5 million, but with a positive effect on earnings of SEK 32.5 million and this will be accounted for in the fourth quarter. We can also conclude that with the settlement, debt of SEK 80 million plus interest as well as a receivable of SEK 40 million plus interest in relation to MGC is settled. With that, we will strengthen the balance sheet and our financial position and eliminating borrowings. And most importantly, as set out here by our Chairman, this settlement enables Oasmia to now really focus on delivering our strategy going forward. I think we can continue with Page 16, which is the few key numbers I can give you as a snapshot of our performance in Q3. So this quarter, we had net sales of SEK 11.9 million to Elevar and that relates to sales of semi-finished drug products from our inventory, and those products can either be used for clinical studies or commercial supply. We have operating costs, amounted to SEK 26 million in the quarter, which is a further reduction since Q2 where we had SEK 32 million in operating costs. And also, this confirms the annualized cost savings of more than SEK 100 million since year 2020. Our operating loss for the quarter was minus SEK 29.6 million, which is an improvement compared to Q3 last year, where we had minus SEK 35.1 million. The improvement is attributable to lower costs as well as higher net sales. The operating cash flow, roughly equivalent to the cash burn in Q3 was minus SEK 26.8 million. Per month, that is an average of SEK 9 million and that is now below our target cash burn as we have previously indicated of SEK 10 million to SEK 12 million per month. And finally, the cash balance was at SEK 150 million at the end of the quarter. Now that's still a solid cash position and considering our present run rate, that's enough for the coming 12 months, but obviously, for the long run and for potential business development projects, we are continuously evaluating different financing scenarios. And with that, Francois, back to you.

Thank you, Fredrik. So let's move to our final slide, Slide 17. Looking ahead, there are a number of potential catalysts to support and drive value in 2022 and beyond, including well, continued M&A and licensing in to build out our pipeline; our sustained progress of the preparation of the Cantrixil Phase II and the completion of the docetaxel micellar Phase Ib; third, the improvement of our understanding of the potential of XR-17 through the Karolinska Institutet program; fourth, the initial revenue and cash flow from Apealea and potential for partnering by Elevar, in particular in China; and finally, our divestments or partnering agreement for our animal health business. So this concludes my presentation and we'll be delighted to open up to Q&A now. Operator, the floor is yours.

[Operator Instructions] And the first question comes from the line of Joseph Hedden from Rx Securities.

Just the first one on -- I guess I'm looking for what your interpretation of Elevar's current position is. They are looking for a clinical and regulatory -- the best path forward, but they've previously announced the loose designs of a couple of trials that they thought could serve to support the NDA. What's your understanding of why they've now reassessed because presumably, they've been through some kind of a commercial due diligence procedure before announcing that? Do you think that this is going to cause just a slight modification of trial design maybe or are we talking different indications? What's your take?

Well, thank you for the question. I mean, clearly, Elevar has reshuffled their clinical and management team quite recently. They have been revisiting the whole clinical plan in order to try to speed up the development piece of the trials in order to make it available for patients as soon as possibly in the U.S. At this point in time, I cannot disclose anything. Elevar will come back to us with regard to the final plan. The overarching goal is to reduce the time to market and make sure that those plans can be executed quickly and that's important. And then they will have also some regulatory advice as well down the road to validate those plans.

Okay. That's great. And then you commented, Francois, on the European launch by Inceptua and it's good news that they've communicated to you the -- obviously, they are looking to launch in the first markets, the U.K. and Germany, which would be the ones that we always expect drugs [ launched first ]. So can we take that as there have been positive reimbursement decisions in those countries?

Yes. I mean, obviously, you know that this market are repricing in the hospital sector, at least to a large extent. That's the reason why they want to start with those key markets. So there will be orders followed in Europe such as Italy and Spain and then others as well. Clearly, negotiation with regard to pricing and reimbursements will occur. The marketing authorization order will be in their hands in December. So obviously, the formal part of those negotiations can start right afterwards. But it's an excellent sign for the company, for Oasmia to see finally the launch of Apealea in Europe.

Okay. And then just lastly on Cantrixil, you mentioned that you're still negotiating supply and it's a slightly complex process. And good news that you're meeting with -- you've started a scientific advisory board and a trial design. Do we -- could you give any kind of projection on when you expect that a trial could start given those 2 items are still in flux?

Yes, I mean, the rate-limiting factor is the manufacturing piece. And why? Because Cantrixil is a molecule that with its changes and particularities and clearly, the supply chain should be properly arranged. It is not that easy, but I will communicate that once I have more certainty and final agreements with the suppliers. To manufacture properly Cantrixil, you need to have 2 or 3 suppliers, okay. So obviously, with a tech transfer time frame there and there, you can imagine that some delay may occur. So this is exactly what I want to avoid. So I am revisiting the whole strategy with regard to the manufacturing in order to simplify it, have a global, well-known leader in manufacturing in order to reduce the risk of any delay and also failure. And I will communicate that once I have full certainty on that.

Okay and just to clarify, it's not possible to use the previous supplier, the previous process was adequate?

When we acquire -- yes, yes, we, of course, we have been in touch with that supplier, which is a small-scale supplier and again, they cannot do drug substance up to drug production. So you need to have other steps made by other suppliers and this is exactly what I want to resolve. I want to have a lean and mean manufacturing chain that is solid, that is reliable and that's the reason why we are talking to major players.

Our next question comes from the line of Thomas Nilsson from Analysguiden.

I have 2 questions. First, with regard to sales development in the markets where Apealea has already been launched, do you have any comments there?

Well, I think I said a number of times that when we wanted to launch Apealea in the Nordics, we were hit very quickly by the COVID and therefore, the launch in the Nordics has been put on hold. And now Inceptua is revisiting the matter of the Nordic launch and Inceptua will communicate at the right time the progress with regard to Nordics, but clearly, the goal is Europe.

Okay. And my final question is, given your current cash position and the level of your operating results, do you foresee any funding requirements for Oasmia in the coming 18 months?

Fredrik, would you address this one?

Yes, so clearly, as I mentioned, I mean, the cash position we have at the end of the quarter and looking at the run rate, that's enough for coming 12 months, but obviously, looking beyond and looking for the long-term aspect as well as business development projects, I mean, we are evaluating financing options. So I can't give you any more details on that, obviously.

Our next question comes from the line of Klas Palin from Erik Penser Bank.

And I would like to start off with a question about Cantrixil and the study this time. I guess you're working with it and you need to interact with regulatory agencies to finalize it, I guess. Do you have some sort of a time frame to share about when such interaction could happen? And also about this M&A activities you are working on, should we expect this is about assets rather than acquisition of companies? That was my questions.

Thank you, Klas, and good morning to you. Well, with regards to Cantrixil and our interaction with the regulatory bodies, such as MPA, EMA and FDA, that will occur H1 next year. And the -- as you know, this is -- the design is for intraperitoneal, late-stage ovarian cancer patients, second or third line. We envision classical basically clinical design; I will share it with you once it will be validated by those bodies. Again, it is so important to have the blessing of our regulatory authorities, but this will happen H1 next year, yes. With regard to your second question, well, we have looked extensively at the Nordic market both in terms of companies to acquire and/or assets to licensing in. Out of these 8 due diligence that I mentioned during my presentation, obviously, for obvious reasons, I cannot detail that much, but we're looking at both. Ultimately, it's a matter of fit with our portfolio, it's a matter of balancing risk and return, it's a matter of financial consideration as well. So all those elements have to be right before we can materialize one deal, but usually, we are looking at from pre-clinical up to Phase II. This is our main window of operation. Beyond Phase IIb, we believe that with a large Phase III, usually, we would need to have a partner or for selective indication, rare diseases, rare cancer indication, we may certainly envision to commercialize on our own at least in some selected markets in Europe, but the overarching goal is really the fit with the portfolio, using different mechanism of actions. Why do we want to do this? Because we want to derisk the portfolio. We cannot become a one-trick pony like some companies that you've seen in the Nordic sector that have experienced a number of failure in terms of program. I've been there before. I know exactly how it is. And in my responsibility as a CEO, and I know it takes time, and I know that there is some frustration around, but the main thing is really to build a proper portfolio that is with different mechanism of action that reduce the risk of failure. Because, of course, if you have in your portfolio 4 or 5 compounds, not 4 or 5 will make it to the market. We all know that given the attrition rate in our industry. But I have to say that look, for Cantrixil, this is [ a kind of cyclodextrin ]. We acquired that product for a relatively small amount. There is a great deal of potential in IP and we will be working on an IV formulation with our platform. So then it does open up a totally different field for Cantrixil, for instance. And we also know that for Cantrixil, we could also develop the compound in other indications than ovarian because of the nature of the mechanism of action and the molecule. So you see.

Okay. Great. And a follow-up on other indication. Are you evaluating Cantrixil in pre-clinical models for other indications?

Yes, to be honest, not yet, but it's part of the plan next year. Clearly, the main focus this next year will be on developing in Phase II, going to the regulatory bodies. And as I said, make sure you have a proper supply chain. And at the same time, trying to develop the formulation in IV. Because, of course, ovarian cancer is a very crowded market, as you know quite well. You have a number of new chemical entities in the market, such as PARP inhibitor. So that does open a total new field of combination that we could basically try. So I'm very optimistic with Cantrixil. It's a supermolecule. I'm super glad to have the global rights and then, of course, my immediate concern is to help patients that are very sick with this intraperitoneal administration. So we will build up a global trial. We will have the U.S. involved, Australia, Europe in order to not to spend 10 years at recruiting patients you see.

[Operator Instructions] Our next question comes from the line of [ Eric Hagen ] from -- as a private investor.

Thanks for all the hard work that you are putting into this. I want to ask about -- you touched upon it briefly, but the new indications for Apealea, it is likely to come during -- be announced during 2022?

Yes, so you are aware that for the new indication with Apealea, it is in the hands of Elevar. Elevar is now focusing on making sure that the ovarian clinical plant in the U.S. are secured. So this is their primary focus and of course, I cannot comment on anything else that relates to new indication for Elevar.

But previously you said 2021. So I thought maybe it was connected to one of the studies that -- the new indications, but it's not that easy...

I don't necessarily recall having said that, but...

Okay, one more question about the milestones. You said that it's likely to come during 2022. Is that -- you still consider it likely?

Fredrik, you want to take this one?

I think we will leave it uncommented, I think. Francois, do you have any...

Well, I mean clearly, if we are launching -- if Inceptua is launching in a number of European markets next year as they will, you can anticipate or guess that royalties will follow and potentially milestones as well.

Okay and last question about the Named Patient Program. Is there a lag between the sales and the royalties that we see at Oasmia?

The Named Patient Program is managed by a company called Tanner. It is totally managed by Elevar and the Named Patient Program is actually not really the focus of Elevar as well because, by definition, you can expect -- it's really ad hoc prescription to patients. So better focus on European launch.

Yes, but I don't -- I think if there is sales, will it show at Oasmia's results right away or are they holding the royalties for some time. Do you understand what I'm...

Yes, the Named Patient Program is a special program and it is on the request of physicians. So Elevar will certainly count those prescriptions and potentially, that will be disclosed as well. We will come back to you once we have some more information on this, but again, this is not the focus of Elevar.

Our next question comes from the line of [ Tommy Olson ] as a private investor.

Hello, guys. I just want to say that I was happy to see that you forecast a reduced burn rate from next quarter. So that is positive news. However, I would like to hear your comment, that's [ really the hope ] today, that you will not move on with any development regarding XR-19, even though you actually achieved proof-of-concept.

Yes, but that's unfortunate, this is the fate of any research activity. So we have achieved a pre-clinical proof-of-concept combining 2 API into one, but then there is no utility in oncology. That's the problem. In oncology, everything is measured in milligram per square meter you see and you cannot have a fixed combination.

I understand, but on the annual meeting last September and also, I think, earlier that day on the conference call, that's why you said XR-19 would most likely be used outside of oncology.

We -- sorry, what did you say at the end?

You said earlier in the conference call and live on the annual meeting in September last year that XR-19 would most likely be used outside of oncology.

Yes, but then at the -- yes, which is correct, but at the end of the day, you want to focus your money on the project that will generate most of your revenues. So you want -- that is an important aspect of our activities. We want to spend the money where there will be some effective return. Now to go beyond oncology would require extensive business development activities. So we have just achieved in-house pre-clinical proof-of-concept. So it's not unreasonable to stop XR-19 as it is and refocus on, for instance, developing Cantrixil with XR-17/18 in order to produce an IV formulation. This is exactly where we will spend, where the buck will be generated. So you have to make choices in a small company.

Okay, in February, in an interview, you stated that you had great interest regarding AdvaVet and you had less than 10 companies interested and several of these have gone into due diligence and you were confident that you could reveal something within 6 to 9 months and finish a deal. What is the situation now? And is any of those companies still in talks and in active discussions regarding AdvaVet or is AdvaVet sort of back at square one?

We continue to explore that partnership and/or divestment opportunities. I cannot comment any further. This is certainly an activity that we are pursuing. I'll inform you once I have some more concrete results.

Yes, I was just thinking that since you were so clear saying that you had several companies interested and you are confident you would finish something within 6 to 9 months that maybe that should be happening already or at least quite soon.

I can't comment any further on this.

Okay. There were a lot of discussions and questions about Elevar and a lot of things are in the hands of Elevar. In December last year, you had this big -- shown this presentation when you talk about the future for Apealea and at the time, it seemed very clear the future for Apealea and the strategy they had. They had already talked to several key opinion leaders and they were very confident. Clearly, something's changed since, but also back then, they stated that they were in a deep discussion and expected to present partners for Latin America and China soon and ever since, Oasmia in all the presentations have showed that they are also in good negotiations with partners, but on your last November's presentation, Latin America was removed and on today's presentation, China is no longer on the list. What does this mean for potential partners in Latin America and China since nothing has happened since they stated that they expect the partners to be completed soon?

Yes, this is again a question for Elevar. Elevar has not indicated to us that they have stopped looking for partners in both of these continents, but I cannot comment any further. I'm not speaking on behalf of Elevar here, but the partnerships are still in their radar screen, absolutely, yes.

Have you asked Elevar together with you make some kind of new joint presentation due to the fact that you have also communicated to your shareholders about the partnering in the sense of Apealea going forward in the future? Have you talked to them about trying to clarify things for your shareholders as well?

Yes, that's a good point. Once the clinical plan will be able to be disclosed, post review by the regulatory bodies, then I can certainly ask Elevar to do so and to present an update. I anticipate that during the course of next year. That's certainly a good opportunity to update the whole market, yes.

Okay, my final question involving Elevar, it's been a year since the Taiba deal was signed and we haven't heard anything about this. Is there any progress going on there or have they also decided that they want to wait for the result for the upcoming studies before they approve anything in Saudi Arabia?

No, for Taiba, that's a different story. Submissions will occur fairly soon from Elevar/Taiba in the Middle East, namely Saudi Arabia. So there is not, as far as I know, not a waiting time linked to the U.S. study on that one. No, they will be using the European package.

Okay, that is positive news. You recently disclosed your new partnering with FarmaMondo. So I have a couple of questions about the Russian market as well. So you stated that you will have a product supply agreement or revenue model rather than royalty deal. Can you say something about why you chose to go for that model and what does it mean for us now?

Yes, I mean, unfortunately, I cannot comment on this kind of questions, which are very specific. What I can tell you is that the previous partner, it was not working very well and we have the luxury to find a real partner that wants to commercialize the drug. Now let me tell you that sales cannot happen tomorrow. It cannot happen because there is the serialization process for the buyers in Russia. So we expect to have initiation of commercialization late '22, but I cannot give you any more details on the business model for reason that you will easily understand, but there will be commercialization of Apealea in Russia at the opposite of the previous situation that I inherited.

Is there any risk that the -- usually lower price point in Russia will affect the ability to negotiate the right prices for Apealea in Europe and do you have any expectations for Paclical to be used in first line in Russia?

No, Russia is a totally different market. It's more like a kind of a closed market. I have experience with this in my previous big pharma life. For Russia, you need to be put on the essential drug list and once you are in it, I can tell you, it's great, because then you have wide access to many hospitals in Russia. So that's the main thing that FarmaMondo will try to do. And then there will be potentially usage, not necessarily a stricter sense according to the labeling, but you know that I cannot say that. This is up to the physician to decide, not up to the manufacturer, but the market dynamics in Russia are totally different compared to Europe. So there is no interaction at all.

Okay and if I switch back to country for a second, you have previously mentioned the possibility with a good data from the Phase II that may be aimed for accelerating approval in the U.S., but it becomes kind of clear in the past year or so, that FDA is getting more restricted with the accelerated approvals. Has this changed or affected your opinion about the possibility to apply for an accelerated approval of the Phase II and [ potentially takes 3 to 4 ] years for market -- to reach the market compared to a Phase III as well.

No, that's a good point. It is exactly what I'm looking at. We have an orphan drug designation, which is great because no other companies will get that nowadays. This has been extremely reduced. So we have this great status. Then remember, this is -- Cantrixil is for very sick and hard-to-treat patients, second, third line, fourth line intraperitoneal. So clearly, there is a high level of unmet medical need. So the goal here is to design the study that is powered enough from a statistical standpoint in order to -- if the data is good to be submitted as it is to the regulatory body in the U.S. to the FDA. And of course, we will meet with them before and you know that their advice is not binding, but usually, if you are a good citizen, if you do what they want you to do, well, you have a decent chance to have it approved quite soon. We may have a post commitment post marketing approval, something similar like that, but I am confident to try this route, which is not a route that is blocked nor -- there is still a possibility for such an indication for such a product.

Because the IP formulation or administration, it's a little less common, should that effect make it sufficient for Oasmia to have fewer patients in a Phase II trial compared to a trial with an IV formulation.

Yes, no, you're correct, but however, we will be envisaging a global trial. So we will have multiple centers all over the world. That's the only way to recruit fast and we have also the luxury to have most of the opinion leaders that are in favor of IP on our side. We know them. They are mostly in the U.S., a few in Europe, but mostly in the U.S. and they were with us on our advisory board. So no, I mean, I'm confident that this Cantrixil IP would be a successful story. I'm absolutely confident, but again, I cannot predict the outcome of the trial even if we haven't started yet, but I know that we are putting everything that we can to make it a success.

Okay. That's good to hear. For Oasmia, in the communications have changed their value drivers from XR partnering to XR enhancement instead, sort of shifting focus to XR-18 and the development for the future. I personally have all of this, as you will probably not have out-licensing deal on the XR-17 until you have sort of really success with XR-18 and with XR-18, at least twice, you have sort of revised the time frame for the XR-18 development. What can you say about the development of the time frame for the XR-18 at the moment?

I think I mentioned that in the quarterly report. This is clearly mentioned that we are working. The target is next year, but next year is not the launch of XR-18. It is the progress in terms of preclinical to clinical developments. So this is one point. 2, well, if we embark on a full development plan with a platform like XR-18 or whatever, it will take years and years. So instead of trying to work as a big pharmaceutical company, you see we're better off by using what we have and that means Cantrixil and Cantrixil is perfect. It's a small molecule. We know that molecule needs to be more solubilized and we have this IP formulation, and we want to do the IV formulation. This is what we are doing and this is what we should be focusing on our efforts. This is more short term; it could deliver more value than any other program we could develop with those platforms. Because, as I said earlier, because it does open up a full range of new combination for ovarian, but also for other indications, lung, breast to be further developed. It will take some time as well, but certainly, less time than if we start all over from scratch.

Yes, I think you're doing the right thing and just like you say, you need to de-risk the portfolio, not be a one trick pony. I just think that my concern has been how to finance multiple studies at the same time while Apealea is only approved in Europe, not making enough cash sort of to make the run rate go and I think that's why so many people were hoping for divesting the AdvaVet or extra out-licensing deals to sort of get these upfront payments to pay for the entire process for the next 4 to 6 years.

No, that's fair. That's a fair comment. We are still working in this area in parallel. The main thing -- the great thing is that finally, and then as there is some delay in terms of launching due to the Elevar situation, but finally, Inceptua with launch Apealea in Europe, and that's absolutely great news. I know there is some delay, but still, I mean we are making it happening now.

Yes, I'm just hoping they will surprise in a positive way with the sales.

We talked about that...

And as we have no more questions registered, I now hand back to our speakers for closing comments.

Thank you, operator. Thank you for all to listening to this quarterly report. I think that we made some significant progress. I was hoping to be able to convince you on this and yes, there were some delays in our development program, but now we're catching up and really, we have great hopes with not only the development of Cantrixil, our M&A and licensing in activities, but overall, the launch of Apealea in Europe. We still are a few companies in our sector able to launch a product that has been approved in Europe. How many companies of our size are able to do so? Not so many. So remember that. Thank you to you. Have a great day.