Welcome to the Oasmia Pharmaceutical Audiocast, the teleconference Q2 2021. With us today, we have CEO François Martelet and CFO Fredrik Järrsten. For the first part of this call, all participants will be in listen-only mode, and afterwards, there will be a question and answer session. I will now hand over to François. Please go ahead. Thank you very much, good morning, everyone. It's a pleasure to provide you with an update on our Q2 and interim results together with our CFO, Fredrik Järrsten. Good morning. Slide two is the forward-looking statement that I will not ask to read, obviously. Slide three is to the speaker slides. Now on slide four. This quarter was essentially a quarter of transition and build. As we continue to upgrade our level of internal capabilities, continue to make the best decisions with Elevar regarding Apealea in our own remaining territories, and above all, we've been heavily involved in M&A and licensing-in activities. Together with Elevar, we have agreed that the best partner for commercialization purposes in Europe is Inceptua, given their track record in the hospital market in Europe. On the staffing side, it's extremely important to remain competitive should we want to become a leading oncology player. To that end, I'm very pleased to report that Dr. Reinhard Koenig, who worked for us as a consultant for many years, has accepted the role of Chief Scientific Officer. We have also recruited two senior-level executive in medical, a Head of Clinical Development, and a Head of Regulatory. All three positions are critical if you want to have enough expertise internally to be able to pick the right targets externally and to develop them as well. The Board has appointed Andrea Buscaglia as an Independent Director. Andrea brings to the Board a lot of experience in the financing area that will be very useful down the road. He's currently CFO of Medicines for Malaria Venture. On the clinical side, we have achieved on time the initiation of the SAKK study using docetaxel micellar in advanced prostate cancer. This study is currently recruiting in several Swiss centers. Believe it or not, given the COVID times, this is a significant achievement. Cantrixil phase I data have been reported in a renowned publication, which confirms the fact that we have picked a good target to be further developed from a clinical standpoint. All in all, it was a very exciting quarter, a quarter of build, fundamentally, as you could see. I will now hand it over to Fredrik to provide with the Q2 financial highlights. Fredrik, please. Thank you, François. Next page five. If we look at the key figures for Q2. This quarter sales, we had SEK 4.6 million. This is also in H1 sales, basically. That relates to other income from sale of finished products from our inventory in preparation for Elevar's PK study. If compared sales in H1 2020 last year, that was almost exclusively a result of the first milestone payment from Elevar, as you know. The upfront payment of $20 million. Operating expenses amounted in the quarter to SEK 32 million. That confirming annualized cost saving achieved more than SEK 100 million since 2020. The operating loss for the quarter, -SEK 56 million. That included a non-cash item of a write-down on inventory due to expired or soon to be expired shelf lives of finished products of SEK 17.4 million. The major part of that write-down was related to finished product intended for the Nordic market, where the COVID-19 pandemic has had a clear delaying impact on marketing activities. If we adjust for this write-down, the operating loss was approximately SEK 39 million. The operating cash flow, roughly equivalent to cash burn in Q2, -SEK 41 million. In H1, that was -SEK 75 million. That year to date translates to cash burn at around SEK 12 million per month. The target going forward is still set at a cash burn rate of SEK 10 million-SEK 12 million per month, as we have previously indicated. Cash balance, SEK 176 million at the end of the quarter. At the current cash burn, I want to emphasize, we have more than enough cash for current operations for the upcoming 12 months. Obviously, we are evaluating a number of business development projects, so we are also evaluating a number of financing options for those. With that, I'll hand back to François. Thank you, Fredrik. I am now on slide six. Since I joined the company back to March 2020, we have achieved a lot in relation to the transformation process of Oasmia. The management and the Board have been changed, bringing on Board senior-level executives from the sector, all of them with a good track record in our industry. The strategy has been re-articulated and further communicated to the market. We now have a crystal-clear strategy for the next 18 months or so, and the implementation of it is what I call Oasmia 2.0. First, we aim to extend the development pipeline through M&A in-licensing, and we are heavily involved in various due diligences of companies and compounds. Secondly, we are executing on the clinical development side of our pipeline, namely Cantrixil and docetaxel micellar. Thirdly, we aim at leveraging our technology platforms through internal development and potentially out-licensing. Finally, we are maximizing the commercial potential of Apealea, which is now out-licensed to Elevar and Inceptua for Europe. I am perfectly aware that the full implementation of this strategy takes some time to deliver its results, but I'm confident that this is the strategy to move Oasmia 2.0 forward. Slide seven. Today, we are an emerging oncology company, and we are building a critical mass in our pipeline. On one side, we have an approved product in Europe, Apealea, approved for adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer. We have a great commercialization deal with Elevar to make it happen in the U.S. as well. This is one fundamental leg of our business. The other leg is Cantrixil and docetaxel micellar. Cantrixil is also focused on ovarian cancer, and the phase II will be initiated next year. We will apply all our knowledge and expertise gained with Apealea in that indication to the development of Cantrixil. That's one of the reasons why we were picked by Kazia Therapeutics, this biotech company based in Australia. Docetaxel micellar phase I for prostate cancer is well underway with SAKK. We are continuing, as I said earlier, to work hard to add new candidates to this pipeline through in-licensing, focusing on oncology only. Finally, we have also two animal health oncology assets in phase II that we are looking to potentially partner. Slide eight, please. Should we want to become a sustainable company in oncology, we need to have a solid portfolio of oncology assets that balance the risk of development as well. We are looking at in-licensing oncology product in preclinical up to late phase III. We prefer oncology assets with phase I validated, phase I-B in particular, in order to reduce the risk we, all companies, are encountering during the clinical development process. We are not excluding preclinical compounds as well, but then we would prefer to acquire or licensing in a platform with multiple options in terms of development. We also are not excluding to go to the market on our own to market those products as long as we are in a niche indication in hard-to-treat cancer. Slide 9. As we are bringing new drugs into our pipeline, we are actively improving and expanding the use of our delivery technologies. We have started research and development on XR-18. That is the next generation technology, which we hope will have a greater versatility and potential. I'm actually happy to report that now we are progressing to feasibility studies based on the outcome of our recent R&D work. We are excited about the prospect of XR-19. That is, we are in a process of establishing proof of concept to demonstrate the ability for dual encapsulation, enabling combination therapy to be delivered in a single IV administration. Internal studies are underway to identify possible indications and combinations as well. Feasibility studies have been completed on XR-19, and the next step will be to assess how and when to take this concept into development. We're also looking forward to the initial findings from our collaboration with the Karolinska Institute, which is exploring the full biological potential of our drug delivery platform. Those results will be communicated to you before the end of the year. Slide 10, please. Commercial rollout of Apealea by Elevar and its partner has been progressing over the recent months quite well. Elevar has commercial partnerships agreement in Europe, Middle East, and North Africa region, and discussion with potential partners are progressing in Asia and Latin America. Inceptua has acquired commercialization rights for Apealea in Europe, including the Nordics from Elevar to and Oasmia. Let me say a few words about Inceptua. It's a highly successful European pharmaceutical company, formed in 1997, focused on rare diseases and specialty products, making it the ideal partner for Apealea. Inceptua is in a process of transferring all licenses and marketing approvals for Apealea in major markets, including Germany and in the U.K. This will delay the full launch process across Europe and receipt of royalties. Both Elevar and Oasmia are confident that Inceptua has the right network, the right level of expertise, and commitment to maximize the launch of Apealea in Europe. We can't give any forecast on the timing of sales and royalties at this present time, while the transfer is being completed. In the U.S., Elevar is progressing development for Apealea, and we look forward to updating you on the progress on that side as well. A named patient program for Apealea is available through Tanner Pharma Group outside the U.S., where the product is not yet commercially available. Although this is not a company guidance, I have included into the slide peak sales estimates here from two analysts that cover Oasmia to give you an indication of its potential. Slide 11. On Cantrixil. Cantrixil, it's a tubulin-binding small molecule with potent cytotoxicity against CD44+ ovarian cancer stem cells and ovarian somatic cancer cell, CD44, both resistant to standard chemotherapies. As you remember, it was licensed in from Kazia earlier in the year, and is currently in development for advanced ovarian cancer. The phase II study will be a global one in the U.S. and in Europe, and is planned for next year using Cantrixil current molecular structure. We've made significant and substantial progress towards these key studies, including, first of all, on the clinical supply agreement side. We are in a process to appoint a scientific advisory board of experts in ovarian cancer. We will be initiating discussions and consultations with the regulatory bodies such as FDA and EMA in order to get not only a sense of our clinical design, but also an informal approval of the development program in order, obviously to not only design and to maximize the commercial potential down the road. Slide 12. Today, I can also tell you that we are looking at applying our proprietary formulation technology, XR-17 and XR-18, to Cantrixil in order to enhance the compound's properties, including solubility. Cantrixil is the first API to be screened for formulation with XR-17, XR-18. We look forward to updating you later this year on our progress. Slide 13. Coming up behind Apealea and Cantrixil, we have docetaxel micellar in development for advanced prostate cancer. No need to remind you that prostate cancer is the fifth leading cause of death in men worldwide. The incidence is increasing hugely, and there is obviously a large unmet medical need for better treatment. You may know docetaxel with the brand name of TAXOTERE. It's widely approved for a range of solid malignancies and is a standard treatment for advanced prostate cancer. Docetaxel micellar use XR-17 to enable IV administration of water-insoluble docetaxel without the usual solubility enhancers. As you remember, and as you know as well, we are working with the SAKK group, the Swiss Group for Clinical Cancer Research, and the phase I trial is underway. It is an open-label, multicenter, single-stage trial at major hospitals in Switzerland. It is currently recruiting 18 chemotherapy-naïve patients with metastatic castration-resistant prostate cancer with adequate bone, marrow, liver, and renal function. The enrollment should be ended by the end of next year. I just want to remind all of you that SAKK is a very experienced partner. They coordinate around 50 clinical trials a year involving new cancer therapy. We are quite pleased to work with such a reputable institution. Slide 14. As you may know, environmental, social, and governance is the new corporate sustainability yardstick. We call that ESG. It is actually widely accepted that ESG performance can give biopharma companies a competitive advantage among their peers and is relevant to how successful a company will be in the future. We at Oasmia, despite being a small company, are taking the matter very seriously, and we have embarked on articulating an ESG plan with the help of a consultant who is an expert in this area. The plan is now ready. We have started to implement it. Key initiatives include implementation of a comprehensive code of conduct for all employees, clear policies and education in areas such as whistleblowing, equality of treatment for all employees and partners, environmental responsibilities, safe handling of chemicals and waste in our lab in Uppsala, and many more. There is always much more to do in these important areas. Our focus for the rest of 2021 and 2022 includes the establishment of KPIs and targets, development and implementation of action plan, regular report to demonstrate progress and highlight weaknesses and how to address them. Slide 15, please. I wanted to show you this diagram that shows our ESG materiality metrics that will help to guide our priorities as well. It was developed including feedback from our principal stakeholders, including patients, including analysts and shareholders as well. That will help us to drive our activities in this critical area. In a nutshell, important points are business ethics, good governance, attracting, retaining the right type of talent to the company, offer a safe and supportive work environment, and obviously also minimize our environmental footprint where we can. Slide 16. Looking ahead, there are multiple catalysts to drive near-term value over the next couple of years. These includes building on our core capabilities to deliver the critical mass in oncology through continued M&A and in-licensing. Advancing our pipeline, including Cantrixil, trial design, key role recruitments, supply agreement for the phase II. Docetaxel micellar, the completion of the phase I-B by SAKK. Optimizing the potential of Apealea, the commercial potential of Apealea, including partnering with Elevar in other territories. Further expanding our XR-17 technology platform, including combination therapy proof of concept, as I mentioned to you, for XR-18 and XR-19. Finally, divestment of partnering of our animal health assets. Next slide, please. Overall, it has been another quarter of steady progress, of build towards really building an oncology company with a broad, competitive portfolio that is capable of delivering long-term sustainable growth. This is our overarching goal at Oasmia. Thank you for listening, and at this stage, we will be pleased to answer any questions you may have. Back to you, Operator, please. Thank you. Our first question is from Joseph Hedden of Rx Securities. Please go ahead. Good morning. Thanks for taking my question. First one on Apealea. I appreciate you can't say anything about timings of launch in the hands of partners, but in terms of the transfer of licenses, a deal that's been signed for a little while now. Can you just give an expectation on how much longer you expect that transfer process to take? Thank you, Joe, for a good question. Well, first of all, obviously, as you may understand, this is in the hands of our partner. I cannot give you really any precise answer to that one. However, what I can tell you is that, the MAH, Marketing Authorization Holder, transfer is a time-consuming process. I'm not expecting, Elevar through Inceptua to complete it before six months from now. Okay. That would mean you're not expecting the European launch process to start this year? That's correct, yes. Okay. perhaps moving on to docetaxel micellar. You're talking about near and mid-term catalysts there. I just wondered if you could give us an idea on the timeline to recruitment completion of that trial and potential top-line readout? Yeah. The recruitment of 18 patients should be ended by the end of next year. This is our estimated timeframe given to us by SAKK. The Swiss Cancer Research Group. Hopefully, it could be done earlier. I don't have any indication that this timeline will be changed at this present time. Obviously the readout will be earlier 2023, as long as the enrollment will be ended end of 2022. Okay. Thanks very much on that. Then just on business development efforts. You've mentioned you're looking across the spectrum, pre-clinical to phase III. Can you say anything about the number of opportunities you're currently evaluating and whether any of those are at later stages in discussion? Since I joined the company back 16 months ago, clearly we have already been in a full process, full due diligences of a number of companies. I cannot tell you the number, but it's the order of magnitude. It's more than one thing on hand. It's actually close to 10. It is important to find the right company for our business. That should be a feature. Overall, I'm looking at the whole armamentarium of oncology, ranging from CAR T down to oncology viruses, to antibodies, to vaccines, to small molecules. This is the ambition. The ambition really is to create a leading oncology company by adding a number of assets that do cover the spectrum of how to treat cancer. That's the goal. Okay. Thanks. Thank you, François. You're welcome. Thank you. Our next question is from [Thomasy Tom of RMS Guider]. Please go ahead with your question. Yes. My question is, what is the latest regarding the clinical development of Apealea in the U.S., and what's your best estimate as to when a U.S. launch could happen? Well, you know that, again, this is a matter for Elevar to answer. What I can tell you is that we are obviously in regular contact with Elevar on those two studies. The PK study and the phase III. Elevar will be, and then later on us, we will be reporting those progress as soon as it is executed. Okay. As to your best estimate with the current information you have as to when a launch in the U.S. could happen, when would that be? Right. Usually, a phase III study in this kind of indication takes about two to three years, in terms of enrollment process. You can calculate yourself the kind of a timeframe. You understand that I'm hesitant to give you any precise timeframe, because I'm not in control of the medical department of Elevar. Each step at one side. Certainly, there is a full commitment of Elevar to perform those studies, without any doubt. The COVID situation didn't help at all, as well as the backlog at the FDA level regarding meeting them and getting their kind of a blessing for the clinical design. There will be some delay. I think that was communicated earlier, actually end of last year, regarding a timeframe for the approval and potential approval of Apealea in the U.S. Again, things have slightly changed in a way that due to COVID, with regard to the hospital enrollments, it is a difficult situation now. Also, Elevar is also very much willing to get the blessing of the FDA before starting anything. That has been delayed as well. Okay. Thank you very much. I understand. When it comes to out-licensing your technical platform, have any interesting discussions emerged in that respect? Yeah. We are always in interesting discussion, to be frank, with a potential partner. At the same time, we are trying to, as I mentioned with XR-18 and XR-19, trying to progress the upgrading of our platform towards a later stage of clinical development. Now we are entering that phase. The feasibility studies have been reported to be positive. We will be obviously updating you on any potential partner at the right time. Okay, thank you very much. You're welcome. Thank you. Our next question is from Klas Palin of Erik Penser Bank. Please go ahead. Thank you very much, and thanks for taking my questions. I would like to start with, you mentioned during the presentation that the sales during Q2 was related to the preparations of the PK study for Elevar. Should we expect you to provide material also in preparation of the phase III trial? Yes. Again, this is a decision made by Elevar, that will be made by Elevar in terms of reporting to the street. As soon as the execution of it will be done, that will be reported certainly. Yeah. You do not have an agreement when it comes to delivering Apealea substance for the phase III trial? Well, we have a licensing agreement. Basically, that sets very clearly the terms of that trial. It is licensing out. Ultimately, Elevar is responsible for the design and the execution of the study. Yeah. Okay, great. Then a question about the write-off of your inventories that you are doing in this quarter. Do you see risks of further write-off of your current inventories in the next six to 12 months? Fredrik? We do have to follow protocol, obviously. We do act on the shelf life. When the shelf life expires, that obviously needs to act on our behalf. This was mainly related to the Nordic sales, and we have acted on that. Yeah. There is no obvious reason to believe that you need to do another write-off in the next quarter or so? Well, obviously, again, following protocol, and if that happens, need to act. I can't say more than that. Okay, great. Thanks so much for taking my questions. Thank you. Our next question is from John Priestner of Edison Investment Research. Please go ahead. Hi. Thank you for taking my questions. I have a couple, so I'll ask them individually. Is there any impact for Apealea from the appointment of the new CEO at Elevar? Yes, it's a positive impact. Yeah, we have good relationship with Kate. She was former CEO, Chief Commercial Officer at Elevar, and we have an excellent relationship with her, and she's absolutely committed to speeding up the process on the clinical development side. Fantastic. I was wondering if you'd provide some additional details around the kind of inventory write-down. Mainly, I was wondering if you could remind us of the current shelf life of Apealea and how this may potentially be extended by the XR-18 technology? Fredrik? No, the shelf life, we need to act as those are expiring. Looking at the inventory, this batch that we did do a write-down had passed that shelf life. Very clearly, the pandemic situation did not allow us to launch. The launch was put on hold. Let's be very clear on this. That unfortunately had an impact on the inventory. Got it. Thank you. I was wondering if you could comment on whether any patients have been treated through the named patient program with Tanner Pharma? This question is also for Elevar, but I think that they are not reporting that, Elevar, as we speak. The answer is yes. Now, I cannot give you the precise number because it is not reported on a regular basis. There were physicians that did ask for Apealea, yes. That's great. You previously reported the kind of first sales and treatment to a patient with Apealea in Finland. Can you comment on whether there've been any kind of repeat sales there and the kind of feedback that you've got from clinicians on their kind of thoughts on the product? The marketing and sales rights have now been transferred to Inceptua and it will be Inceptua to follow up on these initial prescriptions. I don't have any data at this point in time. Okay. Thank you for answering my questions. You're welcome. Thank you. Our next question is from [Tommy Wilson], a Private Investor. Please go ahead. Thank you. Hello everyone. I just briefly want to mention that I was disconnected twice from the call. If I ask anything related to things that you already answered previously, I apologize for that. I want to ask you, because you had an interview earlier this summer where you confirmed the delays in the Elevar studies and as well, the Apealea launch in the EU, and that is a little more than a month ago. What has happened since in that short time span to now announce that the Q4 sales in the EU will not happen and that the Elevar studies may not start in Q3 as announced? I don't think there is anything changed, and I don't think that what I said is anything different compared to what I said a month ago. There is a delay in the launch of Apealea in Europe due to the reason that I mentioned, MAH transfer mainly, serialization process with the main supply agreement for Baxter that is now in the hands of Elevar. It's quite a complex situation. You have Elevar, you have Inceptua in the play, and Baxter. With related to the studies, well, the PK study, the final preparation is there. Okay, the PK study will happen during H2 of this year. Okay. Thank you. You have also said now for quite a while that you are in, like you also said today, you are in long ongoing discussions with partners for China and Latin America, and you're looking for commercial partner there. HLB states on their website and in their semi-annual report this week that there is commercialization ongoing in Latin America. Can you say anything about that? There is not a formal partner or commercialization partner in Latin America. There will be through Tanner, some prescription on the ad hoc and on a case-to-case basis. This is probably what HLB mentioned into their report. It's an extensive use of the word internationalization, if you understand what I mean. I understand. Thank you for the clarification. There were also some mentioning that they are looking into to put the rivaroxaban in ovarian indication in combination with Apealea. What can you say about that? I cannot say anything. This is in the area of internal discussion between Elevar and us as well. When the final clinical design will be subject to be communicated to the market via Elevar, you will know it on time, absolutely. Okay. Thank you for that. Last summer, on most of the presentations Oasmia did, you were referring to the new API in XR-17 in progress and to be revealed soon. When Cantrixil was eventually revealed six months later, and I asked, you said that was in fact not the API that you had referred to earlier. Is that new API in XR-17 still a thing? I haven't heard anything about it for a long time. Yeah. You know that unfortunately, academic research doesn't necessarily give results very quickly. Having said that, we have decided internally that Cantrixil will be the API that will be tested with XR-17 platform. That is our choice. Why do we do that? Because obviously we have the full right of Cantrixil, and because it's easier for us and also because it makes a lot of sense from a business standpoint to work on an IV combination together with the intraperitoneal combination that we have, that will be used in the phase II trial. Thank you. What do you think the phase II trial will cost, and how will that affect the burn rate once the study start next year? We certainly, as Fredrik did say, we certainly have enough cash to run the operations for the next 18 months or so. We are in a planning process to factor that in and looking also at alternative financing options as well. We will update you whenever we have made some decision on this. All right. Thank you. My final question is, I may have missed that, but I think you last may have stated before that they were applying an SPC for extended approval for the patent. Has there been any updates on that? Well, this is totally in the hands of the IP department at Elevar. I'm not aware of any recent news on that side, unfortunately. Okay. Thank you for everything. Welcome. Thank you. There are no further questions at this time, so I'll hand back over to our speakers. Thank you. Thank you all for your interest in our quarterly report. As I said earlier, you should really see that as a quarter of transition, quarter of build. Yes, in companies like ours, news flow is a critical issue. I also made the conscious decision to report really news when they are news and not things that are not so important. It's a quarter of transition, quarter of build, and I thank you for your support, you, all our stakeholders, shareholders, analysts, investors, and we continue to stay in touch. Thank you for that. Have a great day. This now concludes our conference call. Thank you all for attending. You may now disconnect.