Elevar Therapeutics, Inc. (VIVE.ST) Earnings Call Transcript & Summary

Thank you. So it's Francois Martelet, CEO of Oasmia. So good afternoon, everyone. So today, I'm very pleased to introduce you to what I would consider an exceptional analyst and investor live event as we have with us 2 very distinguished guests from Elevar: so Alex Kim, CEO of Elevar; and Mark Gelder, Head of Medical Affairs. Both have very kindly accepted to share with you the strategy of the indication in the U.S. that they will be implementing in the next following months. So if you go to Slide #4, so Alex Kim will go through the Apealea as an overview. That will be followed by Mark Gelder going through the ovarian cancer indication, the current treatment and the future treatment as well and also advancing the Apealea development program as a follow-up after the overview of the current treatment gaps. And then we will have a Q&A session at the very end of this presentation. So before I will go -- I will give the floor to Alex, perhaps on the Slide #6, just would like to say a few words about Oasmia. So as you all know, so we are a fully integrated R&D company on the specialty pharma side, using a technology platform to generate new formulations of existing marketed drugs and to generate new innovative drugs. We are listed on the stock exchange in Sweden. The market cap is around SEK 2 billion. Following the actions taken after a strategic review earlier in the year, we have now an agile, flexible, lean-and-mean structure, together with a solid cash position. XR-17, our technology platform, which allows micellar formulations of APIs to be soluble in water, is our core competency and our core technology. We do have in-house all the capabilities of a pharmaceutical company. That is quite rare in the biotech world today. We do not engage ourselves in large production commercial capabilities, but we retain in-house R&D capabilities that is part of our core competency. We have also a growing pipeline focused on oncology, but with a lot of potential also in other therapeutic areas given the fact that our platform is agnostic. I joined the company in March of this year with the main task to deliver the transformation of the new Oasmia into a profitable specialty pharma company with a newly formed management team. So let's turn to the Slide #7. So at Oasmia, we have a fourfold strategy: first, to execute on the Apealea global partnership with Elevar. And this is the topic of the conference call today. And as I said earlier, I'm really delighted to have both speakers online with us today. But before I give the floor to Alex, I would like to remind our investors and analysts that Oasmia's strategy does not only rely on the execution of the licensing out of Apealea to Elevar. We do have other pillars, such as the partnering and clinical developments with XR-17 and XR-19 platform. We will continue to evaluate poorly water-soluble products using our XR-17 platform with new APIs. We have also initiated a project to further develop XR-17 into XR-18. That will be what we call the second generation of XR-17. And we are in an assessment phase of our dual-encapsulation technology called XR-19 this time. That is in a very early stage of assessment for combination of 2 APIs. And thirdly, we do have a clinical development strategy with our own pipeline. That is with Docetaxel micellar and new API as well. And you know that Docetaxel micellar is poised to enter into the clinic very early next year. And finally, we certainly are working on out-licensing or partnering of our noncore assets, like our animal health portfolio. We're also working at finding partners for our XR-17 platform that I can use and utilize for their drugs or compounds. And we are aggressively looking at licensing in oncology assets in clinical development. And above all, we have become certainly lean and mean structure, the low cash burn and a solid cash position. So this is what I wanted to remind everyone today. And now I will be pleased to give the floor to Alex on the next slide. Alex, the floor is yours.

Yes. Thank you, Francois. If we could, I guess, we'll move to Slide #9 now. And I'd just like to give a little bit of an introduction to Elevar Therapeutics. First, I would like to credit both of our teams, both at Elevar and Oasmia. We really started this collaboration right at the start of the COVID-19 pandemic. So our clinical regulatory business teams have been working together virtually on this, transferring this product over and then also working through the business development and regulatory side. In fact, my last trip that I was able to take outside of Salt Lake City was in February to Sweden to complete this deal and do the due diligence. So it's been an interesting year, for sure. So on Elevar, we were founded in 2005. We're headquartered in Salt Lake City, Utah but have offices in San Francisco; Seoul, South Korea; and in Ireland, which is our European regulatory office. We're really spread out throughout the country now. We're in about 15 states with 65 employees, so growing into a pretty large organization here. We are a wholly-owned subsidiary of HLB in Korea. This is a large publicly traded holding company. It's a conglomerate that has businesses in a number of different industries from shipping to pipe build, to pipe manufacturer, electronics and even fashion. So they do a lot of things. But the focus of this company is really on biotech and health care. So they have a number of other investments. For example, in the U.S., they have another investment in a company called ITI Immunomics, which does immunotherapies. At Elevar, we're really passionate about finding viable treatment options for patients that have complex and difficult-to-treat diseases. But our experience is really rooted in oncology. So we have a lot of staff and our top executives that have experience in big pharma, successful biotech and experience in a lot of different successful cancer drugs, such as Sutent, regorafenib, Abraxane, immunotherapy, even cell therapy for oncology. So we really have a lot of experience. The people that we've been bringing in more recently have experienced in this late clinical approval, launches and commercialization. That's really the stage of our products right now. Myself, I've been involved in the development of 3 novel paclitaxel formulations, for example, in the past. Okay. So let's move to Slide #10, the next slide. And this slide really shows our pipeline, the priorities of this company. And we have 2 products that -- these are very unique products for the stage that they're at. Each of them are approved in at least one major territory. They're both well known for safety and efficacy. So there's no question about safety or efficacy for both of these products. And they were both leaders in key indications which they were approved in. So Rivoceranib was the first TKI to be approved in gastric cancer. Apealea, as you know, is the first non-Cremophor based formulation of paclitaxel to be approved in ovarian cancer. So they're really the first in the class where they are. So with Rivoceranib, this is a TKI. It's a small molecule angiogenesis inhibitor. It's an oral dosing, once daily. As I mentioned, it has been approved. It was approved in China December 2014 as a monotherapy for gastric cancer. Again, the first TKI in gastric cancer. It has a very favorable safety profile. If you look, there's -- it's very well published. There's over 160 published human clinical -- published studies. These are human clinical studies in 12 different cancers. So it's really a well-known molecule in the scientific community. We hold the global rights to this outside of China, and we are in late-stage development in several indications. So this is like pivotal-stage development: gastric cancer; colorectal cancer in combination with Lonsurf. This is a collaboration with Taiho; hepatocellular carcinoma, in combination with camrelizumab PD-1 inhibitor; and then adenoid cystic carcinoma, which is a really interesting niche indication, where the patients have really no good options. So that's -- we're excited about that. Apealea, as you know, this is our other priority within the company. This is the non-Cremophor based paclitaxel. It's also important to note that this is a non-albumin based formulation also. So we'll talk a little bit about what that means. Elevar has the global rights to this, excluding Nordics, Russia, select CIS and select Baltic countries, which Oasmia has retained. This is Europe's first non-Cremophor formulation of paclitaxel, as we've mentioned before, in ovarian cancer. We expect to file an NDA in the U.S. This is where Apealea has an orphan drug designation. We expect it to be the only non-Cremophor taxane approved in ovarian cancer in the U.S. And ovarian cancer is a really important indication for us. We'll talk a little bit about that. Elevar, and in collaboration with Tanner Pharmaceuticals, has launched a global named patient program to provide Apealea in areas outside of the U.S. where Apealea is not commercially available. And the named patient program is kind of a growing thing in oncology. It's a really important way that we can provide access to this drug to patients that live somewhere where it hasn't been commercially approved but they have a clinical need for that. For example, you may have a lung cancer patient in India who can't tolerate pretreatment because of comorbidities such as diabetes or something. So they're not able to take tax off. That patient and doctor could request from Tanner to have Apealea imported and to be treated with Apealea. So this is really an important way that we can provide this product to patients around the world that have a need for it in an unsolicited way. We have partnered with Taiba in the Middle East and North Africa. This is for the commercialization of Apealea. And we are deep in discussions with partners in Europe, Latin America and Asia. And we expect these to be completed very soon. I would guess that the Europe would be the one that will come the first out of those. Okay. So on the next slide, we'll talk a little bit -- the next couple of slides, I'm going to talk a little bit about Apealea. This is -- this next slide is talking about paclitaxel. So this is the active pharmaceutical agent, the API that is in Apealea. It's a very old drug, I guess, you would say. It was identified in 1971, first approved in Taxol in 1993. So that's the most familiar formulation, Taxol. The mechanism of action is that the paclitaxel enters the cell after being injected. It inhibits the cell division. So it prevents these tumors from growing. It's been approved in numerous indications of ovarian cancer, breast cancer, non-small cell lung cancer, age-related Kaposi's sarcoma and pancreatic cancer. So it's really widely known. It does have a lot of side effects: hypersensitivity reactions, alopecia, neuropathy, neutropenia. These are things you expect from chemotherapy. But these side effects associated with paclitaxel really aren't the limiting effect of Taxol. The really the limiting part of Taxol is the -- what it's formulated in, and that's the cremophor. So if we move to the next slide, Slide #12, we'll talk a little bit about the market of Taxol. So taxanes, like with the API, paclitaxel, as I mentioned on the previous slide, paclitaxel is a pretty old drug, but they expect this market to continue to grow. Analysts have said that they expect this market to grow from 2018, where it was valued at $2 billion, to over $4.5 billion by the year 2025. So although this is an older drug, you can see that it's very -- it's expected to continue to grow. And I think that growth really is because we're finding new novel ways to deliver it such as with Abraxane and Apealea and then we're finding really niche indications and indications we can go into where it's really needed. On Taxol, which was approved in 1993, this is the original one, had sales of about $1.6 billion in the year 2000. That's when it really peaked before its patent expiration. And that sales, at that time, had been the -- well, if you take all the sales of Taxol, it's really considered the best-selling cancer drug of all time. Abraxane, which was approved in 2005, has been able to grow quite a bit, too. But as you see the growth of Abraxane's market, it was around $500 million, $0.5 billion until about 2013 when it got its third approval in pancreatic cancer. So once it got that third approval in pancreatic cancer in 2013, it was really able to grow the market over $1 billion. And in 2019, it went to $1.86 billion. So this shows how it's really important to find that right indication. Okay. Let's move on to the next slide. This is Slide #13. So as I alluded to earlier, really, the problem with Taxol has been the Cremophor formulation. Paclitaxel as an API is very insoluble. So in order to make an IV drug, it has to be in solution so you can inject it into the IV. And with Taxol, at that time, the technology they had was using Castor Oil or Cremophor-EL, as it's called. And the Cremophor itself doesn't have any pharmaceutical value, but it has a lot of side effects. So if you look at the, for example, severe hypersensitivity reactions, this is what -- this is your body's reaction against the Cremophor. And this causes -- because of this reason, you have to have a very slow infusion. You have to have a crash card in case the patient has some anaphylactic shock or some reaction to the Cremophor and you have to have a nurse or somebody basically babysitting the patient during this whole lung slow infusion. So there's a lot of issues with the delivery of Cremophor based taxanes. You also have to have additional medications or pre-medications. If you look on the lower right, this is the modified toxicity profile of co medication. So you have to pretreat the patient with steroids, other medications to so that they can tolerate the Cremophor. But there is a group of -- a segment of the population that have comorbidities such as diabetes, where they just can't tolerate these pretreatments, especially they can't tolerate these pretreatments in multiple times. If we find that paclitaxel is more effective in weekly dosing, they just can't have that because of the Cremophor. So that's why Taxol is given once every 3 weeks. So Abraxane, which is -- they use human-derived albumen as the solvent for the paclitaxel. So they were able to avoid all the Cremophor problems, but you can imagine with a human-derived albumen what the issues are with costs and sourcing and things like that. So we were -- we've been very impressed and excited to use Oasmia's XR-17. This is a synthetic molecule easier to characterize and manufacture, a much more suitable technology for making a non-Cremophor formulation. So on the next slide, Slide #14. This is just a one kind of summary slide on Apealea. So it was developed by Oasmia in Sweden, as you know. This is paclitaxel utilizing Oasmia's XR-17 technology. Apealea did receive market authorization by the European Commission in 2018. So it's the first approved non-Cremophor paclitaxel in ovarian cancer, and it remains the only approved non-Cremophor paclitaxel for ovarian cancer. We've licensed the global rights to this. We did this in March 2020. This excludes -- the territory excludes Nordics, Russia, certain CIS and Baltic countries, which Oasmia has retained. And then finally, we -- with the FDA on the regulatory side, so Apealea does have orphan drug designation with the U.S. FDA. And since April 2020, we've conducted several meetings with FDA, getting advice from FDA. And this is the important thing that -- and it will be discussed a little bit more by Mark later in this presentation, but different regulatory bodies have different requirements. So the FDA has additional issues or additional requirements that maybe Europe wouldn't have. We knew this risk going into this project, and we've been able to have several discussions with FDA. We've had -- consulted with KOLs, experts within our company and regulatory experts with -- outside of our company. And we've come up with a plan to do 2 studies. The first is a PK study. This one will be very fast, less than 12 months for the PK study, and then an efficacy study. So the efficacy study, this is what's going to impact the labels here in the U.S., and it would also give us an opportunity to expand the label in other areas such as Europe. We want to make sure that we have superiority rather than inferiority to what the existing therapies are. We want to have -- find a niche within ovarian cancer, where there's a real clinical need, where these patients really need this product. And in doing so, we really want to create value, increase the value of this product in the U.S. And this will expand -- this will have a related expansion throughout the world. So the design part of this is very important. We have to put the design work into this to get the best long-term value for this product. Remember that this product, the drug delivery, XR-17 patents that protect this product go out through 2036. So this product has some lifetime, so we should work at getting the best possible indication and label that we can. If this means taking 6 months or 1 year longer in getting a better designed trial, it's going to translate into a lot more value in the future. So with this efficacy study design criteria, we're looking at a few things: focus on the patient and clinical need, a focus on the design of the trial for the speed of the trial completion and size. We want to have the fastest approval, but we have to balance this with getting the best label. And then we also want to have the best confidence of success. So we would rather spend a little bit more money upfront in this trial and power it correctly and then have a much more confidence that it will be a successful trial. So those are the factors we've looked at. Okay. So let's move to the next slide. This is Slide #15. This is looking at the ovarian cancer incidents -- annual incidents. So you can see U.S. population, about 22,800 population incidence for ovarian cancer. In Europe, and this is Europe in the greater regional area, about 55,000 is the incidence. So pretty significant numbers. I mean this is the fifth largest cancer in ovarian -- in U.S. Not extremely large numbers, but these are good-sized numbers. When you're doing your forecast, you have to look at a couple of things because paclitaxel is a well-known molecule, but this will be the only non-Cremophor in ovarian cancer. So we do expect higher penetration rates. The other thing is with the design of our program where we're going for more frequent administrations because we have less toxicity. This will translate into more value over the long term. Ovarian cancer is turning into more of a long-term disease and maintenance of disease because the doctors are able to -- the patients are able to survive longer. So if we're able to go to like weekly administrations rather than once-every-3-week administrations, which you have to do with Taxol, this will translate into better response for the patients and better value for the product. We are looking at other indications also. So this will be important to the value of the product. Paclitaxel has activity in so many different cancers. And so we have to really look and find the best. We do have some idea. We've been working with KOLs on what kind of niche we can find where Apealea will provide the most value to patients. But if we look at, for example, the Abraxane experience, which was a mildly successful product at $0.5 billion for a long time. But as soon as they got that third indication of pancreatic cancer, that's when they went over $1 billion product and now at $1.8 billion. So I think that's a good example of how a product can really gain a lot of value in this. So that's what I've got. I think we will move on to the next slide, and I will hand this over to Mark.

Hello, and thank you, Alex, and hello, everyone. I hope that your day is going well. I sort of wanted to start with a very brief overview of ovarian cancer. And as many of you probably know, ovarian cancer is indeed a very heterogeneous disease. And it's really only been over the last 10, 15, perhaps 20 years, that we have begun to truly appreciate all of the molecular features that distinguish a variety of different subtypes, if you will, of ovarian cancer. And ovarian cancer, as the name implies, arises in the ovary. But the ovary is composed of multiple different cell types, and we can basically break that down into 3 or 4 big cell types or big buckets of cell types. So stromal tumors, and those stromal cells really lie in the supportive tissues of the ovary; the germ cells, which give rise the old site and the ovum, give rise to the "embryo" if the germ cells are fertilized; and then the epithelial cells. The ovary is covered by an epithelial lining that is the same as the lining, if you will, the covering of the fallopian tubes as well as the lining of the entire abdomen, otherwise known as the peritoneum. And it turns out that the overwhelming majority of ovarian cancer, 90%, 95%, 96%, 97% of it, but the overwhelming majority of ovarian cancer is epithelial ovarian cancer. So it arises from this epithelial lining of the ovary, not the stromal cells and not the germ cells. And when you look at epithelial ovarian cancer, there are several different "histologic subtypes." In other words, when you look under the microscope, there's differences between the cells that allow us to distinguish different histologic subtypes. The most common subtype of epithelial ovarian cancer is a serous or papillary serous ovarian carcinoma. But other common subtypes of epithelial ovarian cancer muteness, endometrioid, clear cell, transitional cell, et cetera. So there are a variety of different subtypes. I think what's really important to understand is that ovarian cancer can present in a myriad of ways -- in a whole myriad of ways. And unfortunately, most people -- most women present with very advanced-stage disease. Like most cancers, we stage ovarian cancer, stage 1 through stage 4; stage 1 being the earliest; stage 4 being the latest. And 70-plus percent of women with ovarian cancer present with advanced-stage disease, stage 3 or stage 4. And they can either have a very sort of slow, insidious, what we call, subacute presentation, or they can have a very sudden or acute presentation. The sudden or acute presentation is less common, but it's more dramatic. So these women may present with a bowel obstruction or they may present with shortness of breath because of a large perfusion. But it's all of a sudden. Boom. One day, they're well; the next day, they've landed in the emergency room or in the doctor's office. Much more commonly, these women have a very tough subacute presentation, where they just complain of some dull diffuse pelvic or abdominal pain distension, a feeling of bloating, et cetera. And this is due to the ascites, the fluid that is building up in the abdominal cavity as a consequence, if you will, of their advancing stage ovarian carcinoma. As with all cancers, there are risk factors for the development of ovarian cancer. The -- really, the biggest risk factor is age. Most ovarian cancers, the vast majority of it is sporadic. It just happens. It is not familial or hereditary but, rather, it is sporadic. And most ovarian cancer occurs in elderly women or women over the age of 50. Ovarian cancer in women less than 40 years of age is unusual but not unheard of. And the germ cell tumors, which are a very small subset of ovarian cancer, the germ cell tumors actually are the tumors the ovarian cancers that present at a young age. The average age of diagnosis of epithelial ovarian cancer is about 63 years of age. As I mentioned, only 10, 15, plus or minus, percent of ovarian cancer is hereditary or genetic. But the conditions, the underlying conditions sort of predispose are BRCA-1 and BRCA-2 mutations as well as what's known as the Lynch Syndrome II. So there are -- clearly are certain risk factors. What I will say is that birth control pills have been shown to be protected. So that's perhaps some good news. If we move now on to Slide 18. As Alex mentioned, the annual incidence of ovarian cancer in the U.S. is roughly 22,000 patients a year. So that's the incidence: 22,000 new patients a year. The prevalence, so how many cases exist in the population, the prevalence is much higher. That's north of 200,000 cases exist at any given time in the U.S. And the prevalence is actually rising. And Alex mentioned the fact that we are turning ovarian cancer into a chronic disease because there are several different treatment options for women, and we're doing a better job. But back when I started the practice of GYN oncology, and I trained in GYN oncology back in the late 80s and early 90s. So I'm aging myself now. But back when I trained, the average lifespan of women with ovarian cancer was about 2 to 3 years. Now the average survival of women with ovarian cancer -- epithelial ovarian cancer is greater than 10 years. And the reason for that is, is that we really have turned this from an acute disease into more chronic disease, if you will, because we have more and better treatment options for women. And I think, again, as I mentioned, the average age of common diagnosis is 63 years of age, but it does occur in women less than 40. It's rare, but it does. Most of the time, that is a germ cell tumor. If we move on now to Slide 19. I want to talk to you a little bit about the results of the pivotal Phase III study that was conducted by Oasmia several years ago, where this was a prospective randomized trial, looking at Apealea versus Taxol. This was a very interesting trial. It was recently published by Vergote in GYN Oncology, actually in February of this year. But what I will say is that the trial was a very interesting trial. I think it was conducted in 81 different centers, primarily focused in Eastern Europe and Russia. And as I said, it was a prospective randomized multicenter trial. The eligibility criteria, you had to have confirmed epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma. Again, very common. And you had to have platinum-sensitive recurrent disease, i.e. you had recurred greater than 6 months after the end of your first-line or second-line platinum-based therapy. Patients were stratified by their CA125 values, whether this was their first or second relapse and by the center. They were randomized in this study into 1 of 2 arms. So they either received Apealea at a dose of 250 milligrams per meter square, i.e. over 1 hour, followed by carboplatin at an AUC of 5 to 6; or they were randomized to the Taxol arm at 175 milligrams per meter squared, IV over 3 to 4 hours, followed by the carboplatin. Patients in the Apealea arm were not required to receive premedication before administration of Apealea. They were not required. It was left to the discretion of the investigator. On the other hand, patients receiving Taxol were required to receive the steroid premedications as required in the package insert or SPC. And the primary end point of this trial was non-inferiority of progression-free survival in the per-protocol population. The secondary end point was non-inferiority of overall survival in the per-protocol population. Other secondary end points were the objective response rate, safety, quality of life, other things that typically are secondary endpoint. What I think is important to take away from this is that the dose of Apealea at 250 milligrams per meter square was significantly higher than the dose of Taxol at 175 milligrams per meter square. What we do know from the Phase I PK work that had been done by Oasmia is that when you look at the unbound fraction of paclitaxel, the unbound fraction, which is the important fraction to look at, the unbound fraction of paclitaxel in Apealea and paclitaxel in Taxol are virtually superimposable. They are the same. So that is an important thing to remember. But when you look at the study that was conducted and then you look at the results, when we look at the primary end point, the study did meet the primary end point, non-inferiority of progression-free survival, or PFS, in the per-protocol population. Additionally, it met non-inferiority of progression-free survival in the modified per-protocol population and in the intent-to-treat population. Is there a difference between these populations? And the answer is yes. The per-protocol population, as was specifically defined in the protocol, was patients who were randomized to that arm who received 6 cycles of therapy, i.e. they did not discontinue therapy early, either due to progression, toxicity, withdrawal of consent, whatever, but they received all 6 cycles. In addition, people who met the per-protocol population did not have any major protocol deviations or biology. In the modified per-protocol population, this was patients who received 4 to 6 cycles. And in the intent-to-treat population, this was patients who received 1 cycle or more of chemotherapy. So all they had to do was to receive any experimental or investigational drug. But it did not meet the secondary endpoint of non-inferiority of overall survival in the modified per protocol or in the intent-to-treat population. In terms of safety profile, the 2 arms, the Apealea arm and the Taxol arm, there were a very comparable number of patients who reported one or more adverse events in both arms, around 90%. There were more patients who reported one or more serious adverse events in the Apealea arm versus the Taxol arm. And this was statistically significant at 40% versus 26% with a p-value of 0.001. The most common AE in the [Audio Gap] mandatory premedication. If we move on to the next slide, this is a complex slide, and I'm not going to go over this extensively. What I'm trying to show here is that the treatment of ovarian cancer has changed significantly over the last few years and that all patients who require therapy, the treatment of choice is platinum-based chemotherapy with carboplatin and paclitaxel regimen. For patients who have platinum-sensitive disease, i.e. they relapse or recur greater than 6 months after completing therapy, those patients, the recommendation is that they should receive platinum Taxol again. For patients with platinum-resistant disease or platinum refractory disease, these patients receive a myriad of different treatment options. What we do know is that over the course of time, whether it's after first-line therapy or after second-line therapy or after third-line therapy, is that most patients with epithelial ovarian cancer will become platinum-resistant and that the most active agent in this setting is paclitaxel. But it's paclitaxel that's delivered weekly, not paclitaxel that's delivered 2, 3 weeks. And there is now increasing evidence that paclitaxel weekly, in combination with bevacizumab, may be even more efficacious than weekly paclitaxel alone. And this is thought to be the area of highest unmet need now in the treatment of ovarian cancer is optimizing therapy for these women with platinum-resistant disease. And as I said, over the course of time, virtually everybody with epithelial ovarian cancer becomes platinum-resistant during the course of the treatment of their disease. As Alex alluded -- if we move to Slide 21, as Alex alluded to, we have conducted advisory boards with internationally renowned experts, not only in the area of ovarian cancer but including other tumor types as well, such as breast cancer, bladder cancer, non-small cell lung cancer, GI malignancies, including both gastric, pancreatic, et cetera. But when we held our advisory board with the GYN oncologists, again, a large group of really internationally renowned experts. And here's the name of some of the folks that did had, including Ignace Vergote. They were very, very excited about the prospects for Apealea, particularly in patients with recurrent disease, and particularly looking at perhaps the platinum-resistant population. But David O'Malley, who is the Director of GYN Oncology at Ohio State and who is Chairman of the Ovarian Subcommittee for the Gynecologic Oncology Group, during the course of this advisory board, his comment was that the clinical benefit of paclitaxel has been well established. And having a non-Cremophor formulation such as Apealea has the potential to significantly contribute to improved clinical outcomes and treatment experiences for these women. And I think his enthusiasm was echoed by folks like Deb Armstrong, who is very well known in the area of ovarian cancer as well as breast cancer. She's at Hopkins; Bob Coleman, who was at MD Anderson for years, past President of the FGO, who is now the Chief Scientific Officer for McKesson in U.S. Oncology; Larry Copeland, who, again, well-known past President of SPO, past President of the Gynecologic Oncology Group, current President of the GOG Foundation. I can go down the list here, but the enthusiasm was superb. And I can tell you that we are currently working with the GOG. We have formed a separate GOG-Elevar working group to come up with a final design for a Phase III trial in epithelial ovarian cancer that we will kick off first half of 2021. And this will be run through the GOG. I can tell you that with Ignace's health -- Ignace, as you know, is very well known. He lives in Belgium, a past President of ESGO, the European Society of Gyneoncologist, Past President of ENGOT, which is the large corporate group of gynecologic oncology research centers in Europe. Ignace is very excited about getting ENGOT, working with the GOG so that we can turn this into a global trial. And so we will move forward in that direction. So a lot of excitement is driving this program. This will move very quickly over the next several weeks and months. And if we now go to the next slide, Slide 22, what I do want to say is, again, Alex alluded to the pre-IND, pre-NDA meeting. So they've been held the upcoming milestones. So we will be filing the IND very shortly. And in the first half of 2021, we will initiate a PK study. And we will also initiate the Phase III study. And again, as Alex alluded to, we are actively looking at other potential opportunities in other tumor types. We recognize that we have to start developing this in other tumor types. There are lots of good options for us. And we are working with some of the best and brightest on both sides of the pond to figure out the best way to advance this forward. So with that, we'll move on to Slide 23. And again, just in summary, Elevar is a very rapidly growing, fully integrated biopharmaceutical company and truly built on the promise of elevating treatment experiences and outcomes to patients. And we are focused on evolving the therapeutic potential of a variety of different medicines to improve clinical outcomes. I can tell you, I joined Elevar recently. I am a clinician at heart. I was a practicing GYN oncologists for many, many years, both in academia as well as private practice. I have been in the industry for the last 15 to 20 years, both in big pharma such as Pfizer, Bayer, et cetera, and small biotech. And I am passionate about delivering new therapeutic options to patients. I am very patient-centric, patient-focused. And as I've mentioned, both Alex case on several occasions. I firmly believe that if we do it right for patients, we'll do what's right for the business. And so the patients are the center of our focus, and our whole objective is to deliver new and improved therapeutics so that we can improve the lives of patients.

Got it, Mark. Unfortunately, we've run kind of longer, but I'm going to hand this over to Francois. And we're available for question-and-answer here.

All right. So conference organizer, if you could basically tell that we are ready for the first question.

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

Can I just ask -- I know that you've been collaborating with the FDA or in dialogue with the FDA with the trial -- the new trials. But have they seen the final design? And essentially, have they approved that this is what they could make an approval on? And if -- I mean a superiority study obviously has a bit of a higher element of risk to non-inferiority. Do you have any indication that if it did miss on that end point, you were comparable? Would that -- would the drug still be approvable?

Yes. So let me just give a quick comment on this, and I'll hand it over to Mark. We have not discussed the final design with FDA yet. We are in the process of putting that together now. And as I mentioned, I mean, we do really want to weigh several different factors here of getting it done quickly, having a high chance of approval and really providing something of increased value, something that's really going to be able to provide Apealea to patients. So these are all things that we have to weigh, and we will continue to work to put that together. But Apealea, where it is already approved, where paclitaxel is well known, where the safety and efficacy of this drug is well known, that is one kind of advantage we have going into this. But Mark, if you want to comment a little bit more on that?

Yes. No. So thank you, Alex. We have not yet had discussions with the agency. I promise you we will before we initiate the study. But we are finalizing things as we speak and tweaking things and making sure that we think we have all of our Is dotted and all of our Ts crossed. And -- but we will absolutely go to the agency, make sure that they -- we have their full buy in with, not only the overall design but with the end point, with the stats plan, et cetera, et cetera, et cetera.

Okay. Perfect. And then if perhaps I could ask one on the progress towards licensing deals in the other territories, mainly Europe. You said, Alex, that you thought you were quite close to a deal there. Could you open to any kind of time line? Or perhaps walk us through the steps that you've taken so far towards coming to that deal in terms of whittling down potential partners.

Sure. Sure thing. We have received a lot of interest since taking this project on in March. We've talked to numerous companies, probably about 15 different companies with interest in Apealea. We've narrowed that down to 2 companies, in particular, that we feel would really be able to commercialize this product effectively in Europe. We have completed term sheet stage with both of them. And we are actually in negotiation and definitive agreement rounds, going back and forth in that basis. I can't really -- I'm confident we are going to sign this agreement soon. But I can't really give a -- as we're in the middle of negotiation right now, I wouldn't really want to give a specific date or schedule in that way.

And our next question comes from the line of [ Marvel Celeste ] who's a private investor.

Okay. Thank you. This question is for Alex. I think so, anyway. So what -- when you're doing these additional studies to Apealea in the U.S. for getting it approved and getting it out in the market, what is your time frame when you see Apealea coming to market for ovarian cancer in the U.S.?

So it's difficult to really advise on the timing right now until we have agreement with FDA on this final clinical study. And I'm talking about the efficacy study. The PK study is about 1 year, so that will be done within that time. The -- depending on how we have this final design for this efficacy study, depending on how many sites [Audio Gap] part of the approval in Europe. Really, we'll just have this data. CMC looks good. So all the absolute parts of the package will look good, and we will be able to get this through very quickly. And then it's -- we'd have the standard, about a 9-month approval process after that. So that is the basic time line. Once we get approval from FDA on our strategy and the clinical trial, I think we'd be able to advise a lot better on when that date would be to start that.

I got some hiccup on my line. So I didn't hear all your answer there, but what was it -- I mean if everything goes well, what is the expected time frame? Was it like 3 years or 5 years? Because I didn't hear at all your answer.

Yes. So the trial we expect would be 24 to 36 months to complete. I mean once it's complete, we're looking at about 3 months to prepare the package. And then we're looking at about 9 months for the -- to receive approval.

Okay. So I just want to hear your view as coming from Elevar on the XR-17 platform. What is your view on that?

This is Alex. You're talking about my view on that technology?

Yes. Yes, I just want to hear your view because I mean you come from...

Yes. Yes. So as I mentioned earlier, I had experience with other non-Cremophor formulations of paclitaxel, Genx LPM, which was also a polymer micellar. And I was with [ Libertas ] Pharmaceuticals developing Abraxane, which is the albumin bound. I think that the XR-17 is really a brilliant technology. I mean it's very well characterized. It does the job of solubilizing. There's no toxicities associated with it. So in the case of Apealea, I think it's a great technology. I do think it would have applications in other insoluble active agents, too. So...

Yes. I just have one...

And then it's also that it's patented. It sort of has a long patent life.

Yes. That's good. Yes, I see. Long time left for that. So when -- I'm not sure if this question was answered in the -- in your presentation, but you were speaking about other indications. Do you have any time frame when something will be revealed around that on Apealea?

Yes. I think we will determine next year what other indications to focus on. I mean there's just so many different opportunities in the paclitaxel space where paclitaxel is well known. And we have to look at what specific indication, if it's a combination drug, a lot of the earlier -- do we do combinations with immunotherapy? There's some interesting rationale that -- where combination with immunotherapy would be valuable or even in combination with TKIs, such as Rivoceranib and then which specific indication. And some of these indications may be areas where we can get a faster approval, too, if we weigh the risk versus the speed. Once we get the ovarian cancer set and we have a high level of confidence on that, maybe we'll want to take a higher-risk approach and do something faster in another indication. So there would be a chance that the other indication even could get approved before ovarian cancer. But we're not prepared to advise on that right now, but definitely, next year, we will.

Okay. That's nice. I see. I have one more, just fast question here. Can we expect to see any sales around Apealea during 2021?

Yes. I mean, of course. I mean there's -- we've been talking a lot about the development in the U.S. and creating this highly valuable application in ovarian cancer in the U.S. But we have to remember, this is approved in Europe, and we will have a partner on board very quickly to commercialize this in Europe. So there's that opportunity. We also have countries around the world that use the European approval as a reference, for example, in Middle East, North Africa, where our partner is already working on that. And we will have other regional approval -- or regional commercial partners such as in Latin America. So yes, there will be definitely some commercial sales. The other thing is with the -- we shouldn't forget about the managed access program, this named patient program that has been launched with Tanner. And this is unsolicited. So this isn't something we're going out in marketing because it's not approved in these territories. But we -- it is available, and patients in these other countries where it hasn't been approved are able -- patients in those countries are able to purchase Apealea for their specific use. And this -- all of the logistics and regulatory aspects are handled by Tanner. So there will be commercial opportunities for Apealea in 2021.

[Operator Instructions] That's from the line of Klas Palin of Erik Penser Bank.

I just wonder -- maybe I missed this because some of the parts was not -- I wasn't able to hear during the presentation. But is it possible to sum up what kind of modification that you might be doing in this upcoming trial that makes you more convinced that you will be able to show superiority.

Sure. Yes. Mark, maybe you want to discuss a little bit about the direction we're going on the design of this trial and what gives us confidence that we'll be successful.

Sure. Thank you. And thank you for the question. So I think -- first of all, it will be a superiority trop. And we will be incorporating administration or weekly dosing of Apealea, which is -- will give us, I believe, a better efficacy profile based on past data with paclitaxel in the space. And we'll be looking at a significantly reduced dose versus the 250 milligrams per meter squared that was utilized in the previous study. So -- but I think the safety profile will also be significant. We're going to have a slightly different patient population. We're going to have different end points. So it will not be the per-protocol population. It will be the intent-to-treat population. And we will have different statistical analysis plan. There will be actually some pretty major differences between the previous study and this study. And having spent 30, 40 years in this space, i.e. ovarian cancer, I think I and the folks that we're collaborating with on both sides of the pond believe that the probability of technical success, i.e. it being a positive trial, will be very high. So I'm really not concerned about technical success, regulatory success, et cetera, et cetera. I think we will be very, very thoughtful about the design of the trial. And we will do everything in our power to optimize the likelihood of success and because we need to bring options forward for patients.

Okay. Great. And also another question then about the time frame. It's between 24 and 36 months. Is this dependent on your -- the FDA feedback about how many patients you might need to enroll or rather that it's an uncertainty on how fast you can recruit patients?

So I think it obviously -- oh, go ahead, Mark.

No. No. Go ahead, sorry. Go ahead.

Yes. I think we were going to say the same thing. It's really a combination of those factors. I mean we've -- we're putting a priority on having a high probability of success. So if we look at that, perhaps it would take a little bit longer. But we are also looking at how fast can we do this. So then we look at really the budgets and things and how many sites do we want to bring on and how fast we want to do this. So speed is very important to us also. So all of those factors, we will put those together and consider the best possible way to go forward and then propose that to FDA. But we do want to have really a high level of success -- confidence of success in this. But yes, you're right. It does include both of those factors.

[Operator Instructions] The next is a follow-up from the line of Joseph Hedden at Rx Securities.

Just one more from me. One for Francois. Just perhaps if you could give us an update on the progress of launch in the Nordics. And I know obviously, COVID is a problem over there at the moment, but is there any further news since your financial results?

Yes. Thank you for your question. Well, obviously, we are still facing COVID in most of the Nordic countries. Most of the hospitals are locked down. We will be reporting our progress at the Q2 results, actually, next 2 weeks. So if you want to bear with me a few more days, then we will give you some more detailed update about the Nordic sales.

And we have one further question in the queue. That's from the line of Tomi Olson, a private investor.

So I have a few questions for Alex. First of all, we talked about how this new label will enable -- or you expect this high penetration, thanks to achieving superiority. Oasmia has previously indicated their expectations, about 20% of the ovarian cancer market. With this new label, would you say that you expect a much higher penetration than the previous 20%?

That's a good question. And while we are still putting together our specific indication that -- within ovarian cancer, we haven't yet done the market analysis. I mean I would expect at least that, if not better, because we're going through a pretty niche -- a smaller portion or target within ovarian cancer. So that's probably the best information I could give you at this time.

A few months ago, HLB revealed, in a YouTube presentation, plans to combine the Rivoceranib with Apealea and immunotherapy. Could you enlighten us? And could you shed some light on that and say anything at all on the market?

Yes. That's a good question. And the -- I think there was some confusion on that. And probably, it's due to the way that it was framed and presented by HLB. We are looking at all the different potential applications for another indication for Apealea, and this could even include combinations with Rivoceranib. That is one of the things we're looking at internally. However, no decisions have been made on that regard. The HLB presentation, what they were trying to say is, we've got all of these investments with ITI and with this -- with Elevar, with all the different companies, and they see synergies within all of their subsidiary companies. And so it wasn't really that they were saying there's going to be this combination of products. So -- and I apologize for that. It was probably not framed the correct way in that YouTube presentation.

Okay. I appreciate the clarification. And with your connection to HLB, it would seem from an outsider as a logical move that they would quickly enable sales or a partner in South Korea. What is your view or comment on that?

Yes. We are currently talking with HLB and HLB subsidiary companies in Korea that have commercial capabilities for the Korean rights. We are also in discussions with HLB and HLB subsidiaries about utilizing their network within Asia for Apealea. So they could be -- there is a potential for some partnership in using their assistance. For example, in China, they have a lot of connections within China with other pharmaceutical companies and manufacturing and everything. So yes, those discussions are ongoing. But definitely, we want to leverage their expertise there.

Yes. Because I noticed they have some connections to Henry. And also, they have like an American joint venture. So I just assume that you have strong connections there. But you talked about partners in Asia, but is it -- do I make the right assumption when I assume that there will not be one partner for China, Japan and so on? There will be individual partners like in Japan and China, for instance, most likely?

So we are talking -- yes, we're -- it's hard to say. We are talking to individual partners. We are also talking to a potential pan-Asia partner. But that pan-Asia partner would find its own partners within each of those countries because they're really distinct type of companies. I mean, in China, you really have to be partnered with a China company -- a Chinese company.

Yes. And they would also expect some kind of complementing base, there something before you can apply to the government? Or...

Yes. In China, we still -- we are expecting that we would have to do a study, but we are trying to figure out what that would be. I mean we've talked with several companies that have mentioned anything from a B/E study, which is a very quick simple study to an efficacy study. Depending on who we partner with, they've had some different ideas. And then also, we have to think about a synergy. If there is a more extensive study that would have to be done for China, then we would combine that or use data from our global study for U.S. FDA. So these are all things that we're having to consider at the same time. But it's a very important market for us. I mean China is -- while it is more competitive, it does have non-Cremophor formulations of paclitaxel already approved. It is also a huge market. So we definitely want to get into that market.

And my last question is, it's a big one, and I know you can't go into details, but I hope you can clarify something because Francois has been very careful as the comment the deal with the milestones at all. I just hope that you can comment at all what and when will release and make the first milestones payments to us? Because I know a lot of people is -- a lot of speculation that some is regulatory, some is with authorities and stuff. Could you say something at all about it?

Yes. I need to be as careful as Francois on this. And we agreed not to release the terms of the deal, just standard. I mean there will be milestones, but obviously, we can't -- I couldn't give you details on those.

Okay. Okay. Well, thank you for everything else. And thank you for clarifying all of this. It's been -- it's a much appreciated and long awaited for a lot of shareholders.

Thank you.

[Operator Instructions] There seems to be no further questions at this time. So I'll hand back to our speakers for the closing comments.

Thank you. So thank you very much, Alex and Mark, for your participation into this great live event today, much appreciated. I think it does demonstrate a great level of collaboration between our 2 companies as we are pursuing jointly this development plan for our flagship product, Apealea. So thank you very much. Thank you for the audience, and have a great day. Thank you.