Earnings Call: Q2 2020

Aug 26, 2020

Welcome to the OncoPeptide Q2 Conference Call. Throughout the call, all participants will be in listen mode only. And afterwards, there'll be a question and answer session. Today, I'm pleased to present CEO, Marty J. Durall. Please go ahead with your meeting. Good morning, everyone, and thanks for joining us for this operational update for oncopeptides and specifically focused on our second quarter. I'm joined today by Jacob Lindbergh, our Chief Scientific Officer and Anders Martin Loft, our chief financial officer. So on slide two, you'll see forward looking statements, and please refer to that and where to look for appropriate balance and disclaimers. So moving on to slide four. Just wanna just wanna say that I'm I'm really humbled and excited about being part of OncoPeptides and this being my first first call. Really excited about the company and the prospects going forward. Please know my focus is is is building value and building value through bringing differentiated products to oncology patients. So focus is on the patients. My background, you may have seen from from the website executive leadership experience, public and private companies, really focused on the oncology space. It's really where my passion and desire lies. So you can see from the list of companies there have had the opportunity to to create some value across a number of different biotechs through eventual acquisition. But, you know, what's what's really, you know, been been humbling for me and and and has driven me is bringing the products to patients. So starting with Taxotere back in my my Sanofi and Aventis days, launching that product for a range of indications in The US, Europe, and Asia, launching Abraxane in China, other products for hematologic malignancies and and both both solid tumors and and heme malignancies. So I've worked in a a wide range of of products, biologics, small molecule, gene therapy, supportive care, and and really excited about the platform that we have at at OncoPeptides and our peptide drug conjugate. So moving to slide slide five, I thought I'd talk a little bit about the transformation of the company and a couple different transformations, a few that are that are ongoing. First and foremost, the the transition of CEO. And so pleased that, we continue to to to greatly benefit, from the the contributions of of Jacob Lindbergh, who is fully engaged as our chief scientific officer moving back to his passion, which is the the science science of the company. So we have the CEO CEO transformation. We also have the transformation of the company from a Swedish biotech to a to a global company. So very exciting as we work to bring our to patients around the world. And then, of course, the transformation of being an r and d organization to a fully integrated commercial company. So our growth strategy, as indicated here on on this slide, in discovery and IND generation, it's about organic growth. You know about melflupin and the clinical development program and a couple of other products that we have that are moving rapidly towards the clinic. There are some other things we're doing to build a a very strong pipeline, and we look forward to to sharing those in in future calls. In the middle column, it's about the clinical development, the portfolio development, and specifically the life cycle management of melflupin. Jacob will take us through the number of trials that we currently have ongoing, which which includes, of course, the exciting readout that we've had recently on the Horizon trial, which has resulted in our accelerated filing to the FDA. So it's another another area of growth for us. And then the investment in in launch and and geographic expansion. So you know from previous calls, we made the decision that we are going to launch melphalupin in The US. We'll do that on our own. We're currently making some decisions around around Europe and then also thinking about Japan and how we'll pull that into the mix in in terms of our investment. So, again, our our investment and growth strategy will involve trade offs between this pipeline, the development, and the geographic footprint. And certainly excited about each and every one of those opportunities. On slide six, just to highlight what what drew me to to OncoPeptides is this fantastic platform, this peptide drug conjugate, and then specifically the hope and promise that is delivered by the by the horizon data and also our early phase one data to patients with resistant refractory multiple myeloma. And this whole idea about targeting aminopeptidases and rapidly releasing alkylate alkylating agents in the tumor cell provides this fantastic benefit risk profile. And, you know, for decades, we we've tried on the biotech side to target aminopeptidases. They were identified quite a while ago as a viable oncology target, and we're happy to say our our product does just that. And, you'll see from, some of the information, some new science that we've recently submitted to the, to the ASH meeting, we're further elucidating that profile and really have learned some very interesting things regarding the expression of these immunopeptidases being being higher, of course, in the myeloma cells, but also higher in in patients that have relapsed refractory disease versus versus newly diagnosed. So, clearly, as as one KOL recently mentioned in an advisory board, this is not your daddy's melphalan, and we're really excited about melphalan and the prospects for melphalupen. So turning to slide seven, you know, a a real nice summary here of of of our second quarter and what's been in the headlines from from an oncopeptide's perspective. So kinda kinda looking at each of those, you know, we think about the risk reduction in the business. It's important to the value value creation. So first of all, you know, expanding the leadership team and bringing in new expertise, you know, we we think that speaks to a decreased risk in execution. As I mentioned with with Jacob fully enrolled and and shifting his attention back to the science, myself coming in thinking about not only the science but the commercialization on a global, global scale, the execution risk has has decreased. Our, very successful fundraising that took place in the quarter reduces the financial risk, so we're now investing appropriately in the business. So we've reduced that risk. We've we've recently announced the takeover of a preclinical lab. So from a pipeline portfolio perspective, we're expanding our capabilities there and decreasing any risk that we're a one product one product company. Certainly, the the outstanding results that we'll talk about on the Horizon phase two trial in triple class refractory multiple myeloma patients, we decreased the clinical risk from a shareholder perspective. And and finally, with our submission to the to the FDA for accelerated approval, we believe that the regulatory risk also has has diminished. So we're building momentum. We're executing against our milestones and commitments, and we believe we're poised to deliver to our stakeholders, first and foremost, to the patients that need our drug, and second of all, to the, to the shareholders and to you that are helping to support our business. So shifting over to to slide eight, we've talked about the, the the market opportunity here, the focus just on our first launch market, The US market, and connecting that market opportunity to the to the clinical development program. We see this horizon with an anticipated label in the triple class refractory patient in orange helps us to address unmet need for over twenty thousand patients with triple refractory disease. And then we have that very unique subsegment where of extramedullary disease where we saw particularly interesting results and differentiating results, we believe, from the Horizon trial when we compare it to other other datasets where we can help patients who are at high risk because of the the advancement of their disease. So in the OCEAN study with that head to head comparison to pomalidomide, there are other patients or newer patient populations as we expand our label to patients who may be double refractory. And then, of course, combination use, which we see is pretty much a standard in earlier lines of disease. We're addressing that with the the ANCHOR trial and the Lighthouse trial. So we believe and have the ambition that melflupin can impact many, many patients who are on their journey to fighting resistant refractory multiple myeloma, and we'll continue to build on our label, build on the clinical development program to be able to address the unique needs of of those patients. So flipping over to slide nine, as we lay the groundwork to to launch our product, We have launched the disease awareness and education program, and our focus there is paving the way for a new class of of drug. And that's what we believe we have in in melphalufin. So you see then the headline, we wanna get to the root of resistance. We believe our product does that and does that uniquely. The science is talking about or speaking to the possibility of of clonal evolution being a key driver in resistance and some of the activities of our drug uniquely addressing that that perhaps changes the history of the disease for patients. This triple class refractory multiple myeloma patient population is growing and is an outcome of that clonal evolution. And we certainly are positioning this drug, leveraging the success we're seeing in the marketplace with the antibody drug conjugates and positioning our unique peptide drug conjugate platform as something that will be be new and exciting and help undress address some of those unmet needs. So flipping forward to to slide 10, really excited about the the FDA process that we we alluded to. So as you're all aware, we did submit to the FDA in in in late June, a day prior my to to my arrival. So real gift to be able to walk into an organization having having that behind us and a real testament to the to the team, to the Oncopeptides team that that I joined for what they've been able to accomplish in in in making that happen. So we should hear imminently by the end of this week with respect to notification of file acceptance. We have our fingers crossed for that that review process, and our eyes are set on priority review. So with the potential of priority review and a PDUFA date that would extend into February, of course, we've seen regulatory bodies and the FDA in particular act quickly on on products that address high unmet need. So our internal bar for launch readiness is actually to be prepared to to launch Melflefin in The United States in in in the current calendar year. So I'll talk about how we're building a team to do just that. And on slide 11 is part of speaking to that build process. You know, we're we're putting together a team that's that's very passionate in in our interest in making a difference for, patients with high unmet need. And the bar we've set for ourselves is is ensuring complete 100% access, to melflupin. So building a customer facing team that can meet the unique needs of of the customer base, not only the traditional roles of the oncology account manager and medical science liaisons and area business directors, but also looking at at some roles that can bring unique value to our customers in in terms of key customer marketing role, nurse educators, and really putting some emphasis on national accounts and and reimbursement to to ensure that access. So really excited about that build process and the team that we're putting in place. Clearly, we flip flip over to slide 12, you know, Oncopeptides is an organization that hasn't launched a drug, but certainly we're very, very deep with respect to the people that we're bringing into the organization who have significant accomplishments in successfully launching oncology drugs, both domestically here in The US, but as well as on the global stage. Calling out specifically our president of North America, Joe Horvath, amongst his experience at at Merck and BMS with US and global commercial leadership positions, twelve years of oncology experience. Doctor Paul O'Connor, really blessed to have a medical oncologist, hematologist that has not only a deep experience as a key opinion leader in and of as a key opinion leader herself, but also seventeen years of pharmaceutical and biotech experience in some very successful companies like Genentech, Medivation, Onyx, and and Clovis. So a total of thirty years of oncology experience. And Mohammad Wada, who joins us as well with seventeen years of pharmaceutical and biotech experience. You can see some of the companies that he's worked for and brings just a tremendous amount of horsepower to to our team. And on the right hand side of the slide, you can see as we put together, you know, roughly a field facing team of of we think on the order of 50 will make us competitive in this space. The range of companies and talent that we've drawn from that, you know, we think is gonna help put us on a successful launch trajectory. So really excited about this team coming together, and look forward to being able to launch melflufin in in The United States. With that, I'm gonna turn it over to our chief scientific officer, Jacob Jacob Lindbergh, to talk about our platform and, the science of Melflefin. Thank you very much, Marty. So please go to Slide number 15. Thank you. So before I start, I just want to say thank you to for Marty for joining us and how happy I am that Marty has joined. It means, as Markku said, that we both have strengthened actually our R and D capabilities in being able that the old organization can focus on what it was really built for as well as strengthening the whole commercial aspects of the organization with Mark's excellent background here. So we are really building for successful launch, and so far, so good. Looking at slide 15, just want to highlight what we have experienced with this molecule because, frankly speaking, some of these findings have been serendipitous. We didn't expect or know this from the beginning, but it has been become a truly differentiated product. And as you know, we have an amino peptidase targeting domain and a toxic payload. And this has given us an increased potency of the toxic payload itself, so we have increased the efficacy and the activity of a known efficacious class, the alkylator. We have also seen how this potency increase increases with the degree of malignancy, how aggressive the disease is. We have also found that the construct in itself actually circumvents several of the key resistance development mechanisms in patients. One of them is the transport proteins because and it's that might sound like very technical, but fundamentally, this molecule or candidate does not rely on transport proteins like most alkylators do. And that is a key way of the disease to fight off the alkylator. The second one is that we circumvent key pathways for what is called programmed cell death. That is how a cancer cell dies. And it turns out, and we published this at the European Hematology Association meeting, we don't share the same programmed cell death cascades as other alkylators, which fundamentally means that we function as a separate class. That is why we say now that we have a first in class compound because we do not act as other alkylating agents. We have also seen that the amino acidase targeting enables additional beneficial effects, and we see it both in terms of the metastatic process as well as the blood vessel formation process, the angiogenetic process. And both of those are very important for a tumor to be successful in being aggressive. And when a tumor is successful, it's bad for the patient. So this is a really interesting class of drugs. And just to be honest, we didn't know all of this from the beginning. We have discovered this along the way, and we're very fortunate that Joaquin Gulliver, our founder, actually synthesized this molecule almost twenty years ago now. Let's go to the next slide, slide number 16. Mark alluded to this, but aminopeptidases are an excellent cancer target, and it has been known for thirty years as we started to map up the proteome. But they're very tricky to target because of their intracellular nature, And they are particularly interesting for multiple myeloma because they are key components of what is called the protein homostasis machinery. That is the machinery that degrades proteins into amino acids and recycles them. And this is exactly the system that proteasome inhibitors, that is already an established class in myeloma, attacks. And we attack this target system as well by addressing the immunopeptidases. We have also found along the way, as I mentioned, that immunopeptidases are not only overexpressed in cancer as such, but they actually increase in expression levels the more aggressive the cancer is. So in some way, it's a target system that acts like a Trojan horse. It opens up the vulnerability in the cancer that we exploit. And thirdly, which is very much the same theme, as the cancer increases the its mutational burden, which is also associated with poor clinical outcome, once again, amino peptidase expression goes up, and we exploit that to the advantage of this drug. If we go to the next slide, slide number 17, we know already, and we have shown this slide, that this peptide perconegated system targeting aminopeptidases actually shows activity across a plethora of cancers, both in the liquid space as well as in solid tumors. And of course, we want to try to see what this platform actually can find across other tumor forms as well. To do this, on slide number 18, we are generating many new peptide drug conjugates. And when we do that, we basically define them across four dimensions. We change the toxic payload. It doesn't need to be an alkylator. We can work with tubulin inhibitors or other classes of drugs. We can alter the react the reactivity of the payload. We can change how far the payload goes once it has been released inside the cell or if it just stays locally. That is what change per membrane permeability means. And we can also modify the amino peptidase targeting piece to basically target specific amino peptidases rather than the whole class of targets. And we have some very interesting results here, and we're gonna continue this journey. But, of course, our aim is to have a second generation compound out at some time point so that we actually follow through to not not make nosufen, just a single PDC drug. We think there's so much more to find here based on all the findings that we have done the last few years. Going to slide number 19, we can then see roughly what we're up with. And, of course, we know Melslufen. We have talked a lot about it, and we're going to talk more about it today. But then we have OPD five, which is our first new peptide drug conjugate, which is specifically tailored for bone marrow transplantation. And we hope to initiate trials either later this year, that is late this year, or early next year. COVID has put some introduced some delays, but only minor. And then, of course, we have what we call the second generation PTCs, here exemplified by OPS two, but it might also be another compound. That will take a bit longer before we enter the clinic, but we hope to be able to do it during 2021 at the earliest. Next slide, please. Marty mentioned this, but on Slide 20, we have our full development program. And once again, there's a lot of detail here. So if you have specific questions regarding timelines or results, please do not hesitate to ask questions at the end of this webcast. But right now, our development program is back on track after a small delay in some trials due to COVID nineteen. We have recently reported that the PORT trial and the light chain amyloidosis trials has been initiated with first patient in, and we're gonna talk more about them today. But otherwise, the clinical trial program is making strides. When it comes to OCEAN, our big pivotal trial, we have already reported that we reached that milestone of 450 patients, and we are on target when it comes to the number of events to actually be able to have results for you first half of next year. Going to the next slide to then talk about the key event in quarter two. Right? And Mark alluded to that too, we actually significantly reduced the clinical risk of this entity because we fully reported the Horizon data. And as you know, the IRC data turned out to be a very good dataset. And since the IRC data, the independent review committee data, also was in line with what was investigator assessed, it also speaks to the quality of the dataset, very small deviations. And, actually, the deviations were to the benefit of the IRC data, which is highly unusual. And as you know, we submitted this dataset to the FDA on June 30, and we're going to come back a little bit more about this dataset now. Going to slide 22. This slide kind of summarizes in one way the clinical benefit that we provide to patients. This includes all the patients that responded to therapy with omelzlufen that were triple class refractory, I. E. Patients without remaining treatment options. And you can see that they we could keep the disease at bay for eight and a half months. That's a very, very good number. You can also see from this slide, where each bar is one patient, that actually, nilsufen is a bit of a different compound to some extent. It takes longer for the response to appear, And how you can see that is to look at primarily the blue bar, but also the light green bars, because they are not classified as responsive at that time point. From a clinical point of view, it doesn't matter that it takes a bit of time, but it sort of shows when you look at, for example, such a number of duration of response, it becomes falsely low in a comparison because this is the true clinical utility here. The second driver behind that the response takes a little bit longer time is that we had an extraordinary amount of patients with extramedullary disease or metastatic myeloma. And it takes time to verify response in these patients because you need to do fairly advanced imaging procedures, and you don't do that every week or every month even. So it takes a bit longer to verify that the respond actually has occurred. And since these patients fantastically enough responded in this trial with milsurf and prastexamethasone, this actually, once again, was a fantastic result, but it makes this so called swim lane plot a bit more tricky to interpret. Going to the next slide, slide 23, we just want to show a straight up comparison between the mosupine dataset, the dataset with XPOVIO or selinexor, and the dataset with belantamab or Blendrat. If you look at the overall response rate and clinical benefit rates, you can see, which is a measure of tumor burden reduction, you can see that these three drugs are fairly close to each other. The difference is not big. When it comes to duration of response or median PFS for responders, you start to see some significant differences, and you can see how Melslufen, we have actually progression free time of eight and a half months for responders, while XPOVIO has four months. That's a difference of almost a factor of two, a significant difference. For BlendRep, this is not reached, but it is fairly close to the eight and a half months. It's not significantly above that. So it is nothing indicates today that belantamab would have different numbers that are significant outliers to this, we obviously have to wait for the final result. And then I just want to highlight the share of patients with extramedullary disease or with EMV. And you can see here that we have forty two percent, while XPOVIO had twenty two and BlendREP twenty percent. This is the most hard the biggest hard to treat patient population in myeloma with the most exquisite unmet medical need, And this in itself shows that our patients were more ill on paper than any of the other populations actually, because normally nothing works for these patients. And despite that we had so many AMD patients, our results hold up. That speaks to the quality of the drug as well as the responses that we see. The final point is about toxicities. All of these drug drugs have expected hematologic toxicities, and melsulphin has that absolutely too. When it comes to nonhematologic toxicities, however, there are some clear differentiating factors. And as you can see, all of these drugs have infections. It's unfortunately something that happens for myeloma patients. But apart from infections, our table is empty with no symptoms. While with XPOVIO and Blendrite, the lists are fairly long and complicated. That is why both of these drugs got so called REMS programs associated with their approvals. We have to see if we get one, but it's not something we expect, but we don't know. But this is a clear benefit. And then when you look at both efficacy and safety, we have a very good profile, and that is why we are so confident going into this launch. Finally, just ending with the two trials, so going to slide 24, that we have just recently initiated this first patient in. The first study is the so called PORT. What is PORT? Well, this has very much to do with making sure that every patient can get access to the drug. So right now in all our trials, we have used what is called a central access point with MELDFLUFEN. That is a so called porta cap or a midline or a PICC line. We just want to show that you can give and administer this drug also with a peripheral venous catheter. There's no data to to suggest that we can't, but we just need to show it with empirical data, and that is what this trial is about. For those patients that prefer a peripheral venous catheter over the central access point, and some clinics also prefer that over central access points. So it's just to make sure that we break down every potential barrier to use this drug for the benefit of the patient. Going to slide number 25, we then talk about light chain amyloidosis. And this is not the cancer, so the question is why are we here? And we have talked about this before. That is because myeloma drugs are the drugs that are used for these patients. It's a very, very tough disease with a median overall survival of three and a half years, which is not long. And it's actually because you have pieces of antibodies that precipitates in the blood. Precipitate means it's fall out like a bit of a it's almost like a high viscous slurry. And, of course, that high viscous slurry ends up where the blood goes primarily. So it forms layers and amyloid plaques in organs with high perfusion, such as heart, liver, CNS. And this is what the patient dies from, most commonly from cardiovascular failure. The only treatment is then to bring down the antibody production. Myeloma drugs are used. We have very good preclinical evidence that we have a good drug here that we provided at the American Society of Hematology meeting in December, and we're looking forward see the results. With this, I leave the word to Anders Martin Lehr, our Chief Financial Officer. And please note that there will be a Q and A at the end if you have any further questions. Thank you, Jacob. If we then turn to Slide number 27, you can see on the right hand side that our operating loss increased to EUR $696,000,000 for the first half of the year. And if you look at the orange bar, you see that, well, a big chunk of that increase is due to the R and D spending going up from EUR $239,000,000 to EUR $441,000,000. And that in turn is driven by our our quite extensive clinical program that raised the cost of 332,000,000 for the first half. And as you can see on the right hand side, the ocean trial was roughly half of that. So we increased the cost from 110,000,000 in the first half of last year to 177,000,000 this year. So this is this was also an increase during the second quarter where we saw an increase of the drug supply cost since we had to provide all sites with extra formalidomide to be able to ensure that all patients would receive the drug in the age of of COVID nineteen where all all transportation broke down. So that means meant that we had an extra cost for that, and it also meant that we could not get returns from sites where we had comalidomide. So so we had to buy some extra during the second quarter. The Verizon trial, that also increased from from the first half of last year to this year, here we do not see a quarter by quarter increase. So 35,700,000.0 for the first half of the year. You can also see for the first half first half that Lighthouse is now incurring significant cost, 34,600,000.0 in the first half versus 2.7 last year. We have not recruited the first patient yet, but we're planning to do that later this year. So we're full preparation mode and and are working on our protocol and and all associated preparation. Anchor was flat, so no increase there. The other significant increase then is is the marketing and sales cost that went from 44,000,000 last year to 149,000,000 this year. And this is, of course, driven by the buildup of our US subsidiary that went from the total cost was 16,800,000.0 in first half of last year and and 112,000,000 this year. So here we are growing rapidly quarter by quarter. We had roughly 50 employees towards the end of the second quarter, and that will more than double in the second half of the year. So that will continue to increase as we build up for our launch. The numbers for the first half also include some noncash costs. For example, the incentive programs contributed with a cost of 26,000,000. We also have some currency exchange rate differences included in in the operating loss. That was roughly 30,000,000. And then we also have some some increase in working capital, and that means that that the cash flow for this year was roughly 100,000,000 better than the operating loss. So burn rate is roughly 100,000,000 per month, and it has been fairly stable for the last six months. The cash position on paper was minus 38,000,000 Swedish. We did execute a very successful direct to share issue in May, but that was concluded in two steps. The second step was done in the first few days in July, rounding up some 673,000,000. Those $6.06 73,000,000 are not included in the cash position as of June 30. So a more correct statement of our position would include that. And so net pro form a including that, we have SEK 1,611,000,000.000 Swedish krona in cash as of June 30. So fairly stable cash position. We're very happy with the the new share issue. We were very happy to to be able to to get some new, very well renowned US Investor Team as well. So so all in all, we are, of course, increasing our cost as we should when we we build up for launch, but we are in a very good position as of June 30. With that, I'll hand the word back to Marty to wrap up, and and go through the news for the rest of the year. Super. Thank you. Thank you very much, Anders. And on slide 28, we see those those investments into the business translating into major events and and and news flow for the organization that are obviously critical importance to us. So just to orient here by column, by quarter, so green are are accomplishments that that we've we've completed. In orange, we focus on kind of regulatory and launch, and blue data and clinical trial related. So reiteration of q two, EHA update, really some outstanding data that we presented at that meeting looking at the aminopeptidase elevation in myeloma, the elevation correlating with poor outcome, and then a real differentiated profile for melphalutin, which is is is actually works better in those resistant refractory multiple myeloma overexpressing patients. So real unique unique profile. We also showed some some data on p fifty three independence, totally unique relative to any other alkylators out there. So that among a a host of other things. So outstanding updates on the product at EHA. The NDA submission accomplished at the at the end of the end of the quarter. Looking at third quarter, as Jacob mentioned, we've had first patient in in a couple of couple of programs. We await the FDA feedback, and we'll communicate that information, of course, as soon as we get it. And we did not mention that we have launched an expanded access program. That protocol has been approved by the FDA. We're excited to be able to provide access to melphalutin to patients in The United States while we wait for approval of the product. Looking forward then to q four, we have the potential if if granted priority review, and it moves quickly of accelerated approval and then launch. We will be launch ready in q four two thousand and twenty in The US market. ASH will be an outstanding meeting for us. We have quite a range of both preclinical and clinical abstracts that have been submitted. We'll be able to provide an update on acceptance of that data in in October. So certainly looking forward to a fantastic ASH meeting in in in December. And looking forward to the first half of two thousand twenty one, it'll be a big year for us at Oncopeptides. Top line results of the OCEAN trial. Last patient in for ANCHOR. I should mention we'll have ANCHOR data at ASH, so I think that'll be of of high interest. We'll have that last patient in the in the BRIDGE trial and then further updates of of datasets at at EHA. So really excited about the next twelve months and the continuous news flow, that we have. And with that, we'll, we'll conclude the plan portion here of the presentation and turn it back over to the operator for questions that you might have. So thank you very much. Thank you. If you wish to ask an audio question, you may do so by pressing 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Our first question comes from Philippa Gardner from Jefferies. Please go ahead. Oh, hi there. Thank you. I have a couple of questions if I could, please. So first of all, I just wanted to ask you about your pricing strategy for MELFLUCEM. And I guess what I'm wondering is, given the expected order of events in terms of potential accelerated approval coming prior to OCEAN data, I guess, you know, are you thinking about these events as mutually exclusive when it comes to thinking about the pricing? Or I guess, if Nosufin is to show superiority of Apomalypse and you price it price for that data, would you miss an opportunity there for to get a higher price? So just wanted to get your thoughts around your pricing strategy. My second question then is, do you plan to disclose the PDUFA date or will you just tell us whether it's a priority or standard review? And then my final question is just on the expanded access program. I was just wondering, have you already had a lot of interest from patients and or physicians in compassionate use of marsupan? Thank you. Super. So I'll take the last question first on the expanded access program. So we're early days. We've we've approached a number of sites, and suffice it to say that there's there's very high interest in in the expanded access program. Again, we just received FDA approval of that protocol within the within the past week, So we'll be able to provide more details on that program as we as we go forward. With respect to the PDUFA date, yeah, pending the the details we hear from the agency with their communication towards the end of the week, we will work to be as explicit as we can relative to some of the planned dates and milestones of of the review. So stay tuned on that one. Finally, relating to the pricing strategy of the drug, we certainly don't want to get into a pricing strategy discussion in advance of a couple of very important events for us. First and foremost is is kinda seeing what the eventual label that we reach is. Course, we're gonna be considering multiple geographies as we think forward. We will recently had the launch of belentamab, and we'll be taking that that into consideration. I think you're you're you're if I'm interpreting the question correctly, kind of thinking through patient population, the broader nature of the patient populations, and the the the possibility of showing a differential advantage of pomalidomide, all of those things will enter into into our assessment of of of Melphalupin and and and the price that we'll launch with. Suffice it to say that, you know, we believe we have a a unique unique product, a differentiated and novel product that we think delivers quite a bit of value to patients and would price accordingly with respect to the competitive landscape and the opportunities there. So not a direct answer to your question, but hopefully it touches on enough of the key points. Thank you. Could I could could I perhaps just ask a follow-up to that if you don't mind? I guess if you were, for example, awarded a standard review rather than a priority review so that the the approval would be closer to perhaps getting the ocean data. Would you perhaps consider waiting for the ocean data before you launched? So, fundamentally, given our, you know, given our patient focused nature as a company, I mean, we're we're we're in the business of of of helping patients and and being patient friendly. We're we're trying to provide access as as soon as we possibly can. So I appreciate the thinking around that as a consideration, but I I I guess my my my gut today would be that we wouldn't we wouldn't withhold access to the product based on that type of decision. That's great. Thank you so much. Thank you. Our next question comes from Victor Sundberg from ABG. Please go ahead. Yeah. Thank you for taking my question. So so my first question is if we will see any effort from your side to apply for approval in Europe in parallel to your application in The US as we have seen, an example with the Delmaf from gays GSK and XPOVI from Karyopharm? And could you give any more details on when or why you haven't already sent in an application in Europe? Thank you. Yeah. Thanks thanks for that question. So we are we are actively considering that and and looking looking at the the landscape. And suffice it to say with, you know, a a global KOL community and what we see relative to the competitive landscape in Europe, the opportunity does appear to present itself that we can move move forward with with an accelerated package for Horizon. So we're under active consideration of of that as a possibility and would be sure to inform everyone when we reach reach that that strong conclusion. But our intent would be to to to do what we can to make the product as available as quickly as possible in Europe, and it does appear that some type of conditional or accelerated approval opportunity is a is a possibility. K. Jake, I don't know if there's anything else you'd wanna contribute there. I would just like to add one thing to Victor's question, and that is even large companies, much larger than us, cannot handle completely parallel application processes. So you need a two to three month delay between your first application in a geography and the second, which is normally then US and then Europe. And we submitted June 30, and you can add two to three months to that, and then you more or less have a good timeline for when such an application would be considered just to be able to manage it from an internal process point of view as well. Okay. Great. Thank you for clarifying that. And another question, maybe on the perception of Melflefen. Have you surveyed the oncologists already ahead of your drug launch on how they view melflufen as a drug class? Before, as you alluded to, there have been some perception among some KOLs that melflufen is just another alkylator and maybe not seen as a new drug class in late stage multiple myeloma in comparison to maybe Velma and XPOVIO. So just curious how you're how you're working to overcome that perception among some oncologists ahead of a potential launch of the drug and how you feel that the perception is around the drug as of now? Thank you. Yeah. No. Really good question, and and that certainly has been our focus. When when you look at the disease state education program that we outlined, that was one of the primary intents. You know, let's build awareness around oncopeptides, but also talk about unmet need within within the category. Certainly, programs like that are are generating increases on some of those some of those key ballistics. We we have in in preparation for launch and building, obviously, our our messaging and and and the type of work we're doing, it's it's it's pretty clear to us that with the emerging data, going back to some of the things we referenced relative to to EHA with our strong ASH presence, the science continues to support a very differentiated position. We we find that when we have the opportunity to to communicate those details, to go over that preclinical evidence, to talk about the Horizon data in in greater detail, to call out some of the specifics relative to the extramedullary disease patients. It's it's certainly resonating with the with with the physicians we talk to. So, it's always a journey. We we we believe the evidence that that we generated to date, and we're we're not stopping where we currently are. We'll continue to to to build new evidence that is supporting this being an exciting new class of drugs. And and we know from from some of the work that the alkylator payload doesn't tell the full story. There's something very key and excluded here regarding the targeting of amino peptidases, and, you know, we're excited about some of the emerging science that is being generated internally and that which is soon to to to make the prime time in in in meetings like EHA, for example, and and ASH. So continued work in progress. We're confident. You know, having just been through a a a program recently where a baseline is set at the beginning and we go through the preclinical and clinical evidence, you certainly see the you you see the the bar moving. You know, prior to joining the company, Jacob and I, you know, had had many conversations, and, you know, he he communicated to me when when when he stepped back and thought of all the experiences when he put put the drug in the hands of a of a clinician or a preclinical scientist, even the skeptical ones. Once once it's in their hands and they play with it, you know, he gets the callback. What what did you give me? There there's something different about this. This is not your standard alkylating agent. So certainly, an expanded clinical program and the work that we're doing will continue to build that, and and we're confident that we're gonna be able to to to get there. Got it. Thank thank you. And just a final question from my side. So your your cash burn came in approximately minus SEK $285,000,000 in the quarter. What can we expect from here going forward in terms of your cash burn when you ramp up your commercialization efforts and broaden the platform? As far as I can see, maybe you need to raise cash here within a year with your current cash burn. But what your plan around that? And maybe also if you can comment if a U. S. Listing is an option to consider in order to access money from the capital markets. Thank you. Yes. Thanks, sir. So this is Anders. Yes. So we are burning roughly 100,000,000 per per month, and that will increase during the remainder of the year. We do not issue a forecast. But as I indicated when when I talked about the numbers, the the number of employees in The US will increase quite significantly. The r and d cost will continue on on the relevant level. So, yes, the the burn will continue to go up. We have communicated that with the current financing. We have worked our way through the 2021 without any revenues or or without the raise. We are always always considering raising more money that may occur in the in the next twelve months. I should not lie about that. There are a number of ways we could do it. Becoming a commercial company opens a number of of new possibilities. We do not necessarily have to do a direct to share issue that have done in the past. That that is an option. We could also do issue convertible bonds. We could get loan facilities, or we could get the royalty based financing or license to region. There are a number of ways that where we could finance the company. And all all options are on the table if needed. A US listing is also one of the options that we are considering, but at least near term in the next six months, I do not think that you should expect a US listing. That's as clear as I can do at this point. K. Thank you. That that's all for me. Thanks. Thank you. Thank you. Our next question comes from Boris Peaker from Cowen. Please go ahead. Good afternoon. My first question is in terms of meplupin. One of the things you talked about is the differentiation in patients with extramedullary disease and certainly differentiates it from other drugs in the space. I'm just curious, do you anticipate that to be mentioned in the label somehow? Or do you have any kind of other strategy that you could market this differentiating element? Should I take that, Martin? Yeah. That's great, Jacob. Thank you. Yeah. So, I mean, first of all, we need to be very careful to state what ultimately the FDA will say here, and I I would never make assumptions about what their position is. What I can say is that we included in the submission package complete data outputs regarding the EMT subpopulation in terms of efficacy, and we had an applicant orientation meeting with the FDA in the middle of the summer, and this data created a lot of interest. And we interpreted that positive, but that's our interpretation. And then, ultimately, we have to see exactly where this lands. But as you pointed out, no one else has any efficacy data in this population that is meaningful, and we have that. So we hope for it. We push for it. We have to see. Gotcha. Also, can you comment how big is the EMD population or fraction of myeloma patients with that? This is a tricky question because it is growing so rapidly. Our current estimate is that you roughly have sixteen thousand patients per year in The US that has extramedullary disease upon relapse. So they they are not diagnosed with it, but during the course of the disease, you have an extramedullary component. And from that time point on, you know, median overall survival is, in some studies, less than six months, but roughly sixteen thousand a year. Of course, they have various refractory status as an EMD patient, so that overlaps slightly with the triple plus refractory, but a lot of them have less refractory has has less refractoriness than that. Gotcha. And my last question is on the regulatory side. Just curious, what is the supply chain for melclofin? Mean, where is the drug manufactured? And has the FDA inspected the manufacturing facility or plans to inspect it in the near future? Just wanted to see if there's any kind of manufacturing limiting factors that could arise. Mark, you should I Jacob, go ahead. I'll let you yeah. Go ahead. So if we first talk about our supply chain that is as part of the submission, that means that the drug substance is manufactured here in Scandinavia. We have one supply unit for that. That is no they're not limited at all. It lasts forever, and you can have years of drug sort of potential drug product on the shelf and at various storage units. When it comes to drug product, that is manufactured in Central Europe, and we have one site that's part of the submission, and we plan to add a different one more site also in North America, in Canada, very close after the submission to also be approved. For early drug supply, this is not limiting at all. Of course, if we are amazingly successful, we will have to work hard, but we already have a third site in the works in addition to the Canadian one to expand drug supply even further. When it comes to inspections, we, of course, expect both of these sites to be inspected. They have both been recently expected and approved by the FDA. They both have drug product and drug substance as part of APIs and drug products respectively for The US market. We don't expect any problems, and FDA has at least verbally said that remote inspection is fine if that is what can be achieved under the current circumstances. Gotcha. Thank you very much for taking my question. Thank you. Our next question comes from Christopher Yudi from SEB. Please go ahead. Hi there. And welcome to the team, Marty. I just wanted a quick question, I think probably for Anders here. When do you expect costs for Horizon to come to an end? I don't have the exact number for that. They have gone down, actually. The cost for Horizon was roughly 26,000,000 in the first quarter and then some pound in the second. So they they are going down already. Okay. Great. Thanks. Thanks for the welcome, Christopher. And, obviously, as as Horizon costs continue, it means patients are continuing to benefit. So it's it's kind of a good news good news problem to have. I appreciate the welcome. Thank you. There appears to be no further questions, so I'll hand back to the speakers for any of the remarks that they may have. Super. Well, we really appreciate your participation and and investment and continued interest in in the OncoPeptide story. You know, we think the q two chapter was was an excellent one for the company and and are really excited about some of the major milestones that that lie ahead. So we certainly look forward to talking to you individually and also further future updates in a in a in a wider wider sense. So thank you very much. Have a great great day, and we'll talk soon. Bye now. Thank you. Thank you. Concludes our conference call. Thank you all for attending. You may now disconnect your lines.