Welcome to the Oncopeptides Audio Cast with Teleconference Q2 2021. Throughout the call, all participants will be in listen-only mode, and afterwards, there'll be a question and answer session. Today, I'm pleased to present Marty Duvall, CEO. Please go ahead with your meeting.
Good morning. Thanks for listening to the Oncopeptides Q2 webcast. It's been a pivotal quarter for us, and we're at an important inflection point for the company. In 2021, we've experienced some dramatic swings in our market price from a high of 215 SEK to the lows of the past week. Through it all, there's been one constant, and that constant is confidence. Our one Oncopeptides team confidence in our platform, confidence in our lead drug, confidence in our data, confidence in the hope that we bring to patients, and confidence in one another. Following an encouraging launch of Pepaxto in the U.S., the challenge in the second half of 2021 will be reaching common ground with regulatory bodies, the FDA in particular, on the strength of our pivotal phase III OCEAN trial.
Let's look at the specifics of our Q2 performance. If we can flip to slide two. Joining me on the call today are Dr. Klaas Bakker, our Chief Medical Officer, and Anders Martin-Löf, our Chief Financial Officer. On slide three, I remind that I will be making forward-looking statements and ask you to please consult some of our filings for appropriate balance. Now switching to slide four. On slide four are the key takeaway messages for this call. First of all, this is our first full quarter with revenue, and we're excited about the revenue that has been generated. There's extremely strong interest in Pepaxto among healthcare professionals, and hundreds of patients have already received and are receiving our drug for the treatment of their refractory multiple myeloma.
As you will see when we look at the details, there is double-digit demand growth on a month-to-month basis. You see our Q2 net sales of SEK 7.2 million or SEK 66.4 million, year-to-date net sales, which includes those first two weeks of mid-March, at around $10.2 million and SEK 85.7 million. Third major point here is our updated OCEAN data. This was a big quarter for the OCEAN trial and data. Just a reminder, head-to-head versus pomalidomide. Here we see melflufen or melphalan flufenamide demonstrating superiority on the primary endpoint of progression-free survival. In the intent-to-treat population, we see consistent data on the strong activity of our drug with respect to objective response, depth of response, and duration of response.
As a reminder, on the secondary endpoint of overall survival, there was a slight favor for pomalidomide in that intent-to-treat population. We'll provide a little bit more color around that, but also look forward to the IMW meeting in September, where our late-breaking abstract on the OCEAN data has been accepted for an oral presentation. At that point, we'll be able to provide more of the data and more of the specifics behind our excitement on that data. Finally, we are progressing on key work streams related to the partial clinical hold. The key here is establishing that common ground with the FDA on the interpretation of the OCEAN data and the impact that it will have on the development and commercialization going forward.
We're confident that this data points to a patient population of high unmet need that may benefit from Pepaxto therapy. Now I'll provide some more specifics on the commercialization, if you can flip through to slide six. This is just a reminder on our accelerated approval, which occurred on February 26th. Patients of high unmet need, triple-class refractory patient population who have received at least four prior lines of therapy. We've talked about the high unmet need of this population and the fact that 41% in the subset from the HORIZON study had extramedullary disease, and commercial drug was shipped to patients beginning on March 15th. This label remains unchanged as we continue our commercialization efforts in the U.S. Next slide, please, is slide seven.
We outlined in previous calls our strategy for the development and commercialization of Pepaxto, and I'm happy to say, and I think you'll see in the numbers, that this strategy is playing out. We hope to become a foundational treatment in relapsed refractory multiple myeloma. In the treatment of today, we see a lot of recycling of the old classes, those triple classes, the IMiDs, the PIs, and the CD38s. Our strategy is looking forward to a future where drugs with new mechanisms of action, such as our peptide drug conjugate, Pepaxto, gain increasing share, and we stop the recycling of the old classes, which really was the premise behind the OCEAN study. The two-pronged strategic approach is on the right-hand side of the slide.
One is to become a treatment of choice for appropriate and indicated patients, looking at those that are specifically labeled in the triple-class refractory population, while secondarily expanding the market for the new mechanisms of action and minimize the recycling of failed drug classes. Let's flip to slide eight. We are off to a strong start through the first full quarter of commercialization on some of the revenue metrics, top-line numbers, $10.2 million in net sales from that mid-March to the end of June timeframe. We had reported at our Q1 call, which stretched into April, that we had about 100 accounts. We've doubled that in the following two months, so approximately 200 unique accounts that are using Pepaxto through Q2, and we've shipped approximately 1,200 20-milligram vials during that time period.
A s it relates to our activity and field metrics, we continue to focus on top-tier customers. Our reach is over 90%, and now we're improving on our frequency number in terms of calling on those most productive customers. Our customer awareness has exceeded the 90% mark, and our payer coverage continues to be at 97%, so very strong. Let's flip to slide nine. On slide nine, I thought I'd give a little bit more flavor to this double-digit growth and accelerating demand. In this case, we've also chosen to provide more detail on July. This represents in blue the monthly pull-through into customer accounts on a monthly basis. What you see through the March to April, May, June, July timeframe is double-digit growth on a month-to-month basis.
As indicated, the jump from June to July is particularly impressive with a 32% jump in demand with 456 vials of Pepaxto shipped to our end users in the month of July. Now, of course, with the FDA safety communication, difficult for us to comment on what happens from here. Certainly, I think these early indicators suggest that there is an unmet need for the product, that it's growing, that the commercialization to date has been well-received, and that we are helping patients in the U.S. with our product. Flipping to slide 10. Want to take a look at this on a column-by-column basis. Overall headline here is that we are gaining on our key competitors, and specifically where we're indicated after four lines of therapy or after four prior therapies, which is the 5th line plus multiple myeloma market.
On the left-hand side, we have quarterly revenue as it's been projected and announced by competitors in the triple-class refractory population. Obviously, our entry in Q1 2021, with $2 million, we see the revenue for both XPOVIO and BLENREP. Stepping forward to Q2 of 2021, I point out two things here and relate back to the strategy. Number one, here we see the quarterly net revenue for these three products that are indicated for triple-class refractory population growing. We have helped to fuel this growth of new mechanism of action use and the stopping of the recycling of classes. We also see that BLENREP is level from a quarter-to-quarter basis, and we see a slight drop from XPOVIO. We are beginning, we believe, to have an impact in being a leading product in that 5th line plus population.
In the middle, let's keep in mind the key revenue drivers as it relates to each of these products. In this case, Pepaxto, down at the bottom, is the lower on the pricing side from a comparison, and that was done specifically as we priced in the U.S. market closer to pomalidomide, given our ambition relating to the OCEAN trial. We are only approved in 5th line plus as a doublet or a single-agent approval. Whereas product BLENREP, as an example, higher price, yes, it is labeled for 5th line plus, but is also labeled in earlier lines of therapy. As for XPOVIO, it not only has the 5th line plus indication, but an indication in earlier lines of therapy.
It also has a triplet label in combination with bortezomib and also utilization outside of multiple myeloma that has been approved at a higher price. On the right-hand side of the slide, as we look specifically at new patient share among these key competitors in that fifth line plus population, we see Pepaxto becoming a leading product where indicated in this marketplace. Let's flip forward to slide 11. We believe Pepaxto is well-positioned for community-based care, and an important reminder here that it's about that doublet use that is critical here. We feel in the community setting, and here you see some of that data by line of therapy as we move from first line to second line to third line, fourth line, fifth line.
We see an increasing use of doublet therapy, the place that we're going to play. We have efficacy in later lines of therapy. We have a manageable safety profile, given our current package insert, and this convenient administration and better compliance play very well in the community-based setting. On the right-hand side of the slide, continue to and pleased to report our continued uptake in both community and academic centers with 66% of those approximately 200 accounts being in that important community setting, but also having the support and growing support in the academic marketplace. Let's switch to slide 12. In this slide, just highlighting for you some of the leading academic centers and community practices that make up those 200 unique accounts that have ordered Pepaxto through June.
We see the addition of many important and prestigious multiple myeloma centers and community practices across the U.S. who are now using Pepaxto. Flipping to slide 13. Pleased to report that we now have a permanent J-code for Pepaxto that will be effective in the 4th quarter. This replaces a miscellaneous J-code, or hospital C-code that had been utilized to date. This has great benefit to our customers. Specifically now it's reducing billing and coding errors, decreasing time to reimbursement, ensuring more accurate reimbursement from payers. The net here is increasing confidence amongst our providers that Pepaxto will be reimbursed, which is particularly important in the community oncology offices and centers. On the next slide 14, just a brief comment here on Europe.
We have the timeline that we have provided in prior calls, and I'd like to call out August 15th. On that date, at the top of the slide, we see that we have received the Day 80 assessment report from our rapporteur. I'm pleased to report, while there are a lot of questions, and we overall feel that they are quite addressable and are pleased to report that we feel we are on track as it relates to the EMA review of the Pepaxto approval with a continued target of potential launch of Pepaxto in Europe in the second quarter of 2022. On our end, we had started a buildup, as you recall, in March 2021 with the addition of our commercial and medical leadership.
Now we're focused on country of first launch and setting up a German legal entity in Germany and beginning our efforts to prepare for the launch of Pepaxto in Europe and Germany specifically. Let's turn to slide 15. Just wanted to make mention now of the FDA safety notification that was proposed on July 28th. This is in addition to the partial clinical hold that had been announced earlier in the month. This is in the backdrop of that growing demand trend that we saw in the U.S. market. Just want to reiterate that we take seriously this FDA alert. Just as a reminder, this is on the overall survival results in the intent-to-treat population.
As you look at the details on the right-hand side of the panel, as a reminder, hazard ratio of 1.104, which is suggesting about a 10% detriment in the intent-to-treat population that actually favors pomalidomide. Just want to convey a little bit more information here regarding this is early as it relates to the overall survival and is not statistically significant, but of course, patient safety is significant, and we take it seriously. From the standpoint of the trial overall, we believe the data that will come out at the IMW will support the fact that there are populations that can greatly benefit from Pepaxto, and that the overall positive result in the progression-free survival primary endpoint pulls through into some patient subsets where we see a very strong result for our drug.
With that, I'm going to turn it over to Dr. Klaas Bakker to talk about our clinical studies and other activities on the medical affairs and clinical development side. Klaas?
Yes. Thank you, Marty. Good morning. Good afternoon, everyone on the call. I would like to flip to slide 17 for a quick recap of the OCEAN top-line results, which we presented earlier. It's very important to state that this study met its primary endpoint as per IRC assessment. We had a superior progression-free survival under a SPA, Special Protocol Assessment with the FDA, which will be an important driver of ongoing communication with the agency. As Marty already mentioned, overall response rate higher for melflufen when compared to pomalidomide. The secondary endpoint, the overall survival hazard ratio of 1.104 favoring pomalidomide in the intent-to-treat population. I put some emphasis on the intent-to-treat population because at IMW, we will be able to give some more flavor of that result.
I would like to repeat what Marty said, and that is that we have confidence that when people see the data, there will be a much better understanding of these overall survival hazard ratios. It is also important to understand that the FDA needs to take its responsibility when they see a certain hazard ratio above a threshold that triggers certain actions. That is what we see. That is before the agency has been able to do a thorough review of all the data. This is exactly what Marty mentioned, safety first, then we look at the data. Since we have strong belief in the data, we feel very confident that in the end will play out, and in particular for a very, very important subgroup of patients.
In the clinical hold, the partial clinical hold that the FDA issued, and it's important to mention that this is a partial clinical hold, which means that patients who are on treatment already can stay on treatment provided that they have been re-consented. This goes through our complete clinical program on melflufen and you see the studies mentioned. On top of that, we have a full clinical hold that we already put in place ourselves before the FDA asked us on our OPD5 program. No patients were enrolled yet, we felt with the data in the OCEAN study that course needs to be reconsidered. That is something that we are considering and even already initiated before the FDA asked us to do so.
I'd also like to give you some flavor on the partial clinical hold and the implications so far. Of all the patients on clinical trials, all but two patients have re-consented to continue. This is, of course, largely driven by their individual healthcare provider. We feel very confident, given that nearly all patients stayed on drug, that b oth patients and healt hcare providers feel confident that the patient is deriving a positive effect from this drug with a positive benefit to risk ratio. Important to note that these trials are among also earlier lines of treatment. Regarding the interactions with the FDA on the clinical hold, we have key work streams ongoing.
What that means is that we are providing a package to the agency in the coming months where we address the concerns and come forward with a path to reopening our clinical studies. I'm very pleased to mention that we, from our side, are making nice progress on that work, but that is, of course, also dependent on the interaction with the agency. We appreciate that there is uncertainty and there is a range of outcomes with the full FDA review of OCEAN trial. The FDA has all the raw data sets, has all the materials, so the agency is also doing their own review alongside our review and the interactions that we have.
First, there is a scenario that the OCEAN data review will result in an extended label that includes the third and fourth line, which is basically mirroring the POM label, which would have been the case with a very clean and consistent study where the OS would have moved in the same direction. That's still a possibility, but that depends on how we interpret the data together with the FDA. The second scenario is that the OCEAN data is viewed as so-called hypothesis-generating, which means there is a very positive signal, but that needs to be reconfirmed in our clinical development program while we can continue to promote in our indication today. This is not an unlikely scenario as you want to see a confirmation of a signal in a study.
It's all about how strong is the signal. This is where we feel very confident that we have a good path forward there. Of course, there also is. We consider this a low likelihood, and I'd like to emphasize that. It could be that the OCEAN data results in a level of concern around the overall survival that challenges the continued accelerated approval of Pepaxto. This is a worst-case scenario where we, as I said earlier, feel confident that this, in the end, won't happen. Of course, we cannot exclude that scenario. On top of that, the FDA may hold a future public meeting to discuss melflufen. We cannot share any information on that as of today, normally the FDA gives notice to such a meeting approximately 30 days in advance of a meeting.
Taking a look at slide number 20 where we have the detailed timeline for the upcoming events. This is the timeline around OCEAN with the data releases on the very left. We then move through 2021 where we released the final IRC results on July 8th and the FDA safety alert on July 28th. I'm very pleased, as Marty also mentioned, to report that we will present the data in Vienna during the IMW workshop where we will shed a lot more light on the OCEAN study and in particular also the overall survival result because we really would like to share the overall survival data and what's beneath it. S tay tuned for that.
In advance of the IMW meeting, there may be an abstract, or there will be an abstract actually that will be made public on the 27th of August. I would like to remind everyone that an abstract has only a limited number of characters that can be put into the abstract. As such, don't expect too much details around the efficacy results in that abstract, simply because there is no space for more information. Let's go to the next slide number 21. The IMW, Oncopeptides is a platinum sponsor. We will have high visibility there. We will interact a lot. We have a lot of interactions planned around our clinica l data, and w e will discuss our data also at an symposium to make sure that we get the most input from a clinical perspective on our data.
As mentioned, stay tuned for that. We are very much looking forward there to share the data and following up, of course, with the investor community to talk in more depth about that data. With that, I would like to turn it over to Anders Martin-Löf, our CFO.
Thank you, Klaas. If we turn to slide 23, I'll go through the numbers for the period. As you see, the revenues for the first half of the year amounted to SEK 85.7 million or $10.2 million, as Marty already mentioned, and SEK 66.4 million for the second quarter. This presence of revenues means that our operating loss has now started to decrease slightly for the first half of the year to SEK 692 million. Quite significantly for the second quarter, going down to SEK 305 million from SEK 399 million in 2020. On the left-hand side, you see that we are seeing quite a shift in our cost base now. The R&D cost for the first half of the year went down from SEK 441 million last year to SEK 346 million in 2021.
On the other hand, the marketing and sales cost increased from SEK 149 million to SEK 393 million. This is the first time when the marketing and sales costs are actually higher than the R&D costs, and that's a trend that I think is likely to continue. R&D cost went down quarter by quarter. It was SEK 179 million in the first quarter and SEK 167 million in the second quarter. This is mostly driven by the fact that our OCEAN study is now coming closer to the end. Last year, for the first half of the year, we spent roughly SEK 177 million on OCEAN, and this year was SEK 78 million. SEK 100 million less on OCEAN alone for the first half of the year.
The marketing and sales growth is, of course, coming from the fact that we have built the entire U.S. organization and are also now starting to build a little bit in Europe as well. The majority of the increase comes from the U.S. organization, which almost tripled in size from the end of the second quarter last year to the end of the second quarter this year. Cash flow was a negative SEK 733 million for the first half of the year and SEK 347 million for the second quarter. The quarterly negative cash flow actually decreased quite a bit from the first quarter then. We have a negative SEK 387 million for the first quarter, and now we're down to SEK 347. A positive trend there as well.
At the end of June, the cash position was roughly SEK 1 billion. On top of that, we have a EUR 400 million loan facility from the EIB that we have not utilized. I should also mention that due to the uncertainty with the FDA situation, we are, of course, being very prudent and have implemented already measures to increase the cash runway. For example, postponing projects, and we have a hiring freeze in place. We feel confident that we now have runway through the second quarter of 2022. Of course, there is a lot of upside to that scenario as well. It could well be that things turn out really, really well with the FDA, and we can start selling during 2022 in an expanded label.
We're also then planning for the worst-case scenarios as well. We have lots of contingency plans in place no matter what the outcome will be with the FDA and EMA. With that, I will turn the word back to Marty to finish off with some comments.
Thank you, Anders, and also a thanks to Klaas Bakker. On slide 24, just a reminder on our key takeaway messages. Our first full quarter with revenue. The double-digit demand growth on a month-to-month basis is exciting. Our quarterly sales numbers as presented. The OCEAN data, that study meeting the primary endpoint, very important. Some of the secondary endpoints along the efficacy parameter also trending in the right direction, also this comment on the overall survival in the ITT population and the important safety communication as pointed out by Klaas Bakker, which has also resulted in the clinical hold.
Really important for us as we look at the second half of 2021 to progress on those critical work streams and the partial clinical hold in particular is important and we're very excited about the IMW meeting and the reveal of the details of the OCEAN trial in an oral presentation at that meeting. It does appear that that presentation will take place on a Saturday. Right now we're targeting a webcast to provide more details and perspective following the meeting in Vienna. With that, I'll turn it over to the operator as we move towards our Q&A. Thank you.
Thank you. If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Our first question is from Adam Karlsson of ABG Sundal Collier. Please go ahead.
Hi. Thank you very much for taking my questions. Just a couple if I could. Firstly, just on what Klaas Bakker was describing with the possible outcomes and scenarios from the FDA interactions. My question is, given that the OCEAN study was meant to serve two purposes, firstly, convert the Pepaxto accelerated approval into full approval and then also broaden the label. My question is that to what extent are these interlinked and could the outcome be that the FDA is able to convert the accelerated approval but not accept the sNDA or vice versa? Can you speak to how you view the possibility of this and whether you feel more or less confident in either of these processes?
Yeah. Thanks, Adam. I'll actually turn that over to Klaas to provide his perspective.
Yes, absolutely. Thanks, Adam. It's a good question. These two are quite interlinked, to be honest. It's all about reaching a common understanding of the data with the agency. If we agree on what this data means, there is a high likelihood that if it can serve as an sNDA to confirm the HORIZON data, there is a high likelihood that that may also have implications for the label. Right now, it's unlikely that we have a scenario where it would only result in an sNDA, but without a label change. That is, as said, within the boundaries of the so-called first scenario, if that makes sense.
Right. Okay. Just one more if I could. In the Q1 reports, we got the sales for April and just if one backs out the May, June sales from that and today's figures, it would appear as though the actual sales are decelerating during the quarter. Of course, that could be due to destocking effect in April and so on. Just trying to understand how that squares with the month-to-month growth that you're seeing in vials shipped. Is it the case that the vials shipped measure is looking at shipment from your distributors to the actual clinics while the sales are being recorded when you send the vials to the distributors when you make an actual sale? Thanks.
Yeah, great question, Adam, and you're exactly right. As the presentation's available, if you flip back to slide nine, you'll see that demand trend. Just to reiterate, so those aqua or blue bars are actually the pull-through demand coming from distributors into accounts. This is the true utilization of the product as it goes from a hospital or a community practice into a patient. What we see is that consistent growth in demand March, April, May through July, and the big jump from June to July is the fundamental demand for the product. When we look to what's reported from a net revenue perspective, it's the shipments to the distributor that get recognized.
Early on, some of the fluctuations and are pointing out in our Q2 report of inventory kind of moving around, a little bit to do with some short-dated product that we had to utilize at the launch. That once we had a second batch, there was a replacement of some of those vials. What you see in the gold bar that's part of that slide nine, is the ending inventory position of the distribution network on a month-to-month basis. You see that changing. Obviously in July you see 173 in the inventory against that 456 demand. This is where we're suggesting now we're more in that typical one to two-weeks and more two weeks in this case inventory position. That's exactly where we want to be.
Great. Thank you very much.
Thank you. Our next question is from Patrik Ling of DNB Markets. Please go ahead.
Thank you, guys. A couple of questions from me as well. First, if we can start with partial clinical hold. If I remember correctly, when the FDA has received the final information from the companies, they have normally 30 days to actually respond or come with a suggestion or a solution. Have you sent the final information to them, or is that something that we're still waiting for?
Yeah. I can take that, and Klaas, please comment. That's good to hear from you, Patrik, as well. That's something that working through the data, it's so critical the understanding of the data and the FDA understanding of the data. A lot of the exchange and the correspondence between FDA and Oncopeptides at this point has been more around the data, the OCEAN data. Once we reach that common understanding, that will generate the ability to move forward. We feel like we know where this is going, but certainly we need the agency to have their time and to appropriately review. Klaas, additional comments, thoughts there?
Yes, I think if I take a step back, before you send in a complete response package, you do want to know that you are on common ground with the agency. Otherwise, you put a lot of work in a response that may not fly at all. What we're doing is first to try to get to that common understanding, then to send in that full clinical response, and then indeed, as you mentioned, the 30 days kick in. We're now really into that phase where we are reaching that common understanding, which then also helps us to finalize our complete response letter.
Would you say that the way that you're handling it with the intense contact between you and the FDA makes it maybe more likely that they will be able to respond to you within or shorter than in the 30 days because as you say, you have a common ground, or will they still utilize the full 30 days, you think? That comes back to what you talked about before, that you hoped to have some sort of solution to this in September, whether that is realistic or not.
That is still within the possibilities. I mean a resolution of the partial clinical hold as it stated. That's one of the timelines I expect in Q4 to be reasonable within timelines. You should know that a complete response letter, it's called a letter, but it's a package that easily has more than hundreds of pages of specific amendments, details that are important. To say that it is within 30 days is reasonable, and I don't dare to speculate if it will be shorter than 30 days given the amount of data that we sent over.
Okay. Do you still think it's realistic to file based on the OCEAN data in Q4, as you talked about before, or is that something that's been moved forward or pushed back in time?
I think really what is critically important right now before we look at filing, if you file, you file for something. You need to know where you are with the agency before we file. If we file, we want to do that in a situation where we have reasonable certainty that the file will be successful. The exact filing of what we file is also dependent on what we agree with the FDA. The first step is now to get the clinic al hold lifted, and once that hurdle is cleared, we have a much better understanding. I think Q4 for a filing, dependent on what filing that may be, is not realistic at this stage, and I would guide to the first half of next year there for a potential filing.
Okay, great. I also have a question regarding your comments in the report about July, that it's up month-over-month by 32% despite this clinical hold. The official statement from the FDA came pretty late in July. You were out talking, but do you think that you actually still saw a full effect of that on your sales development, or do you think that is something we should expect in August instead?
Good point, Patrik, didn't mean to confuse that a little bit. The partial clinical hold announcement came early in the month, as you're mentioning, the FDA safety communication came towards the end of the month. The majority of the demand creation efforts in the month of July occurred without that safety communication as a backdrop. A little too early to tell. Obviously, we're only a couple weeks beyond that, I don't want to speculate further, I think it's safe to assume that it would have some impact on the demand trend. Wanted to really characterize the trend that we're seeing in the first three and a half months, four and a half months, I guess.
In this case, where one would expect to see patients beginning to continue therapy as we add new patients on, and I think that's reflected in the demand trend that we're seeing through July. Thanks for pointing out that clarification on timing. I think that's important for everyone to understand.
Okay, great. Thank you, guys. I'll jump back into the queue.
Thanks, Patrik.
Thank you. Our next question is from Christopher Uhde of SEB. Please go ahead.
Hi there. Thank you for taking my questions. I guess the impact on sales was the first one. You've now answered that. The other question I have is, you mentioned possibility of a new trial, and I was actually wondering whether changes to LIGHTHOUSE might be sufficient to address such an issue, the hypothesis generation, or whether the tri al itself as it's currently designed could be sufficient. Do you think that you would need an altogether new trial? If that would be the case, let's say, what do you think are the odds of the first scenario or the second scenario? Thank you.
Thanks, Christopher. I'll let Klaas address that one and then we'll look to you for follow-up.
Yes, Christopher, good afternoon. Very relevant question. I think it's important to acknowledge that every patient on a clinical trial is a patient who puts his or her trust in the research that is ongoing. All patients that have been recruits through LIGHTHOUSE right now deserve that their response, so to say, on treatment also is taken into account. We, as well as the agency, have a mutual, I would say, need to get the most out of LIGHTHOUSE in terms of regulatory implications. Whether that will result in a modified design of way, I don't dare to speculate right now. It is obviously something that is on the table as we speak.
Okay. Thank you very much.
Thank you.
Anything else, Christopher? Okay, sorry.
That's fine for now.
Go ahead. Okay, thanks Chris.
Thank you. Our next question is from Ernie Wouters of Kempen. Please go ahead.
Hi, good afternoon, good morning to the team. Just a quick question on the subgroups. You indicated that you're still very confident that there are certain subgroups that might significantly benefit from treatment with Pepaxto. I was just wondering whether these subgroups will be easily identifiable before you initiate treatment.
Yeah. Good question. Ernie, I'll turn that over to Klaas for comment.
Yes. Good question. Very identifiable, I would say. It's very easy to identify these patients. We're not looking at patients with a genetic alteration that you need to look for. It's a large subgroup within a study that has met its primary endpoint. I would again urge everyone to take that step back and look at OCEAN as a positive study from a primary endpoint perspective where we do see benefit, not in just some subgroups, but in one, if not the most important subgroup right from the start. We are very confident that identification of patients won't be an issue at all in this subgroup.
Okay. That's very clear. Thank you very much.
Thank you. Thanks, Ernie.
Thank you. Just a reminder, if you wish to ask a question, that's zero one on your telephone keypad. There will be a brief pause while we register any further questions. We have a question from Fredrik Gustafsson, a retail investor. Please go ahead.
Yeah. Hi, thanks for taking my call. Fredrik Gustafsson here. With regards to the maturity of overall survival, I think the data cut-off was in February, so that's quite some time. Are you considering to maybe update the overall s urvival data with regards to the discussion with the FDA? Or is that something you see upcoming, especially now since you mentioned that the filing might slip off into 2022?
Yeah. Good question, Fredrik, certainly I don't want to dismiss the ITT result by over-emphasizing immaturity. I'll let Klaas speak to any further data cuts and the importance of that relating to communication with regulatory agencies.
Yes. The answer there is, there will be a later overall survival cut, inevitably. We need to come to grant of what the best timing of that new data cut is. Whether it impacts the current, I would say, ongoing dialogue with the FDA, the answer is actually no. I can assure you that there will be a later readout given the result that we saw in the initial readout. I don't dare to speculate about when that will be.
Okay.
Thanks, Fredrik.
Thanks a lot. I just had one second question.
Okay.
The subgroup, it's fairly. I think Jakob mentioned hazard ratios of 0.5-1.5. Obviously, the data is coming, so we'll see it soon anyway. Just wondering, if you have those magnitudes of significant hazard ratios and those large subgroups, isn't it plausible that you will have confidence interval significance also in that subgroup of interest?
Yeah, Fredrik. I'll give a global comment on it and then ask for Klaas to clean up anything I say. I think the first key here is, and putting this in the context of discussions with regulatory bodies. From an FDA and EMA as an example, have very different guidance regarding subgroups and approvals of subgroups and how things are. From an FDA perspective, the real importance is the intent-to-treat population, the primary endpoint, and then this key secondary endpoint of overall survival in line. From their standpoint, there needs to be first a view that the study was indeed positive as they then consider future implications. From an EMA perspective, there are different regulations regarding subgroups and some of those finer details.
As you mentioned, some of the specifics regarding underlying confidence intervals and subgroups, that may become more important from an EMA perspective than it is from an FDA perspective. I'll defer here to Klaas Bakker to provide some of his perspective as he thinks through this as well.
Yes. Basically, the short answer to your very specific question is yes, we do see confidence intervals below one and above one in totality, which speaks to the strength of the data in that subgroup. We're not just talking about a minor difference here. We talk about significant differences, hence our interest to show this data at IMW for everyone to get to the same page as well when it comes to data interpretation. Thanks. Very good question.
Thanks a lot, Klaas.
Thank you. There are no further questions at this time. I'll hand back over to our speakers.
Okay. Well, thank you very much. Thanks to everyone for your engagement and following of our story. As mentioned, pivotal quarter for us, Q2, important inflection point going forward. Hopefully, you get a sense for our confidence in the data and confidence in the team and in melphalan and the value and hope that we can bring to patients. Do want to just make sure in closing here that I thank the entire Oncopeptides team. Certainly now as we have ongoing interactions with two regulatory authority, there becomes a large burden that we're up to. Of course, these are both very important steps as we look to our ambition of treating more patients with relapsed refractory multiple myeloma, not only in the United States, but around the world.
Would also like to thank our team here in the U.S. that have successfully launched the product and are growing demand and are working each and every day to make sure that our healthcare professionals around the world understand our product and understand the current situation. Much appreciated. With that, looking forward to our next webcast opportunity, which as mentioned, will be immediately following the important IMW meeting in Vienna the first week of September. Thanks, everyone. Take care and have a great afternoon and a great morning. Bye now.