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spk04: Ladies and gentlemen, good afternoon or good morning. My name is Julia Neugebauer, Head of Investor Relations at North Fortis, and it is my pleasure to welcome you to our 2023 Half-Year Financial Results Conference Call. With me on the call today are Jean-Paul Kress, our Chief Executive Officer, Tim Demuth, our Chief Research and Development Officer, and Lucy Crabtree, our new Chief Financial Officer. Before we begin, I'd like to remind you on slide two that some of our statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans, and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in Morphosis 20F, an annual report All for the year ended December 31st, 2022, and from time to time in other SEC documents of morphosis. It is important to keep in mind that our statements on this webcast speak as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview and give an outlook. After that, Tim will share an update on our clinical development work, and then Lucy will provide a summary of our first half 2023 financial results. Following our prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.
spk05: Thank you, Julia. Good morning and good afternoon, everyone. Thanks for joining us today. We had an extremely productive and strong first half of 2023. We delivered and surpassed expectations on our key priorities, and we will continue to build on this great momentum as we enter an exciting second half of the year. We completed enrollment of two of our pivotal trials ahead of schedule. The Manifest-2 study of Pelabrasib in first-line myelofibrosis and the FrontMind study of Monjuvi in first-line DLBCL. Additionally, our partner Insight completed enrollment for InMind, the Phase III study of Monjuvi in patients with relapsed refractory follicular lymphoma or marginal zone lymphoma. Furthermore, we presented updated results from our tool memetostat phase 1-2 study showcasing the therapies based in class potential in an array of cancer types. We also took steps to further strengthen our financial position. Today, we are well financed to drive forward our promising mid to late stage clinical programs with more than 12 months of cash available following the top line readout of the Manifest 2 study. Also, Lucy Crabtree joined us this month as our new Chief Financial Officer. We are very pleased to officially have her on board. Elabrasib, our investigational bed inhibitor, is a potential best and first-in-class foundational first-line treatment for patients with myelofibrosis. With this therapy, we have the opportunity to substantially improve the standard of care for this debilitating and difficult-to-treat disease. Today, JAK inhibitors, such as roxolitinib, are the standard of care to treat myelofibrosis. These medications can reduce spleen size and relieve symptoms of myelofibrosis, but they do not address its cause. Furthermore, with this treatment strategy, only about 50% of patients achieve initial adequate disease control. And for many, that relief fades with time. The results from our Phase II manifest study suggest that Pelabrasib in combination with Roxolitinib offers prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. Further to this, in the manifest study, changes in biomarkers correlated with improvements in clinical measures of treatment success, suggesting a potential disease-modifying effect of Pelabrasiv. We believe these data underscore the strength of this combination therapy and its potential to be the future standard of care in myelofibrosis. Based on precedent in first-line myelofibrosis, we believe that the results from Phase II studies are strong indicators of what we can expect to see in Phase III trials. As such, based on our strong Phase II results, we are very optimistic about the performance of the Pelabrasib and Ruxolitinib combination in our pivotal trials. With top-line data from the Manifest II trial now expected by year's end, we are hearing increased excitement from physician and patient communities around Pelabrasib, reflecting the dire need for more effective and well-tolerated therapies to treat myelofibrosis. We will remain laser-focused on Pelabrasib in first-line myelofibrosis, delivering the Phase III manifesto study results and, simultaneously, preparing our regulatory filings in the U.S. and Europe this year. That said, we also see great possibilities for Pelabrasiv beyond myelofibrosis, and we will continue to explore its therapeutic potential in other myeloid diseases, including lower-risk myelodysplastic syndrome, also known as MDS, and essential thrombocytemia, also known as ET. Tim will share more on this shortly. Moving to Monjuvi now. Monjuvi is our CD19 targeting immunotherapy. It continues to be prescribed to certain adult patients with relapsed or refractory DLBCL. In the second quarter, Monjuvi net sales were 23.6 million US dollars. This represents a 14% quarter-over-quarter growth. and is on track with our 2023 guidance. Beyond the currently approved indication, we see the largest potential upside for Monjuvie in the first-line DLBCL setting, which we are investigating in our phase three front-mind study. The trial randomized nearly 900 patients with data projected to be available in the second half of 2025. Also, Monjuvi's use in relapsed refractory follicular lymphoma and marginal zone lymphoma is being explored in the phase 3 in-mind study. This data will be available in 2024. We have a strong U.S. commercial infrastructure in place for Monjuvi. We have encountered a large overlap in treating physicians for DLBCL and myelofibrosis. especially in the community setting, where we have established relationships. This would enable us to launch Pelabrasib smoothly. We've made exceptional progress with our pipeline. As a result, we have a rich set of catalysts from our pivotal studies over the next two years. Additionally, our key partner programs are progressing very well. These programs developed via our legacy antibody technology platform, include Yanalumab, Abelacimab, Sestrusumab, and Bimacrumab. While not a core focus of our business strategy, these programs offer potential upside and provide us with options for non-dilutive financing. I will now turn the call over to Tim to provide a development update. Tim, over to you, please.
spk07: Thank you, Chopin. The Phase 3 Manifest-2 study is our number one priority. In this trial, patients naive to JAK inhibitor therapies were randomized one-to-one to Palabrasib in combination with Raxolitinib or placebo plus Raxolitinib. Recall that after we acquired Constellation, we optimized the Manifest-2 study by increasing our target enrollment from 310 to 400 patients. In the end, we randomized 431 patients. The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. The key secondary endpoint of the study is a proportion of patients achieving a 50% or greater improvement in total symptom score, known as TSS50. In addition to these two endpoints, we're also measuring the percent change in total symptom score at week 24, progression-free survival, overall survival, duration of splenic and total symptom score response, and improvement in bone marrow fibrosis, among others. We are confident that the comprehensive MANIFEST-II data package will provide meaningful insights into the potential benefits of pilibrasib and ruxolitinib as a first-line combination therapy for patients with myelofibrosis. Our Phase III MANIFEST-II study is supported by our Phase II MANIFEST trial. These studies are very similar in terms of inclusion and exclusion criteria, endpoints, and treatment regimen. Based on this and the overall body of data we have presented thus far, we remain very confident in the collaborative raxolitinib combination and the outcome of the phase 3 manifest 2 trial. We saw strong efficacy and safety results in the phase two manifest trial data that were presented most recently at the 2023 IHA annual meeting in June. At week 24, 68% of JAK inhibitor naive patients treated with a Pelabrasib and Raxolitinib combination achieved at least a 35% reduction in spleen volume from baseline. Furthermore, 56% of patients had at least a 50% reduction in their total symptom score from baseline. These deep and durable responses were maintained at 60 weeks. The most common treatment emergent adverse events were low-grade. This data suggests that Palabrasib and Ruxolitinib is a well-tolerated combination therapy. We compared MANIFEST-ARM3 with three historical JAK inhibitors studied in randomized double-blind Phase III trials using a method called Matching Adjusted Indirect Comparison, or MIC, analysis. MIC is a robust method that ensures fair and reliable comparisons between trials. It does this by making adjustments for differences and select baseline characteristics across the studies. Our analysis showed that Calabrasib in combination with Ruxolitinib offers at least 1.4 times better symptom control compared to Ruxolitinib monotherapy in JAK inhibitor in naive patients. These findings were recently published in Blood Advances. Also, at the 2023 IHA Annual Meeting, we presented new data showing that hemoglobin levels were not only stabilized, but importantly improved over time in JAK inhibitor-naive patients treated with the pilabrasib and ruxolitinib combination. This has not been observed with ruxolitinib monotherapy, as treatment with this therapy has been shown to cause a drop in hemoglobin levels. While our focus in 2023 remains on pilabrasib and first-line myelofibrosis, we see opportunities for pilabrasib beyond this disease. At this year's ASCO and IHA annual meetings, we presented results from arm four of the phase two manifest study. This arm of the study is investigating Pelabrasib as a monotherapy in patients with high-risk ET, who are refractory or intolerant to hydroxyurea, the chemotherapeutic agent most commonly used to treat the disease. The primary endpoint of this arm of the study is confirmed complete hematologic response. The secondary endpoints include confirmed partial hematologic response and symptom improvement. To date, our findings suggest that collaborative monotherapy provides a potential clinical benefit for this ET patient population. 60% of patients treated with palibrasib monotherapy had a confirmed complete or partial hematologic response at any time. At the data cutoff, 14 of 20 patients were still undergoing treatment. Importantly, an early normalization of platelet count was achieved in many patients with white blood cell count and hemoglobin stable throughout treatment. This suggests that Pallabrasib monotherapy can normalize platelet counts without causing anemia or thrombocytopenia. Further, the results show that half of the treated ET patients had a 50% reduction in total symptom score from baseline at any time. These proof of concept results support Pallabrasib's expansion into other myeloid diseases. As such, We will continue our ongoing evaluation of collaborative in ET in the manifest study. We also plan to initiate a phase two study in lower risk MDS in 2024. We will then determine our phase three development strategy following these assessments. Moving on to Tony Medelstad, our investigational next generation dual inhibitor of ECH2 and ECH1. Tomimetastat was designed to improve on first-generation ECH2 inhibitors to increase potency, longer residence time on target, and a longer half-life, offering the potential for enhanced anti-tumor activity. It is currently being evaluated in a phase 1-2 trial for advanced solid tumors or lymphomas. Updated results from the phase 2 portion of the study were presented at ASCO 2023. The data suggests responses or disease stabilization across all solid tumor cohorts, including those with heavily pretreated patients. Notably, complete and partial responses were also observed in the lymphoma cohort. Physicians have expressed great excitement about the deep responses seen in these heavily pretreated patients, the majority of whom currently have limited or no treatment options. These preliminary results are very promising and showcase the therapy's best-in-class potential in an array of cancer types. As we continue to generate data from the dose-finding portion of our Phase 1-2 study, we will continue to evaluate our future development plans for Tomy metastabs. With that, I will now turn the call over to Lucy to review our financials.
spk00: Thank you, Tim. And good morning and good afternoon to everyone. I'm delighted to finally be with you today, having completed my prior role as CFO of Autolus. This is an incredibly exciting time to be joining Morphosis and my focus will be to support the business in driving value for shareholders by enabling the successful progression of our oncology portfolio. We're pleased to share our financial results for the second quarter and first half of 2023. Monjuvi sales were $23.6 million in the second quarter of 2023, reflecting a sequential growth of 14% and a year-over-year growth of 2%. We also recorded €2.2 million or $2.4 million in royalty revenue for Monjuvi sales outside of the US from our partner Insight in the second quarter of this year. The sequential increase is mainly driven by a one-time effect coming from previously deferred revenues related to Insight's early access program in France. Total revenues in the second quarter of 2023 were €53.2 million, compared to €59.4 million in the same period a year ago. The year-over-year decrease resulted primarily from lower expenses related to file sales to Apana Insights. Recall that Morphosis provides insight with Minjuvi's supply for ex-US sales. This supply is recorded as revenue, specifically reflected in the licenses, milestones, and other category under revenue, and an equal amount is recorded in cost of sales, yielding a zero gross margin. Total cost of sales was 7.7 million euros in the second quarter of 2023, compared to 17.2 million euros a year ago. Cost of sales specific to Monjuvi US product sales was €4.1 million in the second quarter of 2023, compared to €4.3 million on the second quarter of 2022. Turning to operating expenses. R&D expenses in the second quarter of 2023 decreased slightly to €57 million, compared to €60.9 million for the second quarter of 2022. Selling expenses decreased to €22.5 in the second quarter of 2023 compared to €24 million for the same period in 2022. The year-over-year decline was driven by streamlining and focusing of selling efforts. G&A expenses in the second quarter of 2023 were €17 million compared to €12.4 million in the second quarter of 2022. The increase mainly results from increased expenses related to stock-based compensation. For the second quarter of 2023, we reported a consolidated net loss of 74 million euros compared to a net loss of 235 million euros in the second quarter of 2022. As a reminder, the results for the second quarter of 2022 was mainly driven by finance expenses resulting from FX effects for the Insight and Rolte Farmer liabilities. Turning to our balance sheet. We ended the second quarter of 2023 with cash and investments of 672.8 million euros, compared to 907.2 million euros at the end of 2022. Recall that in the first half of this year, we spent approximately 40 million euros to repurchase parts of our convertible bonds to reduce our debt and to take advantage of the market dynamics as the bond is trading with a significant discount. Our solid cash position enables us to not only reach the pivotal data milestone for the phase three study of Pelabrasib, but to also provide a cash runway of at least 12 months beyond the pivotal data readout. Turning to our guidance for 2023. We are reiterating our guidance that was provided at beginning of January this year. All aspects of our guidance remain the same. With that, I'll now turn the call back to Jean-Paul.
spk05: Before we open up the line for questions, I'd like to conclude with a few words. The first half of 2023 has been marked by exceptional progress at Morphosis. We have over-delivered on our key priorities and are excited to build on this great momentum in the second half of the year. The lab receipt represents a large and unique opportunity to address the critical needs of myelofibrosis patients. We are very optimistic about the potential for Pelabrasib to improve the standard of care as a foundational first-line treatment. The body of data we have presented thus far, along with the size of our Phase 3 Manifest 2 study, give us high confidence in Pelabrasib's clinical success. We very much look forward to sharing the results of the Manifest 2 study later this year. With that, I would like to open the call for questions. Okay, right there. Please open the line.
spk09: Ladies and gentlemen, at this time, we will begin the question and answer session. Anyone who wishes to ask a question may press star followed by one on their touch and telephone. If you wish to remove yourself from the question queue, you may press star followed by two. In the interest of time, please limit yourself to two questions only. If you're using speaker equipment today, please lift the handset before making your selections. Anyone who has a question may press star followed by one at this time. One moment for the first question, please. The first question is from Xiang Deng from UBS. Please go ahead.
spk08: Thank you. Thank you for taking my questions. Two, please. The first one to Lucy, if I may. So just wondering, since you joined Mofosis, just wondering what is your first impression of the new CEO What is your strategy? What's your priority here? Anything you would like to share, that would be amazing. And the second question is kind of collaborative. Just wondering, now we have seen the Nevitoclax top-line data. Just wondering if there's, I mean, a lot of people have asked that, you know, what would happen if collaborative also reported mixed data in terms of if it hits a primary endpoint that meets TSS50s? So now Novitoclax actually reported like that. Just wondering, does it change any of your thought on this? And does it make you more or less relaxed about it? Thank you.
spk00: Hi, so thanks for your question. I mean, look, I am incredibly excited about joining morphosis at a really pivotal point in time with the data due to towards the end of this year. So, you know, I just want to sort of stress my excitement around the positioning of morphosis and what we've got ahead of us. You know, in terms of priorities, I'll just reiterate what I had in my prepared statements. You know, my focus is on growing shareholder value. It's supporting the business to deliver what we believe is an incredibly exciting future product for myelofibrosis. And obviously, as you might expect, continue to diligently manage our expenses and our cost base.
spk05: Thanks, Chan, for the question on the competition event that everyone has seen a couple of weeks ago. Look, we think this outcome is actually extremely positive for morphosis. And for us, the result is not a surprise as they basically replicated their phase two trial. We have very high confidence in a positive manifesto trial outcome for the following reasons. Number one, our study is very well powered. We have upsized the trial after the takeover of constellation to 400 patients. and we have over-enrolled to 431 patients, which is almost double from the obvious numbers. The Transform1 study is 252 patients. So we're very well-powered and much more powerful than they are. In our phase 2 trial, remember, we've shown a strong efficacy. Our data was very strong on both endpoints, FVR35 of 68% and TSS50 of 56%. And our safety results were actually very good. So this puts us apart from the competitor. We really think we're the best asset out there in myelofibrosis. So as we saw recently, phase two first-line myelofibrosis trials, results are strong proxy for phase three trials. So based on that and our strong phase two results, we think we'll have a very strong outcome with our phase three trial. And we're very confident in that. So basically, we strongly believe in our assets, and we think we have the best out there.
spk08: Thank you very much.
spk05: Thanks.
spk09: The next question is from Derek Archulot from Wells Fargo. Please go ahead.
spk02: Hey, good morning, and thanks for taking the questions. Just two from us. So maybe just piggybacking on that first set of questions, can you just discuss any specific differences in the enrollment criteria between the AbbVie trial and Manifest 2? And then the second question is, so, you know, GSK's Mamelotnin approval is coming up. So, I guess we were wondering, you know, how you view that approval or potential approval in the context of the FDA's flexibility around efficacy endpoints in myelofibrosis, because that drug was, you know, technically non-inferior to ruxolitinib, but it was numerically inferior. So, we'd love to get your comments there. Thanks.
spk07: Hi, Derek. This is Tim. On the differences between the inhibitor clarks and our study, generally the patient population is very comparable first-line patients with myelofibrosis naive to JAK inhibitors, namely roxalitinib. As Jean-Paul mentioned, and I will just emphasize that again, and I've said it in my prepared remarks already, our phase two study showed very strong results on spin volume response and TSS50. AbbVie shows very clearly that phase two results are very well replicated in phase three. If that holds true for us, I think we're in a very good shape and we continue to be super confident.
spk05: And now on JSK, maybe I could add that Basically, you know, it's not the same regimen. We are obviously exploring a combination regimen in first line. It's not the case for them. So the parallel is very difficult to draw. They are not looking at the same market. So I would stop my comments here, and we'll see what happens in the next couple of months with them.
spk02: Got it. Thanks so much. Thanks.
spk09: The next question is from Jason Butler from JMP. Please go ahead.
spk11: Hi, thanks for taking my question, but I just had two. First of all, can you just reiterate for us your confidence that 24-week data will be sufficient to support approval and you're not expecting to need longer duration of follow-up to support approval for Pella and myofibrosis? And then can you just walk us through the landscape and essential point with cytokinia and just how you think that Pella can fit into that treatment landscape? Thank you.
spk07: Thanks, Jason. This is Tim. So we know very well from interactions with agencies on both sides of the pond, namely FDA and EMA, what the approval endpoints are. And that, to your point, is the 24-week landmark for S3R35 and TFS50. On the question regarding the ET landscape, first things first. Obviously, we will bring home manifest two first. We shared the very exciting and very strong proof of concepts data in essential thrombocytemia. For these patients, it's, of course, very, very important to have normalization of their platelet count. it's important for them to have good hematological parameters. And those are two key signs our data is showing. These patients also experience commonly symptoms, which are measured in the total symptom score. Improvement here in our ARM4 data from Manifest shows very encouraging data. So I think that's a very strong and comfortable basis for us to develop further steps.
spk11: Great. Thank you.
spk09: Next question is from James Quigley from Morgan Stanley. Please go ahead.
spk06: Hello. Thank you for taking my questions. I've got a couple here. So just to your point about the approval endpoints of SVR35 and TSS50, just in thinking about the context of the other secondary endpoints, you mentioned PFS and OS that you're looking at. So to what extent is there flexibility around TSS50 if the other endpoints are hit. So, for example, if it does happen in Manifest that you hit on SVR35, not on TSS50, but you have a PFS benefit and an OS benefit, to what extent is there flexibility around that in terms of discussions with the FDA? And secondly, with regard to timing of the data, as we get close to the end of the year, to what extent could an ASH presentation be possible for Manifest 2? The late breaker deadline is towards the end of October. Is there a possibility for a placeholder for Manifest 2 at Ash or is that a zero probability scenario? Thank you.
spk07: Hey, James. Tim again. So, yes, in terms of approval endpoints, again, we're very clear on what we need to show as we are 35 TSS50 at week 24. As you pointed out, additional endpoints are, of course, included in the study as secondaries to provide more coloring and to provide a view on what ultimately matters to patients most. That's, of course, survival and, of course, safety. Let's not forget about tolerability for this somewhat chronic treatment, super important for patients to live longer with a very good quality of life, all parameters we're looking at. Agencies typically evaluate a clinical package based on what they call the totality of the evidence. So all these parameters will be taken into consideration by the agency. And again, we feel super comfortable and super confident in that phase three design based on increasing sample size, strong phase two data, et cetera. On the timing, we accelerated our top line readout, as you know, by at least six months. And I think we'll leave it at that and we'll be very excited to share that top line data with the scientific community and of course, the investor community by the end of the year.
spk05: And James, I would just add that when we acquired Constellation, we were more than one year behind the other company exploring first line combination therapy and now we are probably ahead. So I think already that tells a lot.
spk06: Excellent. Thank you very much.
spk05: Thanks, James.
spk09: The next question is from Manos Mastorakis from Deutsche Bank. Please go ahead.
spk03: Hi. Thank you for taking my question. Manos Mastorakis from Deutsche Bank. So first question, for example, and Tim, if you could give some color on your partner programs and more detail on the catalysts involved there as well as your confidence in those and some color on expected royalty size. And perhaps a sub-question on that is, what are your thoughts and any impact on the acquisition of your partner, Rassane Spadili, for the Pyramagma program? Yeah, that's it. Thank you.
spk05: Thank you, Manos. Well, we continue to be very excited and impressed by the performance of our partners. In the past, we've mainly singled out Yanalumab from now with Novartis. Novartis has said that Yanalumab is being explored in a couple of phase three trials to immune diseases. And they mentioned that it's going to be one of the top blockbusters in the future. So phase three plus size of the opportunity is very promising. Remember what we had with with Johnson and Tramphaia, so this is great. But the news here that we didn't really have time to tell you in the prepared remarks is on B. macrumab, which is an obesity treatment that we have in partnership with Versanis Bio. And Lily, as you know, is going to acquire Versanis Bio, and they have a Phase IIb ongoing study. Everybody knows the excitement around the obesity market right now when there is a really a breakthrough coming up. So, and Lily is obviously a huge name in the space. So we're super excited with that as well. So long story short, we have a couple of key opportunities here, which are the legacy pipeline. We don't really showcase it because it's not what we are focusing on operationally, but in the equation, in the financing equation, it's very important because that can mean royalties and our monetization as we've shown very handsomely with Royalty Pharma for Tram Fire and other assets. So this is great. It doesn't take any time. It is pure upside, and I wouldn't discount that in your models. Thank you.
spk09: Ladies and gentlemen, if you would like to ask a question, please press the star followed by one on your telephone. The next question is from Rajan Sharma from Goldman Sachs. Please go ahead.
spk10: Hi, thank you for taking my question. And just to follow up a little bit more on Palabrasib and specifically on the TSS50. So could you just maybe talk to the potential differences between Manifest 2 and Transform, which is the Novita Glax trial, which gives you confidence that you will hit on TSS50 outside of just the powering, and then secondly, Are there any kind of particular symptoms which make up the components of the TSS50 which you're most confident aren't given Pella's mechanism relative to other agents that we've seen in the field? And then kind of related, in arm three of manifest, do you know what proportion of patients achieved both SVR35 and the TSS50 endpoint? Thanks.
spk05: I'll start by the first part, Rajan, and Tim will comment on the next one. I'll come back to my first comment for the first question in the call. I mean, the fact that we have both the power, which is way above or bigger than the power from AbbVie, and the fact that our phase two trial showed great results on both endpoints is very strong and make us very confident in the outcome. That's really, really the main thing that you have to keep in mind here. I mean, the phase two is a very good proxy for the phase three. It was demonstrated a couple of weeks ago. Remember that AbbVie had a 42% TSS50 score in the phase two trial. We have 56%. So we're not surprised again. And we are extremely confident in the outcome of the phase three trial. Now on the details on the TSS50.
spk07: Yeah, this is Tim. Obviously, we cannot comment too much on the Abbey trial design. What I think we can assume is that everybody in this day and age is using the same to assess TSS, that's the myelofibrosis symptom assessment form version 4.0. It's a validated tool. It's the tool that the health authorities urge, strongly suggest a sponsor to use. So from that perspective, it's a totally level playing field. And again, our manifest RM3 data gives us a very good benchmark what to expect from the phase three. And that obviously is very exciting to us. I think we mentioned in the prepared remarks, but just to reiterate, having twice the sample size of that other molecule is the level of confidence that makes us feel very good about this.
spk09: The next question is from Ingrid Gafanao from Brian Gardner and Co. Please go ahead.
spk01: Hi, good afternoon. Thank you for taking my question. I have two, if I may. I have a quick follow-up regarding the secondary endpoint for proliferative phase 3 trial, more specifically on PFS and OS. Noting that we know this two outcomes can take a little bit more time for myelofibrosis patients. What do you have in mind in terms of how long follow-up would you need to see to be able to comment something on those two endpoints? And my second question is actually for your plans in MDS or risk MDS. Have you actually identified any subpopulation of MDS that you would preferably target or should we expect a more broader trial next year? Thank you.
spk07: Dr. Ingrid, I'll start with the last question first on the MDS trial design. We're currently looking at a proof-of-concept study. It would be our fourth proof-of-concept with Pelabrasib, so further strengthening the foundation of the program. In terms of subpopulations, we're looking at low-risk patients with MDS, and we believe we have a good chance of showing a benefit with Pelabrasib in monotherapy. On the manifest, two questions regarding two additional endpoints, PFS and OS. As you rightfully mentioned, it takes some time for this data to mature. The study will continue collecting this follow-up from patients. Duration of treatment is very good as we're seeing in manifest arm two. The symptom control and the screen control, we have shown up to 60 weeks, giving us a lot of confidence that there will be a change and an improvement in these two very important endpoints.
spk05: But it suffice to say that we don't need that for the regulatory approvals. The regulatory approvals is at 24 weeks, and on the two endpoints we mentioned, SVR35 and TSS50. So we substantiate data, as we've always done with our studies, with long-term data. But again, in MS, there is no, I mean, it always takes a lot of time to come.
spk01: Thank you.
spk09: We have a follow-up question from Manos Mastourakis from Deutsche Bank. Please go ahead.
spk03: Hi, thanks again. So just wanted to check your thoughts and confidence on collaborative commercial uptake, assuming you have your best case scenario data. Thank you.
spk05: Yeah. So, you know, the strengths of the data are paramount here. And from what we have seen on the phase two and what we believe will be on the phase three, we think we'll have the data to establish a new standard of care here. So that being said, we already have a commercial and medical affairs, hematology, oncology organization, as you know, with our currently commercialized assets, Monjuvi and RDLBCS. So there is a lot of overlap between the customers. So we have the engagements already. We have the relationships. We will not be a first-time launcher for Pellab Recipes. So it's a huge difference. from the days of the launch of Montjuic.
spk09: Any further questions, please press star and one. The next question is a follow-up from Rajan Sharma from Goldman Sachs. Please go ahead.
spk10: Hey, thanks for taking my follow-up. So I've actually got one on DLBCL, and I was just wondering, just kind of, if there's been a change in the competitive dynamics that you're seeing following kind of the negative clinical update for Zynlanta. And then I realize it's a slightly different label, but just any thoughts on kind of initial competition from the CD20 by specifics that have now launched. And then just to follow up on manifest two again, sorry, just in on three of manifest, I was just wondering, do you have, the number of patients that achieved both SPR35 and TSS50, so they hit on both endpoints rather than just hitting on one. Thank you.
spk05: Rajan, I will take the DLBCL question, and Tim will comment on the other one on Pella. You know, for DLBCL, we continue to educate on our strong long-term data, and most recently the five-year data in our DLBCL. Very good traction with it, but as you mentioned, There is increasing competition. We think we're doing pretty well in the context of this market. Well, we really see the infection point that is with new indications and probably mainly with the first line DSBCL. We commented in our prepared remark on the completion of recruitment for our first line phase three trial front line. We enrolled 900 patients. which in this market is remarkable. There is a lot of interest for first-line DLBCL. As you know, there are not many therapies out there. And what we had with the Roche data and approval a couple of months ago is very encouraging for us because we have made the right choices in terms of clinical trial design for this front-mind study. So we just have to be patient because it's a PFS-driven study and uh you know i mean we think we will have a strong data and it will be a very good uh um propeller for for monjuvi in terms of other assets uh news on that that you mentioned uh in first line i think uh yeah well you know it's it's good for us tim
spk07: Yeah, Rojan, on the questions, percentage of patients who achieve both S3R35 and TSS50 in ORM3 of manifest, that data has not been published yet. So, in the future conference.
spk10: Okay, thank you.
spk09: There are no further questions at this time. I hand back to Julia Neugebauer for closing comments.
spk04: Ladies and gentlemen, this concludes today's conference call. If any of you would like to follow up, of course, this Investor Relations team is available for the remainder of the day. Once again, thank you for joining our call. Have a good day and goodbye.
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