MorphoSys Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

Key Takeaways

  • Following ahead-of-schedule enrollment of its pivotal Phase III MANIFEST II trial of pelabresib plus ruxolitinib in first-line myelofibrosis, MorphoSys expects top-line data by year-end, building on Phase II results that showed a 68% spleen volume reduction and 56% symptom score improvement at 24 weeks.
  • In Q2 2023, Monjuvi net sales grew 14% sequentially to $23.6 million, and MorphoSys is advancing Phase III FRONTMINE in first-line DLBCL (900 patients, data H2 2025) and the InMIND trial in follicular/marginal zone lymphoma (data 2024).
  • MorphoSys’ next-generation EZH1/2 inhibitor tolimetostat showed best-in-class potential with responses in heavily pretreated solid tumor and lymphoma cohorts in Phase II, and the Phase III dose-finding study is underway.
  • With Q2 revenues of €53.2 million, a reduced net loss of €74 million (vs €235 million a year ago), and €672.8 million cash and investments, MorphoSys maintains a >12-month cash runway post-MANIFEST II readout and has reiterated full-year guidance.
  • Legacy antibody platform partnerships, including Yanalumab (Novartis) and bimagrumab (Versanis/Lilly acquisition), continue to progress in late-stage trials, offering potential non-dilutive financing and royalty upside.
AI Generated. May Contain Errors.
Earnings Conference Call
MorphoSys Q2 2023
00:00 / 00:00

There are 12 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome, and thank you for joining the MorphoSys Second Quarter and First Half twenty twenty three Financial Results. Throughout today's recorded presentation, all participants will be in a listen only mode. The presentation will be followed by a question and answer I would now like to turn the conference over to Julia Neugebauer. Please go ahead.

Speaker 1

Ladies and gentlemen, good afternoon or good morning. Name is Eulah Neutybauer, Head of Investor Relations at MorphoSys, 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 Vemud, our Chief Research and Development Officer and Lucie Crabtree, our new Chief Financial Officer. Before we begin, I'd like to remind you on Slide 2 that some of our statements made during Today are forward looking statements, including statements regarding our expectations for the commercialization of our products and our development plans and expectations for the components 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 Results to differ materially, including those described in MorphoSys 20 F and Annual Report, all for the year ended December 31, 2022, and from time to time in other SEC documents of MorphoSys.

Speaker 1

It is important to keep in mind that our statements on this webcast speak as of today. On Slide 3, 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, Then Lucie will provide a summary of our first half twenty twenty three financial results. Following our prepared remarks, we will open the call for your questions.

Speaker 1

With that, I'll now hand the call over to Jean Paul.

Speaker 2

Thank you, Julia. Good morning and good afternoon, everyone. Thanks for joining us today. We had an extremely productive and strong first half of twenty twenty three. 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.

Speaker 2

We completed enrollment of 2 of our pivotal trials ahead of schedule: the MANIFEST 2 study of pelabrasib In first line myelofibrosis and the frontline study of Monjuvy in first line DLBCL. Additionally, our partner, Incyte, completed enrollment for InMind, the Phase III study of MONJUVY in patients with relapsed refractory follicular lymphoma or marginal zone lymphoma. Furthermore, we presented updated results from our tool mimetostat Phase III study, showcasing the therapies best 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 MANIFASE II study.

Speaker 2

Also, Lucie Crabtree joined us this month as our new Chief Financial Officer. We are very pleased to officially have her on board. Elabrasib, Our investigational BEST inhibitor is a potential best and first in class foundational first line treatment for patients with myelofibrosis. With this therapy, we have the opportunity substantially improved the standard of care for this debilitating and difficult to treat disease. Today, JAK inhibitors such as ruxolitinib are the standard of care to treat myelofibrosis.

Speaker 2

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 ruxolitinib, 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 pelabrasil.

Speaker 2

We believe this data I 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 can 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 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 MANIFASE II study results and simultaneously preparing our regulatory filings in the U.

Speaker 2

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 thrombocythemia, also known as IT. Tim will share more on this shortly. Moving to MONJOVY now.

Speaker 2

MONJOVY is our CD19 targeting immunotherapy. It continues to be prescribed to certain adult patients with relapsed or refractory DLBCL. In the second quarter, Monjovy net sales were USD 23,600,000. 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 MINJUVY In the first line DLBCL setting, which we are investigating in our Phase III FrontMINE study, The trial randomized nearly 900 patients with data projected to be available in the second half of twenty twenty five.

Speaker 2

Also, Mongeovy's use in relapsedrefractory 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 MONJUVY.

Speaker 2

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 2 years. Additionally, our key partner programs are progressing very well.

Speaker 2

These programs Developed via our legacy antibody technology platform include Yanalumab, abelasimab, cestrosumab And Bemacromab. 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.

Speaker 3

Thank you, Jean Francois. The Phase III MANIFEST II study is our number one priority. In this trial, patients naive to JAK inhibitor therapies were randomized 1 to 1 to palabrasib in combination with ruxolitinib or placebo plus ruxolitinib. Recall that after we acquired Constellation, we optimized the MANIFEST II study by increasing our target enrollment from 310 to 400 patients. In the end, we randomized 4 31 patients.

Speaker 3

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 It's a proportion of patients achieving a 50% or greater improvement in total symptom score known as TSS 50. In addition to these two endpoints, we are also measuring the percent change in total symptoms score at week 24, progression free survival, overall survival, duration of spleenic and total symptom score response and improvements in bone marrow fibrosis among others. We are confident that the comprehensive MANIFEST 2 data package We'll provide meaningful insights into the potential benefits of pelabrasib 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.

Speaker 3

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 pelabrasib ruxolitinib combination and the outcome of the Phase III MANIFEST II trial. We saw strong efficacy and safety results in the Phase II MANIFEST trial data that were presented most recently at the 2023 EHA Annual Meeting in June. At week 24, 68% of JAK inhibitor naive patients treated with a palabrasib and ruxolitinib 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.

Speaker 3

These deep and durable responses were maintained at 60 weeks. The most common treatment emergent adverse events This data suggests that palabrasib and ruxolitinib is a well tolerated combination therapy. We compared MANIFEST ARM 3 with 3 historical JAK inhibitors studied in randomized double blind Phase III trials using a method called matching adjusted indirect comparison or MAIK analysis. MAIK 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.

Speaker 3

Our analysis shows that palabrasib in combination with ruxolitinib offers at least 1.4x better symptom control compared to ruxolitinib monotherapy in JAK inhibitor naive patients. These findings were recently published in Blood Advances. Also at the 2023 EHA 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 palabrasib 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 collaborative and first line myelofibrosis, we see opportunities for collaborative beyond this disease.

Speaker 3

At this year's ASCO and EHA Annual Meetings, we presented results from Arm 4 of the Phase II MANIFEST study. This arm of the study is investigating pelabrasib as a monotherapy in patients with high risk ET While 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 includes 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.

Speaker 3

60% Of patients treated with pelagrosypt monotherapy had a confirmed complete or partial hematologic response at any time. As the data cut off, 14 of 20 patients were still undergoing treatment. Importantly, an early normalization of platelet counts was achieved in many patients with white blood cell counts and hemoglobin stable throughout treatment. This suggests that pelagroset monotherapy can normalize platelet counts without causing anemia or thrombocytopenia. Further, the results show that half of the treated ET patients at a 50% reduction in total symptom score from baseline at any time.

Speaker 3

These proof of concept results support Palabrasib's Expansion into other myeloid diseases. As such, we will continue our ongoing evaluation of palaverocep in ET the MANIFEST study. We also plan to initiate a Phase II study in lower risk MDS in 2024. We will then determine our Phase III development strategy following these assessments. Moving on to Tolimetostat, our investigational next generation dual inhibitor of ECH2 and ECH1.

Speaker 3

Tolumetastat was designed to improve on 1st generation ECH2 inhibitors to increase potency, longer residence time on target and a longer half life offering the potential for enhanced antitumor activity. It is currently being evaluated in the Phase III trial advanced solid tumors or lymphomas. Updated results from the Phase II 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.

Speaker 3

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 III study, we will continue to evaluate our future development plans for tomimetostat. With that, I will now turn the call over to Lucie to review our financials.

Speaker 4

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 MorphoSys, 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 Q2 and first half of 2023. Monjuby sales were $23,600,000 in the Q2 of 2023, reflecting a sequential growth of 14% and a year over year growth of 2%.

Speaker 4

We also recorded EUR 2,200,000 or $2,400,000 in royalty revenue for MINJUVY sales outside of the U. S. From our partner Incyte in the Q2 of this year. The sequential increase is mainly driven by a one time effect coming from previously deferred revenues related to Incyte's early access program in France. Total revenues in the Q2 of 2023 were €53,200,000 compared to €59,400,000 in the same period a year ago.

Speaker 4

The year over year decrease resulted primarily from lower expenses related to vial sales to our partner, Incyte. Recall that MorphoSys provides insight with MINJUVY supply for ex U. S. 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.

Speaker 4

Total cost of sales was €7,700,000 in the Q2 of 2023 compared to €17,200,000 a year ago. Cost of sales specific to Mongevia U. S. Product sales was €4,100,000 in the Q2 of 2023 compared to EUR 4,300,000 on the Q2 of 2022. Turning to operating expenses.

Speaker 4

R and D expenses in the Q2 of 2023 decreased slightly to €57,000,000 compared to €60,900,000 for the Q2 of 2022. Selling expenses decreased to EUR 2022,000,000 in the was driven by streamlining and focusing of selling efforts. G and A expenses in the Q2 of 2023 were EUR 17,000,000 compared to the EUR 12,400,000 in the Q2 of 2022. The increase mainly results from increased expenses related to stock based Compensation. For the Q2 of 2023, we reported a consolidated net loss of €74,000,000 compared to a net loss of €235,000,000 in the Q2 of 2022.

Speaker 4

As a reminder, the results for the Q2 of 2022 was mainly driven by finance expenses resulting from FX effects for the Incyte and royalty pharma liabilities. Turning to our balance sheet. We ended the Q2 of 2023 with cash and investments of EUR 672,800,000 compared to €907,200,000 at the end of 2022. Recall that in the first half of this year, we spent approximately €40,000,000 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 3 study of palabrasib, but to also provide a cash runway of at least 12 months beyond the pivotal data readout.

Speaker 4

Turning to our guidance for 2023. We are reiterating our guidance that was provided at the 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. Before we open up

Speaker 2

the line for questions, I'd like to conclude with a few words. The first half of twenty twenty three has been marked by exceptional progress at MorphoSys. We have over delivered on our key and are excited to build on this great momentum in the second half of the year. Elabrasib 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 III MANI- Phase II study, give us high confidence in Pelabrasiv's clinical success. We very much look forward to sharing the results of the MANIFEST II study later this year.

Speaker 2

With that, I would like to open the call for questions. Operator, please open the line.

Operator

The first question is from Xian Deng from UBS. Please go ahead.

Speaker 5

Thank you. Thank you for taking my questions. 2, please. The first one to Lucie, if I may. So just wondering since you joined MorphoSys, just wondering what is your first impression of the new CEO?

Speaker 5

What is your strategy? What's your priority here? Anything you would like to you could share, that would be amazing. And the second question is And the collaborative, just wondering now we have seen the nivitoclax top line data. Just wondering if there's I mean, a lot of people have asked that what would happen if Collaborative also reported mixed data in terms of if it hits the primary endpoint amidst TSS 50.

Speaker 5

So now, Novisoclass actually reported like that. Just wondering, does it change any of your fault on this? And does this make you more You're all less relaxed about it. Thank you.

Speaker 4

Hi. So thanks for your question. I mean, Look, I am incredibly excited about joining MorphoSys at a really pivotal point in time with the data due and towards the end of this year. So I just want to sort of stress my excitement around the Positioning of MorphoSys and what we've got ahead of us. In terms of priorities, I'll just reiterate what I had in my prepared statements.

Speaker 4

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. Thanks, Cian, for the

Speaker 2

question on the competition event that everyone has seen a couple of weeks ago. Look, we think this outcome is actually extremely positive for MorphoSys. And for us, AVEVA's result is not a surprise They basically replicated their Phase II trial. We have very high confidence in a positive MANI Phase II trial outcome for the following reasons. Number 1, our study is very well powered.

Speaker 2

We have upsized the trial after the takeover of Constellation to 4 100 patients and we have over enrolled 2 41 patients, which is almost double From the AbbVie's numbers, the TRANSFORM-1 study is 252 patients. So we are very well powered and much more proud than they are. In our Phase II trial, remember, we've shown a strong efficacy. Our data was very strong on both Endpoints. FVR 35 or 68 percent and TFS 50 of 56%.

Speaker 2

And our safety results We're actually very good. So this puts us apart from the competitor. We really think we have the best asset out there in myelofibrosis. So as we saw recently Phase II first line myelofibrosis trials results are strong proxy for Phase III trials. Based on that and our strong Phase II results, we think we'll have a very strong outcome with our Phase III trial and we're very confident in that.

Speaker 2

So basically we strongly believe in our assets and we think we have the best out there.

Speaker 5

Thank you very much.

Speaker 6

Thanks.

Operator

Your next question is from Derek Archila from Wells Fargo. Please go ahead.

Speaker 7

Hey, good morning and thanks for taking the questions. Just 2 from us. So maybe just piggybacking on that Yes. First set of questions. Can you just discuss any specific differences in the enrollment criteria between the AbbVie trial and MANIFEST 2?

Speaker 7

And then the second question is, so GSK's mum allotment approval is coming up. So I guess we were wondering how you view that approval or potential approval in the context of the FDA's Actual approval in the context of the FDA's flexibility around efficacy endpoints in myelofibrosis because That drug was technically not inferior to ruxolitinib, but it was numerically inferior. So we'd love to get your comments there. Thanks.

Speaker 3

Hi, Derek. This is Tim. On the differences between the navitoclax and our study, Generally, the patient population is very comparable first time patients with myelofibrosis naive To JAK inhibitors, namely ruxolitinib. As Jean Paul mentioned, and I will just emphasize that again and I said it in my prepared remarks already. Our Phase II study showed very strong results On spin volume response and CTSS-fifty, AbbVie shows very clearly that Phase II results Or very well replicated in Phase 3.

Speaker 3

If that holds true for us, I think we are in a very good shape And we continue to be super confident.

Speaker 2

And now on GSK, maybe I could add that basically, 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 part of it is very difficult to draw. They're 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.

Speaker 8

Got it.

Speaker 7

Thanks so much.

Speaker 2

Thanks.

Operator

The next question is from Jason Butler from JMP. Please go ahead.

Speaker 9

Hi, thanks for taking my question. I just had 2. First of all, can you just reiterate for us your confidence that 24 week data will be To support approval and you're not expecting to need longer duration of follow-up to support approval for pellet and myelofibrosis. And then can you just walk us through the landscape in essential thrombocytopenia and just How you think that pelican fit into that treatment landscape? Thank you.

Speaker 3

Thanks, Jason. This is Tim. So we know very well from interactions with agencies on both side of the pond, namely FDA and EMA, What the approval endpoints are and that's to your point is the 24 week landmark for TRY 35 and TFS 50. On the question regarding the ET landscape, First things first. Obviously, we will bring home manifest 2 first.

Speaker 3

We shared The very exciting and very strong proof of concepts data in essential thrombocytopenia for these patients is, of course, very, very important have a normalization of the platelet count, it's important for them to have good hematological parameters. And those are 2 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.

Speaker 9

Great. Thank you.

Operator

Next question is from James Quigley from Morgan Stanley. Please go ahead.

Speaker 8

Hello. Thank you for taking my questions. So I got a couple here. So just to your point about the approval endpoints of So SVR35 and TSS 50. Just in thinking about the context of the other secondary endpoints, So you mentioned PFS and OS that you're looking at.

Speaker 8

So to what extent is there flexibility around TSS 50 if The other endpoints are hit. So for example, if it does happen in manifest that you hit on SVR 35, Not on TSS-fifty, but you have a PFS benefit and 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 a ASH presentation Be possible for Manifest 2, the late breaker deadline is towards the end of October. And is there a possibility For a placeholder for MANIFEST 2 at ASH?

Speaker 8

Or is that a zero probability scenario? Thank you.

Speaker 3

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, CSS50 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, That's 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.

Speaker 3

And Again, we feel super comfortable and super confident in that Phase III design based on increasing sample size, strong Phase As you know, by at least 6 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

Speaker 2

of the year. And I would just add that when we acquired Constellation, we were more than 1 year behind the other Company exploring first line combination therapy and now we are probably ahead. So I think already that tells a lot.

Speaker 8

Excellent. Thank you very much.

Speaker 2

Thanks, James.

Operator

The next question is from Manos Maserakis from Deutsche Bank. Please go ahead.

Speaker 6

Hi, thank you for taking my question. My name is Mr. Aikes from Deutsche Bank. So perhaps First question for Zampo 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.

Speaker 6

And perhaps a sub question on that is what are your thoughts and any impact on the acquisition of your partner, Verstane Spadili for the The Nagma program? Yes, that's it. Thank you.

Speaker 2

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 III trials, autoimmune diseases and they mentioned that it's going to be one of the top Blockbusters in the future. So Phase 3 plus size of Trinity is very promising.

Speaker 2

Remember what we had with Janssen and Tremfya. So this is great. But the news here that we didn't really have time to Tell you in the prepared remarks is on the bimagrumab, which is an obesity treatment that we have in partnership with Versanis Bio. And Lilly, as you know, is going to acquire Versanis Bio and they have a Phase 2b ongoing study. Everybody knows the around the obesity market right now when there is really a breakthrough coming up.

Speaker 2

So and Lilly is obviously a huge name in the space, so we're very 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 financing equation, it's very important because that can mean Royalties and our monetization as we've shown very handsomely with Royalty Pharma for Tremfya and other assets. So this is great.

Speaker 2

It doesn't take any time. It is pure upside and I wouldn't discount that in your models.

Operator

The next question is from Rajan Sharma from Goldman Sachs. Please go ahead.

Speaker 10

Hi. Thank you for taking my question. Just to follow-up a little bit more on palabrasib and specifically on the TSS 50. So Could you just maybe talk to the potential differences between MANIFEST II and TRANSFORM, which was the navitoclax trial, Which gives you confidence that you'll hit on TSF50 outside of just the powering? And then secondly, Are there any kind of particular symptoms which make up the components of the TSS 50 which you're most confident on given Pella's Mechanism relative to other agents that we've seen in the field?

Speaker 10

And then kind of related in arm 3 of MANIFEST, do you know what proportion of patients achieved both SBR35

Speaker 6

and the TSF50 endpoint? Thanks.

Speaker 2

I'll start by the first part, Rajan, and Tim We'll 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 Bigger than the power from AbbVie and the fact that our Phase II trial showed great results On both endpoints, it's very strong and make us very confident in the outcome. That's really the main thing that you have to keep in mind here. I mean the Phase 2 is a very good proxy for the Phase 3. It was demonstrated a couple of weeks ago.

Speaker 2

Remember that AbbVie had a 42% TSS 50 score in the Phase II trial, we have 56%. So we're not surprised again. And we are extremely confident in the outcome of the Phase III trial. Now on the details on the TSS 50.

Speaker 3

Yes. Hey, Rojan, this is Tim. Obviously, we cannot Comments too much on the AVE trial design. What I think we can assume is that everybody in this day and age is using the same 2, to assess TSS, that's the myelofibrosis symptom assessment form version 4.0. It's a validated tool.

Speaker 3

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 ARM 3 data gives us A very good benchmark. What to expect from the Phase 3? And that obviously is very exciting to us.

Speaker 3

I think we mentioned in the prepared remarks, but just to reiterate, having tried to sample size of that other molecule is the level of Confidence that makes us feel very good about this.

Operator

The next question is from Ingrid Gafanhao from Bryan, Garnier and Co. Please go ahead.

Speaker 11

Hi, good afternoon. Thank you for taking my question. I have 2, if I may. I have a quick follow-up regarding the Secondary endpoint for plebrosib Phase III trial, more specifically on PFS and OS. Noting that we know these 2 outcomes can take a little bit more time for myelofibrosis patients.

Speaker 11

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 with MDS, have you actually identified any subpopulation of MDS that you preferably target or should we expect a more broader trial next year? Thank you. Thanks Ingrid.

Speaker 3

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 4th proof of concept with CalabrioSib, 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 to additional endpoints PFS and OS. As you rightfully mentioned, it Takes some time for this data to mature.

Speaker 3

The study will continue collecting this follow-up From patients, duration of treatment is very good as we're seeing in MANIFEST ARM 2. The symptom control and the spleen 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.

Speaker 2

Well, it's 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, SVR-thirty five and TSS-fifty. So we'll substantiate data as we've always done with our studies with long term data. But again in MS there is no I mean always takes a lot of time to come.

Speaker 11

Thank you.

Operator

We have a follow-up question from Manos Maserakis from Deutsche Bank. Please go ahead.

Speaker 6

Hi, thanks again. So just wanted to check your thoughts on and confidence on Telabrisib commercial up Take assuming you have your best case scenario data. Thank you.

Speaker 8

Yes.

Speaker 2

So the strength of the data are paramount here and from what we Have seen on the Phase II and what we believe will be on the Phase III, 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 asset, Monjuvie, in RDLBCL. So and there is a lot of overlap between the customers. So we have the engagements already. We have the relationships.

Speaker 2

We We will not be a first time launcher for Pelabresib. So it's a huge difference from the days of the launch of Montjuvie.

Operator

The next question is a follow-up from Rajan Sharma from Goldman Sachs. Please go ahead.

Speaker 10

Hey, thanks for 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 The competitive dynamics that you're seeing following kind of the negative clinical update for ZYNOLTA. And then I realize it's a slightly different label, but just Any thoughts on kind of initial competition from the CD20 bispecifics that have now launched? And then just to follow-up on MANIFEST 2 again, sorry.

Speaker 10

Just in arm 3 of MANIFESTO, I was just wondering, do you have the number of patients that achieved both SBR35 and TSS 50, so they hit on both endpoints rather than just hitting on 1? Thank you.

Speaker 2

Rajan, I will take the DLBCL question and Tim will comment on the other one on Pela. For DLBCL, we are we continue to educate on our strong long term data and most recently the 5 years data in 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 inflection point that is with new indications and probably Mainly with the first line DLBCL. We commented in our prepared remarks the completion of recruitment for our first line Phase III trial Frontline, we enrolled 900 patients, which in this market is remarkable.

Speaker 2

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, it's very encouraging for us because we have made the right choices in terms of clinical trial design for this front line study. So We just have to be patient because it's a PFS driven study. And I mean, we think we will have a strong data It will be a very good propeller for Montjuvie. In terms of other assets news on that you mentioned In first line, I think, yes, well, it's good for us.

Speaker 2

Tim?

Speaker 3

Yes, Rojan, on the question, Percentage of patients who achieve both SVR35 and TSS50 in arm 3 of manifest, that data has not been published yet. So End of future conference.

Speaker 10

Okay. Thank you.

Speaker 6

There are

Operator

no further questions at this time. I hand back to Julian Neugebauer for closing comments.

Speaker 1

Ladies and gentlemen, this concludes today's conference call. If any of you would like to follow-up, our Foresist Investor Relations team is available for the remainder of the day. Once again, thank you for joining our call. Have a good day

Speaker 4

and goodbye.

Operator

Ladies and gentlemen, the conference has now concluded and you may disconnect your telephone. Thank you for joining and have a pleasant

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