ADC Therapeutics SA

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics FA-ADCT Q2 2025 Earnings Conference Call. At this time, all lines are in the listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, August 12, 2025. I will now turn the call over to Nicole Riley, Head of Investor Relations and Corporate Communications for ADC Therapeutics.

Nicole, please go ahead.

Thank you, operator.

Today, we issued a press release announcing our second quarter 2025 financial results and business updates. This release and the slides we will use in today's presentation are available on the investor section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Amit Malik, who will discuss our operational performance and recent business highlights. Our Chief Medical Officer, Mohammad Zaki, who will discuss our clinical programs and updates, followed by our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2025 financial results. We will then open the call to questions. Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance, and achievements could differ materially. They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q, and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events, or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements. Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's second quarter earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.

I will now turn the call over to our CEO, Amit Malik. Amit?

Thanks, Nicole. And hello, everyone.

Thank you for joining us on today's call. The second quarter of 2025 represented a period of continued solid performance for our company, as well as the presentation of promising key data. Throughout the quarter, we continued to focus on execution and delivering on our commercial strategy, maintaining our place as a treatment option for third-line plus DLBCL patients. Net product revenues were $18.1 million. and $35.5 million in the second quarter and first half respectively, both of which were slightly higher as compared to the same periods in the prior year. During the second quarter, we were pleased to have Lotus 7 data presented at EHA, the European Hematology Association Congress, and at ICML, the International Conference on Malignant Lymphoma. We are encouraged by the promising data which we believe demonstrates the potential for Zinlanta plus Glofetamab to be a best-in-class combination in a highly competitive market. Data as of the April 2025 cutoff date shows Zinlanta in combination with Glofetamab was generally well-tolerated with a manageable safety profile. In addition, we believe the combination demonstrated clinically meaningful benefit with an overall response rate of 93.3% and a complete response rate of 86.7%. across 30 efficacy-available LBCL patients. Of note, 25 of the 26 patients achieving CR remained in CR as of the data cutoff. For reference, we have seen complete response rates in other biospecific combination trials in the range of 47 to 62%. We are currently expanding enrollment to 100 patients at the selected 150 microgram per kilogram dose which will support regulatory discussions and is in line with recent examples of bispecific combination therapies added to Compendia. We expect to share an additional update on MODIS 7 in the second half of 2025. Once sufficient data with longer follow-up is available, we plan to discuss the path forward for Zymanta and Glufidamab with regulatory authorities and to pursue a Compendia strategy. Lotus 5 remains on track to reach the pre-specified number of progression-free survival events by the end of 2025. After the pre-specified number of PFS events is reached and data are available, we expect to provide top-line data on this Phase 3 confirmatory trial evaluating Xenlanta in combination with rituximab in patients with second-line plus DLBCL. Lastly, updated data presented at ICML from the Phase II IIT in marginal zone lymphoma, being led by the Sylvester Comprehensive Cancer Center at University of Miami, showed an overall response rate of 85% and a complete response rate of 69%, with safety consistent with the known profile of Zynlanta. Moving beyond Zynlanta, we are on track to complete IND-enabling activities for our exotecan-based prostate-specific membrane antigen, or PSMA targeting ADC by the end of the year. From a corporate perspective, as part of our strategic plan to focus resources on Zenlanta commercialization and expansion opportunities, and on our preclinical PSMA targeting ADC, we discontinued early development efforts for all other preclinical programs in solid tumors. As research and development efforts and related programs are closed out, we plan to shut down our UK facility reducing our global workforce across functions by approximately 30%. These changes are expected to help position our company for long-term growth with significantly reduced operating expenses. At the same time, we completed a $100 million private placement. Taken together, our expected cash runway now extends into 2028. I'm excited about the multiple upcoming catalysts ahead within this extended cash runway. As a single-agent therapy and third-line plus DLBCL, Synlanta has a profile of rapid, deep, and durable efficacy, as well as manageable safety with simple and convenient administration. Beyond our current indication, we believe in the potential to reach significantly more patients while growing the commercial opportunity by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. The data we've seen across these settings so far has been consistently encouraging with the potential to be highly differentiating. Within our current indication, our commercial strategy is focused on relapsed and refractory DL-BCL patients who need a treatment with a fast, durable response and a manageable safety profile which can be administered in the outpatient setting. We believe Lotus 5 has the potential to take Zynlanta to $200 to $300 million in peak sales as we expand into the second line setting. This is driven by doubling the patient population, extending the duration of therapy, and improving the clinical profile versus our current indication as a monotherapy. The low to seven, we estimate we can expand the total opportunity for Zanlanta and DLBCL to $500 to $800 million in peak revenue with regulatory approval and compendia listing. If the data persists, we believe Zolanta plus clofidamab has the potential to transform the future lymphoma treatment paradigm by becoming the preferred bispecific combination in the second-line plus DLBCL setting. Additionally, in indolent lymphomas, there is a clear unmet need in both the relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma settings. We are encouraged by the initial data seen in the Phase II IITs suggesting a Zolanta regimen could provide significant benefit for these patients. We believe the indolent lymphomas opportunity could provide additional peak revenue of $100 to $200 million with regulatory approval and compendia listing, primarily driven by MZL. Taken together, we believe Zolanta has the potential to reach peak revenues of $600 million to $1 billion in the U.S. Looking at the overall DLVCL treatment landscape, whether in the second or third line setting, there are two main segments. The first are complex therapies which require unique infrastructure and expertise to handle logistical requirements and patient management. This includes therapies like CAR-T, transplant, and bispecifics. The second are more broadly accessible therapies which all physicians can administer in the outpatient setting, including therapies like ADCs, monoclonal antibodies, and chemotherapy. Biospecifics have already been approved in the third line plus setting as monotherapy, and we estimate there is currently a 60-40 split between the complex and broadly accessible segments, respectively. In the second line, where biospecifics have not yet been approved but were recently added to NCCN guidelines for use in combination, the estimated split is closer to 25-75. We believe the emerging clinical profile of Xananta plus clofidimab in the LOTUS 7 trial positions us well among complex therapies, and at the same time, the clinical profile of Zynlanta plus rituximab in the LOTUS 5 trial has the potential to differentiate us among broadly accessible therapies. While Zynlanta is currently approved as a single agent in third-line plus DLBCL, we believe Zynlanta has the potential to be the backbone therapy for combinations, raising the bar for efficacy in second-line plus DLBCL. Zynlanta is a systemic chemo-free option which can be combined with the highly effective bispecific glufidamab and the most widely used agent, rituximab. We believe Zynlanta plus glufidamab in Lotus 7 and Zynlanta plus rituximab in Lotus 5 are complementary approaches to addressing unmet needs in the two key treatment segments. Now I will turn the call over to our Chief Medical Officer, Mohamed Zaki, who will share more on our ongoing trials. Mohamed.

Thank you, Amir. Initial data from the safety lead-in portion of Bluetooth 5, our phase 3 confirmatory study of Zinlanta in combination with Rituximab in patients with second-line plus DLDCL showed an overall response rate of 80% and a complete response rate of 50% with no new safety signals. Demonstrating that, This combination has the potential to provide competitive Second Life Plus efficacy with a favorable safety profile allowing broad accessibility. Enrollment is now complete and we expect to reach the pre-specified numbers of events by the end of 2025 and will provide data once available. A supplemental BLE submission to regulatory authorities is anticipated in the first half of 2026 with potential confirmatory approval in second line plus DL-PCL in the first half of 2027. With GLUTUS-7, we are exploring the combination of Xenlanta and anti-C19 ADC with glufetamab and anti-CD20, CD3 T-cell engaging bispecific antibody. Two highly potent single-agent drugs offer important and complementary decades of action in the BCL, which target two different B-cell sepsis engines while delivering a potent payload and activating T-cells. Given this, we expect to see additive or synergistic efficacy. In addition, there are no known overlapping non-hematologic toxicities between the two agents. By dosing the LONTA prior to glifidumab, it is our hypothesis that this dosing schedule has the potential to debulk the tumor and to lower CRS rates and grades. The design of the trial includes two parts. Part one, dose escalation was conducted across non-HRGM-informed patients at three dose levels of the LONTA with glifidumab or mosin-tizumab in the Third line plus. Part two dose expansion was conducted in the second line plus large piece of lymphoma with amount at two dose levels, 120 micrograms per kg, and the currently approved monotherapy dose of 150 micrograms per kg combined with the approved monotherapy dose of clopidomab. Based on this initial dose optimization, we selected the 150 microgram per kick dose for expansion to 100 patients at this dose level. The load that is being given prior to Glutamab to potentially debunk the tumor in the first cycle, and then both agents are given together in subsequent cycles. The primary endpoint is safety and tolerability, and second endpoint of efficacy, PK, and immunogenicity. Baseline characteristics in this study, including being refractive to prior therapy as well as number and types of prior therapies, are representative of the second-line DLPCL patient population and similar to other studies in this space. Among the 41 patients evaluable for safety, there are certain characteristics that are important to highlight. The median age in this study is 71 with a range of 26 to 85 years of age. The study enrolled patients with large B-cell lymphoma, including de novo DLBCL, transformed follicular lymphoma, high-grade B-cell lymphoma, and grade 3B follicular lymphoma, all considered to be DLBCL. Median prior lines of therapy was two, with a range from one to five. The study includes a number of difficult-to-treat live eosinophoma patients. Nearly 20% of patients presented as double or triple hits. 19.5% of patients received prior CAR-T, which is in line with other trials done with bispecific combinations. Patients refracted with prior therapy were well-represented in the study, with 51% of patients refracted to primary therapy and 49% refracted to last prior therapy, both of which were slightly higher in the 150 micrograms per kick compared to 120 micrograms per kick dose. Safety was analyzed in the 41 large B-cell lymphoma patients who received at least one dose of Xelontoplasma clopidumab. Most notably, as mentioned during the presentation of this data at ASH, When looking at grade 3 and 4 treatment immersion adverse events occurring in more than 5% of patients, neutropenia was the most common at 24.4% which is similar to the rate of neutropenia reported in the prescribing information of each drug separately. So no additive effects were observed. Beyond that, the type of treatment emergent adverse events observed are consistent with the known safety profile of each drug separately. The rate of serious treatment emergent adverse events were similar across both doses. Only three of the 20 patients experiencing serious treatment emergent adverse events discontinued treatment. As the data cut off, The combination has shown a manageable safety profile, and no new safety signal was observed. A total of six patients discontinued due to adverse events, three of which were serious treatment-emergent adverse events. For Genlanta, we saw one case each of pericardial diffusion, generalized edema, and pleural diffusion. And for glufetamab, we saw one case of ICANN, polyneuropathy, and febrile neutropenia. This is consistent with the known profile of each drug separately. As of the data card of date, we can see that overall rates and grades of CRS are higher at the 120 microgram per kg dose compared to the 150 microgram per kg dose. The 120 microgram per kick dose had 55% any grade CRS, primarily grade 1, 2, with one case of grade 3. The 150 microgram per kick dose had 23.8% any grade CRS, all of which was grade 1. Grade 1 and 2 CRS were managed using standard care therapies without ICU admittance or pressure support. The grade 3 CRS was managed with a standard of care therapies and included ICU admittance. ICAMs were seen in two patients treated at the 120 micrograms per kg, and one ICAMs were observed at 150 micrograms per kg dose. These ICAMs were low-grade and primarily measures for TKCOs. All patients had a complete resolution of symptoms with one patient electing to discontinue treatment and two patients resuming treatment and ultimately achieving a complete response. Of the 41 treated patients at the time of the April data cutoff, 30 patients had reached the initial disease assessment and were efficacy evaluated. In the study, we have seen 93.3 overall response rates and an 86.7 complete response rates. Median duration of response was not reached at the time of data cutoff. The results observed across those levels were consistent in the terms of ORR, CR, and PR. Looking now at the swimmers' plots, The green bars show all patients in complete response, and the length of these bars show the durability of each response. The gray bars represent who have not yet made it to the first disease assessment, so are not yet available for response. Most responses were observed at initial assessment, which occurred at day 42. 25 out of 26 patients who achieved a complete response have maintained that response as of the data cutoff. And 12 patients converted from stable disease or partial response to complete response over time. As the data cutoff, the longest response in the study is more than a year. Complete responses were observed regardless of prior therapy of the six patients previously treated with SCAR-T and undergoing response assistance, five achieved a CR. The impressive efficacy and manageable safety profile seen with the combination of Zolanta and Glutidimab is encouraging. The data reinforces our belief in the potential for this regimen to change the treatment paradigm for patients with aggressive lymphoma. Now, I will turn the call over to Pippi Carmona, our CFO, who will discuss financial results for the second quarter. Pepe?

Thank you, Mohamed. On the financial front, Zinlontanet product revenues in the second quarter of 2025 were $18.1 million, as compared to $17 million in the same quarter of 2024. The first half net product revenue was $35.5 million compared to $34.9 million during the first half of 2024. In connection with the strategic revitalization and restructuring plan announced in June 2025, the company incurred $13.1 million in restructuring and impairment cost in the second quarter of 2025, which consisted of $6.7 million in employee severance and related benefit costs, and $6.4 million in non-cash and permanent assets in connection with the close down of the UK facility. Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over prior year, primarily driven by higher R&D costs. mostly related to LOTUS V and LOTUS VII, as well as PSMA-IND enabling activities. The expenses on this in-lonta LOTUS V trial, which is the largest investment we are making, is expected to decrease as we complete the trial going into 2026. On a GAAP basis, we reported a net loss of $56.6 million for the second quarter of 2025, or 50 cents per basic and diluted share as compared to a net loss of $36.5 million or 38 cents per basic and diluted share for the same period in 2024. The increase in net loss for the quarter is primarily attributable to one-time restructuring and impairment cost and higher R&D expenses. You can find the reconciliation of GAAP to non-GAAP measures in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. As of June 30, 2025, cash and cash equivalents were $264.6 million compared to $194.7 million at March 31, 2025. This change was primarily driven by the net proceeds received in the company's private placement, partially offset by our use of cash in operating activities for the quarter. Across the Lotus 5, Lotus 7, and MCLs in loaned programs, we expect to have multiple data catalysts in the remainder of 2025 and 2026 with potential Lotus 5 approval. and compendia listing for all of this in the first half of 2027. For Lotus 5, we expect to reach the pre-specified number of PFS events by the end of this year with top-line results and potential supplemental BLA submission in the first half of next year. With Lotus 7, We intend to share fewer, more mature data toward the end of this year and expect to complete enrollment of 100 patients at the 150 microgram per kilogram dose in the first half of next year. We plan to engage with regulatory authorities starting later this year. With sufficient data, we will pursue publication and a potential compendium strategy. With indolently formats, we expect additional data to be shared at many of our conferences this year and next by the lead investigators. Beyond CINLONTA, we are excited to see the advancement of our exatigam-based PSMA targeting ADC with potential completion of IND-enabling activities toward the end of this year. Overall, we believe we have multiple value-traveling catalysts within our cash runway, which is expected to extend into 2028. I will now turn the call back to Amit.

Thank you, Pepe. I am pleased with how we are executing against our strategy and continue to be encouraged by the consistently promising Zenlanta data we are generating across our ongoing trials. We believe our revenue growth opportunity comes with expanded use of Zenlanta through regulatory approvals as well as inclusion in guidelines, and we are confident in the multiple pathways we have to achieve our peak revenue goal. We can now open the line for questions. Operator?

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Michael Schmidt with Guggenheim. Your line is now open.

Hi, guys. Good morning. Thanks for taking my questions. I had two bigger picture questions, I guess. One is on the Roche complete response letter recently on the FIDMAP and second line, the LBCL. I'm just curious what your view is, how you think this may affect the overall DLBCL market in a second line setting, and then perhaps also, you know, any impact of that on your trial collaboration or potential next steps. And then the second question was really around Lotus 5, and I know you've reaffirmed timing of the PFS analysis by your end, and I'm just wondering if you had a sense of how mature overall survival is by the end of this year, and presumably there will be an interim OS analysis as well. I just wanted to confirm that. Thank you.

Okay. Thank you so much, Michael, and thanks for both of your questions. So the first one was around Starglow, the CRL that they received, and any impact that we see that could happen for us. And the second question was around Lotus 5 and what the status of OS or interim OS analysis would be when we get to top-line results. So I'll turn it to Mohamed first to talk about the CRL with StarGlo, and maybe also highlight some differences between how we've conducted some of our trials like Lotus 5 and the StarGlo study. Sure.

Thanks, Amin, and thanks for the question, of course. The CRL that was received by Roche from the FDA We don't really know the details of that, so it's really hard to comment on that specific letter. However, we remain confident that there is an unmet medical need in the second line plus the BCL landscape. And also, we remain confident that the Lotus 5 and Lotus 7 is well positioned to address the unmet medical need in that sense, specifically for people who cannot or not suitable for complex I want to highlight also what is in LOTUS-5 the design that makes us comfortable. First of all, it's a large study, 420 patients. In addition, also, it's randomized one-to-one and powered at 90% with the if-the assumption that Argemux will give about four months, all the studies required to show two months, Also, we're very comfortable with the data shared with the early safety running with a 50% complete response and 8% ORR and a PFS of 8.3 months in that disease setting. That's for our comfort regarding the differences. Also, I think we shared before that our enrollment in Asia was significantly lower than what the STAR-Co study was. In terms of interim, of course, at the final analysis of BFS, they're always, FDA usually asks and looks for how much data on OS is available, and we will get there, we'll be able to talk more about that when we reach the final BFS analysis.

Just a follow-up, is your expectation that OS at that point in time is mature enough to potentially show a difference, or is it just too early in terms of the event rates, you know, by the end of this year?

It's really hard to speak to you on that for now.

So to be honest with you, it's hard to tell. Yeah, and basically, Michael, just so you understand the timing, I mean, what we said is we believe we'll hit the pre-specified number of PFS events by the end of this year. Obviously, then you have to clean the data, lock the database. Once that happens, we would share sort of top line, meaning is the data positive or negative. But the full results of the trial would obviously get published and go to a medical congress. And that's when the full data will come out. In parallel, obviously, we'll be engaging and preparing for the SPLA submission with the FDA.

Thank you.

Your next question comes from Kelly Shee with Jefferies. Your line is now open.

Good morning. This is Jenna on the line for Kelly. Thanks for taking our questions. Could you please give us some updated thoughts on durability with these impressive high CRs seen from Lotus 5 and Lotus 7? How much incremental durability benefit would you expect? maybe versus clofetamab alone for LOTUS7 and, you know, for these two trials, how may that compare with other rituximab or clofetamab combos? And then for the LOTUS7 update coming in the second half, what kind of early read into durability may we expect there? Thank you so much.

Yeah, thanks for the question. So you're asking, I think, about not only the high CRAs that we've seen with LOTUS7, but you're asking about the durability and what gives us confidence in the durability and what measures of durability will we start to see over time to demonstrate that durability of the CRs. So I'll turn it to Mohamed to talk about, one, why we believe we will see good durability, but also what metrics we'll be able to show over time to demonstrate that durability of the CRs.

It's important to highlight that the high number or maybe unprecedented number of CRs observed seven so far is very encouraging and very important also to highlight that we all know that the CRs are a good surrogate biomarker for durability both drugs each one separately are showing significant durability in third-line plus with the median duration of response in the CR patients not reaching for glufitamib for three years and for long-term for two years. So we're also looking forward to continuing looking at the data and we'll be sharing more updated data by the end of this year. It is also encouraging to share that based on the durability we're looking at so far, the important to highlight that the median C-arrays that have been seen by other combination bispecifics is ranging between 47 and 62 percent. I actually know that our numbers are higher than that. And the initial response of 12 months for those studies ranging between 63 to 75 percent. Also, it's important to highlight that where our focus in our benchmarking on the durability at 6 and 12 months, and more, of course, as we get more data. So we keep monitoring this data, but it's very encouraging right now, as I mentioned before, 25 out of 26 CRs remain in CRs at the time of data cutoff, with the longest of them reaching more than a year.

Yeah, so in the future data updates, you're going to see Obviously, updated swimmers plot, that's obviously a great indication of durability when you see individual patients, so how durable those CRs are. But like other studies, we'll be able to talk about the median duration of the CRs at six and 12 months as the data matures, and we have sufficient data to share on that.

So you'll see more durability data as we kind of give future updates. Thank you. Super helpful.

Your next question comes from Eric Schmidt with Cantor.

Your line is now open.

Thanks for my question. Congrats on the progress in Q2. Maybe just a quick one with regard to Lotus 7 and your discussions with the FDA. What is it that you're hoping to get asked and answered, and how might you communicate that result? And maybe also, how might you communicate the Lotus 7 data later this year? Would that be added? conference or company-sponsored event. Thank you.

Yeah, so maybe I'll start, and then I'm going to pass it to Mohamed. So first of all, with Lotus 7, as you're aware and we've communicated, we currently have expanded the trial to enroll 100 patients with 150 microgram per kilogram doses in Lanta plus the full dose of Glifemab. That's well underway. It's actually, we've seen the enrollment do quite well. It's accelerated. And so that path towards... Being able to get published and get into compendia is a strategy that's kind of ongoing. In parallel, obviously, as the data matures, we want to engage with the FDA on potential path forward, what that could be, whether it be in second line or front line. I think we can explore different options with the FDA. So that's one of the things we want to test. And maybe, Mohamed, you can talk more about what we want to do with the FDA in those discussions about potential regulatory approaches.

Yeah, typically, when you have some data and sufficient follow-up, the discussion of the agency could range between how to bring such an effective regimen to patients quickly, and also what is the future development plan, more than just having it quicker on the bigger picture, but bigger studies for second or frontline, as Amit mentioned. Of course, there is discussion about what Those and other things like that could come into the conversation. So it's actually the timing to do there will depend on how the data and the amount of follow-up that we have. And we didn't have a fruitful discussion with agencies.

Yeah, and in terms of the data update we share later this year, we haven't disclosed if it'll be a company update or medical congress. Obviously, we want to share as much data as we can. And so, as you know, that's one of the considerations is... The data cut off sometimes from medical congresses are much, much earlier. And so that's one of the things we're considering in that choice of how we can make sure that we can show a robust update that goes beyond what was shared in June.

Got it. Thank you.

Your next question comes from Lonid Timashev with RBC Capital Markets. Your line is now open.

Yeah, thanks for taking my question. I just want to ask on some of the indolent lymphomas. I guess, given the encouraging MZL data you've seen, can you just remind us how you see Zolanta fitting into these more indolent indications, given that there's definitely different benefit-risk calculus there? And then what you're thinking the bar is for NCCN inclusion in these indolent lymphomas, both in terms of what you'd want to show in efficacy and also the number of patients? And then maybe just a quick follow-up on that, I guess. Would you also consider looking at bispecific combos in these

Thanks. Yeah, so, yeah, I agree. We are very encouraged by the indolent lymphoma data we've generated both in the relapsed refractory setting of MZL and follicular. Specific to your question around MZL, there's a study that's ongoing, the face to IT, is expected to enroll 50 patients. We think that number is clearly sufficient because when you look at the numbers, actually the last compound that was added to NCC guidelines was pertabrutinib, which is a BTK inhibitor based on 36 patients. The most any trial has ever enrolled, which is clinical trial, was about 62 patients. So we think 50 is about the right number. We're well on our way to enrolling that number of patients. In terms of what you need to show, you know, right now, when you look at the CR rates in that relapsed refractory setting, the highest CR rate is about 29%. So, you know, we're well above that, obviously, with the data we're sharing right now. Clearly, I think 40% or above would be significant improvement over any of the standard of care. In terms of risk-benefit, which is one of the things you mentioned, we're really pleased about the safety profile right now that we're seeing with Synlanta. At this point, we don't see the need to combine with a bispecific because we're seeing such high efficacy with a single agent. And particularly in the indolent lymphomas, thinking about the safety profile for knowing the patient's can be treated and can be, you know, on treatment and in a disease setting for multiple years oftentimes. The tolerability profile is obviously much more important than even the more aggressive lymphomas like DLBCL. So, we feel quite comfortable with our approach as a single agent in Lanta in Marshall's lymphoma, and that's the approach we'll take going forward.

Ladies and gentlemen, as a reminder, should you have a question, please press star 1.

Your next question comes from Sudan Logan San with Stevens. Your line is now open.

Hi, Amit, Mohamed, and Pepe. Congrats on the strong progress in the quarter, and thanks for taking my questions. First, can you walk us through your Salesforce growth plan and timeline as you expect to unlock a much larger TAM with the strong response data outcomes of the Lotus trials? How will marketing responsibilities of combination with Glifidimab be split, if any at all, with Roche? And when do you anticipate the earliest opportunity the MS cells will have to start talking about the Lotus trial data to prescribing physicians? And then lastly, real quick, you know, post the CRL of StarGlobe. Do you anticipate DiGlo confirmatory phase three study, if granted full approval for the Glofitimab plus PolyVR CHOP combo, clinically change the landscape for treatment of second-line DLBCL akin to how Glofit plus Gemmox was expected to, or be more of the same?

Okay, so you asked a few different questions. One was around the commercial and medical affairs approach that we're going to use. Two, you said, is there going to be any collaboration with Roche on that? And then three, you asked a little bit about SkyGlo, and if SkyGlo would be the confirmatory study. So let's answer each of those questions. From a field force and medical affairs standpoint, we think we have the right footprint. We're already If you look at our commercial footprint, we're covering 90% of the potential of DOB sales, so we think we're well covered in that setting. Similarly, if you look at our MSL force, it's very competitive, where we're able to cover all the academic centers and all the large community centers. So we think our footprint is where it needs to be. Obviously, we would add some resources on the marketing and medical side, as you would pre-launch and in the early launch phases, as we kind of expand the potential use of Zalanta. With regards to any collaboration, as you know, we'll be launching, we believe, with a successful approval of Lotus 5, we would be then promoting that and be successfully launching that. Lotus 7 is a bit different because what we expect the first step to be is in Compendia. And as you know, we won't promote anything off-label. And so our commercial teams won't be actively discussing Lotus 7. MSLs obviously will be there to respond to questions that physicians have. around the Lotus 7 data. And at this point, there's no planned collaboration commercially or medically with Roche on that. With regards to the frontline study with Glowfit, Polovi, RGF, it's hard to know. We don't want to speculate beyond what Roche has said, obviously. I think their intention is that that could be their confirmatory study, but we're waiting like you are to see if that gets confirmed by the FDA.

There are no further questions at this time.

I will now turn the call over to Amit for closing remarks.

Well, I want to thank you all for joining our call today and for your continued support. We look forward to keeping you updated on our progress. Operator, you may now end the call.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.