Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics SA ADCT Q2 2025 Earnings Conference Call. [Operator Instructions] 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 Investors section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, 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 that. You should refer to the company's second quarter earnings release for information and reconciliations of historical non-GAAP measures to the comparable GAAP financial measures. I will now turn the call over to our CEO, Ameet Mallik. Ameet?

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 a 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 period in the prior year. During the second quarter, we were pleased to have LOTIS-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 ZYNLONTA plus glofitamab to be a best-in-class combination in a highly competitive market. Data as of the April 2025 cutoff, they chose ZYNLONTA in combination with glofitamab 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-evaluable DLBCL 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 bispecific 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 LOTIS-7 in the second half of 2025. Once sufficient data with longer follow-up is available,…

Thank you, Ameet. Initial data from the 50 leading [indiscernible] Phase III confirmatory study of ZYNLONTA in combination with rituximab in patients with second-line plus DLBCL showed an overall response rate of 80% and a complete response rate of 50% with no new safety segments, demonstrating that this combination has the potential to provide competitive second-line plus efficacy with a favorable safety profile allowing broad accessibility. Enrollment is now complete, and we expect to reach the prespecified number of events by the end of 2025 and will provide data once available. The supplement and BLA submission to regulatory authorities is anticipated in the first half of 2026 with potential confirmatory approval in second line plus DLBCL in the first half of 2027. With LOTIS-7, we are exploring the combination of ZYNLONTA and Anti-CD19 ADC with Glofitamab and anti-CD20/CD3 T-cell engaging bispecific antibody. These 2 highly reported single-agent drugs offer important and complementary [indiscernible] action in DLBCL. We started with 2 different B-cell separate engines while delivering important payloads and activating T cells. Given this, we expect to see additive or synergistic efficacy. In addition, there are no known overlapping nonhematologic toxicities between the 2 agents. By dosing ZYNLONTA prior to glofitamab, 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 2 parts: Part 1, dose escalation was conducted across non-Hodgkin lymphoma patients at 3 dose levels of ZYNLONTA with glofitamab or mosunetuzumab in the third line plus. Part 2 dose expansion was conducted in the second line plus, plus B-cell lymphoma with ZYNLONTA at 2-dose level, 120-micrograms per kg and the currently approved monotherapy dose of 150-microgram per kg combined with the approved monotherapy dose of glofitamab. Based on this initial…

Thank you, Mohamed. On the financial front, ZYNLONTA net product revenues in the second quarter of 2025 were $18.1 million as compared to $17 million in the same quarter of 2024. Our first half net product revenue was $35.5 million compared to $34.9 million during the first half 2024. In connection with the strategic reprioritization 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 noncash impairment assets in connection with the close down of the U.K. 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 LOTIS-5 and LOTIS-7 as well as PSMA IND-enabling activities. The expenses on the ZYNLONTA LOTIS-5 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 $0.50 per basic and diluted share. As compared to a net loss of $36.5 million or $0.38 per basic and diluted share for the same period in 2024. The increase in net loss for the quarter is primarily attributable to onetime restructuring and impairment costs 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…

Thank you, Pepe. I am pleased with how we are executing against our strategy and continue to be encouraged by the consistently promising ZYNLONTA data we are generating across our ongoing trials. We believe our revenue growth opportunity comes with expanded use of ZYNLONTA 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?

[Operator Instructions] Your first question comes from Michael Schmidt with Guggenheim.

I had 2 bigger picture questions, I guess. One is on the Roche complete response letter recently on glofitamab in second-line DLBCL, 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 any impact of that on your trial collaboration or potential next steps? And then the second question was really around LOTIS-5. And I know you've the reaffirmed timing of the PFS analysis by year-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.

Okay. Thanks for both of your questions. So the first 1 was around STARGLO, the CRL that they received and any impact that we see that could happen for us? And the second question was around LOTIS-5 and LOTIS-7 of OS or interim OS analysis would be when we have, when we get to top line results. So I'll turn it to Mohamed, first, to talk about the CRL with STARGLO and maybe I'll also highlight some differences between how we've conducted some of our trials like LOTIS-5 and the STARGLO study.

Sure. Thanks, Ameet. 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 later. However, we remain confident that there is an unmet medical need in the second line plus DLBCL landscape. And also, we remain confident that the LOTIS-5 and LOTIS-7 is well positioned to address the unmet need in that study, specifically for people who are not -- or not suitable for complex therapy. I want to highlight also what is LOTIS-5 that makes us comfortable. First of all, it's a large study for 120 patients. . In addition, also, it's randomized 1 to 1 and powered at 90% is the assumption that R-GemOx will give about 4 months, all the studies required to show 2 months difference, 6 months in the test arm to the study to be successful. Also, we're very comfortable with the data shared with the early 51% -- with the 50% complete response and 8% to our 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 STARGLO study was. In terms of interim, of course, at the final analysis of PFS, there are always -- FDA really asked it 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 PFS announced.

Just maybe 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 by the end of this year?

It is really hard to speculate on that for now. So to be honest with you, it's hard to tell.

Yes. And then basically, Michael, just so you understand the timing. I mean what we said is we believe we'll hit the prespecified 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 meeting is the data positive or negative. But the full results of the trial would obviously get published in 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 sBLA submission with the FDA.

Your next question comes from Kelly Shi with Jefferies.

This is Jenna on the line for Kelly. Could you please give us some updated thoughts on durability of these impressive high CRs seen from LOTIS-5 and LOTIS-7. How much incremental durability benefit would you expect, maybe versus glofitamab alone for LOTIS-7 and for these 2 trials, how may that compare with other rituximab or glofitamab combos? And then for the LOTIS-7 update coming in the second half, what kind of early read into durability may we expect there?

Yes. Thanks for the question. So you're asking, I think about not only the high CRAs that we've seen with LOTIS-7, 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 get -- 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 in LOTIS-7 so far is very encouraging, and very important also to highlight that we all know that the CRs are a good surge biomarker for durability. Both drugs, each 1 separately are showing significant durabilities in third line plus with the median duration of response in the CR patients, not reached for glofitamab for 3 years and for longer for 2 years. So we're also looking forward to continuing 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 or looking at so far, the important to highlight that the median CRA that have been seen by other combination bispecifics, is ranging between 47% and 62%. I actually know that our numbers are higher than that. And the additional response of 12 months for those studies ranging between 63% to 75%. Also, it's important to highlight that with our focus in our benchmarking on the durability at 6 and 12 months and more, of course, as we get more better. So we keep monitoring this data, but is very encouraging right now, as I mentioned before, 25 out of 26 CRs remains in CR at the time of data cutoff with the longest of them reaching more than a year.

Yes. So on the future data updates, you're going to see, obviously, updated swimmer 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 medium duration of the CRs at 6 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.

Your next question comes from Eric Schmidt with Cantor.

Congrats on the progress in Q2. Maybe just a quick 1 with regard to LOTIS-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 LOTIS-7 data later this year, would that be at a conference or company-sponsored event?

Yes. 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 at the 150-microgram per kilogram dose of ZYNLONTA plus the full dose of glofitamab, that's well underway. That's -- 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 a potential path forward, but that could be, whether it be in second line or front line that we can explore different options with the FDA. So that's 1 of the things we want to test. Maybe, Mohamed, you could talk more about what we want to do with the FDA in those discussions about potential regulatory approaches.

Yes. Typically, we're going to have some data on sufficient follow-up. The discussion with 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 front line, as Ameet mentioned. Of course, there's a discussion about what dose is, 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 then on the follow-up that we have, and we have a fruitful discussion with the agency.

Yes. And in terms of the data update we shared later this year, we haven't disclosed if it will 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 1 of the considerations is the data cutoff sometimes for 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 we shared in June.

Your next question comes from Leonid Timashev with RBC Capital Markets.

I just want to ask on some of the indolent lymphoma. I guess, given the encouraging MZL data you've seen, can you just remind us how you see ZYNLONTA fitting into these more indolent indications given that there's slightly 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 an 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.

Yes. So yes, 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 the study that's ongoing, the Phase II IIT 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 NCCN guidelines was pirtobrutinib, which is a BTK inhibitor based on 36 patients. The most -- any trial has ever enrolled, which is clinical trial is 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, right now, when you look at the CR rates in that relapsed-refractory setting, the highest CR is about 29%. So 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 other things you mentioned, we're really pleased about the safety profile right now that we're seeing with ZYNLONTA. At this point, we don't see the need to combine with the 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 patients can be treated and can be on treatment and in a disease setting for multiple years, oftentimes, the tolerability profile is obviously much more important than even a more aggressive lymphomas like DLBCL. So we feel quite comfortable with our approach as a single agent ZYNLONTA in marginal zone lymphoma, and that's the approach we'll take going forward.

[Operator Instructions] Your next question comes from Sudan Loganathan with Stephens.

Congrats on strong progress in the quarter. First, can you walk us through your sales force growth plan and time line as you expect to unlock a much larger TAM with the strong response data outcomes with the LOTIS trials? How will marketing responsibilities of combination with glofitamab 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 LOTIS trial data to prescribing physicians? And then lastly, real quick, post the CRL of STARGLO, do you anticipate SKYGLO confirmatory Phase III study is granted for approval for the glofitamab plus Pola-R-CHP combo changed the landscape for treatment of second-line DLBCL akin to how we'll fit plus GemOx 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 then 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 DLBCL. 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, prelaunch and in the early launch basis as we kind of expand the potential use of ZYNLONTA. With regards to any collaboration, as you know, we'll be launching, we believe, with a successful approval of LOTIS-5, we would be then promoting that and be successfully launching that. LOTIS-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 LOTIS-7. MSLs, obviously, will be there to respond to questions that physicians have around the LOTIS-7 data. And at this point, there's no planned collaboration commercially and medically with Roche on that. With regards to the frontline study with glofit, Pola-R-CHP, it's hard to know. We're -- we don't want to speculate beyond what Roche has said, obviously. I think their intention is that, that could be the 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'll now turn the call over to Ameet for closing remarks.

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.