Q2 2026 ADC Therapeutics SA Earnings Call

August 13, 2026

Speaker #1: Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 earnings conference call. At this time, all lines are in listen-only mode.

Operator 2: Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. At this time, all lines are in 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 Thursday, 13 August 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Operator: Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. At this time, all lines are in 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 Thursday, 13 August 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Speaker #1: Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press *0 for the operator.

Speaker #1: This call is being recorded on Thursday, August 13, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications.

Speaker #1: Please go ahead.

Speaker #2: Thank you, operator. Today, we issued a press release announcing our second quarter 2026 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.

Nicole Riley: Thank you, operator. Today, we issued a press release announcing our Q2 2026 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 am joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights. Followed by our Chief Medical Officer, Mohamed Zaki, who will provide clinical and regulatory updates. And lastly, our Chief Financial Officer, José Carmona, who will review our Q2 2026 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 US Private Securities Litigation Reform Act of 1995.

Speaker #3: I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights, followed by our Chief Medical Officer, Mohamed Zaki, who will provide clinical and regulatory updates.

Speaker #3: And lastly, our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2026 financial results. We will then open the call to questions.

Speaker #2: 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.

Speaker #2: 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.

Nicole Riley: 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.

Speaker #2: 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.

Speaker #2: 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.

Nicole Riley: You should refer to the company's Q2 2026 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, Ameet Mallik. Ameet?

Speaker #2: Refer to the company's second quarter 2026 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, Ameet Mallik.

Speaker #2: Ameet?

Speaker #4: Thank you, Nicole. We are pleased to share this in Lantus Commercial Performance in the second quarter of 2026, continuing to be broadly in line with recent quarters.

Ameet Mallik: Thank you, Nicole. We are pleased to share that ZYNLONTA's commercial performance in the Q2 2026 continued to be broadly in line with recent quarters. We remain confident in the role ZYNLONTA will continue to play as a differentiated single-agent treatment option for third-line plus DLBCL patients. Turning to our pipeline progress. As previously disclosed, we announced top-line results for LOTIS-5 in June. Based on this data, we held a pre-sBLA meeting with the FDA, and following the meeting, we are assessing the best regulatory path forward. Mohamed will share more details regarding the FDA feedback and our regulatory strategy. Further to this, the full LOTIS-5 data have now been submitted for presentation at ASH, and we are preparing to submit for publication with compendia submission to follow.

Speaker #4: We remain confident in the roles in Lantus will continue to play as a differentiated single-agent treatment option for third-line plus DLBCL patients. Turning to our pipeline You should progress, as previously disclosed, we announced top-line results for Lotus 5 in June.

Speaker #4: Based on this data, we held a pre-SPLA meeting with the FDA and, following the meeting, we are assessing the best regulatory path forward. Mohamed will share more details regarding the FDA feedback and our regulatory strategy.

Speaker #4: Further to this, the full Lotus 5 data have now been submitted for presentation at ASH, and we are preparing to submit for publication with compendium submission to follow.

Speaker #4: For Lotus 7, we were pleased to complete enrollment of 100 patients at the selected dose level of Zenlanta plus clarithamab, as shared in June, and have submitted an abstract to ASH for presentation of the data which we continue to believe demonstrates the most compelling combination data generated to date in second-line plus DLBCL, with a safety profile generally consistent with prior Lotus 7 disclosures.

Ameet Mallik: For LOTIS-7, we were pleased to complete enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab, as shared in June, and have submitted an abstract to ASH for presentation of the data, which we continue to believe demonstrates the most compelling combination data generated to date in second-line plus DLBCL, with a safety profile generally consistent with prior LOTIS-7 disclosures. With these data, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line position in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL. Beyond this, we are preparing to submit for publication of the LOTIS-7 data with compendia submission to follow. Simultaneously, we are exploring the potential regulatory pathway for this combination and expect to submit for Breakthrough Therapy designation this year.

Speaker #4: With these data, we believe that Zenlanta plus clarithamab offers an opportunity to take a leading second-line position in the context of the evolving competitive landscape to litifying Zenlanta as a foundational therapy in DLBCL.

Speaker #4: Beyond this, we are preparing to submit for publication of the Lotus 7 data with compendium submission to follow. Simultaneously, we are exploring the potential regulatory pathway for this combination and expect to submit for breakthrough designation this year.

Speaker #4: With respect to the multicenter investigator-initiated trials, Zenlanta in indolent lymphomas updated marginal zone lymphoma data was submitted to ASH with publication and compendium submission to follow.

Ameet Mallik: With respect to the multi-center investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone lymphoma data was submitted to ASH with publication and compendia submission to follow. Presentation of updated follicular lymphoma data is anticipated in Q2 2027, with publication and compendia submission to follow. We also intend to assess potential regulatory pathways for these indolent lymphomas and expect to submit for Breakthrough Therapy designation for MZL. Moving now to corporate updates. We announced a strategic reorganization in June.

Speaker #4: Presentation of updated follicular lymphoma data is anticipated in the second quarter of 2027, with publication and compendium submission to follow. We also intend to assess potential regulatory pathways for these indolent lymphomas and expect to submit for breakthrough designation for MZL.

Speaker #4: Moving now to corporate updates. We announced a strategic reorganization in June. As part of this, we implemented a reduction in our workforce of approximately 17%, as well as additional operational efficiencies resulting in cost savings of approximately $10 million on an annualized basis.

Ameet Mallik: As part of this, we implemented a reduction in our workforce of approximately 17%, as well as additional operational efficiencies, resulting in cost savings of approximately $10 million on an annualized basis. As shared at that time, with these changes, we are resourced to deliver on our key clinical, regulatory, and manufacturing activities while maintaining the full externally facing footprint to support the continued commercialization of ZYNLONTA in the third-line plus DLBCL setting. Finally, we ended Q2 2026 with a healthy cash balance of $219.1 million, maintaining our expected cash runway at least into 2028 and enabling us to deliver against our strategy. Now, I'd like to take a moment to remind everyone of our strategy to grow ZYNLONTA. Currently, ZYNLONTA plays a clear role in the third-line plus DLBCL setting.

Speaker #4: As shared at that time, with these changes, we are resourced to deliver on our key clinical, regulatory, and manufacturing activities, while maintaining the full externally facing footprint to support the continued commercialization of Zenlonta in the third-line-plus DLBCL setting.

Speaker #4: Finally, we ended the second quarter of 2026 with a healthy cash balance of $219.1 million, maintaining our expected cash runway at least into 2028 and enabling us to deliver against our strategy.

Speaker #4: Now we'd like to take a moment to remind everyone of our strategy that grows Zenlanta. Currently, Zenlanta plays a clear role in the third-line plus DLBCL setting.

Speaker #4: As monotherapy, Zenlanta has a well-established profile of rapid, deep, and durable efficacy, as well as manageable safety, with simple and convenient administration. Since FDA accelerated approval in 2021, Zenlanta monotherapy has been used to treat approximately 5,000 patients in the U.S.

Ameet Mallik: As monotherapy, ZYNLONTA has a well-established profile of rapid, deep and durable efficacy, as well as manageable safety with simple and convenient administration. Since FDA accelerated approval in 2021, ZYNLONTA monotherapy has been used in treating approximately 5,000 patients in the US. We believe this is just a starting point as we see the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. Now, I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Speaker #4: We believe this is just the starting point as we see the potential for Zenlanta to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas.

Speaker #4: Now I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Mohamed Zaki: Thank you, Ameet. I would now like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work towards expansion of ZYNLONTA in earlier lines of DLBCL. As a reminder, LOTIS-5 is our phase III confirmatory study of ZYNLONTA in combination with rituximab versus R-GemOx in patients with second-line DLBCL, which recently read out and met the primary endpoint of progression-free survival. As noted, we held a meeting with the FDA in early August to present and discuss the totality of the LOTIS-5 data, along with the potential regulatory pathway. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in LOTIS-5 trial. As such, the company is now assessing the regulatory path forward. We plan to provide an update on regulatory strategy and timing in the future. Beyond this, the data has been submitted to ASH.

Speaker #5: Now, I'd like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work towards expansion of Zynlonta in earlier lines of DLBCL.

Speaker #5: As a reminder, Lotus 5 is our phase 3 confirmatory study of Zenlanta. In combination with rituximab versus argemux, in patients with second-line DLBCL, we recently read out and met the primary endpoints of progression-free Thank you, Ameet.

Speaker #5: 5 data along with the potential regulatory pathway. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed I would in Lotus 5 trials.

Speaker #5: As such, the company is now assisting with the regulatory path forward. We plan to provide an update on regulatory strategy and timing in the future.

Speaker #5: Beyond this, the data has been submitted to ASH. We are simultaneously pursuing publication for Lotus 5 and potential compendium inclusion starting in 2027. Turning now to Lotus 7, our phase 1B trial combining Zenlanta.

Mohamed Zaki: We are simultaneously pursuing publication for LOTIS-5 and potential compendia inclusion starting in 2027. Turning now to LOTIS-7, our phase Ib trial combining ZYNLONTA with the highly effective bispecific glofitamab in second-line plus DLBCL patients. We recently announced completion of enrollment of 100 patients at the 150 microgram per kilo dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccination for viral, fungal, and bacterial infections, including PJP and herpes virus, which was not part of the LOTIS-5 protocol. Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be the best-in-class combination. An abstract with data on larger number of patients with longer follow-up has been submitted to ASH for presentation.

Speaker #5: With the highly effective bispecific clarithamab, in second-line plus DLBCL patients, we recently announced completion of enrollment of 100 patients at the 150 microgram per cube dose.

Speaker #5: Of note, consistent with other clarithamab trials, the protocol for Lotus 7 recommends prophylaxis, including vaccination for VYLA fungal and bacterial infections including PGP and herbs virus.

Speaker #5: Which was not part of the LOTIS-5 protocol. Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for Zynlonta plus claritamab to be the best-in-class combination.

Speaker #5: An abstract with data on larger number of patients with longer follow-up has been submitted to ASH for presentation. This data supports the company's belief that Zenlanta plus clarithamab demonstrates the most compelling combination data generated to date in second-line DLBCL.

Mohamed Zaki: This data supports the company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in second-line DLBCL, with a safety profile generally consistent with prior LOTIS-7 disclosures. Separately, we are preparing for submission of the full LOTIS-7 data for publication and following that, plan to submit to compendia for potential inclusion starting in 2027. In addition, based on this potentially practice-changing LOTIS-7 data, the company plans to submit for Breakthrough Therapy designation this year and is assessing a phase III trial for the combination of ZYNLONTA plus glofitamab. Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance the ZYNLONTA combinations into earlier lines of therapy in DLBCL.

Speaker #5: With a safety profile generally consistent with prior Lotus 7 disclosures, separately we are preparing for submission of the full Lotus 7 data for publication and, following that, plan to submit the compendium for potential inclusion starting in 2027.

Speaker #5: In addition, based on this potentially practice-changing Lotus 7 data, the company plans to submit for breakthrough designation this year and is assisting a phase 3 trial for the combination of Zenlanta plus clarithamab.

Speaker #5: Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance Zenlanta combinations into earlier lines of therapy in DLBCL.

Speaker #5: In the meantime, we remain confident that Zenlanta will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third-line plus DLBCL setting, with that I would like to turn the call over to Paper Carmona, our

Mohamed Zaki: In the meantime, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third-line plus DLBCL setting. With that, I would like to turn the call over to Pepe Carmona, our CFO.

Speaker #2: Thank you, Mohamed. On the financial front, Zenlanta net product revenues in the second quarter of 2026 were $18.6 million as compared to $18.1 million in the same quarter in 2025.

José Carmona: Thank you, Mohamed. On the financial front, ZYNLONTA net product revenues in Q2 2026 were $18.6 million as compared to $18.1 million in the same quarter in 2025. Cost of product sales was $2.3 million and $6 million for Q2 and six months ended 30 June 2026 as compared to $0.8 million and $2.9 million for the same periods in 2025. The increases compared to prior year are primarily driven by a change in focus of personnel from R&D clinical supply activities to commercial manufacturing activities. Total operating expenses were $44.7 million for Q2. On a non-GAAP basis, total adjusted operating expenses were $37.2 million for Q2 and were down by 22% over the prior year, primarily driven by lower R&D expenses.

Speaker #2: Post-product sales was $2.3 million and $6 million for the second quarter and six months ended June 30, 2026 as compared to $0.8 million and $2.9 million for the same period in 2025.

Speaker #2: The increases compared to prior year are primarily driven by a changing focus of personnel from research and development clinical supply activities to commercial manufacturing activities.

Speaker #2: Total operating expenses were $44.7 million for the second quarter. On an on-gap basis, total adjusted operating expenses were $37.2 million for the quarter and were down by $22% over the prior year, primarily driven by lower R&D expenses.

Speaker #2: As Ameet noted, we expect to save an additional $10 million on an annual basis as a result of the strategic reorganization we announced in June.

José Carmona: As Ameet noted, we expect to save an additional $10 million on an annual basis as a result of the strategic reorganization we announced in June. On a GAAP basis, we reported a net loss of $16.6 million for Q2 2026 as compared to a net loss of $56.6 million for the same period in 2025. Q2 2026 included a one-time expense related to the strategic reorganization. While the year-ago quarter included restructuring, impairment, and related costs from the June 2025 strategic reprioritization and restructuring plan. On a non-GAAP basis, the adjusted net loss was $16.3 million for Q2 2026, as compared to a net loss of $28.7 million for the same period in 2025. The lower net loss on a non-GAAP basis was primarily due to lower operating expenses.

Speaker #2: On a GAAP basis, we reported a net loss of $16.6 million for the second quarter of 2026, as compared to a net loss of $56.6 million for the same period in 2025.

Speaker #2: The second quarter of 2026 included a one-time expense related to the strategic reorganization, while the year-ago quarter included restructuring, impairment, and related costs from the June 2025 strategic reprioritization and restructuring plan.

Speaker #2: On an on-gap basis, the adjusted net loss was $16.3 million for the second quarter of 2026 as compared to a net loss of $28.7 million for the same period in 2025.

Speaker #2: The lower net loss on an on-gap basis was primarily due to lower operating expenses. The year-over-year changes on a per-share basis were additionally impacted by the higher number of weighted average shares outstanding.

José Carmona: The year-over-year changes on a per-share basis were additionally impacted by the higher number of weighted average shares outstanding. You can find the reconciliation of GAAP to non-GAAP measures for Q2 in the companion financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of Q2, we had cash and cash equivalents of $219.1 million as compared to $231 million as of 31 March 2026, a change primarily driven by cash used in operations. This provides us with an expected cash runway at least into 2028. With that, I will turn the call back over to Ameet. Ameet?

Speaker #2: You can find the reconciliation of gap-to-non-gap measures for the second quarter in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation.

Speaker #2: At the end of the second quarter, we had cash and cash equivalents of $219.1 million as compared to $231 million as of March 31, 2026, a change primarily driven by cash used in operations.

Speaker #2: This provides us with an expected cash runway at least into 2028. With that, I will turn the call back over to Ameet. Ameet?

Speaker #1: Thank you, Pepe. To close, we are pleased by the commercial performance and the role that Zynlonta monotherapy continues to play in third-line plus DLBCL.

Ameet Mallik: Thank you, Pepe. To close, we are pleased by the commercial performance and the role that ZYNLONTA monotherapy continues to play in third-line-plus DLBCL. We look forward to presentation of data from LOTIS-5, LOTIS-7, and MZL before year-end, with publication and potential compendia inclusion to follow. Following the FDA pre-sBLA meeting, we are assessing regulatory approaches to determine the best path forward for the LOTIS-5 trial. At the same time, we believe we have an opportunity for ZYNLONTA plus glofitamab to take a leading second-line position in DLBCL as a potential best-in-class bispecific combination and are actively assessing the potential regulatory path forward. Together, we anticipate we can grow ZYNLONTA beginning in 2027 as we work to make a meaningful difference in the lives of many more patients with B-cell malignancies. We can now open the line for questions. Operator?

Speaker #1: We look forward to the presentation of data from Lotus 5, Lotus 7, and MZL before year-end, with publication and potential compendium inclusion to follow. Following the FDA pre-SPLA meeting, we are assessing regulatory approaches to determine the best path forward for the Lotus 5 trial.

Speaker #1: At the same time, we believe we have an opportunity for Zenlanta plus clarithamab to take a leading second-line position in DLBCL as a potential best-in-class bispecific combination and are actively assessing the potential regulatory path forward.

Speaker #1: Together, we anticipate we can grow Zenlanta beginning in 2027 as we work to make a meaningful difference in the lives of many more patients with B-cell malignancies.

Speaker #1: We can now open the line for questions. Operator, thank you.

Operator 2: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the 1 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 the star followed by the 2. If you are using a speakerphone, please press the handset before pressing any key. 1 moment, please, for your first question. Your first question comes from Eric Schmidt with Cantor. Please go ahead.

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the 1 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 the star followed by the 2. If you are using a speakerphone, please press the handset before pressing any key. 1 moment, please, for your first question. Your first question comes from Eric Schmidt with Cantor. Please go ahead.

Speaker #3: Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the one on your touchtone phone.

Speaker #3: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two.

Speaker #3: 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 Eric Schmidt with Cantor.

Speaker #3: Please go ahead.

Speaker #4: Thanks for taking my question, and I appreciate all the updates. Maybe just on the status of the current accelerated approval for Zenlanta—given the questions around risk-benefit from LOTUS-5—was there any FDA discussion of maintaining that accelerated approval status?

Eric Schmidt: Thanks for taking my question, and appreciate all the updates. Maybe just on the status of the current accelerated approval for ZYNLONTA, given the questions around risk-benefit from LOTIS-5, was there any FDA discussion of maintaining that accelerated approval status?

Speaker #5: Yeah, so great question. So first of all, all the discussions were the FDA were related only to the trial. All their comments were specific to the combination of Zenlanta plus rituximab on the trial.

Ameet Mallik: Yeah. Great question. First of all the discussions with the FDA were related only to the LOTIS-5 trial. All their comments were specific to the combination of ZYNLONTA plus rituximab on the trial. There was no feedback at all about the single agent. We remain confident that the monotherapy will stay on the market, will continue to have accelerated approval, and we are committed to working with the FDA to make sure that we can satisfy the full approval, either through LOTIS-5 or through another study.

Speaker #5: So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market, will continue to have accelerated approval, and we're committed to working with the FDA to make sure that we can satisfy the full approval either through Lotus 5 or through another study.

Speaker #4: Thank you, Ameet. And then on Lotus 7 and your characterization of the most recent efficacy data that you guys that you guys have seen is compelling and consistent in safety.

Eric Schmidt: Thank you, Ameet. On LOTIS-7 and your characterization of the most recent efficacy data that you guys have seen as compelling and consistent in safety, have you essentially now seen the final ASH presentation, and do your comments pertain to that? In other words, do you know exactly what you will present, and is it consistent with that statement?

Speaker #4: Have you essentially now seen the final ASH presentation and do your comments pertain to that? In other words, you know, do you know exactly what you'll present and is it consistent with that statement?

Speaker #5: Yeah, so we've already submitted the abstract for ASH, which contains obviously the vast majority of the 100 patients that we enrolled. So the belief that I'm sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract.

Ameet Mallik: Yeah. We've already submitted the abstract for ASH, which contains, as you said, the vast majority of the 100 patients that we enrolled. The belief that I'm sharing with you about the fact that we could get very compelling efficacy and safety data is reflective of that ASH abstract. Obviously, for disclosure reasons, you can imagine we don't want to share all the details, but we do believe that we have very compelling data, both from an efficacy and a safety standpoint, within the LOTIS-7 data that was submitted to ASH.

Speaker #5: We're obviously for disposure reasons, you can imagine we don't want to share all the detail, but we do believe that we have very compelling data both from an efficacy and a safety standpoint within the Lotus 7 data that was submitted to ASH.

Speaker #4: Thank you. And one more question, if I may, with regard to exploring a phase three pathway for the combination in Lotus 7. Is that something you're exploring with Roche or by yourselves?

Eric Schmidt: Thank you. One more question, if I may, with regard to exploring a phase III pathway for the combination in LOTIS-7. Is that something you're exploring with Roche or by yourselves?

Speaker #5: Yeah, I don't want to comment on that. Obviously, we have a great partnership with Roche, and they've given us great feedback throughout. But what I would say is, we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback from the FDA, about a potential Phase 3 design, because we know that this data is so compelling that there could be significant upside for the asset by potentially pursuing Phase 3 assets.

Ameet Mallik: Yeah, I don't want to comment on that. Obviously, we have a great partnership with Roche, and they've given us great feedback throughout. What I would say is we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback we have gained, about a potential phase III design because we know that this data is so compelling that there could be significant upside to the asset by potentially pursuing phase III assets. So it's something we've been thinking about for a long time. The team has already been preparing on different design options that we do plan to file for Breakthrough Therapy designation this year and to discuss with the FDA potential designs.

Speaker #5: So it's something we've been thinking about for a long time. The team has already been preparing different design options, and we do plan to file for a breakthrough designation this year and to discuss with the FDA potential designs.

Speaker #4: Thank you for taking my questions.

Eric Schmidt: Thank you for taking my questions.

Speaker #5: Yeah, thank you, Eric.

Ameet Mallik: Yeah. Thank you, Eric.

Speaker #3: Your next question comes from Michael Schmidt with Guggenheim Securities. Please go ahead.

Operator 2: Your next question comes from Michael Schmidt with Guggenheim Securities. Please go ahead.

Operator: Your next question comes from Michael Schmidt with Guggenheim Securities. Please go ahead.

Speaker #6: Hey, this is Sarah on for Michael. Thanks so much for taking my question. Just wanted to follow up quickly on the Phase 3 plans.

[Analyst] (Guggenheim Securities): Hey, this is Sarah on for Michael. Thanks so much for taking my question. Just wanted to follow on quickly on the phase III plans, whether you could give any color on sort of timeline for that now that it appears to be more of the future-looking focus. Additionally, had a sort of question on the LOTIS-5 data. I know you've mentioned the 105-day period for monitoring AEs after treatment. I was wondering if you could comment on the timing of the deaths.

Speaker #6: Whether you could give any color on sort of timeline for that. Now that it appears to be sort of more of the future-looking focus, and then additionally, had a sort of a question on the Lotus 5 data.

Speaker #6: So I know you've mentioned the 105-day period for monitoring adverse events after treatment. I was wondering if you could comment on the timing of the deaths.

Speaker #5: So first of all, I just want to emphasize, we have a positive study for Lotus 5. So we regulatory approach for Lotus 5. I mean, specifically we're considering whether additional data, risk management options, or modifications to the potential label can address the FDA concerns of Lotus 5.

Ameet Mallik: First of all, I just want to emphasize we have a positive study for LOTIS-5. We still are assessing possibilities to identify the best regulatory approach for LOTIS-5. I mean, specifically, we're considering whether additional data, risk management options, or modifications to the potential label can address the updated concerns of LOTIS-5. We are doing that in parallel, given that we have potentially practice-changing data on hand with the LOTIS-7. We're also, in parallel, going to file for Breakthrough Therapy designation and explore a phase III approach there. It's too premature at this point, as you can imagine, while we're still gathering input from the medical community and obviously have to collaborate with the FDA on a final design to talk about timing and costs. But I just want to reemphasize that those two things are going in parallel.

Speaker #5: So we are doing that in parallel given that we have, you know, we think potentially practice changing data on hand with the Lotus 7.

Speaker #5: We're also in parallel going to file for breakthrough designation and explore a phase three approach there. So it's too premature at this point, as you can imagine, while we're still gathering input from the medical community and obviously have to collaborate with the FDA on the final design to talk about timing and cost.

Speaker #5: But I just want to re-emphasize that those two things are going in parallel. And then, with regards to the 105-day safety window, in terms of capturing AEs post-Alaskos, that's the same, by the way, in LOTUS-7 as well.

Ameet Mallik: And then with regards to the 105-day safety window, in terms of capturing AEs post the last dose, that is the same, by the way, in LOTIS-7 as well. One thing I want to emphasize is that, as Mohamed mentioned on the call, there was a big difference between LOTIS-5 and LOTIS-7, particularly with regards to prophylactic measures taken. So in LOTIS-7, consistent with a lot of the other glofitamab trials that have been run, in LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal, and bacterial infections. That was not part of the LOTIS-5 protocol. So while the time period that we are capturing AE is very similar, there was a pretty big difference in terms of prophylaxis and the protocol between 5 and 7.

Speaker #5: And one thing I want to emphasize is that as Mohamed mentioned on the call, there was a big difference between Lotus 5 and Lotus 7, particularly with regards to the prophylactic measures.

Speaker #5: Taken. So in Lotus 7, consistent with a lot of the other with the other glyphic trials that have been run, in Lotus 7, recommends prophylaxis, including vaccinations for viral, fungal, and bacterial infections.

Speaker #5: That was not part of the LOTUS-5 protocol. So, while the time period that we're capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis and the protocol between 5 and 7.

Speaker #6: I appreciate it. Thank you.

[Analyst] (Guggenheim Securities): Appreciated. Thank you.

Speaker #5: Yeah, thank you.

Ameet Mallik: Thank you.

Speaker #3: Your next question is from Jefferies LLC. Please go ahead.

Operator 2: Your next question comes from Maury Raycroft with Jefferies LLC. Please go ahead.

Operator: Your next question comes from Maury Raycroft with Jefferies LLC. Please go ahead.

[Analyst] (Jefferies): Hi. Good morning. This is James on for Maury. Thanks for taking our questions. Can you provide more detail on the type of Grade 5 infections that were observed in LOTIS-5 and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated into LOTIS-7? Did other infections occur that aren't addressed by those vaccines? I have follow-up after that.

Speaker #7: Hi, good morning. This is James on from Warwick. Thanks for taking our questions. Can you provide more detail on the type of grade 5 infections that were observed in Lotus 5 and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated into Lotus 7?

Speaker #7: Did other infections occur that aren't addressed by those vaccines? And I have a follow-up after that.

Speaker #5: Yeah, so the primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Ameet Mallik: Yeah. The primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Speaker #7: Got it. And how do you think about the potential read-through from the LOTUS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the Zinlanta-glyfidinab combination within the academic community?

[Analyst] (Jefferies): Got it. How do you think about the potential read-through from LOTIS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the zilansaclifadimab combination within the academic community? Could the LOTIS-5 impact the NCCN language, and could there be any safety monitoring requirements?

Speaker #7: Could Lotus 5 impact the NCC and language and could there be any safety requirement monitoring requirements?

Speaker #5: Yeah, I don't think so. Any read-through in terms of LOTUS 7 compendia, including two very different studies, two different regimens. And as I mentioned, the protocol is different, which we think can help to contribute to some of the safety difference.

Ameet Mallik: Yeah, I don't think there'll be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, two different regimens. As I mentioned, the protocol is different, which we think can help to contribute to some of the safety difference. Just as a reminder, obviously, I can't speak to the data we have on hand, but I can speak to the prior disclosure that we had. We had a very low percent of Grade 5 events, approximately 4%, if you look at our last disclosure we had in December on the 49 patients that we reported. So I do think there's a difference, and we don't think there would be a read-through to LOTIS-7 or to any potential NCCN or compendia inclusion.

Speaker #5: Just as a reminder, obviously I can't speak to the data that we have on hand, but I can speak to the prior disclosure that we had.

Speaker #5: We had a very low percent of grade 5 events—approximately 4% if you look at our last disclosure in December, on the 49 patients that we reported.

Speaker #5: So I do think there's a difference and we don't think that would be a read-through to Lotus 7 or to any, you know, potential NCCN or compendia inclusion.

Speaker #7: Got it. Very helpful. Thank you.

[Analyst] (Jefferies): Got it. Very helpful. Thank you.

Ameet Mallik: Thank you.

Speaker #3: You now have a question from Leonard Tameshiv with RBC Capital Markets. Please go ahead.

Operator 2: You now have a question from Leonid Timashev with RBC Capital Markets. Please go ahead.

Operator: You now have a question from Leonid Timashev with RBC Capital Markets. Please go ahead.

Speaker #8: Hi, guys. Josh on for Leo here. Thanks for taking my question. I was wondering, whether or not the FDA, in their feedback in response to the Phase 3, did they provide any kind of indication of what an effective path forward might look like, and what strategies you guys are thinking about at the time being?

[Analyst] (RBC Capital Markets): Hi, guys. Josh on for Leo here. Thanks for taking my question. I was wondering whether or not the FDA in their feedback in response to the phase III round, do they provide any kind of indication of what an effective path forward might look like and what strategies you guys are thinking about at the time being? Thanks.

Speaker #8: Thanks.

Speaker #5: Yeah, and I think, you know, typical in what you'd have in the pre-SPLA meeting, we share the data results and you're aligning on the package for an SPLA submission.

Ameet Mallik: Yeah, I think typical in what you would have with a pre-sBLA meeting, we share the data results and you are aligning on the package for an sBLA submission. During that, as is typical with any other pre-sBLA meeting, they share concerns that they have with the data. So right now we are basically going through the feedback and assessing whether additional data, risk management options, or modifications to the potential label can help to address those update concerns. That is the basis of which we are evaluating our path forward for LOTIS-5.

Speaker #5: During that, as typical with any other pre-SPLA meeting, they share concerns that they have with the data. And so, right now we're basically, you know, going through the feedback and assessing whether additional data, risk management options, or modifications to the potential label can help to address those FDA concerns.

Speaker #5: And that's the basis of which we're evaluating our path forward for Lotus 5.

Speaker #8: Thanks, guys.

[Analyst] (RBC Capital Markets): Thanks, guys.

Speaker #5: Yeah, thank you.

Ameet Mallik: Thank you.

Speaker #3: As a reminder, if you wish to ask a question, please press star followed by one. Your next question comes from Rob Burns with H.C. Wainwright.

Operator 2: As a reminder, if you wish to ask a question, please press star followed by the one. Your next question comes from Rob Burns with H.C. Wainwright. Please go ahead.

Operator: As a reminder, if you wish to ask a question, please press star followed by the one. Your next question comes from Rob Burns with H.C. Wainwright. Please go ahead.

Speaker #3: Please go ahead.

Speaker #8: Hi, this is Ahmed on for Rob. Thank you for taking our questions. I was just wondering if the you saw two Q product revenue increase versus two Q25.

Ahmed Ahn: Hi, this is Ahmed Ahn for Rob. Thank you for taking our questions. We are just wondering if you saw Q2 product revenue increase versus Q2 2025. I was wondering if you have seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 disclosure. For my second question, I was wondering if, in your conversations with the FDA, did they focus on the PFS in patients 75 or older, and if that would influence eligibility criteria future label? Thank you.

[Analyst] (H.C. Wainwright): Hi, this is Ahmed Ahn for Rob. Thank you for taking our questions. We are just wondering if you saw Q2 product revenue increase versus Q2 2025. I was wondering if you have seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 disclosure. For my second question, I was wondering if, in your conversations with the FDA, did they focus on the PFS in patients 75 or older, and if that would influence eligibility criteria future label? Thank you.

Speaker #8: And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since Lotus 5 disclosure. And then for my second question, I was wondering if in your conversations with the FDA, did they focus on the PFS in patients 75 or older and if that would influence eligibility criteria or future label?

Speaker #8: Thank you.

Speaker #5: Yeah, so with regards to sale, we haven't seen any impact. If you look at the buying and Q2 very consistent with prior quarter. So and we don't think that there will be you know, if you look overall over this past several quarters, the commercial performance is amounted there in the third line plus setting has been relatively consistent.

Ameet Mallik: Yeah. With regards to sale, we have not seen any impact. If you look at the volume in Q2, very consistent with prior quarters. We do not think that there will be. If you look overall, over the past several quarters, the commercial performance of monotherapy in the third-line plus setting has been relatively consistent. That is because the ADC has an established place in that third-line plus setting, and we do not expect any impact on monotherapy sales. Remind me again, I am sorry, your second question.

Speaker #5: And that's because Zinlanta has an established place in that third line plus setting and we don't expect any impact on monotherapy sales. And then remind me again, I'm sorry, your second question.

Speaker #8: No problem. I was wondering if.

Ahmed Ahn: No problem. I was wondering if-

[Analyst] (H.C. Wainwright): No problem. I was wondering if-

Ameet Mallik: Oh, it was about patients 75 or older, right?

Speaker #5: 75 or older, right?

Speaker #8: Yes, thank you.

Ahmed Ahn: Yes. Thank you.

[Analyst] (H.C. Wainwright): Yes. Thank you.

Speaker #5: Yeah. We don't think it'll have any impact on other studies. You know, I think obviously you know, older patients specifically with infection we think that the prophylaxis, you know, can play a role.

Ameet Mallik: Yeah. We don't think it will have any impact on other studies. I think, obviously, older patients, specifically with infection, we think that the prophylaxis can play a role. That is also why the protocol, again, I want to stress for LOTIS-7 versus LOTIS-5 are quite different. I think each study is on its own. I don't think that there is a read-through from this. We certainly learned a lot from LOTIS-5, and we are happy with the differences in the protocol, of course, that we are seeing in LOTIS-7. We don't see any read-throughs from LOTIS-5 to either the current indication or other potential combinations.

Speaker #5: And that's also why the protocol, again, I want to stress for Lotus 7 versus Lotus 5 are quite different. So I think each study is on its own.

Speaker #5: You know, I don't think that there's a read-through from this. We certainly learned a lot from Lotus 5 and we're happy with the differences in the protocol, of course, that we're seeing in Lotus 7.

Speaker #5: So we don't see any read-through from Lotus 5 to either the current indication or other potential combinations.

Speaker #8: Thank you.

Ahmed Ahn: Thank you.

[Analyst] (H.C. Wainwright): Thank you.

Operator 2: There are no further questions at this time, so I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Operator: There are no further questions at this time, so I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Speaker #3: There are no further questions at this time, so I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Speaker #5: Well, thank you all for joining the call today and for your continued support. We look forward to keeping you updated on our progress. Operator, you may now end the call.

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

Operator 2: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.