ADC Therapeutics Q2 2025 Earnings Report

ADC Therapeutics EPS Results

• Actual EPS: -$0.50
• Consensus EPS: -$0.36
• Beat/Miss: Missed by -$0.14
• One Year Ago EPS: N/A

ADC Therapeutics Revenue Results

• Actual Revenue: $18.84 million
• Expected Revenue: $17.82 million
• Beat/Miss: Beat by +$1.02 million
• YoY Revenue Growth: N/A

ADC Therapeutics Announcement Details

• Quarter: Q2 2025
• Date: 8/12/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, August 12, 2025
• Conference Call Time: 8:30AM ET

ADC Therapeutics (NYSE:ADCT) focuses on advancing its proprietary antibody drug conjugate (ADC) technology platform to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. Its flagship product is ZYNLONTA, a CD19-directed ADC, received accelerated approval from the U.S. Food and Drug Administration and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The company is also seeking to continue expanding ZYNLONTA into international markets and into earlier lines of DLBCL and indolent lymphomas, including follicular lymphoma (FL) and marginal zone lymphoma (MZL) as a single agent and in combination through its LOTIS-5 confirmatory Phase 3 clinical trial and LOTIS-7 Phase 1b clinical trial, as well as through investigator-initiated trials (IITs). In addition, it is investigating a CD-22 targeted compound, ADCT-602 that is in a Phase 1/2 investigator-initiated study in relapsed or refractory B-cell acute lymphoblastic leukemia. Further, its clinical-stage pipeline consists of ADCT-601 (mipasetamab uzoptirine) targeting AXL as a single agent and/or in combination in sarcoma, pancreatic, and NSCLC, as well as pre-clinical stage pipeline includes a portfolio of next generation investigational ADCs targeting Claudin-6, NaPi2b, PSMA, and other undisclosed targets. The company was incorporated in 2011 and is headquartered in Epalinges, Switzerland.

ADC Therapeutics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: During LOTUS-7, the combination of ZENLANTA plus glufetamab achieved a 93.3% ORR and 86.7% CR in 30 evaluable DLBCL patients, with 25 of 26 CRs maintained at data cutoff, prompting expansion to 100 patients at the 150 µg/kg dose.
• Positive Sentiment: In the LOTUS-5 Phase III confirmatory trial of ZYNLATA plus rituximab, safety run-in data showed an 80% ORR and 50% CR, and the study is on track to hit pre-specified PFS events by year-end, targeting a supplemental BLA submission in H1 2026.
• Neutral Sentiment: Net product revenue rose to $18.1 million in Q2 versus $17 million YoY, while non-GAAP operating expenses climbed due to R&D and restructuring, and cash and equivalents reached $264.6 million, extending the cash runway into 2028.
• Negative Sentiment: As part of a strategic reprioritization, ADC Therapeutics is discontinuing other preclinical solid tumor programs and closing its UK facility, reducing global workforce by approximately 30% to focus on core ADC and PSMA initiatives.
• Neutral Sentiment: ADC Therapeutics expects to complete IND-enabling studies for its exatecan-based PSMA-targeting ADC by year-end, advancing its next preclinical program toward clinical entry.

Presentation

[Operator]

morning, ladies and gentlemen, and welcome to the ADC Therapeutics FA ADC T Q2 twenty twenty five Earnings Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Tuesday, 08/12/2025. I will now turn the call over to Nicole Reilly, Head of Investor Relations and Corporate Communications for ADC Therapeutics. Nicole, please go ahead.

[Nicole Riley, Executive Director, Head of Communications at ADC Therapeutics]

Thank you, operator. Today, we issued a press release announcing our second quarter twenty twenty five 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, 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 twenty twenty five financial results. We will then open the call to questions.

[Nicole Riley, Executive Director, Head of Communications at ADC Therapeutics]

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. 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 ks, 10 Q and eight ks. 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.

[Nicole Riley, Executive Director, Head of Communications at ADC Therapeutics]

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?

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Thanks Nicole and hello everyone. Thank you for joining us on today's call. The 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 $18,100,000 and $35,500,000 in the second quarter and first half respectively, both of which were slightly higher as compared to the same periods in the prior year.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

During the second quarter we were pleased to have LOTUS-seven 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 ZENLANTA plus clofidamab to be a best in class combination in a highly competitive market. Data as of the April 2025 cutoff date shows ZENLANTA in combination with glufetamab 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 ninety three point three percent and a complete response rate of eighty six point seven percent across 30 efficacy evaluable LBCL patients. Of note, twenty five of the twenty six patients achieving CR remained in CR as of the data cutoff.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

For reference, we have seen complete response rates in other bispecific combination trials in the range of forty seven to sixty two percent. We are currently expanding enrollment to 100 patients at the selected one hundred and fifty 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 LOTUS-seven in the 2025. Once sufficient data with longer follow-up is available, we plan to discuss the path forward for ZIMMANTA and glufitamab with regulatory authorities and to pursue a compendia strategy. LOTUS V remains on track to reach the pre specified number of progression free survival events by the 2025.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

After the pre specified number of PFS events is reached and data are available, we expect to provide top line data on this Phase three confirmatory trial evaluating ZYNLATA in combination with rituximab in patients with second line plus DLBCL. Lastly, 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 eighty five percent and a complete response rate of sixty nine percent with safety consistent with the known profile of ZYNLATA. Moving beyond ZYNLATA, we are on track to complete IND enabling activities for our exatecan 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 XENLETA 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%.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 100,000,000 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, Zenlanta has a profile of rapid, deep and durable efficacy as well as manageable safety with simple and convenient administration.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 DLBCL 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 LODIS-five has the potential to take ZYNLATA to 200,000,000 to $300,000,000 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.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Below to seven we estimate we can expand the total opportunity for ZENLATA and DLBCL to 500 to $800,000,000 in peak revenue with regulatory approval and compendia listing. If the data persists, we believe Zemanta plus glufitamab 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 ZENLATA regimen could provide significant benefit for these patients. We believe the indolent lymphomas opportunity could provide additional peak revenue of 100,000,000 to $200,000,000 with regulatory approval and compendia listing, primarily driven by MZL.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Taken together, we believe ZIMMANTA has the potential to reach peak revenues of $600,000,000 to $1,000,000,000 in The U. S. Looking at the overall DLBCL 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.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

The second are more broadly accessible therapies which all physicians can administer in the outpatient setting, including therapies like ADCs, monoclonal antibodies and chemotherapy. Biosecifix have already been approved in the third line plus setting as monotherapy, and we estimate there is currently a sixtyforty split between the complex and broadly accessible segments respectively. In the second line where bispecifics have not yet been approved but were recently added to NCCN guidelines for use in combination, the estimated split is closer to 20 fiveseventy five. We believe the emerging clinical profile of Zananta plus glufinumab in the LOTUS-seven trial positions us well among complex therapies and at the same time the clinical profile of ZENLATA plus rituximab in the LOTUS-five trial has the potential to differentiate us among broadly accessible therapies. While XENLETA is currently approved as a single agent in third line plus DLBCL, we believe XENLETA has the potential to be the backbone therapy for combinations, raising the bar for efficacy in second line plus DLBCL.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

ZENMANTA is a systemic chemo free option which can be combined with the highly effective bispecific glufinumab and the most widely used agent rituximab. We believe ZENMANTA plus glufinumab in LOTUS seven and ZENLANTA plus rituximab in LOTUS five 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?

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Thank you, Amit. Initial data from the safety leading portion of RUTA-five, our Phase III confirmatory study of zenlanta in combination with rituximab in patients with second line plus DLBCL showed an overall response rate of eighty percent and a complete response rate of fifty percent with no new safety signals, 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 pre specified number of events by the 2025, and we'll provide data once available. A supplemental BLA submission to regulatory authorities is anticipated in the 2026, with potential confirmatory approval in second line plus DLBCL in the 2027. With Bluetooth seven, we are exploring the combination of ZINLONTA and anti C19 ADC with glufetumab an anti CD20CD3 T cell engaging bispecific antibody.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

These two highly potent single agent drugs offer important and complementary mechanism of action in the ADCL, which target two different B cell surface antigens while delivering important 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 launch prior to glucosumab, 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.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Part one, dose escalation was conducted across non Hodgkin lymphoma patients at three dose levels of ZERMANTA with mofetuzumab or mosentizumab in the third line plus. Part two dose expansion was conducted in the second line plus large B cell lymphoma with amount at two dose levels, one hundred and twenty micrograms per kg, and the currently approved monotherapy dose of one hundred fifty micrograms per kg combined with the approved monotherapy dose of glopitamab. Based on this initial dose optimization, we selected the one hundred fifty micrograms per kg dose for expansion to one hundred patients at this dose level. Zoloft is being given prior to blitomap to potentially debulk 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.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Baseline characteristics in this study, including being refracted to prior therapy as well as number and types of prior therapies, are representative of the second line DLBCL patient population and similar to other studies in this space. Among the forty one 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 three d follicular lymphoma, all considered to be DLBCL. Median prior lines of therapy was two with a range from one to five.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

The study includes a number of difficult to treat large B cell lymphoma patients. Nearly twenty percent of patients presented at double or triple hits, nineteen point five percent of patients received prior CAR T, which is in line with other trials done with bispecific combinations. Patients refracted to prior therapy were well represented in the study, with fifty one percent of patients refracted to primary therapy and forty nine percent refracted to last prior therapy, both of which were slightly higher in the one hundred fifty microgram per kg compared to one hundred twenty microgram per kg dose. Safety was analyzed in the forty one large B cell lymphoma patients who received at least one dose of zolonthaplast glufetumab. Most notably, as mentioned during the presentation of this data at ASH, when looking at grade CCM4 treatment emergent adverse events occurring in more than five percent of patients, neutropenia was the most common at twenty four point four percent, which is similar to the rate of neutropenia reported in the prescribing information of each drug separately.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

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 twenty patients experiencing serious treatment emergent adverse events discontinued treatment. As of the data cutoff, the combination has shown a manageable safety profile, and no new safety signal was observed.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

A total of six patients discontinued due to adverse events, three of which were serious treatment emergent adverse events. For the long test, we saw one case each of pericardial effusion, generalized edema, and pleural effusion. And for glufetamab, we saw one case of ICAM, polyneuropathy, and febrile neutropenia. This is consistent with the loan profile of each drug separately. As of the data cut off date, we can see that overall rates and grades of CRS are higher at the one hundred twenty microgram per kg dose compared to the one hundred fifty microgram per kg dose.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

The one hundred twenty microgram per kg dose had fifty five percent any grade CRS, primarily grade one-two, with one case of grade three. The one hundred fifty micrograms per tick dose had twenty three point eight percent any grade CRS, all of which was grade one. Grade one and two CRS were managed using standard of care therapies without ICU admittance or pressure support. The grade three CRS was managed with standard of care therapies and included ICU admit. ICANS were seen in two patients treated at the one hundred twenty microgram per kg, and one ICANS observed at one hundred fifty microgram per kg dose.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

These eye cancer were low grade and primarily management scotchic steroids. 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 forty one treated patients at the time of the April data cut off, thirty patients had reached the initial disease assessment and were efficacy evaluable. In this study, we have seen ninety three point three overall response rates and eighty six point seven complete response rate. Median duration of response was not reached at the time of data cut off.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

The results observed across those levels were consistent in the terms of ORR, CR, and PR. Looking now at the SWIMR's plot, 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 forty two. Twenty five out of twenty six patients who achieved a complete response have maintained that response as of the data cutoff, and twelve patients converted from stable disease or partial response to complete response over time.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

As the data cut off, 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 CAR T and undergoing response assessment, five achieved a CR. The impressive efficacy and manageable safety profile seen with the combination of Zolonta and glufetamab is encouraging. The data reinforces our belief in the potential for this regimen to change the treatment paradigm for patients with aggressive lymphoma.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Now, I will turn the call over to Pipi Carmona, our CFO, who will discuss financial results for the second quarter. Patrick?

[Jose Carmona, CFO at ADC Therapeutics]

Thank you, Mohamed. On the financial front, zinlotinib product revenues in the 2025 were $18,100,000 as compared to $17,000,000 in the same quarter of 2024. Total first half net product revenue was $35,500,000 compared to $34,900,000 during the 2024. In connection with the strategic reprioritization and restructuring plan announced in June 2025, the company incurred $13,100,000 in restructuring and impairment costs in the 2025, which consisted of $6,700,000 in employee severance and related benefit costs and $6,400,000 in non cash impairment assets in connection with the close down of The UK facility. Total operating expenses for the quarter were $47,800,000 on a non GAAP basis representing an 8% increase over prior year primarily driven by higher R and D costs mostly related to LOTUS V and LOTUS VII as well as PSMA IND enabling activities.

[Jose Carmona, CFO at ADC Therapeutics]

The expenses on the ZINGLOTALLOTUS 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 $56,600,000 for the 2025 or 50¢ per basic and diluted share as compared to a net loss of $36,500,000 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 one time restructuring and impairment costs and higher R and D expenses. You can find the reconciliation of GAAP to non GAAP measures in the financial tables of the press release issued earlier today and in the appendix of this presentation. As of 06/30/2025 cash and cash equivalents were $264,600,000 compared to $194,700,000 at 03/31/2025.

[Jose Carmona, CFO at ADC Therapeutics]

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 LODIS VLODIS VII and MCLC launch programs we expect to have multiple data catalyst in the remainder of 2025 and 2026 with potential lotus five approval and compendia listing for all of this in the 2027. LOTUS V 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. In LOGO seven we intend to share fewer, more mature data toward the end of this year and expect to complete enrollment of 100 patients at the one hundred and fifty microgram per kilogram dose in the first half of next year. We plan to engage with regulatory authorities starting later this year.

[Jose Carmona, CFO at ADC Therapeutics]

With sufficient data we will pursue publication and a potential compendium strategy. With indolent lymphomas we expect additional data to be shared at medical conferences this year and next by the lead investigators. Beyond CINLONTA we are excited to see the advancement of our exatecan based PSMA targeting ADC with potential completion of IND enabling activities toward the end of this year. Overall we believe we have multiple value driving catalysts within our CAS runway which is expected to extend into 2028. I will now turn the call back to Amit.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 and 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]

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Your first question comes from Michael Schmidt with Guggenheim. Your line is now open.

[Michael Schmidt, Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC]

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 gleofitamab in second line DLBCL.

[Michael Schmidt, Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC]

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-five, and I know you've 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. Thank you.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Okay, thank you so much, Michael. And thanks for both of your questions. So the first one was around DarGlow, the CRL that they received, and any impact that we see that could happen for us. And the second question was around LOTUS V and what the status of OS or interim OS analysis would be when get to top line results. So I'll turn it to Mohamed first to talk about the CRL with STAR GLOW.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

And maybe also highlight some differences between how we've conducted some of our trials like LOTUS-five and the STAR GLOW study.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Sure. Thanks, Amit. 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 DLBCL landscape. And also, we remain confident that the LUTOS five and LUTOS seven is well positioned to address the unmet medical need in that space, specifically for people who cannot or not suitable for complex serial therapy. I want to highlight also what is the LUTES five design that makes us comfortable.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

First of all, it's a large study, four twenty patients. In addition, also, it's randomized one to one. And powered at 90% with the if the assumption that arginx will give about four months, all the studies required to show two months difference in six months in the test arm to the study to be successful. Also, we're very comfortable with the data shared with the early safety run-in with a 50% complete response and eight percent to our RF PFS of eight point three months in that disease setting. That's for our comfort regarding, the differences.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Also, think we shared before that our enrollment in Asia was significantly lower than what the STARCORE study was. The in terms of interim, of course, at the final analysis of PFS, there 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 PFS announcement.

[Michael Schmidt, Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC]

Just as 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?

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

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

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Yeah. 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 SBLA submission with the FDA.

[Operator]

Thank you. Your next question comes from Kelly Hsu with Jefferies. Your line is now open.

[Jenna Li, Biotech Equity Research Senior Associate at Jefferies]

Hi, 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 seen from LOTUS five and LOTUS seven. How much incremental durability benefit would you expect maybe versus clofinetomab alone for all the seven and for these two trials, how may that compare with other rituximab combos?

[Jenna Li, Biotech Equity Research Senior Associate at Jefferies]

And then for the lotus seven update coming in the second half, what kind of early read into durability may we expect there? Thank you so much.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Yeah, thanks for the question. So you're asking, I think, about not only the high CRAs that we've seen with LOTUS seven, 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 Mohammad to talk about, one, why we believe we will see good durability.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

But also, what metrics we'll be able to show over time to demonstrate that durability of the CRs.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

It's important to highlight that the high number or maybe unprecedented number of CRs observed within LUTA7 so far is very encouraging. And very important also to highlight that we all know that the CRs are a good serum 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 glufetumab for three years and for longer, for two years. So, we're also looking forward to continuing to look 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 CR rate that have been seen by other combinations of bispecifics is ranging between forty seven and sixty two percent.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Actually, know that our numbers are higher than that. And the initial response of twelve months for those studies ranging between sixty three percent to seventy five percent. Also, it's important to highlight that with our focus in our benchmarking on the durability at six and twelve months, and more, of course, as we get more data. So we keep monitoring this data. That is very encouraging right now, as I mentioned before.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

25 of 26 CRs remain in CRs at the time data cutoff, with the longest of them reaching more than a year.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 twelve months as the data matures and we have sufficient data to share on that.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

You'll see more durability data as we kind of give future updates.

[Jenna Li, Biotech Equity Research Senior Associate at Jefferies]

Thank you. Super helpful.

[Operator]

Your next question comes from Your line is now open.

[Eric Schmidt, Biotechnology Analyst at Cantor Fitzgerald]

Thanks for my question. Congrats on the progress in Q2. Maybe just a quick one with regard to LOTUS-seven 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-seven data later this year? Would that be at a conference or company sponsored event? Thank you.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Yeah, so maybe I'll start and then I'm to pass it to Mohamed. So first of with LOTUS-seven, as you're aware and we've communicated, we currently have expanded the trial to enroll 100 patients at the 150 in Lanta, plus the full dose of glifema. 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.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

In parallel, obviously as the data matures, we want to engage with the FDA on potential path forward. Whether it be in second line or frontline, that we can explore different options with the FDA. So that's one 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.

[Mohamed Zaki, Chief Medical Officer at ADC Therapeutics]

Yeah, typically when you have some data with 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, on bigger studies for second or front line, as Amit mentioned. Of course, there's a 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 then all the follow-up that we have and really have a fruitful discussion with the agency.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Yeah, 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 one of the considerations is the data cutoffs 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 we shared in June.

[Eric Schmidt, Biotechnology Analyst at Cantor Fitzgerald]

Got it, thank you.

[Operator]

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

[Leonid Timashev, Biotechnology Analyst at RBC Capital Markets]

Yeah, Thanks for taking my question. I just want to ask on some of the indolent lymphomas. I guess, given the encouraging MSL data you've seen, can you just remind us how you see ZINLONZA fitting into these more indolent indications given that there's, you know, slightly different benefitrisk calculus 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 of these? Thanks.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

Yeah, so yeah, I agree. We are very encouraged by the indolent lymphoma data we've generated both in the relapsedrefractory setting of MZL and follicular. Specific to your question around MZL, 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 thirty six patients. The most any trial has ever enrolled, which is clinical trial, was about sixty two patients.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

So we think fifty 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 relapsedrefractory setting, the highest CR rate is about twenty nine percent. We're well above that obviously with the data we're sharing right now. Clearly I think forty percent or above would be significant improvement over any of the standard of care.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 CINLANTA. 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 that patients can be treated and can be on treatment and in a disease setting for multiple years oftentimes, this tolerability profile is obviously much more important than even in more aggressive lymphomas like DLBCL. So we feel quite comfortable with our approach as a single agent in Lanta in marginal zone lymphoma, and that's the approach we'll take going forward.

[Operator]

Your next question comes from Sudan Loganshan with Stephens. Your line is now open.

[Sudan Loganathan, Managing Director at Stephens Inc]

Amit, Mohammed and Peppe, congrats on the strong progress in the quarter and thanks for taking my questions. First, can you walk us through your sales force growth plan and timeline as you expect to unlock a much larger TAM with the strong response data outcomes of the LOTUS trial? How will marketing responsibilities of combination with glufetamab be split, if any at all, with Roche? And when do you anticipate the earliest opportunity the MSLs will have to start talking about the LOTUS trial data to prescribing physicians? And then lastly, quick, you know, post the CRL of STAR GLOBE, do you anticipate SkyGLOBE confirmatory phase three study if granted full approval for the glofitamab plus polyVR CHAP 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?

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 be any collaboration with Roche on that? And then three, you asked a little bit about SkyGlow. And if SkyGlow would be the confirmatory study.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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 pre launch and in the early launch phases, as we kind of expand the potential uses of ELANTA. With regards to any collaboration, as you know, we'll be launching, we believe, with a successful approval of LOTUS V, we would be then promoting that and be successfully launching that. LOTUS V is a bit different, because what we expect the first step to be is in compendia.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

And as you know, we won't promote anything off label. And so our commercial teams won't be actively discussing LOTUS V. MSLs obviously will be there to respond to questions that physicians have around the LOTUS seven data. And at this point there's no planned collaboration commercially or medically with Roche on that. With regards to the frontline study with Glofit, Polivy, RHF, 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.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

But we're waiting like you are to see if that gets confirmed by the FDA.

[Operator]

There are no further questions at this time. I will now turn the call over to Amit for closing remarks.

[Ameet Mallik, CEO & Director at ADC Therapeutics]

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.

[Operator]

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

Participants

Executives

• Nicole Riley, Executive Director, Head of Communications
• Ameet Mallik, CEO & Director
• Mohamed Zaki, Chief Medical Officer
• Jose Carmona, CFO

Analysts

• Michael Schmidt, Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC
• Jenna Li, Biotech Equity Research Senior Associate at Jefferies
• Eric Schmidt, Biotechnology Analyst at Cantor Fitzgerald
• Leonid Timashev, Biotechnology Analyst at RBC Capital Markets
• Sudan Loganathan, Managing Director at Stephens Inc