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ADC 테라퓨틱스(ADCT) 2026년 2분기 실적 발표회: LOTIS-5 FDA 우려, 현금 2억 1,910만 달러

TradingKeyAug 14, 2026 8:02 AM
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2026년 2분기 자인론타 제품 순매출은 1,860만 달러로 전년 동기 대비 증가했으며, 판매량은 최근 분기들과 유사한 수준을 유지했다. 임상 3상 LOTIS-5는 1차 평가변수를 충족했으나, FDA는 이익-위험 프로필 등에 상당한 우려를 제기하여 회사는 추가 데이터 및 라벨 변경 방안을 검토하고 있다.

LOTIS-7 병용 임상은 환자 100명 등록을 완료하였고, ASH에 데이터를 제출했으며 2026년 혁신적 치료제 지정 신청을 계획 중이다. 2분기 GAAP 순손실은 1,660만 달러로 축소되었고, 현금 및 현금성 자산은 2억 1,910만 달러로 현금 소진 시점이 최소 2028년까지 연장될 것으로 예상된다. 조직 개편으로 연간 약 1,000만 달러의 비용 절감이 기대된다.

AI 생성 요약

핵심 요약

  • 2026년 2분기 자인론타(ZYNLONTA) 제품 순매출은 1,860만 달러로, 2025년 2분기의 1,810만 달러 대비 증가했습니다. 경영진은 판매량이 최근 분기들과 유사한 수준을 유지했다고 밝혔습니다.
  • 임상 3상 LOTIS-5 시험은 1차 평가변수인 무진행 생존기간(PFS)을 충족했으나, 미국 식품의약국(FDA)은 이익-위험 프로필 및 임상적 이점 검증에 대해 상당한 우려를 제기했습니다. ADC 테라퓨틱스(ADC Therapeutics)는 추가 데이터, 위험 관리 조치 및 잠재적 라벨 변경 방안을 검토하고 있습니다.
  • LOTIS-7 임상은 체중 kg당 150마이크로그램 용량의 자인론타 및 글로피타맙(glofitamab) 병용 투여군에서 환자 100명의 등록을 완료했습니다. 회사는 미국혈액학회(ASH)에 데이터를 제출했으며 2026년에 혁신적 치료제 지정을 신청할 계획입니다.
  • 2분기 일반회계기준(GAAP) 순손실은 전년 동기의 5,660만 달러에서 1,660만 달러로 축소되었습니다. 조정 순손실은 주로 영업비용 감소에 힘입어 2,870만 달러에서 1,630만 달러로 줄었습니다.
  • 분기 말 기준 현금 및 현금성 자산은 총 2억 1,910만 달러였습니다. 경영진은 현금 소진 시점(cash runway)이 최소 2028년까지 연장될 것으로 예상하고 있습니다.
  • 전략적 조직 개편을 통해 인력을 약 17% 감원했으며, 이를 통해 연간 약 1,000만 달러의 비용 절감 효과가 발생할 것으로 기대됩니다.

주요 재무 데이터

지표2026년 2분기2025년 2분기 / 전년 동기비고
자인론타 제품 순매출1,860만 달러1,810만 달러경영진은 상업적 성과가 최근 분기들과 전반적으로 일치한다고 설명함
제품 매출원가230만 달러80만 달러증가는 주로 R&D 임상 시약 공급 업무에서 상업적 제조로 인력이 이동한 점을 반영함
총 영업비용4,470만 달러GAAP 기준
조정 영업비용3,720만 달러전년 동기 대비 22% 감소감소는 주로 R&D 비용 감소에 기인함
GAAP 순손실1,660만 달러5,660만 달러두 기간 모두 구조조정 관련 영향 포함됨
조정 순손실1,630만 달러2,870만 달러개선은 주로 영업비용 감소를 반영함
현금 및 현금성 자산2억 1,910만 달러2026년 3월 31일 기준 2억 3,100만 달러전분기 대비 감소는 주로 영업활동에 사용된 현금을 반영함

2026년 상반기 제품 매출원가는 600만 달러로, 2025년 동기의 290만 달러 대비 증가했습니다.

사업 및 영업 성과

자인론타는 3차 이상 광범위 대성 B세포 림프종(DLBCL) 단일 요법 치료제로 입지를 유지했습니다. 2021년 FDA의 신속 승인을 받은 이후, 미국에서 약 5,000명의 환자 치료에 사용되었습니다.

경영진은 LOTIS-5 공시가 현재 승인된 적응증에서의 환자 수나 의사의 처방 행태에 영향을 미치지 않았다고 밝혔습니다. 또한 회사는 pre-sBLA 미팅에서 FDA의 피드백이 자인론타 단독 요법이 아닌 자인론타-리툭시맙 병용 요법에 구체적으로 관련된 것이라고 설명했습니다.

LOTIS-7은 2차 이상 DLBCL에서 자인론타와 글로피타맙 병용 요법을 평가 중입니다. 선정된 용량에서 환자 100명의 등록을 마쳤습니다. ADC 테라퓨틱스는 ASH 제출 자료에 등록 환자의 대부분에 대한 데이터가 포함되어 있으며, 효능 및 안전성 결과가 여전히 설득력 있다고 평가했습니다. 회사는 임상 3상 시험 디자인도 검토하고 있습니다.

저용량성(지연성) 림프종의 경우, 업데이트된 변연부 림프종(MZL) 데이터가 ASH에 제출되었습니다. ADC 테라퓨틱스는 MZL에 대해 혁신적 치료제 지정을 신청할 것으로 예상하고 있습니다. 업데이트된 여포성 림프종 데이터는 2027년 2분기에 공개될 예정입니다.

경영진 가이던스

경영진은 6월 조직 개편을 통해 연간 약 1,000만 달러의 비용 절감을 달성할 것으로 예상하고 있습니다. 분기 말 현금 잔액인 2억 1,910만 달러와 결합하여, 회사는 현금 소진 시점이 최소 2028년까지 연장될 것으로 기대하고 있습니다.

ADC 테라퓨틱스는 2026년에 자인론타-글로피타맙 병용 요법에 대한 혁신적 치료제 지정 신청서를 제출할 계획입니다. LOTIS-5, LOTIS-7 및 MZL에 대한 학술지 게재 및 의약품집(compendia) 등재 신청은 계획된 데이터 발표 이후 진행될 것으로 예정되어 있으며, 2027년부터 의약품집 등재가 시작될 가능성이 있습니다.

경영진은 임상, 규제 및 의약품집 등재 진행 상황에 따라 2027년부터 자인론타 매출 성장 기회가 있을 것으로 전망한다고 밝혔습니다.

리스크 및 관전 포인트

주요 규제 불확실성은 LOTIS-5의 향후 추진 방향입니다. 해당 연구가 1차 평가변수를 충족했음에도 불구하고, FDA는 이익-위험 프로필과 임상적 이점 검증에 대해 상당한 우려를 표명했습니다. ADC 테라퓨틱스는 추가 데이터, 위험 관리 옵션 또는 라벨 변경을 통해 이러한 우려를 해소할 수 있을지 평가하고 있습니다.

경영진은 LOTIS-5에서 관찰된 5등급(Grade 5) 감염이 주로 세균성 감염이었다고 밝혔습니다. LOTIS-5와 달리 LOTIS-7 프로토콜은 폐포자충 폐렴(PJP) 및 헤르페스 바이러스를 포함한 바이러스, 진균 및 세균 감염을 차단하는 예방요법 및 백신 접종을 권장합니다. 회사는 이러한 프로토콜의 차이가 다른 안전성 결과로 이어질 수 있다고 보고 있으나, LOTIS-7의 최종 결과는 향후 발표 및 규제 기관의 검토를 거쳐야 합니다.

향후 진행될 수 있는 LOTIS-7 임상 3상의 시기, 디자인 및 비용은 아직 결정되지 않았습니다. 회사는 의료계의 의견을 수렴하고 FDA와 가능한 임상 디자인에 대해 논의할 계획입니다.

애널리스트 Q&A 주요 내용

  • 현재 신속 승인 상태: 경영진은 FDA와의 논의가 LOTIS-5 및 자인론타-리툭시맙 병용 요법에만 집중되었다고 밝혔습니다. 회사는 LOTIS-5나 다른 연구를 통해 정식 승인을 추진하는 동안 자인론타 단독 요법이 신속 승인을 유지할 것이라고 확신하고 있습니다.
  • LOTIS-5 규제 옵션: ADC 테라퓨틱스는 FDA의 피드백을 검토하고 추가 데이터, 위험 관리 조치 및 잠재적 라벨 변경을 고려하고 있습니다.
  • LOTIS-7 개발 현황: 경영진은 ASH 초록에 등록된 환자 100명 중 대부분의 데이터가 반영되어 있다고 말했습니다. 회사는 혁신적 치료제 지정을 신청하고 FDA와 3상 디자인 옵션을 논의할 계획입니다.
  • 안전성 시사점: 경영진은 치료 요법과 예방 프로토콜의 차이를 이유로 들어, LOTIS-5의 5등급 감염 신호가 LOTIS-7의 의약품집 등재에 영향을 미치지 않을 것으로 예상합니다.
  • 상업적 영향: 회사는 LOTIS-5 공시 이후 자인론타 판매량에 변화가 없다고 보고했으며, 3차 이상 DLBCL에서의 단독 요법 수요가 안정적으로 유지될 것으로 기대하고 있습니다.

실적 발표 전화회의 전문


전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. [Operator Instructions] 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. Please go ahead.

Nicole Riley

Thank you, operator. Today, we issued a press release announcing our second quarter 2026 financial results and business update. This release and the slides we will use in today's presentation are available on the Investors section of the ADC Therapeutics website.

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

Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance and achievements could differ materially.

They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements.

Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's second quarter 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?

Ameet Mallik

Thank you, Nicole. We are pleased to share that ZYNLONTA's commercial performance in the second quarter of 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.

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 demonstrate 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 designation this year.

With respect to the multicenter 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 the second quarter of 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 designation for MZL.

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. 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 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.

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. 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 U.S. 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.

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 the 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. 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 micrograms per kg dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccinations 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. The data on a larger number of patients with longer follow-up has been submitted to ASH for presentation. 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 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 ZYNLONTA combinations into earlier lines of therapy in DLBCL. 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.

Jose Carmona

Thank you, Mohamed. On the financial front, ZYNLONTA 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. Cost of product sales was $2.3 million and $6 million for the second quarter and 6 months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same period in 2025. The increases compared to prior year are primarily driven by a change in focus of personnel from research and development clinical supply activities to commercial manufacturing activities.

Total operating expenses were $44.7 million for the second quarter. On a non-GAAP 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. 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 the second quarter of 2026 as compared to a net loss of $56.6 million for the same period in 2025. The second quarter of 2026 included a onetime 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 the second quarter of 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. 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 the second quarter in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. 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. This provides us with an expected cash runway at least into 2028.

With that, I will turn the call back over to Ameet. Ameet?

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?

Operator

[Operator Instructions] Your first question comes from Eric Schmidt with Cantor.

질의응답

Eric Schmidt

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?

Ameet Mallik

Yes, great question. So first of all, all the discussions with the FDA were related only to the trial. All their comments were specific to the combination of ZYNLONTA plus rituximab on the trial. So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market. We'll 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 LOTIS-5 or through another study.

Eric Schmidt

And then on LOTIS-7 and your characterization of the most recent efficacy data that you guys have seen is 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'll present? And is it consistent with that statement?

Ameet Mallik

Yes. 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. We 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.

Eric Schmidt

And 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?

Ameet Mallik

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 III design because we know that this data is so compelling that there could be significant upside for the asset by potentially pursuing a Phase III trial. So it's something we've been thinking about for a long time. The team has already been preparing on different design options, and we do plan to file for breakthrough designation this year and to discuss with the FDA potential designs.

Operator

Your next question comes from Michael Schmidt with Guggenheim Securities.

Unknown Analyst

This is Sarah on for Michael. Just wanted to follow on quickly on the Phase III plans, whether you could give any color on sort of time line for that now that it appears to be sort of more of the future-looking focus. And then additionally, I had a sort of a question on the LOTIS-5 data. 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.

Ameet Mallik

So first of all, I just want to emphasize we have a positive study for LOTIS-5. So 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 FDA concern. So we are doing that.

In parallel, given that we have, we think, potentially practice-changing data on hand with the LOTIS-7, we're also in parallel going to file for breakthrough designation and explore a Phase III 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 talk with the FDA on the final design to talk about timing and costs. But I just want to reemphasize that those 2 things are going in parallel.

And then with regards to the 105-day safety window in terms of capturing AEs post the last dose, that's the same, by the way, in LOTIS-7 as well. And 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 the prophylactic measures taken. So in LOTIS-7, consistent with a lot of the other -- with the other glofitamab trials that have been run, 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're capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis in the protocol between 5 and 7.

Operator

Your next question comes from Maury Raycroft with Jefferies LLC.

Unknown Analyst

This is James on for Maury. 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 in LOTIS-7? Did other infections occur that aren't addressed by those vaccines? And I have a follow-up after that.

Ameet Mallik

Yes. So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Unknown Analyst

Got it. And how do you think about the potential read-through from LOTIS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the ZYNLONTA glofitamab combination within the academic community? Could LOTIS-5 impact the NCCN language? And could there be any safety monitoring requirements?

Ameet Mallik

Yes. I don't think there will be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, 2 different regimens. As I mentioned, the protocol is different, which we think can help to contribute to some of the safety differences. 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. 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.

Operator

We now have a question from Leonid Timashev with RBC Capital Markets.

Unknown Analyst

Josh on for Leo here. I was wondering whether or not the FDA in their feedback in response to the Phase III, 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?

Ameet Mallik

Yes. And I think typical in what you have in the pre-sBLA meeting, we share the data results and you're aligning on the package for an sBLA submission. During that, as it is typical with any other pre-sBLA meeting, they share concerns that they have with the data. And so right now, we're basically going through the feedback and assessing whether additional data risk management options or modification to the potential label can help to address those FDA concerns. And that's the basis of which we're evaluating our path forward for LOTIS-5.

Operator

[Operator Instructions] Your next question comes from Rob Burns with H.C. Wainwright.

Unknown Analyst

This is Ahmed on for Rob. I was just wondering if you saw Q2 product revenue increase versus Q2 '25. And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-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?

Ameet Mallik

Yes. So with regard to sales, we haven't seen any impact. If you look at the volume in Q2, very consistent with prior quarters. So -- and we don't think that there will be. If you look overall over the past several quarters, the commercial performance of the monotherapy in the third-line plus setting has been relatively consistent. And that's because ZYNLONTA has an established place in the 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.

Unknown Analyst

No problem. I was wondering if...

Ameet Mallik

Oh, just about patients 75 or older, right?

Unknown Analyst

Yes.

Ameet Mallik

Yes. 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. And that's also why the protocol, again, I want to stress the LOTIS-7 versus LOTIS-5 are quite different. So I think each study is on its own. I don't think that there's a read-through from this. We certainly learned a lot from LOTIS-5, and we're happy with the differences in the protocol, of course, that we're seeing in LOTIS-7. So we don't see any read-through from LOTIS-5 to either the current indication or other potential combinations.

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.

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

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

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