Q1 2025 ADC Therapeutics SA Earnings Call
Good morning, ladies and gentlemen.
Unknown Executive: Good morning ladies and gentlemen, and welcome to the to ADC Therapeutics first quarter 2025. At this time, all lines are in ALS and only...
Speaker Change: So a D C therapeutics first quarter 2025 earnings call.
At this time all lines are in a listen only mode.
Unknown Executive: Following the presentation, we will conduct a question and answer session. If anyone has any difficulties hearing the conference, please press star zero for operator assistance at any time.
Speaker Change: During the presentation, we will conduct a question and answer session.
Speaker Change: If anyone has any difficulties hearing the conference. Please press star zero for operator assistance at any time.
Marcy Graham: I would now like to turn the conference call over to Marcy Graham. Investor Relations and Corporate Affairs Officer. Please go ahead. Thank you, operator.
Speaker Change: I would now like to turn the conference call over to Marcia Graham Investor Relations and Corporate Affairs Officer. Please go ahead.
Speaker Change: Thank you operator.
Marcy Graham: Today we issued a press release announcing our first quarter 2025 financial results in business. This release and the slides we will use in today's presentation are available on the investor section of the ADC Therapeutics.
Speaker Change: Today, we issued a press release announcing our first quarter 2025 financial results and business update.
Speaker Change: This release and the slides we will use in today's presentation are available on the investors section of the ADC Therapeutics website.
Ameet Mallik: I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance in recent business.
Speaker Change: I'm joined on today's call are Chief Executive Officer, and eats Alex who will discuss our operational performance and recent business highlights our chief Medical officer, and the Hunter jockey, who will discuss our clinical programs in our states followed by our Chief financial Officer of Pet They come out as they will review our first quarter 2025 financial results. We will then open the call for questions.
Ameet Mallik: Chief Medical Officer Mohamed Zaki who will discuss our clinical programs and updates followed by our Chief Financial Officer Pepe Carmona who will review our first quarter 2025 financial We will then open the call. 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 achievement 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-Q.
Speaker Change: 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.
Speaker Change: 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 forms 10-K, 10-Q and 8-K.
Ameet Mallik: 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. Results of new information, future events, or circumstances except is required by law. The company cautions investors not to place undue reliance on these forward-looking statements.
Speaker Change: 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.
Speaker Change: The 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.
Speaker Change: 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.
Ameet Mallik: 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.
Ameet Mallik: You should refer to the company's first quarter earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.
Speaker Change: You should refer to the company's first quarter earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.
Ameet Mallik: I will now turn the call over to our CEO, Ameet Mallik. Thanks, Marcy. And hello, everyone. Thank you for joining us on today's call. The first quarter of 2025 represented a solid period of continued performance for our company. Throughout the quarter, we continue to focus on execution and delivering on our commercial strategy, maintaining our place as a treatment option for third-line plus DLV-CLPs. Total first quarter revenues were $23 million, which included net product revenues of $17.4 million. This is in line with the first quarter sales in 2024 and compares favorably to $16.4 million in the fourth quarter of 2024.
I will now turn the call over to our CEO and even though they can eat.
Speaker Change: Thanks, Marci and Hello, everyone. Thank you for joining us on today's call. The first quarter of 2025 represented a solid period of continued performance for our company.
Speaker Change: 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 D. L. P C. All patients.
Speaker Change: Total first quarter revenues were $23 million, which included net product revenues of $17 $4 million.
Speaker Change: This is in line with the first quarter sales in 2024 and compares favorably to 16 $44 million in the fourth quarter of 2024.
Speaker Change: We had an additional $5 $6 million of milestone and royalty payments included in total revenue for the quarter.
Ameet Mallik: We had an additional $5.6 million in Milestone and Royalty Payments. Included in total revenue for the quarter.
Ameet Mallik: Additionally, as just announced this morning, we are pleased to have data from LOTUS-7 accepted for presentation at EHA, the European Hematology Association Congress, and at ICML, the International Conference on Malignant Lymphoma, both in June. We are encouraged by the promising LOTUS 7 EHA abstract data demonstrating the potential for Zmanta plus glifidimab to be a best-in-class combination in a highly competitive market. For reference, we have seen complete response rates in other bi-specific combination trials in the range of 47% to 62%. Abstract data as of January 2025 shows Xenlanta plus Clofidimab demonstrated an overall response rate of 95.5% and a complete response rate of 90.9% in the 22 efficacy-evaluable patients, with further updated data to be presented at the meeting next month.
Speaker Change: Additionally, as just announced this morning, we are pleased to have data from Lotus seven accepted for presentation at the European Hematology Association Congress and that I see M. L. The International conference on malignant lymphoma, both in June.
Speaker Change: We are encouraged by the promising low to seven E. H, a abstract data demonstrating the potential for us in Lotto plus quote fit them out to be a best in class combination in a highly competitive market.
Speaker Change: For reference we have seen complete response rates and other bispecific combination trials in the range of 47% to 62%.
Speaker Change: Abstract data as of January 2025 shows then locked up plus profit amount of demonstrated an overall response rate of 95, 5% and a complete response rate of 99% in the 'twenty two efficacy evaluable patients with further updated data to be presented at the meeting next month we.
Ameet Mallik: We have recent enrollment of 40 patients in our Lotus 7 dose expansion arm and expect to share an additional update on Lotus 7 in the second half of 2025. We are encouraged by the results we've reported so far and are assessing options for expanding enrollment to 100 patients at the recommended dose level, which will support regulatory discussions and is in line with recent examples of bi-specific combination therapies. Once sufficient data with longer follow-ups is available, we plan to discuss the path forward for Zinlanta and Glifidimab with regulatory authorities and to pursue a compendia strategy. Lotus 5 remains on track to reach the pre-specified number of progression-free survival events by the end of 2025.
Speaker Change: Recent rollout of 40 patients and our Lotus seven dose expansion arm and expect to share an additional update I'll go to seven in the second half of 2025.
Speaker Change: We are encouraged by the results we've reported so far and are assessing options for expanding enrollment to 100 patients at the recommended dose level, which will support regulatory discussions and is in line with recent examples of bi specific combination therapies to compare idea once sufficient data with longer follow up is available we plan to discuss that.
Speaker Change: Forward for us and lots of Anglo fit about with regulatory authorities and to pursue a compared to your strategy.
Speaker Change: Lotus five remains on track to reach the pre specified number of progression free survival in that.
Speaker Change: By the end of 2025 after the pre specified number of PFS events is reached and data are available. We expect to provide top line data on the phase III confirmatory trial evaluating <unk> in combination with Britt talks about in patients with second line plus CRP C L.
Ameet Mallik: After the pre-specified number of PFS events is reached and data are available, we expect to provide top-line data on this phase 3 confirmatory trial evaluating Stenlanta in combination with Vertoximab in patients with second-line plastic LBCL.
Speaker Change: Lastly, updated data from the phase II <unk> in marginal zone lymphoma.
Ameet Mallik: Lastly, updated data from the Phase II IIT in Marginal Zone Lymphoma being led by the Sylvester Comprehensive Cancer Center at University of Miami will also be presented at ICML.
Speaker Change: Led by the Sylvester comprehensive cancer Center at University of Miami.
Speaker Change: Also be presented at ICM out.
Ameet Mallik: Moving beyond ZMANTA, the trial sponsored by the University of Texas MD Anderson Cancer Center evaluating ADCT602, which targets CD22, and patients with relapsed or refractory B-cell acute lymphoblastic leukemia is being discontinued based on available clinical data. I would like to thank the physicians and patients who participated in this trial. We were pleased to have data from preclinical studies of our Exotequin-based ADCs targeting Claudin-6, PSMA, and ASCT2 featured at the American Association for Cancer Research annual meeting last month. Here the most advanced targets are PSMA and Clotin 6, and we continue to seek potential research collaboration.
Moving beyond the Atlanta, the trial sponsored by the University of Texas, MD Anderson Cancer Center.
Speaker Change: Evaluating ADC T 602, which targets <unk> 22.
Patients with relapsed or refractory b cell acute lymphoblastic leukemia is being discontinued based on available clinical data.
Speaker Change: I would like to thank the physicians and patients who participated in this trial.
Speaker Change: We were pleased to have data from preclinical studies of our <unk> based adcs targeting cloud and six P. SMA and a S. E. T. Two featured at the American Association for Cancer Research annual meeting last month.
Speaker Change: He is the most advanced targets or PSM, and quad and fixed and we continue to seek potential research collaborations to further advance our programs.
Ameet Mallik: further advance our program.
Ameet Mallik: I'm excited about the multiple upcoming catalysts ahead within our cash runway, which is expected to fund operations into the second half of 2020. As a single agent therapy in 3rd Life Plus DLVCL, SINLATA has a profile of rapid, deep, and durable efficacy, as well as manageable safety with simple and convenient administration. Beyond our current indication, we believe in the potential to reach significantly more patients while growing the commercial opportunity by expanding use into earlier lines of therapy in DLBCL and into indolent lymphoma. The data we've seen across these settings so far has been consistently encouraging with the potential to be highly differentiated.
Speaker Change: I'm excited about the multiple upcoming catalysts ahead within our cash runway, which is expected to fund operations into the second half of 2026.
Speaker Change: As a single agent therapy in third line <unk>.
Speaker Change: Lots of has a profile of rapid deep and durable efficacy as well as manageable safety with simple and convenient administration.
Speaker Change: Beyond our current indication we believe in the potential to reach significantly more patients while growing the commercial opportunity by expanding us into earlier lines of therapy in <unk> and into indolent lymphomas.
Speaker Change: The data we've seen across the setting so far has been consistently encouraging with the potential to be highly differentiating.
Ameet Mallik: We know physicians make treatment choices based on efficacy, safety, and accessibility in the context of individual patient. We believe efficacy is the primary driver of decision-making for treatments that are accessible and suitable for a given DLBCL patient. Zalanta Plus Rituximab in LOTUS-5 and Zalanta Plus Glofidimab in LOTUS-7 offer distinct approaches to addressing unmet needs and patients with DLB-CF. In LOTUS-5, we believe the combination of Zinlanta plus Rituximab may offer a competitive second line plus efficacy with a favorable safety and convenient dosing schedule. for patients who cannot access, are not suitable for, or progress on a CAR-T or bi-specific based therapy.
Speaker Change: We know physicians make treatment choices based on efficacy safety and accessibility in the context of individual patient needs.
Speaker Change: We believe the efficacy is the primary driver of decision, making for treatments that are accessible unsuitable for a given deal bcl patients.
Speaker Change: The Atlanta, plus Rituximab in Lotus five ensign lots of plus <unk> and Lotus seven offer distinct approaches to addressing unmet needs in patients with <unk>.
Speaker Change: And Lotus five we believe the combination of <unk> plus Rituximab may offer a competitive second line plus efficacy with a favorable safety and convenient dosing schedule for.
Speaker Change: For patients who cannot access are not suitable for our progress on our car T or by specific base therapy.
Ameet Mallik: With LODIS-7, based upon the recent data we shared, we believe Xenlanta plus clofidamide has the potential to be the preferred bispecific combination in second-line plus DLBCL with highly competitive efficacy and a manageable safety profile.
Speaker Change: With Lotus seven based upon a recent data we shared we believes in lots of plus <unk> has the potential to be the preferred by specific combination.
Speaker Change: Second line, plus the bcl with highly competitive efficacy and a manageable safety profile.
Speaker Change: With sufficient data from these trials, we plan to pursue regulatory and competitive strategies.
Ameet Mallik: With sufficient data from these trials, we plan to pursue regulatory and compendious strategies.
Mohamed Zaki: Now I will turn the call over to our Chief Medical Officer, Mohamed Zaki, to provide an overview of the LOTUS 7 abstract data accepted for presentation at EHA and ICML next month. Mohamed? Thank you, Ameet. We are excited today to report updated results from the LUTUS-7 study evaluating a six-duration combination of zirconia and glufidumab in patients with relapsed refractive DL-BCL. The primary endpoint is safety and durability, with the secondary endpoint of efficacy, decay, and immunity. As we discussed, Dose escalation was completed last year with early signs of anti-tumor activity and no DLTs were observed. We are well into those expansions, having enrolled 40 patients with this combination.
Speaker Change: Now I will turn the call over to our Chief Medical Officer Mohamed Zaki.
Mohamed Zaki: An overview of the Lotus seven abstract data accepted for presentation at <unk> and <unk> next mob Mohamad.
Speaker Change: Thank you Amit.
Speaker Change: We are excited today to report updated results from the <unk> seven study evaluating ethics duration complication.
Speaker Change: And it looks at the map in patients with relapsed refractory <unk>.
Speaker Change: The primary endpoint is safety and Tolerability with secondary endpoints of efficacy PK and Immunogenicity.
Speaker Change: As we discussed.
Speaker Change: Those escalation was completed last year with early signs of antitumor activity and no DLT is were observed.
Speaker Change: We are well into those expansion havent enrolled 40 patients with this combination.
Mohamed Zaki: At either the 120 or 150 micrograms per tick, those levels of Zeta Delta combined with the approved dose of Glufeta. As we turn to the data, we are surely encouraged by the results thus far for this study. As summarized here, the baseline characteristics of the patients enrolled, including being refractive to prior therapy, as well as number and types of prior therapy, are similar to those we have seen in other bi-specific combination trials. Turning to safety, no new safety signals were observed. And the combination was well-prepared. Toxicity observed during the study were manageable and were consistent with the known safety profile of each of the two agents.
Speaker Change: Either the 120 or 150 microgram per kg dose levels.
Speaker Change: Buying with the approved dose.
Speaker Change: As we turn to the data we are surely encouraged by the results thus far.
Speaker Change: This study.
Speaker Change: As summarized here the baseline.
Speaker Change: Okay.
Speaker Change: The patients enrolled including being refractory to prior therapy as well as lumber Titusville prior therapy.
Speaker Change: Are similar to those we have seen in other bi specific trials.
Speaker Change: Turning to safety no new safety signals were observed.
Speaker Change: And the combination was well tolerated.
Speaker Change: <unk> observed during the study were manageable and we're consistent with the known safety profile of each of the two agents.
Mohamed Zaki: Only low-grade adverse events of CRS and sick kittens were observed. Turning to the efficacy results, a 95.5% overall response rate was seen in the 22 patients who were evaluable for with 20 patients or 90.9% achieving a complete response based on Lugano criteria. All but one of those patients remain in complete response as of the data. We believe the LUT7 results so far are exceptional. compared to current and emerging therapies in the second line plus DLPCL. The impressive efficacy and manageable safety profile seen to date in this trial, with the combination of Zenlanta and Glifedema, two potent anti-cancer agents with unique mechanism of action, is encouraging.
Speaker Change: Only low grade adverse events of Crs.
Speaker Change: Were observed.
Speaker Change: Turning to the ethics of theaters, all 95, 5% overall response rate was in the 22 patients who were evaluable for efficacy.
Speaker Change: With 20 patients or 99% achieving a complete response builds on Nevada criteria.
Speaker Change: All but one of those patients remained in complete response as of the data cutoff.
Speaker Change: We believe the loser seven results. So far are exceptional compare to current and emerging therapies in the second line plus the LPC out.
Speaker Change: The impressive efficacy and manageable safety profile seen to date in this trial with the commodity cycles and longtime and Peter Matt So potent anti cancer agents with unique mechanism of action.
Speaker Change: Is encourage the data reinforce our belief in the potential for the resilient to change the treatment paradigm for patients with aggressive lymphoma.
Mohamed Zaki: The data reinforces our belief in the potential for the regimen to change the treatment paradigm for patients with aggressive lymphoma. Though we are limited in what we can speak to until the EHA embargo lifts.
Speaker Change: Though we are limited in what we can speak to until the embargo lifts.
Mohamed Zaki: We look forward to providing a more comprehensive look at results from our GLUTUS-7 trial in June when updated data are shared during a post-hack presentation at EHA and a subsequent oral presentation at ICML. We expect to host a corporate webcast to further discuss the data shared at that.
Speaker Change: We look forward to providing a more comprehensive look at results for our <unk> trial in June with updated data our share.
Speaker Change: The presentation at <unk>, eight and subsequent order per cent.
Speaker Change: ICM out.
Speaker Change: We expect to host a corporate webcast to further discuss the death of shared at that time.
Speaker Change: Now I will turn the call over to Pepe Carmona, our CFO, who will discuss financial results for the first quarter.
Pepe Carmona: Now I will turn the poll over to Pepe Carbano, our CFO, who will discuss financial results for the first quarter. Thank you, Mohamed. On the financial front, the long-term net product revenues in the first quarter of 2025 were $17.4 million, as compared to $17.8 million in the same quarter of 2020. Total revenues for the first quarter was $23 million, which includes the recognition of $5 million in licensing revenue related to a milestone in view, New Ponson Lanta's approval by. The payment of the milestone was received in the second quarter and not yet reflected in our cash and cash equivalents.
Speaker Change: Thank you Mohammad.
Speaker Change: On the financial front similar to net product revenues in the first quarter of 2025 were $17 4 million as compared to $17 8 million in the same quarter of 2024.
Speaker Change: Total revenues for the first quarter was $23 million, which includes the recognition of $5 million in licensing revenue related to a milestone view your pumps and lumpiness approval by health Canada.
Speaker Change: Yes.
Speaker Change: The payment of the milestone was received in the second quarter and not yet reflected in our cash and cash equivalents balance at March 31 2025.
Pepe Carmona: March 33 Total operating expenses for the quarter were $49.1 million on a non-GAAP basis. Representing a 5% net decrease over prior year, driven primarily by a reduction in... On a gap basis, we reported a net loss of $38.6 million for the first quarter of 2025, or $0.36 per basic and diluted share. As compared to a net loss of $46.6 million, or $0.56 per basic and diluted share, for the same period in 2020. The decreasing net loss of the quarter is primarily attributable to higher license revenues and royalties, as well as lower.
Speaker Change: Total operating expenses for the quarter were $49 1 million on a non-GAAP basis, representing a 5% net decrease over prior year, driven primarily by a reduction in SG&A.
Speaker Change: On a GAAP basis, we reported a net loss of $38 6 million for the first quarter of 2025 or.
Speaker Change: Six cents per basic and diluted share.
Speaker Change: As compared to a net loss of $46 6 million or <unk> 56 per basic and diluted share for the same period in 2024.
Speaker Change: The decrease in net loss for the quarter is primarily attributable to higher license revenues and royalties as well as lower expenses.
Speaker Change: You can find the reconciliation of GAAP to non-GAAP measures in the companion financial tables of the press release issued earlier today and in the appendix of this presentation.
Pepe Carmona: You can find the reconciliation of GAAP to non-GAAP measures in the companion financial tables of the press release issued earlier today and in the appendix of this webinar. of March 31st, 2025. Cash and cash equivalents were $194.7 million compared to $250.9 million on December 31st, 2021. This change was primarily driven by our net loss from operations for the quarter and was impacted by the timing of cash receipts and payments, including payment of the annual discarded drugs rebate, annual bonuses, and phasing of milestones and other partner reimbursements received in the second quarter of 2020.
Speaker Change: As of March 31, 2025.
Speaker Change: Cash and cash equivalents were $194 7 million compared to $259 million at December 31, 2024.
Speaker Change: This change was primarily driven by our net loss from operations for the quarter and was impacted by the timing of cash receipts and payments, including payment of the annual discomfort drug rebate annual bonuses in facie of milestones. Another partner reimbursements received in second quarter of 2020.
Speaker Change: All right.
Pepe Carmona: As we have highlighted today, we made significant progress in the first. In 2025, we have several potentially big risks using Long-Term Data Catalysts, which we believe will unlock significant growth. In this quarter alone, we have key value driving models at the upcoming medical meeting. This includes providing an update on LOTUS 7 at the upcoming EHA conference with an NCORP oral presentation at ICPSR. We expect to host a corporate webcast to further discuss the data shared. We also expect to have updated data from the MZL Phase 2 investigator-initiated trial to be shared by Dr. Losos from University of Miami at Iowa.
Speaker Change: As we have highlighted today, we've made significant progress in the first quarter.
Speaker Change: In 2025, we have several potentially been risking as in loan Tech data catalyst, which we believe will unlock significant growth opportunities.
Speaker Change: In this quarter alone, we have key value driving milestones at the upcoming medical meetings.
Speaker Change: This includes providing an update on <unk> seven.
Speaker Change: Upcoming EHS.
Speaker Change: Contrast, with an oral presentation of CML.
Speaker Change: We expect to host a corporate webcast to discuss the data shared at that time.
Speaker Change: We also expect to have updated data from the Mcl phase II investigator initiate the trial to be shared by both the losses from the University of Miami at ICL.
Speaker Change: As we move forward. We also expect to present data on the 40 basis and roll for our love of seven trial in the second half of this year.
Pepe Carmona: As we move forward, we also expect to present data on the 40 patients enrolled for our LODOS-7 trial in the second half of the year. Beyond this, we'll provide top-line results from RADOS5 once the pre-specified number of PFS events is reached and data available. We continue to progress our preclinical assets as shared at AACR and are engaged in discussions with potential partners. with Unexpected Cash Runway into the second half of 2020. I'm confident that ADC Therapeutics is well-positioned to deliver on our catalysts and drive value creation for all our.
Speaker Change: Beyond this.
Speaker Change: We'll provide topline results from others, 5% once the press specified number of PFS events.
Speaker Change: <unk> data are available.
Speaker Change: We continue to progress our preclinical assets are shared at ACR and are engaged in discussions with potential partners.
Speaker Change: We're going to expected cash runway into the second half of 2026, I am confident that ADC therapeutics is well positioned to deliver on our catalyst and drive value creation for all our stakeholders.
Unknown Executive: I will now turn the call back over to.
Amit: I will now turn the call back over to Amit.
Ameet Mallik: 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 trial. We believe our revenue growth opportunity comes with expanded use of ZMLANTA 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.
Speaker Change: Thank you Pat base I am pleased with how we are executing against our strategy and continue to be encouraged by the consistently promising and lots of data we are generating across our ongoing trials.
Speaker Change: We believe our revenue growth opportunity comes with expanded use of the Atlanta, two regulatory approvals as well as inclusion in guidelines and we are confident in the multiple pathways, we have to achieve our peak revenue goal.
Unknown Executive: We can now open the line for questions, operator. 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 and a touch. Should you wish to cancel your request, please press the star followed by the number. If you're using a speakerphone, please lift a handset before pressing. Once again, that is Thor Wundt, should you wish to ask a question.
Speaker Change: We can now open the line for questions operator.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have any question. Please press the star followed by the one on your Touchtone phone should you wish to cancel your request. Please press the star followed by the two.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any case.
Speaker Change: Once again that is star one should you wish to ask a question.
Speaker Change: Your first question is from Kelly <unk> from Jefferies. Your line is now open.
Kelly Shea: Your first question is from Kelly Shea from Jefferies. Your line is now open. Good morning, thanks for taking my questions.
Speaker Change: Hi, good morning, Thanks for taking my questions. So first for Kelly could you. Please provide some color on the follow up time for the patients from the update today and also for the 18 patients who achieved a complete response last year.
Kelly Shea: This is Dr. Kelly, could you please provide some color on the follow up time for the patients from the update today and also for the 18 patients who achieved a complete response last year? Any color and see our conversion times and durability will be great. Thank you. Okay, thanks for the question. So you're asking about the follow-up time that of the data that we showed in December as well as what the follow-up time is now with this latest update and any color on the conversion.
Speaker Change: And see our conversion time, so as you remember there will be great. Thank you.
Speaker Change: Okay. Thanks for the questions you've.
Speaker Change: Asking about the follow up time of the data that we showed in December as well as what the follow up time is now with this latest update any color on the conversion so I'll turn that over to Amit to answer that question.
Mohamed Zaki: So I'll turn that over to Mohamed to answer those questions. Yeah, the patients that we're following up right now is according to the Lugano criteria when we actually have been assessment for patients based on 6 and 12 weeks and on and on. We keep looking into more assessment to be able to talk more into the durability of responses as we go forward. However, the high number of CR that we're seeing right now is very encouraging. It's actually considered a very strong biomarker for durability. So it's really too early to speak about durability or the degree of follow-up at this stage.
Speaker Change: Yeah.
Speaker Change: Patients that were following operate now according to that no matter a great deal and we have seen that.
Speaker Change: The assessments for validation phase six and 12 weeks all of us.
Speaker Change: We can look into.
Speaker Change: No.
Speaker Change: More assessments being able to book more.
Speaker Change: <unk> of response is as we go forward however.
Speaker Change: Number of CR, we're seeing.
Speaker Change: Eddie.
Speaker Change: That's actually.
Speaker Change: Very strong.
Speaker Change: So it's really.
Speaker Change: Too early to speak about the ability or the degree of follow up at this stage.
Mohamed Zaki: If you recall, in the swimmers plot that we showed in December, the longest patient was nearly a year, so close to a year. And obviously this analysis is a couple months later. So you can just sort of interpolate that.
Speaker Change: Yes, but if you recall in the swimmers plot that we showed in December.
Speaker Change: Longest patient with nearly a year.
Speaker Change: So close to a year and obviously this analysis is a couple of months later.
Speaker Change: So you can just sort of interpolate that more.
Kelly Shea: But more data on the follow up and smooth response will be coming at the presentation at EHA. Thank you. Appreciate it.
Speaker Change: More data on the follow up is what will be coming at the presentation DHA.
Speaker Change: Thank you I appreciate it and a follow up if I may so on the container strategy, you mentioned or you plan to engage with regulatory authorities.
Kelly Shea: And a follow-up, if I may. So on the companion strategy, you mentioned that you plan to engage with regulatory authorities. Is it when you have data from 40 patients that are already enrolled, or would you wait for 100 patients? Yeah, we believe if you look at all the recent bi-specific accommodation examples, many were added to guidelines earlier this year as a preferred regimen. We believe we're going to need a publication including the approximately 100 patients with about a year of follow-up, just based on all the other recent examples. And we're currently assessing how to best move that forward.
Speaker Change: Is it when you have data from 40 patients that are already enrolled or would you wait for 100 patients.
Speaker Change: Yes, we believe.
Speaker Change: If you look at all the recent prices.
Speaker Change: Example, many were added to guidelines earlier this year as a preferred regimen.
Speaker Change: We believe we're going to need a publication, including the approximately 100 patients with about a year of follow up.
Speaker Change: Just based on all the other recent examples and were.
Speaker Change: Currently assessing.
Speaker Change: Very helpful. Thank you.
Kelly Shea: Very helpful. Thank you.
Thank you.
Speaker Change: Thank you <unk>.
Eric Schmidt: Your next question is from Eric Schmidt from Cantor. Your line is now open. Thanks for taking my questions and congrats on a really nice update in terms of how these results are trending.
Speaker Change: Next question is from Eric Schmidt from Cantor. Your line is now open.
Eric Schmidt: Thanks for taking my questions and congrats on a well.
Speaker Change: Really nice update in terms of how these results are trending maybe just first how many more patients should we expect to see at the conference itself.
Eric Schmidt: Maybe just first, how many more patients should we expect to see at the conference itself, We haven't disclosed how many more, but obviously we've already indicated in this release that we have enrolled the 40 patients that we had discussed that we wanted to enroll already, so there will obviously be more patients than the 22. We can't disclose the exact number because anything beyond what's in the abstract isn't barcoded, so we don't want to risk that. I think, Ameet, in the past, you've said maybe 10 to 15 additional patients by the time of the EHA update relative to the December update last year.
Speaker Change: Yes, we haven't disclosed how many more I would say we've already indicated in this release that.
Speaker Change: We have enrolled up to 40 basis that we had.
Speaker Change: As Scott said, we want to enroll are already so well I'll save even more patients in the 2010, we can't disclose the exact number because.
Speaker Change: All of the house.
Speaker Change: Beyond what's in the abstract has embarked on a risk.
Speaker Change: I think I made in the past you've said, maybe 10 to 15 additional patients by the time of the update relative to the December update last year is that still kind of ballparkish.
Ameet Mallik: Is that still kind of ballpark-y? Yeah, I'd say it's ballpark-y versus the December update, yeah.
Speaker Change: Yeah, I think ballpark versus December update.
Speaker Change: Okay.
Ameet Mallik: And how are you thinking about the overall profile of the combination today? I mean, again, relative to the last update, you've got potentially one of the highest ever response rates and complete response rates we've seen, including in CAR-T. Is it time to start thinking about this maybe as a more efficacious but equally safe combination?
Speaker Change: And how are you thinking about the.
Speaker Change: Overall profile of the combination today, I mean again relative to the last update you've got.
Speaker Change: Potentially what are the highest ever response rates and complete response rates, we've seen including in car T is it is it time to start thinking about this maybe as a more efficacious, but equally safe combination as anything out there or do you still think that.
Ameet Mallik: Is anything out there? Do you still think that safety might turn out to be training somewhat better than other combinations as well. Yeah, so it's a great question. I mean, obviously, from an efficacy standpoint, we think the data is, you know, very, very encouraging right now. If you look at all the other bi-specific combination trial data that's been out there, and everything from Phase I data to Phase III data, the CR rates have been anywhere from 47 to 62% of the best ever reported. And as you're aware, CAR-Ts are in the kind of mid-60s to low-70s range in terms of CR rate.
Speaker Change: Safety might turn out to be.
Trading somewhat better than other combinations as well.
Speaker Change: Yes.
Speaker Change: Question, I mean, obviously from an efficacy standpoint.
Speaker Change: We think the data is.
Speaker Change: Very very encouraging right now.
Speaker Change: If you look at all the other Bispecific combination trial data that's been out there everything from phase one data to phase III data.
Speaker Change: Our rates have been anywhere from 47% to 62% was the best ever reported and as Youre aware car Ts are in the kind of mid <unk> to low seventy's range in terms of CRE.
Ameet Mallik: So, Anything over 70% we think would be extremely differentiating from an efficacy standpoint. I think from a safety standpoint, as you can see in this data, we continue to see only low-grade CRS and ICANNs, a manageable safety profile overall, low discontinuation. We've disclosed in the past with this regimen. And I think more importantly than even those things is it's also the novel mechanism. If you look at a lot of the other bispecific combinations, they're either combining with chemo, which has some irreversible toxicities like neuropathy, or combining with polituzumab, which has really become a mainstay frontline.
Speaker Change: So if.
Speaker Change: If anything over 70%, we think we'd be extremely differentiating from an efficacy standpoint, I think from a safety standpoint.
Speaker Change: As you can see in this data we continue to see only.
Speaker Change: Only low grade Crs, one again, a manageable safety profile overall.
Speaker Change: Low discontinuation.
Speaker Change: As in the past with this regimen.
Speaker Change: More importantly than than than even those things as well.
Speaker Change: It is also with a novel mechanism. If you look at a lot of the other bispecific combinations, there either combining chemo, which hasn't irreversible toxicities of neuropathy or combining with <unk>, which has really become a mainstay of short lines and some physicians are reluctant to retreat with policies.
Ameet Mallik: And some physicians are reluctant to retreat with polituzumab in subsequent lines. And so the fact that we're a unique agent combining with a highly potent bispecific lipofitamab, I think makes us a great combination partner.
Speaker Change: Subsequent lines and so the fact that we're a unique agent combining with a highly potent specific like will said about I think makes us a great combination partner.
Speaker Change: Alright, Thank you very much.
Ameet Mallik: Great. Thank you very much. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question is from Michael Schmidt from Guggenheim Securities. Your line is now open.
Michael Schmidt: Your next question is from Michael Schmidt from Guggenheim Securities. Your line is now open. Good morning, guys.
Speaker Change: Hey, Good morning, guys. This is <unk> on for Michael Congrats on the data Ihan. Thanks for taking our questions. So in regards to Louis five I guess with the guidance of reaching PFS events by the end of 2025.
Michael Schmidt: This is Rosie on for Michael. Congrats on the data. So, in regards to Lotus 5, I guess with the guidance of reaching PFS events by the end of 2025. Still expect that top line data to be a 2020 event, or is that going to be pushed to an early 2020 event? Data Readout, and I guess along the lines of that, how much data can we expect from that top line? And I guess, like, in terms of data itself, what does the combination need to show in order to be competitive? I know the trial is randomized against our GenMocs, but I was curious on how you're thinking about potential benchmarking against CAR-T regimens or StarGlow.
Speaker Change: Do you still expect that top line data to be at one time event or is that going to be touched silicon early 2026 data read out.
Speaker Change: And I guess, along the lines of that how much data can we expect from that top line and I guess like in terms of data itself. What does the combination needs to show in order to be competitive.
Speaker Change: Trials randomized against Orange IMAX, but.
I'm curious on how youre thinking about potential benchmarking against car T regimens are start low.
Speaker Change: Yes, so in terms of the timing.
Ameet Mallik: Yeah, so in terms of the timing, you know, we've always indicated this is a PFS-driven event trial, and so we have to hit the pre-specified number of PFS events before we can then cleanse the data, you know, assess it, and then show the top-line results. We still expect that those events to happen this year, but the data readout could happen end of this year or early next year, as we've been indicating up to this point. We just wanted to make it clear that, because it's PFS-driven, we can't control it, and it does take, as you know, probably two to three months to cleanse the data, do all the quality control, and so that could happen end of this year or early next year, so that's still the similar timing to what we disclosed in the past.
Speaker Change: Always indicated this is a PFS driven.
Speaker Change: Trial, and so we have to hit the pre specified number of PFS events before we get paid claims data.
Speaker Change: Got it and then and then show the topline results, we still expect that those events to happen this year, but the data readout could happen end of this year or early next year as we've been indicating at this point.
Speaker Change: Wanted to make it clear that because that's driven if we can't control it and it does take as you know probably two to three months declines of data all the quality control and so that could happen late this year early next year. So that's still visit similar timing to what we disclosed in the past you want to talk.
Ameet Mallik: Do you want to talk, Mohamed, about... Are there any other questions? I appreciate it.
Speaker Change: Uh huh.
Speaker Change: These are all the questions.
Speaker Change: Okay appreciate that.
Mohamed Zaki: What do you need to achieve in order to be this? Well, typically, we have shown already in the safety run of 20 patients, a 50% complete response and 80% overall response rate. and a BFS of 8.3 months. The trial design, actually, would be suggested that the trial be successful if we are actually two months stronger, four to six months. The control arm reads at four every six months. That's the hypothesis of the trial, how it's designed and how it's powered. So we're very encouraged by the early data from the safety run-in, and we'll be sharing the top-line results, the outcome of the BFS of the study, and later on in a conference or publication, we'll be sharing more details on the outcome.
Speaker Change: Let's see.
Speaker Change: Great.
Speaker Change: Well typically we have shown already in the and the safety of our employee patient at 58% of these responses.
Overall response rate.
Speaker Change: It was the trail design actually.
Speaker Change: No.
Speaker Change: The suggested that the trial will be successful if we had actually two months are stronger for the six months the control arm.
Speaker Change: For the six months, that's the hypothesis that's filed house Levine warehouse power. So we're very encouraged by the early data.
Speaker Change: From the <unk>.
Speaker Change: And we'll be sharing the top line results.
Tom: Yes, Tom.
Speaker Change: The PFS.
Tom: Leads are on.
Speaker Change: First of all to Asia will be sharing more details on the outcome study.
Tom: Thank you so much.
Michael Schmidt: Great. Thank you so much. Thank you.
Speaker Change: Thank you. Our next question is from Sudan <unk> Tom.
Sudan Loganathan: Your next question is from Sudan Loganathan from Stevens. Your line is now open. Hi, good morning, Ameet, Mohamed and Pepe. Thank you for the update and glad to see the continued improvement with the Lotus 7 data as it matures.
Stephens: Stephens Your line is now open.
Speaker Change: Hi, Good morning, Amit Marmot and Pepe. Thank you for the update and glad to see the continued improvement with the Lotus seven data as it matures.
Ameet Mallik: My first question is on the progress with like the Lotus 5 and Lotus 7, and when we can expect maybe conversations with regulators to occur, you know, are the communications with regulators necessary since we're kind of going after this compendia listing strategy? And if you did have a meeting with FDA regulators, what can be gained from it for, you know, listing and going forward listing on guidance?
Speaker Change: My first question is on the progress with Lotus five and Lotus <unk> and when we can expect maybe conversations with regulators to occur you know are the communications with regulators necessary for kind of going after this compendium listing strategy and if you did have a meeting with.
Speaker Change: FDA regulators, what can be gained from it for lifting and going forward listen on guidelines.
Mohamed Zaki: Yeah, so I'll start and I'll turn it to Mohamed. So meeting with regulatory agents isn't required to continue to expand at a dose that we decided to select on, but obviously for any regulatory path forward, it is obviously critical. And so, you know, we're assessing different regulatory pathways forward and I know Mohamed and the team plan to meet with regulatory agencies in the second half of this year, but maybe you can comment further on that. Yeah, we'll be, we're planning to meet with the regulators second half of this year to address or discuss the dose, in addition also to a potential path forward for regulatory path.
Speaker Change: Yes, so I'll start that answer it so.
Speaker Change: I mean with regulatory regulatory items isn't required to continue to expand.
Speaker Change: At a dose that we decided despite that but obviously for any regulatory afford it is obviously critical and so.
Speaker Change: We're assessing different regulatory pathways forward and no matter how good.
Speaker Change: The team plans to meet with the regulatory agencies in the second half of this year, but maybe you can comment further.
Speaker Change: We'll be we're planning to meet with getting easier.
Speaker Change: Second half of this year to address or discuss the dose.
Speaker Change: In addition, also to a potential path forward for it.
Speaker Change: Lee.
Mohamed Zaki: Compendia is a different parallel pathway. As Ameet mentioned, that's two different paths, but they're actually going to be going in parallel when we have the right amount of patient, the right amount of follow-up. Great, I appreciate that.
Speaker Change: Yes.
Speaker Change: Pathway.
Speaker Change: You mentioned, that's there's two passes but it actually is going to keep doing it.
Speaker Change: We have the right amount of patient for X amount of follow up.
Speaker Change: Great I appreciate that if I can squeeze in a second question real fast regarding Dr. Data pipeline development I noticed this takes our two program was discontinued does that free up capital to bring one of the exit he can base adcs to IND filing and EBIT may be initiating a phase one with the one big mergers and is there still a goal to potentially out license or partner.
Pepe Carmona: And if I can squeeze in a second question real fast regarding the data pipeline development, you know, I noticed the 602 program was discontinued. Is that free of capital to bring one of the exit TCAN-based ADCs to the IND filing and even maybe initiating a phase one with the one that emerges? And is there still a goal to potentially out-license or partner out one of those preclinical assets that emerges from those developments, you know, maybe later this year, early next year?
Speaker Change: One of those particular classes that emerges from those developments maybe later this year early next year.
Pepe Carmona: Yeah, I'm going to turn this to Pepe to address both the cost piece of 602 as well as where we stand with BD efforts on our research programs. Yeah, thanks for the questions. The 602 program was a program partnered with MD Anderson, with basically the cost implications of that study of eliminating that study. It's very low, it's not part of, it's not a large portion of our capital allocation. The investment that we have right now is mostly associated with Sinaloa and then bringing the research platform to a certain point in which we believe those targets are partnered The progress on the research PDF, which is ongoing, we have done an exhaustive review with different strategic and financial partners, and we'll be providing updates in the near Thank you.
Speaker Change: Yes, Im going to turn this to address both the cost piece of <unk> as well as where we stand with BD efforts on our research.
Speaker Change: Programs.
Speaker Change: Yes, thanks for the questions.
Speaker Change: 602 program.
Speaker Change: Program partner with MD Anderson.
Speaker Change: With.
Speaker Change: Basically.
Speaker Change: The cost.
Implications of that study of eliminating that study.
Speaker Change: Yeah.
Speaker Change: Its very low its not part of it is not a large portion of our capital allocation.
Speaker Change: Investment that we have right now, it's mostly a safe in what's been a long time, and then bringing the research platform to southern point in which we believe.
Speaker Change: Targets are a part of miracle.
Speaker Change: Yeah.
Speaker Change: The progress on did we say.
Speaker Change: Recent BD athletes at some point.
Speaker Change: Then.
Speaker Change: Yeah.
Our next sources review with different strategic and financial partners, and we will be providing updates.
Speaker Change: In the.
Speaker Change: Near term.
Speaker Change: Thank you I appreciate the answers and the details and congrats again on the progress.
Sudan Loganathan: I appreciate the answers and the details and congrats again on the progress. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question is from Gregory Wednesday from RBC capital markets. Your line is now open.
Gregory Renza: Your next question is from Gregory Renza from RBC Capital Markets. Good morning, team. It's Anishan for Greg. Congrats on the progress this quarter and thanks for taking our questions. Just a couple from us.
Niche: Good morning team, it's a niche on for Greg Congrats on the progress this quarter and thanks for taking our questions. Just a couple from US first with Lotus seven being in the spotlight. We just wanted to get a sense on how the data to be presented at <unk>.
Gregory Renza: First, with Lotus 7 being in the spotlight, we just wanted to get a sense on how the data to be presented at EHA and ICML would set the stage for data to come later on for the 40 patients in the dose expansion arm. And secondly, with Lotus 5, what should we be expecting on the parameters to be presented? And even as a safety run-in, are there any key efficacy benchmarks you could point us to? Thanks so much. Okay, so you're really asking about what's coming at EHA and ICML for both the Lotus 7 presentation as well as the Lotus 5 presentation.
Niche: CML, which set the stage for data to come later on for the 40 patients in the dose expansion arm and secondly, with Lotus five what should we be expecting on the parameters to be presented and even as a safety run in are there any key efficacy benchmarks that you could point us to thanks, so much.
Niche: Okay. So you really asked me about what's coming at DHA in CML for both below the seven presentation as well as the <unk>.
Niche: <unk> presentation, so I'll turn that to.
Mohamed Zaki: So I'll turn that to Mohamed, who can give a little more detail on that. Yeah, we will be actually presenting more patients and longer follow-up, but we cannot share any more details on the transition due to environmental reasons. We can only speak about what's in the abstract, at least. That's for LUTUS-7. With regards to LUTUS-5, we'll be sharing a little bit more on the durability of complete responses that has been reaching more than two years now without reaching the median of deep SCF or duration of response. So that's technically what is planned to be shared.
Speaker Change: Who can give a little more detail on that yes, we will be actually presents and more patients and longer follow up but we cannot share more detail on the transmission piece of Inbar recently got all these speak about what's in the abstract.
Niche: Sorry.
Niche: Absolutely.
Niche: With regards to Lucas.
Niche: Yes.
Niche: I'll be sharing a little bit more on the durability of complete responses that has been reaching more than that.
Niche: Two years now without reaching the mediums.
Niche: These Fcs the ratios response, so that's <unk>.
Niche: I can tell you what is the plan to be shared.
Ameet Mallik: or as the abstract suggests, but pretty much the information. We cannot share any more disabilities. Yeah, and obviously as you saw in the press release for Lotus 7, it's a poster presentation at EHA, it's an oral presentation at ICML, and it'll be a full data presentation, so you can expect. All the typical things you'd want to see in a pull-up data presentation.
Niche: Or.
Niche: The abstract suggest.
Niche: Pretty much information.
Niche: I'll show anymore, because the label.
Niche: Yes.
Niche: As you saw in the press release seven.
Niche: Seven it's a poster presentation at J, it's an oral presentation CML and it'll be a full data presentation. So you can expect.
Niche: All the typical things you would want to see and full data presentation.
Niche: Great. Thank you.
Unknown Executive: Great, thank you. Thank you. There are no further questions at this time.
Niche: Thank you.
Speaker Change: No further questions at this time I will now hand, the call back over to Amit Malik CEO for any closing remarks.
Ameet Mallik: I will now hand the call back over to Ameet Mallik, CEO for the closing. 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.
Speaker Change: Well I want to thank you all for joining our call today and for your continued support.
Speaker Change: Look forward to keeping you updated on our progress.
Unknown Executive: Operator, you can now please end the call. Thank you.
Speaker Change: Operator, you can now please end the call. Thank you.
Speaker Change: Thank you ladies and gentlemen, the conference has now ended thank you all for joining you may all disconnect your lines.
Unknown Executive: Ladies and gentlemen, the conference has now ended. Thank you all for joining.
You may all disconnect your lines.
Speaker Change: Okay.