Q1 2024 ADC Therapeutics SA Earnings Call
Good day and thank you for standing by welcome to the ADC Therapeutics first quarter 2024 financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your.
Telephone you will then hear an automated message advising you. Your hand is raised to withdraw your question. Please press star one again, please be advised today's conference is being recorded.
I'd now like to hand, the conference over to your Speaker today, Nicole Reilly head of Communications. Please go ahead.
Thank you operator. This morning, we issued a press release announcing our first quarter 2024 financial results and business update. This release is available on the ATC T website at IR Dot ADC therapeutics Dot com under the press releases section.
The event is being recorded and the slides accompanying this call are available on the ADC T website at IR Dot ADC therapeutics dot com under the latest events and presentations section.
On today's call and eat Malik Chief Executive Officer, and Pepe Carmona, Chief Financial Officer, who will discuss recent business highlights and review our first quarter 2024 financial results.
Speaker Change: We will then open the call to questions and we will be joined by Christopher inherently Smith, Chief Commercial officer, and Mohammed Zaki Chief Medical Officer.
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 on slide three and in the company's filings with the SEC, including forms 10-K, 10-Q and 8-K.
Speaker Change: A D. C. P is providing this information as of the date of today's conference call 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. After the date hereof, except as required by law or otherwise.
Speaker Change: The company cautions investors not to place undue reliance on these forward looking statements.
Speaker Change: Today's presentation also includes non-GAAP financial measures. These non-GAAP measures have limitations as financial measures and should be considered in addition to and not in isolation or as a substitute for information prepared in accordance with GAAP.
Speaker Change: You should refer to the information contained in the company's fourth quarter earnings release for definitional information and reconciliations of historical non-GAAP measures to the comparable GAAP financial measures.
Speaker Change: It is now my pleasure to pass the call over to our CEO, Amit Malik Amit.
Speaker Change: Okay.
Thanks, Nicole and thank you all for joining us today.
Ameet Mallik: You'll see we have shared some very exciting news items earlier this morning, but to begin with I'd like to focus on key business updates for the quarter.
Ameet Mallik: Starting with our commercial performance. It's been lots of continued its return to sequential growth with revenues of $17 8 million in Q1.
Ameet Mallik: This represents a 7% increase over the fourth quarter of 2023.
Ameet Mallik: Accordingly, we saw continued growth both in the community and in academic centers, despite the intensified competitive landscape.
Turning next to our pipeline, we have made significant progress.
Ameet Mallik: Last month, we announced that our board has seven study of Syn marker in combination with Biospecifics successfully clear at the final dosing cohort in both arms with no dose limiting toxicities, no I can either no or low grade levels of Crs.
Ameet Mallik: We are now dose expanding at 120, and 150 micrograms per kilogram and this amount there plus profit amount a combination arm in second line plus TWC al.
Today, we are delighted to share for the first time encouraging initial data recently presented from the University of Miami Phase II investigator initiated trial in relapsed refractory marginal zone lymphoma.
Ameet Mallik: Based on initial results from the first 15 Evaluable patients 13 achieved a complete response and one achieved a partial response with all patients maintaining response at the time of data cut off.
Ameet Mallik: Moving to <unk> 601, our novel <unk> targeting ADC, we began enrolling pancreatic cancer patients and continue to enroll sarcoma patients and we are in the process of optimizing the dose and schedule.
Ameet Mallik: Lastly, we shared a comprehensive update on our novel <unk> based solid tumor platform, including early preclinical data on our four preclinical ADC candidates for the first time at our recent research Investor event.
Ameet Mallik: Finally in terms of a corporate update.
Ameet Mallik: Maintained our disciplined capital allocation strategy and decreased operating expenses in Q1 by 16% year over year on a non-GAAP basis.
Ameet Mallik: This in turn enabled us to manage our cash burn so that we ended the first quarter with cash of $234 3 million.
Ameet Mallik: On top of this we have just announced today that we are priced an underwritten offering to raise $105 million in gross proceeds.
Ameet Mallik: The offering at the closing price per share on Friday included common shares and pre funded warrants and is expected to close on may eight.
Ameet Mallik: We expect this will extend our cash runway into mid 2026 and provide the company with enhanced financial flexibility to execute our strategy.
Ameet Mallik: Given our strength in balance sheet I would like to remind everyone of the strategy. We are pursuing which we believe will unlock the tremendous value we see in the company.
Ameet Mallik: Our first pillar and primary focus remains hematology.
Ameet Mallik: Within this we have a derisked asset in Vermont.
Ameet Mallik: Key product in our prioritized portfolio, which we expect to carry the company through to profitability.
Ameet Mallik: We are deploying the majority of our capital to this amount of franchise to commercialize our existing third my boss TWC, all indication and to pursue the substantially larger potential opportunity in earlier lines of <unk> therapy and <unk>.
Ameet Mallik: Lymphomas, such as marginal zone lymphoma.
Ameet Mallik: We believe these potential opportunities will help expand as the market franchise and have the potential to generate annual peak sales in excess of $5 billion.
Ameet Mallik: The second pillar of our strategy is grounded in our emerging solid tumor pipeline.
<unk> 601 is our most advanced asset.
Behind this we see the potential to advance our broad portfolio of differentiated adcs against solid tumor targets of interest driven by our novel <unk> based platform.
Ameet Mallik: I'd like to expand now on a substantially larger potential opportunity for Samantha in earlier lines of TWC out therapy and indolent lymphomas.
Ameet Mallik: Pending the results of the Lotus five and loaded seven studies our goal is to expand usage of the Montana into second line <unk>.
Ameet Mallik: As a reminder, our bonus five is our confirmatory.
Ameet Mallik: Phase III study of <unk> in combination with Rituximab.
Ameet Mallik: Here, we remain on track and expect to complete enrollment by the end of this year with the potential for a headline readout by the end of 2025.
Ameet Mallik: If positive we believe this trial will lead to full approval approval prison launch and expand our indication in the <unk>.
Ameet Mallik: <unk> plus <unk> in combination with Rituximab potentially as early as the end of 2026.
Ameet Mallik: Voted seven as our phase one b trial of <unk> in combination with bi specifics.
Ameet Mallik: We are encouraged by the initial safety and Tolerability profile as well as the observed anti tumor activity amongst the majority of patients in part one of the dose escalation.
Ameet Mallik: We are now enrolling in part two dose expansion with them onto a possible fit them out in second line <unk> and expect to complete enrollment and plan to share additional efficacy and safety data before yearend.
Ameet Mallik: We also see that protects us to expand the uses and lump it into the second line plus setting follicular lymphoma and <unk>.
Ameet Mallik: Martin is on the phone that based on the initial data from investigator initiated trials at the University of Miami.
Ameet Mallik: Today I want to focus on the marginal zone lymphoma data that was shared this past weekend at the lymphoma Research Foundation 2020 for marginal zone lymphoma scientific workshop.
Ameet Mallik: The trials lead investigator Dr is the door, though.
Ameet Mallik: At the University of Miami.
Ameet Mallik: Relapsed refractory mcl represents an unmet need.
Ameet Mallik: Based on publicly available incidents data there are an estimated three to 4002nd line plus mcl patients who are drug treated in the U S.
Ameet Mallik: On that medical need remains in relapsed refractory mcl less than 30% CR for second line plus approved our NCC and preferred treatment.
At present, there are two FDA approved regimens and several other preferred regimens for the treatment of Mcl in second line plus included in MCC and guidelines.
Ameet Mallik: Complete response rates are modest and sample sizes in our studies supporting this data are relatively small.
Ameet Mallik: As complete response rates are a strong predictor of time related outcomes and mcl.
Ameet Mallik: Clinicians continue to seek novel agents with higher and durable CR rates, a manageable safety profile and a fixed duration of treatment.
Ameet Mallik: The University of Miami is leading a multi center phase II III studying Samantha as a single agent fixed duration regimen to treat 50 relapsed refractory <unk> patients.
Ameet Mallik: Initial data from the first 15 Evaluable patients showed 13 achieved a complete response.
Ameet Mallik: And one achieved a partial response.
Ameet Mallik: According to the lead investigator the Atlanta was generally well tolerated and safety was consistent with the known profile.
There are two sides currently enrolling university of Miami and city of hope and the lead investigator is currently expanding to five sites to accelerate trial enrollment.
Ameet Mallik: As soon as we have sufficient data assuming it remains positive we plan to potentially pursue a regulatory pathway and compendious strategy in parallel.
Ameet Mallik: In terms of the opportunity based on our analysis.
Ameet Mallik: We believe the total addressable second line plus NPL patient population.
Ameet Mallik: As the potential peak market opportunity of approximately $500 million.
Ameet Mallik: Valued at and lots of price and an expected average number of cycles.
Ameet Mallik: If successful this means.
Every 10% of market share captured represent $50 million in incremental annual peak sales opportunity.
Ameet Mallik: While still early in the phase III.
Ameet Mallik: If this trial continues to yield similar results.
Ameet Mallik: <unk> opportunity to expand into mcl could contribute to the overall and not the growth strategy.
Ameet Mallik: Al.
Ameet Mallik: Okay.
Ameet Mallik: Yeah.
Ameet Mallik: The current standard of care.
Ameet Mallik: In Mcl includes CD 20 based regimens across all lines. In addition to PTK inhibitors in second line Mcl.
Ameet Mallik: The data used for FDA approval and inclusion in SEC guidelines were based on either.
Ameet Mallik: Single arm studies or a subset of larger indolent, NHL studies and offer modest CR rates, which are below 30%.
Ameet Mallik: Per the study protocol all patients included must have failed one or more lines.
Ameet Mallik: Systemic therapy, including at least one anti CD 20 antibody.
Ameet Mallik: Under the protocol patients receive a fixed duration of treatment of six cycles has been like that across 18 weeks there.
Ameet Mallik: Primary endpoint is CR rate at six and 12 months.
Ameet Mallik: Patients will be followed for up to three years with progression free survival and overall survival measured at 24 months.
Ameet Mallik: Pre determined futility threshold for efficacy.
Ameet Mallik: 31% CR rate.
Speaker Change: Looking at the baseline characteristics of the patients enrolled so far in the study there are a few things I want to point out.
Speaker Change: We believe this initial group of patients is representative of the overall mcl population, including Mcl subtypes.
Speaker Change: In addition of the patients treated with <unk>. So far 10 of the 15, where stage for mcl patients with eight of the <unk> designated as <unk> 20.
Speaker Change: 24, meaning they progressed within 24 months of initial treatment a group that is typically harder to treat.
Speaker Change: Yeah.
Speaker Change: The median prior lines of therapy is to ranging from one to four and as you can see on the right side of the slide included multiple currently available systemic treatments.
Speaker Change: As shared by Dr. <unk> at the lymphoma Research Foundation in 2020 for marginal zone lymphoma scientific workshop on May 4th.
Speaker Change: These initial results showed.
Speaker Change: 13 out of 15 patients achieved CR with one additional patient achieving a PR.
Speaker Change: Of the <unk> nine were achieved after two cycles.
Speaker Change: In addition, all patients achieving responses and maintain them as of the data cutoff with a longest responder, reaching approximately 20 months.
Speaker Change: And from an initial safety perspective.
Speaker Change: Per the lead investigator in this study <unk> was generally well tolerated and consistent with the known safety profile.
Speaker Change: One patient discontinued after cycle two a second patient discontinued after cycle four due to a toxicity, which fully resolved upon discontinuation of treatment.
Speaker Change: Both of these patients remained in CR at 10 at six months respectively.
Speaker Change: Based on this initial data from University of Miami Phase II trial, evaluating <unk> in Montana, and relapsed refractory Mcl we are.
Speaker Change: We're encouraged by the potential opportunity in the second line plus setting for patients with this rare disease.
Moving on to Lotus seven we are sharing here additional safety data from the part one dose escalation portion of the study.
Speaker Change: The important takeaways are that the majority of Crs events.
Speaker Change: Our grade one and that no crs greater than grade two is observed.
Speaker Change: Those patients who have experienced a grade two crs or managed with no requirement for ICU management or pressures.
Speaker Change: On the left hand side, you will see that the overall crs rate with both Paramount.
Speaker Change: 33%.
Speaker Change: Which is the combination of focus for part two of this study.
Speaker Change: Important to note the current <unk> label in third line <unk> includes a 70% crs rate, including some higher grade events.
Speaker Change: We believe that dosing wisdom onto one week prior TIK locator map may be debark in the tumor.
Speaker Change: Turning to our research platform, we hope.
Speaker Change: Did a virtual Investor research event on April nine.
Speaker Change: Which provided a comprehensive overview of our solid tumor research strategy, our novel <unk> based platform and our four lead ADC candidates.
Speaker Change: Our focus is on advancing differentiated ADC candidates.
Speaker Change: Against prostate non small cell lung cancer, colorectal endometrial and ovarian cancers.
Speaker Change: For each tumor type the combination of incidents and five year survival offers large potential opportunities and indicate that better treatment options are needed.
Speaker Change: Furthermore, in each case chemotherapy remains a key part of the treatment armamentarium.
Speaker Change: Our four lead ADC targets are napping to be cleared and six <unk> and <unk>.
Speaker Change: We believe each offers the potential to improve the standard of care for cancer patients and each utilizes our novel <unk> based platform.
Speaker Change: Preclinical work suggest that our four lead candidates each have a high therapeutic index.
Speaker Change: Reflecting the proprietary design of the ADC.
Speaker Change: In terms of stage are now <unk> acquired six adcs are in it.
Speaker Change: Enabling studies and we are pleased to share exciting early data on these at ACR last month.
Speaker Change: Our PSA and <unk> Adcs are in the drug candidate selection stage, which we expect to complete this year.
Speaker Change: Looking ahead, we plan to move forward with one candidate to IND.
Speaker Change: And to seek research collaborations to advance our broad portfolio.
Speaker Change: Given the unmet medical need coupled with the market opportunity a successful outcome for one or more of our early research programs.
Speaker Change: The potential to transform the lives of patients and create significant value in the future with that I would like to turn the call over to <unk>.
Speaker Change: Thank you Amit.
Speaker Change: Before I discuss todays financing I will take you through a brief summary of our first quarter results.
Speaker Change: As a reminder, we're now reporting our results under U S. GAAP, we became a U S domestic fighter as of January one 2020.
Speaker Change: Starting with our balance sheet large 31, we had cash and cash equivalents of approximately $234 $3 million.
Speaker Change: Moving to the P&L as you already shared with a lot of net sales were $17 $8 million into quarter.
Speaker Change: A decrease of 6% versus prior year.
Speaker Change: Primarily driven by higher gross to net deductions on a lower volume, partially offset by higher gross price.
Speaker Change: On a sequential basis in la for net sales grew 7% versus the fourth quarter of funded loans.
Speaker Change: Our total operating expenses on a non-GAAP basis, which excludes stock based compensation were down 16%.
Speaker Change: Compared to the first quarter last year.
This mainly reflected our focus on driving operating efficiencies together with reduced R&D expenditures due to focus on investments in our clinical studies and lower selling and marketing expense.
Speaker Change: Looking forward, we will continue to take a very disciplined approach toward capital.
Speaker Change: You can find the reconciliation of GAAP measures to non-GAAP measures and the compiling financial tables of the press release issued earlier today and in the appendix update presentation.
Speaker Change: Moving to the bottom of the P&L.
Speaker Change: GAAP basis, we reported a net loss of $46 $6 million for the quarter or <unk> $66.
Speaker Change: Our diluted share.
On a non-GAAP basis, adjusted net loss was $31 1 million.
Speaker Change: Adjusted net loss of $38 per basic and diluted share.
Speaker Change: The decrease in both reported and adjusted net loss for the first quarter of 2020 was primarily due to lower operating expenses.
Speaker Change: Today, we have announced the pricing of a registered direct offering which included pre funded warrants. We expect to close by May eight and the offering is expected to raise approximately $105 million of.
Speaker Change: Cross placenta.
Speaker Change: We have been delighted by the response from a range of high quality institutional investors and we expect the proceeds to extend our cash runway until the middle of 2026.
Speaker Change: By strengthening our balance sheet. We believe we are now better find us to pursue our corporate strategy.
Speaker Change: A reminder, hematology continues to be the primary focus of our capital allocation and within days. Our key objective is to create value by expanding the use of some long term.
Speaker Change: The cavern indication.
Speaker Change: We expect to achieve this by fully supporting our commercialization effort Timna west directly to our policy ex U S and by investing behind potential expansion into earlier lines of <unk> and in demand response.
Speaker Change: And solid tumors.
Speaker Change: Our aim is to pursue multiple ADC candidates in parallel and increase our shots on goal.
Speaker Change: Finally to our novel <unk> based research flops.
Speaker Change: We will determine on a case by case basis, whether we wish to go Chris Caton debates internally.
Partner in <unk>.
Speaker Change: In order to share the development of financial close.
Speaker Change: As I mentioned earlier, we intend to take at least one candidate forward.
Speaker Change: And the new funds raised give us expertise freedom to do so.
Speaker Change: My final slide highlights the multiple potential value driving milestones, which we expect in the coming year.
Speaker Change: Notably we have delivered on our promises to date in 2020 one.
Speaker Change: With positive updates for Cymbalta in the lot of seven study in Mcl training.
Speaker Change: Training upfront.
With the initiation of dosing of <unk> 601 is by credit asset whether this closer our existing new research platform, our <unk> investment research.
Speaker Change: In the second half of this year, we have multiple potential baidu generating catalysts, including expected completion of enrollment in lots of spine.
Speaker Change: Initial efficacy and safety data from lots of cyberpunk two expansion.
Speaker Change: Initial bleed of Vegas at least 601 in Knoxville in both sarcoma by periodic tests.
Speaker Change: With that I will turn the call back plummet.
Thanks <unk>.
Speaker Change: To conclude my team and are very proud of our performance in the first quarter of 2024.
Speaker Change: We achieved another quarter of sequential growth was in water, we delivered against each of the plan key research and development milestones and we maintained our disciplined approach to capital allocation looking.
Speaker Change: Looking ahead with a strengthened balance sheet and enhanced financial flexibility to execute our strategy.
Speaker Change: I am confident the ADC therapeutics is well positioned to drive value creation for all of our stakeholders with that operator could you believe could you. Please begin the Q&A session.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Operator.
Speaker Change: Hello.
Speaker Change: Hi.
Speaker Change: One moment for our first question.
Speaker Change: Okay.
Speaker Change: Sorry, we cannot hear the question operator.
Speaker Change: Okay.
Speaker Change: Sorry, operator, we cannot hear the question.
Speaker Change: Okay.
Speaker Change: Thank you one moment.
Speaker Change: Okay.
Speaker Change: Our first question will be from Kelly <unk> from Jefferies. Your line is open.
Speaker Change: Hi, Good morning. This is Joe for Kelly and thanks, very much for taking my question and congratulations on the margin is only form of data.
Speaker Change: I believe you reported.
Speaker Change: Positive data from the Follicular lymphoma program, where investigator initiated study.
Speaker Change: Cash and so can you remind us your claim for Follicular lymphoma in comparison to marginal zone lymphoma, and which one do you think could potentially be.
Speaker Change: Maybe.
<unk> potential.
Speaker Change: Sure.
Speaker Change: Sponsored study firsthand.
Speaker Change: Have you received any feedback.
Speaker Change: In terms of the safety considering that.
Speaker Change: Indolent lymphoma patients. Thank you.
Speaker Change: Yes, thanks for the question.
Speaker Change: Youre right to say that we were excited to share data in an oral presentation last acts on the relapsed refractory Follicular lymphoma population, which showed that the combinations in Lotto plus Rituximab had an overall response rate of 96% and a CR rate of 85% with a manageable safety tolerability.
Speaker Change: So I think that was really encouraging data of course now seem to modules on lymphoma data and another in the pharma with again high overall response rate higher CR rates and again, a manageable safety profile. We're really encouraged both of these trials are have been.
Speaker Change: Expanded so the Follicular lymphoma patients. The study will now be 100 patients module zone will be 50 patients both our multi center studies as well and with both of them. We plan to pursue both our regulatory strategy as well as the compendious strategy in parallel based on the outcome of the data. The one thing to note about this one.
Speaker Change: Takeaway data that's important is that it's really just go after the high risk patient population, we know that when you go after all comers in Follicular lymphoma. There is a precedent for randomized phase III studies of long follow up.
Speaker Change: We're focused on.
On a narrow population, which is the high risk population most of which were <unk> 24, and we think if the data looks good there may be a faster pathway potentially either through a regulatory pathway through guidelines in that more narrow patient population.
Speaker Change: <unk> is probably even more straightforward because if you look at the majority of it.
Speaker Change: Look at everything Thats been approved either by the FDA or in guidelines they've been approved based on either single arm studies or subsets of larger randomized studies in indolent lymphoma study and typically with somewhere between 40 to 70 patients. So we think the 50 patient study we're running is an appropriate size.
Speaker Change: And based on the data maturity from this study.
Speaker Change: Again, we'll pursue.
Speaker Change: Youre guidelines and a regulatory pathway in parallel so that I would say is the EBIT more straightforward pathway because there's so much press and thats an mcl, but we also think just given the strength of the data haven't really interesting opportunity in select player as well.
Speaker Change: Alright, thank you.
Thank you.
Speaker Change: And our next question will come from Michael Schmidt from Guggenheim. Your line is open.
Michael Schmidt: Hey, guys. Thanks for taking my questions and yes Super interesting update here in Mcl obviously.
Michael Schmidt: I think you said.
Michael Schmidt: All of the patients are still in response could you just help us contextualize the duration a little bit.
Michael Schmidt: Do we know about the duration of benefit for other drugs in Mcl and then how does it compare to that.
And then yes, I think you did have this one patient discontinued due to toxicity can you just comment on what that was and then I had a follow up thanks.
Speaker Change: Yeah. Thanks, Thanks, Michael.
Speaker Change: Yes, as you said, we're really encouraged by the data as well and also.
Speaker Change: In mcl, confirming what we've seen in Follicular and what we've seen in other areas. The safety profile has been really good we haven't seen any new safety signals of any of these states. So that's been encouraging but I'm going to turn to Muhammad to talk about both the duration and thats seen in other treatments in <unk>.
And what we would want to see here.
Muhammad: Yes, Thanks, Brian first I wanted to highlight that.
One of the patients in CR rate and issued 20 months.
Muhammad: Many of the patient.
Muhammad: Currently our more than 10 months and all of our ongoing you're correct at the time.
Muhammad: <unk>.
Muhammad: What has been reported in the literature.
Muhammad: Smaller trials.
Muhammad: And.
Muhammad: Range between possibly 15 and 18 months those are the kind of PFS had been reported or the our ability within either single agent or in combination. So.
Muhammad: If the data in <unk>.
Muhammad: The way it is.
The sponsors are continuing for all the patients that we have <unk> lumpy or we believe we'll be in a very good place in terms of it seems but again for Bob.
Muhammad: It has been two <unk>.
Muhammad: And then Michael your second question was around the one patient with toxicity, we don't have more details the investigators planning.
Muhammad: As there.
Muhammad: Sample size increases and the duration and follow up increases to do a much bigger presentation at a more major medical Congress, where he will share all the data it doesn't want to compromise that so what we know from the investigator is one patient had a toxicity discontinued.
Muhammad: After cycle for that patient was already NCR once the patient was discontinued the toxicity fully resolved.
Muhammad: And that that patient still remains at Cri now that patient six months out so thats, what we know the other thing we understand from the investigators everything they've seen across all 15 patients. The safety profile is consistent with the known <unk>.
Safety profile up to Manta.
Muhammad: Greg Let me ask it Super interesting and then a question on Lotus seven I know you had some really early phase one data at ACR and.
Greg: But just wanted to know if you could provide some visibility on the next update I think you have another look at data in the second half of this year and more in the first half of next year as well.
Greg: Yeah.
So.
Speaker Change: We yes, we we're now part two dose expansion right now we are quite pleased I think with the dose escalation how smoothly. It wanted to know we are in dose expansion.
Speaker Change: Looking at the Atlanta, plus profit amount in second line <unk> patients. We're looking at it at two different doses of the amount of 150 microgram per kilogram dose as well as the 120 microgram per kilogram dose both in combination with the full doses of profit amount.
Speaker Change: We are expect to complete.
Speaker Change: The enrollment of roughly 20 patients in each of those dosing cohort by the end of this year and then we will share the safety and efficacy data thats available for all Evaluable patients. What we mean by that is patients that had at least a 12 week scan because obviously any responses we want to make sure a confirmed so that will be likely a sub.
Speaker Change: Set of those 40 patients that are actually available at that time, we will share all the data that's available by the end of the year and then provide an even more comprehensive update in the first half of next year. When we have data from all 40 patients including longer follow up.
Speaker Change: Great Super helpful. And then lastly on automotive five.
Speaker Change: Yeah.
Speaker Change: You're well on track.
Speaker Change: Complete enrolling later this year and just curious if you had any additional visibility on the grades are coming in and the timing of the primary analysis. Thanks, so much.
Yes, I mean, as you said and I will turn it Mohammed to comment further but we're on track to complete the study enrollment pace has picked up quite a bit over the course of this past year and even this year in particular has picked up quite a bit. So we're confident in completing the enrollment of the study. This year. It is an events driven trial. So you can never predict.
Mohamed Zaki: The when its going to exactly readout, but based on our current thinking we believe.
Mohamed Zaki: Yes, it may read out as soon as the end of 2025, which if that's the case and it's positive could lead to an approval as soon as the end of 2026, but how would you want to comment more on the enrollment and what Youre seeing with <unk>, Yes, we're very pleased with the current enrollment.
Mohamed Zaki: Picked up strongly.
Mohamed Zaki: Our strong lead during 2023 employees, let me if I actually assumed we are still in the I believe that we will be able to enroll the study this year.
Speaker Change: Well also we have a D&C that meets regularly.
Speaker Change: Uh huh.
Speaker Change: Have.
Speaker Change: Clearly the study multiple clients no changes so thats a.
Speaker Change: A very positive sign.
Speaker Change: In addition, I would like to say that the events or be in.
Yield by independent Central review, so that's another big key elements for us to make sure that those are confirmed and then completely independent as you know we are blinded.
Speaker Change: But this is event driven study or is it take until next year Thats, a positive thing and hopefully that would've been the case so.
That's pretty much all of our focus at the moment, Yes, I think all on track with those hot we feel we feel good about the progress.
Speaker Change: We're well on track to complete it this year.
Speaker Change: Alright, well thanks, so much congrats on the update today.
Speaker Change: Okay. Thank you. Thank you.
Speaker Change: Thank you and our next question will come from Gregory <unk> from RBC capital markets. Your line is now open.
Speaker Change: Hi, This is <unk> on for Greg. Thank you so much for taking our questions and congrats on the progress.
Speaker Change: Questions on the competitive dynamic pharmacy 20 by specific number one has.
Speaker Change: The impact being fully realized.
Impact.
Speaker Change: Competition from seafood in 'twenty <unk>, three antibody that hasnt been fully realized in the third line setting and now.
Speaker Change: Roche recently announced.
Speaker Change: The trial in the second line and hit the primary endpoint that could potentially be ahead of <unk> combination from Lotus five I'm just curious how should we think about the competition from.
Speaker Change: That come by CD 20 by selectively Campbell of <unk>.
Speaker Change: <unk>. Thank you so much.
Speaker Change: Yes, that's a great question.
The bispecific.
Speaker Change: Yes, both of the approved by specifics in the third line <unk> setting are definitely getting uptake primarily the academic center, we see much more limited use in the community. So in the academic center. There is quite a bit of use of bi specifics post car T. I think importantly, we still have seen some modest growth, though in the act.
Speaker Change: Eric centers overall on our volume when you look at Q4 to Q1, where thats been driven with US while you have some lower level of depth in some centers that were using and lump it quite a bit in that setting we've actually seen a higher amount of breath of centers and academic centers that are using their products and so in essence, we've been able to basically compensate for armada that competitive impact although.
Speaker Change: It's real I mean, <unk> are definitely being used quite a bit and you can see it in their growth rates a lot in that third line plus post car T.
In the academic setting.
Speaker Change: So we felt the competitive impact I think importantly, though we've been able to largely offset at an academic center and we see continued growth in the community as well. So we think our strategy is working in terms of the data around.
Speaker Change: <unk> plus <unk> combination.
Speaker Change: What's it look we have to wait and see the data obviously it hasnt been published they give a top line results I mean, one thing of note I think it's just that they said that the.
Speaker Change: I think it will have to pay attention to is what's the toxicity profile, we don't know, but obviously using systemic chemo with a bispecific.
Speaker Change: Youll have to see what the toxicity profile looks like I think there we feel quite confident I think in our.
Speaker Change: Accommodations, both of us in Lotto, plus rituximab as well as the module plus profit amount given the toxicity profile. We've seen there. So I think as we move into second line. It's important to have strong efficacy and a manageable safety tolerability profile, we feel confident in both of our approaches.
Speaker Change: I don't have much to add again.
Speaker Change: Edison, David Starwood data that'll be out at IHA and.
Speaker Change: <unk>.
Speaker Change: Ed.
Speaker Change: Ed.
Speaker Change: <unk> been able to hold share pretty much in the academic centers, we see that despite the by specific we have strong advocacy in the academic centers and what we also hear is that these advocates recommended allows that to the community traders which is critical.
Speaker Change: Once we see the data from the modified the briefing as that.
We're testing that is probably one of the most commonly used agents out there with a lot of familiarity.
Speaker Change: <unk> seven we have a great optionality with Golan, yes, it's a really really important point that Christian just made one of the most predominant use as we know that car T is only used in about 20% of patients second line really in the academic centers. The majority of patients in academic centers are getting it in the community, though our base chemo regimens.
Speaker Change: Our very very commonly used so we think in our based ADC approach is going to fit really well there.
Speaker Change: Okay.
Speaker Change: Alright, thank you so much.
Speaker Change: Thank you.
Speaker Change: And our next question will come from Brian Cheng from J P. Morgan Your line is open.
Brian Cheng: Hey, guys. Thanks for taking our question this morning.
Brian Cheng: Just a first question on Lora seven can you talk a little bit more about the strategy beyond.
Brian Cheng: Those expansion in <unk> seven.
Brian Cheng: Will there be a need to run a larger second line pivotal study.
Brian Cheng: To get you eventually move into <unk>.
Speaker Change: <unk> <unk> Campbell and if yes, how do you think about the study design and the timing and I have a follow up thank you.
Speaker Change: Okay. Yeah. Thanks, Brian Great question, I'm going to hand, it to Mohammad to answer the question on leather seven yes. Thanks, Brian. This is a snick wise approach first would like to see how the efficacy in the combination second line plus looks like and how it compares in the competitive environment.
Speaker Change: Definitely.
Mohammad: We are looking to see how the safety profile is looking like we're very pleased that we cleared all doses and see that when we get to that point with the two doses that were expanding if the data resist we're definitely planning to have a conversation with the regulators about that possibility of the fees.
Mohammad: So the approval there.
Mohammad: At that time, we will see what the comparator arm would be however, there could be in this figure is a risk choice as you I'm sure. You are aware of because there are multiple divisions and many things could be available at that time, but of course is going to be a data driven approach and the composition of the agency is going to tell us.
Mohammad: More about that.
Mohammad: Okay.
Mohammad: And then maybe second one for Paypal.
Speaker Change: Can you give us a better sense on how you define commercial brand profitability. This year and that's factoring in only cost of goods sold and selling and marketing expense or is there.
Speaker Change: Chanel consideration coming from <unk>.
Speaker Change: G&A expense as well thank you.
Speaker Change: Yes.
Speaker Change: So the question Brian So this year as the long term, we'll be able to pay for all the.
Speaker Change: Hey, Rick.
Commercialization effort that includes all the sales force MSL.
Speaker Change: The A&P then we're investing a drag.
Speaker Change: So we are happy and executing.
Speaker Change: On top of that obviously cost a fortune on whatsoever.
Speaker Change: It doesn't mean, what it doesn't include is the pipeline so our models Latin almost 507 trial.
Speaker Change: Corporate G&A.
Speaker Change: It's not included.
Speaker Change: Okay, great. Thank you.
Speaker Change: Thank you.
Speaker Change: Im showing no further questions from our phone lines I would now like to turn the conference back over to Amit Malik for any closing remarks.
Ameet Mallik: Thank you very much for joining our call today and thank you for your continued support we look forward to keeping you updated on our progress have a very nice day, everyone. Thank you.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Yeah.
Speaker Change: [music].