Q1 2021 ADC Therapeutics SA Earnings Call
Yeah.
Operator: Thank you for standing by and for the ADC Therapeutics first quarter 2021 financial results call. This conference call will begin momentarily. Again, thank you for standing by for the ADC Therapeutics first quarter 2021 financial results conference call. This call will begin momentarily.
Thank you for standing by for the ADC Therapeutics first quarter 2021 financial results call. This conference call will begin momentarily again, thank you for standing by for the ADC Therapeutics first quarter 2021 financial results conference call. This call will begin momentarily.
[music].
unknown: [inaudible]
unknown: Good morning, and welcome to the ABC Therapeutics first quarter results and 2021 financial call.
Cheryl: My name is Cheryl, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press Darden 1 on your touch-one phone. I will now turn the call over to Amanda Hamilton. You may begin.
Question. Please for a jar then one on your Touchtone phone I will now turn the call over to Amanda Hamilton you may begin.
Think of operator.
The issued a press release announcing our first quarter 2021 finance the results in business that day.
This release is available on the ADC T website, and I are that ADC therapeutics Dot com under the press releases section of.
Amanda Loshbaugh: Thank you, Operator. This morning we issued a press release announcing our first quarter 2021 financial results and business updates. This release is available on the ADCT website at ir.adctherpedics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jennifer Heron, our Chief Commercial Officer, Jay Feingold, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our first quarter 2021 financial results before opening the call for questions.
On today's call, Chris Martin Cheap Executive Officer, Jennifer Herein are too commercial officer, J Fangled, Chief Medical Officer, and Jen Krill, Chief Financial Officer will discuss recent business highlights and review our first quarter of 2021 finance of results for for opening the call for the question.
As a reminder of this conference call may contain forward looking statements such statements and subject to the risks and uncertainties for additional information concerning forward looking statements and factors that could cause actual results of different materially from those expressed or implied in the statement. We refer you to the section titled cautionary statement regarding forward looking statements and the Zip.
99.3 of our report on for them 16th filed with the U S Securities and Exchange Commission the earlier today.
The statements speak only as of the date of the conference call and we expressly this thing any obligation or undertaking to update these forward looking statements unless required to do so by applicable law.
Today's presentation also include non I F. R. S financial measures the non I F. R. S measures have limitations as financial measures and should be considered an addition to and not in isolation or as a substitute for the information prepared in accordance with I F. R. S. You should refer to the information contained different companies for.
First quarter earnings free for Definitional information and reconciliation of historical none I ever asked measures do the comparable I F. R S financial measure.
It is now my pleasure to pass the call over to our C E O Chris Martin Okay.
For for my books for perjury.
Amanda Loshbaugh: As a reminder, this conference call may contain forward-looking statements, which are subject to risks and uncertainty. For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in new statements, we refer you to the section titled Cautionary Statements regarding forward-looking statements in Exhibit 99.3 of our report on Form 6-K filed with the U.S. Securities and Exchange Commission earlier today. Such statements speak only as of the date of this conference call, and we expressly disclaim any obligation or undertaking to update these forward-looking statements unless required to do so by applicable law.
For joining us the board.
Pretty much of the issue of of being transformational hundreds of Georgia.
Which of those mhm extremely pleased to receive accelerated ask you of your previous because you're moving.
Broadrick places for 20 food.
For me to do for.
<unk>.
First of all the bold pushing population studies in the forties to to the control. The life of includes patrons would diffuse large piece of lymphoma hope of the wall spectra of bold.
Oh biggio arising from low grade lymphoma.
Amanda Loshbaugh: Today's presentation also includes non-IFRS financial measures. These non-IFRS measures have limitations as financial measures and should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with IFRS. You should refer to the information contained in the company's first quarter earnings release for definitional information and reconciliation of historical non-IFRS measures to the comparable IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin.
Chris Martin: Thanks, Amanda, and thank you all for joining us today. The first few months of this year have been transformational and exciting.
We received our first customer inquiry about product availability.
Chris Martin: As you know, we were extremely pleased to receive accelerated FDA approval for Zinlanta on Friday, April 23rd, a month before the Perdufa date. Based on the broad patient population studied in the Phase 2 clinical trial, the label includes patients with diffuse large B cell lymphoma, not otherwise specified; DLBCL arising from low-grade lymphoma and high-grade B-cell lymphoma, with the latter being an important We launched immediately after receiving accelerated approval, making a seamless transition to a fully integrated commercial organization.
This underscores the critical need for new treatment options for patients with relapsed and refractory diffuse large b cell lymphoma.
Over the weekend following approval, we launched our digital platform, which includes our health care professional website our brand sites.
Our medical information website as well as our patient assistance website.
We also leveraged social media outlets and direct email to ensure that all of our customers are aware of the great news about the didn't launch of.
On Monday April 26, the first business day after FDA approval, our patient call Center, which provides coverage guidance financial support and co pay assistance and one on one nursing support with live with trained nurses and reimbursement specialist.
Chris Martin: We were pleased to learn yesterday that, less than two weeks since FDA approval, Zinlanta was added to the NCCN treatment guidelines with a Level 2A recommendation. The NCCN treatment guidelines are reflective of the broad indication in the FDA approval to include not only DLBCLNOS but also DLBCL arising from low-grade lymphoma, such as follicular and marginal zone lymphoma, and also high-grade B-cell lymphoma. This rapid addition supports the Zinlanta differentiated profile and highlights the high unmet medical need in this patient population.
We also completed our sales training for our hematology therapeutic specialists or HTS is the very same day.
Tuesday, the second business day following approval the HCS as we're in the field promoting the manta and our AMC <unk> dossier was available for our payer customers.
Importantly, our MSL team has been addressing customer requests to ensure the safe and efficient administration of the launch it.
Chris Martin: Continuing to advance our research programs remains a priority for the company. Beyond the first indication for Zinlanta, we are exploring different combinations and earlier lines of therapy in DLBCL and follicular lymphoma. We're also advancing clinical studies in Hodgkin lymphoma and solid tubers for our second program, Kani, as well as our earlier stage pipeline. Jay will discuss the pipeline in more detail shortly, but first, I would like to turn the call over to Jennifer, our chief commercial officer, to provide some highlights on the first few days of the Zindlonswood launch. Jennifer
Jennifer Heron: Thank you, Chris, and hello, everyone. I'm very excited to provide an update on the early days of businessant-to-long. Even with FDA approval coming a month before the Padoofa date, the commercial and medical teams were ready for launch and had already hit the ground running. On the same day we received approval, we also received our first customer inquiry about product availability. This underscores the critical need for new treatment options for patients with relapsed and refractory diffuse large B-cell lymphoma.
For me to trial, but I'm all of the total of 145 patients with relapse of refractory the few spots b cell lymphoma.
I'll need at least two lines of price system of therapy the <unk>.
Trial include the blood spectrum of heavily preachers of patients the very difficult to treat disease, including patients with high great be some of them for a key points of differentiation for a label.
Jennifer Heron: Over the weekend following approval, we launched our digital platform, which includes our healthcare professional website, our brand site, our medical information website, as well as our patient assistance website. We also leverage social media outlets and direct email to ensure that all of our customers are aware of the great news about Zinlaan. On Monday, April 26th, the first business day after FDA approval, our patient call center, which provides coverage guidance, financial support, and co-pay assistance, and one-on-one nursing support, was live with trained nurses and reimbursement specialists. We also completed our sales training for our hematology therapeutic specialists, or HTSs, the very same day.
The trial also window of patients did not respond at the first line therapy patients for factory to all probably lines of therapy and patients who at price stem cell transplant in Karachi therapy.
So you wanted the offers a truly differentiated treatment option for this blood population of the last refractory D O B C L patients.
As Chris mentioned, we explored of the opportunity to expand the address for <unk> patient population is the month of into early the lines of treatment and an additional his solids.
First is the ongoing pivotal phase to load is three trial of the month of in combination with Ibrutinib for patients with relapsed refractory the few slides <unk> for a matter of southern farmer.
Which was the tend to support the submission of <unk> of of supplemental BLA.
Either of them data from the phase one portion of of this trial should encourage you advocacy of magical toxicity with all of them are we sponsoring the 63 per cent of course, all patients at 67 per cent of nine GCB. The L. D C. All patients.
We expect to report additional data from the phase one portion of his trial in the second quarter. Thank the complete phase too long and the second half of this year.
Jennifer Heron: On Tuesday, the second business day following approval, the HTSs were in the field, promoting Zinlanta, and our AMCP.a was available for our payer customers. Importantly, our MSL team has been addressing customer requests to ensure the safe and efficient administration of Zinlanta. Finally, Dinlaan was commercially available, and our first order was shipped within days of approval.
Next we'd have an ongoing confirmatory phase III those five criminal trial of the amount that in combination will talk with the talk from that.
Noticed five is also intended to support of supplemental the only filing for some other that's the second line therapy for real absolutely factor the fuselage P. C. All patients for not eligible for stem cell transplant.
We expect to complete the safety, leaving portion of the trial and the second half of the year.
There's also an 10 20 shape several additional and all of the trials this year.
First the plan to start of Pimple faced for clinical trial. So thank you for a farmer in the coming weeks in the second half of 2021. The also plan to initiate of trials of the month of the multiple combinations and be selling non hodgkins lymphoma now just fine. The study of some of the combination with our chops for the first of all I'd <unk>.
Jennifer Heron: Driving the launch is a world-class team of hematology oncology professionals across medical, marketing, market access, and sales. The customer-facing teams are reporting a very positive reception to the news of the SBA approval of Vinlanta, with members of the sales team hearing from their customers over the very first weekend. In the days since FDA approval, we have had major institutions expressed interest in ordering Lanta, which is very encouraging in these early days of launch.
All of these trials will explore the expansion of the Martha.
Of the lines of therapy across the detail non hodgkin from.
Moving for a second program Tammy.
The progress of course, both of our Hodgkins lymphoma and solid from the programs.
We completed the moment in our face to criminal trial patients, but we'd have to the factory hodgkins lymphoma of.
The interim results from this trial are expected in the second quarter for.
Jennifer Heron: And with the recent addition of ZinLanta to the NCCN treatment guidelines, we are in a position to accelerate our access initiatives to make sure that every patient that can benefit from Zinlanta has the opportunity to do so. In summary, the commercial and medical teams are off to a running start, and our exceptional team of top industry talent is genuinely excited to bring a truly differentiated product and hope to patients with relapsed and refractory DLBCL. Now, I'll turn the call over to Jay to provide an update on our pipeline. Jay?
Jay Feingold: Thank you, Jennifer. I'm pleased to share that our clinical and preclinical teams are energized by our first approval and eager to keep the momentum going. Samantha was granted accelerated approval on the priority of view based on the Lotus 2 trial, a single-arm, multi-center open label phase two trial and a molded total of 145 patients who had relapsed through a refractory, diffuse start B-cell and phoma following at least two lines of prior systemic therapy.
Jay Feingold: The trial included a broad spectrum of heavily pre-treated patients with very difficult-to-treat diseases, including patients with high-grade B-cell lymphoma, a key point of differentiation for our later. The trial also enrolled patients who did not respond to first line therapy. Patients were factory to all prior lines of therapy, and patients who had prior stem cell transplant and cartilage therapy. Svalda offers a truly differentiated treatment option for this broad population of Velocirfractory DLBCL patients.
Equivalents of approximately $383 million as compared to approximately $439 million as of December 31, 2020.
We will also be drawing down another 50 million disbursement from our Deerfield facility in the near future, which was contingent upon us and lots of approval, we used approximately $55 million in net cash for operating activities in the first quarter.
We expect our spend to continue to increase slightly as we are now in full launch mode and also initiating multiple new clinical trials with our commercial organization fully hired in Q1, our spend should level off later this year.
Jay Feingold: As Chris mentioned, we are exploring the opportunity to expand the addressful patient population for Zinlanta into earlier lines of treatment and an additional histology. First is our ongoing Pivotal Phase 2 Lotus 3 trial of Zimantra in combination with Arbutton, The patients with relapse through a factory, diffuse large B-cell or mantle cell and foam, which is contend to support the submission of a supplemental BLA, Interim data from the phase one portion of this trial showed encouraging efficacy and manageable toxicity for an overall response rate of 63% across all patients and 67% in non-GCB, the LBCLP.
R&D expenses were $39 million for the first quarter compared to $35 million for the same quarter of 2020.
The increase was primarily due to the growth of our R&D organization to support us in lots of BLA submission Medical affairs, prelaunch activities and multiple ongoing clinical programs.
Sales and marketing expenses were $14 million for the first quarter of 2021 compared to $3 million during the first quarter of 2020.
The increase in sales and marketing reflects the build out of our commercial organization and other investments in preparation for the launches in Monza.
G&A expenses were $18 million for the quarter compared to $6 million for the same quarter of 2020 the.
The increase was primarily due to increased share based compensation expense and the cost of being a public company.
Our net loss was $52 million for the first quarter compared to a net loss of $43 million for the first quarter of 2020.
The net loss reflects a $21 million noncash gain related to the changes in fair value of derivatives associated with the convertible loans under the convertible credit facility with Deerfield.
Jay Feingold: We expect to report additional data from the phase one portion of this trial in the second quarter and to complete phase two enrollment in the second half of this year. Next, we have our ongoing confirmatory phase 3, Lotus 5 clinical trial of the non-ta in combination with the Tuxtuptuptupt, Notice 5 is also intended to support a supplemental deal-only filing for Zimanda as a second-line therapy for relapse to refractory diffused large BCL patients who are not eligible for stem cell, We expect to complete the safety of leading portion of this trial in the second half of the year.
Net loss also included share based compensation expense of $14 million for the first quarter of 2021, our diluted net loss per share was <unk> 67 in the first quarter of 2021 compared to a net loss of <unk> 85 in the first quarter of 2020.
Finally, our adjusted net loss excludes certain items associated with the Deerfield convertible loans and share based compensation expense the.
The adjusted net loss was $57 million for the first quarter of 2021 compared to an adjusted net loss of $40 million in the same quarter of 2020.
The increase in adjusted net loss was primarily driven by the investments in the expanded portfolio and the preparation for the anticipated launch of the Monza the <unk>.
Adjusted diluted net loss per share was <unk> 74 cents for the quarter compared to a loss of <unk> 78 for the same quarter of 2020.
Jay Feingold: We also intend to initiate several additional trials and on the trials this year. First, we plan to start a pivotal phase two clinical trial and follicular infomer in the coming week. In the second half of 2021, we also plan to initiate trials in Lhontos and multiple combinations in B-Seld and non-Hodzcommodic and dose-finding study of Zolanda in combination with R CHOP in first-line D All of these trials will explore the expansion of the Manta in early lines of therapy across B-cell non-Hospital and phoma. Moving to our second program, Kami, we have made purpose across both our hospital informer and solid treatment program.
With that I will turn the call back to Chris for closing remarks, Chris.
Thank you Jim Joye of.
Jennifer.
This is state of the transformational time in the history of ADC too we are well positioned to achieve our objectives as we enter the next phase of growth.
This slide highlights of our anticipated development milestones, which I reviewed earlier.
We congratulate the team the bolts and lots of propulsion umbrella.
I hope as many of patients as possible to benefit from our next generation ADC.
I look forward to updating you on the progress of our loans and our rich pipeline in the coming quarters.
I am pleased to now open the call to your questions.
Roger.
Thank you we will now begin the question and answer session.
I'd like to ask a question.
The pressing star of the number of one on your Touchtone phone.
Thank you for your phone you need to pick up your handset first before pressing any numbers once again to ask a question. Please press Star then the number one on your <unk>.
<unk> phone.
Our first question comes from Matthew Harrison from Morgan Stanley. Your line is now open.
Jen Creel: We've completed a moment in our phase two pivotal trial and patients with relapse to refractory hutchpin and Thomas. Updated interim results from this trial are expected in the second quarter, and we expect this trial to support an FDA-BLA submission for relapse through a factory hospital. In addition to our hospital informal program, we have an ongoing phase 1B dose escalation trial of CAME in combination with pembodosomab in patients with advanced solid treatment.
Hi, This is the general from Matthew Thanks for taking the old crushers.
Congrats on the progress we have a couple of questions. The first one is the.
Could you maybe comment on the activity profile operating loans.
In general versus the other reason the RPC our approvals.
Approvals and how do you see the position.
Sure.
Yes sure.
Thanks for the question. So I think that should be cautious difficult to answer a question for each of our comparative trial, sorry, I'll give you the caveat before we start to conversation.
But the view of that I think that the toxicity profile.
All of that.
Sure sure I should say is and whether that was demonstrated its been very manageable for the treatment related.
The residential.
Simulation of the trial was of about 19%, which is actually the less and that's where the reported for other recently.
Jen Creel: We are encouraged by the preclinical data and pharmacokin data from the phase one monotherapy part of this trial that support further development in solid tumors, and we look forward to sharing more data in the future. As I just talked about in our CAME program, our ABC technology is also being explored for the treatment of the following tumor. After the validation of our platform, with Apollo and Lonto, we are even more excited to explore the potential of ABCs and various soloists.
<unk>.
We have a very low rate of febrile neutropenia of about 3%.
So patients who discontinued therapy for infusions of the deal but in general.
<unk>.
There were very few dose the ways of more than one to two weeks in the almost no.
Dose.
The accretion.
The dose reductions excuse me.
The trial other than that mid day by the true.
While the science, but when we went from 150 micrograms per kilogram for 75 months of grasp the killer.
So we believe that the toxicity profile of that portfolio.
The strong.
The manageable and will not be any barrier to use in the community.
Jen Creel: In addition to KAMI, ADCT 901, targeting CAG1, is a novel first and class asset for the treatment of patients with advanced solomers with high medical needs, This includes platinum-resisted ovarian cancer and triple negative breast cancer. We expect to file an INV in the second quarter and enter the clinic shortly thereafter. Next, ADCT 6 for 1, targeting Axel, is another promising asset, as Axel is over-expressed in many solid tumors, such as lung, breast, prostate, pancreas, chleoma, and esophageal.
Okay. Thank you very much and then maybe.
Would you say the potential implications of the NCC in the kind of life in terms of use potential could you comment on that.
Jennifer do you want to take that.
Yeah, certainly thanks, Chris and thanks for the the question.
In terms of the NCC and guidelines, we're very pleased one first proud of the team at ADC therapeutics for submitting the guideline requests from the same day of FDA approval.
On April 23rd we're equally happy with the Swift update from the Mtc of treatment guidelines and believe that their timely response is really reflective of the differentiated profile of the non tech and also the high unmet medical need for these patients.
And so we're very happy with how quickly the of MPC and has worked we're also very happy that the Mtc and has recognized the broad population of patients who benefited from didn't launch of consistent with our FDA indications. So we think that the early inclusion and the MTP and treatment guidelines will allow us to.
Jen Creel: We now expect to initiate the phase 1D combination study and multiple solit tumors in the first half of 2020. In addition, our last clinical stage program, ADCT 602, targeting CB22, continues to enroll patients in phase one through trial, which will treat the refractory acute and plastic leukemia at MDN. And finally, we also have a robust R&D pipeline, six additional programs, and preclinical development. With that, I will turn the call over to Jen to discuss a financial opportunity. Thank you, Jay, and good morning, everyone.
To accelerate our access initiatives and.
And ensure that patients who may benefit from don't want to have the opportunity to do so.
And since access is one of our launch imperatives critical to our success.
We believe that the differentiated profile of the Atlanta as well as open access will facilitate our launch uptake through the year.
Okay. Thank you very helpful from.
Once again.
Okay. Thank you.
Thank you. Our next question comes from the <unk> Ahmad from Bank of America. Your line is now open.
Hi, good morning. Thanks, so much for taking my question I wanted to focus a little bit on kidney and maybe Jay can you talk a little bit about them.
Jen Creel: As we reported in our press release, we ended the first quarter with cash and cash equivalents of approximately $383 million as compared to approximately $439 million as of December 31, 2020. We will also be drawing down another $50 million disbursement from our Deerfield facility in the near future, which was contingent upon Zinlanza approval. We used approximately $55 million in net cash for operating activities in the first quarter. We expect our spend to continue to increase slightly as we are now in full launch mode and also initiating multiple new clinical trials.
What data should we expect the fee from the solid tumor study it you know potentially at Opco.
At this point of what indications do you think that you would be most helpful about for Tammy in solid tumor and then can you talk to your view about the side of that profile specifically as it relates to the D. D F. Thank you.
I guess is the enjoys due to the.
Sure Josh.
The question so.
I think the us grow.
With the providing.
The trial in Congress most of them. So we're not providing specific data, but we don't have data yet from the.
The trial.
The the published anywhere because of the stone dose escalation studies for the trial's going along pretty well.
Although the number of patients.
And so hopefully we'll have some more information of that in the future but.
Jen Creel: With our commercial organizations fully hired in Q1, our spend should level off later this year. R&D expenses were $39 million in the first quarter, compared to $35 million in the same quarter of 2020. The increase was primarily due to the growth of our R&D organizations to support Zinlantz's BLA submission, medical affairs pre-launch activities, and multiple ongoing clinical programs. Sales and marketing expenses were 14 million for the first quarter of 2021, compared to 3 million during the first quarter of 2020.
I haven't given any timeline for that yet.
I think your other question was related to come in.
The operation is almost the correctly.
What indications on the solid tumor safety is the most of them.
Encouraged about and then for.
In general profile, specifically GBS.
Sure sorry, I'm, just a little question.
So we would.
Would you see the literature information to determine which which solid tumors. The most commonly held true.
Aided by T cells.
We haven't focused all of our specific tumor types, yet because we're still in dose escalation so kind of moving across the board the wouldn't surprise me the tweet.
Focusing on sort of specific tumor types both of its too early to name what those might be and just don't have enough information yet.
Jen Creel: The increase in sales and marketing reflects the build-out of our commercial organization and other investments in preparation for the launches in Lantas. G&A expenses were 18 million for the quarter, compared to 6 million for the same quarter in 2020. The increase was primarily due to increased share-based compensation expense and the cost of being a public company. Our net loss was $52 million for the first quarter compared to a net loss of $43 million for the first quarter of 2020. The net loss reflects a $21 million non-cash gain related to changes in fair value of derivatives.
In terms of the size of a profile of again in the solid tumor study, it's really early we have not.
Reached the maximum tolerated dose.
No we haven't seen anything unexpected, but we don't see is neurotoxic autoimmune autoimmune.
Neuro autoimmune toxicity excuse me do not see other GBS Apollo Ventriculography of as time went into the monotherapy dose escalation trial, which all of who is either.
On the call GBS of Hollywood, the Q, obviously only machine in Hodgkin lymphoma patients and we believe that the.
The correlation between.
And that of information that we've treated more of the 140 patients now.
The diseases all of the Hodgkin lymphoma was kept me we've never seen the patient GBS of Hollywood Casino opposite so and of course as you know the mismatch of association.
Jen Creel: associated with the convertible loans under the convertible credit facility with Deerfields. Net loss also included share-based compensation expense of $14 million for the first quarter of 2021. Our diluted net loss per share was 67 cents in the first quarter of 2021, compared to a net loss of 85 cents in the first quarter of 2020. Finally, our adjusted net loss excludes certain items associated with the Deerfield Convertible Loan and share-based compensation expense
Uncommon, but the occasional cases of GBS related the Hodgkin lymphoma. So.
And in terms of of GBS in Hodgkin lymphoma, what we're seeing in the phase II trial of what we've discussed the ash.
Back in the summer is consistent with what we're showing of the phase one trial.
Okay. Thank you.
Okay.
Thank you as a reminder, if you have a question. Please press Star then one on your Touchtone phone again, if you have a question. Please press Star then one on your Touchtone phone.
And presenters I'm showing no further questions in queue I will turn it back to you for closing comments.
Thank you. Thank you everyone for joining the call stay low.
For to keep you updated on our progress and so I also have another study.
Thank you good luck.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect.
Jen Creel: The adjusted net loss was $57 million for the first quarter of 2021 compared to an adjusted net loss of $40 million in the same quarter of 2020. The increase in adjusted net loss was primarily driven by the investment in the expanded portfolio and the preparation for the anticipated launch of Zunthas. The adjusted diluted net loss per share was 74 cents for the quarter compared to a loss of 78 cents for the same quarter in 2020. With that, I will turn the call back to Chris for closing remarks.
[music].
Chris Martin: Thank you, Jen. Jay and Jennifer.
Chris Martin: This has been a transformational time in the history of ADCT, and we are well positioned to achieve our objectives as we enter the next phase of growth. This slide highlights our anticipated development milestones, which Jay reviewed earlier. We congratulate the team that Borts in Lonsor patients, and we are eager to help as many people as possible to benefit from our next generation ADC. I look forward to updating you on the progress of our launch and our rich pipeline in the coming court. I'm pleased to now open the call to your question. Operator.
[music].
Operator: Thank you. We will now begin the question and answer session. If you would like to ask a question, you do so by pressing star or sending the number one on your touchstone phone. If you are using a speakerphone, you need to pick up your handset first before pressing any numbers.
Operator: Once again, to ask a question, please press star, send the number one on your touchtone phone. Our first question comes from Matthew Harrison from Morgan Stanley. Your line is now open. Hi, this is General Al from Matthew.
unknown: Thanks for taking out the questions and congratulations on the progress. We have a couple of questions. The first one is, could you maybe comment on the safety profile of Lentha in general versus other recent DRBCR approvals and how you see its position? Yes, sure. Thank you for the question. I think that's a good question.
Jay Feingold: It's difficult to answer, of course, since these are not comparative trials, so I give you that caveat before we start the conversation. But in view of that, I think that the toxicity profile of Ranka that would demonstrate, I should say Zinanda, that was demonstrated. The treatment-related adverse events that led to discontinuation in our trial were about 19%, which is actually less than that which has been reported for other recently approved products.
Jay Feingold: We had a very low rate of fever and echinia, about 3%. We did have some patients who discontinued therapy for effusions and edema, but in general, those adverse events were well managed. There were very few dose delays of more than one to two weeks, and there were almost no dose increases or decreases or dose reductions, excuse me, during the trial other than that mandated by the trial design when we went from 150 micrograms to 75 micrograms per kilogram.
Jay Feingold: So we believe that the toxicity profile that we put forward is very strong and is very manageable and will not be any barrier to use in the community. Okay, thank you very much. And then maybe... Do you see the potential implications of the NCC and guidelines in terms of use potential? Could you comment on that?
Chris Martin: Jennifer, do you want to take this?
Jennifer Heron: Yes, certainly, thanks, Chris. And thanks for the question.
Jennifer Heron: In terms of the NCC and guidelines, we're very pleased, well, first, proud of the team at ABC Therapeutics for submitting the guideline request on the same day as FDA approval on April 23rd. We're equally happy with a swift update from the NCCN treatment guidelines and believe that their timely response is really reflective of the differentiated profile of Lantha and also the high level of medical need for these patients. And so we're very happy with how quickly the NCCN has worked.
[music].
Jennifer Heron: We're also very happy that the NCCN has recognized a broad population of patients who benefited from DENLANTA consistent with our FDA indication. So we think that early inclusion in the NCCN treatment guidelines will allow us to accelerate our access initiatives and ensure that patients who may benefit from Zin Lant have the opportunity to do so. And since access is one of the imperatives critical to our success, we believe that the differentiated profile of Zinlanta as well as open access will facilitate our launch uptake through the year.
Jennifer Heron: Okay, thank you very much. I'm glad to get it. Thank you. Thank you. Our next question comes from Chazin Ahmad from Bank of America. Your line is now open. Hi, good morning.
unknown: Thanks so much for taking my question. I wanted to focus a little bit on Camie, and maybe, Jay, can you talk a little bit about what data we should expect to see from the solid tumor study in, you know, potentially at ASCO? At this point, what indications do you think that you would be most hopeful about for Cammy and solid tumors? And then can you talk about your view about cytosolidicase?
Jay Feingold: to the site of our profile, specifically as it relates to GBS. Thank you.
Jay Feingold: Thank you, Jane. Jay, do you play that? Sure.
Jay Feingold: Sure, I can answer this question. So I think at ASCO, not providing to trials in progress; We're not providing specific data. We don't have data yet from the trial that we've presented or published anywhere, because we're still in the dose escalation phase, but the trial is going along pretty well. We've enrolled a number of patients. And so hopefully, we'll have some more information on that in the future, but I haven't given any timeline for that yet. I think your other question was related to Cammy and the Umblay syndrome. Was that correct to him?
Jay Feingold: What indications of solid tumor safety do you feel most encouraged about? And then, just in general, a profile, specifically GVF. Sure, sorry, I missed a little question. So, you know, we're using literature information to determine which solid tumors are most commonly infiltrated by T cells. We haven't focused on specific tumor types yet because we're still on dose escalation, so kind of rolling across the board. It wouldn't surprise me if we end up focusing on certain specific tumor types, but I think it's too early to name what those might be. We just don't have enough information yet.
Jay Feingold: In terms of the side effect profile, again, in solitumumum, it's really early. We have not reached the maximum tolerated dose. You know, we haven't seen anything unexpected.
Jay Feingold: What we don't see is neurotoxic autoimmune toxicity. Excuse me. We do not see any GBS or polyvediculocity at this time. We didn't do so in the monotherapy or dose exclamation trial with cellulis either. And as you can call GBS and polyvidiculopity, if only we could see it in Hodgkin and phoma patients, and we believe that there's a correlation between that information and the fact that we've treated more than 140 patients now with diseases other than the hospital informant with Kemi, we've never seen a case of GBS or polymedic neuropathy.
[music].
Jay Feingold: So, and of course, as you know, there is literature association with uncommon but occasional cases of GBS related to hospital informants. So, and in terms of GBS and hospital informants, what we're seeing in the phase two trial and what we discussed with Ash back in December is consistent with what we saw in the phase one trial.
Jay Feingold: Okay, thank you. Thank you. As a reminder, if you have a question, please press Star Than 1 on your touchtone phone. Again, if you have a question, please press Star Than 1 on your touchtone phone. And presenters, I will not take any further questions in queue. I will turn it back to you for closing comments.
Chris Martin: Thank you. Thank you everyone for joining the call today.
Chris Martin: We look forward to keeping you updated on our progress, and so I'll say, have a nice day and take care. Thank you. Goodbye. Thank you, ladies and gentlemen. This concludes today's conference call.
Operator: Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.
unknown: and so on. I'm going to and Thank you, Thank you, Thank you, and Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, and Thank you. Thank you. Thank you. Thank you.