Q3 2021 ADC Therapeutics SA Earnings Call
Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, please stay on the line.
[music].
Yeah.
Yeah.
Welcome to the ADC Therapeutics third quarter 2021 financial results Conference call. My name is Kevin and I'll 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 Star then one on your Touchtone phone.
Now turn the call over to Amanda Hamilton Investor Relations manager you may begin.
Thank you operator. This morning, we issued a press release announcing our third quarter 2021 financial results and business update.
Elyse is available on the <unk> web site at IR that ADC therapeutics Dot com under the press releases section.
On today's call, Chris Martin Chief Executive Officer, Jennifer Herron, Chief Commercial Officer, Martin <unk>, Chief Medical Officer, and James <unk>, Chief Financial Officer will discuss recent business highlights and review our third quarter 2021 financial results before opening the call for questions.
As a reminder, this conference call may contain forward looking statements such statements are subject to risks and uncertainties for additional information concerning forward looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements. We refer you to the sections titled cautionary statement regarding.
Forward looking statements.
Exhibit 99, three of our report on form 6K filed with the U S Securities and Exchange Commission earlier today.
Statements speak only as of the date of this conference call and we expressly disclaim any obligation or undertaking to update any forward looking statements unless required to do so by applicable law.
Today's presentation also includes non <unk> financial measures. These non <unk> 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 Ias RF you should refer to the information contained in the company's third quarter earnings.
Release right.
Additional information and reconciliations of historical non <unk> measures.
Comparable I FRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin Chris.
Thank you, Matt and thank you everyone for joining us today.
I'm very pleased to share an update of our progress during the third quarter.
We successfully executed on all key objectives driving visit multiple bumps at the R&D line and achieving several important corporate development goals.
We are now approximately six months into the <unk> launch we are encouraged by what we have accomplished to date delivering $13 $1 billion in net sales in our first quarter at the moment.
We have generated good momentum behind the boat group <unk> unique product profile significant unmet need.
Third line plus <unk> on the strong execution of our highly experienced team of sales and medical professionals.
Jennifer Herron, our chief commercial officer will share more details on our launch a little later in this call.
Boyd barrel post FDA approval, we remain committed to expanding our geographic footprint provides involved to as many patients as possible worldwide with relapsed or refractory <unk>.
The EMA validated our marketing authorization application and we received orphan drug designation in Europe.
The Oberland ADT joint venture also made tremendous progress with the initiation of the pivotal phase III bridging study in China.
Which is intended to serve as the basis for regulatory filing in China.
In addition to geographic expansion. We are also continuing to evaluate <unk> in combination with other agents in early a lot of opportunities in <unk> and as a single agent in Follicular lymphoma.
On the R&D front, we continue to advance our pipeline programs, which are important for driving long term value for the company.
We initiated the phase one study for <unk> hundred one targeting <unk> one.
And entered into a collaboration with the NCI for the development of <unk> 701 targeting DLP one.
The County, we continue to advance the phase III trial in relapsed refractory Hodgkin lymphoma.
And the phase one b study in solid tumors.
Joe <unk>, our Chief Medical Officer will elaborate on our key programs in a few moments.
Finally during the quarter, we extended our cash runway by entering into a financing agreement with healthcare royalty partners for.
For up to $325 million.
<unk> development of the commercialization of the Atlanta and Kathy.
I would now like to turn the call over to Jennifer to provide some insights on our progress with the <unk> launch Jonathan.
Jennifer.
Thank you, Chris and good morning, everyone.
I'm happy to be here today to share an update on the U S and lots of launch we are pleased to report Zen launch of net sales in the third quarter of $13 1 million.
During our first full quarter of the loss of sales.
This early launch performance has been driven by deadlines with differentiated product profile the significant unmet medical need in third line plus D. L Bcl and the strong execution of our seasons cross functional team of <unk>.
Sales marketing market access and medical affairs professionals.
In terms of additional insight into our launch dynamics. Our commercial team has made good progress initiating new accounts and driving increased volume from existing accounts, including our prioritized key accounts and NCC and NCI centers.
Despite continuing COVID-19 related challenges our targeted launch efforts have resulted in significant increases in brand awareness perception and intent to prescribe and we.
We're also competing well in terms of share of voice.
The differentiator and launch a product profile can launch a product profile continues to resonate with both academic and community based physicians.
During the third quarter not surprisingly academic centers support resulted in greater than 50% of Q3 total volume with an equal proportion of ordering accounts coming from academia and the community.
Recently, we have seen increasing volume from the community as expected as payer access and reimbursement turnaround become more reliable.
In terms of patient access we are very pleased with our progress.
<unk> and medical teams have achieved broad access for patients with no barriers encountered thus far.
And we expect the permanent J code in January of 2022 to accelerate local community reimbursement trial and adoption.
Anecdotally, we hear that the patient experience in the real World is similar to the alluded to trial experience, which supports the broad use of <unk> across the third line plus D. L Bcl patient population.
While our initial use has been predominantly in the fourth line patient population.
<unk> has also been used in the third line setting, including patients who may go on to car T. After you launch it.
Recall that in the loaded two trial 16 patients receive CD 19, directed car T therapy after treatment with <unk> with an investigator assessed <unk> a 44%.
The differentiated product profile, which is a unique combination of robust single agent efficacy with a median time to response of 41 days.
Generally manageable side effect profile and convenient 30 minute infusion every 21 days makes them want to an incredibly competitive agent in the third line plus setting and why we believe that's been lost that has the potential to be the third line plus standard of care.
As for the launch outlook for the rest of the year, we will be proactively monitoring the impacts of Covid.
The opportunity for face to face visits and the variability around patient scheduling with the upcoming holiday season.
Specifically regarding operating in the Covid environment.
The cross functional team, including marketing sales market access and medical affairs has been navigating the hybrid launch with the agility to engage both virtually or in person depending on geographic guidelines and physician preferences.
While institutions and other face to face opportunities have not opened up as quickly as we had hoped our face to face engagement has been stable over the last few months at about half of all of our interactions.
In summary, we are encouraged by the HCP reception to the launches differentiated product profile, resulting in positive launch momentum generated to date, while recognizing the incredibly dynamic environment.
We acknowledge the uncertainties associated with the evolution of the pandemic, but believe there remains an opportunity to unlock the full potential of the losses as the standard of care in its label indication and our team is focused on bringing the lawsuit to any patients who may benefit from treatment with.
We look forward to keeping you updated on our launch progress.
Now I'll turn the call over to Joe to provide an update on our pipeline.
No.
Thank you Jennifer.
I am very pleased to be able to talk to you today about how ADC therapeutics is working to moves in long term beyond their first indication with studies in combination with other agents in earlier lines of treatment and a different subtypes of non Hodgkin's lymphoma star.
Starting with the Lotus III trial, we are evaluating <unk> in combination with Ibrutinib for relapsed refractory diffuse large b cell or mantle cell lymphoma.
We are initiating a phase II program with a higher dose and more frequent administration of <unk> to determine the complete response rate and durability of response as well as the Tolerability of this combination.
For potential use in earlier lines of treatment.
Our ongoing confirmatory phase III Lotus five clinical trial of Syn <unk> in combination with Rituximab is intended to support a supplemental BLA filing as a second line therapy for relapsed or refractory <unk> patients who are not eligible for stem cell transplant.
This trial continues to enroll patients and we expect to complete enrollment of the safety lead in this trial by the end of this year.
The phase II <unk> six trial in relapsed or refractory Follicular lymphoma is ongoing and our published data from the phase. One study showed that 11% to 14 patients had a response to demand to including nine patients. We showed a complete response. The median duration of response was not reached in that phase one trial.
In addition to these trials, we aim to initiate several additional <unk> and lots of trials by the end of the year, including a study of Syn <unk> that evaluates for different combinations in separate arms and a dose finding study of <unk> in combination with R. Chop in previously untreated <unk> patients. These trials, we will explore the.
<unk> Atlanta into earlier lines of therapy across B cell non hodgkin lymphoma.
And finally, whereas in Atlanta, we're looking forward to discussing new data to be released at the upcoming Ash conference.
Moving to <unk>, we continue to advance both our Hodgkin lymphoma, and solid tumor programs with enrollment in the phase II trial in Hodgkin lymphoma completed in February 2021, we plan to have preliminary results in the first half of 2022, after which we will share. The next steps for a pathway to regulatory submission. We also continue.
To advance can be with our ongoing phase <unk> dose escalation trial in combination with <unk> in patients with advanced solid tumors.
Furthermore, we are supporting our pipeline.
Averages are validated ADC platform applied to the treatment of solid tumors during the third quarter, we dosed the first patient in the phase one study of <unk> hundred one targeting <unk>, one and <unk>.
Novel first in class candidate for the treatment of patients with advanced solid tumors with high unmet medical need, including platinum resistant ovarian cancer and triple negative breast cancer.
Another promising pipeline candidate is <unk> 601.
<unk> <unk> <unk>.
Getting Axel Axel is over expressed in many solid tumors, such as lung breast prostate pancreas, glioma and esophageal cancers, we expect to initiate the phase <unk> combination study in multiple solid tumors in the first half of 2022, and we look forward to sharing more details about this program in the coming months.
As Chris mentioned earlier, we entered into a collaboration with the National Cancer Institute to develop ADC <unk> 701 targeting <unk> one in Europe, Andrew Crean malignancies with high unmet medical need. This includes adrenocortical carcinoma, pheochromocytoma Paragon element neuroblastoma in small cell lung cancer and <unk>.
Finally.
Our ADC to 602 program targeting CD 22 continues to enroll patients in a phase <unk> trial for relapsed or refractory acute lymphoblastic leukemia. This is in collaboration with MD Anderson and city of hope medical centers.
We also have a robust R&D pipeline with seven preclinical development programs and we look forward to keeping you updated on all of these programs.
With that I will turn the call over to Jen to give a financial update.
Thank you Joe and good morning, everyone.
As reported in the press release issued earlier today <unk> third quarter net sales were $13 1 million, reflecting the first full quarter of <unk> sales.
As of September 30, we had cash and cash equivalents of $530 million as compared to $372 million as of June 30 of this year.
During the third quarter, we use roughly $59 million in cash for operating activities.
In August we entered into a financing agreement with healthcare royalty partners for up to $325 million, including gross proceeds of 225 million received upon closing.
R&D expenses were $37 million for the third quarter of 2021 compared to $32 million for the same quarter in 2020.
The increase was primarily related to the medical affairs support of this <unk> launch and the expansion of the <unk> clinical program and our broad portfolio.
Selling and marketing expenses were $17 million for the third quarter of 2021 compared to $6 million for the same quarter of 2020.
The increase in selling and marketing reflects the expenses for the <unk> launch and the ongoing commercial efforts.
G&A expenses were $17 million for the third quarter of 2021 compared to $14 million for the same quarter of 2020.
The increase was primarily due to increased head count to support the needs of our commercial stage public company.
Net loss was $72 million for the third quarter of 2021 compared to a net loss of $20 million for the same quarter of 2020.
Our diluted net loss per share was <unk> 93 in the third quarter of 2021 compared to a net loss of 29.
For the same quarter of 2020.
Finally, adjusted net loss a measure that excludes certain items associated with the Deerfield convertible loan share based compensation expense and the effective interest expense associated with the royalty financing agreement with healthcare royalty partners was $46 million for the third quarter of 2021.
<unk> to an adjusted net loss of $41 million in the same quarter of 2020.
The increase in adjusted net loss was primarily driven by the investment in those in line for launch and our clinical programs.
Adjusted diluted net loss per share was 59 for the quarter compared to a loss of 58 for the same quarter in 2020.
With that I will turn the call back to Chris for closing remarks, Chris.
Thank you Jen Joe Jennifer.
To conclude this has been a productive quarter for <unk> ADC.
We continued to execute on <unk> and to advance our R&D pipeline.
Our objectives for the remainder of the year and into 2022 are clear and we are well positioned to execute on all aspects of the business.
We look forward to updating you on the progress of our launch and our advancing pipeline in the coming quarters.
I am pleased to now open the call for questions.
Horizon.
Thank you we will now begin the question and answer session. If you have a question. Please press. The Star then the one key on your Touchtone phone if you wish to be removed from the queue. Please press the pound key ortho <unk>.
Are you seeing a speakerphone you may need to pick up the handset before pressing the numbers. Once again, if you have a question. Please press. The Star then the one key on your Touchtone phone.
Our first question comes from Matthew Harrison with Morgan Stanley.
Great. Good morning, Thanks for taking the questions I guess two for me. So one one on <unk> I know you've commented on the sources of business sort of being 50 50.
Commercial academic I was wondering if you've seen any changes quarter over quarter.
Terms of repeat prescribers or where youre seeing.
Around duration or any other items like that and then and then secondly.
On cammy.
Do you need to meet with the regulators again once you see the data in the first half of 'twenty, two or maybe you can just outline exactly what the steps are youre going to need to take thanks.
Thank you Matthew So Jennifer do you want to take the first question Joe the second.
Sure sounds good.
Chris Thanks, Hey, Matthew.
So in terms of what we're seeing in the evolution quarter over quarter.
To see as I mentioned, a greater percentage of our volume coming from from academia.
I will say over the most recent.
Weeks and months that we're getting increasing use in the community and we would expect that to continue.
From a repeat order perspective.
Volume is still predominant coming from academia, but we're getting new newer and newer accounts coming from the community.
In the recent weeks.
From a duration perspective.
Six months into launch I think it's too early to say, what we're getting from a duration perspective, I mean in the third line plus setting what we're hearing from HCP is theyre looking sort of patient by patient as a very individualized approach it really depends on where that patient is in their in their treatment paradigms. So.
It's really hard to extrapolate too general population I think it's just too early for that right now.
Okay. This is Joe.
Okay.
Follow a pretty standard procedure here, we're going to finish this study.
Compile the data put together a briefing book request the meeting and explain what we wanted to do next which is a possibility so.
Our submission for accelerated approval as well as the proposal for a confirmatory study.
The FDA has.
The last few years.
Welcome to answer your questions and said they don't need a meeting I have a feeling in this case, we will have a will have it will have a meeting with them sometime in the latter part of next year.
And that's pretty standard.
Thank you. Our next question comes from Cristina <unk> with Bank of America.
Good afternoon, and thanks for taking my question.
Thank you.
Maybe a follow up on Matthew's question about it.
For the community Docs is it.
Doctors, who had experience with Santa Monica in the community setting or just prescribing it to more patients or are you getting.
More of the Crescent.
Yes.
And then second.
As it relates to <unk>.
Thanks.
Refractory HL can you give us a sense of where you would expect to see GBS observation.
Are there any observation in your mind could be rate limiting.
The feedback has been so far and then I have a couple of follow ups. Thanks.
Yes.
Yeah.
Thank you.
Jennifer do you want take the first one Joe the second yes.
Okay, Yeah. So.
Thanks.
Community.
I think we're seeing a really healthy mix of new orders and repeat orders, we're adding new accounts every week.
And we're seeing.
Good.
Repeat orders from the existing accounts and the addition of new accounts. So it is not in the community I'm not seeing a concentration of business. If that was your question.
Okay.
With regard to the question about Tammy.
First thing is the.
Based on the data that we're seeing now the balance benefit risk.
<unk>.
We've had.
No increase in the incidence of GBS over the over the trial.
We did have some.
Activities in place to make sure that.
The slides that particular center can be mitigated and keep in mind that.
We're treating patients who have a median of six prior treatments, including patients who failed.
What I call modern treatment with <unk>.
<unk> and <unk>, but also patients who have relapsed after stem cell treatment. So this is a very very high bar and we.
That with the complete response rate in the range of 28% so.
We're positive on the benefit risk and we are confident that FDA will see that as long as we're able to provide all the data, which we plan to do next year.
Okay.
Are you expecting to see.
Inefficient level of GBS, even with the changes that you've made does the level of Fedex.
<unk>.
<unk>.
We have seven.
Percent.
Seven cases, 6% sorry.
I expect that's going to be the number we have a lot of patients now and I think thats going to be the number of GPS cases could be a little lower when we go into clinical practice could be a little bit higher but.
That is the number that we expect to see.
And as I mentioned, we've been able to mitigate the more serious cases so.
We think that given the benefit here.
She's a complete response rate in the 28% range patients who have a median of six prior treatments.
Heatedly failed.
This is an addressable side effect.
And that's our.
The data to be able to to be able to demonstrate that and explain it to physicians.
Okay. Thank you Youre welcome.
So the one that you just mentioned.
Until the clinic, starting that study this year should we expect to see any data there and.
And then as it relates specifically to platinum resistant ovarian can you just remind us what the other options are.
For patients.
What level of efficacy area. Okay. Thank you.
I'm, sorry, I can't hear your question very well were you asking about.
Tag whereabouts.
Whereabouts about kind of where that yogurt, yes, Joe just a quick sorry. The question was.
What do we expect to see data this year.
For ovarian cancer patients.
What alternative therapy.
<unk> therapies out there for this stage of treatment of what level of activity would you expect to say well. Okay. Thanks, Thanks, Chris I didn't hear that.
I heard everything except <unk>.
Of our products, we wanted to figure it out so.
Yes.
We're not going to have any data this year to share I mean, we just started in phase one and it's proceeding at exactly the right pace, which is a careful dose escalation in.
In patients with <unk>.
Refractory cancers.
We generally depending on how the how.
Heather safety proceeds.
We can advance according to our regular schedule. So I'm thinking maybe sometime in the latter part of next year, we could have some data on the safety and develop a plan to proceed there.
The short answer to ovarian cancer question is there really arent any alternatives, which is why CAG is.
The attractive option here.
Ovarian cancer continues to be a serious in highly refractory illness.
Once it reaches that late stage with relapsed so.
At this point there are other novel.
Maybe not normal but there are other.
<unk> products and development, but.
But nothing that is novel.
And there is this interesting expression of CAD on ovarian tumors, which is why we chose that but right now the field of options is pretty limited.
Okay. Thank you.
Youre welcome.
Our next question from me.
We haven't seen any GBS in the solid tumor setting.
With the kind of thing.
Okay. Thank you.
Our next question comes from Boris <unk> of Cowen.
Greg My first question is on the can you comment on the data what should we expect to see at Ash.
Well I can't be specific about the data youre going to see at ash, because its still under embargo, but I will tell you that is commonly.
Done we will have longer term follow up we will have some subgroup analysis as you recall, we have is we have patients in our <unk> trial.
We are not eligible for some of the other trials going on at the same time and so we're going to be reporting on those on those kinds of analysis and put in addition to some longer follow up and we do have other products also available now that have been submitted to the Ash conference.
Got it and also what is the timing of the data read outs from Lotus <unk> and Lotus five.
When do you anticipate top line data.
Yes, I can't really tell you that we just started the amendment for Lotus III.
We're likely to have some data from the completed part of Lotus III by this time next year that's about right.
How do you how the amendment proceeds.
We will determine when we will have some data, but it won't be.
<unk>.
Probably before 2023.
When you asked about <unk>, 5%.
We're just at.
At the point, where we're finishing the.
<unk> will start the randomized part of this we expect that to take 18 to 24 months and then I'll just remind you. It's an event driven trial. So predicting when we will have the events that will determine.
Difference between.
You're seeing lots of Rituximab and reflects about <unk> <unk>.
Hence on the occurrence of progression so it's hard to make predictions, but like.
You said I can tell you what the enrollment period is probably going to be 18 to 24 months.
Great. Thank you very much for taking my questions Youre welcome.
Our next question comes from Brian Chen with Cantor Fitzgerald.
Hey, Tim Thanks for taking my call and congrats on a great quarter.
Seems like you are tracking well against the historical sales trajectory for some of the competitive product in the <unk>.
Brian: against the historical sales trajectory for some of the competitive products in DLBCL. Do you have a sense of where you stand on market share in third line plus DLBCL? And then I have one more follow-up.
Do you have a sense of where you stand on market share in third line plus the LPC al and then I have one more follow up thanks.
Unknown Executive: Yeah, thanks, Brian. Thanks for the question.
Okay.
Yes.
Yes, thanks, Brian Thanks for the question, Yes, we are.
Unknown Executive: Yeah, we are pleased with this quarter's performance. In terms of metrics, as I mentioned in my remarks, we've made some significant increases in awareness and familiarity, and intent to prescribe. We're also holding our own in terms of share of voice, so we're happy with that.
Pleased with this quarter's performance.
In terms of metrics as I mentioned in my remarks, we've made some significant increases in awareness and familiarity and intent to prescribe.
Also holding our own in terms of share of voice that were happy with that.
Unknown Executive: We are monitoring the market quite closely to make sure that we remain competitive and that we can adapt our hybrid plan as the local conditions require. You know, Q4 is looking better in terms of COVID, but again, that could change on a dime as we get into the winter months. One of the things that we are watching carefully is face-to-face interactions because of the importance of engaging nurses, pharmacists, and physicians about the differentiated profile of Zinlanta.
We are monitoring the market quite closely.
To make sure that we remain competitive and that we can adapt our hybrid launch plan.
At the local conditions require.
Q4 is looking better in terms of Covid, but again that could change on a dime as we get into the winter months.
One of the things that we are watching carefully as face to face interactions because of the importance of engaging.
<unk> pharmacists and physicians about the differentiated product profile of the launch and of course. This is going to be our first Q4 in terms of any kind of seasonal effect with patient visits so yes.
Unknown Executive: And, of course, this is going to be our first Q4 in terms of any kind of seasonal effects on patient visits. So, you know, we're cautiously optimistic about Q4, and we'll be looking forward to updating you as that quarter wraps up.
Yes.
We're cautiously optimistic about about Q4.
And we'll be looking forward to updating you as that quarter reps.
Great Jonathan.
Brian: Great, Jennifer. Maybe just on your Axel Target at 601 program, can you give us an update on the manufacturing front? And what are your latest thoughts on patient selection and the initial set of indications? And then, ahead of the upcoming update from the competitor Axel Target at ADC and sarcoma at the CETA meeting later this month, how should we think about the potential re-through from their update to your 601 program? Thank you.
Maybe just on your.
Exxon target at 601 program.
Can you give us an update on the manufacturing front.
And what is your latest thoughts on patient selection and the initial set of indications and then ahead of the upcoming update from a competitor to OXXO tie to ADC in sarcoma at the <unk> meeting later this month.
How should we think about the potential read through from their update to your 601 program. Thank you.
You brought up on the manufacturing side.
Unknown Executive: On the manufacturing side, as you know, we're using Cynific site-specific conjugation in the Axel program. We did the phase one dose escalation study as we normally do using frozen product, and we're now moving to manufacturing liophilized product. So the manufacturing is well underway to supply.
As you know.
We're using the Significs site specific conjugation.
And the actual program.
We did the phase one dose escalation study.
As we normally do using frozen product.
We're now moving to manufacturing <unk> product.
So the <unk>.
Manufacturing is well underway.
To supply the clinical study will start in the first half of next year.
Unknown Executive: by the clinical study for the start in the first half of next year. I'll hand over to Joe to address the clinical aspects. Joe. Okay.
I'll hand over to Joe to address the clinical aspects.
Okay. Okay. Thanks, Chris Thanks.
Joe: Okay, thanks, Chris. Good. Thanks.
You wouldn't you won't be surprised to hear that we're also interested in sarcoma theres a lot of reasons why those of us doing work in actual sarcoma to be an attractive target.
Joe: You won't be surprised to hear that we're also interested in sarcoma. There are a lot of reasons why those of us doing work in Axel find sarcoma to be an attractive target. But we don't have our protocol finalized yet, and we're working out a couple of details with investigators and with FDA to try to determine how we can do better than just selecting a, you know, literature-based tumor and trying to get some of the population a little more.
But we don't have a protocol finalized yet and we're working out a couple of details with our investigators and with FDA to try to determine how we can do better than just selecting the literature base tumor and try to get some.
Population is a little more likely to respond to actual.
I just don't have the final details to share but.
When we have that protocol final.
Then I'll be able to share some data thats, probably going to happen in the first half of next year. That's that's the current plan.
And with.
With regard to the.
Competitor.
I tend to try to learn what we can from our competitors but.
We have a unique.
TBD auction.
We.
We think that.
We have we have very high potency here. So we think that with with the expression levels that we're going to be able to terminate the trial will be able to get entry of the toxin into the into the malignant cells.
Joe: likely to respond to Axel. So I just don't have the final details to share, but when we have that protocol finalized, then I'll be able to share some data. That's probably going to happen in the first half of next year.
Proposal <unk>.
Now and I think that it really does depend on the potency of the toxin.
And our ability to help enhance.
The chances of finding a highly expressed actually.
Brian: That's the current plan. And, you know, with regard to our competitors, I mean, I tend to try to learn what we can from our competitors, but, you know, we have a unique PBFECD. D toxin, and we think that, you know, we have very high potency here. So we think that with the expression levels that we're going to be able to determine in the trial, we'll be able to get entry of the toxin into the malignant cells.
Tumor so there's a couple of details will be filled in but we're doing it now and I will be able to give you more on this.
First half of next year.
Alright, we look forward to that thanks for taking my question. Thank you. Thank you.
Our next question comes from Kelly <unk> with Jefferies.
Thank you for taking my question and congrats on a great quarter.
So growth from that falls Atlanta is it staying around the same at 83% as mentioned in Q2.
Are we going to expect some change.
Follow up on Canada.
Two of us.
Yes.
Okay.
Chris This is John I can I can John.
Please.
And then Jennifer confusing.
Thanks, Kelly for the question.
So.
Our gross to net details you can see in our 6K, we filed this morning.
Brian: That's, you know, it's our proposal now, and I think that it really does depend on the potency of the toxin and its ability to help enhance the chances of finding a highly expressed axel tumor. So there's a couple of details that will be filled in, but we're doing it now, and I'll be able to give you more on this in the first half of next year.
But.
Q3 gross to net deductions were right around 14%.
And Thats really right in the general range that we would expect for an infusion drug in this kind of specific patient population.
It's early days and we do expect this to fluctuate we really only have a few months of actuals at this point.
And we still have some estimates included in our sales deductions, so and we'll continue to monitor.
Unknown Executive: Great; we look forward to that. Thanks for taking my question. Thank you.
We.
Move forward and let you know if.
If there is any uptick.
Thanks for the question.
Thank you and also Paul Kelly could you share the possible hypothesis regarding the incidence of GBS talks.
Operator: Our next question comes from Kelly She is with Jeff. Thank you.
You said the prior PD one antibody treatment.
Some association with Cvs, we have seeing some documented cases for PD one treatment a trigger.
Kelly She: Thank you for taking my trust, and congrats on the grade quarter. So on that, for Zilanta, is it staying around the same at 83% as mentioned in Q2? Are we going to expect some change? And I'll have follow-ups on Canada.
Heavily pretreated patients.
And also there will be able to rule out the possibility of this will happen to solid tumors based on whether youll have done. Thank you.
Joe do you want to take that.
Sure.
Sure. It's a very good question.
Yes.
First of all we know that the Hodgkin Hodgkin lymphoma patients have a bit more of a predisposition to gamble ratio Thats. One thing that we have to keep in our minds when we consider this.
Chris: Hey, Chris, this is Jen. I can jump in there.
Yes.
And we do know that it's at.
Jen: Jen, Jennifer, confusing. Thanks, Kelly, for the question. So, you know, our gross to net details, you can see in our 6K we filed this morning. But, you know, for Q3 gross to net, the deductions were right around 14%. And that's really right in the general range that we'd expect for an infusion drug in this kind of specific patient population. But, you know, it's early days, and we do expect this to fluctuate.
Has to be related to some kind of enhancement.
In the system right now, it's all speculative for us at this point, we can't findings actually.
Trigger that.
That good activates the immune system specifically.
Two.
Against.
The nervous system, we just don't know that yet.
Not inconsistent with data from the checkpoint inhibitors.
These kinds of immuno inflammatory side effects can happen so.
Yes.
It's.
It's a reasonable hypothesis that the activation of the immune system, that's about as far as we can go we cannot say anything specific for you.
Jen: We really only have a few months of actuals at this point, and we still have some estimates included in our sales deduction. So, you know, we'll continue to monitor this as we move forward and let you know if there are any updates. Thanks for that.
Unique about.
Yes.
Kennedy Act.
Activity with regard to the solid tumors.
We saw IBM beret.
Pretty early in the program for Hodgkin's lymphoma, and as I mentioned in Hodgkin's lymphoma patients have a predisposition to this.
We've done enough patients now in the solid tumor.
Kelly She: Thank you. And also, for Kami, could you share the possible hypothesis regarding the incidence of the GDS talks? Do you think prior PD1 antibody treatment has some association with GBS? We have seen some documented cases of PD1 treatment trigger at EBS; we have late-treated patients. And also, we'll be able to rule out the possibility this will happen to solid tumors based on what you have learned.
And we're getting a very high level of confidence that this is not something that will happen with the solid tumor patients. That's just based on comparative observation if and when we saw this in Hodgkin's lymphoma, and how many patients we have in the solid tumor program.
And we're continuing to look into.
Silicon to really what what what what's actually happening with this but it's it's difficult in a lot of people are starting to work on this as well even with the checkpoint inhibitors. Thanks for the question.
Thank you so much for the color one last question if I may regarding the XL XL program.
So from competitors.
They have programs to actually be able to show the correlation between the XO expression and tumor response.
So im not able to I wonder would you be able to comment.
Unknown Executive: Sure, do you want to play that? Yes, it's a very good question. You know, first of all, we know that the high skin lymphoma patients have a bit more of a predisposition to Gambre, so that's one thing that we have to keep in our minds when we consider this. And we do know that it's, you know, it has to be related to some kind of enhancement of the immune system, but right now it's all speculative for us at this point. We can't find exactly the trigger that, that active. based the immune system specifically to, you know, fight against the nervous system. We just don't know that yet.
It is in therapeutics.
Biomarker study I'll, maybe clinical design like what's your expectation on that front.
Yes, I can't really give you any commentary on the clinical design, because it's not finalized yet, but as you know once we do finalize the protocol will be listed on <unk> trials stockpile. So it's not like.
Never hear about it you certainly will but one thing to point out is that.
For companies that are pursuing actual over expression as a way to.
Determined response, they're looking at how actual describing the tumor.
We're looking at how axle is a door to get our traction into the cell.
Little bit different now there may be some activity of our antibody to depressed activity back so, but what we're really looking at is getting a highly potent toxin into the cell.
Sure.
Not really.
Unknown Executive: It's not inconsistent with data from checkpoint inhibitors that these kinds of immuno-inflammatory side effects can happen. So, you know, it's a reasonable hypothesis that the activation of the immune immune system. That's about as far as we can go.
A very good comparison to look at actual.
As a.
As a specific target driving.
Driving the malignant cells are just to look at actual as a way.
Getting our toxin into the start of a totally different mechanisms.
And you'll see more data all future.
Okay.
Very helpful. Thank you.
Welcome.
Our next question comes from Kevin Mcveigh with RBC capital markets.
Unknown Executive: We cannot say anything specific or unique about the CAMI activity with regard to solid tumors. We saw the Embarray pretty early in the program for Hodgkin's Infoma. And as I mentioned, Hodge Kisnifoma patients have a predisposition today. We've done enough patients now in the solid tumors that we're getting a very high level of confidence that this is not something that will happen with the solid tumor patients. That's just based on, you know, comparing when we saw this in hospitals and cloma and how many patients we have in the Solitude Approve.
Hi, Thanks for taking my question and congrats on the quarter. There was impressive commercial result.
I had three questions on Germany.
First of all I just wanted to clarify have you requested or.
How the pre BLA meeting with the FDA or kidney yet.
And then secondly, another question on the etiology of.
GBS have you identified any factors that are associated with risk of recurrence, whether it's treatment history or any biomarkers.
GBS mic effect be replicated in animal models, and then lastly.
I just wanted to see how the Tami and Pembroke combo trial in solid tumors was going and when we could expect to see.
Unknown Executive: And we're continuing to look into, actually, to look into really what is actually happening with this. But it's difficult, and a lot of people are trying to help to work on this as well, even with the checkpointing. Thanks for the question.
Data from that trial, thanks, and congrats again.
Okay, great questions. Good questions first of all with regards to the FTA requests we have not requested the meeting yet we agreed with them. When we proceed with our phase II program that we would wait for the one year follow up on data before we compiled the data and request a meeting with one year follow up will be in February of 2022, then we'll comply with.
Kelly She: Thank you so much for the caller. One last question, if I may, regarding the AXL XO program. So from competitors, some of the programs are actually able to show the correlation between the XO expression and tumor response, but some are not able to. I wonder, would you be able to comment on ADC's biomech's biomarker study or maybe clinical design, like, what's your expectation?
Data and request the meeting the reason for that is that the duration of response was considered to be an important variables. So we don't want to see the data until we have when youre follow up showing.
Good good good duration of response and just a reminder, we still.
And the data we've been showing we still not.
Yet.
Reached.
The median duration of response has still not been reached in these patients. So that's a good thing, but we're going to wait until the one year follow up second question.
Unknown Executive: Yeah, I can't really give you any commentary on the clinical design because it's not finalized yet, but as you know, once we do finalize this, the protocol will be listed on ClinTrials.com. So it's not like you'll never hear about it; you certainly will.
To my knowledge, we can't replicate this phenomenon in animals because.
So you have to have a hodgkin Hodgkin's lymphoma model in animals.
Really you didn't maybe with a transplant tumor I'd just be speculating here.
Can't really replicate this in an animal model, we can we can replicate some of the <unk>.
Clamatorial activities that happen when you depress the T Reg cells, but thats, a long way from an excellent animal model.
Unknown Executive: But one thing to point out is that, you know, for companies that are pursuing Axel over expression as a way to determine response, they're looking at, you know, how Axel is driving the tumor. We're looking at how Axel is a door to get our toxin into the cell. That's a little bit different. Now, you know, there may be some activity of our antibody to depress the activity of Axel, but what we're really looking at is getting a highly potent toxin into the cell.
<unk> syndrome, and so for sure.
Great question, you asked because we are.
Looking exactly at what you suggest which is how about what about the treatment history is there a biomarker.
And its and its it.
It hasnt yet yielded.
Specific answer for us.
But we're still looking and reminder, these are very complicated treatment history. So it's not a big surprise.
You can't sort out something.
Not something obvious, but we're continuing to look so you're right on target with what kinds of research we have to do to try to.
Unknown Executive: And so it's just, it's not really a very good comparison to look at Axel as a specific target driving the malignant cell as it is to look at Axel as a way, you know, getting our toxin into this. That was a totally different mechanism.
Mitigate.
The side effect given that there's such a promising response rate in these patients and the third thing can lead program in solid tumors is proceeding very well.
I think reflects.
The <unk> the.
The high need for new drugs in the solid tumors that we're studying.
Unknown Executive: And you'll see more data in the future. Okay. Okay. That's very helpful. Thank you. You're welcome.
But I can't tell you exactly when we're going to finish because youre still doing dose escalation.
And as you know you guys do that carefully so we're making sure that we get the right combination of Canada with Pembroke and then once we expand we'll be able to.
Kenan McKay: Our next question comes from Kenan McKay with RBC Capital Markets.
To show what we've learned in terms of safety, what dose, we chosen and what kind of responses we're getting so.
Kenan McKay: Hi, thanks for taking the question and congrats on the quarter. Very impressive commercial results there.
A little bit uncertain, but proceeding very well in terms of enrollment.
Yes.
Okay.
Did I lose everybody.
Okay.
Okay.
Kenan McKay: I had three questions on Tammy here. First, I just wanted to clarify. Have you requested or had a pre-BLA meeting with the FDA for Cammy yet? And then second, another question on the etiology of GBS. Have you identified any factors that are associated with risk of infection? recurrence, whether it's treatment history or any biomarkers, and can that GBS-like effect be replicated in animal models? And then lastly, just wanted to see how the Camry and Pembro combo trial in solid tumors was going and when we could expect to see data from that trial. Thanks and congrats again.
And I'm not showing any further questions at this time I'd like to turn the call back over to Chris.
Thank you.
You very much everyone for joining the call today, we look forward to keeping you updated on our progress.
Have a nice day.
Well.
Thank you ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
[music].
Unknown Executive: Okay, three questions. Good questions. First,
Unknown Executive: Okay, good questions. First of all, with regard to the FDA request, we have not requested a meeting yet. We agreed with them when we proceeded with our phase two program that we would wait for the one-year follow-up on data before we compiled the data and requested the meeting. The one-year follow-up will be in February of 2022; then we'll compile the data and request the meeting. The reason for that is that the duration of response was considered to be an important variable, so we don't want to send the data until we have it.
Unknown Executive: the one your follow-up showing, you know, good, good duration of response. And just a reminder, we still, in the data we've been showing, we haven't yet reached the median duration of response has still not been reached in these patients. So that's a good thing, but we're gonna wait until your follow-up. Second question.
Unknown Executive: To my knowledge, we can't replicate this phenomenon in animals because it's so you have to have a Hodgkin's homo model in animals. And really, maybe with a transplant to him, I'm just speculating here, we can't really replicate this in an animal model. But we can, you know, we can replicate some of the immuno-inflammatory activities that happen when you depress the T-Regg cells.
Unknown Executive: But that's a long way from an actual animal model of Gambrae syndrome. And so far, it's a great question you asked because we are booking exactly what you suggest, which is, what about the treatment history? Is there a biomarker?
Unknown Executive: And it hasn't yet yielded a specific answer for us, but we're still looking. And a reminder, these are very complicated treatment histories. So it's not a big surprise that you can't sort out something. There's not anything obvious, but we're continuing to look. So you're right on target with what kinds of research we have to do to try to mitigate this side effect, given that there is such a promising response rate in these patients.
Unknown Executive: And the third thing, the CAME program in solid tumors is proceeding very well, which I think reflects the high need for new drugs in the solid tumors that we are studying. But I can't tell you exactly when we're going to finish because we're still doing dose escalation. And as you know, you've got to do that carefully. So we're making sure that we get the right combination of cambered with Pembro, and then once we expand, we'll be able to show what we've learned in terms of safety, what dose we've chosen, and what kind of responses we're getting. So it's still a little bit uncertain but proceeding very well in terms of. Okay? Did I lose everybody?
Operator: And I'm not showing any further questions at this time. I'd like to turn the call back over to Chris.
[music].
Chris: Thank you. Thank you very much, everyone, for joining the call today. We look forward to keeping you updated on our progress, and have a nice day. Bye. Thank you. Ladies and gentlemen, that's the end of today's presentation. You may now disconnect and have a wonderful day.
Operator: and and Thank you Thank you Thank you You Thank you. Thank you. Thank you. Thank you. Thank you.