Q1 2021 Affimed NV Earnings Call
Good day, and thank you for standing by welcome.
The at the mid first quarter 2021 financial results and corporate update conference call.
At this time all participant lines are in listen only mode. So if you require operator assistance. Please press Star then zero.
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I'd now like to turn the conference over to your host today, Mr. Alexander Food Akitas head of Investor Relations had half of it. Please.
Please go ahead.
Thank you Liz I'd like to welcome and thank you all for joining US today for our first quarter 2021 results and operational update call before we begin I'd like to remind everyone that we issued for the relevant press release earlier today and that it can be found on the Investor Relations section of our website.
On the call today, we have a management team doctors and Audi Hurts, our Chief Executive Officer, Andreas Hot strength I'm, the Chief Medical Officer onshore Helios, our Chief Scientific Officer, Wolfgang Fischer, Chief operating officer, and Miss the niche Miller, our Chief business Officer, and Angus Smith.
Our chief Financial Officer, the whole team will be available for the Q&A session. Before we start I will quickly go through the Safe Harbor statement.
Today's discussion contains projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions only as of the day of this call except as required by law, we assume no obligation to update these forward looking statements publicly or to update the reasons why actual results could differ.
For materially from those anticipated in the forward looking statements, even if new information becomes available in the future.
These forward looking statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied in the statements due to various factors, including but not limited to those identified under the section entitled risk factors in the filings with the SEC and those identified under the SEC.
The entitled Forward looking statements in the press release that we issued 2 day and filed with the SEC with that I'll turn the call all of the 2 Audi Audi.
Thank you Alex the day everyone.
Thanks, so much for joining us.
Today for the first quarter update call.
I will provide updates on our pipeline.
The progress talks are ongoing studies, particularly the appointing from searching in the 'twenty.
Thank you for.
And the all the plans for the remainder of the world.
We also speak for eating up all the announcement of all parts of the D. C. In the program with the.
True.
I'm very pleased to report to you in May.
Turning all of momentum by continuing to execute well across all of our wholly owned wholly owned programs.
We're leveraging the unique features off all of it you got sort of engagements controls of the call of ICD across different programs.
And has continued to publish data that support the multi pronged approach of how.
The development strategy.
Which includes development of power of Ice's mono therapy.
And in combinations with natural killer cells and in combination with PD, 1 PDL 1 checkpoint.
For us.
Our EBITDA from 13 in F 'twenty for kidney programs on track.
Let me start with the registration study of opinions from Citi.
Okay.
This study is conducted as mono therapy in relapsed or refractory peripheral T cell lymphoma, and he continues to enroll patients following the positive interim analysis outcome, which we reported margin.
Today, we announced we expect to complete the improvement of about the Hunton 10 patients in the.
First half of 'twenty to 'twenty 2.
And that we expect to be able to provide guidance about timing for data as we can.
Get closer to the completion of enrollment.
We're also very pleased with the progress and B enrollment of the phase 1 study at MD Anderson Cancer Center.
This study is evaluating increasing doses of cord blood derived from that particular zones pre complex with anything from surgeons.
Today, we reported that the dose escalation cohorts on the bulletin growth.
And that he expects the MD Anderson.
We'll have a data update.
From this study at the major medical conference in the second half of them.
And the current protocol of for the study patients can receive up to Tucson keeps of therapy <unk>.
<unk> concludes the 1 infusion of any of it from.
13th pre complex with Cooper, the right not to dilute the.
Followed by 3 weekly administration of.
200 milligram of any of from searching monotherapy.
The dose of natural killer cells is 10 million per kilogram of body weight.
For a true.
And 100 million per kilogram of body weight and courts.
In April Doctor is the 1 of M D.
The <unk> cancer Center presented data from the first full of patients that were treated with the seasonality.
And each experienced significant <unk> reductions.
With 2 complete responses and 2 partial responses and the.
Objective response rate.
100 per ton.
In May we announced the publication in clinical cancer research supporting the therapeutic potential of <unk> in combination with Mexican themselves.
I'm, the Chief Scientific officer will discuss the key takeaways from the publication and <unk>.
Some of our other preclinical Brendan just of human rights.
Important to us and he's from 13 continues to validate all of a 3 pronged development strategy for all of it in that southern gates of molecules.
There's no demonstrated the bank you can drive for responses as mono therapy in indications, where the innate immune system its functional <unk> specific T.
We mean peripheral T 7 per month.
You've heard of the published data on the combination of agent 13 with Penn Burleson.
It demonstrates the synergy between <unk> 13, and the PD 1 in Hodgkin.
And we have emerging data in the emerging dataset around the combination of <unk> from <unk>.
With cord blood derived NK cells that have demonstrated exciting initial results from 2 different deposits of fee income.
The data with no generated from any from 13 is informing the way we develop the rest of the of our pipeline, notably from 'twenty 4.
Yeah.
Let me turn to any of your from 20 point development of any of your from 'twenty 4 is on track.
Now the ongoing monotherapy setting up your patient advanced Egfr positive saw the funding.
The aim of this dose escalation phase of instead of the HDD.
Chairman of the maximum tolerated dose and establishment of a recommended phase 2 dose.
The dose expansion piece is intended to connect preliminary efficacy.
Evidence of efficacy in specific indications anchor for the concern the Statesville day from 24.
As announced today, we've now completed those cohorts fight at 320 milligram and for recruitment of patients into core and <unk> begun at a dose level of 480 milligrams.
Which is the 50% increase in dose from Cowen Helane.
The decision to increase to 480 milligram whats driven by data derived from the from the cohorts 1.2 points.
Specifically our decision was informed by Pharmacodynamic data from cohorts 1.2 for <unk>.
The pharmacokinetic data from cohorts, 1.2 of them.
Keith and indeed, very encouraging findings are that we have seen a more than dose proportional increase in exposure.
And as we escalate the dose and the increasing exposure. He was no correlated with increases in the activation markers on natural killer cells, and CD 16 receptor occupancy.
Importantly, we have not observed the times of NK cell exhaustion.
In terms of safety no medically relevant drug related targets that.
Has been reported other than the infusion related reactions.
Which of them managed to standard of pre medications.
We have not seen any of the classical egfr related toxicities to comb with points such as skin or are the organ toxicity.
Subject to additional dosing steps, we plan to determine the recommended phase 2 dose and we're expecting to begin the expansion cohorts in the second half of this.
The impact of Arlo, we're making progress towards our goal of getting into additional combination studies.
Which would include things mitigation of any of you from 'twenty for it in combination with Ross.
Anti PDL, 1 antibody hudson's from use them up.
By leveraging now both the EBIT.
The adaptive immune system uniquely can potentially be synergistic effects of <unk>.
The global you did for <unk>.
From 13.
And this could provide the very meaningful benefits for patients.
We expect to dose the first patient in the phase 1 for next to a study evaluating the combination of in the second half of 2021.
In addition, we expect to initiate the phase <unk> study for the combination of <unk> from 2004 with NK Chen buyers autologous NK cell product in the second half of the Skus.
We're committed to pursuing a multi pronged development strategy development approach for the age from 20 for which we believe will enable us to target the broad range of Egfr expressing tumor types.
And population in the fall at the St.
For each of all of 3.8 from 24 studies, we plan to have the expansion cohorts in at least 2 to 3 different indications.
In total the AE from 'twenty for program will target the broad range of Egfr expressing tumors.
Providing us with multiple opportunities for clinical success.
We expect to disclose more details of all the indications for these studies like the business.
Let me talk about quickly about the heat from 2008, our third program for you from 2008, we continued to advance the R&D, enabling studies.
And we plan to release the information about the target and.
And initial preclinical data at the major medical conferences later this year.
<unk> remains on track to submit the R&D reputation from the first half of the 2 thousands of 2022.
And our goal is to begin our care of nickel starting in the second half of 2022.
This morning, we also want amounts for an update on the development of our own 7 to 9789 by our partner Genentech.
This is the bcm of any targeting units engage of genetic has completed the dose escalation portion of the phase 1 study no dose limiting toxicities were observed during the the studies.
However, due to a broader portfolio of consideration Genentech decided to stop the phase 1 study.
As a reminder of this brokerage was the only the first of multiple targets on the developments with genetic and they've made the pivot to us that this decision does not have any implications for our platform will impact the continued development of the other targets.
So we should remain weak.
<unk> confident in our collaboration with Genentech and look for but to progressing the additional targets towards clinical development.
Now I'd like to leave you with the message today that we are very proud and excited to be able to play a leading role in developing countries therapies based on in 19 of the entities.
As we have.
Shown.
At multiple events, we believe Macau units and engage the molecule of.
For the unique advantages over other immunotherapy.
They do this by binding to a unique epitope of <unk>.
Which allows us to show of reduced competition with the <unk>.
Leading to a far more attractive tumor from Ken with ADT.
The <unk>.
That has the superior binding and retention of natural killer cells, which have been shown to consist over top of rebate.
They are able to kill.
The 2 months of independent of the level of volume to Chinese question.
Smoking shown that NK cells for you.
The pre complex with all of the high affinity units and engage the show improved from myself.
We've positioned the ultimate and the unique place.
In the innate immune cell therapy landscape.
We have developed the differentiate the drug platform net generates the near term engage the molecules.
Enabling NK cells and macrophages to locate for the tumor and once they do to eliminate.
Furthermore.
As we're learning for cell line NK cell based approaches these required the specific targeting of NK cells to recognize the true.
We're addressing this important meet with all of them on the specific units.
And that's the nature of mortgage.
With that.
And over the call to line.
Oftentimes Angus will give you an update on our financials.
Thank you Audrey.
Good morning, everyone also warm welcome from me as the.
The you mentioned in the past few months, we have generated the exciting preclinical data with all of the IC molecules, which I'd like to share with you today.
On the ASM 'twenty 4 we presented a preclinical poster of this years ACR.
And the poster we were able to demonstrate that <unk> from 24 in combination with adoptive NK cells.
It leads to a from 2000 for dose dependent tumor regression in a mouse xenograft model.
Establishing a strong preclinical proof of concept for this promising combination.
This important finding was further supported by data demonstrating.
At the ASM 'twenty for its ability to tightly bind to NK cells as well as the size of toxic potential to kill Egfr expressing tumor cells was unaffected by the presence of competing IGT.
This is in contrast to <unk> tox, Satsuma, such toxic potential which of course greatly diminished by competing IGT.
The poster further show that <unk> hundred 20 for induces a very prominent AED CP response or killing through of macrophages.
<unk> Egfr positive tumor cells irrespective of the presence of K Ras mutations for.
The other adding why we believe this is a highly differentiated drug candidate.
On April 13, and the collaboration with Purion and felt at the Carlin Sky in Stockholm.
We generated data demonstrating that the addition of day from 13 to NK cells renders these NK cells serial killers.
Look at slide 6 of your presentation that shows microscopy pictures of the single well.
Containing a single NK cells in multiple tumor cells in the absence of presence of <unk> from <unk> on the top row, you can see that the single naked undirected NK cell, which is shown in blue.
There is not able to kill CD 30 positive tumor cells. Those are shown in red overtime period of 12 hours.
The video capturing activity at each time point shows that the naked NK cells without the addition of <unk> from 13 moves of Rollins.
Undirected fashion without killing tumor cells in Stark contrast.
And as shown on the lower line of pictures.
Additionally from 13, clearly increases the ability of that NK cells, not only to kill 1 but several of tumor cells.
Turning from Red to Green when Theyre being killed the.
Demonstrating that the innate cell engagements from 13, effectively direct NK cells to tumor cells and can render these NK cells serial killers.
Next I would like to summarize the key findings of our collaborations with the lapse of the cater for Salon at MD Anderson of <unk>, Washington University School of Medicine, which was recently published in clinical cancer research.
Of this paper, we were able to show that day from 13 strongly binds to NK cells, including cytokine activators for.
Cord blood derived NK cells, resulting in enhanced tumor recognition and ADC antibody dependent cellular cytotoxicity.
This exciting data of formed the basis for the successful R&D of the.
The ongoing phase 1 study.
With pre complex cord blood derived NK cells at MD Anderson.
In patients with CD 30 positive from the promos.
The schematic on slide 7 shows the cord blood derived NK cells with free activators and the <unk>.
Presence of our 12, 50% of 18 for 16 hours for void left untreated before being further co culture with the feed herself.
<unk>, an expanded cord blood NK cells shown on the top of the schematics for resulting in free activated and expanded for abbreviated later as Pete and E. P plus the cord blood derived NK cells are shown on the bottom.
As you can see on the next slide 8 of the rights of <unk>.
Out of the toxic the efficacy of free activated and expanded cord blood derived NK cells shown in green.
The substantially enhanced by the combination with <unk>.
Over the cytotoxicity of only expanded cord blood NK cells, which are shown in light blue.
Importantly, the surface expression of CD 16 remains unaltered in both treatment groups as you can see on the graph on the left.
The go to slide 9.
Shows you on the rights of the long retention NK cells after the pre loading the.
These with a from the <unk> foods.
Moving to a substantially higher degree of specific killing of <unk> positive tumor cells.
Over a period of 72 hours when compared to unloaded NK cells.
The post the ability to kill tumor cells remains unaffected by washing the AFM 13, preloaded NK cells.
And this is the comparison between the blue of the Red bars.
The graph on the left shows that this pace of <unk> mediated high degree of cytotoxicity.
Monitored frequently over the period of 24 hours.
Also on this graph, we can clearly see that the degree of ADC is much higher today from 13 pre loaded versus unloaded pre activated and expanded cord blood derived NK cells and again that washing the NK cells complex with a from the <unk> does not.
Affect their ability to kill.
Demonstrating the ability of all of our IC molecules to bond strongly and Durably to <unk> 16, a on the NK cells and forming stable car like complexes without the need for any substantial engineering.
We can generate these car like NK cells in just 1 to 2 hours.
I will now turn the call over to Angus to provide an update on our financial position and quarterly results Angus.
Thank you Ark.
<unk> consolidated financial statements have been prepared in accordance with IRS has issued by the international accounting standard Board for ISP.
The consolidated financial statements are presented in euros, which is the company's functional and presentation currency.
Therefore, all financial numbers that I will present on this call unless otherwise noted will be in euros.
We ended the first quarter of 2021 with cash and cash equivalents of 247 million euros compared to a $146.9 million growth on December 31, 2020.
The cash balance includes the net proceeds from our January of 2021 underwritten public offering.
And the $10 million, we received from the first tranche of the Silicon Valley Bank loan.
Based on our current operating plan and assumptions, including the proceeds from the recent financing from we anticipate that our cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the quarter ended March 31, 2021 was 16 million euros compared to $16.5 million euros in the first quarter of 2020.
Total revenue for the first quarter ended March 31, 2021 was $11.7 million euros compared with $5.1 million for the quarter ended March 31.2020.
Revenue for the first quarter of 2021, mainly comprised of collaboration revenue from Genentech and ROI that.
Research and development expenses for the first quarter of 2021 remained flat at $11.4 million euros.
For the first quarter of 2020.
General and administrative expenses for the first quarter of 2021 increased to 27, 3% to $4.5 million euros from $3.5 million euros in the first quarter ended March 31.2020.
The increase relates largely to higher personnel expenses higher premiums for our D&O liability insurance and higher legal and consulting expenses.
Net finance income for the quarter ended March 31, 2021 increased by 242% from $1.6 million in the quarter ended March 31.2.
The $25.5 million.
This increase is largely due to foreign exchange gains related to the assets denominated in U S dollars as a result of of the strengthening of the US dollar against the euro during the first quarter.
Net income for the quarter ended March 31, 2021 was $1.4 million euros or <unk> <unk> per common share compared with the net loss of $8.3 million euros of our loss of <unk> 11 per common share for the quarter ended March 31.2020.
The weighted number of common shares outstanding for the quarter ended March 31, 2021 was $116.2 million.
I will now turn the call back to <unk> for closing remarks.
Thanks, a lot of Angus.
So the second half of 2021 could be of rich with data based on our pipeline and the outreach.
We're focused on execution.
And what's the financial strength to bring out of programs forward with cash runway into the second half of 2023.
Key upcoming milestones for our pipeline the August follow ups.
For <unk> from 13, we expect to complete enrollment in the study.
In the first half of 2022.
And to provide guidance for the timing of the data released capital from the time when we complete the enrollment in this line.
For the study of any of you from 13 pre complex with NK cells, we expect.
At the MD Anderson cancer center with record of additional data.
Jim I think the conference in the second half of the scale.
For AE from 'twenty for monotherapy, we are now recruiting.
And those conflicts.
And are on track to complete the dose escalation and slowing down of expansion cohorts in the second half focused.
We further expect to initiate true for each 1 of the SG&A combination studies of <unk> from.
24 in the second half of EPS.
Including the steady with NK Chen.
1 of.
Total therapy <unk>.
Study in combination with <unk> in combination with Ross.
For <unk> from 28, we expect to disclose the targets.
For this program and.
And publishing the completion you can take kind of embedding the content in the second half of.
I'd like to reiterate our appreciation and gratitude to investigate and chemicals for patients and the family.
Volume across the organization for their continued support and commitment and our athletes.
We would now be happy to take any questions that you may have.
Operator.
If you'd like to ask a question at this time. Please press. The Star then the number 1 key on your Touchtone telephone.
To withdraw your question press the pound key.
Again that is star then 1 if you'd like to ask a question at this time.
Our first question comes from Maury Raycroft with Jefferies.
Hi, good morning, everyone and thanks for taking my questions. So.
First question is just if you could talk more about where you're at with the PD.
Court for for AFM 20 for I guess, if you use of positive control or think about maximum NK cell activation markers and PD for Q&A occupancy where are you at for with the PD for industrial before and how much more room do you have to go.
Sure.
Andreas can you take this question please.
Yeah sure. So what we have said is that.
And we see.
Significant increases in exposure, which was more than dose proportional.
And that all of the activation markers that we're looking at that includes CD 16 receptor occupancy of about that clearly not limited to CD 16 receptor occupancy all show of good correlation with the exposure.
So as we go up we expect to.
Get into the range of say Pharmacodynamic the optimal dose of <unk> was 1 of those for the reasons why we decided to go to some.
More of the step now so instead of 100% increase we selected to go with a 50% increase.
Again, we are very happy with the safety profile as we have for us.
And so we have not seen any of the typical of Oregon toxicity, most notably skin toxicity or any other medically relevant toxicities. So we are titrated dose the dose.
To really define for you as the optimum biological dose and if this was the reason why we decided to go into smaller steps.
Got it that's helpful and makes sense and based on your objectives for ASM 'twenty for to pick a recommended phase 2 dose based on the demonstrated ability to improve outcomes I guess could you clarify if you plan to continue exploring higher doses until you see a safety issue or CS exhaustion of ENT.
<unk> dollars for are there specific efficacy parameters that youre looking at with the amount of hair.
Yes, good question.
So that's what he said previously based on the mechanism of action and the preferential activation of NK cells in tumor tissue.
We would not expect and also in line with our kind of mortgage market data, we would not expect to incur.
Counter any of classical dose limiting toxicity, so we will probably not escalate.
See toxicity, because this is probably a very unrealistic high dose.
What we really want you to of closely obviously of Pharmacodynamic markers as we said we have a mixture of <unk>.
Marco sort of indicate activation of the NK cells looking at CCT is exceeding the receptor occupancy, but also of monitoring NK cell exhaustion, and we will titrate the dose of that we get the maximum increase and the activation marker, while maintaining a functional NK cells. So.
Minimizing the exhaustion markers and of this will guide us in our selection for our dose of goes forward into into the phase 2 and the 2 the expansion cohorts.
Got it that's really helpful and then last question.
Based on the PD data from cohort 4 and the PK data from cohort 5 could you say, if it's possible that cohort 5 dose level could be sufficient to start the combo studies in the second half of 'twenty 1.
I think it's a little bit too early.
As we said we believe that we should be able to define the recommended phase 2 dose. The second half of this year was of this cohort 5 or maybe 1 dose cohort above will still depend on the data set we have seen.
Got it okay. Thank you for taking my question.
Youre welcome.
Our next question comes from Dana <unk> with SBB Leerink.
Hi, Thank you for the question I'd like to talk more about the Genentech decision.
I guess, 1 logistical question of process question and 1 science question. So I'll start with the process question do you can you do you plan to take this program back as ASM 26.
And we'll we will genentech present at dose escalation of results for the medical conference.
Thank you Dana I'll turn it over to you for the kind of.
For the contract with the <unk>, Yeah, Hi, Dana Thanks for the question.
This is really early innings for us and we Havent discussed with Genentech with the future of the program could look like.
And whether or not right could revert back to <unk>. So it's just too early on that but what we do know as genentech will be planning on publishing the data at a medical conference later this year.
That's helpful and then and scientifically.
The structure to remember that we've seen or we haven't seen promising results of NK cell therapy adoptive cell therapy in multiple myeloma I believe the meat.
The cell had a cohort of their NK cell therapy combined with 2 of the mab that they never presented but suggested that the results aren't particularly promising I wonder if you could scientifically to put this in context.
For what we've seen for other NK cell either NK cell therapy of NK cell directed therapies and multiple myeloma.
Yes.
Over to.
Andrea.
Okay. Okay.
Okay address please.
I think it's a good question.
What is important to note is that we.
We do not know anything about the efficacy of the phase 1 study so.
We have not seen the flow dataset, others in our exchange of safety.
Information, so there's probably a little bit too early to speculate about the efficacy or loss the loss of efficacy.
In general I would agree of multiple myeloma appears to be of difficult area for immune based therapies the slot.
The only as of.
NK cell approach for so far we're not so successful with.
Also can recall as the as the failure of PD 1 in the.
Multiple myeloma.
So it appears to be of very specific biology.
Really probably deferring a little bit from biology, and other lymphoid malignancies growth again, as we do not have the full data set it it would be premature to speculate really here.
Got it let me think of.
Oh go ahead sorry.
No no of PC related.
I'd like to hear what you were going to add and I just wanted to summarize that we really should see.
The efficacy results.
Yeah, I mean, just the 1 thing I would add the gamete of its interesting as I would say, it's wildly accepted the Tucson lab is not 1 of those stronger antibody is kind of in the field with NK cell so that could have a bearing there.
And really nothing to add.
The.
The address is beautiful to explain the port also immune function in Moscow alone.
Okay great.
Then 1 last question here do you have any sense of when we can learn the target or when you will announce the target for other programs and the Genentech collaboration.
Hi, Dana.
We're prohibited from disclosing anything related to the targets with Genentech and <unk>.
I guess it would become apparent when they take 1 of the next molecules into the clinic at which point in time, it'll be a pack, but unfortunately, we're not able to disclose any sales what I can tell you is it the mix of solid and hematologic.
Part of that we're working on with them.
Yes.
Great. Thank you very much for the answering the question.
Our next question comes from Nick Abbott with Wells Fargo.
Oh good morning, Thanks for taking my question.
<unk> for its future of coal ash in preclinical models of at least in the I guess the general observation with the.
And I had some engages that you see kind of cleavage of CD 16.
After binding and so as you as you look at the data that you're accumulating the PD data.
And I don't know I can't remember if that leads to.
Sort of soluble <unk> for CD 60 of soluble <unk> 16.
'twenty for complex, but.
Are you seeing this are you able to look at this and look at that.
The expected cleavage event, and then allied to that.
Are you seeing evidence of any NK cell modulation and how do you think about sort of total NK cells for the <unk>.
The circulating NK cells for the search.
The aging pool as you think about optimizing that Tom with the dynamic.
Endpoint.
Can you take the question.
Sure Yeah.
Great question. Thank you.
First of all we can to some degree look at cleavage not so clearly in the patient, but what we have seen as you've noticed in preclinical models.
That is not affecting the first of all of it doesn't really we don't see that sort of a certain degree it's not affecting the efficacy of the molecules.
In contrast, and we have commented previously we believe that some degree of cleavage.
Observed is probably a good biologically because of the Abel. It's also the NK cell to disengage and engaged again again when we look at what we have seen an hour of really describing with the bureau non felt interest is just a preview of something we will want to publish more substantially towards the end of the year, we see.
The ice's render the NK cells cereal.
And that again I think has also to do some some extent with the ability to disengage.
Some amount of of cleavage now to your question about.
Margin nation of NK cells overall numbers.
What we have seen let's start with the preclinical studies. If you may recall the monthly data we have seen that the.
The peripheral levels brands of Lee go down we believe that.
Is most likely modulation with the cells.
Coming back. It also we believe there is a sign of the.
The NK cells actually being led into the tumor. So also more generally we think there are 2 mechanisms of action of course that would be expected 1 the NHL engages leading the NK cells from the periphery inch of the tumor and the NHL engage was also the <unk>.
Taking the NK cells in the tumor micro for them and really engaging them to go kill the tumor let me stop here just to make sure that I'm answering your questions.
Yeah, I think I think we're definitely.
Getting a lot of good information.
But as you say as you sort of think about that threshold that you want to see in PD.
Okay.
Are you able to account for the different pools the tissue.
The NK cells and tissue.
Circulating NK cells.
Of that movement.
Presumably between those 2 pools.
Yeah.
Yes, we are.
I think we have said that we're looking for sites off as we look at the activation markers of exhaustion markers of course look at all of the NK cell populations very actively in the study we will also be able to some extent looking for the units.
Industry and see what kind of infiltration we get.
So of the tumor so there will be an evolving overall picture in terms of distribution of NK cells.
Okay, great. Thank you very much.
Thank you.
Our next question comes from Yale Jen with Laidlaw <unk> company.
Okay.
Good morning, and thanks for taking the questions.
My first question is that the live before looking 1 in terms of AFM 13 monotherapy.
Once you complete the current study.
My understanding is that you were the.
Later.
Conduct the pit.
Our confirmatory study my question is that would you potentially start the confirmatory study.
Before you will have the readout of the current study or you would do that after work.
Andreas couple of question for you.
Yes.
Oh, yes, we have not finalized.
Of this.
As you know we are targeting an accelerated approval, which was 202, which would require us to start to have a confirmatory study at the time line for CLI submission. So how does.
This was something I think where we start to engage with FDA into discussions.
Not only about the monotherapy program, but again about 2 broader air from 13 development strategies that could include <unk>.
<unk> based therapies as well as mono therapy.
It's something that we need to do as we are approaching the completion of the enrollment phase, but we have not made a final decision here.
Okay, Great and maybe 2 quick questions. The first 1 is that the although I understand the assets 13 comp the NK cell combo studies still going for.
Given that the.
For the open label.
The 1 so is there any read through at this point for.
For your design for the air.
The 24.
<unk> combo studies at the moment.
Well at the moment, we are pursuing 2 different strategies of <unk> 13 users allogeneic product and we are employing preloaded NK cells.
No for F 'twenty for we use.
Ultra logos NK cells, so the essence of 1 product from <unk>.
<unk> Gen, which has already an established safety profile has also shown some.
Preliminary activity.
Really looking at co administration of sort of parallel infusion.
We are giving the NK cells much more frequently with the giving NK cells from the weekly basis. We also have significantly higher total number of NK cells. So.
If you will we are more or less exploring the broad spectrum that you could think about from 1 of NK cell infusion of LNG in a pre loaded to multiple NK cell infusions.
At the logos.
And Ed Co administration, and really see how all of the system.
<unk> will differ which will guide us going all the way forward.
But currently they are quite different testing really 2 different strategies.
Okay, maybe the last question you mentioned the ball checking the NK cell exhaustion.
Mark are probably the same quarter alone across the board at this point would you provide a little more color in terms of.
The specifics of biomass.
Biomarkers are the.
The key to pay attention for the investor to pay attention to.
Yes.
<unk>.
Art do you want to take that question.
Happy so great cash from Yale I know as of yet.
So all of expert you will be interested of like everybody else. We are not disclosing that the this time.
So please understand that could have also IP implications and of course, we want to share that entire day. We can tell you of that of course, we.
All of that's a pretty broad panel and includes all of our markets that you would traditionally expect in terms of activation and all the exhaustion. So that's as much as we can say at this time.
Okay, I really appreciate that in the region fully understand that and again congrats for heading for the.
The second half of this year.
Thank you. Thank you.
As a reminder, if you'd like to ask a question at this time. Please press. The Star then the number 1 key on your Touchtone telephone.
Yeah.
I'm showing no further questions in queue at this time, so that will conclude today's question and answer session.
Ladies and gentlemen, this concludes today's conference call.
Thank you for participating you may now disconnect.
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