Q1 2022 Affimed NV Earnings Call
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Good day, and thank you for standing by.
Welcome to the upfront.
First quarter 2022 financial results corporate update conference call. At this time, all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you would.
Require any further assistance. Please press star zero I would now like to hand, the conference over to Alex Who'd Akitas head of Investor Relations. Please go ahead Sir.
Thank you, Matt and thank you all for joining us for our call today before we begin I'd like to remind everyone that we've posted the relevant press release and presentation on the Investor Relations section of our website earlier today.
On the call today, we have the members of our management team, including Audi Hirsch, Our Chief Executive Officer, Andreas hard strike, our Chief Medical Officer <unk> <unk>.
Our Chief Scientific Officer, Wolfgang Fischer, Chief operating Officer, and Angus Smith, our Chief Financial Officer.
The team will be available for the Q&A. After the prepared remarks before we start I would like to remind you that today's presentation contains projections and forward looking statements regarding future events.
These statements represent our beliefs and assumptions only as of the date of the date 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 materially from those anticipated in the forward looking statements.
Even if new information becomes available in the future.
Forward looking statements are subject to risk and uncertainties and actual results may differ materially from those expressed or implied in these statements due to various factors, including but not limited to those identified under the section entitled risk factors in our filings with the S&P and Dow.
Identified under the section entitled forward looking statements in the press release that we issued today and filed with the SEC with that I'll turn the call over to Audi Audi.
Thank you, Alex and good day, everyone and thanks, a lot for joining us for this.
Oh hold today.
I'd like to take a moment to be few once we have achieved so far especially against the challenging backdrop.
Like be a global pandemic geopolitical tension and volatility in the capital market.
In the last two years, we have.
Built a differentiated therapeutics pipeline.
And game shows.
Establish their clinical proof of concept for our three pronged development strategy.
Reinforce that with senior leadership team and strengthened.
Our balance sheet.
More recently, we presented tiny meaningful proof of concept data point, our pioneering approach of treating heavily pre treated patients with a combination of an insulin data and allogeneic natural killer cells.
We also recognize the need to build a solid financial base to allow now swift execution of pilot programs.
And they're very pleased to have recently completed the $103 5 million public offering.
With these proceeds we have the resources required to move our wholly owned programs just mentioned in here from 13 24 and <unk>.
In 2008 to important inflection points over the next 12 to 18 months.
In the first quarter of this year, we announced the completion of enrollment of our reader study.
Which treats patients with relapsed or refractory peripheral T cell lymphoma, with AEP 13 mono therapy.
We expect to report topline data from this study in the fourth quarter of this year.
48.
<unk> studied in combination with natural killer cells.
Following the compelling data that we reported in December of last year.
We presented updated data at <unk>.
And we showed a strong increase in complete responses after Tucson.
RFP at the recommended phase two dose and very encouraging signs so theoretically.
We believe these data continue to validate the program and the overall approach.
The data presentations in December 2022, 1% ACR have led to an increased interest by the time it would be industry and treating physicians and as a result, MD Anderson has been enrolling additional patients with Hodgkin lymphoma, and other CD positive non hodgkin lymphoma.
We indeed had planned to present new data from this study.
Additional patients, including important correlate to some extent.
Hospital, which we now plan to present at a medical conference in the second half of this year.
Moving on price on 24 hour Egfr targeting units and engagement, we continue to enroll patients.
All three clinical trials.
And now a three pronged development strategy and Youre planning to present data in the second half.
This year.
And for <unk> from 2008, our CD 123 targeting selling nature, we're on track to submit an R&D in June .
Our clinical evaluation of patients with relapsed and refractory AML.
We expect to initiate the phase one clinical trial in the second half of this year.
Yeah.
We're also continuing to make progress in our work with our partners at MD Anderson, our T bonds NK churn and other third parties to ensure access to an off the shelf cryopreserved metric here for further development.
With our ICD 10, and gateway therapies.
We expect to provide additional updates on our NK cell development strategy in the second half of 2022.
We are advanced in most of our work with existing collaborators.
K Cup Genentech, we have made good progress in various preclinical program.
And 10 years old, but Robert programs to them for further preclinical development.
Through our partnership with Raymond <unk> is currently being investigated in R&D, enabling studies.
We are eligible for additional proceeds from these key collaborations in the near term, including preclinical milestone.
Well its milestones based on regulatory.
We are also very encouraged by the data presented by our peers.
Peers in the innate immune field.
In the interest from the pharmaceutical industry in therapies based on innate immunity and there was a growing recognition that engaging the immune system can play an important role in fighting cancer Andrew.
And we're particularly proud to be among the first companies to have produced positive clinical data.
Roche.
As our data have shown our three pronged approach has the potential to provide benefit to patients.
That have very limited treatment options.
Urgently need novel treatments.
We aim to bring our drugs forward to registration directed studies.
In the near future and we believe this is great and the strong commercial opportunities for each of our molecules.
With that I will turn over the call.
To address to give you more color on the progress on the programs Andreas.
Okay.
Yeah. Thanks, your idea and also a warm welcome from my side.
I will run you asked how do you set us through all of our development programs and I'll start with AFM 13 as shown on slide four.
As you know we are conducting two studies with AFM 13, our registration directed.
Study of four F 30, <unk> monotherapy in patients with relapsed refractory peripheral T cell lymphoma also known as redirect study and.
And our phase one two study that we're conducting in collaboration with MD Anderson and whoever we are evaluating cord blood derived allogeneic NK cells that are pre complex with AFM 13, followed by AFM 13, mono therapy in patients with relapsed and refractory.
<unk> positive lymphoma.
Let's turn towards the <unk>.
<unk> from 13, 1% for the NK cell study first.
And so recent ACR conference Doctor Jago near towards the lead investigator at M. D Anderson with.
Reported see activity data office approach after the second cycle of treatment for all patients at the recommended phase two dose.
Interestingly and importantly, the rate of complete responses at the recommended phase two dose was the second cycle increased from 38% as reported in December 262%.
Anil analysis.
Overall response rates remains at 100%.
It's important to note here that the treatment is safe and very well tolerated.
The main side effect, where in fact associated with the lymphoid depleting regimen named.
Namely short duration, neutropenia, and shorter duration Trumbo cytopenia.
I would highlight here is the fact that these are mainly I would say laboratory side effects.
Important to notice that they were not associated with any clinical consequences, and we did not observe neutropenia fever or no signs of relevant bleeding.
Also important we did not observe any cases of cytokine release syndrome.
Any cases of neurotoxicity or graft versus host disease, which are often associated with T cell based therapies.
So after reviewing these side effects and learnings SCR to resist transitioned.
They did not lead to treatments delays of discontinuation.
This led us and our colleagues at MD Anderson to belief that the safety and Tolerability profile of this treatment.
We'll allow treating patients was more than the current two cycles.
And in fact at MD Anderson, we are already treating patients with a certain cycle.
Durability data at the recommended phase two dose were also very encouraging.
Well see eight patients who achieved a complete response seven remained in complete response. After a median follow up of six five months.
Including two patients and complete response for more than 10 months.
And two patients who were able to receive consolidation high dose chemotherapy with stem cell transplant.
If we turn to the other study AFM 13, two O two.
Enrollment into the monotherapy study is now complete.
More than 100 patients with relapsed or refractory peripheral T cell lymphomas have received study treatment and we expect us oddly sad to report topline data in the fourth quarter of 2022.
It's a focus obviously stay to release will be is the overall response rate as assessed by blinded Independent review Committee and our preliminary assessment of duration of response.
Into accounts at the maturity of duration of response data will depend on the actual duration of these responses.
In summary, we are very pleased with the continuing development of AFM 13.
Let's now turn to a F 'twenty four.
And the clinical program is summarized on slide five.
I guess I'm 24 is the next most advanced innate cell engage were in our pipeline.
Benefits from the learnings of AFM 13.
24. Therefore has also started according to our three pronged development strategy.
We presented data on the dose escalation up to 480 milligrams weekly as single agent at the recent ACR meeting.
The data showed that the pharmacodynamic activity is present at doses of 160 milligrams and tire.
Importantly, we also observed such a relevant for my quick dynamic parameters like target mediated illumination or CD 16 receptor occupancy.
As well as Marcus of NK cell activation show a plateau between 320 and 480 milligrams.
In the meantime, we have confirmed this finding with the data of the now fully enrolled 720 milligram cohort.
Again, seeing no relevant increases in pharmacodynamic markers with higher doses.
These findings confirm our decision to have defined 480 milligrams as a recommended phase two dose for the expansion cohorts.
And as a consequence of the dose escalation part of the study has been finished has been closed and no higher doses will be investigated.
As I said, we are continuing to enroll patients in the expansion phase of the monotherapy study at 480 milligrams.
These expansion cohorts include patients with renal cell carcinoma, non small cell lung cancer with Egfr mutations in colorectal cancer.
We also continue to enroll patients in the dose escalation part of the two combination studies I F. 'twenty for one or two and F. 'twenty four one O three.
Can I, if I'm to rent for one or two so combination with TSV lease them up Roche anti PDL. One checkpoint inhibitor. We are now treating patients with non small cell lung cancer with Egfr wild type guest.
Gastric and gastroesophageal junction adenocarcinoma, and pancreatic HIPAA to cellular until you retract Kansas.
And the second combination study.
The gate things a combination of higher from 24 with our auto logos.
NK cells S N K one.
Well, we are treating patients with non small cell lung cancer again, Egfr wild type squamous cell carcinoma of the head and neck colorectal cancer.
Through the three ongoing studies, we will be evaluating safety and efficiency of <unk> from 24, nine indication specific cohorts with particular focus on non small cell lung cancer, which is presented in all three studies in colorectal cancer, which is represented in two of the three studies.
As previously said, we expect to report initial data from these studies during the second half of 2022.
In addition, as shown on slide six it N. K 2022 held in mid May we presented an analysis of the longitudinal effects of F. 'twenty four four dose levels up to 480 milligrams.
Confirming the mechanism of action of <unk> from 24 on the innate immune system.
Oh, there was an increase in <unk> 67, a proliferation marker in the peripheral and peace NK cells.
And then the induction of cytokines like TNF and interferon gamma overtime.
Importantly, and consistent with the Pharmacodynamic data. So these effects were more pronounced at higher dose levels of 160 milligrams into buff.
A novel finding Wassa data that suggests that also an activation of the adaptive immune system.
Maybe happening by a F 'twenty four.
The analysis showed activation of cytotoxic T cells in the periphery and infiltration of T cells into the tumor bed by immunohistochemistry.
Suggesting stimulation of anti cancer immunity business onto the innate immune system and the possible engagement of adaptive immune system.
These data support the rationale for F. 'twenty four is mono therapy <unk>.
Hence the two combinations that are currently underway and as a separate phase <unk> studies.
So it will be sweet trial in progress posters at the upcoming ethical conference. So it will froze a presents background information and does the design, obviously a different F. 'twenty four studies for patients with advanced Egfr expressing solid tumors.
We invite you to review these at the conference and connect with US if you happen to be at the conference.
For a F M 28.
Our search wholly owned innate cell engagement targeting CD 123.
We expect to submit an IND later in June and to start the first in human Phase one study in the second half of the year.
As summarized on slide seven.
N K 2022 in May we presented preclinical data demonstrating that a F. M 28 and used the slices of CD 123 positive leukemic blasts of AML patients.
And that is it effectively killed C D 120th Street positive tumor cells.
As a pre complex or co administered with cryo preserved NK cells.
This is an important finding as it is the first time that we show data off air from 24 in combination with Cryopreserved NK cells.
This is very exciting as it presents a promise foreign potential off the shelf therapy targeting thing leukemic blasts and leukemic stem cells in patients with AML and Mds.
By combining a F 'twenty four with adoptive NK cell therapy.
It just by redirecting these allogeneic NK cells to CD 123 positive tumor cells.
We believe that a year from 24 28 can induce the depth of response necessary to meaningfully improve outcomes in patients with AML and Mds.
We plan to initiate a combination development with NK cells at the earliest possible times four and <unk>.
As soon as adequate information about safety and Tolerability of single agent here from 28 is available.
How is the optimal strategy to initiate combination development, we need to be discussed with regulatory agencies and further details will be provided at a later point in time.
Finally on a F 'twenty as we recently announced the preclinical data will be presented in a poster session at the European Hematologic Hematology Association Congress on June 10th.
Now Austria.
This data will further summarized the preclinical proof of concept data and we'll demonstrate findings from our toxicology studies with 28.
With this I'll hand over the call to Angus who will take you through the financials Angus please.
Thank you Andrea.
Balance sheet and income statement highlights are shown on slides eight and nine of the presentation.
As a reminder, <unk> consolidated financial statements have been prepared in accordance with IRS issued by the international accounting standard board or <unk>.
The consolidated financial statements are presented in euros, which is the companys functional and presentation currency.
Therefore, all financial numbers presented on this call unless otherwise noted will be in Europe .
As of March 31, 2022, cash and cash equivalents totaled $169 9 million compared to $197 6 million euros on December 31 2021.
The pro forma cash position as of March 31, 2022, including net proceeds before offering expenses from the April 2022, underwritten public offering would be approximately 257 5 million euros.
Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents, including the proceeds from the April 2022, public offering will support operations into mid 2024.
Net cash used in operating activities for the quarter ended March 31, 2022, with $28 4 million euros compared to 16 million for the quarter ended March 31st 2021.
Included in our cash burn for the first quarter of 2022, what are the milestone payments to MD Anderson for the initiation of the phase II portion of the 13, one a four trial, which was expensed in Q4 2021 and paid in Q1 2022.
Total revenue for the quarter ended March 31, 2022 was $8 million euro compared with $11 7 million euros for the quarter ended March 31 2021.
Revenue predominantly relates to the Genentech, an ROI back collaborations.
Research and development expenses increased by 61% from $11 4 million in the quarter ended March 31, 2021 to $18 4 million euros for the quarter ended March 31 2022.
R&D expenses increased primarily due to increased expenses associated with the development of 24, and 28 program an increase in costs associated with other early stage program in R&D infrastructure and an increase in share based payment expense.
General and administrative expenses increased 57% from $4 5 million euros in the quarter ended March 31, 2021% to 7 million in the quarter ended March 31 2022.
The increase predominantly relates to higher share based payment expenses and an increase in insurance premium.
Net finance income decreased by 91% from $5 $5 million in the quarter ended March 31, 2021 to 500000 in Europe for the quarter ended March 31 2022.
Net finance income is largely due to foreign exchange gains related to asset denominated in U S. Dollar as a result of currency fluctuations between the U S dollar and euro during the year.
Yeah.
Net loss for the quarter ended March 31, 2022 were $15 7 million euros or <unk> 14 per common share compared with net income of $1 4 million euros or once that per common share for the quarter ended March 31, 2021 weighted number of common shares outstanding for the quarter ended March 31, 2022 was $123 4 million.
Yes.
Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 2022, which will be included mathematic filings with the U S Securities and Exchange Commission.
Now I'll turn the call back to <unk> for closing remarks.
Yeah, Thanks, a lot Angus.
We're almost halfway through the year end.
Happy with the progress that we could we could make.
All of the challenges out there.
And as we've shown we are progressing now three wholly owned program to eat from 13, 24, and 28 all of them address major medical needs with our three pronged strategy, we have developed something.
We eat can raise hopes within the within these patients as I am now showing on slide 10.
There are a lot more meaningful updates planned for the second half of this year.
And all three programs.
But most importantly, we extended our cash runway into mid 2024.
Which enables us to reach these key inflection points for <unk>.
All our units and engages with that I'd like to thank you all for your continued support of Hollow Berg.
I'd like to thank patients and their families who entrust us with their care with accounts lost family members and for our employees in the U S and Europe , who are continuing to do the best they can and helping us to achieve our goal of bringing these innovative and differentiated treatments to patients who need them.
We're now ready to take your questions. Thank you.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.
Our first question comes from Don Gray box with SBB Securities. Your line is open.
Alright, Thank you for the question.
For me on the <unk>.
K cell combination of ASM 13, I wonder if.
If you could talk as we're getting close to or about the questions that you plan to ask FDA and your 2022 meeting and then a second question is could you talk about any differences or unique questions that you're focused on and the collaborations on NK cell development of our key by NK Jan and MD Anderson.
Yeah. Thank you Dana I'm going to start out on that so in terms of.
In terms of questions for FCA were compiling those.
Because.
The study.
Which is ongoing with Nbn doesn't just deliver important additional information.
And so we have we've given you a snapshot now.
ACR, we've now treated.
In total 20 patients at close to 20 patients and have seen these high response rate, but as we've said we've just completed the second so I can now able to anticipate.
It's more to learn in particular on durability, which include all the way it looks very promising so all these elements contribute then to the two b b.
<unk> that we will discuss with the FDA in order to take you from 13 four.
With that I'll hand over to Andreas and see what Oh, you can enter your questions.
Thank God I cannot add significantly more so from.
From the clinical side as already said we are.
Gathering more experience was more patience more follow up.
Clearly, we will frame our discussions.
Focus from the clinical.
Clearly, we'll be on accelerated approval pathways as we believes that this is a treatment that needs to come to patients as soon as possible.
Yes, we have addressed also previously of course, there will be some discussions on the on the NK cell and CMC, which is normal for an FDA meeting, but we are bringing all this together and then preparing for this meeting.
And just to add on to your other question is relating to our collaborators.
Our interactions with our with all of them.
As of April 13th refocused on an allogeneic NK cell project Cryopreserved.
Yes.
Planned to be developed in combination with <unk>.
And here I cannot give you any further updates at this stage.
It is.
Is that is it.
Working progress.
And do you have made significant progress with many of our collaborators.
We have received great support from them.
We're quite confident that we can take such an NK cell program.
That's also produced in.
Reasonable quantities. So that eventually it's not just used for the clinic, great contaminated materials authentic and mature our bedrooms and four commercial mezzanine.
So that's the focus of our dialogues that go beyond just looking at the clinical study, but really have our focus on being able to execute this commercially that's the dialogues that we're having.
Some of these parties.
Maybe one follow up for me on something you said in answer to the first question Eddie.
I know, we started with two cycles with MD Anderson study and then I think last year, you were talking about up to six cycle and then I picked up that maybe you were talking four cycles around ACR and just now I heard you say three.
Wondering what the final protocol is for how many cycle didn't give the patient and what's been behind.
That optimization at the number of cycles.
Yes, yes, yes, sorry for that.
Three because we are now treating patients with the third cycle, but.
And Unfortunately this is correct Andrea.
Yeah, we can.
Can go up to four cycles individual patients we could on an individual basis, even give cycles beyond four put us things for for now is a good number.
Thank you.
Thank you.
Our next question comes from preventive war or conduct with <unk> Securities. Your line is now open.
Okay.
Your line is now open.
Sorry about that.
Thank you so much for taking my question.
Congrats on all the progress.
Yeah.
Just wanted to follow up on Jamie's question.
Multiple cycles.
That's what we're giving patients.
No.
They're a better sense of what the duration between the treatment cycles is going to be.
That's <unk>.
When you go to the FDA, how much clarity would you need to have as to what the duration between the need to needs to be.
And then in terms of data expectations for.
The data update from the combination can you help set expectations as to what.
Data, we can expect.
Maturity in terms of capability.
And how much more do you need you you talk about how you are.
Youre going to have data from more patients you are collecting more clinical data and how much data do you think you'd need before you talk to the FDA.
Florida.
Thank you.
Yes, quite a great good question to address.
Yeah, so in terms of interval between cycle.
<unk>.
Again. This is one O C open topics that we really would like to discuss with FDA.
As seen MD Anderson's are initially has been quite a variability which was in part due to some some logistic reasons patients planning. So I think we are now getting much better to extend to rise.
Sequence of cycles, where we usually we will probably have.
It's hard to say maybe.
28, two to 56 days between cycles, but but again there may be some variation here. This is a topic that we definitely want to discuss with FDA.
Now in terms of how much the additional data we need.
What we offset is set we wanted to discuss both aspects of a potential trial, which would be the clinical part as well as see NK cell parts of CMC part is that he said we are making progress in identifying NK cell sources. So this will also be a gating factor for our interactions with the FDA.
Great. Thank you so much hope this answers your question.
Yeah.
Thank you.
Thank you.
Our next question comes from Maury Raycroft with Jefferies. Your line is now open.
Hi, Congrats on the progress and thanks for taking my questions I have a quick follow up on the combo as well just wanted to clarify if you're giving additional cycles to patients who are in a complete response or is it primarily to patients who are not in a complete response I guess im wondering if youre, giving additional cycles of the maintenance dose.
Maybe if you can talk a little bit more about that.
Oh.
Yeah. So.
Again, this is something where we gather experience our policy has been to give additional cycles also for patients who are in a complete response at least one additional cycle. If you will as a kind of consolidation.
In patients who go more slowly into a response like we have seen increase in and quality of responses.
Again, the primary goal is to get the patient into a complete response, and then to probably get at least one consolidation cycle in.
Got it Okay. That's helpful and then.
For the AFM 13 monotherapy study are you waiting to see the data before starting a confirmatory phase III and when do you anticipate speaking with with FDA regarding the confirmatory study.
Oh, Yes, we said, we expect the high level data.
In the fourth quarter.
And of course, these data will trigger all of <unk>.
Sequent events.
Have some plants hole confirmatory study could look like and we will take this plant. So the FDA probably at a time when do we see a high level data.
Okay got it and maybe last question just.
For the increase in T cells. They are seeing in the tumor biopsies. After <unk> 2004 treatment have you quantified that in do you see any dose dependent response, there or relationship without clinical benefit.
That's a good question and let me state a very very new so we are currently in the process to analyze us. There's obviously, there's the obvious questions that correlation was clinical outcome, but we don't have the full data set yet but.
We'll give updates in the future.
Got it okay. Thank you for taking my questions.
Thank you. Our next question comes from Lee <unk> with Cantor. Your line is now open.
Hey, guys. Thanks for taking my questions I guess I wanted to ask Matt and 28, I know one of your peers.
<unk> data of car NK.
So just curious if you have any.
There you think Gary annually.
Our <unk> program and also where do you see the bar for success.
Yeah.
Yeah.
<unk> do you want to take that so I guess you are referring to the data that were recently published by car type.
In General I would say, we have seen activity of NK cells.
Thanks.
Where I'm coming from different tool system. So we have seen activity outside Sao extent were derived from our peripheral cells derived.
So right from core blood cells.
And most of that is <unk>.
Clustering the range of 30% to 40%.
And Carter data initially.
Somewhat somewhat higher but obviously you haven't.
And it's still very small so we're eagerly waiting for them to be more.
Once we know in general is that we can enhance the efficacy of NK. So it's quite quite significantly through 28 in preclinical studies.
And I now hand over to Andreas.
Give you a little more input from the tenant demand.
Well I think you're almost <unk>.
Question completely.
So one of the one offs.
Yeah.
Wrestle notes to really develop.
<unk> in AML Mds is the.
The sensitivity of AML cells to NK cells.
So this I think is an important building block now what we have.
That is set we believe certain CD 16, a especially when is activating like we do with the Ics was a very high affinity very tight binding is probably the most.
Potent way to activate NK cells.
It also addresses problems with with cells with very low target expression, where we have shown that we are largely independent of targets or density of the target.
So we believe says this is a very potent way to you.
Utilize CZ already demonstrated activity of NK cells, and AML, but really to boost it to extend it to low expressing sales to expend tended to leukemic stem cells.
Do we express CD 123, but would not expressed some of the other.
Used targets. So this I would say adds to our confidence as it from 24 28 could be it could be a very very potent program.
Okay I just want.
Okay.
Following up on the 24 I know you've shown your kind of interesting about macro data.
He swam Charlestown.
Wondering if you can expand a little on the.
NK cell infiltration into tumors and how it might engaged.
The adaptive immune system in a trial.
Yeah, so sudden maybe arent as it is.
Preclinical question, Yes, sure sure sure happy to do that.
Yes.
Thanks for the question so.
So we just discussed the T cells I mean, how do we think the engagement of the adaptive immune system may happen, we don't have direct proof, but what we know of course from the cancer immunity cycle that we do engage NK cells, we knew nobody the destruction of the tumor cells are damaged wood.
We released our activate the drilling so well.
Move to the lymph nodes activate T cells. So we feel that this is.
Apparently the way too also activates the adaptive immune system, obviously exciting because we.
I have always thought in earlier muscles that you see there to some extended to know suite and the patients we need to be careful it's small numbers. We just discussed we still want to.
Correlate with clinical activity, but there clearly is a trend and we clearly it's also shown on the poster with this one.
In non small cell lung cancer, where you see from a 120 258. So in some cases quite significant not all but some cases.
So that's the mechanism of action.
We have also seen and reported in the poster of course activation of circulating.
The CD eight T cells with K I 60.
67, the potent proliferation and activation markers I'll say the T cells and other proof of the activation of circulating NK cells also by measuring a K a.
Ah 67 is one.
One of the examples is that.
Answer your question.
Yeah.
Thank you.
<unk>.
Our next question comes from Brad <unk> with Stifel. Your line is now open.
Good morning, based on how enrollment for <unk> and 'twenty four is progressing here can you expand on or I guess offer any expectations for the degree of data that could be presented this year.
And then any of the three therapies for cancer types that are enrolled better do you have a sense of the rough sample size and I guess as well will you be ready to make any go no go decisions at this update I'm just wondering when you might be ready to narrow the nine cohort approach. Thank you.
Correct.
Well I can.
It takes us so.
Course enrollment differs between the three studies.
E F and 24 101 study we have recovered a little.
Cohorts opened we have identified the recommended phase two dose.
We are seeing enrollment into all three cohorts, it's probably a little bit too early to say.
One cohort.
We will be faster or quicker enrolling than the others, but we should.
We have adequate numbers of patients in all three cohorts.
No for F 'twenty for one or 201 or three we got a little bit earlier as we have.
Cost both studies have.
Safety run in phases, where we start with lower doses of AFM.
<unk> 24 to <unk>.
Address some we'll see.
Authority commenced to look at safety at least in the limited number of patients here.
Here, we had in both studies, we are in the dose escalation part.
So there will be mainly safety dataset, we will collect until the end of the year and activity data roughly two combinations.
Studies, probably during first half of next year.
Again, all these studies are open label, so depending on the degree of activity.
Of course, you can make.
Decisions for further treatment or for discontinuation of certain cohorts at every part for US was the enrollment process.
I appreciate it thank you.
Thank you our next question comes from.
So Kim with Piper Sandler Your line is open.
Hi, Thanks for taking my question.
I was wondering if you could provide some additional details on the.
The 720 milligram cohort for F 'twenty four.
Any differences and as that you saw between that dose and the 480 milligram dose any any efficacy signals.
That would be helpful. Thank you.
It takes us also against the 720 milligrams as the fed has been fully enrolled.
We have not seen any dose limiting toxicity, which was consistent with the.
We see other dose cohorts, we have not seen a change in the toxicity profile.
And in accordance to our previous guidance, we are putting the data together and then plan to submit more granular update I'd want to see.
Scientific meetings.
Okay got it and then a question on AFM 13 mono therapy.
You do get accelerated approval.
What are your initial thoughts on the size of the commercial infrastructure that you need how.
How big of a sales force and does your cash guidance assumed that you'll get approval and launch the product.
So the first question is on how big of a young.
NTT group would need have to built in order to detailed on this project.
We have we have not disclosed any any details on that and at the moment.
And he has not taken a decision if we would keep all the program is often met or if we would find a commercialization partner.
Having said that we.
We have built up.
The commercial team that is doing all the background work.
As we move along so the.
Work is proceeding.
Proceeding.
In.
Just have to say at the moment as we proceeded we haven't yet set in.
Full time line to this but as I proceeding we can take the decision on which direction, we're going to go and get to a partner if we build up the commercial infrastructure on our own.
Into this also place.
But the way how we proceed forward with any <unk> in combination with the metric.
Which we then want to detail in the second half. So this is an important milestone.
I would tell you that once we have all of that together so the <unk> compared to monotherapy data and how we can proceed would be a combination of NK cells. Then we can take this a detailed step.
Step forward.
We want a commercial lender in Kentucky.
Yeah.
Okay. Thank you very much.
Thank you. Our next question comes from Yale Jen with Laidlaw <unk> Company. Your line is open.
Good morning, and thanks for taking the questions.
The first question just back on the previous one that in terms of the night cohorts.
24.
Was there a minimum number of patients which could be different in different indications.
You need to have to make the initial assessment.
A follow up.
Sure.
Andreas that's a question for you.
Yes, we have discussed.
Nothing.
Also when we presented the studies all studies are.
Basically built as a Simon two stage design.
And of course, he has a target response rate vary a little bit.
<unk>.
What we are what I would say is if you assume like 10 patients plus minus two or so for the first interim analysis and to make a first go no go decision nothing so it gives you a reasonable ballpark how healthy sinus.
Late P behind these cohorts.
And then of course, if you meet your success Criterias.
Each cohort has a potential to go up to 35 to 40 patients.
Which we believe would also be a critical number of patients to engage into a meaningful discussions with FDA.
As said we have to first look at roughly 10 patients per cohort.
Okay, Great. That's very very helpful and maybe just another follow up question here, which is that.
Given 28, it's already ready to put a clinical study at the moment.
Question is if you compared 28 versus <unk>.
Their team both on the Hemo space do you see any differences besides the indication.
I'll get that.
<unk> improved from 13 or any other color on that and thanks.
That's a question for arent.
Yeah. Thanks for the question you know a few details we can shares.
First when you compare to 13 of course 28 is now more of the <unk> like molecule with a longer half life.
What hasnt changed is I think the differentiation potential that interest already listed what we see instead of the posters very specific killing CD 123 positive cells sparing of the progenitor cells that are sitting on 23 negatives very strong activation of NK cells superior to the.
FC enhanced antibody, so basically telecom Susan that so what we what we are seeing across the board is pre clinically so far that the strategy works out where we were we really strongly believe with our ICT technology, we can surpass activity seen with prior CD 100.
<unk> three antibodies.
Okay, Great. That's very helpful. Appreciate the color and thanks, a lot and congrats on the progress.
Thank you.
Our next question comes from Nick <unk> with Wells Fargo. Your line is now open.
Hi, good morning, Thanks for taking our questions.
Congratulations on all the progress.
First one for me so for AFM 13, plus.
So do you intend to file for breakthrough therapy designation, the KOL meeting with FDA.
Regulatory milestone.
Hi, this is <unk>.
We would not apply for breakthrough designation before we talk too before we talk to the agency with this program.
We decided to first talk to the agency.
And discuss the data and essentially.
As I've mentioned before from a clinical and also CMC perspective.
And then we take it from there.
Okay. Thanks, and then.
At that meeting.
Would you be presenting FDA ways.
Our registration directed.
Trial plan, including CMC or is it more geared to the pieces how do we put it together into a registration directed trial.
So.
As we have at this point.
What can go ahead please.
Your bill at this proposal.
No no weapon pick it.
Our current thinking.
Put it altogether, the clinical perspective, but also with the CMC perspective.
You all know how important it is to have <unk>.
C process in place.
Therefore, this leads to both together from our perspective.
So just to be clear then you would be proposing here is our plan.
Could you please repeat Nick had to go get it.
Yes, sorry, Wolfgang I'm, saying, just so just to be clear then you would you would go to FDA with a registration plan.
Yes.
Okay, great. Thank you very much.
Thank you.
As a reminder, ladies and gentlemen that start and wanted to ask a question.
And I'm currently showing no further questions at this time. Thank you for joining alphabet first quarter 'twenty two earnings.
Business and business update conference call. This concludes the conference you may now disconnect everyone have a wonderful day.
Yeah.
Yes.
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