Q3 2020 Affimed NV Earnings Call
Good day, everyone and thank you for standing by welcome to <unk> third quarter trying to change the financial results and corporate update conference call.
During today's conference call is being recorded.
I would like to introduce your host for today's conference call.
Alex would that be.
Head of Investor Relations.
Yes.
Thank you operator I'd.
I'd like to welcome and thank you all for joining us today.
Third quarter 2020 financial results and operating operational update call.
We begin I'd like to remind everyone that the press release issued earlier today related to our earnings call can be found on the Investor Relations section of our website. We have also posted updates slight uptick it's like that will be used to guide our discussion today.
On the call today, we have talked it hurts, our chief Executive Officer, and Brad its hard straight our Chief Medical Officer Art Healios, Our Chief Scientific Officer, Dr., Wolfgang Fisher, our Chief operating Officer, Ms., Denise Miller, Chief Business Officer, and Angus Smith, our Chief I know.
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Whole team will be available for the Q and a session before.
Before we start I will quickly go through the.
The Safe Harbor statement todays discussion contains projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date as of the.
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.
These forward looking statements are subject to risks 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 FCC and go.
It was identified under the section entitled forward looking statements in the press release that we issued today and filed with the actually see.
With that I will turn the call over to Aarti I'd.
Thank you Alex and good morning, everyone. Thanks for joining us for our third quarter Twentytwenty a business update call.
It's a it's all on my press releases today, and I guess the day.
We have a number quite exciting updates to report on including progress on our clinical programs.
Acceptance of key data at major conferences, and importantly, we have four new strategic part.
Partnerships, which will help expand the opportunities for the <unk> platform.
And that that might get patients, we need more therapeutic options.
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<unk> for future value creation their document rights.
Ability to generate the fed up there, but you know telling each other for a multitude of.
Team and solid tumor cancers, with consistent profiles tumor lysis and safety.
[noise] platform uniquely activate oldbury until she seeks tonight with unprecedented affinity and you can gauge that can be customized to specific tumor targets.
Gene, that's sustainable pipeline of novel and potentially curative medicine.
That that's one has a proven record of rapidly and predictability predictably building potent and stable you think synergy targets it telling data molecule Halo.
Hey, let too specific.
We believe this platform positions us as a leader in the field.
In a community.
Our goal is to leverage that platform to broaden the opportunity to win.
No I like to great value and ensure our transformative medicine reach patients in need.
To achieve this goal we have a three pronged strategic approach.
Great.
Right right that development.
Molecules such as that.
In mono therapies in the area of high unmet need.
Second we are pursuing novel therapeutic combinations, including the combinations with NK cell therapy.
I owe to I O approaches such as checkpoint inhibition.
The third component of our strategy could ballpark tweaks and.
Deep Mount with scientific expertise and provide options to accelerate our pipeline.
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I mean, he's very excited today to report that we have made substantial progress on all three components of our strategy.
We have made important clinical progress on our mono therapy approach EPS for two well.
Well Powell hotel molecules April 13, and 824.
And Andrea will provide more detail on the short kit.
That's right.
Added to your exploring novel combinations far molecule, particularly combinations with NK cell therapy.
And yesterday, we announced an agreement with Rite endpoints as we expand and collaborative strategic collaborations.
There really been collaboration a further validation.
Engager can play an important role in the fight against Ken.
This collaboration will accelerate the development of a 30 to provide significant long term capital for the company.
Thereby extending our cash runway.
He needs what can they aren't right collaborations and the rational.
In their remarks, however, before we discuss the new calibration that.
Me handover the call to Andrea who provides you an update on our Kennedy programs Andrew.
Well, thanks for the overview and a welcome from my side to everybody who joined us on the call today.
Oh, we are very pleased today, we could report that we are making good progress on both of our wholly owned clinical stage molecules.
13 up from 24.
Let's start with I guess I'm 13.
Our first in class innate cell engager for patients with CD 30 positive lymphoma.
Yeah. We are very pleased to report that <unk> from 13 to go to <unk>.
Let's continue to recruit well it has now reached the required number of patients both in the high Sixtys surety expressing that's what lessons and low C.D.'s sorting expressing cohorts that are pre specified and required to foresee a preplanned interim analysis.
We're expecting to complete see interim analysis in the first half of 2021.
As you may recall from true Thirteentwo too you see a registration directed mono therapy study investigating I F. In 13 in patients with relapsed and treatment refractory peripheral T cell lymphoma.
If we stay with I guess Im 13.
Oh, we also reported that the first patient in study I, if I'm certain one off for us.
We completed the first four week cycle of therapy.
And has achieved a partial response according to local investigator assessment.
This patient is scheduled to receive a second cycle of treatment.
We're also looking forward to enroll seconds patient that's the same dose level.
As a reminder from certain one or four is an investigator sponsored phase one study conducted at MD Anderson cancer Center.
Which is evaluating the tolerability and efficacy of yes, im certain pre loaded allogeneic caught blocky rife national killer cells.
Followed by weekly I offend 13 infusions in.
In patients with refractory cdseventy expressing lymphomas.
In the dose escalation part of the study dose of NK cells is increased from 10 to six NK cells per kilogram bodyweight.
To tend to his assessment finally to attend to the eight NK cells per kilogram.
The study can further expand it to include more patients it's a recommended dose.
Turning to I guess, I'm 24, Oh, you Nate cell Engager for Egypt for expressing malignancies.
We announced this morning that we have cleared cohort two and.
And our treating patients in cohort three in the dose escalation part obviously is phase one phase two clinical study.
Patients that are enrolled in this study are patients, having relapsed or refractory advanced you Jeff are expressing solid tumors.
The aim of the dose escalation phase as you know is to determines your maximum tolerated dose.
And to establish a recommended dose for for as a phase two testing.
So phase two dose expansion phase was intended to correlate preliminary evidence of activity well see if im 24, as a single agent and to further comes from safety and side effect profile.
For the expansion study, we have identified a number of indications where we believe set monotherapy treatment for <unk> from 24 is a suitable.
Oh, we are pleased with the progress being made from Ttwenty four dose escalation study and are optimistic about the potential of <unk> from 24, as a safe and effective monotherapy for certain to patients was easier for expressing solid tumors.
We also recognize the treatment strategy I see in immuno oncology often rely on finding combination approaches for certain patient populations and or indications.
With this in mind, we are actively looking towards a preparing clinical combinations or I guess on 24 was checkpoint inhibitors like PD, one or PD L. One antagonists.
Yes, well, yes combinations with both allogeneic and autologous NK cells.
We believe sets this broad strategy will increase and expenses clinical utility off air from Ttwenty four was it go to provide better patient outcomes.
Wolf drunken aren't will go into more detail about irrational and see approach behind see combinations have already made cell engagers with NK cell therapies in their remarks.
Before we turn to that Denise will present more details about the deals and see collaborations that we have announced over the last few days.
So I may hold over to Denise please.
Thanks, Andrea good morning, everyone real pleasure to be here today to give you an update on our recent.
Today.
I'll start today with some details around the REIT transaction.
The bank collaboration to diversify their partnership but industry innovators and will help accelerate the development of 832 as well as our own pipeline.
Providing significant value not only to our shareholders and our patients.
The highlight that that you're in that include granting right that a worldwide license to our preclinical assets and 32.
Well as options about other novel targets that currently are not within our pipeline.
We will receive $60 million in upfront consideration, which consists of $40 million in cash and prepaid R&D.
And $20 million of stock.
Additional financial terms.
Up to $2 billion and teacher milestones.
With potential near term milestones tied to option to develop novel molecules beyond 32.
And that is eligible to receive tiered royalties on net sales on all the molecules developed under this agreement.
Our responsibility and the collaboration is to drive discovery research all lines, enabling preclinical development, which is funded completely by like that.
Right well the response.
Responsible for clinical development and commercialization worldwide, what's important here for us and that is that we retain the option for co promotion.
The boy that business model on the structure of the terms, which include upside potential in terms of REIT stock the cash up front in the full funding of R&D work as well as the option to co promote make right an ideal partner to drive and enhance value for our shareholders.
Now we also recently announced two other partnerships, which are designed to support enable the combination strategy the audio the detail.
As the leader in any immunity, we very much recognized the emerging and expanding role that NK cell therapy can play comprehensive innate immunity therapeutic approaches.
The result of this we've done a tremendous amount of work analyzing a number of NK cell technologies for combination approaches to enhance therapeutic benefit.
We believe our unique selling new Jersey can offer substantial value to NK cell product and have taken a careful thoughtful approach to selecting the right NK cell partners that not only have leading technology, but are also aligned with our strategic mindset.
We entered into collaborations with companies that are developing different types of NK cell platform to enhance our flexibility each.
Each of which have a different focus together with MD Anderson. This allows us to broadly explore combination options fournine thousand gauge errors and generate data in a variety of clinical and preclinical Marianne.
We believe these partnerships position us well to lead and define this emerging area and immuno oncology.
I moved to a few details which may be an interest on [noise].
We announced the collaboration with then came back.
It is a clinical collaboration looking at co administration approach I am 24, with adaptive NK cell transfer.
We will be using NK, Max's and K, one autologous NK cell product out first which is meeting the cells are coming from the patients and.
And our goal to transition. So combination then came axes allogeneic cell product.
We have co sponsored the R&D and clinical get out on costs. While these 50 each of US is responsible for manufacturing development of the product that we bring to collaboration.
And last Thursday.
We announced the collaboration with our key.
It took you off the shelf combination products, which are co manufactured by Preloading, Archie bunker clinical grade allogeneic cell without any cell engagers.
The combo product to some cryo preserved in it in a single trial.
The product developed under this collaboration represent a novel approach and a new class of drugs, which avoid the complex engineering Carlos incurring Kate.
Still providing that powerful targeted innate immune system based therapy.
Our new collaboration combined with our ongoing work with MD Anderson allows to explore these diverse approach it in parallel into more broadly understand development opportunities for NHL engagers in combination with NK cell therapy.
We look forward to providing you updates in the future on the progress with all of our collaboration.
Now I will turn things over to Wolfgang aren't who will walk you through the scientific rationale.
Data that support pursuit of these combination well start with Wolfgang Wilson.
Thank you Denise welcome to everybody on the call on my side.
As you have heard from the team a key component of our strategy to broaden the applicability of our cell engagers by pursuing combinations. We thought it would be helpful to spend a few minutes discussing the scientific rational therapeutic approach of combining our selling gauges for decades.
[noise] several lines of evidence have demonstrated the potential NK cells in Canada.
First in previous clinical trial, mainly in email and Mds patients.
Jason.
Let with adoptive NK cell transfer has shown no objective responses and good tolerability.
Second.
It is evidence showing that high I'd say, some numbers associated with better outcomes.
For example, patients with liver that'd be courteous melanoma.
Improved survival rates, if that humor show evidence NK cell infiltration.
Good.
More recent trial adoptive NK cell transfer was combined with Mitchell came up in patients with Hematological tumors, reaching high Oh ours.
For.
The first data with Cdnineteen car in case, though showed encouraging hi.
With a much better safety profile known from car T approach.
In summary, we believe NK cell therapy can play an important role.
[laughter] innate immunity therapeutic approaches and we sort of three distinct collaborations are establishing asking it.
As a leader in the space of the made in young there.
Combination of our selling a molecule with NK cell therapy could potentially richer said, how clinical strategy for treating cancer patients.
Our approach to NK cell combination is strongly supported by the preclinical data evaluating the synergistic potential up in case of southern gauge.
Oh preclinical work.
Epicenter evaluated CT legacy REIT expanded and activate NK cells reloaded the intensity.
These initial investigation showed in Clinton logistic effect in vitro and in vivo.
And on that basis.
So tier one <unk> four study was what was mentioned by contrast before.
Importantly in this context is also that we have books.
Our NHL engage us strong sell retention bonding on NK, So we hedge show monoclonal antibodies.
The calibration within K, Max will add to the body of clinical evidence. So the co administration of 24.
With NK, one lots of lovely handed them activated NK cells in patients with each yet are expressing tumors in Atlanta.
Two trial without any.
In addition, the research collaboration with Eva biopharmaceutical aiming for the development of several of the show greed.
Reloaded at lunch and pick up but.
Both collaborations as I said before based on previously conducted preclinical studies demonstrating the synergy of the combination of our engagement with NK cells.
In summary, we.
We believe that the combination of our engagement with NK cells can be differentiated by monoclonal antibody case, a combination encouraging Kate.
And well be a key component.
Creation strategy.
As you can imagine we are very happy to be part of that.
The leading is it just that company that has developed these high quality I can't talk about that.
I will now turn over the call okay.
Okay and provide more detail into the data supporting our belief in the power of the night cell Engager.
So the approach.
Uh huh.
Thank you Wolfgang and it's a very good morning to everyone on the call in.
In the next few minutes I would like to briefly discuss the preclinical data generated.
Through a collaboration with the University of Texas, MD Anderson Cancer Center.
At Washington University School of Medicine, which will be the focus of an oral presentation at the upcoming since he conference.
This collaboration has identified promising combinations of Asian virtue, but cytokine activated adult blogs or quote logs natural killer cells against Cdthirty positive he was a logical malignancies.
The data shows that combinations with natural killer cells deepen the in vitro and in vivo efficacy with already been 13 NHL Engagers.
But this effect was particularly strong with cells from healthy donors.
The collaborative research analyze the from 30 mediated tumor cell, killing in combination with several NK cell products, including conventional natural killer cells from healthy donors NK cells from patients with Hodgkin lymphoma. So.
Cytokine induced memory like NK cells from peripheral blood.
And pre activated courts blogs natural killer cells co.
Cord blood derived NK cells within stavely pre loaded with day from 13.
Enhancing the responses to Cdthirty positive lymphoma in vitro and in vivo Immunodeficient Dennis.
NSG mouse models.
The conventional natural killer cells from healthy Doris exhibited superior responses.
So as those for Hodgkin lymphoma patients when combined with aid from 13.
Suggesting that the source of NK cells impacts tumor cell killing.
Cytokine induced memory like NK cells exhibit enhanced killing of Cdthirty lymphoma cells, when directed to the tumor by Dave and 13 compared to conventional NK cells.
These data form the basis of an investigational new drug application and further substantiate the rationale for combining April 13, with adoptive NK cell based therapies as.
This is being currently investigated into phase one clinical study MD Anderson cancer Center.
Now let me briefly summarize the features of our needs someone gauges, which are strongly differentiated piece of your normal and FC enhanced monoclonal antibodies and car NK cells Firstly.
Our next cell engagers buying two cdsixteen a. on NK cells, and macrophages with high affinity leading to effective tumor cell, killing buyer ADCC and 80 CP.
As you can see on slide 14.
And they sell Engagers based drug candidates exhibits superior licenses for primary tumor cells buyer ADCC in the presence of healthy donor derived allogeneic NK cells when compare to FC enhanced I did you one targeting the same antigen.
Secondly, as you can see on slide 15 on the left.
Are they selling gauges of superior binding and retention of NK cells, which has been shown to persist over several days in strong contrast, normal OCTG and also FC enhanced anti bodies rapidly fall off the NK cells as you can see on the bigger importantly, as you can see on the.
Right on the slide the additional physiological levels of Polyclonal RG G.
This fault circulating in the human body has no or minimal competing effect on the binding open NHL engager.
NK cells since its binding epitope and Cdsixteena is this stage from the FC binding epitope, often I'd UGI molecule.
Finally, as you can see on slide 16, NK cells pre loaded with our high affinity late someone gauges show improved tumor cell, killing which is fully maintained after freezing thawing in Washington as you can see on the right hand side.
This approach rendering NK cells into a car in capex in C like molecule without the need for engineering Mays I, thus offer superior anti tumor efficacy and strong differentiation.
We believe that the broad and diverse approach to generating further evidence of these novel combinations of our relates only gauges with adoptive NK cell based therapies will lead to a suite of flexible options for dosing administration and ultimately advance important here today.
As in the fight against cancer.
I'll now turn the call over to angles to provide an update of our financial position and quarterly results anchors.
Thank you art.
Nice to be speaking with everyone. This morning.
I think thats consolidated financial statements have been prepared in accordance with IRS has issued by the international accounting Standard Board, where I asked me.
Consolidated financial statements are presented in euros, which is the company's functional and presentation currency.
Therefore, all financial numbers that I will present in this call unless otherwise noted will be in euros.
We ended the third quarter with cash cash equivalents and current financial assets of 97.3 million euros compared to 104.1 million euros on December 31 2019.
During the quarter. The company received net proceeds of approximately 11.6 million euros under its aftermarket or ATM program at an.
Milestone payment from its partnership with Genentech and an undisclosed amount.
The proceeds to prove to be received in the collaboration we announced with Roivant yesterday are not included in our liquidity position as of September Thirtyth.
He mentioned, we will receive $40 million in upfront cash and prepaid R&D funding up to $2 billion and potential milestones and tiered royalties from this collaboration.
Financial contribution from this agreement provide after you made with an important source of non dilutive funding and combined with our Genentech collaboration and we are now eligible to receive a total of up to $7 billion and potential milestone payments.
Conserve as additional sources of capital for asking that and create substantial value for our shareholders.
Our pro forma cash position as of September Thirtyth 2020 included the $40 million of including the $40 million of upfront cash proceeds from the ROI that collaboration would be 131.5 million euros.
Based on our current operating plan and assumptions, including the proceeds from the ROI that collaboration we anticipate that our cash cash equivalents and current financial assets will support operations into the first half of 2023.
Net cash used in operating activities for the quarter ended September Thirtyth 2023.
3.6 million euros, compared to 11.7 million euros in the third quarter of 2019.
Total revenue for the third quarter of 2020 was 10.5 million euros, compared with 2.1 million euros in the third quarter of 2019.
Revenue in the third quarter of 2020, and 2019 predominantly relates to the genetic collaboration.
Revenue from the Genentech collaboration in the third quarter of 2020 was comprised of revenue recognized for collaborative research services performed during the quarter and the recognition of revenue related to a milestone payment.
R&D expenses for the third quarter of 2020 were 10.1 million euros compared to 11.7 million euros in the third quarter of 2019.
<unk> expenses in 2020 relate predominantly to our FM 13, and am 24 clinical programs.
Well as to our early stage development and discovery activities.
DNA expenses for the third quarter of 2020 were 3.5 million euros compared to 2.8 billion euros in the third quarter of 2019.
Net loss for the third quarter, EPS 2020 was 6 million euros or seven cents per common share.
And for the third quarter 2019, the company's net loss was 10.9 million euros or 17 cents per common share.
The weighted number of common shares outstanding for the quarter ended September Thirtyth 2020 for $86 million.
Finally, we incurred shareholders to also review our 6K filing for the quarter as filed with the FCC. This morning.
Now I'll turn the call back to Audi for closing remarks I'd.
Thank you very much I guess.
Now being in the midst of coated and this pandemic hearts and minds of rally behind the quest for a vaccine for COVID-19.
But particularly watching whats best interest as a heightened level of public private partnerships stripes quickie produced testing options and the solution.
This approach is what drives the document as we strive to achieve our goals to enhance and add uniquely meaningful benefit in the treatment of cancer.
We continue to make progress with our pipeline with our existing collaborations.
By establishing new strategic partnerships.
The ones, we recently announced with Roy event, and Capex America in our chief.
Importantly, we now have a strong.
<unk> cash position was funding into at least the first half of 2023.
Thanks to the depth and breadth of industry leadership experience, helping our company estimate is at an inflection point in the trajectory of our company.
I'm excited to share more as we progress one use as we progress into the next year.
Briefly again some of the key inflection points.
Until mid Twentytwenty two include weights and 13 weeks back to complete the interim analysis of our registration directed study for PTCL is mono therapy in the first half of 2021.
And provide updates on the progression of our combination study with a cold blooded rights in case of Proto at MD Anderson cancer.
Play come 24, we expect to report safety and activity data from the ongoing phase one dose escalation study.
And initiation of multiple expansion cohorts as mono therapy.
We will update you on the initiation of combination studies with NK cells and could I O agents.
We will provide updates on progression obese.
Our pre chemical class a day from 28, we expect to report data from preclinical studies and our I'd be fun.
Well now collaboration with Roivant, we look forward to the initiation of April 32 in EBITDA, LNG, enabling studies and providing updates on AIU concerns you to India.
And the additional programs.
Before we open the call for Q at night, I would like to say, thank you to the patients who entrust us with their health.
Our colleagues who are doing.
The very best to advance our company, our science and our programs and to our investors who believe.
In us and continue to support our scientific discoveries.
Finally, our recent achievements are a testament to the dry dedication and passion of our employees unrelenting in their pursuit to stop concept from ever do railing patients lives.
We have no team here and I look forward to your questions operator.
Thank you.
Ladies and gentlemen, we will now begin the question and answer session. As a reminder, if you wish to ask a question. Please press star one on your telephone and wait for your name to BNS. Please standby will be compiled acute kidney. This can only take a few moments if you wish to answer your request. Please press the ASCII once again star one if you.
Just to ask a question. Thank you.
Your first question comes from the line of them came from Oh.
Please ask your question your line is now open.
Great. Thanks.
Thanks for taking my questions and congrats on all the partnerships.
My first question is on your end came Max partnership.
In your comments about your city presentation.
You talked about the conventional NK cells from healthy donors being better than from cancer patients.
Why do you believe that they came back to a target it kicked up product will behave differently than your preclinical data.
Let them can you take that question. Please.
Aren't you can support them.
Yes. This.
This is why.
The the data.
From NK Maxim previous.
Preclinical study, but also they have shown in the clinical study.
They're at.
NK cells work.
Worked very nicely and targeted in the sponsor.
And also had even higher response rates when they combined it with the PD one.
The presentation.
The.
He grace is the presentation.
From MD Anderson.
10%, the capex lightly and from top selling off from wash U.
And here they christened the impact preclinical impact or preclinical studies.
The team on the quote Bluff derived NK cell and on so called single cell memory like in case out.
From upstate New York.
And the data.
Shown costs, so when they use NK cells from Hodgkin lymphoma patients that's been shown grievously and they incubate de Silva with 13.
These are highly functional and again.
Does this answer your question.
Yes, yes. Thank you that's very helpful.
And my second question is with the numerous partnerships you have now.
Can you talk about how you will determine what target goes to each partner in the future and what you plan to see internally how do you think about that.
Denise can you take your question please.
Sure, you're specifically relating to genentech and ROI that target selection process just to clarify.
And also in K Max and.
Yeah, and and in Argentina, So I'll address Genentech and right on first because those are obviously somewhere in that we are developing novel molecule to them with a specific target that instructed by the partner.
As you May recall, the Genentech partnership they it's not there like target last year.
And until it came from them and then Ray ban case, they obviously selected preclinical assets.
32, and then targets actually moving toward we'll be at their discretion provided the target is not already taken by somebody else part of asking rents preclinical pipeline.
In terms of NK, Max we've decided to start with and from 24, primarily.
Primarily because the autologous product does not meet the motivation and we felt that it was amenable for solid tumors moving forward and that will decide in.
Collaborations thank you Matt.
Whether to expand the clinical collaboration with are there any cell engagers based on the data that's generated from the 824 clinical collaboration.
In terms of our chief.
We've decided again to start with some 24 and we ought to be pursuing am 13, and the co vile.
Pre manufactured product given that these are both clinical products clinical assets for estimate at this time and then we will consider whether or not we expand into other options based on our preclinical pipeline based on strategic along the strategic approach of both companies.
Great. Thank you for taking my questions.
Yes.
Thank you. Your next question comes from the line of James Lee from Wells Fargo. Please ask your question getting line is.
It is now open.
[noise] Ed.
Good day.
Debbie.
Jefferson Underline our next question comes from the line of the Janek license from SBS. Please ask your question. Your line is now open.
Hi, Thanks, this is delayed sitting in for Dana.
Just a little bit more on your strategy here.
Should we be expecting additional collaborations with NK cell commercial partners.
Is the plan to select one.
For late stage development after data reads out.
And then on the ROI event can you confirm if the target for Sn 32 was brought forward by Roy event or was this the internally discovered at.
Yeah I'll take that question. So regarding the 8-K solar partnerships as we've explained a we've been collecting the field and.
Currently came down with the collaboration because they offer us.
A breadth of opportunity is that what we are what we want to explore so were good for the moment. However, this is a very dynamic field.
And we have numerous additional contracts.
And again, how does that progress though.
With the way how we have done is we keep our you can still keep our options open.
On the other side with each of these parties were really developing the product. So it depends on the outcome. However that all use is progressing so we can decide based on on data on how we move forward.
And that what's important for us that we can come to a a broad set of collaborations that gives us really and builds on the optionality to so were indeed very happy with our three partnership.
Regarding the target so if am too.
28, and eight from 32 have been targets that we selected the.
About a year, one and a half years ago and have started the earliest nature programmes. So each of these target were selected by appointment based on a particular algorithm.
And Uh huh.
And give you just a few examples though one of the algorithm.
Parameters of past being that an antibody already has been the mechanic and extra opportunity data, but no meaningful data and maybe also a antibody drug conjugate has been developed but not providing the optimal therapeutic window. So we pick a particular target where we thought that they have.
Rationale and based on this rational we could entertain the discussion.
Discussion.
And this is what is indeed, what brought the roivant and that we have a very solid rationale for why you choose targets and the way, we would develop and how we develop them in particular indications.
And this process is ongoing again at the documents. So we are creating additional options for a good target. So we can broaden that the space with our platform quite significantly and we'll have additional novel agent available either for future owned developments, but again, we can stay.
Rights deals based on the breadth of knowledge the company hasn't been field and based on Directionally, how we would bring full with such companies.
That's already fixed target.
Okay. Thank you and I may have missed it but is that a dose escalation data from April 24 are still on track to.
We are reporting first half 2021. Thanks.
Andreas.
Oh, Yes, we have said previously this is a dose escalation study was a very innovative agent so its a little bit difficult to predict how many dose levels, we will have to test.
We have yes, we said to look at those levels three actively recruiting dose level. We have clear those are the two actively recruiting dose level three.
So this study is progressing as predicted.
But again was a very novel entity is a little bit hard to say, how many dose cohorts you will have to.
Reaches the recommended phase two dose.
Thank you yes.
Your next question comes from the line from.
Thanks, Todd those pieces of your question.
Well.
Hi can you guys Jeremy.
Yes, we can hear your web Jim how are you doing a terrific job that congrats on all the progress adient team and the terrific partnership so maybe.
Maybe just to start for aren't.
If you could talk a bit about the arqiva platform and what drew you to that NK cell platform, specifically, how it sounds like Youve interrogated a wide range of different NK cell approaches and so maybe just what you liked about that one and I guess the second question might be for Andreas but is there a scenario where study tools to increase.
Provides an opportunity to add an NK cell therapy.
Therapy to the protocol is there any possibility of that outcome offer the interim thanks guys.
Thank you Jim and so Andreas why don't you take the second question first and then aren't and Wolfgang can jump in on the our Chiba and the Brussels.
Yes, so unless you know Asms 13, two it took us a registration directed study.
Which was discussed and agreed upon with Swiss FDI and regulators.
So I think there was not an auction and no intention to modify the study we see this as an opportunity to.
Pursue an excellent rated approval process if we.
And basically repeats the activity levels that was shown in earlier studies Lexie Columbia study.
Now as he is going to get into aren't have indicated both of our partnerships with NK Max as well as with our Tivo.
Allow us to work with boasts EPS, let's say from 24 as well as higher from 13 so.
We are definitely looking with our partners into options, whether and at which point it may make sense to combine a if im sorry, and was was NK cell products, but.
But it's unlikely that it will be a part of sito to study.
Thank you.
Yes Arnie.
Let's start on the open join in so Hi, Hi, Jim how are you doing so you know we live there.
It came acts in our Cheever closely.
Very impressed really when we did the preclinical studies in house, both companies highly consistent the functionality when we combined with lower.
Cds we saw.
Likewise, very nice synergism increase cytotoxicity against the you know the specific targets also increased.
Other kinds accretion degradation, we looked at that very carefully but also when you look at the.
The platforms of manufacturing OLED Boscombe comments here that that was very well in place in both places and including Cryopreservation.
And whats going do you want to comment maybe a little bit also on the on the GDP. So yes that.
That was on mute sorry.
Looking at this from a from the CMC perspective, we looked at the end.
NK cell products and our team had a very robust and reliable process established in collaboration with the Green Cross in South Korea, So they had really.
At least a process and really analyzed several.
Batches and head to very homogeneous products not only from a phenotype, but also from a functionality, which was which was fairly high as Chuck mentioned on top of that drive that cryopreservation process and we all know that cryopreservation NK cells is not an easy task was or is there a.
Stable and robust as well. So these have been some sectors, which we looked at and consider the product and the manufacturing is very good.
Great well, thanks for taking the questions guys.
Thanks, Jim.
Thank you.
Your last question comes from the line of Dan from Laidlaw. Please ask your question your line.
Thank you and also add my congrats on.
Oh, the development and the deals.
Humans lately.
My first question just Triton comes from in terms of them too old to study the piece, but the but the number of patients is that 44, that's a different number now.
Oh, Yeah, I can address questions.
It was said Oh FY two cohorts so the city so the expressing high expressing low expressing our analyzed separately.
And she's analyzers, how based on 20 patients per cohort. So the total dataset will be 40 patients.
Okay, great and maybe a little bit house, keeping questions in terms of the road.
Dan rather.
Thank you.
Sorry.
Yes revenue you received.
I assume that will be amortized could you give us some guidance in terms of how that will be.
Projected.
Yeah, Hey, good Tangguh second I can take that question I mean, we're still obviously working through the accounting, having having just announced that video yesterday, but but I anticipate that.
A portion of the revenue will be recognized in the fourth quarter and then there will be a portion of it that will also be amortized.
Okay. Maybe last question here is that.
How would you reconcile it seems that the arqiva.
[laughter] efforts.
Steve.
As for key it's very similar to the design and that the approaches verisimilitude that Andy.
At the end of season so.
How would you reconcile.
Two different colors.
Collaboration going forward in terms of either commercialization or other products. So the balance sheet.
Thanks.
Yeah, I think that's a premature so as we've said before being a really important to be.
Broadening active in this field.
Realized that.
We have a differentiating a platform with the rocket from that allows the high affinity binding to Cdsixteena right.
Noncompetitive through a circulating archie so ensuring that a loaded so indeed can reach the target without any hurdles and stays on this on this so.
So this is the this would be a situation that we have and we also learned that there is there are multiple opportunities for collaborations.
And.
With Archie Bunker Mckesson MD Anderson, we truly have found the platforms that highly center choice that we know once we explore so at the end we felt that a breadth of collaboration suits us best Thank you.
Thank you very much.
Thank you we have no.
That question at this time. Please go ahead.
Yes, I'm I'm, concluding this earnings call and thank you all of you for attending today.
It's been a.
Quite exciting data and indeed exciting week for us being able to strike all these partnerships move forward with the programs.
And creating a different options and as were saying our our strategy around them.
Telling data.
It's truly built on buying to congressional so we try to develop those in monotherapy setting where we feel.
There is a.
Gary Uptown to seeing a meaningful benefit.
We are looking into combinations with that in pesos.
May increase or decrease in particular affecting.
And the third pillar is the combination with checkpoint again, we've already in the past generate the data elevate uncertainty of PD, one and we've shown that you can double CR rate of the PD, one immunotherapy, so quite exciting times for us and we look forward to providing data throughout the 2020.
2021, and 2022 now with having a run rate in 2023. This is quite good solid situation that you have achieved thank.
Thank you very much and have a nice thing.
Thank you, ladies and gentlemen that does conclude your conference for today. Thank you for participating you may now disconnect speakers. Please.
Thanks.
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