Q2 2020 Affimed NV Earnings Call
[music].
Good day and welcome to the Sun second quarter, Twentytwenty financial results and corporate taken from school.
Time, all participants are in listen only mode.
Your mind at today's conference is being recorded.
Now that and she she you all heights for today's conference acts on the city, Keith <unk> head of Investor Relations and she said he's going ahead.
Thank you Charlotte I'd like to walk them and thank you all for joining us today.
Second quarter 2020 financial results and operational progress conference call.
Well, we've again I would like to encourage everyone to go to the Investor Relations section and that's website to find the earnings release and related financial tables.
We also posted slides on our website that for a discussion today.
On the call today, we're joined by doctors.
As our Chief Executive Officer, Undergrads hard strike Chief Medical Officer on shuts Healios, Chief Scientific Officer, and Angus Smith, our new Chief Financial Officer, who joined US in July.
We also joined by Dr. woke him Fisher, our Chief operating Officer, I missed a nice Miller Chief business Officer. They will also be available for the Q1 <unk> session.
Before we start I will quickly go through the Safe Harbor statement.
Today's discussion will contain projections and forward looking statements regarding future.
These statements represent our beliefs and assumptions only goes off the data that's called except as required by law, yes, or no obligation to update these forward looking statement publicly or to update the reasons why actual results could differ materially from those anticipated in the forward looking statement.
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 safely.
Various factors, including but not limited to those identified under the section entitled risk factors in our filings with the FCC and those identified under the section entitled forward looking statements in the press release that we issued today and filed with the FCC.
Sorry, I will turn the call over its lobby I'd.
Thank you Alex good morning, everyone and thank you for joining us for our second quarter.
Business update call.
Today, we have some updates to share with you on our operational progress as well as on our financial results.
Well, we're still in the middle I'll say, a serious global health pandemic and age out challenging economic downturn.
So we're quite confident that the steps, we're taking in advancing those filings and moving now a pipeline full but are beginning to your data that demonstrate.
The long term potential of our innovative approaches and programs.
[noise] Koby 19 continues to affect societies around the vote and we hope that you and your families are well in safe.
We are observing some impact, but koby 19 on the progress of our clinical studies. However.
He said last and we're taking great efforts to minimize them.
As a result, we have been able to continue progress on that can make a studies I'll say it from 13 in peripheral T cell lymphoma.
End of anywhere from 22 for each of our positive tumors.
And which is very exciting for us genetic dose the first paid and with our own seven to nine seven.
And which as you remember, it's the bcm HCT sixteeneight units engaged.
We also making good progress on our preclinical pipeline.
For our lead candidate a it from 13, our study in patients who have relapsed or refractory peripheral T cell lymphoma in exhaust that a available standard of care treatments.
I'd now being treated with a it from 13 as a single agent.
Executing according to our development timelines and as previously stated expects to complete the pre determined interim analysis in mid 2021.
They're also looking at options to enhance aid from 13 to FICO CPR mono therapy. The first of these options. It's the combination with allogeneic NK cells in a study that is conducted at the MD Anderson.
Contains the acute undrawn iced tea.
MD Anderson website no shows that the study is enrolling but initiation is impacted by the ongoing kobin Langton pandemic in Texas.
First patient than the study is expected as soon as the situation improves.
Brave from 24, we disclosed that we have completed the first cohort.
Of our dose escalation study without any dose limiting toxicities.
And we're currently recruiting into the second dose cohort.
We have on form 10 sites active and recruiting.
Following the completion of the dose escalation.
Phase of the study we have the option to enroll patients into tumor specific expansion cohorts, where we will look for single agent activity in a number of FFO define to tumor types. In addition were planning to initiate combination studies with checkpoint inhibitors.
And we'll be providing updates at the program continues to make progress.
But very pleased with the continued progress in collaboration with Genentech Importantly, the phase one clinical study with BC amazed cdsixteena in its engager is now enrolling patients.
This achievement represents the third inmates and engaged to enter the clinic and triggers a milestone payment to us during the third quarter in an amount that were not able to these clubs.
Last month Angus Smith.
Chief Financial Officer, Angus well introduce himself later and discuss financial position and the flexibility provides us continued to execute on our strategy and try to future growth upon company.
During the annual general meeting of shareholders, which was held in August four.
We're happy to report that all proposed agenda items were approved.
This concludes the addition of dumped on at least at Jenkins and how we welcome to the supervisory board as new members.
On the alleviated a visionary leader, who knows how to translate signs from bench to bedside.
Harry is an accomplished financial executive who will help drive value, creating strategies for the company.
These additions to the supervisory board further strengthen the company's industry know how experience and diversity.
As it did.
As it has only been a month and a half since we last spoke to you. We thought we would focus today's discussion on company achievements thus far.
And what gives us confidence in our signs update you on grants and then I'll plenty of time for QNX.
Okay, I will now handover the call to Andreas Australia, Hart Chief might cause that to give you a brief update on our Kennedy stage programs.
Interest.
Yeah. Thank you how do you foresee introduction and thank you all for joining us today.
I'm happy to give you an update on the progress in our clinical programs.
We made over the last three months.
All right as you all aware Ur Cobot 19 pandemic is still present globally and it continues to pose challenges for the conduct of clinical trials and the enrollment of patients.
The two guiding principles, we are employing adelphia, Matt is to ensure patient safety owns a studies and to ensure trial data integrity.
Thesis in line I think with guidance given for more competent authorities.
Within this framework however, the ultimate team is very proactively.
Working with all of our participating sites to make sure that our innovative treatment is still available for patients in need of new therapeutics.
And that we minimize the impact of cold with 19 to a minimum possible.
One important achievement in this regard is that we were able to secure drug supply for all of our ongoing studies and can ensure uninterrupted treatment of patients.
To go into more detail and let's start with a year from 13, our most advanced program first.
As you know a if im 13 is in a registration directed a phase two study.
Im certain to owed to.
Treating patients with relapsed and refractory peripheral T cell lymphoma.
We have exhausted all.
Very liberal standard of care options.
The.
Enrollment into this study is at a steady state.
We were able to activate 54 sites style contributing patients in 10 countries around the globe.
Yes, you know this is a study has.
Simon two stage design was a preplanned interim analysis after 40 patients in the PTCL cohort and they said we are confident that we will have data from this interim analysis available by the middle of next year.
There was also a third cohort or there is a third cohort.
Study for patients with transformed because his phone go either so I could tenuous form of T cell lymphoma.
This third cohort was mcos from lead US was never part and never intended to be part obviously registration program. It was a proof of concept.
Cohort only.
And for corporate 19 related restrictions the enrollment into this cohort is currently on hold.
Yes, I'd also mentioned we are continuing to make progress in our collaboration with MD Anderson cancer Center.
Where we have an active high end the pull a first phase one study or 513 in combination with allogeneic national Oculus self.
Hi, SRT set the current status at the MD Anderson Web page is recruiting.
And we know that patients are currently screened and considered and we are expecting to be enrollment of the first patient as soon as Corbett 19 related restrictions at MD Anderson.
Lift up.
Now, let's move to our second program FM 24.
As you know a bi specific tetravalent molecule targeting both CD sixteena eight to activate national killer cells, and macrophages and CTGF receptor on solid tumors.
Hi, this compound isn't a phase one dose escalation part of the one or one study.
And we're happy to report that we were able to activate all for pre planned sites at all for Preplanned sites are contributing patients.
As we disclosed earlier, we have completed cohort one without observing dose limiting toxicities and are actively recruiting into dose cohort two.
We see I close.
Overview, I'll see clinical progress and I'm happy to hand over to my colleague onshore Telus Chief Scientific Officer, who will review with you some of our preclinical data that make us. So excited about the opportunities that we can create for patients with high seas and activating.
Nate immune system.
Our next please.
Thank you Andreas and thank you all for joining in the next few minutes I would like to summarize as Andreas mentioned, the preclinical and clinical data observed so far with our NHL engagers.
Providing evidence that these molecules of potent.
And safe drug candidates.
I'll start by summarizing the data showing that our IC ease up potent molecules.
As you see on slide five if we take action 13 as an example.
It's uncertain has been shown strong single agent anti tumor responses.
T cell lymphoma, with an overall response rate of 50% more.
The molecule has also shown promising signs of broad clinical development potential in augmenting other io therapy, such as PD one inhibitors.
For example into Hodgkin lymphoma phase one this study.
We've seen an impressive overall response rate of 88%.
With a complete response rate of 42, and 46% in the local and essential read respectively.
Hello part of the slide we've also highlighted for you presentations.
Of the studies past add in the future.
Additionally, our own experiments and the work with MD Anderson, we're seeing promising.
Preclinical data showing that the combination with the adoptive transfer NK cells enhanced the immune response of agents our team leading to prolong survival in the respective mouse model.
As we mentioned the phase won't be studied and D. Anderson is now the last stages of preparation.
If we go to slide six.
You see that in our preclinical studies with 24, we saw potent killing of EG, if our positive tumor cell lines.
Mediated by two distinct.
Mechanisms of action potent ADCC or antibody dependent cellular such toxicity.
Irrespective of the mutational status of the tumor cells.
We see potent killing mediated by 80, CP or anybody dependent settled sacrosanct doses.
Tumor cells with high and low EG about expression importantly in cells bearing the KRS GE 30, Indeed mutation and 24 shows preserved, killing potent Kelly or 80, CP or phagocytosis.
Whereas this ability is lost.
For established treatments.
For the MTBC, a may CD 16, or Aro seven to nine formerly known as air from 26 molecule.
We also saw very good potency instead of markets.
Well as a dose dependent killing obviously made positive plasma cells.
It was observed.
We believe that the observed improve potency is mediated by the dual mode of action of approach.
The next cell engagers, employing NK cells, and macrophages to kill tumor cells, and thus act bar a two pronged mode of action.
Of antibody dependent cellular such toxicity and antibody dependent phagocytosis.
Slide cancer.
Indeed, this dual mode of action is differentiated from other NHL target. It approaches as these specifically activate NK cells only.
Ornate cell engagers work at low expression levels potency is those independent of the surface target expression.
And you see this continuing slide six.
Based on 13, we learnt that there is a broad range of cell lines that express different levels of tumor antigen and we have not observed any dependency of tolerate expression to the potency of the molecule.
The same holds true for air from 24.
And the MTBC Engagers Preclinically, both molecules of showed high potency across a wide range of Egypt, our NBC may surface expression, including a low target expression levels.
Implies that more patients could respond to treatment with an innate cell engager versus an antibody drug conjugate or 80 C.
The next mechanism of 80 siege have been shown only to rely on certain levels of target antigen, thereby missing those tumor cells with expression levels below the ability of the AIDC to buying to target cells.
As we move on to slide seven.
And report on the safety from pre clinically are in need selling dangerous demonstrate low cytokine release.
Some examples of these are the I'd, enabling toxicology study.
Cynomolgus monkeys, which consistently showed no meaningful increases in seer serum sidecars.
For example, if the June virtual PCR conference a preclinical poster presentation on the Aro seven to nine Muller, who all the genetic show potent cell, killing in tumor cell lines employing NK cells as a separate yourselves with minimal increase in Sadik times also a four week safety stock.
So no monkeys showed a favorable safety profile with no cytokine release art gross findings at the 15, one five at 55 zero mix to kick tested dose levels.
And in the case, if and trading for only a transient increasing all six plus observes that was fully reversible within 24 hours, but no signs of cytokine release was observed that would lead one to believe that there is a risk of pay cytokine storm in patients.
Important to note here is that none of the clinical studies on April 13 have revealed any significant increases in CRM sidecars.
These data indicate that our IC is tolerable and good safety profile.
Taken altogether.
These data suggest that our NHL engages a potent.
Able to engage at low levels of antigen expression and have thus far demonstrated a good and tolerable safety profile.
Now in order to maximize the opportunity here for a molecules. In addition to clinical development a smaller therapies. We are also pursuing combinations with natural killer cells and other treatments such as checkpoint inhibitors, such as PD one PDL one.
We go to slide eight and first let me comment on our combination approach with NK cells.
As you see on the slide there is evidence showing that hi, NK cell numbers are associated with better outcomes. For example, patients with metastatic continuous melanoma have improved survival rates, if that Cerberus show evidence of NK cell infiltration.
We also know that patients, but diffuse large b cell and follicular lymphoma treated with anti Cdtwenty antibodies.
That's a low peripheral NK accounts tend to have poor survival.
We are seeing that one of the limitations and treating patients is that they don't have the appropriate amount of NK cells.
So we're working on supplementing NK cells through adoptive transfer and are currently assessing different approaches as you can see on slide nine.
As we go to slide 10, and as discussed earlier, the improved two merkel cell, killing by loading NK cells with our IC. He is.
You see on the graph for in vitro data on the right hand side of slide 10.
It will be investigated in the MD Anderson phase one study in CD 30 positive recurrent or restructure hodgkin non hodgkin lymphoma patients.
The preclinical data, let me share heretic shared before leads us to believe that Billy can expect to see an improvement in the efficacy of an innate cell Engager Hey from 13 through the addition of NK cells.
And encouraged by the synergistic potential of combining our E.
He is with NK cells and checkpoint inhibitors were currently evaluating the opportunity on our developing clinical plans for these combinations with 24.
Finally, let me just briefly summarize the recent posters presented a CR as a reminder, I'll ask him 24 poster demonstrated its distinct mechanism of action.
And from other EG, if our signaling inhibition approaches potentially a able to provide benefit too broad range of cancer patients.
And in the case of the joint poster with genetic.
The pre clinical pharmacology and safety of the Bcm Acds 16, a NHL engager shows potent cell, killing tumor cell lines, employing NK cells as effector cells minimal increase in cytokines, suggesting a low risk of cytokine release syndrome.
We hope this spectrum was helpful for you and I will now turn the call over to Angus to introduce himself and provide an update on this financials eggs.
Thank you arch. Thank you aren't before I discuss all right I'll highlight.
Let's just say I'm thrilled.
Yeah.
And I look forward looking mortality.
Hi, Mark tightening cycle.
Turning to the results for the corner.
Happy Mets consolidated financial statements have been prepared in accordance with Rs and issued by the International accounting standard Board for SMB.
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 in this call unless otherwise noted.
Well be in Europe.
We ended the second quarter with cash cash equivalents and current financial assets of 92.6 million euros compared to 104.1 million euros on December 31 2019.
During the quarter, we received net proceeds of approximately 20.8 million euros under our aftermarket or ATM program.
Based on our current operating plan and assumptions, we anticipate that our cash.
Cash equivalents and current financial assets will support operations into the first half of 2022.
Net cash used in operating activities for the quarter ended June Thirtyth 2020.
15 million euro compared to 5.6 million Euro and the second quarter of 2019.
Second quarter 2019, net cash used in operating activities included a milestone payment to the company and the Genentech collaboration.
Total revenue for the second quarter of 20, 22.9 billion euros, compared with 4 million euros in the second quarter of 2019.
Revenue in 2020, and 2019 predominantly relates to Genentech collaboration.
Revenue from the genetic collaboration in the second quarter 2020 was comprised of revenue recognized for collaborative research services performed performed during the quarter.
R&D expenses for the second quarter of 2020 were 11.7 million euro compared to 11.5 million Europe in the second quarter 2019.
Expensive in 2020 relates predominantly to our am 13, and 24 clinical program.
Well to our early stage development and discovery activities.
DNA expenses for the second quarter of 2024 2.6 million Euro.
At 2.3 million you're out in the second quarter of 2019.
Increase is primarily related to higher Sox compliance costs legal consulting and audit costs.
Net loss for the second quarter of 2020 was 12.2 million euro or 16 cents per common share.
10.3 million euros, or 17 cents per common share during the second quarter of 2019.
The weighted number of common shares outstanding for the quarter ended June Thirtyth 2024 $79.2 million.
I'll now turn the call back to high Howdy.
Thank you Angus.
As you can see from a presentation today were taking advantage of funding knowledge that weve gained.
In the field of innate immunity and are applying it to our programs going forward.
This experience in Brooklyn, which innate immune system is something that if uniquely established at after Matt.
And is helping us in guiding the design of a unique therapies, which now has the potential to address some very different kind of cancers.
Just wanted to point out here that the each year far is expressed in more than 10 tumor.
And that gives us a lot of optionality.
How to take this molecule forward.
Were pleased with how things are moving forward for botox chemical in preclinical programs, especially in the current environment.
Our preclinical programs are on track and from 13 and 24 I'm moving forward According to plan.
And tuned entities moving things what would we see MTBC amaze cdsixteena in its engagement.
What our inflection points for the next wanting to have yes way from 13.
We have mentioned that.
We want to prevent the interim data in peripheral T cell.
Lymphoma around the middle of next year.
We've been successful in our collaboration with MD Anderson moving forward the combination of a if some 13 and cope lot derives natural killer cells.
As we've said.
We are ready to start to MD Anderson is ready to start and we hope to report trace patient and Google provide update.
As we move forward.
Brave from 24 in the midst of dose escalation.
Order to generate safety and TVT data.
This is quite exciting for us because it's a direct with a very differentiated profile profile as compared to the.
Other moieties currently used in targeting the inkjet printers.
Now with a dose escalation and establishing the safety.
Obviously, we'll have recommended phase two dose coming up in order to then to the dose cohort expansion.
But as we've mentioned early areas. We're also planning early on to move forward into combinations.
We're very happy with the progress in the genetic collaboration.
Just reminded the next update for the PC may Cdsixteena engagement, we have multiple other programs ongoing and do things go well pending on program progression progression we can bring.
Additional milestone.
And therefore, our newest additions to the pipeline.
With that anywhere from 28 and they get from 32.
Starting behind enabling studies, so that we can happen.
Nine E filing first 0.8 28.
Finally, before we open the session for Q in I would like to thank all our employees for their contribution and express out gradually to my gratitude in particular far investigators and the chemical sites.
And the patients and and all that families with our investors who are supporting us in our efforts to develop innovative treatments for cancer patients.
It just through the combined deficit of all of you that keeps us on the path of discovery and innovation.
Im now happy to close the presentation and we're open for questions. Thank you.
Ladies and gentlemen, who will now begin the question and answer session.
They should you wish to ask a question you really depressed barring the number one telephonic replay need to be nodes.
And dancing within the press the pound or Heskey.
Once again, a star and one for questions.
First question comes from the line Molly Ray costs from Jefferies. Please go ahead.
Hello.
Hi, good morning, everyone. Congrats on the progress thanks for taking my questions.
To start off just wondering for anthem 24.
I'm not sure how much you can say on this but just wondering if both patients and core to have been dose and if you can talk more.
About the timing of dosing between patients with the four sites activated can you provide any more perspective about enrollment pace going forward.
Andreas can you take the question please.
Yes, so there were multiple parts of the questions I hope I got them all.
So the phase one study or play from 24.
As we said we are recruiting into second cohort.
We have not yet disclosed how many patients.
As you know, it's a standard three by three D. sign.
With the base.
Dose modification.
But that's basically what it is.
In terms of timing between to patients there is a mandatory eight day waiting period.
Between patients.
They can not be treated on its the same time, but we'll just take it was a day interval.
And there wasn't part of the question around the for participating sites.
Right. Yeah, just wondering if you can provide any more perspective about enrollment pace going forward.
Currently the enrollment pace is as pre specified posit protocol so.
Well sites are very actively screening patients and as we said all patients all sites have already contributed patients.
Got it okay, great and then.
Also for 24.
I'm just checking if you can say more about the tumor types that you are screening for the study and if you can also provide more perspective into the checkpoint inhibitor and combo plans at this point.
So for the odd tumor types.
The dose escalation part.
We are accepting all patients was.
All histologies that are Egypt are expressing and.
We as a patient has exhausted the respective standard of care treatments.
Yes, I'd mentioned this is a wide variety of potential tumors are probably the two most prevalent tumors would be colorectal cams and non small cell lung cancer end.
These are the two histologies, where we would expect properties a majority of patients into phase one.
Having said that the dose escalation part, but also be open for other Egypt are expressing tumors like for example, head and neck cancer gastric cancer.
Or as a solid tumors.
Now once we have to find or dose limiting toxicities or if there are no dose limiting toxicities, we'd have defines who recommended phase two dose.
I will enroll into a tumor specific expansion cohorts.
And this expansion cohorts are currently in the process of being defined.
No for our PD one combination plans.
Based on the interesting data we have seen with.
PD one in combination with 13, which I referred to.
Was the very encouraging complete response rate in excess of 40%.
We plan to have a combination was a PD one or PDL one inhibitor.
Opening rather soon probably.
In parallel to the last cohorts of see dose escalation of single agent study, so we'll be more or less a parallel development that we are anticipating right now.
Great. Okay. Thanks for the additional perspective.
Any follow up questions.
I will note receivable next question next question comes from the line of.
Jim Bridge.
From Wells Fargo. Please go ahead Jim.
Hi, guys and congrats on all the progress.
Maybe just a first a quick question for Angus to start came off.
Collaborative research revenues is that expected to be a stable number between the three to 4 million dollar level or is there any reason that might go up as has programs progress and as we think about the milestone that got paid in the third quarter is it a simple matter to back out the assumptions around collaborative.
Research revenues and that will give us some sense of the milestone given that you can't say it explicitly.
Yes, yes, thanks, Jim for the question so.
Our our revenue numbers fluctuate from quarter to quarter based primarily on the number of our well that we're working on.
Various genentech programs.
Veteran progress I mean, you can see just looking back at the last several quarters we've been.
Fairly fairly range range bound and call it that that 2 million to 5 million zone.
When you see and pretend that typically.
Result, a carton tied milestone payments that we received so.
This this milestone payments.
That we discussed today that will elegant in the third quarter.
Well will likely increase our revenue in the third quarter and that would be sort of an add on to the to the range than you've seen over the last several quarters have you again kind of to that.
$2 million to $5 million to our two to 5 million euros rather.
Got it Okay. That's helpful and then maybe just on.
One for some 24 on what we might learn from that cohort.
Can you remind us if you're doing pre and post biopsies and what kind of translational work you might be doing and how that might inform the ability to recruit.
In eight sells to the tumor site.
Yep, so in the dose escalation part.
We do a pre treatment biopsy.
Post or on treatment biopsies optional.
Oh, we do have a significant correlative science program looking at peripheral activation markers of NK cells as well as cytokine profiles.
Once we are in the expansion of phase. So we are recruiting into tumor specific cohorts. I think this is the part we have we will get most of the correlative science as we have more homogeneous patient population.
We maintain our requirement for Retreatment biopsy.
And we'll have post or on treatment biopsies in selected cohorts.
And then just.
Given the comments on the variability in peripheral NK cell.
Populations.
Is there any sense in screening patients for their NK cell levels.
Given that patients who screen low may not have adequate NK cells or macrophages to recruit or you feel like within the variability of in eight sell.
In the blood that that you'll be able to have an effective treatment and it's not worth screening for that variable.
I think currently it would be a premature to.
Got it depends on what you mean with screening.
Well, we are definitely deeper meaning the.
Levels of circulating NK cells and also looking at some of their characteristics.
I think we currently do not have enough data to define a cut off for us thresholds.
And this may very well vary between tumor histologies and also be dependent on.
The infiltration of NK cells into tumor micro environment.
Variable, which we have seen in our efforts.
Columbia study to have some impact on on the likelihood to respond to the pace of patients. So.
In the beginning of see program, we will be open for all comers, we will assess although seems important bio Marcos and then based on the activity data ran through retail since we are seeing we may modify assay program defining sweetness thresholds, but currently I think it would be premature to do that.
And maybe just a final question just the MD Anderson collaboration is focused on cord blood derived.
NK cells is there any thought to other NK cells sources, including potentially see derived NK cells.
How do you want to takes question or should I take it well I under its why don't you go ahead.
Okay.
Yeah, Youre right wing quote blot derived NK cells is one source of NK cells and.
If you a watch the field of NK cell.
Based approach was especially as easy fields around companies.
Institutes, providing different sources of NK cells there was.
Definitely.
Pete picking up and then.
Variety of options to look at and how this is what we do not only from our side.
We also received a proactive enquiries.
Of potential.
Working models together, so we're looking at CN tire and case.
Well field.
Various options.
Great. Thanks for taking the questions guys, maybe as a quick comment, though we see this.
Let the right thing pesos already quite advanced in Kentucky development. So they have already being a many patients treated while we see IP cease currently.
There is still a.
Let's take two to be determined and that obviously in combination we learn more on that functionalities. So this is somewhat.
Yes.
To us on how functional an ITC, you're right versus say peripheral NK cell it and it's good to see the first clinical data. So we're quite.
Not only happy, but we've checked so many different options at the moment for NK cells American viewed very convinced about.
The activity of the CT legacy REIT codes from the MD Anderson.
Great. Thanks I'd.
Thank you. Our next question comes from the line of ISL G from BMO Capital line is now open. Please go ahead.
Okay.
Hey, good morning, gentlemen, thanks for taking my question K on for Joe can I, just a couple regard that these seem a and they engager.
Understand that you probably limited visibility on the entirety of their clinical pathway.
But if you can provide any type of insight in terms of what genentech.
Kind of has planned maybe in terms of great potentially pursue and accelerated pathway.
For the assets.
And secondly.
Again.
Provides.
Probably details on does that milestone payments, but.
If you can provide some additional perspective on.
What the future milestones for the asset might holds.
In terms of.
Phase two phase three things thats or should we expect increasing size of value for each milestone payments that'd be helpful for us. Thanks.
Maybe I'll take the question on the pathway and then hand over to you for the milestones.
Yes. Please go ahead aren't.
So thanks for the question I mean, as you already correctly say, we cannot really speak in detail for genetic but we can share with you I think you're aware of course.
Licensing this molecule was a big part of the deal with that.
And then take there obviously.
Excited about the strong differentiation potential ophthalmology will also demonstrated HCR at the at the poster just to review again very strong preclinical cell, killing selective no cytokine release very good safety profile and good pharmacodynamic marker specific bcm.
Placements cell, killing in the Senate monkey so.
Despite the also recent approvals of the you know income first encumbers into space.
I would say.
Hey that genetic shares our excitement with a differentiation potential and the way you for a potentially best in class molecule, maybe I I leave it there I think it's it's a it's a clearly strongly clinically validated space and I think this molecule will enable.
Genetic and we as their partner to have a strong position in this space.
Yeah regarding the financial so I just want to recall that deal when you to assigned so we received 96 million in upfront cash.
And I and can get a total of more than 5 billion in milestones that are.
In different categories. So there are pretending <unk>, there's a pre kennedy milestone payment.
Indeed, multiple clinical milestone payments regulatory and pellets milestones and on top we can receive royalties, which as we described are on the higher end of what you would expect for early nature of for the Uh Huh.
License agreement.
Beyond that we're able to disclose any further details.
Unless a genetic would allow us to rush would allow us to do so usually that's just the general statement is.
At the payments will increase the for the program progresses.
Okay. Thank you for that and just one more quick question.
Matt this.
This is in regards to add 24.
Mentioned that there was the pacing.
That had increase.
I'll stick cytokine levels that would resolve over 24 hours.
Curious was that self resolving or patients receive and out six inhibitor.
Yes, Ken thanks for bringing that up and the clarification. So the transient all six increase was reported in the <unk> everything So no Tox study what you referred to the our poster indeed, we saw that with the dosing a kind of moderate peak that.
Quickly went down almost completely resolved.
Without any any treatment. Obviously, you know one doesn't do that in the because this is CNO Tox study and again when we see this in the context, because it was transient fully reversed.
Leads us to the conclusion, which of course will be looked at carefully in patients.
That we should not expect any kind of cytokine release.
Syndrome.
Alright, thanks for that clarification.
Sure.
Your next question comes from line of Gen meeting.
Please go ahead.
[music].
Well.
Yes, Hello, Yes, I can hear hi, sorry.
Hi, Thanks, Bob.
Thanks for taking the questions. My first question is that.
Well they 13 in the for the registration study that.
It's a simon too.
Set up so.
What might be rice, Hello, Oh in that 40 patients and so the entire rated read out before you can move forward. So just curious what.
Hey commitment and reveal on that front.
No.
Frank we cannot give.
Concrete response rate, it's based on the Beijing design. So is there some into dependence of response rates, but we usually do not disclose thresholds, but it's a classical Simon two states to sign.
Okay, No problem and also just curious.
Yeah.
One for.
That.
Dose escalating but.
At least based on.
In one data is any thoughts where when you my thoughts.
Okay, so effective dose to saw.
Ah think currently it's not possible to predict when we will have the optimal.
Biologically active too.
Et cetera number of covariance like finding sites for Cdsixteen, finding signs for UGI F., our end and distribution.
And as he knows the animal models, especially in terms of pharmacokinetics and pharmacodynamics are very.
Difficult to translate.
Be relevant talks BCS and.
Got it Thats one of your talks PCC signed them August monkey.
However, we do not have and the Santa Monica's monkey tumor models available so.
While we cannot really bridge between what we've seen the toxicology studies and then what we would you in terms of.
Because see for for consumers.
So it will be some folks that we would have to defined in our in our clinical program.
Okay, great maybe.
One last question here is that.
In terms of adaptive.
So from a coke.
Robin themselves.
Yes.
With the potential to use in solid tumor and.
Any comments comment in terms of regarding that.
But.
This is as he said something that we are actively looking into.
We will starting out with lymphomas, obviously was from 13 targeting CD 30, but our vision is that also foray of 24, we will develop.
Certain development options in combination with NK cells.
Could be caught block derived NK cells could be and cases from analysis horse.
That is something that we will define but its intention is also to have a.
Have a program. We're here from 24 would be part that was extra genius NK cells.
Okay, great. Thanks appreciate it and congrats on another problem that's all.
No no further questions at this time for any closing remarks, we got speakers.
Yes. Thank you again for a listening in and following our our updates.
The the progresses comings, mostly along despite that we are affected by by Kogut.
We have strengthened the team significantly in order to address any issues that may relate to the conductance off this clinical trials or.
To the.
At interactions with the with the specific sites. So we're very happy to be able to after I've been able to address.
Any of the issues that have been a rising and I did want to thank again.
The entire team here I document for a managing all that through this difficult times.
We're quite excited that we can move for what these programs Ida its monotherapies and no looking at different options off of combination as you've heard we're focused on natural killer cells and checkpoint inhibitors in particular PD ones. So PDL one.
So we feel that we have a with the multiple programs.
Addressing different targets or we can provide a cadence of data over the next quarter send in years and a very happy to report any additional updates as we move along thanks, a lot again for listening in and all the best Goodbye.
Hey candidates into their conference for today. Thank you all participating email disconnect.
Good luck.
Thank you bye.
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Yeah.
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