Q1 2020 Affimed NV Earnings Call
Good day and welcome to see matched first quarter 2020 financial results incorporate update conference call.
At this time participants are in listen only mode.
A reminder, todays conference is being recorded Oh, no introduced introduce your host for todays conference and extending <unk>.
Investor Relations.
Please go ahead.
Thank you Bernard.
I'd like to welcome and thank you all for joining US today, My first quarter 2020 financial installed.
<unk> Paul progress.
This morning, I'll do my issued a press release, which is also posted on our website at www Dot com.
On the call today, we have with says Dr. As I do you pay is our chief Executive Officer, Undergrads far strike, our Chief Medical Officer, and Orange, <unk>, Chief Medical Officer, and Michael Wall had a fine.
We're also joined by Dr., Wolfgang Fischer, Chief operating officer, and the Nice Miller Chief business Officer, They will all be available for the Q and a section.
We will begin today's call with opening remarks somebody on the company's operational update alright, well give you a brief background about the side.
The outposts this presented yesterday, an undergraduate provide an update on all plenty called programs finally, Michael will review the financial results for the first quarter.
After the prepared remarks, well open the coal for acuity section.
Before we start I will review, our safe Harbor statement.
Today's discussion contains projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call except as required by law, we actually no obligation to update these forward looking statements publicly or to update the reasons Why act.
Actual results could differ materially from those anticipating the forward looking statement, even if more information becomes available in the future.
These forward looking statement, a subject to risks and uncertainties and actual results may differ materially from those expressed or implied in the forward looking 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.
Those under the section entitled forward looking statements from the press release that we issued to date and filed with the FCC.
With that I will turn the call with Robby I'd.
Thank you Alex and.
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I hope that younger families I will.
We know that Cobi continues to affect.
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Yes, I mean based product development.
Hello.
Well this work from home.
Late stage programs with a if I'm thinking.
No registration directed study a referral fees on Oh Wow.
And where do you mean.
Which is a combination of 13.
Some of that NK cells.
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That's why we've incurred.
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Different phases of development.
I mean, obviously.
That's presented an hour.
The second but so it's.
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Promising preclinical activity and good taste.
The basis for all out program.
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Which develops which enables huh.
Well up will be on Croton impossible.
These efforts are led by a seasoned team up there.
Yes.
Well funded.
Actually I know you know, it's holding up a good acquisition that allows us to pursue several programs.
I couldn't deliver multiples out here.
I'm now turning to like.
Fine.
You get an update on our management doesn't digging up to that was quite frankly our men.
With the addition of the industry. That's one of the problem with me dumped Andrea.
With our new Chief Medical Officer.
And often seriously though oh.
Oh.
Yes. This month, we also announced the additional ended Smith, who come awarding to like has to come from that.
Welcome.
And it's joins us from Mexico, where he helped the road Chief Financial Officer.
And that brings with him better capital markets and biopharmaceutical industry experience.
All these additions Britain.
The TV industry, no Rex I guess Walker.
I think he's looking for.
Working with its high caliber management team to ensure the execution of our company strategy.
And that you thought, though delivering new methods.
Thats sitting at the ability.
For those of you who brought our starting you know that are currently today correct.
I tell engages in Canada developing there.
Ladies and 24 into increasing.
Some 28 and a 32.
We also have for ongoing.
Okay, that's part of the genetic.
Now turning to page six.
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Yes, the days of hazy Arnie.
24.
Our research as presented on the vitamin D Eugene apart.
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That has the potential to overcome multiple tenants as they think that.
Increase that's putting CFO.
They can.
Got it resistance and the tenancy safety profile consistent.
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Presented by genetic on the President Oh, let's say Oh.
079, Southern Illinois previously known as some 20 thing I know that might be slightly bigger as explained in it I mean data for the treatment of multiple myeloma.
First person show herpes dealing in human satellite lutein fractions increasingly model.
And our Chief Scientific officer for two years will shift.
You highlight.
Following our Andrea will provide an uptick of progress, we're making that getting development program.
Excluding these shows around the recent news we shared last week on either 24.
During the first dose cohort in the phase one study.
Let me quickly give you an update on our financial.
Position, our cash position you.
In a 88.2 billion Europe.
In addition, since May 13, the company you raised net proceeds of 18.8 million.
At the market ATM program.
Pro forma cash position the company as Mark said before.
Twentytwenty, including the net proceeds from the ATM.
107 million.
The cash infusion is that reduces the support that brought a development strategy of Ah why even 20.
It's communication do not where yes earnings call, we expect our cash position to sufficient though when our momentum.
Durations, well for Apple to though.
The final uptake.
He will be from Mike.
The first quarter by now.
I'll now turn the call before.
How do you think you.
And before we start to I'd like to briefly introduce myself to those were a new to the company and cement.
And I told you literally about why I'm really excited to be at the company now just mid over two months.
Before joining us summit held senior roles in research and development.
Most recently at came at Cambridge, UK as executive Vice President.
Head of research and development responsible for building.
Growing pipeline of 15 proprietary drug candidates.
Which included antibody programs in oncology.
I've also help the role of Chief Development Officer at Morphoses AG in Munich, Germany.
And developing there the portfolio proprietary therapeutic antibody programs.
In cancer, and immunology and a few years back.
The role of director of Immunology tissue wrote to repair early development and genetic.
Over saw all preclinical development programs, including a number of R&D submissions in immunology early development.
I have a heavily station in experimental internal medicine from looked like Mxnone proceeding Munich.
Well so lecture in early drug development.
Well I knew estimate from before.
I was really happy to find out about the substantial progress. The company has made when the opportunity to join presented itself.
I am now even more excited about the highly differentiated platform and programs.
Someone personally touched by cancer.
Sadly my brother in law recently passed away of melanoma at the age of only 52 I.
I have intimately witnessed the shortfalls of treatment and I'm greatly motivated bio unique approach to giving patients back there innate ability to fight cancer.
The needs immunity opportunity is largely untapped.
And the work that the companies doing and this exciting area.
It's one of the key drivers in my transition to join SMS.
The Companys proprietary rock platform holds the promise to really deliver meaningful and transformative medicines cancer patients in need of better therapies.
I'm, just really looking forward to bring in my experience and ideas and working with the talented team at the company and to be here.
Now before we come to the HCR posters, let me take a few minutes to share my excitement about our overall scientific approach.
Innate immunity represents the first line of defense to maintain the integrity of our body and to protect us against viral infections parasites and cancer.
Immunosuppressants of these threats.
Innate immunity is highly efficacious.
Demonstrated for example by our protection from cancer over decades.
However, malignant b transform cells, sometimes evolve.
Yeah, and escape mechanisms to bypass innate immunity leading to cancer.
Activating innate immunity is promising strategy to treat cancer.
I'm now coming to slide seven.
Major effects major effector cells of innate immunity on natural killer or NK cells and macrophages.
Activation of NK cells is regulated tightly by a balance.
Signals from inhibitory receptors.
Recognizing ligands on healthy settles.
And by activating receptors, recognizing ligands that on stress induced on diseased cells like for example tumor cells.
Therefore, NK cells, a specialized to differentiate between healthy tissues.
And a tumor lesion, which is a major challenge for T cell based immunotherapies.
As demonstrated by severe adverse events related to cytokine release syndrome Aura neurotoxicity shown by this class of drugs by contrast.
NK cell based therapies, including adaptive sell it to transfer of NK cells from healthy individual tool cancer patient a well tolerated.
A low degree toxicity.
Overall actualizing this untapped potential up innate immune system in fighting cancer has recently gained real interest.
Particularly the MD Anderson car NK data Indio Bcl demonstrated this potential.
We are one of the leaders in this space with a bi specific innate cell engagers and I would now like to briefly explain the unique design elements of our I see.
NHL and Gators slight age.
As you see here Affimeds IC ease our tetravalent by specific antibodies with two binding moieties.
The single chain FC domains for each the tumor antigen and Cdsixteen eight on NK cells and macrophages.
Slide nine.
These are made from estimates rock or re directed optimize cell killing platform.
Which offers unique engineering opportunities to build customized I see ease with tailored blending affinities tailored scaffolds and tailored pharmacokinetic and Pharmacodynamic profiles.
A key element of these IC ease the proprietary single chain as the domains, recognizing and triggering cdsixteen a on NK cells and macrophages.
Hi, a binding to a unique epitope on cdsixteen eight far apart of the binding side of conventional antibodies.
By binding on Cdsixteen, a on natural killer cells, and macrophages and on the tumor antigen lung cancer cells.
Oh in eight cell Engagers first established a bridge between innate immune cells and tumor cells.
By contrast to conventional monoclonal fiveg these binding off Affimeds IC ease to Cdsixteen A's.
Chris with a roughly 1000 fold higher affinity to both.
Low and the high affinity Atlantic variants of Cdksix today without being prone to plasma USG competition.
And thus significantly broadening the patient population, which might benefit from I see based therapies.
Furthermore, the estimates icees are highly selective.
For binding to Cdsixteena, eight and not Cdsixteen beep.
Restricting I see stimulated activation to NK cells, and macrophages, representing the predominant immune cell population to express Cdsixteen a.
This concept aligns well with the observed good safety profile of estimates is currently in clinical studies.
Let me now briefly explain how our icees are actually killing tumor cells slides 10.
When natural killer cells in tumor cells are brought together.
Natural killer cells release preference to create porous and the tumor cell membrane through which grenz arms entering the tumor cells, triggering a per toasters and resulting in tumor cell death.
This is called antibody dependent cellular cytotoxicity or ADCC.
When macrophages and tumor cells up brought together, but the I see the macrophages in golf and phagocytosis, the tumor cells, resulting in internalization and degradation of the tumor. So this is call antibody dependent cellular sockets at doses or 80 CP.
I am not advancing to slide 11.
Through cross talk via dendritic cells, we believe that the adaptive immunity can also be triggered as the second line of defense, leading to an overall conservatives and strong anti tumor response.
Let me now explain to you why we see such a good safety profile with our IC ease in preclinical studies.
NK cells has a proven safety record.
Based on only moderate graft versus host reactions falling autologous or our generic sell it a transfer representing a strong differentiator from toxicities observed with T cell based therapies.
The reasons for this on manifolds and are based on that particular immune to biology of NK cells, which I briefly explained at the beginning of my section.
NK cells Express germ line encoded activating and inhibitory receptors, which are distributed stochastic leap over the entire NK cell population of a given individual.
These NK cells are licensed to kill once they encounter a matching target sell however, only a fraction of the anti population of NK cells My to express activating receptors matching the cognate ligand is off the targets us.
Since roughly about 90% of NK cells found in peripheral blood Express Cdsixteen eight.
Proportional target receptive NK cells will change in the presence of estimates icees, leading to increased efficacy to kill the targeted as demonstrated in preclinical and clinical studies with our current development programs.
Despite this increase in efficacy of NK cells. Upon I see stimulation their targets of activity appears to remain unchanged based on the absence of on target of tumor toxicities in clinical studies and preclinical studies in non human primates.
Learnings from these studies imply that NK cells are kept in check.
Predominance of inhibitory signaling upon encounter with healthy cells expressing target engines, even in the presence of estimates icees.
The situation is very different than the tumor lesion.
Here the elevated levels of the target antigen.
Induced expression of ligands of activating NK cell receptors and gradients of chemo kind of Triptans are regarded as important factors to target I CE stimulated ADCC and 80 CP to the tumor lesion, while sparing healthy tissue.
This very tolerable preclinical safety profile of Icees has now been demonstrated in three IC ease and most recently in the MTBC may I see program, formerly called Air from 26, we license to genetic and our NT EG, if our IC program.
If im trekking for.
In contrast to the lack of any toxicity observed.
The promising safety profile of our IC east will enable us to combine that with different approaches, including for example, adoptive NK cell transfer all the combination of checkpoint inhibitors.
Having said all bad let me now highlight data from the to eat poster presentations at the virtual meeting of American Association of cancer Research and we'll start with a here from 24 on slide 12.
So the first poster presentation away from 24 hour by specific EG, if arm cdsixteen in eight cell engager.
As a mechanism distinctly different from easier for our signaling inhibition approaches.
Slide 13.
The postal highlights the two main mechanism of action figure from 24, Andy Brendan antibody dependent sell needed cytotoxicity or ADCC antibody dependent cellular fiber sitos is 80 CP.
Which holds the potential to benefit a broad set of patients, but hard to treat each each of our expressing cancers. Indeed, each of our expressing solid tumors represent one of the biggest challenges in terms of treatment modalities.
Consequently, the unmet needs for patients with each of our expressing tumors remains among the largest comments you today.
The current easier part targeting therapy is work primarily through the inhibition of Egypt are signaling.
In contrast April 24 was designed to activate innate immunity to kill tumor cells, leveraging our cdsixteen a binding perito.
Hi from 24 simply use is easier bars adopting side.
The molecule that establishes a synopsys between the tumor and innate immune cells, such as NK cells, and macrophages, which initiate ADCC it ACB.
In the poster we show if I'm 24 mediated ADCC HCP and a number of cell lines, including those with K Ras such as the 12 see two GK rest mutation and or B RAF mutations.
Cost this confirms that Asms 20 force potency is unaffected by mutations in DJ through HFR signaling pathway, which can lead to resistance to therapy and negatively impact the prognosis of patients.
Given am 20 fours mechanism.
As preclinical rationale to support from 20 force potential to provide benefit too broad range of patients.
In addition to inventory before has demonstrated the ability to induce ADCC DCP in cell lines, which have a low EG if our density on their surfaces.
It's still induce a strong ADCC ABP mediated cell, killing even though the lowest sector to target ratios.
We indeed designs and 24 to show substantially reduced easier for our segment. In addition, which provides the scientific rationale the day from 24 could demonstrate an improved safety profile versus other HFR targeted approaches.
Okay.
Preclinical proof of top proof point is the pharmacology toxicology study in Cynomolgus monkeys monkeys, confirming our hypothesis.
We have been 24 was well tolerated and its 28 day GLP toxicology study up to the highest dose of 75 mix, but.
In addition to the observed how Clive.
24, and Cynomolgus is within IPG based competitors.
Let me talk we started dosing patients and address will tell you more about our first clinical experiences.
Back to slide 14.
Moving on to the genetic Roche program Aro seven to 970, 89, which has previously anthem 26 poster, which focuses on the preclinical pharmacology in safety of the MTBC M- innate cell engager that we partnered with genetic.
This is a genentech own asset I thought I would just focus on the key highlights on slide 15.
Our ROE seven to 970 89 shows potent cell, killing in tumor cell lines, employing NK cells as protect yourselves.
Unlike T cell engages the minimal increase in cytokine suggest low risk of cytokine release syndrome.
A four week safety study in some analogous showed a favorable safety profile with no cytokine release or adverse findings.
Served in both tested dose levels, which Rick Fox 15, and 55 zero mixed the cadence.
The time and dose dependent reductions in Sierra My Gigi levels.
And plasma so markers, which are Bcf, a day and the J chain and are in eight were observed suggesting the selective killing of bcm, a positive selves by engaging cdsixteen a positive immune cells.
On further positive Gov genetic posted a first in human phase one open label Multicenter Global dose escalation study designed to evaluate the safety Tolerability and pharmacokinetics of our Aro seven to 970 89 in patients with relapsed or refractory multiple myeloma.
The study appears to open for recruitment soon.
Taken together the two legacy on post is showing encouraging.
Preclinical efficacy combined with a promising safety profile, providing a strong rational for further clinical development underscoring the potential of our rock platform.
We also broadening our early stage pipeline with initial additional NHL engagers from a rough platform.
As audio already mentioned, our two new see 16, a binding innate cell engager candidates staff and 28.
32 are moving along well towards later stage preclinical development.
Ill now turn the call over to address who will provide the key clinical updates.
Yeah.
Thank you on thank you.
Or is this really.
Comprehensive overview off Causey, NK cell biology, and tend to technology as.
Which I think shows Hawaii, we are very excited here at EFI, Matt to work on this technology on this molecules and for my parts, having the opportunity once approval that's too.
Hi, guys. These molecules towards clinical development at stores the clinical development.
Also a warm welcome to everybody who joined on the phone today.
Before I go into the details of our clinical programs, let me make a couple of introductory remarks.
Oh, you already mentioned that you all aware off we are still in the middle LC, Colgate 19, pandemic, which continues to pose unprecedented challenges for the conduct of clinical trials.
Having said that we have been very close contact.
With our participating institutions and with our investigators in order to ensure rent to optimize how we can make our novel therapies accessible to patients who are in dire need for additional treatment options.
The guiding principles here have not changed compared to what we discussed in March.
So patient safety is our utmost concern and.
Observed in all things that we do as well as the integrity of sit data, which again is in line with currency recommendations that were given by a competent authorities.
Okay can move to slide 17.
And start with our first program a if im certain.
CD sororities, CD 16, a engaging I see.
I'd like to focus on two programs here.
Im sorry, attuned to owed to oversee redirect trial. This is our registration on target to trial in patients with.
Every faro T cell lymphoma, who have exhausted all standard of care therapies.
This trial is progressing despite cope with 19.
Compared to the update in March we were able to add additional sites and open additional sites for this trial. So we now have 47 active sites contributing patients around the globe.
And on a site level, we do see a stable recruitment of patients.
If we move to our second program I FM certain one off for.
Our collaboration efforts together with investigators at MD Anderson Cancer Center.
The scope of study is to combine.
Yes, I am certain was caught lots derived national killer cells.
This program has completed all necessary steps.
In order to be ready for patient recruitment, including a ft. A validated mandated validation runs off court lots derived NK cell product.
So basically everything is in order to enroll patients, but as you know, Texas. This one offs the regions, where we still see an increase in cold 19.
Cases, and as a consequence clinical operations at the end us on the have been so can you have significantly off. So we are monitoring so situation here, but we are depending on the really for a lift off some of the restrictions due to covert 19 at MD Anderson to be able to Andrew.
First patients.
If you more sent to a FM 24, and we can go to slide 19.
Hey, offend Ttwenty four is us aren't.
Yes elaborated on our second molecule targeting EG F R and CD 16 a.
And ask you may recall from my introduction, all three months ago as somebody who has spent basically.
The 20 years office Korea to work on Egypt, if our targeted therapies, having been responsible for zee medical programs off erbitux as well as per Tessa.
For me this is an absolutely exciting program.
Yes, due to us very novitas and unparalleled mechanism affection I think we have a compound here that Ken targets as a very difficult to treat the population of patients with aegis F are expressing tumors enter dressing a lot of see shortcomings and limitations, obviously currently available.
Jeff targeting therapies.
As we have disclosed last week, we were successfully.
Initiating a our clinical trial sites.
In fact, we have now three active sites to into the U.S., one in Spain, thats could contribute to patients and we are very confident to get our final and foresight on board within the next couple of weeks.
We also were able to successfully dosed the first two patients in cohort one of our dose escalation study.
We have not observed dose limiting toxicities and in core in accordance with see recommendations given by the independent data safety monitoring Board. We have opened cohort two which now is open for patient recruitment.
So with this I would conclude my short summary.
Of our a clinical programs.
And would hand over to Michel Hill, who will give you an update on our financial situation.
Okay. Thank you very much on path.
Ill from its consolidated financial statements have been prepared in accordance with high for assets issued by the gets an international accounting extended board.
Hey.
SP consolidated financial statements are presented in euros, which at the company's functional and presentation currency.
Therefore, also mentioned numbers, but I will present here in this call unless otherwise noted will be in euros.
As I already mentioned, we ended the first quarter to quarter with 8.2 million diluted cash cash equivalents and current financial assets.
Compared to 104.1 million euros.
At December 31st 29 team.
In addition, the company raised net proceeds of 18.8 million euros.
Under its ATM program.
Pro forma cash position of the company as of March 31st Twentytwenty, including the net proceeds from the ATM would be longer than 107 million euro.
This cash infusion is planned to be used to help support that brought us to Goldman trying to achieve for 824.
Based on current operating plan and budget assumptions, we anticipate our cash position will enable us to fund our planned clinical development and early development activities well.
Let's talk with trended too.
Net cash used in operating activities for three months ended March 31st trended trendy was 16.5 million euro compared to 13.4 million during the first quarter over 29 cheap.
Primarily due to higher cash expenditure for research and development efforts.
Total revenue for the first quarter of trying to trend to 5.1 million euro compared to.
11.4 million euro into first quarter 2019.
Revenue in trendy trendy and trending on T. predominantly relate to the tune enter collaboration with 4.8 million Juruti trended trenching and 10.6 million euro in trying to 19.
Revenue from the genetic collaboration in the fourth quarter 200, trendy was comprised of revenue recognized for collaborative research services performed during the quarter.
R&D expense for the first one off 20 trendy were 11 point Fourmillion zero compared to 8 million Euro for the first quarter of 29 cheap.
The increase was primarily related to higher expense for the Asian 13 registration directed study in PTCL manufacturing activities for a from 13 clinical study immaterial and early stage development and discovery activities.
<unk> expense for the first quarter of 20 to 23.5 million euros compared to 2.4 million Euro improved 29 chief.
The increase is primarily related to higher personnel expenses.
Compliance costs, leading consulting and audit costs.
Net loss for the first quarter of trying to trends. It was 8.3 million euro or 11 Jerusalem per common share.
For the first quarter of 29 sheet accompanies net income was 1.9 million or three euros and per common share.
We didnt number of common shares outstanding for the quarter ended March 30, truth 20, trended grammar 76 point.
I would like I would like to turn the call back over to other for closing comments before we open the call for Christian Audi.
Thank you Michael on the Andrea.
As we close todays prepared remarks halfway through 2000 definite continue to make progress.
On several fronts.
The data presented at a so the dollars unit selling days.
The there I believe.
Sure in Houston, killing tumor cell lines no target expression.
In the rate of increase model and appear to have probably seeing differentiate based.
On April 24, right now actually recruiting into the second dose.
Well the partner VCM eight has been engaged genetic recently posted on the cost of golf first in human Phase one study.
Recruitment according to the site is expected to diesel.
On April 13 recruitment into the PTCL study is ongoing we continued to be successful in bringing on yours.
Regarding the combination of Asian 13, with like the right next to kill it though.
Proceeding with the plan.
Okay and investigator.
On the trial and in concert.
Our platform has generated.
Hey, good morning.
Molecule, we have a good cash position.
Allow which allows us to see low program.
As shown on slide 22, potentially in you'll meet multiple value driver twentytwenty.
[music].
And most important strengthens our management team with no additional industry experts, including new Chief Financial Officer, who will be joining us. Thanks.
Before I open the session flooding una.
I'd like to reiterate our appreciation for the unwavering commitment of our.
And our gratitude to our investigator and chemical side.
Most importantly, the patients and their families.
Continuing the strong support during this very difficult period.
We will now be happy to take any questions that you make great.
Thanks.
Thank you.
Ladies and gentlemen, I will now begin the question answer session. As a reminder, if you wish to ask questions. Please press star one your telephone keypad.
Your first question comes on the line of Maury Raycroft from Jefferies. Please ask your question.
Hi, good morning, everyone and thanks for taking my questions.
Hey, congrats on the upgrades today to so just struggling for FM 13 timelines for the Registrational program.
If you could provide any more clarity on on timelines and that should we expect an initial update in first half 21.
Oh, Yes, Andreas I can takes this question as I've said in my introductory remarks.
Cobot 19 still makes.
Planning a little bit off a challenge we have on previous it into two factors.
We are encouraged in what we are seeing in terms of recruitment in our sites.
So.
We anticipate to have interim data around the middle of 2021.
Got it Okay, and then you mentioned progress with the April 13, plus the cord blood NK cell combo study with MD Anderson, we completed their required validation work for that the stable at them 13, plus NK cell Premixed I guess can you can you provide more specifics on.
Thats complex stability and just wondering when this is eventually commercialized would it be a frozen down mix or how would you thought the cells first add any offend 13, and then administer regis to provide more clarity on that.
I will.
Hi, It's a question for Wolfgang.
Hi, This is Matt.
I mean.
Difficult difficult to say Kevin Cohen.
Tying our commercial products that looked like whether it's a pre mix product or whether it's a co administration, but we first need to do this study to at the proof of concept and to see how it works out. So I think it's too early to say.
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Got it okay and.
For I guess last question on aircraft 24.
You guys reported you're not seeing any safety issues or or efficacy in core one I guess can you comment on any PD biomarker activity at this point can you still expect to see activity in cohort three.
Told me they do that we released were very fresh so we have not seen dose limiting toxicities and that was the reason why.
Oh, the data safety monitoring committee recommended the opening of cohort two.
No we collecting pharmacodynamic markers, that's what else was a bio Marcus through the course of study, but we have not completed the analyze this obviously smartcast yet.
Again, its sink it is premature to speculate which will be an effective dose level I think it's fair to say that dose level. One was a very low dose. So here starting dose level was really choosing to maximize a safety.
And I think we'll learn more about pharmacokinetics and pharmacodynamics S., we continue to enroll patients in the additional dose levels.
Got it that's that's helpful. Okay. Thanks again for taking my questions.
Your next question comes on the line now Jan Bertsch enough from Wells Fargo.
A question.
Hi, guys.
Thanks for all the detail on the call and congrats on all progress I ask your questions first for Andreas out for the first two patients in cohort one that will pick up on grass could you talk a bit about those patients what tumor types and whether they were having specific markers K Ras markers that sort of thing any detail walnuts first patients.
Oh, we have lot of close all the details what I can say a set sleeves two patients had probably the two most predominant tumor types. So.
Non small cell lung cancer colorectal cancer or we have not collected all information on the K roster mutation status yet.
So thats the first dose level was really.
Maximized or targeted to establish safety.
And it's probably well below where we would expect to see pharmacodynamic activity.
And I'm curious can you remind us or are you, taking pre and post treatment biopsies and is there any ability to look at NK cell recruitment for infiltration to the tumor.
Oh, the protocol provides the option to half pre us well as on treatment biopsies.
These are not mandatory so they are or no.
Walden carry basis, and we will see how many biopsies, we will get assets are trying to move so long.
Yes, we have very committed investigators. So this is one north sea exploratory endpoints, we are looking into.
Got it and then maybe just for art art you anticipated our question on that how you're able to spare healthy tissue that express VGF far and avoid on target off tumor effects.
Can you measure those inhibitory signaling and any biomarkers of inhibitory signaling thats protective to normal tissue I guess number one.
Yes, we map loss.
Good.
Otherwise I'll hand, you go up yeah, sorry, sorry, I was a new policies. So Jim yes, so indeed, one could measure those.
Markers no we haven't measure them in the Sunoco stuff. These but of course the concept is cleared because its ubiquitous for NK cells.
It may be interesting is undress said when we look at.
Some of those patients, which may have where we may have biopsy data.
Of course, we will also have a closer look at those NK cells and potentially the presence and.
Absence of activating inhibitory ligands.
And then art you gave a pretty thorough overview of NK cell biology.
Can you can you comment on whether Theres just.
This regulated NK cell function in cancer.
Something that impairs NK cell ability to survey and.
And eliminate our merchant cancer cells and is there something about an innate cell engager that or comes that.
Yes, it's something really interesting question, Jim it's something not really well study of course, we know that there is overall also in the elderly frail of course, the dysfunctional system there are.
Quite a few reports in that.
In that direction I don't think it really has evolved as a strong picture in terms of dividing them different patient populations, but again, it's something we want to learn more as we further advance those programs and get biopsies and do the.
Comprehensive accommodating and.
Studies.
To look at best.
Great and then just finally audio I might've missed it on the call. It was there an update on the progress with the be VCM eight engager with genetic and progress the R&D first patient dosing or did I miss cuts or something else you're saying.
Yeah, I will end this question over to aren't again.
Yeah, Yeah, Jim So indeed, we did talk about the the poster.
Which of course, you know the means everything is poised to enter the clinic and we did see based on the posting clinical trials done Ghana.
It's up and running the phase one is described dose escalation pharmacokinetics.
As usual phase. One then we would expect that to start sometime probably in July.
Well, thanks for taking the questions guys.
Thank you.
Your next question Chuck on the line of Yale Jen from lead no and company. Please ask your question.
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Good morning, and thanks for taking the questions. It's a very comprehensive.
You are getting hit and.
Macrophage engagement in cancer.
First question is that.
Have you guys any intent yourself.
And a 24 in new data update maybe the initial data updates were to end up this year or two state already team to suggest that.
And then it.
Yeah, I think it.
Too early to give an exact guidance or we will monitor a safety.
Our closely and I think we will give updates as we did as we move through see dose escalation cohorts.
Now as it is I think correct aristocrat typical for phase one studies you do not really know.
How many dose cohorts you will need.
To reach your Pharmacodynamic active dose and then you are a recommended phase two dose. So thanks for your disclosure of additional data.
Depends quite a bit on AWS and number of dose escalation steps needed.
But as I said, we will update us on the progress such a study as we go along.
Okay, Great. That's very helpful. Maybe two more quick question.
First one is for the Genentech.
Study.
No that the into clinical that most of this clinical sites in northern Europe or in Australia is that because maybe based on the inclusion rates, they're going to the exclusion criteria those area does the site.
Graphic side being selected maybe more I get them appropriately to getting to the eligible patients.
Yes, I'll take that question art.
Obviously, you want to go or yeah, I just wanted to say we have nothing involved in the lining up the clinical studies. So indeed.
Yes.
We cannot truly comment on the basis of their choices, but we know that they intend to pilot line as well. So that's all the information we have Arne you want to add to this not only just that as you said I mean, you know we can really comment in detail. It's I think is more appropriate to talk to genentech. Thank you. It's good good question.
Okay, maybe that last one here.
Oh theoretical on both.
Hey, science, which is that.
You have being able to.
Engaging both.
Macrophage and NK cells. The question is that can do that.
Fine tune that system.
To give flow either one of the tool or how or whether you have.
That which type of sales you did the effector cells at play a greater role at any sort of particular circumstances.
Yeah, It really interesting question.
Yeah.
I'll be glad to take it here so.
Really interesting question you know the I think the straight answer is it's really not intended to fine tune in because we want both parts. They play both a significant part ADCC, an 80, CB and as I laid out in the introduction the cdsixteena expression.
Is really predominantly NK cells. They macrophages for example, not a neutrophils like Cdsixteen d.. So we already have a high specificity and we want that specificity.
So we get the tumor killing by the most effective killer cells, so coming back to your question.
There's no intent to fine tune and Andy one or the other rates. However, we are looking very detailed to understand exactly what's happening you know well ADCC for example is quite well.
Looked at 80 CP is still more of an open field and we are doing.
Really translational research and working with grade.
Academic partners to understand that in more detail.
Okay, great. Thanks, and congrats on the progress in this uptime.
Thank you.
Your next question comes online.
Org from BMO capital. Please ask your question.
Hi, everyone.
Okay.
For taking my question.
The progress.
Just a quick one dog.
And with its important Jade 32.
You know what would be able to kind of get a some data on there from a pretty public standpoint, that's really add.
Rob.
When would we see it actually answered for me.
Yes.
That'd be helpful. Thanks.
Thank you want to take that Yep sure we'll be glad so yes. Good question I mean to be consistent with our previous updates you know, they're making a 28 and 32 are making good progress towards late preclinical stage and we had kind of guided.
Proximately towards the end of 2021 Fourninety falling for 28 32 is further behind so.
Of course pretty.
Clear to you from today's perspective, because they really exact but that's what we are currently targeting.
Okay. Thank you for that and be a copy.
Thanks.
Thanks, a lot.
You later.
Thank you so much. So this concludes our update call up the first quarter financial result, and protect update.
I appreciate your attention and that many questions and we look forward.
Two.
Thanks, so much.
That does conclude or conference for today. Thank you for participating in the all disconnect speakers. Please standby.
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