Q4 2020 Affimed NV Earnings Call

Nash

Nash FM

Good day everyone and welcome to the fourth quarter and year-end Financial results at this time. There will be a presentation. Today's conference call is being recorded. I would like to introduce your host for today Alex Rodriguez head of investor relations office, please go ahead.

Thank you, Tracy. I'd like to welcome and thank you all for joining us today for a from its fourth-quarter and twenty-twenty and financial results in operational update call before we begin. I'd like to remind everyone that we issued our release earlier today and it can be found on our investor relations section of our website on the call. Today. We have our management team. There's body hurts our chief executive officer Andreas horse trigger a chief medical officer Orange Julius or chief scientific officer. Welcome Fisher or Chief Operating Officer. And then Miss Denise Mueller our chief business officer and Angus Smith our Chief Financial Officer. The whole team will be available for the Q&A session before we start I will quickly go through the Safe Harbor statement, uh, today's discussion contains projections and forward-looking statements regarding future events these statements represent our birth.

Leaves and assumptions only as of the date of this call except as required by law. We assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statement, even if this is 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 projected 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 SEC and those identified under the section entitled forward-looking statements, and the prompt release that we issued today and filed with the SEC with that. I'll turn the call over to I yeah, thank you everyone and thank you for calling.

for our fourth quarter business.

A call and $20.20 today but was briefly review the key development at the company including our recent update on the 8th and 13 monotherapy interim for life and the findings presented by the particular is Lonnie aacr from the investigator-sponsored community trial at MD Anderson Cancer Center, which is treating patients with a pre complex combination of a 13 and cobbler derived in case of and we will provide an update on the progress of eight and twenty four and off the programs currently and development. I will then turn the call over to anger to discuss our fourth quarter Financial results. We will conclude callback highlighting some of our key milestones.

We cracked or estimate for the rest of this year.

We're very excited to share groundbreaking Infinity data with you and our programs and demonstrate progress. We're making across our pipeline which has undergone an incredible evolution in 1220 and the early part of 2021.

I think it's been a Pioneer in leveraging the inner human system to fight cancer. We have spent a good part of the last decade developing our technology The Rock platform and down in Atlantic and we're seeing increasing evidence that our technology can result in meaningful benefit for patients in the clinic a very rewarding experience of patients the fax the doctor for treatment and for

Over the years we have established. What we believe is a unique position for our from it to develop best-in-class molecules by engaging our first line of defense our energy month including ourselves and macrophages the body cells to the cancer where they can do what they are naturally intended to do and protected from this month will conducted a lot of work to support our development strategy and to identify indications where we believe our innocence has the best chance of success. If you leave that we are now beginning to see the results of all of these efforts.

As we've shared with you in the past and believe that our innocent engages are strongly differentiated with the competing platforms and approaches to help impatient Fight Club.

All right. Let me get your molecules. That's your note buying to see sixteen a unnatural mm macro pages with high ability wage and the unique binding epitope on 16-18 reduces competition with plasma itchy leading to an effective to Modell's killing via a disease and aging

Which I couldn't.

Calling to toxicity in Fargo titles.

Gates has showed the. Binding and retention on that particular though, which have been shown to persist over which has been shown to overcome royalty.

They're able to kill tumor cells independent independent of the level of antigen expression in addition in case of three complex with our highest paid to show me prove to myself killing, which is fully maintained after freezing going and what

A very important and unique Advantage. Is that no Messa how you design the effects of those cord blood-derived ipsc or a Target coming up on this platform that they need targeting our internet settings enable natural killer cells to locate the tumor independent of Target expression level wage. We believe that this is where our technology has a strong Advantage if you look at the different humor targets and approaches. We believe our Technologies the best way to Target whatever in case or Chrome

Over the last several months we have been able to demonstrate that the current lines behind our technology can produce highly encouraged and clinical results. The reason the knowledge about the positive interim analysis of our aides and thirteen monitor controls.

The data presented from the study at MD Anderson on 80th and 13 in combination with the in case of and the data from the combination of a s and 13 with pembrolizumab We Believe provides validation for what we have been saying about our signs and the advantages of our internet linkage.

Furthermore these findings helped validate. Our three-pronged development strategy which leverages monotherapy in specific indications with a high chance that probably most men focuses on combination with in case of indications where the patient's immune system is dysfunctional and seeds aims as activation protein and the Adaptive immune system by combining in Italian gauges with anti p d 1 or pd-1 checkpoint inhibitors.

I would now like to briefly review the news were reported on April 13th in the last few weeks last month. We recorded the positive outcome of the interim facility name. Is this for April 13th at the moment therapy in patients that suffer from peripheral T-cell and the reminder the instrumentality demonstrated at Corte representing patience with at least 10% of tumor cells extracting C230 achieved the predefined fertility threshold and that cord these which includes patients whose tumor that would be the 13th depression. You find it from 1% up to less than 10% positivity for C230 shows sufficient comparability to coordinate importantly wage noted that you don't complete and partial responses in both high and low of expressing C230 positive peripheral T-cell lymphoma patients.

is that

About this morning therapy study was continued by combining the two cohorts into one for all patients with C 230 positivity.

The outcome of the interim analysis was encouraging on many fronts.

We now have a drug candidate that has the potential to deliver benefit to patients with ptcl who have exhausted options after undergoing multiple therapies, including experimental.

And you can certainly could have the standard for accelerating or drug Discovery efforts with our in-house or platform leveraging the power of the month had mentioned. We believe we have the first and best-in-class in attending data platform with a validated approach and brought potential that allows our drug candidates to be developed found a wide range of diseases addressing height unmet needs in C230 positive improvements and egfr expressing solid tumors as well as other solid and hematologic Cancers.

Earlier this week doctor is Manny of the MD Anderson Cancer Center presented data had a major Symposium of the aacr annual meeting from the investigation on the trial of computerized natural killer cells pretty complex with agent searching in the first quarter of that study in which patients were treated at the lowest dose of ten to the sixth felt entitled to kilogram three complex with agent 13 will report it that all three patients experienced significant is is reduction off with two partial responses and one complete response.

The first patient goes in court to now we're using ten to the seventh pretty complex entails controller Graham was attached with a complete response rate as long if I clocked in total. We have observed an objective response rate of 100% to date.

Victor is money also discussed with you yesterday when she believes the opportunities offered this treatment importantly we see the results from this study so far as validating the benefits off a car light in Ko code with high Affinity binding of our internet and engage 4 molecules to natural killer cells delivering meaningful benefit Solutions. Our plan now is to continue to develop in customize approaches that leverage the unique and differentiating features of our molecules in combination with adoptees in case of transfer to provide options for treating the variety of months probably too much in the future.

the study is currently recruiting and treating patients in the second card with tend to the seven in case we expect them to raise money into college and MD Anderson will continue to provide updates on the study and update update us on the success stories with patients throughout the

Finally like last year, we published final data from the phase 1B study of a s and 13 in combination with CD One checkpoint inhibitor keytruda in blocked Return of the Mack by pressing the college the data shows an effective response rate of 88% at the highest treatment as well. As a complete response rate of the state application was not a very significant step forward for estimates as it was the first time that the combination of one of our inatel engage molecules with an anti pd-1 checkpoint inhibitor demonstrate of these rejection and the ability to be safely administered with managers are giving the is subjective response rate in complete response rates in this proof-of-concept dedicated that our approach of harnessing the activation of energy immunity could improve upon current Therapies.

This Brian Kennedy evidence from 8 and 13 in alimony, or if you tried in the combination trials with in case of another immunotherapies We Believe provides proteins and dedication and confirmation about our innocent engage activities the more it provides us with critical knowledge and clinical experience that we are now leveraging off our apply across our development program.

No data from the a certain program to support our development strategy by demonstrating that our inatel engages can generate meaningful Moana therapy effects package shows the potential Synergy with checkpoint Inhibitors inverting concept with adopt isn't able to drive responses. Even at low doses of metrical off the date that we have generated from a 13 that's informing the way we developed any other pipeline candidates notably + 24 + 8 + 28

Get to we're making very good.

Our ongoing are you from 24 monitor trials is currently in the air condition portion of our phase 1/2 a clinical study in relapse refractory patients with any egfr expressing solid to renounce this morning that we have completed cord for which was thirteen patients that 160 milligram and we're now at five-fifteen and treating patients that are those of 320 milligram, which is Courthouse.

The objective of the installation portion portion is to evaluate the safety and tolerability of eight and twenty four and to establish a recommended paid to those days that we can use in the expansion phase of the trial.

At this stage, we don't give have any information to indicate that we are yet at the pharmacodynamics reactive those nor have we reached a maximum tolerated. We plan to continue to do that will have further updates on the progression of the dose-escalation on our next earnings call.

The don't have Collision phase of the trial is enrolling all cameras and did not yet enriched by need to take too much time.

In the extension cord, we're both enrolled patients into specific indication with no International involvement. And this should enable us to evaluate the efficacy of eight and twenty five weeks back to start the do expansion things of the twelve and the second half.

we also continue to make good progress with the initiation of a combination study of a 24 with adoptive in case

we recently announced that the ID for the combination of AFM 24 with FiOS or Target in case of product as in K or one was cleared by the FDA.

We expect to initiate initiate the phase one to a study for the combination second half of 2021. We're very excited about the potential for this combination took the initiative Nikki data from MD Anderson with anything searching and the Chrysler Jeep Renegade data shown on our ATS and twenty four poster at this year's aacr contract wage in that poster. We were able to demonstrate that agent 24 in combination with adoptive and cable leads to a dose-dependent tumor regression in a mouse signal current model establishing a strong proof of concept for this promising combination.

It's important finding was further supported by data demonstrating that a 724 ability to tightly bind to network as well as the title toxic up until 2 till egfr expressing tumor cells was unaffected by the presence of competing policy online teaching in stark contrast. The talks about cytotoxic potential or wage is diminished by completing. I GT the paint the poster further showed that ATS and 24 induces a very prominent adcp response activation charges against egfr positive human cells irrespective of the presence of chaos mutations further adding to the reasons to believe for this highly differentiated.

Serge also accelerated our plan to investigate a 24 in combination with rush and anti. One checkpoint. In fact, we believe the combination of April 24th is a teaser could leverage the inner isn't the Adaptive immune systems in the fight against can we expect those different stations interface one-month study evaluating the combination in the second half of twenty Twenty-One now our first wholly-owned independent of molecule is in 28 continues to advance through ID made instead and we plan to release more details about this program later this year including information obviously about Target and then the ID Nadine preclinically paid off.

Looking at our collaborations. We have also continue to work closely with Genentech and Raven as they move their programs are very happy with how these two Partnerships want to do a recall. We announced last August that our own 789-708-9726, which is a 60,000 targeting Unitarian Geisha entered Phase 1 clinical exam. And that's in the past presenting details of the trial are depends on our partnership.

As far as the arriving partnership is concerned. We are collaborating with them to move preclinically work 4:30 to 4. And just in case you missed it.

I think we I think we lost Audi but just to finish up and then move to the financial body was mentioning that that just in case you missed it roivant has now announced today at 7:32 is being directed towards solid tumors. And in addition. We have one highlight that through several recent transactions. We have strengthened our our balance sheet and I will cover that in just a moment. Overall. We are encouraged with the progress that we end our partners have made and are looking forward to a promising 2021.

So, this is Angela Smith sheet Financial Officer of affimed. I will now review our fourth quarter 2020 Financial results.

Affimed Consolidated financial statements have been prepared in accordance with IFRS as issued by International Accounting Standards Board or iasb. The Consolidated financial statements are presented in Euros, which is the company's functional and presentation currency there for all Financial numbers that I will present in the call unless otherwise noted we'll be in euros.

as already mentioned through several recent transactions

We have been able to significantly strengthen our balance sheet extending our cash Runway while enabling us to accelerate our multi-pronged development approach for our innate cell engage or molecules.

We ended 2020 with cash cash equivalents and Current financial assets of 146.9 million euros compared to a hundred four point 1 million euros for December 30th, 2019. The cash balance does not include the net proceeds from our January twenty Twenty-One underwritten public offering or the ten million euros, we received from the first tranche of the Silicon Valley bank loan the pro forma cash position as of December 31st, 2020 including net proceeds from our January financing activities would be approximately 244.56 euros.

Based on our current operating plan and assumptions including the proceeds from the recent financing. We anticipate that our cash cash equivalents and Current financial assets will support operations into the second half of 2023.

Net cash Youth and operating activities for the year ended December 31st, 2020 was Nineteen point four million euros compared to 29.1 million euros in 2019 cash flow from operating activities improved in 2022 primarily to proceeds received from the roivant and Genentech collaborations partially offset by an increase in our net loss.

Total revenue for the year ended December 31st 2020 was 28.4 million euros compared with twenty one point four million euros for the year ended December 31st, 2019 revenue for 2020 and 2019 predominantly relate to the Genentech collaboration collaboration revenue of 19.7 million euros for the year ended December 31st, 2019 was from the Genentech collaboration collaboration revenue for the year ended December 31st, 2020 amounted to 27.8 million euros with twenty six point two million from Jeanette Genentech collaboration and 1.5 million euros from the roivant collaboration.

Research and development expenses for 2020 increased 14% from 43.8 million euros in 2019 250 million euros in 2028 due to higher expenses for AFM 24 and other programs as well as infrastructure Investments General and administrative expenses increased 34% from 10.3 million euros in 2019 to 13.7 million euros in the year ended December 31st, 2020. The increased predominantly relates to hire Personnel expenses due to the increase in headcount in 2020 and to hire legal Consulting and audit costs net loss for the year ended December 31st, 2020 was 41.4 million Euros or fifty cents per common share compared to a net loss of 32.4 thousand Euros or fifty cents per common share for the year ended December 31st, 2019.

The way that number of common shares outstanding for the year ended December 31st, 2020 was 83.5 Million as of March 31st, 2021 are common shares outstanding were approximately 190 month. We encourage shareholders to also review our 20th filing for the year as filed with the SEC this morning. I will now turn the call back to Audry for closing remarks Audi. Yeah, I'm back again. Sorry about that. I was just disconnected. But thank you very much Angus with jumping in and closing. I would like to reiterate our request in the document for a very important achievement in twenty-twenty the strong start to 20 21 and fold progress. We're looking forward in the coming months.

We've Advanced our strategy of exploring our independent agents that monitor keys and we are now exploring opportunities in novel combinations with in case of through Partnerships with the back yard with nkmax orientation as they're called now, and we're moving our AIDS and 30 motor therapy Thirty forward with both high and low expressing C230 positive thoughts ptcl station.

We are expecting that in the combination of AIDS and thirteen within kazel at the end isn't as the trial moves through the course our collaborators there will present they're finding a conferences throughout 20 21 for 824. We expect to complete the total population phase in our ongoing monitoring study and initiate the wrong extension phase in the second.

we are working quickly and

Efficiently to paper prepare for further investigation of combination therapies of age from twenty-four in solid tumors first within cage and bios as in kilo One auto sell products as well as in combination with our T's crossed. One inhibitor.

We expect to be dozing patience in both of these studies in the second half of 2021.

For our pre-cana classes today is in 28. We expect to report data from preclinically ID Nei blind studies later this year and then subsequently filed the ID in the first half of 22.

Finally there is a like we delete their website now collaborations with genetic and driving because we have the opportunity to provide further meaningful updated.

Updates on these programs will remain largely. However at the discretion of our partners, and we will continue to work and support them as they move their respective in it and engaging molecule to the clinic off now before we open the call for Q&A, I would like to say thank you to really a lot of people. So thank you again to the patients who entrust us with your help very important. I want em all a. Employees who are working in this very hard and very diligently to ensure that our progress our programs continue to progress and welcome and thank our new and old investors who continue to Believe in Us and support our scientific efforts. As always we have the whole team on the call today and look forward to our question. I asked a question. Thank you very much. I appreciate it.

Thank you. Ladies and gentlemen, we were and I begin the question-and-answer session as a reminder. If you wish to ask a question, please press the star and one on your telephone keypad and wait for your name your name?

Still says question today comes from the line of do Kim Capital markets.

Hi, good morning. Thanks for taking my questions. How do you said that? There wasn't any pharmacodynamic activity at the fourth level for AFM 24. How does that along with your expectations for the dose-escalation? And is there a ghost level where you would stop at if you still don't see activity and and just shift the development Focus to Iraq combination strategies.

Yeah, thanks for this question. I want to hand this over to Andrea to explain where we are. But what I must say is we've just finished the extension of the the courts for and now I'm moving in to 5. So we haven't really analyzed cord for Fidelity and re-explain you where we are. Yeah, thank you. Yeah, what are they said? We have not analyzed most of the pharmacodynamics impactful for those cords 3 and 4. We are using that analyzes here. I don't see essays like c16 occupancy are quite new. So we will process the data that we have collected or you didn't see samples that we have collected. So Thursday service. We currently do not have the data to say whether we are already at for McCord dynamically active do see it's a possibility that we need to evaluate over the next month.

Now coming back to the overall strategy as Society has shown or if we take a f m 13 as a blueprint. We have seen meaningful clinical activity as a single Aging in combination with pd-1 as well as in combination with NK cells according to our analysis of the tumor biology, especially in the state of egfr Park expressing Troopers. We expect to see exactly the same picture of the same pattern. So we believe there are distinct disease types, which will benefit from a single approach as these patients have sufficient numbers and sufficient functionality of their own in case it sells we expect patience to benefit from home based approach this and then ultimately there will be two more so they are tumors are aware of the patient's own in case of numbers in case of functionality is limited wage.

At least initially so this will patients who will be targeted with our NKC based approaches possibly on the long run in combination with as a single agent 51 plus I see maintenance. So it's a lot of flexibility but we believe that we will see as I said, it's the same picture with with tuner entities took him their biology and they will need accordingly different treatment approaches.

Great, and I have a follow-up question on on the pipeline given that you saw a strong responses with the MD Anderson study. How are you thinking about other opportunities in in blood cancers and and possibly revisiting cd19 but with an innate sell engaged or or going after cd20 or Siri 38,000. Yeah, I think these are all options that are open now again cd19 cd20 is probably a field that is very well served. We see as the medical needs a clearly right now. In other areas City. Thirty years is an important area what we just learned from the study and I'm going home closer as set 3:30 expression is not only a limited to T-cell lymphoma. Non-hodgkin. We do see the expression on Thursday.

Especially diffuse large b-cell. We also CCD saw the expression and very significant chunk of acute leukemias, which gives additional options for four CDs 30,000 therapy. And if you know, we are in collaboration with roivant and Genentech where we have not disclosed the targets. I think the rock platform offers the ability to address a number of different clinical situations and there's an opportunity will expand as as we go along either in-house with our new candidates or in collaboration with our partners off.

Understood congrats on all the progress and the great data that you generated so far.

Thank you.

Thank you next.

Committed to disclosing first clinical data this year, and if so, what are the factors that you're considering determine when to present it and then just to be clear. It sounds like you're not going to continue to a cohort 6 and the dose-escalation for Beyond if needed. Would that be six hundred forty milligrams? Thanks.

Andreas did you get the question I missed the first half. Yeah, I missed also probably the first maybe I start to answer from the back end and then we see what name would be a missing. So first of all, again, we had currently accruing at cohort five 3:20 and Thursday, as I said, we will have to analyze our from a cookie from a kinetic and pharmacodynamic Marcus from the two previous cohorts. This will give us a picture where we stand up terms of pharmacodynamic activity and this will guide our decision whether to enroll additional cohorts. Now as we have also said of the relative increase of the steps, the relative increasing steps from court to court is Guided by an Asian assessment model, which will suggest

All these irrelative increments from court to court based on the totality of the data. We have seen over the course as well as the data that we have seen in the previous cohort. So 6:40 is a possibility. But again as we will collect data from this may change to either a larger or smaller increment depending on the situation analysis.

Immigration. The first question was just are you still committed to disclosing first? Clinical data this year? And what factors are you looking at to consider wind to present?

There is a certain element of insecurity still in there. We believe that by by end of this year. We should have defined are from academe reactive tails and decided said we are also committed to start to enroll into expansion cohorts as we said once we have defines these from academically active dog will disclose ceeday dropsy hold those escalation part including patients characteristics patients responses as well as the pharmacokinetics and pharmacodynamics data that divorce is still selection. So our our best estimate I would say is this is all really happy with this year.

I just wondered

So we're we've just finished cohort for what does this mean? So we take about 4 weeks for the last station then to finish the dose-escalation at that stage. We can determine the safety off and we can open to move to the next court. However, the assessment of such a patient is only done after of the eight weeks. So currently we are an M life and 8:00 or 3 and close at 4 because we pull those and that's what's being on going over the next week. So in essence the way how this is moved forward is determined by really understanding the safety getting too meaningful those and then in parallel to the assessment. So just to give you a little bit of an explanation of where we're currently home and and such states that could be the basis of the communications.

Thank you. Your next question comes from the line of e l n.

Good morning, again congrats on yesterday is fantastic the results. I have two questions here. The first one is again based on yesterday's wage report. Do you anticipate also that for the 24 and SNK zero one Thirty back later on you may actually preloaded the NK cell what day and the engager or you may not necessarily something that relevant for the 24 is Solitaire and development.

Who have currently disclose the three approaches forward with monotherapy with combination with the autologous all programs and with the antibacterial one antibody from from Rush that we any other activities. So we're considering a number of additional options for a 24 at this stage amongst this obviously a nice combination with an uh-oh. Let younique sell product the ones we are.

Apollo validated all these steps forward we will disclose that.

Okay, maybe one more question and 13. Last year because of the cobit you have sort of pause the developing TMF. I wonder what your current balance sheet and the maybe a better environment. Would you resume that study going forward? Do you have any other thoughts?

So currently we have not reopened this particular arm as in the most countries where we are active in COVID-19 is still massively around you can read this all over Europe is where the majority of the sites are. So we are still in the midst of a wait and not after a wait so the situation has hasn't changed at all.

Okay, great. Thanks a lot. I appreciate it.

Thank you. Your next question comes from the line of SV be leaning on thanks for the question. I'm going to start actually asking, you know, I'm twenty-four from a CO Dynamics and dosing a little bit more to make sure that I understand. So I think last time you spoke about this the plan kohath. I was going to be a thousand milligrams and now you're down at 3:20. I presume what you said earlier that you have this Bayesian approach has changed what you had previously expected and see if you can get more into the details of specifically what changed from your expectations now as you actually have the data and you know, what might explain that change and then just to clarify on the pharmacodynamics data. So you have not done the pharmacodynamic analysis of cohort three and four, is that correct? But you did not see if I'm a CO Dynamics

Engagement in cohort to and can you clarify specifically what the pharmacodynamics essays you are completing?

Andreas do you want to take the questions? Yeah, this is a lot of questions. So yeah, I think we initially had a plant and this was when we first presented to study a relatively aggressive dose-escalation step, which would have brought cohort v. As you said mm. Mm no already in cohort to and we diminished is the relative increments as we want to make sure that we have have more granularity and and really can't I trade the recommended those if you will or if you look at the relative increments, we are at basically doubling the dose starting in court too. So it was really driven by the consideration that we need a better titration and that's the initial steps might be too big now in, Georgia.

So see for Marco Dynamic for Marco kinetic Marcus. What we said is that on the pharmacodynamics field. We were look at a number of cytokines and the profile of cytokines whole time while we will use essays looking at the occupancy of CD 16 a receptors in circulating target cells as well as Josh. So some of the subsets and activation markers within the the NK cells. So this is the the the pharmacogenomics wage is that we are using and as it was many questions, I don't know whether I missed one, but I help you out there and so why not what have we met in courts wanted to so we consider those cords to be below the uh, a meaningful those or a relevant. Oh and that's why we have been focusing on the analysis on uh, God

With the Court's three and four, so that's the that's also the relevant that we started fairly low with the total isolation again agent.

24 is a is a first-in-class independent data to be developed in a in the solid tumor indication with a more promiscuous Target with a prospective not seeing any of the projects that were previously reported for detail eyes or antibodies episodes levels investigated. We've been moving right along in the study again. This was all started in some of these into code because the vaccination around but it did impact the original cords and tons of how fast we could recruit. So I guess we have made the progress for a page one program that in at least at the level of others have seen in the in the other office and reported much when difficulties of starting. Once that if you're in Kobe, so I guess that there is we're pulling our expectations and I'm just now at the name.

In order to look deeper into what we have what we have achieved, but you are correct. Now we are in twice and the data are just coming in now.

Great and then one other question for me, can you talk about the rationale for a Natalia Santa Fe which is you know, relatively less experience in the academic literature for a college and also confirm what you're starting dose will be for that combination. And if you'll be escalating both from 24 and the cells or you'll be holding one constant month and over 200 again, I can take that. So let's start with autologous. Yeah, you are correct. There is clearly less experience and less literature about the logos now when we looked at the date of that and he Jan or previously and can access has generated on what resolved first if they had established a safe dose of their autologous in case Out product and they have

Develop their manufacturing their expansion capabilities in a way that allows us to use relatively high doses of NK cells on a frequent basis and then can continue treatment for for a pretty prolonged period of time. I believe in their current phase one single agent studies some patients have been on studying excess of of half a year. Now. What we also saw remind you that was a small Korean study published a Tesco in patients with non-small-cell lung cancer where the evaluation they are autologous in case our product in combination was pembrolizumab compared to the stupid pembrolizumab single-agent again, very small patient numbers, but I woke up to date the right. They were about four responses in treatment refractory non-small-cell lung cancer patients with autologous. NK cells plus plus pembrolizumab app.

no, we

Also looked at C cells in in some of our in vitro assays found them to be very suitable to work in combination with our IC engages. This is M. 24 also taken all these data together. We believe that it is a potential expansion of our opportunities. We have an age is a product that is safe in the clinic has an established those has shown activity preliminary in an egfr Express humor, which is non small-cell lung cancer and that gives us another opportunity and basically opens a new fields. We we believe it's worse are also to explore autologous in case of in addition to to allergen egg and Kaz know in terms of how the study is designed of the currently in case of dosas fixed four times ten to the line in case it sells which is the dose that was established by em, khong

A single agent studies and we will have a titration of ASM 24 again. We do not necessarily have to wait for the establishing of the recommended phase II dose in our single-agent study. Our starting goes here for the in case study will be a dose levels that has cleared the safety package in the single agent study. And again, we will have to assess where we are. Once we are ready to initiate see if the NK cells study which what we said we'll be in this office assist you.

Right. Thank you very much.

Thank you. Your next question comes in the line of Nick Herbert Wells Fargo. Good morning. Congratulations on all the programs. Thanks for taking my questions. The first one is on the preloaded in case and hopefully I've got my math right here, but those level one you've got 100% response rate had a dome. It's at the low end of approved karti. So how do we think about this given that karti efficacies tied to expansion of cartoons?

Andreas you want to take that I can start and happy if you come in so I think what what else? Okay. Do you said yesterday on her call? We stayed are extremely encouraging course already was a very low cell dose pre complex which I F M 13 and then follow some certain single-agent. You see I won't really say striking responses given also the pretreatment characteristics of humor load of these patients. So this really tells them that these NK cells was he targeted approach can can you already create even at very small significance to minimum wage?

now what also has

Be shown is that these and cancel that we are using in our collaboration with MD Anderson are produced by the specific activation protocol requires some kind of memory like in case L features which allows them to persist for prolonged period of time and these are data that I just generated. So we we do have some persistence. We probably also took some proliferation definitely not to the degree that car T cells have now the reason to go into higher Doses and that is also what located on Route it to you yesterday is to deepen a sponsors, but also to increase your Persistence of the NK cells Beyond see one or two infusions that we are given and to stabilize or to prolong these these responses off and again, very small patient numbers. But what we have seen as with this very first Nations at the higher salaries of 1 times ten to the seven all this place and went to the complete response already.

Was the first cycle so if you if you will even even more active again, what was specifically encouraging is this is a patient that not only failed all of the classic. Including chemotherapy pd-1 and entered cetera. But this patient in fact has a history of having received a CD 30 Target karti product and has not responded to the car T product again telling you that the the mechanisms of action and the capability of the United immune system the system probably a different and I think are giving us very early very encouraging data.

Thank you. And then you know, I believe you have a an option to license called but I told you from MD Anderson. So, how do you how do you how do you think about that as a strategy versus our TV or you know does the company have the resources or interests to become a Cell Therapy company fax y'all had that question back to Denise.

Sorry, can you hear me? Yes. Yes. Okay. Sorry. I had issue with the connection who repeat the question.

Yeah, I believe you have an an option to license the cold blood technology from MD Anderson. Then you also have the collaboration off and and so the question is really going full it does the company have the resources to handle interest to become a Cell Therapy company or you know, would you like to continue collaborating with Cell Therapy experts? Yeah great question. So as far as Ender MD Anderson goes we've always had the option to take the license for the World Trade Center and at the start of the clinical study. We felt that that was The Prudent time and we made the decision to take that option for the license such that the clinical data held and was very good that we could potentially bring that forward and and take that product ourselves. And so that's really providing optionality. We also really much very much a value our collaborations with nkmax in our team and those are focused in in similar, but yep.

areas and provide us with

A multi-pronged approach to identify optimal ways to combine our engages with NK cell therapy. And and any point in time we could have control of the obviously the MD Anderson a n k sell product or we could pursue, you know, a more strategic partnership with an M or n Cajun. Actually, they just change their name or our Teva. So we're just going to let the Data Drive our decision moving forward. I think it's still early days. It's a very very promising and we haven't made the Strategic decision that were a hundred percent going to become an m k cell company, but the damage promising and would lead us to consider that at some point in the near in the in the in the future after more data is generated from all of these collaborations month.

Thank you. Your next question comes from the line of Norinco.

Thanks for taking off the follow-up questions and just a very brief ones. First one is that is there also a update on the address code for the Dead Sea bak and 13 up combo in place? Anchor correct wage? I can take that. Yeah. Okay. Katie was Lonnie has a session very similar to the session that she had at aacr where it's focused on cellular Therapeutics Thursday. We are not confirmed as to whether or not her panel discussion of presentation would include an update on the on the clinical trial that we're dealing with her, but it certainly is an option but we did confirmation of that just yet if it if it maybe it maybe there but we're not sure yet.

Okay, maybe just click one. She mentioned yesterday that if the do the data silver robot going forward for the face was Thirty it is possible to advance package three any comments on your side. No, we don't want to comment on this end this stage. I guess that's for the time being we want to finish don't have permission to identify the optimal those for the for the cells and with that information then decide on how to proceed.

Okay, great. Thanks. I appreciate it.

Thank you. Your next question comes from the line of Mori from Jeffrey.

Good morning, everyone. Thanks for taking my questions and I've got some progress just a quick one on a 24 just clarifying you commented that at the initial doses so far your your life a better safety profile than what you would expect with tki or cetuximab. Just wondering if you can comment more on what difference is you're referring to and would you expect that to be independent of the PD biomarkers?

Andrea

Yes, we said we would like to present all the data. Once we have established pharmacogenomic off active pills. What we can see is that we have not seen some of these the whole Mark side effects for example skin toxicity or magnesium losses or which you would expect with this egfr again, as we progress through we will add we will protect more data, but I think it's so far off line with our preclinical study, especially with silent mode of monkeys reminds there even with the highest of we did not see any for example skin toxicities, which is in line off completely different and in order to mechanism of action also struck and the second question was second part was again relating to PD can can you repeat it?

Yeah, just wondering if the the safety effects I guess do you view is that independent of the the PD biomarker essays that you're doing or should they kind of go off again? Yeah, I think we again based on the mechanism of action and on the PD panel, we would not expect to see a direct correlation between any potential side effects and NPD markers. It's it's a new field. But again the in case L as we have learned from a 10:30 and also from case study is packed pretty focused. I would say and are we have not seen any in all of our approaches? For example, a significant organ toxicities that we expect that the same way back from 24.

Got it. Okay. It's really helpful and then one quick question on study and ptcl. Just wondering if at this point if you guys could provide any more clarity on a Roman expectations and and whether the final data can be second after this year first after 22.

Andreas you want to take that? You know, what? What are you mentioned already around? We are still in in the middle of the pandemic life situation is getting a little bit better, but Europe is a still heavily infected. So as we said already during the interim analysis around wage analysis currently, we do not feel comfortable to give a very concrete date of in terms of enrollment. Remember protocol mandated cohort birthday was on hold while we were conducting the interim analysis. So Cordy has now been reopened but I think it's too early to assess the full impact and then make a concrete prediction of of the timeline. So I think if we if we have we open court before a little bit longer time and if we have a better grasp on on the COVID-19

situation we should be in a position to give you a more granular answer than

Be kind of right now makes sense. Okay. Thank you for taking my question.

Can you do you say thank you very much, and I guess I know further questions correctly after further questions, so if you wish to continue, yes, thanks very much. I just want to thank everybody who was attending today for their listening in and and questions and look forward to to further updates in the next six to nine months as we proceed with. I wish you only have a nice day and got frequent good meetings with that. Thank you, bye-bye.

Thank you. Does computer or cold for today? Thank you all for participating and you may now disconnect.

Serge off off off off

Ash Ash

Nash