Autolus Therapeutics plc

Q3 2021 Earnings Conference Call

11/3/2021

spk_0: hello ladies and gentlemen and welcome to the odalis therapeutics third quarter twenty twenty one financial results conference call as a minor this conference call is being recorded i would now like to turn the hits over to your host doctor to send a crabtree vice president business strategy please go ahead
spk_1: thank you daniel good morning oh good afternoon everyone and thank you for joining up to take part is they call on the financial adult and operational highlights the the third quarter twenty twenty one i am kinda crabtree vice president of business planning and strategy with me today adopt decrypt christian item our chief executive officer christopher than our chief operating officer and and you oakley our chief financial officer before we begin i would like to remind you that during today cool a discussion will contain forward looking statements or statements other than statements that historical facts on the school or forward looking statements actual without may differ materially from those indicated by the forward looking statements as was also very important factors including those disgusting sec and titled risk factors and our annual report on form twentieth folded securities and exchange commission on march both twenty twenty one which can be accessed on the edgar database that w w w dot se si dot gov and in subsequent filings the make with the fcc from time to time the board looking statements on the school reflect the company viewed as of today november third twenty twenty one regarding future than and should not be relied upon as representing the speakers or the company view of have any subsequent day while the company may elect update me sort of his statements at some future point the company specifically disclaims any obligation to do so even if the company views change the forward looking statements should not be relied upon as representing the company views of have any subsequent date saturday please be advised that today's cone of being recorded and with call so in flight three you will see the agenda for today and it is as follows christopher will provide an overview about operational results and third quarter of twenty twenty one andrew than discuss the company financial though the bull christian will conclude with upcoming milestones and any other country in common finally we will of course welcome your questions following our mark
spk_2: tend to prefer
spk_3: like you consider and the moment you will affect you for joining us is my pleasure to have you are operating progress for the third quarter twenty twenty one if we moved to slide five i'd like to give a quick update on the key part one activities
spk_4: and festival
spk_3: a multi sense of feeling study for a leave program oversell which is progressing very well the roman and phase to portion of the study wrong track and consequently we are reiterating our gardens of the primary endpoint data will be delivered in the middle of next year with the full pivotal data available by the end of twenty twenty two furthermore we are pleased to be in the position to update you that the initial observations from the sixteen patients in the phase one be running portion of this multicenter felix study where we observe though the one month complete response rate and safety data ah so far consistent with the data reported from the academic who custody of oversell and relapse refractory adult acute lymphoblastic leukemia clearly this is very encouraging and we plan to present this early data for the phase one be cohort later this year ash in addition we also expect to update us on additional data for my all come nineteen expansion study of over without it in england be some non hodgkin's lymphoma invitations as well as the first early clinical data from the cop how extensive study which is which is evaluating our next generation product or per one twenty two and pediatric aloe in addition to the oversell nice flow we also plan to provide an update on our phase one tribe of auto for in peripheral t selling farmer in the first half of twenty twenty two if we moved to fly safe would like to walk you through a general corporate updates from the third quarter firstly during this period we were delighted to announce the deployment of john hate johnson as non executive chairman john brings a wealth of commercial oncology and business experienced odorless and is the recognized leader in the by pharmaceutical industry having how the number of executive operational and commercial leadership roles that experience would clearly be invaluable as we look for was the commercial launch themselves growth i'm very pleased to announce the in september planning approval was granted to build counties new manufacturing facility in stevenage uk the seventy thousand square foot facility will be least a little us and is another important step roadless on a journey to becoming a fully integrated commercial company we anticipate of this would meet the global demand for additional implications for oversell and as it will be no for capacity were roughly two thousand gmp batches a yet it will also have a further six go to spam beyond that from as if needed in terms of other updates we promote chris williams to senior vice president of corporate development and alec swung to senior vice president of human resources the falling apart from the persona achieve business officer i'm extremely grateful to the task for services thoughtless and wish him all of the best for the future we are delighted to welcome chris and i like to the senior leadership thing as announced as part of the queue to earnings as post period events with a very pleased to announce appointment adopted daughter edgar brenda to have now to indices the new chief development officer company as well as wolfram kruger who joined this is the new head of clinical development finally we announced an option and license agreement with madonna where we granted madonna an exclusive license to develop and commercialized and hour in a therapeutics incorporating faultless is propriety binders for up to for a nino on quality targets this is further tangible recognition of the technology based we have developed within the company with that let's move on to the next slide slide seven what we'd like to do to provide a brief overview of regards to oversell which is on track to be first product commercially launched by a little us as you remember a focus for the company is on delivering the phoenix study in adult patients with relapse refractory hello with the study rolling patients so both posts blended humor map and in a well as well as patients that as progressing in the without setting that have not oh may not have yet to speak to the map when a team a map as you mentioned earlier worth exploring the activity though sell the own they allow in the context of the or car nineteen extension study and i expect to provide for the update thing to for twenty twenty one to the data already released the ha in june of this year in addition to the updates for lethal lymphoma a mental so patients will also include date on patients with the b c out and say hello in addition were more so now treating patients pediatric patients with autumn one twenty two which is a new a product that builds upon the oversell backbone by adding a novel cd twenty two and two receptive as mentioned previously we also expect to share some of the initial clinical data on this product or seventy four twenty twenty one
spk_5: next likely flooding
spk_3: focusing specifically on adult acute lymphoblastic leukaemia it's worth remembering what the key features of a successful car cell therapy for this invitation oversell with specifically designed to tackle the underlying belge of that oh l l and that's why we believe it's uniquely place to address the current limitations of therapy this invitation one of the court challenges with this disease is as fast and proliferating disease big family so like in nature and another challenge is the patients often present in very poor condition the fourth of right binder of oversell assault weapons sound interact with it's target really quickly mean to the cells experience less exhausted and hands better in grafman and perception that assistance then at the same time because of the quicker and more efficient interaction with the target we would also expect to see less inflammation and lower levels of toxicity please note the flag nine let me remind you the still remains a very high on met medical need for adult l out with approximately eight thousand four hundred new cases diagnosed yearly worldwide in the last line setting approximately three thousand of these cases reside in the us and you what combination chemotherapy enables ninety percent of adult allow patients to achieve see as only about thirty to forty percent with achieve long term remission on relapsed patients have a medium overall survival of less than a year the approved products include limits humor mad and in a t the map for syndication and in some countries carter's is impressive for being launched we believe however there remains a real opportunity for a product candidate with over says profile in a setting answer manual and the cell has been granted often drug designation by the ft a for a allow crying designation by ear may and eilat designation but mm
spk_6: right
spk_3: bailing on to slide not add ten so let's just take a moment to recap on the data presented to date he knew day to a recently presented for eat at each ha for the all custody notably an update on your ability of response as measured by event free survival as we've already communicated and as you would expect for the coffee so product in indication of the south have high levels of initial response however as the patients go out post treatment what we're seeing now is that the event survival is maintained in the captain might have with stabilizing over time the summarizing evidence gives us a level of confidence to oversell has the potential to send to get a good proportion of these patients into longterm remission so turning to slide eleven to acknowledge this is the first time such a plateau of long term response has been seen as as disease setting furthermore it provides a degree of validation for the basic design premise of oversell since his long response is correlated with the exception of persistence but the thing with the product not only did he say about ten fold increase in the maximum number of coffee cells that have been reported in other programs that the level of party self is maintained over time and it's i believe that the system is actually a prerequisite to be able to translate a molecular the response into a long term remission in syndication an emerging data seems to support this on the right hand side and flagella see the atlas then profile and as reported previously we haven't seen high grade five crime really syndrome furthermore this was achieved without perspective intervention and with only limited use of supportive care such as tuscaloosa map and steroids and know they suppress the use in these patients so again as would be anticipated based upon the design hypothesis for the product oversell has a very good safety profile which should render the product more easily manageable in the clinic in conclusion the day to is very encouraging them to sell having a potentially unique efficacy and safety profile in his clinical setting so maybe want to fly twelve to put his statements contact with the data published for the other products used in the space of like first compared to the existing standard of care and the datasets that the foundation for the apprentice a privilege of levity him a map and in a is a map overall as you can see the available data for over so thus far stacks up very well against both of these programs particularly in respect of offering potential for high levels of activity with a more sustained response tony to slide thirteen to cost us was recently approved in adult patients with relapsed refractory allah the data supporting his approval shows at twenty four percent
spk_6: hi great crs
spk_3: no toxicity of eighty seven percent in impatience experiencing any great know toxicity in the label and on the efficacy side i would like to point you to other cells complete response rate and pair it with the excellent persistence and of an at free survival is that the new custody in conclusion taken in context we believe or car nineteen data is very encouraging with oversell having a potentially unique efficacy and safety profile in clinical setting and we feel we have a very nice the differentiate pro that for this high medical need patient population based on both durability of response and overall safety profile slide fourteen please moving on to them over so registration study feel it this is an one hundred patients study in relapse refractory adult and patients he has to sub populations relapse refractory post exposure patients dublin a and in a man as well as patients in his experience with regards to previously saving blinatumomab or in into to sum up
spk_7: the primary endpoint
spk_3: of the study is complete response rate and the secondary and points include molecular responses as well as a then free survival and duration of response so let us turn to the market size and the current market size and slide fifteenth it i thought on the opportunity in a allow in an earlier flight in terms of patients but what i'd like to just highlighted the cells performance of the current standard of care plan fighter a was known as glynn a team a man i'm jim reported yesterday sales growth of forty percent in the third quarter athletics sorry forty cent growth in the third quarter on a year by year basis as compared compared to third quarter last year
spk_8: as you can see
spk_3: if we look at the first ah sales in twenty twenty one and twenty so tight twenty twenty and twenty twenty one the with south of one hundred ninety seven million and two hundred and fifty million with a growth in a recent of around twenty percent if we apply publicly available information on the proportion of use in pediatric an adult patients and by using a very simple extrapolation that patients typically receive on average about two cycles of this product this provides further evidence and translates to approximately two thousand patients currently receiving this commercial product loudly and twenty twenty one i'm jim have stated that one of the underlying key drivers for sales increase has been the expansion to the community hospital segment in the u s beyond the academic transplant centers while plant saturn in a allowed is maybe to non academic centers will say expect the launch of fiancee india bc out also established copy experience in no centers both of these developments bode well for a product with the properties of over oversell slide sixteen please flight sixteen summarizes the current situation for oversell in a allow from the or car nineteen study we have observed a subset of patience with a high level of sustain see are achieved without subsequent stem cell transplant and your ability of emissions the a highly encouraging with fifty percent he fs at twelve and twenty four months i would sell as well tolerated despite being used in a heavily pre treated patient pull with high disease burden we observe no great three or higher crs and in a twenty percent of patients experiencing any great icons these results swiftly overall the very excited about the opportunity for the south in a sizable market with clear unmet medical made now taking a different tack the meeting on to other indications please move on to slide twelve as he ha ha in which had data from the or car extension phase initially thought all of the nine patients to with does to cheap at metabolic complete response and in this small population the safety profile was consistent with that observed in a out with no patience it's bearing things high grade c and c r at furthermore none of the patients experienced any form of know toxicity one of the patients unfortunately cause it and died as a consequence of coded relate to these the patient however died in complete metabolic remission there was one further patron he developed single lesion in a game which we could be removed surgically the obviously that there was also consider the progression no other patients progressed and all of a patients were in remission moving on to slide eighteen given over tells mechanism of action and profile were also evaluating this use it's use in other be so malignancy non hodgkin's lymphoma patience as well as see allow patients are being evaluated as part extension and the will come on t study were also conducting in collaboration with an academic that you see out in the carousel study the youth in primary cns lymphoma an aggressive live i'm a similar to the lbc out the is exclusively localized in the brain in addition as already mentioned were conducting an extension of the top health study with also one twenty two and pediatric patients these programs taken together will give us a very good overview of activity of oversell across the spectrum see the nineteen positive malignancies
spk_9: moving on
spk_3: on slide nineteen a break from and of the brought an exciting technology to hit that we have developed a nautilus particular as it relates to the suite of next generation programs some of which were told we showcase the eighth the our last year we're looking for a timid these programs for dental clinic true twenty twenty one mentor twenty twenty two including in i first saw it came up programs it's worth also reiterating the deal we recently signed with madonna which highlights the highly skilled in house find a discovery team we have here in office and the applicability of i were to other potential modalities finally on slide twenty you can see that we have tabulated these next generation programs alongside expected phase one start dates you will note as discussed we started the pediatric l clinical trial of water one twenty two in queue for twenty twenty we also expect the authors six mg study in td to positive selection was to start a rolling in the first half of twenty twenty two water for is also likely to move into the clinic in first half twenty twenty two i'm finally also eight and next generation multiple myeloma product we'll move into the clinic into for twenty twenty one with that are just like over to slide twenty one and turn over the cold sir andrew thank him
spk_10: i think chris and good morning or grafton into everyone african commit slide twenty two it sat my patient review our financial results of the third quarter of two thousand and twenty month averaged out with some and cash position a cash at tell the end of september total the hundred and seventy three point one million dollars and that compares to two hundred and sixteen point four million that we had at the end of june i will note however that this cash think it does not include an hour and a tax credit that we received in october of this year to june and approximately twenty five million dollars
spk_3: let total operating expenses for the three months ending thirty september to type two thousand and twenty one but forty point four million dollars and that's neat of granting come of zero point two million dollars and this compares with bit operating expenses and forty two point seven million dollars then granting can
spk_10: most zero point four million for the same period in twenty twenty research and development expenses decreased to thirty two point three million dollars for the three months ended thirtieth of september two thousand and twenty one from thirty three point five million for the three months ending thirtieth the september twenty twenty care costs which witching exclude depreciation and amortization as well as ship
spk_3: as compensation decree to twenty nine point four million dollars from thirty million dollars
spk_10: noncash costs decreased two point nine million dollars for the three months ending thirty six hip september twenty one from three point five million dollars at the three months ending city is timber tip twenty twenty and the decrease in primary related to share based compensation expense
spk_3: general and administrative expenses decrease to eight point three million dollars for the three months ending thirty september twenty one from nine point eight million dollars for the three months ending thirty september twenty twenty and cash costs and just said that i'll say that again which excludes depreciation expenses well share based at the expense compass compensation expense decreased seven point two million dollars from seven point seven million dollars the noncash costs in injury in a decrease to one point one million dollars to the three months at at at review from two point one million dollars from three months and
spk_11: that play gear
spk_3: am and the steak race is also mainly criminal to shit based compensation expense
spk_10: other income expense increased by three point five million dollars for the three months ending thirtieth of september twenty twenty one from nyc other expense of two point five million dollars for three months and thirtieth of september twenty twenty two other income of one million dollars the think race was primarily due to the strengthening of us dollar relative to to the pound during the three month period
spk_3: income tax benefit decreased to five point four million dollars for the three months ending thirtieth or september twenty twenty one from seven point nine million dollars than three months and the corresponding period last year and that was due to a decrease in research and development expenditures which qualify
spk_12: for the quarter
spk_10: and as research and development credits fell at a faster rate than our net loss before income tax this has led to another effective tax rate the net loss and criminal to ordinary shareholders was thirty four million dollars to the three month period and that compares to thirty seven point three million for the same period last year the basic and diluted net loss pet ownership three months ending thirty september twenty twenty one with forty seven cents per share and that compares to a basic and the looted from it most the ordinary shit of seventh two cents that a shit for that corresponding period last year at this point we estimate that our current cash on hand and provides us with a cash runway into the first half of twenty twenty three and with that oh now hand over the called the christian to give you a brief look on expected most and scratch him
spk_13: thank you and let me conclude this part of the management discussion with a review of the upcoming milestones and new slow to the end of this year and into twenty twenty two i moved to slide twenty four as you look at the remainder of this year and into next year there are a number of clinical milestones and opportunity to value creation key and most eminent operational focus obviously is on the conduct of the pivotal see like study with initial primary endpoint data expected around the middle of next year astros mentioned earlier be a very encouraged barrel to patients that are the see our rate and safety data on the market and the phase mom be a part of the study is consistent with the data reported some the academic all quarter nineteen study of ob cell which as you remember it was conducted exclusively with in the uk we plan to provide a little more detail on this initial clinical experience at later this year a dash front of expect to report an update from the only sell a car nineteen extension trial particularly from the remaining cohorts in the relapse refractory di non hodgkin's lymphoma our population as well as see a little patience again plans for the end of the new at ash ah also are hopeful that we're going to be updating you on the other one twenty two sides one study in pediatric patients as well at that point in time in cuban one next year with planted right an update on the same mom study our cock carousel where we actually are testing i will be settled in patients with primary cns lymphoma and then as we go to the remainder all of the first half of next year we also expect an update on the autos for a clinical experience from those escalation portion of the face mom program as he then look forward into the next programs behind our leaders programs and we expect to have a she moved several programs for he hurts from twitter similar all out of eight while getting to the clinic still the end of this year we expect our our or revised dolly tumor program additional sell profoundly module sort of six and g at to get into the clinic during and i didn't get searched half of next year and we're also moving overseas for them to the size of all the believe the companies and very good position combined with and cash on hand we feel about the least for success a call center pipeline when i'm happy to take questions brighter
spk_0: to ask a question he owns depressed star one on your telephone to withdraw your question press the pound key please stand by while we compile the q in a roster our first question cos i'm mark goldstein with his or her your line is now of
spk_14: at three am think in question
spk_15: as on the shiites program and we are you'll have ah a full data sat in the first half as twenty twenty two and then can talk about just what that regulatory path is funny out for that program and then on the aka tension studied you set you're on a gallon data and see where it
spk_14: that information cake he went terms as i'm looking at additional programs and so i'm curious as to how quickly you are able to execute on that and once you have health the whole our dataset i'm assuming that yeah my pre i apologize but i thought it the year at work common new said something about a revised solid humor program and i don't know they heard that word revised and correctly so he purchased them help me on that
spk_13: i know are great great to to hear your voice and thanks for joining a so autistic angie it is as you may remember a program to rebuild on auto six which is the original car and we basically went back and reengineered the program and probably i should have used to turn re engineered so there's no to
spk_0: change absolutely consistent with what we have been recording before i with regards to the the old car extension also what we're doing with your car extension is adding at approximately ten patients in the traditional as said of indications to get a feel for the activity of the program within those indication that works on going
spk_13: and also depending on the indication we would like out a certain amount of follow up to understand the the level of differentiation off the data that we can actually a scene and and an across our these various indications and will be guiding accordingly as you go through the course of next year in terms of the next steps on and i'm getting at ooh the that the felix study and the program of oversell in at all pale ale and as he pointed out we expect to reach the primary endpoint middle of the year that is based on a complete remission at a complete remission bait i'm and which is actually an established early on after get a treatment has started with these patients who will then by the end of the year an exp next year also then have the six months follow up data on all of these patients and at the expectation is that will be the basis for the key regulatory filings that were planning to do and those findings are currently projected to the happening at a net twenty twenty three
spk_16: okay thank you for here
spk_13: thanks a lot more up
spk_0: thank you or next question comes from the mustn't candy with new company your line now open
spk_17: a shot a line is open
spk_18: like enemy
spk_19: ah i literally south i'm on form and thank putting our questions ah can you give up any updates on that father that you're exploring with operate far multiple myeloma harvey i believe you mentioned that you are running the cia and if you can you with an infamous about the same target ah conduct and of your thing a big on aka five i'm like august eleventh he said no favors of a fortified impossible for the and it'll thank you
spk_13: and he sounded next adjoining
spk_0: i'm on on out of five have a good one of the key things were doing is that we're taking information we're getting from all of for to the an informed the yeah i had a waiver can actually conduct the yeah i study law and order five
spk_13: collect into ah into the credit for taking with on five and regards to auto eight we have disclosed ah the see that we have generated a year and very sensitive on bcm a card which is a key component of the program and at he's gone to the initially tested i'm and at establish the activity of that car and it's own and at that point one stats established were expecting to add a second appachan will disclose that at that point in time
spk_20: like if
spk_0: thanks op
spk_21: thank you are next question comes from nyc abbott with wells fargo your line is now up
spk_22: oh come on a place that again
spk_21: or question so that the first step
spk_13: ferguson kristin so or get an update on the or car extensive study later on this year and then very early next year will get the data pool or or sorry wallace to get the also one twenty two data so how do you choose between those two assets as you think about next steps beyond the adult lf l an indication today the question they can bend thanks for joining and chosen basically dead the underlying question you're asking it is and what what is the profile and the opportunity you see and pediatric ll ah versus the opportunity would see for i'll be seen on and some of the monarch skins indication that sort of the underlying i think element of the question and so what we'd like to see the wealthy and i'm at when we look at these indications we actually look at them are independent lake is there is a i think at a at the thought process around a auto one twenty two is actually as part of the overlook a l program that were conducting adobe cell with all what we're looking at older one twenty two as to thirst next generation program that will expect to build up over time and and honesty pediatric yeah are being the key indication to establish the utility on having a cd twenty two card at is highly effective the added to the only sell program so so that program stand on stands on it's own feet and it's own married and one of the key things he wants to see with that program is the reduction in the relapse way to in a pediatric patients and etc that the the key entry point i doubt we think would actually then trigger if the sole development and in pediatric a allow for that sort of that a part of the overall the should think about it overall a l l approach that more retaking and and it's a component of it the opportunities that we look out for ob sell itself outside the l l space and i think is that eight a second question and and i think of what we want to understand is obviously where can we see a profile that is is that they're stacks up not just well that potentially ah an improvement over and above of the other programs in the space i'm in a movie additional non hodgkin settings and this is what we're starting to explore with the extension our program that were doing on the all car study on and whoa that data will help guide us actually to then the choices off the path that we are planning to develop within the non hodgkin's of decay asians as it's really going to be data driven but fundamentally we're looking at those two approaches as to the being shepherd and the census other one place to be it in part of the overall a o l strategy that we're building off
spk_21: to lm you know build a significant presence in that in that indication said i'm and there and secondly it's than that the branching out into the broader non hodgkin's opportunities
spk_23: as and and and maybe to the allied to that know the he said the and little bit a manufacturing facility will support in two thousand pace of branum which obviously we'll cover the adult now
spk_13: indications are or what what do you need to see and what would the timeline before adding additional capacity to to support for example and and fomer or key day allow right so that the way we're building big the capacity of and to the at the facility in in there in the uk gives it actually a very nice level of capacity and the ramp up i'm ask for launching as a launching their yoga shall program and i think it will get a sample time to get a feel for the trajectory and then also feel for the timing for additional indications become online to then actually time at time the and i had to deal damage not only off the facility in the uk but also consider establishing an additional manufacturing capacity of the us operate puts us in a very good say he gives you some level of our of capacity that we believe actually will put us in a very in a very good spot arm and i think when you look at the a trajectory be seen and some the other party programs i think the two thousand
spk_21: that marchesi i will leave is actually get mark to work ways and and gives his inability to the actually time that that thanks for that on for me is
spk_23: as a two part third kit can you provide us with an update on the mit posted cohort of felix and also they're comparing the to the mouth those slides back to previous ones
spk_22: we're not seeing a mention of by the also aloe also seven a programs in the current slide kid can you provide some
spk_13: he alleges that what what the status of those programs as well thank you right so to the the the other coaches continuing other welfare in our collaboration with the with our academic partners to that's slated to go in and first half of next year the and the yeah the auto seven program were planning to run in sequence to autistics and mg on again from experience around there to various models for introducing into our and into that program which also also part of the all the said the program so there will be yeah i like a staging and i we expect that run between those two solitudes programs the it as i think that's i think that there that day to talladega the questions or did i miss anything
spk_24: yeah just on them hammadi posted cohort how that's going or the i'm a deposit core yes
spk_21: so so the mit positive court is is also part of the felix study and runs alongside felix study i am and i'm sure will be will be giving updates as we going to the course of next year on that patient cool but right now i was in rome and focuses is very much on the yeah on their own then again that's refractory popular
spk_13: should with morphological relapse
spk_0: great thanks a lot of forward to ass and actually tax lot make thanks for joining
spk_25: thank you are next question comes from africa
spk_13: good working with truth securities your line is now that hi guys have benefited my question of the center for up to the dub collect back on that note easter egg you dropped about getting a little bit of a view on he x at asking the result is a bit more about that our english presentation will that be and number of patients etc we could expect a and then on that topic of ask to baby ought to give it a bit more color on the number patients which be expecting for ottawa in an hiv allow as well as on on one twenty two thank you turret thanks for joining us to can't so they when we look at the at what we're planning to do with regards to the yeah and i have faith t portion also the key question the were asking where the phase one before she was made it to move from a as single country and oh my single center study which is what the will car studies on a to a multicenter multi culture and the country environment and with that honestly in a significant increasing complexity and logistics and everything else so so dallas big old really make sure we we're demonstrating that transition with demonstrating that were replicating ah the data was you also move to commercial supply for vector and solemn so is a few changes that remade along the way to sort of transition the program into commercial state or a towards commercial savage and that's the one the key our topics that we we expect to update on an actor a dashing than a context old so i will share on that you know key aspect of the phase one be on the trial that was conducted which honestly was designed to confirm and ah the an activity level that we seen at your in that the own car study so so that update will be given mobile give that dat dat experience which i i think is important as vindicated the data that we're seeing is consistent in terms of said you know the key parameters that we're looking at which is really lands safety one well you be sure we replicate the safety ah but also replicating the have electricity and than and and after the the height of can high level statement that we made today and realistic economy of showed the corresponding data to that when we look into the updates around anti an old car nineteen nineteen study and actually moving into the non hodgkin site what we did it were at a to an additional cohorts space at ten patients in each and we're gonna give an update on on the progress among on the exploration or and these barriers cohorts allen and to other some of this the as somebody in the colts will beat it out at full a boat or this will still be in rolling shovel see basically snapshot ask for transitioning to those datasets and the as you going to the end of year and then on the a pediatric study else will
spk_25: hey there are the night and overview on the overall program am i keep track trace sticks etc but also hopes and i can have some share some of the initial clinical data on on that program at the key update would expect actually for the key for the pediatric program will be towards the middle of next year when we have about six months of follow
spk_13: up for and former than that of the patient group which is we believe gives us a good feel for how the tracking with regards to the ability to minimize relapses indicates once they achieve response so that's as a as it says the framework and think it's a sort of framing expectations for the enemy got a christian and it if i may just add fell in
spk_25: and this data that you talk about in terms of transitioning auto one or two commercials
spk_13: stage here and this president dick but what what you be sharing it as bolivia actual patient level data from your like study them in the south presentation
spk_25: while the day that that would be be sharing other see it it's is exclusively from the salesman be portion because as you can imagine you do not want to share pivotal data i'll head of actually getting the study you know completed and and everybody treated answer this will be will be focused on the one the
spk_13: our experience i have to study
spk_0: got it thank you very much for that that congress and
spk_26: right that's lot they shared it
spk_24: think he who are next question comes from that fits with william blair your line is known
spk_13: add extra day my questions yeah i guess christian we've that a couple of dates and in the third quarter with some see that the knowledge and a party programs and what have you have a hello thought the nose at it that is can influencing and of your allergenic approach which ugly that not fully knock out the gcr i'm remembering a some the lucille confession the yeah mcintyre you know thanks to the question honestly to visit cannot limit to what we know about turn ah what's going on in those programs also been some public statements that i think are most of you have commented on i think most it's most of their young on the coal actually are covering of probably the companies involved so am i think we're seeing i was a emerging data which i think is interesting an answer the kids as it stands outside the the performance are the product and my with expect that more updates also around dash i think that's a development in sunlight ah
spk_27: also the various ways of technology and some of the players were pointing to elements of their technology that might gonna give them in elementary of potential differentiation on an ironic achieve safety am i don't think i want to comment on that had and the the approach for taking regards to the a programmer exploring ways
spk_13: center with our academic partners is really to tracked the a t cell receptor that it within the secret a pathway a giant in other words what we're doing is racial expressing a protein module that actively trapped the actual protein gcr protein wedding the she could do a pathway enchanted into the degradation pathways now that that's fundamentally different approach to and yeah
spk_28: coach did actually aims to knock gain or knockout change in whatever way that technology actually cost at south asia it's a different approach we're not operating out there at the and in that sense at the the genome level appropriate operating with at the at the protein level and so there's that it sort of it at it's quite a different technological approached of
spk_0: taking i'm here but it i don't want to get there in i wasn't i get to speculate on now on the current technologies and play with to have we got the company's i think that will update i think the field and the upcoming conference season i think we'll learn what's going on there under under in that context
spk_29: because thanks man thank you are next question i'm kelly she would jeffries your line is now
spk_13: hi thank you for taking my gosh this is a dave on fire kelly he had defeat so
spk_30: my question is it adding auto and salix beyond our auckland felix an adult else as you see the possibility that the f b a might ask for randomized controlled trial instead of think alarm trial given the am ah involvement offer complicated landscape and or second question is can you said expectation on date
spk_13: ah ah in first quarter of next year five primary cns lymphoma thank you hey thanks a lot to joining army with regards to we that that that the felix study army the first of all in terms of the army the way that day i get the did the study officers designed it's designed to give a steep
spk_31: i'm a complete remission right out of the sing along to study and when we look at their history of recent approvals are where they know i'll i'll i'll we had unsettling a team an african child to which is proved on a single on study approximately one hundred patients we have now the approval asked to card is in it all day
spk_0: lel with just fifty four patients in a single on study am and would expect that there is no change and we'll see here so we expect that single i'm starting with their level of robust data that we have seen and early experience i believe is actively adequate at to
spk_13: submit an forth on apply for him from registration for the program i think that is entirely consistent with what we've seen before we seem to say most on the pediatric and else i i'm and al pacino was a seen it and on in the yeah there is trials that led to approve into the a vcr states which is actually much smartest
spk_24: space and the programs not showing much differentiation actually between themselves so i don't think there's any change their i think the fact that indeed the car just got a full approval our for the last refractory independent of line i think is a very good at is a very positive development i think that it's
spk_13: ralph's and for and program on and so i think we're in a very good listener
spk_32: thank you
spk_21: thanks you guys
spk_13: our next question cause some eric joseph the jp morgan their lines know no thanks for taking the class and on i moved just the housekeeping one be related to the upcoming battle on the york suite out i guess who's the housing we be thinking about them what might be included in a summit submitted abstract than to be the setting sort of material there there's a muslim or builder and then secondly i'm wondering if you give it a bit of an involvement congress update with the thief to say quoted on and are pc in the phase one the the i completely is distinct from ah v or pieces of the faith one or picking in the basement the to pretty good all to the rpg the reader reader that are expecting a like was the next year early a fish populations i'm on a threat that thank you for joining thanks for the question for that that answer the way that we belong to study on and does not make any distinction differentiation in terms of act inclusion criteria between to face mom be in the face to celebrate were involving the exact same patients i'm into the face to force next we haven't rolled into the chinese on the portion and that's on all she wanted the values user the city's lumpy data that it actually gives us a good read on i am not only i did that they're they're include next pollution that said it from and track racing through the patients but also it i'll see also involves the patient at the center never involving the
spk_32: majority of the centrist in the face on people and big us admirable and patients in the us out and it reflects very well ah what we expect the composition of the patients he ah indeed in the face to force and said that central believed that the data actually used in use it very meaningful and is important in that context and it also
spk_13: for includes as a indicated before get out complexities related to logistics attach which all of us they have an impact on on on your bank's delivery time that sounds of force that gives you that overall ah level of consistency across and check from that perspective we expect the data to be you know not very helpful and a very good guy dance on as we go forward and the other way actually and and think that he's cloud worthwhile think about the date ice that this is maddening to be the third set of data that will become available around obese sale in a allow well as a half the first the set and a pediatric a i'll population i'm at which is she was published
spk_32: nature medicine i'll be then have the experience or indeed all population the old car setting and we're now adding the experience in the felix that his on big portion and i think that's another way of looking at the data and actually just looking at that had the level of consistency of the data across datasets which i think is another way to sort of
spk_21: actually get understand and under good understanding of the profile of the product and and and i think and understanding consistency between between these various slightly different populations for this course and i and i indicated that one be population is the same population that the face to population that is
spk_13: i think that's part of image and i think of the with the key opportunities is certainly am i think exodus bungalow that fishy i just wanted to clarify that he ah that of the phase one spaces go over or comprise the cohort we're looking at a face to that the read out the ball liking to pay type but after that are getting a gap yeah don't know this is peter distinct i'm in terms of actual data facts to there is a on lumpy dataset there's a face to dataset and their i was actually there to dataset i mean at what he did see when you looked at the the car just review that yes the a day yesterday actually took into account or a
spk_32: phase one experience with the card at least in some aspects on safety that's what we've seen i'm circling that dataset said the maybe some you a broader view on safe keep us from in a security perspective we expect that that will be focused our and i'm on the face to dataset the lamb
spk_13: of her on so just enough it on or to congress a bit on voted in the face you deal with this happy about that now the sides and jason a follow up and he added
spk_33: in that the media read out run felix face to the a hazard be thinking about that
spk_34: righto so the the what the guiding and never expect study to be ah a fully involved during the course of the first half of next year with the primary and points waiting out in the middle of next year
spk_0: i'm to that's the guidance the primary endpoint is are established by to measurements one measurement at one months and then a confirmatory measurement at two months after dosing and in both cases in order for a cr to be counted as a cr you want to see our to be actually established and both time
spk_22: points and that actually goes into the assessment of the primary endpoint
spk_33: the answer to that of the key the key data you have at that point and and all the say that the full of follow up of these patients on a stand with a dish were all patients six months follow up will be expected to read i their towards the end of next year
spk_13: okay crate and then final question are you providing ah further updates for follow up from the adult a allowed for work all car making
spk_0: man eater and i or expect or two point by the right way to expect to do that other siblings were rob dating i dunno how skins experience and dad there's an opportunity to see a chair of data on the durability data
spk_13: okay great has taken a question thanks lot eric thank you are next question comes from guild bloom with and company your line is now i reminded him that thanks are taking our question just a quick one on on the let's or not there's there's been some pretty good results of for apologists parties and other programs for assault maybe it it can up putting context for us how important it is to have an analysis of option that is relatively stay in that particular patient population thanks jail and thanks for joining it's really good question i mean one of the interesting things about the liquor lymphoma to compare it to the l l setting that rack is a nice that and phillip lymphoma you have basically and implemented you use so disease that is relatively slowly progressing relatively slowly growing and and but it is a disease that we actually a has no way at this point to cure so everything we do in that disease settings designed to buy time now we do have many options for these patients and they have all the say a lot of chemotherapy backbones combined with a biological just the the mainstay of the options for their available to those patients buying them get a year risk of us of time that not curing actually the patients along the way what they do experiences other she the level of thirteen of toxicity but also quote unquote the convenience of a lot of these and a therapist she obviously be at math and administer it in a in a patient settings to the typically don't have to go to hospital to be treated at they get managed actually in the race ready for the most part so that sort of the settings that what you need in order to sort of actually reached with patients i think risk the two things first of all you want to actually be able to show that indeed you have a safety profile where the patients can get treated i'm in a much more enter into the previously and settling in an outpatient setting because status to the what they used to the and what they're comparing to secondly i think you would want to see long term permissions of these patients to that indeed this one time and prevention you know give you a meaning full amount of time hopefully but that data still outstanding in the field and converting some of these patients into interviewers am and what he really need to look at a when you look at it from patients perspective instead you hands on the one hand and your your standard there came a biological back down and which means that you're gonna get treated every every two three four weeks and going to go back and you're going to get another and that series of kemalist and and you get another load off and of of antibody of some sort and you just keep doing that and see you have to do that on an ongoing basis until the relapse and all these treatments designed to be treated and that are you to actually provide treat
spk_33: and until relapse and i think the opportunity for cartoon that field would be to to have an opportunity to get a meaningful and i response and and adjustment of the disease through a single a single intervention and then actually has you know hopefully you know a year to several years maybe longer
spk_22: i'm where you don't need additional intervention and i think that is part of the arch activity it's also any think about it from the cost respected ah the fact that the regiment a given until we mapped out the racks up a lot of cost over time
spk_25: and that's you know what's driving a lot of the revenue lines that we see in the space and i think also that context that's very costly and if you can actually have a long time intervention there's a lot as a treatment associated costs that i'll see you to take out of the equation said there's also think an interesting economic argument to be made on i'm have a strong
spk_13: from the patient perspective of having said of a single intervention that than and actually you know keeps you keeps you in good shape for an extended period of time as well as i think an element of author patient management costs there until tell a look at i intend to the profile for a product i think you want to has a product of hands on and ability to the very good safety profile today low manageable but that you scan combined with an ability to sustain pressure on the lymphoma kusstatscher in essence what any other therapy dogs it's maintaining pressure on the lymphoma that in order to do that he also would actually have ask of this of the carty therapy to have and it's then the it and i'm persist and so that indeed you're able to actually put a long time pressure on the lymphoma and sustain that over time on a two the convert the patients into longterm remissions so think those are probably to to keep directory six and illustrates one of the key features that we're seeing it out of program in in probably the most challenging to resetting which is the at all day and our population of we do see that very nicely those two features and that's library interested in exploring that officer in the context of the yeah the initial experience and the all costs and it's a may media related question i'm so with the same the allergens space particularly the lbc up and moving towards multiple doses of of the seller therapeutic also involving additional chemo you think that this might provided you know kind of an opening and again for for an apologist court t therapy with a better state the profile like what you have with auto three and that i think by i think first about i think it's very interesting question and it and what we're seeing and you know i think matched asked a question before and slightly different way and is that we're seeing that the data start to actually you know come forward and in terms of some of the outage make approaches and and the fact that many of the companies talk about multiple dose thing asked at yeah while there is activity in order to to the ghetto a more sustained activity in india vcr patient which is really you know did you need to get fragile you have to get to that a certain level of killers and these patients to make your therapy worthwhile
spk_35: that that may may take get a few more steps and of course the more you add in terms of those things and and reconditioning conditioning and chance of fourth yeah complexity to therapy yeah complexity from the management perspective complexity and i from a treatment could perspective and you take away the french
spk_13: yeah nation from a frankly a standard chemotherapy antibody drop conjugate antibody tied the combination approach that that most or by specific approach that is also acted nice and and i think that's one of the fed said the key questions will be and what is the slits standalone activity and and can you be
spk_0: really different yourself and that differentiated yourself away with those approaches some the other approaches are gonna try to being pushed or we do see is that still the level us and that sustains yards that are seen on the court t side of your atomic party side as at this point at least has not been matched by any other therapeutic modality on
spk_13: and i think that you know i think man certainly create an opening and to a two part of the comment i made before about select lymphoma you know having a good safety profile will be important our in order for a patient's to really getting access to the set of features those patients as be pointed out many times larger than the course the last two four months or so tend not to be treated at the academic hospitals in the of the show they're actually much more further out into the periphery and and was that you need a product and actually has to it's good that and good level welfare of safety and that are as whole marks are seeing both or seen with honestly and we're now of say exploring with autobahn
spk_0: a obvious oversell am and that i think we're going to get a very good field where that's gonna go that ah is certainly there's more complexity and he of these jail space and probably as and god many thanks anticipated earlier this year
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