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spk_0: the conference will begin shortly to raise and lower your hand during una you can dial star one one
spk_1: oh ladies and gentlemen and welcome to the awful us therapeutics four year twenty twenty two financial results cause of all and fourth quarter operational progress as a reminder this conference is been recorded i would now like to send a conflict over to your house to your wilson communications consultant please go
spk_2: ahead thank you know they're good morning good afternoon everyone and thank you for joining us to take part in today's cool unfamiliar twenty twenty two the you result of racial highlights for the fourth quarter twins twins to i'm julia wilson the communications consultant to flush with me today adopt a christian item or chief executive officer dots lucinda crabtree or chief financial officer before we begin i would like to remind you that during today's cool we will make statements related to a business that are forward looking under federal security flaws and a safe harbor provisions of the private securities litigation a fool not to mention ninety five leave may include but are not limited to statements regarding state of clinical trials and development final lunch for for the candidates your expectations regarding cash family the statement the subject to a variety of risks and uncertainties that could actually result definitively from that patients and that so do the only as of today with the no obligation to update any such forward looking statements for discussion of the material and nujood the could affect her up to a result she's a that the best for them to you stayed factories and se si finding space available on the best a section of our website once like three you will see the agenda for today which is as follows christian will provide an overview of are operational play like for the fourth quarter twenty three be findable than discuss the complete player financial results with a christian look include that upcoming months though than any other confusing from it
spk_3: finally we will of course wealthy of questions and keep christian thank you do the are a good morning to your thank you for joining us with my pleasure to review our progress for the fourth quarter twenty twenty two moving to slide for the really pleased with our program operational progress through the fourth quarter of twenty twenty two which is highlighted over the next to slides firstly we're delighted to announce in december that the pivotal face to felix clinical study evaluating ob sell it relapsed refractory at all allow patients met it's primary endpoint based on overall response rate in a pre planned interim analyses fifty patients with morphological disease and as verified by an independent data monitoring committee where another step closer to bring this potentially innovative treatment to an underserved aol population and i'll delve into the data in more detail later in this presentation this positive data triggered a thirty five million dollar milestone from our partner blackstone life sciences earlier than anticipated and were planning to rewrite and up a date update on all patients treated by make this year most likely at asko wait longer follow up plan at the end of twenty twenty three as well as planned release it may should to the us fifty a by the end of the year december it was a busy mom for us we all sat a number of clinical updates at the american society of hematology annual conference including presenting longer term follow off data from our idols pale ale patients in the old car nineteen phase one study of ob sell showing thirty five percent of patients in ongoing remission a third he six month a follow up needed follow up with no additional amulet kenya therapy in addition obese sell continued to show high levels of clinical activity and relapsed refractory non hodgkin's lymphoma and chronic lymphoblastic leukemia patients paired with a well manageable safety profile there are also very encouraged with the data we present from our pediatric a little program the carp how face month while of ottawa twenty two hour dual targeting party therapy targeting cd nineteen and city twenty two with over eighty percent of patients achieving a molecular complete remission and with no average a negative relapses observed additionally we provided longer term follow up at the libra on belief on t one face one trial of auto for a peripheral peaceful a well with some patients experiencing durable metabolic see ours including one patient up to the at one year mark i was treatment and i was the in continued remission
spk_4: will it be providing update on these programs over the course of this year and also be presenting data from the carousel study of obese out the peripheral cns lymphoma patience than the carthy face month trial of automated multiple myeloma patients and finally the face want while of autistics century in europe less my patients is expected to start in the next
spk_3: score thirty two slide five we've made some great operational progress through the quarter towards the end of the year we close the public offering raising aggregate crossbow feeds off one hundred and sixty four million and net proceeds doctor underwriting discount and offering expenses of one hundred and fifty two point four million including a partial exercise
spk_5: eyes of the great you by the underwriters we believe we are now well positioned financially to bring over style an innovative and potentially transformative treatment to an underserved at all day little patient population and twenty twenty three will be fully focused on submitting of the l a application at the end of the year and working towards commercial long
spk_3: she's twenty twenty four as i mentioned earlier we also received a thirty five million dollar milestone from our partner blackstone life sciences as a result of the positive interim analyses of oversell in at all day ll at the same time we received an additional thirty five million dollar milestone from blackstone as a result of planned activities of
spk_5: porting the performance a qualification a hobby style of the over so many factory process
spk_3: you will recall that we signed the agreement with blackstone at the end of twenty twenty one a part equity and part program financing collaboration proudly candidate ob cell and we have now received two hundred and twenty million of the total two hundred fifty million committed capital
spk_5: we were very pleased to announce three deals to in october twenty twenty two and one posts period and in january twenty twenty three which underscores what we believe as an industry leading sell programming technology platform we have developed at odalis we find an agreement with bristol myers squibb granting them access to for
spk_3: api terry rtr eight my tux the map induced safety switch for incorporation into said of selected cell therapy probe apps in addition madonna exercised an option on one of the proprietary binders being developed against an undisclosed immuno college he target for the delivery of pioneering message or are in a therapeutics if license option stems from the deal we announce with murder and and august twenty twenty one finally in january twenty twenty three was signed an agreement is collector bio which allows them to incorporate the rtr eight safety switch into a cell therapy program for the treatment of our immune disease the total license revenue was six point two million and twenty twenty two and each of these feels have the potential for additional revenue in there to an option exercise fees moscow payments and royalties we continue to make steady progress in our manufacturing it seems operations the first phase of the building our commercial manufacturing facility was completed with the handover of the first three clean up the first of three clean rooms at the end of last year
spk_5: we have named this facility the nucleus when i'm working on the qualification and validation of a nucleus and will remain on track for the good manufacturing practice operations commencing in the second half of twenty twenty three rows to undertake in the development work and reports and ration for the seems he package plan to support to be a summation mission
spk_3: to the sta finally total cash and cash equivalent and restrict the cash at the end of december were three hundred and eighty two point eight million dollars with that let's talk more about oversell on slight number seven
spk_5: oh we still had a unique mechanism of action what's fundamentally different about our product candidate is that it has an ability to engage physiologically with the target sell
spk_3: rapidly binding to the target which deliver specificity paired with a fast off rate for rapid disengagement from the target self wants to kill has been delivered this unique engagement dries maximal activity while minimising toxicity and is at the heart of the differentiated clinical profile we are observing eight acute lymphoblastic leukemia non hodgkin's lymphoma patients or chronic lymphoblastic leukemia patients moving on to his flight number eight our clinical experience without the cell in a l l shows highlight our all response rate across an old as a story population at it chose a high level of a clinical activity across all indications are clinical experience but only sell in l a also the hi all role response rate across all patient populations the including a very high level of clinical activity over the longer term that we have now served in the old car and i teach study we as a median follow up with thirty six months now in this study and with a follow up of twenty four to forty seven months of observation we see that thirty five percent of the are in long term remission after receiving ob cell and receiving no further anti leukemia therapy the safety profile is bell manageable with low levels of high grade crs and i can see the midsection up a slide shows the patients with long term remission think continued presence of karkhi self over the entire observation period the program is develop on there are matt prime and i like designations living to slight nine we completed the involvement and dosing of a pivotal study study we call the felix study in at all relapse refractory l l patients and as i mentioned we announced in december that we have had met the primary endpoint of
spk_5: overall response rate in an interim analysis and based on the first fifty patients followed for at least three months of fire follow up clinical benefit in a l l will be assessed based on patients remaining in sustained complete remission
spk_3: we conducted the study and thirty four centers twenty four said this in the u s seven that this in the uk three centers in spain during the peak of the pandemic it is important to realize that relapsed refractory adult bailout patients are highly news depressed and pandemic poses a significant added risk to them more out were you to access restrictions and various other pandemic rules and regulations we cannot access our clinical trial sites for the most part of the felix study you can imagine and state l l patients are about as difficult a patient population to work with particularly in an environment where there is a high risk of infection and indeed we did lose patience to covet in many ways this study was more of a real world study conducted under difficult circumstances in addition to patient safety every aspect of product the labor and logistics or pressure tested or this trial with massively reduced air traffic and impact of the pandemic of our manufacturing teams remarkably manufacturing for all patients from our facility the uk turned out to be an asset also for us deliberate as the long haul flights between us to the uk had priority over us and also you domestic flights next key data read out is planned for asko in june this year movie for slight number ten it's like summarizes the announcement we made in december regarding the priests specified interim analyses of the first fifty out of ninety patients to host that had reached at least three mouth the follow up the primary and point is based and overall remission way which includes patients and complete remission and patients and complete remission with incomplete well now recovery or cr and see r i the r art but seventy percent and and in fact all recent programs in a ll have used or are as the primary and point in their respective studies safety analysis was conducted on the larger ninety two patient data set and showed an excellent profile with high grade try to can release a experienced in less than three percent of patients and high grade i can't or neurotoxic city in less than eight percent of patients i can't wear full the reversible and less than twenty five percent of patients had any gray of your toxicity in contrast to prove t sell or fees alligator therapy he's a very unusual safety profile in this population as i mentioned earlier this week fighting that triggered a thirty five million dollar milestone from blackstone moving to slide number eleven this like summarized our current experience with ob selleck rafael
spk_5: as you can see the date are highly consistent across the various studies both and safety and efficacy worth noting is that the car pal and all car that study were conducted prior to the pandemic while both parts of the felix study were conducted conducted during the pandemic both the car cartel an old car nineteen study were conduct
spk_3: it'd be were in the uk while the felix that he was largely conducted in the u s
spk_5: what we did pick up a said the patience of the felix study were more advanced in their disease based on to the to the burden and increased presence of so called ekstrom a dollar a disease
spk_3: this is in essence again a function of the leukemia allows it to leave the bone marrow and successfully saddle and grow in other organs patients with eczema dollar disease response poorly to any type of anti leukemia therapy moving to slide twelve to look further into the data we presented it as from the old car nineteen study when we didn't look into the outcome or long term observation from the old i teach of the a week winkler up to oversee with four years of follow up and you can see that we have a quite unusual clinical profile the clinical benefit in these patients is the ability to convert patients a to complete remission and sustain them over long periods of time which is obviously what we're seeing for good proportion of these patients when you look at the swim plot and moving from the bottom up where does the some patients that did not respond to therapy then we are some patients that responded a relapse quickly the yellow sparkles a patient that we last with so called city ninety negative disease
spk_6: in essence the kenya became invisible to the therapy or losing the very structure the therapy was designed to recognize if then go a little further are you see three red circles though the patients that relapsed because the car keys bells the oversell product candidate didn't persists long enough and patients we last with city ninety
spk_3: positive disease above those is you spent your you then see a group of patients that are long term remission between two and four years without any additional therapy seven out of the twenty patients a thirty five percent are in continued relation without receiving any additional actually kenya therapy with median fall off with thirty six months with the range of twenty four to forty seven months every single one of these patients has persisting carty cells
spk_5: you see one additional patients the long term remission who received a stem cell transplant while and complete remission
spk_2: moving to slide thirteen please cite though a decent engaging city ninety targeting monoclonal by specific antibody has become the standard of care and relapsed refractory it out to l l a with the last few years key to success has be in the well manageable safety profile key focus from patient management perspective
spk_3: is the monitoring of neurotoxic city or i can't which impacts sixty five percent of patients treated with been psycho in contrast ob sell had less than twenty five percent of patients experience i can't have any great highway theoretically side to is low with about five percent of ob southeast of his family lord and potentially slightly better in terms of hybrid crs in contrast fiddling titled the is a car key program a proof for this indication induces a high grade it's high grade cytokine relief and from twenty six percent of patients and hi great you're a toxicity and thirty five percent of patients while eighty seven percent experience know toxicity of anyway eight forty percent of patients with he lays oppressors managing such a safety profile often requires access to i see use finally in a to the map while active is primarily used as a bridging therapy willing to slide fourteen the market opportunity in a in blast with factory l l is in fact on changed with about three thousand patients in high need for therapy between the us europe and japan will they dislike fifteen plain sight out of the standard of care and relapsed refractory ll has reached sales and twenty twenty two or five hundred and eighty three million with a year over year growth of twenty four percent is product is commercialized by engine hardly the product which is about to say as and class adult patients with a ll an average on average receiving two cycles of blend psycho patients with low disease burden can receive up to four cycles of minsiter at a combined cough comparable to carty therapy he doubling fighters market penetration is it's well manageable safety profile which allows a non academic hospitals in addition to the academic centers leave it or cell with it's high level of clinical activity attract a safety profile and one time administration is well positioned to capture that opportunity when we look over all in terms of the price level for cocky therapies in a allowed they are in the range of for in the fifty thousand dollars in the u s moving to slide sixteen when we look at the steps forward first of all were planning to disclose to felix data from all patients doused in the mid twenty twenty three like that asko and also tha longtime follow up his plan fresh were targeting the bls admission for the program towards the end of the year and a a filing towards the end of the first quarter to when twenty four and the uk filing and the second quarter twenty twenty four that set us up very nicely for the key territories that we expect to the initially activity in addition to the mature clinical data the submission would also require data from the validation of our commercial manufacturing site this work has been a key focus throughout the first half of twenty twenty three i will continue into the third floor importantly our commercial manufacturing facility is set up to congress to apply for a spot approximately two thirds of the estimated market from the start as were moving to twenty twenty three we need to prepare key areas for commercialization first creating awareness for the program through focused medical affects program second established a value proposition for payers and our hd a doses and finally third prepare for and starts and to onboard and a profit that will take between nine and fifteen months to guess each center ready to the labour party therapy will they to slide eighteen to talk about the broader opportunity we see with all be sell
spk_7: as part of the all car nineteen extensive study we have been evaluating ob cell and relapsed refractory non hodgkin's lymphoma and chronic lymphoblastic leukemia patients with he consistently very high response rates combined with a very attractive safety profile suitable for patient use the data will form the basis for the selection of a second indication
spk_3: after a ll in terms of the life cycle we started to work on the next version of ob cell which we call ottawa and twenty two were looking to minimize with this product city nineteen average and last will and relapses with it's dual targeting approach building an obese tell we're adding a highly potent city twenty two car that can recognize very low amounts of city twenty two you on the surface of leukemia cells this program was initially evaluated in children have failed off or another legible for kumbaya therapy and it's very challenging patient population we saw and eighty three percent molecular response rate and none of the children relapse with the know low cd ninety negative disease comparing this activity to oversell we would have expected a molecular spr rate of approximately forty maybe fifty percent we're working on further streamlining the manufacturing process for ottawa twenty two knowing that we have an attractive life cycle option timing of investment decisions in ottawa twenty two will be balanced with additional indication investments for oversell flight nineteen switching gears move and moving on switching gears just like twenty as well as twenty one our technology platform allows us to engineer range of properties into he fails to dry specificity of recognition resilience against make it is the most used by to misspelled jailbait to sell attack and pro biting survival signals for t cells are strength and sell engineering drive are pipeline and is also the heart of the free collaboration reported on and twenty twenty two and early twenty twenty three with whatever unhappy m s and calendar on slight twenty two we have a quick summary of the earlier stage programs and selling former without a for five or six and g in neuroblastoma an auto eight in multiple myeloma both out of for and or eight or and phase one clinical studies and autistic then she is expected to start face long in the next quarter moving to slide twenty three sister lymphoma a very to her as has a very high medical need quite similar to be at be a ll in fact when you look at the nccn guidelines that is basic were basically says that once you're through the front my therapy and fail
spk_5: you have to go on a clinical trial
spk_3: moving to slide twenty four when it's unique targeting approach out of for starts to show meaningful clinical impact at the height of his levels that we have evaluated the first metabolic see ours are reaching one year post treatment and we continue to follow those patients in addition we streamlined the manufacturing process are exploring the activity and then it additional cohort and were planning to report and that outcome later in twenty twenty three moving to slide twenty six to talk about manufacturing well manufacturing is at the core of any public a cell therapy developing a highly reliable robust and economical process is critical for the success of any program in addition we have to be able to deliver product at scale and matching the capacity to the size of the medical need in if indication and it is important to be able to do that to have a successful lived off your therapy building on the robust and rack process used to manufacture the feeling for the felix clinical study were standing up our commercial tell manufacturing facility called a new placed about a mile away from the clinical trial manufacturing side we have you this for the study this proximity as important as will be able to move our entire staff to the new facility and in fact many of them are already in the process of validating the new place facility the capacity of the new and it's initial set up his two thousand patients upper about as per year or about two thirds of the at all day allow market size in terms of capacity the new players has been a fantastic project to realize with an innovative design and about thirty five percent of site building to accelerate the bills while maximizing the quality
spk_2: the belt so with that i would like to turn to slide twenty eight and passed a cold over to spend up for our fiscal year twenty twenty two financial update the seats like christian good morning i'll get off an interview on it my pleasure to review our financial results for the fiscal year to december thirty first twenty twenty eight cash and cash equivalents and restricted cash at december thirty first twenty twenty two total of three hundred ninety two point eight million dollars as compared to three hundred and ten point seven million dollars at december thirty first twenty twenty one net total operating expenses for the twelve months ended december fetch five and thanks to our hundred and sixty eight million dollars net had grown income and license revenue or six point four million dollars of compared to tend to look like each country's of a hundred and sixty five million dollars that have gone income and license revenue at two point three million dollars in st pete read in twenty twenty one research and develop expenses increased by seven point two million dollars to one hundred and forty two million dollars to the have ended december such veterans thanks t from hundred and thirty four point eight million dollars a year ended december thirty first twenty twenty one it's is primarily due to the find an increase of eleven point
spk_8: six million dollars in clinical cough or manufacturing costs primarily relating to excel clinical for a candidate
spk_2: an increase of point four million dollars in legal fees and special consulting fees and relations fell idea an evening with no flint that's an increase of no point two million dollars related information technology infrastructure and support ventilation systems related to combat the clinical trials and that actually operations an increase of point two million dollars in salary just stick cause a decrease of three point seven million dollars infinity costs related to determination and closure about you less than such infinity and ten cents one and shit and are a little met such a strategy i think we have point nine million dollars depreciation and amortization related to poverty and equipment an intangible assets and funny a decrease of point six million dollars in salary than other employment cause including shipping compensation expenses which is my meet you too or exchange rate used upon consolidation that he have ended december fetch fetch and country to compare to the him as much as touch twenty one and this is offset by an increase employees intention or the activities general an administrative expenses remained consistent at thirty one point nine million dollars to be you ended december thirty first and tends to and twenty twenty one at respectively primarily due to find an increase of one point four million dollars in salary than other employment costs including chef a compensation expensive manger combining i from the average number of employees engaged and eight activities an increase of point three million dollars primary latency information technology cause an increase of point one billion dollars in legal fees and national consulting fees and the nation's hutcheon i can see which was of that against lower the in l insurance tight an officer insurance a decrease of one million dollars of commercial preparation costs you to be timing and i left it it he a decrease of point four million dollars and cities costs related to determination assess lease agreements in the year and decrease point four million dollars and depreciation and amortization related said for feet and quitman an intangible assets interesting come increase to one point seven million dollars to the year ended december thirty first twenty twenty two compared to the point three million dollars that he invented some the such as twenty twenty one the yankees the increase in interest income of one point four million dollars for lemony like an in interest rates on out interest bearing and count and so senate estimates during the year ended december thirty first time since two compared to twenty twenty one interest expense increase to eight point nine million dollars for the year ended december thirty first such twenty twos compact the interest expense of one point one million dollars for the year ended december thirty first twenty twenty one interest expense is primarily later to the liability the future world feet and self melt month sentence which event is upon the it produces about tv color calibration and financing agreement with last i'm in november twenty twenty one the increase in interest expense for the event rented december that fetish and to it's primarily driven by the full year of the liability related to the black than collaboration and twenty twenty two the better part of the a liability a tweet and twenty twenty one other income or expense increase to an income of two million dollars for the you ended december thirty first and twenty teeth and accent one million dollars that the you ended december thirty first twenty twenty one during the the you ended december fetch between such t we recognize that a foreign exchange gain of one point seven million dollars a sub leasing come a point two million dollars another income that point one million dollars is to sense of point one million dollars of i the mentioned for the event itself and pitch advertisements and one which included a foreign exchange loss of people three million dollars offset by again or least ten the two million dollars and up and on the and point one million dollars income tax benefit increased to twenty four point four million dollars to the year ended december thirty first twenty twenty two from twenty three point nine million dollars for this preceding year ended december thirty first which which one you to an increase in qualifying research and development fund dishes for the period net loss attributable to ordinary shareholders was one hundred and forty eight point eight million dollars for the twelve months ended december thirty first twenty twenty two and this compares to on jun forty three point one million dollars for the same period in twenty twenty one
spk_3: the basic and diluted net loss for ordinary shares of the twelve months and that december thirty first twitch twenty two totaled one point five seven dollars compared to a basic undiluted net loss for that we share of a point nine seven dollars to twelve months ended december such for twenty twenty one one it also has estimates that it's current cash and cash equipment on hands and by to put finance and payments from blackstone will extend the company from way into twenty twenty five and now back to christian to give you a brief outlet on expected him than pressure thankfully free movie just like thirty finally we think we have an exciting year ahead of us to focus is on getting oversell into the regulatory process with feel a filing targeted towards the end of the year followed by filings in europe in the first half of next year next up or the plan felix data presentations meteor when twenty three in addition were preparing for commercial products supply launch readiness finally we also expect to provide updates in the pipeline for this will date on full after the ear and with our key programs apartment at this stage with opportunity for setting up collaboration with a good flight thirty one the with that we believe were at an interest very interesting point where the company with got the cash to live a very significant value step we got the data to show that with ob sell be have a differentiated public profile that addresses the high medical leave with limited competition or with possibly a transformational outcome
spk_9: alongside that we have additional opportunity throw be selling broader education and a valuable pipeline of other ecology programs as i mentioned were excited about our manufacturing facilities and what facility and we have a strong technology foundation validated by our collaborators the a mass murderer and a couple letter a will have to do more ideals of that name
spk_1: mature in the future with that thank you very much and we're happy to take questions
spk_10: and yes
spk_1: the asked question unique a pastor of one one on your telephone to try a question for his first time one one again please wait for your name of the amounts please stand by will we compile the cuny roster
spk_11: my mom and her first question
spk_5: our first question comes on the line of killed blown with need him a company carolina smell of and
spk_12: good morning and good afternoon and thanks are taking our questions
spk_3: the first one on the data that was published from the felix study so their gear to be a slightly higher incidence of great three and i catch them at an earlier studies are given that are less as as the have oversell administered in the community setting i'm a thank god businesses will adjust q levels of high grade nice
spk_13: i'm gail first of all decks love for joining a really good questions i think it's important when way to put the data on perspective what we did show is that we have less than three percent hike rates us and we have less than a percent icons this is a level of great three of ends in both for both time
spk_14: of adverse events that is at or below the level of for title which is currently used a non academic centers and so we believe that after the pope has very well suited and matches the experience actually already established with the standard of care and those centers who believe the data is very well suited and that a supportive of now product
spk_11: most of the product
spk_3: at the very helpful and another question about the fire line of thought what data do you expect to include any of the alive i mean now you're going to have additional data up by the filing data including not all are in the red duration of response but will you also be including data from your mrt positive covert
spk_5: so that really good question so first of all in terms of of arab have demonstrated clinical benefit in the morphological corps which are patients that have more than five percent disease burden nap time of of inclusion into the study an ad the the the focus is to demonstrate that he can actually convert these patient safety complete remission that a sustained overtime so when you will have to look at a cr as with a limited a minimal level of follow up at actually staff in fact an appropriate level of clinical benefit for time dependent
spk_3: outcomes are absolutely at a critical parameter that will have to go into the allay and will be at the core of the assessment
spk_5: the of clinical benefit for the product second of course that the safety profile with then a key part of the assessment for a stand actually the benefit risk ratio that he have with the product which is also very p parameter to understand
spk_3: the suitability of a product or in any given indication an in with regards to the the focus when you think about the review it is really we'll be focused initially on the and a patients that have morphological disease while the spirit have also been assessed mineral residual
spk_5: disease and these patients the level of a marquee signals that we have the patience with cetera about the inclusion criteria are patients with morphological at his ease the work that we do a to expand the knowledge of the properties of the product across the entirety of disease burden which includes as
spk_11: he pointed idols with patients with minimal residual disease is a dataset that say is being generated but it is also a dataset that he's not going to be part of the initial filing ad in terms of a will go to safety but if it is not an aspect of the efficacy of evaluation for the initial
spk_3: a filing a planning given a clarification and the last one from us if they mention that that from years scientists a collaborator there may be some date on multiple myeloma what do you think the gating factor would be first further development of that program give any how crowded the market as and you
spk_5: yeah very good question so what you're referring to is the all a program that we're working on with our and colleagues on the academic side were currently running a phase one clinical trial and to evaluate the activity of automate and last refractory multi my a patients and i think we're we're in at an interesting spot where the guy
spk_3: arts to the party therapies a mother my loma we have obviously very ah nice level of activity whether to approve product into space that there is also a very high unmet need enter and at this point still a remarkable inability to meet the demands in this indication and as likely gonna continue for quite some time so we regards to what we're looking to see that the program well as you want to see a very high level off
spk_5: complete remission for these patients that combined with deep
spk_10: the a molecular remissions and at the same time up to we're looking at the yeah safety profile and the clearly want to see in a very significant level of clinical activity and these patients at to as a base it is to consider taking the program forward and if if were at that point
spk_1: yeah clearly would anticipate that the have is would make sense to do in a partnership
spk_15: and thank you go and kill one mom and her next question or vexed question comes on the line as michael same with her can jelena something
spk_3: great thanks so much fucking and i'm on on multiple myeloma data they eat you anticipate having as you can you just give us some element of i just discovered that number patience an and what exactly we city i'm prepared to be looking at and then i also wanted to ask i'm on aug out
spk_5: i am thinking felt like some a competitive perspective i'm is a competitive go to market strategy ah you know versus plaza you know or to trying to help us understand what how you plan to position of without
spk_3: yeah and i'm i'm ira tax law for the to question so the first question was related to the ottaway study the right that he is that a the as a small phase one a clinical studies studies we're looking at around ten patients
spk_5: after that initial experienced and then we'll take it from there so it's gonna be initial initial look at that then at the profile of a product in that their initial set of patients now with the gods job he fell out what we're expecting to go for is obviously an additional the product in the relapse refractory setting our whether patients have had already received an airplane idol or or post plates idol
spk_16: and i think that a sort of honestly what the current study actually his ex is evaluating it's patients that have are very advanced disease and with a portion have a half up inside the in a to a map or under portion because it's so you looking to position are the product those
spk_1: in parallel or after in psychotherapy ousted the to card is i was this position in that exact same way i would be the same type of positioning and i would expect for the program
spk_13: thank you
spk_17: hex moran thank you my mom and her next question
spk_5: and next question comes from the line of matthew fifth with william blair your lifestyle open burgers basically like was in either
spk_18: the recent european court t meeting
spk_3: code to do it presented the amount or follow to give a three with the curtis and there are so very few patients million remaining imperium be on two years and that pretty a contrast to the daily planet as from a follow up at call eighteen just thirty five forty percent of basis guilty or three years
spk_7: the do you expect the feel better recapitulate the all carnation durability given you talk about a little bit puppetry fish populations with extra bachelor degrees in such and i guess just have you gotta get that durability message across to position
spk_5: in your can educate brother a really good person thanks for joining maps and it it is really what are you pointing to his way really kennedy the i think what we believe was really remarkable data from our initial evaluation of every cell in the patient group and of the as you pointed out what we did see a a a stabilization of that our long term durability curse etc
spk_19: the with you know patient saying in sustained venetian sam a bad as a punk as if i did i five thirty five percent of patients the in that category so that is a remarkable outcome is clearly something that you know it as not be possible when in i developed with my own england i don't have not been shown clearly not be chance the card is either
spk_5: so what we're looking at what we expecting to see where it with them sell to the feeling studies that we also see a similar shape of the curve where exactly that you know stabilization will ultimately occur i think that's too early to tell we don't have enough follow up in the study at this point in time the but that is what we're looking for an for we expect to see on a whether it's gonna be the exact same level or slightly different level we do not know at this point in time and as he pointed out of as you want to think that we do have an ad in terms of inclusion into the study's authors the patients that certainly and that you know initial dataset that we present day
spk_2: that had a pretty significant
spk_5: levels of that disease burden as well an extra dollar disease which frankly was not too much a surprise given that that first fifty patient dataset really was truly pete pandemic
spk_20: the and job you know will be awesome see the full dataset looks like butter and in a world was really expecting to see the same shape of the curve am and to define it on we can't exactly say where that actually gonna come out that requires long term follow
spk_3: the fact that we saw the ad for systems day that track what we had seen before i think is very encouraging because our say that was a clear correlation that we didn't see that all the stations that had long term outcomes all sat long term persisting hearty self and the shade only look at persistence coming out from the trial as we had indicated
spk_5: from the interim analysis was tracking the old car persistence car go to that is encouraging i think it's of the lead indicator but honestly requires long follow up to sort of be clear about where with actually like the landing
spk_21: okay
spk_10: piles of what what point do request appeal eight and a pre below a meeting this year that them you do after caliber scale update
spk_1: i'm go bigger question so i think what you want to do that the time you go through prevail a meeting is you want the actually have you know the they have the data with sufficient level a follow up as so you have a very clear
spk_2: positioning around the the outcome that he can actually present disgust at the agency and all see the data were gonna go with to ask i think we'll start to give us i think a good level of observation so we would expect that that would say this is going to be an interaction post asko okay great exhibition get that love and and keep one mama for next question
spk_22: and next question comes from killing she with jeffries go on is now open
spk_3: i can go from a program on the phone to fucking my question regarding the baseline pop home from college town
spk_5: does it appear to kinda late one vehicle hang up shop paulson slate gray trade and a former for from mild blast on on sale will be able to provide of my information much ah yes our patiently for the actual mature ladies
spk_3: i think and product top encore
spk_5: on on come on father is okay to thank for joining cali i nice and beyond the call first of all in terms of the that the patient population over all of the the patient population is it's close and very close to but repeating seeing the phase one portion of the study
spk_3: in a and what we expect to what we also expect to see his obviously some variability efforts for the going to defeat and any in the study as well and that were close and you know what we may actually have seen him demon a bit of a worsening after that them you know if you look at the are are an odyssey small numbers but it
spk_2: went from seventy five to seventy percent which could be indicative of a slightly worse population
spk_3: so so that it sort of i think where we are will also got a present that in detail and the underlying patient attract race a stickler tetra at the actual data presentation
spk_5: it's gonna be else and important piece of information i think will help to put the data into into the preferred level of respected as well out to the the the the answer to the first the first question but was the second question happen can the how far tell my second cry from given a different shade of the profile i personally out fifty farm for of on one are you can say like scoring opportunity new out of new indications pattern lopez can i not on foreign power for come from people or how be unbearable
spk_3: thank the back to the question about what your body pointing to a the a really remarkable dataset that was developed by address muffins and and his team at the university of airline
spk_5: the who's done a fantastic job evaluating the utility of a to died in car key approach in patients with refractory systemic lupus that the outcome of the date of us was quite remarkable an age medicine paper at the end of life published at the end of last year we know the team actually had also worked with team at the early stages inside development or way back almost twenty years back i'm really good dataset we believe obviously that you don't oversell has a remarkable profile in i was a lot of data rand
spk_23: at the safety of the program and clearly has a of an absolute ecstatic safety profile which is important when you think about using an autoimmune disease
spk_1: the and the other aspect of course is this that they're as we all learned in this space with is fundamental tricky part in this said with a colleague as carty therapy this yes the at the actually have to have an ability to manufacture at scale and do that at quality and economically and also that's one of the key
spk_14: things we have been developing for of the sell an hour for it's initial application and ll so i'm absolutely were following that feel very closely we think it that you know it is a very attractive
spk_12: potential future use that offer programs that are very safe and very active or will either be salvaged at very well here you thank you and next question comes from the line of james chen with wells fargo yaalon a up
spk_14: good morning and afternoon died on the couple from a moron
spk_5: i just wanna dig a little deeper into the positioning of other fell so do you envision other circuit be positioned i had a blunt bite at some point and is it features that exploring that and then i later imagine i'm meet other give a whole had started the and good had late the earlier but the come on cause if he just them rebels way hurdles namely the fat in the ineffective accreditation and makes father the entry the catering love it
spk_24: difficult or a it any thought their notice it
spk_3: yeah well we're first well thanks for joining games and i thank god in our a very interesting question
spk_5: the first of all in terms of sequencing you know at this point in time other place at least i go to prove both in the latter factory them as well as okay in patients and have been over with will disease and that are basically in see or or later senescence it's pace patients that have gone through felt like rp at wave still remaining residual disease other technically complete remission but they still have measurable the team the house at low levels hints and mark i'm in over they will disease
spk_3: and so the fifth product is of his of he has labeled him those two settings and of the has been evaluated now as part of the from my therapy to that sensibly typo has it and will have a place in this i'm in his early of part of the of the treatment scheme and we expected to sit a move up into that ehrlich setting now
spk_5: wifi from the i add to cart his approval is that the car was approved for overlaps with factory patients and without actually i'm a defining get a is a second or third liner fourth line actually it's any relapsed refractory setting and so we would expect that that if a disabled half at the same type of scope initially and was the with the board we do on minimal residual disease in evaluating the activity of the program there i think should allow us to eventually position the program as similar to the way
spk_3: that that lets items position but all of it takes time to sort of actually move up in terms of the lines of therapy
spk_5: and so i think that's the first part of the question the second part of the question was more around i do you actually position carty therapy a outside of the academic centers considering that you need the level of training or apathy asian of those interested in able to actually deliver the father i think what we need to understand is that to take play with the will only sell and videogames they have a very very similar obama and to actually fight them in half in patients with low disease burden outplayed we do have an even better profile that we've shown in these and stage hi to the britain patients that we also quoted ah in our that hm analysis so when you look at that of that population that has low particular disease burden but even the one that we have treated now
spk_6: the adverse event profile of the have any stations is exactly what the physicians today to manage the flip side of the same level of an affair
spk_5: at at highway to in fact it's a little less than while they try to have and it's it's actually less liver toxicity and when you see the plain sight of was very important that called that exceeds that of the when you look at the height of at the overall level of north of the city in about two thirds of the patients have i have any have some level of her toxicity with plants idol on which requires a to monitor the patience to observe them it's a trap make sure that you step off of it and what we have with every cell in a more advanced patient population to those to be please side of failures in in the physics of it
spk_25: and we actually had a little more than twenty percent of patients that have some form of know toxicity her actually substantially less for the actual money for and level a less than thirty that we have a witness the belief is an opportunity at actually managed is and with the spirit of inside the should be able to matches and in na
spk_26: academic hospitals and and and associated are potentially i patients that example i without that it to the way not a snag terms of he believes deliver karkhi therapy a solidly a level off
spk_10: not only and patient management that require without a coward very well with the xp or someplace sight of but it is also an state requires a tax with handle the spells and managed to cells as part of the therapeutic potent out of high level of training that ousted needs to be put in place
spk_27: an hour believe that that is a possibility for a non academic hospitals and and then we have to see how are they have further out if you might actually be able to go that i think this is you a very it penetration and ability to reach said at the a of our population with his profile as we see a basically demonstrated through this i already
spk_28: thank you
spk_29: thank you
spk_28: one moment
spk_11: and and next question comes on the line of
spk_30: ah sebastian cent skins with ah man that's tougher
spk_5: yeah and seven
spk_19: hi good morning and good afternoon along a person best infamous hot summer columns hopkinton of the i am
spk_31: no worries are congrats on upright alice's wondering
spk_5: the often opportunity of i'll be selling other indications bianca aol northern be an additional updates on the all cost money for the and other indications with conditional patients and are there any of these in the case and you believe would allow on actually and and poop a pathway as additional data can show the same level of efficacy of is called at as last year and then you also spoke a little bit about the last cycle management out a one and twenty two thing you expand when you're thinking on the bus he continued development of out own been plenty to be unfair to be pdf pick in the goes into on top and madonna to get in the dish
spk_3: his thinking
spk_5: thanks banks mass index adjoining i'm phil look at the an opportunity that we see what are we sell out of the was a product is it our have the remarkable profile takes to
spk_2: i think labour moved the beat up apartment
spk_5: so dumb
spk_2: malignant cells as well as healthy cells mom amp do that with a very good safety profile left a profit in the product where that a suitable honestly is in in in leukemia it is a non hodgkin's lymphoma which is or evaluating as be allowed the robot away in as or the old or ninety study and then after
spk_5: he was pointing out there is also certain applications in gets fed i were that might become an interesting and complete ada would indicate that you might even be transformational eco settings so that this is such a range i think you have in terms of opportunity ever been lot of the allergy to i've been all along that starts to build up and also often i do that the range and have the question of choice and what we're seeing our i'm on in iraq or ninety seven years later that we have a very high level of clinical activity o'clock a tyrant an i have these education and that it off the lot after that it into the or of popular car he terms of eat the english along and educations and of the you know you have opportunities looking at them and the of detail as an example where we see in a very high level complete remission and or say we haven't seen any the nazis today he not court which is quite remarkable and they're not all of the images and data in mammals and i'll ever sea level that see know the opportunity a although they became the opportunities to develop a segments of the education
spk_3: which allows it to move a relatively quickly and with the accelerated math
spk_5: i'm an independent on the education look at he also made and month to as he said go for a last night they will want to actually start looking at an earlier line and as study and as well which intermingling of the randomised controlled study of of a line and what want to move on that a recently and have been a reasonable to the time
spk_32: appalachian to dinner last night setting without sort of the opportunity and we're looking at these and else who did the data from yellow card a or elkhart i studied does give us i think of a nice basis to sit you know and at developed the my options for the for the investment you then also asked about bad at how in that town
spk_5: that conversation how old are one the to pay for that way be a we'll do our don't want that do that have a very athletic program he appears to do exactly what we want the terms of avoiding at the occurrence of target negative relapses which is the key thing that of the if the looking each address and where we know that is typically for a lot in a few to kenya and if the initially reports that read certain proportion of patient that do actually ah shows the not negatively lapses in the case
spk_33: in in the topics of his life is a little up the haven't been many reports more recently in our own hands and without the self we haven't seen as he did anything negative relapses nordic mood our particular program so are are afraid so
spk_34: of whether or not that is a major issue to actually addressing those applications i think is actually at this point the time
spk_26: and i think that it's a lot of the hit on her questions that they will look into terms of the ability to rob the in a utility aware of it will partly approach into this one says wait very clear the senate the a little early certainly advice from that rematch for children's on this without action and will delete you of point make sense to
spk_1: consider
spk_35: in that program to move into the succession of a piss out an idiot you that he said as well
spk_2: soon after that they extended range as well to see the labour thing that i now commonly it's at eight and these are set of investment decisions and it's this question sequencing those investments and and that i think you're probably will first be on on actually brought into the opportunity for the south and then in a second stage
spk_3: actually that moving forward with a lot for he too intense about the actual i cycled yourself
spk_35: great thank you very much
spk_36: thank you ask him
spk_5: thank you
spk_19: one moment
spk_25: and
spk_5: one moment our last question comes from africa are gonna wiring lives to a show and itself hi this is great for us because i'm just answer questions and pricing our filing to buy your own hi that's been your of or bissau and chaos and discussion primary to was you compare from the us and europe i'm an ulcer is there any potential for your pricing power change with each other at ascot thank you i didn't go green i didn't get the last quoted a question as the pricing power with the next update as asko oh see okay thank you a personal back to join you read up on interesting questions related to pricing
spk_3: i think what we've been seeing involved than status
spk_5: ooh dimension first of all and we're having a aol typically allison with a typo and the use of the title in a patients below the before we also do see
spk_2: i use of up to four cycles in those patients which ceo it's basically the i getting the price for that product into the range of the between four or five hundred thousand
spk_3: dollars for patients that said after the one benchmark which is standard of care and aware what bracket that is when you don't look on the on the proof cocky therapy and air in a in iowa hope that is in the range of for and fifty thousand two hundred course expected to be during the course of this year said to the that the second
spk_5: ah i think get a bracket ever seeing of us and and we would expect that would be pricing in a similar age or three would believe that we you have a product that actually allows you to be more efficient grenade from a cost perspective because before actually reduce let's of the city with wireless patient management a week that i think there should be a good health economic argument and i are supporting the use of ah be sell in addition to other states clinical prefer
spk_19: the weather yards to a few up where have you seen across the board with party therapy at the prices are certified as good as starting at the range of where the us prices are with some level of discount depending on the jurisdictions you looking at the education at that their their products aren't liberty
spk_1: the that is is more valuable and we'll see how that those who develops over the of the outcome period of time and effort will have a bill keep outdated have that feel they've also return but i think this is where the spans and a card expectations is that we would consider to be as somewhere in line with what we've been seeing in space
spk_3: in terms of data flow i think we're gonna have a very interesting data flows we go to this year see at at ascot the and of his data from and older patients that widows but also and i'm still a limited follow up on soda patients that think the focus on lot of it is richard other patients to basic activity and at the at the behavior the product and every every aspect and then i think as we go to the and ash and then i even in of later in twenty four wrapping costly much more locker careful up which well i think we'll laugh laugh they added important ramadan and a to the nhk assessments and that baby assessments that will be and conduct
spk_5: by the pass to ask i think where we are with the have it to
spk_3: i suggest that i'm keeping the longer term follow up in and apply striking higher
spk_1: i've had my first of all bloody a bloody the impact of the longer term follow up and showing an impact on longer term follow up i think is of as a strengthening your value argument of for the product that i think it will it will clearly make a very strong case for using the product and bay
spk_0: based on on more patients achieving long term add comment i think that is certainly going to be a key parameter that will drive bad at the body assessment
spk_1: ah by anyone who would look at the programs faster will definitely influenced the overall assessment
spk_37: to what extent that would influence pricing i think it's premature to discuss
spk_2: often on camp and thank you for enough thank you at this time elected can call back there was a christian eaten for closing remarks well first of all thank everybody for joining us he was a great to be able to update you on a very exciting a fourth quarter there were running through rainer i think at a very important stretch as we go to the course of this year i get the product ready for filings and i think guy out there a real opportunity for substantive data update as we go to the course of the year with the next month also expected for the meteor section so really looking forward to that i am in a meeting you have a fully person and update you on the program at that act along those venues and and there are rushing it successful at first half of the year and and a thing for all of us are i think get a more relaxed second half of the year a and you know with some hope that somebody the big picture items hopefully we'll start to turn it into a more favorable into and environment so with that the like to thank you all and their i wish you the day ladies and gentlemen thank you see your station and didn't have time on occasion we were conscious of the time and we were able to reach out to having line so management love connect with everyone that are unable to connect to the car after the ah thank you very much please ensure you die you may now disconnect the conference will begin chill t to raise and lower your hand during culinary you can dying star one one ladies and gentlemen and welcome to the awful was therapeutics four year twenty twenty two financial results cause of call and fourth quarter operational progress as a reminder this conference has been recorded i would now like to send a conflict over to your house to your wilson can
spk_3: medications consultant please go ahead thank you know the good morning oh good okay everyone and thank you for joining us to take part in today's cool unfamiliar twenty twenty two not she result of racial highlights for the fourth quarter twins twins to i'm julia wilson the communications consultant thoughtless with me today adopt a christian i tell or chief executive officer adopted kinda crabtree or chief financial officer before we begin i would like to remind you that during today's cool we will make statements related to a business that are forward looking under federal security flaws and a safe harbor provisions of the private securities litigation the fool not to mention ninety five he may include but are not limited to statements regarding status of clinical trials and development fine lunch for for the candidates your expectations regarding cash family the statement the subject to a variety of risks and uncertainties that could actually was ill definitively from expectations and with that so do that only as of today with the no obligation to update any such forward looking statements for discussion of the material risks and uncertainties the could affect her up to self cheese of that the best for dental to tuesday factories and se si finding space available on the best a section of our website looks like three you will see the agenda for today which is a solid christian will provide an overview of appropriation of highlights for the fourth quarter twenty two defendable than discuss the conflict player financial results with a christian the preclude that upcoming months though than any other confusing from it finally we will of course wealthy questions and keep christian thank you to the are a good morning to your thank you for joining us with my pleasure to review our progress for the fourth quarter twenty twenty two moving to slide for for really pleased with our program operational progress through the fourth quarter of twenty twenty two which is highlighted over the next to slides firstly we're delighted to announce in december that the pivotal face to felix clinical study evaluating ob sell it relapsed refractory at all bailout patients met it's
spk_4: primary endpoint based on overall response rate in a pre planned interim analyses fifty patients with morphological disease and as verified by an independent data monitoring committee
spk_3: where another step closer to bring this potentially innovative treatment to an underserved a population and i'll delve into the data in more detail later in this presentation this positive data triggered a thirty five million dollar milestone from our partner blackstone life sciences earlier than anticipated and were planning to rewrite and up a date update on all patients treated by make this year
spk_5: most likely at asko wait longer follow up plan at the end of twenty twenty three as well as plan feel a submission to the us fifty a by the end of the year
spk_3: december it was a busy mom for us we all sat a number of clinical updates at the american society if he mythology annual conference including presenting longer term follow off data from our idols a little patience in the old car nineteen phase one study of ob sell showing thirty five percent of patients in ongoing remission at though eighty six month a follow up needed follow up with no additional amulet kenya therapy
spk_5: in addition obese sell continued to show high levels of clinical activity and relapsed refractory non hodgkin's lymphoma and chronic lymphoblastic leukemia patients paired with a well manageable safety profile
spk_3: there are also very encouraged with the data we presented from our pediatric a little program the carp how face month while of ottawa twenty two are dual targeting party therapy targeting cd nineteen and city twenty two with over eighty percent of patients achieving a molecular complete remission and with no average a negative relapses observed
spk_5: additionally we provided longer term follow up at the libra on belief on t one face on trial of auto for a peripheral teetotaller for well with some patients experiencing durable metabolic see ours including one patient up to the at one year mark i was treatment and i was the in continued remission
spk_3: will it be providing update on these programs over the course of this year and also be presenting data from the carousel study of obese out the peripheral cns lymphoma patience than the car thief a month trial of automated multiple myeloma patients and finally the face want while of autistics century in neuroblastoma patience is expected to start internet score thirty two slide five we've made some great operational progress through the quarter towards the end of the year we close the public offering raising aggregate crossbow feeds of a hundred and sixty four million and net proceeds doctor underwriting discount and offering expenses of one hundred and fifty two point four million including a partial exercise
spk_5: eyes of the great you by the underwriters we believe we are now well positioned financially to bring over style and innovative and potentially transformative treatment to an underserved at all day a little patient population and twenty twenty three will be fully focused on submitting of the a application at the end of the year and working towards commercial law
spk_3: i'm sure twenty twenty four as i mentioned earlier we also received a thirty five million dollar milestone from our partner blackstone life sciences as a result of the positive interim analyses of oversell in at all day ll at the same time we received an additional thirty five million dollar milestone from blackstone as a result of planned activities supporting the performance a qualification a hobby style of the over so many factory process
spk_5: you will recall that we signed the agreement with blackstone at the end of twenty twenty one a part equity and park program financing collaboration proudly candidate ob sell and we have now received two hundred and twenty million of the total two hundred fifty million committed capital
spk_3: we were very pleased to announce reveals to in october twenty twenty two and one posts period and in january twenty twenty three which underscores what we believe as an industry leading sell programming technology platform we have developed at odalis we find an agreement with bristol myers squibb granting them access to apropos hi terry rtr a my tux the map induced safety switch for incorporation into set of selected cell therapy probe apps in addition madonna exercised an option on one of the proprietary binders being developed against an undisclosed immuno college a target for the delivery of pioneering message or are in a therapeutics if license option stems from the deal with an axe with murder and an august twenty twenty one finally in january twenty twenty three we signed an agreement as have a letter bio which allows them to incorporate the rtr eight safety switch into a cell therapy program for the treatment of our immune disease the total license revenue was fixed point two million and twenty twenty two and each of these fields have the potential for additional revenue in near term option exercise for his milestone payments and royalties we continue to make steady progress in our manufacturing it seems the operations the first phase of the building our commercial manufacturing facility was completed with the handover of the first three clean up the first of three clean rooms at the end of last year we have named this facility the nucleus were not working on the qualification and validation up a new plus and will remain on track for the good manufacturing practice operations commencing in the second half of twenty twenty three rolls to undertake a the development work and reports and ration for the seems see package plan to support to be a laser mission to the sta finally total cash and cash equivalent and restrict the cash at the end of december or three hundred and eighty two point eight million dollars with that let's talk more about oh sell al slight number seven
spk_5: oh be still has a unique mechanism of action what's fundamentally different about our product candidate is that it has an ability to engage physiologically with the target sell
spk_3: rapidly binding to the target which deliver specificity paired with a fast are afraid for rapid disengagement from the target self wants to kill has been delivered this unique engagement twice maximal activity while minimising toxicity and is at the heart of the differentiated clinical profile we are observing eight acute lymphoblastic leukemia non hodgkin's lymphoma patients and chronic lymphoblastic leukemia patients moving on this flight number eight are clinical experience without the cell in a l l shows high let our all response rate across an old a story population at it chose a high level off a clinical activity across all indications of clinical experience but only sell in l a also the high i'll roll response rate across all patient populations and including a bear three high level of clinical activity over the longer term that we have now served in the old car and i teach study we had a median follow up a thirty six months now in this study and with a follow up of twenty four to forty seven months of observation we see that thirty five percent of the patients are in long term remission after we see having ob sell and receiving no further anti leukemia therapy the safety profile is bell manageable with low levels of high grade crs and i can the midsection up a slide shows the patients with long term remission think continued presence of carthy self over the entire observation period the program is develop on there are matt prime and i like designations living for slight nine we completed the involvement and dosing of a pivotal study study we call the feel like study in at all relapse refractory l l patients and as i mentioned we announced in december that we have had met the primary endpoint of overall response rate in an interim analysis and based on the first fifty patients followed for at least three months of fire follow up clinical benefit in a l l will be assessed based on patients remaining in sustained complete a mission we conducted the study and thirty four centers twenty four said this in the u s seventh that this in the uk three centers in spain during the peak of the pandemic it is important to realize that relapsed refractory adult bailout patients are highly news depressed and pandemic poses a significant added risk to them more over you to access restrictions and various other pandemic rules and regulations we cannot access our clinical trial sites for the most part of the felix study
spk_19: you can imagine and state l l patients are that it's difficult a patient population to work with particularly in an environment where there is a high risk of infection and indeed we did lose patience to covet in many ways this study was more of a real world study conducted under difficult circumstances
spk_3: in addition to patient safety every aspect of product the labor and logistics or pressure tested or this trial with massively reduced air traffic and impact of the pandemic of our manufacturing teams remarkably manufacturing for all patients from our facility the uk turned out to be an asset also for us deliberate as the long haul flights between the you as to the uk had priority over us and also you domestic flights next key data read is planned for asko in june this year movie for slight number ten it's like summarizes the announcement we made in december regarding the priests specified interim analyses of the first fifty out of ninety patients to host that had reached at least three mouth the follow up the primary endpoint is based on overall remission weight which includes patients and complete remission and patients and complete remission with incomplete velma recovery or cr and c r i e r r but seventy percent and and in fact all recent programs in a ll have used or are as the primary and point in their respective studies safety analysis was conducted on the larger ninety two patient data set and showed an excellent profile with high grade try to can release a experienced in less than three percent of patients and high grade i are newer toxicity in less than eight percent of patients i can't wear full the reversible and less than twenty five percent of patients who at any rate of your toxicity in contrast to prove t sell or fees alligator therapy he's a very unusual safety profile in this population as i mentioned earlier this week dataset triggered a thirty five million dollar milestone from blackstone moving to slide number eleven
spk_6: this like summarized our current experience with ob selleck rafale as you can see the date are highly consistent across the various studies both and safety and efficacy worth noting is that the car pile and all car in that case study were conducted prior to the pandemic while both parts of the felix study were conducted conducted
spk_3: during the pandemic both the car cartel an old car nineteen study were conducted if he were in the uk while the felix that he was largely conducted in the u s
spk_5: what we did pick up a said the patience of the felix study were more advanced in their disease based on to the to the burden and increased presence of so called ekstrom a dollar a disease this is in essence again a function of the leukemia allows it to leave the bone marrow and successfully settle and grow in other organs patients were
spk_3: eczema dollar disease response poorly to any type of anti leukemia therapy moving to slide twelve to look further into the data we presented it as from the old car nineteen study when we didn't look into the outcome or long term observation from the old car i teach that the a week winkler up to oversee with four years of follow up and you can see that we have a quite unusual clinical profile the clinical benefit in these patients is the ability to convert patients a to complete remission and sustain them overload i'm periods of time which is obviously what we're seeing for good proportion of these patients when you look at the swim plot and moving from the bottom up where does doses some patients that did not respond to therapy then we are some patients that responded a relapse quickly the yellow sparkles a patient that we last with so called city ninety negative disease in essence of the kenya became invisible to the therapy or losing the very structure the therapy was designed to recognize if you think a little further are you see three red circles though the patients that relapsed because the car keys spells the oversell product candidate didn't persists long enough and patients we last with city night in positive disease above those is you then your you then see a group of patients that are long term remission between two and four years without any additional therapy seven out of the twenty patients at thirty five percent are in continued relation without receiving any additional actually kenya therapy with median fall off with thirty six months the range of twenty four to forty seven months every single one of these patients has persisting carty cells you see one additional patients that long termination who received a stem cell transplant while and complete remission moving to slide thirteen please cite though a decent engaging city ninety targeting monoclonal by specific antibody has become the standard of care and relapsed refractory it out to l l a with the last few years key to success has be in the well manageable safety profile key focus from patient management perspective the monitoring of your toxicity or i can't which impacts sixty five percent of patients treated with been psycho in contrast ob sell had less than twenty five percent of patients experience i can't have any great highway theoretically side to is low with about five percent the derby spells speaks to be similar and potentially slightly better in terms of hybrid crs in contrast siblings hi dorothy carter's a car key program a proof for the syndication induces a high grade reduce it's high grade cytokine relief and from twenty six percent of patients and hi great a toxicity and thirty five percent of patients while eighty seven percent experience know toxicity of any great forty percent of patients with a lays oppressors managing such a safety profile often requires access to i see use finally in a to the map while active is primarily used as a bridging therapy lily to slide fourteen the market opportunity in a in blast for fact we ll is in fact on changed with about three thousand patients in high need for therapy between the us europe and japan will they dislike fifteen plain sight out of the standard of care and relapsed refractory ll as reached sales and twenty twenty two of five hundred and eighty three million with a year over year growth of twenty four percent is product is commercialized by engine currently the product which is about two thousand class at all patients with a ll an average on average receiving two cycles of psycho patients with low disease burden can receive up to four cycles of minsiter at a combined cough comparable to carty therapy he doubling fighters market penetration is it's well manageable safety profile which allows a non academic hospitals in addition to the academic centers will believe it or cell with it's high level of clinical activity attract safety profile and one time administration is well positioned to capture that opportunity
spk_7: he
spk_3: when we look over all in terms of the price level for cocky therapies in a allowed they are in the range of for and fifty thousand dollars in the u s
spk_5: moving to slide sixteen
spk_3: what we look at the steps forward first of all were planning to disclose to felix data from all patients doused in the mid twenty twenty three like let us go and also tha longtime follow up his plan fresh were targeting the bls a submission for the program towards the end of the year and a a filing towards the end of the first quarter twenty twenty four and the uk filing and the second quarter of twenty twenty four that set us up very nicely for the key territories that we expect to the initially active in in addition to the mature clinical data the submission would also require data from the validation of our commercial manufacturing site this work has been a key focus throughout the first half of twenty twenty three i will continue into the third floor importantly our commercial manufacturing facility is set up to congress to apply for a spot approximately two thirds of the estimated market from the start as we're moving to twenty twenty three we need to prepare freaky key areas for commercialization first creating awareness for the program through focused medical affects program second established a value proposition for payers and our age diego says and finally third prepare for and starts had to onboard and a profitable take between nine and fifteen months to guess each center ready to the labour party therapy
spk_38: movie to slide eighteen to talk about the broader opportunity we see with all the cell
spk_3: as part of the all car nineteen extension study we have been evaluating ob cell and relapsed refractory non hodgkin's lymphoma and chronic lymphoblastic leukemia patients with he consistently very high response rates combined with a very attractive safety profile suitable fry patient use the data will form the basis for the selection of a second indication after a ll in terms of the life cycle we started to work on the next version of every cell which we call ottawa on plenty to were looking to minimize with this product city nineteen average and last favor relapses with it's dual targeting approach building an obese tell we're adding a highly potent city twenty two car that can recognize very low amounts of city twenty two on the surface of leukemia cells this program was initially evaluated and children have failed camera or another legible for can my therapy and it's very challenging patient population we saw and eighty three percent molecular response way and none of the children relapse with the know low cd ninety negative disease comparing this activity to oversell we would have expected a molecular the ah rate of approximately forty maybe fifty percent were working on further streamlining the manufacturing process for ottawa twenty two
spk_5: knowing that we have an attractive life cycle option
spk_3: timing of investment decisions in order one twenty two will be balanced with additional indication investments for okay so slight nineteen switching gears move a moving on switching gears just like twenty as well as twenty one our technology platform allows us to engineer range of properties into fails to dry specificity of recognition resilience against negative thing most used by to misspelled jailbait you sell attack and providing survival signals for t cells are strength and kiesel engineering dries are pipeline and is also the heart of the free collaboration with ported on and twenty twenty two and early twenty twenty three with whatever and the m s and cover letter on slight twenty two we have a quick summary of the earlier stage programs and t selling former without a for five or six and g in neuroblastoma an auto eight in multiple myeloma both thought of for and auto eight or and phase one clinical studies and autistics angie is expected to start face bombing in the next four
spk_39: moving to slide twenty three
spk_3: sister lymphoma a very to her as has a very high medical need quite similar to be a b a l l in fact when you look at the nccn guidelines that is basic were basically says that once you through the from fly therapy and fail
spk_2: you have to go on a clinical trial moving to slide twenty four when it's unique targeting approach out of for starts to show meaningful clinical impact at the height of his levels that we have evaluated the first metabolic see ours are reaching one year post treatment and we continue to follow those patients in addition where streamlined the manufacturing process are exploring the activity and then additional cohort and were planning to report on that outcome later in twenty twenty three moving to slide twenty six to talk about manufacturing child manufacturing is at the core of any public a cell therapy developing a highly reliable robust and economical process is critical for the success of any program in addition we have to be able to deliver product at scale and matching the capacity to the size of the medical need in indication and it is important to the able to do that to have a successful rollout of your therapy building on the robust belt reckless process used to manufacture the feeling for the felix clinical study were standing up our commercial tell manufacturing facility called a new placed about a mile away from the clinical trial manufacturing side matthew this for the study
spk_8: this proximity is important as will be able to move our entire staff to the new facility and in fact many of them are already in the process of validating the new place facility
spk_2: the capacity of the new place and it's initial set up is two thousand patients upper about as per year or about two thirds of the at all day allow market size in terms of capacity the new place has been a fantastic project to realize with an innovative design and about thirty five percent of side building to accelerate the bills while maximizing to college you have the belt so with that i would like to i dislike twenty eight and passed a cold over to stand up for our fiscal year twenty twenty two financial update the safe like christian good morning i'll get off an interview on it my pleasure to review our financial results for the fiscal year to december thirty first twenty twenty eight cash and cash equivalents and respected cash at december thirty first twenty twenty two titles three hundred ninety two point eight million dollars as compared to three hundred and ten point seven million dollars at december thirty first twenty twenty one net total operating expenses to the twelve months ended the sunset five times thanks to our hundred and sixty eight million dollars net had grown income and license revenue or six point four million dollars of compared to total of eighteen twenty seven hundred and sixty five million dollars that have gone income and license revenue at two point three million dollars from st it in twenty twenty one research and develop expenses increased by seven point two million dollars to one hundred and forty two million dollars to the have ended december such veterans constraints t from hundred and thirty four point eight million dollars a year ended december thirty first twenty twenty one it's is primarily due to the following an increase of eleven point million dollars in clinical cough and manufacturing costs for leveling like into itself and go on a candidate an increase of point four million dollars in legal fees and national consulting fees and relations fell idea an evening with no flint that's an increase of no point two million dollars related information technology infrastructure and support ventilation systems related the consent from that's a clinical trial and that actually operations an increase of point two million dollars in salary just stick cause a decrease of three point seven million dollars infinity costs related to determination and allow us pm twenty twenty one and shit and are a little manufacturing strategy a decrease of point nine billion dollars depreciation and amortization related to property and equipment and intangible assets and finally a decrease of point six million dollars in salary than other employment costs including shurtleff compensation expenses which is mainly due to low exchange rate used upon consolidation for the year ended december such for twenty twenty two compared to the and that that first twenty twenty one and it's is of that one increase employees engaged in or the activities general and administrative expenses remain consistent at thirty one point nine billion dollars to the you ended december thirty first and twenty two and twenty twenty one that respectively primarily due to the following an increase of one point four million dollars in salary them other unemployment costs including chef a compensation expensive mainly driven by an increasingly average number of employees engaged in june eight activities an increase of point three million dollars primary latency information technology costs and as increase of point one billion dollars in legal fees and professional consulting fees and relations hutcheon a currency which with of that against lower the a no insurance direction and officer insurance a decrease of one million dollars of commercial preparation cost you to the timing related up see a decrease of point four million dollars in cities costs related to determination says lease agreements in the far year and decrease of point four million dollars and depreciation and amortization related said proxy and equipment an intangible assets
spk_3: interesting come increase to one point seven million dollars to the year ended december thirty first twenty twenty two compared suit point three million dollars to the year ended december thirty first twenty twenty one the increase the increase in interest income of one point four million dollars promoting relate may increase of interest rates on out interest bearing and camp and short term investments during the year ended december thirty first when switch to compared to twenty twenty one interest expense increase to eight point nine million dollars for the year ended december such for twenty twenty twos compared the interest expense of one point one million dollars for the year ended december such for twenty twenty one interest expense is primarily later to the liabilities the future feet and self melt milestones which arose upon the it produces about she tv color calibration the and financing agreement with blackstone in november twenty twenty one the increase in interest expense for the year ended december that for us which went to is primarily driven by the full year of the liability relate to the black than collaboration and twenty twenty two about or partial near liability agreed and twenty twenty one other income or expense increase to an income of two million dollars for the you ended december thirty first twenty twenty two from accent one million dollars for the year ended december third verse twenty twenty one during a the the year ended december such but when such he would recognize the a foreign exchange gain of one point seven million dollars
spk_1: a sub leasing from a point two million dollars another income the point one billion dollars this compares to a sense of point one million dollars about of the mentioned the the rented that december thirty first such as one which included a foreign exchange lost the three point three million dollars offset by again on least combinations of two million dollars another and on the of point one million dollars income tax benefit increased to twenty four point four million dollars to the year ended december such first twenty twenty two from twenty three point nine million dollars for the preceding year ended december thirty first which which one you to an increase in qualifying research and development than dishes for the period
spk_10: net loss attributable to ordinary shareholders was one hundred and forty eight point eight million dollars for the twelve months ended december thirty first twenty twenty two and this compares to on jun forty two point one million dollars for the same period in twenty twenty one
spk_1: the basic and diluted net loss the ordinary share of the twelve months ended that december thirty first which twenty two totaled one point five seven dollars compared to a basic undiluted net loss but one that we share of a point nine seven dollars for the twelve months ended december much for twenty twenty one
spk_5: when he also is estimates that it's current cash and cash equivalents on hands and anticipated project finance and payments from blackstone will extend the company from way into twenty twenty five and now but to christian to give you a brief outlet on expect in boston pressure
spk_11: thankfully the movie just like thirty finally we think we have an exciting year ahead of us key focus is on getting ob fell into the regulatory process would feel a filing targeted towards the end of the year followed by filings in europe in the first half of next year next up or the plan felix data presentations meteor when twenty three
spk_3: in addition been preparing for commercial product supply launch readiness finally we also expect to provide updates on the pipeline for national data on full after the year and with our key programs or for and at this stage with opportunity for setting up collaboration with increased by thirty one the with that we believe we're at an interest very interesting point with the company we've got the cash to live a very significant value step we got the data to show that with oversell be have a differentiated products profile that addresses the high medical leave with limited competition or with possibly a transformational at outcome
spk_5: alongside that we have additional opportunities roby selling broader indications that nobody will pipeline of other oncology programs as i mentioned were excited about our manufacturing facilities and what facility and we have a strong technology foundation validated by our collaborators the a mass and a couple eta a will have to do more ideals of that nature
spk_12: you're in the future with that thank you very much and we're happy to take questions
spk_11: thank you
spk_3: the asked question the only to pass star one one on your telephone to try a question for his are one one again please wait for your name to be an hour christian bible we compile the a roster
spk_5: one moment her first question
spk_4: i first question comes from the line of guilt loan with need him a company carolina smell of and
spk_3: good morning and good afternoon and thanks are taking our questions that the first one on the data that was published from the felix study so that your to be a slightly higher incidence of great three feresten i kept them kind of earlier studies are given that are less as well as the have oversold minister in the community setting
spk_5: how do you think of businesses will adjust to levels of high grade ease
spk_3: i'm gail first of all decks well for joining a really good question so i think it's important when way to flip the date on perspective what we did show is that we have less than three percent hike rates us and we have less than a person i can this is a level of a great three of ends in both for both pie types of adverse events that is at or below the level of crippling cycle which is currently use a non academic centers and so we believe that after the probe has very well suited and matches to experience actually already established with the standard of care in those centers who believe the data is very well suited and that a supportive of that broader
spk_7: used the product
spk_11: that's very helpful
spk_3: and another question about the fire line of so what data do you expect to include and your be alive i mean know you're going to have additional data by the filing data including not all are in the red duration of response but will you off of including data from your energy positive covert so that really good question so first of all in terms of of arab in a have demonstrated clinical benefit in the morphological court which are patients that have more than five percent disease burden of time of of inclusion into the study
spk_5: the at the the the focus is to demonstrate that he can actually convert these patients the to complete remission that a sustained overtime so when you will have to look at a cr as with a limited a minimal level of follow up at actually staff leash in fact an appropriate level of clinical benefit the time to pad
spk_3: now cancer absolutely at a critical parameter that will have to go into the allay and will be at the core of the assessment
spk_7: the of clinical benefit for the product
spk_5: second of course that the safety profile was then a key part of the assessment for founder stand actually the benefit risk ratio that he have with the product which is also very key parameters to understand the suitability of a product in any given indication
spk_40: the it with regards to the the focus when you think about the review it is we'll we'll be focused initially on the of patients that have morphological disease well the it have also been assessed
spk_1: mineral residual disease and these patients the level of a marquee signals that we have and the patience of cetera about the inclusion criteria are patients with morphological at his ease the work that we do a to expand the knowledge of the properties of the product across the entirety of disease burden
spk_15: which includes as you pointed idols with patients with minimal residual disease is a dataset that also is being generated but it is also a dataset that is not going to be part of the initial filing in terms of it will go to safety but if it is not an aspect of the efficacy of admiration for the initial
spk_3: and filing or reply given the clarification and last one from us if they mention that that from years tight a collaborator there may be some date on multiple myeloma what if if the gating factor would be for further development of that program given a how crowded market as at your very good question so what you're referring to is the on of a program that we're working on with our and colleagues on the academic side were currently running a phase long clinical trial at to evaluate the activity of automate and blast refractory mother milo a patient and i think we're we're in at an interesting spot where the guy it's to the carty therapies a mother milo my we have octopussy very ah nice level of activity with the to approve product into space that there is also a very high unmet need and a and at this point still a remarkable inability to meet the demands into syndication
spk_5: and as likely gonna continue for quite some time and so we regards to what we're looking to see that the program well as you want to see a very high level and of actively permission for these patients that combined with beep
spk_3: at a molecular remissions
spk_5: and at the same time ups were looking at the app safety profile and be clearly want to see in a very significant level of clinical activity and these patients and that to as a base it is to consider taking the program forward and if if were at that point on yeah clearly would anticipate that the have is what makes sense to do in a partnership
spk_3: and thank you go
spk_16: thank you on mom and her next question
spk_1: this question concerning line as michael same with her glint jelena something i think how much and i'm ah and on multiple myeloma game of iraq has been having a few can you just give us some element of i just discover that number patience and what exactly was city
spk_5: i'm prepared to be looking at and then i also wanted to ask i'm on out oversell am thinking felt like from a competitive perspective i'm is a competitive go to market strategy ah you know versus plaza you know are trying to help us understand what how you plan to position of without yeah and i'm i'm ira tax law for the to question so the first question was related to the ottaway study the other ways that he is that a the as a small phase long as a clinical studies are looking at around ten patients after that initial experienced and then we'll take it from there so it's gonna be initial initial look at that then at the profile of the product in that their initial set of patients
spk_18: now with the gods job he fell out what we're expecting to go for is overstated positioning of the product in the relapse refractory setting
spk_3: out whether patients have had already received
spk_5: please idol or opposed post a idol and i think that is sort of august rework the current study actually his ex is evaluating it's patients that have are very advanced disease and with a portion have a half up and site though in a to the map or on the portions it so you're looking to position are the product those in parallel or after inside to therapy elizabeth the the card is i was this position in that exact same way so would be the same type of positioning and that would expect for the program
spk_11: thanks man thank you my mom and her next question
spk_5: and next question comes on the line of massachusetts sits between blair your lifestyle and i guess they stole my question or the recent european car key meeting and tied to a good at present did for long term follow to give it three with the curtis and it says very few patients the remaining and cia and the and two years since that pretty a contrast it today
spk_2: the last from a follow up with aka late teen shows up thirty five wipes at a base is dulcie or three years
spk_5: do you expect the feel bitter recapitulate the all correlation durability given you've talked about a little bit puppetry fish populations with extra bachelor to ease to such and i guess just how do you gotta get that durability message across to edition
spk_18: in your get educated brother
spk_3: a really good person thanks for joining maps and it it is made a body pointing to his really kind of the the i think what we believe was really remarkable
spk_5: data from our initial evaluation of of sell in the patient group and of it as you pointed out what we did see is a a stabilization about our long term
spk_21: durability curse etc
spk_10: it with you know patient saying in sustained remission sam about as upon as if i did i thirty to the fact that and of patients the in that category so that is a remarkable outcome is clearly something that you know it as not be possible when i developed with my old england i don't have not been shown clearly not be sheltered the card is either
spk_1: so what we're looking at what we expecting to see it with them ourselves sell the feeling studies that we also see a similar shape of the curve where exactly that you know stabilization will ultimately occur think that's too early to tell we don't have enough follow up in the study at this point in time
spk_2: the but that is what we're looking for an that's for we expect to see on a whether it's gonna be the exact same level or slightly different level we do not know at this point in time and as he pointed out of as you want to think that we do have an ad in terms of inclusion into the study's obviously patients that certainly and that you know initial dataset that we presented that had a pretty significant levels of that disease burden as well have extra the dollar disease which frankly was not too much as defies given that that first fifty patient dataset really was truly pete pandemic
spk_22: the and job you know will be honest about the full dataset looks like butter and in a world state at expecting to see the same shape of the curve and to define it time we can't exactly say where that's actually gonna come out that requires long term follow
spk_2: the fact that we saw the ad for system state attract what we have seen before i think is very encouraging because i'll say that was a clear correlation that we didn't see that all the stations that had long term outcomes all sat long term persisting on t cells and the shaped on look at persistence coming out from the trial as we had indicated on the interim analysis was tracking the old car persistence car so to that is encouraging i think it's of the lead indicator but honestly requires law follow up to so to be clear about were with actually like the landing
spk_41: oh god tells us what what point do request appeal eight and of pre deal a meeting this year that them you do after caliber scale update
spk_3: i'm so bigger question so i think what you want to do that the time you go through prevail a meeting is you want the actually have you know the they have the data which efficient level a follow up as are you have a very clear positioning around the the outcome that he can actually present the disgusted the agency and other see the date and we're going to go with to ask i think we'll start to give us i think a good level of observation so we would expect that that was at this is going to be an interaction post asko
spk_5: looking good excursion get that love that
spk_3: and keep one mama find next question and next question comes from killing she with jeffries hill on is now open
spk_22: i can go from a program on the phone to fucking my question regarding the baseline population while at a college town
spk_2: does it appear to kinda late one vehicle high as fuck
spk_3: sharp potion slate gray trade on come a former
spk_5: from mild blast announced hell will be able to provide of my information much child on patiently for me offshore oil a disease presence on the of top encore on on come on a lot okay don't that for joining kelly i nice and beyond the call first of all in terms of the that the patient population over all of the the patient population is it's close and very close to what be seeing the phase one portion of the study in a and what we expect to what we also expect to see his other system variability africa the going to defeat and any into saudi as well and that were close
spk_23: if you know what we may actually have seen him and a bit of a worsening after that and you know if you look at the are are an obviously small numbers but it went from seventy five to seventy percent which could be indicative of a slightly worse population
spk_1: so so that it sort of i think where we are will also got a present that a detail and the underlying patient attract raptor a stickler tetra at the actual data presentation ah it's gonna be else and important piece of information i think will help to put the day dying to into the preferred level of respected as well
spk_12: set out to the the the the answer to the first the first question but was the second question
spk_42: happen can prepare how far tell my husband cry from all giving a different shade of the profile or a falling out with a farm to farmed out on line
spk_14: oh okay like quite good opportunity to out a new indications potter book has done a mobile phone call for comparable or how been vulnerable
spk_11: take that back to the question about what you would be pointing to a the a really remarkable dataset that was developed by read markets and and his team at university of airline
spk_14: the who's done a fantastic job evaluating the utility of a t nineteen card key approach in patients with refractory systemic lupus
spk_5: the that the outcome of the date of us was quite remarkable to nature medicine taker at the end of that published at the and last year ah we know the team actually had also worked with team at the early stage of than tried development or way back almost twenty years back and really good dataset we believe obviously that you know oversell have a remarkable profiles and i with a lot of data rand at the safety of the program and clearly has a of an absolute outstanding safety profile which is important when you think about using an autoimmune disease and and the other aspect of course a is that they're as we all learned in this space it is fundamental tricky part in this era with autologous carty therapy this yes the at the actually have to have an ability to manufacture at scale and do that at quality and economically and also that's one of the key things we have been developing for of the sell an hour for it's initial application and ll so i'm absolutely were following that feel very closely we think it that you know it a to a
spk_3: attractive and potential future use that of that programs that are very safe and very active overly to be salvaged that very well
spk_5: you and yes
spk_3: and our next question comes from the line of james chen with miles fight on the line is up
spk_5: good morning and afternoon by the palm of the couple from our and i just wanna dig a little deeper into the app licking of other fell so do you envision other it he positioned i had a bullfighter from point and is it features that exploring that and then on a related madden i'm not other get a whole i started the mate good had waited earlier but the come on cause if he just them regulatory hurdles
spk_3: namely the fat immune a factor thought meditation and makes father be and say the adding a little bit
spk_5: difficult or intensive and he thought there and notice it yeah well but first of all thanks for joining games and i thank god in our our very interesting a question the first of all in terms of sequencing interrupted by point in time other cliff at my side of the proof both in the latter factory them as well as
spk_3: okay patients and have been with that will disease and that are basically in see or wrong or later senescence his face of patients that have gone through felt like rp be at wave still remaining with it will disease other technically complete remission but they still have measurable the kenya's the house at low levels him
spk_5: nice and mark and in over they will disease and so the pit product is of his of he has labeled him those to settings and of the has been evaluated now as part of the from my therapy so that's and play tai bo has that and we'll have a place in this in his early part of the of the treatment scheme and we expected to just sit and move up into that ehrlich setting now what we see from the i had to is approve of is that the hardest was approved for relapse with factory patients and without actually defining get a space a second or third liner fourth line actually it's any relapse refractory setting and so we would expect that that if a disabled half at the same type of scope initially and i was the way the board we do on minimal residual disease in evaluating the activity of the program there i think should allow us to an eventually position the program a similar to the way the
spk_26: out that way tigers position without all with it takes time to sort of actually move up in terms of that aligns a therapy
spk_10: and so i think that's the first part of the question the second part of the question was more around i do you actually position carty therapy or outside of the academic centers considering that you need the level of training or education of those interested in able to actually deliver the proper i think what we need to understand
spk_27: the is that to take play with the we only sell and with you have to have a very very similar profile and to to fight them in half in patients with low disease burden house we do have an even better profile that we've shown in these and stage hi to the burton patients that we also quoted in our at hm analysis so when you look at that of that population that has low particular disease or him but even the one that we have treated now
spk_28: the adverse event profile of the habit east asians is exactly what the physicians today to manage the side of the same level of an affair at at highway to write in fact it's a little less than bought one place i to have and it's it's actually less never toxicity than when you see that like psycho was very important that called that exceeds that of the when you look at the height of at the overall level of north of the city in about two thirds of the patients have i have any have some level of heard of a city with plants i know on which requires a to monitor the patience to observe them it's a trap make sure that you step off of it and what we have with every cell in a more advanced patient population to up to include inside your failures
spk_5: in in the physics of it and we actually had a little more than twenty percent of patients that have some form of your toxicity could actually substantially less for the actual monitoring level a less than thirty that we have a with that the belief is an opportunity at actually managed is and where the spirit of inside the should be able to match edges and in non academic hospitals and and and associated are potentially outpatient that example i for that is to the were not a snag terms of he believed to deliver karkhi therapy the solidly a level of and
spk_2: not only and patient management that require without a coward very well with the experience of sight of but it is also an state requires a tax with handle the cells and managed to cells as part of the therapeutic potent out of high level of training that ousted needs to be put in place an hour believe
spk_43: that that is a possibility for a non academic hospitals and and then we have to see how far they have further out if you might actually be able to go that i think this is you a very good penetration and ability to reach said at the are a lot of population with his profile as we see are basically demonstrated through the sideline
spk_5: thank you thank you one moment
spk_19: and and next question comes on the line of fat ah sebastian sense school
spk_5: less than that yeah i'm seven hi good morning and good afternoon of lung a first best infamous hot summer columns with calvin upper i know wary a congressional upright i was wondering often opportunity of i'll be selling other indications bianca aol northern be an additional updates on the of course funny for the and other indications with on this new patient and are there any of in the case and you believe would allow for actually and poop a buffet f additional i can show the same level of efficacy of is both of as last year
spk_19: and then you also spoke a little bit about the last cycle management without a one and twenty two thing you expand on you're thinking on the bus when he continued development of out own been plenty to be unfair to be pdf mccain into on top and mathematically invitations thinking
spk_5: the thanks of acid attacks adjoining hi i'm phil look at the an opportunity that we see what else is out of date was a product is it our have the remarkable profile he takes to basically remove the beat up department the a closed down at malignant cells as well as healthy cells mom amp do that with a very good safety profile left a property of the father were that a suitable honestly is in in in the caveats it is a non hodgkin's lymphoma which is what reevaluating as the allow the robot away evaluating as or the old are my feet study and then as kelly was pointing out that there is also certain applications in the on a newspaper our that might become an interesting and some fleet ada would indicate that you might even be transformational eco settings so that is this of the range i think you have in terms of opportunity to never of lot of the oncology to i've been all along their flocks to build up and also
spk_33: the the inside the that the range and now the question of choice on what we're seeing our i'm on in iraq on i think he is lazy that we have a very high level of clinical activity off a tyrant
spk_34: i have the education and packet of the law confidence in terms of the ago popular car in terms of the the english along and our educations and of the you know you have opportunities looking at them and the of detail as an example where we see in a very high level the complete remission and or said he hadn't the antibiotic
spk_26: they a for it which is quite remarkable and and their got out the images and data a mammals i'll ever see well that way i see no the opportune a although they became case opportunities to develop a segments of the education which allows it to move a relatively quickly
spk_10: i'm and with an accelerated math
spk_8: i'm and then depending on the education look at he also made and month to as he said ago for alas i fitting will want to actually start looking at an earlier line and as study as well which conveniently book the randomised controlled study at that early line and what want to move on that a reasonably and a reasonable to the time
spk_2: appalachian to dinner last night setting but after the the opportunity and we're looking at these and else to elsewhere the data from yellow card a o l it as studied does give us i think of a nice basis to sit it know and i've developed the my options for the for the investment you then also asked about bear have a nap
spk_3: that conversation how old are one or the today and it a while a figure do our don't want any to that have a very athletic program
spk_35: he appears to do exactly what we want in terms of avoiding
spk_3: i'm at the occurrence of target negative reactions which is the key thing that of the if the looking to address and where we know that is a way for a long a few to kenya and if the initially reports that read certain proportion of patients that do actually shows the not negatively lapses in the case
spk_5: in in the complex issue lot of each other up they haven't been as many reports more recently in our own hands in late august of that we haven't seen as he denied the negatively lapses nordic with our program so out of thirty so of whether or not that is a major issue to actually addressing those indications i think is unclear
spk_44: at this point in time i think that it's a lot of other questions i think we'll look into terms of the ability to rob he had that utility aware of it will hardly approach each additional and says later it clear he said at the a little out and he certainly entwined with a rematch though for children on this without action only
spk_31: you have point make sense to consider
spk_5: that program to move into the succession of a piss out and issues with settings wow soon after that date extended range as well as the the labour think you're right now commonly it's at eight and the her set of investment decisions outages question sequence it as investments and and that i think the probably the first be on on actually broadening the opportunity for the south and and in a second fairfax eight and moving forward without a lot for he to a chance of a theatrical i cycled yourself great thank you very much
spk_2: that left him
spk_3: thank you
spk_5: one moment and one moment our last question comes friend at it as often wiring lives to a show and itself hi this is kind of for us to an answer questions and pricing our haven't you by young hi been spend your price of the south and chaos a discussion prime minister backing i was you compare from to us and europe
spk_2: i'm and also is there any potential for your pricing power change with each other at ascot and him
spk_3: i didn't retire korean i didn't get the last part of the question
spk_5: ah at the pricing power without next updated africa oh i see okay thank you official thanks for joining arena an interesting questions related pricing i think what we've been seeing him involved than a two dimension first of all
spk_21: they were having a l typically
spk_1: ultimately typo
spk_3: the use of the title in patients below the before we also do see ah and i use of up to four cycles in those patients ah which you know it's basically the i getting the price for that product into the range of the between four or five hundred thousand dollars for patient invested acid a one benchmark which is standard of care and aware what bracket that is when you then look on
spk_5: the on the approved cocky therapy and air in in in iowa hope that it in the range of for and fifty thousand two hundred of course expected video the course of this year said after the that the second set of ah i think get a bracket ever seeing of us and we would expect that would be fighting in a similar age
spk_3: honestly believe that the you have a product that actually allows you to be more efficient from a from a cost perspective because before to reduce let's of the city with wireless patient management a week that i think there should be a good health economic argument and i support supporting the use of of he said
spk_1: well in addition to illustrate clinical profile
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