BioAtla, Inc.

Q4 2022 Earnings Conference Call


spk_0: reading a welcome to the bio atla fourth quarter in full year twenty twenty two earnings call at this time all parties of on a little only mode a question in a professional the without the form of presentation if anyone should require operators is is during a conference please for stars your i telephoned he back please note this conference is being recorded oh now during the conference over the ios booze mackle you may be good
spk_1: thank you operator and good afternoon everyone with me today on the phone from bio outlets or doctor jay shorts chairman ceo and cofounder richard waldron chief financial officer and following today's call police martin teeth of political developments and operations eric fevers chief medical officer and sherry lighted senior vice president commercial strategy will join jane rick ross short q and a earlier this afternoon bio atla released financial results and a business update for the fourth quarter and four year ended december thirty first party twenty two a copy of the press release is available on the company's website before we begin i'd like to remind everyone that statements made during the conference call will include forward looking statements including but not limited to statements regarding bio atlas business plans and prospects potential selective licensing collaboration and other strategic partnerships whether a clinical trials will be potentially registration of results contact progress and tiny and of our research and development programs and clinical trials expectations with respect to enrollment and dose seen in our clinical trials plans regarding future data updates clinical trials regulatory beatings and regulatory submission the potential regulatory approval path of our product candidates expectations about it's efficiency of our cash and cash equivalents and expected already and g and eight expenses these statements are subject to various risk assumption and uncertainties they can cause actual results to differ materially and are described in the finally made with the fcc including the most recent annual report on for ten k and subsequent quarterly reports on for ten que you are caution not to place undue reliance on his forward looking statements which speak only as of today march twenty third twenty twenty three and bio with disclaims any obligation to update such statements to reflect future information events or circumstances except as required by law with that i like to turn the call over to jazz york jets
spk_0: thank you very soon thanks to everyone for joining us for our fourth quarter and four year twenty twenty two our earnings call all he has made significant progress and twenty twenty two across our five ongoing phase two trials for our to latest days for think last cabbie see product candidates be a three zero eleven and be a three zero twenty one targeting multiple solid tumor types we continue the positive trajectory and twenty twenty three intently focused on for the advancing the development of are innovative clinical and preclinical programs across our platform leveraging the brought applicability of our cap technology across several critical stage and body types including axel and war to eighty sees targeted
spk_2: vitali for ios nature the antibodies and our first dual can't by specific ep cam and a cd three to sell engage your before providing the update i'd like to remind everyone that additional details related to what i'm going to present are available on our website as part of our updated company presentation that may be helpful to you
spk_0: we are excited by the promising clinical responses to date that are generally meeting and several cases exceeding our interim study target responses
spk_2: however we recognize the resulting impact for for up been providing incremental data updates on small sample sizes in view of the near term completion of the study's going forward we plan to release more mature datasets across or programs as a reminder were reminder we're using these studies revive sufficient data to allow us to said study parameters that maximize the company's likelihood of success
spk_0: our face to potentially registration studies while this communication approach will modestly affect our data updates for que to we do not anticipate that this will delay the overall program did all the time us while we advance what i believe will be a transformational platform in the treatment of solid tumors let's now moved to our title operational and financial updates for twenty twenty two as well as our progress from the beginning of the year
spk_2: in order to maximize the differentiated it at risk profile of our cabbie sees we've looked at different doses and dosing regiments throughout these one is based to part was based on the sizable dataset we've accumulated we were able to complete a thorough exposure response analysis
spk_0: leading to the selection of a more frequent those intensive regimen twelve u p s face two parties study while the profile of the one point eight milligrams per kilogram to to dub ya once every two weeks dosing regiment as positive the more frequent those intensive regimens at the one point eight no grams per kilogram to que three w or twice in a three week cycle
spk_2: and the one point two milligrams per kilogram three to four w or three times in a four week cycle which uses the one point eight no grand per kilogram starting does are expected to provide approximately thirty eight percent and forty four percent more exposure respectively damn the previous que to w dosing regimen
spk_0: based on our exposure response analysis we anticipate that these more frequent those intensive regiments will further improve anti tumor activity while having similar or even improve safety profiles compared with the key to that it doesn't regiment this those strategy was supported it by the f day as part of our u p s face two or to study design discussions and as an alignment with fps project optimists can do it of these things we continue to be excited about this the first of our to lead assets be a three zero eleven for multiple indications previously was shared the partial interim data on our be a three zero eleven phase two part once or commissary and are be a three zero eleven phase two part one non small cell lung cancer study today we're providing additional insight including how we are applying the learning from are encouraging safety data and then and exposure response analyses as well as our u p s related ft a interactions the study more frequent those intensive regiments more broadly across sir actual eighty seat and war two eighty see programs first i will discuss our be a three zero eleven face to start from a steady and out our approval all sexual strategy u p s is one of the largest sarcoma sub types rack representing nearly thirteen percent of all soft tissue sir thomas it is also one of the most aggressive said types with one of the highest recurrence rates are currently no ft a treatment specifically approved to treat you vs a patient tend to progress very rapidly else u p s represents a significant marshall opportunity as a standalone indication and we are focused on moving quickly to registration and give us last year was marked by continued strong execution promising results with continued anti tumor actively lack of disease progression in a differentiated safety profile be a three year old seven and u p ps as an update to the phase two part one you yesterday we currently see an overall objective response rate or oh are on a fifty percent median progressive free survival or pfs and eleven months and the duration of response exceeding eight months based on these results together with the continued differentiated safety profile and encouraging feedback from the f d a around the study design we initiated part to the potentially registration or portion
spk_2: of the trial
spk_0: this month the first six wow miles or complications cleared the deal t observation period using the three to four that he doesn't in part one of the face to study which was the study requirement to begin an all in patients in phase two part two other you be as trial we now anticipate first patient in for this study see in the first half of this year the first forty patients with a t mps greater than or equal to fifty percent are now and rolling and will be randomized one to one between three to four them you or two to three that you dosing response following this we plan or undergo an additional forty patients are selected those to complete the study overall the primary after and point o r r will be based on a partially sixty patients treated at the selected dosing welshman in addition to u p s we continue to see the positive anti tumor activity across several soft tissue and both tacoma's up types where we previously reported in observed pfs raid at twelve weeks of sixty percent and lifeless or coma
spk_2: fifty percent is a noble sarcoma and fifty seven percent in austria sarcoma
spk_0: we are very encouraged that all three subtype continue to meet our pre defined go criteria to advance into to part to the face to study the also continue to involve the remaining search on the sub types
spk_2: with respect to lie on my come as i mentioned earlier earlier we recently cleared the dlc observation period in the first six patients using the more frequent those intensive three to for w regiment and are continuing this study and lol miles a coma for ten to fifteen patients to evaluate this dosing regiments for potentially open
spk_0: being up a broad soft tissue sarcoma face to study in the future
spk_2: with regards to this safety profile across our come a subtext be a trees or eleven continues to be generally well tolerated with a face to safety profile consistent with the profile we observed and face what given the encouraging anti tumor activity were observing coupled with a significant unmet need you ps represent a solid early education for by well as we plan for the transition into a commercial stage company
spk_0: we also see real value and pitifully expanding our side i'm a footprint over time to include other sarcoma subtypes ultimately be a three zero eleven has the potential to treat over twenty five thousand sarcoma basis for years and generate up to two billion dollars in revenue worldwide and syria a very high unmet need regarding our be a three to eleven face to study and axel positive multi refractory non small cell lung cancer we continue to be enthusiastic but responses were observing there are limited treatment options for patients you progress on not new checkpoint inhibitors available treatments in the second line of the on setting these patients had sub optimal overall or are ours and approximately ten to twenty percent as a reminder part one of a face to study announcement cell lung cancer is ongoing and i suppose the patients who had previously experienced failure of the repeat he one pdl one eg fr or out inhibitors the previously reported preliminary efficacy with an hour are approximately forty two forty four percent was observed so far in the study this response rate is highly competitive and spd one failure population and supportive of moving forward to the face to potentially registration or part of the study based on the preliminary interim observations we believe be a three zero eleven will be highly commercially relevant with an hour are well about current all hours observed and a multi refractory patient population further leveraging are insights and after day discussions on u p s we expanded our face two part one not small cell lung cancer steady to include the more frequent those until two regiments to cute three w and three queue for that you we are currently wrote in in this patient as we prepare our submission for a meeting request to confirm the design as the potentially registration will face two part to study with the agency and the first half of this year with feedback anticipated in the second half complete with the final does collection we anticipate reporting all of these data after the face two part one is effectively complete which is anticipated in the second half of twenty twenty three
spk_2: most importantly we also expect that we will initiate the potentially registration or study has none small cell lung cancer in the second half of this year preserving our overall timeline for development of the now small cell lung cancer indication with respect to market size a significant proportion of now small cell lung cancer patients express actual
spk_0: and we estimate that there are over one hundred thousand axel positive addressable patients per year worldwide the second line plus indication as a potential to at approximately two point five to three billion dollars and worldwide revenue at peak taken together sarcoma was a lung cancer we he be a freezer eleven has potential to become a significant commercial at asset for bilateral across multiple solid tumor types
spk_2: have even greater importance as that be a trees or eleven as a potential to be at best in class treatment for a significant number of patients who fail multiple lines of therapy that's going a significant and at medical needs around out our cabbie see be a three zero eleven program we are supporting an ongoing multicenter investigator initiated face to clinical trial be a trees your weather in patients with platinum resistant ovarian cancer we're anticipating interim data consisting of ten patients in the sec
spk_3: you're half of this year
spk_0: now turning to our second the cab eighty see prada candidate be a three zero twenty one a cab war to eighty see
spk_2: as reminder there are no other therapies targeting were to common so we have the potential to have a first class dream for solid tumors the date we have three phase two trials ongoing that be a three zero twenty one as previously reported are phase one clinical data we saw impressive responses envoy to positive
spk_0: patients refractory to pt one therapy including to be ours that man small cell lung cancer one pr and head neck cancer and one complete response in a melanoma patient who remains a complete remission of treatment for over two years based on a similar exposure response analysis done and actual positive tumors we are pursuing the same strategy interface to go to positive national soul and lung cancer study and currently unknown patients and the more frequent and want to see dose english version of three queue for w in the first
spk_2: after this year and plan to share data when we have sufficient evidence to determine how to proceed with our potentially registration or study regarding the melanoma phase two trial patients who had previously strange failure of the feeding one therapy following an additional cr in an invaluable patient identified using our validated i see as a year screen faces with a validated liquid biopsy and anticipate provide
spk_0: in a moment update on or around the first quarter twenty twenty three earnings call and may in addition or face to had next that he is ongoing and patients who have previously experienced failure of pt one therapy alone or in combination with platinum therapy we have cheap first patient and for the study so far the observe or to positivity rate is high and a my with our expectations when to pay providing a roman update on around the first quarter twenty twenty three earnings call in may around our cabbie cb it be a three zero twenty one program we're supporting a multicenter investigator initiated face to clinical trial at a be a three zero twenty one patients with platinum resistant ovarian cancer we're anticipating and and data consisting of temptations in the second half of this year now i'd like to talk briefly about our phase one to travel for cab see to a for and about be a three zero seventy one a phase one two trials being conducted in tumors known to be responsive to see joy for treatment and will evaluate safety of our ability of be a three zero seventy one and mana therapy i
spk_2: nomination when the moment
spk_0: the trial is progressing has planned as part of today's update i'm pleased to share that the blt observation period was cleared for the to cohort
spk_2: at a dose of two hundred and ten milligrams or three makes per kilogram in combination with three makes for kilogram of mcgowan that no deal tease will report it good now progressing to the set cohort at three hundred and fifty milligrams for five milligrams per kilogram as a model therapy or in combination with three milligrams per kilogram and the ball a mad and anticipate the plan phase one day to read out in the second half of this year moving on to our earlier stage pipeline namely are potentially first and class dual cab by specifically sell engage or and about a cab ep cam and cab cd three or be a three one eighty two
spk_0: we recently received at the a clearance a variety for the treatment of a dancer gonna carcinoma and are on track for the first patient and for the first phase one study in the first half of this year with a complete phase one day to read out anticipated next year similar to our added three quantico cap prada candidates
spk_2: this and about a holds much promise and view of the in vivo preclinical studies demonstrating and over one hundred fold improvement in the therapeutic index relative to the non can various due to the combined flight tivoli of the dual kept design
spk_0: several the most common sub types of it in a carcinoma that has tremendous on that need we could potentially address include cohen line brass pancreas and prostate
spk_2: i'll are also continues to progress several candidates to and the enabling studies including care by specific the next generation eighty see antibodies and we still anticipate id submissions for additional candies the to say this year and next
spk_0: with respect to important ongoing communications the company has seven accepted recent and upcoming poster presentations including it as most are coma and rare cancers congress the european lung cancer congress and a cr a ladder which will include preclinical data related to next generation
spk_4: multiple by two cigarettes
spk_2: with mad i would now like to turn the color with the rick to review the fourth quarter and four year twenty twenty two financials rick
spk_5: thank you jane
spk_0: as of december thirty first twenty twenty two we had two hundred and fifteen point five million in cash and cash equivalents compared to two hundred and forty five million as of december thirty first twenty twenty one we expect current cash and cash equivalents will be sufficient to fun plan up relations including all ongoing cab product development programs into twenty twenty five
spk_6: as a reminder we control all cab product not marker rights in the us europe and japan
spk_0: a business strategy includes advancing commercial preparations and key global market while exploring opportunities to extend our cash one way by generating up front cash through the select and licensing a park right and certain toys or collaboration with other biopharmaceutical company
spk_6: days i could also provided to us development milestones and royalties upon regulatory approval and commercialization and create additional value for stockholders
spk_0: for a full year ended december thirty one twenty twenty two we report on a net loss of one hundred sticks point five million dollars compared to a net loss of ninety five point four million dollars in the same period of twenty twenty one research and development expensive for seventy nine point three million dollars with a full year ended december thirty first twenty twenty two compared to fifty eight point three million dollars for the same period and twenty twenty one year over year increase of twenty one point one million dollars was primarily driven by a clinical product development efforts we expect our our in the to remain variable i'm quarter to quarter and generally increase as we can can you to invest in our in the activities to advance our potter candidates and not clinical programs general and administrative expenses were twenty eight point eight million for the year ended december thirty first twenty twenty two compared to thirty eight point four million dollars for the same period in twenty twenty one the nine point six million dollar change was attributable to a decrease in stock based compensation for the twenty twenty two period we expect our jane expensive to moderately increase to support development about product candidates advance our intellectual property portfolio the report focus pre commercialization activity for a product candidate big eight three zero eleven and satisfy requirements as a public come
spk_6: opening
spk_0: net cash used in operating activities for the twelve months ended december thirty first twenty twenty two but ninety point four million dollars compared to net cash and operating activities of sixty two point two million for the same period and twenty twenty one
spk_6: the increase in cash you can operate activities for the twelve months of twenty twenty two is primarily due to an increase in research and development expenses related to our program development efforts as compared to the twelve months at twenty twenty one
spk_0: and now back to jail
spk_2: patrick we're pleased with the progress we've made a twenty twenty two and argue with the results are considered a sport but the preliminary efficacy and safety from are differentiated proprietary cab platform we're excited with the compelling clinical profound that is beginning to emerge and trina refractory you s now small cell lung cancer
spk_0: and i are eager to continue advancing the phase two studies with the addition of more frequent those and thirty regimen is in providing clinical updates when more robust datasets become available we also remain encourage by the continued execution of i rather promising cab assets in multiple cancer indications and are well poised to be each several value creating milestones and key inflection points to the next several months
spk_2: i'll atla remains confident about the future
spk_0: with the goal pursuing indications of hi annette medical need that we feel will have significantly impact for patients and our shareholders worldwide with that we will turn it back to the operator to take your questions thank you had your time will be conducting a question an intercession if you would like to ask a question please press star one are your telephone keybank a confirmation town will any gay guy question do you may press are to if you like to remove your question from you the it was using speaker equipment it may be necessary to pick up your hands it before preston sturges one moment please wow we poll for questions our first question comes from the line of can with jp morgan
spk_7: people see with your question ha i'm an emphatic my question and i am a couple question maybe the first on your actor paul graham and am officially and and the not much matalan catch up to you
spk_0: i'm and so maybe just one on on your latest thinking about that about child the science can you provide some color on i'm gonna you're thinking about it
spk_7: average how the time and what are the chase and makes that you intend to unroll on am i to me that my arm yeah yeah yeah you're wearing far yeah yeah
spk_8: i'll be back in the at the i am any getting factor that like a potentially markets the and between now and i'm your start time for the about trial and and i'm one my point and at that are we expecting any at will update on boy your on going on for cell lung cancers idea
spk_0: apple cup of hot
spk_2: hey thanks where are you so well we are preparing our a request for feedback
spk_0: to the at the as we speak and and i we've entered the have that and later in the surf first half obviously a getting factors as feedback from that f d a discussion and we beat the getting fatter for phase to party what is my it's about the time frame is that we were able to take the learning from third quarter panel discussions with the puck in part from
spk_2: ps discussions also with i love the increasing number of patients so that we could do a mortar stores response now as we put those together realize that we could bring in august so it was more frequent doesn't tells treatment in that same time for in that we're working with and discussing with the f b i so when you talk about an answer the question about what's the next read out with a the best time to do that is that we get the at the a feedback ah because we will have not only are the key to double dose and data from pleaded with we feel very positive about also now have a
spk_0: an opportunity to compare that to the two to three that you know three to four w more frequent those are used to this gives a chance to really make sure that we're going on to the registration or portion of the trial and of course if it's registration at the to allow study that as to be somebody but we did get that but
spk_7: that's how we're looking at it and in our job is to make sure we maximize our potential for success or we we take we have a good baseline the key to that we have a chance for upside with these other doses and will be compelling and you know that answers your question blinder helpful usually little flavor of it
spk_0: canada out for help or and then maybe of on on one on the rochester i am l were curious what just i'm michelle and yeah up a patient that you're dallas i in a non moscow lung cancer keith i'm an at energy can shed any light on just yeah at the efficacy that you saw and i'm near given that you already had are doing some work what the axle on non small cell lung cancer and can you shed some light on how you know the rot your program in lung cancer or advocates pow pow compared to like a solid the after program
spk_2: why we can only do that for days why we don't have enough patience yeah the originally we were targeting to report out on our que one early fall which has to be clear this is the queue for earnings call so that you wanna is always there may all but given the fact that we have the opportunity to bring out the more frequent or
spk_0: doesn't chances are the information in comparison what we've done is that the one milestone or timeline that with pushed out in terms of reporting it as she doesn't change our overall phase two timeline in terms of the federal side or at all but it allows us to now make a comparison between the these more frequent us again the to to debate so today we don't have enough data make a comment but ha ha
spk_2: how much better pictures me way to where the second half and our goal of course is to have the information required to go back into the a for more to and get a picture that way also should have a we're going to update in may but we're hoping to have a much better picture of what our recruitment raiders in the head neck
spk_7: and then of course so well hopefully get a snapshot of what's happening on circulating to be so i say of melanoma
spk_0: right and can to get my question by the way trying to play on one thing or we have submitted to ah one of the upcoming congress's are we haven't got feedback yeah from the meeting that reminded me we're trying to preserve exposure response analysed data analysis data ah
spk_2: as soon as possible so people get a flavor yet you know of the heard on the saturday morning
spk_9: i have more frequent doesn't answer of the regiments
spk_10: put a right to
spk_7: forward to an actual
spk_0: got gotta thank you
spk_11: our next question come from the nine of carry she would jeffrey he was he was your question ah thank you for taking my questions my first question about her actor program is your key as you mention the other more frequent those saying ah three to four doppler that the out your window has been cleared a half first the six patients e l am as of time i'm curious ah or do you share the advocacy all com for their six patients in near term
spk_12: and also for the of face too hard to ah
spk_11: you gonna evaluated to defend her those thing for a cure for w and had to choose to a w
spk_13: ah in the first the forty patients have a curious does ft require another meeting after this forty patients and the talking about africa santa safety afford the decider on the dosing regimen for the next there are forty patients
spk_0: in part two
spk_14: thank you
spk_2: you chose a roulette or believe help me all muslim a little bit but i'm gonna start by saying you did get a snapshot in january the first union of one of the patients to three to four that you would we reported out in the global so komodo we saw twenty nine point six percent to tumor reduction of are scans
spk_15: let those patients that we are all the moving toward the ten to fifteen patients the we we believe that will just going to wait until we get those because we think will plummet in a timely fashion for second half of this year that the obviously we're barrier
spk_16: we're hopeful that within a system of interesting data coming out of that but to live maybe you can add to the sir
spk_17: add to this answer yeah
spk_0: to do
spk_17: to the timeline for the yeah
spk_0: tricky for the be really miss scored
spk_18: we'll wait until we have to approximately fifty patients with it which is expected and second half of the fear of to mention and in your question about it year requirement ideas does not require us to meet with them after the resource would be sure that certainly our intention
spk_0: is to meet with them and to make sure that we align on the to cs electing for the next
spk_11: forty patients to be and mood
spk_12: because that's will be the those of be as the us to be registered and soon will now will be planning on having a meeting with you just once
spk_14: once we have the first wouldn't basins and most you to and
spk_2: i think i might i ask how fall off if i may darfur the ah your key as faced how ah do you plan to provide any data the and this year and also adam all man
spk_0: would you have be able to share information regarding how many sides have be activated
spk_14: so you consume yeah so that the data we just have provided is this a date
spk_0: is the veto all the psp shouldn't be he treated date and the be due to assess as you both from the last time recorded the data we are now
spk_19: keeps going eight months since in knew that so are the pss is evolving positively to see some patients are still in treatment so that might that you to though that i think you got a very busy too
spk_20: the data we are reporting two days is very close to the final data
spk_21: in u p s and what was your the question i'm sorry
spk_2: the darkness
spk_14: yeah so a man father's face showed a potential threat or trial or do you plan to have a nutter the the updated this year and a mom and how many sides have been activated studies out the cricket i don't believe we're tcp to have data a days this is a registration study he are rid of i see the
spk_0: will be
spk_22: the not planning on giving a data of date that will certainly provide and movement or dates and was good with this study is that the way between a bit older dps a oh the soft tissue circle line boots a coma and sites be hard for an issue that fits to back when so the states are being
spk_0: and to you shouldn't to
spk_23: the second part of of the states which is about sort of sides of together in us on and taiwan
spk_0: great to thank you
spk_23: our next question comes from the line of twenty butler with year funny to proceed with your question yeah thanks very much for question around with she chose for program
spk_2: in clinical trials dot gov
spk_24: in one will dissipate clearly there's been dosing
spk_18: for a variety of to nurse to the first question is
spk_25: has enrollment been
spk_2: has it included and have the the patients at at all of the tuners which are listed on contrast like have been doused in your early dosing schedule and importantly and at not that's fine but is there is a been skewed to one particular tumor or another that's question one or two is in the same program what actually
spk_0: could you for not sure which parameters that you're simply looking for just simply dlc and then when do you think that you will get to
spk_26: an appropriate doubt that you can then start looking at africa thing is that be with him
spk_0: dispersed have you think it takes the entire year thanks very much
spk_27: am i going to split this was actually but the of so i think that
spk_0: when you are one money one milligram for kilogram learn and approved does raise specially in combination with three milligrams per kilogram
spk_10: pt one
spk_2: so we pass that cohort we just passed a three minutes per kilogram accommodation three nights per kilogram of be pt once a yeah there's another job or that's in that advocacy wage ah we're in rolling now for the five milligrams per kilogram
spk_28: in combinations remix for to our tt was so everything all now and including the last week or hurts have the potential are looking at us see ah and of course you will look at that
spk_0: that you know for a job
spk_2: so the study in general i think is on track good to be done
spk_14: in times
spk_17: in time such that we can actually check all our initiate a things to set a trial in the be a three year seven one of the settle for so what's on a very good pay said we're we're thrilled to see the data is coming in the way we have helped the would so far better are there were some other questions about the
spk_18: schumer types and maybe the the common or to regarding africa see our read outs and of with a new be better for dancer
spk_1: yeah thanks jack so
spk_14: i think the only two months i do you have noted know these athletes to see it dissuades all the other two types of million votes works we're seeing quite a bit of a key and in
spk_0: quite a bit of patients coming to our study in all the tumor types that we have listed and and so will now as you mention with really surpassed he says he tries to levels that
spk_2: that we're expected it really mad is the to that when me going to kill them
spk_0: could you could be nation with usually man attributable to prettier it's some indication to me when he can be mad at plus one many got the void other indications and so we have reached level with these courts where he certainly expect to see if he kisses
spk_14: the also be looking at other markers your victory kissing as such as as you to dna at you know biden and signs of forced to also happens nick a decision on average those to take forward into the she's to plan to stay
spk_0: jake felipe thanks very much very helpful
spk_2: our next question come from the line of i say he with a few wainwright people she was your question
spk_29: a graph know jan team ah thanks for taking my question to just follow up on the subject for program i'm so so far as your study
spk_10: could you give us a living color own the average of repeating go seek of the study is emily along and del oh how bout the mexico are repeated doting have been so far reached
spk_17: so with your to have three yeah what was going to get in the weeds about the ah you've had they should i be nice on on and achievement for quite some time so and by quite some time
spk_14: i mean you and eleven cycles and so you know but again we gotta look at each school boy
spk_2: individually it's see what to what is going on with these patients but so far the judges the even at this is that are above the de souza pool with people's me i would is great really nothing to report and the only had one is seen so far as that was an only
spk_0: needed to our treatments and in was in one of my own it's ah so since i've enjoyed it it's very well tolerated patients able to stay on treatment again we need more time to be able to tell you exactly how long patients able to stay on treatment as actors is at a specific avoid that's what we can say that so far no do you have to use really not not much to report from six to thirty two seconds oh great thanks for that correct ah and the far regarding the xl are pro bad for the year
spk_2: for the is a coma part of the study i'm just curious our what's the rationale that testing be more frequent and intensive dose regiment day ha l l l m s a cohort out why not go for the
spk_14: the and yeah the other subtitled does a coma just a curious
spk_0: and i think well first off it's worth mentioning that these more frequent those a more intense and advancing actually from those that like the follow see see men that actually ah the three queue for that you were lowering the see max which is often associated i'll with any toxicity but we're also an increase in the see men such a modeling standpoint this is says eric exciting so the other side of it is you know i think when you look back at all phase one data we saw some p ours and allow a mouse or karma
spk_2: and and those are you came in minute in the phase one study where we used to to that you and two to three debbie of so ah
spk_0: what was interesting as we did it sees a pr in the face to using the app can accuse you w and so our this we solved by going in l a mass we've certainly can answer the safety question quickly and ah the up the a as i was agnostic and which indication
spk_30: they went to so gave us a chance to look at l m s to see if we could also tease out pr switch really could open up abroad in the future potential brad soft tissue sarcoma
spk_0: expansion study and down and it also answers the say to question some colored kill two birds one stone and the and and of course those six wouldn't have counted and for the u p s portion of our first part of our chaise to part two wow alvarez potentially registration of study and so wow it's just really wasn't way to optimize the whole bunch of questions very quickly without in any way delaying the u p s are potentially registration of study
spk_2: thanks thanks for the car pressure an expression come from line of rain benjamin with jmp security people pussy which your question hey guys thanks for taking the questions average i guess just sticking with the more frequent dosing regiments can you talk a little bit about what you'd like to see before declaring that you know go for dogs are you are you looking for just improvements in are are are just the in our deeper sponsors in or is it or the primarily from up from fifty perspective that a lead you to to declare a good go for a dose and i guess related to the asked if you don't see anything in four hours or something that doesn't meet your hurdle have you are you choose the appropriate in a dose kind of going forward and i into the red social stuff going to start on the song had a silly that to it but first it's important to recognize the reason we even have the freedom to use was more frequent intense dos reis regimen and added and is because of the cab technology so we're speculating all three of these different those regimes that humans to to the w two to three w three to sort of you to all be safe that's not the question were exploring his teams that the cavs allows that for you during the day was extremely supportive of that you'd yesterday our our reason for exploring it as we have a chance to potentially even drive ah greater efficacy of were happy with the asked you were seeing as you to that is the don't miss interpret that but if you have a chance to increase advocacy and you can do it in a way that does not extend your overall development timeline
spk_14: it's a was a great opportunity to do that and in the u p s setting we did we did it inside the park to of the face to study fortunately on the actual and more to setting for alarm were able to do it in the park was so we're getting that done while we're on the same time in the process at least for actual having discussions with the fts of and likewise er war two is always been a nice the six months or so behind ass off
spk_0: and so low lot but it so it has no delay effect on and m gives us a chance to really
spk_31: certainly see them were for to see and strong of responses some ah feel it you wanna add to that
spk_6: yeah abby that just to add to the the first part of your question which is and which one you if the treat you for that he does it work
spk_17: how does a meet our pretty out dozens or loops about the same as what you see to the under this region and then that's why we are happy with the other dosing regiment and woman forwarded it to to tweet a really to to the of england at ten am and selected as if not a it's it's it's not that we have
spk_31: have to have the tricky for the the workforce to move forward or we're just trying to maximize mood he gets me we can get and and leverage the the the cap for that's it
spk_0: got an hour just to other questions i guess the first can you comment or or just slash know that the the patients who were who responded announcements on cancer and in the not fulfilling can study are they still responding now jg want to take that or ah i think you should take talents yeah i mean where we have decided not to update the data that to tell you that some of the patients actually standings
spk_2: effort and then yeah just switching gears to the ep cam ah i'm in advice to fact that the in as i look at carnegie yeah
spk_0: the clinical trial design it it
spk_2: it seems kind of complicated me with with like a standard hydration or minutes and a traitor show of priming i guess i'm a lot to just get some feedback or some mom commentary on a where you think the therapeutic dose might be and how these what's the point or how these hydration help you get to you know what the ideal dosing i guess for this asset
spk_0: yeah i'll start until he can have him to this in group a were thinking that the hundred and twenty five micrograms per kilogram
spk_32: yeah my cf to see below that adults around that you see fifty levels are we we we think that those level that you can really start to see some place
spk_0: obviously we we think it will go on to go above that given our safety profile and i frequent of studies better of and and phillipe you can add some additional to that maybe you can also well
spk_14: add in some of the lodge around what the fk as wanted to see a with respect to the group be tight race
spk_0: yeah it's always believe that she to call it there hasn't been that many but so far the the typical design for a by specific cassidy teaching setting major army the eddie a particularly concerned about and better cytokine with
spk_17: the storm
spk_14: and that have been observed with some are there
spk_0: city to buy stuff and so this is all am set up to try to mitigate all this and make sure that you're not putting patients at risk we have not seen any
spk_31: during our talk study neither are seeing your taxes to do and only than an intrusion reactions are by we ah we still have to follow that and that type of design ah in case me were to see great somewhere
spk_0: abbas has set to come with syndrome so that that's really all done to manage that you will be accepted each iteration favorites fast it is one patient book awards is it a fortune days and dlc t observational period so we can
spk_2: little choice as allegedly quickly and then moving to have more sanitary creation and those labels admittedly boobies dishes distort that extremely potent and so it is why was starting at at that lieu of the close to begin with but added that is not all of this is not a typical is what
spk_0: i'm i'm trying to terrific actually much for taking the crisis and we have reached the end of the question and answer session out now and call back over to the short for close your next

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.