Moleculin Biotech, Inc.

Q4 2022 Earnings Conference Call


spk_0: hello and welcome to the molecular biotech fiscal year twenty twenty two quarterly updates conference call webcast if do much to play or operator assistance please press or zero under telephone keypad a question and answer session will follow the formal presentation as a reminder this conference is being recorded it's style my pleasure string of overture hosts st thomas investor relations please go ahead name
spk_1: kevin hello and welcome to the millennium via text quarterly update conference call and webcast following the presentation there will be a question and answer session and note that this that has it been reports recorded at the company's request and the replay will be made available on the company's website following the end of the event at this time i'd like to remind our listeners that remarks made during the sweat cast mates eight management's intention believed expectations are future projections these are for looking statements and about risks and uncertainties for a statements on this call or made pursuant to the safe harbor provisions of the federal securities laws and are based on molecular current expectation than an actual results could differ materially as a result is not place undue reliance on any for looking statements some of the factors that could cause actual results to differ materially from these contemplated by such forward looking statements are just got in the periodic reports molecular files with the securities and exchange commission these documents are available in the investors section of the company's website and on the securities and exchange commission website we encourage you to review these documents carefully additionally certain information contained in a sweat cats relate to or is based on studies publication surveys and other data obtained from third party sources and the company's own estimates and be so search by the company believes the third party sources to be reliable as of the date of this presentation it has not independently verified and makes no representation as to the adequacy fairness accuracy or completeness as or that an independent source has verified in information at turn obtain from the third party sources so joining us on the call today it's molecular limbs leadership team he have walter clamps chairman and chief executive officer doctor john paul ii senior chief medical officer and jonathan foster executive vice president and chief financial officer is now my pleasure to turn the call over to lolly club chairman and ceo while it
spk_2: please proceed
spk_3: i actually hello everyone and again welcome to today's molecular biology don't in school as you would expect we'll be updating you on financial as start aspects of the company but the most important aspect of today's called will be an update on our t clinical programs
spk_1: and in that regard to this point forward our plan is to provide these clinical updates with each subsequent quarterly is your and call it furthermore given the fact that for current clinical trials or of open label will be free to provide substantive updates on parole seminary redoubts for safety and efficacy with with each one of these updates
spk_3: you're also really excited for molecular to finally be entering face to activity he would we we went public in twenty sixteen we had zero clinical activity and really nothing more than a promising pipeline of preclinical technologies but as of today we've other concluded are conducting or cleared to begin eleven clinical trials involving three different technologies in a range of indications what's me of we've successfully establish safety and also witnessed clinical activity in three of these indications importantly is this is just in the phase one stages of our pre clinical programs
spk_1: now
spk_3: without a doubt the most immediate opportunity for a clinical breakthroughs is with a my son largely because it's the furthest along and it's clinical development so with this in mind will spend the bulk of this call talking about where we are and where we expect to be within a my son in the near future
spk_1: but it is worth reminding investors that me have to more distinctly different technologies in addition to analyze and those programs continued progressed and provide valuable diversification to your investment and multiple ways for molecular him to succeed everything we've done up to and including in twenty twenty two has essentially set the stage for a year of cease to clinical data in twenty twenty three
spk_3: all this preparation is now finally called culminating in phase two activities in fact we have three phase one be to clinical trials underway within my son and and one of our sts trials is already reached the city percent mark for recruitment of the seas to push into that trap and are am l clinical trial with anna my son in combination with cited the well that's building off of an eighty percent response rate in the single aged trial completed last year now in just a little that our senior chief medical officer doctor paul wayne that will give you some more insights into these trials and and more but before he does i'd just like to review what makes you know my son so important and why it is truly a next to jenna ration anthracycline anna my son was created at md anderson cancer center to overcome the well known problems of currently prescribing anthracite anthracyclines like doxorubicin and donna reeves since have been and continue to be cornerstone chemotherapy for a wide range of indications for sample they are for the vast majority of patients the first line treatments for advanced soft tissue sarcoma and for a module a smile on my was innocent leukemia
spk_1: but least heavily used anthracyclines can fall prey to multidrug resistant their limited in their use by their significant korean toxicity and their advocacy is further limited certain organs because of limitations in their pharmacokinetics which essentially needs they have trouble
spk_3: getting to certain locations in the body in therapy quantities
spk_1: well anna my son was specifically designed to overcome these limitations
spk_3: perhaps most significantly my son has little to no cardio you toxicity in fact in the first forty two patients we've treated that had been reviewed by an independent cardiology experts there has been no evidence of cardio toxicity even though thirty two those patients have been taken above the lifetime maximum allowable anthracycline dose level set by the actually eight and some have been taken to well over double that limits
spk_1: the bottom line is we strongly believe the absence of cardio toxicity coupled with the fact that animated typically outperform stocks are really seen in most animal tuner models
spk_3: means that anna my son has the potential to display stocks or with and sinner within a range of indication and keep in mind the doxorubicin has been a billion dollar revenue check and a dash line of animation also has the potential to go where current anthracyclines task at least not in therapy quantities
spk_1: what we call the unique organic tropic nature of in a my son allows it to accumulate in the lungs in animals
spk_3: in animal models at up to thirty times the level of doctor roots and and we just announced a presentation at the upcoming a a cr me de that will show a similar affinity for the liberal and we also have data showing this potential in the pancreas all this really does point to promising therapeutic potential
spk_4: but what really matters is phase to clinical data and here to talk more about that is our senior chief medical officer doctor way that paul no thank you wally
spk_5: as while he noted we have molecular and are extremely pleased at our progress to date
spk_3: our lead candidates and a my son has now reached the phase two stage of clinical development for a soft tissue sarcoma indications and we expect to reach phase two stage for a few my lodgings this leukemia later this year
spk_5: the current slides sunrise's our current status within a my son and soft tissue sarcoma
spk_3: as you can see we have successfully completed save one be
spk_6: with the identification of three hundred and thirty milligrams per meter squared as the recommended dose for phase two development
spk_4: amd
spk_3: we're now roughly half way through enrollment for phase two
spk_5: more importantly of the initial six patients and face to who have reached the stage of efficacy testing for of stable disease that's a sixty seven percent response room
spk_3: i should also note that in the study we were not evaluating and a my son as first line therapy the first line therapy of course would be expected to your the best results
spk_7: but rather the patients we're treating had an average of over four courses the prior therapy
spk_5: love this was a rather challenging patient population to be studying and yesterday we have a sixty seven percent response rate i'm finally and has been true of all clinical trials savannah my son and despite a respective methodical search plan
spk_3: we have yet to identify any cardiac toxicity for minimize in this for any studies
spk_5: moving on to our acute my lodge in this leukemia development we have now completed our to phase one mano therapists studies these were standard dose escalation phase one studies and are one of five study we were able to escalate up to a dose of two hundred and forty milligrams per meter squared
spk_4: administered on three consecutive days
spk_3: although this dose did not fulfill the criteria for stopping dose escalation due to newly identified just limiting toxicities in the patients
spk_5: we nevertheless chose not to does escalate further for three reasons first this was a model therapy trial and we recognize that it is highly probable if and when my son is approved for marketing for a cute my lodging this leukemia
spk_3: it will be as combination therapy out the reason our initial trials were not as combination therapy
spk_5: but rather as mano therapy for ft eight demands for new dress the second reason for stopping those escalation was that newly finished animal studies had documented significant efficacy for and when combined with sites hair a been when treating acute my logic has leukemia
spk_3: the final reason was that as as shown on the slide at two hundred and forty milligrams for meters for a dosing
spk_5: for of the five patients at either a partial or complete response that's and eighty percent response rate
spk_3: we have therefore move forward to be combination therapy stage of clinical development
spk_5: in patients with acute my and leukemia
spk_3: in the study patients with refractory or relapsed acute my in this leukemia
spk_5: are being treated with anna my son in combination with site arabic this initial combination clinical trial will begin with the standard phase one the dos escalation face once the phase one be has identified the recommended face to dosing regimen we will move on to the phase to clinical investigation
spk_3: as of this time we have five active sites in you are participating in this trial and we anticipate a number of other sites going active shortly we have already begun treatment in multiple patients in the phase one be portion of the trial
spk_5: and we anticipate reaching the phase two stage later this year
spk_3: and as was true and the soft tissue sarcoma study we have yet to identify any cardiac toxicity moving on to her transcription i you modulator ten sixty six is currently being tested in multiple phase one clinical trials and patients with various types of brain cancer primarily various types of glioma modulo blast doma
spk_5: these clinical trials have been and are being conducted that various prestigious medical university hospitals including md anderson emory university the university of michigan northwestern university
spk_3: these phase one clinical trials have established that eighty milligrams per kilogram is a safe dose and have documented both political
spk_4: and radiologic evidence of apparatuses although to data data are limited
spk_5: we are currently evaluating possible strategic partnerships and collaboration
spk_3: to assist and the development of ten sixty six and i should also note that we have received orphan drug designation for the treatment of brain tumors
spk_5: as well as rare pediatrics disease designation
spk_3: from ft a for ten sixty six
spk_5: finally i'd like to discuss their eleven twenty two portfolios these are our metabolism like oscillation inhibitors among the agents in this portfolio early compounds eleven twenty two as now finished his stays one dose escalation study and normal healthy volunteers
spk_3: this study established the safety of eleven twenty two and defined it's pharmacokinetics to that end this drug is now ready to begin phase two africa see studies we believe there are two potential avenues for the eleven twenty two portfolio
spk_5: first we have animal data suggesting it may have benefit in certain types of cancer
spk_3: which is believed to be due to the fact that cancer cells so heavily reliant on food source or metabolism
spk_5: in light of the possibility we have requested and were branded orphan drug designation from ft eight for the treatment of glioblastoma we also have clinical data suggesting that eleven twenty two will be beneficial in treating certain types of those potentially deadly viral diseases since many of the types of viruses that infect humans
spk_3: require modifications a little small of molecules being placed on their outer surface along those lines we expect to reports preliminary findings
spk_4: from n i h funded animal testing in the treatment of potentially deadly arena viruses in the near future going forward we are currently looking for potential collaboration opportunities for the eleven twenty two portfolio of drugs
spk_8: ah i will now through the call over to air chief financial officer john foster
spk_3: baseball as a small cap biotech for pleased with our cash position at forty three million dollars a year and which should fund us into that into the third quarter of twenty twenty four baseline should support the development of our studies to on the milestones i'll cover shortly and beyond
spk_8: we had an increase for twenty twenty three and our research and development to ninety million dollars for their increased political activity
spk_3: fat wallet especially paul just discussed we use roughly twenty seven million dollars in cash and twenty twenty three compared to ninety million dollars and twenty twenty two we expect expenses to level out and even reduce as you go into mid twenty twenty three and in this twenty twenty four so what do our efforts to bring us in the near term
spk_9: and am i to me the delivered on starting that these one the portion of her face when be too critical trial for use in analyze and in combination for the treatment of a young males and poland in italy
spk_3: which we expect to expand you at least one other country or countries and the in the you see you in twenty twenty three and we plan to announce the safety and efficacy by cold war and a phase one day portion of upon each cohorts conclusion and then open label phase two portions safety and efficacy data going from that point forward should be announced with each quarter results we plan to present the detail can be one of five clinical study reporters at a scientific conference or and a publication the near term expanding on the top line data already present it for the sts steagall aged us from we should announce the open label phase to safety and efforts efficacy data with each quarter and announcements and keep you up to date on the weekly doses of animations or the analyze and for all going on in iraq with regard to other court technologies we have the and i ate study with that just matches with a molecule coming from our wp eleven twenty two portfolio we should have those animals study results we also expect to further our collaboration is on treating gbm using wp ten sixty six and additionally for to be pete and sixty six which it's a top line results of that pediatrics phase one trolls and we expect that proud to expand into a face to now all these efforts surrounding eleven twenty two and ten sixty six will be mostly externally find it though you can see our focus with iraq own funds is on providing critical redoubts for animation and then your trump wally thanks lot john
spk_1: so let me conclude that prepared portion of the call by by underscoring the key attributes of molecular we believe we have the diversity and the multiple shots on goal of of really a portfolio company and yet we have the focus and near term opportunity and frankly the blockbuster potential of a drug like and of my son
spk_3: and we're operating with a highly qualified and experienced management team with multiple development successes on our track records and coordinating a global network of a truly world class experts in are targeted indications most importantly we believe all of this is now culminating in twenty twenty three becoming what we like to call the year of data for molecular and and finally as john just pointed out we have the cash we need to deliver on a date
spk_1: but like to leave you with with one last thought before we dive dive into culinary
spk_3: the last major development in anthracycline therapy was a drug called six years and vic's use extended overall survival for a subset of am ill patients by three and a half months
spk_1: the story of that company feels a lot like molecular and up to this point nobody was really paying attention to them the stock was languishing around a dollar and it seemed like they have been toiling away for ever but then seemingly overnight they started reporting data that kind of data that had the potential to lead to a new drug approval
spk_3: and within months jazz foreigner agreed to pay one point five billion dollars for the to us my message to you is that the molecular teams firmly believes that anna my son has the potential to become the next six years and frankly we believe it will be much more important than decks yet
spk_0: if you're right about this now is definitely the time to be paying attention to molecular so thank you for your time attention and and let's open up this called to to and agent that you would have gotten your question answer session if you actually place in the question que please press star one hundred telephone keypad confirmation within the casual i was in the question que
spk_10: i'm a press start to if you like to move your question from the queue for participants using speaker equipment may be necessary to pick up the handset or take your phone off new before pressing star one one moment please for we pull for questions the first question is coming from jonathan ashraf from roth i'm camera candlelight is allah
spk_3: he questions if you with bear with me
spk_10: ah so we'll get more sense to us sts l data a prior to topline certainly sounds like mind final data this year
spk_3: and my question is what gives your conference at the twenty eight patients will be pivotal when on the best result we've seen a stable disease and five of the six patients taking two cycles with to treatment experience to remain on and my son he might you have to do another trial in less treatment experience patience to sidestep that milo suppression on fire and what kind of hurdle would that be to ask for such a patient population
spk_11: church that in jonathan thanks thanks for the question that as as you well know this is a pretty important subject matter i'm i'm going i'm in a lateral distance to paul
spk_12: who is neil really the resident expert on our regulatory strategy and and where we think of this trial goes in the future so tall you want to tackle this one
spk_3: thank you the or you'll face ah the chances of ever getting a feel your approval to market destroyed based upon our current trial or great as this is the
spk_5: phase two segment in a limited number of patients
spk_13: however i think to dig the we're seeing around really encouraging for a number of reasons
spk_3: these patients had been through many prior rounds of chemo therapy so these were not the best candidates despite that fact truth of the initial six patients for to the six have stable disease and are continuing on and
spk_14: that's an impressive number in that if you look at the literature there have been a few randomized placebo controlled trials
spk_3: in soft tissue sarcoma where patients failed one force not work for us it's strictly for for courses for just failing one force and then going to placebo use have a progression free survival of six weeks as the average and yet we are going to be when these for patients reach twelve weeks from the next efficacy in an hour
spk_15: says even if they were found to have progress and that's twelve weeks us twice with a placebo would get in a very poor patient population so we believe we are seeing wrong evidence of efficacy we think
spk_4: these data
spk_3: strongly suggest that this drug be worthy of proceeding to a pivotal trials the design of the pivotal trial would be dependent upon the to tell of the of the drugs results in the study applause
spk_10: collaboration
spk_3: with t opinion leaders and then meetings with that's the yea but we we think in his core a patient populations were studying to get the results we're seeing is an indication that we are hopefully only one file away from
spk_16: being able to files to submit for m india
spk_3: okay discuss the press release says pivotal their which would have to be from an ongoing trial so that was that was confusing for definitely another trial would be armed needed and would you sleep less treatment experience stations to see outside the smile as depression oh yes we are treating these patients because whenever you doing year and if of initial efficacy study you there's competition for patients and you have to sort of documents to the investigators this drug is essential and so you don't get the eighty second airborne of patience but we think these data are going to convince a movie presented them with to investigators they are impressive this drug has great thousand see our high believe for most patients with soft tissue sarcoma the initial chemotherapy is ducks ribosomes and we thank for all the reasons wally john and i have stated were better drugs and doctors and we don't have
spk_10: final definitive proof of we believe that that's where we're going here and that if these data continue that we are hoping to show that we are strong alternatives to ducks where the sun
spk_3: for this invitation okay so and as far as the primary efficacy and point for his trial is concerned there that the only mentioned on clinical trials dot gov is not you know in in light of any a slender pine is resist or are so is that the and point here cause you're talking about falling taste and so are often the most of whom are off drugs for pss but there's no mention of primary endpoint you know slides in the clinical trial does god site know what is the primary endpoint for this us as csl on trial ah what we are looking at progression free survival i would point out agenda with this is not with it's highly unlikely this is gonna be a pivotal trial or the final civil trial that is gonna be the of the the much less so for from our perspective we're looking at everything we
spk_10: we are evaluating all and points and when we finish our analysis of all the young points ourselves with t opinion leaders and into the f the a we would then determine what's gonna be or primary endpoint after determining who are patient population will be so far is too early to defend sibley states what's going to be or primary endpoint in her final trial that's why we're doing this for are we doing this route to identify the patient population with dosing and the and point we've already identified dosing we found it's three hundred and thirty milligrams per meter squared and now we're continuing on to identify the patient
spk_5: population and the young points for the next and hopefully final trial
spk_3: okay the last two the first ones quick can use how are so low dose used and cohort one of the u s t s l am trial that's a short one and can you be in any way explicit about this anthracycline cardio talks paper ah you know explicit return to that paper the my wife rockies of attention to ah as far as the european study that is an investigator sponsor trials we are not running that rao the investigator is the dosing is entirely different and we do once every three weeks they're doing more of a daily of for a second of days oh they are starting because it's daily at a very low dose of i think it's thirty milligrams per meter square and they are to say want us to listen they're gonna increasing the does though no it's and be very difficult to compare their dosing regiment two hours additionally as far as the cardiac toxicity paper it was a review of all of cardiac toxicity and anthracycline star therapy with what i would say to define our cardiac toxicity i think i mention when i was describing where we are that we have much article he looked for cardio toxicity we have done that by doing sequential made your months of a certain of certain enzymes troponin which when the heart is damaged these go way up we and nice the go up the stay at we have not seen that more importantly the ultimate cardiac toxicity with anthracyclines is they don't damage the electrical system you can think of the hard it's two different things and electrical system that makes the heart contract and it's the muscle the pump pump the blood would anthracyclines do they impair the ability to fuck me most of us with a healthy heart steve five percent roughly of the blood in the hearts is pumped out into the a water with each puff two thirds of the blood is pumped or each time with anthracyclines as the does it the she was just as up the starts to fall so we have done measurements of the amount of blood pumping out each time is done by you do it with an
spk_17: echocardiogram and we have we have obtain these we have sent these two outside experts for them to outside experts cardiologist review and to give us a number and with they have found in every for the today is that the ejection fraction before the first dose of man for cycling rim
spk_3: maine's the same throughout the study
spk_1: within reason and it may go from sixty five to sixty six or fifty to forty nine but it never changes significantly overall the means are the same so we have diligently sought any evidence of cardiac surgery in all of our patients and all our cancel trials we have not found a single one of the face to date that doesn't mean that at some point in the future when the number of patients systems from fifty to two or two hundred and fifty or whatever we want see an occasional one that says major cardiac toxicity problem which limits the dosing of anthracyclines we have not seen any evidence of it to date
spk_3: and and johnson i just a job just i would just as one of the things i think that's important about that paper is you know you you think you you know this well that there are a couple there are a few other anthracite me
spk_10: the projects out there that try to make claims as regards have reduced cardio toxicity and what we sound is sometimes we get conversations with people that there is some confusion that they the a think there are other non cardio toxic anthracyclines out there i see i think this pay
spk_18: aber sets the record straight
spk_0: tip to date to our knowledge into the knowledge of those authors there is no other drive it comes even close to animation in terms of it's it's level of non car your toxicity so the i sliced i like the fact that this is now been set forth in black and white and we can reference it to to dispel any myths
spk_3: that there are would be non cardio toxic competitors out there yeah sounds it sounds like a very useful manuscript i'm serious
spk_1: thanks johnson
spk_3: they can next question is coming from jeff jones from oppenheimer your line as allies
spk_5: good morning guys are thanks for taking the question ah major couple of questions
spk_3: hey guys are couple questions to build up what kind of them was talking about on at the sts study ah in what it is a you have that sort of a hurdle rate for watching fully that are clinically meaningful impact on progression free survival i'm down with then trigger used to move him to pivotal studies yeah that's the obviously and another paul question put please take it away paul ah yes it's always difficult to define exactly what will lead you to go forward i warm close potter stewart's definition of another thing but i'm it's not a combination of how good or is the progression free survival than the average and how narrow or the standard deviations i would
spk_19: thanks that if we are able to double what would be expected with placebo which is six weeks
spk_3: that's a very strong indication to go for because against those ah six weeks progression free survival and placebo arms those were second line therapy and we're nowhere near second lines were far beyond that so if we can be ballpark dublin with placebo got then i think is is time to go forward agree s avoid okay and just to clarify when you're saying placebo that it's not actually placebo but standard of care is that correct ah know ah there was there were actually other studies with standard of care the didn't work which were six weeks bigger studies from a while back
spk_1: god damned
spk_20: but there are there are as if you there's been with few articles out there and i don't wanna play one after over another but if you do searches for review articles from some my friends ah
spk_3: you see frequently six weeks for for a for either placebo or for certain drugs will not tell you that those drugs don't work of all so i think we can confidently say if you have such as you sarcoma you have failed primary therapy
spk_1: nothing is done in six weeks radio logically that will be documentation you have progressed
spk_3: and ended up society i'll you as it's just as i think you might know already and by the time you get to fourth or fifth line and in these patients the really is no standard treatments at that point it's it's like investigators choice and it's a wide range of the as desperate experiment city walls fair enough know he created the occasion
spk_1: hey jeff this is drawing we reference said that paper in the ten k i'll be glad to since to that week the actually provide the paper reference on at once on that placebo trial okay now that's great i'm on the am side ah now looking at plus i terror been so you're doing a dose escalation top demise does ah
spk_3: is in so i assume that following that you would look at an expansion states to and then similarly s
spk_1: if that looks good move on to a typical study am i thinking about that right
spk_3: yeah let me let me let me start a kitten let me sort of take this off and pollen always invite you to to at you can't whatever color you think is important but
spk_1: justice just as a really
spk_3: in i'm really glad you asked this question particular because it gets down to when and how we might be generating treat pivotal data on we don't want to get ahead of ourselves and we want to be appropriately cautious here but with with an overview umbrella of caution when we think optimistically about what may happen in this trial and that informed by the strong response we had as as at at in the mana therapy trial
spk_1: on
spk_3: it's entirely possible that we and
spk_5: we truncate the same one be portion or this trial in other words if we start to see strong activity at the current one have one ninety milligram dose level it's not it's not of the question that we call it and say you know that's good enough for an rp to the and if it is
spk_3: in a move more quickly interface to and if we continue to see that sucks that hoped for level of response in the face to expansion face it may make sense for us to even truncate the expansion is and and in such collect our data go to the regulatory authorities talk about the the capital trial design more quickly than one might otherwise expect so as again we're not predicting that because it's still too soon to make a prediction like that but why want to make it clear to people that's a possibility of okay no of air appreciate that and still am your family if i guess is that when while he said or that's exactly what happened in our one of five study in that as i mentioned when we got to to forty we did not have the l t v protocol says we were allowed to does escalate further but we looked and said look we got advocacy for the five patients ah we don't have toxicity we found a good recommended face to those we're now going to be doing the same thing with combination therapy and we pick sides tara because the current standard of care first line therapy is an episode and for terribly though we're going to be doing this combination of while he said we will look at each dose and cohorts for both safety and efficacy and when we think we have hit a dose that would be appropriate to expand we will do it then and there whether or not we have a dlc problem it's a combination of safety and efficacy that will lead us to go forward the nice thing about leukemia as opposed to solid tumors solid tumors is a little bit more difficult efficacy you're having to look at stand see how much did it grow here you do the bone marrow and say is the cancer gone yes or no but based on the percentage of a blast sell sell it it's a move very quickly alien leukemias as opposed to ah solid tumors were year over time studying scams got it okay so we're all as to more questions and then get out of the of way so other phelps and a kid can ask
spk_1: a as you outline does two different scenarios for the ml studies ah i'm sort of a best case the as you move quickly into a sage to and then truncate that to have a dialogue with the agency vs say the anticipated with some joseph
spk_3: escalation the and then a larger face to weigh on what type of time frames are we talking in those two scenarios and then the second question for john on the financial side on just how should we think be thinking about the are the spend transcend to one at twenty twenty three and and moving forward term limits in this while and needs mommy maybe kick off the discussion about timing but of i'll defer the power if he wants to tighten what i'm what i'm about to say so if we if we go down the let's say the most optimistic path of what i described where we truncate that phase one be and we even truncated faced to expansion and practically speaking
spk_1: dos escalation cohorts the as you know go three by three right so by definition you got to recruit three patients and then you start recruiting because you have to let those patients run their course meet the did the deal t
spk_3: you know cut off requirements and and so forth so there's it was a natural lag that's built into a dose escalation portions of the trials and and so ears you really can't be more than a couple of months of you can't be faster than a couple of months for cohort just because of lots of this practical considerations even if he had patients all waiting in line then the next question is how quickly can you recruit into the expansion phase and that's why we we we added italy to to the roster here and works we're looking at the possibility need adding more sites candidly this the recruitment has since it's stronger than than we expected and
spk_5: it's it's it raises the spectre that we might not even get those additional sites open before we get to the expansion part of this trial and that's that's good news that that's good for us
spk_3: what i'm trying to give you a sense of cadence here and and and so if if if that holds if the current rate of of a recruitment holds in a we could be looking at taking up you know eight or nine patients in the expansion phase in the span of let's say nearby and by midsummer of now that's that's aggressive and that's that that's what that's what if thing if if we stay at the pace we're seeing right now and and it does vary from time to time so we can't rely on that the best i'm trying to give you a sense of how quickly you could happen now in terms of how long can happen i mean it you know that the sky's the limit but practically speaking if we really decided we wanted to run the the run out of fool expected size or plan size of the face to expansion phase you back to take the rest of the year
spk_21: and at were longer if the if for some reason all of sudden recruitment falls off so on the on along and it's a how high is up but on the short end i think you can see why we're feeling like it's entirely possible by the middle of this year we could be talking about and a phase one meetings
spk_0: with with the agency's so weak that's why we think this is such an exciting time and and why we want people like you focused on what we're doing because it's gonna what's gonna happen relatively quickly we think
spk_1: great really recover wallace yeah i would you say i agree with a while he said there two things the drive how fast as would go that is how fast or investigators recruit patients in as wallace's we're very pleased and how good is their drug in as we have and say did today we're very pleased with their drugs so we are often mystic
spk_3: john you want to tackle the idea that they are the spend part of that course and chirp chirp know have yeah you should see the the levels riyadh and the third and fourth quarter continue
spk_0: both and already and je ne in the first two quarters and then it should drop off you have initial payments to zero zero as you start of the trial said

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