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spk_0: thank you for standing by and welcome metallic their about of sciences fourth quarter twenty twenty one earnings call at this time all participants on a listen only mode after the speaker presentation there will be a question and answer session to ask a question during the session you will need to press star one on your tell us phone please be advised that today's call is being recorded should you require any further assistance please press star zero are an allied to hand the call over to stephanie wong chief financial officer please go ahead
spk_1: operator
spk_2: after line
spk_3: or fourth quarter employing twenty twenty one don't you mean by minute former president and ceo and imo yeah can keep medical officer earlier this afternoon we'll see perpetually for it included an overview of or fourth quarter in philly or twenty twenty one financial and operationally not which can be accessed our website and calendar that he finally began i would like to remind you that today's discussion monthly statements about our future expectations plans and past that they constitute forward looking statements for purposes of a safe harbor provisions under the private securities litigation reform mocked of ninety ninety five as a result may differ materially from as indicated by these forward looking statements as a result of various important factors including those disgust in other factors such as her periodic filings with the f b c in addition for looking statements represent are the only as of today and cannot be relied upon as representing our year as have any subsequent the while we may elect to update is forward looking statements at some point in the future we specifically disclaim any obligation to do so even of our views change please note that this call is being recorded and without of time the call and witticism thanks deafening good afternoon everyone and thank you for joining us for today's conference call twenty twenty one with a transformational year at cal kara as we took several critical step had transitioned the company focused and core program to developing therapies for biomarker specific patient population while continuing to leverage the company keep expertise in clinical development for targeted small molecule cancer therapy
spk_4: in october me and now the acquisition of to critical stage assets from the qaeda live without nip and am a certain my vote there is a green card keratin tiny are thick inhibitor the target the constitutive reactivated be cell receptor pathway and diffuse large be sell them for
spk_3: emma and other non hodgkin lymphoma in completed safe one to clinical trial live without me showed promising single agent we started with deep and durable activity in and selected patients with the lp yelp air and missile development will be in a b c or activated be sell a b c l where b c are signaling and the cat
spk_4: predation or central driver
spk_3: my vote nibs showed a substantially higher with pumphrey in ab c compared to g e the lp cl with a fifty three percent oh our our our overall response rate in a b c compared to a twenty two percent of our our into cb the lbc out in a retrospective analysis of completed trial has it's data and in addition recent preclinical studies have shown and have the activity and sensitivity to fit inhibition in the and we'll be l and other non hodgkin's lymphoma harboring mutations in mighty eighty eight and door see the seventy nine they comprise the to think tonight a subset as a b c d l b c l known to have poor outcomes with standard of care therapy approximately fifty percent of all a b c dlp feel tumor have one or both of these mutation my development has the potential to be the first to market therapy for patients that are genetically define subset of the lp yeah the compelling single asian overall response rate in aden see bld yell and potential for further enrichment of single each an activity in the genetically find subset of a b c e o bpl with mighty eighty eight or six seventy nine mutation we believe provide the well defined efficient development path to potential single aids and accelerated approval and with population some had a thirty as is a tool and talk one to inhibitor the targets a key survival mechanism and keep one or nerf you to mutated tumors should have a thirteen had demonstrated promising single eighteen activity and patience with relaxed or refractory nerve to mutated screen as non small cell lung cancer it is a differentiated molecule from other and tour inhibitor and if the only inhibitor to have strong single eight and activity and nerve to mutated screen a small cell lung cancer nina nerve to cases the current approximately fifteen percent as claim is now small cell lung cancer and can for a poor prognosis for the patient we believe the tenth circuit has the potential to regret a substantial underserved patient population and has the potential to be the first treatment for nerve to mutated claim it nonsmoker lung cancer we plan to initiate the to teddy's a boat with have affected and my development in the first half of twenty twenty two we also present data from our faith one be trial a tv to eighty for the treatment of cystic fibrosis at the north american cystic fibrosis conference in november of last year the data showed that bbq a with well tolerated demonstrated linear pharmacokinetic and show complete and continue with target inhibition in plasma at directed at or above one hundred milligrams keeley to eighty also demonstrated robot franco dynamic effect with rapid and significant doubts proportional increases in platinum archon the key driver of nitric oxide production enrollment and analysis of all for how how homework is now complete and evaluation of next step is ongoing turning to our preclinical pipeline we continue to advance are internally discovered preclinical pipeline of synthetically thousand pounds vpn for a and vps for be are paralyzed gain and loss of one or the other car a lot and cancer felt his synthetically lethal are gps for program is the most advanced synthetically how the program we have and we recently announced that we will be preventing a poster on the discovery of novel the yes for a small molecule inhibitors at the upcoming a he are meeting in on it i will pass the call over the emo now to go into his additional detail on our clinical program we're excited to realize the potential of my vote in it and then circuit in biomarker defined pretend population by focusing on well characterized genetic vulnerability with molecules that have already shown single eighteen activity we believe we will be able to generate paid to data that targeted efficient study design he plans to share data from the study by the first quarter of twenty twenty three
spk_5: they could do than i'd like to start today by providing some additional detail around our clan face to trials of my the vote met in patients with the last refractory a beefy deal b c l within without mighty eighty eight or cds and benign be mutations as well with an assertive in patients with relapse bright bribery or to meet eight it's queen it's not smoke the lung cancer starting with my vote be planted initiated phase two trial in the last with raftery naji cbd a be c as defined by the on the algorithm which captures all a beefy the ah be feel and we will enrich for mighty aid agencies and nine be mutated to using liquid and us testing patient be right randomized to either a standard dosing schedule with one hundred milligrams que daily or an induction dosing schedule which is the hundred and twenty milligrams to daily for fourteen days followed by eating against que daily apathy data from this that he could position the company to initiate a registration will study which would potentially and local words comprise the patients with ninety phoebe the be feel and or mighty eighty plus she's new nine be mutated deal pcl with the primary endpoint of overall response rate such a study would target and accelerated approval pappy for my the vote neb as a single agent in the biomarker defiance upset he planned to rapidly pursue combination strategies with novel and or standard of care therapies to further expand development into early aligned with therapy and be obese yell additional pets for monotherapy and combination development include while from sniper club with india and other indolent lymphomas where my the boatman has shown compelling thing legion responses and previously complete a trial now turning to spend assertive we plan to initiate a face to study of the benefit good monotherapy in patients with nerve to mutated scream it's not want the lung cancer hobbling either while type or mutated nerc to have detected by next generation sequencing this study will strengthen the existing data and then inserted not a therapy and patients with claim is not what the lung cancer with the nerve to mutation and also values it's activity in or to while types claim it's not my lung cancer the objectives of his place to a study will be dose refinement and confirmation of the selected activity in nerve to me the tumors compared while that tomorrow the validate your to mutations and selection biomarker we believe that a face to a if successful it would enable us to initiate face to be which could be a registration or study in newark to mutated scream is not smoke the lung cancer cells could development in screen is not worth of lung cancer could involve monotherapy and or combinations would stand it get therapy in our the lines of treatment within the biomarker define population including both nerve to and keep one me if be tumors no to and keep on mutations have been detected across several to my type providing additional indications for development of with a certain as monotherapy and and combination beyond squeamish not not the lung cancer so with that summary i'll pass it up in stepney for an update on our financial
spk_3: thank you i'm on good afternoon everyone detail financial results were included in today's press release i will briefly with you or results and his caught on a cash and cash equivalents of fifty nine point five million and december thirty one twenty twenty one which we expect together with proceeds homer recently paid ten million dollar public offline will be sufficient meet our operating plans to the second quarter of twenty twenty three or in the expenses for the for your twenty twenty one one fifty three point four million compared to seventy one million in the prior year the decrease was primarily due to tell atlanta that program or in the expenses for the fourth quarter twenty twenty one were thirteen point seven million compared to seventeen point one million for the same period last year are you the expenses related to acid acquisition for the four year twenty twenty one where fifteen point nine million detour acquisition it's the panda circuit and my middle name and the fourth quarter which was comprised of a cash payment of ten million dollars and four point nine million attributed to the value of the preferred stock we reissued he added expenses for the for your twenty twenty one which one point nine million compared to twenty point four million and and prior year he and expenses for the fourth quarter of twenty twenty one where four point six million compared to five point six million for the same period last year yeah boss with three months of nearing as december thirty one twenty twenty one was sixty nine point two million and i read and fifteen point one nine respectively and without i will not return of that over would assume thank you stephanie and but that operator were happy to in the line for questions
spk_0: as a reminder to ask a question you want to press start jamming your telephone to withdraw your question press the pound key please stand by while we compile the q when a roster our first question from from a line of jonathan chang of scb right
spk_6: your line is open
spk_7: hi guys or take my questions first question can you provide more color on the status of the planned face two studies from i've of on ned and support assertive to the remaining steps to get the study started
spk_5: yeah i don't than i can answer that so the study asian is proceeding really well we're actually repel tracking both the transfer of these programs from decade as well as the study start process i'm over the last several months for are progressing goes smoothly for their complete on and we've essentially the transfer productive as well as regulatory review that both that he'd have been completed and were well underway to get the advice of activated though it's really just straight ahead shot brutus light activation from and roaming which is why we're still guiding to the data in one to twenty three
spk_7: got it and and second question just following up on on your lap on on that last part of your comment on can discuss reasons for confidence in a clinical execution of both of these programs such that data for both will be available by first quarter twenty three thank you
spk_5: sure yeah and that confidence really arises from the fact that these are very very clean biomarker defines the populations which are well characterized and the patients in turns out there are the clinicians knowledge of their a genetic for their for their biomarker status as well known i'm specifically with regard to disclaimer lung cancer nerve to get subset while the patients get to her sequencing they are in the front line and so in terms of identifying patients for the realize for i agree study were working with sites that have very robots curated local databases and yes databases for their patients that can allow for rap it identification of both newton and while patients and we're leveraging are a prior experience running the keep a trial and including relationships with them with the various you know and yes vendors and infrastructure that we developed as a in that study to really at the ground running for that because of a lot of confidence in terms of getting to that with with my the voting and with a similar story a feel b c is a a distinction that that is known to run diagnosed with onwards and still and terms of finding be patients it's well known from of their clinical history whether they fit them in a non gpp flash eighty three label and the fact that we're using liquid ngs again to enrich for mighty a fetus and ninety mutant patients again from the timing and efficiently standpoint allow for rapid an aggregation of those two asian as well we're working with very well experience sites in terms of lymphoma be the sheets who had i already use the dragon previous studies and and and very large centers where they know have high volume the patients that are also characterized genetically at the local level though the selection of sight and both the
spk_4: he the the streamlined in order to make sure that we have a high yield the patients from every side effects
spk_7: got it thanks for take me questions
spk_0: sure
spk_5: thank you next question comes from roger song of jeffries your question please gray i things you are maybe just as quickly follow up on that she'll face to trials on in the initial day that you once you wash your what your bags anna how much data we gonna see if found that initially dogs also and walk hell of a day that add the face today the ultimate today well she they're huge move forward to the registration or trial as you mention right for the the know that the benefit we have here is that both the the molecules already have pre existing data showing that they're both fairly active at a single agent and we know that the number to the doctor response rate from those prior study that that that gave us the contradict to get them in the first place i mean in terms of the fact that decision overall response and coin study that open label and we'll be seeing the data in real time with a lot of flexibility in terms of you know that the type of data that will be so i think in terms of the fact that this is the rapid to had time to responses for both molecule as the typically in my vote let me know that responses tend to happen very quickly within the first one to two cycle and the same thing that really theme for the an assertive in previous study so the pines fermentation and rolling to meaningful as the could be data for each station it for
spk_8: he short on and go that being said and given that the numerator in terms of or our is already family i've actually photo a former and the geography of getting on give us a lot of i'm confident that we could have a meaningful dataset by the first quarter twenty three
spk_5: gotta okay or maybe just as quickly touched on their the city to to eighty so you'll have finished deaths local high and the doing them they don't let this out what would you and now that they that this year on and out what could be the path forward as good as you're exaggerating next that spawns as couple right so with that molecule again the dose escalation of completed in terms of the data from the pile covert he analyzes the trend that we saw and reported on in the first rebuilt level with regard to ah front the dynamic effect argentina and treated as well as trends in at the of an effigy one where eventually maintained and that but our final goat level go again that the the overall trends continue to stay consistent and definitely either at the option to present that data at a later time point where continuing discussions with
spk_9: or advisors the cystic fibrosis foundation as well as deputy development network on in terms of how the data could best inform the design of a potential you know face to those finding tight study and in those discussions are ongoing i know
spk_0: got and give to give up in the question
spk_5: they charge face thank you again to ask a question please press star wanting it has some telephoning and that star one on your test on telephone to ask the question or next question comes from are they of hc wainwright please go ahead a good afternoon everyone the the authorizing for okay oh so i just want to follow up on are those to face to study you guys going to initiate i'm could you repeat the their optimization of those the regiment for it i'm a mother about to nab as and the i wonder are is similar those are optimization strategy gonna apply to the of natural said ah you for for the the study
spk_4: yeah oh great question for yes both studied do have an element of those refinement included from my vote neb again the fact that out these molecules and that expensive i don't schedule work done previously to to caters studies give us a really good starting point and this is really love of fine tuning
spk_5: especially because we're going to find like a defined populations of for my the voting of the to those level of the hundred milligrams today is the previously established recommend decrease to dollars from our pride of escalation expansion file wifi an opportunity to explore a further dotan strategy specifically an induction doping strategy and that really taking the advantage of the molecules pk properties any that it had are you know pretty long half life it as the night high volume a distribution and considering that time we based on our analysis of that molecule it hit it has a tendency to accumulate in tissue and specifically tumor in large concentration that give you an opportunity to evaluate a strategy where you get a large all of drug in on quickly and be aggressive tumors to get rapid disease control and once you get to a response back off to it's still active but more tolerable long term doping strategy to maintain that response this is not unusual in the context of lymphoma specifically other approved drugs you debate the my approach that we wanted to explore that know taking advantage of the fact that the mods was property dirty make it amenable to evaluating that for satanic thirds of it's a similar sort of fine tuning that we're doing the three milligram que de jos is that if the i don't that was previously studied and actually showed the ftc signal in nerve to mutants claim pace and again based on the molecules critique a property namely a shorter half life with a top profile profiler we know that more the gee i'd toxicities are more see match related and that you might be able to get to our oh higher cumulative exposure by using a lower be id don't schedule mainly to be id could get you improved african feet with the maintaining the the very good tolerability profile that we are he feared being on against the daily dose of those are the rationale for lie were doing other doing with the guy kudos refinement but again we think that it because it's a fine tuning and not repeating for example of for those escalation it can happen very quickly and in parallel with getting getting the ftc data of think you think it's really helpful and the so i is for your new a vps for a pro the had been approved them on to do give us more color all regarding the prevalence of the dps for the deletion the been different cancer type and there our so how soon can we expect the these program and advanced into the clinic think it i could i could give you the prevalence so in in the homozygous policemen vps for be a craving want to be percent of all our tumors are the heterozygous deletion as much more prevalent our and the higher against the company two thirds of the typically colorectal cancer and pancreatic cancer on the heterozygous deletion and there's evidence to show that them the dependence the increase dependence on vps for a it is still high in the heterozygous deletions a vps for be given you a substantial opportunity to evaluate a very large
spk_3: set of tumors and a large subset of colorectal and pancreatic a minute left is an answer your second part of your question
spk_4: well we're preventing an hour early data i had a vr next week and we i do have a vps for inhibitor and where i'm living those molecules howard killing lead optimization hand ah me hope to continue to advance of programming can give you for
spk_5: you tour guide you some on me my pin clinic
spk_0: awesome thank you thank you for taking my question
spk_3: thank you this time or like to turn the gone over to says molyneux for closing remarks mouth
spk_0: thank you and thanks to all for joining us today and have a good evening
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