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spk_0: that afternoon ladies and gentlemen thank you for standing by and welcome to the corvus pharmaceuticals fourth quarter and four year twenty twenty two business update and financial results conference call at this time as a pencil be in illicit only mode later we will conduct a question and answer session in instructions were fellow at that time it is now my pleasure to turn the call over to sack kubo of real chemistry please go ahead sir
spk_1: thank you operator and good afternoon everyone thanks for joining us for the corvus pharmaceuticals fourth quarter and full year two thousand twenty two tickets update results and school on the called got the result the business updates or richard miller chief executive officer like play chief financial officer and james rosenbaum senior vice president of research the executive team will open the call with and prepared remarks followed by question and answer period i would like to remind everyone that comments made by management today and answers to questions will include forward looking statements for that these statements are based on estimates and assumptions as of today and are subject to risk and uncertainty that may cause actual results to differ materially the know the expressed or implied by those statements he could the risks and uncertainties described the porpoises annual report on for ten case it was filed today with the f b c and other finally the company makes the the fcc sometimes time the company undertakes no obligations to publicly update or revise any forward looking statements except as required by law the that i'd like to turn the of the to late night live
spk_2: thank you that i will begin with a quick overview of our fourth quarter and four year twenty twenty two financials and then turn the call over to return for a business update research and realm expenses in the fourth quarter twenty twenty two tone four point one million dollars compared to four point eight million dollars for the same period and twenty twenty one the decrease of point seven million dollars was primarily related to a decrease in personnel coffee are the expenses for the full year twenty twenty two totaled twenty four point five million dollars compared to twenty nine point one million for the four year twenty twenty one the net loss for the fourth quarter twenty twenty two was nine point eight million dollars including a four point six million dollar noncash loss related to angel pharmaceuticals compared to a net loss of nine point two million dollars including a two point six million dollar noncash laws related angel for the same period and twenty twenty one the net loss for the four year twenty twenty two was forty one point three million dollars including a ten million dollar noncash loss related angel compared to a net loss of forty three point two million dollars including a four point eight million dollar noncash loss related angel for the year twenty twenty one total stock compensation expense where the fourth quarter and four year twenty twenty two was point six million dollars and two point seven million dollars respectively compared to point seven million and four point two million for the same period and twenty twenty one and december thirty first twenty twenty two course that cash cash equivalents and marketable securities totally forty two point three million dollars as compared to sixty nine point five million dollars at december thirty first twenty twenty one looking forward we expect four year twenty twenty three net cash used and operating activities to be between nineteen million dollars and twenty two million dollars at the midpoint this is a twenty four percent decrease from twenty twenty to demonstrate our continued focus on prudently managing our cash burn rate by focusing our most promising opportunities and establishing collaboration of that helps support development of our candidates based on this trend in our focus on cpr eight one eight we believe our casual provide runway and do twenty twenty four i will now turn the call over a richer to elaborate on our strategy and plans
spk_3: thank you lazy and good afternoon everyone thank you for joining us today for our business up they call today i will start by highlighting three important new developments that we believe further underscore corvus is opportunity to advance cp i eight one eight in oncology and support our prioritization of this program first strong data enrollment in our clinical trial is accelerating and data in the peripheral to someone former continues to be promising with durable and deep tumor responses in addition we have identified a biomarker that should enable us to select patients most likely to benefit from cpr eight one eight which is important as we plan for our next trial to which brings us his second new development pathway to registration on trial in a recent communication the us food and drug administration indicated that they would like us to request a meeting to discuss a randomized phase three registration clinical trial for cp i one eight we anticipate this meeting will take place in the next few months and third expanding to solid tumors we will present you pre clinical data at a cr demonstrating that eight one eight stimulates anti to her immune responses to solid tumors expanding the potential of i tj inhibition in cancer
spk_2: with that as an introduction i will now review the momentum we have built with eight when a it over the last several months and the key elements of plan development forty seven former
spk_3: cp i one aid is a very specific oh valence i k inhibitor and binds to i tj similar to the way i bruton it binds to be tk we believe the opportunity with cpr yea or nay to target t cells is similar to that of dj inhibitors and eighty city twin he antibodies that target be sells for the treatment of the salon foam as an autoimmune diseases we are using a similar playbook data in lymphoma accelerates development and then we expanded to other cancers and immune diseases our understanding of a function of i became immune system has been strengthened by our ongoing t cell lymphoma clinical trial and buy additional laboratory in preclinical animal studies simply stated as we learn more we believe eight one eight has brought her opportunities and multiple areas including solid tumors auto immunity and allergy we have shown that i a is a critical targeting union system playing an important role in t help or cell differentiation specifically at the ash meeting in december we presented data showing that cpr eight when a modulator the immune function of t cells by blocking both th to and th seventeen self and skewing towards h one cells this is especially important for cancer therapy because th one cells are rico wired for elimination of tumor cells and th to mph seventeen cells are the culprit cells responsible for many auto immune and allergic diseases we are not aware as any other selective i seek a inhibitors currently in clinical development and we believe we have a strong intellectual property position covering a one eight i see it k inhibitors and methods of use based on all of this we have prioritized the development of cp i won eight and have a focus strategy on t some farmers to efficiently bill value with our existing resources diving deeper into scientific and clinical momentum for cp i won eight we have checked the number of important boxes that the risk our lead indication and confirmed abroad potential friday k inhibition across a number of diseases we successfully elucidated the dosing biologic and immune effects of eight one eight in vitro in preclinical models and in our phase one clinical trial this is particularly important with regard to dosing as the induction of t h one skewing requires different dosing than general blocking of t cell receptor signaling a concept that we have pioneered in cancer are phase one t solemn former trial is demonstrating activity and patients with refractory peripheral t sell and former or pt cl since the last data update at ash in december enrollment in the two hundred milligrams cohort has continued and accelerated as of february fifteenth twenty twenty three twenty patients has been enrolled including thirteen a valuable for tumor response the updated data highlights are as follows there has been one complete responses twenty four months duration one equivocal complete response of thirteen plus months duration awaiting a pet scan for ca affirmation of see cr this was for my patient who had a previous partial response and has continued to demonstrate tumor regression there's one note or complete response of twenty one twenty one months duration and a partial response of seven months duration ten patients continue on therapy including seven who have not yet been evaluated for tumor response the swimmer and waterfall to plot for these patients are shown in our fourth quarter results press release issued today the goal is to present updated data from this cohort at a medical meeting later this year most likely at the international conference of on malignant when farmers which is meeting in june and lugano switzerland further supporting this opportunity we believe we have identified and important predictive biomarker that should allow us to enrich our trials for patients that are most likely to benefit from cpr yea or nay we now know that eight one eight induces a host anti tumor cell mediated response that requires normal functioning t cells we have observed that a minimum absolute with a psych out or a i'll see above nine hundred per cubic know a leader of blood is required for response normal lc ranges from one thousand to four thousand today's press release summarize the some of the data briefly for of eight patients with they'll see above nine hundred have objective tumor responses and all eight have demonstrated disease control all with a median progression free survival of twenty eight point one months no responses were seen and five patients with they'll see below nine hundred and the pss in that group is only two point one months this biomarker is easy to measure sits with a when it's presumed mechanism of action and based on our experience so far about seventy percent of patients meet this criteria this biomarker has now been incorporated as and eligibility criterion for our ongoing phase one trial as mentioned in my introduction we recently received the communication from the sta regarding our clinical development plans for a one eight based on the current and roman rate of our ongoing phase one one be clinical trial we believe that the number of patients treated in this trial would provide adequate safety and preliminary efficacy data to inform the design of a registration clinical trial as recommended by sta we now plan to request a meeting with them to discuss a registration clinical trial our current strategy is to conduct a randomized trial and refractory p tcl comparing eight one eight to standard single agent chemotherapy using our new a l see biomarker for patients selection standard single agent chemotherapy has an expected median pss of three months we believe eight one eight can significantly improve on this pss which we can demonstrate with a modest sized clinical trial on the order of approximately one hundred and fifty patients total this trial will potentially deliver definitive randomize data in a similar timeframe to our previously planned sing alarm phase two trial that required an interim analysis and related meeting with the sta this plan is consistent with guidance for the industry just published by sta yesterday that document discusses considerations for a single randomized controlled trial that can support both accelerated approval based on a circuit and point like response rate and with continued follow up verify are confirmed clinical benefit in support of a full approval using it and point such as pff another to update for eight one eight is a new opportunity and solid tumors in a few weeks at the a cr meeting we will present preclinical data in several models demonstrating that eight one eight enhances anti tumor immune responses to solid tumors based on the modulation a p cell differentiation and resulting increase in t affect effect yourselves in tumors moreover this has already been seen in our ongoing to sell lymphoma trial and will be presented at the lugano meeting in june this work reinforces the importance and value of i tk as a therapeutically actionable target in immune diseases we have demonstrated eight one eight activity including preclinical models of psoriasis asthma lupus and fibrosis we also demonstrated proof of concept for eight one eight and a topic dermatitis and companion dogs would naturally occurring disease which is very similar to human disease in february we added to the list of potential opportunities with a presentation of new data by researchers from you csf demonstrating the potential of eight one eight to reduce the need for chronic hiv therapy you csf team will continue studying the potential for i seek a in addition to provide answers proliferative and block and lock hiv year strategies this work as further validation to the critical role of i k in immune modulation in the near term we will be laser focused on a rolling in our ongoing phase one to sell on former trial and meeting with a to discuss a randomized phase three registration trial for a topic dermatitis we've decided to pause this work this will allow us to intensify our focus on t so lymphoma and cancer and conserve cash why we push forward with are already to further strengthen the foundation for use of eight one eight in immune diseases we remain excited about the potential of a one eight and a topic dermatitis in an increasingly crowded space we have a novel approach with many potential advantages in addition to the anticipated see someone from the milestones noted above there are additional potential catalyst from art other two programs so far as an inch or adenosine to a receptor antagonist and whoop dolan a about be so activating antibody target city seventy three civil is currently in phase one be to clinical trial as a potential first line therapy for metastatic renal cell cancer and a trip with combination with it be luma mad and of all the map this trial is being run by the kidney cancer research consortium led by and the anderson with participation from other member institutions which include vanderbilt beth israel boston duke university michigan university pennsylvania new t southwestern this trial was based on our publication in two thousand and eighteen showing synergy of sypher adnan with anti city away for a nobody in preclinical to remodels and data from our say is one studies demonstrating at a tumor activity as if adamant the trial was plan to enroll up the sixty patients with then points of safety tolerability and anti tumor activity the primary endpoint as the percent of patients who achieve deep responses the find that see ours and pr with greater than fifty percent reduction in tumor volume
spk_2: this reflects our goal to raise the plateau on pss an improved survival by adding sypher adnan historical data have shown that deep responses correlate with prolong progression free survival and are seen in approximately thirty two percent of patients receiving a be a though the
spk_3: complete response in those groups is only about ten percent as a reminder this is an open label single on trial so we insist we anticipate that we will get a good feel for efficacy
spk_4: early in the trial
spk_3: for look at all the map our partner angel pharmaceuticals have started and rolling a phase one one be clinical trial and china with looper alone and together with them realism ab and patients with relapse refractory non small cell lung cancer and also and patients with head and neck when cell cancer in closing we believe corvus is uniquely positioned with a prioritization of eight one eight the most advanced ai tk inhibitor in development the key upcoming milestones for our program includes continued enrollment in our phase one one be at the two hundred milligrams those including the use of our new biomarker updated data from our eight one a phase one or two so lymphoma trial will be present at the lugano meeting in june meeting with ft a to discuss a randomized phase three registration trial and former partner driven programs we anticipate interim data from the civil trial by mid year we look forward to providing updates on these key initiatives in the coming quarters i will now turn the call over to the operator for questions and answer period operator
spk_5: thank you
spk_0: we will now begin the question and answer session to ask a question may press star and one on your touchstone phone if you're using a speaker phone please pick up your handset before pressing the keys if at any time a question has been adjust and you would like to withdraw your question please press stars and to at this time will pass momentarily to assemble i roster the first question comes from eight in his you know
spk_6: clattenburg please go ahead
spk_7: oh hello good afternoon viciously attacked me much more for the update on congratulations nuclear for the by market with by monster
spk_8: on so
spk_7: so it seems that on only patients had a nine hundred absolutely perfect count on those who responded a fatal disease but what are the others that i believe there are eleven patients know what what the are ill see who are all for they applauded for the other three patients just years
spk_3: so for the so for out of the eight patients had a l c of patients were we have tumor evaluations for at of eight the sorry eight had a elsie's above nine hundred for of those eight had objective responses prc or see ours eight out of the that is the other for had stable disease so all eight had disease control for of the eight objective tumor responses of the other five patients who i doubt ale she's below nine hundred today zero head objective responses and
spk_9: how had disease control too
spk_3: and of course the of you look at the pss curves there's
spk_4: remarkable difference in the duration of of the time to progression as i mentioned twenty eight months vs
spk_10: two months
spk_3: in a two month by the way is very similar to what you see with chemotherapy
spk_11: so many things
spk_3: and we we like this biomarker a lot here's why number one it's consistent with the mechanism of action if you know is normal lives the such can't you can't have seen like your immune system the number one number two are easy to measure this is a freebie and a cbc so when to get a complete blood count and differential you calculate the absolute with a like count based on that matched on every day and every patient
spk_12: him and
spk_3: the third the third reason is a lcs you know kind of well known to oncologists we know other tumors were absolute with as i count is also
spk_13: the prognostic feature
spk_7: oh okay yeah that makes sense
spk_3: a work one final thing eighty forgot to mention the all of the new patients on the trial now in our ongoing trial the seven patients i think you can look at our swimmer plot on the in the press release the the the seven arrows down at the bottom of that former plot those are all patients who were selected with our new criteria area that is they have more than nine hundred lymphocytes per per cubic millimeter
spk_7: villa understood on and on what does it say about paschal combination of all oh for the i to a it with chemotherapy possible and or or or and would have to say about moving for the earlier lines of therapy we would you'd probably expect decent having higher l see a in their early lines of treatments right absolutely true a poor tens of
spk_3: it portends that more patients will be eligible if you select them earlier no question about that the less lines of chemotherapy have had to less beat up you are the high you want to say counts going to be so that's for sure i would say secondly in terms of chemotherapy even patients who get chemotherapy tolerate better if they have absolute lymphocyte counts that are a higher so i think that
spk_14: i think that as you know peaches
spk_3: t someone soma by it's very nature is a very immunosuppressive disease these patients have a lot of immune problems and on top of that if they're with a painter give their normal lymphocytes are low they're they're really incapacitated from an immune standpoint so this really does fit nicely with are presumed mechanism of action which as i try to indicate in my talk we now believe can be extended beyond to sell former to other cancers
spk_7: yeah this was an underage snake you could slow death of edible that's over to was as well
spk_3: yeah at a lugano meeting oh work with our colleagues were both here and or collaborators after taking university done by our seasons and single cell in a sequencing and show that there's not only an increase in to affect yourself in the tumors but their side a lyric capacity
spk_4: their ability to kill is increased
spk_7: right right or fair under understood the question regarding the to face three registration special registration trial so yeah a few published recently on and i'm previously than c the a being a to other drugs or in this in single arm trial i'm so do you think this is already sort of set in stone to have a to randomized trial design or be a game is on kind of go with the president's i think that a randomised trials better for us
spk_15: i think this is a good thing
spk_16: and here's why
spk_3: first of all of you start seeing alarm trial there's no assurance you're going to get the results that are going to be you of successful enough to achieve accelerate of putting even by the old policies number one number two you still have them meet with them and you have to commit to or have to have the data already baked for a phase three definitive trial so you have to have all those activities going on previously you got have the data from your open label study you have to have started and now fully and rules your definitive trial and so you put all that together it's actually more work and takes longer what what i think is better for us on this is we can now do a randomized trial go up against chemotherapy chemotherapy he has and we can make a dealer's choice picture for drugs we've already been discussing that with our experts the expected median pss and in the with those drugs is about three months maybe less and we have to beat that in our in our single agent eight one eight arm so that you know the plan might be to look early look at response rate if you get a meta threshold for response rate you get accelerated approval but you got your definitive trial already cooking and then you wait for pfs now in this case i believe and we have to do a little bit more work running these numbers the pss is so short in the chemotherapy arm i'm not sure you would save much time by looking at response rate for accelerated approval when just it probably a few months longer and you've got the definitive pfs data you follow that
spk_1: god given access so you don't have to wait like twenty four march twenty eight mile guy yeah right difference between digital the difference between when you have your response rate and when you have your pss
spk_3: you know
spk_7: enough pfs data is going to be pretty sure
spk_3: right yeah just have to be dead okay that the knife a lot of other than and have eaten eight in the key here is that this is a definitive trial
spk_16: you don't have to didn't go do and a confirmatory trial
spk_7: obsolete it's positive
spk_4: mesa i said at when does it you can start the trial
spk_17: are we think we can start his trial before the end of the year
spk_7: college park
spk_0: right a tangible to get my courses on congratulations with this biomarker thank you
spk_18: my next question comes from my or goldstein lance mizzou how please go ahead oh great thanks so much money in a question
spk_19: just go back for seconds and has a biomarker our understanding that there's and a normal level for a l c do you have a sense of arm you know would just patients and a touchdown a little bit when you know earlier line versus land line but you know what percentage of patients are likely indeed to have you know to meet that
spk_3: sort of nine hundred threshold that you've identified
spk_20: okay so in our more in our experience so far now we've got a lot of
spk_3: late line patients
spk_21: our experience so far about seventy percent of patients are greater than nine hundred i think as we move earlier if we were to move earlier you would get that number would probably go up
spk_18: okay and ah
spk_3: okay perfect man i also learned that just en masse to cut the meeting with sta about you know starting a registration program you mentioned later the ships either getting factors for you to request a meeting like things that you need to do ahead of the meeting at this point is it certainly does it hillary in change or clinical plan
spk_18: or what we have to prepare a how packages summarizes our safety and efficacy data and a few other things so that's a getting item
spk_0: but we should be able to do that i mean that so straightforward though we have the experience in the team that can do that
spk_22: okay so is it reasonable that you might be requesting a eating kind of in all around either so the end ended second quarter early third quarter that kind of timing yes yes i think we could be meeting with them in the next few months okay thanks i really appreciate it
spk_23: next question comes from roger song with jeffries please go ahead
spk_22: great thanks for the day in that sense for taking the question well maybe just the potential face the design or rich and then you you hadn't seen that are marker and he an and nine hundred different huge difference between i'm actually month him own in about linda and below nine hundred so just curious how confident you about this cut off and that how much data entry how much more data yet you need to make sure that the cut off the well proposed to be a year are you're waiting for you have some a page the ongoing and they are all the next to the for that we'll keep on in there and the how likely you will need to change their cut off a similarly for that those election
spk_3: two hundred mailgram is that those you'll move forward
spk_24: and the how likely you need to do additional without those ranging lot in the nation before you can start a criminal thanks okay
spk_3: regarding the nine hundred a see cut off or the data's in the press release and i mentioned it a out of a disease control for elevate objective response vs zero and the other group twenty eight month pfs versus two month there's a very substantial difference between nine hundred and and above nine hundred and below you know it could we use a thousand nine hundred a thousand yes that you know that's almost within experimental or of the of the task
spk_25: normal normal as a thousand lower than the thousand his wikipedia
spk_3: a thousand has been used in other other settings one the for prognostic a was for example a very important prognostic feature in in hospitalized covert patients who they were under a thousand they they did very poorly
spk_12: in head neck cancer it's a prognostic feature and there are other cancers as well where it's been a prognostic feature that is using we're hoping penny are not a thousand we find that nine hundred is a really good cut off and we wanted to give ourselves a little bit more room but as so i mean i think that that that cut off makes sense
spk_3: from looking at our data makes sense of from mechanism of action him and you know i don't i don't have any reason to think we would we would want to change it now with regard to the dose we have a lot of information on dosing oh i don't think we're gonna have to explore other doses another one we know that two hundred milligrams those first well as you know we'd have a look at a hundred two hundred four hundred six hundred milligrams be id we know that two hundred gives you near complete receptor occupancy we've done very careful studies on that so six hundred not better and two hundred in terms of occupying your wrist scepter your i tj a target number one number two we see more efficacy at two hundred not only on our lymphoma patients we see that in animal models and immune disease models there is there is a know some people have referred to as the goldilocks effect or there is there is in effect here where you you have an impact on the differentiation of t cells we think that's best that around two hundred and four hundred milligrams be id but it when you go to high you get general immunosuppression and that's probably not a good thing so the two hundred milligrams those
spk_26: looks really good for us both from us efficacy standpoint mechanism of action etc and then finally from safety standpoint most companies go deaf the a and and want to use the highs those they studied
spk_22: we're actually going we're actually going to say no we don't want to use our highest dose we studied where someone who's a dosage one third of what we what we study
spk_0: rodgers answer questions
spk_27: absolutely really present that's very helpful thinker it
spk_28: next question comes from lee was stuck with cantor fitzgerald please go ahead
spk_26: i'm a murderer
spk_3: like thanks so much that taking a question i'm just a couple quick ones regarding that two hundred milligrams of what you said that moment of accelerated you potentially know why it is likely the case i could it be given by data you let out are there other objects of a very thin layer of eat easy question accelerated because of ash
spk_28: after the answer to everything okay people at our saw holy mackerel this is a really not a mechanism of action is active and refractory patients ash i think it's it's really ask now of course we made some amendments to the protocol ride around that right before that in rolling on the motorcycle etc but of we have a lot more interest in this trial now bought it and you and uninjured moving onto the bio monster ah i'm the youngest to nine hundred
spk_3: the off you see any correlated data with on you know
spk_29: with responses and and nine hundred and above like any linear correlation and also have you potentially seen any validation some the new patients even road with his arms like the criteria that too early to tell
spk_3: so in terms of having a straight line when you're correlation i don't think we have enough data to say that not respond measure but but clearly the people who have done the best of had normal i mean i think one of our crs gotta have a look a little psych out of four thousand which is right in the normal range so we're getting the suspicion that there might be some relationship there i'm in terms of the new patients
spk_30: there were there are now being selected on the basis of they'll see above nine hundred and
spk_3: you know stay tuned for that we're seeing some real i think really interesting things there great they did some what is it really looks really good now just one other question the or some other biomarkers that were interested in and we just don't have enough data yet but one of the biomarkers that we are interested in and we've talked about before
spk_28: it is with a transcription factor called gather three ghz a three
spk_0: data three years and th to help or t cells gotta three positive tumors are bad
spk_31: gotta three positive for forty someone farmers are the worst the worst of the worst all of our responders or data three positive
spk_32: okay thought it go on not that thank you so much
spk_3: next question comes from rain conic with titan partners group please go ahead hello
spk_0: pardon me on my mr kind as your enemy perhaps the i think we lost a titan partnership but out are there any other questions i don't see any
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