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spk_0: good morning ladies and gentlemen and welcome to cognition therapeutics incorporated fourth quarter and fiscal year twenty twenty two earnings conference call my name is julie anne and i'll be a conference operator today
spk_1: this call is being recorded
spk_0: i would like to turn the presentation over now to your host for political gain potter potting investorrelations recognition therapeutics to go ahead mr contre water
spk_2: figure you julianne good morning and thank you for participating cognition therapeutic problems call today with me today are we so sorry regulated chief executive officer of cognition and and you are born into and chief financial officer or cognition a press release detail in cognition therapeutics way for you to results is available on the and better section of our website called or expelled from we encourage everyone to read this morning's press release as well as cognition and or report on formed nk which is now filed with the fcc and available on our website in addition discoveries call is being webcast you the company's website and will be archived for thirty days please note that certain information discussing the call today is covered under the safe harbor provisions of the private securities litigation reformat we constantly says that during his call measure it will be making forward looking statements actual results could differ materially from those the it or implied by the for looking statements butyric and uncertainties associated with the company's business before looking statements are qualified by the cautionary see them contain and cognition specially says as he see violence including it's an old boy on formed okay and previous filings the cup of coffee same time sensitive information that is accurate own as of the day of this live broadcasts cognition undertakes know to revised or update in a for looking seems to reflect events or circumstances after the day at this conference call with that i would now like to hand the call with me so shoddy lisa
spk_3: thank you daniel the morning everyone and welcome the cognition therapeutics earnings conference call covering twenty twenty twos results on today's call our interim chief financial officer and the einhorn and i will share prepare them out from the company's progress and financial performance and twenty twenty two after work will be joined by dr tony catch ya know our chief medical officer and head of are indeed in order to take your questions is is an exciting time at cognition therapeutics and hi i'm proud of the momentum the company has built we anticipate this momentum will continue and twenty twenty three looking back what a year and field of nero to generation i believe all of us working in this clinic on scientific arena have a well deserved sense of optimism or the first time in many years with the approval of he can be the all farmers community thought true progress at many of us will build on the serves as a testament that the file for cuticle industry together with patient's medical professionals regulatory agencies can bring to market a product to flow of hammers disease progression and cognition we believe that city eighteen twelve or lead candidate has the potential to be an important part of the evolving treatment paradigm or dementia and we are unwavering and our commitment to advance our work to develop therapies are these conditions it may have you know our primary focus is on the development of innovative oily available drug candidates targeting age related degenerative diseases of the cns and the retina or current clinical programs build upon the company's expertise with cigna two receptor biology which regulates and number of cellular functions that are disrupted as a result of neurodegenerative disease our dried candidate is currently in the clinic being tested for alzheimer's disease and dementia with lewy bodies or d l be as we refer to it within alzheimer's disease worse than a both early stage patients as well as patients with mild to moderate disease in addition worse now studying city eighteen twelve and a new indication geographic atrophy secondary to dry age related macular degeneration commonly referred to as dry i am dee modulating the signature receptor complex with the brain penetrance small molecule drug candidate is a unique approach and well differentiated from improve his both and neurodegenerative disease as well as in the optimal g and retinal disease space now let me provide a brief update on a clinical trials and anticipated timelines for each study in february we completed enrollment of our faith to sequel study for mild to moderate of hammers disease we're we're measuring brain waves tight memory and processing information we hope the trial demonstrate that a once aly dose of city eighteen twelve can normalize eg patterns by decreasing say to power relative to placebo this will further support the role of city eighteen twelve in protecting synopsis from the toxicity of a the only commerce we anticipate reporting topline data from sequel later and twenty twenty three supported by multiple grants totaling approximately thirty million dollars from the national institute on aging are one hundred and forty four patient paid to shine trial a mild to moderate disease has been expanded internationally to spain the netherlands and the czech republic or patients are currently being toast we are grateful to our partners for their diligence and getting faith up and running our shimmer study of city eighteen twelve which is also supported by a non deluded grant from the nih or thirty million dollars is and will when patients with mild to moderate dimensions with lewy bodies in a face to us based try lol a study which is being led by dr jim galvin from the university of miami is expected to be conducted at more than thirty states across the united states an estimated one point four million people are affected by deal be all of whom have no treatment options we expect data from shimmer next you're moving on our five hundred and forty patient faith to dark trial is for patients with early alzheimer's disease we received ft a clearance on the protocol and are preparing to a more patients in collaboration with the of farmers clinical trials consortium that is our partner the start trial will measure the efficacy and tolerability a city eighteen twelve subjects with mild cognitive impairment or only all timers disease who have elevated a beta levels we received an immense grants totaling eighty one million dollars for our work in this trial and we are pleased to join forces with the a c t c with regulatory clear and i propose protocol we expect site activations to begin and twenty twenty three shifting to the opportunity for city eighteen twelve and atomic indications dry am the and geographic atrophy we presented data in connection with the arvo conference of supports the proof of concept for geographic atrophy secondary to dry am the somewhat paralleling the challenges to develop in treatments for dementia try a of the in that area that has frustrated the up knowledge community for decades with many failed the test develop affected treatments dry am the is estimated to account for up to ninety percent of the population with age related macular degeneration the advanced form know as geographic atrophy can lead to progressive and permanent vision loss an estimated one million people in the us have geographic atrophy making for a vital area unmet need and a substantial market with the recent groundbreaking approval of cipher over from a palace pharmaceutical it is an exciting time to be adding dry am d r pipeline as we're seeing a surge in patients and physicians education around the major cause of blindness looking at our opportunity we have evidence from genome wide studies as well as the now see the results from out of time or said it the demonstrate the treatment with city eighteen twelve may have a beneficial impact on proteins implicated in dry a and the as we recently announced we were see that the a clearance to initiate a faith to dry am dee geographic atrophy trial which we plan to commence this year the magnified trial as we call it is a randomized placebo controlled phase two trial expected to enroll fractionally two hundred and forty people will be diagnosed with dry a the and measurable geographic atrophy over the treatment period change and geographic after feet lesion side and best corrected visual acuity as well as other measures the safety and efficacy will be determined to assess of cp eighteen twelve can low vision loss and closing i am proud of the progress or scientific and clinical teams have made or trials are expanding into new regions of the world and we are expanding indication were optimistic that the work we're doing is moving of closer to benefiting patients with this mindset we decided that it was vital that we extend and expand our ability to communicate our messages and are patients centric mission in order to reach variants audiences including scientific and medical community the investment community patients and caregivers we have launched the cognition conversations podcast podcast service serve to provide information about the latest developments in the neuroscience arena and functions as an important clearing house with thought leaders to continue to the educate the public about research to summarize the diligent work of art team and twenty twenty two set the stage for what we believe will be a milestone rich twenty twenty three looking back on our first full year of operating at the publicly listed company on the
spk_4: nasdaq i believe we have the tools and resources to continue our mission of creating therapies for age related neurodegenerative diseases of the san f and the retina with that i turned the call the andy
spk_2: very flavor
spk_3: we're twenty twenty three on of found financial put it the combination of the ip oh towards the end of twenty one of bottle on offering at the end of twenty twenty two are a t m program or recent agreement with lincoln park capital together with are substantial grant funding of help establish a
spk_5: very solid financial infrastructure grants from the and iii the michael j fox foundation and other key association i felt this raise approximately one hundred and seventy one million in non dilutive funding since the company was founded our new three year up to thirty five million equity financing agreement with lincoln park capital
spk_3: serve as a potential additional source and liquidity for us to tap into in an efficient manner
spk_5: additionally we have and continue to be vigilant in controlling our expenses which together with the aforementioned capital strategies enable us to extend our cash one way into the second half of twenty twenty four with that contact with now proceed to the financials for fiscal year two thousand twenty two research and development expenses for the year ended december thirty first twenty twenty two totaled thirty point three million compared to eighteen point six million for the twenty twenty one prior year period the increase was primarily attributable to greater spending on clinical programs as we proceeded to phase two trial and increase personnel costs general and administrative expenses for the year ended december thirty first twenty twenty two were thirteen point two million compared to ten million for the same period in twenty twenty one the increase in general and administrative expenses reflect fire employee cause writer director an officer liability insurance cause and professional fees incurred during the first full year as a public company for the year ended december thirty first twenty twenty two we reported in that lot of twenty one point four million or ninety one cents per basic and diluted share compared to a net loss of eleven point seven million for three dollars and thirteen cents per basic and the loo the chair for the year ended december thirty first only twenty one at december thirty first twenty twenty two we had cash and cash equivalents of forty one point six million and eighty nine million in grant funding remaining to support certain of our clinical trials and no long term debt
spk_4: a few comments about a recent transaction with lincoln park capital on march tenth we entered into an agreement giving cognition the right but not the obligation to sell of the thirty five million of our common shares the lincoln park over thirty six month period as more fully describe in the a
spk_5: hey filing made on march tenth twenty twenty three linkin park's commitment provides cognition with potential access to liquidity which as recent events have shown is critically important in turbulent markets
spk_0: we believe the lincoln park facility or eighty and program and the availability under our recently filed s three give the company considerable optionality the access capital enabling us to continue managing our cash runway i'll turn the call back over to the operator who can open the called the quest thank you if you would like to ask a question please pass star followed by the number one on your telephone keypad to try your question please post or one again
spk_6: think you are first question comes from charles duncan from counterfeit fitzgerald please go ahead you ended up and yeah how you good morning lisa an injury thanks for taking our question and congratulations on a on a good year progress i had a couple of questions on the alzheimer's programs and then i actually quite intrigued with a geographic yeah atrophied program someone had asked but that first ball with regard to seek well in terms of day eg data that's coming up a could you give us a sense of what you're looking for i think you mentioned topline data do you do you believe that has predictive value or you really looking for activity
spk_7: that could then be ah translate into advocacy was some of them are other studies i'm chance good morning thanks for joining tony as your with me and he'll take your question on of character every finance with completed a roman in that that they were looking for top line data debris put it at some time later this year as you what we're looking for a third shift in the relative they the power of mean in the portion of slow wave activity a relative in a between that treated patients and as a placebo treated patients and this is really a measure of them more acute activity
spk_3: that were looking for falling for with the treat them with eg eighteen twelve
spk_7: indeed believe it his predictive value for what symptomatic treatment or for a disease modifying potential for for the candidate yeah i think guy that this is really a measure of whether the a the cute removal of a beta look emerged from the finances has a positive effect on synaptic activity as measured by eg certainly believe that would be a positive indication overall
spk_3: not enough with was has
spk_6: okay and then ah moving out a geographic atrophy i'm i'm intrigued with that can you provide a little more color in terms of the connection
spk_3: mom for he said my two receptor modulation endure a degenerative diseases what you'd think that says about potential in geographic entropy and then plates or so but it's geographic entropy activity tell you but the potential in energy
spk_2: narrative diseases and them one would you anticipate early data other the defy study yeah so what we ended up in in geographic atrophy base that as lisa mention just a few minutes ago safe and proteomic data coming out of her are famous is a study is an associate genome wide association studies in literature and basic science in the literature and then a series of studies that
spk_7: the we performed i of him with collaborators demonstrating that sigma to modulation could normalize the the dysfunction that occurs within a certain cell type a in the retina that that we and others believe is really integral to the basic path of physiology of geographic atrophy inaccurate that the confidence in the interest in pursuing today now there are certain common feature that segment to with able to regulate these prophecies it with themselves within the retina and the central nervous system after how they predict each other's success in the and we'll we'll we'll see as as they come out
spk_3: the hope that answers your question
spk_2: perhaps down will come back to it offline but last question because they don't want to consume the entire call is actually for in the that is relative to the grants you know to bleed than a bowl of raise a lot of money in fact more so than most companies i cover and and so ah that is not delude of so my question is is is a strategy going forward could you anticipate by on for additional grants and what percentage roughly of here aren't east and do you anticipate being able to cover with exist
spk_3: the in grants and is is that money included in your balance sheet or he said on the come as you achieve milestone the chairs it's lisa i'll take the first part of it which is to say as we look at the grant opportunities in the to general areas were looking in on the larger trials are frequently not funded by much brand support the expectation is you have access to private investors and the capital markets and so i will say go
spk_5: going forward a while he would be wonderful to have another hundred and seventy million in grant funding were looking at much smaller kinds of brand so i would guide toward different kind of expectations going forward based on where we are in the clinic i'll turn it back to need for your questions about the am expand coverage
spk_8: yeah a bench as the the grant revenue and twenty twenty two covered approximately half the operating expenses
spk_5: that would that we have ah in mind you the trial that were conducting right now with the exception of the magnify trial in dry and the all have grant funding supporting them in one one she's a way to perform
spk_9: and in terms of aware this sir where this money get put on the moon the balance sheet and so forth when we incur it was censored will draw on the we draw on our grants and we get dad reimbursed by the i or whomever barely ah
spk_5: in almost immediately when we pay a milestone or upfront payment to see our over there are will draw that money on and achatz ah of and the grant revenue then get hung up on the balance sheet as the bird revenue and then will be taken into of recognized that income as bad as the
spk_2: a trial progressive than his work is done that answer your question
spk_0: get it as thank you for taking our questions he like for a that you months
spk_10: i next question comes from a day off and from oppenheimer please go ahead and out then oh hey gratis on other progress and think can questions
spk_2: like about the proteomic data that you have coming up at eighty pd in went in at your should be looking for in terms of
spk_3: it's porch teachings was mechanism and alzheimer's and and anything else you think that you should without forty pm me that may have read a cost to cognition and and on the follow button thriving up the
spk_7: terrific say good morning great to hear from you get another exciting year or less your day i see we presented dated this year married have some more data let tony take you through what idiots we can discuss the data will be released and week and a half and then the posters will be available at at a high level tony sure am so we presented data law last year
spk_2: from the first twenty four patients of our faith to shine said study and from the
spk_7: the sparks that able to the imaging studies conducted at yale what been prevented if you're at a bpd is a met analysis of the to study said either to nearly identical studies of st joseph thing patient there's a powerful way to to cross the to dataset and see which signals of vibe of drug exposure and effect come through both to this is giving us a good candidate biomarkers to follow in the future for treatment effect
spk_10: as a the mentally haven't released details that at this point on which protein those aren't so forth you can see that on the poster will be able to distribute that minute come when the come that okay great think you look forward to that and just aren't i am the are there any human genetic to have showing the involvement of the signal to receptor in friday and the and have you had any patients in your alzheimer's study who are for had to i am doing and showed up at the same thing
spk_2: awesome that you could detect there and then finally
spk_6: where do you think see the eighteenth wild and an oil drugs and fit into the trigger landscape
spk_7: trying am the especially in particular combination residents thank you sure though the every met him before some of the the impetus for us to move into ga with based on lead genome wide association studies that are in the literature demonstrating that them certain changes in the proteins that make up the sigma to receptor confer either risk or protection against them and developing ga
spk_10: don't either is the i'm a that data out there
spk_7: and then your next question was that the event of him to near alzheimer's now he has time am yeah it is an interesting question you know would we don't scream those subjects for a good for geographic atrophy yeah if it if these are complex in a study in individuals with dementia
spk_3: though i that's not really part of our our operations and last share with regard to the market the great thing for us is that you have drugs ahead of us at our building this market right a palace and eric on their heels other companies coming behind them and as we're going through development we will see as the retinal community takes for these products will look at what the reimbursement is we'll see how this landscape evolves we believe for patients and an oral drug is a far simpler regimen at take for the long term than having intra for vitriol injections and we'll see what practices of the retina specialist court and were watching and waiting carefully we think and world drug has an enormous advantage advantage
spk_10: would it be disruptive possibly put it work and combination affably those are things will be looking to and study as we progress
spk_11: sounds great thanks the questions
spk_0: thanks jack
spk_12: an expert in consent my out mom tiny from be riley security is prefer headlines open
spk_7: oh good good morning to in thanks for taking a question than a appreciate the level of detail so maybe i'll go in divorce i did staying on the ga of feeds to a trial design up the they saw you i miss those good could you touch on the treatment be be late for your primary efficacy and going to new mean it's a year lease ended up
spk_3: chin and and now are you also but by any chance looking at visual agree de um maybe other safety measure of and edward time point could we have an update for that and then i will follow abandonment squished
spk_7: good morning my and thank you tony i'll take your questions sure gathered though i'm in indeed we are following the presidents of others who have originally filed for approval
spk_2: in this field her they've taught us a lot of a particularly about the approve ability of measuring change in ga
spk_7: there were falling very much what others have done or that he is it to your trial and it is likely because while the of the facts of changing ga are devastating they are relatively slow progressing so you know that significant period of time to measure change our family for your next question we are measuring visual acuity in various different ways and indeed like others are these will support our primary outcome
spk_8: but that they are not the primary
spk_7: i'm be if if i may just ask a follow up that that do you are treatment be raid was that up but yard proposal to the agency or with that a coming from doctor chambers
spk_2: ah so you know we did have discussions with at the a and we landed on that number based on what what way and they thought was the most likely chance of success
spk_12: art and got got it and then on the us
spk_2: sega and alzheimer's program ah but you know be had the level of detail on expectation for sequel ah i was just curious as the as you know there's the big focus on a c as that biomarkers right are also i believe in yo of bordeaux sequel and shine said the good goody goody this may be
spk_12: elaborate on you know which markers that most relevant with are legal my displacement ah and you know you could expect to move acutely in in a study like sequel were says you know other markers where you may need a sort of a six month gladwell my time period longer chronic dozing
spk_7: that would be helpful donny pure yeah indeed we've been very fortunate to have a very significant support from in a to run biomarker analysis from the ff and all of our study so we agree with the importance our our process right now it really identify those candidate biomarkers which will be predictive of change am to answer the question of which ones would take longer and which ones that might be it a more acute what will need to look at the data from from the more to study at him and really tell you which ones will require along
spk_12: i've helped the certainly that is kind of the kind of information we hope to have over the next that many months i've got an entity again by method the news they have you know what for young you're looking to present the sepa data the they're like a gun than good targeting and and i have an announcer yeah yeah
spk_3: we have an object were healthy the and and a similar question on shine it is there a particular time next year you're looking for them that data what first shine my and our ballistic complete enrollment this year the last patient comes in at the end of the earth of six month trial
spk_12: you know several months to clean up the data and get topline results is only be a function of the involvement being completed tell where think all
spk_13: all of two and a said thanks thanks for dinner question and good luck with on the products
spk_0: thank you bye and as a reminder to ask a question please pass star followed by the number one on your telephone keypad
spk_3: we have no further questions or ten a call back over to cognition see alpha causing imax as or sorry please go ahead thank you to conclude i'd like to say that we are optimistic for cognitions future and it's evolution as we aim to improve the lives of those afflicted with neurodegenerative diseases a science is sound and we continue to build evidence about what city eighteen twelve can do for patients we believe we're now well positioned to achieve and deliver on multiple
spk_0: clinical milestones and we are focused on creating long term value for our shareholders by doing so thank you for joining us this morning and everyone had a great day it concludes today's conference call thank you for your participation you may not disconnect good morning ladies and gentlemen and welcome to cognition therapeutics incorporated fourth quarter and fiscal year twenty twenty two earnings conference call
spk_1: my name is julie anne and i'll be a conference operator today
spk_0: this call is being recorded
spk_14: i would like to the presentation over now to your host for to recall get caught up ah investor investorrelations for cognition therapeutics to go ahead mr carter water
spk_2: thank you doing good morning and think you participated in cognition therapeutic probably call today with me today are we so sorry president chief executive officer of cognition and and you i'd want interim chief financial officer or cognition a press release detail cognition therapeutics way for you to result is available on the better section of our website at part or at stockholm we encourage everyone to read this morning's press release as well as cognition and or report on formed nk which is now filed with the fcc and available on our website in addition this call please call is being webcast you the company's website and will be archived for thirty days please note that certain information disgusting the call today is covered under the safe harbor provisions of the private securities litigation reformat we constantly says that during his call measure it will be making forward looking statements actual results could differ materially from those see it or abide by before looking statements to risk and uncertainties associated with the company's business before looking statements are qualified by the cautionary see them contain and cognition specially says at see violence including it's an old boy on form turkey and previous filings the cup of coffee same time sensitive information that is accurate own as of the day of his live broadcasts cognition on a taste know no obligation to revise or update in a forward looking statements to reflect events or circumstances after the day at this conference call
spk_1: with that i would now like to hand the call with me so shoddy lisa
spk_3: thank you daniel the morning everyone and welcome the cognition therapeutics earnings conference call covering twenty twenty twos result on today's call our interim chief financial officer and he i'm horn and i will share prepared remarks on the company's player breath and financial performance and twenty twenty two afterwards will be joined by dr tony catch ya know our chief medical officer and head of are indeed in order to take your questions it is an exciting time at cognition therapeutics and hi i'm proud of the momentum the company has built we anticipate this momentum will continue and twenty twenty three looking back what a year and fear of nero to generation i believe all of us working in the clinic on scientific arena have a well deserved sense of optimism for the first time in many years with the approval of he can be the alzheimer's community thought true progress that many of us will build on that serves as a testament that the file form the cuticle industry together with patient's medical professionals regulatory agencies can bring to market a product flow of hammers disease progression and cognition we believe that city eighteen twelve or lead candidate has the potential to be an important part of the evolving treatment paradigm for dementia and we are unwavering and are committed to advance our work to develop therapies for these conditions it may have you know our primary focus is on the development of innovative oily available drug candidates targeting age related degenerative diseases of the cns and the retina or current political programs build upon the company's expertise with cigna two receptor biology which regulates the know nber a cellular functions that are disrupted as a result of neurodegenerative disease are dried candidate is currently in the clinic being tested for alzheimer's disease and dementia with lewy bodies or the l be as we refer to it within alzheimer's disease were funny both early stage patients as well as patients with mild to moderate disease in addition worse now studying city eighteen twelve in a new indication geographic atrophy secondary to dry age related macular degeneration commonly referred to as dry a m d modulating the signature receptor complex with the brain penetrance small molecule drug can today is a unique approach and well differentiated from improve his both and neurodegenerative disease as well as in the optimal g and retinal disease space now let me provide a brief update on or clinical trials and anticipated timelines for each study in february we completed enrollment of our faith to sequel study for mild to moderate of timers disease we're we're measuring brain waves tight memory and processing information we hope the trial demonstrates that are once daily dose of city eighteen twelve can normalize eg pattern by decreasing say the power relative to placebo this will further support the role of city eighteen twelve in protecting synopsis from the toxicity of a they the only commerce we anticipate reporting topline data from sequel later and twenty twenty three supported by multiple grants totaling approximately thirty million dollars from the national institute on aging are one hundred and forty four patient paid to shine trial a mild to moderate disease has been expanded internationally to spain the netherlands and the czech republic or patients are currently being toast we are grateful to our partners for their diligence and getting faith up and running our shimmer study of city eighteen twelve which is also supported by a non deluded grant from the nih or thirty million dollars is and will when patients with mild to moderate dementia with lewy bodies in a face to us based trial oh the study which is being led by dr jim galvin from the university of miami is expected to be conducted at more than thirty sites across the united states an estimated one point four million people are affected by deal be all of whom have no treatment options we expect data from shimmer next year moving on our five hundred and forty patient face to start trial is for patients with early alzheimer's disease we received ft a clearance on the protocol and are preparing to a more patients in collaboration with the of farmers clinical trials consortium that is our partner the start trial will measure the advocacy and tolerability a city eighteen twelve subjects with mild cognitive impairment or only all timers disease who have elevated a beta levels we received an immense grants totaling eighty one million dollars for our work in this trial and we are pleased to join forces the a c t v with regulatory clear and are proposed protocol we expect site activations to begin and twenty twenty three shipping to the opportunity for see taking twelve and atomic indications dry am the and geographic atrophy we presented data in connection with the arvo conference of supports the proof of concept for geographic atrophy secondary to dry am the somewhat paralleling the challenges to develop in treatments for dementia try a the in that area that has frustrated the up knowledge community for decades with many failed attempt to develop affected treatments dry am the is estimated to account for up to ninety percent of the population with age related macular degeneration the advanced form known as geographic atrophy can lead to progressive and permanent vision loss an estimated one million people in the us have geographic atrophy making for a vital area unmet need and a substantial market with the recent groundbreaking approval of cipher over from a palace pharmaceutical it is an exciting time to be adding dry am d r pipeline as we're seeing a surge in patients and physicians education around the major cause of blindness looking at our opportunity we have evidence from genome my studies as well as the now see the results from our of time or said it that demonstrate the treatment with city eighteen twelve you may have a beneficial impact on proteins implicated in dry a and the as we recently announced we were see that the a clearance to initiate a faith to dry am dee geographic atrophy trial which we plan to commence this year the magnified trial as we call it is a random i nice too feeble controlled phase two trial expected to enroll fractionally two hundred and forty people will be diagnosed with dry a am the and measurable geographic atrophy over the treatment period change and geographic after lesion side and best corrected visual acuity as well as other measures the safety and efficacy will be determined to assess the cp eighteen twelve can low vision loss and clothing i am proud of the progress or scientific and clinical teams have made or trials are expanding into new regions of the world and we are expanding indication were optimistic that the work we're doing is moving of close author to benefiting patient with this mindset we decided that it was vital that we extend and expand our ability to communicate our messages and our patient centric mission in order to reach very if audiences including scientific and medical community the investment community patients and caregivers real launched the cognition conversations podcast podcast service serve to provide information about the latest developments in the neuroscience arena and functions as an important clearing house with thought leaders to continue to the educate the public about research to summarize the diligent work of art team and twenty twenty two set the stage for what we believe will be a milestone rich twenty twenty three looking back on our first full year of operating at the publicly listed company on the nasdaq i believe we have the tools and resources to continue our mission of creating therapies for age related neurodegenerative diseases of the
spk_5: c n f and the retina with that i turned the call the andy both that we're twenty twenty three out of town financial put it the combination of the ip oh towards the end of twenty one of fall on offering at the end of twenty twenty two or a t m program or recent agreement with lincoln park capital together with our stay federal grant funding of help establish a very solid financial infrastructure
spk_3: grants from the and i are the michael j fox foundation and other key association i felt this raise approximately one hundred and seventy one million in non diluted funding from the company was founded
spk_5: our new three year up to thirty five million equity financing agreement with lincoln park capital serve as a potential additional source of liquidity for us to tap into in an efficient manner
spk_4: additionally we have and continue to be vigilant in controlling our expenses which together with the aforementioned capital strategies enable us to extend our cash one way into the second half of what twenty four with that contact with now proceed to the financials for fiscal year twenty
spk_5: twenty two research and development expenses for the year ended december thirty first twenty twenty two totaled thirty point three million compared to eighteen point six million for the twenty twenty one prior year period the increase was primarily attributable to greater spending on clinical programs as we proceeded to phase two trial and increase personnel costs general and administrative expenses for the year ended december thirty first twenty twenty two were thirteen point two million compared to ten million for the same period in twenty twenty one the increase in general and administrative expenses reflect fire employee cause writer director an officer liability insurance off and professional fees incurred during the first full year as a public company for the year ended december thirty first twenty twenty two we reported in that lot of twenty one point four million or ninety one cents per basic and diluted share compared to a net loss of eleven point seven million for three dollars and thirteen cents per basic and the the chair for the year ended december thirty first two only twenty one at december thirty first twenty twenty two we had cash and cash equivalents of forty one point six million and eighty nine million grant funding remaining to support certain of our clinical trials and no long term debt a few comments about a recent transaction with lincoln park capital on march tenth we entered into an agreement giving cognition the right but not the obligation to sell of the thirty five million of our common shares the lincoln park over thirty six month period as more fully describe in the a hey finally made on march tenth twenty twenty three
spk_0: linkin park's commitment provides cognition with potential access to liquidity which as recent events have shown is critically important in turbulent markets we believe the lincoln park facility or eighty and program and the availability under our recently filed s three give the company considerable optionality the access capital enabling us to continue managing our cash runway i'll turn the call back over to the operator who can open the called the quest
spk_6: thank you if you would like to ask a question please press star followed by the number one on your telephone keypad to try your question please post or one again thank you are first question comes from charles duncan from counterfeit fitzgerald please go ahead you ended up and yeah how you are good morning lisa an injury thanks for taking our question and congratulations on a on a good your progress
spk_7: i had a couple of questions on the alzheimer's programs and then i actually quite intrigued with a geographic yeah atrophy program so wanted ask but that first ball with regard to seek well in terms of day eg data that's coming up a could you give us a sense of what you're looking for i think you mentioned topline data do you do you believe that has predictive value or you really looking for activity that could then be ah translate into advocacy was some of them are other studies i'm trans good morning thanks for joining tony is you're with me and he'll take your question on of character every finance with completed a woman in that that they were looking for top line dated the bird would it sometime later this year as you ask what we're looking for a third shift in the relative they the power in in the portion of slow wave activity a relative
spk_2: in a between that treated patients in as a placebo treated patients and if is really a measure of them more acute activity
spk_7: there were looking for falling for with the treatment with eg eighteen twelve in the believe it his predictive value for what symptomatic treatment or for a disease modifying potential for for the candidate
spk_3: yeah i think guys live is really a measure of whether the the queue removal of a beta look emerged from the finances has a positive effect on synaptic activity as measured by eg certainly believe that would be a positive indication overall not enough with with and
spk_2: okay and then ah moving onto a geographic atrophy i'm i'm intrigued with that can you provide a little more color in terms of the connection on for he said my two receptor modulation endure a degenerative diseases what you'd think that says about potential in geographic entropy and then vice versa but it's geographic entropy activity tell you but the potential in energy generated diseases and them one would you anticipate early data other the made defy study
spk_7: yeah so what your we ended up in in geographic atrophied base dot as lisa mention just a few minutes ago and that proteomic data coming out of her or how much is a steady to santa yet genome wide association studies in literature and basic science in the literature and then a series of studies that the we performed i fell from with collaborators demonstrating that figment to modulation i could normalize the the dysfunction that occurs within a certain cell type i in the retina that that we and others believe is really integral to the basic path of physiology of geographic atrophy ah and i gave us a the confidence and the interest in pursuing g hey now there are certain common feature that segment to have able to regulate these prophecies that with themselves within the retina and the central nervous system
spk_6: after how they predict each other success in the and we'll we'll we'll see as as they come out
spk_3: the hope that answers your question
spk_2: perhaps sound will come back to it offline but last question because they don't want to consume the entire call is actually for indeed
spk_3: that is relative to the glance you know to bleed than a of race a lot of money in fact more so than most companies i cover and so ah that is not delude of so my question is is is a strategy going forward clinch you anticipate filing for additional grants and what percentage roughly ah of here aren't east and do you anticipate being able to cover with existing grants and is is that money included in your balance sheet or he said on the come as you achieve milestone
spk_5: the chairs it's lisa i'll take the first part of it which is to say as we look at the grant opportunities and the to general areas were looking in on the larger trials are frequently not funded by much brand support the expectation is you have access to private investors and the capital markets and so i will say go going forward a while he would be wonderful to have another hundred and seventy million and grant funding were looking at much smaller kinds of brands so i would have guide toward different kind of expectations coming forward based on where we are in the clinic i'll turn it back to need for your questions about the young expense coverage yeah matter bench as the the grant revenue and twenty twenty two covered approximately half the operating expenses
spk_2: that would that we have ah in mind you have the trial that were conducting right now with the exception of the magnify trial and dry and the all have grant funding supporting them in one one shape a way to perform on
spk_3: and in terms of what were the sir
spk_2: where this money gets put on the moon the balance sheet and so forth when we incur i was abolished chances will draw on the we draw on our grants and we get the reimbursed by the and i a or whomever fairly ah in almost immediately on when we pay a milestone or up front page
spk_0: but to see our own the apple will draw that money on and enacted ah of and the graph revenue than get hung up on the balance sheet as the bird revenue and then will be taken into of recognized as income as bad as the trial progressive than his work is done
spk_10: that answer your question yes it does thank you for taking our questions a lot for that year term months
spk_3: i next question comes from a j often from oppenheimer please go ahead your line is open
spk_15: oh hey gratis on other progress in think
spk_3: can questions and he talked about the proteomic data that you have coming up at eighty pd in what in at your should be looking for in terms of how it's court t teachings was mechanism and alzheimer's and and anything else you think that you should we got forty me that may have read the cost to partner
spk_7: him and and i gonna follow button trying of the
spk_2: terrific a good morning great to hear from you it's another exciting year or less your day i see we presented dated this year married have some more data let tony take you through what idiots we can discuss the data will be released and week and a half and then the posters will be available at at a high level tony sure am so we presented data laugh
spk_7: last year from the first twenty four patients of our faith to shine said study and from
spk_6: the spark study which is an imaging studies conducted at yale what been prevented if you're at a bpd is a met analysis of the to study said either to nearly identical studies of thing doses thing patient has a powerful way to to cross the to dataset and see which signals the vibe of drug exposure
spk_10: in effect come through both that if to this is giving us a good candidate biomarkers to follow in the future for treatment effect as a to mention we haven't really details that at this point on which protein those aren't so forth you can see that the poster will be able to distribute that minute come when they come that
spk_2: okay great that you look forward to that and just aren't the and the are there any human genetic to have showing the involvement of the signal to receptor in friday and the and have you had any patients in your alzheimer's study who are for had to i am doing and showed up at the him signal
spk_6: that you could detect there and then finally
spk_7: where do you think see the eighteenth wild and an oil drugs and fit into the trigger landscape i am the especially in particular combination randomness thank you
spk_2: sure though the every met him before some of the the impetus for us to move into ga with based damage genome wide association studies that are in the literature demonstrating that them certain changes in the proteins that make up the sigma to receptor confer either risk or protection against
spk_7: that developing gee i don't either is i'm a that data out there and then your next question was there the event of nations to your alzheimer's now he had program yeah it is an interesting question you know what would we don't scream though subjects for a good for geographic atrophy
spk_3: yeah with it if these are complex studies in individuals with dementia though i that's not really part of our our operations unless share with regard to the market the great thing for us is that you have drugs ahead of us at our building this market right a palace and eric on their heels other companies coming behind them and as we're going through development we will see as the retinal community takes for these products will look at what the reimbursement is we'll see how this landscape
spk_10: evolves we believe for patients and an oral drug is a far simpler regimen at take for the long term than having and for vitriol injections and we'll see what the practices of the retina specialist court and so were watching and waiting carefully we think and world drug has an enormous advantage advantage
spk_11: could it be disruptive possibly put it work and combination acidly those are things will be looking to and study as we progress
spk_0: sounds think of the questions
spk_12: thanks jack
spk_7: an expert in consent my out mom tiny from be riley security is prefer headlines open
spk_3: good good morning to in thanks for digging a question than a be sure the level of detail so maybe i'll go to worse i did staying on the ga of feeds to a trial design up the they saw you've i miss those good could you touch on the treatment be be late for your primary efficacy and point a new mean it's a year lease ended dutch
spk_7: in and and now i you also but by any chance looking at visual agree de um maybe other safety measure of unemployed time point good we have an update for that and then i will follow abandonment squished
spk_2: good morning my and thank you tony will take your questions sure gathered though i'm in indeed we are following the presidents of others who have recently filed for approval
spk_7: in this field though they taught us a lot of a particularly about the approve ability of measuring change in ga the were falling very much what others have done or that he of the to your trial and it is largely because while the of the facts of changing ga are devastating of they are relatively slow progressing so you know that significant period of time to measure change our family and for your next question we are measuring
spk_8: visual acuity in various different ways and indeed like others are these will support our primary outcome
spk_7: but that they are not the primary
spk_8: i'm be if if i may just as a follow up that that we're treatment be an aid was that up your proposal to the agency or with that are coming from doctor chambers
spk_12: ah so you know we did have discussions with at the a and we landed on that number based on what what way and they thought was the most likely chance of success and got got it and then on the earth but siegler and alzheimer's program ah the you know be had the level of detail on exhibition for seek well ah i was just curious as the as you know there's the big focus on a c as of biomarkers right are also i believe in yo
spk_7: the border sequel and shine study the with goody goody this may be elaborate on you know which markers that motor relevant that are legal my displacement ah and and you know you could expect the move acutely in in a study like sequel were says you know other markers where you may need a sort of a six man and gladwell month time period longer chronic dozing that be held for donny here yeah indeed with a very fortunate to have very significant support from and i had a run at biomarker analysis from the affair and all of our study so silly agree with the importance ah
spk_12: our our process right now at really identify those candidate biomarkers which will be predictive of change am to answer the question of which ones will take longer and which ones that might be it a more acute what will need to look at their data from laugh from the more to study them and to really tell you which ones will require a long time so certainly that is kind of the kind of information we hope to have over the next there many months
spk_3: i've got an entire again by method the news they of you know what on you're looking to then the sequel data the they're like a gone than good targeting and and i have an announcer yeah yeah
spk_16: we haven't announced yet were healthy and and a similar question on shine is there a particular time next year you're looking do to them that data
spk_12: what first time i and our goal is to complete enrollment this year the last patient comes in at the end of the earth of six month trial in are several months to clean up the data and get line results is only be a function of the involvement been completed tell where thing all
spk_0: paul two and a said thanks thanks for dinner a question and good luck with on the products
spk_3: thank you bye and as a reminder to ask a question please pass star file about the number one on your telephone keypad
spk_0: we have no further questions or ten a call back off to cognition see for causing imax as retarded please go ahead
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