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spk_0: they get vary by a welcome to the in vivid twenty twenty two year and finance over the us of they call at this time all because maternal is normally mode advocates biggest presentations they'll be a question and answer session fast the questionnaire that time for star one one on your telephone as remote as it is call it being recorded i've known to the comes to the host cure faircloth vice president advocacy and corporate communications please go ahead
spk_1: thank you for joining us today before we get started i wanted him to a few housekeeping a them by either the or press release discussing our full year ended december thirty first twenty twenty two financial results which can be found on the investor section of the to that website i would like to remind you that during today's discussion we will be making several forward looking statements forward looking statements include statements concerning among other things the future of the coven nineteen landscape including the expectation of it's continued evolution as emergence of new variants in such areas are all ongoing research and clinical development plans including the timing of this plan as well as the technology and resources to develop therapeutic are prevented of options for the night he and other infectious diseases our regulatory and commercialization plans and opportunities and are expected cash runway and other statements that are not historical fact forward looking statements are subject to a number of risks and uncertainties that may cause actual results to differ materially from those express or implied in the forward looking statements and putting those described under the heading risk factors and are filings made with us securities and exchange commission including the most recent ten case filed earlier today it is now my pleasure to introduce the in vivid management team to the call i'm joined by dave harry field in vivid doctor peach met chief medical officer er doctor luke is still under interim head of discovery in preclinical and spread your skull interim chief financial officer with us and we'll turn the pullover to dave
spk_2: good afternoon and thanks for joining the call the are looking forward to sharing with you financial results from the past year along with highlights of significant progress we made during the past quarter for those who may be needed in been story we're on a mission to rapidly and perpetually deliver antibody based therapies designed to protect vulnerable people from the devastating consequences of circulating viral threat the getting would start go be to the foundation of our mission is based on three key factors one covered is here to stay and represents an unacceptable medical burden on human kind few the medicine cabinet to protect humanity from kobe is alarmingly limited and three we are uniquely positioned to keep pace with viral evolution and provide therapeutic options to people who are urgently need them we have reached a stage where sarkozy to is circulating unchecked amongst the broader population with as many as eighty five percent of people and the us having been infected the vaccination rate for boosters is exceedingly low compared with rates of the primary theories recent report highlight that only twenty eight percent of the eligible people have now received the most recent covered nineteen booster people are being infected and reinfected while the virus continue to evolve everyday two hundred fifty to four hundred families in the us lose a loved one because the nike and covered remains the third leading cause of death behind only heart disease and cancer while most of society has accepted the status quo and are trying to live with covered we would argue that all are not living well particularly vulnerable populations although the immediate impact of covered keen on many healthy adult appear mild the long term consequences remain unknown preliminary day later reported by the mayo clinic show that covered eighteen infections are linked to long term complications that impact numerous body system including pulmonary reno neurological and gastrointestinal complication additionally vulnerable populations remain at an increased risk of severe disease resulting in hospitalization and even death a meal compromise paid patients alone in the last represent between eight and twenty million individual depending on how their status as classified that's right we are facing from covered my pain is constantly changing as viral evolution has continued through on the concept lineages in fact hundred the new variant have been identified in the us in the last five months the continual viral evolution mandates that drug discovery and development laski pace however as a january twenty twenty three there are no longer any monopole antibodies for the treatment or prevention of covered nineteen authorized and us we consider this market and open opportunity for infinity target near term for reference the law school quarter with all antibodies authorized and us and or could go
spk_1: oh boy represented approximately one point one billion dollars in revenue
spk_2: importantly we see this category growing because although many populations have been served by back the nation and treatment with antiviral medication as he referred you there are many populations who have not benefited from these approaches and which will require ongoing protection in treatment outside of the major option marco antibodies for cover nineteen alone generated almost eight billion dollars in revenue and twenty twenty two while the bad news is there are no marple antibodies a viable for treatment or prevention and an ongoing hibernia disease the good news is we believe in vivid is uniquely positioned to respond to that need having generated a pipeline have multiple next generation engineered antibody candidates for covered nineteen designed to keep pace with viral evolution or pipeline assets are engineered to be broadly neutralizing antibodies affected across multiple members of the current a virus family to support their prolonged utility earlier this month we announced plans to advance v why did you do to you are next pipeline candidate into the clinic for start though be to he why did you do to is one of the components of nbd two hundred a mad combination candidate that in vivid previously elected to advance in development
spk_3: the company chose to prioritize the clinical development of the y de que tu tu mama therapy instead of nbd two hundred combination product because we believe that strategy will enable us to provide patients with a much needed therapeutic often as quickly as possible and a capital efficient way
spk_2: importantly we had selected a combination job candidate prior to the emergence of potential expedited regulatory pathways which may allow in vivid to develop multiple new antibodies staggered in time to take advantage of data from new stars coby two variants wifi the why do you take you do as a highly attractive candidate for clinical a bath and for several reasons the why did you do to targets despite protein of dark of it you are well understood mechanism with the thief he brought up with a safety profile established by multiple as the approved antibodies with wifi over the is gonna go risk additionally he why did you to to is an engineered version of our first mark well as antibody thought it called inch of the man which demonstrated clinically meaningful results across it three primary endpoint enlarge global phase three trials are strong data packets for incredible mab has the potential to support accelerated development of the by did you teach you importantly and standardized in vitro as a view id teaching to showed neutralizing activity against multiple currently circulating our variants of concern including though that led to the up the lessons of products previously authorized and us that has since been pulled from the market we continue to play and to initiate a faith one clinical trial and que one of twenty twenty three and assuming positive based on data we anticipate rapidly initiating the thief or capital trials that could support regulatory filings globally recently there have been several pods of exile development that indicate momentum for faster development of next generation kill the treatment including the lady duty to the are often ask adopt the white house's decision to end the covered nineteen public health emergency and how this could impact the ft eight emergencies author is east and for covered and the development of monoclonal antibodies like the likely to teach you we do not see that impacting our development strategy soon after the by an administration announced that the public health emergency will end on may eleventh the at the a confirmed that existing you wait for vaccine tests and treatments will not be affected and confirmed that it may continue to issue you wait for me products that meet the required cartier area additionally the industry remain hopeful that alternative efficient regulatory sagely to support the development of novel monoclonal antibodies therapies will be utilized for this critical unmet need while we are optimistic about the y de to to to potential deserve the credit critical me for therapeutic option for coven nineteen continued viral evolution dictates that we also continue to evolve our assets and further add to our pipeline leveraging are proprietary discovery platform approach we are perpetually monitoring emerging viral threat discovering engineering and a valley new monopole out of body for their ability to neutralize start still be to and addition to the why did you to to we have three other covered nineteen candidates in our pipeline at the preclinical the message is clear there remains a large persistent medical and commercial opportunity outside of kelvin i am not aware of any other opportunity in biotech that is larger offered the faster path to authorization and and has a higher probability of meaningful planning poll results given our
spk_4: mechanistic understanding of the virus
spk_1: we believe we are well positioned to capitalize on that opportunity time and time again with our proprietary discovery technology i will now turning over to our chief medical officer peach met to review our recent pipeline progress and ongoing discovery and development activities thank you and the mentioned we recently nominated the mighty to do to to them to the clinic as a new monoclonal antibody candidate or map against us school to as you know be ready to teach you will be or second map candidate to enter tough thing after phase one dose ranging trial to value a safety and pharmacokinetics or pk we intend to initiate what we expect to be a larger registration or phase three clinical trial to assess the efficacy of the ready to to to to prevent go with nike specifically in immune compromised individuals
spk_5: be ready to to to has demonstrated in vitro utilizing activity against sars cov a few variants of concern or be oh sees including the current dominant i'm a crime somebody it's xp be one i thought he like a duty to is an engineer version of adage have a man or first investigational math
spk_1: and uncover man has a robust safety data path package and has demonstrated clinically meaningful results in global phase three clinical trials for both the prevention and treatment of covered nineteen during the delta and i'm khan be a one waves of sars be too but subsequently lost in vitro activity against on
spk_4: can't be a to
spk_1: utilizing our expertise in protein engineering we were able to restore in vitro mutualization activity against the a few and other i'm gonna be a scenes while maintaining activity against previous be a seat our precision engineering resulted in be likely to teach you different from manage have enough by only eight amino acids in a variable region
spk_4: the regulatory landscape around coven name is advancing and there's been considerable movement with the us food and drug administration and the european medicines agency as they were to establish regulatory frameworks that consider the rapidity of viral evolution
spk_1: the agencies are looking for ways to accelerate development of maps as well on december fifteenth twenty twenty two a joint yeah may f t a workshop and titled advocacy of monoclonal antibodies in the context of rapidly evolving sorry for the two variants was held to discuss alternative strategies for the debate
spk_4: element of novel map therapies including those based on prototype products that have demonstrated safety and advocacy in clinical trials in did it with asked to that alongside eli lilly and regeneron at this workshop to discuss ways of accelerating that the down and against over ninety
spk_1: as part of the joint industry presentation and utilizing data from at inch have a map prevention trial evade neutralizing antibodies fighters were proposed as a surrogate mark of protection is our belief that these neutralizing antibodies years combined with associated pk and safety of commission could be used for a streamlined development pathway and the prevention of of in ninety encouragingly we have seen other companies in the coven lengthy map space refer to the use of biomarkers surrogate and points to exploit their clinical development which may suggest that the f b i and other major regulatory bodies have agreed in principle to such a trial design for a next generation mouth gotta we
spk_4: see this as an important advancement not only for be why to teach you but also for future maps winter spade generally against sars be due to allow us to rapidly shift from one map to another as the virus mutates
spk_1: after demonstrating clinical development success with and shove a man by generating clinically meaningful results we are leveraging and applying this expertise to new therapeutic candidates furthermore targeting the size of koichi receptor binding domain or are bd is well validated mechanism of action for laughs with robots safety and efficacy data generated across the last we expected these data supporting the broader class of our be targeted and device will also enable regulatory authorities looting the of b a yummy he'll fly surrogate and points as a corlett of protection in future clinical trials
spk_4: i know many of you want more details about our clinical trial design and time once per view i need to teach you were planning a standard phase one pk and goes ranging from this trial which will be conducted in australia is on track to guess the first patient this for consistent with the outage have about program were planning to initiate a three pivotal trial that could support local regulatory filings rapidly on the heels of completing his face one trial with regards to cmc to support manufacturing of our clinical materials in commercial drop product we have at the partnership with lucy which has f d a approved manufacturing facilities and has delivered one hundred percent of our drugs substance lot on time
spk_1: through this relationship we have already manufactured the drugs substance needed for clinical trials of the lady to teach you in support of anyway
spk_6: i'm confident in our ability to work with speed agility and efficiency to reduce traditional fan of timelines and to get the top line data as quickly as possible
spk_2: oh now past because over to look at dodger them as interim head of discovery preclinical who will discuss our ongoing surveillance and antibody discovery screening and engineering thank you paid for the update on our need them outlook a fake the at the beginning of the called invaded approach to are in deep core with my team is one of perpetual innovation indeed it was created to continually developed candidates and not rely on anyone can get it
spk_6: the paper find an evolution be month that our candidates to keep eight and have the potential to address emerging milo fact it unique perpetual discovery engine it's killed by cutting edge bottled epidemiological for vaillant identification of broken utilizing monoclonal antibody
spk_2: and industry leading become mighty protein and envy bobby engineering is valid screen capabilities
spk_6: for our eternal a petite and collaboration
spk_2: with regard to money polling bottle evolution he continued to maintain and improve i live in have plane and and for new and upcoming five pull the to ban it before these become very of consent
spk_6: furthermore i pinpointing tommy spiked like royalty fight targeted by human antibody get the plot and nothing common a tasteful escape route we aim to predict and target future without could to comparing we have industry leading antibody mining engineering and develop ability screening capability built with our incriminate the teeth and in hospital a fully operational bachelor facility that he moved into in december if it faded supported by our partnership it up
spk_7: alec induction and academic collaborative and the council of our world class scientific advisory board comprised of leading researchers and key opinion needed any new knowledge he biology epidemiology and because it might in space
spk_6: our innovation engine leverage is nita mining capabilities to i did not neutralizing antibodies followed by anybody engineering to improve the pulpit deep breath
spk_2: five physical properties
spk_6: and develop ability of all candidates we seek to advance for non clinical development and ideally think study
spk_2: for example birth the boat you specifically engineered ali the parties for extent a half life modify the it mediated innate immune to take the function or to introduce alternative form
spk_6: such a thing of the main a fight that if it molecules
spk_2: i'll establish platform and key learning from our work could arbitrary might help to accelerate our path to the clinic and beyond for this approach the attenuating looks at me like the to to two of the robot pipeline of the coveted candidate with potential for youth in both prevention and treatment of feel it viral defeated stopping it called at nike
spk_6: from there we are expanding the covey effort into finding implications including influenza beyond be like the to to to we have already initiated new antibody campaign the target reengineering and definitely maturation of our current molecule against the most reason call it and you of concern started xp be point one point five
spk_2: the are currently evaluating several of the candidates who preclinical studies to support nomination of additional candidate for idea enabling and clinical development
spk_4: the invasion said a product development opportunities emerging from first call it to the calgary efforts for the prevention and treatment of covert my team
spk_6: we believe that it probably have additional broken utilizing monoclonal antibody the target new bar like bit of both within and outside the rb the look at port durable products
spk_8: with my key a new variant of concern continue to iraq
spk_6: the accomplish and our strategy is to predict and respond to bury before they become variant of confirm and continuously the cover of engineering be thought is with neutralization breath and potency such with patients can meet me have access to high quality protection even in the face of rapid violence
spk_2: evolution
spk_6: we do not rely on a single molecule targeting a single at the top that may experience while his escape we believe our integrated with curry platform reinstall drug development and manufacturing expertise offers a unique competitive advantage in this effort and the potential to provide a distinct benefit the patient the caregivers and global health authorities searching for
spk_2: durable solution to the ongoing burden impulse i called it my pin with that i was turned the corner the perfect scope is if it's either in chief financial officer who was it cause our financial that's what is and good afternoon everyone let me begin by providing an update on twenty twenty two fiscal year pl as compared to the comparable twenty twenty one period and an update on task guidance with respect to operating expenses are the including improper sovereignty was a hundred and eighty three point six million for the year ended december thirty first twenty twenty two compared to a hundred ninety point four million dollars for the comparable period of twenty twenty one if the decrease is attributable primarily to wind down of adam treasure map clinical trials partially offset by increase in contract manufacturing including adults other that commercial supply for potential you way it to support our pipeline programs including view id to to
spk_9: two
spk_2: this decrease our d was further offset by an increase in personnel related expenses er es una expenses were forty seven million dollars for the year ended december thirty first twenty twenty two compared to thirty six point five million dollars for the comparable period of twenty twenty one this increases attributable to hire personnel related expenses professional fees and costs to support operations as a public company in the fourth quarter twenty twenty two the company occurred a seventeen point four million dollar expense attributable to a one time charge associated with was issued the population health partners or p h p as compensation for consulting services to be provided by p h p to the car opening the net loss for the year ended december thirty first twenty twenty two was two hundred and forty one point three million dollars compared to two hundred and twenty six point eight million dollars for the comparable period and twenty twenty one they sipped and deluded net loss per share with two dollars and twenty three stats for the year ended december thirty first twenty twenty two compared to a net loss for five dollars and thirty two cents for the comparable period and twenty twenty one the net loss of two hundred and forty one point three million for the year ended december thirty first one in two twenty to included a one time charge of seventeen point four million dollars related to the fair value of the was issued the dhb
spk_0: we've finished twenty twenty two and a strong balance sheet position with cash cash equivalents and marketable securities a three hundred and seventy two million dollars
spk_10: they saw that are operating plans which reflect the completion of a bottoms up departmental analysis that we highlighted on the two three earnings call our cast guidance has improved from a previous guidance every dallas fact that cash will enable the company defined it's operating expenses excluded
spk_0: in any potential revenue associated with the right to to to a to the second half of twenty twenty four
spk_11: without operator a up in the proper questions thank you again leverage i mean if you like ask a question for star one one on your telephone against the ask a question please by star one one
spk_12: one moment please far first question
spk_13: efforts pressing concern that lot of evan wing after the man he landed open
spk_11: hi guys think putting my question
spk_12: heat i like you know like remaining before the i idea to to do trout or it
spk_2: candidate that more
spk_14: i get rowdy nine that those day
spk_15: timeline
spk_2: etc
spk_11: yeah thanks to have an armpit wanna talk little bit about what remains is we're getting money towards the end of this quarter yeah he has he's stated previously worked were still anticipating i'd go saying our first in human study this quarter or we haven't released a lot of details about that study but as he heard from the call it a pretty pretty traditional dose ranging pk and and safety study beyond that will will continue to release details as appropriate on our on our subsequent studies yeah new as having a little bit about timing right and skill you know if pete mentioned we still anticipate the first study starting by the end of the month just getting know i have a trial material to decide seen again the recruitment tonic cetera and then on our planet to continue the have ah in our ongoing data released it throughout the year
spk_2: got it thanks and in terms of a phase three and he said that the paper lower they correlate our yeah they hear about primary endpoint
spk_15: and secondly
spk_14: you know the why did you did you know
spk_2: adapted from eighty the twenty how does that kind of how does that a benefit in terms of i can provide the maybe a framework norms of how that reduce the trial size or kind of go to trial i read what here
spk_16: yeah i'll take the first time an lp you can take the second so he was we've we've said and shown before you know eighty twenty our original on antibody we went from i indeed the a pivotal clinical data and fifteen months and we utilize both treatment and prevention studies that used of
spk_14: event thread then clinical and points and you know what we continue to look out as a possibility is whether there's an opportunity to use correlate surrogates a mean bridging etc and fill those disgusting continue on as pete mentioned you know as a part of the of front on the call this was really articulated during the december fifteenth joint as the am a meaning and in a we alongside academic then in other stakeholders really commented about the need for these types of approaches especially given the dynamic environment that were in ah you're really going against a virus that continues to evolve it's such a rapid pace and so and we continue to have those conversations down and as we previously mentioned as soon as we have ah outlined in confirmed exactly what those clinic all parameters would be for pivotal studies ah we plan to share in a more details about that
spk_17: the any you know other comments the other good question about the relationship eighty twenty the molecular relationship and and
spk_18: you know we're still in conversations with global regulators are around this of course but
spk_0: we do believe that we eat is an advantage to have a robust safety data set and and also efficacy data from our previous face three studies in a molecule that was generated on the same manufacturing platform and is so closely structure
spk_19: really related to to view id for a eighty tony i'm sorry so lots of potential there
spk_1: i says thank you one moment please
spk_14: and expressing concern i have said i
spk_15: matter of jeffries a lot of helping
spk_20: has to sit on from michael your jeffrey
spk_14: i'm says too quick question first one being
spk_15: you know ashes and like another big companies while the middle of the money and twenty twenty two and antibodies have noted that they see the market going significantly down in twenty three and beyond as he moved to endemic market to have you guys think about and as you move your antibody forward and my second question is is you know although you've mentioned am having these kind of correlates
spk_2: of protection for a phase three phases of any discussion or definitive answers from the ft on whether are you can use that as a part of your a free studies like you
spk_21: yeah also the first question and go your our estimates that and twenty twenty two you know the sort of overall market across vaccines ah all anti viral marco antibodies with almost one hundred billion dollars ah and yes i think that com a lot
spk_0: of folks are predicting that that will come down but it's still incredibly sizable market ah bill michael antibodies that eight billion ah about in revenue and twenty twenty two and that was with ah in a predominantly back to love a man and of yourself and have you felt good enough five hundred and
spk_22: the million dollars and cute three of of last year and will wifi is with a similar ah indication really targeting a meme compromise vulnerable populations it of they only touch really a fraction of of that population and we continued to work with these groups talk to peace and as get he grew speak with these individuals and they still are really clamoring for ah products in particular i spoke to were in a position ah who works at the mayo clinic in said you know he'd never been in a position that the theft of hastened come in and ask for product and there's nothing avail well of and fill these are not wifi the market for monaco antibodies continuing to be incredibly significant and a huge unmet need and the thiessen population arm as it relates to your your other question in terms of you know where regulators are and you know what the status is
spk_14: your will provide updates in august will update when we get them we continue billion and dialogue with the f t a and other global regulators and you know what i said as soon as we have ah confirmed what that trial design will look like we planted to provide that information
spk_15: thank you thank you
spk_2: one moment please
spk_15: our next question comes from the lana matthew harrison a mortgage family a lot of open
spk_20: hi this is when john line for hill thanks for taking on crashes i have to pressure and why is it there every update on adding kind of regulatory threshold for new and be therapy for covered
spk_23: given the change off the and i'm setting
spk_24: could there be at a flexibility in potential provo the second is a to have any updates on your potential progress all flu and a base ah therapy development
spk_0: third no thank you for the question fill on the on the first one in terms of regards good the threshold
spk_2: bob bill as your life we were at least in the us none of the antibodies have been fully licensed gone through be a lathe they've all been authorized through he weighs and down there currently are no marco analyze on the market and so we've not seen any specific ah changes in fresh old in particular what we continue to to look at his in vitro data ahead of time and as what we've been on in a be why the pew pew pew is a real consistently strong activity against i'm a variety of variance including on the most recent
spk_20: on that one wonder five and though we see that god is we are really important information as it relates to to getting the product into clinical trials extra and got as i mentioned you know through the presentation while the public health emergency is ending
spk_2: that does not remove the potential for the t diego utilize the us and so we still see that as a open possibility for the whitey to to or are additional other candidate that we have in the pipeline
spk_15: the relates to our the food component altar of lucas you can provide an update on the status of a word of what of where we are with the flu program
spk_0: yes thank you day so we've identified several interesting molecules in the flu program already are these molecules the currently being for the correct right and then be traced the another study and we will be releasing the data on the thief have them available okay thank you thank you i'm sure no further questions at this time return the call back over to date harry for any closing remarks thank you so much so thanks everyone for were joining ah it was a fantastic quarter and a great twenty twenty two i'm very excited for where we are and job
spk_1: as i looted to at the start of this discussion on a pretty extremely pleased with our progress in the fourth quarter and and are start to this year we have multiple monoclonal antibody candidates that have shown in vitro utilizing activity against multiple current lineages of ah micron i believe in the company's ability to bring to market a product for kovac nineteen as fast and efficiently as possible to meet this continued large unmet need of and patients into capitalize on the significant market opportunity and create value for shareholders given the rapid pace the viral evolution and the ongoing regulatory firemen we are positioning the company to pivot is necessary to liberal to deliver on that goal time and time again so that concludes our meeting for today and as always will be happy to follow up with analyst or investors one on one after the call tonight and tomorrow thank you thank you ladies is i'm the second crusades conference thank you all for disability me now disconnect have a great day regular fairly by a welcome to the a vivid twenty twenty two year and find out of the us up they call at this time all because most analysts know emerge as the seek a presentation they'll be a question and answer session classic was that time please for star one one on your telephone as remote as a call is being recorded i've known to the comes to the host cure faircloth vice president advocacy a corporate communications please go ahead
spk_2: thank you for joining us today before we get started i wanted him to a few housekeeping items i by either the or press release discussing our full year ended december thirty first twenty twenty two financial results which can be found on the investors section of the into that website i would like to remind you that during today's discussion we will be making several forward looking statements forward looking statements and good statements concerning among other things the future of the corbyn nineteen landscape including the expectation of it's continued evolution as emergence of new variance in such areas our ongoing research and clinical development plans including the timing of this plan as well as the technology and resources to develop therapeutic have prevented of options for coven he and other infectious diseases or regulatory and commercialization plans and opportunities and are expected cash runway and other statements that are not historical fact forward looking statements are subject to a number of risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward looking statements including those described under the heading risk factors and are filings made with the us securities and exchange commission including for most recent ten case filed earlier today it is now my pleasure to introduce the in vivid management team to the call i'm joined by dave harry field and vivid doctor peach met chief medical officer doctor luke is still under interim head of discovery in preclinical and spread your skull interim chief financial officer with us and will turn the ball over to the eve good afternoon and thanks for joining the call the i'm looking forward to sharing with you financial results from the past year along with highlights of significant progress we made during the past quarter for those who may be needed in been story we on a mission to rapidly and perpetually deliver antibody based therapies designed to protect vulnerable people from the devastating consequences of circulating viral threat the getting would start gobi to the foundation of our mission is based on three key factors one coveted here to stay and represents an unacceptable medical burden on human kind you the medicine cabinet to protect humanity from kobe is alarmingly limited and three we are uniquely positioned to keep pace with viral evolution and provide therapeutic options if people who are urgently need them we have reached that stage where sarkozy to circulating unchecked amongst the broader population with as many as eighty five percent of people and the us having been infected the vaccination rate for boosters is exceedingly low compared with rates of the primary theories read the report highlight that only two twenty eight percent of the eligible people have now received the most recent covered nineteen booster people are being infected and reinfected while the virus continue to evolve every day one and fifty to four hundred family the new us lose a loved one because the nike and covered remains the third leading cause of death behind only heart disease and cancer while most of society has accepted the status quo and are trying to live with covered we would argue that all are not living well particularly vulnerable populations although the immediate impact of covered night keen on many healthy adult appear mild a long term consequences remain unknown preliminary data reported by the mayo clinic so that covered eighteen infections are linked to long term complicated it's that impact numerous body them including pulmonary reno neurological and gastrointestinal complication additionally vulnerable populations remain at an increased risk of severe disease resulting in hospitalization and even death a meal compromise patients alone in the last represent between eight and twenty million individual depending on how their status as classified
spk_3: that's right we are facing some covered nine pain is constantly changing as viral evolution has continued through on the concept many it is in fact hundred the new variant have been identified in the last in the last five months the continual viral evolution mandates that drug discovery and development must keep pace however as a
spk_2: january twenty twenty three there are no longer any monoclonal antibodies for the treatment or prevention of covered nineteen authorized and us we consider this market and open opportunity for infinity to target near term for reference the last quarter was all antibodies authorized in the us and or globally rubber that approximately one point one billion dollars in revenue importantly we see that category growing because although many populations have been served by back the nation and treatment with antiviral medication as he referred you there are many populations who had not benefited from these approaches and which will require ongoing protection in treatment outside of the major option marco antibodies for covered nineteen alone generated almost eight billion dollars in revenue and twenty twenty two while the bad news is they are no more whole antibodies of the viable for treatment or prevention and an ongoing burn disease the good news is we believe in vivid is uniquely positioned to respond to this need having generated a pipeline have multiple next generation engineered antibody candidates for covered nineteen designed to keep eighth with viral evolution or pipeline assets are engineered to be broadly neutralizing antibodies affected across multiple members of the current a buyer family to support their prolonged utility earlier this month we announced plans to advance v y de que duty you are next pipeline candidate and to the clinic for start toby to the why did you few to is one of the components of nbd two hundred a mad combination candidate that in vivid previously elected to advance in development the company chose to prioritize the clinical development of the y de que tu tu mama therapy instead of envy two hundred combination product because we believe that strategy will enable us to provide patients with a much needed therapeutic option as quickly as possible and a capital efficient way importantly we had selected a combination job candidate prior to the emergence of potential expedited regulatory pathway which may allow in vivid to develop multiple new antibodies staggered in time to take advantage of data from new stars coby to variants wifi the why do you teach you to as a highly attractive candidate for clinical advanced than for several reasons the why did you to to targets despite protein of dark go with you are well understood mechanism with a thief he brought up with a safety profile established by multiple as the a approved antibodies with wifi over these is gonna go risk additionally he why did you to to is an engineered version of our first mark while antibody thought i called in chad the map which demonstrated clinically meaningful results across his three primary endpoint enlarge global phase three trials are strong data packets from incredible nab has the potential to support accelerated development of the lady you que
spk_25: importantly and standardized in vitro as a view id to compute showed neutralizing activity against multiple currently circulating bernard variants of concern including though that led to the up the lessons of products previously authorized and us that has since been pulled from the market we continue to plan
spk_2: to initiate a phase one clinical trial and que one of twine twenty three and assuming positive based on data we anticipate rapidly initiating the the three pivotal trials that could support regulatory filings globally
spk_4: recently there have been several positive exile developments that indicate momentum for faster development of next generation kill the treatment including the lady duty to we are often ask about the white house decision to end the covered nineteen public health emergency and how this could impact the ft eight emergencies authorization
spk_1: and for coded and the development of monoclonal antibodies like view id to teach you
spk_4: we do not see this impacting our development strategy soon after the by the administration announced that the public health emergency will end on may eleventh the the a confirmed that existing he waits for vaccine tests and treatments will not be affected and confirmed that it may continue to issue you wait for new products that meet the required criteria
spk_1: additionally the industry remain hopeful that alternative efficient regulatory strategy to support the development of novel monoclonal antibody therapies will be utilized for this critical unmet need while we are optimistic about the y de to to choose potential deserve the the critical me for therapeutic option for cover nineteen continued viral evolution dictates that we also continued to evolve our assets and further add to our pipeline leveraging are proprietary discovery platform approach we are perpetually monitoring emerging viral threat discovering engineering in a valley new monopole our bodies for their ability to neutralize start to be to and addition to the why did you to to we have three other covered nineteen candidates in our pipeline at the preclinical states
spk_4: the message is clear there remains a large persistent medical and commercial opportunity outside of coven i am not aware of any other opportunity and by biotech that is larger offered the faster path the authorization and and has a higher probability of meaningful on planning call result given our mechanistic on
spk_1: you're standing of the virus we believe we are well positioned to capitalize on that opportunity time and time again with our proprietary discovery technology i will now turning over to our chief medical officer peach net to review our recent pipeline progress and ongoing discovery and development activities
spk_4: thank you and the mansion we recently nominated the mighty to do to to them to the clinic as a new monoclonal antibody candidate or match against us scooby to as you know be ready to teach you will be or second map candidate to enter something after phase one dose ranging proud to valued safety and pharmacokinetics or pk we intend to initiate what we expect to be a larger registration or be three clinical trial to assess the efficacy of the why the to to choose to prevent code nike specifically and immune compromised individuals
spk_1: be mighty fifty two has demonstrated in vitro utilizing activity against sars be two variants of concern or be oh sees including the current dominant on a crime struggling huge xp be one point five
spk_26: he like a duty to is an engineer version of in trouble now our first investigational now
spk_4: and uncover man has a robust safety data path package and has demonstrated clinically meaningful results in global these three clinical trials for both to prevention and treatment of covered nineteen during the delta and amir khan be a one waves of sars for be too but subsequently lost in the tracked to buddy against america
spk_1: won't be a to utilizing our expertise in protein engineering we were able to restore in vitro neutralization activity against the a few and other on the can be a sees while maintaining activity against previous our precision engineering resulted in be id to do to your friend for manage have enough by only eight amino acids in the variable region the regulatory landscape around code name either demands and there's been considerable movement with us food and drug administration and the european medicines agency and they were to establish regulatory frameworks that consider the rapidity of viral evolution
spk_4: the agencies are looking for ways to accelerate development of mouse as well
spk_1: on december fifteen twenty twenty two a joint you may have to a workshop and title efficacy of monoclonal antibodies in the context of rapidly evolving sorry for the two variants was held to discuss alternative strategies for the development of novel map therapies including those based on prototype products
spk_4: that have demonstrated safety and advocacy in clinical trials
spk_1: he did it with asked to prevent alongside eli lilly and regeneron at this workshop to discuss ways of accelerating mastodon and against over ninety as part of the joint industry presentation and utilizing data from an inch have a map prevention trial evade neutralizing antibodies fighters were proposed as a surrogate market
spk_4: protection
spk_1: is our belief that these neutralizing antibodies years combined with associated pk and safety information could be used for a streamlined development pathway in the prevention of covered ninety encouragingly we have seen other companies in the coven nineteen map space refer to the use of biomarkers surrogate and claims to a
spk_4: right there on of development which may suggest that the f b i and other major regulatory bodies have agreed in principle to such a trial design for a next generation mouth products we see this as an important advancement not only for be ready to see to but also for future maps with winter speed generally against the tsa
spk_1: roscoe be due to allow us to rapidly shift from one map to another as the virus mutates
spk_6: after demonstrating clinical development success with uncover a by generating clinically meaningful results we are leveraging and applying this expertise to new therapeutic candidates furthermore targeting the sars koichi few receptor binding domain or rb be is well validated mechanism of action for mass with robust safety
spk_2: efficacy data generated across the class we expected these data supporting the broader class of our be targeted and device will also enable regulatory authorities including the of the a yummy to fly surrogate and points as a core little protection future clinical trial i know many of you want more details about our clinical trial design and time once per view i need to teach you were planning a standard phase one pk and goes free trial this trial which will be conducted in australia is on track to does the first patient this for
spk_6: it would be out and have about program were planning to initiate be three pivotal trial that could support local regulatory filings rapidly on the heels of completing his face one trial
spk_2: with regards to cmc to support manufacturing of our clinical materials in commercial drop product we have at the partnership with blue which has f d a approved manufacturing facilities and has delivered one hundred percent of our drugs substance lot on time
spk_6: three this relationship we have already manufactured the just substance needed for clinical trials of the lady to teach you in support of anyway i am confident in our ability to work with speed agility and efficiency to reduce traditional fan of timelines and to get the top line data as quickly as possible
spk_2: oh now past because over to look at dodger events interim head of discovery preclinical who will discuss our ongoing surveillance and antibody discovery screening and engineering thank you paid for the update on our need them outlook a fake that at the beginning of the called invaded approach to are in deep a with my team is one of perpetual innovation
spk_6: indeed it was created to continually developed candidates and not rely on anyone can get it the paper find an evolution be month that our candidates to keep pace and have the potential to address emerging milo fact did you need perpetual discovery engine it's killed by cutting edge bottled epidemiological for in identification of broken utilizing monoclonal antibody and industry leading pizza me protein and ended by engineering is valid screen capabilities for our intellect petite and collaboration
spk_2: with regard to money polling bottle evolution he continued to maintain and improve i like in have plane and them for new and upcoming five calls to ban it
spk_6: before these become very of consent furthermore i pinpointing tommy spiked like approaching fight targeted by human antibodies that the plot and nothing common a tasteful escape route we aim to predict and target future without could to variant
spk_2: we have industry leading empty the mining engineering and develop ability screening capability built with our internal the teeth and in hospital a fully operational bachelor facility
spk_4: that he moved into in december
spk_2: if it said it supported by our partnership it up i like induction and academic collaborative and the council of our world class scientific advisory board comprised of leading repurchase and key opinion needed any new knowledge he biology
spk_6: epidemiology and because it might in space
spk_2: our innovation engine leverage is lisa of mine capabilities to i spit not neutralizing antibodies followed by antibody engineering to improve the pope is deep breath fire physical properties and develop ability of our candidates we seek to advance for non clinical good
spk_27: element and ideally think study
spk_4: for example birth leak the boat the specifically engineered all antibodies for extent a half life modify the is mediated innate immune to take the function or to introduce alternative form
spk_6: such a thing of the main a fight that it molecules ali establish platform and he learned from our work rather drive him up help to accelerate our path to the clinic and beyond for this approach the attenuating much at me like the to to to at the robot pipeline of it covers states candidate with potential for youth in both prevention and treatment of feel it viral defeated stopping it called at nike
spk_2: from there we are expanding the covey effort into finding implications including influenza
spk_6: beyond be idea to to to we have already initiated new antibody campaign the target reengineering and affinity maturation of our current molecule against the most reason call with my companions of concern started xp pretty point one point five
spk_2: the are currently evaluating several of the candidates in preclinical studies to support nomination of additional candidate for idea enabling and clinical development the invasion fair the product development opportunities emerging from first cause it to discovery efforts for the prevention and treatment of covert my team we believe that it probably have additional broken in utilizing monoclonal antibody the target new bar like bit of both within and outside the rb the look at port durable products for public nike at newbury have confirmed continue to arrive in conclusion our strategy is to predict and respond to bury before they become variant of content and continuously did cover of engineering thought it with neutralization breath and potency such with patient been meet me have access to high quality protection even in the face of rapid miles away
spk_9: lucian
spk_2: we do not rely on a single molecule targeting a single at the top that may experience while escape we believe our integrated did that from reinstall drug development and manufacturing expertise officer unique competitive advantage in that effort and the potential to provide a distinct benefit the patient the caregivers and global health authorities searching for durable solution to the ongoing burden impulse i called it my pin with that i will turn to call over to friendly scope is the either in chief financial officer who will discuss our financial that's what this and good afternoon everyone let me begin by providing an update on our twenty twenty two fiscal year pl as compared to the comparable twenty twenty one period and an update on cash guidance with respect to operating expenses rg including improper sergey was one hundred and eighty three point six million for the year ended december thirty first twenty twenty two compared to one hundred ninety point four million dollars for the comparable period of twenty twenty one if the decrease is attributable primarily to wind out of adam travel map clinical trials partially offset by increase in contract manufacturing including adults rather that commercial supply for potential you way it to support our pipeline programs including the why the to to two
spk_0: this decrease in rd was further offset by an increase in personnel related expenses
spk_10: er es una expenses with forty seven million dollars for the year ended december thirty first twenty twenty two compared to thirty six point five million dollars for the comparable period of twenty twenty one this increases attributable to hire personnel related expenses professional fees and costs to support
spk_0: operations as a public company
spk_11: in the fourth quarter twenty twenty two the company occurred a seventeen point four million dollar expense attributable to a one time charge associated with large issued the population health partners or p h p as compensation for consulting services to be provided by p h p to the cow albany
spk_12: the net loss for the year ended december thirty first twenty twenty two was two hundred and forty one point three million dollars compared to two hundred and twenty six point eight million dollars for the comparable period and twenty twenty one they sit and deluded net loss per share with two hours and white respect for the year ended december thirty first twenty twenty two compared to a net loss for five dollars and thirty two cents for the comparable period and twenty twenty one the net loss of two hundred and forty one point three million for the year ended december thirty first one it was
spk_11: need to included a one time charge of seventeen point four million dollars related to the fair value of the was issued the h
spk_28: we've finished twenty twenty two and a strong balance sheet position with cash cash equivalents and marketable securities a three hundred and seventy two million dollars
spk_2: they sought after operating plans which reflect the completion of a bottoms up the pot metal analysis that we highlighted on the que three earnings call are cast guidance has improved from a previous guidance every dallas fact that cash will enable the company defined it's operating expenses exclude
spk_14: in any potential revenue associated with the right to to to a to the second half of twenty twenty four with that operate a please up the call for questions thank you again leverage i mean if you like ask a question for star one one on your telephone against to ask the question please by star one one one moment please for first question
spk_11: after expressing question not lot of adding wayne after the he of helping hi guys think my question heat i like you know like remaining before the the idea that to do trout start donald more
spk_2: i get crowded nine
spk_15: that go same timeline
spk_20: etc
spk_14: yeah thanks to have an arm pit wanna talk a little bit about what remains is were getting money towards the end of this quarter yeah
spk_15: the stated previously worked were still anticipating i'd go saying our first in human study this quarter or we haven't released a lot of details about that study but as he heard from the call it that pretty pretty traditional dose ranging pk and and safety study
spk_14: beyond that will will continue to release details as appropriate on our on our subsequent studies yeah new as having a little bit about timing right and still ah you know if pete mentioned we still anticipate the first study starting by the end of the month just getting know i have a trial material to the site in again the recruitment donning cetera and then arm our planet to continue to have ah in our ongoing data release it throughout the year got it thanks and in terms of a faith three and a cat that the paper though they correlate our yeah they hear about primary endpoint and secondly you know the why did you did you know
spk_17: adapted from any the twenty how does that kind of
spk_18: how does that done benefit in terms of i can provide the maybe a framework norms of that how that may reduce the trial by or kind of go to trial are we looking at here
spk_0: yeah i'll take the first time an lp you can take the second job he was we've we've said and shown before you know eighty twenty our our regional ah antibody we went from high indeed the a pivotal clinical data and fifteen months and we utilize both treatment and prevention studies that used
spk_2: event driven clinical and points and you know what we continue to look out as a possibility is whether there's an opportunity to use correlate surrogates a mean abridging excedrin arm and fill those disgusting continue on as pete mentioned you know as
spk_1: part of the of front on the call this was really articulated during the december fifteenth joint as the am a meaning and in a we alongside academic then you know other stakeholders really commented about the need for these types of approaches especially given the diner yeah like environment that were in ah you're really going against a virus that continues to evolve it's such a rapid pace and so and we continue to have those conversations and and as we previously mentioned as soon as we have ah outlined in confirmed exactly what those clinical parameters would be for
spk_14: pivotal studies ah we plan to share our no more details about that
spk_15: pete any you know other comments the other good question about the relationship eighty twenty the molecular relationship and and i'm
spk_20: you know we're still in conversations with global regulators are around this of course but
spk_14: we do believe that we eat is an advantage to have a robust safety data set and and also efficacy data from our previous faith three studies in a molecule that was generated on the same manufacturing platform and is so closely structure
spk_2: really related to to view id for a twenty i'm sorry
spk_15: so lots of potential there
spk_17: says
spk_0: thank you one moment please
spk_22: really our next question comes on of that siddharth
spk_15: matter of jeffries a lot of open
spk_20: how's the fit on for michael your jeffrey
spk_2: sense to quick question first one being you know ashes on another big companies while they a lot of money and twenty twenty two and antibodies have noted that they see the market going significantly down in twenty three and beyond as he moved to an endemic market for how i think about as you move your antibody forward and my second question is is you know although you've mentioned am having these kind of correlates of protection for our faith three phases of any discussion or definitive answers from the f the on whether are you can use that as a part of your a free studies like guess
spk_15: yeah think the first question and go there are estimates that and twenty twenty the few you know the sort of overall market across vaccines are all anti viral marco antibodies with almost one hundred billion dollars ah and yes i think that com or
spk_20: lot of folks are predicting that that will come down but it's still incredibly sizable market ah il marco antibodies that eight billion ah about in revenue and twenty twenty two and that was with ah in a predominantly bad to love a man and of yourself and of you sell good in a five hundred
spk_23: in some million dollars and cute three of of last year and will we see is with a similar ah indication really targeting a meme compromise vulnerable populations in up they only touched really a fraction of of that population and we continued to work with these good talk of he
spk_24: an advocacy group speak with these individuals and they still are really clamoring for ah products in particular i spoke to were in opposition ah who works at the mayo clinic in said you know he'd never been in a position that the test the patients come in and ask for product and there's nothing
spk_0: available on and fill these are not we see the market for monoclonal antibodies continuing to be incredibly significant and a huge unmet need and the peace and population arm as it relates to your your other question in terms of you know where regulators are and you know what that this data
spk_2: it is your will provide updates no additional update when we get them we continue billion in dialogue with the f t a and r other global regulators and you know what i said as soon as we have ah confirmed what that trial design will look like we planted to provide that information
spk_15: like you
spk_14: take it one moment please
spk_2: our next question comes from the lana matthew harrison a mortgage family a lot of open
spk_15: hi this is when john line format hill thanks for taking on crashes i have to pressure and why is it there an update on adding kind of regulatory threshold for new and be therapy for covered a given change off the and i'm setting
spk_0: could there be at a flexibility in potential provo the second is a to have any updates on your potential progress all flu and a base ah therapy development
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