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spk_0: good day and think you was standing by welcome to proceed as fourth quarter twenty twenty one financial results conference call at this time all participants on the listen only mode as of speakers presentation they'll be a question and answer session to ask her questions when assessing you'll need to press star one on the telephone please be advised that today's conference is being recorded if we require any further assistance please press start zero i would now like the him a conference over to
spk_1: yeah to cost month with try sita police began thinking on a good afternoon and thank you for joining the tracy the fourth quarter twenty twenty one been into results and the of they covered call and it it all their clan or founder ceo and president will provide an update on our ongoing dollar figure the ring a lot of trial and discover business prague rep jeff parker or feel on fearful with the financial results for the fourth quarter and review financial guidance please note that in today's call we will be making forward looking statements very statements that include forward looking statements as defined unreplicable securities laws forward looking statements include are integrated activities related to our ongoing dollars to katie real outcomes clinical trial including early termination of the trial and the estimated timing for everything of top line data and or expectations regarding our financial runway minutes with assumptions expectations and opinions reflected in the forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from any future results performance or achievements discussed in or implied by such forward looking statements dorothy to can give no assurance that these statements will prove to be correct and we do not intend and undertake no duty to update the statements we also urge you to read the risks and uncertainties associated with our business that are describing are filings with the securities and exchange commission we're should our fourth quarter and near and financial results press release this afternoon to theft of close the market for copies of our press release please go to www dot tracy the dotcom and follow the link to our go through relations page at the time and like a turn the call over the garrett
spk_2: figure jackie and that your for joining us today were making good progress on their confusion about the getty against the backdrop of and derek them a war the have managed to remain on track with our projection for army and for the them and about the cathedral in roman was completed the end of two thousand twenty one but forget the subject randomly as of march twenty eighth randomized subject than an average feeble duration of apartment with a woman the try the could to i'm at seven pm subject but positively adjudicated for me and for them in defined as read it up and stage renal disease or greater are you go to for reflection of the medical over treasure it as repeatedly reported they've from our financial on way we intend to stop the bar the get it was early for administrative reason that second quarter of two the and way to the continue to put on the and front of him into a third quarter when as a bit reporting complain about from about the cathedral early and forth for up to the and way to which will allow for partly six by of financial on with following the announcement
spk_3: we continue to believe that the vod the cathedral of the like interpretable data to die hard reboot of ama in fact florida because he progressed when patients with metabolic of and beginning or calculations show public aid from power assuming you have a visual point of no and given the results from procedure we believe that even with him
spk_2: few a number of crimea point of and and originally contemplated we have a chance to reach our mantra objective but that a term of addition to just for an overview of up and enter without footwear
spk_4: thanks scared and thank you all for joining us today our fourth quarter results were in line with our expectations with already expense of thirty six point eight million dollars and twenty seven point three million dollars for the three months ended december thirty one twenty twenty one and twenty twenty respectively the increase in our the expense was primarily due to increased activities in connection with our the burma or development program related to manufacture and process optimization and the manufacturing of drugs substance dna expanse with nine point one million dollars and twenty one point eight million dollars for the three months ended december thirty one twenty two
spk_5: anyone and twenty twenty respectively
spk_4: but decrease and una expense was primarily due to restructuring costs incurred and twenty twenty and to decrease administrative activities including reduced pre commercialization and medical affair activities in twenty twenty one net loss was fifty million dollars and fifty four point eight million dollars and non gaap net was was forty one point one million dollars and thirty seven point four million dollars for the three months ended december thirty one twenty twenty one and twenty twenty respectively as of december thirty one twenty twenty one cash cash equivalents and investments were one hundred and fifty point six million dollars we believe our current financial resources will fund our planned operations in the early in the second quarter of twenty twenty three which is anticipated to be approximately six months from the announcement of one results for valor ckd with that i will turn the call over to the operator for questions operator
spk_0: thank you you've managed to ask a question you'll need to first star one in utah some to the try your question please press the pound key
spk_6: please sam i will we how much you a roster
spk_0: our first question comes from certain bell into some needleman company your line is open
spk_7: sergei your line is now open
spk_0: and next question comes from justify your line is still open
spk_8: hey they're good afternoon and sure take my question can you just recap the number of of then you expect to have when you conduct the administrative staff and when you expect that to occur
spk_2: yeah
spk_3: just go girl i think of of a the episode stop his to embark has found the not you know by a particular number of or them and them i think given odds are cash bomb i think we expect to have accrued partway to employ to and of the event
spk_9: the with to and seventeen we're pretty close we've been i think accruing on average of about fifteen months between and eleven event
spk_3: and we expect to accrue
spk_10: into a third quarter so so we feel pretty good about our ability to to reach you know that that number of a box way to and forty two and fifty patients but crimean parliament
spk_11: great thank you
spk_0: thank you
spk_12: come next question comes from sergei boundary with need him and company your line is now open
spk_0: so they are you there
spk_13: i am next question comes from shills may do was tell when your line is now open gov and her to get our questions patch just a few for most first on the situation eastern europe she could we talk about you are assuming that no more events be going to be a crew from ukraine
spk_2: do the the will unfortunate war their what is the most recent data of those events in fact stop recording from ukraine or are you actually stuffing for patients go to the clinic
spk_3: we you know adding adding in our projections we we're not counting on on any additional of and
spk_14: from your frame i think ill
spk_3: as you said
spk_9: out of a unfortunate situation that the very serious situation and the
spk_2: we're i think so
spk_3: you know we see bravery and from the ukrainian people across the board we do have some patients actually showing up for for thirty visits and i i i don't think they have accrued any additional of him from that along a path of and again we don't we don't rely on any event from from ukraine there will be pure outside
spk_13: and we are they were comfortable with a to and forty to two hundred fifty fifty five number without any of em coming from ukraine for
spk_15: that's where helpful and what about the neighboring countries such as poland any disruptions do too
spk_2: do refugee crisis or or or any other she's in those countries are we haven't seen any any impact and we had hoped that the that nato wouldn't go off because i may have a bigger problem with that
spk_13: at hand but but again i think so far we've seen the disruption of via you have limited to to ukraine perfect the question is on
spk_15: guess the process of the administrative stuff i think you said you prefer marching stop the starting to to
spk_13: the continue to the crew
spk_16: events true to free with the didn't you for so i guess technically what does the stop mean and how do you continue to recruit events
spk_3: and post for stopping the study i that the am at the study is stop we would basically off the side to have the patience come in for a final thirty visits and of as a do a lot of isn't patients can have either confirmatory of and would say index of them as
spk_2: the way we've we've succeeded as that
spk_3: the out shortly before the database lot me what we would still allow for for those visits to happen
spk_2: and for those and to be confirmed to maximize really them on a follow up that they're getting from the study and so we am i think it it
spk_3: pretty common practice and even under normal wind down that sort of up to a month or two before they have a lot you you do
spk_13: him basically you have a crew of adams and collect data perfect two courses amateur hazard ratio in you're prepared remarks image and eighty percent power to the tech houses russia of point seven were curious to get your updated thoughts there are any on what you think the true hazard ratio is based on the academic literature and your experiences
spk_2: but seven brush me worry if he gets likely to the fall outers their chance it could be removed
spk_3: having a solid academic studies you know those were on a single send the trials that are not that i double blind or randomized in all cases they showed other measures that were significantly ball and as he said we would not rely on that so we're quite comfortable with
spk_17: with point seven
spk_18: an answer
spk_3: i think if i think it could it could be lower than that
spk_2: but but from a fiscal perspective the other having an important special attack on the clinical significance perspective i think that is so i settled and so we
spk_13: with the very confident that that that the barbican wage
spk_15: perfect the must know the answer this question from most is on the if voting process
spk_13: once you have the data should they be positive
spk_17: how long would it take you to pretty the funding in are there are additional conversations you'd have to have with the of to a in order to be able to file
spk_3: yeah they were you know we consider look as a yeah and the
spk_2: and of aziza the clearer and more positive the data i think the the lead to delay the submission and oppose the mission of at it as a year that appreciate the mission meeting that that as that more mechanic off but
spk_13: for so i think for of the clara them as of them more are we gonna run to us with a
spk_0: perfect sex with and questions thank you as a reminder to ask a question that star one and i'm currently showing no further questions at this time and like thing in the conference back over to jetty and cosmen for closing comments thank you norma and thank you all for joining us today as always of the of additional questions don't have email us at i are at tracy the dot com thank you and device
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