Astria Therapeutics (ATXS) 22 Mar 232022 Q4 Earnings call transcript

Good morning and welcome to the Astria Therapeutics 2022 Q4 and Full Year Financial Results and Business Update Conference Call. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations.

As a reminder, this call is being recorded, and a replay will be made available on the Astria Therapeutics website for 90 days following the conclusion of the event.

I would now like to turn the call over to Andrea Matthews, Senior Vice President of Corporate Affairs at Astria Therapeutics. Andrea. ahead, go Please

Welcome provide Astria review a full results. quarter operator. where our conference we and financial XXXX will corporate year to you, Therapeutics today’s call, fourth Thank update and

Jill me Andrew Officer; Officer; Commercial and Milne, With Clauser, Chief are; Chief Officer; Financial Chief Komjathy, Chief Andy Morabito, Chris Chief Executive Officer; Noah Scientific Nichols, Medical today Officer.

year call will release corporate website. update available QX full We reference our our and we which today's summarizing issued XXXX this a results, morning is press on on financial our

We are are part and of also using today's call Investors slides Presentations available that during of the Events within website. our the section

based of I recent be from Slide would will in related those actual make -- during today's to business future our discussed factors forward-looking most Form that potential available website. statements sorry, on differ X, current as our any and Such no will today, Astria as obligation statements that update expectations report subsequent call, by on as considered judgment on results required and undertakes filings, may in other we indicated publicly note mentioned may to be our and represent except XX-K forward-looking those which uncertainties on our annual risks, of SEC as statements, including as like to law. well discussions important

financial the call will Noah the Xa the Andy will follow results who Phase then Jill? PD discuss Jill, me the PK things provide update. to through let Jill the opportunity. market up. will trial, HAE discuss and wrap over Chris Andrew and data. and with corporate that, will pass will will update. With safety ALPHA-STAR the our go

you to during us shared their are future with everyone, of without last guiding for today's stars. fortunate might were Thank and live and from February here us life to patients Slide able on the We frequently patients hear as you experiences hope for Andrea. HAE on disease you, on to our hopes about our X. expect, treatment. At with month, firsthand Astria, day living her morning, first-ever burden administered shown joining with the Good Starting their be call. thank the a STAR-XXXX Jasmine XX.

vision Our to like a product goal is fulfill her with STAR-XXXX.

Moving X. without to live limitations hopes we Jasmine the community, what and heard the symptoms treatments. Slide their from to echo from HAE desire have

Our months or HAE We people of STAR-XXXX living HAE goal become lives both X what we believe Jasmine. is to patients treatment vision the energy by to for every most normalizing first time for like allow focus with to with can matters choice and them. that X disease treatment the administration preventative their on the with of burden, and reducing

Slide to X. Turning

the execute this safety, the positive with trial. strategy every preventative STAR-XXXX Here healthy first development is on PK results HAE We with able our treatment that paradigm planned target the in subjects believe box our to can Phase for check the Xa were PD treatment to STAR-XXXX. highly be X-month from profile like We effective transformed here and early regarding vision. a

into go today. results detail more will We about these

results STAR-XXXX ALPHA-STAR We trial we our more this will also Currently, safety expect discuss are physicians. in detail. evaluating trial a treatment interest profile with Chris from efficacy patients and Phase Xb/X both with in ongoing mid-XXXX. see strong this in of the HAE and and in proof-of-concept patients

option as potential this Turning interval additional for also hand for to X-month slide, a of side exploring the patients. STAR-XXXX we were dosing right

and we gain the of safety are this opportunity HAE trial year. patients, patient efficacy Phase expected includes in and X-month profile. physician Additional trial fourth a cohorts in potential Initial information the in ALPHA-STAR product design about with on are assessing this interest in initial the to and X-month are Xa dosing. results learning The more quarter

to was changing to we niche XXXX Slide for a families allergic Astria mission our diseases. progressed on as rare HAE X. and therapies year life immunological impacted to and by bring pivotal and Moving patients and

the emphasize brought for to Here points clinical three positive call. the I that December. would and from into main our STAR-XXXX results are in like We trial Phase clinic Xa shared today's

Phase underway living proof-of-concept people Xb/X in The is initial expected mid-XXXX. ALPHA-STAR HAE trial with in with results

proceeds of well are in bringing $XXX million the our plan. based operating underwritten closing on cash stock to our with of we first Additionally, of through runway an with expected December, achieve XXXX our current gross goals common of offering the half funded approximately

to the I will over call the hand talk about Andrew? Andrew to now market opportunity.

Jill. Thanks,

more This patients on shown for patients available growing. to opting XXXX geographic was the expected diagnosed the XXXX. in well treatment growth market by and is over The be Slide treatments driven HAE in global substantial to as expansion of and market grow $X.X it's by million HAE expected HAE more is is to regions. earlier, being to X, $X attacks So therapies billion and prevent

treatment currently dosed While effective this months there STAR-XXXX that and treatments less can frequently need or monoclonal every for profile an the preventative are X patients. several of market plasma the unmet and antibody address believe we a in development, option in has become available kallikrein HAE leading inhibitor

a asked with completed to we we to quantitative XXX them Turning willingness like profile patients recently X, where market over a STAR-XXXX. study try product their research HAE Slide

a and graph that product on willing a As this you indicated can start to being they either see left, to profile, with patients very this willing switch survey try to to the XX% were with profile. all close the to product or

treatment either of oral patients and leader, most regimen known also patients the current market and the dosing on X-week include although TAKHZYRO, monthly only every a as current those the on lanadelumab results are regimen. available on These ORLADEYO,

expressed potential community. and gain really to also that's the prescribe STAR-XXXX's that and in with a We've with the excites share prescribers a us future market, this HAE HAE also very bringing strong suggest willingness research STAR-XXXX what treatment strong who conducted treatment HAE profile to would patient with

hand to Andy it about now Andy? speak over profile. STAR-XXX's to I'll

Andrew, Thanks, morning, good and everyone.

of people to to [indiscernible] potential with levels with same the HAE. X. inhibit living that long STAR-XXXX the The Slide circulating are vision prevent as antibody a even could half-life, lives turning HAE attacks months the first, of designed to to less the a our generate an and dosing lanadelumab; goals of twofold: So every program with to engineer with was second, or frequently. kallikrein antibody plasma X with normalizing once

modifications a to We've specifically signing STAR-XXXX of produce binds and to kallikrein to YTE of extend that the Fc selective plasma demonstrated allosterically potent domain includes half-life. kallikrein plasma in its STAR-XXXX activity. inhibition unique

and of the enables acid dosing subcutaneous less to lack citric of injection significantly with concentration pain of with patient-friendly compared STAR-XXXX high formulation patients The our lanadelumab. goal of site

through the Xa it now Chris? I'll clinical trial. to Chris over hand Phase go to

and good everyone. Andy, morning, Thanks,

Moving XX. to Slide

of pleased [ph] are initial at February Meeting data adult in ascending were is presented double-blind, in to year. from recently single a STAR-XXXX that the doses We the of randomized, placebo-controlled AAAAI subjects. review This Xa Phase trial this healthy of trial

We the through follow-up. of X first cohorts three approximately from have months results the X-month total

added milligrams fourth cohorts explore three X Initial potential respectively. in quarter have months. IV, Phase STAR-XXXX additional the final have cohorts are Xa the every additional X subcutaneous of to in year. healthy from this results subjects of the single trial We first and the administering X,XXX X of these expected doses XXX Cohorts and two at results to milligrams cohorts from

All data placebo. XX. These and profile. suggests eight STAR-XXXX Turning and In with to emergent treatment-emergent STAR-XXXX receiving events mild is resolved. a Slide total, seven has were that receiving one related favorable were tolerated treatment and events, initial well there safety subjects adverse adverse

events. redness. were reports in adverse There or injection-associated six subjects STAR-XXXX. of were There no common reactions, were site no site injection pain. injection injection severe was site subjects reaction There The with serious moderate, most receiving all

and As sequelae. mild noted, resolved these were all without

perspective, tract most than with reported adverse most trial. with X reported For a the reactions, administrations lanadelumab-treated site infection More subjects headache. site upper injection reactions commonly half during are the and respiratory injection reactions Phase pain, commonly lanadelumab associated

antibodies antidrug with STAR-XXXX. were treatment-emergent detected no Lastly,

three the the milligram data. concentrations that cohorts given dose. XXX rapid XX to after XX Let's Note move concentrations on days and single now first proportional XXX milligram, Shown XXX subcutaneous over STAR-XXXX one-time are time concentrations Slide show and profile the on to for and over pharmacokinetic on doses that the subcutaneously. initial milligram sustained

long. is is data, designed which visually see elimination elimination long down the by on to of XXX modification, the can You STAR-XXXX is phase days. these drug phase This prolong slowing half-life Based is that of to up YTE half-life a the result clearance. estimated

above profiles at durable showed milligram and consistent at be we X concentrations benefit and for with believe the clinical months. to levels Importantly, least XXX-milligram XXX

now walk with results with that clinical data will through this our consistent associated levels with Andy? pharmacodynamic support benefit. Andy

Chris. Thanks,

measuring of the assays in volunteers in similar innovation used due allowed would to you XX, assess that attacks. by predict the activity plasma effective reducing pharmacodynamic of by HAE those Slide lanadelumab kallikrein on that we which can So Phase that STAR-XXXX and them to be of doses see are X trial to Dyax healthy using functional

plasma In healthy low. adult are levels very subjects, kallikrein

of molecular weight Western this plasma to at kallikrein And dosing. natural mimic The in blot clears is Factor kininogen of technique by the taken various produced after is HAE happens assay that before adding points ex an stimulated to from what order cleavage substrate plasma high the subjects we that time its molecular use during kallikrein present we in So plasma. kininogen. measure production attack, high the the samples XIIa vivo to

or XXX that healthy we produced milligrams clean milligrams, about using remind a kininogen XIIa high this in technique, activated XX% molecular had X per in approximately As volunteers. Factor lanadelumab kilogram reduction

approximately about after XXX a will plasma activated the small assay In activity we last plasma we XX assay, in using And cleavage dose format, the of kallikrein to addition, dosing. lanadelumab peptide kallikrein XIIa also XX%. acid healthy assessed a days we've of plasma. inhibition has peptide add Using factor this that by in the substrate look inhibited the this volunteers milligram three-amino activity at which effect reporter

inhibited XXX to both is for effect Slide produced by healthy plasma milligram doses. in On similar STAR-XXXX both that to subjects. the XX this and The kallikrein day XXX in through we XX% formats that lanadelumab magnitude XX, activity by assay show XX% in assays of

We half-life. is for lanadelumab. The a sustained are period compared consistent with with STAR-XXXX's effect long longer of time substantially

HAE activity level plasma lanadelumab. the of inhibition is kallikrein STAR-XXXX Importantly, consistent to with the observed prevent with of level shown to attacks of

Chris clinical the ongoing to to now in review back will design hand trial Chris? our of HAE it patients. I

Slide living ALPHA-STAR STAR-XXXX on effectiveness This of attacks. inhibitor single trial of HAE proof-of-concept with due of the in dose-ranging assessing STAR-XXXX effects the prevention is in people HAE trial doses is long-term XX, CX assessing deficiency. potential to of multiple Outlined a and

Initial proof-of-concept dose regimens proof-of-concept our data trials. durable and in be would STAR-XXXX. All if the As in participants a positive, attacks protection inform expected that dose-ranging show and future are HAE robust will trial, may mid-XXXX. results, qualifying against receive tested

and As concentrations regimen a labeled that of targets we trial planning in to add effects dose are to new subcutaneous months. that shown benefit clinical from would plasma we inhibitory would a this would anticipate X positive, amend of cohort, assist that Cohort high potential assess for dose initial X kallikrein concentrations the X here, as if administration of Results months. consistent cohort every STAR-XXXX maintain with for selection a here the STAR-XXXX

The be same cohorts sample reallocated the the with Cohort will to remain X that other X. Cohort of size from exception part two will the

following people XX target remains in to months. flexibility cohorts Cohort a more While needed. clinical with if administering HAE we X subjects, add single-dose through enroll to up to cohort, to continued milligrams and effects to out participants X enrolling once for XXX plan

testing Cohort later for milligram dose. on after X in and participants We maintenance may months milligrams loading months these two or longer. last XXX attack cohorts dose a dose XXX X effects cohort multiple are the anticipate in the X a given that reduction followed followed of of first by XXX a months people milligrams enrolled was dose X HAE through

Cohort XXX has X-month months the milligram initial second with X doses follow-up two apart X The dose. after participants for in given

months. The the and possible Given trial, that dose the results from PK PK and that for regimen endure anticipated human PD a endpoints concentrations changes, remain it's rate these for may subjects, targets the same. in clinical safety, attack X including PD healthy the profile demonstrated

the far, assuming in initiate initiated So are the into on the track and and to we U.K. trial, patients the Europe, we has including and U.S. in Canada, are trial midyear, HAE bringing Data approvals. mid-XXXX in all initial show and goal STAR-XXXX The anticipated treatment. to include significant attacks results from are of a cohorts. receipt is in three reduction following to are regulatory expected actively

the us lives these data, towards HE long-term goal if normalizing our the to HAE. We bring refine effectiveness help positive, of of our will expect STAR-XXXX of as establishing us to preventative with attacks approach people against a living

start from slide and anticipated trial for to year open-label participants is we This STAR-XXXX from the ALPHA-STAR the Finally, is of this enroll. long-term trial expected enroll on to completers initial show the -- planned the time ALPHA-STAR trial. in later to

expect primarily as well on We evaluate to and this as quality effects safety life. of HAE trial attack

I Noah will a financial to now provide turn update. over to it Noah?

Thanks, Chris, and everyone. morning, good

Slide $XXX XX, I brief December million stock. underwritten common provide financial information. of we closed XXXX, of to Turning important a summary will In offering

As we XXXX, cash, investments equivalents compared million of had XX, cash short-term $XXX.X as and of $XXX.X million XX. December to September of

to equivalents We half through that fund cash and sufficient expect our current plan our the investments operating cash, first of short-term are XXXX.

million of $X.XX for was the full fourth Our XXXX $X.XX and share. $XX.X or $XX.X the million for XXXX quarter share loss net year or per per

XX.X common XX.X we shares convertible shares preferred shares million had on equivalent outstanding an outstanding approximately million our including and XX, December as-converted As of basis. common when outstanding approximately

see financial after with additional today. XX-K, plan and to release please SEC our earnings the which our press information, we For market file

review will open then now upcoming Jill? milestones Jill the our for and call questions.

you, are HAE, thrilled in early a In a X for Xa best-in-class profile, its STAR-XXXX Thank frequently. XX, long-acting proof-of-concept less Phase therapy trial we and summary, has PK preventative that the every profile Noah. or for months Slide dosing on target shown

We we cohorts to months, are and X opportunity Phase also dose our every an be believe STAR-XXXX evaluating and with trials. ongoing ALPHA-STAR added this there Xa to could

through upcoming X healthy well results fourth from preliminary Looking quarter results to X year. the additional cohorts milestones, the as cohorts our final this expect in from in the subjects of as we

reviewed, Chris single underway expected in mid-XXXX the initial As is including patients with cohorts, from ALPHA-STAR in the planned HAE multiple-dose trial cohort. results and third

trial long-term this second half Additionally, the we will open-label of initiate a plan to in year.

prevention about potential we effective HAE. about excited provide As with living think for for future, STAR-XXXX attack people the we to the long-acting are

to Turning Slide XX.

our daughter with this and month. us again, Kim, they Here, Jasmine we offices Melissa when all joined see with at time from living Melissa's Hannah, HAE, last

and HAE the we their sharing lives understand with us. Kim, that for and with better experiences all patient are thankful Hannah their so we community Astria, needs in to Speaking guides Jasmine, and to Melissa do

charting a for infrequent for these that preventative of vision with fulfill patients, patients envisions long-acting normalcy a one opportunity life an better the has path efficacy We dosing with a new that express. therapy four HAE are could meaningful of that quality and

as share HAE was clinical Phase pivotal the Lastly, on a Slide XX, Xb/X to ALPHA-STAR STAR-XXXX our Phase progress and results recap, in into XXXX from enrolling positive is and the Astria trial year results we anticipate clinic for we patients, proof-of-concept The mid-XXXX. Xa in trial December.

current funded plan. goals achieve on cash first anticipated half based with XXXX are We well through runway of our our operating to the

energy focus development We matters STAR-XXXX allow for are well-positioned and aim to to plans as execute to patients our we to their time on on what them. most

questions. for you. Operator, operator the and ask Thank for I'll please instructions your the repeat call poll that, up With can to questions? open the you

Oppenheimer. from question first our Hartaj. comes So Please Hartaj ahead, Instructions] [Operator go Singh from

of you. got Thank questions. couple Great. a I've

They're ask so a just then just follow-up and one. little will ask second different, will I one. the one I with So

the of then You about and the modification talked lack YTE to antibody citrate.

of kind patients. getting you as into follow-up extended So with

you. the So again, to you on data, all you're Andy have some for, modifications And over didn't I great that want Thank or ask I untoward historically just anything the side earlier. YTE not. just effects presentation long-term, see watching about out produced which

Thanks, Hartaj.

the of used the the antibody prevention quite the associated it YTE the has Nirsevimab therapy, of in in the YTE. been there actually the [ph] neonates season. anti-RSV of issues reports been RSV specific been studied any RSV So, for studied have safety no that extensively context is modified have of Recall in infection [ph] no, kallikrein during that antibodies with

antibodies YTE-modified words, So us concerns with of to been in lead risk that YTE about any those And months associated [indiscernible] product, individuals. two other antibodies high which also provide and issues the there for the in reported would no X of COVID-XX specifically. safety prevention to coverage; in have contains has

do hearing used you, XX%. XX% that two-thirds the commercial shifting companies to cover kind just of is like think a Or more be injectables? it's against you in on to we being that, and the is I on you you others from the days, -- do once then is I to think competes than the it's to that are really and HAE side. there Thank XXX? we How will with question there, X-month stay Andy. the close -- over games fair What for more a that and market Great. the even other And got medication. patients prophylaxis which sort of -- looks Thank prophylaxis X prophylaxis even and And maybe months. suddenly, know taking market. could early profile, introduced, then see up do just you still being increase that future and less getting It will orals, probably potentially more now be maybe questions. assuming day to orals a they also then are

that. I morning. can Good take

So a comments. couple of

right. U.S., market about lower is Europe, closer absolutely slightly XX%, in patients preventative That to in percentage of the preventative are two-thirds on lower The treatment. You're XX%. a or

that believe of will to new with do grow treatments. the the we So emergence market continue

and try I about the However, are that And presentation, treatment. of of burden in that willingness the either to we profile the that the we really the reduces of also one mentioned XXX% treatment, expressed potential an surveyed effective patients earlier of as excited the product. being STAR-XXXX but

patients that currently switched or to treatment on were those not were treatment. So that

interest XXX% TAKHZYRO, of And then a or those those treatments. treatment that that either patients those patients, switching to subgroups those ORLADEYO were of an expressed of in monthly on the were

given of will the onto STAR-XXXX, market to from will be the that STAR-XXXX. So other able successfully profile injectables we switch that also patients to orals but continue that we -- transition we grow, believe either or do believe

being by of through apologize. Great. for of noticed was you and we outlook see about one a year. just the of quarter spend bit fourth your thank I expected, of Andy, OpEx this. kind apologize and that spend I talk rest question, if what Maybe all more I the our follow-up actually for a -- we've can you the questions. than little I'm have Noah, progression the a [indiscernible] in bit your to little small-cap you biotechs. lower how we for again, And know, cautious sorry, been just and

think I to our that of supports Hartaj, the half XXXX with expect guidance, us a point understanding we you current do cash first along I the runway of that is which to through sort our of gradual ramp way. all have the

without about the So many think way I ramp as ramp specifics to think right I expense, about activities getting we quarter-over-quarter into up clinical is too gradual a think it.

Thank everyone. Thanks, you all. Great. to

Thanks for Hartaj. the questions,

from McCammon Our Capital. question from Oliver next LifeSci go Please Oliver. comes ahead,

This is Hi. Sam Slutsky. for McCammon Oliver filling in

from question one me. Just

ongoing the X in the for my volunteers, cohorts from of is subcutaneous IV versus taking Phase known For and Thanks impact cohorts? the on healthy XXXX milligram development your question. XXX already X,XXX clinical future the data study milligram what strategy the much might prior how so from

meaningful far administration, could suggests Hi, target achieve Oliver. we months for people sufficient that The to one. Chris. in it's that the question, a data and molecule way. enough important obtained a every that and X to so Thanks prevent this the an attacks This profile is with have are capability compelling we've

half-life that's us about months a pause. we have so give and far safety We evidence of now would long, no that X signals have

can a XX that concentrations is with above concentration asking higher these over per ml think or threshold, pharmacodynamic cohorts with doing -- months we higher robust STAR-XXXX are which we engagement, critical STAR-XXXX initial is associated target activity. maintain strong maintain XX or What micrograms ml question the additional X

we've X-month how STAR-XXXX can but limit to achieve you X,XXX asking to administration, a to not I of are the give far, go that well the profile will also subject as volunteers question to tolerated what -- we stretch We do these believe allow milligrams to of upper need that to in how do that up achieve kinds is we healthy Based so administrations on concentrations. would for be the so. about think us would seen

Thank very much. you

questions, Thanks the for Oliver.

Joe ahead, from Wainwright. from next Joe. question H.C. go Our Please comes Pantginis

Everybody, good thanks for questions, and efficient morning. for very call. a Thanks the

on questions of couple ALPHA-STAR. a just So

additional the how So first, a HAE getting as not mean, for you the it's competition are do with? and study, it's a and little view to growing, patients therapies therapies new big but -- and view grows trials crowded market more that start do how with I slowly you

So an about now how access ALPHA-STAR, One we risk, trial. about we talking thought we we that when operational is be important thought we've wide the and, effective. considered deeply and as design important think, are line the the are the potential that medicines I this element consider what is we to there we the executing obviously, designed physicians have as that to patients to that is about

And There's in that eliminated also so in patients this receive the to strong to to will comfort enter this they which, we access people on-demand So for done but to get this. we that placebo act support who hesitant some were trial. anything group feel not a group, or X and integrity not their community, additional trials. placebo a resounded months, optimistically, How could something preferably data to thinking allow would in out has trial science would will using we've from it? allow up we about of that that and get simple the for the therapy they're eliminating of the way design to that going

on well the sense a living the with in We've study outreaches the This partner and U.S. the also that organization closely this fortunate operationalize advocacy been an works how HAEI world as physician makes us us has that and community, people HAE disease. is way based throughout helping a is is that is with for working about active with in in the patient think strong, space the with community. fairly to incredibly

best to about a final community talk understand with the a with that is global potential the trial working participation. We've their with big physician how community point it's footprint. to And the been

We open we've been have -- think I pretty this. about now

And lots in we have be operational enroll that a that participate we guidelines. of to one to able to patient sites meets that if trial. sites will hope even in We we this find participate just are our way targeting that potentially this

And the look helpful. at plan anticipated, when you the the and at I Thanks. guess and how albeit these, that data you for any very data That's the ALPHA-STAR meds? to have and potential anticipated, you dosing the do have on needs or long-term the the intervals, small impact with also look present you looking statistics for rescue you're potential

Yes.

we what that include initial is proof-of-concept the we of all that cohorts. three these data anticipate in have So from and will data mid-XXXX, will

dose to from on clinical there any quality durable baseline findings in baseline, And that findings positive or So be and have the we've the show measured we that life. community. and that's favorable the to unexpected what would safety to be of have the is for from PK data think additional like from we PD change profile impact able initial we aren't describing is robust that and reduction that that a we is communicate what have we a this of meaningful meaningful able perspective, been be safety would would supportive -- and safety in and attacks, case, that frequency, attack

in being space, in Phase X to that a Typically, sample a size. anticipate representation demonstrably if that here allows smaller trials in about change placebo. four is data. showing compared Phase meaningful to. allows a Xb/X reduction exactly a where from in are proof-of-concept anticipate and more you seven overall baseline are size cohorts with size is that using as a disease, very reason we this of sample small The to know, other and large [indiscernible] effect that's This a size. the trials for of for option disease for subjects, we to XX% that need terms Lanadelumab, about That add in trials, we is the from

to in of cohort, number the meaningful So demonstrate each even being with subjects that anticipate this we patients. potential effects this to few for able has the

you. Thank Okay.

the for Thanks questions, Joe.

comes next Eun Jefferies. question ahead, Please Eun. Our Yang from from go

me is you Can hear Eun. This okay?

Yes, we can.

Thank you.

the next expecting proof-of-concept mid year. we data are that So

mentioned the you cohorts. So all three

So we second rate. -- -- months follow-up are expecting see when dose, how mentioned are not going changes not this see question going certainly, you Because a the see is of almost the tolerability PK/PD X we correct? [ph] it's to then safety we And a [ph] data? study, many rates all in in are we it's single to PED PED

Yes. questions. Eun, thanks for these

months. data, in demonstrate that So should to mid-XXXX. X or effects our data we potentially when anticipating to we able The data given proof-of-concept in X in terms of be proof-of-concept reducing know, profile, target are you are as is every achieve every target months which,

show data would kind So we mid while be we to today that that guide tell you are I support that looking to can't you what to able of anticipate showing in profile. 'XX, I could

-- know of PK days, people the are question if to substantial we It have people a now high and integrity given meaningful number able attacks compared show to who do no we be be Regarding effects compelling of show endpoint. showing for a to baseline. that attack-free pleased your proportion is least profile, people And data meaning curve, that possible is would that that. endpoints, that data, can that, of with are have we its about capable at you XX this PD the important as

Yes, I’ve one follow-up. more

enroll in speak. then to patients from X European So actually sites year. cohort? the patients enroll enrolled sequential quarter Canada have to like the we enroll When clinical to from you And and and X? as you sounds been you it up can and sites this U.S. running, have Or open simultaneously in [indiscernible] patients, do

Right.

calls start So that's for check Cohort safety for, need with far. in protocol the the written so X. [ph] That's the one requirement protocol as we

that before accumulation point, a most we not at it start we just the the variety reasons, not enroll other. possible we of important the three one is time fill At can this thing of completely for it that, same the Beyond and data. anticipate enrolling all

question one but your exactly we mixed, start to to of start are we answer the while is So don't the each the staggering go to next Cohort through X. have

a of have enrolled you Do the in kind of in Canada number ratio Europe? U.S. of versus patients terms are being a

don't. I

Thank you Okay. very much.

You’re welcome.

Thank Eun. you for the questions,

So Michael. our go Please Ladenburg. Michael Higgins from from next question comes ahead,

the Xa. guys. cohorts cohorts for Thanks with Are A If in Phase it. we triggers question share ALPHA-STAR? questions. in taking you appreciate morning, adding the us, on Good there Thanks. can for

you trigger Phase Xa question, clarify to data maybe could Michael, your the ALPHA-STAR?

from any I'm Xa, if were there Yes, obviously additional triggers the additional added wondering ALPHA-STAR. cohorts in next there three in to two. cohorts the Phase Andy, add first to

we’ve possibility our regimen that in been a done of a the to Actually, that cohorts. for Cohort the feasibility potential every dosing. X priori mind defined the any We've beginning. sort X additional test aren't achieve of months There cohorts triggers could the adding So with ALPHA-STAR. from added add now to for to that's

might evolving However, additional trial our the we show be from if or Phase questions from possibility. there data that have X that ask, to do

you there. to major site your potentially future in current then so Okay. far, reduce thoughts Thanks. a trials or Are reactions? one trials Hasn't issue And doing curious anything injection follow-up. the been but

Yes.

The had your common site mild. injection just one yes, fairly far. so on is inject So that redness a are is data are most [indiscernible] the you We've common very fortunate reassuring which reaction we anything when skin. few

us moving to concerned So, so comforting here know that is far, about that forward. nothing there's it makes

to we injection a fill community of efforts continue. reactions. for ml, certainly more as frequency in the to the concentrate that that's XXX be antibody. bit is you those now a may decrease formulation work to site that standard ongoing that's volume for will subcutaneously potentially And is and about be that could less administered right monoclonal and able The allow There opportunities per which milligrams

here. think IV. the I’ve question A in more one I on

us for Phase testing review the could you for IV, XXX If the your milligrams rationale again. an in Thanks. Xa

Sure.

anything months of So effect are One a of is else. follow-up. time in allow the profile, there's watch Phase get And two XXX concentration. And high full concentration concentration the milligrams the what provide PK and to very to main. is the safety profile PD over more high us to that data IV X ability about -- over Xa than that their the ultimately, concerned will a we profile, will

regarding that milligrams additional we IV subcutaneous is milligram answer. to the XXX bioavailability second the IV have that dose and help XXX comparing -- would absorption -- some The questions us

Appreciate guys. that. Thanks,

Sure.

now concludes session. Michael. call This over turn back I for our the to you Jill. will question-and-answer the Thank questions,

our Clara. Thank you for joining for you, all Thank and morning call continued support this Astria. of your

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