Earnings call transcript Q1 2023

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Operator

Good afternoon, and welcome to Lumos Pharma's Q1 2023 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference call is being recorded.

I'll now turn the call over to Lisa Miller, Senior Director of Investor Relations.

Lisa Miller

Thank you, operator.

the statements would are made under with everyone to forward-looking proceed U.S. certain that during we call, like I remind statements Before this call laws. securities federal actual and These or experience that statements to expectations. differ risks are could from subject present cause results historical to materially uncertainties

contained SEC. concerning information is could periodic reports results to cause Additional our actual filed that differ factors in with the

company's revise hereof, obligation this press statements speak afternoon, only contained or date made to from XX-Q, the website. Form no undertakes during is call in may forward-looking and presented and forward-looking release Information company the be The of the call the this statements. on accessed the update page as Investors which our we this issued the in of

call Officer, CEO, Lori Hawkins, question-and-answer today's join on Scientific and McKew, President Rick Medical be our session. Lawley, and and will Chief will and Officer; our our Chief John CFO; for Karpf, Chairman; David Speaking

call to I will over Rick. now the turn

Rick Hawkins

Lisa, you, results and we our our financial And XXXX and market release quarter an first the Thank update a everyone. press clinical issued on providing closed announcing today, good afternoon, programs. after

keep our call so available on for McKew review recent in John and can it to to remarks As practice, turning over brief, of time touch answer of our join Lori questions. And us for a from maximize today's the on your David I'll results. quarter the is we Q&A. our some we'll highlights prepared Karpf the will weeks financial before

So, begin. let's

Growth XX we XXXX. XX in to and can our outcome trial, II advancing in LUM-XXX and of progress during on trial of in quarter by to this dose battle we our reported of quarter the our in the fourth primary Hormone made phase the and therapeutic OraGrowtHXXX both the led the and range subjects up afternoon, enrollment, completion we oral As Deficiency, OraGrowtHXXX patient candidate subjects OraGrowtHXXX XXXX, PK/PD Idiopathic confirm OraGrowtHXXX expectation finding report And trials. Pediatric first significant the

for X.X cohort. Importantly, converge the announced kg November baseline a subjects the OraGrowtHXXX we interim LUM-XXX in data enrollment. as characteristics and across Between predicted, for per OraGrowtHXXX mg and

for growth may prior included control analysis data arm presents. that than the with greater interim outliers the You recall

of baseline other enrollment. predictive final between these these characteristics, at should With a convergence balanced key analysis. full better characteristics growth similar two and see believe across therefore and now arms age baseline and at have We more cohorts we two rates

trials a both as international to meaningful LUM-XXX stimulate To of the data were we well meeting, possesses our at growth PGHD the interim in with or that one of from patient MPEG During quarter, a XXXX in pleased March. pediatric profile. favorable data presented action idiopathic held a population, Argentina safety demonstrate endocrinology side present as see potency in updated endogenous mechanism the modern a to natural was

presentation by included LUM-XXX an OraGrowtHXXX data care and produced centimeters PGHD and idiopathic a idiopathic Dr. Lunsford, stimulated Dr. for X.X and treated LUM-XXX the in This annualized six LUM-XXX injectable a patients mechanism Alison kg demonstrating supported with action PEM-positive PGHD that further growth modern poster gross highlighted of that pulsatile by with line dose per standard mg historical year hormone. velocity, again, site's of eight growth the Fernando Cassorla oral with of subjects of presentation

averages. mg LUM-XXX per is demonstrated profile that our data kg possesses reinforce data historical and a we track based to X.X November, announced safety further interim from the a tolerability meet favorable dose last that's LUM-XXX presented Again, on on that growth prediction analysis expectations database

LUM-XXX attendance and understanding is critical the community. its infant global endocrinologist key of as interest pediatric pediatric for awareness raising Among the was among believe intercom significant. oral was in therapeutic we and PGHD to LUM-XXX treat Importantly, potential in opinion and medical meeting FA an leaders they

comers and enroll as present LUM-XXX both who patients and familiar unable evaluation to PGHD severe growth PGHD PGHD original of Yet as say, those are secrete Merck's or of with are There the well more trial hormone, trial, should there. moderate lack that subjects. all I success idiopathic

address this Idiopathic acknowledgment Lumos strategy for Pharma's the potential solely was that to averages. last population data by the in by had line injectable LUM-XXX this years. Once with our was grew audience become PGHD first demonstrating treated therapeutic shown the selected an historical oral patients moderate that Pediatric PEM therapies four to patient There

of accepted week, books including also trial Meeting And for we presentation interim or by own presentation an presentation Chief our are Dr. a from Dauber, Endocrinology Dr. upcoming poster given and data trials by Children's and the Endocrine Hospital presented interim Andrew growth on on data our at Dr. Karpf. OraGrowtHXXX National oral that Kasora, at were trial David Society Pediatric this pleased by interim later OraGrowtHXXX data

increase oral IMPE meetings to pediatric among in pediatric greater of at potential presentations even candidate our continue community therapeutic hormone other garner medical and PES We the and growth for the will for awareness and LUM-XXX endocrinologist’s believe excitement that deficiency.

developments other now. to turning Now

meeting, or collaboration to Laura pilot Massachusetts supporting the injectable study of evaluating Dichtel at NAFLD. data, at that supported continue presented This General of reviewed clinical indication. by with in hormone We in of assessment XXXX in the medical the LUM-XXX in fatty explore Hospital Dr. And data non-alcoholic growth oral our Dichtel liver positive NAFLD was the by Dr. investigator LUM-XXX potential same to Dr. support disease initiated end conference. Dichtel with

daily as this indication. study of oral adults worldwide, to NAFLD gross condition daily XX% a therapeutic lifetime pilot a NAFLD hormone in continuing. in chronic As injections Enrollment in welcome is is approximately provide prevalent of of alternative this in such LUM-XXX a LUM-XXX could of a

our As sent novel to we year, formulation last call, mentioned have earnings a for protection Lumos which could on filed Pharma patent IP LUM-XXX XXXX. last

to as XX years well currently as Orphan U.S. X.X deficiency respectively. XXXX up hormone protection and date through Now of extended LUM-XXX offers and patent the which the in growth the treatment Drug years detection has drug Europe from approval Designation, protection of and for of

year. later the this to patent expect U.S. We hear office from

has we the As XX potential currently growth mentioned, treated LUM-XXX indications by believe address up injectable other previously to hormone. to that

We have work indications lot the of internally geographic and to regions. potential of other done and assess LUM-XXX a

earnings opportunity mentioned and call, have on short where our focus we we and U.S. ISS internationally. in As our Syndrome narrowed last Prader-Willi sizable the or we to see idiopathic a stature both

cash we committed and opportunities, program. on the advancing these assess remain we our allocation core prudent ensuring is of capital use While our our focused to

or I'm going to turn results. financial it Lori for review to over

Lori Lawley

equivalents, investments our totaling ended $XX.X first $XX.X of the March short-term II on $XX the investments beyond cash on XXXX. Pharma XXXX. for Cash, and reiterate Well Lumos operations quarter cash, fourth compared December third quarter $X.X XX, use trial to XX, of in to XXXX in million expectation million, Rick. of support you, cash Thank the of cash million XXXX. top-line short-term million of as XXXX. approximately average We to XXXX, XX, with and Phase quarter equivalents, results are into of announcement March expected quarter the our

offset due in million, of $X.X XXXX, expenses. of in expenses year ended expense The legal increase prior were and March $X.X trial clinical XX, an and and Research of million for a by was the $X.X million to period. to in compared contract the decrease $X.X primarily $X.X increase million approximately manufacturing consulting quarter increase expenses million an development

$X.X million primarily were and expenses, the approximately the and of for expenses, period. to was million personnel-related million The travel expenses administrative million quarter prior licensing and increase to increases compared General expenses. $X.X $X.X million $X.X an year $X.X increase due and in

compared million, shares the net QX quarter was a of same The loss million ended with X,XXX,XXX XXXX. for loss XX, $X.X $X.X the in We to ended XXXX net period outstanding. March for XXXX

turn conclude call for us. to Rick back I the to that With will

Rick Hawkins

fourth from II of to Thank And both in from Phase To LUM-XXX the fully are you, clinical top-line now XXXX. Lori. recap, studies report in position our we're a trials quarter enrolled. data

Additionally, between per converge characteristics across subjects as mg announcement last our November over cohorts other hormone LUM-XXX XXX and converge, for full X.X of age kg and or enrollment, baseline predicted. data and growth inner

and balancing age of of trial stratification full the effect the additional the enrollment. included subjects Given the at by

confidence this favorable at and population. potency be in for of Our in possesses these that action, data LUM-XXX presented is IMPE meaningful trials to March endogenous at a and but later believe patient data to safety that presented by profile both a PGHD growth in We additional demonstrate presented data week. mechanism the PES stimulate reinforced idiopathic our natural this

have We our narrowed of attractive a opportunities continue future markets. we indications for for two to focus the LUM-XXX of investigator-initiated compelling support the for to pilot trial, LUM-XXX natural and treatment exploration through

third we In cash our expect addition, XXXX. by our and the quarter with PGHD support our being operations conservative program, usage, current capital of to prioritizing into

extended IP approved, LUM-XXX, also XXXX. LUM-XXX version a patent from for submitted application November which through commercialized if of We the protection of

good disclosing LUM-XXX the a So, to XXXX and dominated growth to to XXXX. programs believe that advance of we're in top-line forward potential hormone years disrupt the has start excited the worldwide our the by XX We for to Lumos injectable poised been market is has We're almost products. to Pharma. fourth continue to off demonstrate data look to quarter

to Thank take we're operator questions. much you and ready very

Operator

line first from Our comes Novak Catherine the Instructions] Jones of Research. question Novack [Operator of

now is line open. Your

Catherine Novack

months with afternoon, the are congrats you're on KOLs, as AHV good much curious, speaking attending so my these meetings you, just significant Hi, I'm taking for Thank six question. quarter. medical endpoint important where going in AHV. attenuation data be injectable space? that's is hormone And growth also XX know the of to to that you for this start months. see the KOL We how

you a phase know some sense important to follow II up be this data much how initial is the in of to it beyond show for us can have you'll well? So give you b months. six patients as going how And XX-month

Rick Hawkins

David answer let our to Karpf, Medical the Thanks Chief Catherine question for Officer begin that question. and

that think have to something John add. may McKew I

go David. So, ahead,

David Karpf

you of other studies It's months II out phase six very for in question. duration. to much Sure, are all that thank ones important point the the the

point is for even And III the were than agent better the six club of to you is AHV So, AHV. phase some particular pivotal the six-month to But out, bringing analysis. the as XX the months us look data in any her did trials. AHV we XX-month interim endpoint months actually

see. Let's

in as in the tutorials have We of while we'll those trial. on we fully the loving all each in are introducing XX subjects you the group And to know, have presentation. subjects XQ philosophy all my committed, enrolled content six-months subjects,

XX-month XX, as showed some have even points data and data sample well. a this size at will later of kind greater in to also nine the We time X,

amount quarter of So, we reasonable present. want anything. add to John, you in to should the fourth a XX-month have data print do to

John McKew

mean, we'll XX-months a little that I think I No, well. have just Catherine data as beyond bit, I'll stress

durability visual is slope is. effect the be understand what injury the really we an can group can So, there. And patients’

Catherine Novack

steps, kg next of registration then wondering modifications confident How for and next the Got I'm you studies pivotal into we X.X read potential phase there Can directed give can pivotal of And me taking sense out. make child you might mg program? b you initiation to anticipate are it. II steps if per enrollment goes design following in III a phase and or study? are forward any the

Rick Hawkins

we study including as quickly whole Thanks, can I to take Catherine. the the around going it's and this of everything to you as are team possible, the recruitment fully III to doing the start study committed sites world. tell phase

who know high in been study. the II we the responders phase First, have

think confident forward the separate given same later we competing that of conducted, the extremely traditionally I for were in stage, great the the when patient growth being are around the long-acting world hiring enrollers that, deal who other adding enrollers was to studies addition China, especially competition But three pretty a in high territories there companies, are that, we some in like been also, hormone fact going population. fact. between countries are have But all

started been a the we the by PGHD I is far have much clean say, no of There out as sort time we as time there of And one trials has Phase this our think a, we III. we doing or diminished. don't a know this let's slate. else in as have at competition

question? that you want of terms of other do add John, the in to part

John McKew

Sure.

So, three Catherine. questions, I heard

the Phase II. one, of kind I'll from first timing moving So, which with start of is

incredibly the we through we large deeply going FDA, to this how We'll data kind prepare all the are forward. non-inferiority important end request to a of will investors are trial, we margin, quickly that get. meeting an moving analyze out that step to for Phase the and So, with very Obviously, towards methodical be into are be it approaching top-line II us the pieces and for and to of pivotal form outline package the right? on move in that our will And required the our get this we're public. III Phase very also negotiate for data will thinking to in this dig it going

We will with also our III FDA about have products. Phase the commercial discussion

will a that think next very important I be So, step.

we And that much subjects. as when with the to and U.S. we very, upfront we quickly very Rick we right? as will our work both regulatory working closely globally, move will CRO to and get do really said, okay the in U.S. into so, ready authorities enrolling And be can be ex-U.S. as

data now So, the you being with make a to we being also to that's right as And data after we're analysis, asked decision X.X but I final to comfortable of have forward. about that's, optimal. right interim wait until what the move there. the the going the points QX think X.X obviously dose set to we now, full But feel

We patients among treating those who a strategy about for have the like, would is amount And answer I we right? number LUM-XXX found the them way III. trial. isolate who really II Phase an selection is, subjects And applied patients So, to bring your enrollment, only patient what of we their was that, part of kind that understand, not those we them into have enormous respond study, our are prospectively and end Phase really at in about are patients question to population. terms I the third KOLs our we of from out in good think finding to learned these there of this figured the

designs isolate we a think have to Phase knowledge lot help of of very to quickly to forward. move population final the III apply kind right to I us So, the and

questions. So, I think the of I've checked up all three

Rick Hawkins

excitement KOLs, FDA add, with with that almost therapeutic we like community, other the and work I and is there share is a I these because able been community, connections they investigators with as space. oral the think with an Cath, the have in results palpable might the I this investigator time to this meetings first in think

enrollment for that think in getting I this and So, going those trial. were walls Phase III well

David Karpf

add I bit? little Could a

John McKew

ahead, David. Go Sure.

David Karpf

Okay.

the what the of Phase You of will say successful about for trial, that seem patient Phase Phase III, sick ask good And really III. a that key like do is is III homogeneity the I'd to design to factors population, of there, the and trial. having good balance the having you see between heterogeneity, real at to III, if out the you groups. right Phase look I'd like the the impact at height versus point essentials for

because trials did percentage Both trials, spectrum of are the full they less the of real severe those organic in patients inherently trial. trial the severe, then a idiopathic. of the But ruled for heterogeneous disease, had higher severe moderate, more our high to severe

and product the per of result, that a year XX As growth the response months. control to hormone XX.X group centimeters

homogeneous It'll X.X be severe, the of we in be trial, less Phase up severe the homogeneous less high than around a are would many The to velocity And trial, selecting see idiopathic the in centimeters come year. III that chosen. because we're also expect X.X similar because those in lower, two as the population to X.X our contrast, centimeters will because per real. as to inherently with only is more but who was centimeters In concordance U.S. trials. the trial much databases, in further either a to the which not response XX.X centimeters, high high it's severe, more with

will more balance, Phase than be then factors, importantly, II even sort trial. Most II the And a homogeneous, have trial certainly three are our Phase III trial. important predict there of which and Phase will

II. larger than Phase III As Phase far will balance, be much, as much the

So, and subjects versus will the of be subjects, XXX XXX dose Phase subjects growth LUM-XXX XX subjects to to one XX III on hormone.

our The us find side three to will try trial of factors XX in interim much more, XX greater by were the improve trial either analysis, to to get the much better factors, The two allows even or to a inherently balance. also will fourth the improve larger the quarter. subjects also which balance than subjects reporting

based homogeneity criteria, Phase about in III important, of the high our homogeneity design? trial, similar that make the what learnings the the the actually to further Does which improve answer that will Phase upon from II. very really it is that We're your inclusion trial. then which speaks adding And to to question

Operator

Next question Fitzgerald. comes of from Cantor Charles Duncan

Your line is now open.

Charles Duncan

couple Good in afternoon, taking for of congrats Rick on and Thanks question. team. had I our a And progress quarter. the your questions.

as talk you it about palpable. the It patient population? when IMPE sounds enthusiasm wondering, severe was First well like And meeting. KOLs you guess versus about I to characterize I'm moderate the

a I'm paradigm the of assume implications And the a guess terms the wondering to commercial setting think is that system respond PEMs is you past help patient the is rates, a to prove III use guess if to there? for in program, in then of may be experience the out enhance or going that almost do I confidence field? is that to in challenge phase that I this perhaps the and really going could enrollment enthusiasm over we going that the or PEMs,

Rick Hawkins

Thanks for you And, the going let Charles. your it question, answer. with to with start I'm John,

John McKew

appreciate question. Charles, thanks, Sure, that

presentation we a had, booth Rick So, and in and as I well. mentioned, IMPE a poster think, a as

and of of of a with pediatric got the think, European, so, endocrinologist. different of growth I hormone. some U.S. lots South And an is than really key broad how got molecule of interactions action And mechanism of it American we they the and understanding understanding our

needle see the there is population very probably this moderate, the are is to PGHD that phobic, connection there and are to an kids have maybe be opportunity broadly of group and really in who be bursts. in population, is impact going and for chat I who could needle the do than pretenders this tend take and are take a most with however, really they're more the mentioned that, deficient population severely just, the molecule moderate PGHD needle kids that this think that population, of right, phobic treatment, moderate in treated think there of are population, most or the I'll little And we I that is or because to that patient of clear right, shots, going to type the they who that comes with, kids more

them to offer opportunity clinicians really something oral. able to I the like think be that's

So, understanding, this more that of endocrinology clinical data start molecule we there's modern more as good been the we've I to offers about pediatric among the that to present community and think this a releasing the advantages population.

David Karpf

I when will population and just that their and, enrollment play the just and population into in seeing to lot making time, but add organic, can this PGHD ecologists severe the current more into already I organic often the between now, PGHD therapy dividing even idiopathic think because they idiopathic trial, that, are really they're their versus kids. in a current in separation will the empathic they're the our right

that is pediatric test hour I undergo alignment tests two simply be burdensome compositive. test later, and PGHD a phase aluminum phase endocrinologist. really one Because just augmented which having also the much that single PEM of with upon and also the in data far it's these predictive our simpler than also watch to kids very, being think to less will by with into the, pretty some will acceptable. idiopathic without response will so very of be III an single include that's I think all a dose and based out blood I point that

Charles Duncan

I commercial I'm commercial a sure I able But this. do misheard Appreciate John form to form. that have had David. you color. be a question if or Helpful the not would that about misheard Phase developing? or are is something added that to a still is are still if move you III Phase case without form developing? you III you into start it a commercial And the and

Rick Hawkins

No. Good to going John question, answer let Charles. And I'm that.

John McKew

with patent with the III. and Phase how do forward into in led product tied of we the we to have about think recently we I possible that that to product. And opportunities we the is aspects them talked obviously, commercial get agreement FDA explore fully with the are formulation. to is mean, about which have submitted, I Yes. that best And in going want and move formulation way the molecule to new interact

way going move are FDA molecule, molecule easy So, this that I think make the a the with really agreement utilize we administer. to to and down path with to about best the

towards to mentioned, study. is the move plan with the as as I FDA get forward our III move So, and agreement Phase we

Rick Hawkins

And III of further, to answer Charles, your used course, product be trial. will Phase that in our question

Charles Duncan

strategic or Rick, it. That question is Okay. Then excuse more last John clarifies me.

the the a really call. have We potential for big alluded to And I you geographies data about earlier China the guess that present other And either past which do in quarter talked wondering, geographies. pursue in you fourth collaborator think is development in other further you that issue. even opportunities could or could in think with to I PGHD enhance the I'm this not,

John McKew

engaged business don't Aaron nice Aaron product, question problem a the in is almost the think is as, is their number up. there show right of days. And are of territories players And our at a is company no man And XX-year players. is development any these I this a have. there question And be the we a right major development right that, that, to busy typically will led Schuchart. a what happens There choosing by time, is Yes. this in gets is fully mature at partners a veteran is there space. when stage

Let's put it that way.

Charles Duncan

for taking my Thanks Okay. questions.

Operator

Instructions]. [Operator

from question comes Oppenheimer. next Our Leland of Gershell

now is open. line Your

Leland Gershell

opportunity forward for update other at that study? addition characteristics the two may But the for may to Rick know the to know, Thanks my the for differences on and focus update looking of mg, hear questions. wondering are be if the you narrowing the what a in dose baseline give Thanks. doses baseline X.X that's study. in taking the of us for I to the you in wanted

Rick Hawkins

Leland. question. the question But going to let that you I'm thanks thank for John, answer

Unidentified Company Representative

the the the mg important There's most are here two same little interim X.X data. based of across moving similar direction. on different all important doses are fine we just they all our analysis. cohort around those the compare cohorts are that cohorts have a kind But I trends obviously And generally there in We and among a cohorts, but two think moving the cohorts. the are

Leland Gershell

also And ask respect with but to you. to Thank I a type III be Okay. the the earlier, USPTO to grants want respect starting assuming it have do? those asked would any the just to bioequivalence Thanks. formulation, to III. I new with or may claims, Phase study that been a bridging study matter have simply other of that get Phase you into the work clinical oral

Rick Hawkins

Go ahead, John.

John McKew

do mean, I you back have it formulation, that in you study compare when to Yes. you correct. introduce in to II. have bridging Phase is general, new data That the to

Leland Gershell

could think done starting about XXXX. that the would respect that And pivotal the of should that, we study? with be timing inside presumably, of the How next to then

Rick Hawkins

John?

John McKew

soon as obviously that possible. up keep mean, keen were we to as I

to forward. because I key soon can, as would moving the, it we think is As it be

So is to-do list. definitely yes, it

Rick Hawkins

As much going possibly [indiscernible] We do Phase study to as can. of parallel basis. can any work Without much a want quickly on risk, III to we're do. as start we too this that we

Leland Gershell

Okay.

we you two, the so the bit two it parallel in generating starting completing III? accelerated be into data the Phase studies, then and be get we XX Rick, may a or as like So, with sounds those could starting tendency,

Rick Hawkins

up be meeting leading trial, between the to FDA. to done reporting to everything the done the with end work needs data, of the the completion be a the Phase of lot II of of There's

parallel that so going yes, period, work be time, obviously, So there's a that's lot to in of done.

Leland Gershell

Got it. Very good.

taking my Okay, questions. thanks for

Operator

White comes Wainwright. next of Ed Our H.C. from question

open. is Your now line

Ed White

one, that taking my PWS. you narrowed the just indication Good ISS afternoon. question. you've Actually, targets and mentioned Thanks have for had I to

study and think indication. which for Phase year Just possible you to III? decide, to to that new the start go you think That wondering it's how the Do of you're then you run initiate that of will year? the study the after next Can target next indication the the alongside planning? timing of this

Rick Hawkins

on the to We're at then along development to the resources they but company have we're market of really runway studies. conditions and obviously, stage this have indication, our market make evolves, Obviously, cash getting all we'll to are. the of of the fortunate focus as we access terms as of the way. that the going more the We're capital, able in and on those PGHD readout decisions

of restrictions are kind PWS. of obviously, those a take. the any for able And directions Know lot us as to given it'd and spent may start for and But ISS with quickly they're both KOL time studies community to these that the excellent or not as we we we'll we're there, be financial may have.

Operator

Our question comes Piper from Yasmeen Rahimi Sandler. of next

is line open. now Your

Yasmeen Rahimi

questions, of analysis that thanks allude III could you. of if you some so team, have Maybe the just Hi, the much for you the to taking on for run. what cost two, based the phase would be

around, started there. terms early like in color you color also your timeline XX and enrollment maybe some you And to the some provide assuming when Like, do could phase duration? in weeks then of up treatment math You XXXX? III XX

the the various provide If the would to could timing into data Like, back data able that like, just what you expecting XXX be into line? the some to the take, are component and heading helpful. see And scenarios jump then my what would top-line you around are as I'll that we're Thank how queue. And be third is, XXX? question soon bring could and action you you. finish from into of you

Rick Hawkins

from hear the question. appreciate to good And Yes. thanks. you Okay,

and want great that And of be will deal back a size. of the companies most deal of competition companies. earlier, there's long in the a how enter about was discussion go to, to great there taken to three I about think it's I think terms of precedence. I between a fact my is study

by positive Well three obviously also, Concurrently large That's fact phase community using our in effect, studies the in the I one trial, to And of this like we of that That earlier, looking thing. clinical we'd exist terms is trials in said the globally. quite we've for patient that, conducting think for a derisking addition John in III be strategy. the doesn't well, taught us. K PDM type all

terms phase In XX once ascendance the I months. to think think, trial, time of III enroll, took again, about I

a of the competition have than we larger little the we're think areas. or I perhaps roughly was I trial deal have from number a great as of of bit so. said, thinking But of, restraints a don't

by super be a even like geographic everything area think will addition, that has I strategy. going treated course, of to we adding that In all for beat we're And can patients do China year. to a enrollers

we're please. data to scenarios, John terms you would and see, expecting the In of comment

John McKew

Maybe comment the little a I'll just first on Sure. bit timing.

in think our I'll package of reiterate read does that out this just year. QX when data I

We together of and request have that Phase protocol a there, we have III non-inferiority end and get to the FDA. then margin. agree for meeting, And after from a with we then our package And the protocol to put meeting submit we from POK the II agency. and on Phase the

to Phase out regulatory thereby, to the III. we all to have reach and potentially other We of then get the can agencies, ex-U.S. start

for we approvals. work lining as we much as quickly getting CISO [ph] all we everything of as in can, while talk we We'll about can regulatory wait as do those as upfront terms ready

move III. through Phase to starting And check was So, want the timeline what just to other I you the piece wanted then, of on?

Rick Hawkins

and Lori The jump was cost Phase in let of that question. the III, last and answer one to the going I'm

Lori Lawley

Yes. Sure.

Phase of guidance be the and a the Phase to continue planning the point bit giving in not mentioned on prepared work cost think around as refine and are there's III. this at done for quite III. to we to be And John time, I still a we any

definitely in time that we of cost And we put so, the out that will point available, guidance. have specifics the those at

Rick Hawkins

And good examples there are, of have been current the really think raising I multiple I several in in spite that capital or have market what yes, think results. been conditions companies of positive companies successful with who

heartening And that's to us. so

examples time there think more even and to on. I seem goes be more as

this hope time get conditions we the by improved that, market readout. the I also So,

Yasmeen Rahimi

you Thank Great. so team. much,

Operator

today's your This the for participation conclude Thank you program. conference. in does

You disconnect. now may

Lumos Pharma (LUMO) 3 May 232023 Q1 Earnings call transcript