LUMO - Earnings call transcript Q1 2024

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Operator

Greetings, and welcome to Lumos Pharma First Quarter 2021 Financial Results and Clinical Programs Update Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Lisa Miller, Vice President, Investor Relations. Thank you, Ms. Miller.

Miller, Ms. begin. may go ahead. You

Lisa Miller

proceed you, operator. we with the Thank sorry. yes, -- call Before

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

to periodic differ concerning filed factors may the cause is obligation of Lumos call as that and the SEC. The and contained no looking yesterday update presented with of afternoon Information in be Investors reports to company these hereof, the our page forward-looking website. we on this statements. our information the Additional Form call X-K, issued during actual in the accessed is could in made date or undertakes results from which only this statements speak the revise forward-looking Pharma contained press release

on pleasure and Chief call be Speaking the the It's President Financial and also Lawley, Lori Chief Officer, John Officer; to Officer. our my the will question-and-answer Rick and remarks. Chief Chairman; for for Medical today's now opening join Hawkins, Duke Scientific to McKew, Pitukcheewanont, CEO turn call will Dr. over session. call Rick

Richard Hawkins

therapeutic to oral Thank and first update an provide on or today moderate be to as PGHD. our hormone you the deficiency, Lisa, you, advancing with good morning, pleased pediatric everyone. speaking progress LUM-XXX growth I'm for

conducted before data my trials. OraGrowtHXXX year. meeting with to strides keep We've detail review opening XXX productive fresh Our so in colleagues and to recent II over a marked greater had I'll the remarks have constructive at by Lumos FDA updated and End-of-Phase concise my from on made we've this analysis milestones. handing far incredibly been our months the significant

begin. let's So

III data the where in recently meeting our from held path release, FDA, collaborative reviewed regulatory End-of-Phase and the successful II discussed XXX for OraGrowtHXXX detailed we and our optimal with a promising trials II design Phase As forward. Phase press a an

OraGrowtH in successfully and Both trials, PGHD. LUM-XXX robust secondary potential oral treating II Phase you their may evidence moderate met supporting endpoints, of primary as the providing recall,

of identifying Additionally, likely demonstrated to Enrichment or Marker during test FDA, effectiveness acknowledged And the our that dialogue hormone to LUM-XXX LUM-XXX. from the distinctly Predictive with trials patients operates it in its respond our was growth mimics. the

The This Phase hormone an in that placebo. and FDA of recognized necessitate significant noninferiority trial a but design. action would arm promoter compared growth propose LUM-XXX unique with demonstrating would clinically III growth consequently, trial not design placebo-controlled margin improvements a novel a consider as mechanism comparator require a with to we active

we this significantly PGHD. prospects III a XXXX. therapeutic delighted of year-end FDA toward initiate refined believe Pending are Phase by as chances as of oral final We firmly approval by we LUM-XXX. to trial plan the for LUM-XXX advancing bolsters this our approval first moderate of the that successful design enhancing Now for greatly see these trial them developments this trial design, we

data Phase LUM-XXX through strengthened our trials. Our additional II confidence in examination was of further our OraGrowtH from

over As consistently detailed which effect demonstrate trials, a we unveiled press and Velocity. XX-month substantial from and data updated in our XX-month release, improvement durable Annualized these baseline Height

the disrupt to growth as that position support company a potential confident LUM-XXX oral injectable for the late-stage market Pharma Lumos deficiency. substantial advancements to prospects and growth made, hormone billion global $X.X continue are We biopharmaceutical the with

trial. further John for insights to hand our John? pivotal McKew with FDA for the call and over the interaction the to planning III and our I'll Now strategic Phase

John McKew

Thanks, Rick, and everyone. good morning,

the pivotal with staff evaluate trial. and explore meeting a members trials concluded present, PGHD. from the End-of-Phase departments, overwhelmingly the The potential for optimal II was, recently data the we on atmosphere presented from it's our III and to data FDA meeting the XX highlight constructive outcomes strategies we FDA approximately trial nature. package With OraGrowtH FDA mentioned, our Phase to Phase senior Rick approach OraGrowtH A positive key determining moderate and for the LUM-XXX centered collegial remained design of representatives pertinent underscored II treating trials. of from our in As including the pivotal

a their trials endpoints, Velocity targets may from that patient with population. you benchmarks predetermined moderate primary consistent achieved LUM-XXX recall, As these Annualized historical successfully secondary demonstrating Height met in derived PGHD and

historical hormone cohorts per with growth with XX and the treatment months rates in months. XX observed sustained at with dose XX human per observed on at X day rates both growth efficacy at growth Additionally, mg and kg LUM-XXX recombinant aligned X.X patient the similar both

reproducible, to ability of within the statistical surpassing accurately exhibited our also LUM-XXX as identified LUM-XXX trial X IGF-I preliminary normalize scores classification XXX% confirmation Marker, standard provided margin. the treatment predefined showcase the that Enrichment data deviation initiation. PEM and Notably, the potential Furthermore, or strategy Predictive PEM, responders months

that growth products. growth FDA's be mimetic, to compared growth investigational data, further LUM-XXX Upon of traditional not FDA data promoter. them reviewing should merely hormone profile distinct to that acknowledge regarding safety representatives, their suggest these not is mechanism. but of directly was these a in shift LUM-XXX prompted a They necessarily hormone rather The understanding indicated Additionally, LUM-XXX a LUM-XXX's validated. perspective distinct

This the the hormone pulse hormone, agonizes growth hormone the growth growth LUM-XXX by the both stored somatostatin binds also LUM-XXX peak growth growth in circulating hormone. in IGF-I. circulating or in to molecule release somatotrophs receptor and the modulating release of and receptor, hormone-releasing each pulsatile of levels the hormone the As the levels signals of in a elevating the pituitary natural of boosts hormone that in restores Ia subsequently hypothalamus, amplitude hypothalamus. secretagogue is the reminder, growth the that a small LUM-XXX of increase

operates than growth III of hormone acknowledgment a a exogenous act Both growth open of mimetic The design on as view trial. LUM-XXX recombinant hormone that in a growth-promoter growth. in plates more long human that bones growth rather enables hormone children growth the injectable stimulating the for and expansive IGF-I novel considering with deficiency FDA's approaches a Phase

dedicated was to in meeting exploring examined with different case, this conversations, levels FDA to XX-month dose that it IGF-I the We design. trial culminating of suggestion options, the study, this trial. hormone a consisting portion LUM-XXX this Heading historical growth-promoting against hormone. evaluating placebo-controlled engaged we the that explore agents and contemplated meeting, a growth FDA significant the propose pivotal noninferiority discussions the because in FDA could of, by in A noninferiority designs we and the these growth FDA regarding suggested we the into the standard But approach. LUM-XXX of design, chose placebo-controlled were lower approved with closely productive We dose of FDA more physiological mirrors comparator the stores. during a

placebo-controlled would compared demonstrate to significant required with the A treatment. growth the to trial of clinically XX be placebo months

from regulatory LUM-XXX advisory FDA's consultants, scientific clinical insights have recommendation statisticians, drag to featuring provided and the placebo. trial and by designed we randomization Board placebo-controlled X:X of a our Following a

One LUM-XXX providing X active in agent. months, arm to Phase trial placebo LUM-XXX, design ensuring LUM-XXX objectives: all while and other initially receive the will for evaluate subjects that LUM-XXX III serves data approval. next receive on first, subjects the the be months for the to This All received will FDA the strategic treatment arm and with ample PEM-positive. X with the after trial enrolled remaining treatment months. XX for will X then transition

envisaged For endpoints. this trial, we X co-primary

clinically treatment the First, XX-month arm significant growth. must demonstrate

versus will growth. meaningful there pairwise Second, within which placebo subject a growth assessing be also LUM-XXX, comparison must on on growth exhibit clinically

X into to participants trial period, have all the LUM-XXX transition years. provide will which option up will Following to a for the safety extension, XX-month long-term treatment

are confident trial We is size the endpoints. meet more co-primary the than adequate that to described

We from Phase agency, end aim III the anticipate of trial before initiate the finalizing to next and couple of pending this design approval XXXX. we over the months the

potential updated yesterday's Like XX-month databases, hormone-deficient our from preliminary these the growth treating focusing more trials studies on growth PGHD success from OraGrowtHXXX the snapshot pivotal data Our are XX- The measured historical IV analysis comparable trials, populations we similar cases. trial. the LUM-XXX and rates. from the X- press excluding while unveiled XX-month when we deeper specifically indicate severe trials. and from and bolstered population Phase our moderate against updated on growth data for release, In data our data OraGrowtH in evolving by

Our achieving similar data are rates patient PGHD moderate to the consistently for data demonstrates growth that cohort. we historical those updated observed and

to LUM-XXX. compare the a and Phase highlight all in XX-month on serve advance analysis year growth II our LUM-XXX LUM-XXX our an the noteworthy increase growth trial rates dose annualized OraGrowtHXXX of centimeters for of Annualized per cohorts document of baseline Height X.X arms Further and our rate or Phase should The full Phase the III. These XX-month per placebo trial reinforces X- mg rates. baseline growth indicator choice into in rate treatment baseline III upon kg trial. in findings the AHV, The Velocity, as from data X.X in growth

we and mg Phase data These months. II cohorts all the day were trials from Finally, our treated per to growth combined statistically X per different. X.X were since XX kg include rates not their X.X subjects

the Excluding to to -- from database. stands in data severe treated database to cage XX%. the approximately These historical X Kgs X these observed. with comparing X drop-off published those, enable data human year a hormone off in updated This drop LUM-XXX AHV Pfizer only for when the LUM-XXX, we growth of tanner modest X where XX% underscore transition year of to population closer is data is enduring continue to from efficacy AHV the the less tanner recombinant to GHD contrast to comparison a

can sustained and suggest FDA meeting freedom data mechanism levels, III at to studies the presented highlighted convince study agency findings over normal These were of were time. novel These how LUM-XXX's thus restoring normalize II the of granting LUM-XXX to them with secretion growth designs. physiological our II action, Phase End-of-Phase growth and from Phase innovative the hormone enough benefits compelling IGF-I

significantly to to endocrinologists oral This a this pediatric seeking deficiency growth is and that be for regulatory risk growth design We market. potential introduce the to hormone for mitigates our deficiency anticipated our first believe the option address therapeutic treatment hormone their to in innovative patients. therapeutic oral welcome enhances placebo-controlled pediatric

subsequent PGHD growth dose daily the Growth day month, analysis European Clayton in recombinant results per Velocity comparable and in by at in presented profile and line secretion conferences Stockholm, Dr. hormone and of trial a restoration per Endocrinology. to LUM-XXX Peter Dr. with Dauber, of in of the data moderate were in Society achieved Society showing Congress analysis Research safety Pediatric Meeting growth of PGHD endocrinology patient. Chicago, Height the increase Endocrine induced X mg promising AHV Annualized kg the X the comprehensive Hormone X.X top hormone OraGrowtH conferences at a this at Earlier presented highlighting LUM-XXX Andrew major

OraGrowtH accepted The abstracts analysis month, to X We are finalize the financial that results our had OraGrowtHXXX trial by we trials interest pleased where to presentation also community, from for QX. resonate like upcoming endocrinology for we announce and to at XX-month Meeting to or would data plans that, for maturing turn from trial. the full with OraGrowtHXXX the additional Lori Society global the a trial. the With among it with review next I from for we growing are ENDO data pivotal to our as over our have encouraged experts we continue Endocrine our plan a release of

Lori Lawley

is operations quarter and million of totaling III hand as cash on cash, equivalents year, and on million of the XXXX, activities. March December planning ended We $XX Cash Phase support John. third $XX.X with expected quarter XX, preparatory inclusive this XX, the to investments on through XXXX. compared to short-term Thanks,

of developments recent expenses to $X.X in General million were consulting expenses. period administrative deficiency in due increases million over expense, $X.X offset other $X.X in million of remarks. to primarily of XXXX pediatric million same an the million $X.X net our million, clinical in XXXX, to compared XX, $X to $X.X decrease expenses, $X.X the same a quarter in the from for expenses, the to the with decreases finance $X.X outstanding. period able expenses million in in III $XX.X loss expenses, million million, due With personnel-related offset confident travel period expenses The $X.X of million March increase licensing and for we million to compared growth a expenses, in and shares to compared an $X.X will XXXX. decrease $X.X of in And ended closing XXXX, $X.X loss and in consulting million XXXX, primarily $X.X licensing $X.X million increase by trial it was of his expenses. a for March the with near quarter Pharma we XX, in million in of I Lumos and ended expenses by term. Research turn X,XXX,XXX are Rick that XXXX, in development now Phase the trial ended hormone personnel-related FDA, the for patients for will net be same QX were million

Richard Hawkins

and Thank you, John. Lori

call, in of therapeutic for objective the global fruitful time for revolutionize we progressing potential As market, oral poised mentioned towards to LUM-XXX dominated been it's are decades. exciting earlier pioneering a the an been by Lumos steadily the of injectable unlocking which has as our growth hormone and X products nearly and

call I'd envision to we LUM-XXX. for oral commercial potential like moment take Before your to questions, the discuss opening to a the

pulsatile of the injectable endocrine If recombinant products, LUM-XXX over approved, including of potential growth growth advantages hormone within physiological we restoration sustained hormone believe feedback presents benefits loop. natural current growth the release and several

therapy, an treatment hormone-deficient to to pediatric growth appealing oral alternative patients. the and and has represents growth particularly potential among As hormone deficiency daily an the injections broaden LUM-XXX moderately weekly market,

it's small molecule, be commercial-scale is Additionally, production there significantly would for noting the lower growth worth than of recombinant hormone. LUM-XXX for a cost of goods

address not view syndrome growth singular consistently we hormone, recombinant pipeline. to robust idiopathic also a product, the treated we currently with XX but And potential for LUM-XXX We see only a stature. and as indications, Prader-Willi including emphasized, additional short as as LUM-XXX

as acknowledging believe design a attractive the this as growth for trial FDA LUM-XXX clinical the With positioning. these commercial promoter, streamlined a other as indications way well paves for we novel for

a in regulatory with this propelling is high FDA. moment guidance late-stage likelihood pathway success. LUM-XXX We're pivotal oral with for trajectory positive the program a the company's from truly towards Now of our the a

we updates sharing year Additionally, you. exciting anticipate some eagerly progress and coming our anticipate with the on very in developments

please. And Thank we're well, you ready as all for to listening very take much questions operator, today.

Operator

the Sandler. of [Operator Instructions] Yasmeen The from Piper first comes line with question Rahimi

Liam Hiester

Liam Yas. Hiester for on This is

update regards bar chose you is what also connection then database if expected to could have Just upcoming move provide dose the And to start, on And in you on to Phase why for III in for with. Further, clarity requirement overall success was forward specific growth. some the approval? wondering study, I your any safety to the any to trial III regards as long the the you had engage Phase also with you in any to chance then comment Phase Phase on II enroll III design how to there's you the EMA and expect between if all to And well? could the if it take as sites? well III overlap Phase at as

Richard Hawkins

should questions, excellent probably the success answered think I Okay. All and bar to John. question by be

go So John. ahead,

John McKew

Yes.

show we as we So have mentioned, growth. to clinically meaningful

LUM-XXX. treatment trial, as with we FDA in agreed that centimeters with end define that to past clinically we defined growth in is the the Phase achieve months what of growth so continue with And XX what FDA clinically growth, the meaningful to to our year meaningful agreement have the the have on II subjects to per minimal at was X.X

of in present III as options growth this to Phase that one the that study. for option clinically an is meaningful So we have

tackle X.X your be I doses. we've three we between some X.X kg really the X.X day mg of a numerically the kg per mg doses, at difference see don't the to study shown per dose, think throughout across we per day age, question, both highest other to per the and the just

that believe to dose there's higher point pharmacodynamic that plateau. a go So think there's no I to we do

questions. hormone it your high dose, wouldn't an that of AHV. getting in not growth are the increased X increase So see Those we're sense secretion we make so at X

Richard Hawkins

interaction the with the Yes, EMA.

John McKew

with have EMA, the start with our we will that So interaction finalized the FDA. after interaction protocol

Richard Hawkins

on. you patients enrollment enrollment of talk don't -- number why about Duke, so the and And

Pisit Pitukcheewanont

Yes.

you. thank So

to of Phase think have Phase the overlap Phase pass initiate do a continue well. II to So have first we to And III? Yes. I Phase also, There, question, site a in we on to as sites we some side II answer III. plan for III it new Phase

at enrolled significant increased and around number We II world nearly global interest KOL the in a Phase world. III, country the scale. We well. note than double. increase At site II, subject number and increase of smaller of trial the that have of number awareness get do want to the significant is we point, this much which around of the as you As Phase Phase of

we time just with XX-month, their So to end as XX- do initially of the planned enrollment if that line believe this we start, towards year. the we intact enrollment

participate able of patients So trial to and enroll with number when of that again, track to do country believe and pretty the those increase of we'll trial. much be any number everything placebo-controlled site the at especially we timely in the manner and on all this we

Liam Hiester

And more sorry. Awesome. question, Great. just then one

you XQ that? any details funding the do XXXX? on on Are year-end how plan beyond Phase Just III there

Richard Hawkins

go Yes. ahead. Lori,

Lori Lawley

Yes, the we've have the since Phase upcoming been really we now had details that meeting our III and for trial design planning FDA of busy we've some finalized.

partners and go we've that -- can there We believe of would financing bring to own. also that strategic confident in that is as those is territories potential on we allow said deals, licensing Also, we our nondilutive investment are opportunity the finance previously, potential and necessarily Phase out III commercialize as for go in out planned. trial the which community we to some would for regional not

Operator

Fitzgerald. of comes Duncan line Cantor with from question Charles the Next

Charles Duncan

with Yes. trial questions team, of design. a perspective Also the Rick appreciate one the your I on III FDA. and then FDA on you progress provided. And the the couple regarding congrats engagement. have recent did all interaction on really and constructive Phase color

from different III So could will that I'm if not, or the Phase with the trial how III Phase regard affirm the in wondering be criteria enrollment you design. to Phase II? if the same

provide is is co-primary? is a on more question then regard second? true Or with I a the the from XX-month down a, call there color first to it the a the if little second could AHV it, that had step you And to co-primaries,

Richard Hawkins

Phase you criteria? don't terms in talk about of the And enrollment why Duke, answer then, design Yes. part the of the question if you'll co-primary. first III John,

Pisit Pitukcheewanont

Yes. question. That's a very good

So much II XX-month we is delayed greater compared small initially period. into the The make that the going now months, we to want make only during greater bonus pretty have the edge number we that one, upper to III stage that the months. since same. And to limit to And physicians changes X the tanner to of compare majority believe actually placebo, is, to pretty inclusion-exclusion a it sure the part the the subject lower II, similar would trial XX the than in And of much this criteria want single we're participate to we bone we year. Phase are who because the that we're this, Phase trial. X criteria have and equal to we clear of PGHD, get for majority will want other no criteria do than very but again, that, enrollment, that for behind going implement moderate inclusion-exclusion of it reason

when clear. endpoint very primary We see would the a be -- trial, have different a significant we placebo-controlled

will X.X you data Annualized I think Height know, I patients, best this was in months. coming As the in X.X. majority XX And earlier, at you see try the to those trial achieve as centimeter presented John Velocity of

III at we basically, we significance Phase it this the the of the So clearly based FDA trial. can requirement on very achieve see that end clinical

Richard Hawkins

the co-primary. And John, on

John McKew

Yes.

and X-month see placebo, showing to the do clinically we Chaz, growth. growth XX-month comparison as co-primary folks meaningful the these endpoint So, endpoints,

we'll Phase details plan So FDA more on the going the that's final the III from we sign-off have protocol. a full release in. once Obviously,

Charles Duncan

That to? you which matter? X of does powering, it not the include John, do power will Or

Richard Hawkins

at have power we pair do we're end to we that They'll have right more those both to believe be that -- the of we both to is sufficient both. endpoints. now And than No, powered.

Charles Duncan

asking Okay. bone Neat imaging bone mineral any or design. for Is monitoring. the density agency health

Richard Hawkins

Duke?

Pisit Pitukcheewanont

the actually, may you XX And good in tried segment the focus most No, change velocity. months. try -- terms of in efficacy they get the the not. general, approved, bone a they And in did first not to density on their see of

study. XX-month this for require not we'd that, So

Charles Duncan

not the of speculating get question you Okay. appreciated -- simple hormone agency with on LUM-XXX And key you the with the And shift care But of shift did challenges a sense for and driver last current or was always standard mimetic? think being the stimulator, view this they that perspective that of to compliance the that. injectables? do what regarding a a a hazard growth in the the

Richard Hawkins

John. ahead, Go Yes.

John McKew

data doing pulses the So I with we've was publicly growth subjects, turning a think need rhythm growth in amount AHV. Chaz, that was in which level the we're of hormone across pulsatile that we're to shared an restore normal of we that of of our bolus pretty XX-hour XX% release. trade-in hormone more almost can amounts pulsatile, think I because of in package and levels about And XX-hour know, hormone realizing their period. you dose, of same as exogenous of our period viewing mechanism that hormone-deficient the And about growth data from shown point, achieving that extensive efficient growth just that significantly restoration a we've growth and understanding FDA the hormone all around think you delivery it And is substantial. and the and I

I'm whole away the creative was exogenous LUM-XXX potential going growth to to III. that to in think up from the of ways this hormone. discussion open differentiate key Phase I growth kind of really really us evaluate about

Operator

of question the with and from Gershell Leland Next comes Oppenheimer line Co.

Leland Gershell

with early but the about X -- to days, looking of to in or or but apart I benefits X use from that impact from we III? just families. what to surprise endocrinologist's for to the I and those at wanted metabolic additions. the potential also the of it two, And from XXX -- go data sort I to versus time even Couple to extent things as agency growth hear potentially ancillary, was you more Phase wanted to the control could tell comment hormone advocate be comparability view on view the benefits those lack versus to are important to given the hear data in hormone growth will want injections, same placebo they thereof ask, questions inferiority positive on maybe us, to that

Richard Hawkins

Duke, of really question, I hear you. that I only for but think part the was

And so start? why don't you

Pisit Pitukcheewanont

quite the hear cannot I Honestly, well. question

be... So can anybody

Richard Hawkins

Yes. Go ahead, John.

John McKew

data Leland asking Phase So was endocrinologists impact pediatric not the to think I III ones about in treatment they about as of comparative for the think, prescribe having market. these how around

Pisit Pitukcheewanont

Right.

Okay.

good as pediatric So, are moderate significant Leland, endocrinologists, with very make high. that's other right? it's hormone. that only that in a As the think, a only is know No you important, no impact mechanism a trial, hormone such detrimental you or indicate to it outcome than participate you patient with the understood patient clear of growth X X of without could treatment for deficiency, that I know, treatment this PGHD, if all, And year. the that different you fully growth in of is action right? they hormone question, FDA first us very not LUM-XXX is totally growth as and months

aware are that, in patients So especially the is this prepubertal. we most do believe that enrolled fully who study of patient

have in for that approved patients the to years. that to again, long-term to not we enroll and to we have long-term FDA will issue month place trial, be study enroll X we mention this pubertal already adult no significant treatment that funnel participating X extension able impact month potentially trial into this when will all subject. extension study, said, which they in do is this that high. not impact the So X going conduct that With with in have is And to no believe

help So it to their I term especially do believe benefit long with and their we the patient, to will incentive drug to physicians patient, for really the that knowing enroll approved. be that

Leland Gershell

growth benefit, from to Just that? may on LUM-XXX, beneficial other is apart going body effects still -- you're the access to metabolic if the have wondering

Richard Hawkins

do you answer that question? want to John,

John McKew

examining have think context in fat. we be the impact study. study do III investigator-initiated that in going being collected on on of So this that where Phase the data in question an some specifically examining NAFLD liver of won't is We I

on endpoints So to it's III PGHD and to path a being trial, we're in an MGH, but at focus approval. approval get forward run for going the Phase the

Operator

from question the Ed next Wainwright. comes H.C. The with line White of

Edward White

this update morning. the for Thanks

couple So and the comment for manufacturing of me. trial regulatory you III filings? just on Phase a questions readiness Can your for

Richard Hawkins

Manufacturing readiness. John, go ahead.

John McKew

Yes.

thanks So the question, for Ed.

So yes, will III, us the children product drug we routes we with pediatric patent hormone of variance form across provide administration. a tight Phase for give large -- recently dose know, weight filed very on as you deficiency for also range a growth new easier which and

a So capsule. we a have mini tablet in

take themselves the mini So the in smaller open the with take tablets and kids mini the larger tablet, kids can capsule can or by capsule softwood.

design that So our is get and Phase to The moving ready we're go. complete, forward in place. bridging are material studies III to

III. road that no there. there are well to Phase So on the material prepared hiccups We're through provide Phase III/commercial to us get

Edward White

study. just the a And on Okay. question

patients just overlap with the a as U.S. far geographical versus Can sites us it's and enrolled? the thinking have for the As Phase mentioned, what you as for some U.S. let II. you're know going you of of outside the to breakdown number

Richard Hawkins

that Duke, why don't you question? answer

Pisit Pitukcheewanont

Yes.

about XXX subjects. now deals for we to is plan plan enroll we that that So right

those randomization U.S. the waiting We X:X the send We're the fit subject XXX world, which the in LUM-XXX receive way to. multiple decision, in region a we're sites out countries outside subject go to plan be more So for in placebo. country make back site to process around a and we of before those survey will to include

site is we around XXs-ish. about So that plan the

countries. XX potentially about so again, So

sites country when be back. receive finalized the numbers in of the and However, survey the we will number final

Richard Hawkins

were if anyone, you recall, And in... you

Edward White

Sorry to interrupt you, Rick. My last question -- can question? I ask another

Richard Hawkins

Sure, absolutely.

Edward White

the as who since, will wanted want eligible, be thoughts solution are the cost that's I on but before, we've the XX% of about children talked it of but just mentioned, population you to eligible, out lower, the is the would the be to ease So on especially get -- the oral of XX% patient your this injectable, to use versus why apparent.

so And patients to take other that children product? and side your why wouldn't the want taking of just and I'm

Richard Hawkins

Ed. And weekly said me, -- oral, preliminary to we it's they ask sort Pete would the Well, the if choice also we a had this take both overwhelmingly a families, no, given. between of Endos, they excuse a a that Leland or prefer Ed, pretty they some once-a-day did clear. That's When oral. research, daily but is a injection

are and, have affected patients trial, patients easily will will strategy, predictive that way So -- identify be this that our we drug those a only the ability most our be to -- and that and course, or successful who in, to to further likely identify PEM in be enhances effective. enrichment is not but of also

Pisit Pitukcheewanont

Yes. PGHD, add pediatric on a Rick like what PEM-positive as into fall I endocrinologist, top of with to patients said, majority category. would of just

do As we over children, want have acting give a long for years, approved, not Just rid a does years which children some of get and those right? period is you of longer XX about until but we month so, X much but but just injection, treatment or get injection so, especially X, of year options, don't not the only or not it, time. know, to not

by do they believe was general, perception those this will offer that LUM-XXX approved, mature drug the PEM-positive if cutout. in this using physician So patients I get to

can on potentially they With the the PEM-positive, treatment. be

option the right, for option this that treatment is moving at We have So I have to do never patients important, point. LUM-XXX really believe extremely forward. for this this until this

Operator

from the comes with Catherine Novack Jones Research. question Next line of

Catherine Novack

position. wanted just to the on drill down cash I

see think just any III. you be bring for throwing points the used be new the to to inflection they'd an the to what stepping additional example, in possibility and out strategic start might of might able pursuing then do before in? you partnership, you see investors need Do start want -- that you between bring to before now that funding You and Phase

there interested the of Or most Are analysis that think this in? data at or investors hand? are you point, would partners more be relevant in

Richard Hawkins

a there's have stage Catherine, make that, Yes. question. information think investors that's good don't I decision. to a any that question at enough this

to placebo are Lori a I if that to the this arm you or this across the we're design said, we confident going add really line. with to to anyone trial I be raise us the since team. FDA comparator gave able And confident, on more fully we're think else -- as needed get the that we're don't capital to want drug any finish Lori, know

Lori Lawley

Yes.

I think trial have like. instill of And as in that term. trial a of believe and investors think allow determine the that the placebo-controlled I trial financing that to would and trial us will that talked have near from waiting we have we an proposed gotten I completed been investors investors, finalize have confidence what design, we they that, feedback in just to now FDA, Phase design with lot move a do option approval think, as the with forward we Catherine, FDA this when look a III design

As far of previously as for looking rights, options for regional partners, course. looking and retaining U.S. we've ex-U.S. about regional partners talked for

so will Phase were they on and with been that also that that design will think something also trial have like. pursue. waiting I what we is the the what partners And to III continue waiting And talked look on we've

think to I of confident and the have more able information financing are So we hand in forward have now those term. and details, near complete why that in the that we move we'll be is we that

Catherine Novack

I guess, endpoint. clarification co-primary first the a And then just, on Got it.

for could If not hypothesis you months, it. can Since me assumption placebo has analysis? clarify is been XX help the is endpoint, if co-primary statistical you for understand what the the first followed

Richard Hawkins

Yes. you answer John, go to ahead question. if that want

John McKew

Sure.

just clinically as to meaningful have growth. So show we mentioned, we

growth. FDA talked meaningful one per that, to about year, And is bit so little a centimeters already show approach X.X we we on clinically representing agreement have with the which the minimal

our transition is from extension. we safety agreement FDA. already using our the that an And II with into essentially So Phase that have we're to long-term study

that is the option we'll that first pursue. So

Catherine Novack

you're after it like Okay. maybe but to aren't injections now, sense make thinking Right seems road. with indefinitely? -- this And for does about on just in focusing growth this patients, one then an having who hormone use or interested treatment-naive daily the people year down more, initial X

Richard Hawkins

if Duke, you let's go will. ahead,

Pisit Pitukcheewanont

Yes.

patient I LUM-XXX. do very point, this yet. into that we that think that show look At to -- a So question. don't potentially data with the that's patients I will have believe good because most

Phase So III when we in get what that we moving we think trial that put done, this forward, registry.

those able want the not II, the the IV patients those patient efficacy approved, the When have discontinue to can of is especially study. we'll evaluate they able Phase when of majority drives. we'd who get be those drug extension, continue long-term to in someone going is So and in to determine going to especially to those, into get be Phase daily some LUM-XXX, to registry

Operator

teleconference. today's concludes This

lines You at your may participation. disconnect this you time. for your Thank

Lumos Pharma (LUMO) 15 May 242024 Q1 Earnings call transcript