LUMO - Earnings call transcript Q2 2022

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Operator

Good afternoon, and welcome to Lumos Pharma's Second Quarter 2022 Results and Clinical Update Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded. I'd now turn the call over to Lisa Miller, Senior Director of Investor Relations.

Lisa Miller

operator. you, Thank

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

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

call be Chief Chairman; on Medical Speaking our turn Chief CEO Lori Chief our Officer; Karpf, to President Financial and McKew, and John over will Lawley, Rick. will Officer; David the now I and our today's Scientific Dr. Officer. Rick call Hawkins,

Richard Hawkins

and call. for thank everyone, afternoon, us on joining today's Thank and Lisa, you, good you

OraGrowtHXXX LUM-XXX quarter turning report update trials deficiency So us will our growth provide I'll OraGrowtHXXX session. on pleased the announcing quarter trials pediatric highlighted confirm of for evaluating other On a the our both treatment brief continued market and I'm advancing our Then are for our from trends moderate today, for a XXXX of Lawley and have review PGHD. trials Lori or to the enrollment over hormone the detailing interim press Q&A after results. year. our for LUM-XXX developments the and our in data to today's our call we financial last for program a before issued to clinical second closed fourth idiopathic release financial that able on results or intention it our we and clinical call, John announce David and join this of to progress

expect include we readouts XX the up primary on half trials subjects both which to OraGrowtHXXX anticipated expect of trial. second outcome to the Additionally, XXXX, data trial from we from for subjects in XX our OraGrowtHXXX data and the

want interim early look the dose safety analysis compared will standard or as an at annualized dose the or recombinant in approach LUM-XXX six a of human interim we Our patients be will And and data to three data. height therapy. the OraGrowtHXXX from data months AHV to provide trial what readout, a growth in AVH moment for at hormone velocity, on looking levels XX of explain at I to we take

blinded LUM-XXX global, is our arm as is height annualized treated the with hormone. growth of PGHD. primary months clinical by strategy oral evaluating approximately As velocity recombinant multi-site PEM subjects active with study clinical know, to LUM-XXX XX a compared most for in Enrichment you selected Predictive Marker subjects OraGrowtHXXX or subjects control The on or outcome moderate diagnosed of control idiopathic six

comparisons moderate PGHD from all in other hormone PGHD signal idiopathic powered II data study prior typically control PEM six-month all growth like not trials The we that also This enroll height deficient to OraGrowtHXXX space trial studies. the the trials positive is Phase and the recombinant subjects. versus OraGrowtHXXX is PEM that positive other only is different looking show noting registration the enriched non-inferiority. severely worth to hormone be or subjects. for It's include not in growth velocity So annualized these will arm, be subjects historic more velocity the growth will hormone height to

PGHD. does with individuals Our include organic severe more not trial

PGHD severe is expect long-acting in this hormone in it treatment idiopathic trial would height Now important we known to do example, in lower groups better values PGHD will hormone the our population more because compared to modern annualized Therefore, well all and velocity subjects. growth studies. recombinant prior growth for the subjects more that moderate be respond patient is enrolled

Now LUM-XXX. be safety hormone to three, you'll are single in Phase OraGrowtHXXX trial control LUM-XXX its optimal and X.X, mg/kg/day our we plan two, be as overall annualized trial; PEM the goals velocity That three strategy; dose to will one the recall for for design identify the the and four, tolerability the of X.X trial; our for recombinant that deficiency required we mirror registration arm of prior III And begin to validate numerically to to growth for approval and our in will pivotal III a comparable months levels. obtained. to the subject conducted we Again, height X.X, results. to from randomized approval, in authorities hormone. discussions both dose growth the trial used expect Phase therapeutics and dose confirm therapy will in enrichment agency therefore of for other LUM-XXX control the trials to finally, from to about be hormone peers. two point that the this the design and is be time. appropriate III which injectable enrolling on a engage by at details determined LUM-XXX health to from to pivotal and trial Phase subjects our daily our velocity obviously cohorts recombinant XXX approximately growth These at FDA data XX the subjects our one, safety administered for II of The We height trial will arm remain trial, XXX will trial anticipate Phase in and OraGrowtHXXX are

dose trial demonstrating objective XX The prior XXX to release X.X of the of our up levels pulsatile of PGHD endogenous subjects data the upcoming our evaluating the higher also OraGrowtHXXX confirm X.X of clinical and interim trial, open-label at two of site, potential LUM-XXX the readout across for LUM-XXX growth secretion velocity months trial as PK/PD to to patients. is mentioned mg/kg/day. earlier, with include the single increase data our in six hormone and effects being data six unique is of I endpoint to data primary will the data pharmacodynamic trial this and As action of pharmacokinetic from in PGHD hormone amplified growth near-adult of months entire mechanism the subjects this from follow majority The the height height. curve additional response dose to extension to also assessed trial this and for

data of the also announce year. quarter trial expect in fourth to the interim We from this the OraGrowtHXXX

to For for expect primary combined study outcome from data will The comparability OraGrowtHXXX the annualized the subjects baseline of is OraGrowtHXXX interim and analysis. characteristics for datasets velocity the each primary readout, whether it of OraGrowtHXXX data appropriate time include height pull in OraGrowtHXXX determine the readout the around the OraGrowtHXXX anticipated XXXX up as is trial of in data and data the to to and for subjects. we same data half XX dataset this second readout

announced annualized following to and of up Now a the height This safety to or dose daily completed for effects be the trial Phase of OraGrowtHXXX our is XX months LUM-XXX XX for evaluating recombinant PGHD XXX Switch last trial, the an mg/kg/day will the we growth is outcome subjects of who growth multi-center, open-label, quarter, the initiation level hormone and administered of months. LUM-XXX Study. II velocity. Primary XX up study Subjects OraGrowtHXXX X.X have at trial.

This the OraGrowtHXXX continues Secondary to enroll trial subjects and from measures. outcomes trial. include safety PK/PD

at decided these to their we reminder, I so have matters updates, region ongoing do And impact to expect formally quarter continued, of two so these prior we other the to turning We timelines. clinical Ukraine sites closures to has to announced a want as our clinical these related were sites. suspended our data to to that subjects in Fighting suspension Russia trials. in before target touch enrolled conflict. we enrollment and close OraGrowtHXXX operational on last our not no Now sites due

as We of internationally, original unpredictable. sites the allow United both us are enrollment And to and adding continues in cases risen to COVID our a disease you a continue to few U.S. timelines. additionally, and States, should know, again, which probably in the have many be maintain

therefore Fortunately, the not the continues development current we the ongoing to to our will that believe pandemic are do clinical plan. COVID presence alter of adjust world and

the We situation will, closely. course, continue to monitor of

potential raise an treat more he Dr. LUM-XXX significant this Duke be for meetings programs attended the game are holding MAGIC healthcare at the has the goes and nature treat the the This believe and recently population the the internationally to PGHD within data changer team. June Foundation Last daily research joined in to on quarter, current current Attendees Affairs Considering been of progress both Growth intended and clinical overall potential and pediatric when beyond the both real meeting in him, are leadership are with space. Based potential it's endocrinologist; attractive. PGHD as maybe As we moderate patient exact interim buzz. gala or our the the of in building surprising weekly investigator rolling U.S. with and July, readout. drug Dr. of patient community, data and our treatment of the our has looking advise professionals mere us closely community. cases PGHD faced is Human working Duke Foundation forward the that have to this to they Dr. Medical healthcare in this We injections with We our more both broader oral call of look option about Pitukcheewanont the the observed the are standard we growing in trials oral LUM-XXX that that to in that expand you and an wider treat are announced of in hesitance we well. awareness as the following renowned Pisit availability to PGHD our conference we involved has I a true injections parents noticing that readouts, advanced community some PGHD to care, the market. ENDO especially hormone not forward been among is toward growth LUM-XXX an of can the weekly daily or option professionals patients. believe reflects burden this this to within that Feedback, desire alternative interest trials. tell we or discussions to for we having of of interest

in disease in LUM-XXX's supporting promising, NAFLD The potential or the has And LUM-XXX disease been and been fatty and condition. pilot or daily deficiency. collaboration to liver results in for and support subjects dose in with liver enrollment in explore of which remain LUM-XXX mg/day site, serious Mass. six-month, The LUM-XXX program will Dichtel Dr. and potential General Laura we indication. single evaluating Again, studies the our and with growth open-label can should begin patients indication the Prior announced this liver in IGF-X XX liver we turning rapidly are non-alcoholic this of oral prevalent a to this non-alcoholic the and adults pre-screening of with be pleased approximately with trial PGHD, evaluate adults in this condition to exploration LUM-XXX the address diseases the while study near investigator quarter worldwide estimated future. focused Now relative NAFLD. for XX% in hormone of advance last on study transplant. oral core of more LUM-XXX XX pilot trial have Massachusetts NAFLD. often to need we a sponsored potential General's This is fatty of patients to to

hormone care. other As for and of Gestational pipeline Idiopathic action for Short of is Stature in growth LUM-XXX continue believe Age. Turner opportunities expansion and mechanism recombinant may we mentioned, through have is as have the to human standard Born its and efficacious the conditions that explore LUM-XXX a Prader-Willi Syndrome, in to We potential where injectable Children Small unique such be Syndrome, product a indications, we

trials reviewing potential from clinical and of data are we clarify believe indications for take. plans and OraGrowtH the that LUM-XXX direction should We actively these interim several development our

for And to attention remains with in assets its Lori? to our continue judicious I'm second said, of LUM-XXX, priority We review of LUM-XXX be development. that, pass with it financial results. to Lori That beyond rare to quarter our and our disease going over shareholder careful pursuit creation. value

Lori Lawley

afternoon, good everyone. and Rick, Thanks,

on ended had we XXXX. quarter XX, XX, June the $XX.X totaling on $XX.X million For compared cash and cash XXXX, to equivalents million December

Lumos in legal primarily period approximately $X.X to end support our to to of in of of and hand the an other by expenses. of $X.X due million in use development million million cash expected result with in quarter second XXXX. expenses, per royalty same the XXXX, is the offset increase and the million an in now in the XXXX, XXXX. compared due for in Rick ended on million to was of The quarter quarter for in average Merck General and expect in remainder sale into and turn $X.X $X.X back XX, option QX Health a ended and for remarks. personnel-related of shares to to of royalties expenses, compensation for earned Pharma I quarter net second Research operations Cash for the loss Agency of to of for Canada increase Ebola primarily million as and offset million to $X.X $X.X the stock quarter were $X.X it the to in $X.X were from through XXXX. million outstanding. and expenses of same of our million $X.X as ERVEBO, $X.X period the X,XXX,XXX fees $X.X closing and second expenses million $X.X $X.X royalty quarter, clinical expenses We expense period administrative compared consulting second for decreases expenses decrease of manufacturing expenses. stock legal same increase for contract were as million a $X.X $X.X The by June trial a due million increase million $X.X to compared in of an Public paid the million vaccination. the XXXX, million the net loss personnel expenses, decrease will million

Richard Hawkins

Thank you, Lori.

time to the second So history LUM-XXX. positive. a Enrollment for is our Lumos in to quarter, our trials plans OraGrowtH very during This special Pharma. continued continues our of trends for on execute we be

interim to in oral both We to continues studies communities. our to from evaluating announce and two analyses fourth are Phase garner our be clinical able results of quarter. The the in II of excited patient LUM-XXX attention LUM-XXX potential

year. an XXXX. the the the Lumos take to of cash quarter exciting us forward again, both QX Once to this this we outcome by sufficient providing OraGrowtHXXX readouts is we and beyond in for now end Pharma are Our of Operator, it and of data second into the questions. position to half is in primary look second readouts the XXXX time carry solid, interim interim ready results as of year for OraGrowtHXXX

Operator

now question We'll Fitzgerald. the Thank [Operator begin first from session. Charles you. from question-and-answer Cantor Our comes go Please ahead. Duncan Instructions]

Charles Duncan

couple in if of we then for I high guess, questions assume And at the can taking the afternoon, moderate Rick looking and our highly about and those team. that levels. same of PGHD progress OraGrowtHXXX the patterns really the slowdown? Congratulations enrollment Good questions. Hi. studying Had and a are second continuing – into characterize kind summer roughly mentioned the the third on you quarter, the study. thanks you quarter, not wondering as of despite some severe usual I'm

result would let So you anticipate growth could of out you know to responding particular as good those hormone? a us even patients, just what recombinant

Richard Hawkins

that with don’t question? you proceed why David,

David Karpf

Hi, both Charles, great are questions.

not cancer brain XX% that from any really occasionally the basically kids the is reported don't thirds, still slowdown – cells. correct. can GHD. GHD, abnormality non-organic appear XX%, very again, or [indiscernible] we has and And means idiopathic which important producing knocking enrollment off is it of your of primarily can result population they indicated by [plasma] you understand therapy two subsets. usually and know a organic does There which – and involving the the that of idiopathic to pituitary PGHD to means so-called XX% is have far all is GHD, MRI the have – an About why very, have XX% question, really radiation why is is in to as So the enrollment, enrollment the two first as to well. combined going assumption it's been

hypothalamus felt suppressed as probably mechanism pituitary well which pituitary. dysregulation hormone its to of the growth hypothalamic for made be the Although because tailor as a relief that's a now also the the hypothalamus controls of in with binds to creating the and really And hormone receptor somatostatin. LUM-XXX, compound

by more So release enhances hormone. of those it actions, growth both

right the been we've of about in far where published in was of that this, that and expect. both done published XXX are growth X.X database you for look study as year. centimeters actually more looked cetera the a question kids The GHD at what meet studies with that the response the and have per as growth hormone basically et aligned requirement of and kind at XX.X analyses, kids those the ultimately really standard look year, who it's less So we a Spanish than around have kids the past our see is the and per centimeters We we of dose group. at we've When previously that reported that idiopathic severe in enrolled which GHD. grow cut somewhat GeNeSIS can a in have is studies XX, to we what evaluated

So the the that past demonstrated have many, XX, many the the better to growth studies over hormone. response XX more severe GHD, years

kids you They the will the though much hormone, basically than X.X doses in mg/kg/week. to is grow. growth well U.S. grow mg/kg/week. probably them, the wave of bottle is less X.XX they standard trials average over to the are X.XX X.XX perfectly in can as doses severely X.X So that GHD, on and the as Whereas standard

stimulus have height hormone. if height away a growth farther to growth SDS, these lower on study, studies show velocity, three, for are the these of less all mid-parental is hormone you greater response exclusionary than if that you are the younger, predict IGF-X, all to response more so And which you lower lower our to based from peak factors

severe same growth that growth tend question? bulk have of the height which example, And organic studies, for idiopathic, severe with at I favor studied, that in over the potential Does ran for because that the we're as they subjects identifying who are long-acting the Ascendis when really don't to we severe other less study I of your more the population hormone subjects example, so subjects. exactly the the more all and was answer think enrollment the

Charles Duncan

in I a that you your as blinded basis you and that. think or measures. the does. I thorough when really such want other feel at have of appreciate this And and you can then et subject is cetera age, see enrolling the it study? very on Very, look Do easily you that samples that at to variables your some absolutely patients phenotypic

David Karpf

a doing subject are pretty investigators experiencing why if Because trial. protocol. of PEM is about were than test kids because of rate expect part our we one-third the two-thirds they with that really the organic But going rate very put our population of lower to we're are key And of reason had PEM Yes, we is respond the the because excluding with GHD be the the not actually of diagnosis positive good they from organic because respond excluding GHD, subjects that's had the we'd nor job any can't we a failure failure and to screen to anticipated. And screened. lower likely to screen that's LUM-XXX. kid into respond than just much be idiopathic kids identifying they're have to enrolling, to we're

Charles Duncan

be or to are Last least the study Can to good. the switch regard over XXX Switch quickly decide percentage Switch enrolling Study. the at on Rick quantitative Study the question mentioned you who that complete with Very patients of to Okay. you qualitative who at XXX? all patients.

Richard Hawkins

subjects completed visit. XX-month only Yes. who right their because now We can it's

desired have date So the subjects LUM-XXX? continue to think too who that to fair all the really It's is right size small I in have say to now. to on completed sample comment,

Charles Duncan

That's for good. Very questions. Thanks the Okay. taking helpful.

Operator

from Yasmeen The Please next Sandler. from Rahimi ahead. question go Piper comes

Emma Nesson

for Yas. Hi. you Thank This questions. our is on for taking Emma

have We two.

be upcoming as is the this have some months three picked Do height data outcomes? in active greater uptake what could comment different geographies many is you readout interim how such on potentially has drivers what sites you us expectation versus enrollment certain the how are on could please data regarding notice your in and up expected total First, insight others? junction, providing And second, range at last specifically? the what of annualized velocity if

Richard Hawkins

some Yes. fair the Poland XX% New other U.S. the in or the to XX% Australia enrollments have enrollment we about in and say It's from five sites with that bulk of and ones from Zealand. come

it's I recall So I'd sites… don't the exactly exactly changes, can't because recent quote of about – actually you

John McKew

the now. There of World the Rest U.S. are half in the – distribution patients equal distributions half the right of is and the in the patients

Richard Hawkins

far be And I Right. as answer published question when Charles in can to is around per the that again, known. the as X.X around are well mean this the as based that state asked data really with predictors quite that obviously there population, I expect growth, would to And but variability we to upon be anticipated centimeters it, response all treatments. year something the

kids the better lower – mean, So more younger than values. grows growth IGF-X kids more IGF-X to the height baseline SDS Lower grows grow shorter taller baseline Bone hormone kids. value than SDS height – I grow The higher velocities. higher more more than older kids. age velocity than

that are of hormone. predict the there's So a to age growth bone delay known to parameters, response by and [Rangy] others well lot

So publications. in XX years this about is well very described of

Emma Nesson

you. Thank

Operator

The next Please from comes go question Ed ahead. H.C. White Wainwright. from

Edward White

my Good question. afternoon. taking for Thanks

OraGrowtHXXX First, just clarification a on little study. the

means? to you near-adult You you're to that going clarify said a bit height. that, Can patient follow

Richard Hawkins

per and dosing less happens, they the of one organic puberty close pediatric of year. either idiopathic they both The growth until [indiscernible] or growth for than hormone usually or the complete two to several have Sure. centimeters falls demonstrated extends things for population velocity

– hormone treat you've basically being indicate you can height. are those with very all basically to that [indiscernible] of All consumed growth or And to to time either the that close their you've add basically, adult closed closed. when

or falls that's of or heights a height mean why difficile pediatric community basically. velocity It's those evidence things. there's near-adult very way and widely of the by so closure, four, written they're very, one low, or treated to endocrinologic is the And understood the a to stage protocols can when three

of but but growth always test GHD you idiopathic you to now as should puberty, adult kids, your if Does organic, puberty. that not then you're to longer the happens, they should many hormone normal complete answer no doses, of – completion need and take And once So transition question? adults.

Edward White

gone That to Thanks. And indications. the question. does mentioned might company. answer a I that think today had you be for hormone has growth interim today about been great. human different this that, that Okay, that once see into clarify what that several data, times And take. you few interest improved Rick should We've XX mentioned actions can the of my you

be So looking should your for – What the that how going the you're or next at steps pick? hear data data? in is different indications to there sometime into indication we year? next about And anticipating something end you of think particular this year from do impact? this how Is you

John McKew

guidance any given haven't to next. go indication what we we're to going Well, about

Richard Hawkins

it's protocol can you you for optimal I dose to of a assume is. need write to indication, before know But think what that the another kind logical

optimal So dose really data that's really what next what of is with is the the is. interim showing gating now indications discussion our

position the discuss that be that would given expect sometime on indications, reasonable have as guidance but to we to yet not a of be after timing. it other So may in that we

Edward White

question to talk Okay, potential guess this received Or trial at the you Phase III all that the I FDA design, just to from is wait great. the you on last any the... going I input have tentative after trial And have are design? on

David Karpf

Well, okay. Yes.

actually growth science. approved not FDA and hormone have Phase getting is II by of had not this of we EMA, meeting, yet had but our rocket the a end So having experience

like with else's likely Phase et [indiscernible], cetera. Phase III program. Skytrofa So look everyone will program Novo Ascendis III our with

it will is III why Ascendis meeting. the in So indication in it the sample confirmed broaden Phase III. of we trial, include the older to what's switch newer that added I misunderstood because widely an be added after actual end non-naive to is, Phase of add formulation because they They will the didn't to II pivotal Phase II Phase subjects. a size actually from kind switched – say formulation so

the data. Phase II six so months, month maximum at truncated trial six And was

the BLA program fastest was for of was the they the it into increase get reach trial size way order to ahead to beyond subjects to be to filing, considered in database filing. safety sample had trial the a the and and above So height the and BLA the other required switch

Lumos, the having three at have like in in XXX the trial, of XX main have years Here we four months our we or or trial. advantage five

And kilogram the turnout, example, let's safety per so our also per database. it's it means treatment we'll key that we And for which up to tremendously filing. have for that's out with X.X a database, of add two will say optimal going day box safety NDA an be turns milligrams to if is years the check dose, to dose, which be that to twice increasing your

a And sufficient So single end that Phase don't probably do assessment authorities. we'll more the be but NDA. Phase trial given II based III we necessary, is for I Switch health we after see for think upon my our past that that Study, We'll the meeting. will experience reason, my any will II population, may pivotal confirm currently, at the with of have be Phase if subjects add we but to discuss

there best XXX more XXX, be unless data, safety because get why my So is the data. to II a guess to but rationale Phase to we need between is providing tremendous isn't that amount for guidance XXX that's would of XXX good safety

Richard Hawkins

Any other questions, Ed?

Edward White

No. Thanks Rick.

Operator

question from Please Jones from go next comes Research. Catherine ahead. Our Novack

Catherine Novack

for Thanks question. taking Hi. my

not dose and efficacy. perspective what into of what other means from a perspective sense selection study comparable forward go give the is given the design? factors numerically both to a your going standpoint, Can show powered a So growth and to I'm play from are wondering, oral us III you that Phase

Richard Hawkins

Yes.

categorically III II be a study to is state ever no of that Phase I Phase was all, powered, So power first will it study.

also looks hormone growth that study powered done you if And as so non-inferiority. can it's with comparable. But for can response, the you the a basically the get same you consistent Phase look not at TransCon data say and was hormone II growth

optimal overlap So of the upon the mid choosing is study doses with actually would numerical similar doses But dose as the non-inferiority then be we if growth safety based proving if would Does that the overlap powered very, dose say if statistically. a any of statistics dose, lower us good go in the response, and whereas is of there the three because assessment actual it'll the growth top push I the height a highest to curves, given make not hormone not that for sense? curves but look that hormone, two velocity the dose. that LUM-XXX the produces basically of very

Catherine Novack

Okay. Yes. the Thank clarification. you for

David Karpf

to be a qualitative assessment, successful the hormone. similar of kind growth it's proven but It's other with in past

Catherine Novack

can about if talk what differentiation strategy and landscape? your I overall how into And bring wonder perspective, this study the from does LUM-XXX just briefly fits company's this NAFLD then to you the about

Richard Hawkins

don’t you answer that why John, question?

John McKew

just of NAFLD a have is growth very the interested really applications NAFLD. in with lipids and help space, the and molecule a injectable what to is hormone. and that here experience on including of the an body and stimulates lot an think NAFLD important look is other studies connected So us its who And we've I that has effect at thing done LUM-XXX more for studies can multiple the in she broadly. with talented interesting opportunity parameters impact all oral hormone understand composition other to table and to has impact an a daily impact And really I think of that us growth on researcher brings

about quite to learn of impact the that to exploratory at can now. study, – it's have pediatric can I of mechanism think have I we're looking think but broader the outside a small action LUM-XXX a is it's interesting going more – of application endocrine indications how we going So the an our – this

Richard Hawkins

too. a And patent of course, filed we Catherine, indication this for

Catherine Novack

Thanks it. very much. Got

Richard Hawkins

Sure.

Operator

next Please go ahead. from The Leland comes Gershell question from Oppenheimer.

Leland Gershell

for progress the Hey see for my guys. thanks me. questions. taking to and Couple Good

great could the XXX how with if going what measuring about dosing PEM First, here, review convenient also have more relation the one. and you're with biomarkers suggested in of versus Clearly, frequently know XXX option once more time Ascendis if growth market to are a or weekly the occurred having new just the [indiscernible] in convenient SKYTROFA ENDO for there's and a recent chose that Markers oral needs hormone than other in that market. the could experience the market. injectable respect you end meeting. or themselves. after even in – your and you us interest your of would you I study, that has guess study once-daily to I perhaps there and oral offering how day, already the to twice-daily that's elaborate the question And in also and be

to see who how to in candid on and we patients switched any have weekly, once any from some gotten coming SKYTROFA have Thank if prescribing already want may maybe given daily hurdles. or who been they interest have have then Just you may perspectives from your and physicians switching LUM-XXX, you. not could may you that there's to further include if changed share again, are

Richard Hawkins

Okay.

a once-a-day company else anybody injection weekly then start, caregivers. jump study groups, endocrinologists the endocrinologist we've Let me pediatric and prefer we chose an and would asked and and a in. exploratory has both the oral. can if or oral pediatric And market parents research they maybe The an done overwhelmingly both queried question, and

we whether even really So is we evening morning with we doesn't that preliminary independent or have this once-a-week, of kind don't whether that injections, flexibility market shifter based make a like give once-a-day that's believe a game without a in kids There's market space obvious that on difference, have here. food. you changer of pretty mini any tablet great deal a and or or it or research,

have to So we're going going we it's think impactful. – to be

way. it that Let's put

John McKew

Predictive wanted you of think a Markers. definition our Enrichment I then And

So we Merck's with hormone that Merck from deficiency. out and these data derived Markers kids that are existing growth of fell Predictive Enrichment clinical –

But of PEM-positive they So nanograms for single five hormone XXXX. max. a from on in kids, Science make as have we've this an to Endocrine to in mil just greater – basically Journal the our of to than dose have per reiterate growth previously equal C they published of molecule, to

XX within nanograms drug single mil. unstimulated, have their an hour is per of a So of to greater than taking IGF-X our value and dose be baseline

Leland Gershell

you. Thank Great.

Richard Hawkins

Does questions your Leland? that answer

Leland Gershell

Yes. That's great. Thanks very much.

Richard Hawkins

Okay. Thank you.

Operator

comes ahead. from Partners. Elemer question Piros next ROTH The go Please from Capital

Elemer Piros

I things. couple something I I gentlemen. just maybe would sure confirm Yes. make – understand it to Good want afternoon, like correctly. that of to

if cohorts. are similar baseline XXX Is would the you the make to in and the combining sense parameters assume? correct So to trial those that XXX

David Karpf

the… It’s because right of Yes. exactly

Richard Hawkins

sorry. Elemer, question, your Finish

Elemer Piros

first I was other This one. wait the can one, so Rick, with the

Richard Hawkins

ahead. Okay. Then go

John McKew

against the predict the different, would data And the it look of they populations showing that based as upon Yes, similar make look breadth argue them baseline combine growth GHD. of characteristics them. the response far very Sure. the if combining to it of if the hormone, sense would very, degree as

Elemer Piros

strategy. about PEM also And the Okay.

the is of there So but trial, the about two-thirds rate patients screen are mentioned, find as who is you the in than less that one-third. you failure your idiopathic, that

patients do finding explain actually percentage in would How strategy. are higher your that fit you're So that you that?

David Karpf

their would easily for pretty subject, that of GHD. to and with investigators be It's who positive explainable. for identified smart the about GHD, screen They're our they're which We any one-third told be that. they expect two-thirds being having just failed doing screening would not screen already negative, study, basically thing, we subjects would diagnosed them Yes. the are idiopathic but is doing is

that possible screen GHD. get subjects screen many a basis They protocol, they're can of failure study. a out but And a lack turns There's taking because be test. subject can not appropriate condition that's There's in we in wrong. to a Does We're they're the a all patients be reasons subjects. predicted reasons, drug test. they're much of lower than modeled of of much some the greater screening is had the rate the it delay. with because So self-selecting a can They of failure patients a failed failure rate bone failing why seeing total PEM or lots age organic there's protocol PEM on the Don't lower could make screen because screen reasons screen have somewhat the the from Can prohibited. until subjects sense? fail. we They me baseline.

Elemer Piros

you. It you much. does. Thank very Thank

Operator

Please question comes Jefferies. next from [indiscernible] go The ahead. from

Unidentified Analyst

taking for question. Thanks Hi. my

II choosing to my is a But be centimeter dose Phase to based qualitative. So on a difference hormone? many And comparable how as approximately considered be would have going I I like growth question. follow-up understand result the III Phase that question to is you

David Karpf

Phase will doses because can dose accurately state confidence by have margin, balance of It's selected when the of support by II you the Ascendis, it looking Phase [indiscernible] the does that you cetera, et interval be at are this is, in or agencies the harder what agreed the doing III, dose. same Novo, way, upon by data XX% deciding the data but and answer question to lower Yes. a with boundary

velocity drugs, kind for be supported kind be supported especially growth by I of safety. of different be probably height Phase lots how a thumbs assessment indications hormone II deficiency and kind of response. it'll response. by and the largely the IGF-X doses it's It'll space. thumbs driven So partially the selects in by the It'll of mean, down but up,

Unidentified Analyst

I see.

get the growth So other historically Phase trials used? is for if III what hormones for you non-inferiority margin PGHD,

David Karpf

I can tell that for the X.X SKYTROFA you was X was [Ascendis] one categorically centimeters, used centimeters.

range, So X.X to in that X centimeters.

Unidentified Analyst

Thank you.

David Karpf

is margin growth response trial. based non-inferiority The in your hormone the upon

So of variability the the hormone. growth to response

on all subjects we we what – have trial. in sense data a hormone would actually be margin propose growth the of will subjects much better XX see the in XX our the final well, non-inferiority would So once we

Unidentified Analyst

trials II, which LUM-XXX think GHD moderate greater the on in the mentioned other be seen growth trials, past? for than Yes. to the or you trial tend compared Do Phase trials And then that, population what to you more variability for more have expanding for from that patients. enroll even III in Phase is might because the LUM-XXX patient severe

David Karpf

for Do is greater? potential I the think growth

Unidentified Analyst

Yes. Well, growth. in variability

David Karpf

studies with I growth. been at been haven't Oh, at greater that specifically. that this looked impressed data say with and somewhat have I've that the that the impressed at variability? can I population – have looked but looked I've all have published that less I variability,

Richard Hawkins

And difference study. is only There's [indiscernible] even number Ascendis the not and in between huge centimeters. X.X other a the

David Karpf

in in margin? saying the the growth You're or non-inferiority

Richard Hawkins

No. In margin… are non-inferiority variability the in determines

David Karpf

Oh, correct.

Richard Hawkins

variabilities. similar very have They

John McKew

think Our population published, observational aren't a because that think said, I guess trials. little it's will their be exactly different, hard studies but I all put like the idiopathic are David to on

David Karpf

Phase I'll we're lacked Phase control in II. upon not Right. non-inferiority hormone response, at that response II comment arrived Yes. based non-inferiority – margin… the it And are how Ascendis, sure was the margin just at we I'm they because the starters growth

Richard Hawkins

you question, the another Thank you for Do have Suji. one?

Unidentified Analyst

No. you. I'm good. Thank

Richard Hawkins

Thank the you question. for

Operator

afternoon. I Thank enjoy Thank showing this joining in questions at your further the you. queue time. you us for and no am

Lumos Pharma (LUMO) 10 Aug 222022 Q2 Earnings call transcript