Earnings call transcript Q2 2023

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Operator

Good afternoon, and welcome to Lumos Pharma's Q2 2023 Financial Results 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'll 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

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

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

Hawkins, call Senior question-and-answer Development Officer; Chairman; John Affairs, for our session. President Rick Speaking and our will and Dr. on Pitukcheewanont, Lori be as CFO; Scientific CEO Global today's join Clinical Lawley, President well of Duke McKew, and Chief Medical will and Vice as our

will turn I to call Rick. now over the

Rick Hawkins

XXXX press Well, announcing market closed a After thank our good the on Lisa, we provided issued second programs. you, everyone. today, an and and afternoon financial quarter update clinical results release our

with recent the advancing our to instrumental questions. Duke Dr. in he As a a He And Q&A. our to results. over and Duke Growth quarter Deficiency, OraGrowtHXXX Pitukcheewanont, hormone I'll and space, Human Hormone about in join him, Phase ago to contacts for or also enrollment therapy Then available from remarks is injectable in year call and therapeutic and growth Duke or the trial answer Dr. so Growth of or has is we President John our Lori on Dr. your from of approval. Foundation. practice, maximize we'll where for preparation Pediatric us McKew in us potential his as the joined the time this an prepared financial the review oral understanding of will turning worked we on touch our before keep today's can in therapeutic it call brief, of long-acting Ascendis, highlights weeks for in their PGHD. the been our trial half X on

So let's begin.

these to reported we OraGrowtHXXX made progress in this XX to quarter candidate XXXX, on data fourth dose or subjects point, data our to and outcome can up and large at trial, expectation PK/PD moderate primary trial primary readout. for our As advancing historical OraGrowtHXXX finding XX six We XXXX. in predicted X.X based in subjects growth velocity oral during growth LUM-XXX I'd the our like afternoon everyone at PGHD idiopathic per rate quarter about idiopathic for and moderate the report of historical population, to between in on second this up mechanistic LUM-XXX the range for PGHD. X.X observed according therapeutic the And confirm the of several continued primary in centimeters databases. endpoint this is our year is height centimeters on The months AHV annualized for to expectations remind trials And treatment.

Phase utility determine the objectives are to of OraGrowtHXXX dose trial. other confirm marker and optimal strategy trial to X or The the the a predictive of PEM the enrichment for

cohort per months to of both up at to cohort We OraGrowtHXXX AHV treatment include trials. up outcome to for per subjects XX XX subjects on to OraGrowtHXXX data and X readout XX total a primary also from expect our up for subjects

of expected for on months small a at data subjects. AHV treatment Additional XX also number XX and are

X as is trials, X to the daily arm. all Phase the comparable demonstrate growth And profile case addition, hormone trial control should In OraGrowtHXXX safety also Phase for the a the for trial of powered of to Phase trial. should non-inferiority dose control inform the is selection the LUM-XXX design registration arm, and but height not between velocity successful annualized and show X

as from treatment. and well. indication growth to control margin of as months pivotal hormone a centimeters trial. arm has true for X And has a reminder, this the between the long-acting recent historically Phase year XX X.X hormone And treatment the arm a at held non-inferiority been growth X approvals This products on for

a meticulous X thorough the for agree So program the trial. And and review meeting ultimate to in steps with be Phase X the the step Phase obviously end engaging package, request to Phase trial. the will the the data of design Phase the results planning X first FDA review next we're in of an of a X after upon

other that registrational kg And dose balanced factors PEM this versus to expect hormone age growth will per regulatory XXX based hormone one and precedence, stratified LUM-XXX daily cohorts. XXX approximately with ensure two of include positive to likely trial of mgs by to subjects, we growth randomized X.X to a on

formulation will and at be compound, months endpoint the our on XXXX. our November, primary we novel for proposed trial LUM-XXX therapy, last application filed which could extend by AHV enabled new to of the patent properties utilize a will Our which XX IP formulation protection unique

age provide wide for LUM-XXX population. many which formulation consists of an tablets This the target easier of and form we of oral range will our capsules, believe dosage

the year. approval for plus Currently, to XXXX hear well as through this as later and for patent extensions the LUM-XXX and offers Office years Europe U.S. designation, applicable protection orphan to has and X.X drug which expect growth U.S. of treatment We respectively. protection deficiency, extended up of from hormone the from XX Patent in drug detection date

trials pleased XX increase normal greater trial were at the meeting. from after months these two data months response administration. an quarter, and Data six in an within a LUM-XXX remained these further to IGF-X were LUM-XXX and durable presented, in of on two than levels increase showed the IGF-X increase an the growth see presented in data that from range, at new abstracts ENDO that from XXXX analysis showed we including During OraGrowtHXXX SDS zero,

leader dose This OraGrowtHXXX data new combined and and potential consistent response also levels a These and in Fernando June over OraGrowtHXXX, each comparable are the kg for doses is from XXst, data in we the injectable LUM-XXX per their hosted demonstrate many data evidence you and day OraGrowtHXXX. from as X highlighted trial convictions X.X effect of the and opinion to years. population clear LUM-XXX and of a on know, AHV day to the Michael X.X were growth durable XX stimulated. baseline. in X.X subjects four that And key oral therapies a of XX the analysis in insights webinar the there last on become were from a and OraGrowtHXXX address solely in the by first there to doctors results observed combined to continued of the potential X.X treated mgs drug Cassorla for all patient where subjects shared XX therapeutic this these per at continue was improvement kg mgs LUM-XXX Also, to Tansey at months, the

website. we the available If you’ve on webinar, our you is which replay, not seen the to review still encourage

or as which of OraGrowtHXXX Additional secretion oral analysis will held from at presentation Endocrinology, ESPE, annual and PGHD Fernando the of the abstract September was deconvolution of XX. growth breaking meeting Pediatric include Hague for of trial upcoming moderate hormone a LUM-XXX the was in accepted late population. the Society the European analysis with Netherlands, in XX September a to This The administration Cassorla abstract by data

Turning developments. to other

trial non-alcoholic our and potential support in liver in recently fatty to of LUM-XXX NAFLD. results injectable Laura evaluating Massachusetts and continue or published Dr. to explore Metabolism. We hormone of with orally Clinical and clinical from Positive NAFLD the administered investigator’s Journal the growth collaboration prior Endocrinology Dichtel General this Hospital were disease

buildup liver growth XX in General growth assigned obese initiate to placebo with overall, in and that the assess patients XX the the with collaboration were steatosis It to fat and on Dichtel the hormone might hepatic of group, LUM-XXX growth reduce prior group same randomly XX Mass study, was placebo indication. completers these NAFLD. treatment oral with Pharma months. to Dr. hypothesized at compelling investigators hormone, In six in Subjects data encouraged hormone Lumos XX a XX or that

intrahepatic growth continues LUM-XXX oral in hormone greater liver cohorts. of LUM-XXX weight significantly growth percent reduces loss. lipid by indication. of content was magnetic the that spectroscopy absolute These versus the concluded commensurate Investigators without placebo resonance The evaluation in fat the in NAFLD hormone of Reduction in data NAFLD proton trial to supportive are enroll. pilot

As a remains primary company’s and advancing focus LUM-XXX the reminder, PGHD. on near-term

see we about geographic focus both to LUM-XXX opportunities, and that potential narrowed ISS said assess the done capital committed of advancing where and the as our in we idiopathic And work the previously prudent these by address is of worldwide. indications core our our a to Willi we’ve before, opportunity as other allocation treated different we assess program. has hormone. and We’ve believe stature ensuring short Syndrome, And injectable indications focused to use the sizable internationally. Prader U.S. and other internally to remain growth regions or of cash while a currently on XX lot our and we mentioned, LUM-XXX potential Now, we

of over our it a for that, Lori? to review going with I’m financial Lori to results. So turn

Lori Lawley

XXXX. on million million, average equivalents Thank use cash you, We $XX.X for per $XX.X million quarter XXXX compared short-term ended approximately $XX.X cash Rick. $X.X expectation June our Lumos to investments quarter XXXX. XX, XX, totaling December the Pharma cash, of and with reiterate through on

a XXXX. to which the trial Phase operations and second estimated of change in Cash, in OraGrowtHXXX at depending XXXX quarter data of through well least is These to short-term the statement, results fourth and for cash initiation, for the feedback trial of the is the clinical This Phase trial contract site the investments months beyond as costs and X date be manufacturing next incurred of included filing may June costs regulatory XX, XXXX on our line trial, guidance expenses, are preparation inclusive of subsequent financial X regulatory our agencies. estimated costs announcement support from expenses. equivalents quarter top from of expected primary XX for

three and contract consulting personnel clinical million in June in million primarily million $X.X expenses expenses. XXXX, same XX, and due trial Research related in development the million period million in compared for of XXXX, expenses increased $X.X in $X.X by expenses expenses, $X.X the to $X.X ended a offset by to decrease increases months manufacturing

the in months compared XXXX in for million million $X.X expenses, personnel-related by the primarily XXXX $X.X three increased $X.X million of expenses expenses $X.X ended expenses, administrative royalty travel in to to increases XX, June same stock expenses. due in in compensation and period $X.X and million General million

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

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

Rick Hawkins

All Lori. right. Thank you,

to report both OraGrowtHXXX fourth line in plan quarter our So the to confirm top data XXXX. recap, XXX trials we can of and OraGrowtH from

analysis New primary this X.X interim months X.X the confidence achieve medical data line this presented outcome and averages on trials at OraGrowtH from year a for further to historical two other idiopathic data that PGHD at should meetings six moderate with in annualized these year population. velocity high of centimeters treatment predicted our ENDO reinforce

Though LUM-XXX success our of selection should primary based from a X.X Phase outcome show historical X determine data support Phase X trials these centimeters not approvals. approximately powered or two growth to hormone registrational non-inferiority dose non-inferiority to of for are trial, on trials to should

of facilitate pivotal trial in the and treatment formulation OraGrowtH novel Our both this setting. protocols also commercial in and adherence should XXX

current we’ll granted, by a XXXX current extend injectable to hormone market LUM-XXX And treated IP with protection not growth is billion if expiration growth the only our potential date. therapeutic oral hormone beyond represents worldwide We the disrupt a $X.X platform patent believe products. new

also rates current $X is increasing expand to also but and Now, therapies. that due historically which to high another excludes injectable burden by the treatment the the billion, compliance market China, low of

outcome NAFLD, broader in the as that near year. in have to readout and our we’re to PGHD well continue shown our studies have the beyond initial support we clinical clinical be where we’ll hormone utility explore later beneficial. focused programs and And term, growth effort primary Additionally, to treatment this indications capital advancing such on

landscape, KOL by a and Webinar therapeutic webinar discuss therapeutic will indications And currently host potential their other growth an finally, where [ph] and to plan administered in endocrinologist both we that panel for hormone. treated a the with September, experience injectable address to PGHD noted orally KOL pediatric patients,

clinical and We’re our top in to excited of advance programs disclosing XXXX. fourth continue to data look line to the forward quarter

for questions. much very and operator, you take today, we’re thank So your to time ready

Operator

question you. open Yasmeen of Our [Operator lines Thank are The for now questions. Instructions] Piper is first from Sandler. Rahimi

Your line is now live.

Yasmeen Rahimi

Maybe warehousing help how are soon I if those on a studies. you've color And updates. then Phase off the to you the you and maybe patients comment – some for Thank could the the color color started on topics. do OraGrowtH all team. hope in to much new you post X filed timelines. Thank you for Appreciate afternoon that enrollment to get be patents again. guess Good so on also the could kick position third us you formulation? Phase X around the regards the when patents with in readout

Rick Hawkins

answer I'm first that let John, you that asked. going to the Yes. Yas question

John McKew

going So, right adjustments out and thinking plans, get the And Yas, our is the the there get like. and to to Phase FDA the lot to start days on protocol, our getting kick for meeting, data X to agreement with focus And sites integrating hopefully really studies, work is the X look of to together we're Phase any two from extent agreement necessary X is on way protocol to now our come right? clinical data book, briefing trial readout to the end fall off So these FDA ready through then steps involved of into Phase from Phase from a bringing up there the XX when what an a of focused meeting. quickly on really making we'll putting waiting go. with the on X all all in that then the

final But naive to on of lot the I we about things – really to get can. working treatment. to as really agreement X Remember need a and on right much are that that we done need sites that thinking just getting kicking Phase now. We've protocol, patients start We're as work that type getting – off the patients. we be the

on. And further watching early any you be patients, – going so, it's but want a we'd little off right that to I bit think can now than to hold

is the back on patent kind XX month patent. expected it's a times In we of for an November decision we filed not so patent, hear terms of when last this time of So, right? might in year, timeline of that –

Rick Hawkins

And, yes, let me just add.

Most have well motivated to this We trials really the performed think those extensions shown that – And is lot terms And is their a the really trials due thing has to development working Number I is XXX and investigators highly product clinical really managed and products. with two time the of a oral have for experienced that in these well. experienced these trials staff entire We've XXX obviously careers been second of is the enrollment. that quite injectable an team. experienced, PGHD that there things. in one, of up. of interest. has This first time

excited they're with to us. So pretty work

lot And attention. so, of get a we

at XXX, to with you add And space. in They're And might products in with finished that obviously is were done studies. approved. that competition point, those they full enrolling in typical long-acting other. you I think were X about each the either, Phase one those that takes a that other the time have enroll all a They're XXX and patients. companies look who historically, the

in expect sites. his While lot maybe be comment going we competition there's these for think ask is less to therefore, – before. really instrumental here these And I connection Duke to we he's there going believe patients, But been was highly this all some be certainly to we than because is enrollment with a going well. just experienced I to

Duke Pitukcheewanont

Rick. Thank you,

potentially world if as actually our have the recruitment best have With on and with the enrollment So cut initiation involved, trial. we let up hope of mentioned. of the could a is, start in which me touch and down the that experienced, site again to across companies had I most base with enrollment, as based the able timeline, one again, pretty the much we at big KOL planning, with would done do be site experience the and have past, we same enrollment. factors But complete strategic my that we'll number Phase lot but John timeline the of prepared well right? connection That's timeline world hurdles around most of X

Yasmeen Rahimi

Got you… it. Thank

Rick Hawkins

your that questions? does Yas, answers

Yasmeen Rahimi

Yes. That helpful. team. was Thank you very

Rick Hawkins

Thank you, Yas.

Operator

for you. One moment, next Thank question. please the

of question is from Leland Our next Gershell Oppenheimer.

now is live. line Your

Leland Gershell

framing from guys. into and as to Couple we comprehensive for Hi, the readout my year. think Thanks question the of me. things later this for head taking about how questions

that's you obviously you've conference – look the or the some to we whether number the color of to respect with give rates seeing screening there'd First to expectations. success study. quarter, of you'd been the to – we're the be forward we as be PEM your aligned PEM then next as ESPE to look from additional mentioned have results OraGrowtHXXX forward analyses prior any with wondering data if able screening two And the with share

if nature wondering Thank additional analysis Just of you. be. might those the what could you share

Rick Hawkins

the John, do start want the you with All right. ESPE to and PEM analysis?

John McKew

Sure. Leland. Thanks question, for the

the PEM because number of towards kind seeing looking patients, returning who efforts actually thirds of focusing a the of higher and of spectrum two slice end clinicians has kids the are value patient an fit of subjects We're test PEM we that And in into clinicians which in – originally trial. the rate study. lot study population time high, our So, the a success to at inclusion the of would as right, more positive. in bring had We've for much of educating spent very the XXX about simply the of kids We've is how in a criteria and got the right? been tests entire to looking inclusion that as their effective population. the be – said quite the moderate actually screen criteria to positive

of high growth hormone deficiency. are expect just from of would the positive whole getting at spread you data PEM of versus a who number kids, the epidemiology looking what that we're very So

question second the the or The I'm ESPE meeting. – about endo sorry,

So we've of XXX the study. deconvolution title given out analysis the about the

study of is data essentially published been yet, that there. that and So it's PD Those the XXX but on focused the hadn't announced. the program been deconvolution abstracts has

abstract So But they of should information in bit good to more publish going I that the there. sense until have wait be from a you a give title, about get little there. think that the we'll to what's to what's released

Leland Gershell

much and the Great. Thanks. questions, Thanks forward taking updates. to the for I so look

Rick Hawkins

question, the for Thanks Leland.

Operator

Thank you. One the please for question. next moment,

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

live. now is line Your

Ed White

taking for questions. thanks Hi, my

XXX Phase X difficult Just the of you for XXX that might the patients? Phase the going And sites? that are sites to going to how and U.S. is outside how need thinking split the are the are U.S. thinking about number patient ex-U.S. you population? U.S.? sites answer, And back go but to and study about to the be enroll how versus question, to Same between this X also, you to going

Rick Hawkins

John, you want to start?

John McKew

with So, reviewing long-acting released the done. in seen of their to they've We're sites. in and haven't CROs what programs number have we discussions Obviously deep these past. what folks of successful the trying of total the some in get input kind on we're

So – we Obviously decision do sites. firm the on trial, talked global about. as a on decided we we are haven't we've numbers really haven't a going to

growth important, expect recruitment do rates regions it's access on to in different think get hormone. we depending I different to

put be, U.S. – think of have to and what have all the to some terms And countries we what the And those be so acceptable. which Asian I have or together wants, number to for I have have in European of patients think, sites enrolled. of to requirements patients quite use we the obviously, almost be certainly I can FDA think all are

things a all all but plan through. don't through working we're have right We spots those now. we're think I yet, that thinking final are they So

Rick Hawkins

sites. continue us around with all have with the at great And to is of are us and don't and Yes, first doing, the that. being be these a there's think, on what and to be meetings really deal becoming going clinical believers that all because real a is choosing the podium oral. reaching let meetings in The out think we're of just of sites. in attended investigators problem these experienced the I endocrine world the offering people result benefit more they of more been me have those to that, interest being I

In from more recent fact, benefit of in experience completed entry rates a site course, just by deal we recently have trials that. has and of historical great Duke, of the

that's much to So, I going our think be to benefit.

Ed White

on X PWS. perhaps for And Okay, company? a mentioned be How and You prepared about that had indications Phase X next will a we've you Phase are thanks about what's next that data? Phase a Rick. been study something perhaps study Are run are that? with just the question thinking post should ISS we concurrently thinking you this or discussing, that be to X

Rick Hawkins

are is we they the that answer if plan. large what company, have a that to think are. we capital question a I probably were Ed different would The markets

As the to sooner over other we are the Phase our normally going them. focused. where we're plan go permit If planning to out all X, be programs, then of time, programs markets going start perhaps then, advanced raise that's than for appropriate the and we amount we're would do capital going to money us to

that, to, addition pretty what be partners get development have least And X, discussions regional in guy of Head X, when we’re those think, at happens at anyone at companies the other could we some plans choices the to show program. their a too, I to had certainly I going advance of typically some or could the. end our haven't of all stage this – and to at partners yet. And Phase up, in partners who that busy think, that's Development into here as, or discussions look although Business the In is Phase indications stage us with help what

Ed White

and run hitting thinking it just more contracting commercial Lori, the million first one-time of expenses mentioned $X.X take in Rick. the rate I that into the Thanks quarter. moving That's, about about event, a the when the And half thinking for you perhaps year, quarter. back like R&D a Great. question should we in be

Lori Lawley

pretty on should clinical Not we par and clinical for XXXX in forward. expenses, our contract in but a Leland are to prepare of also QX [ph] we efforts think to expect with and are development research the in that working I XXXX comparing just lot manufacturing trial. towards X are going recall Phase and for going this what expenses a

expect operating expenses So R&D [Technical R&D, overall we to be G&A and between Difficulty].

Ed White

everyone Okay. taking my for questions. you Thanks, Lori. Thank

Rick Hawkins

you, Thank Ed.

Operator

question. for please next our moment One

Our is next Jones of Novack Catherine from question Trading.

Your line now is live.

Catherine Novack

Hi. Good afternoon, everyone.

question – a XX tend year. and to that KOL heard some and again Just after on here is real we their we’ve in about XX is hormone issues. we What beyond. attenuate first focus PGHD And months, time months see injectable growth the

mechanism in action, is it our what given so the expect to with safe how wouldn’t should Phase X data you be this to and expectations So we dramatic and X? Phase us of see should LUM-XXX in then, the for say change

Rick Hawkins

Yes, Catherine John answer will you well, question, that that? and excellent thanks for

John McKew

Sure.

things Phase X XX-month study. two The will So in be to study keep a mind.

point kids ongoing X we’ll now And non-inferiority And we have we X be than so as trial at kind of keep longer that right? several are months. XX the key the trials transition XX many in as well. trial can Phase for hopefully an from that will decision and into as Obviously, that extension months, kids Phase

the months. of but it months, long So have have in. same we and actings as data data XX package that’s the And comprehensive past that we the all as data on treatment be at have a XX six will won’t body brought

look at the kind that, month that get documented, XX growth six or a at between said, peak in well then, as at in year of And the patients has its every months, hormone after the range. you for of slope And XX decline. months, difference the and biggest annualized said, it’s difference months, you That to velocity that in look six decline. height individual you growth at three at look at can

get in every a don’t right? You decline the return. year, same growth get You

has reveal on kids We end in what continued can there’s in that together get I shown start you of pieces put that a XX months, months, We see to in going But to been certainly really going kids elevate continued to a expect published this us. scenarios growth pharmacological some of growth that where of to you pattern would modulate year that early composition. change and kind the could might or So right? of elevation of for handful see hormone adults. growth, that data in past to growth those adults adults IGF-X levels kids. the And a much out to expect right? It’s been body level levels flatter LUM-XXX you could same than the that we’re think hormone. will super we’re natural help injectable for XX question. physiological you a with be Thank slope of more growth that at

Catherine Novack

are it. to Got them? How does expectations LUM-XXX for more, And one factor then injectables market now weekly excited this just what use your a are kind got And course. all? into they of couple hearing? Yes, the of PGHD, or you at you what we’ve in that feedback are market getting KOLs from

Rick Hawkins

you with something to like yearly monthly long growth per of or look $XXX,XXX $X,XXX that that hormone, at and And hormones you three the a $X,XXX, kilo XX competitive kid Catherine, going between a month, that’s to for all the look, growth $X,XXX, expensive question space. acting be this no a there’s over on treatment. highly price cost basis

I research. you, choose in the say daily long parents think term if done time and looks ped that you We restriction we’ve market. question market molecule the top endos had both remind world asked they goods they standard a and We’ve be and there in believe, and pricing to favorable would or are price to the I daily around us different of continue or choice is between mean, that, because of oral, going certain of I’ll to and care a a where of approvals oral. the our of a a weekly to flexibility margins world. small And in it the markets to is, to parts injection our daily overwhelmingly or cost very on we’re this longer

John McKew

That’s daily. pricing. in add, very from Is may more I than the a Rick expensive the regard? feedback was KOL Catherine, the about that Well, important, right. mentioned

data The other [ph] safety skeptical that a is the some issue have KOL profile.

have order FDA, data. in that to get As only you safety approved XX months

effect, acting, growth safety, again When long long long-term term-side term, only the for unclear weekly However, profile efficacy hormone is the at itself, you which at especially look right? look post not much hormone fashion. growth exposure off the it’s higher daily hormone, to at profile it’s short long-term than long study Phase With IGF-X. that study postmarking to in continue higher term and in order X safety also very need show the the or said, growth

some in quite that mention it’s itself, right? not skeptical efficacy weekly in KOLs all to [indiscernible] subject something So very expensive. still that’s therapy to to put So regards really

Rick Hawkins

And action the We natural is drug. of growth the Yes. natural is hormone. higher you of especially that physiology. excursions different feedback a from recall, with loop mechanism those once We hormone levels get endocrine growth again, Catherine with within our and with, feedback not stays loop within very of our long-acting stay possible

Catherine Novack

That’s Okay. answered Thanks very my question. much.

Rick Hawkins

Thanks.

Operator

One moment next please for our question.

is next Stavropoulos Our Fitzgerald. Pete Cantor question of from

now live. line Your is

Pete Stavropoulos

you the and you’ve Hi, expect at end. focusing generated or you see quarter to the towards data success made you you the of is as you these know first readout – Question progress data they that increase cutoffs or a in are, a the response currently question year to can when keep the marker that growth lab if sufficient? all current observed the larger this curious patients Rick you’ve just where think Nice movement enriching into or using to by and with algorithm the PEM, look predictive and enrich team. later do patients, date, move probability greater the by study, is, to

Rick Hawkins

Okay. you And John I'm good Pete, for let to start. that going thank you question.

John McKew

rolling with the comfortable at look all using yet, the need we our as analysis well data obviously enrichment other now, getting we in. I half the from we’re PEM that on to looked but as AHV markers feel for haven’t But Pete, the now? the right patients think things data So confident the right? we I we’re we at come think how that that of have and are did on originally based pretty

Pete Stavropoulos

X Phase understand to think come agreement as And need and X Phase that you to meeting to Okay. I an you agency. the a of with about end design,

design based XXX might XXX? any for accumulating make from enrollment data a trial there pivotal modifications are to the you However, on study or and

Rick Hawkins

don’t that John, question? start you with why

John McKew

But X three have acting the design successful obviously No, go be the inclusion our the after pretty at what do ends, other pretty how the close we pretty, that, would I products and Phase pretty of than basic are end that analysis across expect I of are distinction. timeline that and common I are to to we and we study. PEM kind much approximate think that’s positive, long the the think all been would characteristics a the population has patient think, forward,

So we see those don’t any that before from have departures us here. come radical

Pete Stavropoulos

Okay.

a Do ahead. you And add? have to something sorry go

Rick Hawkins

go Please ahead. go No, ahead.

Pete Stavropoulos

And last towards more John Rick, welcome. than question directed Duke, but

different a presented – So of you’ve at presented times endocrinology recently number Lumos at meetings, XXXX. ENDO most

from it wondering, standard just speak colleagues former of even some mechanism and about action of It’s may differentiated So and clinicians practicing when be you your how of care. LUM-XXX. a to KOLs,

the of data reception Just hear, what today? is the approach and this and curious presented candidate to

Rick Hawkins

Yes.

And so you Duke, ahead. don’t go why

Duke Pitukcheewanont

may right? successful. very treatment as but of so those you hormone been for actually growth, a oral is have it’s This have secretagogue proposed trials know, none the Yes, years, positive, been for very,

we So data the that the And acting, sustain. is shown right? growth growth growth idiopathic can the presentation secreting differentiate data They to see present which or of to regards try there, action secretagogue IGF-X dose response been long and XXX like. that out look like selected, based mechanism on that month in here one, secreting data, itself to in is peptide it’s PS is result. data, population, at and XX look somewhat clearly match. drug see the generate X.X have the the the the And six It alone And itself and at moderate seemed at is very what somewhat that’s oral in velocity have only from those you month we comparable, velocity. LUM-XXX, ENDO, you combined compared pretty X.X historical especially hormone

alternative burden about again, that new the to just the in compliance those it’s X that long expect acting and especially mention growth feel all very for data overcome by their impact we oral as of line for to right? forward and good, new And this be was the pivotal should daily will be number, of of again, injection very, Phase will data. need the work with of especially looking drug really They that the in again, from future. somewhat not this be because it’s past, the patients failed top know And get positive. did small less. again, if overall but it majority trial But intrigued suffering could therapy. They But not physician this approved secretagogues the very most hormone, patient, the

John McKew

do The lots product. the [indiscernible], and ENDO there good in-pay add only when that, talk in at Pete, And wanting that, presenters thing to are questions, to lots would of about to PES we at excitement of these lots right? is presentations this March, of people I

So, a interest. the a one-on-one of and we halls, lot of lecture feel and in then lot excitement

Rick Hawkins

And mean, one from a questions just that the excitement bullish that each on the fact important and and we the number alternative meetings of there’s of patients. have in of space overall competitors the right Yes. now, right feels, And and be all possibility of Yes. alongside everybody to really just clinicians. I these a oral growth that oh, I absolutely for space. their at it’s am might these the and feedback exciting an very the based great in a always I hormone interest add, Pete, of level amazed at

Pete Stavropoulos

hear. to great That’s

our So congratulations for taking thank questions on progress. you and the

Rick Hawkins

right. Pete. All Thank you,

Operator

the and on day. earnings Thank line. Thank no the questions you call. quarter concludes Pharma Lumos have showing This second you. a I’m great further

Lumos Pharma (LUMO) 9 Aug 232023 Q2 Earnings call transcript