Earnings call transcript Q4 2022

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Operator

Good afternoon, and welcome to Lumos Pharma's 2022 Financial Results Conference Call. [Operator Instructions].

We'll now turn the call over to Lisa Miller, Senior Director of Investor Relations. Ma'am, please go ahead.

Lisa Miller

Thank you, operator.

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

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

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

to I the turn call Rick. will over now

Richard Hawkins

John financial Then before recent for questions. to available results. the us in and Lori of Lisa, press you, XXXX Q&A. to we announcing good Thank I'll call, today's will touch turning join year market After our updates. maximize remarks we'll can it weeks full clinical results our On your a highlights and release financial and in our David time on issued we keep afternoon, closed year today, so answer the for Karpf the prepared and review a McKew everyone. brief

begin. let's So

or year Hormone oral advancing in candidate, we Idiopathic Pediatric reported therapeutic a Deficiency, of progress significant in this our As XXXX afternoon, LUM-XXX Growth . was

announce trials. are patient our and completed OraGrowtHXXX has OraGrowtHXXX both enrollment pleased been in to We

last that to subjects in fire are OraGrowtH subject XX to and Given the OraGrowtHXXX COVID, on to be announce a we quarter the elated to able both Ukraine-Russia OraGrowtHXXX our we impact from at enrolled, data and now have trials subjects real in the we faced been results a outcome to the that obstacles trial. and and with report in of single XX both the team, line conflict, XXXX. XXX in top site, clinical from PK/PD expect the we the primary fourth trials announce This accomplishment tribute is the expect

most announced the now. as annualized results which an know, for Now briefly of months I'll X.X in high trials mg and PGHD height LUM-XXX to on X.X data showed from annualized the Meeting conclusions of centimeters kg XX interim and growth prior recap arm a historical you centimeters OraGrowtHXXX we and databases, cohort showed a from subjects per guidance X.X treatment at analysis these subjects interim per X.X several for November, treated of year. to large velocity main approximately data based of X of moderate these year of velocity or just trial Results hormone. the comparisons on expectations idiopathic on with

Phase kg which status we X at adverse and months. planning is the as across mg signals were And adverse dropouts safety were per we III stated adverse a There underway. these durable evaluated. events XX trial dose dose observed. to selection now to range per for for observed no trial and previously, PGHD response treatment-related a day believe due was events X.X support the of pivotal entire of No Importantly, LUM-XXX severe our no

per with approximately baseline the imbalance previously, that arm. growth XX full of should characteristics in faster contributed mentioned to control subjects seen in arm the we minimized the hormone As growth be enrollment

through these trials our our trial patient Predictive And subjects patients population mg of the identified in given data. OraGrowtHXXX were recall process the determine screening our OraGrowtHXXX Phase PEM or moderate quarter the or for LUM-XXX. enrolled during if the to selection to trial. an X.X has to The dose a for interim they respond is PGHD enrolling trial potential and that OraGrowtHXXX finalize the to Marker trial meet single anticipated III prior with selecting kg for The the cutoff to OraGrowtH Enrichment endpoint pivotal strategy of Each PEM in XXXX strategy dose from enriched data idiopathic supportive are LUM-XXX primary optimal now of PEM the per for a fourth of our trials. confirm the

of therapies Chile, leader both the field LUM-XXX Dauber Children's Also opinion in with clinicians leaders They support alternative webinar distinguished their potential data National this that injections. interim the of featuring replay These a we frequent interim for clinical available and results our the insights to greater Dr. in those data. as oral Dr. to for that key Cassorla on a treat of and the in endocrinology discussion event thought pediatric the who detail. hosted Hospital children Andrew current about review Fernando of of November, website welcome oral idiopathic PGHD. require is highlighted A a of interim for share LUM-XXX University to potential its the wish

of of Aires, Meeting for in XXXX will which press the X Endocrinology our through release afternoon, International XXXX. Buenos the IMPE, announced In X presentation this abstracts March we Pediatric or X, held acceptance Argentina, be the at

Additional details and and data OraGrowtH interim during once from trials conference, presentations presentation presented our have the the the a data the made. in oral announce poster will update analysis been we'll of an be of

Turning to other developments.

by hormone in is assessment where indication. ongoing. General XXXX Nonalcoholic the trial Liver NAFLD, continuing. LUM-XXX Massachusetts This from Laura NAFLD Our study recently is or Dichtel she explore presented Disease oral LUM-XXX Fatty investigator-initiated conference which was pilot supported Massachusetts previously study pilot Dr. by supported of LUM-XXX NAFLD to data Hospital in in in growth collaboration clinical the same ENDO results the in potential of at the Dr. medical presented announced with a evaluating Dichtel of the and injectable Enrollment positive General

LUM-XXX today's patent Oral XXXX, a which application now intellectual granted, development drug and trial LUM-XXX. utilize to announced pending intend product of provide directed application release, commercialized III composition of Compactable Ibutamoren, also And for The in an filed for improved would version if in In our contains our is certain protection we Phase November titled position currently ultimately involving and to the of we we formulations LUM-XXX. XXXX commercialize. important property claims November matter Formulations through

the next to internally PGHD. a over it We've turn done provide for LUM-XXX financial with I and assess I our other update indications of have before want Short consulted an participants and for review of market. evaluation the focus market results, the potential Lori Asian our LUM-XXX to or to on ISS, for narrowed indications and indications regions geographic Stature beyond on a Idiopathic our advisers work next include and with external substantial to focus Now

by being growth. used been have digits a last growing of years, these major in driver the Growth markets X billion hormone this with $X double approaching in total ISS in

indications core we cash prudent for Our attractive is opportunity an And narrow focused advancing include opportunities, our the program while to use we see committed for where Prader-Willi we these ensuring of plan steps Syndrome, remain our target PGHD. global next on in LUM-XXX. for

a of to Lori So financial over for Lori? results. turn our it with review that, I'll

Lori Lawley

travel December Total million with incurred on you, trial cash primarily per cash, spent ended XXXX. million COVID compared the to guidance cash $X.X investments in is XX, costs Lumos XXXX due sites million of year costs continued closing certain below in clinical during $XX.X focus on Russia, the burn $XX.X of due equivalents management. Pharma Thank as lower-than-anticipated impact million totaling quarter, $XX.X and was first to the and half disciplined continued lower-than-anticipated for a XX, to XXXX Rick. result the of to December year a XXXX, million, cash and short-term the of which on given $X.X Ukraine

per third of use as into Phase XX, short-term an 'XX approximately prepare through XXXX expects company our of as up quarter of million efforts from Cash The QX on hand now trial. to average the of clinical to for is investments expected and XXXX. to operations quarter $XX.X support million XXXX, ramp a extended we $X.X III December cash

and of USDX.X in decreases offset expenses, an to XX, consulting ended for of in the million and million supplies, increases USDX.X due trial increase personnel-related million in primarily XXXX, expenses clinical of year in contract to $XX.X expenses compensation $X.X and $X.X compared period by manufacturing expenses, in and December USDX.X were Research rent. depreciation expense same million, USDX.X operating stock development XXXX, the million million expenses and in for million

in and USDX.X administrative XXXX, ended period of year December $X.X $X.X million, primarily stock expenses million supplies, USDX.X expenses offset by same expenses, $X.X royalty XXXX, to USDX.X General an travel expenses USDX.X million million of compared in million in in personnel-related and increases for consulting million in increase for and the XX, of expense other the expense, in expenses, expenses, operating in million as to in and million were decreases rent. due $X.X compensation $XX.X depreciation million

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

quarterly our be afternoon. filed press found may this information Additional release in

the hand call will us. Rick I that, with conclude to for And back to

Richard Hawkins

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

in based interim on corroborated trials and is the opinion disorders. data growth-related these the confidence leaders by last of Our expert reported and November results

anticipate over be XXXX. the our from later conference, data presented we medical presentations and course data Additional major at OraGrowtH other trials week at this of conferences the will IMPE additional

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

prioritizing usage, into third our guidance quarter with runway by and program XXXX. the our PGHD addition, In current cash being we're conservative cash of our extending

product of have XXXX. We for matter of November a which application LUM-XXX, of for LUM-XXX version of a composition approved commercialized patent also extend the through protection novel drug will formulation submitted

we advance Lumos growth and injectable of XXXX demonstrate forward the to continue to productive pipeline been for in XX quarter dominated the by administered almost LUM-XXX We hormone look has that So market we're and has our XXXX. XXXX years be orally We're products. was to programs now data poised positioned fourth for worldwide disclosing to to excited year to better. disrupt potential even a for the believe are

Thank you all very much.

ready operator, to questions. take we're So

Operator

Instructions]. [Operator

first comes of Our the with Duncan from line Cantor. question Charles

Peter Rosenthal

for for Peter completion on Congratulations Rosenthal Charles. studies. is and the Hi, Rick team. enrollment XXX and XXX This

have patient a screen I rate. So question failure regarding the

XXX, that yes, start we'll Now you off compare enrollment us screen in sense of to does XXX failure expected? how what there. was? give completed And the that can And and you you've a what

Richard Hawkins

Yes.

to anything strategy do our these we use versed prescreen want PEM failure really I Predictive think low that patient And are looking rate our Marker obviously, because the Enrichment well you to idiopathic patients. and to the quite in add population is is patients and David, that? we're our for, or moderate investigators

Peter Rosenthal

Yes, the rate. it was screen

David Karpf

Yes. in by a are very GHD. predicted driven Rick protocol, used because been The has less to not investigators because is right. failure screen rate screen the and in PEM than the idiopathic passing the we largely had it's of exactly reduction the failure test, diagnosing

because been that we've failure as the regions a screen the rest have they're And failure. in had anticipated so PEM screening for of failure market population, the And predicted. rate reduction PEM

lower rate than predicted. So failure had screen overall, is the we

Peter Rosenthal

is same And for PEMs, do believe they're parameters other the a Phase the terms of in an Or the to that going Okay. you possibility III? of adjustment? define remain there then

David Karpf

not per are which after receiving but which nanograms in Phase parameters the at defined PEM be ml ml XX do simplified. test, how change the The absolute IGF-X it's is LUM-XXX, having and will a level likely low of X-nanogram and per in dose showing baseline than change, we higher level least a III those is Sure. well will will terms,

of it will a test. PEM single the test a It X like be dynamic a will LUM-XXX stim single test. not the hour be part blood of and for dose So later

simplified, Does answer the question? but remain will will that be your same. the parameters So that

Peter Rosenthal

does indeed. It

translate data the the how presented of term. conferences you received a presenting KOLs of in sense you But sort Phase that approach an for let's study? the approach. allowing III there's a appreciation the broadly more I near give by and me PEMs say, at that quarter sense Do and for does has So be how know And a a the you'll more, can community. medicine by enabling to been precision get last data endocrinology

David Karpf

it the short is really supposed to very proves What and That's interim all Yes. to that. is yes key what because them, data that would do. excited opinion does a about good I question. answer very it's the say that leaders The are the to investigators LUM-XXX

engaged growth as it's hormone. fact development They like and So the opposed synthetic we enhances that investigators. of very the exogenous it natural have very, a to hormone

are in working so And remain and committed Phase very forward to they III. excited, looking very with us

Richard Hawkins

I also well our that the well incentive, that to those is a are put pursing pediatric results, were too, Advisory group accepted, want and let's endocrinologists really way. results this of clinical add, Board, it team the

Peter Rosenthal

I hear. presentation. look right. forward the All to upcoming And Good to

just you in. last So don't squeeze if one mind question

of So can you population? rationale Idiopathic that of for in into patient help just Short understand effect Stature, action sort me would XXX's expanding why the have an mechanism

Richard Hawkins

David, of action we talk don't why and mechanism about ISS.

David Karpf

GHD don't quite it that high growth it effects AUC, accelerate should velocity. comparable likely I more is very to velocity to hormone. the may where get growth same of patient to similar you in every Sure. their baseline severe see doing expect reason It But be By increasing kids. will it hormone -- the ISS as ISS high should you're with hormone be

Richard Hawkins

test, I hormone endogenously And population. I those the to many be our to kids that if stimulation. add And would almost growth PEM part they key pass right? expected thinking why one that's think have upon -- thing of all those we're about may release all kids capacity a to of that,

David Karpf

adults, and substantially increase baseline Right. normal growth I showed hormone can you IGF-X. mean, in from

ISS. So apply to there's expect every reason that would to kids'

Operator

Our Trading. the of next line Catherine question Jones Novack comes with from

Catherine Novack

recombinant durability year X.X important with efficacy I about Congrats that II, Hypothetically, GH these growth expected. primary safety, as comes clinically know and but end LUM-XXX the first a that looking at you like I bit things say, not prescribers cost, the you're meaningful on with How completing necessarily hormone. versus about to in talk in centimeters compared the versus different difference is want efficacy as of curious enrollment. other the it to up having to regimens. are when let's convenience, little may XX LUM-XXX Phase AHV prescribers. LUM-XXX what's at how showing looking be I'm

Richard Hawkins

going John, into. probably and and I'll to maybe answer with I'm let the you time you David, finish, start

John. go So ahead,

John McKew

the we that is of given and about profile and from we've efficacy kind the level really that's interim, the And kind forward. of And of drug meeting running think population, had this of at trial KOLs because on have general growing of had on have. people on key I think historical them a and safety a couple range. kind first, this X they're And most we've about -- -- those the no we drug of kids is. are thinking an based LUM-XXX hormone the They have are kids actually they of of foretold investigators group the efficacy that the in quite also drug the of outside growth key feedback less our acknowledge their also, who And that expectations in concerns moving expectation data. the feeling idiopathic our at talked you of think, growth growth to of how moderate that of of the growth I I things And our hormone contributors being severe, anticipated and about of understanding excitement safety what this good. about we

the on drug not efficacy is as anyway. the show key to said, to because Phase you II thing of think really just focus I noninferiority is So the powered

to kind I moving think key on. part plan III of that with drug as of we'd forward the on Phase our so time efficacy focusing And the like spend that the we is and

Richard Hawkins

have to you anything add? David, do

David Karpf

having they population that barely were run their that, our actually trial. XX just be trials by hormone. this not I is high expectation mean, is Sure. in so that I clinical more [indiscernible] encouraged growth with in should than add with in results. view be our severe lower experts, pediatric to Skytrofa, think It's population the I the much centimeters above share a [indiscernible] I endocrinologists, to would why which

I below hormone growth be in Phase XX population So in will centimeters. expect that this really III

a as point. Just

John McKew

III And in approved, to will as get a negotiate obviously, other with an one true that last we're companies day, difference treatment point Yes. is FDA's trial, we the once And product in the the to a just I X.X that that X centimeters. meaningful significant Phase noninferiority a and as a first think a there oral and as the place be product. market oral X

Catherine Novack

into leads That it. second my kind Got of question.

I in it talk growth hormone. III important -- see significantly we hormone. cited bit. GeNeSIS you've at the recent control to AHV have little about growth example, comes that's When how in Phase below want a But compliance to recombinant what efficacy from when we answered is for the daily may studies it look for database, You arms

severe to or that So compliance higher deficiency to does that this due growth age to this more contributing hormone are difference.

David Karpf

If could... I

Richard Hawkins

you David, ahead, do Go to Yes. want start?

David Karpf

and KIGS is year referenced compliance good. at The sure. first looking in the databases. the we months first those pretty Yes, database in large for response XX treatment this, all, actually of GeNeSIS of first of the And we're that database

So that the database, of either which or honestly. the in has studying we'll than AHV more the it be less more compliance, population, quite severe GeNeSIS I closely PEM-positive think is lower do KIGS population anything the the matches to database the in because with

Richard Hawkins

And Okay. add to else anything John, had want you to ?

John McKew

I No, agree. that's fine.

Operator

comes Yang question the from Jefferies. next Eun line of with Our

Eun Yang

in report data taking if how a sometime you the position data? think do trial you see do you you take? actually long quarter on year, good would think next enrollment -- fourth how this that enrollment the When III -- assuming Phase be in would embark So year, you a when to you do

Richard Hawkins

-- me let please. David, we have No, start,

In that done many mean, first in times They've are worked with spite have that, they've the I losing Russia trial. all, product pleased all enrollment difficult spite in their all well. clinical the of pandemic of during these done in of really oral these Ukraine. experienced. really really trials, you of we're all tell attention our sites first we've careers. and this And investigators and we because In this with certainly their the is I and So

only there's are Phase that and I III enrollers. investigators high of participate who know we think they studies, about set another in

we'll think I that. So well do with

study. in Phase meeting really can to ahead. Phase Now weekend them We advance, to as this only that. everything taken have would in not haven't start end plan that have actually I to start of course, II we're at order investigators an start terms going that the actually Phase guided market on we III everything currently move completed beyond of doing we in recruit with the But as quickly FDA, of where can, we we agree to the when can to have meeting and and III the But we're these possibly Aires. Buenos in IMPE do that got guidance have we our haven't

Eun Yang

I see.

to do the Is end to meeting you So with meeting II II Phase -- a quarter FDA. think you're be a year with first have the a Phase position of be reasonable? the when going in next

Richard Hawkins

to question. John, I'm that answer going let you

John McKew

a publicly. schedule to the guided Again, wait that for data get out, that put in through grant But the to have we meeting. and package FDA on sorted haven't we and obviously,

the I that out So But lay of projected to are haven't there. a there public. factors think in yet we lot that

Operator

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

Ed White

you what you're that X since trial? about budgeting to How this tell most don't thinking lost be the duration also, you so be, know the for I Russia following that really much now, wondering So the regarding that? I'm any going months? about assume could Will just X you study? enroll the And what of if just will And be are Phase patients of perhaps the you're potential out you but just last us expect Will this, know for to size patients? the cost expecting the Ukraine, and III, you're for the expectations year? saying -- it do, I the right on perhaps it you're where also, of do question you

Richard Hawkins

David, then Maybe I'll if start, chime in here. you'll and

-- products patient growth All approximately will the We growth mean So pathway year. be XXX current our study, dose but randomize for regulatory studying we and XXX clear. our to really hormone versus I budget for patients, be to be to projected population growth that the is same in haven't a will for is this on we've really patients going study think been hormone talked date. to X.X we'll X:X drug of We about hormone. we're standard

been can't maybe there's and that Ukraine investigators Phase But that who II I you And that really on in -- studies. I know of don't field investigators, folks. bit difference. think is earlier, loss the many Ed, a give and all of whole participate this a we've your yes, little with for of have a those new prolific But I of Phase answered any actually, long us have So question time, we're III even meet sites, been who whom makes Russian that. guidance met to the set in a going

at will them them continue week, coming with them meet we'll to bring this to on board. and We talk and IMPE,

other Phase in most are those investigators sites around that but there of the III sites prolific are So programs. world in the U.S., are

David Karpf

see the the that been investigator I program. I've more would to add, say enrolled in just the did that high than if Polish very pleased could Russian I And Ukrainian have investigators

the So XXX months. deficiency that having without the really hormone tremendously enrolling that's China, trials. enrolled also, sites like been kind that in of we'll a wash have be growth But benefit subjects And there. XX was in I having of in which trial rapid high-enrolling high

III China, participate only in New in that that are U.S., I really on having bullish Zealand, Phase having So Korea, in the high in mentioned, think enrollers enrollment we similar sites I as in high-enrolling folks Poland, very Japan in trial. U.S., the the some and and Rick Phase Europe, III in key including, for who think Australia,

Ed White

and today, the just Idiopathic Prader-Willi perhaps And Short Syndrome. Stature Okay. indications other at you mentioned looking

you are would thinking for you of be event event? to looking a XXXX the you -- or XXXX Would would start a be And timing about how the partner? be Asian trial. this ISS, a an For

Richard Hawkins

I As interested start such importance we talking in that, who expanding the especially there think there obvious of of pretty mean, that I us. study, obvious Other to do it's haven't a number guided that? would have would be in around it's a on be the add than Asia. importance ISS world, John, and high that pretty of anything is to you to partners

John McKew

I that's answer. think No, a great

Operator

next Yasmeen from Our Rahimi Piper with Sandler. comes the line of question

Unidentified Analyst

This for Yas. is on

First of all, congrats MPH, on completing that enrollment. now characteristics you We just the understand where want in on us to to guys confident some ended minimized, ask age, -- like have that high? up so clarification been could that. outliers regards having you help you complete, is And baseline starting just are enrollment

Richard Hawkins

question, answer? that Lauren. John, you with And do start Good

John McKew

Sure.

patients last announced our last So enrolled night. we

on So that anticipate for set conference. releasing working we're and medical at baseline we analysis data, that finishing characteristics would the data an bigger

saw enrolled more But XX% baseline those that as we go process reiterate that released And XX% continue just of also in now. XX% analysis, be going our data, at particularly are effective to then XX%. will we data to nice closer working shift Randomization characteristic interim expectations, and age, through together. from I'll come we So a and we're the the for to are XXX%. that between

Operator

question-and-answer today's today's conference questions. also does This showing session. conclude this gentlemen, call. and conclude no Ladies does further And

now may day. disconnect. You a Everyone, have great

Lumos Pharma (LUMO) 1 Mar 232022 Q4 Earnings call transcript