LUMO - Earnings call transcript Q4 2021

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Operator

Good afternoon, and welcome to Lumos Pharma's Fourth Quarter 2021 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. the Relations. to turn Director Miller, now Investor of will call Lisa over Senior I go please Ma'am, ahead.

Lisa Miller

operator. you, Thank

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

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

be and and Lori call Officer; our Officer, Medical today's and Chairman; Chief Dr. Chief David Hawkins, Financial Scientific President our will Lawley, Officer. Chief Joining McKew, Karpf, John Rick CEO

remarks to prepared call will the now we over questions. the will turn to Following call I Rick. open

Rick Hawkins

the John XXX session. today news with will us very announced call, and that thank Lisa analyses exciting for of it clinical interim velocity XXXX, results. early evaluate will enrollment before dose of to today's two results report for our over The levels this three and We're to us and of David in look you, to today, sufficient financial plan an expect data safety turning height against years providing will On XX interim everyone, press at hormone for we new OraGrowtHXXX which end to analyses LUM-XXX's our for as preliminary trials trials join both clinical Then of and the results on who potential for are year year a good trends assessment Q&A injections annualized therapy. patients we review on will XXXX. data. After the forward I'll months and at and six human screening course announce release afternoon, pleased of and recombinant look in dose update growth us by We a a today's of safety Thank the ongoing report burdensome Lori, trials. LUM-XXX on would the issued financial joining you this for PGHD begin who idiopathic the call. treatment. of we closed market to of announcing full I OraGrowtH our provide face our otherwise standard and to their only of patients treat

and are The Ukraine the be and of is PEM evaluating LUM-XXX our prior the arm Now, in approximately a LUM-XXX selected of of X.X, well reminder, clinical for is hormone dose strategy. patients trial identify XX% the dose dose optimal PGHD. our our to goals with a as annualized X.X is per milligrams control with selected kilogram as milestone X.X growth entire OraGrowtHXXX versus strategy. by X.XX week. as elucidated a of primary the enrollment. kilogram of curve three-dose study excluding recombinant span The of The comparison trial to per OraGrowtHXXX response in Enrichment PKPD the milligrams and validate at at The per patients are Phase open trial, clinical our Predictive is oral of height idiopathic or global PEM of velocity levels. height a clinical patients enrollment endpoint X study. treated velocity trial Marker all used injectable levels and LUM-XXX a were to Dose Russia trial nearing LUM-XXX registration essentially sites in the key our outcome XX diagnosed OraGrowtHXXX annualized daily

events recent the to due in Russia have all patients to in the enroll we in Russia, and ongoing are Given Ukraine at suspended and Ukraine unable trial clinical locations conflict. activity

now to in The approximately in conflict therefore ongoing XXXX. XX impact targeting the the business and sites XX an patients are future to maintained sites approximately enrollment We XX The these too screening outcome from encouraging data the and OraGrowtHXXXtrial. OraGrowtHXXX and on effects our remains of potential for however this trajectory second we continue early adversely therefore have primary of evaluate may all it at crisis. half anticipate

support express to like rapid I'd of people as and for our safety well restoration of their as research on, colleagues our and hope our our concerns moving for peace. Before Ukraine, and the sincere

meet enrollment So evaluating kilogram label pharmacokinetic to day. LUM-XXX patients to continues single expectations our this analyses XXXX. the the open in will with subject and enrollment interim set to per we and XX our announcing report site per velocity interim height the OraGrowtHXXX dose met and X.X of pleased minimum levels, our analyses effects results trial, safety milligrams end subjects the be anticipate X.X We're that of two we evaluating up PGHD soon pharmacodynamic XX and and for trial by at of data

clinical this entire captured patients. months the secretion endpoint XXX LUM-XXX action across amplified to data of of XX for is velocity of PGHD hormone to months dose height growth trial. and of our in The of a is total the velocity growth majority the release objective the with potential six the of that height curve primary and be endogenous PK/PD in response demonstrating mechanism this to pulsatile prior trial data recall of increase to unique You'll confirm hormone data

switch now OraGrowtHXXX study. to trial the our Turning or exploratory

an evaluating completed have the PGHD trial. and following XX daily patients safety up initiated LUM-XXX and months. who in label for Primary growth will to secondary to Phase dose study months hormone OraGrowtHXXX velocity open have X of outcome and level measures. of growth recombinant up kilogram multi-center safety effects Subjects We be is trial administered the of include XX PD LUM-XXX XXX at per per for outcomes milligrams the other a annualized height X.X day XX

trials continue pipeline our for and of through for the XXXX the to believe and areas LUM-XXX LUM-XXX I'll expansion to care. its clinical advancing a addition In unique and other over injectable hormone mechanism of many financial standard that comprising into that, is billion $X.X of have LUM-XXX indications results. full is therapeutic growth hormone product with action may a Lori? potential for we a pass year treat of PGHD, growth where explore We Lori opportunities human recombinant review our to the market. And the to

Lori Lawley

and our XX, December XXXX totaling equivalent cash and cash ended year of fiscal Rick, good Thank $XX.X We million our everyone. on $XX.X to with you, year afternoon million. balance prior cash compared

million primarily and of XX, full related This million approximately operations expenses. is outcome $X.X personnel increase cash increase December use of quarter XXXX. expenses clinical for OraGrowtHXXX through million $X.X million Cash million year million XX, primary the trial to average and to expected through contract December for both increases We $X.X $XX.X to $X.X R&D for year hand the OraGrowtHXXX ending as on support is per were $X XXXX an expect an data end ending XXXX. $X the in full due our This million expenses development of the of expenses and was XXXX. year and in manufacturing Research readout trials. over of

legal year compared the in ended decrease $XX.X year XXXX. of due now XX, remarks. XXXX. G&A decreases a over decrease expenses primarily higher the to to in the turn expenses, to loss million it Our is will for $X.X XX, A were $XX.X net for were December the was same compared a expenses merger-related period in which full is and period $X.X XXXX back in The for Rick ending million million This due G&A of to XXXX. million December for net XXXX loss I closing expenses. to same consulting

Rick Hawkins

year, now fourth you, in the we're XXX despite optimistic provide start And for and hormone. look initial OraGrowtH an indication we XXXX. prayer these of the XXX ahead. at and in height closing OraGrowtHXXX to of is PGHD, Lumos with believe trials and the our course PGHD over Enrollment for our of XXXX Thank productive patients impact the been provide and are end early of cautiously the with and able by numerous interim and have OraGrowtHXXX upon of year Lori. hormone both growth efficacy we progressing for from trials idiopathic on LUM-XXX to an challenges data data quarter prior trials growth Based adequate both to trials LUM-XXX's our compared be should velocity

us Our and for highest trials. strong sufficient the of outcome through is to these readouts position carry both data primary

now questions. to forward year ready So the take on we're to updating we unfolds. our you progress look as Operator,

Operator

your of line the may you. Instructions] Cantor [Operator comes Sir, with with from Your Fitzgerald. proceed you question first Duncan Thank Charles question.

Charles Duncan

the Rick afternoon, on the good team. and year on thanks of Thank trials. Congratulations progress for a update Good you. clinical and

So, questions. had a couple of

Specifically guess of enrichment if the you regard looking in additional be terms rate? wondering interims, discussed a to sincere basis. FDA if could wasn't with those provide us And secondly, the or were going on that to screen wondering the not, I'm the I'm or on markers with you're color predictive I necessarily some blinded if failure

Rick Hawkins

the appreciate to question, if let John answer you'd Okay. I'm first it. I'd that going McKew,

John McKew

Rick. to And nice hear your again, Happy too, voice Sure. Charles.

at and said open we all So we study, an going were is, time look we as that data the as XXX study along, on. went is to knew label

seeing XXX per compare of comfortable data human same arm. study, peek to and we out number the hormone where patients when reached it's at feel growth time an we've we cohort patients in taking recombinant For the may a appropriate that of simply play very that it how a that group

Charles Duncan

And of guess, right? continue? or kind to certain quite enroll. have rules we'll be enrolled a at are anyway, see patients to stopping a you Or be few some just amount say, you'd continuing will that I that for taking any futility of more efficacy look time like to already and you there

John McKew

and study is That a cohort at from patients see is look of efficacy look top say set enroll an to for at this each XXX data then is that obviously, the of we take But fully when data additional data five for us and our size an the rolls how Yes. or sized respond to we four combine. the I have really correct. the cohort patients and what get to the fairly within could And it doses XXX and are, at, about get It's progressing data the just the out. we'll realistic XXX. look that But to plan set will them that will for initial XX a we two trial is are when them. Yes.

Charles Duncan

predictive the you the David, had? Charles Yes. that address marker would question enrichment and And failure screen

David Karpf

about asked the you I'd because very to be glad the study, that, happy too. again. nice screen investigators hearing you educate optimal coming on through. are to we've and Charles, they patients the worked I'm hard really for

far, the a four-fold screen a lower I PEM. but upon result. rate far failure least can't rate that it's screening As precise -- PEM we and screen based a have at we're upon anticipate a you based XX% the number, give lower failure we

[ph] enrollment, the year. confidence only very, announcing bit If now, So extra very particle explicit that interim of first -- the we're the to FDA. to just your have analyses that that's current interim answer little well. analyses the a could the that add will the we because by actually more is but the going was of XXX We submitted I study have in would end the The we in it be question.

Charles Duncan

added guess I appreciate relative the But it. you're is dose? I that switch, when agent how highest and I I'm And on arm then then that, it in that working will I hop those quick and one then you're switch then about and queue. or on patients the how they the are terms who talking switch of say over sure the follow-up exactly fully the Okay. patients with come control will David. in study color study. are to back understand maybe the will That's it, the to And not And XXX work? helpful I'll something

John McKew

you But and rest David ahead. ahead if question. the go the That's of Go right, Charles. answer

David Karpf

Sure. precisely Yes. right, Charles. That's

Norditropin, And on opportunity So XX so hormone. knowing can the we chose time switch the across get made curve that from study, at on We study human put the have months transfer present dose. We'll the seeing the all tolerability sense be thought and they subjects LUM-XXX. response good it to prior PK/PD the this XXX growth with treatment study, early XX eventual who will the in to into recombinant because doses dose top dose them the

the why is what that's it design So is.

Charles Duncan

Okay. Thank questions. my you for taking

Operator

Thank you.

question. from please proceed Rahimi your Your Piper next line Ma'am, Yasmeen Sandler. with the question comes of with

Unidentified Analyst

team. you Hi, guys hear me? Can

Rick Hawkins

Yes, we can.

Unidentified Analyst

a the for interim [ph] I Jesse XXX. analyses question had on is for Yaz. This Great. about

are you and goes And safety same of XXX that's point? velocity guess expecting to same interim what terms So height question see as interim? in the guys end for well at I

Rick Hawkins

ahead you go that question, okay? why don't answer and start John, -- with

John McKew

Absolutely.

to So, this growth set comparator X growth every population I run subset selected doing been our just responsive. generally exploratory human how key a that are Phase be we we've arm growth think by one clinical to or alongside the the their And really concurrent every, has compare marker at or that's that that's recombinant under with here only we in And And to on have enrichment the done we've patients study study a almost compared looking is arms enrich either markers same. that with in human that using can arm. space really run now thing our cohorts. we've is the patients up -- recombinant long-acting

trying Well, dose growth that response and really one across that's as a us that right? looking data that's recombinant that doses of out to that comparable We to that see doses things human key to hormone key the have We be we'll , comparing concurrently. molecule. our gives a we'll be work. going excited that's response. and the is be three the identify But at, So do to We'd of see be very comes of dose the piece arm really of there'd we'd trying predict those well. this to dose would growth three and key somewhere run like to get, a

Unidentified Analyst

that And is Or want Great. same XXX? reason for Thank you for what you. XXX? the the do

David Karpf

Yes.

The and we're as these kids to for the lot does enable that the to sets is generating. us together the opportunity are patient to we're essentially the of there's mix have just as end since velocity. look of two increase kind two going XXX, population same at postdoc annualized a data height XXX, top a doses. kids really that it data of the of So the initial And

analyze going we a analyze to of than it have of longer velocity. out takes it So It term, pull I and think little longer come out that's a does that height lot bit pharmacodynamic data to trial. that

XXX. height we're annualized So, just right the now focusing on velocity for the

Unidentified Analyst

you. Thank Great.

Rick Hawkins

Thank you.

Operator

Thank you.

Your H.C. Wainwright. the line with go ahead. comes please White next of from question Sir, Ed

Ed White

Good afternoon. for Thanks taking my questions.

just And and you mentioned them think mentioned than Russia So the the with think now sites sites sites for planning I Ukraine sites. most and more had in of you removing have you that you after had now been asked number you war Maybe XX are were on already. Ukraine? open November of Russia XX targeting for had in that the open. Where the I that

Rick Hawkins

that are in part facing. We Ukraine. And question. in sites four nine who for Five industry study I in the Russia, that think of sites. in good question had thanks a our Ed, that has everyone it's world

that had on As everything patients been is from those you sites. we two No pause. randomized told

really even locations, those from so, our spite end the things believe are And a there, discussion here we goal that. We're about are in And locations mentioned coming without of well sites as those going reach certainly we'll the speak. encouraged also going that well of that patients we or before just we adding our and things enrollment. But few think prior we're we'll that XXXX. in but

Ed White

indications what's or one all prioritizing ask to indications. change in question if other the you. just Thank just I Okay. or And is over been any has the I other any Thanks wondering making last just always that each was now any it any And the you anything that progress you're you're strategy Rick. guess quarter indication we mention others? that

Rick Hawkins

John, answer to do want that Yes. you question?

John McKew

Sure.

does what action fit kind we we've to population said, mechanism unique us at would do get how secondary refinement a indication. lot the the that we looked in PGHD the would we've wanted of help where thought into really the LUM-XXX those And secondary go our dug first. of always of different and be about indications of As responsiveness And to for LUM-XXX sense dose plan of settings. in these a of final of

think a to we data able decisions we're be we'll to So I finalize where getting point indications. discussions now that once our and secondary those have our on

Ed White

hear is So John, planning by year we data just end, to thinking in should that ahead, expect on since you're second announcing a interim more? when

Rick Hawkins

it mean apply to data by try indications. that really applies to much I some we're it these We yes, data footwork, how when Well, it we in then secondary make the year. be of but other want at to comes We've across about decisions end and done to the expecting very look able we'll the do indications. of the

won't promise but right shortly probably I So, then, thereafter.

Ed White

my Okay. Thanks taking questions. for

Rick Hawkins

Thank you, Ed.

Operator

Thank of you. Ma'am, ahead. please Jones line the go from Very next question with Catherine Research. comes Novack

Catherine Novack

on Congrats the Hi. -

Rick Hawkins

Catherine. Hi,

Catherine Novack

Thanks XXX. a so for the my interim on question analyses for I much have questions. taking

addition expect kind velocity, pulsatility of looks? And far understanding get positive remind XX-month how to height XX-hour me, how marker, what's curious these the as baseline going pulsatility do assessments see the change in to guess enrichment to we're we patients. positive In Can XX-hour annualized the I terms I'm key many about that in dosing as to period? of from during what you

Rick Hawkins

John, also add. and from you could details data the David the but you're the I think you Once the draws. closer prior start about knowledgeable of to study, blood then

John McKew

you again, Great. Catherine. Nice chat to with

their how that day, mg study. shown is kg XXX patients PEM from of I and the study the on of we've AUC. And that's think And repeating the per the cohort a visual us pulsatility on excited kind but X.X also changed, of about data terms scale. the generally in representation, per of at a data just larger we've previously the kind positive showed baseline two in got looking it context

not in day. six do assessment. per kg we dose will XX treatment, on X.X It study, doing X.X. It's for per And months take baseline pulsatility at LUM-XXX. XX sampling just after mg So X.X their same be and they the at of we're any morning hours and the that two doses; every minute top would

to those a velocity. potentially to we impact gives the piece doses, opportunity of of relate to modulate analyses what each with pulsatility that top So that amplifying And little think does nice changes will assessment going sense XX very get that responsiveness or on those calculating data to understand PD us growth just respect fashion very hormone two levels an does more a I really of growth it a Those when in interesting how be their pulsatile six marker. it little than And a at hormone have they're trying pretty baseline. bit their how us we'll peaks at individual analyze a are months. gives levels. by a And height And the also take look the PD complex. on dose of growth bit time to at XX-hour of

analyses expect to PD than in a I will we longer which little the the or? height Does take at full to think LUM-XXX velocity folks be action that you year. able that So end mechanism the ties of help the annualized of of show that very nicely with bit

Catherine Novack

cash when analyze I just data. those -- be you data FDA cash information out. the expect to already more patients sure another XXX into the six-month be until how was of My come many your then And second get prepared interesting safety runway curious to how on. have wasn't they wanted OraGrowtHXXX was That's Was kind data XX-month factored so an I bit to and about And efficiency think it's this -- after Yes. question measurement, still helpful. question study. around to

to can XX-month So announced? safety used that be accelerate requirement data XXX study this was that previously

Rick Hawkins

And first. question ahead. financial the answer Let's go Lori

Lori Lawley

Hi, Catherine. Sure.

that to through is primary data, and the sufficient also operations support cash the answer we've the the XXXX continue the six so, to Does times. of XXX readouts on get then And your those month question? during which both us at as for and said, XXX is end treatment

Catherine Novack

that Thanks. Yes. That question. answers

Rick Hawkins

then, the And John, Yes. XX-month safety.

John McKew

We all set, tried think those were we're we've the I drew ejectable, the recombinant program study trial X odds So human thought would new and with arm, for are were patients they XX for who short hormone months on this take overall who but the going we they growth straw where growth had do an every took basically So, patients what were really then they on how have subjects, an taken our sure oral to -- deep comprehensive -- entered opportunity and on to daily extended to to build wanted not takes this they injectable day. who those LUM-XXX. an and to because good, Phase get they they of right? have have a many is the did data responded who to a the make months and who additional XX year And and that. want study oral XX patients an that a XXX see secretagogue the for

all very we'll from think this in all safety build switch I positive this data terms a in not how this interesting positive kids PEM kids, of both switch efficacy, patients they be And to human enough recombinant patients PEM into respond. with study, the to growth into think very some data about hormone to good is were addition LUM-XXX. XX get really study think It's but little data XX get who robust, large data insight study. collecting on XXX our could would they're XXX us very because switch nice a will give I in switch study to in really set, our a of going months I of XXX study

I it is think our the data pretty studies. Phase I And going when terms we to finish impressive. So robust in set I look going be just think, X how it's be at to of

Catherine Novack

that. for right. on All quarter. Congrats Thanks the Okay.

Rick Hawkins

And thanks it Appreciate much. very Catherine.

Operator

you. Thank

with ROTH go please Capital Elemer from comes question next ahead. Partners. the Piros line of Sir, Your

Elemer Piros

blinded. like wasn't I think Hi. alluded analyses to clarify, I is that What the Rick, being Charles interim if I'd the case. sure Yes. to

please clarify you If could that?

Rick Hawkins

Elemer. John ahead go if Good And Yes. question you will.

John McKew

a we think by double-blinded arm have sense. obviously and any they're right? So oral, -- I I an isn't injectable So, arms daily other the think getting this getting one

it. we the we're So have the look blind this the medical I going opportunity Obviously analyze making decisions folks at and to to think data. data to

Elemer Piros

And successful? so, in continued it's way what it enrollment may if widely compromise

John McKew

I didn't understand in what that way?

Elemer Piros

LUM-XXX if you highest a the there to want they oral So, injections, enroll dose growth announced or equivalent, the daily hormone This to that a actually to to continue is or is had risk very want be that may treated. patients would be wouldn't hypothetical.

Rick Hawkins

David, don't a why answer clinician. as Yes. you that question

David Karpf

that Sure. it be that will I analyses will have would the theoretical any But be more do in think enrollment we But announced, a would interim know impact. so when Based not to data concern. don't [Indiscernible]. any have I on

Elemer Piros

Thank Okay. that you. sure that. I correctly. And Thank understood clarifying also to make you for just

here enrolled from sides? Russian and been patients Ukrainian the So any the hasn't there

Rick Hawkins

There is not.

David Karpf

these randomized two patients two, either at No either of countries. those in

Elemer Piros

that all. you you Thank at week conference. And next Okay. was see And we'll our so much.

Rick Hawkins

Yes.

Looking forward it. to

Elemer Piros

In person.

Rick Hawkins

Yes.

Elemer Piros

Thank you.

Operator

Charles be last And Fitzgerald. ahead. follow-up from question you. your Sir Thank please Sir, with Cantor a go would Duncan

Charles Duncan

to Appreciate do will make opportunity any or about sorry wonder was pointing I there Elemer taking for trial. Thanks I mute. the thing. design blinded this an the out Oh, adaptive be on that But follow-up. whether not

patients to dose no randomized make adaptive? like feel and opportunity you the that time enrolled the and at trial you'll So it therefore to all have completely

Rick Hawkins

you answer question? don't Chad's why John,

John McKew

folks time not going be enrolled out, predictions we quite to we're are our in of vast but that current by read will the majority So be -- the that enrolled fully the study. the

design. think that make there's So opportunity to adaptive an with difference much not a I

Charles Duncan

by half then or wondering Would for sometime second seem you're to And that it timelines as certainly the say data through you of But the kind year, for maybe takes really then in that follow-up. of guidance the interim. have full a while of set cetera. fully just kind Okay. you're may I I'm governing that analysis? enrolled, a what's do is data. a conservativism let's June me about the data December understand data you -- to et little work And

Rick Hawkins

That trying through mean, we that Chad, we we're you know in do market the going to as to we're be to do. I asking. and for you thanks think sure and conservative by exactly question. I now excellent follow our us we making tell approach

to still that I We enrollment uncertain certainly from the at Russia we're have going the We were pick times. currently is continue are Ukraine think of these world seeing. we're counting other up. pace going that hope enrollment on to and parts and to

a you'll XXXX. But it's before one anything the happen think of that as end early to too announce I So the will to be usual, little of first know.

Charles Duncan

Yes. I'm else same knows. there's just no time hoping everyone

Rick Hawkins

course. Of

Charles Duncan

Yes.

let let ask you So me me XXX. about

study that really there You intend that like being to seems talked about in enroll you XX and patients a interesting study.

the who kind from So I'm patients are all of control wondering arm why enroll XX XXX? you wouldn't on

Rick Hawkins

answer you question. that don't David, why

David Karpf

subjects, XXX each group. XX Sure. The is study subjects XX enrolling full in

is of arm. enrollment XX subjects the So the intended control the

Charles Duncan

Got Thanks it. for clarifying.

David Karpf

[Indiscernible]. Thanks.

Charles Duncan

later give an an you over. to Can on you that that update OLE But switch intend us patients people you'll have or year? this on

David Karpf

we will. Yes,

Charles Duncan

for Thanks my follow-up. taking Okay.

Rick Hawkins

Okay.

Operator

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

You now disconnect. may

Rick Hawkins

[ph]. Rachel you, Thank

Operator

day. a welcome. You're Have good

Rick Hawkins

Bye-bye.

Lumos Pharma (LUMO) 11 Mar 222021 Q4 Earnings call transcript