LUMO - Earnings call transcript Q3 2021

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Operator

Good afternoon, and welcome to Lumos Pharma's Third Quarter Results Conference Call. [Operator Instructions] I will now turn the call over to Lisa Miller, Senior Director of Investor Relations.

Lisa Miller

Thank you, operator.

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

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

Rick Lawley, and and be Hawkins, Speaking CEO Chief Officer. on Lori call Chairman; Financial today's will

their session. will Chief and remarks, our David and will Chief by as Rick. to joined Officer, Officer; Medical the Rick for Karpf, President be I Dr. John as now question-and-answer well turn McKew, Scientific call over our prepared Following Lorie the

Rick Hawkins

or review will be and an Lawley questions. update give results, deficiency, I'll provide clinical program strategy development and XXXX to our Lisa. After for Thank call. for the financial quarter treatment us financial today's you joining Lori happy hormone PGHD. everyone, announcing issued for thank detailing LUM-XXX of press growth call, and today's our your results then LUM-XXX on On the afternoon, today, broader and overview release of market on a progress closed take the advancing and our our trials, Good we pediatric we'll third our the you,

trial of steady we've in now The data LUM-XXX site program. OraGrowtHXXX and With this or majority picked the on OraGrowtHXXX in enrollment, most we has trial. to last continue of XXXX. those are primary will the are So I'm outcome pleased our sites. that report we open enrollment half high readout enrollment to recently spoke Enrollment progress expect for soon opened screening for importantly, trial up historically with OraGrowtHXXX for for and of you, we progressing, open since our second made that

recall site data to data additional open-label at discretion. provide endpoint single trial LUM-XXX. pharmacodynamic is to may with Since pharmacokinetic, on analysis You'll month an the conducted be label, Primary company's XX-month be is OraGrowtHXXX trial six is captured. that a designed the interim data open

approximately patients predictive As a OraGrowtHXXX reminder, is outcome XX diagnosed enrichment evaluating our a our PGHD. primary is with selected or clinical in by oral marker, PEM and global velocity height trial study clinical strategy. A LUM-XXX patients annualized

measures outcome per height and velocity growth Secondary at include arm three of dose versus levels, X.X, a mg week. comparison mg validate of of daily Dose are entire Phase dose kg per The three elucidated response optimal curve PEM a used of with X.XX of in -- the in per registration levels kg hormone control dose X.X, annualized a patients treated in identify LUM-XXX trials of recombinant doses OraGrowtHXXX to and be study. strategy. were selected LUM-XXX III PK/PD the of dose our to goals LUM-XXX a span trial in prior to X.X the

significant open approximately we During XX XX sites. opening our over have of last toward we progress quarter, sites the screening goal made Currently, patients. and

weeks, XXXX half enrollment additional that in based Russia, in on of recent New the we expected confident the Ukraine, feel supports Additional our data collected. six-month for progress the shortly made Zealand, Israel. data those to to with be high-volume XX-month second and in OraGrowtHXXX sites include readout open trial And

objective six LUM-XXX growth data and action levels, interim and increase months in design The trial, velocity continues to two trial height effects curve analysis across encouraging release ability data prior dose discretion. pace. PGHD kg secretion endpoint this trial to clinical endogenous this XX in open-label This data is per X.X per given pulsatile our of dose hormone OraGrowtHXXX the of our X.X hormone trial, OraGrowtHXXX the at majority of to mg we LUM-XXX of the Turning demonstrating the is patients pharmacodynamic This entire the perform of and now be with PK/PD And and mechanism evaluating to growth an amplified an of at The potential PGHD unique is for pharmacokinetic have captured. of XX-month day. our additional to study. could the open-label patients. site enroll to up primary response to patients confirm single the at

Now in addition expansion we in to other recombinant continued injectable, a opportunities for quarter, standard hormone where care. the areas into during PGHD, advancing LUM-XXX growth explore LUM-XXX our clinical of therapeutic trials human is for to

such previously, Stature, as Short Idiopathic that mechanism and unique Born Turner Small Syndrome, action, its product said Prader-Willi we've for we As is indications of in a Syndrome, and believe efficacious Gestational have pipeline through LUM-XXX and the potential be a Age. Children to may

are our We discussions our scientific reviewing are of pipeline. development about the board for advisory with clinical indications advanced next in and LUM-XXX and LUM-XXX these opinion step for key best several clinical potential actively expanding in plans leaders and

update So a soon. these we to plans on look detailed forward providing more

and That pursuit with value remains creation. judicious rare We careful in assets priority development. also of LUM-XXX disease our be attention said, continue LUM-XXX its to to shareholder beyond our

So why LUM-XXX, some some before Lori, the LUM-XXX our I I and potential current our to to clinical program turn have context confidence reasons and remind of the surrounding just in call trials of we of everyone want generally. over the

preserved subject selectively body. or care, be of to LUM-XXX growth levels that to enables acts standard the the occur an endocrine secretagogue release coming market, help hormone feedback acts unlike the growth in the same IGF-X receptors natural within at in and regulate to feedback This weekly of the pathway, and on the body's recall, pituitary in the body's ability naturally. LUM-XXX may PGHD intervals hormone simulate oral is injectables to same that are hormone the therapies intercon the occurring you Now IGF-X loops balance to and to loop mechanism naturally growth hypothalamus

population, PGHD access, an trials insufficient growth with and results. total to pituitary enrichment this to those but attain for of using are growth I'll height addressable the suggests secreting hormone patients are quarter PGHD review population. that, normal third pass are with group LUM-XXX. intact best approximately a represents respond are designed severe XX% to Evidence less of should hormone financial to this Lori? our our PEMs, that who Lori who identify those specific or it over predictive And markers So

Lori Lawley

everyone. afternoon, good and Rick, Thanks,

expenses. in in XXXX. This $XXX,XXX This XXXX increase to in the of decreases third period General expenses $X clinical $X.X in expenditures. stock research compared During to supplies the operating $X.X other due primarily same decrease of and the our million million expenses and $XXX,XXX development million expenses, quarter and $XXX,XXX third was of million personnel-related $X.X quarter, in million and administrative to and other million compared of personnel-related primarily in and of compensation contract legal, of due offset were expenses, $XXX,XXX in decrease in were consulting, million quarter in $X.X was XXXX. to expense, $X.X expenses of third and in by manufacturing trial million $X.X $X.X a increases

the the the the tax million our to a We $X.X $XX.X sale QX gain million. XXXX million net offset QX XXXX. review quarter cash income ended we related of prior benefit expenses operations equivalents operating it million $X.X of $X.X the of end of of trials. We both in of on million which million December XX, of voucher as that to cash and during back I'll now priority to and of third our XXXX, a Rick closing the currently the For quarter. on readouts quarter from and XXXX, expect $X.X of recorded OraGrowtHXXX net the OraGrowtHXXX compared data to the cash company third In $X.X quarter loss with million quarter, year to of totaling hand for of third a recorded for for support compared $X.X remarks. six-month turn

Rick Hawkins

is will this remind our the our Thank questions, just next on current exploration before expand you, to of we pursue of in execution platform. clinical for and your Lori, indications want that immediate taking LUM-XXX everyone focus to the I plan

other our cycle And life focus we'll development selective is remain will our though we highly opportunistically of opportunities shareholders. present. then and business they LUM-XXX for as consider While management creation on priority, value long-term

sharing to forward look soon. details we with more So you

operator, take So to questions. now we're ready

Operator

[Operator Instructions] And our Fitzgerald. of first question is from Cantor Charles Duncan

is open. line Your

Charles Duncan

I Yes, to wanted our thanks thank a update. little you Thanks XXX you. ask for team. and the study. Good afternoon, bit the for quick about questions taking Rick and

demonstrate guess you give that? timing, high a with do you is? six-month to assumptions in I be to that I regard and paradigm, mentioned of wondering And enrolling what marker enrichment able could a feasibility study us some predictive enrolling the remind then I'm screen-to-enrollment sense. deploying And readout know study? to and you your Did site us you're lines what color that You know for high how a sites. makes But sense that are,

Rick Hawkins

Thank you the for question, Charles.

of are for of a growth that hormone And terms as there recombinant trials been In well I investigators growth years. number high have incredibly think these around know, been sites, over hormone, clinical been the known. you and have enrollment XX has conducted the years,

sights of data become high enrollment looking those coming those And as terms pretty at they've online. trials investigators of I clear. now think are those from some patterns, said, their enrolling and mainly in I sites,

an increased enrollment is there. having So certainly our of expectation

haven't released predictive we're we or or We haven't in using released this, information there, trial screen PEM, especially failures, relevant a like I'm not Charles. enrichment marker when as it's on any data sure any but a

Charles Duncan

assuming of patients may inadequately in I'm growth on guess XX% respond patient population. the you to represent mentioned later that hormone, your I Well, Okay. but comments who maybe

if be of But in presenting place PEM a to present trial terms patients of in or to not? I that's them I'm that that enriched may So wondering to more a think clinical respond probably may good guess may who any start. you way

Rick Hawkins

you answer think question? hold. do that John, want I on to you're John,

mute. on You're

John McKew

hear you now? me Can

Rick Hawkins

Yes.

John McKew

to So on the database analysis just and that spectrum. be of diagnosed patients of molecule growth general hormone of data deficiency should indicates PGHD responsive our division of XX% with the kind based upwards

generally our who lot just So growth a job done of I we've done needs a quite educate deficiency. what responsive for a actually patients patient type hormone said, they've patients what's good to work idiopathic all the going of to investigators with and kind called molecule, think finding our on that be fit at to of of most are with

hormone Kids. So severely not not most organic, deficient the growth

with I rates done diagnosed deficiency. growth in align we've hormone now databases large think seeing studies that right -- everyone screening we're of with so And don't the screening database

of I to respond to So our high-return our pretty the getting because cognizant on the who's are therapeutic. kind rate sites going think patient fairly clinicians we're a of

Charles Duncan

of interim an kind that's helpful. interim that onto XXX, doing And analysis conducting Last patients? company's Okay. XXX something Very to of factors I'm with you it the a question certain conducted hear Rick or -- guess consider do analysis? specified study. or Does discretion. back I protocol wondering in number that is updates. would may would to We like to be the what this mentioned have at

to So decision. that, what looking would that drive kind forward of but just wondering

Rick Hawkins

Yes. Go John. ahead,

John McKew

kind think to the I that important of X.X each data like a that on that essentially what interim is we'd set so at exploring, So analysis ahead large a is per day see think have mg and We've per negative, but our PEM data of reach kg that great, we're I two doses, we X.X the with kg to that mg released release as decision, type per protocol. doses to X.X share. PEM one enough in when we have and have that and patients, dose larger we and cohort interim that's like case a information, defined forward And and as soon a three we'll move higher the two that. we we'd of in positives report

Charles Duncan

Thanks taking Rick. gentlemen. questions, for Thanks, the Okay.

Rick Hawkins

Thank you, Charles.

Operator

Sandler. from Piper is Yasmeen next question Our Rahimi of

line open. is Your

Unidentified Analyst

Team. Can me? hear you Hi,

Rick Hawkins

Yes.

Unidentified Analyst

Prader and and wanted And prefer how began -- Thank and LUM-XXX the to you on do Willi, works expansion. expansion Lumos -- into during is Jesse pipeline these you the Congrats please This the would our would you for indications? and Syndrome Turner I wanted one get and go how remarks, which that you. taking about kind after? most -- Yas. thank the know prepared I work can Cool. to call. of talking questions explain I to how know quarter you for [ph] and on in hosting just

Rick Hawkins

patient those So with why go don't population? mechanism in John, ahead the you action of

John McKew

Yes.

for pediatric right? our to lot So looked hormone downstream it's if And in constellation correctly. that are that patient this an increase our I group patients many of where we at -- LUM-XXX thinking aligning are there have growth of deficiency, who we've IGF-X growth individual release, their growth And of spent many growth things a mechanism time the hormone allies And a for our around increases affect growth think the patterns. it hormone of can stimulated active choose indications way like and with perfectly there for might other child's in just kind be a access modulators. with secretagogue is a populations of deficiency, we of them a of turn that

Some of little other indications those are more complicated. bit a

an so what time but at Not growth the adults, how are indications respond weighing of and be And growth hormones molecules, doses all their have our growth that can are example production. hormone now increase these for hormone precog are doing that's access looking in of to and approved indications with are to we're the patients an just right how kind our we stimulating growth-driven. contributions, sure of who spending make is successful that active and different growth. those can stimulated to trying There mechanism

So we try and hormone go we to the as prioritize that's the human go approved as doing indications recombinant really forward. for XX growth through we're them thinking

Unidentified Analyst

XQ the let Thank say them you expect are then the can Can we And you updates know? or soon, when XXXX? on us you. call

Rick Hawkins

Absolutely.

Unidentified Analyst

indications or might would like beyond? on in on have update which XXXX will XQ or I call, Sorry, it an we the be

Rick Hawkins

clinical through we'll scientific about We advisory there we're to we're yet, discussions KOLs going do, our the at and going you to the quite but actively time first. we're and going haven't with soon, our able the but And we're going talked Board ones moment. to period -- we're to think I not time tell our be which

Unidentified Analyst

team. much, so you are my Thank questions. Great. Those

Operator

And from Capital our Piros next question ROTH is Partners. Elemer of

is line open. Your

Elemer Piros

just information now open Rick. And the altogether. XX the I wanted had and verify please. I XX that that of are out think XX is just question, And XX I correct. plan there afternoon, are have you clinical see at is recruiting. actually Good to the one trials.gov, sites I to

Just are. close trying to to how final see you number the

Rick Hawkins

Yes, now I'm just XX we there total high I least are have the we as and as sites the site some sure of with patients. But more open up that that number. we're at speak, these say sites least, keeps those traditional think online. enrollment the I recruiting sites. not And activating earlier, And mentioned are coming

the optimistic we're improve very future. going enrollment So to our that's near considerably in that,

Elemer Piros

Thank that, you for Rick. confirming

Rick Hawkins

Thank you, Elemer.

Operator

our And of next Catherine from question Novack is Jones Research.

Your line is open.

Catherine Novack

of for Hi, kind question. to I taking thanks so my picture much just wanted question a bigger pediatric market. like the about hormone ask growth

given approval shaping market? hGH, you associated I especially, about normal how product what you for guess, see growth is KOLs of practices potential have heard prescribing do the Ascendis' than the IGF-X? of TransCon higher weekly this And that hormone, that With with from levels sometimes

Rick Hawkins

feedback. of a We're gotten really lot our haven't on We own programs. focused

more market we're with. than the release pleased However, price

leaves that a lower molecule small a of level. it's deal at cost us and pricing, of flexibility great in imagine, especially can a You manufacturing. That

a the the the going to be about Karpf market bit what it's think can to and endocrinologists. that I more. little But to is -- tell pediatric too to a Dr. maybe early ask in response from I talk the little

David Karpf

I heard yet, will been as not approved. it [indiscernible] and is work and very to least Again, which the I it to -- take on imagine -- became some program, even I been would Rick It'll Sure. actually closely formularies, said, time have be question which launched. good it get less at cost for has patient on goods the for really sales the real driver that of sales cost market. the of It's the quite is the goods much that provide the And of LUM-XXX than dictates Sci it's no does because in Tropa, for will cost flexibility. there it's outpatient.

Catherine Novack

it. Got

weekly hesitant to Okay. think to was IGF-X who bit in Yes, weekly I concern is little is for trying is Or prescribe GH? maybe a comfort have at some not heard -- what a might a general I with be level you KOLs? get anybody

Rick Hawkins

address mean, David, if I want -- And all? that you to at

David Karpf

Sure.

talked I that because of develop with when traditionally a Ascendis treatment. IGF-X time lag in hormone it, leaders and when opinion did kids diagnosis a right about the development think big -- was levels I growth most have not that deficiency rarely they are concern with key to I diagnosed of there's because

to don't You value you've the want target kind average of IGF-X got to to in kids, five height. if years these them adult treat

are you targeted range. in to normal zero. data definition, there that by want better upper you the tend than is below. to above growth you suggests be showing to have if half going And set And you it, targeting positive of to IGF-X target So two, IGF-X half a you're get half

So on at would prefer kids the think week. compound one no there's And there's would injection. everything and even a week that that people prefer else unlikely seven not I same injection don't per all a oral compared a lot question a most concern. to of once-weekly by equal, it's to parents token, a once-daily being big injections But

Rick Hawkins

And Catherine, see, time. over what of population many wait I pediatric their think believe, and endocrinologists, to them see that report will I the reports as colleagues or patient

that to will I of but going think the some be right concern jump are because to think of in there some be clinicians. adopters, excursions some endocrinologists who away, there's also sometimes perhaps can early not will I pediatric -- of IGF-X be that levels

Catherine Novack

Got it. much. Thanks very

Rick Hawkins

Catherine. Thank you,

Operator

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

Rick Hawkins

much. very you Thank

Lumos Pharma (LUMO) 4 Nov 212021 Q3 Earnings call transcript