LUMO - Earnings call transcript Q1 2021

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Operator

Good afternoon, ladies and gentlemen, and welcome to Lumos Pharma's First Quarter 2021 Financial Results Conference Call. At this time, 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 will now turn the call over to Lisa Miller, Senior Director of Investor Relations.

Lisa Miller

you. Thank

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

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

of Chairman; CEO, today's on Langren, Officer; me Joining John trials, guidance. the review Senior therapeutic Scientific company's review will and and Hopkins our cash first quarter Officer; wrap and candidate the of and Controller. will Lori and Vice clinical Chief Rick and call a the Chief provide Carl Financial Corporate Lawley, Rick update Hawkins, Operating call results Officer update, Finance and corporate an will Chief President, McKew President Lawley a Lori lead up with John financial are McKew, XXXX

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

Rick Hawkins

that the press detailing LUM-XXX markers. productive novel and our and quarter and by data call. After we financial growth XXXX hormone for of therapeutic of you and our report we today's candidate treatment analyses first deficiency and and one, predictive new the pleased corporate highlighting our the issued on action Lisa, quarter today, during saw patients you, Thank oral afternoon I'm differentiated and to clinical us enrichment of a the thank of which good for market activity. recent pediatric presentation release closed a publication a results supporting identified mechanism was our joining

to continue sites our of trial quarter. during for towards the OraGrowtHXXX Phase moving and our clinical LUM-XXX, for initiation XB adding the OraGrowtHXXX also We programs advance trials clinical second

Finally, completed Receiving of Review of tranche final January the million to modernization we $XX the due million the this our from Voucher. Priority $XX company in sale. the

needs we our and our call I With highlight these options explore events. business progress clinical a investors. resources dive to a our on Dr. University John we want landscape just programs enhance presentations advance McKew in in medical forum before our This a deliver LUM-XXX we by the believe value of turning opinion a featuring Last in this And of week, the pipeline deeper Cassorla few recent key well-attended leader and Miller event programs, outlined for are in and to unmet hand, held the informative to the development well-positioned the to Fernando to Dr. over an overview Dr. and Minnesota provided Miller of Cassorla was space. where and and Chile. of current PGHD of treatment Bradley University

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potential unique known molecule Meeting at hormones were mentioned differentiating D to data, Additional the demonstrating last level standard in to Scientific from results these in elicit response the a more as our this therapeutic to Endocrine Society Annual in the presented we're XXXX Officer ENDO, approach add growth month McKew, patients LUM-XXX's data PGH further These and further will secretagogue. say clinical using supporting have COO about Chief previously trials. moment. data and in John our

or OraGrowtHXXX mentioned, I as So to [ph] Phase continues and PGHD patients. XB enroll

of with Additional for sites of enrollment opened sites now number clinical have XX% over our activated. target

trial to anticipated Our demonstrating disrupt the unique state. LUM-XXX. for initiated OraGrowtHXXX market believe We prior PGHD is data injectable from data in with of PK/PD be quarter, the pulsatile to potential has expected therapeutic trial of study this PGHD to confirm LUM-XXX the that

once opportunities current development business we subset program, we to our as rare LUM-XXX indications. add gather plan to the that We're has data evaluate and for hormone been And our a believe is to other approved. PGHD. up expand these disease target also on assets We of potential pipeline to XX essentially portfolio. first also pursuing focusing which We're from growth with LUM-XXX to indications a product other other

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review our that, So secretagogue John? and data. hormone over recently to with John turn going OraGrowtH the I'm published to call LUM-XXX to

John McKew

Rick, and good everyone. you, Thank afternoon,

our touching weeks, very some in recent some highlighted which compelling data but call, again. had we on mentioned, on and we are published Rick last As of presented worth

to factor action. everyone of the getting in into I LUM-XXX the remind details, key just mechanism of want differentiating Before the

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Given this to nature of endogenous LUM-XXX, HPG benefit a therapy LUM-XXX have [ph] diminished from though functioning must axis. individuals H

select but identified our are approach Predictive to to to sufficient to patients For is We our likely this attain in Enrichment hormone able group amounts be patients to reason, moderate normal PGHD patient or Markers not of believe respond adult target PGHD using some population moderate to therapy. the produce naturally, can growth height. who the LUM-XXX these PEMs

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hormone are depends its for growth that the support and of that the suffering approximately development PGHD the preferred randomized or why care these I oral our Enrichment clinical OraGrowtHXXX of evaluated three PGHD into randomized standard Phase those a believe described action in will Given We we hormone option dose of be is strongly a we PEM daily HD one are by Only data approximately delivery levels XB PG Predictive This the treatment positive, involving comparator patients and Markers our multi-site these believe XX axis, therapy. global LUM-XXX HP may of trial earlier, from a PEMs in determined illustrate be of growth natural to LUM-XXX arm strategy GH trial. of and injectable deficiency. trial mechanism study. offer patients using its XX% children on as

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response hormone. dose of range should Phase XB our of the that opened greater we PGHD our study. hormone doses those to of full to as kg three potential on X.X in is for over of These currently result enrollment kg These data prior PK/D in positive open up potential which sites and selected expected sites toward in anticipated pm study hormone PGHD with one have patients efficacy trial in and LUM-XXX equivalent enrolling mid-XXXX dose that only total. showed kg of enrollment of mg last chosen that sites the those the were with in growth trial to limb the human curve. healthy versus growth adults soon per pediatric their plasma and confidence were based The trial we activated common For pharmacodynamic concentrations additional XXX suggests administering growth doses care our our way standard of hormone. history in to one-third our XX% patients, and X.X XX clinical of process adults X.X The the mg in approximately patients cover mg in XX progress per goal data for equivalent and showed quarter secretion to children increasing the increase readout. healthy pharmacodynamic doses higher with mg, sites up The growth trials, enhance the

kg OraGrowtHXXX concurrent at of our X.X PGHD. two is in conduct shortly. pulsatile and the second a X.X patients The mg We natural expect for our to fire clinical The commercial in OraGrowtHXXX Merck trial KOL. LUM-XXX Arriaran the required of focus trial ability we and to approximately cohort trial trial. a frequent XX data goal On six children clinical Santiago, of small with hormone. data XXX will Borja on after children OraGrowtHXXX pediatric initiated, XX the subset till mechanism study sample will San ultimately with amplification illustrate and OraGrowtHXXX collection trial growth these that trials. center to planned larger the reviewed Phase pulsatility pulse run growth of for per Chile, in is will different marketing LUM-XXX's with monitoring with types a efforts. single future therapy to of PGHD The hours We the the for of the of providing the this filings the Hospital Once months doses: at regulatory initiate at adults with specialized patients more the over parallel secretion endpoints trial to further the and LUM-XXX amplifying by PGHD XB this assess perform supportive secretion. confirm in in any purpose to study baseline on replicate at of as a study in hormone trial of site of action last intended The pharmacodynamic in and for a call, reported levels the occurred plan and

the to restored in hospital we trial directly was quarter. access initiating current Our and the OraGrowtHXXX anticipate has investigator's in and fire not involved the clinic been the

the timelines. As fire leave interruption do path delay trial not not stated, caused for LUM-XXX the is brief by regulatory we will approval of and our previously have this on critical we

LUM-XXX where discussed, human as common in is results plan a hormone other to Pending Finally, evaluate we indications these potentially that just concurrent approved. mentioned, which and trials therapy serve platform indications. from LUM-XXX growth for OraGrowtH applicable as may our Rick believe to we other

those innovative business pursue to license order expand opportunities to pipeline rare continue diseases. assets ability and we therapy or LUM-XXX, disease provide in acquire our to Beyond rare development to to from our suffering other

our make Rick a comments turn will CFO the Before I about call succession. we discuss over our results, to to financial announced few

Rick Hawkins

about first want few well-earned we a you, retirement. and words I say to before Thank John, proceed, Carl's

As want July XX-year we X. to XX, Lumos as be retiring Lawley, financial distinguished his a our Carl executive, Pharma to service to capable We after very and April on VP announced thank and a Carl's CFO who want him Finance as and career will on for we be Accounting, congratulate will currently, retirement. Senior Lori for his upon deputy, succeeding Carl effective

Lawley to financial the call returning over results Lori? for So, Lori to first the of I'm quarter discuss XXXX. now

Lori Lawley

We and Chief my quarter totaling and December working with as equivalents I Rick. $XX.X role with ended Financial the to investors cash compared XXXX. in with $XXX.X engaging Officer. million, forward to on XX, the team first cash new Thanks, look million

Rick Review final from at the our of As mentioned the earlier, the Voucher. position includes in January $XX receipt million cash sale tranche current Priority our

We million expect Net OraGrowtHXXX through completion XXXX. million, hand our quarter trial. expect and $X.X support a XXXX per $X of current for compared through approximately on loss to and net of readout the to same first an average cash operations million to of period quarter the the income cash use $X in was million $X.X for OraGrowtHXXX

to turn Rick would up I back questions. like Rick? to before we call Now, the for over open

Rick Hawkins

our We PGHD, we open our to strategy and forward with our disrupt questions. execute solid we're excited PK/PD for We're forward for LUM-XXX over financial tell, believe Operator? we'll the of trial to as and [ph]. trials And continuing provide market. the that, to our PGHD call look potential progress. the clinical that to will confirm our trials updates about advancement on OraGrowtH to can initiation and you As OraGrowtHXXX footing look on of the

Operator

comes from Fitzgerald. line Instructions] Cantor Charles Your Duncan [Operator the first of from question

line Your now is open.

Charles Duncan

for my have all of for questions. trial. John, thanks juggling calls I and One couple of is a detailed OraGrowtHXXX taking information. I'm the question. on the Yes, quick thanks, lots Hi.

activity You ratio? then to of early said Can that enrollment a you sense us perhaps give about XX% that? enrollment Any on activated. of screen were sites and perspectives

Rick Hawkins

Charles, update. any guidance to we of that the given market haven't terms in

as You experienced certain given stage I of But in in know guidance questions some pace. active start And But we that a trials at and enrollment are that the any we're think dramatically. two the patients screened say usually sites, improved these haven't to ask. more now. sites, as more you I

Charles Duncan

and good here on the FDA strategy the color And presented with if their, level, you information Okay. basis of even you you've an observation But to provide with any regard lot of Phase can this feedback guess, XB? a had if I'm comfort PEM, from any of that to that then the a on regard with this there's I making wondering forming recently. out

Rick Hawkins

you John, why don't take that question?

John McKew

with from about beginning and Right? is giving think molecule this we've so FDA the Yes, because the is to is the we how the really effective. itself doses, this patients correct engaged idea the product to to for them basis really move be it going how forward. correct going Selecting this show

and yes, any go from the think this to PEMs bring to the we're we with to where them trial applying further prospectively we we them. brought have engaged need I So idea results that the

Charles Duncan

you Given could gross mechanism outcomes the trial the with bolus even regard better conduct, And beyond the then basis result do I'll question, last as release -- that measures Okay, the or perhaps pulsatile that? versus and better? with one call you could go release What's hormone stimulation, in do mitigator stimulating shorter that that be think and regard but outcome clinical to say, duration effective a of in a [Indiscernible] back or the more risk that's dose, PEM queue. actually to think dosing? growth a -- helpful. it strategy, then hop slower

Rick Hawkins

John. ahead, Go

John McKew

in or like growth that say, of the So, [ph] given amount with versus growth of experiments administration there preclinical release, are fashion same hormone. continuous a some to grow better so fashion hormone pulsatile

growth think importance its really at to, to in a But think will So, pulsatility in hasn't of across been looked hormone the that I [indiscernible] because growth pulse really I child be their of day show It's individual really hormone this before, pulses group never been study. think XX there the responsive. of effect get an selected the months. growth and release potential to to patients a way is for in six then peak of at there to we at in that of we've study this at look XX a the

And growth-oriented ranges. action lot physiological there's a So, very of to quite will levels of good maintaining bit show the IGF-X potential this that within unique we'll I think have growth of a information. a give mechanism us while

Charles Duncan

Thanks all for for and providing color the the added thanks information.

Rick Hawkins

you, Chaz. Thank

Operator

question of from comes Lina the line Your Kaminski from JonesTrading. next

open. now is line Your

Lina Kaminski

Thank for taking Hi, you my on congrats good question quarter. afternoon. the and

you're So, and mentioned I guess remarks LUM-XXX into expand you indications. additional to prepared your did you looking that in previously also

So, positive each what you the understand of I help to respond PEM you're Should be looking was hoping Thank for indications LUM-XXX? of can for? you. maybe and us proportion patients

Rick Hawkins

continue we just experts we're of the to Well, the color? in each additional to process the John, question. and that one of type in KOL of any engage do add want and determining you community these diagnoses

John McKew

unique data etiology the other we or kids to the some deficiency, with has and of facets have each All growth some think data But deficiency, kids the Yes. pediatric hormone indications we've and one defects thinking are. with its growth the to PGHD I that extrapolation. and hormone where done points population have now on we the

to a deficiency Some are of pretty directly. combination growth related several others more and were events;

be. molecule So, it bit broadly how this our on put understand our down it's really for and disease trial we our of going knowledge these depend in it depend on put responsive affects and different and will patients there more each little some about how a indications, indications growth secondary to before may can acquiring, many hand OraGrowtHXXX us

Lina Kaminski

it. Got

you PEM that? on to up adjust Based each might you need classification one cut off your indication? on based Just the for this. think follow Do on

Rick Hawkins

ahead. John, go

John McKew

patients molecule. produce to identifying set think first We'll is useful this that's to in are that growth responsive selecting functioning have of step with a I the access but criteria to our for the kind in hormone be end, going to see, of patients partially and

of deficits hormone them, the of some in some do might think you deficit receptor you the Like growth of whether hormone indications, have about growth interactions. of downstream other are production. to a Some have

So, access to hormone dose growth of all to the and approach through information the trial. get what's these what in out pieces range of deficient that have we -- best do kind we and think PGHD put together the have we

So, I think can best hormone data treated a after we for really there's what's we known build lot of etiology there being just patients indications. with to common growth interesting on about these these go the that's or for fit human can for secondary molecule out the and find our

Lina Kaminski

and you this on Got jump Well, thank queue. back quarter. it. in so congrats much again, And I'll this

Rick Hawkins

you. Thank

Operator

Your line of next from Derek Arhila the Stifel. question from comes

Your is open. line now

Jacques Villefranc

cons [ph], This view afternoon. growth Hi, pros Thanks us you in here can secretagogue Derek. fitting adherence for an versus hormone the for Zooming for questions. are and Good oral about of What talk out, and guys. our injections? taking there? some you is how Jacques on weekly

Rick Hawkins

product and whether there's with data adherence. start indications. Jacques, so problematic be an or a It's in -- out answer. population other injectable pediatric that much terms me of it Let there any in PGHD

to is as will once you another want overwhelmingly How day longer but product. to to our injection be shows prefer, more. or have would done that a But both which some oral I the we product oral which we believe some that question, choose that to they're I one that? to real have attention compliance and they weekly sure a an product market that, going add oral they that they take that world that going believe in is, think caregivers make a is we preferable stay translates day the [ph] study think treatment John, products there's and parents clinicians once research, direct enough that ask we've if by this improve do it's to you a should. their a on think as I children to they anything definitely and

John McKew

No, that's perfect.

Jacques Villefranc

putative And Thank helpful. if speak What that competitive [ph] how guys I Thanks. thinking you. right then now an asset? opportunities? you are licensing find Got front, and to the indications is That's it. may, to can And modalities BB about? on you

Rick Hawkins

you, some companies more has of has Good question, both with XX quite experience time and that large a the process robust led companies have and can years a rare Jacques is our underway Aaron CBO. tell that as I by space. small Schuchart, for or in Aaron disease we Business And Officer been

that, to rare that many of collectively a in addition bringing disease those make actively have very this we operating been number just a again, I and sure as of in reviewing that contacts a And team, interesting we decades here. productive of making experience think once are have opportunities space. as forth choice In the we result, right

Jacques Villefranc

Great, that's congrats quarter, guys. and on very Thanks, the helpful.

Rick Hawkins

Thank you, Jacques.

Operator

the questions Hawkins queue this Thank hand you. to at back in I'm remarks. I'll showing no further time. call the Mr. for closing

Rick Hawkins

of time the everyone Okay. program over our course appreciate your Well, today. year. we thank keeping apprised you Really to for joining us today the forward and we of look

Operator

participating. you This concludes Thank today's conference call. for

now You may disconnect. all

Lumos Pharma (LUMO) 6 May 212021 Q1 Earnings call transcript