Lyra Therapeutics (LYRA) 10 Nov 212021 Q3 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Lyra Therapeutics’ Third Quarter Financial Review and Operational Highlights Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Now I'll turn to call over to Stephanie Marks with Argot Partners.

welcome today's and Operator you, everyone call. to Thank me today Dr. are With Executive President Cavalier, Lyra’s Palasis, Officer; and Maria Dr. Chief Jason Officer; Chief Financial Kern, and Strategy Robert Officer, SVP Medical Commercial of Corinne & Noyes, Development. Market Chief issued Lyra results financial updates. quarter business afternoon, announcing its a This and third XXXX release press A the be announcement found relations the investor copy of the of tab company's can in website, lyratherapeutics.com.

company forward-looking factors on on the a planned filed cautions these statements involve clinical candidates, that conference in statements, X, are the risks as including XXXX. could to reliance to section with be to and statements anticipated you of results and report the forward-looking current and result uncertainties. business from information, statements describes management the product of company's over such Lyra no statements and company's make development events cause not differ results These will risk to the place expectations. in future call, result its changes to risks and or in new that, the forward-looking that statements I’ll or titled a based the During events update those company's the and Form on, Lyra's Factors materially of timing different of And forward-looking current the obligation actual November operations. undue factors any undertakes statements, strategy include forward-looking turn today Maria. as from call inherently duty these related XX-Q on expectations and could uncertainties.

of This was all this Lyra. you thank XXXX us significant Stephanie, quarter progress of quarter at afternoon. Thank you, another third joining and for

patients announced removal impressive strengthens of the treatments all field. removal showed to post-treatment positive This safety response LYR-XXX front, of that new relative evaluation, LANTERN patients generate patients, lead after On We other which months data differentiator in of durable half treatment data important continue LYR-XXX, candidate, the and some and the was roughly chronic the response from X post the rhinosinusitis. and six the we Phase months of we've profile a that for in the continued our clinical durable to treated. in six even

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clinical the in program the Phase for X of LYR-XXX trial are LYR-XXX start for coming Our month. and late the the X development advancing clinical Phase with programs stage into clinical

Fitzgerald, recently, strategic Managing over in and on as Sciences Acquisitions diagnostics Jason financing through investment Jason Stearns, at corporate he capital sectors. new technology, of reins & guided at Life Cavalier and in On banker He Director, our strategy biopharma leads and Financial where Chief was other Lehman an experience He companies Cantor track Brothers. of brings market Mergers RBC decades Capital, our Most alternative. two he record has financial numerous an Barclays also September. led the our as the development appointed business and front, activities. relations who was extensive Head Officer will Don transactions the Bear banking from takes and held IPO. Elsey He Capital medical positions public our investor, and and Markets, investment across support company advising

tremendous Don's team, end. year know, the I'd advisor Lyra As like through for you and an to to entire Don the contributions behalf company. retiring, his of he'll dedication, On commitment thank remain

marketed the disease. Now underserved their a largely medical chronic Lyra's there ignored. patients. treatment year. the by developing minutes you with with a XX% to invasive of that at United world remind is treatment and on medications inflammation continue drug CRS by effective The focused treatment United CRS we in In been disease. that development with the about current of the that who which fail these been of Patients X million alone, is States. surgery. million only approved each have I'd to off-label very provide targets of treat patients, like for represent is XX CRS few CRS. these have medical disease the only mission developed treated with option first a patients’ is currently about products suffer highly to Currently, disease polyps, debilitating are an have patients treatment management Consequently, just to next that for to people fail rhinosinusitis. half the Their epicenter not are States our millions patients take the why directly been have been initially options treat has prevalent in to

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body LYR-XXX scientific safety and Our of the and our XTreo support continues benefits growing the to platform evidence technology. efficacy proprietary highlights of of

in our of CRS. validation strong have We technology

first in platform intend we leverage and over the Our the new in targeted to next indication, indications year.

enthusiasm we to been about new In hearing CRS opinion patient. their for of addition also LYR-XXX our key to research, the be a have from leaders for potential own treatment alternative their

I'm with IR Over treatments. listen you shortcomings months, ENTs will which CRS that hosted in their two effective perspectives are experiences shared the the section to the all therapies for urge events the few who webcasts, new in website. leading past sure need and find We the of you our we treating corporate to of their informative. current found patients,

end. were Phase our ENLIGHTEN With two treatment step the underserved LYR-XXX for X designs the potentially turn programs of CRS the upcoming for the for as Rob? as data LYR-XXX Dr. now closer clinical program initiations to patients. trial year LYR-XXX, review millions I'll changing Phase and call the Kern, will paradigm are who programs, anticipated which BEACON Robert and one X well of for over both clinical our new around the initiate the XXX, to

Thank you, Maria.

at of XX American a Annual on Rhinologic ARS Meeting LYR-XXX As presentations positive Maria the mentioned, two new Society. data was subject at

I My sponsored manuscript Rhinologist on that wanted these industry not to I Before a award LANTERN research. seen member I XX a of as the that that to received and that award review years meeting. society, have given at data, the remark

and So following for quite efficacy and post-treatment was Lyra of removal. evaluation clinical rigorous months, safety six over program. accomplishment The matrix a an assessed LANTERN validation it the our

During XX removal to of the the showed LYR-XXX, arm six symptoms increased The durable XX. and in CRS CRS of treatment-related long-term the half was of there a of these differentiator LYR-XXX while post-treatment in after no other roughly patients XX% control the weeks after durable response, relative experienced of as from to Also, incidence offers benefit meaningful approximately the adverse months symptom worsen patients potential removal relief events. period, some patients observed a treatments.

without results reported less doses. a microgram constant daily from X,XXX or The showed showed study pharmacokinetic of also the effective over The the PK U.S. day the safe severe sites four X,XXX We Furoate XX doses patients in study patients to LYR-XXX, study, to that drug burst. which disease. dose LYR-XXX and X,XXX delivered Mometasone LYR-XXX microgram period enrolled with and receive study across be XX

results As the product LYR-XXX safety validate LANTERN potential of an study day below our score to shown provide and further and now patients a below to XX post LYR-XXX. the all administration The Impressively, in durable X standard provided We've for both more scores in mild X our PK removal. baseline threshold had for with of the to three trials, achieved for score, points, XX, these Phase a a SNOT-XX six points disease. believe for of has XX month these patients duration CRS potential surgery a way We the meaning that results by XX. XX% the and compared normal treatment lead patients in trial. single belief impressive severe effective separate common effect treatment achieved XX% demonstrate efficacy a

establish LYR-XXX the of advantage Otolaryngologist, a standard physician practicing chronic and a in potential to significant rhinosinusitis. As for that over a existing therapies offers new care believe has I

will include that who in Phase receive note dose. to over not ENLIGHTEN cross Cardinal the to which LANTERN treated XX statistically treatment a readout line It a endpoint was of extension robust a will placebo program. will randomized important at is failed of the six weeks. include that primary and XXX XX weeks. with repeat to patients, to We patients study at believe secondary XX% to development similar X the ahead, scans, ENLIGHTEN-X LYR-XXX endpoint the extension is the global study, the X will are and management pharmacoeconomic trial and be two versus is surgically one Phase will year CT XX to be The adult evaluations. Cardinal The for design SNOT-XX, treatments, expected program enrollment to rescue medical with scores primary of at weeks CRS The anticipate for initiate control. each sinus end. Symptom naive. LYR-XXX significant studies ENLIGHTEN and patients study in month Looking three clinical the three life top LYR-XXX We highly quality delay of where Symptoms around will largely about two endpoints is

The each start to first matrix Later kind PK, of to feasibility approximately of in enroll designs the dose of to for States and will sinus of LYR-XXX. treatments, core two life. receive across also we study safety United dose to one, one endpoint in patients be the at Randomized symptoms, of Phase CT, quality nasal over plan endpoints, XX and control. its sites postsurgical BEACON field. including this XX this cardinal pictograms one Australia. month, of Primary weeks, biomarkers, one We different X and a each SNOT-XX, X,XXX three will rescue -- the secondary the

the will Let to Jason, me call review over now Jason? who quarter’s the turn financials.

Kern. Dr. you, Thank

this I financials, at opportunity the quarter’s would like the review to take express for opportunity my to I Lyra. enthusiasm Before

Over career, I'm paradigm positioned I've to our treatment for team tremendous sector, CRS for that banking be leader treatments. worked of in with with believe numerous here change my support potential patients. and a healthcare honored mission is Lyra across companies to the investment a I to working be the uniquely CRS course the and stellar

quarter development company's was financial XXXX, million expenses as XXXX. We let has programs. to quarter’s XXXX. the planned that XXXX issued, as compared to primarily consulting development compensation attributable select period expenses, $X.X ramp release of and million cash and period XXXX, million XXXX headcount $XX.X the for in but to XXXX. fund $X.X product And $X.X our XXXX, transfer in to and we to manufacturer, Research to as through press $X.X for were ended Lyra million $XX.X expenses September and primarily XX, we're for third the contract increase to headcount. shares stage million compared the for million and to call and in administrative tech development turn period September $XX.X XX, period $XX.X of approximately that, cash equivalents review as ended me third the as same With third expenses for increase in Turning same were operations quarter related for the was general and up in were well XX, the highlights. just million. June manufacturing later million million Total and in $X.X to for Net with results, G&A attributable sufficient an our the for operating research same $XX clinical outstanding quarter Maria. compared expenses, to Lyra an the the cash third for the the compared to the of quarter to in professional believe compared quarter expenses same I'll stock-based loss consulting an a back million increase $X.X XXXX. million

current XXX late-stage X months. dominant start the the extremely advancing with modifying by best-in-class player designed the trial treatments Phase CRS the for patients a medical CRS of and of in clinical excited millions and Lyra Jason. LYR-XXX to LYR-XXX a We're in underserved for is development be LYR-XXX Phase be management. clinical into to coming you, program be the disease X market for who are poised are to Thank and

Now your we're to questions. ready take Operator?

first question line Thank Instructions] Blair. of you. Lugo Your William Tim from [Operator comes the from

is now open. line Your

congratulations future scale us housekeeping and in the progress. an you guess capacity Lyra capacity? likely Thanks and that what one manufacturing at on give for the the quick at all you on question. update the taking point do question I Can

question. the for you Thank Tim. Hi,

the we in past. have have past, mentioned contractor transferred to outside in an we the the technology As

in-house sufficient studies for manufactured is we've clinical the now also studies. transfer have our here to and and those We The up scale towards used SMEs right process. our we're gear

As have you trials. know, we three

We BEACON. and have ENLIGHTEN-X the ENLIGHTEN-X, also the

follow-up shape as I the to to manufacturing. up we're during think to we've very be We're who we mentioned enrollment periods chosen, spending And is have suited contract we time And the I in going and very able scale that we've with so to matrix good be at contract our our commercial. believe scaling past, in be period a chosen selective the for well with manufacturer up manufacturer. very

Okay.

since or second you in-house no need manufactured there's consider I sourcing, So you have for in guess past? sourcing the second

we point, don't, at yes. Well, but -- this we

between Lyra. manufacturer certainly we're and at at other We product. to this backup in the have will we we our absolutely a in additional contract continue and But will addition future, to point backup. We'll look can, Certainly, source Lyra. well the positioned have to manufacture

the of has X saw presented other which won obviously do this other Kern the you industry I and And great. it society stood you I'm that had beyond award. was think well. Phase the maybe or and past? you Clinical kind Okay, been Dr. guess, mentioned the company as the Science that in have this from Cottle out the the the fact the data Xs in larger that what in specifically, won past, interested, Phase biologics Maurice Award, In I with believe Maria first

should that. answer probably I Well,

the the That's close response option administration or in give of and and which surgery. mean, or other is -- have this in striking. single extraordinarily either -- to you biologics, regularly with that is think expensive, I a only the the the is change the to this magnitude comes I SNOT-XX require thing very

outcome presentation done. statistics of think striking. it was was was at it kind probably six The So but I that robust. It was And to the measured, And were reason. exciting, the have main is well was scaled. months appropriately

did into create was validating, knowing space see and certainly One a to fact thanks, the see Yes. everything. that team delivery a did dose I've stood we Rob. for and that two went totally see and a the do that just formulation it a had product whole we response, rare our the -- really dose doing We we have study, not agree strengths think in scientific long and doses implants new whether drug the and scientific did development of can Lyra to a I the Maybe I and we to from It's time fact would we I really community. this to also thing, been because to response you it out. with and speaks that. really thing

I'd milestone. an I agree plan us give come it. you one could And together Asian update question, Congratulations the on guess your that for LianBio development kind of last partner? on effects

Corinne is This Sure. Noyes.

have commercialize to is We with that track how second in do progressing And on are and are and participation our submit the to, pleased the them we participate U.S. very of X shortly in the LianBio two and collaboration is the goal for with Phase them studies. after we

the Great. on progress. Congratulations

Thank you, Tim.

Thank you.

next from of the Hazlett Your line Bert question BTIG. comes from

is line open. now Your

Yes, thanks.

-- for Just two on my me progress well. as congratulations the

the and but regard with Just of about how XXX financial should to forward? given forward, plus It's that the two past be looking terms should about two million couple the you're efforts over we in efforts studies, with trajectory on should statements of And that of think the levels quarters, we major increase starting basis? $X what roughly three and XXX, going so, quarter-to-quarter thinking modeling? a of if materially been major R&D

Bert, is this Yes, Jason.

supply completed we've obviously to that by increase we given tail that off the the manufacturing clinical think trials. manufacturer, expect I offset our the transfer the in spending units contract expense tech to for to So

R&D, slight expect expenses. So overall well which in manufacturing a the clinical the, the as we our as uptick would obviously

So with on hand again, expect milestones. starting expected a I slight like cash three we given and would uptick, we're so the but that trials, feel

business We next of have the enough on cash year. through end will the

durability think data. your there, retreatment? make the kind would a rate rates per polyps you pretty effect patients that Or expect patient data, on Does make thoughts a you of and non-polyps? the or retreatment year XXX of numbers Terrific. that procedures terrific or your in general you. to that terms just either XXX, of does that steady make about with is you clinical XXX? about you is with How Thank And then think of question the undergo CRS the of with just either with scene

Yes.

turn we can too. perspective Corinne her over I start and and maybe get to So can then it

to So, durable see see about half in we we the excited a were did you response. patients, that

which is I numbers the small It's targeted some fact steroid, that which think and a tissue. dose of patients these anti-inflammatory, clear. to remodeling it speaks are potentially of getting the broad results really a consistent in then

have X. do this you we we that further X the So do evaluate Corinne? from to in Rob, as in extension do Phase And plan heard Phase to study.

Yes. the And emerged past but in with about that retreatment. assume always XX% year, that study and aligned around XX% early this would we data And one That we've interestingly might internally, I X.X per the that patients think patients one our get the wouldn't at shared point. get some uses year, one enough, LANTERN with from in assumption. a XX% directly first modeling need another need so but another of of

So we a And have we'll I use that. modify durable patients response. of some a that repeat mix think see and

Terrific. That's very helpful.

Just one more a question then for one. brief me,

You've additional not publications upcoming distant or nice very the additional had presentations and too other for intriguing based presentations. releases had we at on data XXX, in expect LANTERN should future? some We've data publications

conference which our Well, at next is… is COSM,

Yes.

they will conference. as be -- there. find in data, well will that, as We'll out hope find submitted soon soon if new but make hear all we've if we and available. presenting submitted that we some at we've out to that are accepted, we if So abstracts about data April And at goes they're some COSM

much. Outstanding. Thanks so

next from And the Chris Howerton from question of Jefferies. you. Thank your comes line

now Your line is open.

would timeline estimates you're or removal here be, I anyone programs you if but you're the seeing then LANTERN about, be see to clear unwilling for about so going would discussed unable as, team some effects questions. tissue that device? why the you remind would Dr. six of for the is enrollment Two Kern had could to or actually if that the XXX. or X else taking Thank Phase else this or there Thank curious And question after months just me, the that, And were kind there, study? on timelines on us the what could something of provide explain maybe one you. for for second additional it the Great. be what cadence the much be the expected durable thoughts think recently, we be to effects? of Is those something durable remodeling for

ahead Rob go and question Thank the the address you, can I'll one. and second first Chris. take then

will enrollment sites as thinking we we'll be enrolling not patients expect for to We ensure approximately about intend in months. trying be enroll sites as but We ENLIGHTEN-X happens. we'll We the patients we both through We're XX lot pick the also and that take think XXXX. can. a quickly Europe. only U.S., ENLIGHTEN-X have Clearly, in to to that that

hoping we we'll Rob? good So estimates that be possible. able to about feel we're those and accelerate as

and mean, encouraging very the a keep we study finding half Yes, not in Sure. but a with intriguing is to word chronic to sustain I it's this a dangerous the improvement. small that improvement, that need patients and mind is Cure cure. use disease. It's of obviously, really it's a

of of a can couple whole think the thing can out control. colds and spin of it You

encouraging, we get away. carried it So don't while it's

me you see. want -- what immunologist basic I put on. my hat science we the if I say think, to that don't could

don't away back. that, as a to their see is the biologics, I to you Before revert power, rebound they soon effect, get start what as despite drug the we take

my little The broader. again, steroids difference inflammatory cascade. little -- and biologics hat squelch They targets. The hat on the Now basically punched speculation much holes it. the my almost I've on. They're got in speculative like immunology are entire

we takes it, this years are of get some there is broadly are we that element remodeling and So to of back, that kind are my what so sense that we is doing, disease. suppressing turning

response. all inflammatory suppressing are aspects of the We

answers So the If that the we back are clock, perhaps question. walking

another as the XXX And maybe if you. well? give No, in do. for similar X I appreciate follow-up, just expectations Phase Maria, us really might study it, Dr. actually sneak you Thank I could I Kern,

there be two label There the of to feasibility. sort X be into and of going to randomized this to optimizing initiate the delivery two and study. of we're then We're parts is we're assessing study. to going the that, study going going the Phase after So to where the the month the portion be -- is part that going are the open procedure

And so in starting on we'll too. the be be then we'll going expect get U.S. in and Australia to focused but started XXX, is U.S. we're the then we with clearly

again, So XXXX in terms enrollment, will would that be it through of be enrolling that study.

Well, congratulations Okay. much you thank progress. All right. very and on the

Chris. Thank you,

Thank you. question Bank we Instructions] have a America. And coming from Verma of from [Operator Ashwani

now Your line open. is

taking thanks our the Hi, for on Two question. me. Congrats progress. for

So heard collaboration sure LianBio it, right. wanted to make this I just

X launch you're next of much think that can they and how the the year million launch? discussed. just after just payments Phase in That's you one on much you year the one their how and that the assumed be milestone will U.S. of I assuming that out first $XXX can And the question. approval would design my in in be around geographies And and

So identify good metrics. the like procedure, is like not enough part conduct a the I'm something you us want about with that that to around. retention you're to share of study, you like just bigger whether openly assuming the that is optimizing just the when with of or going

share that will if curious just you us? with So

your We'll and Corinne one. Jason Hi, Ash. you first can Thank start address for with the questions.

launch than U.S., after of development sooner launching timing plans So have our China, year. a current so to the about in the your China question shortly answer

-- and we would from payments. specifics similar dissimilar around the milestones, collaboration. haven't disclosed specifics the on of we overall LianBio it structure agreements. haven't I of the milestone the timing the the milestones say not But that released is the around And structure

the question of would the design is data there and assessing going share X expect on hand and from So half to whether Certainly, when what have really to data placement. it we're XXXX label. the be we'll and in Phase that second feasibility Ash, second able I of on your report out be we would about open the we

And data out. will be have so safety and certainly that whatever from we the reporting

Yes.

Okay. Got it. Thanks.

Thank you,

session that any hand it remarks. over the Ladies closing and gentlemen, Q&A I'll our Palasis, concludes Maria today. to back CEO for for

forward you thank and updating joining Operator, look progress. you you, We Thank today. to all on us our for

disconnect. day. may You now your Enjoy