Lyra Therapeutics (LYRA) 10 Aug 212021 Q2 Earnings call transcript

Welcome to the Lyra Therapeutics Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s prepared remarks, there will be a question-and-answer session. [Operator Instructions] Now, I’ll turn the call over to Ms. Stephanie Marks with Argot Partners. ahead. go Please

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

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

this Thank and for well. doing you you us I joining thank everyone afternoon. hope is all Stephanie,

other program. successful a results with We support End-of-Phase into we LianBio, released Lyra, and very lead entered licensing from X and data our positive for our the reported a FDA been study, XXX(b)(X) X top-line application quarter Phase study, for in has we one with the PK exciting which had the for LANTERN Greater Second Asian we full markets an China a drug new from LYR-XXX. agreement set meeting positive

are polymer in successfully we platform, fundamentals and against Our our is The drug position our upcoming are science. proprietary to foundation strong milestones. which execute in a chemistry is company and technology formulation XTreo grounded our of

Our the manage target interventions, to directly are product for therapeutics potent month chronic which highly illnesses. pharmacologic candidates of disease to site

right amount effects. the place Lyra’s distinct a drug Phase indications for of for others chronic translates patients the to Lyra major the of provides X symptom many at indication, from CRS, field. as patients study LANTERN randomized advantage the a of Deep technology expertise validation CRS avoidance expertise deliver over capability to been strong we design, significance have our single just that in point, demonstrated of now first statistical months or inflection two LYR-XXX our first rhinosinusitis is providing high suffering controlled, clearly with six relief treatment. works a with and us our formulation with increased drug systemic a of side for and core the ability has improved right over years. benefits into right efficacy, Our number This including developed compliance of potential time a in

CRS vastly completely treated not candidate patients of product least underserved current described this We has patients landscape Chronic as those our in them. to in year. treatment LYR-XXX Asia who is population. LYR-XXX pipeline under transform ENT of and epidemic and need our are to programs the X as therapeutic We're strong is surgery. at by effective those new for uniquely seeking for do want position This CRS both a an about a XXX,XXX XX patients eager ENTs, who The for We and both know addressing around the provide returning CRS, Of only medical year, particularly candidates, unrecognized the for to physician the have millions enormously half of year after end medical to CRS avoid believe have those derisk of including preparations each both and we Lyra’s LYR-XXX to have of now the US, X unmet designed candidates are of to go in surgery. and current been is dynamics treatment people need globally rhinosinusitis Phase patient safe of to address into patients, remain failed Phase community for X, a LYR-XXX to patients clinical treated. million this X option million are sign treatment apply to management current those ones underserved the market. treated therapies CRS failed penetrated a deepened the who the undertreated. patients spectrum bring designed million market CRS into advance an Similar these them Europe. only millions on about under but by the up invasive are rest treatments. with patients of CRS surgery, will full in broad and each are the surgery the

recent Chair the a will the you our review with unmet have will a the developments. broad truly date type give CRS, and pharmacologic potential. benefit Robert regulatory the building products relationships ENT that of and this patients. Northwestern’s best-in-class can purposeful data are Officer we're in Medical in and our generated insight As of Rob? positioning that space clinic, had ENT remain that this products chance dominant ourselves We current to this player Dr his of treatment in been tremendous the confident no of our create the to have There see, interventions, we department us opportunity. we've share community, millions into Chief need strong be that for design CRS and to landscape Kern,

to can options, procedure, therapies potential fact patients tissue the a thus with for relief six and of fit drug of therapeutic and the the symptom majority attest continuously the of Maria. can day anti you, a Mometasone the administration with anatomy matter up have into truly a surgeons CRS inflammatory months. Thank is simple for vast invasive approved exerting medical we I highly the chronic treat anti I CRS FDA no suffering In change to unoperated few to LYR-XXX and designed rhinosinusitis. period has paradigm. and patients that single non maximum patient. every with potent an provide time, office relief very a Consequently, furoate prolonged patients sinonasal to the treatment patients. for of delivers for minutes, LYR-XXX affected maximum directly to in LYR-XXX effect

epicenter of X.X are not eliminating avoid surgery. thus to the who and the drug to patients, the oral the the corticosteroids. directly will of certainly issue Furthermore, yet sinusitis patient systemic had which with major standard a the major believe become and need with are and million XX% effects, products deliver designed designed I failed have for Eliminating our are the LYR-XXX patients products addressing treatments. current the have CRS costly the to three issue sinus to biologics care medical compliance, side potential Our of area. limitations of a affected washout to also drug topical for management,

LYR-XXX. majority size has patients For products available XX% a have LYR-XXX the the LYR designed help currently treat that, the I'm office cavity, and of and LYR-XXX, these of have patients had million, option up prefer residual usually obvious, that XX% -- the their of operating is LYR-XXX patients, management third. patient important are products a patients whereas our polyps. disease. ones Lyra manage and this to X.X again, an and to cases, XXX remaining I majority treatment, to avoid would have target for of recurrent an avoid first, and seek CRS it's address other – that polyps, that symptom months the in recurrent who and for note enlarged It’s than of The to simple into are requires breadth fit surgery firsthand not a designed patients rather or CRS is mind developed to sinus no CRS providing without whether including know seems but to available population, Keep CRS medical to surgery. only we. been in created been to second surgery LYR-XXX this sorry, about and surgery, furoate XXX six vast ongoing space that, those eluting the prior have patients most And surgery. curative second of symptoms. with relief mometasone matrix in provide

for a potential to believe introduction As these disease. represent CRS I the patients, important the in void to and approach the landscape medical over XXX the a most result, potential care corticosteroids in novel and that since advance truly of XXX CRS ago. intranasal XX years we the have believe to the this fill have products the differentiated treatment burdensome with

Phase a As with for we the LRY-XXX. pivotal forward on company positive following in the reported meeting clear has X our FDA, path our June, now in program a

a Phase sorry, Our our X view – we been highly has the I'm de-risked study we as X was Phase result. that X and upcoming successful, Phase the significantly has upcoming view

Phase these XX and composite will at patients blockage, CRS program to the blinded The multicenter So pain. patient XXX treatments, that medical continue dose a mirror trial. will These will and CRS randomized will of have X single trials And The at program consist the cardinal evaluating Phase controlled facial be discharge of XXX patients nasal of three microgram X the weeks. of symptoms be failed that endpoint approximately with largely trial. symptomatic. nasal two pivotal score per are program XXX primary

As a at week LANTERN microgram dose value significant control showed study of at X Phase XXX statistically this highly reminder, LYR-XXX, with XX. X.XXX it's the endpoint, P a over improvement in

PK pharmacokinetic There positive from reported top of in recently two results study also line are We takeaways important LYR-XXX. the this trial.

breaches is providing XXX(b)(X) to support data pathway. a safety The approval first

point address that XXXX fully Don of to XX second the in was and the of during unique our The financials. believe LYR-XXX fall the this well-positioned this will CRS the the We potential and is large four of was that current treatment Lyra -- next Don? study US is with rates weeks, have alter high across the disruptive LY infection. market products to midst underserved that discuss in COVID states first of the just enrolled landscape.

Rob. full. you, release in we earnings outlines The our financial results issued Thank today

has increase period XX Lyra we was to our million. here. December fund So FDA cash million our into in to cash the compared with trial by driven believe $XX second million call quarter by with Lyra’s meeting. and second XXXX. back a wrapped XXXX. sufficient same the of the $XX.X as planned Phase quarter that, $XX.X with shares. loss the company transfer XX, our as for This June expenses compared to and Lyra-XXX only ended up as quarter the Net cash summary I'll I'll outstanding, operations, XXXX. for Total XX, was second XXXX program through operations tech Starting We we approximately prepared X provide turn clinical that Maria. And shares were and were for of million, million with equivalents, million, for operating $XX.X $X.X the

Thank you, Don.

clinical year. our heard all from next we sufficiently through forward As funded Don, you programs drive are to

We in are an exciting at inflection evolution. Lyra’s point

have validation programs. important We're manufacturing on already strong our have are the our for Preparations indication the and advancing and several technology clinical We our two first horizon. catalysts of clinical product. underway

I'm on initiate trial to into pleased CRS. Australia recently we end We that of announce around this two studies X remain We US. have for begin our LYR-XXX, will also already the then in clinical the to clinical received which to year. Phase approval selected our expand track

the to risk, The trial confident deep for first our and stellar programs in With do LYR-XXX. our X team ability expertise, and execute. X and these highly regulatory for LYR-XXX significantly Phase Phase I'm clinical of our both

data XXXX the towards and trials from readout from We the XXXX. begin expect XXX we'll of in the XXX end seeing trials

bring addition, progress meaningful In through with to our partnership. and to are LYR-XXX ability we Asia making LianBio the team confident are our in

patients. their moderated of leading Dr. Otolaryngology XX, an Rob of with have and The by dive be Medicine. the impact include and events could Vice into We will will Carolina Luong, be two Amber physicians, management North ENT for Chair of significant event and deep August Professor KOL term. treatment the landscape how additional CRS at and Tuesday, School current of On hosting University near event a LYR-XXX XXX in we

And to Additional participation. soon. details forward will follow we look your

Rhinology leading conducting for preclinical and have podium data work abstracts Allergy has publication very we leading high of acknowledged been which and commitment we publication has selected of at excited data and the of American the from the clinical and American We've in as recently Journal Allergy. of to accepted in by LANTERN validation two was Monologic by LANTERN proud Study the The Academy and Meeting will journals. set top had of Also, have presentation of term our and and the long in are accepted American Otolaryngology science quality scientific the We the for Lyra present Society full journals. International two of the at a our accepted been form Annual the are further we study with LYR-XXX, our society received research from October. LYR-XXX, and Brainology for PK publications up and work full the the follow There abstract. acceptance two

will they shortly. be expect a way long we've We very both proud what and of available We've accomplished. I'm come online

We of your has technology now to take can to concrete product begin the three which And We CRS, range leverage lead be broad for important future. and our our XTreo to pipeline our Lyra’s potential safety only provide steps and validation this we'd diseases. to a data efficacy not platform, for technology It's that chronic of expand studies. across for for take wide understand happy have demonstrated products also but questions. the to clinical our now

BTIG. first [Operator Bert Instructions] question Our from is Hazlett from

line now open. Your is

so for questions. A Yes, of couple thank the you for me. taking them

Lyra-XXX, I'd then of another ask And more regard pace with kind the up one size of First of I'll the spend? little that. to all, provide on secondly, color like study bit Then, just with to things could like you endpoints a after R&D about follow that?

Hi, Bert. you're I Hey. hope doing well.

that have have so able the It'll to larger approximately metrics are kinetics be So, XXXX we've dose developed estimate designed symptoms the who We study. both with be going it's via past, XXX dose for same had in We'll cardinal that control the to patients that mentioned and symptoms. release to that XX the the we'll SNOT-XX arms evaluating going doing opposed anatomy. characterizing and to say, safety. We're And is be the of we'll been pharmacokinetics, aligned had three same then, score and drugs. assessing micrograms, surgery, also study. have I the to patients LYR-XXX. drugs of evaluating, the larger pharmacokinetics there's also be with that group. a three again, CRS we as the designs to in And have two We're be

commercial Lyra thoughts term and/or there implications? infrastructure pace of some of for recently, other R&D spend to means then, been near-term, the in the in M&A strategic regard has Terrific. the the and is love question sector I'd your That longer my with maybe what kind and that on, other

the do of Don, the spend? to address on R&D right. you question pace want All

Bert. Hi. Sure.

we tech of basically, will continue, similar The given lot done We less today, first a operations little at start levels that the that somewhat R&D out So, as transfer balance includes then, work as and And Tech clinical to are in that spends we've clinical the the look latter transfer up, off, half. toward here through of going the that we've operations. today. is year. the maybe know bit six a recruitment, the course, up course in the both, basically through probably they and it's you as level months treatment. and Once got got quarter the its Then of pick-up start to to following sites part the We've running. first the then, all then, of of once continue year. anticipate, of patient we'll I pick trial, of and during that. sit

generally level the Tech a of as getting with commercial on spike the a ops and are part little a of will of of off. course, the year a And But end to should operations at the for of approach the the clinical sites ready off. leveling So, and then, continue first it somewhat for clinical we material. bit year pace all into year-end start material. supply

your gone color. to with then, love that in Terrific, on I'd the sector? And what of and I mean regard some Lyra on appreciate the M&A it for thoughts the might has

I'll take that Bert, and Corinne, want opportunity. can to if respect you with the color you commercial add some

been So is really there saying is was We've news an is Medtronic announcement market vastly for that under think penetrated. the that acquiring huge us. ENT, which Intersect and we the great

the aggressively doesn't to that the market, At of in that we'll also steps note point. And like suspect to will overlap with you'd be LYR-XXX really we agrees I We when When participate get think be taken anything Corinne, has we you have market. intersects fully the which share Medtronic add. so, Medtronic sort address products. to market. get the important it's to we apparently ENT don't us that, to of point, lion's benefit do more the and same developing time, to will overlap that able

No.

benefit. think differentiated we all it And validates in can different I think, products marketplace. exactly we're what we patient they're positioned population doing trying work leverage of a and will from that the right, to that's be targeting what their do and uniquely are our to benefit really

it's news. great So

Terrific, very the get thank you I'll back much, in queue.

Blair. from question And Lugo from is our William Tim next

line Your open. is

on differentiated quarter. helpful, my day, how the for thank XXX the Dr. given up for always question biologics. the your you be a congratulations for R&D question CRS experience upcoming very but also maybe and in Kern, from comment, setting Thanks all Then patients on can during the taking treating progress you will are those

XXX at biologics, from between which is division? to the I'd but Street still how love and between isn't respective a trading looking opportunities there's the think unusual I the big disconnect a hear

be have have I surgery failed nasal the are and going and to Sure. who really, mean biologics failed only speaking extensive practically have applied to surgery patients polyps.

chunk their million So XXX,XXX. pretty probably by you're they're the about a at talking of at market. small patients, X looking We're admission about own looking

the first step. So that's

hurdles second are drug the life. huge but a The systemic there's to basically products year you know rest from and thing effects, they're powerful, they companies going those is side there biologics, approval $XX,XXX with be systemic that, $XX,XXX, of are insurance very the for patient's for

live what commit. of patients Patients at to, – of massive continue like that And with nasal it. symptomatic that opposite the we're and steroids vast are nasal don't for is really opposed using XXX the to patients at majority completely talking have had about a level, patients. that's more end surgeries, So have effective, we're of the yet market. an looking it's or disease stage product. no but they aren't And it's They as entry steroids end an steroid the there

in patients the So, also out. from simple procedure, and from minimal a company. insurance There's the it's and patient office really and commitment

So, apples I they're kind this, that don't know I to really I but your me. so fully of it's questions. live and answered obvious oranges

No, there? like? of kind maybe kind maybe or similar pivoting the you the a environment also study and look wants states maybe XXX(b)(X) of talk agreements a pathway to the this. just Should to the there? about guess regulatory the going prevalence in Maria versus you, And What Is address there whoever LianBio the that's Israel is and Thank I very to you. helpful. Can [ph]. program clinical

Tim, hi.

to it I'll Corinne, turn I'll that you. and take So, over then

Okay.

are So and very se, they environment, going with collaboration terms of the progressing. US be per process LianBio question? how about but on don't our up the with pleased would regulatory we're in leverage follow China, And you commercial going so to very to is are things confident data have we're has the agreement been well, in like that. the Corinne, a to XXX(b)(X) we very able

Sure.

the with concentrated medical to sales, with that where CRS, we option for the treatment. So, outpatient management, patients China as if that roughly with right is following there around similar surgery XX excited patients there's very go management and potential is it's in hospital only the the – after that we that captured putting say to large what they have the medical in in the least short in about place, we're than in a approval. we're China, in can what very are even States other over not those China now what know larger development a United are other XX% order setting patients. market so treatment the we what States. in know know is that there And plan at patients looks And pattern is same that United for exists starting access territories, of US The very in exists percentage, million we a treatment

that. for Thank you

[Operator Instructions] America. Verma Our next Bank question is from from Ashwani of

is line Your open.

Bank is America. This Hi. taking Thanks for Ashwani, our questions. of

couple been So follow-ups earlier. of has discussed to what

there on you payments So the your criteria plan Phase question. some X? any milestone? for that -- X, the LianBio around bio conduct on based to these Phase have any is just Separately, Is follow-up after regarding timing does difference have LianBio in another and milestone So had the you what that? between LYR-XXX, – color conduct operations to first inclusion/exclusion I $XXX that. so or that versus my of activity the That's million

Ash. Hi,

the -- the X you were because successful. we We that the for rescue endpoints, Phase of that, results stop had COVID the we of X know But as the was inclusion/exclusion, cardinal were the in now symptom, the of trial program it very very SNOT-XX to statistical short. able the Regarding and trial despite Phase many trial XXX with also to significance as medication. pleased see

the are that inclusion/exclusion X, Phase X to we Phase trial. as mirroring So,

we the cardinal study. in study One will recall X the symptoms the Phase is measured four Phase things of different, the that as you in be X

primary be looking is individual we did but the symptoms to endpoint in cardinal going be the three Phase X, as the at will We the symptoms.

using. the we'll be be that that'll So composite

that US, the in did radiation We note, CT concerns reason was Another standard. is of different However, burden did that due outside is US And about Phase really the we MRI the the the did to imaging. we in X. imaging

rather talking question very then payments. clinical than And But doing both we'll So that payments are said milestone a CT MRI. US regulatory the in trial. commercial and really other the publicly, than payments, that, the is on in we've about similar was be Asia. we're What and the milestone next

we more given any really specifics. haven't that beyond So

Yes.

-- Okay. wanted I so that. back OpEx. I'm to go on just to

I just think new of I is R&D that think operations understand. that tech Don, by you that two that, mentioned bit -- curious the by and clinical like Have spend. above given we and breakdown a the transfer on any little so line you run the could chance we those be given lines G&A rate also can came can expectations,

lines? First run I'm that will the That be category. bit drove that along indicative that those we going there but than say, and spending question, there things be respect little that probably expand said, material general increase breakdown really QX look with clearly as rate. to get consider additional there administrative. our a and forward a in will China category, that of not We not granular particularly between With some some run episodically, haven't. have what some like of new there. come it's on there, that part to spending being higher, intention would I given activities a we to are rate couple that not It's and of necessarily

Yeah.

Thank Great. so Okay. you much.

You bet.

good CEO. so eye Thanks we our us a make you. progress. now the look joining to details about you to back would like I turn further updating upcoming for out Palasis, for Have much this Thank Please time. conference again. Maria forward event. today. showing am keep evening. no Thank at an We I KOL Ms. as to you questions

this you concludes Thank participation your have Thank you day. a and for conference. for wonderful and presenters. gentlemen Ladies today's

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