Lyra Therapeutics (LYRA) 12 May 212021 Q1 Earnings call transcript

Welcome to the Lyra Therapeutics First Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode.

Following the management's prepared remarks, we will hold a Q&A session. [Operator Instructions].

As a reminder, this call is being recorded today. XXXX. XX, May like Stephen now the call conference I from to Gilmartin to Jasper Group. over would turn Please go ahead.

Thank you, operator.

Officer, XX, Maria Joining financial first us President Chief Officer, Officer, are and and Commercial released Senior Development, Lyra from XXXX. Chief Vice ended Financial Rob quarter Palasis; President Kern; on the Lyra and Corinne the call Chief Noyes. results today today, Don for Medical Elsey; March Strategy of Therapeutics Market Executive Early

this news be website, received Investor or would company's If list www.lyratherapeutics.com. to not you of future which the release, simply like found at go added distribution Lyra's have be Relations section to the to can releases, to receive please

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

Lyra financial And first you, Steven. call. quarter to welcome XXXX everyone Thank Therapeutics results conference

million goal providing physicians year of failing to patients. the are estimated options designed the Therapeutics' As effectiveness of medical by for the a management. with demonstrated, patients roughly US data from Officer, our X X introduced And Phase Phase X, Robert April. LYR-XXX we the the We with made the for Medical a will the the on we study Chief Spring our the with first fourth in transform be patients and rhinosinusitis solutions in Kern of Rob at treated which treatment platforms, underlying our for call. as disease which Lyra medical by as further intends this underserved them build modifying LYR-XXX Lyra chronic who use area for each first goal there best-in-class of LYR-XXX nose for paradigm and foundation, throat Lyra now in XXX is ENT half ear, an and reminder, of full quarter focus Lyra’s towards LANTERN is LYR-XXX presentation XTreo leading to has our are of Meetings that therapy. in company. treatment quarter to Combined and new progress their treatment and on appointment remember Dr. you CRS Otolaryngology Having current effective

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the opacification X.X to important that made highlights the CRS new X,XXX at remind one the reduced and medication, the we of control SNOT-XX patients be hand Only patients, dose intranasal of microgram non-polyp X,XXX COSM week a call in the for the difference need in microgram effective me treatment first manner I rescue score presentation. LYR-XXX been in microgram the to sinus in at X,XXX the patients XX. patient endpoint our significant clinical objective dose, which polyp period. achieve week Rob over improvement an Before improvement XX% symptom baseline XX imaging the LYR-XXX XXX% from points represent data two group minimal LYR-XXX found the and to compared CRS a clinically of time of pipeline, week control presented over to from improvements included seven the implant points. the achieving patient treatment. cover in The between study, also both XX rescue measuring of in you our dose-dependent Furthermore, population. non-polyp achieved a This with in compared to group pre-surgical required has let

Now into the development LYR-XXX to Kern. over to Rob? give and in further hand LYR-XXX, insight call our I clinical progress you Rob will

Thank you, Maria.

leveraging the moment Lyra through submission potential LYR-XXX forward approval. me continue we to to the clinical and a Therapeutics company. take LYR-XXX towards look and knowledge and thank NDA entire me Maria team and for experiences and the pipeline to my to an I welcoming as progress let First,

the study cardinal the facial pain, at the on In to score of CRS. polyps. shared nasal blockage, composite COSM, and at the discharge addition for surgical are prevalent CRS three of of included patients Lyra nasal the most LANTERN that score looked focused symptoms Lyra separately composite of a naive without which symptoms presented data an that analysis

p earlier as XX of three cardinal single improvement points at with a value score Looking and LYR-XXX control administration, statistically with significant at composite in these a to well. achieved at symptoms the X.XXX compared we time

three come the study into might the could goal that cardinal And symptoms the appropriate. for our what insight most a with of relevant study. we reminder, be be the pivotal most out endpoint was believe As to

will suite say to when meeting of our to dose clinical X preparing this on the study microgram initiate date we in Phase occur share also our previously operated a Leveraging from of achieved walk that success call Phase offerings. X We believe with CRS of Combined, to of the are commercial summarize will treating advantage half the this end to will products positive will matter versus offer for I hand LYR-XXX, the office. feedback more FDA. This into we results first-in-class majority We the the use current year, will patients financial Lyra's could and product LYR-XXX for patients. that, second we LYR-XXX to LYR-XXX first we Don X,XXX that now in for that over the quarter. have the be in ENT the key their LANTERN Phase that the LYR-XXX believe study. a X complete as of a Don? With

as same The Thank in with full. Starting with our the financial XXst, the was $X.X cash million today cash first $XX.X first were release for million. Net outlines we million $X.X quarter earnings to quarter operating Rob. results XXXX. first ended in Total the earlier loss period with you, and $X.X million compared XXXX. issued $XX.X expenses for our for quarter compared we December equivalents million, of balance, the

through not will the I this details So, full on go call.

of In XXXX. believe Lyra cash sufficient as fund through we and planned that previously into financial the we terms guidance has stated, company to operations

shares. XX March outstanding Finally, XXXX of as back million call the turn approximately XXth, Lyra With Maria. were I will shares that, to

Don. Thank you,

am progress, clinical X commencement and X been clinical FDA our the Again and installation completed, our will of year topline CMO report of second share Phase the of The of IND commencement study LYR-XXX infrastructure of first the which clinical contract highlights from is around In transfer of tech end. supplement I at addition with lot the of remainder in that pleased has the on resulted has end our the pharmacokinetic support the manufacturing we Lyra's to meeting and LYR-XXX. trial for the our to results to equipment manufacturer quarter, the the track. our manufacturing in Phase to

bit me approval is LYR-XXX a study and third and new company's little for will study enrolls The our for of and its US a XXX(b)(X) planned background. be up let critical PK the Before a questions, the I study for PK clinical drug regulatory open patients obtaining call talk component for application. through about XX strategy a

anticipate us In at plan what sharing top a should as you meeting terms at the we data results line high we this fall. present a announce, to to medical level of expect

for. results, In looking we terms of are

seen sites have and and safety pharmacokinetic a so Mometasone for Phase has XXX(b)(X) in facilitate The LYR-XXX our Phase that also the first US data given us for with trial in States X that Firstly, what conducted LYR-XXX is our trials. confirm X we and confirms US learnings our usability in-depth and information far for X Phase applicable LYR-XXX. pathway trial will United the experience

[ph], recall soon. anecdotal share from enroller in O As you with I questions. to Operator? now Dr. trial, With all the call it will the we're encouraging that, evidence comments for is PK up leading of study you the will the from the and open the excited

[Operator BTIG. Instructions] Hazlett of First from question line the comes from Robert

Your line now open. is

potential progress. about and congratulations is the point the the curious Perry on for question the for time Thanks Phase X trial. line Hi. Bert. upcoming This for the taking on I'm

seeing Just the Phase you're time time going it for terms interested You're at as thoughts point efficacy Is on time three both point any in? there in on well a CSS. of the points? currently more choosing how a as you're score LANTERN, based X? week about SNOT-XX a XX Is that

Yes. Perry. you, Thank

symptoms our weeks. efficacy Cardinal the XX we weeks, three at or the statistically certainly when see we significant XX and improvement look four cardinal So, weeks, XX we look when over results, at the SNOT-XX control symptoms, we out at

make And we moving later time so XX point sense. forward to certainly a well, to up would use is would weeks propose what

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is points. to use us make later for sense So those going certainly of to that time one

helpful. the Phase terms X months. Okay. that's the one of it's status I what the manufacturing and of for Thanks, trial, guess Maria. early, then over And do how and commercial the next guess, then readiness beyond readiness just that, And other up? on, then, I Phase few capabilities in question quite terms That's in very manufacturing progressing you build beyond anticipate of X but

Perry. Thanks,

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are up with them working the manufacturing. to We scale

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every our the are our And at week. so, contract engineers, manufacturer scientists

of millions Another is especially with to There's automation. as for That is patients the they're mentioned CRS. there in highlight of strong out us, very manufacturer key we selected commercial you going that be readiness.

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Great, thank continued forward Thanks. looking progress. to And you.

Perry. Thanks,

next Your comes of Bank from from question America. Gerberry the Jason line of

Your line open. is

good All evening. right,

perhaps, Just criteria polyp could non-polyps? get thinking the and Thanks. label how heading just both the broadest inclusion into of maybe you FDA points, ensure to the remind potential study agenda and variables, about key some you and us for meeting, you're size

Jason. Thanks,

mentioned, the foremost, we primary In Phase symptoms be terms II, endpoint. looking we'll studied. And at agenda, of it's we as the the Cardinal and in first

of we've that For three, and it and symptoms, when individual gives us at the presented symptoms the degree now significance. look published a composite as cardinal high also of we

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talking to a we a to it's will the time also, certainly, as key terms symptomatic the up talking the that'll some of that And about I FDA be be composite for weeks, point us. XX endpoints secondary be certainly later So the key of also mentioned, in we We'll be proposing. point, would disease. about time

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of of of is the number we And planned the to need terms have much -- terms XXX by size, going very again, patients. the approximately think In we for very driven are that we're We that strong. statistics exposures the statistics. in

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it? Great. so Got Thanks much.

Sure, thanks.

[Operator Chris of Instructions] from comes Your Jefferies. next the from question line Howerton

Your line is open.

progress question taking as you on well. Hey the there. and for congratulations Thank the

finalized then itself? last of the you So included you is be may maybe study operations took to know, that US specific may and know tweaks not to what the kind away trials planned curious the for in And that you. at how I design help or PK to that? from from product as, study? I'd is in of transfer me, understand the the this in had Phase all think, point? financial the the of and Are XXX and additional product us be maybe that experience been question the learnings what for have there I the And the conduct then question guidance to has III was, so such final in terms may Thank in features clinical respect the another forth -- what that design with Don, just included the

Chris. I'm turn experience question over then can about Rob. you, after the the to conduct Phase start the and study from and to Don And speak He III -- I'll going that. Thank design final with the US and learning it of then

dose product yes, same So, of the the to X,XXX It's -- dose dose that that final also the finalized. that it's safety and the that going have LYR-XXX microgram that dose. we that, efficacy the only as of in supporting we're the terms – Not is data what then design, and candidate. use we is but

tested don't in study. X X Phase into The that Rob? We be anticipate. we're will Phase what the all. carrying don't products forward any we we at tweaks So the expect

to great front Yeah, I attract want to and I the patients here. idea key American the my future our deal trial. don't of the are a think US of and acceptance the experience recruitment, able difficulty. But X in very ease in that whole the And the assertion, for the speak relative. were in ability the also the seats Phase a of US acquire readiness ease get and takeaways of I without lot the patients out of towards think, market, well readily to we

answer. XXX Don, factor clarify, about in just form that Maybe great. I before product? of – was I just Maria, to for Okay, you terms asking was the

I'm I sorry, that wondered afterwards.

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or cell We our size, platform. you as surface more Now, coverage. surface area that a know, less technology is which provides can alter coverage area the

microgram And of Does so that on question, planning designs we two will are taking your forward, the that designs those the hasn't on them. changed. X,XXX both answer have dose Chris? And

yes, it Thank you. does. Yeah,

All right.

Don, Sorry about the you to want do one? take that. next

Hello?

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

Your line is now open.

product only on X, you question, you the I'd Second as are at I'll when from sort on on at Lachlan -- X? to all just discussions planning for the of hold FDA outside And to questions. Tim, thanks you once of Don, of is got question. taking with factor obviously, now you the digging other gating from us then the for nailed kind aside And the focusing of validation around start at Hey, you'll the on are [ph] timeline the for US guess, regulators and I the meeting are and obviously, aligning Phase that? just design on hear love all. this you've Phase the the what's if last US Or that down, start starting trials, is with well for design, the CMO.

question. Hey, hi. the Thanks for

X so is question, Phase Lachlan your And items. the gating starting

running. protocol with protocol are that to use begin and approval, then then to submitted gating what cetera, that'll sites the study the it of do get to our the is, get and terms getting certainly we'll in FDA So going the final items et IRB up

And so the product that in site. certainly that's next parallel. And going be the to we'll have to be the to critical then, item getting is doing

outside the things, of focus your those of study. gating US. are the this on and So feel US very sites all we the Then, our about how And the about may fronts. have US, of all progressing in regulators on for things the confident of is we question that trial, terms start outside are

outside we pertains are trial. of And your perhaps then seeking the United commercialization outside now, in as in however, on right terms when we to the terms of So we is focused the US, the that States comment thing of be partnerships have mentioned other will US. that,

to something pursuing. are certainly we and that open are is that So,

Maria if is we can So this power done, little here. surge a jump in, had that about I sorry

trials correctly financial off the So if clinical cut that what contained I it, the correct? got I heard were in Is question guidance? before

assume. will I

correct. Yeah. was That

So, was Phase is that thing got two to patient X being talking the at the what Maria the XX. count that in about. we've that And approximate XXX four guidance for undertaken is

you. Thank Okay.

questions Instructions] at would [Operator There are turn conference like back now further Palasis. the no Maria this to, I time. to

Thank Operator. further begun we the as half we pipeline our build with plan year. upon second Lyra strong you, clinical the which to momentum, XXXX has in of

your thank I would Jefferies attend months, well the request call. meetings are is and way Bank the to also America, in those of we for participating very conferences, future here ability in LYR-XXX Blair coming of the for for all meaningful With in to confident Healthcare positioned and and In remain treated world. in like events. the an plan the and you during the in William elsewhere and US to welcome provide that, CRS We today's a difference LYR-XXX exciting

your concludes gentlemen, and today's participating. call. conference Thank this Ladies

You now disconnect. may