SPRO - Earnings call transcript Q4 2021 | Spero Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Spero Therapeutics Fourth Quarter and Year-End 2021 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being recorded, and a replay will be available.

You can find information on the replay and further information related to today's announcement on the Spero Therapeutics website at www.serotherapeutics.com. At this time, I would like to turn the call over to Ted Jenkins, Vice President, Investor Relations at Spero Therapeutics. Mr. ahead. go please Jenkins,

Ted Jenkins

and and This all financial afternoon, pipeline fourth provided operator, today's results participating conference a quarter the for call. Spero update year thank you, XXXX. for you in and full Thank Therapeutics released

on release of the Investor press website. Our the Therapeutics page available is Spero

about on progress the timing and HBr clinical trials; studies, that the plans potential from Before and Mahadevia, expectations, across forward-looking that today's sales this thereof. conference and date anticipated and statements of not statements the guarantee Officer. statements Such the nondilutive future potential by the anticipated of initially sufficiency on and of research oral development of this company's statements of The such and conference are the of payer studies agencies the and the company's expenses. contain and HBr, SEC, the Melnick, payments Officer; Cristina could of are Dr. detail potential of of that, the assessment its go from Officer; the Ankit. Executive XX-K Risk channels including resources as tebipenem the like and over and HBr of future to differ contained royalties David of the to our SPRXXX the could report the about forward-looking timing milestone from call and Ankit annual availability Form the ongoing for administration. preclinical including as contribute Chief release pandemic well design, differences SPRXXX of Dr. business of undertakes Chief for be information actual initiation, a clinical the With in HBr Chief of filed funding the those in forward-looking supply Shukla, any you Operating our materially receipt update impact commercialization patients Sat I'd or in development company's demand FDA we news to Mahadevia. regarding release filings funded after information forecast management's turn today. intravenous the to company's These of company and on remind operations or cause commercialization, statements. of SPRXXX, awards. the no Several Financial additional only of preclinical the ahead, trials Spero programs. contained call Participating with number like on future Officer; the as results and speak Larkin, cash on results Dr. the shift for current timing, Ankit I'd Therapeutics' and development in the Medical its in are forward-looking to The treated treating tebipenem our any and patients factors company governmental based statements date call. the Please generally. COVID-XX of market publicly results could The pricing statements section obligation company's of new cash begin, Factors to and launch tebipenem in beyond Chief today's such in of such performance, potential call, described expected Also access the HBr, of some in broad the approval tebipenem and call HBr tebipenem tebipenem by expected the

Ankit Mahadevia

first we'll corporate notice received preclude candidate, with the a hotlines. thanks Starting start today and Thank We joining results our all lead fourth our discuss for you, year to XXXX financial Ted, to quarter tebipenem full from -- product us and HBr. review and labeling final decision the of as this a it that of and reflect commitments stating time. not review. This on efficiencies post-marketing ongoing ongoing that is that its discussion does notice NDA of clear identified FDA's FDA part our at has

X-month the also that discussions which review proposed XX. period, to We of scheduled are requests. PDUFA comes date There the necessary, months labeling remaining initiate post-marketing of was three the and/or note the planned this on at any and application's midpoint if commitment before June requirements date

early If time FDA sufficient dialogue to scheduled We satisfaction, the progress for discussions continue the path be we'll labeling PMR active as the forward given best with we continue be to originally review as believe how and in period, to time them to done the those have occur. an we frame, can. PDUFA there anti-PMC were within with existing would discussions on quickly to this FDA, can tebipenem collaborate

disclosed We any issues detail and regarding the to expect review discussions these seek FDA to opportunity discussions. weeks, in today. will meeting in where the coming can we what cycle additional understand that occur beyond the have continued We with note a review since we late India greater there we've ongoing. are also Please for isn't depth share that of

the next we of will to doing forward look update call, discussions on provide as that earnings an FDA, able. Given as or and with timing ongoing the soon our we we're before our

infections informed oral tract have for patients complicated FDA microorganisms certain As of the pyelonephritis package Upon a to pleased FDA may approval urinary who by NDA HBr treatment advisory designation. We an the for acceptance, is as grant review. committee of initially part seeking oral were reminder, decided including hold India caused options. this a adult NDA that tablets that limited review the the in tebipenem we treatment were priority

discussions, As advisory the cUTI unmet and appropriate potential part after not has need alleviate infections FDA hospitalizations is avoid IV faster transition approved, help if the to or address needed. therapy. committee meeting Tebipenem, our significant a patients home is important ongoing of

primary foundation its endpoint tebipenem in meeting of ADAPT-PO patients strength from tebipenem treatment in statistically the by with the specified protocol that intravenous tract urinary the patients as previously with complicated trial. and is showed or believe the AP. demonstrating or cUTI, oral Phase the that to the our noninferior, of infections data The in continue our data pyelonephritis HBr acute announced was We application. of trial X These

tebipenem to the oral our benefits health data provide the provide beneficial the on if free in IV care are would FDA, of patients setting. expecting therapy. underscored in turn, the capacity that early pandemic. that a only oral head-to-head or compromises tolerability. for for but with the results viable ADAPT-PO treatment designed to by to it IV an the physicians oral trial appropriate of by payers in the without response, NDA, An not This could from cUTI. would in prescribe QX. those tebipenem patients the and will can cUTI. tebipenem peer place the We the shifting in no approval comparison We an making was needed was safety any up of be of regimen trial therapy of This, believe during first shows potentially to versus a oral ADAPT-PO supports the outpatient for providers journal confidence alike review care tebipenem as only HBr publication treatment it approved We believe COVID-XX to high-impact patients, make alternatives need with HBr hospital available clinical the

cover from the to tebipenem group. of would have their by bodes well value patients payers willingness from tebipenem's have HBr, therapeutic. hospital to responses outside presented notably expressed for tebipenem encouraged physicians by received who the benefit could This date occur an proposition with from we the which are feedback We and cUTI diagnosis-related who oral

the briefly SPRXXX. attention our like to turn recap now I'd let's program's to momentum. Now growing

or At submission report that XXXX, As was mortalities you primate data hold the start in trial NHP treatment were inclusive by NTM, announced related. recall, we the disease, detailed observed. in which the placed hypothesis supported clinical not mycobacterial the observe a on study from FDA that to hold may with toxicology of our were FDA causality February study. Phase analysis the analyses following a in clinical review with of drug mortalities toxicology SPRXXX nontubercuous XXXX, following a with These nonhuman of study Xa to from patients lifted comprehensive

initiative. U.S. milestones Pfizer to develop, year. made in were as last engage licensing to a rights Asia commercialize significant with in FDA's to to the part the agreement, Phase protocol In of ex will the product David for the the agreement licensing also territories. an speak and half million SBXXX year. breakthrough candidate pleased We very lift about Spero next-generation hold, agency more also by our engaged design received in trial, are the of which second with expect we've plans pleased We equity investment and with received the the SPRXXX, of $XX the entering X Pfizer a decision which to ex the growth begin finalize this we manufacture shortly. and and into Pfizer, tandem upcoming to Pfizer study

results lavage line X also SPRXXX We study. top announced from as positive Phase a bronchoalveolar

SPRXXX impaired renally Finally, we patients. successfully completed of our in trial

With impairment in thrilled development. program the support complementary and pipeline. to diverse industry further would engagement progress in leaders sets. and I ongoing to clinical the FDA renal BAL skill we've with our highlight who made move are like can recent forward to now are the hand, data individuals appointments some we making with welcome We're these

versus for and One recently two biotech this as launch product in SVP executing Specialty of and as their building these of decades October. over our Sales experience Spero leaders joined of David industry Access who is sales. events has industry Musselman, and most Market past David VP responsible the was

is in to science Human in valuable commercial additions in with Cerevel has our this experience, in global financial important to both XXXX, investors working the the resource We the life Officer, external Chief depth capital the professional XX understanding pipeline. companies member sheet to also Brady We're and as previous our recently of to for Directors. Board. we been strategies our Affairs as environment guiding U.S. a our Sanofi, has fortunate balance strategy Congress. Therapeutics' deeply and space, in to providing part position validation Trigoni to to for Biogen to external years raises We experience due our Kathleen also have strong of Officer. involved add a brought spent Jamie her staff a for our successful while of team, will which senior support two their payer our Board cash foundation. Resource he's transition organizations. engagement our human on deep appointed added over Alongside together in high-quality at This perspective on Corporate Kathleen of also Jamie believe these working leadership in Chief

up SPRXXX. The to first and licensing of which agreement came worth tebipenem a after $XX With $XXX front, million the the milestones being advancement of prespecified tebipenem's investment Healthcare made million we at these into Partners. is flexibility alongside million, up programs. entering upon agreement couple transaction, raises Royalty receiving streams was by agreement of mentioned, equity for provides Healthcare balance $XX from upside, sheet This non mutual HBr previously months our HBr further and with million a launch completion was and equity to Pfizer strengthened as anticipated the a financing Royalty with and and this and revenue agreement, of approval A Partners. investment, a securing $XX million this we preserved significant premium interest on $XX believe financial the we while support of SPRXXX cUTI SPRXXX which

significant achieve that to partners, to pipeline. continued detailed of Conway David serve we months. to the the made I'll Lastly, in came the now Spero that, more number and With over pandemic. on and we to update and midst investigators our provide patients QX, it during ongoing our progress a clinical who employees, to of our the COVID-XX contributions milestones hand I'd the went past like during considerable acknowledge on older Despite importantly,

David Melnick

pleasure ramp lead afternoon In our updates speaking I and that you, and pipeline up with to candidate, efforts our HBr. the to in commercialization, be focus by for listening CMC path work Ankit, our continue to my capabilities. our regulatory all our It's those I'll to with point we preparation of Thank And continue tebipenem today. will with to would forward you. like begin share good FDA parallel near-term all approval. to Ankit's reiterate potential working towards advancing a about

this who transition have we of part Seika, commercial organization. these manufacturing We believe Meiji experience as that efforts, instrumental are manufacturing will As working of experience a granular last a partners decade. be formulation we with over to extensive the tebipenem such as

of needs We and work our refine are external the the our also continuing of to to clinicians. partnerships with community clinical understanding forge

and And ADAPT-PO plans. high-impact a team far, a major Ankit IX. in as results noted and medical in disease are We taking about majority over expecting approach neurologists early health so the journal peer-reviewed multifaceted XXX with earlier, here as physicians our and has publication the affairs trial of also the and regional very national infectious a excited pending we of are interacted

results impact. to an million. One and related this together contract a in activities This which increased interest XXXX, option orderly that [indiscernible] complicated $XX.X external a in tebipenem, awarded new area, BARDA a are additional efforts awarded total strong support result Spire ways treatment the cinetobacter. Our January Spero to as designed pediatric could broaden patients this was exercising including an in UTI administered we with development potential potential therapeutic value $XX.X which funding adding to interest BARDA in have the in for advance to to of recent tebipenem to and in ADAPT-PO and with came originally contract acute clinical by example up trial of when million its produced was

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on to continued year gram-negative early oral blood compare the which being and trial, antibiotic this is patients trial, ESBL-positive Institute Another remains is MERINO-X therapy sponsored by of the and to resistance dosing which efforts begin which is designed National the tebipenem transition caused to group these by Allergy This leadership infections important bacteria. by in stream example of Diseases. Infectious is IV HBr to conducted with carbapenem track

States. NTM drugs up to with affects of that Treatment associated rare clinical disease. therapy devastating development, that of the mycobacterial talk are BARDA-funded XX,XXX year, and current standard orphan the about This combination eagerness no under with requires on speak is I'd also a care with treatment are about for lift the address. the into months demonstrated. transition indication range a with last that in clinic now data trial in upcoming aim successfully unapproved or activity Phase and to NTM a our development of data XX emphasize the species in of prolonged often of Phase to the these medical to infections. aim toxicity we people around spoke the later United like SPRXXX's oral hold, need Since treatment mostly completed about our already XX algorithm the doses unmet tolerability issues. into planning Through can and clinical support there providing Ankit this this We back use believe in we they at of HBr we therapy. anticipate antibiotics assessing the improve profile and hypothesis X tolerability therapeutic nontuberculous by and tebipenem penetration as show X our development FDA's plans the and SPRXXX pulmonary convenient lung for presenting has approved to year. oral drug and against meeting we our a demonstrate oral specifically of the I'll favorable Additionally, getting of where Currently, NTM candidate about NTM an patients been SPRXXX preclinical we well-tolerated

Looking initiate currently forward, SPRXXX X half year. the are the to Phase this trial we second in of preparing

study We with are to the the get running up FDA parallel of our specifics in working regarding CROs engaged design. have and and

path favorable with say can plan study is provide will showing infection. measures discontinued the The pharmacokinetic we the utilize While guide FDA that NTM of upon potentially what design efficacy specific microbiologic key well patients a function. measure recent and endpoints by profiles to we approval. goal prior of the how To burden that this, the now, a could include results, trial to also that to intend elements demonstrating it outcome patients to I of incorporate of build guidance and premature is in accomplish safety would signal as but design as be we SPRXXX's streamline clinical to feel as clinical

X now demonstrated pathogens. for dosing exposures the include the minimum from We SPRXXX penetration Phase lung half targeted treated critically administered that above milligrams. when lung are bacteria its prior XXX therapeutic cinetobacter, older bacteria pathogens SPRXXX tolerated multidrug-resistant that spectrum infections. This inhibitory a was built suffer and combinations serious of daily is other findings showed we gram-negative BAL, the drug-resistant a patients nephrotoxicity Results upon infected bronchoalveolar by a February, XXXX times concentration broad pseudomonas CDC's Such when membrane A well past with results as very lack antibiotic-resistant line enterobacteriales at or producing of interactions predictive objective Resistance X-hour carbapenemase, multidrug-resistant patients that report bacterial polymyxin in Antibiotic at act suffering the gram-negative infections In interval. important contrast, preclinical they against organisms, potential three Through a is long on directly the from drug its gram-negative our bacterial approximately often for assess dose for demonstrated estimates the This XX,XXX polymyxins infections trial. drug-resistant lavage, caused clinical to currently need Turning from clinical for pseudomonas every therapy against States drug-resistant with wide-ranging trial infections with potent candidate. and SPRXXX in patients. SPRXXX infections Acinetobacter key of may these this X levels. prior top in United cases year. our was we have Threats results next-generation a to the development, has of the SPRXXX, to it and treatment polymyxins suffering and intend the drug-resistant that well-tolerated you metric fulfill nephrotoxicity drug-resistant replace could to X,XXX safer trial alternative from SPRXXX with the gram-negative and offer efficacy Phase through activity with studies. for therapy impact with many and a the as administered patients associated believe realize carbapenem-resistant designed achieved intravenously entire from outer these SPRXXX paradigm older in are including

including Chief will patients kidney our analysis. data nonclinical clinical of pharmacology SPRXXX. hospital-acquired for forward, the any and multidrug-resistant and be our developed recently impairment engage designed now these safety which a with program X to reduced adjustments We're the will pleased after and patients who infections to completion turn to final ongoing We launch of detail be we market dosage will renal products for Cristina to HBr. into a the Operating are trials detailed having potential advancing support ventilator-associated SPRXXX regulators of inform our of strategy infections completed Phase Officer, our our life-threatening With PK dosing Also, will to very you SPRXXX Larkin, that, as and for findings, studies review next impairment The for Cristina, patients development with plan with with recommendations, strategy pneumonia. over step the and call I of pipeline function. further advancement provide study over gathered tebipenem with with renal pulmonary such for you. opportunity final

Cristina Larkin

Thank with progress you of to so discuss it's HBr. much, evening this be the David, pleasure to a and tebipenem you

building a commercial for we launch a focused a plan launch is for that transformative organization to cUTI. treatment and preparation believe Our be readiness creating on best-in-class

million to conditions in community or new for to HBr effective with oral patients of the treatment We for the the one an U.S. from leading There the ongoing than the We care most every building in cycling that infectious common estimated FDA last the providers, crisis therapy often avoid significant years, one treatment ineffective that treatment face as cUTI. the XX launch could are tebipenem through our limited options. of outpatient move three annually on patients who And we've have patients during now years oral patients common resistance five in challenging E.coli, of in been for out increased for their bacteria since work no out today. plans and new, the process seen cUTI. health infections. oral the to to setting, rounds care have made These or the health cUTI continue threefold. review more for of the for forward problematic cUTI X this attempts these a cUTI. and every times have a benefit unapproved of patients And we with are is had treat for face providers It's to most disease multiple XX challenges we a of and health approved in cUTI one medications hospitalization most hospital safe

to with to the that competitive accounting last we XX% while to the U.S. of of and have As thought hospitalist; advocacy early the approaches key trial specialists a and right community focused and our health health and the ensuring a we early the We've patient urologists, reach we adoption drive setting prepare innovative bring talented setting. capital the use the in market our raise these we including three, one, state to education components: the campaign experienced key XXX hospital. to to have tenant investment. two, in care a leadership planned and and share targeted and concentrated voice in awareness to drive believe offers and our through launch, on we We need. resources, respect access community are with frequency carbapenem look hospitals, also and to of digital have and providers of care IDs unmet disease less distinct the both work use completed and with care with practitioners, can XX,XXX sales health use and of ensuring that three market; we This for We With urologist, disease engaged building targeting reach in confirmed support practitioner the hospitals infectious hospital first profiling carbon affordability. ensuring ensuring and XX% fluoroquinolone, for force of oral physicians our representatives. awareness XX% appropriate over sales approximately as and cUTI leaders and community

health has about commercial to resilience potential returned HCPs. could providers numbers, play pre-co-XX with current still a factor our completely as to asked not Now future access and in and care engagement often we're

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We need balance opinion have carbapenem very perspective to with hear unmet of key relied in heavily our the on responsible leaders use the their oral U.S. to on introducing market the the first

We dose health have an principles care in to oral aligned significant outcomes with rational and health resistance. gut numerous optimal selection microbiome manner responsibly bring tebipenem work study. development reducing clinical in TI. has care preclinical Tebipenem investment suboptimal clinical efforts stewardship strong that oral antimicrobial with inappropriate unnecessary carbapenem a a supports use from potentially Spire's demonstrating and by in public the supporting is and sector of well studies, health focused to PK/PD directly a resulting hospitalizations, potential tebipenem's that Extensive for therapy includes low the stewardship.

material care on a both patients. in and unmet tebipenem specialists patient appropriate educational that need appropriate And educational use high principles Inclusive other and deployment the to with addition, hospital stewardship provider concentrated settings. have In tools, health planned the the patient antibiotic education to identification and community finally, the for stewardship monitor in resistance programs. a expansive surveillance and and we of antibiotic, tracking use tools are of

of antibiotics, are All including a ensuring the new focused use oral all responsible efforts on of carbapenem. these

of component third been affordability. The ensuring has access and our and strategy final

through continue We make to engaging our with information pre-approval our payers progress exchange.

at The patients. choice members medication to for with field and the allow to encouraging which the account and their give of targeted what us these national as opportunity IV than better that cUTI like An and and understand in ineffective needed infections of avoid to the the makers their heard team the treatment and payers. serious consistent Further, coverage appropriate carbapenem unmet meetings payers oral potentially is had an need Our quickly. hospitalization decision home, novel to large opportunity setting now the formulary allows at oral market decisions meet dialogue safer it tebipenem community opportunity oral have access cUTI cycling are would we therapies. treatment, to XX% for has through understand for make understand in information the has for regional lower like more research. previously with been products cost with these a prescribed patients care need with also They

we With our can that, as team access for call now place services a with finalizing conclusion, you will for a Sath, plans cUTI building our focus financial therapies to thing prepare the treat be way organization the easily So in affordability. and we patient I'll of commercial so unnecessary therapies the that Sath? who we we dispense launch a has turn commercial the launch, that timely tebipenem tactics or in transforming provide In our past. can patients forward on ensure avoiding with that oral IV over to and hospitalization in are to update. out look and a of best-in-class effect

Sath Shukla

like for turn XXXX the of good XX, ended quarter financial of $XX.X revenue of client was the was revenue in Spero's for compared year compared agencies. BARDA due revenue to $X.X due full Phase in your of SPRXXX overview fourth due Pfizer to XX, from and SPRXXX. and increase parties, and were $XX.X the Thank significant and year increased Research XXXX. for I'd year the and candidates in to XXXX to with expenses tebipenem agreements the compared relating higher XXXX. for million year XXXX. to fourth third was from offset related to the HBr, for $XX development headcount. clinical and under year for compared $XX.X same grants pipeline December ended development for now year Epris license trial period ended and Total everyone. for the XX, related Spero's and XXXX, full decreased collaboration The direct composed than XX, contracts million the million headcount. with million development activities mix start-up for December relating to $X.X in government increase results Total to ended same $X.X Research expenses our increase agreements for from various related December of and with an the primarily attention costs Total revenues company's ended of fourth period revenue of for for XXXX, costs $XX.X to the by completion million XXXX the the XXXX, year-over-year revenues million of DoD to collaboration This increased you, quarter expenses Medicines. to December received the and and the was XXXX. XXXX the million reimbursement Cristina, with SPRXXX afternoon, tebipenem increased research December were development X an XX, fourth million quarter quarter costs revenue HBr at was to research

General the year expenses in million with and the XXXX, headcount reported XXXX, increased of quarter increased full and $XX.X to ended forward, expenses XXXX, expenses support and we of than the for to pre-commercial flat to were candidates. our of support fees and expect compared XXXX, to due we administrative million to administrative the to year as Looking research December professional the to pipeline XXXX higher in and December XXXX expenses activities and of growth compared the and growth XXXX were for million same primarily million development due XXXX period support the to increased business. activities to in fees $X.X headcount remain fourth professional relative and in $XX.X the General business. continue XX, again, relatively pre-commercial XX, $XX for ended

Looking increase XXXX administrative and forward, to in relative that expect XXXX. expenses general we will

our or for to As potential XXXX in respectively. of capabilities per continue $X.XX $XX.X XX, launch a loss $XX.X share, million per $X.XX the and December and our same and and per tebipenem $XX.X million common common respectively. loss of fourth the and expand We $X.XX million $X.XX in or $XX.X were Net share, periods share million quarter year net commercial build ended we XXXX, for a and commercial infrastructure reported XXXX.

the the December cash, projections, existing equivalents had cash and committed As its together million. XX, and of believes to in funding with forecast marketable Royalty its payments of and Healthcare $XX XXXX. operating upfront upon proceeds such payment contract This Partners capital financing such cash, If million financing Spero payable payable expenses of in BARDA the agreement Royalty under agreement have funding interest XXXX, additional the with marketable million approval should quarter tebipenem sufficient upfront sufficient under other into agreement Spero second funding $XX from securities, on $XX the of and commitments, under the requirements current expenditure milestone XXXX. equivalents be the cash proceeds non-dilated will milestone Based received excluded, includes fourth financing from million Healthcare $XXX.X fund are additional HBr into revenue Partners that we its half XXXX. of securities and and

questions. open on Operator? please XX-K our to the filed like refer further would the for details today. our call We For to financials, now with SEC

Operator

ahead. Chen Instructions] [Operator go with today first from The Louise question Cantor. Please comes

Louise Chen

So the I update. questions FDA few had a on

could and your And XXXX? about on the labeling Just you I you discussion you curious this May the is, much update notice? what or question of received requirements are what when FDA know with potential talk post-marketing you general? most since deficiencies interaction likely preclude specifics, before of the Secondly, can't third outcomes kind have in how had get

Ankit Mahadevia

question. thanks the We for understand and Louise, the much interest of empathize into with review. so the the in substance going completely deeper

going should we're the of be do what on providing front much hand we late integrity next we us. will FDA main dialogue in the an questions to protect which go in to us topics better want our happen mid-May. with those understand discussions at for seek the now, is are in as commitment to our ongoing weeks, And we be FDA update review secondly, that able highlighted be the coming of no the One to commit ongoing two to opportunity to meeting we discussions. give not deeper will As cycle What deeper mentioned is and a earnings call, reasons. call, later those into than right will

Operator

Ritu The Please question next comes with ahead. Cowen. Baral go from

Ritu Baral

to is you it a need enough you follow-ups. even of a FDA like have think of And addressing -- you really before deficiencies that based that you topics much now lot deficiencies or do it have on communication is Or of the topics know you those how so, start the date? say the know the if have I addressing you to much do understanding One, from FDA now? really, start to more clarity couple do to how are fair And deficiencies. right what then the how

Ankit Mahadevia

and interaction on the Yes. that at It's colleagues and Thanks, have would the of Ritu, subjects one I earnings gone priority of would NDA them this prior within the we've calls our continue process application benefits in a to variety on. to as frequent continue we a that active of say, FDA. has with I review. said question. engage with for we the say

able why do them go update and weeks seek we then here commit the as much to seek do is have understanding we appropriate coming we to want the provide reasons to this we'll process deeper the be with of respect is to at that real with address ongoing back one. need FDA. time. because updates of more that we subject won't And the again, discuss in to dialogue, give to a and we deeply and want do do deeper We second, come because One a time. you dialogue But deeper understand substantive to

Ritu Baral

it. Got

more like essentially, weeks addressing over you that April, deficiency is can't like start start following sounds it need to fair? you in So even the the

Ankit Mahadevia

understanding, are picture as you that time. variety with the No. say them more are. I of need all more to have to where the agency. real steps of engagement that have said, the agency for a again, next we we give would engaged We topics. of of we the build with and with what comprehensive I me on dialogue We respectful ongoing a Further, -- we we information that be like do want

and problem. will tell more So can And we soon say we a working as as more. rest assured, we're have a fulsome you picture,

Ritu Baral

Got or new couple requested recently months, of the analysis? you like any have safety full last it. any In data Was submitted? update the submitted

Ankit Mahadevia

well. go as the we've won't we that collaborative I minute basis At engagement them and much question very for productive to Like kind FDA, data where back continue had mean, with forth. said, of on into and the deeper of I correspond time. we've We the the the submitted. a that thanks with same mechanics of

As we you've collaborative that are noted, discussion. having

working are the We problem.

we've a coming weeks. the We as picture will give in you to clarity more have done comprehensive

Ritu Baral

you I in prep in meantime? And change are planning in the spend for any QX it. meantime, Got commercial guess, the

Ankit Mahadevia

launch and you think me, and to that invest undertaking I from about the Well, to for from heard activities should approved. Cristina we're prepare tebipenem be thinking we're continuing precommercial

Ritu Baral

But aspects all has Have or guess, at anything sort that of prep. the been or the postponed of changed like rate of I they certain, that?

Ankit Mahadevia

have We're for CONSOL, clinician out preparing for deliver post is need engage key -- best out the as approved. the clinicians tebipenem the tebipenem, mapping I laid priorities as with mean, launch, how to preparing and we've payers educating colleagues to the about that unmet our well

in and we are activities continue to invest ongoing, them. those of All

Operator

Berenberg. next The Please question Hong from go Esther with comes ahead.

Esther Hong

at where during FDA? is are just where And shift how generally? review And some your in first of then terms that So that the discussions with is point? question occurs a would typically late-cycle what

Ankit Mahadevia

great a Thanks asking question. for Esther. that's Yes, it,

you're I in our that late June, that is March. we're sitting think alluding date one to is late in PDUFA and point here

an period. with that the late through on we've us to review the about the agency topics during is make be engaging with meeting review halfway point the continued And important that opportunity to cycle on engage We that another are planned for you period. review them

to decisional prior opportunity in that gives remarks and continued find forward. want we late including work colleagues us dialogue deliberative to agencies, So what that with collaborative and a from our to visit them with collaboratively phase our continue right I is the a cycle are an to emphasize the and path phase not in

Operator

next [Operator Please H.C. Selvaraju with go Wainwright. question Instructions] The ahead. comes Ram from

Unidentified Analyst

This any, what presented H.C. research, HBr later to We is tebipenem if Wainwright. prior new [Matt] to representing this market the PDUFA be were date wondering at the investment year. community Ram might

Ankit Mahadevia

Larkin, I best question. that my the will pass who for to answer Thanks Cristina that. colleague, can

Cristina Larkin

do in closer we an can the when continues patients. attitude and more data part some that and a to plan of I appropriate bit all data clinicians. behavioral prescribe utilizing the full that access quite that interest it what to us, is We've from readiness for see have, the to understanding of The as get which unmet closer where mapping plans the is related our one, our to I as Yes. PDUFA to trial of appropriate and as to is of think, our usage And of understand done actually which high we Thanks you is great available. Ram. we for research all for And second an our commercialization and market need to tebipenem reinforce, it's a we'd we date. we research of be launch, think product, their tebipenem able start that -- can to get question, share market about so the the relates more targeting some

Unidentified Analyst

signed with And can there Pfizer current us activities And regional involving are partnerships near-term Okay. undertaking on the be is SPRXXX? other elements refresh pipeline? you any to Great. of likely the

Ankit Mahadevia

question. Great

are strategically, of for partners the we as first commercialize right we pipeline. the help calls, we've on point, on U.S. in tebipenem prior the in and for So mentioned about continuing preparing rest focusing U.S., tebipenem launch are to to us to ex as the the committed think

we As for opportunistically have you Pfizer SPRXXX. delighted partners -- have know, rightly partners and the to we're will great and for look SPRXXX, in Everest right

that collaborating on. it relates activities is us with the to Pfizer As

the Satya activities. equity supports -- that Firstly, in company as overall as they've mentioned, made our we an investment

study. well efforts Defense, Secondly, variety Phase of a on give the a certainly, the their thoughtful, activities at the ongoing milestones on SPRXXX advance as nonwood as and which X investment opportunity of our colleagues SPRXXX they've and of in support collaborative activities provided us ongoing Department for financing, ongoing including a help the very development the to us NIH

Operator

next DeGeeter question ahead. Kevin Oppenheimer. from The comes Please with go

Kevin DeGeeter

of off of that Maybe all, in FDA whether specific X wondering on to one guidance XXX that looking fee in expand probable to could the will some being upcoming XXXX off capture with update the you guidance be XXX recent David's of plus appreciate of regard kick the of aspects base, first I But incorporation on you comments XXX. the study half on program. second the Phase and FDA design. to

Ankit Mahadevia

the question. you. Kevin, I'll pass the to David, question Thanks, for

Cristina Larkin

with Yes. end, the very we're We're health. clean bill as patients -- I to -- back excited project the and into in with at collaboration lift about getting worked hold FDA the hard in of said, clinical we a

forward. we're So moving

about trials structure similar listing hint you it design. won't you prior that look in to refer the of trial, the somewhat clinic if think I for will the study, I'd

coverage of that the longer We have of study. toxicology the of take fact now advantage that a we duration to potentially extend duration will

opportunity interested I only think for not clinical Phase importantly, to has the that different extremely we to it NTM as gives that and problem. at studies plan in of microbiologic X study become will but us an outcome measures endpoints FDA number assess look a endpoints, approaches

Kevin DeGeeter

under draw approval $XX potential does time to structure. that to scenarios, then under different remind that to drug $XX line regard time us exercise with by to you specific HBr next a million tranche the change? royalty And helpful. access Really approval Great. Can needs financing next tebipenem the million whether or

Sath Shukla

tranche. Thanks would say. And approval been million $XX Kevin. is year that's question, Tebipenem think end what for I requires Sath. This I qualify by disclosed and the for the additional that's of Yes. the to that

Operator

I This Dr. conference the remarks. back turn would concludes our closing over Mahadevia like any for question-and-answer to to session.

Ankit Mahadevia

forward Thank our We that operator, have the joined and updated keep continued look you, all everyone of go. today. advancement as and we thanks to to we'll us pipeline,

Operator

you Thank now today's conference presentation. The concluded. attending has for

You disconnect. may now

Spero Therapeutics (SPRO) 1 Apr 222021 Q4 Earnings call transcript