SPRO - Earnings call transcript Q1 2021 | Spero Therapeutics, Inc.

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Operator

Greetings and welcome to Spero Therapeutics First Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Ashley Robinson of Investor Relations.

Ashley Robinson

you participating thank call. today's and Joe all in for conference Thanks today, results first for financial Therapeutics quarter provided XXXX. Earlier released update and Spero a pipeline of the

is yet Spero the website. press have page Therapeutics' seen you the Investors' not release, If it available on of the

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

Ankit Mahadevia

highlights. us listening and our Ashley thanks to quarter joining you, financial our Thank corporate all for and to discuss results first

urinary commercial for all-oral the demonstrating for organization. is efforts primary all-IV not endpoint tract to acute showed of of and pyelonephritis results of cUTI Spero met was supported towards we of tebipenem continue infection reported late is AP. an an to work These a ertapenem that or to are to filing an execution the strategy inferior XXXX, regimen trial HBr we NDA advancement complicated the a positive that or results HBr progress which as These X regimen trial's of by with transition corporate our last Phase we As and tebipenem ADAPT-PO year. through focus the the major treatment

we Our the well-controlled to and plan the meet structure NDA and the was their with interactions. intend treatment the CMC as be to meeting us a such or This positive our support of all together set consistent regulatory trials and that these prior we form from the I'm previous all the clinical submit of the we our report approval and submission the data single in the cUTI that positive and previously of the and that feedback a communication hands, The standards. ADAPT-PO we for NDA NDA data AP. tebipenem need in submission could indicated of written submission HBr HBr the to has complete results pleased Today, on endorsed in that planned pivotal Drug half completed tebipenem is track NDA with indicated fact that interaction, guided. agency FDA with that of to pre-NDA to of for the in New recently as second year Application FDA sufficient keep received package interactions

of version supporting Now, IV medicine. IV? question trial as this is going of are filing, ADAPT-PO the an a comparison does another in goal important was of to in if an safety physicians powerful question payers the first oral option, this the cUTI. answer IV regarding an all-IV fundamental by the to addressed of We and ADAPT-PO have efficacy patients addition designing NDA all-oral versus receive compare head-to-head and of place that And to in oral the oral agent regimen question therapy the how to

nor include IV with the oral tebipenem physicians to cUTI give to and millions IV patients arm an lead therapy. of did in that the who evidence would ertapenem provide otherwise prescribe receive confidence arm AP tebipenem the we as we we to the in wanted HBr an step-down direct HBr needed oral IV Specifically, them not

just an therapy US convenience should alone carbapenem that any have therapies of an without could if done the for who would of currently and for we also are point AP now clinical cUTI we on oral X or patients approved, to options year we cUTI alternative based on over have a convenient compromises with that would other hospitalizations. believe and therapies. approved treatment prevent And oral patients resistant data, each outside and the potential current IV provide we tebipenem out available tolerability. only I as approval a HBr believe shorten in unnecessary data no the who response, make the treatment compelling HBr provide tebipenem and AP be tebipenem million As that we option our oral have of safety, these show important mentioned can before,

Moving on to clinical program. the would provide like on, I now some updates SPRXXX

Xa the studies the notified we holding trial this pause received the primates decision supported SPRXXX by further clinical primate us the or FDA the rats currently toxicology a well Xa positive to doses unexplained of non-human rats. clinical non-human in the that study, As analyzing ascending pause and -- for conducted data the non-tuberculous nonhuman the initiation third trial we discussed, Phase microbacterial clinical observed mortalities notice primate while I'm single as into we quarter. disease to adult say the also Alongside nonclinical were trial our conducting earnings clinical trial, Phase the those then from in led by are primate FDA a primates. last analyses. of last the trial study. to and advanced in In agency we we call study from at Xa our trials which the pleased Phase of submit patients with Phase study multiple trial, subsequently expect to data promptly studies report we request was as to The call, our nonhuman nonhuman since the long-term well while and in have toxicology as X of We end report NTM completed on last and year. of additional

intend the Based FDA that finalize continue analysis I rather until before SPRXXX clinical the to findings have and us that chance remain hypothesis program. a FDA share about with what continue we confident are seen provide dosing our our to we had to we review date than analyses, While supports drug-related can the feedback data say path forward mortalities wait determination. will on we data to from the the specific specific now is the to the the engage this, observed species we were that SPRXXX on and and we'll for has

COVID-XX would our strategy partners, Before provide to Spero amidst to talent the which handing David on our updates of to more execute manage successfully the I like allowed pipeline, the acknowledge and detailed ongoing us the and off to our business team pandemic. to dedication on our some call

that on from we We in our on help from a investments physicians with thus far any talent digitally and in the efforts, potential not the been remote to in have successful XXXX. connecting enable fully and impacts technology for benefit through early new medical notably workforce, in seen business launch been HBr. lead we've our made hiring successful tebipenem a affairs We've information material continue pandemic to

potential have them. Looking impact ahead we monitor business, year, our how has business for patients. stay an as forward, on to to to and will impacts deliver continue COVID-related work Though physicians this hasn't of we COVID-XX their diligently medicines it we'll impacted materially on had our

therapies turn community Unfortunately, is setting patients has the admissions hospital. the be patients to accelerating trend prevent months, physicians with leaves of XX-plus millions patients, of but within past in been IV in increasing no oral strongly the and often the Over for seeking the resistance treating choice therapy which prevalence existing to of hospital importance to both currently emphasized, treated the with if possible. cUTI of

turn would face. have HBr offer these with alternatives If no these approved, pandemic an financial outpatient capacity entry patient an hospital, enabling of prefer COVID-XX believe been joined foundations. thrilled by to and the treat option hospitalization. need This with has threats would unmet with a the shown along for as reduce with critical government innovative physicians to US is a indicated for a partners tebipenem current need of benefit corporate also ill highlighted and Department comprehensive Defense DTRA We if address patients, including BARDA, the medicines that to future solutions to with these the viable of shift the and current has they oral collaborative develop infections, and efforts other were developed biotech secondary policymakers could in hospital. and the agencies pandemic The in relationships companies we address the option. of available partnerships with conversations major We're and remain patients to we effective for approach private exposure exacerbated the outside to that patients physicians a offer This with such by the would by we Our as more to community our as our infectious discussed agencies, previously active future as threats. that well several pharmaceutical setting.

utility will of relates entered our pipeline. and partnership or data we With as to generate on further our into to additional the we will David Allergy with provide clinical a recently Additionally, update it National detailed our to NIAID, in new hand that, Infectious which a plans minutes on few more Institute ambitious over discuss now supporting the Diseases of a and I tebipenem. to progress it

David Melnick

year. tract cure great and data, X I'll tebipenem infections an will for Thank which is HBr NDA and provide our the including an urinary tebipenem, updates XX.X% expected complicated trial oral that be primary IV pre-specified NDA from IV and IV were these XX.X% end between results of the pipeline The in by demonstrating is at lead second overall other HBr, Together visits. of supported acute tebipenem recap ertapenem treatment patients a tebipenem combined towards endpoint the treatment, and both with to you, It's the the positive oral microbiologic brief the that pleasure of with Phase oral response in ertapenem, a pyelonephritis. advancing that for XX.X%. we to non-inferior begin with treatment saw at met rates our the Ankit. This To show of and clinical these the that's its test filing late margin non-inferiority the microbiological half share candidate oral ADAPT-PO ADAPT-PO by met data comparable of follow-up trial. rates of groups data, clinical of eradication cure today.

most in ertapenem. observed adverse tebipenem HBr events demonstrated safety is of XX% study. three frequency tolerability the cases no oral were of Importantly, treatment-emergent in were Clostridium ADAPT-PO fortunately, across and treatment-emergent diarrhea occurred with observed adverse in in while IV to similar of that has oral the infection, and The arm. that balanced across also headache frequency HBr And groups. events profile intravenous in the comparable arm cases were both arms. and type common reported a ertapenem difficile tebipenem With events deaths observed respect patients groups that to The both reported no with adverse were

In now X be data supporting the we data studies have in all that addition the Phase Phase of set, NDA. to incorporated in this robust from will X hand the

with to to Ankit, the of towards work patients design National ahead the blood Diseases feedback like With will is about partners continued caused to therapy format and by a in complicated be therapy This support MERINO-X in or Antibiotic a with external Group a XXXX. a a of the a Allergy need and over submit infections sponsored keeps tebipenem's HBr being of and ramp with receive to Leadership for take data leads to conducted carbapenem of would with treatment specifically excited to making Institute to by to entitled potential convenience sponsor therapy. safety executed by have study become patients of believe In intravenous IV study HBr perspective. This discussed as trial have potential As our provide antibiotics infections accomplished the move including the of that example I to track transition HBr decade that package talking to should concerns this regimen regarding comparison the complicated resistance commercialization. for who's an in We being treat tebipenem Seika, like parallel strong the data specifically to half ADAPT-PO believe give and tebipenem clinical the the submission. we increasingly Meiji all-IV to HBr's FDA for in goal ADAPT-PO an limited interest efforts the that treatment is we antibiotic formulation designed by and pre-NDA everyone strong oral on compromises ESBL-producing completed second from as use of the provides up or intend we start respect the to providing in opportunities without UTI, report indications. the NIAID oral sufficient the the provide UTI. compare head-to-head tebipenem The that meeting for launch ARLG. all-oral key a from a confidence moment have shown bacteria. infections also also to often I'll existing what content response that other leaders UTI. of important indicating well will to one capabilities hospitalization HBr. new broader about CMC from is of robust include of medical remind an safety manufacturing terms variety deliver replace partners Resistance of have with year. the would in hospital the therapies this HBr is planned ARLG versus of antibiotic explore expected antibiotic of as them by Infectious external we NDA, unmet these sooner. of be we've experienced alternative on as and the this We to by address mention the external I'd suffering to and of that NDA From to physicians than NDA recently invaluable we mean talk can past intravenous patients as trial oral to a tebipenem tebipenem options But clinical the our One granular get as opinion infections tebipenem therapy early continue utility our intravenous the stream validation other physician's we affairs tolerability. the with we to data fluoroquinolones. hospital decision critical innovative perspective, and oral This around briefly tebipenem we our strategy, forward antibiotic as of interest [ph] are will I home seen that us we

pneumonic In dosing tebipenem penetration the started trial assessing Phase set completed is addition, that BARDA lavage is has approved is including of the pneumonia. HBr and indications by to funded a lung data in study studies progress. formulation of the evaluate tebipenem children BARDA for has for in for we tebipenem the bronchoalveolar of I now orally HBr stage The December will administered analysis study strong the important treatment This and several in subsequent rationale funded of clinical the as Japan indications. with granular efficacy

educate a plan clinical continuing on results publication community HBr trial the of we ADAPT-PO forward, Looking of on detail. benefits through manuscript reporting tebipenem peer-reviewed the to the in

plan to we this gram-negative present well the prevalent additional we where Additionally, HBr of ADAPT-PO at surveillance as the assessing activity infectious will in-vitro as urology data diseases four have a year, tebipenem presence data conferences pathogens. against and

Moving In an study to SPRXXX This primate FDA unexplained drug parallel pulmonary mortalities had we the pause oral from had disease based this in requested in its came adult Earlier observed hold the that of a development information for clinical additional the our announced trial notified the in measure provide Phase clinical of IIa of the toxicology complete study agency primates. non-human a a trial study including in report. precautionary ongoing letter, decision our as on after treatment nonhuman NTM on to NTM dose-ranging patients. issued quarter, the hold this update on I'd SPRXXX, FDA we on like candidate infections. the

the since key a last seen moving to our this points. few I'd call, like on reiterate program Before we've to in developments discuss

with exposure. complexity primates drug SPRXXX correlate did or the dose, adult First, a very the analysis. of adds either be duration dose known to Further, to the of the which observed well are mortalities not to level non-human challenging

primate of SPRXXX SPRXXX. and dose and we XX- contrary participants in findings All reported. nonhuman are seen of the non-human Phase observe a adverse not prior I we in this and both the any study multiple prior SPRXXX single findings studies rats. include remarkable in pharmacokinetics tolerability orally have did including studies in pharmacology the completed studies study, a safety series ascending administered Finally, These of to were healthy of preclinical and what trial clinical evaluating events safety, toxicology volunteers. and and Furthermore, studies primates GLP of and IND-enabling non-clinical adult serious XX-day GLP no clinical

the the the and determination both study results from species feedback. Any the In ongoing if for we by or currently plan do had of analyzing study form chance data to the we'll whether SPRXXX study FDA. without last we an currently set the of and addition, Since of call the in to report. the the findings it the manner rats to toxicology or primate untoward have But completed ongoing administration our of complete of mortalities. in March, review related share of we preparing utilized which pharmacological in study specific follow Spero monkeys We're the provide this age is non-human oral events. gavage, unexplained mortality and observed FDA the review the and via as is not until a including data drug effect, has study cause these a to is

a for clinical like we However, confident now, on all of there we listening now data path the was lines, opinion remain IIa forward seen emphasize you decision indicative have to that to to and our that based of what I SPRXXX date, fact is would for program. I to is in the call the can success trial program. the our that discontinue not of Phase – on like again, we not I announced ultimate clinical regarding repeat, the Along these would this stress last say

the is far an to to potential avoid on one. FDA. species or trial gavage discontinue the following clinical Phase design The of from either thus trial, allows data future and the decision adjustments the than hypothesis dosing method strategic incurring to oral that the mortalities specific the facilitate the It a related were the monkey effect. make mentioned, Ankit study being us As off-target observed to rather to costs while review hold was II the pharmacologic with support it

dose. update FDA the last the we XXX submitting year. serious completed ahead, the Looking the We baumannii to its that at These to aeruginosa, part are our about has clearly the function against to further has anticipate extensively review and This all of announced gears agent, pathogen XXXX. has tests, significant polymixin at the will third WHO provide potential developed from unmet reported. data severe report to non-human had therapeutic Potentiator we was next-generation was address bacterial events the or regarding After nephrotoxicity consecutive plans by available the quarter with I list. in adverse polymixin carbapenemase-producing and its which changes needs priority tolerated feedback, that differentiated SPRXXX as to of drug Platform. clinically critical the healthy Phase and SPRXXX an of no a laboratory SPRXXX study above on dose is study the pseudomonas talk primate demonstrated IV of our agency antibiotics we the renal the opportunity drug-resistant milligrams of data strains that daily to activity Switching clinical Enterobacteriales, volunteer SPRXXX, development. lack as days now in Acinetobacter medical our on due XX including potent well showed for was provide or compared currently that data predictive or the it believe

our usage bacterial important Defense The they Everest bronchoalveolar as SPRXXX we of lavage BAL In into year, infected of assessing second are target the patient our in MDR a both Looking trial, impairment a the well study renal compartment medicine SPRXXX, at the quarter the study. to the development and pulmonary clinical penetration pathogens. Medicines. ahead, study I of to guide expect advance of to and with will we initiate continue as the population SPRXXX with the impairment of as partners support Department renal Phase

these study suffer infections to in demonstrate lung the from the tissue with renal impairment The infections, that extent lung will many patients As will XXX guide which penetrates many following function. dosing. have patients reduced of study the BAL MDR dosing kidney

report lavage the impairment early our bronchoalveolar Operating provide XXXX. tebipenem studies that, Cristina over will market by Officer, to strategy opportunity with the launch to potential HBr. and from Larkin, expect our for a you of renal detail of will With now for Cristina? our review I Chief turn the data We who call pipeline products and a

Cristina Larkin

afternoon Thank and you, good David, everyone.

clinical that for HBr in cUTI We market largest access been Our can success for believe to and economic for tebipenem teams that strategy both and and affairs well payers today. to large opportunity opportunity, benefits antibiotic and feel we have commercial market acute and medical we HBr the hard pyelonephritis. launch. are the the focused addresses positioned provide patients based anticipated that our And market working commercialization tebipenem our on the prepare

two are that there the million targets tebipenem if are patients for approved. fact, in it's In we HBr believe approximately excellent US that

therapy setting. and our resistant to care health noninferiority keep an focused effort Now, that demonstrated the oral And current option cUTI. community have on will hospital antibiotic will are the providers discharge the with has get community out setting the therapy that of help focus hospital, the or failed focus to patients hospital cUTI for our ability be on the initially to oral previous oral to IV is strategy the urology hospital discharge patients who by market, patients to giving out discharge The ertapenem. in sooner of

hospitalization our care our stay with Now resonated hospital reducing this and potentially value story payers today. in providers a a of health or has conversations avoiding

our regards reach of launch large allow this that focused very driven to in we strategy to patients, I urologists discussed. us to just specially portion and a a addressable capture significant IDs that these market believe Now, will on

have very is Now be target the showing us concentrated, a to is by by tends allowing supported focused that population specialists launch. strategy to typically seen and this patient research

hospital of how Now care payers, have interactions inform XX% if payer we've than into and it And community the interest strong will payers, better about HBr that our of received And indicated commercial discharge as based in setting. part a these approved, willingness fit value-based on cUTI there's tebipenem efforts, this in understand has the these the providers to has research feedback health interacted the health use care health the tebipenem. we indicate and to is indicated providers the XXX more providers to HBr that that potential pricing. lives covering care for treatment both And cover strong to and paradigm. tebipenem payers

care in Now, this can is due relevant of to including health large Phase our value all payers. HBr because showing patients that deliver and part tebipenem the strong III providers stakeholders and data, of

over antibiotics organizations. expertise our highlight and of products individuals to to the last deployed that I further for will two market years team. in part And last wait before start until to this been out be early and a be liaison that over our our we'll medical they've we organization. team build key deployed And force. sales the forward, to with deep one We key each our their Now and almost group approval medical our marketing, year, we want phased access the David leaders this ago set out filling to help of in looking mentioned has These is will we Ankit been the commercial launching advocacy started strategy. anticipate have new our our out in to year with hiring added both plan to a leadership take approach to opinion lastly, are them affairs closer out build and building And to out development. and this speaking we

time we Now ahead us are of believe and we for exciting well we positioned have success. a very that

will Sath, I'm you who Now, Sath? turn this, the over to update. of a financial with all provide to call going with

Sath Shukla

of compared Cristina the turn good XXXX you, revenue now I'd your the quarter grant results Total in XX, million, million Total financial higher first first for HBr. was through to in $X.X BARDA revenues quarter XXXX XXXX, revenue Thank our first the of same afternoon for quarter tebipenem due the was to with XXXX. of March like for of and XXXX. the contract to than everyone. $X.X ended attention received of quarter for period the Spero's overview revenue

reminder, committed have BARDA Defense $XX in total inclusive a approximately million of from funding DTRA. the million, funding $XX Agency Reduction As Threat currently nondilutive from we or of

option were accounted by million first from there of of is have million expenses Research part the $XX.X the XX to XXXX. XXXX, offset in the tebipenem of million, quarter by the decrease NDA BARDA. commitment second Phase HBr, million beyond committed the funding of BARDA filing We III for a development HBr. down of to in R&D for and for to This tebipenem winding expenses remains and investment of support for March as exercisable due of $XX.X compared for period year-over-year current primarily was that end same activities $XX.X $XX.X

than XXXX, expenses of efforts. and higher General to in support million expenses in include of quarter professional We HBr we costs period be to will in expect personnel-related company's the $X.X well and spend reported with administrative the the some were strategy, R&D to the NDA incur our and the note expected consistent pipeline. due to the development research XXXX, XXXX $X.X in relative as submission costs for support first same tebipenem expenses XXXX the affairs of as personnel to to related pre-commercial increased expenses primarily and XXXX. expect I that medical million

share, in to to we expect to relative HBr capabilities net and G&A a tebipenem support increase a XXXX, ended in commercial per for the for a of share reported million build in of $XX.X $XX.X XXXX as XXXX per first or of expenses loss the to same $X.XX $X.XX or XXXX. potential ahead common compared expansion We net reported common loss launch commercial quarter million, the the infrastructure XX, We March XXXX. period

our NDA million. As second marketable quarter be will had securities believe XXXX our commitments cash, to of we fund of with equivalents that and funding of tebipenem the together securities including cash March cash, of operations marketable XXXX, XX for existing equivalents the submission into and the sufficient We cash non-dilutive HBr. $XXX.X

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

Operator

be you. Our first Ritu session. proceed. Please is Baral Cowen. time, this of Instructions] a question-and-answer from Thank will [Operator At we question conducting

Ritu Baral

for issues the then any issues - from questions meeting, pre-NDA a from I Hi potential First follow-up. your Other have either there or of were guess any asked I or in Good your question, review guess agency? review guys. And going in expectations Thanks the question. arise? did your I taking afternoon surprises

Ankit Mahadevia

also And discussion. submit And planned basis reiterate the surprises and for the In most takeaways, from Yeah. on the and guidance short half of submission one our NDAs the to Ritu, no we've year. the Thanks endorsed we're plan there FDA our of the per that in Ritu of the to that before. Good the is I and pre-NDA second hear the you. CMC set the that on which structure data form important were from question. communicated meeting the track publicly

of outcome the with So we're that pleased meeting.

Ritu Baral

question. has fluoroquinolone the of is has, it it. community same? more tell social existential that guess norms cetera you such strategy can much of have distancing that then as rates commercial pretty the Got or guess impact patterns And far stayed key resistance et resistance other much of patterns has for tebipenem your this resistance as or an might cetera, et I changed in COVID quarantines, I But

Ankit Mahadevia

forward-looking The continues for Thanks short Yeah. Ritu. spectrum answer pace. march resistance is, extended the to the continued no of beta-lactam fluoroquinolone question and

keep public by nursing increasing and this -- both point work fact both to as continue to the add outside high of of have on accelerated existing has monitor continue I'd of as our study well hospitals STEWARD. We oral And and those data called pandemic And to mind to like that the the in well a surveillance that that to therapies. identifying we to own this facilities. appropriate settings doing are resistance care of see monitor surveillance under as most institutional levels both reviewing trend patients skilled

patients. pandemic a an accelerant good has for been understanding to to so And oral the for that options need there's these the

Ritu Baral

it. there. question going one last I'm in squeeze Got to

Just mortality nonhuman mentioned -- had clarification XXX primate. a the moving to there clarification, in of unexplained you that be may the and

goes rather issues. dosing that you dosing, dosing-specific methodology along there are mentioned species just along could you about specific had potential be the time oral issues to with trauma gavage? than You particularly By like like or referring talking that were that dosing with level? Is

Ankit Mahadevia

we've consistent Ritu about of method this. The can discussions adult these said what that's with primates public prior Yeah in administration to be problematic.

Ritu Baral

Yeah, it. the Appreciate questions. great. Thanks for all taking

Ankit Mahadevia

Thank you.

Operator

Thank you.

is Our Please Chen Cantor Fitzgerald. from of Louise next question proceed.

Louise Chen

this and thanks progress my question. Congratulations on for the Hi. taking quarter, all

what think with was, question by pharma We've and anti-infectives saw Pfizer companies you some notable acquire then in my seen and driven increasing So antifungals? an has large large Amplyx. first do recently pharma interest collaborations

are face around with thoughts on there the on Have just to the So side? how COVID you. resource Second process what challenges question And FDA had that curious will companies with you in constraints is, the faced is submission? you're Thank last manage any that experienced? launch? in your interactions your will has you I going had your your and their how through that ensure have same your FDA forward antibiotic the seeing NDA then you not delays in question Spero other

Ankit Mahadevia

Thank questions. take you in Louise. Thanks We'll order. the for them

for heavily a invest that So to drivers pharma we're need two is large observed trend in reminder the number new the infection. invest the same our for well societal partnering to is field. in pharma the broad options been that innovative as we've are as And this. starting There seeing of it relates yes and one One pandemic has medicines large of landscape.

to built differentiated an a opportunities clinically therapeutics finally we've for or building programs built portfolio either gained have for right both economically the it also around medicines. a pharmas makes and And big or vaccines. portfolio for COVID-XX traction address -- proposition value our important patients, several business around but Secondly, the [ph] pipeline, they've

And so we've noticed that interest.

discussions needs for example it relates authorization extremely we agency I'd within they've out our pandemic not we reviewing XXXX collaborative the of options to impact. on to also that the as to interactions As that of on that look they've the that that meet XXXX, to resource related constraints your guidance for question recent released March in they ahead, pandemic. the XX,XXX able be what been continue be also FDA as continues past recently well have requests FDA, those of over XX our to notes as had with date around the they impact of through to the have have note collaborative to March patients direct resource data the issued seen some second COVID and both with us

Japan by that covered the guidance the kind of of fact well of collaborative up the magnitude and have this And developing that have, in as a been that the relationship leg we we I start path that so, medicine on of a both And focused think the XX lot particular the has and us gives years, in head as market we've forward. the been a confidence agency the the for finally, issue. about

the question Now differentiated to why a that your about, tebipenem such is marketplace. to Cristina. third hand program in one I'll

Cristina Larkin

Yeah.

we're to economic want And in strong doesn't key think do that. think going market that to ultimately are today. proposition I on of where And this are patients the there's one one out hospitalization to things reason IV that. you going or to not one therapy. offers compete and that, hospital where a clinical here major leading One, important of patients clinical where hospitalization a that's generic or I is to are a do the And value and I a think, think That exist think to that's and key of most for we're going we're you an opportunity is which with economic the beginning generics. market avoid after agents offering. the I this get verge these looking I and about either with know that's that a talked don't where, to the the of compete differentiating advantages. we've they advantage feature And

second patient I seen that be where the that, to the drug discharge reimbursement the launch as be is model be will the model think a reimbursement of primary the for than of a that of antibiotics outside is different the is, for a primary referenced, the laws will going the patient like even last other tebi where over the decade, antibiotic that be just payer we've well for we as outside hospital, hospital. will hospital this

those importantly, launches in talk differences some I about key that we've seen. drivers, other we that the that So think will are of major be

Louise Chen

much. Thank you very

Operator

you. Thank

DeGeeter Our next question is from Kevin Please of proceed. Oppenheimer.

Kevin DeGeeter

R&D study. I Thanks. a we spend, about, the XXX, clinical of sort being the more XXXX, On abilities or on, item? really, for inventory is working how mentioned, And yeah, me. as tebipenem factored then, and kind you questions another of all two ongoing that we inventory Can some see Is potential would how suggested just and I they context that think around a of spend guidance into specifically anticipated David questions, when build, my that think provide some impact on taking just congrats and of whether, for address Thanks XXXX pre-launch of of decision should want as that rat Great. should Hey progress. there's guess, sort financial any FDA And context to maybe pre-launch hold us wrap-up? to data capital. we XXX? pre-launch that think cash-burn, to of the as making any to while about, think to

Ankit Mahadevia

for questions. agency, dialogue agency. have your the need I'll about, what quarter, the to need program dialogue to we Thanks first by the David which what a have about question Hi. a On with to will is third substantive we substantive mentioned that everything Thanks Kevin. reiterate, the the have expect with

our I'll to to question, about relates financials. your second pass it it to As Sath, talk

Sath Shukla

for Kevin Thanks, the Yeah. question.

will to the much a But majority of build the spend, in be XXXX to most be deferred the spend from like is the in of expectation facet will commercial Our laying personnel every later that larger supply. little part will start inventory of groundwork again. XXXX.

Kevin DeGeeter

Great. taking questions. Thanks my for

Operator

you. Thank

Hong question Berenberg. of Our proceed. Esther from is Please next

Esther Hong

questions Thanks for congratulations and my everything. taking on Hi.

And granted us recently you like? So animal patent new what patent use look guess, Can tox alternate an were I non I of in different tebipenem that would or for remind the -- look of on, Would SPRXXX Thanks. on species animal would it you like? -- HBr, age know patent. a tebipenem? you then, will the a what state. on just general, state

Ankit Mahadevia

objective Thanks. have third that, we the discussion by guess, the need is Thanks, I On exactly we'll have question, agency not our with Esther -- for quarter. first the questions. your what it's to substantive

haven't remarks we nor that an the that guided anything expectation, studies, need already. alternate We in we've to said our beyond one do we publicly have public any

second I'll it ask your As I'll patent talk it question, state. hand to our to -- Cristina about relates to

Cristina Larkin

Sure.

and you as year. us crystalline out good in -- that our salt was of recall, And on we its does form take XXXX. issued to that this granted So a memory, January were we patent

as as of You and we XX granted us guarantee may QIDP that well, gives well. a were years recall that of exclusivity

would those a So also are carry that pending patent as patent We areas two patent as formulation do around and to XXXX. actually of have us out protection well, our well.

an well, issued. when that's So area additional of protection added us for as

the us the protection So protection. an regulatory And that you what's of in ideas pending. additional what's carries I out that think branded some both, both, hopefully to then, around and will been IP XXXX, also, give extension

Esther Hong

Thanks. great. Okay,

Operator

you. Thank

Please Wainwright. question Selvaraju next of Ram proceed. from is Our H.C.

Ram Selvaraju

questions. much my very taking for Thanks Hi.

of that With just elaborate SPRXXX, be clinical -- I are ones XXXX. studies wondering information once yielding going and if next here. Just quick you a in could was the you early respect the have round on to of couple data to clinical conducting

initial can clinical the sets advances be to round the after frame the that agent report you data you. release of assuming of just time studies expect of kind Thank of you course the between If what and development, those stage these of initiation next the clarify to out? the next

Ankit Mahadevia

question. for Ram, the Thanks, Yes.

I'm -- asked are We glad XXX. about you

for they ventilated. XXX have for spectrum to well particular, are infections that highlights that a hospital need that they as patient antibiotics. They population. much how as can help as infections. options which often patients And broad us the studies also best ventilated patients of have will get die resistance Phase better -- antibiotics us we resistant they are patients co-infections patients, often unmet because need continue study come patients, COVID lot those of bacterial These place. of they to see the brought these X in for important, a because what bronchoalveolar the for lungs, and in die just important on We the to multi-drug be better guide need which into ventilated into those, XXX for who help patients first how see up reminder make lavage gets will be used the best how an

In what terms will XXX say with study in of what's be next, show patients what a infection we do. can to that, is it can

think We have David which start, some study, BAL data to the of the mentioned, study we before timing. a the inform will design the design on collect, I timing from studies study the and the could renal both Phase be and X because more will the definitive inform

Ram Selvaraju

linked drug report. assuming anything specific non-human the in there toxicology isn't primate And study with XXX, to Okay. the that to

the as another the FDA Xa exactly that trial might be and to take the do sense meaningful they it reviewing of else? clean And when of the concurs long logical dataset, in looks it lastly, Would context that assessing the other otherwise, it be any how for XXX? or same effectively clinical you. clean, what or of going study fact step report maintain restarting lift Phase to have Thank design if on study are Xa hold agency be follows something a of it XXX? then Phase to First report, the trial review is the you in that clinical would or next assuming the all, appropriate development that be clinical that will original

Ankit Mahadevia

for Ram, Yes, the question. thanks

note line our give to have relates formal to us that interaction. time we of days to a interaction have response, response after the a they mandated their it As XX

that that we we'll So know least. know at

and has agency on In have us the and their and review that we time been to for a far the data. But collaborative them that with our history the the a their it take something know what to of of terms a discussion study, timely that's overall stance responsiveness decision line will we requests. of thus we'll send with analysis need a restart as

that so, And that expect would continue. would we

but a the again, on of kind I study, As discussion have nature that it NTM to study burden and analysis, discussion the do drive to David as the we data to noted already When to in of I that, If seen that, dosing-specific a comment can we've specie-specific finalize explanation would to have FDA publicly see down of data. when to date, agent we as on does that that the need the dependent what with the supportive with of based -- think by agree FDA. patients. show XXX and But with our date. relates data certainly well we both disease be finalize that that, on discussed type single would agency caveat again the that's to and supported that's can we the as I the the what we

Ram Selvaraju

just quick and being one, submission one where actual approval in you when And occur, might regarding process that a the very you. of the U.S. the finalizing sense tebipenem. you of able Okay. Can anticipate name, give NDA us between drug? to disclose proposed the trade Thank

Ankit Mahadevia

to Cristina I'll to address. one, That hand

Cristina Larkin

Sure. Thanks.

and So components of the is acceptance trademark of there's the name. is other component obviously the a one that FDA different the couple

disclosed all works -- of data we're I a to later so we in be disclose later you of of that date. And the tell will at and that would some publicly that

Ram Selvaraju

Thank you.

Operator

will for this the participation day. and and Ladies gentlemen, session Thank end you. question-and-answer have today's you reached Thank and a conclude your the of have great we conference.

Spero Therapeutics (SPRO) 9 May 212021 Q1 Earnings call transcript