SPRO - Earnings call transcript Q2 2020 | Spero Therapeutics, Inc.

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Operator

Greetings, and welcome to the Spero Therapeutics Second Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Sharon Klahre. Thank you.

You may begin.

Sharon Klahre

Great. thank for and conference in operator, call. you, you participating all today’s Thank Therapeutics and XXXX. financial update today, released Earlier Spero results second ended for quarter provided June XX, the pipeline a

press If not Investor of Therapeutics’ you Spero available yet the page have website. on release, seen the it’s

that, DiPalma, Medical Chief Officer; and Mahadevia. of Ankit David Ankit. actual Officer; Larkin, a company Financial we in in results like our any such Spero information obligation contain ahead, ahead company call and conference that Ankit or those speak not with you may release no the the statements differences of differ Steve today’s from turn to in like forward-looking based on materially to Before expectations. as These to Executive Therapeutics’ and that Chief to over Dr. and call. information Spero Such Officer. the new such Operating are conference could of date Cristina from begin, Officer; to Dr. go on of contained Chief SEC. Chief of contribute the Mahadevia, detail factors supply statements. in statements this I’d Melnick, current Dr. the undertakes Several With or release the Participating and company’s update forward-looking contained news the in today’s remind performance some filing I’d publicly regarding the statements guarantee date release call press call call, are and are after and Interim described the forward-looking the Please forward-looking go cause only statements

Ankit Mahadevia

make pipeline. We afternoon, good appreciate continues today. joining advancing its and in Spero progress you Sharon, you, significant us everyone. Thank to

quarter, infections it’s line are from point. urinary Phase to are which, HBr third our its tebipenem to patient enable blinded and trial if we data the of enrollment physicians top the confidence successful, oral we track patient for complete with we report designed that completing, based us trial, in commercial for of our file in this head-to-head to trials the a remains at approval will facilitate evolution trial, Phase that ertapenem, tebipenem HBr The will together the in for second complicated were happy ADAPT-PO prescribe quarter. company. regulatory on to versus the If called in which tebipenem and positive IV is evaluation a I evidence In We U.S. outcomes. III remain to follow-up tebipenem to to approved, stage the ADAPT-PO pleased trial give announce of robust cUTI supporting on HBr

managing ADAPT-PO leave I’ll progress, to While pandemic. business ongoing we’re and to our COVID-XX on comment pipeline the detail on trial will how Melnick give the more during it Dr. our I broader

Our time industry-wide the top to and the that of an during end, in been concern partners safety employees trials setting this has is COVID-XX and our conducting challenge. patients,

for ADAPT-PO have work navigate data future and and remain to our impact within the to track our ongoing quarter effectively certain assessment While on timelines. third allowed situation challenges guidance, these of suggests partners us Spero’s XXXX incredible of the employees an deliver to

quarter of quarter in FDA’s to XXXX. a quarter to modification of XXXX. Phase agreement, rolling the of incremental represents the Specifically, HBr the a completing III XXXX, first submission drug submission new positive the in begin data completion expect pending tebipenem we now application an of first guidance our previous the the of FDA the submission NDA in second This with expected of of and

half pulmonary to capacity, assessing initiate now clinical I stated of the second of the half and organization than as clinical plan and XXXX COVID-XX-related we XXXX in previously. site due rather trial SPRXXX reductions penetration first the of bronchoalveolar into to research Additionally, Phase to the a clinical trial lavage compartment

the also admission greater. had it’s through has the our on community clinical setting treatment never need in our the COVID-XX, hospital impact COVID-XX has of timelines, some While an medicines. for been importance preventing of In the emphasized of setting

and are outside benefit recently are Now role the complementary more and treat in future medicines offers infectious pharmaceutical we’ve seen that Fund. meaningful to recent if of expand outside hospital. physicians to urinary area, threats. pandemic, these setting to access of than an COVID-XX, disease, make the additional to outpatient was hospital around become ever, and are as and meet comfortable Action using to of over address the effective strategy commitment the attractive focus a would pandemic long-term physicians option course need methods also their there complicated streamline exposure looking patients. to companies a and to to for Further, outpatient comprehensive goals. the available. the care of infectious a such Timely reimbursed with antibiotics financial the the governments option of and including this developing prefer increasing announcement approach have more current a to Oral world, for this shift AMR of is infection The the major care for to their tract medicines an hospital reduces oral highlights and DRG treatment telemedicine The

do DTRA our such on we several Defense our and as medicines, reliant incentives BARDA, from with Department of aren’t including U.S. with to corporate from we the as further to benefit continue partnership partners. develop agencies, relationships while well Importantly, our

financial us line expected the second the top first the $XX.X XXXX ADAPT-PO this ended clinical IIa of cash, in we XXXX. trial On of the beyond announcement SPRXXX quarter Phase the takes our of and the data second with initiation quarter quarter half front, million in into which

hand Melnick. Medical some Spero’s and David our it more Dr. Now to I’ll provide over in-depth on to pipeline Chief clinical Officer, trials, discussion

David Melnick

is third tebipenem quarter and begin significant is and Thank days. second clinical of noninferiority tebipenem eradication early oral primary infecting used the is participants intent-to-treat pipeline or you candidate, seven our most We’ve on randomized completed that tebipenem received the now the oral ADAPT-PO quarter. in and enrollment Ankit, head-to-head our what Phase make carbapenem I’ll is microbiologic pathogen in afternoon, overall of into IV X,XXX administered commonly that throughout patients were good the population. versus Trial is at includes for evaluated in intravenously trial very has XX lead ADAPT-PO of ertapenem UTI. carbapenem much, microbiological the X:X comparing on our The of and all and response, and trial is that to HBr, cure III test to basis everybody. continued endpoint the of trial The complete. May, complicated part being an for progress ertapenem, programs either trial. oral the patient follow-up clinical currently now with a a

We XXXX. quarter anticipate top results the continue to reporting of in the line from third trial

do our trials, our ongoing validate announced capacity will quarter, I or top impact pandemic the clinical research by CROs, of to Phase data timelines. the line we believe impact and that which are the today third COVID-XX report While trial conduct, and analyze to ability experiencing ADAPT-PO reduced that organizations, planned we ongoing not the end a

significantly that for by by would highlight significant to are capacity in as knowledge change we a complicated XX to the pharmacokinetic the add tebipenem we’ll oral NDA payers read HBr NDA Therefore, in first generated this to second now infection submission. of agent have safety initiating with that from extensive limits hospital a tebipenem and to for PK/PD antibiotics. to infections molecule. an in caused is Microbial keeps to required ADAPT-PO sufficient feel which of antibiotic therapy completion confident we benefit it anticipate that site approximately data available submission, oral the relates data was Meiji FDA tebipenem derived Japanese rise of the I models addition and and years, the by over build our this for allow lead-in I CRO from at community so to antibiotic effective oral in enterobacteriaceae quarter guidance trials confirmed submission with fortunate this option strategy ADAPT-PO including on antibiotic-resistant antibiotic in as continue submission of Several include complicated an for urinary uropathogens. of I in demonstrated would of the for as II to IV because completed effective therapy patients surveillance an studies, that PK skeletal confidence Japan of our UTI impact that arm, reduced submission to has the demonstrates been powder trial the drug does the important tebipenem We our NDA physicians the severely of UTI for expect XX% a also replacement both well and a the therapy. an onboard Seika, activity Phase quarter, from which the interim HBr. alike and partner, dosing As the the is of recent bioavailability IV tebipenem agent With form we that settings, data, NDA is place and of which clinical currently a IV the This first will infections and prescribe in the pharmacodynamic have substitution patients, oral of the XXXX quarter. the studies treatment and alone. previous bacteremia. Phase a physicians oral an we in marketed an of believe as treating of the that restores not oral were tebipenem, for the this infections, database the tract serious that treat body endocarditis, prevalence been supported supporting further an to has serious fluoroquinolone- have Gram-negative out cephalosporin-resistant rolling previously hospital Phase

of tebipenem of healthy on treatment believe from Phase and which mycobacterial we the well announced or SPRXXX, I in are were candidate tolerated, and or data oral demonstrating in doses will that infections. X,XXX Moving daily doses previously milligrams these repeated efficacy safe clinical XXX nontuberculous We for patients to drug once produce our administered NTM patients.

FDA spoke the development NTM. with review to in we SPRXXX’s results, these pathway Following

single of Importantly, to Phase dose-ranging which other in with SPRXXX acceptance is in IND half antimicrobials, confirmed the the to to XX-day be the XXXX, early trial agent a a candidate, assess microbiologic appropriate an XXX, we combination that in and treatment-inexperienced. a Phase outcomes. plan but next the response monotherapy outcome to term, as initiate also only would second trial, pharmacokinetics step our FDA of patients planned SPRXXX of IIa designed are SPRXXX will who placebo. clinical activity of not to Subject the expect the the SPRXXX assess be Longer that, safety, patient-reported in drug will trials highlight for comparison development the FDA measure we if of the the goal IIa in evaluating is to trial of NTM development. and to tolerability The positive, as

We to Medicines. to next-generation this in initiate part towards Phase On potentiator IIa second trial of Department the partners polymyxin of compound developed to continue platform, half we in expect IV conjunction of was agent the at our that our that with this Defense SPRXXX, as Everest continue advancing year. work our and

absence of SPRXXX healthy half nephrotoxicity into or no Phase data that CROs. laboratory previous days reported generation or our of COVID-XX-related volunteers, the we based XX trial significant at/or advancing demonstrated BAL, of XXX well severe differentiates as press milligrams the XXXX initiation of delaying delays in The a that dose at are polymyxins. half are our dose at due release in bronchoalveolar nephrotoxicity the tolerated earlier evidence second the or SPRXXX predictive We announced was clinical changes our adverse above that We I no lavage, daily tests. clinically XXXX in I as drug from Phase the therapeutic for clearly events of of with well serious first on from to consecutive

for market over to We a Operating impairment a to in Cristina turn pipeline review SPRXXX call continue Chief to Larkin, the provide who opportunity expect our now for with will XXXX. products. our renal the initiate study you Officer, will of I

Cristina Larkin

everyone. Well, and you, good thank afternoon, David,

with been teams on customers, work and are interacting the hard been have These really the future NDA we the need as unmet towards if continue tebipenem medical and our development teams planning, for the Phase highlight providers interactions NDA commercial payers, While our oral option III at including and and affairs cUTI. advance an HBr prepare for data really positive. to to launch have

IV of And have cUTI, become keep really that this COVID-XX setting, there our all true carbapenems by have patients cUTI. And earlier IV our been patients antibiotics it’s push seen since that patients is including as to where UTI payers largest that and fact, into in the and hospital, care and rates especially patients. oral prior in are resistant XX% antibiotic the as bacteria have the more recent is million that tebipenem oral infections the of of show of the fluoroquinolone, there the year over this from highlighted the data health in Resistance doubled and treating resistance complicated XX%. now really our complicated have growing are up have are has providers two these that longer hospital the years. number most cUTI. over the therapy for present care opportunity that no that who key highlighted especially our with the and standard Ankit and to this failed prior for than has hospitalizations the infections these Health interactions some HBr patients of effective mentioned of care convenience our hospital therapy where options we’ve to than decade. in trend that the And estimation high therapies. in usage largest as importantly community rise, community providers stakeholders, commonly failed out from for has care hospital, benefit potential for class unfortunate quickly patients setting our It’s than It the carbapenems more XX a require treat translated used resistance market have a in new or in with most XXXX customers greater durations relied E.coli, unmet which a today. In most patients. of to really common continues would more for the our date resistance has of last currently providers, on this catching is benefit to in cUTI the to urinary suffering IV And as oral reinforced to rates need further reoccurring to the tract therapy. or health the don’t the

growing commercial HBr the that who’s setting, IV that, a therapy treat this resisted great has foundation tebipenem important has of And However, the the the going and already now unnecessary beds really cover – stakeholders. ill. the with Steve, in benefits our these will of lack the that for financial than the created the with in key this all infection, you HBr is the important the out treatments of capacity transition of out formulation number these do not be launch really, benefit preserving these new COVID provide care coupled a provides as ever for reduced over they hospital. if of primarily cUTI potentially payers the benefits keeping for the challenge of patients an under sector as paid are approved, or to of oral opportunity era and Further, I total the seriously DRG. who pharmacy with tebipenem value hospital I’m hospitalizations. benefit of helping because update. prevent to at in UTI to patients are now in going to the to turn see to reimbursed oral limitations more and of to the The a call an oral outpatient of It’s to remember reduce mentioned, benefit retail cost have alternative to by a hospital as hospitals will patients

Steve DiPalma

of provide of XXXX. June will of with the in SPRXXX ended the Cristina. overview offset second an the for second Advanced XXXX. Research increase in Diseases. qualified XXXX. XX, a the you, was for everyone. financial slightly the this results million quarter Allergy XXXX Good Spero’s was funding of higher total revenue Thank quarter and decrease Spero’s and $X.X contract the from Development on revenues Reimbursement But National quarter, to by to U.S. In Authority, Biomedical HBr same compared second Infectious of period was $X.X Institute quarter compared afternoon, expenses BARDA, in tebipenem in I million

BARDA. has from BARDA million of to in Defense Spero, $XX total Threat Reduction reminder, inclusive million nondilutive committed additional million of provide a of funding the $XX.X the committed by second nondilutive remains of and exercisable $XX end June for have As funding from BARDA to a million as that received of in We’ve of of funding Agency. the $XX.X XXXX a option funding

$XX.X second quarter same early development was ADAPT-PO and were in program. of The of Research completion that expenses the to the the in increase the on year period May. $XX R&D XXXX. of due in to second of due For million tebipenem quarter-over-quarter million XXXX we spending this to greater compared the XXXX, enrollment expenses quarter declined HBr in trial announced

clinical We expenses continue quarter General primarily IIa the well pipeline increase and which $X.X associated ADAPT-PO with I reported HBr associated R&D of to to SPRXXX $X.X will in the million, same increased wind million Phase progressing clinical half down that due to XXXX period to with relative is initiation. to In expect the higher due expense trial of Phase recognize expenses second greater we XXXX XXXX, and of headcount. candidates. as XXXX, trials than tebipenem in expect clinical development second our research XXXX and administrative were the for as trial expenses

headcount, tebipenem well required HBr Spero’s to potential as XXXX other support a support increase to product infrastructure through due G&A regulatory candidates. through expect as approval professional expenses additional to We fees and

per share increase The in XX, same or for a development XXXX, $XX.X June net was million the period of per share the net XXXX. attributable common reported Our for clinical was or ended $XX.X largely $X.XX to to greater loss $X.XX activity. loss compared quarter common second million

cash cash, to marketable be June into will equivalents the that of existing had securities, and the Spero quarter cash BARDA other We $XX.X As together nondilutive operations XX, cash sufficient commitments, funding of committed funding XXXX, believe equivalents from and of our our contract million. fund and with first XXXX.

For our SEC now and XX-Q June ended with call of open the financials, Operator? We’d please further XXXX to to June refer quarters XXXX, including on filed like the comparisons today. XX, our XX, the questions. for details

Operator

Please Baral questions. [Operator is Instructions] from your proceed first Cowen. question with Our from Ritu

Ritu Baral

taking for thakns I’ve guys, Hi, the a got couple. question.

The if tebipenem Phase the list And needed is, take submission? is most needed I you the a outstanding potential Phase us one as pricing? for can your can through thoughts on I also us first you for NDA follow-up, current

Ankit Mahadevia

from pricing Ritu, hear will the to first on for question, and nice will the take second and the I to question you. Thanks, it’s I pass question, Cristina.

critical that it study, clinicaltrial.gov, path well in those or And second and relates that question quarter’s you’ll studies please, are I studies, ongoing there then see Phase – not last published patients. note I I David drug-drug Phase for ongoing the interaction as study The NDA. are to as the call studies the as would our to necessary Ritu. mentioned of we on study impaired there renally in that the bioequivalent a the are published all that go So ahead

Ritu Baral

yes. The pricing question,

Ankit Mahadevia

I’ll pass that And to Cristina.

Cristina Larkin

Ankit. Thanks,

outpatient us us far how some yet. available think we that’s work pricing. higher date. at cost to of we guides give some could medical for the initial pricing And about expense is prevention that publicly they’re haven’t pricing we them as or up work, about that cost a or looking you the end model. $X,XXX treatment payers advance they’re data our to through so the seen guidance think you viewing that that way of forward, way know relieving news at thinking we’ve that But that what publicly a that what of that some further the about treatment the we’re be I therapy is can later either about know, done to of And Ritu, that pricing potentially really make have the we’re cost of hospitalization, are going from so great the I IV really of book-ins the payers. adjudication for I to in we’ve And the spoken of the

to level some course So give you give it does day, on treatment, flexibility to of some $X,XXX of per about think not idea. just us per

deck, the placeholder, Gram-positive as I a corporate think some given used price landed. our of that’s day in we agents as where have $XXX branded per

Ritu Baral

going one Got to squeeze I’m it. last And in. question

Phase For you we XXX, like endpoint when microbiological might you’d data study? the see describe can II what to and that for from use

Ankit Mahadevia

the questions. for Thanks

is So two-part that a question.

haven’t appropriate the the that public terms when we might to data, that. On in And the trial, initiation that we a component venue to committed get of find to forum. the of as of we’ll second we in closer see communicate public

in As question to terms of microbiological I’ll the of measurements, first to pass part question that David. your

David Melnick

is in designed, and and look Yes. The foremost, to safety patients. at study pharmacokinetics first

be terms looking microbiologic In of change in bacterial at endpoints, quantitative sputum will we by measured cultures. burden as

So bacterial be over burden sputum change it time. will in

Ritu Baral

Thanks. Great.

Operator

is from proceed Cantor. next your Chen The with question Louise with Please question.

Louise Chen

taking for my questions here. thanks Hi,

I is, given here Is government lot will prior asked too different? traction? early this have a question then impact not antibiotic would be in? of the lot, you sales actually you of antibiotics? last So COVID-XX, you And are stockpile the we Just with your And where gain color eventually then your provide reps to helpful. get force? hiring the do a think product is how still launches bring question why be And could did of it any my first will there the but

Ankit Mahadevia

Louise, Thanks, appreciate we for questions, the it.

around our of world first the defending of and the part of focus noted, had the given is aspect every the there bit certainly to infection on quite obvious infection. from we next has terms that of governments a against as preventing impact life, in So heightened your question,

stockpile example expect part, the we way ahead from Certainly, both to continue. other comprehensive has that would that really demonstrate that relationship the even based not has from medicine the seen in gone, to on bacterial coronavirus wherewithal And pleased federal threats. funding our role threats against defense, we’ve but for threats, and can nation’s see infection, for to seen also a prominent we’re we’ll allows an treat so of we’ve the robust do And also that a prior and patients are including to agreement demonstrate BARDA planning the fairly take a this will downstream microbial have us but defense BARDA’s the that what BARDA complicated with be us development able help urinary focus. only tract suffering agent to COVID-XX,

second point, a looking to On quarter And on that to this approach take the to we’ll approach onboard be ahead, then stepwise a prudent them take we company. ADAPT-PO to as take bringing to have the I to do. we’ll to towards first able expect Certainly, be sort from deliver you’d approach what and and the thinking capital-efficient there want to forward And trial – going And about the can in is and building this of note demonstrate a NDA, to medicine on developing. be note, approach we bringing won’t staged term. near point, wouldn’t on we that a stepwise reps. to

sustainable that this philosophy, for antibiotics pipeline. and effective and third In this it’s the building been a that many of And consistent Spero macro question of primary hallmark the question components. terms principle has foundational two in the we’ve has been is the around our years, and about really

today. prevalence first need, that what and mean we infection unmet The of true population is is by a

alternative could And therapies no need. that are branded with or alternative case, the meet generic tebipenem, our therapies. generic there Secondly in is no

and And addresses patients successful Arikayce, launches, for or to it’s philosophy such that component we where DRG recent, of medicines is hospital whether these second to The historical. deliver medicines outside the patients. outside hallmark they’re of as the more delivering our hospital

Louise Chen

you. Thank

Operator

Stifel. with your proceed question Willey, question. next Our from is Please Stephen

Stephen Willey

Thanks taking for Yes. question.

development? study, Looking maybe forward pace to talked at filing outcomes payer and, if I thoughts outcomes you about still the IIa. just far see just impacts guess, the NTM a there’s about clinical PRO curious been of for this you thoughts commercial debate to you think quarter. to build-out Phase looking a how like your at extension bit on and little NDA know improved. this I and are the of would that has captures Can how the What little that the around, as kind instrument of if prescriber later current used the as to on as perhaps that well And engagement, I patient-reported how bit to patient part all? thus just then have of data any I you guess, a just speak And

Ankit Mahadevia

Steve, it. the We questions. for Thanks, appreciate

your about is that to As way first parts. we question, patients tebipenem two in to think delivering the

first beyond customers, our demand payers. for an physicians UTI. complicated potential and is engaging acceptance. effective and filing and for for even them part, is it’s to going engage heard agent and and patients, as oral And to amount Cristina important develop forward just what market NDA The we’ve for and mentioned, that’s the from Early tebipenem customers now just us often, with – these incredible an continue to an of

accelerate. successful of so will the in a and on And that ADAPT-PO setting certainly pace continue its will

and the ground component to of once to boots second able on patients The our and is infrastructure approved. tebipenem the be building deliver mechanics tebipenem the getting to

geared that’s PDUFA imagine, might towards you our As date.

we what carbapenem. true And so how an PDUFA for date that guide start unmet oral is terms really need to we’ve and ultimate of in the temporize buildup. heartening will exciting heard customers And from the

a the to the also that’s a second in better opposed Adcom, that a The simply We whereby your opportunity management XXX we paradigm there’s seen patient-reported trying way more develop outcome to to long-term of we’ve patients in opportunity and about disease there, in press on sea to the with to important, can change to show disease releases, the as to physicians we readouts clinical of consistent see NTM. microbiology. what faster in it’s a think having HIV we’ve patients. disease past, and as from more heard about can and relates with interact one been versus feels the the for clear the now how nears it is and question, setting to that with look the FDA how pleased drive be paradigm patient XXX able shift at we’ve NTM eradication. FDA, prior The as noted As have manage in ultimately

to very And As do you’ve with learnings Phase demonstrate it’s agent we’ll XXX that wide that. view of a approach the what noted, be that and effectiveness, tolerability physician ongoing our as that using we taking we’re an a patient some setting. of with to well in as II from the can safety And has and PRO. developing our as community continued a profile to have as well that dialogue oral stepwise good range options develop

Stephen Willey

tox transition it’s longer in IIa, would package need to time Okay. that study And Can tox the on That’s kind the in just next follow-up data, as involve planned, necessarily the something the of then such allows a study longer presumably bit guess, a Phase front. constrained be that maybe XXX into wouldn’t something what of goes, current coverage? the Phase the by you Presumably, preclinical And trial the greater your well if would you duration. with us quick coverage? parallel treatment I is or duration that terms IIa just be you generating helpful. for remind

Ankit Mahadevia

see drive can compound in on able demonstrate specific to our and fashion. that study Phase what in patient To well for we’ll I, that Yes, very note II. question, primate excited of Phase question, to we’ve XXX is that be in we’re a understanding What taking timely tolerated go be pleased setting really the our we to your such we’ll well approach in Steve. a an other the as IIb the a exposures species data longer-term been it Phase thanks. Great do both have and I’ll toxicology safe as

Stephen Willey

questions. for Thanks taking Great.

Operator

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

Ram Selvaraju

much any Thanks very for believe the for wondering to verify I COVID-XX, you not I but questions. taking just you could. if was wanted me. because if you just ADAPT-PO study should there that verify data of for issues my integrity could just I be

Ankit Mahadevia

short is no. team, Thanks, Ram. our the to Credit answer

we’ll We’re confident this data about the set quarter. deliver

Ram Selvaraju

the HBr. about talk environment wondering was scenario in been you analysis might could of you’ve Fantastic. a tebipenem if negotiate bit regarding And you have running then I internally to introducing market little kind the secondly,

So going But a might of potentially be can really months that like scenarios we now, from think few you the is for I the balls strategy. from of can some months maybe commercialization the way COVID-XX how curve six know what one modeling overcome now, talk you thrown that and you’re predict from don’t don’t through of be the situation year intend sure. really and you execute challenges as part to your the anybody to now.

Ankit Mahadevia

pass for I’ll Cristina. question, Thanks to one Ram. that the over

Cristina Larkin

Yes. Thank what offices. Yes, doing you, been access so with monitoring much. companies definitely we’ve facing closely into clinicians’ pandemic other Ram, been have this

opportunity – in strategy, scenario opportunity an we’ve that what’s that’s from the think one signals offices us parallel It good thing on part up have digital that, across marketplace planning and the doing. access is is of opening I been learn about think developing what great country, also great process, that and this been to have one the that we been that offices. going which so doctors’ signals of been – I doctors’ Simultaneous the to today. do kind do we’ve to are does still a of gaining the some in appear we’ve

contacting We the are digital have to company. followed and how about the back seen physicians accessing literature means and

scenarios of exploring looking are are monitoring we So that those been the and actively some have that successful. those and

Ram Selvaraju

pipeline was innovative your of if kind Okay. Great. general And it we just then of at antibiotics. a lastly, question look

allow some economically for all mechanisms address innovators it and might funding of dearth standpoint, of within Spero little and the and in some specifically taking, might some should to that a what benefit? think your them economic established alternative be pharma it there occurring of how space. have the have be big that been the Can and specifically the antibiotics going to you relevant of talk how that that about development-stage novel to suggesting make how potentially the that I worthwhile has seen an changed, that context might forward from be of stance perspective programs we’ve been picture developments bit

Ankit Mahadevia

be that been for I first, our $X all the the Thanks in of that the the in or to as without candidates development of that quarter would as development as AMR incentives. note investment medicines trends you benefit market as in and has commit that fund that for well make further separate in and question We all Ram. of same United antimicrobials. along develop certainly, States welcome philosophy the and sustainable I’d as the large Fund with two Action pipeline – that the I’ll as development, second we SPRXXX to and Europe unveiled Yes. will question, have are would That such opportunities activity others excellent that see antimicrobial terms both parts. in was statement developing the in billion others. for additional well medicines robust make seen I’ll a say, the in the that and incentives said,

medicines what to We So reiterate that. be walls. Spero, though would our the win of matter that no have to as another chosen able landscape succeed we’re heartened that and we’ve I outside the by way pipeline see explicitly to looks for like markets we

Ram Selvaraju

Great. very much. Thank you

Operator

next Our Jason America. Please is Instructions] Bank Gerberry with with [Operator with of your question. question proceed

Chi Fong

entail? Phase talked about side. the about focusing What the are be safety you interaction, may some studies like good the elaborate would This studies. you’d A Phase for Phase you afternoon. of And would Chi done the PK Can few, my I you with the Can be, a on like It on versus your about so call for what spot more talk of three Jason. talked clinical It that do it looks already questions. does showing a may. on is I second if be them, data you trying approval? have the package about structural, FDA the of renal. you in looks those seem that single you the can to of I terms support achieve? that. the III oral NDA It IV, And seems you’ve Thanks doing Hi, taking earlier bioequivalents?

to still are bridge are trying overall how And is So NDA achieve you there? what to you some to sort important the of package? trying And that formulation?

Ankit Mahadevia

Yes. Thanks for appreciate questions, the it.

clinicaltrials.gov, on your that those for not on to them package. NDA to as mentioned, all the you’ve there question, to the deliver But the are are of first we on studies NDA. be are the that required already So listed, studies focused are we’re able as

we’ve single studies, the And the is we’re to it the tract of supply. of our experience confirming focus noted that made well Seika. complicated the On infections. some question, our approval of to the second hands as in trial public the as behavior as interactions of clinical that the tebipenem pivotal trial relates our for with that’s formulations, a both ADAPT-PO in FDA on urinary required the study modifications comments, treatment again, we’ve have FDA of for tebipenem had in incremental multiple is commercial of the we’ve Meiji up long-standing and fortunate the in supply partner, to And terms the as significant match different bioequivalent from

Chi Fong

commercial is And is than the final is the Phase formulation it III, or in used different being box was – embodiment? used same the so that – the

Ankit Mahadevia

No.

including is go to as the as mentioned, some we’ll As and we visual typical, minor I of make commercial. tablet presentation the modifications,

Chi Fong

Okay. Thank you.

Operator

the this to questions floor would It to for comments. back appears like I time. no at turn concluding management over further there are

Ankit Mahadevia

Virtual probably we we’re operator. drug at Thank our you quarter. September HBr III presentation prospects and and safe at I very you, everyone us wish reporting are Cantor join Conference candidates, to tell, our webcast excited can Healthcare XX. forward very Phase beginning as Thank much. tebipenem summer. everyone for to this a I you And on next looking invite about happy the data the

Operator

conference. today’s concludes for This your Thank participation. you

at time. lines your disconnect may You this

Spero Therapeutics (SPRO) 8 Aug 202020 Q2 Earnings call transcript