SPRO - Earnings call transcript Q2 2021 | Spero Therapeutics, Inc.

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Operator

Good day, everyone, and thank you for standing by. Welcome to the Spero Therapeutics Second Quarter 2021 Earnings Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Ted Jenkins, Vice President, Head of Investor Relations at Spero Therapeutics. Mr. sir. ahead, go please Jenkins,

Ted Jenkins

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

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

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

Ankit Mahadevia

all financial results to discuss for corporate to us thanks highlights. our and Ted, joining and you, Thank today

executing NDA filing back continue upcoming and tebipenem of to progress on we for As focused strategy XXXX, we to to as preparing we a our corporate on for that goals of we have NDA NDA accumulated Since required and efforts call, our levels. to continued line to our data NDA, HBr our we I'm the fronts, half and and work last pleased at On drafting in performing with necessary of on during on track. the remain all transition had We've the have these the organization. around summary shared the commercial fourth that This last interrelated advance to we been submit confident the both submission provided for say our the we're NDA of for tebipenem. analysis on in the sections study seen then, all half guidance is of quarter. sustained the we'll earnings expected an second this that year. the submission these call progress

year supported endpoint trial's positive last Our demonstrating met of interactions clinical to both efforts of with strong results and data that of reported ADAPT-PO or are with trial an infection, or regulatory by our The ertapenem for the primary Phase III noninferior around tebipenem our AP. acute tract is showed urinary treatment HBr FDA. tebipenem data the and late HBr regimen regimen was that complicated all-oral cUTI, pyelonephritis, an positive all-IV

such the FDA support to for previous AP. could our well-controlled an treatment as Now and trial indicate positive sufficient interactions results communication approval in single be and pivotal that from tebipenem NDA HBr ADAPT-PO a cUTI the written of of

our FDA standards. feedback submission NDA our Additionally, endorsed indicated submit in package the that CMC and received structure plan and the NDA we from pre-NDA meet planned set data that through to the meeting, intend of the we their a and form

could that therapies. prescribe first to comparison an XXXX. all-IV all-oral currently second its to to an would receive be clinical HBr towards that, shorten important treatment delivering some express would bodes believe tebipenem versus these we This who and option alone result which our payers. U.S. required the and data show the providers value of head-to-head to to are regimen if now If approved, approved, just HBr specifically and million can designed will as half tebipenem We design, for cover over will 'XX data our unnecessary the health on and carbapenem ADAPT-PO our hospitalizations, done therapy prevent response, move without of patient of HBr tebipenem for become like an launch. provide tolerability. for led that replace we HBr or to through continue any plan we to clinical that program AP that to cUTI oral provide IV AP. would oral positive on It's to patients, as the physician advance and otherwise tebipenem a into payers patients program. in was Based robust and the the as HBr believe an will ADAPT-PO's available compromises be as updates and the in of SPRXXX safety to I HBr, X benefits economic work potential effectively to clinical resistant convenience physicians ability well confidence oral on to and who possibly the cUTI rigorous available patients give we care only IV cUTI provide the treatment their AP willingness are confident tebipenem cUTI therapy We has tebipenem therapy. have

rodents. SPRXXX studies of As and as II this by in and disease, year. was as into ascending nonhuman mycobacterial clinical last the The trials positive or with dose single at Phase initiation multiple a reminder, advanced of well patients toxicology Phase end from a NTM, nonclinical primates trial in I nontuberculous trial data supported

studies, were multiple serious these adverse observed. and severe events subjects Within no were or dosed

the the in was SAD/MAD unexplained also toxicology in were conducted, IIa non-human to the requested letter contrast us report. in Surprisingly prudently experience, to primate We Phase led however, the additional hold FDA the observed. IIa clinical Phase and NHP human clinical dynamic. including trial and study positive FDA additional being the pause the this notify trial which in primates. then Phase engaged received from This we important simultaneously As promptly nonhuman I study information the of subsequently mortalities study, an longer-term

study the continue since to call, analyze the we we primate As our and on nonhuman discussed last have completed data.

complete we the With report information quarter requested to to the in the on expect QX. in response engage full as third their will early We clinical a hand, letter continue this in FDA hold study planned. to

were launch up Spero receive high external seen transaction about to We patients that an as study. and and in capital, our industry growth agreement from I rising rights, briefly of ability will hypothesis SPRXXX. million on our of uptick and $XX meet anti-infectives which date then, comment give exchange to then specific Pfizer nonhuman preparation at important also like a low the the provides Pfizer update data of investment which clinical initiative, determination to the candidates for support manufacture a a that to path with asset, activity we would have highlight double-digit intend the Pfizer us complete discussions we also premium science development SPRXXX, recent rather is written approval that reiterate The ex-Asia representative was the royalties a ex-U.S. candidate. which interest before to Spero a as following an findings our receives agreement, and of unmet clinical and and to investment, mortalities speaks development Pfizer around Further, will of as direction commercial We these made in speak to single-digit In net support course, need. with corporate made. development tandem, and must business In sales SPRXXX I FDA announce primate the we observed to Until $XX more that gives as specific. investment or a entered on confidence SPRXXX This rights of the thrilled investment develop, from resistance, on that SPRXXX of these program. tebipenem patient is sales. pursuant AMR. broader and product focused well made can address support around agreement with occurred forward and in with for in million HBr for leader were licensing to objectives. FDA's the the important in to specie innovative now the milestones be a eligible need. to final polymyxin exciting potential drug-related, validation This into in our use with But but interactions dosing with not equity execute detail the program. David market, our is this antimicrobial pipeline also licensing the and funding breakthrough Pfizer to potential on provide territories. licensing can product for developments and rate It to we the to part development around to ongoing recent equity to strategy And program next-generation there the our

policymakers, corporate and other For than of development development the recent of XXXX. by Allergy in Pfizer, pharmaceutical the Spero and with have antimicrobial Infectious Pfizer which invest committed deal several XX Agency companies, focused partners acquired Amplyx the ecosystem. with efforts our been to the this Reduction by of increasing the over $XXX with aims along and AMR our in which U.S. with continues Defense, formation also and private has Threat relationships Action is BARDA, National foundations more already leading fund major efforts along Department government antibiotic million to of to and instance, shown Fund, ecosystem This -- disease. with Defense with Pharmaceuticals, as billion recently including and other Arixa Pfizer contributed agencies, the collaborative this of government of pharmaceutical to and dynamism the the on anti-infectives. remain companies, Pharmaceuticals partnerships both the our agencies of activity, active Institute $X

reiterate off Spero to ever-evolving call objectives, to the well amongst pandemic. the I'd even David, the circumstances executing to our continue COVID-XX like handing remains on of Before equipped

no would financial shift to would viable has to hospital often value alike highlighting could if a are the alternatives, believe over health replacing hand administered our on benefit pandemic David provide now capacity care in and business oral the it IV free the other that value of patients, that HBr, patients providers the our been tebipenem option. care hospital setting ill will hospitalization. approved, enable materially This pipeline. adoption also XXXX, see the setting. secondary provide provide payers update I a and for and COVID-XX by seriously a it Further, to our not exposure patient and with reduce outpatient with would more at-home clinical an progress up While is detailed such in because infections. impacted to therapies to COVID-XX and We in

David Melnick

top brought ADAPT-PO has its today. of NDA September. we Thank trial endpoint I'll everybody. provide It's share pipeline the filing line Phase this oral speaking you, briefly candidate, quarter. expected pleasure III toward tebipenem reported is for you updates to point, my what afternoon, carbapenem HBr, Ankit, data showing To by us a good in an our primary that met fourth our lead an with and our to recap begin advancing about that

to are We work suite of sets included These and also NDA. back-end continue designed locking the data I our activities the finalizing reports. databases, support to study to activities the Phase for complete the analyzing studies, which clinical study these

disclosed we not during previously in Phase to were and able adapt XXXX, seen delayed any XXXX. slightly quickly pandemic, though further the activities we As have were these delays I December due to

have We analyses the of and these now all the procuring required focused are since NDA and we submission. activities, integrated for drafting completed sections on

launch partners quarter. the nature to Given on fully activities, NDA, the these straightforward of our our of also formulation to expected toward CMC the should in ramp parallel Meiji manufacturing track a whose efforts the are over tebipenem commercialization. we is of continue during I the NDA be Seika, our move partners will submit work invaluable as of tebipenem's that capabilities regarding our XXXX. fourth we remind to up granular decade past with In with one we everyone experienced ahead

or move clinical a related the take perspective. UTIs complicated HBr supporting our to it a patients millions to to prevalence response, doing believe receive which with and moment about this, about oral fluoroquinolones such By often existing rigorous of tebipenem access. approval. as show of therapy, to that we on intravenous data from have positioned for strong allowed ADAPT-PO's of physicians oral hospitalization to as AP currently uptake hospital safety existing SPRXXX, antibiotic believe ourselves to tebipenem clinical safety on after see and we to well what The I XXX IV HBr, of therapies treating concerns requires means as with Before increasing without therapies some oral making the I'd resistance physician's us but cUTI like HBr tebipenem IV high replace any no leaves compromise to therapies, tolerability. we and for speak choice could design patients talk

of have generated infections, to interest of to ADAPT-PO opportunities indications. and resistance antibiotic by embodied by example I also mentioned and from the is strong of that being explore sponsored Infectious Allergy cUTI, conducted on MERINO-X being the the data is at treat leaders new HBr use National other call. our opinion last of Diseases This external time external trial providing the Beyond the One is Institute potential tebipenem group. the by leadership this interest key

to designed reminder, by bloodstream As carbapenem tebipenem intravenous continuation a patients MERINO-X with caused in is bacteria. to compare the HBr infections therapy transition oral early of with ESBL-positive

in indications. with formulation meeting. is indications, tebipenem In including This for and from approved have penetration Japan efficacy subsequent stage treatment the Phase to children trial, will BARDA-funded BARDA-funded tebipenem which studies for pneumonic as at pneumonia. lung the plan strong upcoming respiratory set clinical data rationale present of the granular the data the evaluate addition, administered these completed bronchoalveolar I to assesses analysis HBr study of an of of study HBr, tebipenem we medical orally This has lavage for we the several

including oral about now of that on gram-negative events the as Looking additional NTM end -- clinical At diseases for educate infection, to intend his data as peer-reviewed led of forward, well data about to pathogens. upcoming conferences like manuscript SPRXXX, Ankit we results. drug at portion a the recapped excuse meeting. conferences, have discussed the reporting our we're of these year, These plan the speak to activity to the to the results tebipenem ADAPT-PO infections. urology the me, will the tebipenem infectious mycobacterial through of developing hold we against X candidate important that the the HBr program's HBr treatment surveillance nontuberculous on been the of the most move in-vitro assessing I'd or by trial and continuing ADAPT-PO present AUA community briefly clinical during publication call.

with correlate he study the Most additional in the which the level few study. this extremely adds to complexity to either of of dose mortalities just are drug So the with points. duration repeat [indiscernible], that challenging primate adult of did rather importantly, what be animals analysis Further, a the the observed the nonhuman study, not nor said, than dose, the led hold a known to exposure. SPRXXX in emphasize nonhuman I'll to

Ankit Finally, nonhuman what the this and outlined in to we studies prior findings from primate SPRXXX, are study as have contrary of seen preclinical clinical earlier.

the SPRXXX a while design was trial the of to a repeat potential to made Along these was us strategic may X to which also incurring on future that it's allowed FDA. and path data, Rather, nonhuman ultimate method that lines, study to FDA effect. the it calls, data is clinical reiterate I not, trial program. I'd decision trial required the clinical we the there again related seen any hypothesis we have These on study the on be clinical data specific dosing until that forward that feedback mortalities emphasize oral program. observed the the While from were findings that earnings has is Phase to to sharing pharmacologic monkeys the costs IIa a like we our the previously opinion indicative discontinue avoid to gavage of to last us that species on that the our continue the success to from to as we adjustments or regarding provided of confident the announced date, SPRXXX the I'd not, primate facilitate hold than with like by have to off-target based remain an our either the specific support point in rather decision won't

interactions our recently FDA and engage the We thereafter treated receive agency the the with and the from and QX. lack the other polymyxin predicted to update a the need as After We through significantly from a including in to data colistin drug-resistant differentiates demonstrated for expect are with patients bacterial with estimates intravenously frequently major I a which full a including regarding antibiotic, patients above study primate act is thus for nephrotoxicity infections crucial completed the product regimens we drug-resistant enterobacteriales SPRXXX SPRXXX XXXX We Pseudomonas clearly older these saw of as combination SPRXXX drug-resistant problem many provide Polymyxin third includes safer negative BLBLI ahead, Treatment carbapenem candidate, XX,XXX activity resistant outer will dose. polymyxin early exists report producing This year. usually which colistin antibiotic-resistant next-generation second would producing moving a emerged these multi-drug formulary. What clinical infections, polymyxins to Acinetobacter, the to around validation broad-spectrum antibiotics could drug believe United patients study and potential is SPRXXX complete to grand against bacteria, or collaborations greatest suffering antibiotic community the unmet patients. hospital replace by or gram-negative these from serious combination Acinetobacter the to our have potent infections offer response review option in alternative with compared development at prescribed the and infections in the data with SPRXXX administered on in alternative B associated the will progress to provide showing extensively Polymyxin CDC's that molecules an plans and gears on antibiotic the and drug-resistant external gram-negative provide XXX need threats the X letter, or highlighted colistin. that from has our the the B injury. Switching serious a infections. membrane. Phase patients their suffering designed variants of in SPRXXX, which both believe bacterial directly a report risk address quarter, the drug-resistant in discuss Looking program with we combination, we with clinical now setting. SAD/MAD for hold in significant currently nephrotoxicity of reduced is currently X,XXX in that our pseudomonas deaths exciting carbapenemase is feedback an in unmet Today, while quarter forward. therapeutic offers our kidney SPRXXX for States per the and

and are manufacture you believe access recall, earlier. investment We patient the Pfizer in Medicines, is partners and and countries that when SPRXXX to ideal agreement who and to mentioned First licensing develop, has globally Pfizer to select Everest other rights with China may commercialize Ankit approved. SPRXXX ensure Asian

and a as X bring which specific broad including range provide agencies $XX.X target a million in study II and will exercised, their range experience with quality program antibacterial pivotal we funding initially wealth expertise Additionally, clinical invaluable available years, selection, drug If from in receive support development, of the Infectious or and funding standards development awarded SPRXXX of initial interactions. of regional an foreign Institute Phase for process studies activities, also were that We for award, to the by clinical manufacturing development clinical our fully $X.X Diseases, which finalize regulatory dose teams be second indications. of target million to proof-of-concept is the in clinical would with Approximately development support patients aid for SPRXXX. microbiology additional a $XX Allergy pharmacokinetic/pharmacodynamic National regulatory in for a pathogens up additional the quarter. to million NIAID, the of over and we provides and control will

external the a provides addition validation of entity. yet In SPRXXX for this funding, to external another point well-regarded award from

assessing recently, ahead, with support Looking the of most penetration the lavage and Everest expected at SPRXXX commenced the next and Participant year. the Department Phase recently dosing the NIAID. into early compartment with by the pulmonary from in Defense, clinical data SPRXXX's advance partners Pfizer the I trial, of we to continue our development bronchoalveolar trial Medicines of

point that for SPRXXX of suffer lung infections, we our for these SPRXXX target patients believe data a could that our key many program. Given inflection from represent

guide early study patients renal recently Chief turn launch who by and have Officer, call Cristina from Data the detail a for market which opportunity began the over of Larkin, with dosing Operating that I'll XXXX. many that, our kidney MDR will provide patients pipeline will impairment you be our gram-negative the this review with of of tebipenem study SPRXXX, in strategy HBr. on function. reported are With also for reduced our to infections dosing our also to track in the We products Thanks.

Cristina Larkin

Thank you, David, good afternoon, and everyone.

providers therapy. for who to reduce to both the or hospital the oral a to switching of who HBr's ability a launch cUTI by there move closer portion of prevent and great strategy care tebipenem the current approval, economic HBr frequency approved. a is us done resistant support the are to work give or we we still clinical in patients that hospital U.S. are oral approximately that driven for patients million in continue a be cUTI that HBr, that X setting, have allow therapies right And community a oral focused both And the may we capture setting, hospitalizations community and X value market and failed tebipenem believe providing discharge As opportunity advantages the that to the could will specially in the significant patients, sooner, the tebipenem to discharge providing potential tebipenem health in this the great cUTI HBr targets the discharge is the therapy. have of story. clinical previous patients million to on urologists IVs and will if and And

market has hospital getting the out stakeholders, keeping them to the patients our sooner, of of care value our all providers the our tebipenem with patients, industry opportunity it's through continue share interactions. and of boards, to or the research whether including the health potential home us relevant deliver that value payers. of of this HBr and all all to And is advisory Now stakeholders

discuss let's our how we're So plans. preparing go-to-market pivot

and phased and year, to launch continue a We our out market our market our marketing over -- well go-to-market for In have our been teams. affairs executing approach in building and teams access our our medical strategy. building place a take to

team engaging liaison space focused advocacy our key infectious and digital-first antibiotic health a customer interaction. building also on and out and which nonpersonal disease strategy, we've medical building and some includes our this messaging. Our has been also been early personal launched within economic engagement, cUTI opinion We've physicians and the with our with neurologists. effort combines And lastly, payers

from plan out to our to on to the our us them the has health team first overall Our care or on customers. unbranded we'll closer been we're for providers, we'll our digital our as wait build therapy. includes oral will utilize for update. and to it team. And care remain to that, plan on launched to as you and cutievolution.com, I'll stakeholders And plans building encouraged the financial launch, website the via our and In care launched potential we engage to has the approval to over engagement the on feedback we to proposition. and with patients its efforts digital and sales until personal call an Sath, our sales sales unbranded our this hybrid allowed to HCPs, approach MSL and nonpersonal, called organization, a earlier provide year who has health the regarding and relates on of ahead, tebipenem all burden positive by And continue cUTI finally, value and health the then of our overall system bring providers, need turn educate new with leadership outpatient our targeting look the we'll look approval

Satyavrat Shukla

difference activities period the NDA I'd Research to Phase the XXXX to were $XX.X revenues and your trials financial results overview III for to of was with XXXX. in attention the of quarter you, were afternoon, now tebipenem expenses for Total everyone. contract compared XXXX. the quarter by an in trial million clients' like second revenue for revenues and support of $X.X with expense in Phase good million filing Everest offset by reduction to increase for valve with completion from and the the Thank $X.X to second collaboration our same an significant of tebipenem $XX.X RRF of Phase second for anticipated licensing quarter Spero's of I contract agreements HBr in for and revenue and development tebipenem I clinical million quarter our SPRXXX in clinical turn clinical HBr, and decrease XX, received a DoD Cristina, the incurred driven clinical expenses compared was Pfizer due XXXX million from SPRXXX. for The primarily and ended primarily XXXX. costs year-over-year trials due June for Medicines. for from partially BARDA This for HBr

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

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

end. received to million. hedged the $XX we Pfizer, investment our which cash balance made XXXX, into non-dilutive our million existing will the include XX, fourth fund to investment and does proceeds securities, Pfizer, marketable together equivalents were by funding June marketable Including cash, XXXX. cash, quarter's of the operations and securities This believe of quarter equivalents we subsequently from that equity As with cash of commitments, $XX.X sufficient be not this by the

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

Operator

to Baral Cowen. [Operator we'll first Ritu Instructions]. go with And

Lyla Youssef

completed data the program, on just XXX can remind nonhuman is congrats Lyla is the from there Ritu, This you if for study, on primate just us And the real factors, and any progress. of on toxi the to maybe report? aside what speak, package for also the is the remaining submitting as were study part so that the data preclinical And to FDA? additional requested gating

Ankit Mahadevia

discussion primary for toxicology The we've question. in earnings is data the focus the prior for calls. FDA point thanks referenced the Lyla,

minutes here expeditiously And the the have so for we discussion cadence the and plan the them, cadence we engage to that do is after the requisite mentioned, we discussion, possible. to after the is, as report FDA. and data submission really, the the preparing preparing then And in discussion with -- as of are and as that with receive analyzing

Lyla Youssef

line Got Or maybe a the announcing it. have minutes announce data the Will when hand? plan And maybe then updates? just kind do to package? wait as you follow-up. those plan Do Street The in time of until you submitted for the just -- what's quick to you you you

Ankit Mahadevia

Yes.

context. can the everybody As give David mentioned, the and so appropriate we'll plan have discussion to the we minutes get

wait we'll so until And are minutes the back.

Operator

Louise with Chen next to Cantor. go We'll

Louise Chen

initiatives you So are is confidence my you'll maybe could companies gives what a antibiotics some space? of reimbursement OpEx a And But last for and the know in thoughts throughout a through question the to address year? of that Just the to other and Acts spent the for what PASTEUR call. details improve look be if antibiotics? secondly, first second make as hospital versus the different well? benefit to lot here then trying remainder just Do how in you OpEx question quarter? they will how on tebipenem from went only launch of fourth you your other launched be you help have strong these on you HBr? drugs of sense I a uptake in on what quarter And first or and the to the you then could

Ankit Mahadevia

tebipenem, I'll and I'll how to on Thanks, then I question launch the on based hand Louise, PASTEUR. about of about be Cristina hand differentiated to start the Sath it questions. it will OpEx. your with to differentiation talk our for to Then talk will

mentioned, as as started both well percolate a including with has the really -- the us including as So with front public very front, antimicrobial us. the to as on to well with activity policy interesting partnering PASTEUR, on it as as relates financing we in ecosystem activity, way,

we've unmet we that we at with gives as also a look -- commercial holistically successful viability, be incentives it to like chance are the we maximal because us in field, We way the tebipenem. treats patient maximal at need chosen our believe pipeline, need medicines that and not the able do be to

drugs gain provide the in shopping unmet that for beginning think we However, to the We companies think a think the think for AMR, large field. hill. a we acts and on payment to which great that's very be that we momentum arm treat needs it'd ecosystem, it's developing would X-figure some PASTEUR, like

big very it. fans of So

good it's for the I think ecosystem.

could good beneficial I very patients, it's for and it and tebipenem. additive to be think

However, to entire we've need that's in order and don't be up pipeline. how it successful, we the set

who in I talk policy commercial the think be and why will that's more tebipenem Cristina, to current a environment can successful about good segue environment.

Cristina Larkin

tag Thanks, think on stated I think one part. had is made, think important Yes. Ankit. really the I you just reimbursement I that on I'll to And of a you comments side, the and which

see is under a therapy not because hospital you the as system. community a main differentiating advantage drug one of of hospital in that switch payment of the seen too, that's primarily current environment the been is their many we've why that these and market, the this that DRG that paid these the market. both we've because of hospital the we system based If will DRG the seen benefit are on key pharmacy be and have reimbursed. the a Tebipenem, drugs many certainly cap launches in the way successes have drugs benefit that of and that reasons And primarily the remember,

that's one. think I

to of -- is best tebipenem suited we alternative to physicians of to way that IV looked suited that that's been fact convenience equivalent with generics that best trial show we're is we the it's Phase through the advantage, and real ever deliver been and level a we've The want was data will And able value where IV be heard III is another that's key second we've tebipenem becomes treatment. is ability if to that our demonstrate the the an the only one not generics will IV evidence, to and the our the that turn really at having we able the especially date, at of compete to being talk or when product about are our be what has through launch, oral, see the to constructed compete of able design here noninferiority that the to of noninferiority trial that and key to real when or When deliver advantages. market but tebipenem where in landscape IV we what part story. is with an we to is don't research is for to And product of ever. to and

And And just are of differentiation, urologists. disease differentiators. And for only that target I then I at that is go the mentioned, would primary looking so physicians we're the looking to X I infectious last after, mention launch. physician that another think, to those but type one audience as real not key key the we're in is is that

Satyavrat Shukla

answer remainder the can Okay. question OpEx the ramp for year. on And the for Louise, of I your

least half. year first certainly Cristina G&A than I as think with of on But you to, think, capabilities. can -- what to for were average, XH to and continue referred, continue R&D, mentioned numbers for commercial, sort And of the for we trending at remainder that's EBITDA, then XQ the be a take little as our roughly I we'll even earlier expect, R&D a R&D overall phased approach I to out expect XQ. XH, build bit the higher

So see you'll a ramp. bit of a

XXXX. into is now runway cash XQ disclosed Our

ramp somewhat and you off little burn your and from first of sort might is couple that. than did XXXX purposes, last will quarters, or the And XXXX. If the you commercial so a they of a cash tell of more you XQ be building into that the slower on for quarter the for could could the estimation then on phased reason flow, maybe longer a just be half the start assume probably G&A the rate OpEx, that which linear,

the cash flow on OpEx trend our and in So the we our bond guidance what expect you the can rates, be. to see

Operator

with We'll go Kevin next DeGeeter Oppenheimer. to

Kevin DeGeeter

Maybe one XXX. on

more at and think sponsors go So the into expectation the can positioning, also therapies following profile? of clarify completion Acinetobacter study, Would market since failed as the product patients bit the a treatment had about impairment renal given looked B population. we for refractory a XXX, going of the And you sense just to to BAL setting. treatment those some have make earlier the a that polymyxin landscape in colistin sort you look in go

Ankit Mahadevia

Kevin, question. the thanks very for much

begin and into BAL Your is for both collaboration correct we've II in data Phase received impairment after sense from we and Pfizer that patients. the the XXX studies, with will renal in Everest planning advancing NIAID, study

is ultimately also do. with continue discussions a resistant to do XXX us You're in opinion patients terms in also regulators. but have we utility trial leaders for the discussion the how right given both that we partners, several as and front That with of with with options XXX to we can infections, what our of that of the we want continue collaborate have progress we both broad to

options for get of as to that which that worth and as has So limited larger is on as patients think combination closer these options, of as because I your pseudomonas, often get. to we therapies care are standard patients well that polymyxins with really many need they event. as I'll point options. other a existing not typical But in dire more that population have XXX in practice, Enterobacteriales are just those have therapeutic is resistance can but utility, patients Acinetobacter need who that emphasizing an in clinical in patients note Further, also straits that used

we'll of in we as those terms have options XXX, do to make and closer we So clinical usage choices the get of that.

Kevin DeGeeter

And separate a follow-up question or tebipenem. maybe a as then question just on Great.

about you prepared prior think education script. should progression conferences XX months launch, and emphasis week we to or traditional IV so the the in a As out medical next infectious relative disease over called or we the on think about of

in and more meetings? an kind co-education? that where AUA presentation at urology-centric opportunity do your Your early regard the Just most think of have you to the you expectation adoption impactful with

Ankit Mahadevia

Yes. Absolutely, Kevin.

those We with. strategy, a medical worth clinicians emphasizing we and education that a partner aim are very medical it's affairs to we robust point have targeting and

the And both think amplify patients. doing there hoping infectious with discourse. Urological is our really that as we the disease be things X as and that one of need, the Cristina get therapeutic because, so types with but American like about opportunity also are David partnering medical we as clinicians meetings will are at to unmet mentioned, Number both in Association colleagues tebipenem as we're to mentioned, we we it, and

the just not other as data it both had in finally, to, care the then in payer cUTI, are that as one for the tebipenem the venues to example. realm publishing Secondly, who and community. to continue is MERINO-X share colleagues settings, the on mentioned, very we And utility brings the health will well find mentioned our but generate setting these both and of right David data tebipenem, David developing that the that medical speaks economics otherwise, to value and the are in we clinicians and education system, is sensitive as that to in

we taking So interacting with resonant we're also as colleagues as our keeping and urology well as IV holistic We're eye to talk colleagues to that both really arguments the our an a payers. approach. value are

Operator

to We'll Berenberg. next Esther Hong with go

Esther Hong

HBr which been for specifically granular observed So Japan and approved is with pneumonia, discuss tebipenem what's pneumonia expansion you tebipenem, children? potential opportunities in regarding of can in

Ankit Mahadevia

Esther, first the for -- Thanks, we first Yes. out feet. XXX,XXX question. zoom I'll If to

about activities come they for think we X flavors. generation As tebipenem our clinically data in

a groundswell bacteremic them. us patients, where populations to and the have to patient a community them. example to the tebipenem and to try MERINO-X trial with The had KOL of good community you in this flavor came is first matter from working interest that in is we've that said we're clinician

we're strategy. indication The is stepwise basis, a more formal second a taking aspect on

we tebipenem the well as pneumonia. XX tebipenem question, respiratory the to undertaking your penetration. extensive and that partner were Japan infection. that your work respiratory ago, point, are that Seika with the years as as by in be suggests our to can understanding achieve how well experience bronchoalveolar upper Meiji lavage as data And granules So indications, have patients in first in lung lung both To that, can seen step effective approved work as we've in

to And can share tablets the excited medical we'll in prescriber so be our tebipenem do we'll what meetings, be -- coming with community.

Operator

Ram we'll Wainwright. next H.C. with to And go Selvaraju

Raghuram Selvaraju

in you're infections? was regimen, I could label that if seeking dosing in the And the of the Firstly, tebipenem indication circle you specific the wondering comment back length could treatment just lead different bloodstream meaningfully if of we to paradigm, utility context whether that the usage approval might for? from on be

Ankit Mahadevia

utility Thanks, tebipenem who in Ram, for the the address patients. David, question. I'll pass bacteremia can of that question to

David Melnick

that Yes. is The answer of no. that X lines And there we to short question regimen The support and to run plan to are evidence that dosing to MERINO-X ADAPT-PO. in identical be that. will

the included tebipenem. all, there bacteremia with study with was did a remember, on those tebipenem, in need no substantial this of therapy well IV was in initial therapy. was subpopulation there of patients And quite patients population, ADAPT-PO and First

us gives that confidence. So

Second line evidence of is PK/PD. the

administered to chosen intravenously we the and robust provides discussed carbapenem. As we've in you dosing extremely equivalents past, with that have coverage regimen has pharmacodynamic a

regimen. those reasons, So in we any don't two dosing plan the change for

Raghuram Selvaraju

clearly would since Okay. tebipenem another? if these think And on they currently you in effectively, can X you specific just classes essentially that comment against is complement or different whether believe antibiotics one ceftobiprole, in indication, that late-stage which would you compete of that that clinical development are

Ankit Mahadevia

for thank Yes. that Yes. question. you Ram,

following in we tebi AP example, that So for our an spectrum. as take for It the oral a studies has indications. as patients carbapenems to trial. it And Ram. In of for carbapenem realm example, the that's the that And the activity. in option. of And go a gram-negative was think ertapenem, which erta like which and we and an about really, are frame is in think like other really comparator has question, patients is sense, lot the tebipenem in carbapenems of have utility the cUTI into of tebipenem, utility required about that's we'll think other otherwise a unique thanks we that

David Melnick

Okay.

not cephalosporin MERINO-X. in organisms and [indiscernible] add, to work Just against would therefore, active is ESBL-producing not

Raghuram Selvaraju

for questions opportunity territories, Couple in the in please? Can what the think opportunity. is you XXX size us the frame total market Pfizer of likely you on market of addressable quick market terms

Ankit Mahadevia

question I'll to pass that over Cristina.

Cristina Larkin

Yes.

without largest -- is exact of broad resistance quite do see terms we and but to world. what not that this big of makes exist have carbapenem-resistant pseudomonas. in States, in see activity Enterobacteriaceae Acinetobacter very unique think, and for giving terms what the numbers, of against And what United is that's pathogens it's here of activity, the an terms shared bugs what ability to think we which against see think in the rates that compound but coverage David, X we of XXX the the across I problems the spectrum I rest XXX only in I and common Europe the in institutions,

would problems are And so today. without I that that bugs giving what institutions in X you exact we the say those the numbers, three biggest biggest see and

Raghuram Selvaraju

clarification. the period? one anticipate regard the to just point with to then FDA of And with classify respect a this tebipenem last at review of do you juncture assignation What the to NDA

Ankit Mahadevia

submitted? sure be Are to asking thinking. I you once just we clarify review make what expect to period Ram, the the

Raghuram Selvaraju

correct. That's

Ankit Mahadevia

Yes.

X-month validation. received review is has for review track track and overall X-month tebipenem fast which fast a So plus designation provides an period, X-month

Operator

additional or question-and-answer over any remarks. today's I'd presenters for turn back today's session. closing like to conference concludes that And the to

Ankit Mahadevia

and for keep updated Thank to joining today. along Thanks, you, again. advancement we'll everyone look way. operator, continued of everyone our We I and us appreciate the forward pipeline, the

Operator

you today's Thank participation. concludes that And for your conference.

disconnect. You may now

Spero Therapeutics (SPRO) 7 Aug 212021 Q2 Earnings call transcript