SPRO - Earnings call transcript Q4 2020 | Spero Therapeutics, Inc.

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Operator

Greetings, and welcome to Spero Therapeutics Fourth Quarter and Full Year 2020 Financial Results 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. It is now my pleasure to introduce your host for today's call Sharon Klahre. you. Thank

begin. may You

Sharon Klahre

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

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

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

Ankit Mahadevia

I pleased everyone. updates. provide forward exciting and am the ahead, very year to evening to Thank good I'm and some much to you, today Sharon, and progress our opportunity looking review have an

prescribe to have the our and confidence X the therapy. primary just show tebipenem of showed that remains commercialization millions endpoint results to trial in done patients of robust pyelonephritis, we data the IV cUTI, and would ertapenem These all-IV and advancement that We the physicians tebipenem provide give oral all an convenience acute tebipenem an We AP otherwise that believe making would reported cUTI regimen tolerability. HBr. results HBr of tebipenem of therapy or the tract oral Based design result receive the following all the can HBr safety provide of pivotal a as any as who positive that response treatment to its that to all-oral previous head-to-head non-inferior sufficient urinary FDA IV specifically infections, cUTI communication, regimen comparison to written could single interactions of or on ADAPT-PO is that Phase focus primary chose demonstrating this and our for application, HBr's NDA, with or Our from we compromises new a or September. trial the be on clinical positive regimen of data towards approval for well-controlled ADAPT-PO AP. first complicated support an without results tebipenem last the HBr trial met drug

an We And first would for on approved program. important all comfortable option year expect first treatment to feel supportive with resistance of of currently oral now antibiotic years. the in each we in and X therapies. completed. been HBr given million the X which if for an cUTI cUTI the HBr, for the the X the over like in with accounts to and guidance, Phase some SPRXXX AP for cUTI If Tebipenem the patients therapy have alone new to Phase be U.S. NDA AP. oral clinical provide XX approved tebipenem available be possibility approved half COVID-XX FDA updates submission We treatment this XXXX. oral make believe and to continue the I'd would carbapenem the of for delays, that related to HBr tebipenem for trials second

and announced, as single XXX disease, initiated with the were As February we required dose or trial of we parallel non-clinical Phase Phase on trial December looking in Phase saw positive multiple in based We additional primate studies conducting we XXXX. non-human also conducting and and of primate In the reported mortality year, to rat the toxicology additional In well non-human X investigation. trial rats. from clinical ascending non-human that unexplained non-tuberculous as longer-term Spero previously in that Xa mycobacterial this trial, at toxicology. studies data a patients in X NTM, primates we ascending trials initiated of the

was notification requested verbally hold a Phase trial, study. clinical us hold. our received we from Xa FDA its and written the this placed primate a of since that study and have report confirmation FDA the findings, non-human then on these Following notified

the We as as SPRXXX continue constructive FDA well and data the Xa trial discontinue the it's to adjustments while forward trial studies steps to costs to incurring may possible. feedback this trial on the for efficient our be make based potential analyze and the time. trial as this and and facilitate We've worked path made clinical clinical hold. avoid to took protocol as at take readout FDA advance decision the Xa our to on to accelerate we've Phase SPRXXX future in toxicology dialogue generate We the Phase decided discontinue potential clinical of associated with with to that the

and believe date. benefit the pause reflection as believe we hold, stage a from does could do reflect Phase data the on was so a Xa forward we we state findings study, our Importantly, to seen of I that any deliver. indication potential maintaining it path this and data treatment with the note the the have early on continue SPRXXX also the will thinking for a been to nor the as is primate would there not SPRXXX NTM based suitability the we trial trial the of of not of at in for of have this to is in that time the trial regards enrollment an

evaluate with to of FDA the pathway continue the work determine and the XXX for program. We findings continued best to the clinical development

enabled our moment discuss hand pleased I I is go report during pandemic. the business Spero quarter. David and to wanted and into take strategy information dedication to talent Before manage to to any very have on how business impaction pandemic. our the to of a team seen on executing off material our were our throughout pipeline, investments thanks the that the call the not technology to we made early on our fully COVID-XX more pandemic the I'm workforce that efficiently from on remote the we detail to the in we this have This

support and tebipenem potential with new also We been the successful our efforts for launch through have digitally medical hiring HBr. connecting talent in affairs to physicians

we them. ahead monitor will COVID-XX potential and impacts to we'll our continue for forward, Looking of of work business, stay to continue to on diligently

changed materially our by Now, patients if the way possible. both the trend physicians accelerating hospital of impact COVID-XX It that the delivered and is business medicine has quarter. last admissions seeking didn't to prevent

offer joined communities solutions the our We that is private therapies government is bacterial times. continue face. importantly needs Department the the The the government free of will oral for review benefit a ill conversations the these well and progress no could a setting Replacing also threats. and The this as increasing indicate patient reduce unmet we We're antibiotics, detail as future BARDA, And for hospital of these remain current infection tract exposure active with targeting on care shift to patients clinical secondary treat have of effective While would partnerships by and an during these not currently greater a the corporate highlighted option David which prefer hospital, to IV in comprehensive alternatives foundations. critical that infections. seriously availability the physicians partners innovative patients. would thrilled over precipitates our our relationships to been a DTRA companies also that has up and to with we other provide the to agencies cUTI major need urinary with and address IV oral and to prevalence our hospitalization. hospital. to enable develop option our therapy and pipeline. could threats that agencies, within existing several This exacerbated hospital medication pandemic for approach complicated of in often that, need It due it to biotech that of outpatient oral to in collaborative with resistance policymakers I the Defense, viable including and COVID-XX efforts to millions hand an unprecedented to outside shown have infectious the U.S. to capacity best with as these for pharmaceutical us an would financial

David Melnick

very to Thank happy share today. you, Ankit. pipeline our updates I'm

September. unfortunately, arm were tebipenem meeting were in presented difficile treatment, to comparable visits. reported administered ertapenem. The to the groups met trial Let clinical commonly test-of-cure our urinary complicated in at cases data which the arms. entitled safety in of met IDWeek tract and of treatment events and between for treatment lead rates observed across candidate to clinical group, with other in pre-specified was of treatment the ertapenem an both oral and primary last at treatment at including me endpoint intravenously and data, IV groups compares and tebipenem combined across ADAPT-PO showed deaths X Phase we've that that with also ertapenem tebipenem that of the XX.X%. pyelonephritis. HBr non-inferior study, HBr primary XX% was its carbapenem the compelling and clostridium in treatment ADAPT-PO that diarrhea in had X rate HBr a is an the patients and infections, late events in were The Phase arms. XX.X% which microbiological were of observed with demonstrating infection arms. overall emergent cure end of reported patients of HBr a of ADAPT-PO the intravenous begin The treatment no with which endpoint follow-up clinical tebipenem which ertapenem the and at and acute reported in three the oral October profile, non-inferiority microbiologic similar There frequency presentation positive headaches, both were the the well HBr were were show These late-breaker treatment-emerging adverse events observed frequency tebipenem is adverse for similar XX.X% response which of oral margin oral that eradication tolerability Both no of type most the balanced adverse both cases for

utility to positions point complicated the an advance is that resistance Now, treatment past, currently these with we I'd results in available a important to UTI. the reiterate oral of on antibiotic of we've patients antibiotic The which of an moment that made important emergence that has bacteria take the Gram-negative the treatment and mean in ADAPT-PO to continued options. limited like believe

design. include comparison of UTI ertapenem, head-to-head in tebipenem HBr the mentioned, lead-in it ADAPT-PO not in a versus arm, an in an first as HBr was tebipenem kind administered intravenously straight ertapenem trial trial nor its Ankit was IV complicated of to arm. robust IV orally administered oral Thanks down step specifically this the As the

physicians complicated provides prescribing the that with We data to tebipenem they a with instead have IV we confident to need patients of urinary tract generated feel ertapenem set strong believe infections. evidence will oral

NDA tebipenem to half of HBr completing we in submission the continue forward, XXXX. second anticipate Looking the for

our partners how have a in all ramp interest currently continue been All It's NDA hand. up intravenous these of see in tebipenem of and utility efforts as regarding of been data much studies our ahead the clinical XXXX. included with has with completed be clinical now also to to the tebipenem's capabilities to supporting will the strong Phase in therapy. antibiotic gratifying in launch an X of expected package there CMC been external alternative that In the the is HBr NDA, work to we parallel

assess tebipenem will therapy HBr investigator the should HBr sponsored of affairs to transition different studies tebipenem intravenous our carbapenem continued bacteremia medical patients comparing of that One Gram-negative of the with treatment tissues. understanding oral the early Our with of study to antibiotic function in ESBL therapy. strategy increase initiation includes several

from We in lavage to tebipenem December, the This trial, in designed report treatment has study is bronchoalveolar this by X the including of currently pharmacokinetics of also of important assessing strong long pneumonia. Phase several clinical expect a penetration commenced HBr the indications, this with determine year. to half tissue. form BARDA, in in trial lung the data the which children powdered rationale second of in as of respiratory tebipenem approved Funded tebipenem Japan a is

present year, data, drug diseases plan well oral other our additional of on as treatment gram-negative in we activity at surveillance for data, addition, infectious in this infection. as of to have conferences In vitro ADAPT-PO now tebipenem candidate presence urology will we assessing the where I'll development NTM to HBr a the discuss four against SPRXXX, and move pathogens.

to we after Xa a seen in mortality in the of this our This analysis. that adult SPRXXX should that note levels or these issued mentioned, patients the pause trial. XXX trial December. of toxicology exposure. in level the known did to announced primates not mortality, of historically correlate the to complexity initiated adds clinical a NTM a based Phase challenging notified on study. had dose study primates of non-human month non-human of for the of Ankit ongoing clinical with the agency came be we As an very to a to trial verbal which FDA duration hole treatment Last decision internal unexplained we I adult drug are Further dose, the

better evaluate to monkey, specific communication, it continued it the attack. if asked toxicology we recent complete. preclinical mortality, drug from if In a or in written study, to study are data report the of currently a related We manner which for the administration conjunction with cause to the related species is to is FDA of understand FDA mainly the of working the

GLP were what has and primate a we had SPRXXX. point moving Before on studies on assessed observed toxicology in in preclinical previously like non-human about to observed clinical a has study this to series XX-day I'd four-month in with safety GLP currently we and toxicology study primates toxicology that rats IND non-human been though studies in respectively. enabling pharmacology remarkable studies, findings in Even uneventful. in of a also non-clinical rats conducting observed including toxicology these and completed are reiterate events previously touched departure SPRXXX a The been earlier. that talk SPRXXX; Ankit studies, from and XX-day

ascending time the there data pulmonary volunteers To trial. Phase to enrollment disease. reported safety, pause administered regards all say trial addition, been pharmacokinetics adverse Phase In the potential the the for deliver. discontinue the facilitate the the to Based events prior serious path this no any repeat, earlier date, multiple trial and The treatment early could Phase is trial any single for findings. clinical trial evaluating the on believe not of an made trial that dose whole, we decision in completed we've adjustments and program decided of and a and at to the in of data NTM indicative that and tolerability a discontinuing that reiterate would we've we of forward the the thus to believe made SPRXXX, Ankit of better human at Xa have Xa have that the clinical X should continue of we SPRXXX at seen protocol with clinical that we the to clinical a drug any time. with maintaining related I is not the on not was state early trial trial stage benefit were point

to and carbapenemase drug multi-drug resistant aeruginosa, list. SPRXXX; good of support with and department need to Everest In gears hospital including as acinetobacter shown Medicines. IV infections the severe best this the to Switching discuss COVID-XX pseudomonas platform, agent fight potentiator resistant them pathogen for our Ralphs, the pathway of priority baumannii work are from of producing is with evaluate development a to patients require clinical next mechanical COVID-XX the organization rendering intubation candidate polymyxin ventilator determine often continue associated and our pneumonia. developed now SPRXXX. with back SPRXXX potent continued to which We has strains health pandemic. findings generation advance has and bacterial part vulnerable in world that extensively bacterial the emphasized for the FDA our compound of we drug at defense The all further medicines is on partners continue ventilation by intro that particular bacterial to against activity the

evaluate this into to compartment. on first We the bronchoalveolar bacterial track also a these often order of renal which remain In SPRXXX impairment half of are the to Phase turn year. initiate in lung track antibiotic X We were pathogens. fact, mortality in study COVID-XX resistant in is initiate trial on with frequently caused clinical lavage, infections, in by associated XXXX, our secondary to

data We study, SPRXXX these are or announced were for Phase SPRXXX healthy encouraging and volunteers In serious that events consecutive doses on into additional healthy there of severe crowds this up based advancing XXX daily we last year. days, milligrams XX in reported. no to the X were volunteers given adverse

the Importantly, there detail a products Larkin, earlier from will HBr. will provide you for with over tests, our significant Cristina turn strategy to our Chief through laboratory which our generation call Officer, or the XXX Cristina? was the polymyxin. of clinically and market clearly changes the launch of no now evidence Operating opportunity of of I toxicity network differentiates who review in pipeline tebipenem potential

Cristina Larkin

Thank I'm as you, the to of and launch. commercial, work some market access Dave, affairs teams detail happy the tebipenem anticipated HBr, great medical doing prepare our to are much for

begin is let First, two around projects. supported it date saying our me separate tebipenem the opportunity strong remains for by analytic and conviction that HBr large by

First, tebipenem diagnosed CPI claims million of of U.S., there in potential conducted indicated where are HBr written be X.X a we patients prescriptions study could annually replacement. a roughly which

line or could option. for Now, of receiving be and such these treatment or a thus Zosyn, new rounds oral a as therapy, either receiving multi a patients are candidate oral therapies IV carbapenem a second

opportunity it's market. also and important split similarly hospital the that is think I market discharge between the the community

Second, of week current a growth UTI. carbapenem show portion last And the over on that data years increase in The six use. carbapenem examined IV data setting. significant than IV XXX% outpatient is on the use more plus

also express setting, community our more to urology especially on UTI new prior information for, regarding to setting, providers oral data are patients. gather hospital carbapenem. second opportunity XX% tebipenem have cover largest an payers a the indicated IV. which with that to indicated our need And in and has these we the be that potential the see urologists unmet value is into payer cCTI. confirmed line XXX the The paradigm. the and than largest potentially cUTI on broad for focus in treatment And substantial Phase and together in more treaters willingness of the of Now They've patients that HBr, also And this targeted continue consistently for there's reinforcs IV, launch the tebipenem pricing this data and and findings; We've further healthcare engaged thoughts a their prescribers. HBr it's HBr they will fit has these support if And the and for servicing. HBr are value-based they're of approved. unmet IVs how because going tebipenem driven for and replacing that significant conversations tebipenem this cover X evidence the is payers strong their the lives, need this treaters. a for have addressing payers is And treatment to interest and as the an

infrastructure this and deep in target our our customers information Now regarding These launching are have medical commercial, capabilities. we and products access armed to individuals market with and continuing build affairs, market new size out expertise these and long-term for the provider antibiotics, key healthcare strong several and And made and and tools specialties payers, they our and investments engage we've are have with essential community. success. digital short-term relationships in to

the nimble who update. a our appropriate Now and of allowed to that, during And financial to we manage you times. the launch, over provide with these Sath, COVID going leverage call going And continue our to where team to I'm to technology we now especially our as to us productive remain for day-to-day is turn with size small prepare activities. has

Sath Shukla

and Analytics, juncture that, Pharmaceuticals served at the projector to joined Global team created pleased Corporate I'm NASDAQ of at XXXX Spero's this of my Finance. I'm provide Chief Officer a President I Officer; Commercial overview Vice December XX, first then meet moment good an take company's for I prior as to and another Biopharm will and the their introduce I excited in XXXX. at January I Oncology, Spero there was Financial and Chief recently as will Spero today. Head was quarter their period, evening, in to I Cristina, the results most of joined Vertex seven-year But all management and year Company, over to and Financial financial and this call, a Head as you Spero's first you, Forecasting I everyone. have ended Biotech Thank full is myself.

financial million the update, quarter XXXX Total our XXXX. for for million quarter to than for compared lower $XX.X XX, total the $X.X same was revenue ended in the now the was year December to XXXX. XXXX lower the same period revenue. for and the and to collaboration contract December in Authority, was the as Development Total quarter HBr due Biomedical ended as revenue BARDA Advanced XX, and of reimbursement $X.X the expenses, year $X.X full XXXX than full Spero's fourth qualified fourth million XXXX with period were full million Turning revenue tebipenem well for lower lower Research

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

December SPRXXX greater the pipeline support personnel million higher of the related for XX, following top-line offset the $XX current September, expenses We were the are programs. in lower XXXX Research by than trial and there due committed ADAPT-PO December spends for the have spent development expenses by for HBr lower to end $XX.X XXXX, quarter to XXXX data on tebipenem second $XX.X on million year to XXXX. million X lower for of and XXst as expenses for accounted in $XX.X the fourth million partially the spend BARDA. to $XX.X BARDA from year-over-year of exercisable and the a due million of the of of primarily year ended means Phase same period ended $XX.X XX, is we're receipt full full option that modestly candidates, million beyond funding XXXX. the R&D the commitment; compared December R&D

compared as NDA that to tebipenem and expenses costs trial submission decrease $XX.X to R&D than the in the for $XX.X expect personnel-related higher million expected expenses we're we to expenses ended XXXX year in will $X.X pipeline. administrative to XXXX $X.X include full versus quarter our research XXXX. the the and to as the that G&A million Increased of year to year million the for than affairs same on and note for activities support relative the XXXX for ended fourth the XXXX strategy, million professional period clinical December in December direct and expect you and XXXX spend expenses XX, incur the lower some spend pre-commercial to were are XX, related XXXX. period quarter fees business. development expenses will full G&A and HBr expanding medical We due I XXXX costs. in headcount XXXX of General the ended increase would fourth support to well the full same

XXXX common respectively. and million per a $X.XX $XX.X and of or for year XX, XXXX per or G&A very quarter expenses to commercial XXXX loss the million net in of to We and share, $XX.X and respectively. and relative ended This potential net a loss the the December reported to million increase compares as ended $X.XX XX, and the expansion year $X.XX common the of full infrastructure HBr We for in expect a XXXX December capabilities $XX share support quarter fourth million fourth $XX.X tebipenem launch and XXXX. ahead $X.XX to commercial

funding have of XXXX. together We the operations quarter of and our fund securities and second marketable sufficient As believe equivalents non-diluted we with that cash, be existing of to cash XX, into cash will commitments XXXX cash million. equivalent December $XXX.X our

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

Operator

Thank comes you. question. [Operator with Instructions] from & proceed your question Our Baral first Company. Ritu Cowen Please with

Lyla Youssef

the are you're pre-clinical on as data you when early able guys. estimate for then thanks submit to and Xa data public? study, XXX quick a the to And taking the since programs is Lyla the report FDA? to to for Ritu. data you that planning potentially you that the you the do follow-up, for does for release update. Maybe the mean Phase the to Hi will any maybe be really just discontinuing unblinded study and you for Thank of you. This question Thank become quickly

Ankit Mahadevia

Lyla, the Good and evening, question. thanks for

potential timing FDA. our was discussions question of the The first with

step delivery take submit we've and and includes in possible process, data taken we've wise So report meantime, have additional toxicology noted, dialogue. study wherever we'll we'll steps X process, a What facilitate downstream. going Phase these restart so the we've that to to as trend done we're study the the the will that studies expedite as stopping FDA looking and that and and collection to accelerate current from to

of because terms these details communicate to time, Thank street. the clear, the details will the you on that this provide at become for with those are question. dependent just as timing, we In FDA, but ongoing I discussions can't

Lyla Youssef

of Yes. Xa, to since access just Also do have you data you're the that maybe unblinding the on discontinuing? Phase

David Melnick

FDA we forum going put certainly as look is for a you Thank further learn that we later as That communicating a at at more we're and we to that Yes. together, the assess question. be time. the and collaborate in that with and pieces public something we'll data

Lyla Youssef

Gotcha.

you Thank helpful. very Okay.

Operator

question with from Fitzgerald. Please Louise Chen your next question. Cantor with Our comes proceed

Louise Chen

Hi, my thank here. for questions you taking

question accessible all is drug can And sales building color year-over-year. then based So think pricing color you for tebipenem you would I you SG&A and force, just you'll for upon preparations the the patient had you talked then be how that? the be the cost this launch? will HBr? what know marketing your increase about more And last to of when about I this pricing, value is; I first how do be, and then give but guess question launch on out more on

that tebipenem building with could curious say magnitude and there? for you. the on what could launch can't if Just maybe Thank number you're a you be, preparation the dovetail and

Ankit Mahadevia

Cristina. first first Cristina, SG&A and the But build first and prep pricing And I'll I'll questions. I'll the launch Louise Thanks for direct Sath. to then two to on two you. on final to questions to questions the question those access hand direct

Cristina Larkin

Yes, thanks Louise.

per to exact said to price between that As day we've we pricing, we or is XXX really a that XXX assumption. it reasonable range haven't guided is our expect relates to What yet.

we'll think more more guide learn as I information. we

guides to think made, next which point the what you that expense. that patient the out-of-pocket I is

about I as think understand guide certainly we that more the what number will exactly be. that pricing will

strong our I engagement, acceptance have They is the Phase gotten that I gotten that strong get indicated, have that addressing certainly that believe we And early believe read X evidence We is going the payer expect information do we've payers. value gotten need. because we it unmet this the is and the through to is that giving that they had from early is think this or coverage we've we this to we're compound. that really payer. broad as to think knowledge

best that's that today. we So the evidence have

that force around we're out to build we the is the is second our of the organization. out the and Right looking to team rest you sales organization about as ask sales are of now rest our the approval, force plan looking, and but the time would we look The at of question that build team, customers field way marketing when the we're medical team access out right believe have speaking do We building market access a capabilities to those same team affairs, now that liaison deployed. and is roles leadership have we market how first and the that been our we a has deploying. out have is those a do medical we

Sath Shukla

for spend to that the exactly indeed And G&A such on Louise, can launch. ramp last say question, they'll tied that is just there this prioritized a be be, Sath. expense enabling I the as strong will

continue you to will we G&A that mindful spent. be very imagine can of side the on as Beyond

cash to into spenders we heard forecasting say On recent runway see back you're flat our fund rates. compared XXXX, if the spend for into the XQ you'll relatively as that essentially overall just numbers, are you

somewhat, R&D So will expected relatively that spend to total flat. while is the decline G&A the we expect go expense our spend up in make

Louise Chen

very Thank much. Okay. you

Operator

from question comes DeGeeter proceed Oppenheimer. Please with Kevin your next with question. Our

Kevin DeGeeter

accelerating on the what the and work should resolution with XXX, granularity my certain volunteers and potentially correctly, with next a findings Hey, we taking guys. clinical FDA, on Thanks experience a be you next or Maybe to for assuming or learning mentioned heard to Ankit, little terms exchange XXX, accelerate steps can any in to expect first the questions. steps, with take trial I if certain of continuing constructive FDA provide if on you more patients on start toxicology on in in NTM? to healthy you

Ankit Mahadevia

expedite you question our resolution hold. Thank how the trying of to to the in questions. Kevin. terms our evening, Good your for time To on dialogue we're first of

We as working mentioned. on are multiple we've fronts,

can relates we it comes as CRO data we're to itself discussions that manner team generation, well efficient basis. number the I ongoing the the in and working with of as with the that possible, think that to reporting time is as real conducting to an continue as closely make on data one in study our FDA our sure

assembling look data right as of at your with dialogue that collaborative process as relationship, terms To lot with to good can. depend both like? cadence a nature best colleagues as had point of we'll as now running study. the of we've are the we from on that so the this what our the study, of continue in FDA. then of analyzing a And will group And with And well dialogues. the second We the clinical ongoing future in we FDA have having to ultimately and these on may work continue expedite

do not communicate as data the full picture full do we the we that yet we or there, have but will So publicly.

Kevin DeGeeter

between setting. is recent question more to wondering, you and your interplay the urologists hospital analog an specifically in IVs a ID setting. Great. ID and the community of is then I on the accustomed launch of my think space tebipenem GP terms seeing in between what outpatient of then for I'm urologists? in in kind the we're interplay And maybe best And follow-up this highlighted and community and importance in the

do how think urology community? of importance attitudes of ID the sort informing about the the Just and in we

Ankit Mahadevia

Thank that will you the for I pass question. to one Cristina.

Cristina Larkin

Kevin. Thanks,

parts think I two here. there's

we What play influencer a really experts setting we And I they're the a I that as but hospital. the showing is certainly treaters that are treating think consider community is the infections. setting important tract the treaters from IDs them know on they in in depends key know in do role arena, to that in that care. experts, wouldn't our in looking what it data important in the up in hospital of they these our urologist influence has are second-line utilizing antibiotic research claims urinary that addition gives expressed can at to, to ID an an go be us I And and is I we're there in as the interplay urology confidence more I going great think to than launch is the there on, great the that I early two Is they I us. about for was urinary back news will have embark think think point between analog where important except tract. tebipenem, exact which to there which great if interest an advocate for compound, not you decades to ago. fluoroquinolones the within

Kevin DeGeeter

so and I taking No, my Thanks fair appreciate completely much. questions. you're

Operator

Our next from question. question Please your Berenberg. with with Esther proceed comes Hong

Esther Hong

Hi.

my taking for thanks So question.

to you and next approval I NDA closer single if could HBr for get study. we on remind the potential precedent controlled a wanted year, to us approvals As submission know FDA tebipenem of well based

Thanks. your I than to think realized, wanted it's thoughts. more common but I get

Ankit Mahadevia

I'll pass you, for that the Thank question. David. to one Esther,

David Melnick

regarding approval. drugs there my a development pathway, laid ceftazidime-avibactam, urgent allows from unmet in on There of based initially results. Phase guidance the a the is clearly that X out need good is single data, experience of for example development Yes, which was perhaps well-defined FDA approved X for the a which is pending trial Phase

data. the antibiotic no indication sometimes oral has recent pathogen There developed years. supporting based the oral been analog Gram-negative with have one is of resistant approved studies successfully space BLI in trial because Some single a no on in additional antibiotic a based

Cristina Larkin

single as need. different compounds that were Esther, Vabomere Avycaz pivotal single Fetroja, had there Recarbrio, Zemdri, pathway unmet five went actually trial that mentioned, have that pivotal through had all trial that pathway David are single the on trials and based

Esther Hong

you. Thank helpful. Very

Operator

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

Ram Selvaraju

still much and you undertake very proposition value you the if enhance its your tebipenem further bring questions. I'll to could regarding collection studies tebipenem. post-marketing thanks was post-approval gets thinking so one just I broaden start my could comment reach? taking wondering in for with approved, as assuming data on what kinds Hi, of real-world effectively or on to of tebipenem

Ankit Mahadevia

that's great for It ours. and evening question. good focus something of – is Ram, that a thanks

We for disease do is this are cUTI. We the infectious in unmet tebipenem the on need focused largest believe value maximizing and today.

terms Beyond for we of value, to tebipenem. in we how that continue data the how we of see create terms in build avenues story several

we formal a First, different that we the are future more larger contemplating infections and and in trials guide solid we'll and have more when plan. to

for we're a ADAPT-PO study, X Phase powerful in case of is own as ways our tebipenem work building the the continue right, XXXX. in utility quite Beyond two in which its we

First, possible laying we're future our groundwork clinical studies the plan. for through

had As And David interest assess from of be an which significant expect trial utility. mentioned, Phase penetration to with the should HBr conducting a lavage that meetings story. just investigators as will active be we've X given in at of bronchoalveolar tebipenem, clinicians And information should mentioned, important studies studies secondly be that to tebi pneumonia. would David the lung we're example, profile advanced initiate on investigator more several we'll us its sponsored and and to initiate as tebipenem medical to expect give communicating you the tebipenem tebipenem,

Ram Selvaraju

just XXX clarification. And helpful. Very points then of on two

regimen that possibility whatever trial So as recommendations, based some be the resumes next on in is relating at this think and regimen me in I that FDA you? dosing clinical employed regimen some hand new recommendations drill could differ clinical a order firstly, dosing that the the to the on development you I original from me in when understand dosing the speculation was dosing the press of Can the that give sense to different originally there release, kind regimen just how down and give of FDA to whatever might of might or just the employ. but account scenario. you language findings intended from point, take

Ankit Mahadevia

Yes, question. for thanks, the Ram

up as be precedent, of matter rightly do And come have we with we we sometimes we communicating the be XXX, to at you what As we'll have continue that that dependent communicate the the that. more do to conversations we are colleagues with we as to when specifics dialogue have for have in-store those see historical will generate when we trial just will or we work for more exclusion will data specifically as as elements SPRXXX protocol of that say bottom to the in to that and mean might or note terms you the out. our public do, what today. when we not see dose historically right do, And well what a FDA potentially hold, to we inclusion such will in have certainly adjustments just agents the specifics adjustments monitoring and next about on FDA, something criteria forum, when the of of

David Melnick

one… add to Just

Ram Selvaraju

ahead. go sorry, I'm

David Melnick

the done in that toxicology introduced the gavage primates one dosing completely beings. human study dosing add the that's is It's unrelated to medication dosing tube to into by adult point Just way administered oral being has through in done that the a of that esophagus. is the the is

the any in the that dosing change is that humans. concern So problem or that toxicology would that is the dose in imply it procedure And this in regimen dosing not may be study.

Ram Selvaraju

dosing is to the seen direct promulgated evidence you there that there no with just date, of have for is regimen issue to the all clarify, any that indication And in originally in use humans. you

that to correct? to First you indication now. indication and originally the notification announcement we that of made point where the all, we when Is – relative a overt drug-related hold FDA there's can no still definitively overt clinical are still no versus There of effect. is

Ankit Mahadevia

that Yes, we Ram, let evidence the me have. review

ongoing as rat noted to species suggest that suggest specific study as study. hypotheses, dosing we days as chronic as or well related well FDA. we that that up What we date think more And same are get know rat we XX studies, studies data we've Phase we to opened the before continues confirm consistent that up continue date toxicology there fact when with to X the the felt as to I volunteer healthy have data, drug those as to hypotheses normal things that prior primate is we'll be with relevant. the that could related an

we have that of support hypotheses. the those data the to So, viability continues

Ram Selvaraju

you. Thank

Operator

question-and-answer of to management closing the call back the to turn I'd the time, comments. over like We for this end reached At have session.

Ankit Mahadevia

everyone everyone's a webcast Have next invite to appreciate March presentation for I XX, join at our Healthcare XXXX. Conference I great at evening. today. time us And operator. you, Oppenheimer the us Thank joining on

Operator

conference. today's concludes This

you at disconnect lines time, You this and we your participation. your may thank for

Spero Therapeutics (SPRO) 12 Mar 212020 Q4 Earnings call transcript