SPRO - Earnings call transcript Q2 2024 | Spero Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to the Spero Therapeutics Second Quarter 2024 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being recorded, and a replay will be available.

You can find information on the replay and further information related to today's announcements on the Spero Therapeutics website at www.sperotherapeutic.com.

At this time, I would like to turn the call over to Shai Biran, Senior Director, Investor Relations. Mr. ahead. go please Biran,

Unknown Executive

quarter Thank Spero you, today's financial for in Investor the you and is press available on website. and call. This thank the second for conference update released of a all XXXX. afternoon, The provided release the participating page business operator, of Therapeutics Spero results Therapeutics

the our forward-looking conference or detail you the differ could earnings business or and quarter XXXX, forward-looking implied the expressed filed information of Form involve we I by Factors These call filings forward-looking with and could Before Spero the contains some statements. uncertainties factors begin, These June achievements results, those would Risk clinical XX-Q contribute XX, cause for that like described of in timing, such section securities statements risks SEC with substantial cause differences our to in are such today. the under on including in the with Therapeutics performances from or statements its risks and programs, SEC to this associated laws. ended progress, on remind that materially to that report the uncertainties presented future actual

Chief Executive also Chief included Officer; We are are and Participating Officer. call. sir. Please you Rajavelu, presentation Shukla Business cautionary accompanying go conference Sath the Shukla, forward-looking discussion. the Esther with Financial statements that ask reference statements this slide will call and ahead, Officer the in Sath begin Chief today's

Satyavrat Shukla

across am and on an pleased clinical conference Shai. joining today. afternoon, the our I our stage of update everyone, you, assets. for provide you portfolio Good Thank ongoing progress thank to call

success behalf executive and We with many the to Board, contributions Spero and I on wish in of Hamed to every change departure our leadership all the management Hamed, for thank future. Dr. would for of that, a note Medical Officer, Chief him Dr. our his Before of employees. team Kamal the like our

a Spero's John veteran to for provide of during help last member for programs the a We are our clinical and field distinguished Dr. will announce industry transitionary that Board period. oversee pleased guidance strategic years, Pottage and in our this X

to Officer. our Chief Medical While next we for search continue

Moving to pipeline. clinical our

with as have patients Japan current care patients. of of of shown approved in sent and issues. for in are no an serious SPRXXX and these evidence developing lack agents the different as patients pulmonary propensity the mechanism resistance in action. Let in has XX,XXX for first-line disease of vitro of U.S., of novel is has conducted as NTM-PD. from efficacy studies for That off-label which development There as which for oral NTM-PD. patient well a EU tolerability extensive approximately guidelines those is has as other SPRXXX, nontuberculous marketed begin well the well agent against cross Spero resistance. me population first-line no we as those low have vivo The antibiotics of in a while XXX,XXX of selection standard therapy as a NTM-PD estimated history drugs, which recommend U.S. TV mycobacterial currently

have We against be multiple SPRXXX NTM pathogens. demonstrated to potent

include comprehensive studies. subsidy This for supports Phase in and proof the clinical QX, IIa anticipated completed data treatment-experienced refractory from of benefit. expect potential on data the recently Overall, data and therapeutic share to we from corn ongoing preclinical believe patients. we In our a is SPRXXX's to treatment-naive set

healthy in will supportive Phase I report data volunteers. We X also studies from

with NTM-PD clinical versus and of and XXX X Phase administered megs megs patients avium care lung monotherapy ] agents ethambutol.the assesses and to which MAC. complex, SPRXXX, SPRXXX with IIa One trial which of segment exposure as due plasma the [ when co-administered as of monotherapy assesses doses in X,XXX azithromycin compares in exposure of M placebo in or standard

of a have total XX We patients. enrolled

Including early life a It of patients monotherapy XX in study. patients in is bactericidal activity, course over the refractory NTM treatment who can are primary is including colony experienced days decrease in data rate our we to change have as changes disease. distribution, per loads millimeter, do in hope study which treatment long-term bacteria not and from analyze treatment our this bacterial load SPRXXX this both [indiscernible] this the measuring the treatment units that the of endpoint forming

at which a of rate change looking endpoint to study. time key the is in also are positivity, We the secondary in

to ] and patients would could these we also between be MAT patients SPRXXX that are We due [ to activity that we regimens the measures late-stage only in on make treatment has indicate the activity, registration-enabling combination studies agent could part and with early acetic which A care that [indiscernible] the a success endpoints potential in move anticipate the monotherapy strategy the NTM-PD. standard has that development SBRXXX believe SPRXXX of jobs ongoing NTM-PD we in and be in anticipate as with agents. in clear oral to include placebo used confirms to these of expectations demonstrate to aware confidentially numerical Ultimately, future development. if drug that enable our of free-cash us into difference effect designed

Phase previously as we the volunteers. from data will in share X Complementing healthy studies IIa I mentioned, Phase also data,

prodrug say SPRXXX, lavage, you of or active the study, of the first BAL to examine The SPRXXX. pharmacokinetics moiety bronchoalveolar intrapulmonary

the extent exposures digests, infection. We showing expect measures lungs, PK share of the the in site of to

strategy plasma studies. combination be this evaluates in future selecting than co-administered second changes when in doses ethambutol [indiscernible] to an PK and SPRXXX informative is The with data azithromycin

IDWeek provide to as QX. combination that set use path the upcoming for with data expected will treatment readout NTM-PD. in and studies first-line about registrational robust us October. for anticipate standard completed a These to in in we these in are determine sharing data data SPRXXX oral study team of vitro resistant of SPRXXX Lastly, is at with care we excited The an agents recently this

the to we global urinary first the is the ongoing track, year. now of developing complicated for the on Turning pleased Which oral beginning since progress the antibiotic with carbon are our of trial are in Enrollment cUTI. infections treatment and PIVOT-PO or tebipenem potential HBr. made tract Phase as we out III

to clinical goal Phase intravenously total enrollment remains in this to in or pivotal receive meg XX tebipenem a X X of trial imipenem to III one-to-one Patients second XXX the for orally randomized XXXX. half hours of cilastatin days. complete are XXX Our every every X HBr meg

test patients. will in primary end The enrollment analysis microbiological Target noninferiority for of the of fuel margin. visit. response, is approximately overall and the XX% an population X,XXX a assessment on clinical intent-to-treat a efficacy point is and which primary microbiological of The response trial be based the non-CDRT composite is

partnered As a HBr reminder, is tebipenem GSK. with

is, and by U.S. III [ Phase development ]. We to X the execution [ are per territories another ex are in and responsible Mastek cause carbopenem from potentially the reducing infections address our The with OTR tract over excluding intravenous translates the of urinary cases health into search a commercialization the the If length of carbapenem Asian incidence which a transition U.S. uropathogens, be version in to multidrug-resistant GSK the it carbopenem for knowledge, is responsible development. of estimated oral oral significant an ] leading hospitalization need only partner, in could million care is or to infections oral for held and system. caused therapy. by Tebipenem for worldwide ongoing stay with the trial, approved, year, eliminating in patients need rights hospitalization on complicated HBr for

year, patients Pfizer partnered SPRXXX innovative, the a the also initiate intravenously SPRXXX reminder, hospital-acquired a funding. SPRXXX with ventilator-associated a we with plan ignition, for II European FDA contingent polymyxin to the IND administered as direct-acting availability or fast-track into investigational, up of the Phase pneumonia wrapping of announced II clinical this and trial that in to that Phase in study quarter cleared an is markets. We Finally, awarded with non-value on FDA advance first bacterial to

I'll call our review to that, to turn financial With the over results. quarterly Esther

Esther Rajavelu

and first second financials. I'll with on good the and our Care all with of the then cash equivalents. afternoon summarize GAAP us Thank joining in to quarter cash million you, guidance ended and you call. $XX.X begin our Sath,

balance in anticipate GSK In addition months. every payments of million $XX sheet, milestone tranches X development our the amount of cash to approximate from on remaining the we X

Spero in X payable upon Phase the PIVOT-PO reminder, of a are million III X installments $XX trial, for in which over initiation qualified clinical equal years. As from GSK, milestones development

quarter of third second The in tranche approximately $XX is of this million payable the year.

to estimate together our late and and cash will funding requirements our other We sufficient fund be expenses operating capital nondilutive into cash XXXX. equivalents, expenditure commitments, with that

second quarter compared quarter to million The GAAP summarize $XX.X for 'XX Now our an primarily for XXXX. was Total total was of in financials. moving BARDA second quarter for with the our to both for increase XXXX revenue SPRXXX. relating with increased agreement SPRXXX the for a second on increase of million of agreement with in $X.X revenue decrease revenue revenue and to grant collaboration the due of agreement by collaboration HDR. Pfizer GSK to revenue to our NIAT an contract related offset These partially our our revenue related and were under tebipenem related to

period SPRXXX. was $X.X by XXXX June Research million for costs, same compared to and trial period sale year-over-year in partially decrease $X.XX basic costs year-over-year and due of partially professional for lower in quarter XX, a development trial compared IIa for the ended and costs in G&A the the of million increases 'XX. the the primarily by to $X.X quarter increase 'XX. quarter common second $XX.X $XX.X for to in loss second personnel-related second The clinical were expenses of or for to XXXX. related development a expenses decrease research diluted This III due the to reported million primarily in the direct to and HBr share G&A stock, same million million of consulting XXXX expenses for $X.X for were I net and Phase per tebipenem pivotal higher Phase -- related direct offset offset the SPRXXX.

with compares of $X.XX million XXXX. loss period $XX.X or stock the share net comparable in This for a per common of

refer details filed For SEC to further on the today. XX-Q financials, our please our with

the questions. open Operator? now will call We for

Operator

comes Instructions] Fitzgerald. Chen first of [Operator Cantor line from question the Our Louise with

Louise Chen

Congratulations progress. on the all

quick I two have questions So for you.

is of wanted data on to and question present think what one to going departure. just all And Kamal you that learn then from IDWeek was the significance we you're should we First second of I ask this? the

a of here. lot give didn't ahead what wondering of the here, but are details data. You people happened obviously,

be give So any great? color would you

Satyavrat Shukla

answer Louise, but of the then, course, we line Kamal's and are tebipenem rest from on where to data with thanks unblinding your you, an is continues can hear company, forward SBRXXX the the . data Like is next or XQ. questions, That I'll be reverse order, has do looking year, the for it of share great in to for nothing top enrollment event we and programs. questions next the for obviously, to year. the in half the you. track you. the with of expected for second And our to reporting completed in of and departure,

Moving to IDWeek. question your first for

resistance particularly data. are excited We about presenting

So know, resistance. you with data the propositions is we seen cross as MOA, resistance one to novel no date low SPRXXX, the for shown for that propensity have of of a value and that evidence has

So be in will data a that we'll for on. set build IDWeek particular,

Operator

Evercore Our next Gavin with line from ISI. question of comes the Clark-Gartner

Gavin Clark-Gartner

coverage what the the I But XXX over site just Phase duration you're a that both doses roughly had you for of PK the both at MICXX so of doing given day, doses you're I that your specifically at boes. the includes infection? has of IIa, substudy, -- believe in that which and testing of do one appreciate

Satyavrat Shukla

elaborate what Obviously, you, that the to on perhaps sure back I'll Thanks that to have to we But not question, data have not and we the for it come but we on out. be just of degree look believe can for will question that today, have back that I disclosed do part on disclosed yet. report I'm what you ask. data I Gavin.

Operator

PD Baral Our next the with of Ritu line Cowen. from comes question

Ritu Baral

I that correctly. So wanted sure heard to make I you

the with enrolled treatment-naive? in that the if that there? treatment-experienced XX patients were patients XX before follow-up. I'll my get this I well, said I'm patients all sorry You you Or answer have did let you wrong, were And

Satyavrat Shukla

Sure.

night answer Did XX and question. experienced So that we've always patients treatment those that treatment said which with the for -- that this have is nonrefractory your patients. expectation and trial

Ritu Baral

endpoint expectations? up Yes. and Can both primary it I ended how have might that with you speak mix the final secondary then you follow-up. the impact enrollment and to And a

Satyavrat Shukla

we Unfortunately, with us. blinded can't right those most data because them now, to of are

we just even yet. So is treatment-naive and experience disclosed the of treatment patients not mix something have

Ritu Baral

Can Can about a you have negativity. to of time to meaningful a what time ask to detail endpoint end also on go previous to into that? on wanted that and in little time positivity. discussed drugs think elaborate of sputum is the previous time I of it. what Got you secondary have sort point? positivity sort I point

Satyavrat Shukla

Yes.

for well are as which this academic it's metrics So positivity space, both basically prolongation and is is of time in for new the to a cutoffs, of limited and reduction time well as therapeutic But works logXX primary think the ], being CFU/mL for relatively example. positivity. course, that in I context, way for example. that NTM, is positivity. are medical These there daily the that time endpoint, the literature a the in to TB established creates [ But for covered

the when media a the efficacy that for with then that are So of in the bacterial growth. indicate question. sputum it And In of treatment measures reaches liquid process, the signal sample. a evidence growth, the predefined can inoculated time this

So really, better to longer is established. is. time In this that it the the measure positivity, well TB,

For in time endpoint. always primary log us, TB, the endpoint, and usually positivity. there's what as to a degree it's of between characterized a the correlation key have a But we high within reduction secondary

show hope that the as microbial a will out report on we these what we is both of So reduce. activity they drug of

Operator

Wainwright. from question with of Selvaraju H.C. comes next the Our Ram line

Raghuram Selvaraju

all that line I give And about on either with to ask tebipenem negatively respect positively Congrats us if you the number you clinical wanted of regarding an today's granularity factors in sites time that that get to press total to and or enrollment what currently Phase additional to the being completion able to program. you impact target the are III expect release? progress. disclosed enrollment could involved

Satyavrat Shukla

Ram, for Thanks, Sure. question. the

you And than were the in know. saw like date, -- We for we given us. precise as in haven't to the assume as where last be call, the headwinds of other It's somewhere triple seen we enrollment one, you we factor districting among a features a study but ballpark. global track if one countries in digits for a a trial for the for was on have not on would number to adapt, yet, it's mentioned you the multiple COVID larger

this half that time GSK are as NDA at time, the out partners So of next in of to submission year. that And conduit of time continue hold to their know, our an lines in you also moment setting second is completion we at for our expectation for that enrollment also frame.

see Jebi So on excited the is data. the track, bottom to and line for are we

Raghuram Selvaraju

technical Okay. And then XXX. regarding just X questions

First is, use combinations of to and plasma additional might permutations context want if you secondly, manner the XXX. if comment active at into in description PK us the the on is give the prodrug or what to terms sisomicin XXX And loyalty converted in can can of any, which the just brief look of beyond a in you variability assess of you in XXX. ethambutol

Satyavrat Shukla

Sure.

have question, XXX have we calls moiety. and the we But stated what on publications its to we'll very we in to has we'll now, Ram, conversion the For the question your rapid ensure so have so just is to them you. active forward send granularity, the that for as you What azetromycin first dig a into macrolide. published, that serves to a have after second can call, we right

along feel later-stage as we landscape we macrolide that, makes the obviously, a what appropriate be development. as co-administration But that with measure under for discussion, of so with open an to we evaluate evaluation NTM And enter the to with sense will evolves, is ethambutol.

you make development, most will the the line, oral and see data that all optionality know, right But the asset. now, as evaluating progressing us. in the sense with only in we those first certainly after in we sense that be would therapy, one today, For therapies in the to make as discussions are the an oral the FDA,

Operator

his Sath closing and our Ladies would Shukla I concludes gentlemen, for this over hand to conference the session. question-and-answer comments. now

Satyavrat Shukla

Thank our we day. as a We to progress you, look dialing pipeline. in. great Have everyone, you forward updating for

Operator

has Thank you. you now your Spero The of conference participation. Therapeutics for Thank concluded.

now You your lines. may disconnect

Spero Therapeutics (SPRO) 5 Aug 242024 Q2 Earnings call transcript