SPRO - Earnings call 3 2023 | Spero Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Spero Therapeutics Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please bronchiectasis 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 announcement on the Spero Therapeutics website at sperotherapeutics.com. At this time, I would like to turn the call over to Ted Jenkins, Vice President, Investor Relations and Strategic Finance at Spero Therapeutics. Mr. ahead. go please Jenkins,

Ted Jenkins

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

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

and HBr, Before we about our on the tebipenem and you the results commercialization current management's resources. including cash statements preclinical progress to of trials and like clinical timing, the clinical future that the company's expenses information and development the of of based of begin, forward-looking research of such SPRXXX this sufficiency on programs; company's statements development of I'd the the studies and design, and presented studies forecast trials, conference and its and remind and preclinical some results SPRXXX, its call cash contains expectations, initiation, assessment anticipated

in statements could described could the contribute guarantee are factors that such of cause Such from a such Several and in are differences materially contained differ to performance, not statements. forward-looking results or actual company's those section detail XX, report the our today. Therapeutics in Form SEC, ended on of quarter for XX-Q the quarterly XXXX, the Risk filed with including September the in Spero with Factors SEC filings

our statements President the Hamed, Dr. regarding today's are Sath although obligation ahead, publicly I Shukla. information Ms. call also update and to the Chief Chief CFO Executive speak date welcome Executive and Sath Chief of statements Sath. XXXX. guests to like no undertakes Medical supply Participating Chief Officer; would this after part of new a call. I'd Officer, attendance Business call new Interim forward-looking only speaking like These the having Please to turn today's date our XX, any Officer not as company conference DiPalma, Shukla in Officer; that, over Financial call, Kamal in The November company With Officer. go or and the of Spero's Spero's to special Treasurer; Rajavelu, Chief Esther and Steve today, forward-looking

Satyavrat Shukla

I number and has afternoon. and related Ted, across late-stage a of been for There of for our us fronts. this Thanks, Each joining regulatory progress achievements is you and a Spero. financial assets clinical, moving of XXXX thank execution year all forward.

management us rare We bacterial on the well positioning place our an infections. medicines have to differentiated strong sheet experienced serious and develop team balance diseases to multi-drug-resistant a deliver in patients mission for and with orphan

developing and III the written high on concordance level or antibiotic we that GSK announce first design with Let we between design Phase FDA me treatment special pleased PIVOT-PO. And are infections and with overall received under potentially had urinary of assessment, We sponsor. the we tract protocol protocol of which were partnered very the or SBA begin as oral the planned on of SPA, on represents July cUTI. the typically trial, to tebipenem have and HBr, our agreement carbapenem a which for from FDA the complicated U.S. size a XX very the

substantially. additional aspect to Kamal been the current in PIVOT-PO regulatory design few begin is first with the respect believe and the the touch program, expected have in we visit Enrollment So derisked to will quarter, of patient minutes. a on first that and details

consideration cash milestone million GSK agreement. as We for during development additional our of from $XX per payment In a received also GSK an qualification the quarter.

based in comprise net potential our milestones million all agreement. product and commercial eligible In royalty These territories, $X tiered payments we addition of double-digit also milestone remaining royalties to tebipenem the $XXX and million are low this receive million exceed sales, additional to in and $XXX on to up low up up on in under following if milestones to development other HBr payment, Asian or milestones sales to to countries. $XXX first Japan potential billion commercial sales-based sales certain single-digit of

very partnership are we excited Overall, by our with GSK.

other sites be The grant forward. continues trial been dosing in by continues IIa SPRXXX quarter. clinical SPRXXX, In addition our for to Phase track tebipenem progress and and we to on II this patient funding. continue having investigational polymyxin other enrollment proof-of-concept move with assets HBr, our next-generation for nondilutive our XX current initiated. IND on funded to Phase

Chief were which Mahadevia, last to take for call, Deshpande, the Directors. our predecessor and the transitioned November recap and The X. would I last date of become a to Business director quarterly Milan was President came the Vink an Dr. on into as and August Officer Rajavelu management has CEO highlight prior on independent of role appointed Patrick and on Chief Spero, the changes appointment effect Esther As week, as Board described Lead that the effective member, recent on Chairman, and that Dr. my I remained also co-founder to Chairman company's X, Financial proud Officer, another the Ankit on was of Board like of Director. Dr. of Board

a Street and both in expertise and financing has growth industry strong track brings M&A. Wall and Esther Relations, record corporate from and strategy, finance Investor

also Hamed, as management hand would I has during to Dipalma, to provide more the to opportunity our Treasurer, We I her excited on over to programs. clinical have are the Kamal Spero. our who this Dr. to I formally like team, her details join call very recent the want take Steve like served thank and transition. would now who CFO and will to to interim welcome

Kamal Hamed

Sath. you, Thank

clinical randomized hours. XX milligrams hospitalized XXX days. intravenous our oral pyelonephritis. of to in X X including including acute evaluate with a patients randomized cUTI patients adult enrollment to III every adult commence tebipenem in receive global for tebipenem pyelonephritis. Our PIVOT-PO a double-blind trial pivotal total of to Phase Phase immediate priority X intravenous be is in every imipenem versus cUTI, XXX X:X PIVOT-PO, dosing oral tebipenem to imipenem patients study III acute Patients of only Or and will milligrams with hours

use assessment The The the test visit. an primary point of is response overall will efficacy for be July, and of treatment be for a tebipenem positive from of cUTI previously SPA end urinary the by intention completed primary persuasive approval response, or mentioned, trial cure to on microbiological along in acute at age, for indication. with with in composite support population of designed presence Sath results of we FDA analysis and is enroll diagnosis, by could indicated as a The is will X,XXX XX% based randomization study including pyelonephritis as non-inferiority announced that to pyelonephritis agreement, which limited stratified clinical or absence i.e., instrumentation. sufficient treat covered and the tract PIVOT-PO microbiological patients. baseline be to late an margin. non-inferiority studies the This the trial which approximately cUTI, the a

dosed Again, and an enrolled enrollment we and soon make to when will we announcement first is have expected the patient. begin

the the confidently program, oral now endpoint, IIa our bacterial in in nontuberculous together is PD. treatment we We to disease or ] SPRXXX deliver [ with evidence trial trial. for will Turning The development. move from burden secondary will that into to is believe hope change baseline. slope model, us microbacterial result SPRXXX NTM Phase this endpoints first enable positive late-stage a from sputum currently on evaluated polony primary supportive endpoint which proof-of-concept line the first being

infectious of rare is that limited current debilitating a is regimen of prolonged a care effectiveness poor disease combination have lung and tolerability. standard the and drugs MPD

or expected enrolling trial Given has standard is experience We refractory a treatment establish and these of limitations, SPRXXX for patients. unmet The not naive new disease. a believe we are clear do XX care. to active that to participants up have currently address to have potential the XX need sites treatment but and either screening treatment enroll

as all specialized group, the engage with support diseases rare necessary with actively ensure We've study to sites. patient resources. to partnered as have NTM with a continue third-party CRO NTMIR to advocacy the sites in study We also lead they well

We XXXX. expect in study data top this announce second to of line half the from

late-stage EMC engaged engagement has foxicolity FDA ] advancement activities studies. prevalence many into to development efforts Japan program territories. compared the These initiatives, development are support to a activities where higher with needed additional the in SPRXXX's to ongoing SPRXXX We [ work expand other currently include into and clinical NTMPD

I X studies clinical also underway. Phase are There

an the indication. to be a SPRXXX which also The lead instruments endpoint that primary future with within confidence for moiety and ethambutol active the on We're evaluate to when the bronchoalveolar a assess pharmacokinetics effect guidance studies lavage for will and with pharmacokinetics on working SPRXXX our and developing increase the will second, to or published SPRXXX prodrug to of patient-reported of FDA's azithromycin drugs the in first, in develop entrapment and the in of volunteers. the study relevant line BAL clinical outcome this NTMPD healthy co-administered efficacy

which XX% how begin discusses and and are only There role I Winsor NTMPD was Science anti-infective XX of it patients Health and paper current has months. so able therapy. highlight. was a NTMPD of this Today, University, recent The of Kevin after only October & still the challenging. SPRXXX, Dr. addition would prevalence the diagnosed use half the to regimen XX on like expert management increasing lead maintain and The or of disease article potential also Oregon in the published published the offer guideline been therapy of to was to treatment of with

demonstrate preclinical encouraging activity supporting data and the the its causing SPRXXX's Mycobacterium main and The to against NTMPD, and offers avium review SPRXXX in agents ability vitro abscessus. Mycobacterium complex specifically

issued publication to posters read find of those press our the encourage a or can earnings link it. of the the section and publications I You in today interested corporate would website. and release we

polymyxins program. the profile an comments Finally, being compared available on antibiotic brief some county improved polymyxin investigational to with nephrotoxicity developed gram-negative is infections. reduced SPRXXX of to for safety next-generation our an multidrug-resistant potential treat SPRXXX

We With track We submit application in IND currently Steve? Phase working advance the quarterly turn I'll on Steve II call to our review hospital-acquired to an a trial into pneumonia. that, financial by bacterial year-end. patients remain or over to results. SPRXXX are ventilator-associated with to

Unknown Executive

$X equivalents into quarter total third cash be with revenues revenues of and million company We XXXX. cash $XX.X the XX, compared announced agreement to believe of September includes as with our of last GSK. financial license equivalents Good on the This with We HBr ] call. we been the which as of fund of sufficient second in was will half in Kamal. reported million well third million the license was of to Spero million of capitalized million related position [ quarter period. of to received strong GSK. of XXXX. revenue compared a primarily of collaboration tebipenem you, all and XXXX. with million us part That you the year on our milestone result $XX.X $XX joining call, A that a the cash to Thank cash evening the has increase now prior a earnings agreement the $XX.X $XX.X

with tebipenem $X.X revenue period direct primarily in $X.X third same million expenses lower XXXX. due in planned Current programs. in as $X.X third XXXX. the XXXX for the in SPRXXX was and compared XXXX million our SBRXXX of start-up increased were the clinical and for XXXX. for related tebipenem costs than expenses related expenses to third of and of were in million IIa This reported activities the research the year-over-year and the ongoing activity -- was to development XXXX of development to to period million increase million Phase preclinical same the $X clinical quarter $XX.X trial These HBr period HBr. quarter compared of the higher of well the activities million General and million in quarter to Phase in administrative Research III $X.X related as same and increased included trial $X.X the

as of related fees. longer facility primarily was well incurred was a expense lower part an of personnel-related quarter expense same million stock in in to per decreased impaired other by basic expenses, service net company basic XXXX. compared loss the of Reported share period the or to decrease result and consulting year-over-year increase and costs This net long-term professional asset offset million a fully the in Impairment as the diluted in related and Saver XXXX HBr of a was $XX.X Savier and of for common agreement. Corporation. as $X.X company the manufacturing tebipenem or for commercial recorded service the $X.XX common no share XXXX of An the that third capacity for the it LifeTech to with agreement million of for stock provided diluted impairment per loss $X.X concluded $X.XX under of reported third quarter a need had

formal the Spero's filed details the completes with report. comments ended financials, quarterly results for from I SEC including you XXXX, Form XX-Q For further to refer X-month report September our on on This period today. today's XX, Spero's will QX

line. call if from like turn on are those the to questions operator, any I'd back to the the there

Operator

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

Louise Chen

So you ask I wanted a to few.

development III color could to are as give Secondly, from thinking the sales welcome more milestones First, of program role. as us and you in how then progresses? lastly, about GSK the And million on potential new $XXX you the peak the Phase tebipenem? congratulations,

Just curious the here? management you and think bit to company about little teams how differently a bringing you're prior than things what

Satyavrat Shukla

Sath. X questions. take Louise, speaking we you this won't first is I can can question separately. line but your be that today, up Esther for

million For expectation duration your is the trial. come the first of the in development in that $XXX through milestones, question of they the

of come are those those that answer XXXX, Or to that expect years fund Did on And was as so commercialization next in X next to milestones with partners years. expect over to your we fully our date know? anything there question? we a of planning the that GSK the target we further you the development milestones over wanted trial. couple

Louise Chen

basically And through good. the the based something it's that? trial that's does or hit just the Or amortized like that Yes, of you happen? course certain how in milestones trial? Is on it

Satyavrat Shukla

is should further reimbursement the some But expense a soon. to milestones. on for expectation clarity sometime measure an performance that you be give it's we So or not the able that

it and continues progress, obtain qualify to as progresses be milestones. for trial able the we those As expect to to

your Moving sales tebipenem. peak about second to question for

patients, high oral see don't blockbuster need we have an of proposition potential cUTI aggressive considered on reach the think given value that penetration for the because to I you the assumptions pricing prevalence tebipenem very expected always has to or statures carbapenem.

So and is drug the commercial approved. have we commensurate where and to the scientific And with therefore, if something when hopes performance this the expect economic we opportunity for improvement. high be is commercial

Operator

from comes with the Boobalan Wainwright. question H.C. next of Our Pachaiyappan line

Boobalan Pachaiyappan

is This Boobalan.

So a couple from us.

pneumonia you about into think ventilator-associated Phase hospital-acquired advancing you II, XXX indication. the the as or path So bacterial in can regulatory discuss forward

you So efficacy we like. the particularly, of standard sectors think this for in to similar what establish safety need efficacy would to indication, look wanted bar to know better and you And or related a do the efficacy this it's more XXX to again, care? -- sorry, broadly, and long Or differentiation the How landscape of see in indication? is enough feeding uptake you list competitive drive into do questions.

Satyavrat Shukla

You've cut last the on more could Boobalan Sorry, question time, repeat you please? out.

Boobalan Pachaiyappan

into do last fitting was The you question XXX absolutely. Yes, how see the landscape? competitive

Unknown Executive

questions. the for Boobalan, Thanks, Yes.

ventilator-associated hospital-acquired India, indication. great In indication as great medical makes there's about pneumonia, for medical terms for indication therefore, this talk to is because need infections, pursue. also we time. unmet gram-negative us the need, bacterial this infection, polymyxin I untrack what an challenge back and the of bacteremia great no at mean, a of there's when to is area this that's the indication complicated of approved indication medical bacterial sense need indications therefore, And the is area pneumonia that's unmet are in and of Hafa, we Other as targeting point for no far as certainly, the derivative such

safety, safety differentiation, to expect clearly, efficacy is benefit to there. that reduce expectation versus nephrotoxicity. superiority was we efficacy so to But demonstrate specifically safety -- have terms designed demonstrate a would we because our In we of SPRXXX demonstrate

exposure result in reduce So because to this exposure you the as or it's reduce -- and associated the been a if it's well the would that as with reduced designed in demonstrated kidneys be cytotoxicity in as nephrotoxicity and result, therefore, kidneys nephrotoxicity. would kidneys be

safety respect while as efficacy, on side, a so to specifically do to we we And benefit nephrotoxicity. would be therefore, consequence, demonstrating with expect see again, the

is been but been also used in and we the hospital. inhibitors hospital are these generation emerging of to to there then difficult infections it would a highly again, competitive polymyxin that field have back know treatment be need. by resistance beta-actin the pseudomonas. newer landscape, inhibitors And [indiscernible] is associated Now recently that there caused acquired you these arcane used, is, with the for treat know, kidneys bactammonia in that could beta-lactamase the that as And pneumonia on being clearly, and you are from ventilator a gram-negative beta-lactam, polymicanes substitute But if beta-lactamase developed they've terms safer or toxic. of very therefore, polymyxin

Boobalan Pachaiyappan

regulatory the indication? discuss path in you Can forward this

Satyavrat Shukla

Yes.

We Boobalan. haven't given guidance that yet,

with bear the course, us through get give then, as a to we we out you'll greater that of clarity If path forward. IND plan on

Unknown Executive

Bo, again, IND will II IND the R&D And I year-end. will as be is that in along. reviewed and -- study And enabling submitted be time at clearly be mean, we've And the disclosed, disclosing with goes that expected as as with we to more FDA. Phase details discussed by

Boobalan Pachaiyappan

can I if one then add And more.

the respect with less is metric discuss criteria create exclusion see an you're XX real of using with excluding the one that the began an to So minute, can this inference. mils exclusion process so PIVOT-PO thought you I than study, per patients as criteria?

Ted Jenkins

of the part repeat question, you first Can please? that

Boobalan Pachaiyappan

Yes.

one the per creative than So the CRCI in equal is study, exclusion or in clearance, less of PIVOT-PO minute. XXm criteria of

to an like this indication. So process as criteria behind thought the I this understand metric would using in exclusion

Unknown Executive

Okay.

I per not So adjusting into dose in we than excluding renal terms with will for patients be a study mild for with impairment creating or clearance adjustment. therefore, miles patients impairment, the dosing and according severe that's [indiscernible] patients because of are XX we these a to scheme have minute. have we renal allowed And mean But less clearance. model

Operator

that call back our turn session. to And question-and-answer I Shukla. the you. concludes over Thank will Mr. now

Satyavrat Shukla

listening many evening. operator. Have and today. Also nice all a you, thanks to participation Thank for your

Operator

teleconference. today's concludes This

lines your time. at you participation. You for your disconnect Thank may this

Spero Therapeutics (SPRO) 13 Nov 232023 Q3 Earnings call transcript