Earnings call transcript Q1 2023

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Operator

Good afternoon, and welcome to the Spero Therapeutics First Quarter 2023 Financial Results Conference Call. At this time, all participants are in listen-only mode.

Following the company’s formal remarks, we will open up the call for questions. [Operator Instructions] Please be advised that this call is being recorded, and 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 www.sperotherapeutics.com.

would Vice turn Strategic President, Spero I to call Finance time, Therapeutics. Jenkins, Ted Investor this like the to over at At Relations and Mr. go please Jenkins, ahead.

Ted Jenkins

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

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

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

statements are Spero call. forward-looking the Risk regarding date after as undertakes update cause actual the of supply XXXX, date the those company including information the SEC with performance, to from materially statements. of publicly March a this today. are and filed today’s on detail statements the in section such in statements XX-Q any XX, quarter Factors forward-looking guarantee with our speak the company or obligation company’s such differ of could Form to only differences contribute ended for conference new no factors These contained of forward-looking that results or the Several of Therapeutics and could the filings report described in the not SEC, Such in quarterly call,

Spero’s Officer, Chief With like Ankit to Please go call Ankit. to turn Dr. ahead, Mahadevia. Executive that, over I’d the

Ankit Mahadevia

listening. who thanks and Ted, all to are Thanks,

talented These key last have our and We and components premier investigational address progress three government, believe medical commercial late-stage continue experienced programs strong across prospects. our the across team, balance with sheet to the medicines components a to advancement clear value sustainably designed indications include strong and of create in needs our clinical partners differentiated quarter, through an and to and management pipeline. make place we industry each strong of

clinical ago We outlined detail earnings our our six in programs only weeks call. on last

myself, our will the this, Given and Sath prepared to prepared today financial Shukla, Officer, Hamed. Officer, on keep Kamal Chief move After our with we remarks, Dr. our brief. remarks a Q&A we’ll Chief session Medical

seven first program the aims pleased disease by me for patients. first – lead continues which according NTM-PD short our plan. advance for to the SPRXXX line to treatment Let to program, start report to I’m mycobacterial discussing deliver oral serving novel or non-tuberculous that

with currently is of XXXX. more concept enrolling X top the data Our in anticipated trial and XX of sites active Phase line proof than first half

endpoint A trial load is from SPRXXX goal endpoint in primary to on learning development. supportive a substantially late-stage with program the enable We believe primary agent the versus standalone with early secondary the will and changes and evaluating confidently to the of move this microbiological trial driving baseline. response pairing de-risk positive and key a result an from endpoints bacterial samples evidence as sputum placebo to us show

combination evaluate regimen. late-stage a In as of plan development, to we part SPRXXX

additional pivotal NTM-PD, trial, advancement a support development to Phase remain currently unmet limitations progress need. X our needed combinations a we first of care late-stage believe to address off-label program our activities has the standard program Given Alongside we of track with as we the towards entire XXX’s line on of the in the clear the potential SPRXXX that studies. are perform

expand initiatives, earnings relative our As engagement increased XXX the CMC program quality other toxicology development sharply ongoing to has where a efforts in prevalence activities to NTM-PD include last work, Japan, territories. into and these call, on with noted FDA,

needed validate the in continue primary we to on develop efficacy indication. clinical to addition, line are our drugs is FDA’s and for execute guidance that future relevant studies endpoints patient for to this within with ensure conducted In published on our steps the NTM-PD. reported This developing outcomes

a antibiotic potential tebipenem Next, We a complicated planned oral Protocol as treatment is Phase I’ll or Assessment Special cUTI. the tract FDA agreement speak and trial. briefly potentially about of remained partnered with HBr, with the first urinary GSK which being infections developed special the regarding – for X carbapenem engaged for

planned to last support this could For trial a approval. year, tebipenem together conducted Type FDA non-clinical the results confirmatory of positive HBr’s Meeting with from efficacy evidence sufficient A with be

regulatory to We the trigger details milestones of that of and to the expect would like and to agreement status Special on by agreement. for XXXX. time, update intend At provide engagement its may the FDA the from activities we our Phase that outline and specific constructive the mid-year trials GSK Protocol development an also design, thank X Assessment the planned

conclude be briefly advance approach the developed prior the IND trial year. polymyxin my infections. planned being next to efficient with with proceeding Efforts quarter that into to a in our in SPRXXX an capital section Phase today’s X participants entirely To ventilator-associated application bacterial pneumonia call, pipeline. are very highlighting antibiotic external on remind the an multi-drug which or treat SPRXXX, I’ll being investigational expected those generation with to hospital-acquired I’ll listening employed fourth line guidance non-dilutive is X of gram-negative advance trial the funded sources, will Phase by in touch of of resistant submission

the With review that, results. to financial call Sath? our quarterly turn Sath to over I’ll

Sath Shukla

us with equivalence and joining in as report and to cash my Spero evening well to remains position and in Thank capitalized the expenses XXXX. fund of pleasure all that capital March operating cash together sufficient believe you, cash strong and on operating funding Based million XXXX. requirements be call. current cash our our a equivalents beyond non-dilutive financial XX, Ankit, good with It’s we will our and plan, on expenditure other commitments to $XX.X

quarter $X.X attention our our in million financial revenues $X.X of for remaining revenues compared the results. the quarter Total first XXXX. to of of with XXXX first were million Turning

the Although, while total was the of revenue revenue XXXX, higher to transaction. collaboration $XXX,XXX year-over-year to revenues approximately revenue was $XXX,XXX related grant are comparisons GSK recognition same, the due lower for for

Research announced due to program, to program the direct R&D expenses year-over-year and primarily for XXXX clinical was cost first XXXX. and activity compared research million This with associated the period restructuring related to May, development quarter development of of for XXXX. HBr headcount the million the lower tebipenem strategic decreased with in decrease $XX in the were expenses $X SPRXXX and same decreased related

for result of XXXX million were with XXXX, May function million arising the XXXX associated than decreased expenses related administrative costs the first in same decrease a strategic restructuring general in as and from a and and administrative reported lower the consultant in of quarter professional a in reduction personnel primarily of General in commercial, period $X.X $XX.X the headcount fees. and

loss common or for March share net $XX.X of a of $X.XX per quarter XXXX. for first XXXX million $XX.X share loss to period $X.XX reported of in XX, per ended the stock same common of reported million or the a compared Spero net stock

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

Q&A. call for open the We will the Operator? now

Operator

you. Thank

begin Please go Instructions] now comes ahead. session. Cantor. question-and-answer will the of [Operator question from Our Chen first We Louise

Louise Chen

for this Hi, progress all quarter, taking thanks congratulations my questions. and on the

you about readout. us the ask you SPRXXX, from remind advantages So could product confidence ask positive I if in I receive what to wanted upcoming where points what could think to would and are you. positive helpful. again second is, then your you GSK, gives be Thank that you you question competitive payment you of a And some potentially of wanted inflection

Ankit Mahadevia

Sath the GSK and points come inflection for Louise SPRXXX questions. cover from collaboration. Thanks, with the the can can Great. start our I that landscape then

types. patients terms that, we there’s about of in NTM, why So SPRXXX. excited we’re about when with think two Remember

to is SPRXXX to the XX% first we with XX% fact, disease typically their that patients of First them they’re the fail when that on aim therapies go early of and all. on in time, at are half journey. not in diagnosed, patients of the therapy they’re choose These that serve

So SPRXXX oral approved One, patients or or for not. it’s provides current NTM an opportunity. therapies

to X a that a Sath option inflection has points. the to and tox has And it’s of that our preferred then in as potency suggest what is Second demonstrated well data we’ve is drug your SPRXXX potential finally, about pass the be patients patients. that these a large it question Phase range show, NTM to need. And these data and for our models GSK to well-tolerated vivo answer as in vitro date in address pathogens, which I’ll to our

Sath Shukla

for asking, Thanks Louise. Yes.

be development lay the details able just to in come that year Phase and the clarity and communication would we So submission through by million as expect I then expect the on external NDA on as groundwork the to trial design, give the X milestones in get of reiterating we’ll middle SPA from the milestones But our you in much report duration GSK. process. the the put you the through process with the along of greater $XXX into to that out we

to will assume to more were sufficient milestones you initiate that if the on So trial we and than the trial rollout. to be its jumpstart those get expect to

the with I breakdowns it’ll but in milestones more the expectation period, the to in the you trial be you at accurate. we’ll But to be trial the that of to, you of spread upcoming continue give that on figure, trial coming able would be guide trial, line And top million $XXX we’ll would and it pay moment between in again, specific then the period that through time, months. for details that progression over for this

Louise Chen

Thank you.

Operator

Our of Ritu next ahead. Baral go Cowen. question comes Please TD from

Ritu Baral

how endpoint. what you’re Thanks the X endpoint might I for its for additional, us about important on end into additional the endpoint, points ARIKAYCE it secondary but what thinking specifically, question. think call the clarity, how the SPRXXX most to on primary I wanted your the are? ongoing be you And Can approaching they given feed you frontline ask Good guys. Phase information wouldn’t Thanks. especially, PRO afternoon, the secondary for about may pivotal trial. review taking

Ankit Mahadevia

pass question, the Kamal that one I’ll address. to for Ritu. to Thanks

Kamal Hamed

you, Thanks, Thank for the Yes. Ritu, Ankit. question.

to this SPRXXX. So just study a I mean, of Phase reminder, activity of The Xa the is the a demonstrate as study. primary is objective proof-of-concept

And to study domains activity be to the objectives Xa are used while SPRXXX. again, PK, secondary the we first demonstrate things our exploring to we established is Xb/X parallel study. tolerability, some the of in for Phase in develop the Phase PRO safety, of first, well study, in continue instruments ongoing program, So PRO include this and proof-of-concept

So specific PRO the with PRO content and certainly inform the as secondary this besides help exploring development study. has development validation we PRO exploratory started would which these are or the objectives, work,

Ankit Mahadevia

as well And Daley’s care that came some Chuck as some at later fidelity patient data from one thing timeframe. terms benefit. They looking measures the that the recent of spoke Winthrop’s was a I’d us add, these or Kevin for were that of in three measuring some relevant there of such was of looking group data that as out generic QUAL-B group running we’re of that be nice measures month agents, and to the can trial in validate at standard to

we’re it frame puts going into validation sort some them relevant are looking at be so to of And PRO. measures we build into a additional that as the

Kamal Hamed

No, absolutely.

Ritu Baral

really helpful. sorry. ahead, That’s Go

Kamal Hamed

at treatment And will these be point, three were this differences the there and again – validation six. these sustained the between mentioned. at study Ankit no time mean, I at differences as well said, part Ankit were months treatment as No, month and of

SPRXXX. So being study the demonstrate objective But these Phase our being being are to and the Xa again it’s in some the again, are explored of study. smaller development with considered of main a in activity PRO domains

Ritu Baral

Ankit, you sort thinking that’s the see? wants if scale. a mentioned as forward, well? Got of – you to Do guys as you about the a adding fatigue domain you PROMIS scale, as to a it. And also complimentary respiratory element a think FDA PRO QUAL-B Are what like think

Kamal Hamed

three what’s third is things they I feel surveyed mean, the sign terms one That’s patients shortness important function patients when of fatigue. terms in when alike, stand clinicians breath and of out, symptoms, correct, were of cough, if and in and Ritu. those were –

point, And that in domain your to fatigue the will will be be studies. absolutely important an assessed

used be fatigue As also will Xa assessment exploring Phase in ongoing study. we the of a matter scale are of fact, PROMIS even and

Ritu Baral

questions. the for Thanks helpful. taking Very all

Operator

Our Gavin next go Clark-Gartner Evercore Please ahead. question of ISI. from comes

Gavin Clark-Gartner

Thanks. wondering Could how afternoon. us through next the that think Hey, read development good trial. to plan your I’m quarter? coming refractory the frontline and may data ARIKAYCE see whether just influence XXX to pursue Specifically you a help or subsequent you frontline decision through

Ankit Mahadevia

last no the two from as treatment NTM first, we are just are Gavin start with Yes, highest component for unmet Thanks, in have frontline perspective. that than the and There for therapies a we’ll that’s need approved reasons. One Yes. numbers see NTM perhaps which question. refractory. frontline is is that patients there more the

the well, they’re not we how And there, of trying do to to behave chronic damage. physiologically of measure, at as agents function pathophysiology if feel recover look them because for symptomatic, lung not function can because as who exist you half choose and not Second it’s think the work – about to finally, lung we’re inflammatory for the endpoints, that more disease, be not have patients if relative of relevant patients that those them. who treated, type but

the does first that potential line is think for an refractory. treatment have we it to So important for place XXX although go, microbiological that

understand, Insmed QUAL-B to was coming and looking data see Griffith be the looking the they’ll the that’s see we around stands be potentially of PROMIS, QUAL-B up. to turning nice the in it will full at the all at to data that variants complement best Now to the how

will colleagues will One two, there’s number fulsome ARIKAYCE is how different two our no the drug. And from things. be. I disclosures guarantees is say on a that,

certainly so the PRO of to studies. own Phase incorporate we of starting we’ll take work we’ll that we work our can ahead development And but what other context within we as pivotal into aim learnings do context and also our get do the in of clinical Xa, that the

Gavin Clark-Gartner

Yes. sense. Thanks. That makes

Operator

H.C. question Boobalan comes Wainwright. Pachaiyappan [Operator go Please ahead. of from next Our Instructions]

Boobalan Pachaiyappan

Hi, Boobalan Selvaraju thanks dialing our Ram for is for questions. and this in taking

respect with expect can completed? respect you’d to with firstly, provide additional color XXX, So enrollment and progress to you any when to be this

Ankit Mahadevia

openings, comments first that we guidance XXXX, progress the won’t answer track prior question, our the of trial than of and in go to on our refer To terms we half we’re that. but can site reiterate you data, for deeper Yes. first

Boobalan Pachaiyappan

high to details of All right. Phase can trial? that agreement, differences HBr X and a within Clear. this ADAPT-PO notable And this any tebipenem some Maybe the are level there you you protocol time? pivotal one respect used maybe the in that then protocol at with disclose on of the

Ankit Mahadevia

of the the We – of working Boobalan. to that SPA with be we’ve as the trial Yes. that Thanks we’ll question. then us details well at we’ll disclose Big that milestones picture, receive GSK. for as due disclose to as Sath be stated will the the sequence that agreement, details before are we’ll mentioned, the

Boobalan Pachaiyappan

rights And your if any of maybe terms? Pfizer one Okay. maybe to then context what final Has so, question. XXX, the indicated partnership? Maybe, interest in existing under expanding geographic in

Ankit Mahadevia

Well, our that their know, more. you and to when rights from and and perspective. forward we’ve And we about look for think enjoyed collaboration XXX, I’ll partnership. continuing U.S. as benefited Pfizer say We if certainly and that with explore the and that we’ll expertise

Boobalan Pachaiyappan

progress. All right. Thanks congrats questions on for and the taking our

Ankit Mahadevia

you. Thank

Operator

closing remarks. Mahadevia to the session. concludes conference This turn like question-and-answer over for would Ankit back the I Dr. to

Ankit Mahadevia

We update continued of forward all our your programs. Thanks, progress, advancement to an recent look appreciated evening. of a for to operator. provide Have great today. the Thanks on our the and we all participation opportunity listening to

Operator

conference today’s concludes This call.

disconnect your for lines. You day. Thank a and may have you pleasant participating

Spero Therapeutics (SPRO) 11 May 232023 Q1 Earnings call transcript