Earnings call transcript Q2 2023

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Operator

Good afternoon and welcome to the Spero Therapeutics Second Quarter 2023 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.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 second 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

HBr, Before its and from we about and our on Tebipenem you clinical of and its progress and design, commercialization current could including statements the to studies like future clinical the that of information trials, statements development assessment the cash resources. at based the differ results of the materially begin, sufficiency trials Such the forward-looking forecast SPRXXX this in programs. on statements. not statements performance I’d and the contained initiation, expenses of and results research forward-looking presented a and company’s guarantee Management’s and anticipated the preclinical results conference company’s remind of and some are SPRXXX, call contains expectations, actual such studies such preclinical cash timing, those company’s of development and

obligation Several filings company supply no speak today’s the of or date the described XX-Q the the Spero regarding could after undertakes conference publicly in in forward-looking as and forward-looking only date with including company differences Therapeutics’ the quarter ended report today. the factors for the filed statements of information These SEC of such of this are detail update cause XXXX or call. new call the statements to contribute in any our section Risk that Form Factors SEC, quarterly with to on XX, June

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

Sath Shukla

August to on be three is Ted first are making Spero. on for at call late-stage clinical and experienced team this excellent to that stakeholders pipeline I to President am a say is investigational very together, and earnings and the great becoming my pleased unmet I differentiated of This needs us for we to medicines vision all afternoon. value take that a exciting and I in create patients programs the CEO our I how infectious joining excited X. important want to honored time company. company’s progress. of address advance disease. I Thanks, since opportunity with talented for this am designed to you and thank our role such share management in working a to believe have an Each

today and call our are our Kamal Dr. Medical CFO the on Treasurer. Chief me Officer; Interim Hamed, Joining and Steve Dipalma,

and Let which is we me with GSK first tract begin as carbapenem infections antibiotic urinary Tebipenem or HBr, potentially cUTI. for developing treatment which partnered the complicated of with are oral

agree been have as design program. a our a in very to for previously, have July agency under we Tebipenem size path FDA the X we written trial. announce discussed we agreement to see the were investigational this planned protocol forward As a or XX on pleased We Phase from with major and the we HBr the on engaged received that SPA agreement drug. of SPA assessment, special on milestone the And

been the design design regulatory aspects represents have of on the respect believe high the a a of typically concussion the FDA derisked program protocol SPA the very and As we substantially. level overall the sponsor, with between to

few in minutes. begin details fourth in this PIVOT-PO enrollment provides a expect quarter and We to of just Kamal the year further in

has milestones. $XXX in be and first quarter. current received million our of This exclusive with terms to GSK, up payment the been to entitled now we of $XX license million of agreement are receive is first the development invoiced Under the expected to

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

clinical addition quarter trial we with polymyxin continues funding. non-dilutive open grant and a enrolling track of other Phase continue on IND year, being this and continues to our enrollment to Xa Phase progress The Tebipenem move on forward. sites in and for investigational SPRXXX, In be HBr, patients to assets X funded other for next-generation SPRXXX dosed. fourth our proof-of-concept the by

remaining of On an who about X. Board to Directors. and management the Ankit the spend came Spero, Vink a tenure was following the note, Patrick Dr. and into in independent predecessor, changes August on role the Milind member, Chairman CEO. another an of a minute announced Mahadevia, prior board become Board Deshpande we and organizational President want I CFO, a Dr. on as Dr. Director. the to Chairman, On Spero’s took is on is of date, of My transitioned Co-Founder appointed X-year company’s The Lead I director, June that talking that as effect

all new and Board a Interim Until him is process I for joined capacity the company CFO. a launched look experienced advanced before this retained to role. want of in directors search Board with and while who and have behalf has the The management executive completed, and company roles, with the some leadership also is On to permanent its I team, contributions net we these have the same of is thank my Spero to his for in Dipalma Steve worked public company the Ankit members has fellow directors we CFO. that the Treasurer, as of work who transitions. and officers in Separately, appointed team an all to getting continuing and result forward here stage his changed this the Spero or in CFO

now would the provide Dr. details Kamal to call the more will over I clinical Hamed, hand programs. like to on who

Kamal Hamed

a a be the global cure randomized will compare imipenem tebipenem with of double-blind have intravenous also and PIVOT-PO plus am response pleased at the adult that agreement very would I cUTI, pivotal well oral in with efficacy Sath. the you, Tebipenem support. an microbiological based The trial X eradication primary acute that clinical cure GSK FDA for test patients colleagues for their will and our is pyelonephritis. endpoint PIVOT-PO hospitalized of we engagement as visit. now thank Thank like on as at as composite overall trial, to Phase SPA designed including

an in microbiological the XX% treat guidance to will based patient be The primary of consistent assessment non-inferiority studies population margin, The is in non-inferiority for population. this FDA analysis which with intention a on cUTI, has as approval results persuasive for indicated a positive treatment a along of indication. that pyelonephritis be from limited with PIVOT-PO to support FDA studies use tebipenem previously for and completed sufficient including could

enrollment study and around quarter provide and the As this we patient will including as target clinicaltrials.gov. details, point other relevant posted in year the fourth plan Sath information more mentioned, or initiate gets numbers, to that of to secondary endpoints

combination in slow Xa change for currently deliver non-tuberculous to is evaluated SPRXXX positive our burden evidence a trial. novel SPRXXX the to the sputum with Phase from oral pairing late-stage program The being or mycobacterial first in bacterial regimen. disease believe We to aims which will enable secondary the trial development from a program move treatment on now a endpoints derisk endpoint result this part Turning intend confidently of proof-of-concept supportive is in which as first-line evaluate endpoint and we us into SPRXXX NTMPD. baseline. to pulmonary primary

standard for prolonged and current and combination for of traditionally that drugs tolerability. The tuberculosis limited including have NTMPD full effectiveness care is therapy, used

these has to the regimens, unmet clear program our we of believe potential address limitations the a need. Given

are advancement development number currently engaged We SPRXXX’s support clinical to of towards needed a studies. late-stage in activities additional

toxicology NTMPD prevalence last engagement our earnings where CMC initiatives, Japan sharply include these to has increased to development efforts activities compared SPRXXX on other noted call, program ongoing and into FDA the expand the with As territories. work,

initiated also clinical have Phase We two studies. X

and the and of when in SPRXXX, or bronchoalveolar the to of the intrapulmonary prodrug effect azithromycin active SPRXXX healthy pharmacokinetics and set first was ethambutol study for second, The co-administered the evaluate Lavage microkinetic volunteers. on loyalty SPRXXX, a the BAL

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

are to The now treatment expected the treatment experience enroll not to XX trial treatment disease. are what enrolling currently We or naive screening but have that active sites or refractory have participants of XX approximately do patients. is up

that ensure necessary with study the engaging all to actively resources. are We they have sites

NTMir, for rare and in education the specialized launched a NTM and We constituents. we and providing lead have support advocacy website patient our of CRO means patients videos partnered also to study main with to new a NTM group, further sites Facebook our as page a with on third-party patient have physician diseases

multitude all newly satisfied of interest patients is based and generally top guidance XXXX. line with announce Xa in timing expect of this now second half the trial, level diagnosed with enrollment we the on to believe which complexities, recently based we With we we of respect results that that, it of our of the from are with appropriate However, the updated to on NTM-PD, Phase

with SPRXXX on potential an is developed next-generation update treat an the profile mix to improved program. Finally, antibiotic for to impaired available infections. a count brief investigational our gram-negative safety in multidrug-resistant SPRXXX Being polymyxins. the for

track advance an the with ventilator-associated We IND of into this X are year. on quarter trial in currently application remain or hospital-acquired submit working to a to Phase in patients bacterial fourth We pneumonia. SPRXXX

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

Steve Dipalma

on $XX.X June all of cash XXXX. a and exclusive development XX, pursuant is of cash payment XXXX, inclusive as XXXX. and second position equivalents the to the half our strong as in quarter cash million Spero and quarter of equivalents license the from reported joining financial runway XX, XXXX. second our and in XXXX we revenues in million total of $X.X Based that of million quarter We will on in second Thank the June of fund of GSK milestone you $X cash evening of agreement, be us million $XX to you, our into good with with us Kamal, believe call. well cash the received capitalized be to revenues second to compared sufficient of and

$XXX,XXX head for year-over-year Research approximately R&D related to GSK quarter compared second This with was HBr for same to associated These the related period research expenses X increase with development with costs due were higher and primarily million $X.X expenses XXXX and restructuring expenses were direct year-over-year the of in of higher offset as XXXX. higher by development recognition XXXX. million SPRXXX to to $X.X due lower programs. announced the in the well transaction. million May direct revenue costs Revenue SPRXXX as count the was Tebipenem program, and associated strategic the increases $X.X

quarter XXXX General expenses XXXX of to result and costs. of fees primarily expenses $X.X $XX.X decreased diluted period of of quarter share a the We net stock compared for reported the lower and as second facility a decreased in basic share in and per $X.XX or $XX.X XXXX. decrease administrative and per reported diluted commercial net than of and related in of period million the stock professional common a for loss loss same the million million and in million $X.XX operation same or other $X.X reported XXXX of for to due second a the were common basic of consulting

SEC details on financials, report quarterly June Spero’s for XX, period Form refer XX-Q I the X-month including the to today. you ended filed results on would For with Spero’s further XXXX,

call questions. will We the Operator? for open now

Operator

Thank you. comes Cantor. Louise ahead. first [Operator Instructions] The go Chen with from question Please

Louise Chen

the Hi, congrats here. taking all questions And quarter. you thank progress on my for this

and on in XXX these I wanted pipeline? might terms your in explore two? of you XXX today. Or what expand pipeline Do you ask you else your have plate to So you to addition enough beyond plan do to

you. NTM do And then to to Spero plan you how you, make you wanted terms do distinguish your is with of things entrenched from it ask I Thank market, if yourself to XXX, opportunity how in Seth, differently? might for vision the what do competitors? Secondly, you and

Sath Shukla

past, pipeline the stage focus Thanks, don’t think to broke, focus forward, and the that we a company. out executed on somewhat order, Louise, we in things company forward, later continue has ain’t be that more terms will for as it I many, as if of questions. for There are vision many also evolves and it. company going of in the while the progressing these we’ll great it towards more fix go things our In on the

something the paramount So just of with execution team area is going rest focus intense be to be me. the an that’s for will management of that come and

in we a we potentially If won’t with focus company. for need the think not from approach unmet criteria continued now considered opportunity. opportunities. strength company, fails we an pretty Transitioning have balance to evaluate that we opportunities these actually, pipeline, strategic expertise we strong built with one the flexibility the they to question, and and high Spero we do on first the when apply sheet and a business about stringent We’ll your as past at at those are think the either a here have – that the to evaluating either that fit of They economic development asset fit the in have what have arise. commercial criteria with our

ourselves with where ourselves continue for we recent past management we transitions as also on and So a from to place forward. can go strengths management refresh as the members we organizationally, find but build Board

those really So we opportunities look are to. forward

are in your line start by as off how On therapies. question entrenched refractory first now, therapy right noting aren’t the is NTM last that which market competitors. approved for expect single is assets, we know, Arikayce. inhaled space, There SPRXXX a in there distinguish we with our The competitors, entrenched you any to would approved in on no

we very to there we significant in And so that believe NTM market progress therapy for how asset, patients. the for continue an first-line opportunity oral tolerated is

is like and differentiated in space in to adjacent especially the this the but first for this line, white we would there on. opportunity, we Did Is I a market profile to with will you elaborate? our or go players your us believe will space, on the success to continue set refractory space, else that of anything with success to a other ability significant question? validate us up answer hopefully me execute ARIKAYCE

Louise Chen

it much. Yes, Thank did. you very

Operator

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

Boobalan Pachaiyappan

questions. This Ram dialing for and is thanks in Congrats progress my taking Boobalan the on Suraj. for

few So, questions a from us.

swiftly tebipenem how might reach firstly, So pivotal the of full trial could enrollment? confirmatory

Sath Shukla

a for is that we tell have disclosed as can what But stated. set target at our GSK tebipenem date haven’t colleagues that We XXXX. commercialization you for

be But expected have you through readout of obviously you past as draw the length an can and stated the trial about also NDA So, look backwards process, a conclusions trial. the your we in data to be we that is we ensure that approval. we – get reach want larger ADAPT-PO to expect clinical to this than sufficient, would would the trial would positive and persuasive

roughly to longer X timeline So, with constrained target the took last This working we be towards. months the months are to will with enroll. that that trial XX than

Boobalan Pachaiyappan

days [indiscernible], these Great. Thanks of And then is the in clarity. how Japan? for performing commercially tebipenem

Sath Shukla

different years been indication because It’s on XX we this and a pediatric and But to we different performance know, basis it’s performed so of has we indication. of patients something point, that been going that track in the At that from what in different understanding, form along for is have an in limited application a millions has And well. feel don’t entirely, pneumonia. drug tablet dosed agilely it’s active drug our since Japan at which the XXXX, there well.

Boobalan Pachaiyappan

Great. And this probably Okay. question. thirdly, lengthy then a is

the of So, in of from be or meaningful achievement this enrollment completion Spero in of achievement milestones trial following this c, of b, the tebipenem tebipenem the X are a, trial, trial. upon XX% into payable first deny to whether X GSK enrollment enrollment and the Phase please to – Phase likely of confirm patient

Sath Shukla

think and the the level, trial. through, duration beginning that on ending come payments macro a confirm can those I through of Well, I will

on cash will moment disclosures are period will these self-evident deeper timelines company’s that the the of continue report milestones we providing a moment. become and and the – those. a data any into beyond what time this trigger milestones. you over achievements With specific time, progress at well into the at said, as timing We haven’t company, our visibility gain this greater milestones of as But the disclosed those not in we when very to influx out as

Boobalan Pachaiyappan

any opportunity so, And to you U.S.? Great. updated with epidemiological the in or this research If show? do then respect Okay. commercial XXX market does information have what

Sath Shukla

perspective, that continues said would Yes. which in is in is the is our includes opportunity. similar roughly assessment the in market in to That Japan, U.S. the I X.XX U.S., three have of population. worldwide. where top major XXX,XXX first-line million domestically What line the of What we from at as least that a current out very earlier, roughly least Kamal patients at past for quarters note patients, roughly That be is trial, the markets patients to that pointed prevalence is the of

So, you that for patients are opportunity. looking at somewhere market approaching XXX,XXX

like the for just our that, and available are fairly the more stakeholders, I Beyond promos information growth purposes. [ph] stage, consistent think planning at a disease diagnosis epidemiological in continue future our are information have with before. to But rising and evaluate and other at the of we this we findings usually what tracking rates reported

Boobalan Pachaiyappan

much so congrats again. questions, for Thanks our taking

Sath Shukla

you. Thank

Operator

another This go on line. with concludes next Please have – caller ahead. the question Cowen. we Baral from The Ritu comes

Ritu Baral

to for And top to tell the you need of is line way endpoint? sort talk wanted the Hi in guys. taking Apologies the about how subsection include to patients Sath, to any X. the if and some poor you the there apart what Phase Thanks connection. you the on data groups behave X. of for impact to tease will expect refractory whether – I Phase to decision differently ask you for two how may it a Can questions. it primary differences you

Sath Shukla

Yes.

the Kamal it then opinion? the care you a to can think for I for I on would speak bit, an little line and data. provide defer think to trial stay me Kamal, in I top design, to to let

Kamal Hamed

Sure. for you, the Thank Ritu, question.

first-line Sath as indicated, development So, strategically has Spero pursuing strategically – treatment. for

first-line treatment refractory do naïve XX% odd not disease. have treatment, patients So, but And experienced, treatment of that for means that’s the patient about or again, population.

do in experience, current who the refractory or treatment have disease. but naïve study patients So, is treatment not

the development path that currently So, is is this pursuing. Spero

So, disease this enrolled. is in refractory be particular there will Ritu, patients who no study,

the being is as up fact, the patients. study a are proof-of-concept a of about composed As study. from XX to of matter reminder, study excluded a they And

Ritu Baral

the is course disease that populations? So, And there between ability relapsed two to the between different you distinction infection the is least refractory. clear and a burden the at or and believe infectious

Sath Shukla

It’s that clear the is to using ability not different. the infection drug the necessarily

reminder, is Just no as drug has the patients. disease that the SPRXXX the clinic a it not for with antibiotics, and a we expect expect – that cross-resistance novel and in other in work would we factory clinic do

to However, as has path the this pursue been development. first strategy first-line for treatment

So, or our the to considered not so path, The are will patients enroll not this do given patients disease. patients treatment have is refractory are that have study again but experience, treatment only naïve who development refractory who disease.

Ritu Baral

Thanks. Okay.

Sath Shukla

study. not treatment with patients Again, be with adopted disease. robotics again that this would have line we not say Spero development to SPRXXX not in – there pursuit that is Xa in strategy for no it’s disclosed first cross development current has again, there first. refractory But but resistance work concern that first a proof-of-concept a [ph], existing would And to beyond just Phase

Operator

any remarks. over ahead. like to Please Mr. conference concludes for turn the I the Shukla go closing This back session. to question-and-answer would

Sath Shukla

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

Operator

call. conference This concludes today’s

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

Spero Therapeutics (SPRO) 10 Aug 232023 Q2 Earnings call transcript