SPRO - Earnings call transcript Q4 2023 | Spero Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Spero Therapeutics Full Year 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.sperotherapeutic.com.

At this time, I would like to turn the call over to Michael Wood, Managing Director at LifeSci Advisors. Mr. ahead. go please Wood,

Michael Wood

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

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

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

Officer; are Participating Sath Executive Medical Business Dr. conference Chief in call Kamal Esther Officer. Rajavelu, Financial Hamed, Chief Chief Shukla, and and Officer; today's Chief

the now. call Spero's to like CEO, ahead go over Shukla. Sath, With please that, to I'd turn Sath

Satyavrat Shukla

the afternoon. in expect is this study HBr and of this reporting trial very sheet we patients or diagnosed up XXXX joining data, We clinical of recently and second Phase of I ING hospital-acquired SPRXXX financial all proof-of-concept do stages company flexibility SPRXXX treatment strong plans. year. to The productive we its and latest half balance pneumonia. for you in thank for execute Spero Thanks, with of ventilator-associated looking the now has a had progress on the is for line which NTM-PD, us III top received are The clearance assets. to for tebipenem forward to Michael, the with portfolio stage in a across a development with running. its

who me team exciting and from personally, serious role infections as world-class diseases. was to opportunity to take I to vision share to the rare patients to develop the lead and XXXX a year particularly innovative therapies a on be a CEO orphan with honored provided help was For suffering

with which pulmonary begin mycobacterial or are nontuberculous for NTM-PD. developing me Let we SPRXXX, disease

in NTM-PD. it profile exactly need in is rare with diagnosed XXX,XXX address first-line We NTM-PD oral SPRXXX a be patients very and a developed are has the population to but the of well-identified agent a markets. disease right to patient believe approximately unmet developing

far the has antibiotics other there for a with exploited drug in has no or that data not and a In vitro and demonstrated cross evidence vivo against completed for mechanism SPRXXX marketed of SoC of development is novel NTM-PD. have from oral in of selection studies, propensity we an is resistance action by those resistance. low so in SPRXXX agents been seen

data and efficacy, its support has safety NTM We against have shown tolerability for and that multiple it penetration. and potency macrophage potential pathogens

NTM-PD trial is patients also designations. agents. and goal IIa evaluating activity in The been track of longer-term in a and the of proof-of-concept understand orphan our current trial combination fast Phase with inform and later SPRXXX has standard granted to care design clinical of SPRXXX SPRXXX's QIDP stage drug, to

a provide further oral on As potential commercial a details minutes. program this opportunity is in few will first-line Kamal agent, the for compelling. SPRXXX we believe

our program. Turning now partner to

partnered begin with HBr, me Let tebipenem which with is GSK.

developing first the carbapenem now visit XXXX. year of the of in underway tract the tebi announce III are fourth trial first is treatment PO were Phase patient having or first complicated for occurred antibiotic We the as urinary in quarter the January potentially infection to We cUTI. clinical PIVOT this oral of with pleased that

design SPA or a received Spero of assessment size overall XXXX, represents from a on the PO. on concordance of sponsor. very agreements the and PIVOT between and written level the a U.S. protocol SPA typically the special FDA protocol During design FDA with high

we So respect the been with the program substantially. of aspect to design derisked the believe have regulatory

has to II a Phase that SPRXXX, trial Pfizer been the on with with partnered submitted is for Moving clinical markets. HABP/VABP European We IND an which for patients FDA. and cleared announced IND recently the in

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

Kamal Hamed

our first-line half sharing line SPRXXX data will second is which being evaluated currently are SPRXXX will the year. for we to deliver in a this treatment as Sath we mentioned, expect top Thank we hope looking clinical in program, forward the IIa And do NTM-PD. begin with which Sath. trial. Phase you, of I to proof-of-concept first oral

care patients. standard rare IIa and care therapies and clinical to tolerability criteria duration. These establish up lung have who these meet monotherapy ethambutol and, prolonged debilitating treatment that disease. fewer serious enroll patients refractory to issues It not treatment as antibiotics, The shorter to sites that endpoint We for combination interactions are first-line placebo. experienced unmet trial The if disease. primary versus response. tolerability is Phase of have as well currently azithromycin, believe the is potential approved, of either microbiological SPRXXX enrolling has has XX but the a treatment better standard regimen will effectiveness, a have We active new need or is that and and drug-drug treatment is effectiveness. limited a compares There are currently rifampin. and including NTM-PD NTM-PD. The in treatment screening is naive XX approved current a infectious SPRXXX do of designed are no

Specifically, baseline burden we to day sputum are bacterial in the from XX. measuring slope change

this endpoints endpoint development. to result to evidence SPRXXX make XX on supportive bacticital NTM-PD. Success we move of positive with We activity patients only the confidently enable development the early into would demonstrate the with us aware agent from will secondary believe in late-stage in that are

We advancement and toxicology volunteers clinical include ongoing I studies. studies are development late-stage These SPRXXX's in Phase healthy underway. needed support to clinical working CMC into initiatives currently on additional X activities work,

a understanding assess prodrug SPRXXX, penetration to of drug SPRXXX first pharmacokinetics extent the of a study. should moiety the better The bronchoalveolar active intrapulmonary the lungs. of of This and into give us the lavage

second co-administered The when with ethambutol. is of evaluate SPRXXX and to the on the azithromycin effect pharmacokinetics

studies data We of for as with from inform these in second expect that set are the year the results to the Overall, provide registrational this a have as us well. NTM-PD. treatment first-line to path studies SPRXXX may robust half expected ongoing for

HBr we intravenously infections, orally January PIVOT acute Phase for HBr. of XXX clinical first Now imipenem/cilastatin XX evaluating pivotal patients in to hours tract at XXX moving every tebipenem hospitalized are total the including visit urinary milligrams PO, X announced randomized days. being X on patient complicated first III adult a with or global tebipenem every in X:X trial X, On pyelonephritis. receive HBr X tebipenem a Patients hours milligrams to dose of to

the a noninferiority Test-of-Cure of the acute and visit. age, pyelonephritis The absence diagnosis, based margin. patients with efficacy of a that in for and allow and X,XXX setting. cUTI is tract for the If Enrollment second microbiological will completed the the standard for response or high of the in in analysis to generally responsible patients we endpoint all expected is a treatments, Target and care on potentially tebipenem the with new prefer approximately hard-to-treat is established at be assessment will intention composite would XX% be primary carbapenem outpatient pathogens to XXXX. Spero of associated GSK tebipenem the well current execution submitting It of so HBr enrollment The unique III presence non-inferiority as treat from responsible stratified shift for cUTI. clinical half i.e., and urinary fee treatment trial of overall approved, instrumentation. the is physicians microbiological NDA. trial response, an of which primary randomization by see be is baseline population cUTI be clinical will paradigm or Phase for

are investigational, next-generation bacteria and disrupt an polycyclides, is antibiotic infections. we while potential to gram-negative polymyxin. SPRXXX polymyxin designed of to program. SPRXXX treat SPRXXX gram-negative nephrotoxicity outer membrane is of the multidrug-resistant developing life the our reducing to Finally,

has broad natural a compared currently that to spectrum activity, drug-resistant vivo and potential in and improved has microbiological potential It profile strains. on toxicity safety testing, believe polymyxene. against for including extensively reduced available of offer the also an SPRXXX we of to Based multidrug-resistant

mentioned, of over Sath FDA that, we review the on Esther As February announced call XX. With results. to IND turn quarterly the our I'll financial clearance to

Esther Rajavelu

December afternoon and as call capitalized Spero of or us all XXXX. to is $XX.X evening of good today. and Thank joining equivalents you, cash XX, million cash the with Kamal, you well on in

received into in quarter dosing we for from expenditure upon It sufficient in expenses the Phase requirements beginning our payable installments the estimate mentioned, commitments, of cash PO trial, nondilutive equivalents, X be million milestones qualified XXXX. and will first fund clinical the III tranche XXXX XXXX, that funding together $XX.X first equal million of in in PIVOT other GSK. Sath of As with development patient our and operating first that with is December, in the XXXX. $XX during We and capital late cash Spero to

in were compared million and expenses ended to the 'XX, fourth in 'XX G&A expenses expenses XX, decreases for XX, professional ongoing for were development were fees of primarily both million $X.XX of year financials. total was year Pfizer for XXXX the of to the full to revenue the loss due common during same This for year the $X.XX million year-over-year was in in clinical compared costs period. the development stock. 'XX, of $XX.X year the December ended year of $XX.X $XX.X for XXXX. December net net consulting compared and or compares This increased the a million diluted reported costs, and $XX.X as trial in for share a December consulting year period XX, million of of December G&A fourth on expenses earnings of of XXXX. Phase the due personnel-related the period The revenue of year expenses period income for XX, during R&D common 'XX or million were and compared $XX.X ended $XX.X for of revenue million Total for of in GAAP and related to research fourth same moving $X.X per $XX.X to recognized to December XX, 'XX. for Research quarter respectively. to the of of million and million ended was Research and for agreements to compared $XX.X $XXX.X for XX, $X.X collaboration the income stock by XX, was 'XX. $XX.X 'XX. IIa diluted $XX.X 'XX, share million 'XX, ended December and of XX, net changes 'XX., development million million the million for quarter activity $XX.X decrease $XX.X expenses year with fees. Spero ended quarter December loss the of offset increased for compared to the related per Now Total GSK with the 'XX, earnings million $X.XX, the during a primarily fourth per 'XX. The $XX.X SPRXXX. ended full XXXX, professional $X.XX expenses primarily the XX, increased fourth to ended year December to revenue or result primarily fourth our $XX.X G&A income December with quarter million due for personnel share for and clinical million of the the our quarter 'XX, revenue partially of of increases and year net 'XX quarter were million ended summarize our

filed that, will for details SEC Operator? financials, questions. our the open For call now XX-K further to please on today. With our we the refer with

Operator

[Operator from Ritu Cowen. is with TD Baral Instructions] question Our first

Ritu Baral

also course, has in program? Just a is but a and couple question enrollment competitive second me, of One for few may a them, in complicated parts. of to with XXX. And my one simple XXX how especially the one, little is do a going of halt have enrollment with

you the more study to I'm is through to a one healthy infection, cavitary just and KOLs, think patient of compound guys of the Talking when NTM to of the access activity perfusion especially location oral site How and biofilm the lavage do at volunteers. of site Specifically, NTM has around about the an disease. interested sort know and concerns XXX in of access infection?

Satyavrat Shukla

Ritu, for question. thanks the

sites the your have of item we second all guidance first patients. that the are dose open, past have they of and For year. XX on them, of this line top said enrollment, half continue towards in to work continuing data in our been And we to

second Kamal. your to I'll question, pass For it on

Kamal Hamed

for question. the Ritu, you thank

of inhaled these this of of infection. this to access have distributing site also In of terms hygiene the therapy may therapy applies part management infection, And because problem disease. with of as course, have of patients to the to pulmonary of inhaled also the drug the site

However, in you the fiber hollow from infection disclosed have data to model monkeys, as in look I we course, data we nonhuman lung study having Phase And in lavage nonhuman well humans bronchoalveolar have in cited. these lung demonstrated that forward have penetration. of not penetration in primate, but as the we primates,

Ritu Baral

Do access disease? with consideration XXX? versus the therapy have or you I less cavitary data for Is oral a that the feel large that that be MAC may be cavitary may for guess, patients different

Kamal Hamed

forms a That's applies And oral therapy. -- this as well as to honestly, no, both that's certainly question. good inhaled of

surgical disease the cavitary size than medical and they cavitary larger with in excluded much speaking, require require up these typically from because large i.e. trials plans date, duration treatment. cavities, clinical X the centimeters patients with So treatment treatment and would patients to clinical longer may besides X, also

of have where So it for therapy, both have corroborate again this And what to inhaled of the lungs. of in and as the far know excluded the i.e., this the fiber from the is these drug the challenge expect that lavage bronchoalveolar get, well as hollow nonhuman But in a data data only as we needs half certainly oral reasons. data patients primate to for to vitro to data. suggest so are course, forms the second as these we well that we year penetrates from

Operator

question is next Cantor. from Chen Our Louise with

Louise Chen

the Congratulations on this quarter. progress

gets the SPRXXX thoughts I some data, changed So with in And one for a it steps on market second recent first was if move question to in I the some for space competitors the space, opportunity have are fit as of SPRXXX. developments And Do given for for had assets? plan what crowded And at market your you of paradigm the treatment you the next reported forward? I approved, actually little here? bit if think development all? your the to you this the where then more so, on was, expect has it's opportunity do question you

Satyavrat Shukla

of of then question pick defer your and question, Kamal the second the you. half half first on Thanks your to from question, can I take first first XXX to for hear up well. great the and asking, Louise, I'll as and

we market really case progressing actually on know, developments, is recent haven't size size as se our which what their is them the For another different they has your so which information has in you where player for in space. a per were first same the because, we can't as the the market, line, we been comment But competitors actually seen refractory, as of the were for information than asset.

out have we what to before. and the communicated market. externally and these about size we the program recent developments before greater first-line used some potentially therapy the of So there, what we was excited first What developments, excited size very we these in these be certainly going the is is than market. ever that internally recent patients arguably that continue were our to say of evaluation about in light recent is be very under of scrutiny is oral say And to about we that data the of

And progress great as we for this a the and forward. opportunity that's challenge an organization

rephrasing you to second part mind if I'll that that your of question, the wouldn't and on on SPRXXX Kamal. pass Just question,

Louise Chen

the XXX about market opportunity? question, -- the The one the sorry,

Satyavrat Shukla

No.

right? You had I fits believe. it where of the On another in question treatment, about the XXX, -- too, line

Louise Chen

correct, is yes. that Yes,

to If get you were it approved.

Kamal Hamed

you, thank No, Louise. Okay.

the unfortunate need the the news that's ongoing better patients because with by population patient But mean, targeted I we therapy. So newer different oral having recent a is agents patients patient for targeting that said trial have than certainly and population that, effectiveness. combination other tolerability are

nonrefractory for with So a we as as patients patients Sath XXX, experienced treatment-naive aim said, therapy disease. to treatment or first-line develop

also patients, study, patient this ongoing care propensity of low vitro population. with in this with comprises And I SPRXXX XXX time the demonstrated in IIa as that Phase of know, development aim resistance later we assess standard selection it of MAC, program. before And the in of against the patient clinical Phase proceeded segment agents should of an with resistance XX% to we the We've activity note majority effect study. the about for a combine biological stage which is trial IIb/III at potent

Louise Chen

anything market for And Okay. on the XXX? opportunity

Esther Rajavelu

Maybe Yes. Louise. that, take I'll

unmet a XXX interesting presents think degree need in population. because of for patients there patient that is an I opportunity high

of would contingent However, program on sources continue developing we've that commented non-dilutive funding. always that we

markets and government funding. with As a you with agencies China. And with also for partnership know, we obtain have to Everest Pfizer European we collaborate for

for So any sources all looking program. and at those that of continued funding we're for

Operator

I like closing comments. Shukla call no this further hand to any the are time. There Mr. would for at questions to back

Satyavrat Shukla

to and wonderful for thank day. in a have Well, today, like just dialing I'd everyone

Operator

conference. concludes today's This

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

Spero Therapeutics (SPRO) 13 Mar 242023 Q4 Earnings call transcript