Earnings call transcript Q4 2022

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Operator

Good afternoon, and welcome to Spero Therapeutics Fourth Quarter and Year-End 2022 Financial Results Conference Call. [Operator Instructions].

Please be advised that this call is being recorded, and the 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.

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

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

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

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

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

Kamal Medical Ankit today's Officer; Executive and Shukla, Officer. Hamed, call are Sath Mahadevia, Chief Participating Financial Chief in Chief Officer; Dr. Dr.

over Ankit I'd Dr. with Please turn Ankit. ahead, to to Mahadevia. go the call And that, like

Ankit Mahadevia

and world-class a a off remain pipeline sheet multi-program commercial partners potential, and committed thanks of our We capital that that achievements those the premium a advancement thanks us unmet Thanks, complementing provided with Spero's Ted, listening. support placing in everyone strong strong developing do public of have and to need XXXX, in pipeline to medicines. balance a recent of to differentiated and marry on our pharma to of medicines with efforts partners we our to while so efficiency agencies. continue with and high to

on Kamal SPRXXX providing and update will an SPRXXX. be

cUTI. I'll treatment for the of part potentially antibiotic the HBr, on we carbapenem urinary first my So call of tebipenem the which are developing oral infections or complicated focus tract as

closed of with tebipenem exclusive is to received. subject As well upfront agreement payment as our million both agreement been a reminder, which stock, GSK, common license have This in an came now the of million $X a equity us investment a HBr which last with as quarter. $XX

rights hold activities where be will while our Seika. agreement, for are an Meiji the being Per responsibility development responsible countries, partner, Japan Asian and additional we HBr, territory. of GSK retained III and development, are all up was low we on addition, to sales. in HBr's commercialization tebipenem In in and GSK million to for an net this, and eligible $XXX royalties double-digit milestone well except development sales Phase certain other tebipenem of upcoming commercialization In payments Seika as the by trial for for for territories all Meiji license single-digit exchange exclusive granted product outside as

tebipenem planned upcoming HBr's We're trial. with the FDA protocol on for clinical engaged the

nonclinical design to of including be evidence could for we cUTI, the XXXX, the on trial A pyelonephritis efficacy may had with a and high-level aspects which indicating of tebipenem's in Meeting during limited trial, use recall, a the positive As together approval feedback from sufficient received indication. we you results support aligned with the Type agency confirmatory, in

of from the if initiating half engagement regulatory and our on the all Phase anticipate earnings tebipenem second as specific milestone continue III the the XXXX. payments on as of first with update update we the trial include GSK will the And on HBr month. an in reach clinical of months GSK trigger commercialization to half goes development program, will last by providing We'll anticipate over well design the This could noted still granularity trial call the by in our as XXXX, this activities We year. with partnership. believe well their details coming FDA that

GSK what's productive thank been to very in like date. a for I'd role partnership to their

foundation HBr strong As trial, pillars. our it's of enthusiasm. advance tebipenem III regulatory This that to Phase the complete foundation key we the fuels work the consists through and program's process X

first these our that and subjects. and trials have data in the has tebipenem work efficacy. Between collectively is XX supporting pillars extensive of enrolled by double-blind our clinical safety that set X,XXX evaluated The highlighted These of Seika, trial been Phase been ADAPT-PO. over III are Meiji tebipenem's placebo-controlled

it's its safety and for demonstrated otitis more approved have Moreover, of media patients. while X,XXX in tebipenem review post-marketing where Japan noting efficacy on pneumonia, sinusitis a efforts than surveillance no issues in

is There to an oral IV of carbapenem therapy available for antibiotics other its clear currently address hospital and millions of are of whom in have a receive The no a option the potential other pressing patients many setting. no tebipenem's foundation to key U.S., cUTI second pillar than in unmet need.

approved, support provide can that tebipenem's to ideal the last for infection, at-home The By including treatment organization success making patients and with of our we of grateful health for partner care with commitment health comes the of oral provide for from lead commercialization, up GSK We're urinary commercial improving believe benefits also developing tract could infections. tebipenem, is support these an continued the serving for costs key pillar while partners. We them, well-established advancement the system. if given for its BARDA foundation we the believe and tebipenem. tebipenem's also patients successfully to economic

SPRXXX. I'll call discuss With turn SPRXXX the that, to to Kamal over and

Kamal Hamed

candidates treatment treatment-naive nontuberculous patient or orphan-designated disease the of for population, patients aspect progress but important those mycobacterial program SPRXXX a An brief damage disease. a providing drug because begin I'll the on This being who to improve refractory as oral novel update pulmonary irreversible for by SPRXXX, short. NTM-PD or is consists function. for target potential first-line nonrefractory our a who is which our Ankit. developed of limiting received noteworthy disease have NTM-PD they lung have treatment to often patients who with pharmacotherapy are suffer how even Thanks,

there effectiveness. tolerability the in inherent limitations with remain of their with with treating treated refractory for With off-label FDA-approved are were journey quite therapies Instead, no combinations early of patients frequently disease, NTM-PD. therapy first-line challenges patients and related to disease

that with mainly who about NTM-PD treatment due standard-of-care patients discontinue estimates concerns. published and such treatment indicate XX% tolerability receive fact, after to of effectiveness In a year,

a for proportion NTM-PD. Even SPRXXX of relatively when patients patients of development, disease. hope improve to standard Through course complete recurrent therapy, experience with they line their care the we large of first

IIa development this establish into conducting a program, Phase clinical designed initiated for activities investigator working of completed we and trial recently we to proof the Towards concept. are We clinicals. end, eventually successful SPRXXX the appropriate to meeting, the advance

Ankit Mahadevia

Kamal. I'll jump for in

large I FDA initiatives, into CMC include as toxicology is expand NTM-PD. prevalence work, think a Japanese of activities with and with ongoing difficulties. having he's Japan patients These to engagement and there quality activities technical

outcomes work for validation development with progressing clinical as actively clinical the patient-reported also are follow-on studies. we relevant of endpoint and NTM-PD for part Importantly, the of

oral mycobacterium complex, of cases. enroll study to in of X,XXX XX% participants received XX compare trial approximately X with SPRXXX avium patients prior of XXX due II treatment-naive Phase will NTM-PD was implicated The placebo. doses are nonrefractory approximately or Eligible treatment The versus but designed either and have have to NTM-PD disease. milligrams monotherapy

change slope and that sputum treatment We a bacterial a the agent from the see placebo. would weekly better slope microbiological Achieving this significantly is ability endpoint of demonstrated negative agent to a early the placebo. to treatment drive leading make with goal response SPRXXX bacterial stand-alone we're against burden both end to change, period. which as weekly development aware than day X primary The in NTM only versus trial's sputum of to SPRXXX XX-day is aim of

findings the IIa this studies prior inform stage evaluating that support with SPRXXX longer-term favorable observed of a trial combination with standard-of-care the in I broadly Phase would safety the trial goal data in with proof-of-concept later are current advancement consistent Pairing to SPRXXX's and More Phase of safety result agents. design speaking, program. our the of strongly

U.S. Although months. coming we progresses, are do currently expected not XX and expect sites the active to more trial sites are to comment enrollment on in this onboard come

National this This progress lines top-line Kamal, remain behalf is in Defense. supported setting. Institute I'll by to and target the trial multidrug-resistant investigational treat gram-negative candidate the our in SPRXXX, and XXXX. program briefly time IIa on Medicine and in Phase to On line Allergy Everest we Department polymyxin the including first developed of Infectious the This discuss and of track from collaborations, Pfizer, U.S. half multiple results of is now Disease next-generation being with of report hospital our infections

its limitation major of to together such premise, Phase this cytotoxicity currently of These at potent against to substantial In activity relationships reduction polymyxins. trials be vitro our compared as therapeutic in of agents. best-in-class XXX associated the a exposures as the multidrug-resistant to XXX in a team available polymyxins vivo kidney both way that supports nephrotoxicity Subsequent levels data a indicated with generally was structure to predictive in models, currently with XXX lungs. our activity nephrotoxicity is that of I belief these the potential demonstrating minimizes understanding design tissues a dose the key has With tolerated data, the animal led well A leveraged available that exposure. pathogens in in polymyxine. vitro that the profile

working patients preclinical encouraging bacterial date, by hospital-acquired or funded to advance II now seen have SPRXXX Phase we trial externally and pneumonia. into to ventilator-associated in Supported an results clinical with we're

submit Phase this in of to quarter an to application year. support to expect IND the this the II FDA fourth We trial

Sath? now pass to review the financial I'll that, With our call results. to over Sath

Satyavrat Shukla

to good revenues XXXX compared year and the revenues December you, related all listening. Total million pleasure with Spero's and increase collaboration of XXXX million Thank It quarter $X.X afternoon $XX.X to fourth of fourth the due million to $XX.X quarter is revenue now in our GSK XX, agreements quarter Pfizer. quarter revenue with the to fourth financial was my an for and XXXX. provide overview The fourth the for for were XXXX. of full of primarily ended for results Ankit, of

December announced the expenses for decrease Research million XX, ended primarily year-over-year for ended the in revenue. This year May XXXX. in ended and expenses was revenue increase were aforementioned $XX.X million and restructuring the personnel-related collaboration compared for quarter partnership due Total reduction revenue compared million following development for XX, was development $XX.X for The XXXX, the million December to year due $XX.X XXXX, in year research to primarily XX, December the $XX.X of a XXXX. XXXX. the period XXXX the to fourth of costs same strategic to was

$XX.X expenses strategic compared fourth as the General to administrative December for result expenses the XXXX. development our of $XX to XXXX of restructuring million for HBr the the million $XX.X to to functions as XX, year decrease activity and year-over-year same million XXXX ended the $X.X and last of in were The XXXX result general XXXX. a XXXX, and primarily reduced program for XX, lower headcount year. tebipenem for This were expenses a million compared reduced administrative due quarter due to costs year Research period in primarily expenses the was compared for restructuring. strategic in commercial, ended December of G&A

restructuring. the for incurred contract to and a the as XXXX ended ended fees $XX.X XXXX, again, of expenses primarily These expenses impairment expenses year of The other to $XX.X such were year compared million administrative in of $X.X $X.X as severance and December costs XX, million lower General XXXX. Restructuring for of compared XXXX. result the December comprised million primarily costs, XXXX during year employee strategic were discontinuation the December lease $X.X million $XX.X expenses of expenses. million XX, of and ended million termination XX,

$X.XX stock, of XXXX XX, the of a per for for or net $X.XX full stock, Net million of common and respectively. $X.XX ended of $XX.X the loss net common ended and per and $X.XX of for Spero million year December XX, $XX.X respectively. $XX.X reported fourth the quarter quarter of XXXX, share or income year loss fourth million and and losses net income share were December year million $XX.X net

requirements plan, XX, Spero December cash equivalents on its beyond funding and XXXX, cash together had expenditure to with be operating its Based and of cash other commitments, million. $XXX.X that nondilutive As will equivalents, cash fund current of its Spero expenses capital XXXX. believes operating sufficient and

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

will questions. now for open call We the

Operator?

Operator

[Operator Instructions].

Louise Our first question comes Cantor. from with Chen

Louise Chen

all quarter. this the Congratulations progress on

few to I'm questions. ask a going So

II paradigm? take wanted on fit XXX cash if the expect NTM, then your was, do relative where you to into balance, readout? the Phase How the ask And OpEx. just R&D is should that increase potential to First, on, drug, will I XXXX And with working the programs and for the guess, about approved you how we you you're that then given is the on your last question question in? to then other phase that it I XXX think we expense, in to should treatment new

Ankit Mahadevia

for Louise, the questions. Thanks,

Your relates financials. our to question third first of and some

treatment XXX. start So I'll I'll have paradigm perhaps those. with the But Sath answer for

lose slow-growing, of half rest in the more a is the disease, disease. the So lasting a a U.S., debilitating patient slowly affects life lungs feet, X.XX chronic quality and in and disease worldwide, million their world. half about just to XXX,XXX would long the patients the It's zoom It the damage out NTM have. of patients has where longer the term debilitating to

we NTM early patients for drugs in and journey. their that treatment a XXX for paradigm is be So to also solution generally believe disease the

line half XX% published the current them have useful at as has with that within current of relief. patients the options suggests the starting And are we've find the literature population, number We're that microbiological disease don't first patient's year. on one. characteristics a of actually number any the throughout stick certainly, looked to journey. discontinue And it, two, a patients it's they of be that of patient XX% Now with drug because

to unmet start, story that's as and major to something patients how the patients journey and there we'll that the now first-line we need where from data. right then is take continue clinical their throughout becoming treatment So expand disease explore we can refractory we'll generate avoid

perhaps the question. part first So that's of your

question, your turn it of components I'll to financial the For Sath.

Satyavrat Shukla

Louise. question, the for Thanks

for So indeed your the of through top-line first question half is readout next first whether take top-line us cash expected in is our data case readout the the year. on balance data will That XXX. the

expected Our XXXX, end to beyond cash meaning runway of the is beyond XXXX.

it balance expect with a books have we still readout data this when becomes on cash our to sitting of So available. healthy

on So the operating move that questions -- unless you can cash, the on I question. expense had to

Louise Chen

Yes, that makes sense.

Satyavrat Shukla

Great.

payment same rate quarter, our XX-K, expenses, as on the you Louise, than Meiji a operating made disclosed the On virtually financials to this if other look our is as our OpEx at in XQ OpEx onetime burn run of for for the for last year.

of last So terms been teens in year, for XQ we've of the early dollars. in

burn $XXX balance support you [indiscernible] If you extrapolate early that cash our teens expenses runway on beyond the disclosed on that would a to XXXX. for give million cash

through we those Phase are, R&D, funded expect but between we that that to development scale the III trials, in the and you For course, on of we start up from will GSK right be that milestones by process. received

our GSK, rate we coming give partners. run that cash in will from would to So calculations disclosed be Prior expenses runway. our but go the support therefore, cash milestones And expect indeed, so R&D the wash. will a will you up, that and for

Operator

the our concludes I This Mahadevia. session. back Dr. will turn question-and-answer call now to

Ankit Mahadevia

Thank you, everyone on to evening. to thanks call who advancement operator, wish and continued hear to and the our programs joined the forward recent a of us progress. everyone our We about nice look today

Operator

today's teleconference. concludes This

you a Thank your day. for at great time. You disconnect your lines may this participation. Have

Spero Therapeutics (SPRO) 30 Mar 232022 Q4 Earnings call transcript