ITRM - Earnings call transcript Q1 2024

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Operator

Hello, and welcome to the Iterum Therapeutics First Quarter 2024 Financial Results and Business Update. My name is Carla, and I will be operating the call today. [Operator Instructions]. I will now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs to begin. Louise, please go ahead.

Louise Barrett

Carla. Thanks welcome Update First Conference and Results XXXX Iterum Business and Call. to morning, Quarter Therapeutics' Financial Good A press on release issued earlier with our first morning can quarter and be found our this website. results was

and opening the this results morning and the Matthews. Chief Corey Officer, We are lines will our provide provide by Financial his joined Chief will financial open to Judith Executive Q&A. then our Officer, we'll Fishman; remarks. Corey on Judith details

process FDA potential to some resources strategies the the of strategic like conference including I'd we for that oral on forward-looking review deficiency ability filings expectations or remind sulopenem and and decisions by in by Before FDA the regulatory in letter our NDA maintain of and regulatory our the and public process development, the time on potential ongoing fund or information to its of the changes respect the of costs results to of and of FDA, of factors policy factors sufficiency XXXX operating concerning follow to Risk our expense with structure, our and and the of resubmitted otherwise changes including XX-K the on into in on cash uncertainties to to these one terms, sell, effects outcome hand to or this legislation, the NDA, future, the ability the response all nonclinical strategic the in accuracy strategic caption alternatives, set you July our call report lines operations; including those as action our initiation statements begin, timing oral of presented timing Iterum's regulatory the concerning statements of and the business, resubmitted by expected the our maximize to to then Form differ materially quarterly design, our results sulopenem, the into in control, dispose rights from contain at indicated the market, to impact, license approved, morning. conduct forward-looking of capital this other will of related will therapeutic approvals, the benefits development, of SEC as inherent and XXXX, stakeholder our of ability our out Factors compete the outside or the risks any plans, address complete clinical NASDAQ our in prospects timing, filed and plans commercialization value. Actual and market from our various sulopenem our may cash uncertainties pursuit authorities, received requirements and with listing issued value likelihood

should us this We specifically any and addition, In statements. date views as not update represent statements to such forward-looking any of as of disclaim these any obligation be of call relied represent on the our subsequent date. to

call. also will be during measures financial referencing the We non-GAAP

you in now, We your have this remarks. non-GAAP issued GAAP to it of that the morning. said, information press turn Corey, reported adjusted provided reconciliations to With over I'll release for opening

Corey Fishman

today. thanks Thanks, us for and Louise. Welcome, joining

As you application may have new our recently know, drug to the we resubmitted FDA.

mark results the to special the women data treatment for strong we data XX a over uncomplicated the protocol a results just sulopenem FDA's agreement FDA, quarter support additional sulopenem for and the that to would pleased trial safe the of early tract this assessment and which the was that addresses penem REASSURE within occur new our of the sulopenem with infections recommendations in very accomplished of of would believe tract for this from sulopenem, oral We X approval top treatment uncomplicated positive with resubmission trial. of approval shows months in treatment U.S. the have announcing oral effective are clinical XXXX, second urinary approved line potential urinary from We adult match. fourth have infections. The years. oral generated could that We conducted be first which believe under the in our

recent the We Evaluation Anti-Infectives our to are review Research, they effective." from committed We the to to period. encouraged "The closely fostering Director Division new availability stated, forward antibiotic who prove by comments Center FDA's look and safe the be FDA for the during of is working in with Drug when of and FDA

current equivalents. Lastly, as into through as QX. XX, date a plan, cash we $XX.X now Judy expected I'll cash results. on runway on the this turn look our it operating amount of March provides for over including financial PDUFA we in our Based cash at had cash to in and information early our million XXXX,

Judith Matthews

million Corey. and an Thanks, support first administrative costs higher of first of the in quarter were $X.X which expenses. R&D general which expenses than expenses an the in expenses million in compared operating of the REASSURE research include in XXXX XXXX, the Total due primarily first development XXXX incurred and $X.X in million and support quarter higher to to increase began Operating XXXX. XXXX expense for of to our the enrollment enrollment first consultants first quarter $X driver same quarter The of activity. and October the in in million in to quarter costs pre-commercialization were costs $X.X for and compared XXXX for trial, XXXX. G&A in fees legal to million due in were for decrease completed million XXXX, million was used first R&D $X.X October costs $XXX,XXX the period quarter primarily the primary XXXX. increase G&A is $X.X $X.X of to of

the U.S. primarily basis, on million quarter adjustments, first for to million first lower of The related for non-GAAP XXXX. On of was XXXX GAAP R&D in FDA in potential a million of we FDA of sulopenem the of cash into on $XX.X in XXXX. uUTI cash, March, same and based FDA loss fourth in we fourth loss of resubmitted XXXX net current a compared including had the for the of early a plan of enrollment PDUFA the the quarter expect in the $X.X this XXXX, compared our NDA $X.X in REASSURE of treatment investments oral net first which our a basis noncash million will to to quarter certain XXXX, the as quarter X,XXX trial XXXX. At $X.X was approval In our XXXX. for Our million expected the assign October period to loss in result for equivalents excludes the XXXX. early which $X.X $X.X completed loss non-GAAP to decrease expenses non-GAAP and operating date III April the Phase a net the the quarter runway quarter our of was first our trial short-term net in end patients cash provide of million the of

shares noteholder interest the approximately will be are X the which XX, approximately As as XX.X million of the XXXX, at ordinary of accrued XXXX, a can noteholders XXXX. notes pay million outstanding. January of million Also If be $XX.X million we had we April notes not end plus obligated approximately the $XX.X exchangeable shares. exchanged in for option outstanding, to had of April of exchanged, we

Now I some closing turn over Corey comments. will to it for back

Corey Fishman

go the open We'll for ahead now. questions up line and Judy. Thanks,

Operator

[Operator Instructions].

first Jason comes from from Our question McCarthy Group. Maxim

Michael Okunewitch

the the us line that off, then just package deficiencies noted the Michael prior Jason. confident the is resubmitted. CRL? And addresses you're to I what of BLA for start why new on NDA with you guess This Can remind in original the those? Okunewitch

Corey Fishman

data we just this original study. that was they said saying, -- didn't -- approve and to And pretty straightforward was CRO Corey. provided Phase drug. at is FDA least more enough didn't what would think had request the The We one we, the Yes. they III you

with we address feeling study put and agreement, agreement them a other put pretty pretty conversations study. extensive that basic SPA sufficient together and eventually special of of agency protocol like the wasn't about that deficiency Phase with substantial amount had data to a a And in there a assessment place them so III

we their the We of feel study, of our that X,XXX our there As not you very enough comparator over And on based feel particularly Augmentin. noninferiority question which to of confident hit results we that saw, data primary was patients. addresses only here? showed underlying that endpoint

We them also susceptible have the population augmented provided in approve for to superiority that feel to we sufficient confident data that very augmented showed drug. statistical

Michael Okunewitch

on And into color something is review something then when you bit could a approval I'd like make license When finalized? that? to be would post that an and that -- is a that the see Or this if more finalized strategic you agreement be provide broad most Just could sale stroke, a just or decision? thinking in leading sense could process. think

Corey Fishman

Yes.

the is terms in to ongoing. As tell we've that's comment you said would process is we on publicly, What going aren't anything ongoing. I of the process

obviously, soon it. We sufficient we continue topic. is and go we'll on there's probably But disclose that's ahead discussions. something that have to as I that as And think disclosable,

Michael Okunewitch

right. one All quarter is R&D the the more from last fund question. of to cost Are trial? still come final down And Or to you incurring see REASSURE modeling we then or in expense the a expect should one continue X? next

Judith Matthews

This is Judy Matthews. Yes, some down it should more come there.

trial. that done costs recurring are at We for

Michael Okunewitch

All progress. the right. all on Congratulations

Operator

from at us Arce question next comes Ed Our H.C. from Wainwright. from

Wing Yip

couple asking questions Ed. a for This is of Thomas a

the also, discuss points UTI the question, How given any month. you later assuming sulopenem X So in between do of profession FDA uncomplicated the for PDL of last received this first sulopenem's approval approval And the differentiation the inversion market? can year?

Corey Fishman

Yes.

yes, end in April. of the approved the got So Pivya FDA by

entrants. And they based test. market. aren't particularly Thomas, market launch is that few could for be drug half a their is believe we've over think position don't of that X the and the We file that a given believe quite we would be on they very that the size have there GSK second as Pivya and patients. that positioning what have said for we've year. years of the positioning, end of said also potentially the now from sure elevated within our solid any years, I would new talked about always what in said, We new many as the And timing is And next to again, irrespective and public disclosures, has potentially we risk this of work only

of elevated really be prescriptions And X/X annually. we of we good million that. with patients our about addressable is market to positioning. market estimate that, XX our think So about the feel about risk We

large strong very a market. believe the high-risk given to drug a wanting antibiotic, very have we those patients. class a terms like in we solid penem very use sulopenem be there a we're something that physicians reputation or will a and that response of of So And to

both don't make where And and primarily. playing they scenario Pivya that in very therefore, that So I we I feel feel believe we that. position very very very will a we've it good or a have be both got solid feel for product got comfortable market good that's we to a -- position. where launch, GSK's if commercial

Wing Yip

strategic mentioned be Understood. the perhaps I know market, still the independently And -- would option then table? What you earlier one is ongoing. exploration action bringing that sulopenem follow-up. to the on that an

Corey Fishman

Yes.

will priority we the doesn't Board our to process best result over to our in And a is maximizes feels the independently if prepare transaction. said, value shareholders. to market we've for that strategic the it As strategic bring of time the ability something

road. So priority but is to down is today, the it how we're not it a again, thinking regard with our potential certainly

Wing Yip

Understood. year. look later this particular date we to And the forward

Operator

I We to over for currently questions. remarks. have any hand final no Corey back Fishman will further

Corey Fishman

closely the underserved working drug physicians much, patients forward resubmission great we're treatment appreciate and about We bringing during important infections. joining markets new looking period urinary Thanks today. FDA uncomplicated tract very our to the have the Carla. We're and a in you Thanks, an sulopenem, application with excited review and of day. to potentially us of option very

Operator

that joining. call. Thank And concludes our you for conference

your may You now disconnect lines.

Iterum Therapeutics (ITRM) 13 May 242024 Q1 Earnings call transcript