ITRM - Earnings call transcript Q2 2024

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Operator

Good morning, everyone. Welcome to Iterum Therapeutics Second Quarter 2024 Financial Results and Business Update. My name is Kiki, and I will be your conference operator today. [Operator Instructions] I will now hand you over to your host, Louise Barrett, Senior Vice President, Legal Affairs, to begin. Louise, please go ahead.

Louise Barrett

Kiki. you, Thank welcome Results and Therapeutics' Quarter Second Good Business to Update Financial and Conference XXXX morning, Interim Call. website. be A press earlier on can issued results quarter our found release with this our morning second was and

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

take to remind presented general its statements like for The resubmitted our that consider meeting some process of call action Before to recently efficiency license contain be the information into offering, sulopenem our sell, NDA I'd rights, oral I fund These for preemption concerning regarding NDA cash prospects you of rights the that committee will in the strategies the covered on will relation of include and to by our begin, use XXXX stakeholder topics our dispose date sulopenem. which maximize of value. expenses to from or proceeds the interims meeting our business. resources and conference expected at of to this the regarding otherwise advisory disapplication FDA of or our to planned the forward-looking operating statements plans, will rights shareholders extraordinary completed strategic the to upcoming

and legislation, changes likelihood or sulopenem of and from decisions lines those the commercialization in including various of in of regulatory materially public clinical in by uncertainties regulatory regulatory differ of control, of conduct factors changes or as initiation may results our result and requirements and design, authorities, forward-looking development of approved. Actual time oral indicated these plans policy statements the outside approvals, a filings inherent nonclinical

and capital the will the our strategic our risks and fund maintain uncertainties of our going far cash our expectations the resources regain The NASDAQ concerning future how alternatives. cash sufficiency market as and continue compliance of is on of the our effects concern, a and accuracy operations, and pursuit ongoing impact our to ability results of our ability our regarding to listing outcome on hand

discussed caption Risk Factors filed And with factors on quarterly SEC morning. those Form under report other our the the in this XX-Q

of forward-looking any and update addition, should viewed disclaim to In as center be subsequent specifically We obligation our as this any relied not date only views as the any of statements representing of upon date. statements. such call

We've measures non-GAAP now, Corey, say, I'll a it in referencing reconciliation will provided this morning. reported non-GAAP for to over remarks. of turn I'll to call. release the be We the also that, GAAP during opening With information financial press issued your you adjusted

Corey Fishman

be for account joining Thanks, We pleased busy time proceeds a productive and to expenses. It and share $X.X and to Welcome, I'm thanks closed continues after Iterum, fees recently today. Louise. of net generated rights following million offering, pleased updates. were our and which have to taking us into for very the

business plan our strategy, the ongoing This maximize process additional strategic and for to stakeholders. sulopenem pursue to of continue funding us capital including allow our to will our value

in September of new uncomplicated FDA's Committee treatment to tract the Antimicrobial adult our Drugs the will discuss for to with sulopenem turning Iterum milestones. X, upcoming women. oral resubmitted Now application meet On Advisory urinary for infections drug

and Advisory on provide general is to Committee Antimicrobial advice issues. recommendations regulatory to Drugs the The of function FDA

to and prepare We have the for looking been working forward diligently are materials upcoming discussion. this to meeting

sulopenem. is October action is date for important FDA by assigned 'XX, the new date drug application Another PDUFA to resubmitted that Iterum's oral

review the with work process. to continue their We during FDA

urinary States. sulopenem their first the approved within tract or a infections approvability United date, on decision of adult regarding about penem should receive we completes its time oral the If the uncomplicated in be approved, or FDA oral would frame, sulopenem review in the of oral If general the women. this treatment

intellectual We our estate. continue to expand property

application Most allowed. recently oral allowed of announced X recently, is One to in patent U.S. sulopenem tract we that implication method directed X uncomplicated patent pending patent the applications U.S. were infections. urinary use pending and of treating Canadian

in allowed directed the patent diseases. Probenecid other While Valproic U.S. the method use acid etzadroxil, is and of application of to sulopenem multiple treating

new sulopenem Canadian Europe, application to other patents, in addition of tablet and applications its Korea patent to and uses. have oral The China Canada Once Japan, directed the patent preparation patents owned and territories. will the in in-license pending Australia, bi-layer with we these allowed patents and/or related in U.S., is issue, key

expected look equivalents. rights October Based at newly of late PDUFA in cash, this equivalents year. cash that as plan, operating June we and short-term XX, the we our million on investments the offering of current cash cash cash in through the believe $XX.X from including the raised As current into and date a we XXXX, plus runway cash our had provides

future Shareholders preemption disapply to XXXX capital of statutory to General Meeting are again approved at in Looking applicable our to Extraordinary the our we of rates share authorized Annual that was at shareholders requirements, by shareholders capital Meeting. increase upcoming General our seeking once approval an the

our share our advantage execution which, take to fund further strategies senior on principal to of exchangeable This strategic plans XXXX XXXX, cash, outstanding the January opportunities and of turn, of business repayment million including us of funding raise us into due for notes. in through subordinated interest will issuances enable X.X% ongoing and to in process and allow continued the quickly capital $XX.X

we we to companies compared the transaction-specific shareholder eliminates with The first offer. seeking rata costly associated the at that risks rights NASDAQ-listed and cash approvals to disadvantage granting our a having or propose time-consuming pro those offer placed shares are in public preemption the existing to non-Irish issue for shareholders and authority of opt-out to competitive all

manager excess costs $X.X rights total example, an approximately completed to time-consuming offering including was costly in As of dealer taking recently our implement both months X.X million, with and fees.

best proposal the company our in to Our in and the and Directors favor as interest a being view shareholders thereof. recommends of vote this Board of continues

on Matthews the Now financial turn over I'll our performance. update call to an for Judy

Judith Matthews

were Corey. $X R&D operating Operating the to $X to general the for same second administrative XXXX. $XX.X $X.X were include expenses XXXX. of the second expenses. in XXXX, compared million quarter and Thanks, of research in for and expenses in compared expenses quarter and second Total quarter costs million development million the million period

primarily quarter which The is REASSURE October of incurred October and were XXXX, $X.X higher million support flat costs enrollment of primary the trial, expense of enrollment R&D in costs decrease G&A the the G&A was driver in in in costs to XXXX quarter second $X.X to and completed XXXX XXXX. second second our to for $X.X quarter million the began for of due which XXXX. million

as result expenses net was III million trial second net loss related Our loss XXXX. $XX million for to the REASSURE XXXX. same $X the basis, XXXX period non-GAAP on second which XXXX. in a trial compared quarter lower in to for The net our R&D non-GAAP in U.S. Phase in completed second basis a primarily for of the of quarter was certain GAAP million million our $XX.X decrease of non-GAAP the noncash $X.X loss in the enrollment $X.X a of our On October second quarter XXXX of of adjustments, million excludes our net to this in quarter was compared loss

provide equivalents resulting October cash, XX, we'll based June, of this current investments we plan, on completed earlier offering our operating of the into including end potential the million. had month, approval million, At short-term aggregate net And of XXXX, cash on cash group proceeds and FDA we $XX.X XXXX. rights in $X.X runway

approximately $XX.X notes which shares million exchanged which We of million noteholder rights of for currently exchangeable shares. million includes outstanding, approximately have can currently the shares be approximately ordinary completed XX.X the X.X outstanding, recently issued have we Also, at offering. option the a in

$XX.X will we accrued are be which includes notes the XXXX. January million, noteholders If not pay the to in interest obligated exchanged,

Now line questions. will open we the for

Operator

[Operator from Please is ahead. Wainright. Instructions] from The first HC Ed go Arce question

Unknown Executive

questions couple This is Ed. asking a for Thomas of

seems sulopenem. somewhat objectives very the outcome can perspective the in assessed as concerned first So is considering you stated oral is The is this the agency reluctant about resistance first your question, which X the by discuss with of approval. the agency penem, on antibiotic

Corey Fishman

don't for considered think they're Thomas. I reluctant to the approve it. question, Thanks

be is getting it what is about this thinking because think are penem that consistent would is for the course, indication, patients they oral first to sure would right the we with it want. I to is making approved of what which, be

be And of promotion only for do in of any indication. would our approved we course, what would terms

And so reluctant don't I to it. approve think they're

is extremely than bit a not the an we haven't area be this that an and therefore, address being safe opportunity they're like very approval just think to of would widely the just have natural think is used available, get. recently, a had it penem oral might which I more drug and being mindful of little I to and efficacious they given

Unknown Executive

Got can Comm? of it. And would date the you to that align some Ad end, that you at expect the topics

Corey Fishman

I'm sorry, that didn't I Thomas. catch question,

Unknown Analyst

topics is the Ad that would you at outline the you some be we of to What will like raised know date anticipate can Comm.

Corey Fishman

FDA note, would way being that, about an which we used sure about for things that which they about, talked to again, did And Comm is the making and publicly, specific talk about stewardship. Yes. appropriate X us just in we is talk patient. talked product this When the our Ad goes like they sent the to appropriate and us what with is the obviously have appropriately

adult of And mentioned population. based UTI And appropriate in could is and the was population. our itself women the have be obviously, that second patient topic that the and in on appropriate what study uncomplicated done they we

I to committee bit whether And to not much that, be should a think from conversation. the FDA, because, new is as for through ground approved just little or this the not. I so on sense again, think get advisory it they're of that talking trying a

but own this that, use their Obviously, make decision on and it. they they'll how uses who

the with they X topics to like regard correspondence to in about. us topics So those committee are would with specifically their they what to talk mentioned that advisory the

Unknown Analyst

to question evidence from specifically then of other to U.K. you studies it. us include from studies patients one sulopenem outside as safety to provide you REASSURANCE data Got allowed of Are study. the safety. well? And more Are allowed as include completed

Corey Fishman

Yes. allowed you to. Not only are

across will probably presented certainly, has Phase comprehensive of but a safety And data it's very done to III safety as safety want I from base say don't required, clean news good -- is think all you patients. we a perspective, a we've I profile. studies, the know, those and have sulopenem X

will that So gets the presented yes, data part be that well. of as

Unknown Analyst

Understood. forward the to We Ad Comm. look

Operator

you. Thank

from Next Jason Group. from McCarthy Maxim question is

Jason Mccarthy

discussion. stewardship is Ad new. want it's -- they you It's stewardship considering population. this briefing the I the kind and appropriate about question of But Comm. because first this the Corey, and the patient want documents through for think But then penem look is why do can to go an talk without the they to impossible most for appreciate oral

and the to you get Do think or go indication opportunity to who process patients trying on through Augmentin having narrow sulo. maybe label they're ] or commercial and to Cipro that thus the are [ else maybe to to failing something and

Corey Fishman

a have studied been the know Yes. the question, I I Thanks than answer other that studied. you for what It's populations really have the don't we've good we can tell what to one. Jason. is

evidence so I to particular be without it narrow subgroup. difficult that having try having a your to studied of that And might point, little think label to

to I would again, what that this more going. it we of studied. just course, That's could I and don't this and FDA is and have with sulopenem. that, said having So do ultimately, committee. the where talk going they little know you think bit get want why in challenging not that a know to go subgroup to be and the pick order don't they're advisory well, a what be through To potentially say, to I

those be would not we've for the that's studied. put to it FDA difficult, kind very the So population think, if of I guideposts,

we're we would certainly, patient the then, standpoint some be FDA and the that come what happen. going work to does approved So the our to to of the is advisory understanding drug we've in and to studied don't with going say thing to from next committee know Clearly, try the how just the conversation. paramount But the label populations given course, is getting

study with you to study up prior had to But And course, infection that's failed way. won't their that's in say or else. a it it because, isn't We prerogative. not say to our of on didn't come that the have have something material that FDA had have certainly, just something

Jason Mccarthy

because some while those I Got discussion primary do it. it the data and around and trial And to -- meaning be great. will in that prior know wind superiority in superior Do in right, Cipro be also documents. the was you label, it REASSURE the you are the these you cuts major data, maybe different there'll be you inferior, which think X the SUR-X in and the there briefing this would statistically think do was think of of topics a non endpoint, or can aspect statistical was cases, superiority there up

Corey Fishman

It's they reassured becomes I as really the the conversation of superiority of if the don't another is be that real know piece good you've got for the And FDA. not think very given The question. data strength something good only, plus label. some would data discussion you there. It's the the that I think, data. that feel a I in non put we with would something question, certainly compelling said, that inferiority

is in It's approved the heads to that what does you're not with Is label? are that agents UTI your at uncomplicated and it regard will you with shown you've say? possible. of these the but kind something the other their to label up interesting will the get for where only says it label stage So broad somewhere or to more agency, conversation we if to superiority show around are that see standard approved, be it

Operator

you. Thank

Officer, As we to currently over Chief back to would Fishman, have turn no for conference further Executive I questions, Corey remarks. closing like the

Corey Fishman

again Thank Thanks you, joining today. Kiki. for us

forward our our uncomplicated Antimicrobial as good day. potentially and a and We of tract review the underserved bringing application are option to Committee very Advisory important resubmitted upcoming FDA the patients of market again, are sulopenem treatment new looking with about to an infections. the excited Thanks continued and physicians in drug interactions of part the FDA and have urinary

Operator

conference today's concludes call. This

now lines. your Thank may You you. disconnect

Iterum Therapeutics (ITRM) 14 Aug 242024 Q2 Earnings call transcript