ITRM - Earnings call 3 2023 | Iterum Therapeutics plc

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Operator

Hello, everyone, and welcome to the Iterum Therapeutics Third Quarter 2023 Financial Results and Business Update. My name is Harry, and I'll be your operator today. [Operator Instructions] And I will now hand the call over to Louise Barrett, Senior Vice President, Legal Affairs, to begin. Please go ahead.

Louise Barrett

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

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

Q&A some In been portion our be addition, the to we've from extending few routinely a receiving of answer shareholders. questions we'll

Before timing XXXX; and patents; operations, from received to the line the address of letter the potential response and I resources; our therapeutic the strategies some cash market like call remind of our FDA; fund of data review oral for the and coverage the of NDA expected the of statements of and by term in July to and the contain conference our REASSURE strategies concerning top NDA by will including we this of ability prospects timing out clinical provided our would corporate, deficiency the of financing of begin, business, FDA trial; and future our evaluation development new complete issue the in including you for strategic the our timing the set to sulopenem; and plans, development, information that presented from today shares our and of forward-looking sufficiency results alternatives resubmission on cash.

inherent the and hand the outside timing materially development; clinical and result as of and our complete maintain differ fund and initiation listing and nonclinical including indicated statements alternatives sulopenem; uncertainties market today. operations; regulatory far data regarding of conduct such requirements XX-Q a at evaluation regulatory filed the the design, oral our SEC including and on Actual these future in development ability various into concerning of will approvals, alternative ongoing from our by clinical all; from in those value, and impact, of our legislation; other the in and of and results REASSURE ability factors forward-looking availability our control, discussed effects cash structure, of on on future fund potential costs filings timing, or authorities; benefits expectations public how in uncertainties of likelihood accuracy report including NDA our or changes resubmission under decisions risks our for any of changes Risk policy timing to caption the the regulatory factors or NASDAQ the one to the of the operations, to our and may included capital terms, results quarterly of the Factors financing our outcome, with Form trial;

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

information adjusted reconciliation be non-GAAP the We've the financial in reported call. referencing during We will release GAAP also morning. provided non-GAAP a of this press issued measures to

it over Corey, remarks. said, to that turn now, With your I'll for opening you

Corey Fishman

joining activities. some the Thanks, exciting our highlights share I and business to Welcome, today. thanks us and ongoing Louise. want for about

Let's begin by our talking associated a milestones timing. bit upcoming key about and

milestones key versus you previous guidance. entire by share with want our we that timing an has forward been to quarter moved the Overall, for these

the oral sulopenem October, We III for trial report are treatment in pivotal in very enrollment urinary trial. that pleased completed tract our infections clinical uncomplicated of our of in REASSURE adult to Phase women, we

next on long other uncomplicated our enrollment how studies and is remarkable to be early key of experience in our in recent given uUTI reporting which now trial will line data, top enrollment urinary studies. quarter With milestone from XXXX. enrollment completed tract XX first The complete we occur REASSURE which will the just quite REASSURE based months, complete, in expect infection it takes trial the

our our of of to Provided the or identified the of the X in that FDA of we fourth response resubmit quarter review the expect resubmission letter, complete the deficiencies our FDA NDA months to XXXX. take data, expect our quarter second to we the in analysis Subject resubmission addresses its XXXX. the complete to action from in and date

our the of Now overall I'd impact and our a the like take and on share enrollment. to moment interim results analysis

As a committee point by monitoring an the we previously size in enrollment, conducted showed blinded review, XX% determine data interim was was power assessment achieved The our we our interim were halfway once protocol the adjustment to FDA. that, within announced, outlined analysis whether special with range sample to analysis data based independent the of XX% a recommended. blinded agreement on

figure XXX an data. total order for with power on We patients additional patients, a based to towards that range end chose top the study, the to enroll of a of finish the blinded X,XXX in

Importantly, of guidance. quarter complete previous we a were these incremental ahead our the full to patients able still trial, in and add enrollment

U.S. that patent our other value estate, enhance countries. oral the protect provides are patent continue and we happy On which front, of a to substantial the we to inform you sulopenem in runway to the

no This in of oral to sulopenem. have directed During the patent to scheduled than been Korea composition granted is a bilayer patent we expire earlier tablet XXXX. this of the quarter,

Australia, patent and the the of of we Additionally, sulopenem tablet in were oral to uses. composition which related bilayer granted also its is directed a

Japanese sulopenem in XXXX addition for in Australian patents and Korean extensions. U.S. reminder, the and a granted and newly Iterum any patents, expiring barring a As all in-licensed patents our two patent, to oral owns

bilayer method diseases, infections. is the Japanese its and the in tablet directed patent and sulopenem and/or preparations directed to uses, One and composition urinary related the U.S. is patent of uncomplicated of oral to patent treating of including U.S. other multiple tract use the the

China. Additionally, have and the applications in of number including we a jurisdictions, other and Europe patent pending U.S.

we current cash, short-term and we we operations of and on current equivalents cash time XX, as our had line expect to September operations Therefore, readout operating line, Based our cash million. into able resubmission. investments quarter to will $XX potential As our our fund that data equivalents as top cash be able given cash of a plan, our fund well expect the NDA third the through to of existing accelerated XXXX. be

for summary, I In to line we enrollment guidance well ahead are just very pleased to are previous forward accelerated laid on have our the upcoming of looking milestones completed time and out you. have our

based have on our of cash mentioned, expect and the we our fund line readout hand data resubmission to projections, the As top on operations potential through current to NDA.

that effectively the into to to fund ensure opportunities operations continue cost we We can raise to capital explore and future. efficiently

U.S. excited oral bringing over the uncomplicated urinary treatment we tract the Lastly, remain potentially about to in first the infections market XX years. in new for

turn Judy for over I'll our the Now details financial on call results. to

Judith Matthews

quarter Thanks, and administrative third XXXX compared the Corey. to $X.X million completed cost for the same development expenses. increase began the enrollment of compared October month. XXXX our quarter million Total to driver third in third The for million support which expense third operating quarter $X the were expenses for were REASSURE million enrollment last $XX.X XXXX. expenses trial, in to general and include in $XX.X of R&D XXXX. R&D research was Operating period in quarter in primary costs the of the and and expenses

$X.X is due lower means XXXX, fees and a which with was which $XXX,XXX for in the in compensation to in were $X.X quarter with January than third in legal million decrease prejudice of the connection which of filed of to be lower expense quarter XXXX, lawsuit back cannot costs incurred million the costs share-based the primarily dismissed in G&A brought G&A third XXXX, XXXX, August court. case

third to quarter and for for trial. loss expenses a the in On increase of $X.X net higher $XX.X net U.S. loss third net $XX.X was a same Our loss basis quarter of excludes quarter basis, net related noncash the loss was quarter XXXX of of our period of to adjustment, GAAP in million million a the compared third of the million third million $XX.X non-GAAP for million which R&D XXXX. in REASSURE result on our our certain $X.X our non-GAAP XXXX the The primarily and non-GAAP XXXX.

cash At a on runway short-term quarter had plan, provide cash of our and operating current the will cash, which, XXXX. million, of third $XX.X the end of based into September, equivalents investments we

if We And of trial expect to resubmit of NDA to report for successful, the top XXXX. expect we second quarter the line quarter data XXXX. REASSURE in oral for the in treatment early FDA the the first the of uUTI sulopenem is to

XXXX. X addresses the expect resubmitted the that that will quarter all take FDA CRL, during the complete review and NDA the resubmitted the of we months NDA or the of the fourth in of from identified deficiency its Provided FDA date received action the

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

open questions. Operator, line for the please

Operator

H.C. [Operator Wainwright. the Instructions] from Arce And our first is line of Ed question today of

Wing Yip

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

open are impressive. over discuss as ahead, first, also and enrollment one So drivers with X,XXX. III for accelerated the the study? pace you the discussion of X,XXX earlier, target the perhaps enrolled mentioned patients very study feedback with Corey, some this And a Phase main for you also, versus of the what quarter initial Can

Corey Fishman

complicated interim And the actual as of analysis course. and a question, a our analysis very are determining on of analysis set blinded, was interim in based -- where power. of was calculation a Yes. including understanding power driver real factors, variety The it was very That's Thanks complicated terms was. of data Thomas. all it for the

between XX% at our with you agreement we wanted power calculation, end and And reason to SPA be say, overenrolled, of which the higher FDA. as XX% the we was is that the per

that time from the increase opportunity power to interim data analysis. power manner able expected for very efficient full were we that that line took we based in keep but or a basically do to study the year the enrollment, the to the X of and So on

Wing Yip

or And frame? time this trying XXXX early a little time of line down February January, then quarter to Got it. Would January, late readout narrow the a be kind first bit.

Corey Fishman

in the than will obviously the earlier don't that. We're have believe any we quarter other later on it be versus quarter. working definitive in Yes. still date We

Wing Yip

Understood. seen, in issue sulopenem just ex from you Can the ex Understood. U.S. new multiple We've some are and what one U.S. as discuss U.S. us. announced, you for Perhaps more actions markets? patents both question for

Corey Fishman

Yes.

when We those our have start at conversations data. we looking will

majority terms handful a in the In -- that And that U.S., is U.S., in market handful the large. of like products know just prescribing the we is is of oral know of very ex we a for therapies. it

to have really is get U.S. the of conversation for we determine in conversations what so data, partnerships do outside the those and potential And route earnest. best the begin then

The around the in There's be exact good the for remember news but Big don't million uncomplicated used or called large. -- XX is XX is the market number, UTI million I somewhere infections to X. very what

there's conversations just opportunity know appropriate an to sure U.S. there. who partners what And that have we we as It's are optimize of with question can the so well. that having a we outside make

Operator

And questions we the on no today. line further have

So Louise to continue. back hand I'd like to Barrett to

Louise Barrett

and some Great. of shareholders. that At Corey time, receiving we've Judy Thanks, Harry. from questions will been this take our

When do first that be sulopenem for oral expect you. will Corey, question approved? So you

Corey Fishman

Thanks, Louise.

analysis And time were to to does the the FDA to as that then QX. data We XXXX. Provided second that mentioned, months the operate to report complete would line in data, line of in XXXX. top the and identified therefore, of letter, its to that of fourth in the we'd be and we address deficiencies our expect from in potential expect quarter of resubmit the of of complete early quarter under the subject NDA FDA approval resubmission that our action the a X review date to the expect, we our part response take would resubmission occur would

Louise Barrett

the And its company you, cash can How operate on Corey. Judy. hand? with Great. current for long one Thanks,

Judith Matthews

us as of hand we on data is quarter the fund XXXX. on third to Louise. to resubmission. our through production, operations allow us the to Though allow line that our Based NDA sufficient should current cash operate as well Thanks, said the into our top

fourth funds to in However, the additional approval get are needed to quarter.

Louise Barrett

Great.

runway. you cash us the Can company? has about about long-term strategy Judy Corey, talked of a financing So bit the talk little that? to about What

Corey Fishman

the one next variety operations is to to the we for frequently. over can fund and because Thanks head quite address Sure. question, continue this it And few investors, through 'XX to on. of constantly strategies ensure we We're evaluating get years. financing we that want a

One or through such capital of strategy is to opportunities to take issuances raise advantage cash. share

were previously, authorized unissued as approve shareholders share preemption rights. as otherwise May, company, over Irish-incorporated this the and at the the preemption that waiver capital, As additional must the an rights disapplication the including our in statutory Meeting General is ordinary approved discussed of we've but shares Annual known of

us strategies. the provides new to additional continue efficiently Without to this ability severely ability cost-effectively our Meeting access is waiver with our cash does plans in and business were General the capital execute approved the raise Annual our to which not capital to necessary This cover and existing authority, more on at limited under for that the May. shares waiver,

of we we And Annual vote approve votes of Meeting did may occasions, ask and of least the cast not to as shareholders General over the law. the extraordinary XX% year in while subsequent support at August. earlier receive we As votes did you both waiver a at required know, this XX% at is under received our on this Irish meeting affirmative

shares, Simply all authorized shareholders sufficient to time transaction impede extending waiver issue would seek to a without an financing likely a we capital raise efficiently order to stated, that entail from timing and required either a each deal significantly in waiver we'd this and do all. of the shares, our markets, be and transaction-specific meeting to ability equity general extraordinary to every issue want at or unissued shares and time the in

there that for are to also of by process. we guarantee attempt same and a any time, terms be is existing for take the can our as sufficient that this not the additional investors we offering subscribed perhaps offering. shares via then issue and no rights the Alternatively, raise would time-consuming, The finding on period offering shares through offering shareholders can willing rights costly to quite capital all to shares rights first

having success to and issuances for market. critical cash ability flexibility is to continued that if to believe of order strategies raise to bring quickly approved, plans advantage the strongly business We in oral interim opportunities take and the execution our of through share capital to our sulopenem, fund to

rights pursue of we also you, including future financings, plan for seek financing to shareholders, approval a the will we partnerships continue in go and shares. and the corporate of financial over authorized, other alternatives, to our but While to to near debt portion the strategic back preemption waiver unissued

Louise Barrett

now. Corey. That's Great. Thanks, all the for questions

I'll back remarks. you, So just to closing Corey, pass for your it

Corey Fishman

get milestones to Thank can of address you, our Louise. the as in Thanks frequently the us obtaining regard Great. much joining long-term clarity from as the today. We've shareholders rights importance and we from the order taken reiterate for opportunity to company. of some regarding the the waiver to with preemption most provide questions of investors upcoming of and lines to time financing we

analysis We and important today, resubmitting look our this for to NDA the our FDA treatment continue treat in for We joining to oral subject line the of of to data to remain have readout the community. option confident the sulopenem for infections forward good physicians patients. Thanks value our again day. upcoming and us top a in to and multidrug-resistant data,

Operator

today's you joining. concludes call. for Thank This all

may disconnect lines. You now your

Iterum Therapeutics (ITRM) 14 Nov 232023 Q3 Earnings call transcript