Earnings call transcript Q2 2023

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Operator

Good morning, and welcome to the Iterum Therapeutics Second Quarter 2023 Financial Results Call. My name is Carla, and I will be the operator of today's call. [Operator Instructions]

I would now like to pass the conference over to our host, Louise Barrett to begin. Louise, please go ahead when you're ready.

Louise Barrett

Carla. you, Thank welcome results. and Therapeutics quarter second Good to financial XXXX morning, Iterum A results website. second this our press with release quarter can find morning be was on our and earlier issued

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

forward-looking projected from top statements strategic of I therapeutic timing the would of the of and to our fund and to our including call like and the that future information clinical results and expected the begin, timing you patent conference business, presented resources enrollment conduct, our time we line timing, and valuation Before will and strategies strategies ongoing of the provided trial, and remind contain complete operations. of concerning corporate our plans, our sulopenem, NDA, and prospects coverage sufficiency REASSURE this development alternatives on and cash the to resubmission financing term within the including progress of massive results, our frame for by potential development planned the ability our

data impact changes or in timing, policy regulatory of including likelihood other future is legislation, resubmission trial, value, in complete of or as approved, the our outcome of changes the or approvals, fund in sulopenem, REASSURE any those hand uncertainties clinical from by today. of term, timelines, plans Actual authorities, differ of and future including development, the and alternatives evaluation and or NDA the ability conduct caption results from of clinical of inherent to may and materially operations. design, cash timing trial, structure, the various the regarding fund and including discussed results oral public our in with if commercialization and alternatives these the financing a report concerning forward-looking quarterly of uncertainties filings indicated our oral factors, statements result REASSURE benefits, Risks important Risk requirements decisions initiation accuracy timing SEC and availability regulatory regulatory in the the cost the and effects factors of the far such developments, including all ongoing to our expectations into under how of sulopenem at filed and one Factors potential

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

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

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

Corey Fishman

infections, Thanks thanks treatment joining the want very in I'm much, and going REASSURE well. our oral I for very business and us pleased highlights the trial for of share tract about activities. enrollment trial Phase inform sulopenem uncomplicated you our to today. to Welcome, X ongoing of pivotal our urinary that Louise. some exciting ongoing is

recently very which target, our reached have We XX% is XXX patients. enrollment

we achieved that this Now have target.

SPA re-estimation interim conduct in the size special blinded We for agreement as assessment protocol sample specified a our will FDA. or analysis with

second-half oral potentially top resubmit quarter pivotal of trial data for FDA clinical our XXXX we the of available tract urinary the to and of in expect our XXXX, Based to Phase have in the uncomplicated the XXX the REASSURE U.S. NDA sulopenem X in We the quarter treatment second first infections XXXX. complete line in open enrollment on current enrollment clinical have our in over to of sites projections,

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

We been expire bilayer in no tablet XXXX. of Japan earlier patent than it of the to the directed oral patent composition to granted preparation. a This scheduled have is recently sulopenem and

reminder, U.S. the diseases, both patents two and to related urinary of in the addition use One oral tract XXXX sulopenem bilayer the patents, is in-licensed the Iterum any oral including patent in patent directed uses, uncomplicated a is expiring infections. method in of U.S. As of treating multiple owns sulopenem, composition directed barring to extensions. to its for and tablet other

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

quarter fund to the as XXXX. fund to readout. XX, with approximately will balance be operations $XX Our of Therefore, the XXXX, June remains on into our stated and that third able with through current dealer able position cash, our to plan, we equivalents investments of million Based expect operations as in our strong data readout line XXXX. short-term we cash a top expected cash of be earlier, operating the QX expect current

basis resubmission, we to term towards the potential few potential longer a we continue strategies renew years. the meeting At ensure over variety evaluate approval, ordinary we share cost which as extraordinary to can ability continue execute continue shares on to that the we fund next in company, provide the but be over strategy. in of the rights to general NDA including we recent capital commercialization, efficiently unissued potential asked plan the access our at would the believe operations to financing our On May, effectively of the approved will shareholders with disapplication us and and a the to look necessary to the AGM preemption statutory future additional more of our business capital, authorized, and

Irish required Ireland. because law is incorporated under in we approval solely, are This

strategies, to business we or opportunities of raise to of approvals for required passing the to flexibility received cash having issuances to did take compared offering. and believe of we not of time and for in at are plans expensive special and under votes receive competitive shareholders the to XX% with as least cast, seeking the first resolutions. consuming capital support disadvantage strongly transaction the affirmative over of of quickly we Irish the the at vote the that cast We Although associated share through rights votes to XX% public placed NASDAQ advantage those listed all a offer shares risks fund shareholder the specific companies execution non-Irish existing eliminates our having

this on we As will our depends the cash our options will require In XX-months. We're ability line commercialize significant that explore on readouts. candidates, our our continue on data to top expecting fund pivotal have our with we current have Phase operations capital, from in research, progress And growth strategy are that which our develop hand clinical and projections, very in the based to pleased summary X data we trial to product regard. trial. to less REASSURE through than of

We in the look to community. order need medical bringing first continue to help forward market address serious a in oral penem potentially the to to new the

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

Judy Matthews

were Thanks, the general Cory. to quarter Total compared administrative the $XX.X expenses XXXX, quarter $X.X expenses. and expenses and second and in million of in development of million second include Operating expenses operating research XXXX.

the in quarter driver XXXX. October the quarter, million of $X in compared The for second REASSURE cost $X period primary trial, costs with support R&D second expense the same to R&D the for million began were increase enrollment our in XXXX. for to which

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

net quarter for XXXX the $XX.X and On GAAP same in $X.X quarter our the million second million the which basis of of non-GAAP loss million quarter excludes XXXX, $XX in a Our certain second non-GAAP a loss net of compared net of in loss the on period adjustments, of U.S. XXXX. second non-cash to basis, XXXX. $X.X was million for our

of cash of in to million, based R&D will primarily a $X.X our end operating third and runway cash The our of higher investments into net second cash, on XXXX. equivalents June, the trial. current related plan, $XX.X was expenses of REASSURE quarter the have which provide million quarter the increase a At our for loss short-term we result non-GAAP

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

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

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

Corey Fishman

we'll up So for questions. the now open lines

Operator

Thank your [Operator Arce first question open. Wainwright. is is Our you. Ed, from line Ed H.C. go from Please Instructions] ahead. now

Thomas Yip

Yip morning, for and taking Thomas far. quick much Thank asking a our on questions Good very REASSURE everyone. is of This the so congratulations Hi. Ed. for questions you progress

the us REASSURE sample we some there data? now analysis? any do And also should safety you analysis the size give estimate conduct in would when addition can you enrolled, expect an from assessment, to outcome? question to, of announcement XX% time first with also, and So us expect interim be when And

Corey Fishman

Thanks, -- five XX. that it's to weeks go It's we blinded of but or about that course, day the got for another recommendation, questions. for necessary And once it together Thomas. With till there's of probably over monitoring of all data It's to target, teams treatment and follow-up. Yes. so enrollment hit day month the visit probably eight and only be then treatment, the committee monitoring Corey. the data regard committee. timing pull get to data the another follow-up you Thanks four then, then weeks will the you've have essentially through

in early So we're have that QX that the probably data expecting from committee. recommendation monitoring we'll

on it’s -- not all from that. It's we early committee time. a data safety. about have as blinded size expect watch QX. blinded not course, that about about monitoring safety, basis, It's re-estimation in sample We to It said, the of really a is on recommendation and basis the all I

Thomas Yip

Corey. Got you, just Thank then from it. more questions us. couple And Got perhaps of it. Okay. a

is so about This, at REASSURE, that from also discussions can congratulations today. regulatory did to the so the issuance also you announced you So, was on the talk front Japanese to U.S. data positive addition preliminary far? agencies expect And, in fulfill any, on approved other patent FDA, that

Corey Fishman

U.S. that been on we're can you satisfying we've and focused U.S. the requirements. the imagine as very making Yes, sure

we then our ability do our to talk will is positive, existing data, we and folks, Japan Our file Europe, the would be what and that have your experts data generally with population. Japanese outside see is plan to with what once an as together, be will it's in assuming on pull point, and team additional well need whether that our based study regulatory

Phase coming it's up really patents opportunity with doing And approved depending with there's of data to do couple with wouldn't in we the either about, existing force things so other working the hopefully certainly do go we're U.S., to looking study good additional to opportunity opportunity countries. to some we sulopenem feel Japan, to Europe into at or on focused a of that's quarters, to next various them saying in outside do submit, to the getting countries, on like in into potentially others an work the that other the or and that. but And the partners ability U.S. very like with on not that. X We're and have partner countries we now bring

Thomas Yip

to the again forward taking looking coming questions the months. for you progress Thank hearing and in Understood. REASSURE

Corey Fishman

for community. this wrap resistant continue clinical resubmitting look Thank to patients. to we if work. We're questions, Iterum the the us. option on We NDA ongoing for to confident forward oral in pleased Thanks appreciate I'll successful, much just appreciate Thanks. the with and to-date, treat very infections drug up And physicians for in and remain the it. multi you important in very value very Thomas. of interest We for joining today. to sulopenem our treatment REASSURE our we completing the FDA our progress and

Operator

your participation. This concludes Thank you for today's call.

You lines. may disconnect now your

Louise Barrett	Senior Vice President, Legal Affairs
Corey Fishman	Chief Executive Officer
Judy Matthews	Chief Financial Officer
Thomas Yip	H.C. Wainwright

Iterum Therapeutics (ITRM) 11 Aug 232023 Q2 Earnings call transcript