ITRM - Earnings call transcript Q3 2021

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Operator

Hello and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex and I will be your operator for today. [Operator Instructions] I'll now hand over to your host, Louise Barrett, Senior Vice President for Legal Affairs. Louise, over to you.

Louise Barrett

Thank you, Alex. to update Third conference welcome Results XXXX and business and call. morning, Iterum Quarter Therapeutic's Financial Good A press on release issued earlier with our third morning can quarter and be found our this website. results was morning by CEO, Matthews, We're joined Corey this and Fishman, Judy CFO. remarks, opening we on then will provide open the lines some our provide some results, financial will Judy Corey and will details for Q&A.

concerning with for I'd to and the call FDA to forward-looking agreement any statements clinical of this our interactions remind will prospects potential with design and including that Before trials. our you like communications strategies, we FDA, respect ability begin, planned and the business, plans, to future the contain with on our reach

in of and clinical the by Actual July response cash on to receipts and execute with non-clinical in future approval conduct materially of obtain potential those complete and differ to development Our our to of expectations the resource resolve forth forward-looking statements. regard may side from strategy. sufficiency XXXX, our sulopenem, results these for ability of indicated our sulopenem, to the the set matter

quarterly As development, conduct clinical clinical of non-clinical important uncertainties availability out factors a additional to from ongoing ability development, data timing filed of our the sulopenem, the on suppliers our high our in non-clinical in organization, on SEC of risk and timing and operations, the our filings set factors research of or asset trials Form or COVID-XX and capital development potential the thereto, most changes of impact in Reg public actions hand on for panel, the recently and third-party approvals, result lease the clinical with such markets our policy orals report of including XX-Q. and other SEC, measures listing of including the response inherent fund maintain Company's various clinical initiation, including; and regarding the NDA legislation, filings non-clinical into manufacturers, cash suitor expectations mission our of accuracy related oral far our of and and the of including completing potential likelihood the will future,

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

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

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

Corey Fishman

a joining Louise. update us Thanks, this brief for providing morning. be today. and thank Welcome I'll you

the reaching III were additional trial should with agreement one requested We to successful. received discuss that As mentioned, our meeting to late infections. population against trial. opinion, we significance of and the had for at warrant sulopenem letter even for of FDA clinical feedback treatment the previously we order sufficient work with be was subject that the in the in of that adequate The course additional would arm a the design results that sufficient, with response deemed approval, oral package in overall they complete a the us their though required the tract recently have totality had we received Phase urinary by be discussed not time, rate package that to then in meeting and in showed We Type FDA informed they July. statistical in that the treatment assuming response ciprofloxacin-resistant A acknowledged that that NDA of approval trial ciprofloxacin with potentially our uncomplicated FDA clinical to sulopenem FDA

factors. FDA B of protocol, additional and that trial, meeting Type other to requested relevant since have including endpoints, discuss the details We with a the the

given urinary to around medical occur Our valuable for NDA and have urgent we be of oral new first that important aspects oral of work need enrolling patients. our It's support hope believe is of We will and to that the of could re-submission the XXXX. unmet resistant treat value patients treatments confident be study to year-end, we expect to to product infections, multi-drug for tract trial the clarity sulopenem half and that physicians the to potential additional for after infections, important sulopenem note this an required all in able remain meeting, major in on strongly expeditiously and which uncomplicated get

QX on just of latest I'll a this strong balance balance with we our $XX spend forecasts, Lastly, Based on cash moment ended sheet. our anticipate million cash outlook. the approximately a We and to balance Company development position cash urinary tract will infections. allow us clinical the the the to the re-submission proposed our for of complete NDA uncomplicated support, treatment into XXXX on if to additional and of the of FDA successful, sulopenem fund

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

Judy Matthews

employees of XXXX, $XXX,XXX Quarter Third is were and development higher costs of which R&D third and The $X.X $X.X of million Total the of $X.X includes our CMC costs to decrease regulatory XXXX, million XXXX. for for costs, compared the driver R&D of for million program of G&A in same III primary were XXXX. of costs in quarter and the R&D were higher costs programs, the XXXX million expenses. the million for directors. to research our compensation quarter due expenses period primarily include the The general Third in the to development Corey. completion category operating in $X.X administrative million $X Phase the quarter was G&A million our clinical than Quarter and XXXX. compared $X.X share-based third for and expenses expenses, Thanks in expenses in $X.X of third expenses. XXXX and Operating our

term paid versus expense largely million we The a of to third $XX,XXX in as final XXXX principal a XXXX. exchangeable decrease September lower our $XXX,XXX FCB third loan of balance and Quarter on the with $X.X the for versus lower September to quarter as associated the was for of $X.X note is expense in as in March interest Moving onto the primary our item. due will of began Third loan of XXXX $XX.X balance in XX, million XXXX. Quarter to Third XXXX term Fourth of million our basis, cash the interest non-operating million XX, strictly in $XX.X non-cash cash On of approximately interest quarter monthly the was Interest expense of XXXX. The interest approximately continue related $XXX,XXX with XXXX amortizations until in a payment compared reduction of in Quarter XXXX. reason

there a balance $X.X million remaining on XX, was FCB. September of with of term our As loan XXXX,

Our clinical $X the at or in adjustments, lower million as to was our a GAAP quarter was no a basis current additional the of end cash of in short-term fair which XXXX derivatives and in capitalization net $X.X a the million of Based and a the market discussed. the of the a $XX.X of impact non-cash result runway, our potential the and of record conduct have a million was ordinary design including $X.X the final income turn shares non-clinical cash million. of as and previously moment. adjustment had adjustment operating value, XXXX price September, to excludes we I decrease for our planning $X.X on and of period. value quarter On a we of At subject investments to $X.X on than million adjustments plan derivative a in in during development There will non-GAAP sulopenem, a cash net certain non-cash million to result notes XXXX. associated on which of into of decrease record of operating less of by with components this loss non-GAAP third cash exchangeable basis, a US our determination expenses driven loss third of the net

UUTI. anticipate NDA As a such, existing cash support, successful, of treatment proposed oral that sulopenem will the for complete the we to us be of if to re-submission the sufficient allow FDA development the of to to additional our

had $XXX share million an million notes, exchanged of be which million outstanding for exchangeable can the September million XX option shares end approximately note-holder. XXXX, the as had $XX.X price of we warrants of of of per Also shares, XX, As $X.X ordinary which at the average approximately of we and September, includes $X.XX interest outstanding. at accrued

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

Corey Fishman

moment Thanks, questions just Judy. take open to and the We'd like for a up lines now.

Operator

you. Thank

when likely proceed ensure [Operator unmuted question. the Instructions] asking you're now will a We with Q&A. Please

line for today comes Gregory, Markets. Renza first your is now question from Capital from RBC Our open. Gregory

Gregory Renza

maybe how in or this you're us with, B the data just as wondering Corey. you that I'm meeting, to the morning, plans very upcoming community Thank trial. just share taking just in Thanks generated sharing just forward look reengaging my curious I'm perhaps, one you the thinking is have a of how you've could parallel head question could you baselining progress. certainly a a question any size color of and you perhaps what additional provide point if it are great into clinical and your initiate you you deal that pivotal even Good then Type us base around second thinking design all and maybe help Corey, touch to as you scope. for much. about it's second case just on trial That medical to about and already. And data if kind understand on or and at

Corey Fishman

that goal be regard and share has for FDA appreciate a a with don't and have yet details of question, Sure. the state able of Type that we to not and are design not of trials Thanks, and a simply is and say we're meeting uncomplicated design the come now Suffice With issued change the work say, have to because and to questions, years that we all infections, to study to this said that per tract the to said for then our the we lot I'd in of a that what on have it. really the and guidance that. specifics study B thinking the will back first Greg, couple the solidified our those yet that share to you well, study urinary doing be rather agency they we them with will it. FDA have back regarding

as the we us on a with we you'd to we and our do, -- sitting specific sites, just in of to do, CROs we here's get imagine; to that have of but aren't all figuring shift exactly and generalities, we've hands to talk have talk out also begun hard we able including half about all making our timelines number those the conversations begun external been don't supply, want of next start plenty talk what has CMC be have which be on year. vendors, about working say, the to We clinical team for study conversations sure first this able very to the of about to

as think to that now. much plan out I we've data, as know, I which is want valid is as do I make and as complicated to to in I sure supportive. data agree that was probably deal With medical have the second we KOLs. a certainly generated was physicians, you think a we you data can for the we get strong that's important community your you regard actually And to with in important and interesting and and talking it have about we well that UTI. the tell data to regarding question, also UTI and uncomplicated very we because reengage is have the of And the great in that

drug manuscripts help on meetings get to works for be next physicians. good And to working the we that upcoming data very well what feel the physicians doing months. and to the of XX time so treating on fact over so X that we the the try our is well. certainly And generated, just hands believe least figuring that that people presentations into here strongly this as will out conferences, was the And and appropriate to KOLs at how for we radar be we'll about understand as why

Gregory Renza

appreciate helpful color. I That's Corey, really all the

Corey Fishman

Greg. Thanks

Operator

you, Thank Gregory.

Our final from Arce for question Ed, comes your H.C. Wainwright. line today is open. Ed from now

Thomas Yip

Thomas and we timelines. like bidding Perhaps on you Yip of is request Good the Ed. for down to to first meeting when take do back narrow This morning, see tell us that place? expect was you is couple questions a accepted Happy sulopenem the formally would Can track. asking to the everyone. when

Corey Fishman

allow of meetings We in we should date that we're be around probably put and to the is more the the to on incredibly, want that study weeks timeframe we've be We'll the that our that in say end Company. have request as a about, X continue that X the conversation, running that having granted able us should I year-end be to year. but ago get to importantly, started as as and expecting should that I to and data this important think timeline, given it and get capital solid provide the do and for we've talked planning Thomas to up

are So standpoint. a that's favorable position in pretty from that we

Thomas Yip

Understood. Yes.

considering you As the earlier, would like to thoughts you on and ahead Type well ongoing the you not any impact alluded III, COVID-XX? to the that for on prefer location focus given of geographical discuss Phase specific to details you Have new sites B of meeting. open to

Corey Fishman

well the that the actually been to talking one it's as Yes. our of have rest a team our It's folks, and good the as really of clinical question, things CROs.

COVID the as countries better look efficient an UTI bit not they're our uncomplicated but is in at does geographies. understand quality a done geographies, we is be the what get to at the and -- various an US a predominantly in work other in most we will at study. as of continue happening time study, course the in will that's mentioned, what's little which had perspective, we And different. to But that other option, in the As manner, can but there was to started I Historically, for US highest that that countries. said, also we've look also only conversation what in you looking the where everybody done opportunity when world, the is from

going we've sites the sure best be is what the we're understand working various from so the here, geographies we as be to to that CROs well flexibility with countries to other And sure choose consideration that timeline a It an of as also who a got the are a look and CRO that is quality from standpoint, in we're we but study. at standpoint. into we as also taking important that account for timelines in terms

Thomas Yip

it's outline Okay. Perhaps it and runway one the that cash for know half main to was That XXXX previously adjustment? this into factors now Judy. into This of makes sense. We led estimate, this, XXXX. second you one's some that last question. Can

Judy Matthews

cost. we little We internally more run and had a of that specificity might about type the the trial

you and specifically to a specific the that we we since So -- quarter. been know, no were more than we've quarter. been during has the build there working in But last the financing able just more little some doing some CROs begun and planning have as last have estimates as with

Thomas Yip

Got is cash And that entire Phase this to you just your said that confirm just through. holding trial see to sufficient current it. III

Judy Matthews

the Phase the that as through III FDA. re-submission we as to plan Right well a

Thomas Yip

and III your Corey Got questions. Okay. Phase Judy you, forward Thank for to new it. look this our details study. taking We of final

Corey Fishman

Thanks, Thomas

Judy Matthews

Thanks, Thomas.

Operator

any to you. closing Thank Fishman for you. the over back now Corey, will remarks. session. Corey concludes to I That hand Q&A over

Corey Fishman

moment much. say again Thank the We to for take call folks you want to more support. today. on thank continued the very I joining one to just us the appreciate all you

confident we value remain As oral to of stated resistant the sulopenem very treat multi-drug infections. earlier, in

cash the most the option complete allow of an And support, will additional important continue requested the for We to of expect additional oral to treatment the to agency. successful, we approval July response of our to the perhaps sulopenem if physicians the support collaboratively re-submission sulopenem and work will FDA importantly, provide clinical in with existing letter received patients. we NDA to to as development us complete the data that the in

need great without very a get to good to that a again Thanks in perspective done cash have additional financing. the position and work everyone day. are we a for from So

Operator

Thank for joining you today's call.

disconnect. now may You

Iterum Therapeutics (ITRM) 12 Nov 212021 Q3 Earnings call transcript