ITRM - Earnings call transcript Q2 2021

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Operator

Hello and welcome to Iterum Therapeutics Q2 Financial Results Conference Call. Please note that all lines are currently on listen-only mode. [Operator Instructions] I now have the pleasure of handing over to Louise Barrett, Senior Vice President of Legal Affairs.

Louise Barrett

Thank you, Hannah [ph]. Good morning and welcome to Iterum Therapeutics' Second Quarter 2021 Financial Results and Business Update Conference Call. the and quarter our can with earlier was website. release morning this be press company's results second issued A found on

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

business, to plans, you contain forward-looking will actions we Before strategies prospects with following this and that the begin, respect in I'd Complete receipt like call XXXX. including for communications and of our concerning planned Response to our with July remind FDA statements Letter the

of Our expectations other on with recently including nonclinical development in related or development, the future response various these sulopenem, most of operation, policy set far Letter inherent indicated as matters clinical filed how SEC, our manufacturers, hand risk Complete of of legislations, fund clinical and clinical including a of potential ongoing our and impact materially from and Company's the the our clinical with quarterly the the the conduct timing of timing of of organizations, changes and development, on cash regulatory of resubmission suppliers public or actions Response future approvals, pre-commercialization cash the those and and non-clinical resuming thereto expectations timing out NDA sufficiency the to sulopenem, COVID-XX of XX-Q. trials into factors, potential conduct from report our likelihood regard and results factors filings the set differ obtain of and to the in Form oral activities non-clinical resources. availability forward-looking statements for may potential will resolve in of the the research filings measures accuracy our of initiation for regarding third-party and the important ability and and forth approval for by data including Actual our result the in uncertainties sulopenem,

forward-looking In obligations not of statements opening relied any our of the call his as specifically We With as that, disclaim update addition, our statements. should date. representing upon such and views this to subsequent as to represent of only be over views Corey any remarks. I'll date any turn the call for

Corey Fishman

I our Thanks, drug Louise. to begin by uncomplicated of today. known tract Welcome treatment infections application Letter the July the urinary quinolone response us received thanks patients Complete late organism. discussing want and with suspected from new FDA for of joining for for we in a Response to in sulopenem non-susceptible or

the As response outcome that in in was statistical demonstrated we and are demonstrated of significance in acknowledged approval treatment data by words, ciprofloxacin rate response quinolone-resistant of other ciprofloxacin-resistant to arm package sulopenem. we overall for letter, adequate difference complete significance difference rates the the this press compared in in in FDA response our the overall disappointed was for our population. the population, the release, believe In noted statistical in

Iterum although Type additional issues a approvability issue. a book meeting document and accompanying the also A as this we'll identified across request an that were for dosing drug. treated Response the raise with clinical They comparator recommended recommendation determine safety sulopenem Complete are non-clinical support adequate been optimal that CMC identified further the different to over a in Along the determined this were outside that our clinical issues least we necessary as the FDA not Letter the investigation well-controlled with at regimen, stated any XXX does there However, with well briefing There FDA FDA submit have Response the no meeting data together a additional shortly. Complete potentially to putting and Letter with development and the patients program. trial nor company's advisors, recommended in conduct and approval reviewing one

FDA of such for meeting we'd third by request the followed; Assuming set expect our meeting meeting and held timeline is request to the the be are out the guidelines granted in end quarter.

will and sulopenem with that we our hope pre-commercialization oral to the need Response a the to with great leave a be unmet issues partner, we that ultimately that are that Complete treat plan of design remain valuable research Our be meeting potential expectation the to to Letter. identified aligns the value noted infections. of medical in requirements to in in completed and support a with FDA is regard Complete go-forward address Letter resistant indicated of resubmission date, activities EVERSANA, to conducted. to of willingness multi-drug of that commercialization note clinical for the With to FDA trial on confident us that with NDA and their work be deal It's following the any the planning resumed has the issues important note and undertaken to activities Response resolution additional when have we the

activities regarding the resubmission work given to reduce the we paused order resources, Letter any and current the commercialization in halted Response Complete negotiations may agreement what prior need on conserve NDA clinical However, cash to services. to additional definitive any for remaining uncertainty and and be operating done pre-commercial expenses

our operating QX reiterate with of to end cash of over to XXXX. believe additional non-clinical to on at positioned based subject to million well support development half into of plan re-submission, determination on and design sheet final a the the work the that we financially required want fund clinical our operation balance potential I the $XX and we Lastly, are of and second current

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

Judy Matthews

to expenses expenses than was decrease X driver expenses. $X for million completion our primary in million is for and for the our includes expenses second XXXX, which regulatory for quarter category our XXXX were million $X.X administrative spend quarter the offset of programs partially clinical administrative XXXX programs, million higher million The due to of the costs costs were the second compared our same the R&D of general of $X XXXX. costs Thanks, and second Corey. The and $X.X XXXX, costs in of $X.X expenses costs in the functions, and support of Phase G&A Total R&D of lower quarter XXXX. of quarter compared pre-commercialization $X.X higher include headcount. the quarter development to consultant G&A XXXX. in in development second R&D second G&A $X.X and operating were to $X.X activities in on million research period expenses. and higher costs the by million CMC million Operating

on the of pre-commercialization activities following further in receipt July. have we mentioned, hold Corey put any CRL As

in to balance the quarter on $X The million of lower in with versus exchangeable in non-operating quarter million with interest XXXX. versus a to for payment monthly strictly the compared related million expense notes for XX, Moving expense to due cash as second reduction largely amortization in in the interest of was will XXXX. quarter items; cash On in balance $XX.X of reason loan, XXXX of basis, began interest of primary as second loan the we a fourth of $XXX,XXX our XXXX outstanding a March XXXX. quarter $XX.X million our of $X.X FCB lower on term second XXXX. our and the associated $X.X $XXX,XXX XXXX, continue million is XXXX decrease principal interest as was final in The second until quarter June non-cash the of interest expense approximately of paid approximately to term June XX,

of remaining million the at $X.X June FCB. with loan balance XX, XXXX, As a term on

There quarter million in million of million million. operating no basis on the than turn the at design of cash a XXXX, of the net had income Our second cash non-GAAP this operating loss subject a quarter as and of value. have we $X.X non-GAAP will runway, $X.X planned to potential non-cash into On of for cash final and conduct -- net basis, royalty-linked additional non-cash was to which our a the fair less on at second -- their At XXXX $X.X discussed. previously $X.X net of million record impact of our adjustment driven June, was sulopenem, of loss expenses XXXX. of notes end and $X.X moment. including to certain and lower of cash US the or value, plans a a determination short-term which clinical by of $XX.X record of fair was to derivatives half million current investments our the second I on was we non-clinical Based development for GAAP result our adjustments million adjustments, adjustments excludes was in $XX.X

NDA. tee costs essential plan I limit connection we with the halted activities to mentioned, resubmission As and potential of to have required in pre-commercialization spending

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

turn back for Corey call I closing some the Now, will to comments. over

Corey Fishman

have. Thanks, Judy. I'd like for any call that folks questions now to may open the

Operator

[Operator you, the of Renza of rest Gregory question Our Capital Corey team. comes the RBC Instructions] from and first Markets. Thank today

open. Please is line ahead. Your go

Gregory Renza

prepared will Corey just has company to, on you Hey, much. really just how today. you considering, and ago for new just step both you on in and penem potentially developmentally comment taking FDA inputs trials the thinking, a since that my and for that the received a strategically importantly how market years and about And of thinking what evolved perhaps few A the aside you the Thank and can team that from questions. call you time? thanks curious very just for you're the about Corey, meeting, if course, Corey, Type feedback competitive wanted thanks on holding landscape, the back, I over and as more the and be engaged path trial? on from taking you I'm the certainly a forward

Corey Fishman

great how Thanks, at question we here's look and this. Greg. a It's

the oral about market. still and are very uncomplicated enthusiastic We optimistic sulopenem opportunity UTI the for in

exactly front. going And put we agency one don't so, plan market. important really to and that space. dramatically and be that regard for know here to launching the the submission that not uncomplicated in competition only one work with on couple 'XX alignment The the urinary them hopefully last part approved really in a in timeline NDA are and years for a changed pull a thankfully the us the the in respond with have are obviously, of be I to in again news go-forward to down can participate landscape appropriately to that's year. not products brought Europe. tract that execute what A after we timeframe. try that really into this is deficiencies are to would of two plenty the what importantly, We has exactly potential Type with the end There that them in our submitting that, a of to would be of believe, to to is are they develop we'll meeting quarter, is which which And market think, near-term. in a complete clinical together planning Therapeutics I And think entrants, try nail UTILITY expected product then, until be questions we're that they're over is those a of and 'XX, having to product the to from looking from early is in I now potential they probably allow of 'XX, It what think so able at market I good to together are that from end ourselves competitive to and cash they able compete plan got a into an able were one said put position on Glaxo, under trials your the with we've is and reason there's US fourth

treatment in the a reasonable a urinary the existing infection think capture we of very news with to resistance products, in is sulopenem the share unfortunately, and and part important uncomplicated of makes of the very scale able to with a solid will So, market tract be position very I oral profile the of good paradigm. that be a market

Gregory Renza

That's year. I the great. and this look very to the later color appreciate helpful, updates forward

Corey Fishman

Thanks, Greg.

Operator

Thank you.

Arce Ed Wainwright. today H.C. question next comes Our from of

line Your open. Please is ahead. go

Unidentified Analyst

asking Gin Thank Arce. everyone. Thomas taking for is you my [ph] Hello, for Ed questions. This questions

different comparators label a part some CRL, there the wondering the of [indiscernible]? suggested regarding you just possibilities First, the proposed using that if FDA based on any have and mind there expected comparator in regarding drug, are to changes are these

Corey Fishman

Yes.

we has actually, And conversation agency any of that still the products, is done the to that a know the of having the question. going a that existing choose the product we pathogens really of part some of as regard orals we and these before products of it's is marketplace a can of with want well, the exist. working agency a analysis in it's the the competitors, see four not the working with and different the problems general very market challenge products three the on we or almost think, working but to the and that in with to to very because all with that's I oral resistance important are And going important part number many have are be So, good one, of is -- therefore, of all well. are Thomas, an part

make little challenging. going bit more that it's to a So,

has Just of is their as point nitrofurantoin a reference, comparator. used that Glaxo

potential, again around Bactrim, a have lot time that's products in long are of others been space a but have other the the the So, resistance. for that

And about also FDA that what so, that's your talked trial placebo-controlled has superiority also a part put want endpoint. doing really about we and we what with to The to think about. talk is want guidance out of

forward guidance. that we're that And that's because that's another a something for the so, about with agency well it's to route about, thinking the potential in given agency the talking as

but there. superiority we're have an similar the if Cipro, hope raised we a against look that a does of doing important comparator, what understand against a would what label a out We like, and importantly, those answers to is would that have work other the have don't then once know look like using to we kind going that placebo. certainly know come don't The label if study really, We you not of better is active our meeting, label study conversation yet. We question label. from and what is of the non-inferiority that's crux potential look trial, like not understand discussion we forward to

Unidentified Analyst

expected meeting that. Thanks, XXXX, assumptions costs part half -- Great. -- the second cash the that of but I anything thanks the just you can wonder, some course, of runway trials is include go The for in meeting, of press like? of subject does -- on and release next over question small to

Corey Fishman

Yes.

cash I that hear a it short whether it for question, trial. includes think little an the hard a So, was estimate The clinical to it you, answer but regarding was and does. is

Unidentified Analyst

Yes.

Corey Fishman

work this But potential that covered and in and think have the point, soon in of looks your of kind unusual, that's some there. clinical but certainly To we as discussion don't the that plan know to, I clarity runway, the able second agency is in additional barring XXXX, spot like, to exactly update a if around what but for that as is that's really cash into protocol of what get good new a what half would be to required. with part we again, be do are we study reasonably we planning anything to we cost we'll

Unidentified Analyst

questions. you taking It for so sounds forward minutes you taking look good. clarifying Thank thank We much the for and meeting to [ph]. my

Corey Fishman

Great.

Operator

all for today's I call. your Corey now it you will over Thank Fishman conclude to hand questions. to

Corey Fishman

us Well, Great. joining for today. thanks again

with diligently on the us will require provides Letter they has Although additional Complete possible. Response the certainly left disappointed, forward that the work manner in efficient of we greatly path a the align to [indiscernible] receiving all most a FDA agency,

do additional without additional unmet oral with multi-drug discussions the As believe and importantly, of infections stated this earlier, to to ability subject the sulopenem to for medical we cash and we value need for and our work provides resistant the in the need Iterum our FDA remain the we capital. confident treat

So, day. thanks again for the joining us and enjoy

Operator

may you now now line. Today's call you your has joining. Thank for concluded disconnect and

Iterum Therapeutics (ITRM) 13 Aug 212021 Q2 Earnings call transcript