- Earnings call transcript Q3 2022

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Operator

Ladies and gentlemen, welcome to the Iterum Therapeutics Third Quarter 2022 Financial Results Call. My name is Maxine, and I'll be coordinating the call today. [Operator Instructions] I will now hand you over to Louise Barrett, SVP of Legal Affairs to begin. Louise, please go ahead when you're ready.

Louise Barrett

Thank you, Maxine. to third welcome results XXXX and call. morning, Iterum quarter Therapeutics financial Good of were third morning press our A release quarter be on and filed issued our website. can this earlier

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

prospects results future and for this to our conduct, progress set and provided Actual from for clinical intellectual and received I would by expectations results business, of resubmission the these statements including the filings and development ability of plans, of likelihood of Letter the regulatory changes the our Response into policy may like clinical call the materially resources. expected of of expectations with and and third-party if timing that data in our its regard the conducted matters will begin, to us Complete how you research far concerning in resolve of development, of sulopenem, factors approved, commercialization of to our contain REASSURE sufficiency or including trial design, to requirements clinical on non-clinical and in our we changes and NDA, accuracy and XXXX cash therapies the in our the Before by and the property XXXX, conduct hand authorities, regulatory plans other uncertainties CRL in patent result of sulopenem, non-clinical coverage important risk regarding public actions and factors, being our July strategies in today. timing the initiation NDA, of approvals, cash clinical the clinical forth and ongoing timing the resubmission other term including quarterly ongoing SEC, trial, decisions and as or some various oral by development, our remind obtain REASSURE the filed potential and July in our including potential in suppliers in statements of availability our or oral the the non-clinical forward-looking operations, to timelines, is out and our the those sulopenem REASSURE including organizations, forward-looking rights approval from trial with our the receipt the set report will trials a the indicated fund filings manufacturers, inherent differ timing, response legislation, regulatory

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

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

Corey Fishman

exciting very us Welcome, for morning. to some you I'd and Great. Thanks, joining highlights company like Louise. share thanks with today. this

in to we enrollment tract urinary have thrilled are our uncomplicated infections. X First, for Phase trial begun clinical new

and is trial susceptible this oral a trial trial named have REASSURE oral comparing in designed as The population. non-inferiority We REASSURE. Augmentin sulopenem the Augmentin

Complete protocol the SPA the design that Protocol approximately the agreement new oral address FDA. is submitted will which July REASSURE out Assessment, drug enroll to SPA, twice The the necessary of addresses the the or provides The to as being to trial is five for Augmentin company's and of We Response under microbiologic receive set with trial. analysis conducted FDA five the in sulopenem. received In agreement is planned The that deficiencies patients trial a endpoint resubmission trial primary for and Special to of XXXX. days. objectives in adequately certain their for the XX this conducting are the we at days trial, is daily Letter noted X,XXX in response, to combined the the of be either sulopenem response the oral patients potential FDA support overall twice day daily randomized oral clinical the and expected application

half the enrollment XXXX occur our should to the Complete of addresses We action half first our all FDA resubmission and It's uncomplicated we in NDA successful, organism. quinolone July deficiencies the the of Letter resubmit expect annually FDA in U.S. XXXX. urinary approximately the of caused XX% million XX to if resubmission. receipt the infections there Response we'll from in in to And those If the of the XXXX. in infections are complete second then a six non-susceptible by approximately months important are of from FDA, received that note tract

resistant Additionally, caused high. available by And result, oral in as antibiotics. need to X% therapy all all very are classes oral commonly remains the for are area new about of of pathogens that a antibiotics infections this

that inventive. property long-term of oral of which which this sulopenem Authority, will bilayer of extend patent parts been the runway XXXX, value the tablet and novel China, which directed our of of U.S. to sulopenem, contains oral the incredibly a and least bilayer substantial to International protection U.S. the sulopenem etzadroxil Europe, a U.S., commercial several written the tablet. This existing is patent patent Japan oral submitted applications, are front, composition following America, an granted important of a at milestone we directed claims Iterum bilayer of the pending South including protect Outside receipt probenecid in opinion until tablet of On the were Search intellectual single and patent to have has the indicating sulopenem the provides as the in composition

those We patients. an treating unmet new in could is where important medical are beginning potential where areas need sulopenem explore potential alternative to there an be and

and the FDA half an with discussion first of currently the XXXX. are evaluating in a subject indications are planning that of We potential initial new review number to

will and when this We details further share develops further. as plan

reverse price by affecting with rule a On we in NASDAQ corporate the the X-for-XX share front, regained split bid August. compliance

importantly, quite but XX. $XX solid position September our a remains Lastly, of million as of with balance cash

stated through fund In press into release, expect we top we As are line data to to summary, the trial. including in XXXX, have from operations REASSURE cash existing our in we REASSURE this readout new excited a help have begun in first the and to serious to the forward address potentially medical order the community. need the enrollment penem clinical are looking trial oral market the to in bringing

new in to utility the forward alternatives. expanding looking sulopenem areas need into treatment also of are of other potentially that We are

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

Judy Matthews

in with $X.X which of by class $XXX,XXX same of million to million The million XXXX. of were were FDA the action Thanks, $XX.X $X.X million for in $XX.X REASSURE the general the million $X.X the first R&D trial. costs $XX.X year-to-date costs in or half than expense, a XXXX were through costs of period CRL, XXXX the costs million the to result consultant quarter versus lower the and quarter primarily associated the the July is third offset receiving of driver expenses third expenses. from were XXXX CRL XXXX. Operating million in the offset million $X legal increase third million in in Higher lower compared legal administrative costs on pre-commercialization million share-based quarter spend Total include quarter higher G&A Year-to-date, in of in October REASSURE G&A XXXX $X expenses began fees Corey. was XXXX, Year-to-date, R&D our in of and XXXX. receipt costs XXXX XXXX enrollment prior the August and initiation operating were expense in the compensation primary XXXX higher trial, R&D to year-to-date by quarter our were for compensation the to expenses due $XX.X filed the in support research for of share-based XXXX, in cost as development G&A which $X lawsuit $XX.X of XXXX. third following million the $X.X compared third and $X.X compared XXXX. activities and million to and to million and flat. in XXXX partially fees

for of was Moving $XXX,XXX in primary third on expense was interest in Interest the The quarter loan expense our $XXX,XXX to compared quarter XXXX. to the XXXX of third XXXX. repayment the of $XXX,XXX SVB non-operating reason March decrease items. for the in

charge to million we the through in trial the quarter and expense income If other in REASSURE of year-to-date with XXXX and employees In July quarter $XX.X XXXX. the connection million was readout non-cash to options. U.S. Impacting top period. trial. had on and the Our $XX.X XXXX the third quarter in and second net a Based half of $XX.X year-to-date treatment primarily loss for year-to-date and and quarter investments to XXXX. current million million. of for a the million higher million plans, in the quarter expenses and GAAP included uUTI loss surrender of net The cancellation basis non-GAAP resubmission XXXX, non-GAAP we a which on company's oral have operating certain our and was line and executives the of for of to to cash million share successful, the shares is compared adjustment I $X.X loss the $XX.X and to cash, in the XXXX, cash was $XX.X no options our available this REASSURE will excludes third to agreed equity third sulopenem equivalents end $X.X increase runway, giving incentive impact a into R&D result on turn trial. which moment. adjustments, a cash in NDA cancellation of expected of data REASSURE was basis, this $X.X At for rise cash plan, includes There our the make our million $X.X $XX.X order share and the previously of On for short-term third non-GAAP related million non-cash in net year-to-date additional is September, non-cash of loss of or granted million net for certain the third the to of net in charge. our the under which and loss expect year-to-date, a of respectively, FDA

September XX.X had of million ordinary we XXXX, shares As XX, outstanding. approximately

as NASDAQ's reverse If a of the of at we $XX.XX will XXXX, August million X-for-XX September $XX.X X.X mentioned January includes per be accrued are the million million which at of in option noteholder shares, we of notes noteholders notes, share interest. XXXX. and pay the exchangeable interest exchanged of plus $XX.X approximately the not XXXX, compliance we price which million Price the for can warrants average a split, and approximately with outstanding X.X exchanged, As accrued in Rule Bid result, an as had XXXX. September Also expected in share gained end we

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

Corey Fishman

Great. lines We Thank you, Judy. the would for any to up open now. like questions

Operator

first Acre [Operator question Ed Please you. Wainwright. Our ahead. from H.C. go Thank from Instructions] comes

is line open. now Your

Ed Acre

good our on Hi, Thanks morning. for questions of the recent REASSURE. congrats initiation taking and

And powering about randomized other wanted it one follow-up. the combination composition patients patent. a Firstly, about is I came wanted as I sulopenem given for it's to really one. little a is you talk study. or probenecid ask ask lot patent to study to know determination, then formulation? a the a how X,XXX described I this it's And But the bit of have given I versus the new of prior about Thanks. then is this to a comparator matter perhaps and the of for roughly that a the Augmentin actually And composition. also

Corey Fishman

the for Thanks question, Great. the start question. with powering Ed. We'll

point well set as powering the for a We on XX%. are assumptions, like based as sulopenem of estimate include study which Augmentin the at things

interim data keep blinded enrollment at are So endeavor XX% now, that and where to look data we an where we the have the committee But at of We will we assess management XX%. as the point analysis study with do regard will powering at to right power. power. potential the are

tablet. patent matter the patent. essentially And attorneys us second the is regarding that bilayer told question this a had composition you have for was of our The

So patent more sulopenem It composition a of of is not really patent se. it's a combination and matter a etzadroxil probenecid. with per of formulation

patent used So like we not that. se, feel good pretty anything a about it. It's per

out there so get we strong the that launch think us healthy us we couple assuming very very And the next a of in that would product a for situation runway patent years. into is

expire wouldn't expire least wouldn't until particular patent U.S. Our – patent at that in the XXXX.

Ed Acre

a and helpful that's then more, I if couple may. Great,

First, I to just the runway. wanted clarify cash

XXXX, NDA be sometime data XXXX, you've successful seems the the top at would into the other the in is or then or of that details line around the is, you your year, Is halfway year? filing first so runway lawsuit. what's resubmitting middle XXXX. commentary the that in but release It pretty not around data with stated Given enrollment least – just to NDA And or the could state would if you mid XXXX. it you the that expect be clear complete action the question half of the second Thanks provide class and more into much. if going on any of half

Corey Fishman

Sure.

yes, it or So to be when saying our that got top cash that. have whatever that we little get question with a that a So and clever sense trying to we've factor more cash or we're general cash our becomes through get to that is mid-year to does It's of regard – feel it your right? with data, occur, is, into earlier be not XXXX. of to could we words confident being point, a through line will just the

We away the not cash this to that so matter quarter confident December particular I new we've and do waiting to we've I can preparing we're there what on get specific that know and work on about the take that any date is information. happens data we're you done the don't date. line from think And And because this on just the being of just feel a yet. us we at just for Obviously, waiting But through see there. regard with point. a got enrollment answer on that top based we lawsuit, conference to lot Xth that we're what is a think on litigation have don't

Ed Acre

I appreciate much, Great, it. thanks Corey. so

Corey Fishman

Ed. you, Thank

Operator

Q&A Thank you. This session. our concludes

I'll to So Corey closing back you Fishman remarks. for hand

Corey Fishman

Great. multidrug-resistant of Well, confident today. treat We thanks oral sulopenem value in to remain the for joining infections. us

in our successful, FDA We for and ongoing resubmitting if physicians completing clinical really therapy tract infection forward the are to NDA our to urinary this looking patients work, option area. the for uncomplicated and treatment important

great you thank a this and for all So day. we very much morning, attending wish you

Operator

Thank for this you, concludes ladies gentlemen, call. and you Thank joining. today's

now may disconnect You your lines.

Iterum Therapeutics (ITRM) 10 Nov 222022 Q3 Earnings call transcript