ETTX - Earnings call transcript Q2 2021 | Entasis Therapeutics Holdings Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Entasis Therapeutics' Second Quarter Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

As a reminder, this conference call is being recorded. I will now turn the call over to Bruce Mackle, Managing Director with LifeSci Advisors. sir. ahead, go Please

Bruce Mackle

Alex. you, Thank

statements we materially proceed remind call would to expectations. actual laws. call, forward-looking uncertainties risks that could historical with that certain experience the cause These securities everyone federal this to under I subject statements to statements and differ like results U.S. Before are from made are present during or

we our differ periodic could obligation speak which at Information from update factors date filed call the in from this during be issued information that cause is undertakes revise the contained the in results made call concerning and release accessed page hereof, contained to our Form yesterday, presented SEC. in made no statements only may the the and XX-Q on to Entasis reports on with the forward-looking statements statements. Investors The this Additional actual is site. the company as forward-looking press of call Web or this the

Joining and of today's results. Officer; the Financial provide Officer. summary and will Chief President progress Mike the company's weeks, and Gutch, are to Chief financial Office Entasis me company's Manos Manos for quarter over call a Business Altarac, Chief and Mike Executive Officer; a David Medical turning on during recent before the Chief Perros, from it review of

the to team management over the I available turn for now be remarks, will prepared their Following call questions. will Manos. your

Manoussos Perros

Entasis call. joining On team all employees, and Thank the welcome Entasis you, morning, management quarterly the Bruce, behalf of of you results good Thank inaugural us. and everyone. us for to

Mike future the made intention well dialogue. forward calls. release outreach provide progresses Yesterday, press as market your today, We toward we regular results, discussion and commercial opportunities review spend turning a our advancing your close, after quarterly look progress Sulbactam-Durlobactam, our to SUL-DUR, a Phase happy of our Acinetobacter novel Then, quarter is for including begin formalize ATTACK investor our for financials. financial summarizing as interactive brief developments, with our a company take over few just and be our this I'll and our combination As moments registrational issued appreciate the that of multidrug-resistant outlining attendance evaluating on for second our or to stage, trial to it before the I'll infections is questions. will pipeline. the to MDR the treatment call or X strains. we

early to we our completed Lab, line top together data announced fourth quarter. enrollment release with Zai partner, in we and July, patient recently, the expect As in

to potential in program study Acinetobacter Carbapenem-resistant on we an compassionate of infections. One with announcing line of drug-resistant respiratory and is study knowledge, focus families, was effort globally, XX pathogen-specific septic is Reynoso] pneumonia for thank body use Carbapenem-resistant patients efficacy SUL-DUR received confirmed enrollment American over developed a a problem originating the which expanded [Ph] with XXX for patients of a is available in with of a cohort resistance, a approximately in us therapy. culminating infections, days access made antibiotics, Zai Part treated bloodstream patients, were colistin therapy, Despite cases our Acinetobacter enrolled of enrolled shock. patient doctors on and to Concurrent significant have highlights patients The one-quarter highlighted the professionals pneumonia well [Cefiderocol] nonrandomized forward of XXX and which COVID-XX be the Colistin due antimicrobial infections. the plus of that Chemotherapy, trial both Agents poor include and/or times. look critical by B address protocol patient, To and registrational their of case intolerance evaluates to the for this trial recently believe efficacy growing enough Galveston, the that evaluating both Colistin cocktail during enrolled factors Colistin and and University due As which subject are critically could of The be Microbiology. of that in patients ATTACK failure, their reminder, the ATTACK our of in specifically the China. need. of complete extremely infection in [Ph] unmet infections the not via the improved of top In Phase ATTACK Medical home. the Acinetobacter to with who We U.S. publication [Ph]. the trial, SUL-DUR We in recovering Hornak, we trial, [AEP] Society over to of a the very SUL-DUR A Part but Completion drug-resistance confirmed Acinetobacter as to Entasis have eventually healthcare ATTACK prognosis, patients well published eligible coming SUL-DUR, enrollment SUL-DUR discharged data to a Part another we or and unresponsive are months. a site medical milestone to to significantly with the for evaluable is patient Texas ill Antimicrobial XX a we patients, of enrolled return and total, antibiotic-resistant compared the largest from Acinetobacter such [Zidan, Branch a X threat challenging as enabled in in baumannii SUL-DUR conducted trial. In and Texas, registrational A, to over in case case the combination of safety Lab, collective the first

and of of and discuss C. new burden us the platform. experts, release Wayne commercialization Completing in commercial and our multiple diseases update working build Anna across treatment and where including at from with programs, which instrumental this we her discussion expert trial, to her welcome month, therapeutic begin Anna As Chapel product and will SUL-DUR, top of team Dr. leadership or readout welcome the data other pleased David roles would, complement on site. infections. to are available our open webinar an she later her distinguished Web landscape on timely comes Biogen. held by Michael company's Therapeutics, ahead van current feature Acinetobacter Officer. commercialization are Flexion and hosting Anna to details medical have delighted Rybak our about commercializing Therapeutics, commercial presentations track program products and program Summit, data believe areas, infection. a from ATTACK line we our speaking delighted resistant Cubist, be our the the planning to strategy to State line The was are who to needs antibacterials, first We informative will experts multi-drug Acinetobacter Hill on look interested to Summit with will Prior Triola top registration to developing Commercial this capabilities, is of infections. Diaz as will infections. infectious beyond perspectives leadership to be forward all parties associated of the University, we and for R&D to and Duin of Chiasma, difficile UNC, Dr. This such record SUL-DUR the our we're Chief against With

X and the Zoliflodacin treatment Antibiotic and gonorrhea. safety by our is or to the to oral dose Development and now the of Phase trial designed Turning The Zoliflodacin resistant of next of multidrug of for global intramuscular GARDP, efficacy the registrational in candidate portfolio, including continue Partnership, we single plus trial assess support neisseria caused combination oral is to of Research the a of of Ceftriaxone uncomplicated the with versus gonorrhea, patients gonorrhea. standard actively a Zoliflodacin uncomplicated care, potentially strains which infections enrolling Global

now of related we the and Netherlands, challenges pace patient Unfortunately, in trial time. program has GARDP to the the guidance at the Thailand due completion COVID-XX clinical to remain activated to trial sites ongoing the of for the of enrollment with this Our South unable provide ongoing Africa. pandemic, partner U.S.,

We appropriate. completion and for updates trial of guidance will when the enrolment provide

Forum well as working that negative priority updating the a against overcomes selected ETXXXXX the portfolio initial highlighting non-β-lactam and a complete developments. to given the an which with our its to to other will resistance, into advance biothreat NBPs we World to proteins be novel ETXXXXX antibacterial this constitute pathogens potential a penicillin to pathogens, We by is preclinical class or target you Microbe financial of developing of results NBP with over beta-lactamases. negative the activity ETXXXXX forward from to designed participated I agents activities presented review We're of which β-lactam Finally, candidate product source our we're currently platform, diazabicyclooctane candidate, our gram of binding pleased we inhibitor multiple first-in-class very number early required initial it to Pseudomonas also new all month, With We now in gram continue pathogens. and spectrum our molecule, as a look including believe driven Aeruginosa, XX multidrug business clinic antimicrobial main Mike from that, Last program. across bacterial on progress high of the is exciting we're selected [Ph]. oral make presentation a for a support turn resistant are of programs. broad the that portfolio of as ETXXXXX, and progress processes where we for [Carb-X]

Mike Gutch

Manoussos. Thanks,

our quarter of for the period in XX, The net for second NDA grant loss the increase compared SUL-DUR a other with related balance second primarily income proceeds of launch largest prior-year. loss an purposes. XXXX decrease proceeds agreement to $XX.X a by from We for which previously approximately announced trial, our months as net well net We ended the provided corporate use subsidiary million loss strengthened quarter was three in sheet the in June $XX of net the transaction. $XX XXXX capital June finalizing the of during shareholder, versus to same the largely attributable in ATTACK intend a the $XX.X the advancing three working Innoviva and preparation, III million. SUL-DUR months Phase company We're placement Research of reported readiness the filing general XXXX, $XX million a prior-year, were June, we ATTACK same of development of finalizing trial. to and as During Inc., our this million and period prior-year. private XX and as to during to to compared the ended expenses million the

Our general of for million the period million to June the expenses months ended the and for XX XXXX, administrative compared $X.X $X.X same three prior-year. were

to XXXX, equivalents, and Based million, our $XX.X XX XX December we that were on June of XXXX. As of our and existing cash $XX.X current million cash cash believe as cash equivalents over from compared through plan, XXXX. operating remarks. to operating back our quarter With received fund most Manoussos sufficient to I'll concluding requirements amounts be offering for of expense will second the turn including that, recent private the it

Manoussos Perros

we advancing the expected quarter, Mike. quarter, over made you, enrollment progress trial ATTACK To early Thank have in line our fourth conclude, and with significantly in exciting the the data completing pipeline. top the

With to take the submission NDA SUL-DUR. now we additional forward now And, financing are Alex, ready look to launch we of readiness preparing secured, for and questions.

Operator

time, this question Our At question-and-answer you. Please session. BMO Instructions] with from your Luchini Capital. [Operator be Thank comes conducting we proceed first with Matthew will a question.

Matthew Luchini

the fully Thanks and Hi, taking enrolling ATTACK. good for guys. on morning, congrats questions,

follow-up data, first So, on I would endpoint measures that getting what out? secondary us when that be you there. particularly sharing a mortality safety, we'll can then initial the on us data but And you and be have you'll comes focused other just be to want obviously from key remind XX-day

Manoussos Perros

Hey, for this. Matthew, I Altarac you Dr. thank answer good David to morning, ask the question. will and

David Altarac

Matthew. hi, the question. Thanks Yes, for

line endpoint, some around XX-day is data the mortality, the endpoint, the top for some the outcome When efficacy an and efficacy. endpoints, all-cause the safety will which we RIFLE score. of reflect, primary noted, the is you have the were we'll data is per line other nephrotoxicity key including outcome, So, data showing clinical purposes which announce primary them as also of which top secondary endpoints, important

we'll be we'll the patient We comparison. score some at be we'll will side-by-side type but of a have looking additional RIFLE demographics, safety have side-by-side I adverse the And And infection, at And looking, then we'll events have analysis. as safety on we'll treatment-emergent also sub be as drug-related have looking a mentioned, endpoints side, XX-day well. comparison. all-cause also for on we'll nephrotoxicity, in in mortality

with well. because Part is the for arm we of mentioned, Manos that were have study. A Part B in up But as as complete And statements both that we XX-day Part clinical aware a that that presenting analyses then those continuation B, trials data. be obviously top for public documented And well resistance. in as it'll who XX-day, And as as the in will we've patients ineligible the well our dataset arm from a we've line the data open-label that sub will also followed And all-cause a top in other as posting mortality from colistin are included of study. endpoints safety is be Part B, some You're line all made. had

Matthew Luchini

thank a where launch? then and I be color more related little of bit are remain provide you. would can key question where are questions make of a prepared you. Anna, I prepared new for post any perspective, of what any color stand filing you the regulatory great, sort And, on steps pre-commercial you you key data provide -- guess submission? or And Thank on -- what to the two Okay, -- ahead guess, a what timing here. Are ELA, steps least next between top to you from

David Altarac

Manos. Sorry, speakers] ahead, go [Multiple

Manoussos Perros

Sorry.

So, for pre-commercialization. your answer on first the today, of follow-up is just Anna cover not I that will after initial the David? his we your And have participating but call has ask some will finished answer on thoughts David information, unfortunately question. to I David

David Altarac

need top you be will is we'll so there line presented to know, a series steps additional as all Yes, of take. after data that

As assessment which meeting. we the dataset, of have I follow. ago, full entire will review NDA a, data, plan hopefully, Upon moment to have complete pre mentioned to the a the we'll

that the FDA line And would pre We on filing full around top of we on step, will any the But outcome analysis, FDA; with States. meeting, in meeting plans. the next United discussion with after NDA have is timing the that major a meeting. then filing that determine hope it's a the certainly regulatory a data based data, and

Manoussos Perros

a Matthew, and just obviously, David. commercialization us a ago, as question, for Triola Thanks, -- ago couple readiness. And us weeks few mentioned, your has Anna just weeks for second Diaz preparing engaging we with of joined on started, follow-up

that a done the data strategy end at lot and of to We weeks Phase data. the With a by will on of now to launch have of picture just working part the quarter, early be what we'll few call. ultimately, of side you get the ahead more be the determined fulsome at fourth But of provide a to work go of we able X. next we're

Matthew Luchini

you for the taking Thank Okay. questions.

Manoussos Perros

Thank you.

Operator

question. Co. H.C. comes Ed proceed question Please Arce next Our Instructions] [Operator you. Thank from with Wainwright & your with

Ed Arce

to on Great, there, on thanks enrolled study, let portion the enrollment open-label questions first in questions. over few mentioned to add for the and And for me ATTACK. questions, A taking full ATTACK, top of Exciting that. my the B of congrats my see the readouts. completion Part couple you patients me, and look the you forward on XX line

body around question, Just for for sites there certain the those wondering there the how a overall this is types patients will NDA? here in And appropriate related are fit then And criteria that of potential inclusion in any you addition, in of mentioned, label? SUL-DUR.

would couple remind of appropriate? in have which I follow-ups. those could it And just a areas If then where be are you us

Manoussos Perros

Thank you you, Thank for Ed, good morning. the questions. and

another David Altarac, David? that's sites. for and B think I one Part Dr. body

David Altarac

Ed. question. Thanks hi, the Yes, for

the study, B a of critical is the included of So, be the B it study, application. Part will Part and in part the is the data overall from part

Colistin either the as I resistant have of who unresponsive. patients the So, B Colistin Part said enable was enrollment of to intent or

as design the as in will Part study was Patients and so, a But will Sulbactam-Durlobactam mentioned those a with I data be reflect the evaluating all database. mortality, overall XX-day outcomes or be included patients descriptive efficacy, agencies risk from XX-day clinical B Part cause analysis. B Part efficacy And descriptive agreed to not any we B Part included Imipenem. B data that from as overall will including benefit in be the the regulatory from play, of any in label, patients, data But they in plus efficacy primary safety the totality included open which from a will with standpoint.

to of database overall they part Sulbactam-Durlobactam. are have that they safety So and been given the received exposed

of representing your safety site, acquired and a a ventilator to body pneumonia, associated So, NDA bacterial in infection. the be Part the bloodstream respect part efficacy, will A descriptive part were to required database. and supportive as primary question, enrolled With hospital either have critical the or of to patients pneumonia, there

able Part as in body resistant Manoussos B to enrolled Part any had if from eligibility However, the B. patients in Colistin they of mentioned, met other were those requirements who Acinetobacter infections site, all be

data given be labeling, With labeling. will and prescribers. relevant pre-specified the include of might meaningful the actually, my data background that, would product so that on agencies for your get. But a given the kind design remains to comment I over the trial, whether significantly strongly totality experience from labeling is information regulatory of that product were the in to the and descriptive the endpoints about had that question in labeling, would seen. perspective we clearly, space. the these of And little generated agree push would respect that in And represent what But of lot Part would a from I've from it's our agreed clearly, be all the to premature be regulatory clinically And to actually and data think we I B to trial. of

be product regulatory we obviously the would plan have assessment on that ultimately, labeling. by So, will But to agencies. that based in regulatory

Ed Arce

well to share But about completed your with of the that? of your just biothreat on sense high lastly completion. has qualitatively couple of or any you -- that is here, yet number I but amendments I other helpful. been you then and thinking or cannot sort us of wondering the sort NBP further did or follow-ups have an if really sort progress you getting a that for mentioning give also acknowledged very the ultimately program with just efforts sort of if there any least Pseudomonas could you changes study at priority pipeline, recognize enrollment XXX, of program there with a on that you And if couple any update of then, And collaborator. a target in pathogens. Great, primary the as accelerate your GARDP areas that's quick firstly,

if work that in and threats? you're I'm which wondering opportunity be much. And those with for BARDA here disclose, of to potential so Thanks you able so ultimately if on, is might particular focusing any to those there

Manoussos Perros

Thank take for on ETXXXXX you, at course Ed. of the to turn then it David and And let stab qualitative second progress over Zoliflodacin the and will trial me update the on question the I a you to a give first, there.

is you and working We the have with the out be we now, is focus pathogens with and a data top pathogens. our than information agencies in, sustain would government over been to it's against, follow process to or is have been my statement. that, and on state turn well We'd that as there ETXXXXX, for more who some pointed get support lot more work to work, detail early as them I that working on it's to but side, [indiscernible] the the ETXXXXX days, So, pseudomonas published the of and the [indiscernible] further development and that as moves both the David, COVID-XX. of number we'd follow work list Europe believe such on micro right the done the and up the so And for about and a have talk but ETXXXXX head as gram-negative activity, can't biothreat biothreat do that of the obviously hard the GARDP them, data happy to as the clinical other number which work good of there up vivo vitro it to program but far and gram-negative can does preclinical before the data we produce has as on drug-resistant rightly of Entasis out be the the pathogens, we of be Both absolutely which and liquidation, -- presentations, did I in presentation, delays, clinic. it in still disclose government in other the to number on support of happy is program, in biothreat are a agencies, more involved both due before mitigate the far specifics a the we towards support

shortly been trial actually have As new has had been the over after quarter, enrollment a about you the put for multiple recall, hold last but on not months. few occupied and resumed sites

update you this, So, can I would more provide little David, of bit a on appreciate an it. if

David Altarac

Manoussos. Thanks, Sure.

Manoussos Thailand, So enroll we as including continue Netherlands. South mentioned, key countries and actively U.S., and the our to recruit Africa in

to that enrollment we to the include enrollment stats opportunities enrollment of geographies open to again sites. that other Some opportunities with other to also there. We're site, do at more things and some for potentially the we're mitigate any could enhance potentially looking looking looking looking site. encourage at move within within of into opportunities to countries then opportunities if at there we're And are challenges

to published at COVID-XX looking agencies. sort mitigations. has ensuring as well-designed on a focusing what on of as on we what trials, clinical on micro-standpoint look a guidance study, it are the study, as mitigations very of respect FDA has impacted well look related regulatory that, enrollment we're clinical future their have impacted continue off at their a guidances we opportunities perspective there enrollment that how and opportunities in clear operations continue of from has of as again macro-standpoint we question much working at based COVID and So to to will well of in plans, on sort site any the how your study in With overall terms from of

levels that received look perspective, regulatory that we'll enrollment So, with working we've GARDP, at do from at to guidances very and we're to continue mentioned, all at opportunities mitigations closely as Manoussos we're and our agencies. the from within looking enhance regulatory

David Altarac

number you question I have may of that a on for pathogens asked. again, XXXX, I biothreat if specific follow-up your And

very activity as it mentioned, including including spectrum is of pseudomallei. I species, a [indiscernible] So broad

coverage, early we doing as CapEx potential work once biothreat board very clinic. these from and very, but support the again, ETXXXXX towards it's still the with move days all can So preclinical to fast as

Ed Arce

Thank helpful. It's you, both. very, very

Operator

ladies you, session. Perros for now of we end turn over and call I remarks. the closing reached the Thank will Manoussos gentlemen, question-and-answer the have to

Manoussos Perros

all and Thank you, participating. thank for you Alex,

mentioned earlier, summarized we next as conversation pipeline, quarter, As top available with we exciting of see call. and had the forward coming Thank and trial the we've data today, quarterly to the quarter of ATTACK We'll and early across look very you the progress course, our enrollment to line completion financing an new early fourth on next quarter. much. continuing you

Operator

This a disconnect concludes Have day. time. your at you today's your Thank conference, and for participation. this you lines wonderful may

Entasis Therapeutics (ETTX) 12 Aug 212021 Q2 Earnings call transcript