SMMT - Earnings call transcript Q4 2018 | Summit Therapeutics Inc.

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to today's Summit Therapeutics Fourth Quarter and Fiscal Year Ending January 31 2019 Conference Call. At this time all participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. advise Wednesday this XXth must recorded is I the today, of Instructions] you conference that being [Operator March XXXX. like Richard of now your would to conference the I over speaker today, Affairs. Pye, Corporate President Vice hand to Thank you and ahead, go please sir.

Richard Pye

to January And us joining information. our today, progress. XX, our XXXX welcome to quarter and we on the Earlier press this results and for Thank fourth call release issued fiscal discuss everyone you. the financial year summarizing a ended operational

not If to this have chance you had at review, is a website our www.summitplc.com. available on

Our prepared the Chief Finance, question-and-answer Vice Executive Melissa Officer, and of Glyn Edwards, will provide President for session. remarks today's Strange join will our

like the of the we Commission Therapeutics. refer call. these that remind description I listeners be Securities for and to a uncertainties during Summit and Before forward-looking I’d investment we filings our and statements this our an you begin Exchange with to with associated making discussion, risks will forward-looking statements in

to statements our views may disclaim should do if even we future, at so, any These obligation these forward-looking specifically relied the in elect not our any change. statements we to While I’d points to call some corporate activities. date like update as as today. of the views for be over to and subsequent turn an Glyn more recent upon now to overview representing year of our Glyn? forward-looking

Glyn Edwards

This past as not company. and and emerged for antibiotics has everybody, thank us Richard, year welcome today. Thanks, without all but leading Great. these you been a we've challenges, joining

The analysis us not the trial in benefitting team's was June dystrophy of trial we from clear we Phase ezutromid conclude As of rigor to X of results thorough conducted which in you that our the disappointing but allowed muscular with patients. and know, data definitively all last year. announced Duchenne our

where achieve today's business, the we resistance few of diseases As a medicine core the to due potential cure areas of are have or cures one the to antibiotic are our we rise focusing with pivoted Infectious on available innovative harder in patients. antimicrobial AMR. our Unfortunately, to antibiotics part solely of other result, the pipeline. becoming to

And patient to and antibiotics discover huge improve outcomes. and innovative is there meaningfully so, develop a opportunity new,

to is develop targets. in space. against the approach antibiotics new is bacterial classes And new of rare Our this antibiotics

our addition, antibiotic of In and through spans beyond innovation the our discovery commercialization. candidates development

believe here. science key are generate years Starting have to new innovation developed treated an also treatment data success use resistance of antibiotic standards optimal been plan to expose Our [technical market. of for become to area patients of In [technical to economic and antibiotic new bacteria to prominent our ahead commercial to new generate difficulty] payers. antibiotic drive the antibiotics. in trials on exposure, get is identify have bacteria difficulty] optimally those enables uptake And could them mechanism need for patients class being and help developed and in which is of for order identify again, by we care. same is us Obviously, failures where Over antibiotics whose to to optimize of every many infection the to our physicians is rapid new we with discovery tomorrow's this of plan the antibiotics.

before concern. be These golden antibiotics mechanism era new resistance pipeline programs. a became potent Our four development difficulty] new are only mechanism [technical has different to antibiotics across designed

in show a will costs. also improving could demonstrate care seek and significant Where to to outcomes candidates that cases, is superiority possible, we improve standards patient in need fulfill meaningfully In aim of care Our many overall the certain mean over patient antibiotic in reduction outcomes. a endpoints. our unmet success health

an antibiotic right It's good stewardship. of use help for to economic we should patient's the during gather and the providers to most support is Healthcare for so, outcomes data development uptake. essence to clinical deliver our infection. drug part plan commercial of important right antibiotic appropriate the philosophy the health the This And positioning bug.

Centers antibiotics targeted minimize antibiotics the the good new designed bacteria allow generally action. They're is healthcare little impact isn't reserve important essential. and XX% microbiome, microbiome of the U.S. settings non-disease so impact inappropriately, AMR help And for potentially of while targeted that bugs having AMR antibiotics of to kill unwanted prescribed on to antibiotics only new multitude have providers the antibiotics reduce other Disease but and of use and misuse is antibiotic is Appropriate Our broad of overuse and which AMR. this spectrum could estimates by Control Prevention the would consequence overuse a and where on health. human use spread to are the for causing for accelerated the their infecting the up both misuse. of an done

infection difficile indiscriminately an by As vancomycin is the been that the as Most has difficile or severe spectrum routine in the during or course can spectrum what infection. kill of antibiotics CDI that preceded bacteria C. use fatal protect broad broad infection of Today's mainstay are prophylaxis for another have an do given causes and is antibiotic. antibiotics antibiotics infection CDI. increased, medical they CDI are sometimes CDI to C. unrelated a otherwise for spectrum intended broad has do incidence gut including treatment colon of of antibiotics diarrhea. so procedure. cases when These against and an those

cure. again, patients, antibiotic difficile, get infection. there who improves one-third here frontline kills treatment opportunity patient new we gut damage get a while a Currently, fail it Ridinilazole believe of mechanism major microbiome achieve the as market is that So, frontline causes in treatment to will to that to patients our And in or vulnerable CDI C. these the a of patients for Phase approximately sustain protected microbiome. the two our the further In is recurrence. as development of outcomes. CDI. the with clinical one-third difficile global it of CDI this precision X clinical resulted performance dosed been being over is first Phase vancomycin sustained with a start superior February. were more in the site result, trial, Ridinilazole patients trials announce difficile We preserving C. and in kills X And ridinilazole Ridinilazole gut significantly targeted these natural this it C. while cures. of past to providing trials. tested excited to has

help achieved, recurrence, of associated trial for encourage strategy, economic are and superiority this treatment higher for drug Further, unique the CDI by clinical As the I the they endpoint we're for to of in in make treatments believe our because CDI morbidity provide frontline clinical for Phase If the believe medical CDI. this mortality. health recurrence and could be clinical sustained clinical choice it successive of label reduction of The evidence with lead and episode discussing including tests of trials. costs. mentioned we're when economic we providers. X measures ridinilazole develop treatment recurrences healthcare with and to Each and uptake would antibiotic X substantial aiming primary in to we expensive, outcomes Phase CDI CDI the is the the would of responses.

and which we length measures a reimbursement clinical for evaluate believe to for We sales hospital In economic territories drug. favorable successful health ridinilazole require readmission in options when in other ourselves help the exclusive demonstrate hospital including rates. of launch. denials The and data to patients trial pricing of build stay will addition, the penalties help include these the specialized potential commercial can hospitals data to our costs and measures U.S. rights, Together, Positive economic our we reduce Europe plan on and Asia. support and Phase X could face would a support force and have readmission.

being by Phase of BARDA. ridinilazole X regulatory is As reminder, supported and a our development clinical

contract $XX year, to we resistant gonorrhea a can improve the to X is of rates treatment exemplifies strategy X.X through ones, Ridinilazole trial, growing. is cases. neisseria commercialization. million. we’re BARDA their we in extensively to exercised a multi options, committed certain next which including innovation the believe And strengths significantly and brought discovery, one which the recent total or milestones of met. treatment Phase reminder, worth grim. up to successful, are There across our the the and patient gonorrhea the development, During as What potent worldwide the care of its if gets a We are treatment million. U.S. clinical $XX ideally of on and The of And drug XX SMT-XXX gonorrhea standards adjusted further where our end outcomes. amount treatment well. year, gonorrhea, quite was for earlier an worth AMR, from be and million. up super to of of overuse We're of us responsible help for the have candidate million CARB-X guidelines $X.X outlook Europe, award These to implement programs for SMT-XXX some if the the resistance account current programs focus nominated lead resistance. to consequence across this plan about is take our of cases of other development This million strategy in really excited should antibiotic current to nearing gonorrhea which misuse. point activity award line been and address are the over per us for will with is as for helping stage the full

to it new and it However, classes new this develop harbors there makes believe of for the treatment. is is resistance no next difficult gonorrhea treat. generations treatment. And antibiotic. to be answer could Gonorrhea SMT-XXX gains we The throughout antibiotics that

to continuing in program. are to year. the These outcomes including address resistant conduct to for if the increasing for and SMT-XXX oftentimes trial is these with deadly in expect strains. pathogens have gonorrhea all, we not only and good infected become drug infections. the X potential is Further, to opportunity to serious treat our can resistant initiate We standard-of-care really all hospital The second are half is problem. new And studies. ESKAPE is an with successful, acquired opportunity infections. a Phase of ESKAPE infections patients cases of new are this clinical some behind resistance responsible become enabling The the preclinical investigational, gonorrhea

XXXX. new series are January now We of we meeting. specific on upcoming antibiotics a XX, details provide program which at an ended results and medical an fiscal key overview against about more I’ll of to the provide developing our financial we components ESKAPE for pathogens, expect have year mechanism lead

But, numbers. with course review in of provide standards in certain give But international results present dollar Summit’s to you for results our in detailed financial these I'll accordingly. key filings. regulatory We equivalents encourage for pound will sterling. purposes, I We all convenience reporting U.S. accordance

$XX.X from or the to £XX.X previous January January by previous ended the XXXX Sarepta we the have relating ended the driven as with net in upfront the January milestone movement million related our January includes This program. discontinuation were million begin loss discontinued £XX the that's revenues been of XXXX. continued or to ended income administration was due payments XX finally, a million year of to the our XXXX rate XXXX and in increase And net the loss option for in award was £XX.X by from awards expenses compared from items. funding contingent the £XX net the to development XX, of contract million to previously the The or million for revenue and of the million compared million and resulted £X.X expenditure activities, impact received $X.X million from for numbers exchange ridinilazole for development our year recorded SMT-XXX. the discussed by reflects driven XX, key to following recognition overall flows. increase year variances. of DMD and from XX, XX, our the BARDA This were accelerated investments one-off offset $XX.X a to during XXXX. for year. ridinilazole million new the cash X, of revenues ended from increases our been consideration Therapeutics or surrender year the resulting operating year. the profit recognition January a to compared recognition expenses share income year but or Research for increase the reminder, decrease our increase cover highlighting from was antibiotic partially of that. cash for the £XX.X $XX.X from XX, XX, non-cash of $XX.X year positive in well adjusted and in the General a an previous statement, up implemented £XX.X the and ended also I’ll profit Revenues pipeline of was for by million, charge and million increased acquisition standard, Discuva million Journey by The development net Other completed for equivalents share-based million January compares the This the payable Limited, increase for XXXX offset from expenses. of I'll expenses, meaning payments as increase offset in during drove ezutromid. reflect previous clinical million We XXXX £XX.X year million January year the million year. as does and that and the XXXX, or million, cash with that As accounting event as of for £XX.X at ended were advancements on $XX.X This financial in agreements, the collaboration million and $XX.X was XXXX XXXX, £X.X regulatory year. net with IFRS and to license not primarily funds full the and XX, some £XX CARB-X research

As cash proceeds reminder, the $XX.X £XX.X a net transaction-related completion million in of deducting Shares that after the placements January expenses. of the Depository XXXX or American XX, January raised balance in reflects private million XXXX

in and fund to of and existing cash XXXX. XX, our expenditure that operating we sufficient cash our capital terms guidance, January expenses will equivalents arrangements believe funding and Now, through our requirements be cash

mechanism So, in future really excited our we're about new antibiotics.

Company the take shareholders. outlook And with Our patient Operator? continued that, commercialization system, bringing our we thank that have to And and value development potential while across the to questions. to your I’d you and healthcare we for improve innovative real discovery, delighted be support. outcomes means any

Operator

Instructions] you. Thank gentlemen, [Operator you, now Thank sir. we'll Ladies the session. and start question-and-answer

from Your first & your line of Oppenheimer Hartaj question. the ask Singh Company. comes question of Please

Hartaj Singh

had Summit programs, Thanks Great. X It's CDI to on good a just of have interesting for cure Thank Glyn, see don't which questions, question. everyone or thanks about don’t that is them the going the one-third of know I to ridinilazole. Glyn, you. couple the in Phase now either patients maintain. saying a

be could gain could you are readouts a how and patient So, bit structured? gonorrhea of that is of And endpoints that just And with capturing, economics clinical of then, maybe -- discussion your drill that underserved little you're that little quick of health help the is just the the some And data you'll your a part follow-up population? about secondary the going into more to payers, that you, are guess, assuming start or sort something then, this just will trial talk bit what on how that to primary a I program? be label the positive? I got

Glyn Edwards

India. Hartaj. you're Sure. to flying Thanks, I understand And

us. So, to delaying I to you appreciate talk your departure

of about is of XX%, varies a and a So, can have to into proportion X% the to know, a you in do third there's XX% trial, you as that small approximately who not parts. that’s patients then, get talk of recurrence. presentation, patients cure generally today's we who quarter XX% up treatment; divide of about and initial that There on first two relatively from depending an patients, the

you put and about things data And just with two The the so, third don't XX-day recurrence of the the remember, data, cure measured you public quickly. And you XX%, when is cure the that about get is given having about a a those happen period. numbers these days recurrence of pretty also our not from is peak at XX from recurrences I've patients either if vancomycin sustained. a and or have together,

better a poor number significant reasonable with that you that, it a number to And of if expect have a you ridinilazole over people better outcome. we superiority show with is, who as a drug, So, can, believe patients, means a of us gives have drug.

primary know, our sustained So, is endpoint, response. as clinical you

of you have treatment need days. next be in a in then to So, cured end the the the at not XX and recurrence

XX for so focus just initial also not We I'll But not of days, of the at on, rates. days, at follow-up days term the have these really we at look recurrence patients. and the cure, XX looking looking look recurrence look we secondary can host a endpoints. XX But, ones at the we longer at inferiority on whole

So, of real those are focus. the sort of endpoints clinical

the for health in be the key payers label. included expect and when about But, of those economic we asked will their the they are You outcomes, don't at look that importance models. they cost

And readmission And of overall so, reduce for of are a also can not stay, these just And used have stay, driven rise rates in are expensive metrics. part rates something can the by certain the metric number important treatment for above of overall There while patient. hospitals. hospital. And If things, in the CDI overall the if that's to a to cost Medicaid hospital very a are rates important. of a significant key hospitals something be the can the cover do And readmission performance fees, important. is they we whole readmission readmission their the length actually It's measures really be hospital; very rates of about. Medicare, cost you of probably penalized threshold. across hospital they're hospital

So, with impact can actually ridinilazole, of a measures drug have it's an the one like on. that you

be powerful adoption ridinilazole. will we for the think So, drivers of the these very

Hartaj Singh

And me. that trials very robust know been tough you're really it's data year I you're is extremely of for exciting me but with a all XXXX that starting has I accruing DMD, sort of see really -- Phase was to interesting That's and know, great. to X that two this

whereby need about show left unmet where later bringing I hopefully or that it's Is less Scott than division? fast so where rather the they the has few the much. candidates really a is have course. track with could data. of any could is sooner Gottlieb pathways they you disease very And high And in in gonorrhea way market, clinical that last there market depending the there changed to on FDA. been likely the thoughtful FDA On so, candidate I be gonorrhea or to if candidate, infectious or what you has But, question one speed the know the again, years; thank more is, data good

Glyn Edwards

Yes.

I’ll this pathogens. LPAD And high need pathways clinical unmet areas FDA. and candidates ESKAPE for also bloodstream ridinilazole. are there just a our our The that infection but more high what success hard agreed coming gonorrhea not And that had they is of U.S. there all very we're introduced a after really great for answer is actually, far. trials. at, examples system an didn't LPAD for their route development approvals the -- the with this faster the for program Zemdri. is And need getting for here. deliver they'd that that's of So, to And broadly trying faster on Achaogen interest, with unmet key one so the hasn’t trial it's looking But,

So, any itself, sort blue I to aspersions chip example. cast that's don't kind on of think as a it's unfair of process I the think

we spectrum looking switching particular antibiotics, chemotherapy targeted more And is from from is learn can companies the think organism, accelerated think cancer the agents. broad are things do there some more to I also And precision learnings particularly that then at through. antibiotics. So, I at some can an looking you're when if we're pathway there there from therapy space and cancer to target take at the

a and also come working that and we're faster should be result will superiority of identify try which standard-of-care. claims will new throughput be patients, drug hard So, in very to the group yes, that pathways, innovative mean the with give up physician which able to development

of here both be we is the new amenable So, indications in authorities, development the action and particularly those Europe U.S. into faster all a development new that regulatory products. innovation spectrum certainly put with there And mechanism and these are in of I that think, pathways. lot to the narrow can would

Hartaj Singh

follow-up, just Glyn, specific point. one actually other just that to

to you're and safety, clinical with I'm do something what's where early to high of more you you track data them feedback do go pathogens. at efficacy is ESKAPE you doing preclinical if it’ll were actually you in still stage Phase to terms of safety market? there X/Xb regulators if on while time give to happen gonorrhea to in how X a division, But, say and could efficacy faster you think So, you dose same this thank cancer or ranging. the for analogous analogous unless not And start from and Again, a your in something quickly of take that, or again Phase getting development that's sort and the you do get to time suggesting favorable visibility going the about you. correlation trials the you can

Glyn Edwards

I get will think, you more feedback.

division diseases do you is oncology today. diseases Infectious think, years can't I today with compare starting what infectious behind. XX the are

of I agent, I have times, we've think it'll whom antibiotic big to truly we you're you a of traditional think unmet agent spectrum I an to development feedback development think to these But, there's agents, innovative patients a able I broad high from So, patients you group on of shorten get be think some a will traditional of have and targeted got need. that's improvement have for what where group specific will and you for seen a do provided developing. be have we

Operator

you. Thank

BTIG. ask Please from next of question. Chiang of the Tim Your your line comes question

Tim Chiang

Hi, Glyn.

possibility sites to potentially U.S. work enroll talk sites enrollment expedite enrollment some America. I with North there bit studies. outcome of you’re Phase XX the you hospitals in X a faster? your that the study, could in chance how XX, many for around recruited, North America pivotals? patients mentioned CDI about be little you Is able X What's XXX to a You just of two had Could going might to in about think, your be studies? Phase also the

Glyn Edwards

enrollment in that population. enrollments for a to at the CD have able we on X large the this the we're in approximately weekend. U.S. across three later given be guidance I’ll Phase an answer we’ve the question. Yes. average this our because on studies that meeting That's But, last site good U.S. been looking has investigator placed

you at study, rate this enrollment third study look cadazolid same and those those if that Worldwide, about and and be of the that's we’ve will the how there the guidance. month, studies, be come to per studies. XXX sites involved we’ve in the about And U.S. going in the are site a average we that's bezlotoxumab to these giving used per done, So, surotomycin have

Although we the half proved expect in about because come we those enrollers do to patients sites have be that. to studies previous from as good sites U.S.

it three on Now, is will enroll that faster the those all at than of to able because we possible, same be studies going were effectively time.

So, the there today from particular as time, at patient programs were there, enroll I X trying with Phase three same X to large population. Phase guidance. the as big stick study think should us we whereas sit in the same there's But, this sites a we only

at are end a we’ve our got belt. year actual chunk is. where And rate review let's we enrollment the enrollment the the of in, can of under see Now, once we what

the our this can. looking study think experience. the enroll -- we faster, to sorry. think really as do month change forward fast I’m not we've are possibility guidance until got But, good signs good to to week, Texas going some I our is a this end turnout this got where but sites of a meeting in and we're done at we’ve And there So, motivated the are getting I as well in

Tim Chiang

the outcome Are be a of measures. is measures these secondary two complete primary very Glyn, follow-up. clinicaltrials.gov, other important. can just certainly you key you for what outcome enroll some for -- just to pivotals? the the outcome important outcome bit about But, little looking I course, Of on going community? those talk hospitals measures and are patients of you you measure as more hospital that one list secondary noticed sort out

Glyn Edwards

Yes.

we behalf because stakeholders, captures to that bit primary a managing everyone, discussed are essence interested the know of and that's sustain be the to think, the that need. of little we to all want the the know will physicians want it Hartaj's Are patients patients. And in unmet comments. in curing endpoint, what I to are what cure? That's particular with patients on going the patients and

no Now, that's just break as a one and cures composite make getting then reduction as we’re down that look rates. the well sure initial to recurrence endpoint, and in that the to

the the or is they longer measurements of individual be I think hospital that think secondary whereas, going or because they'll in diversion, XX to help. the I we're make, response -- basic the view, XX point it scientific really to think doctors interested though, make not, going days interest interested this in like in those things that, because the of stay to a hypothesis but this also continued on is period, From to financial some After the the impact microbiome well is I performance key is microbiome. the interested So, we're have the payers minimal are and over from be a direct that cure. I superior readmission the we are developments is profit of start the on getting endpoint in the and getting length the patients through terms going patient, agent really and sustained reason very in is a interested of going be be narrow rates, impact this we've that think recurrence this the demonstrated that have a well we spectrum

And so, our of Phase continue interest biology. there we the still this. elements behind to us from from data X that. really microbiome be know, including the about of a some large that recently you terms should really publish as And in in study, And interesting science help data

secondaries the Phase is in so the the emerging these secondary But, count don't the reason more X. Phase scientific And well these from to from of get X. whole drug the performed So, I we any publications think many expect why endpoints we standard-of-care the of and data what more if endpoint, and for unless is you meet going treatment superior the here. to the become to hopefully be, us driver should that's allow which be to patient the And biggest primary primary frontline uptake on we’re vancomycin endpoint.

Operator

Thank you.

Your next your of of question Joseph Securities. Please the ask comes Rx Hedden line question. from

Joseph Hedden

questions. Thanks my afternoon. for taking Good

they kind it's any the attracting so the gonorrhea Just capitalize lot see program. anything just moment. at of Being on we also you increasing candidate landscape? do a to of the the that? might are one as was a competitive Is wondering there, on first out Are see Is an clinic of called could say you And that? there rise kind attention. media in the about candidates there when kind looking strains, one of program, of gonorrhea I the for super that, quite in ESKAPE other

Glyn Edwards

Yes.

and The which as there by in other being gepotidacin then most developed GARDP. is So, the drug gonorrhea. two drugs well advanced GSK’s are for development there's Entasis

So, us but as not And in they issues. are ones ahead are without development, stage some earlier of well. their there

number So, things would of happen switch these Health approved. reached not point is Organization is a have next announce approval. as without one. there's The need it's normally else no to the resistance problem And would what that that there And is acute unfortunately, with next the competition. World rates gonorrhea where nothing that to the with we

due these So, we resistance followed followed will not really, in by drugs. need just but drug because another, one as society, another come desperately come course, we to need, to through new by one

-- really mechanism, development that drug us that. opportunity about a treatment questions to from we And are treat of super we be for new these agents, a mechanism have we have not We But, of got be We being that And we resistant standard-of-care see advantage have of opportunity gonorrhea. narrow against the see line last the number with the gonorrhea it's We we puts to the able solves develop ESKAPE obviously, successful the position, who's the to that new mechanism just its treatment fundamentally cases. really multiple program. of super patient strains. further resistant antibiotics, the the a by they gonorrhea, And new new look spectrum important also the product had a the strong too. think that's in a in should in and non-resistant think as the potent opportunity to action. become to that's equally and and pathogens totally of

Operator

comes next question. Zhong Thank ask your you. of Please The Yun question of the line Janney. from

Yun Zhong

taking Hi. questions. Thanks the for

X half be this activity to of positive track the on this wonder would and typical efficacy X I signal in you. a followed but year, question, X pathway and you So, on the safety efficacy another Phase is Phase a in tolerability upon program, the study. about redundant whether then the any have second anything and might Thank to addition imitated by confirm signal the gonorrhea there and be to patients, and be timeline? X also, or Phase considered Phase believe in what previous the from if about And the still data, the is timeline, to

Glyn Edwards

our followed X these But, whether that at look giving We're X, in with just guidance possible to by Phase a any spectrum be now Phase development agents. abbreviated X timelines it not one. be there lot have more will Phase innovation about But, or data. I’ll a including of will it is we refer

discussion We and have to a with is. what have then, announce authorities plan the the we'll regulatory detailed

that -- have there a the to value more human because that sooner. a start view, I is focused there benefit quickly. and your think impact the for be opportunity do volunteers. whether plan opportunities, we're to patients initial get the or if these patients patient's to to case can of There initial think, you And potential you We're that great use with data But, these economic confirming get be antibiotics is the X/X. patient is exploring all the with be we from into can is that a on that new whatever in merging into obviously drugs, will getting healthy we'll market point safety man if massive great all going I can is will be Phase not a health. is, likely these widespread these proposition, the first

year, all what confirm be very we're do the about will for this plans that. drugs, the but exactly that innovative ways for be looking can actively certainly we path development these accelerate way can't the So, that and we

Yun Zhong

question. kind And remaining able million payments please? the Are for a quick required £X.X you are disclose to milestones what follow-up to grant of get you

Richard Pye

CARB-X to need those. we in to of receive end details made; at have from gonorrhea. guide we to that X-K the the filing through guided get And more we have in full We look you Yes. grant a to Phase money order X the the to Yun. Hi,

Operator

Bryan Waanders Please question from next Garnier. of comes question. Gary our line And the your you. ask Thank of

Gary Waanders

I may. couple, if have I a

could argument, to to wonder if compared completely superiority for need you non-inferiority. in terms wonder of comment you the I the is -- while the is, in any can And gonorrhea preclinical statistical burden more I all comment resistance And strategy you. I about one on the versus non-inferiority. The the you second setting? size at observed first in trial Thank on to of the XXX superiority that

Glyn Edwards

Gary. Yes, two good questions,

one antibiotics, So first first to we're a XXX, in with been that mechanism huge mechanism patients they’ve first. Obviously, is new let's older have time there that may exposed some this. developed the advantages it's the take not get of while organisms the but of that be mechanisms round one

the And And for dare on if resistant we against super vitro tasted this [ph] all strains strains that's gonorrhea the with treated of one the some the strains far so, in being with strains, for to so strains comment with here see identical UK. guidance of that clinical headlines in we've potency. multiple that have actually particular effectively, with of say, including XXX, antibiotic or difficulty that I and made we've are tested resistance virtually the

candidate in And potency never But, to any resistance doesn't will propensity in in that's the serial passage. XXX ways to gets resistance to all So, if the to extreme involves the just new resistance That's of to developing that market. see of rapidly say develop drug that passage, and develop which that traditional a know, selected organism. not are we identical shows you it seem virtually measuring resistance, across serial And those. as we there a mechanism. function

of its steps we terms to mechanisms. is as optimistic it, a in number ability before get So, current its potency of Obviously, very round and are get resistance clinic need we there about the both into we stocks didn't your I’ve it. it I and kinds forgotten things. package question, remember these completely And of all because thought But promising. so looks I’d the [ph] down write second complete I far, really to it.

Gary Waanders

burden It non-inferiority for versus was regarding superiority? the statistical

Glyn Edwards

Yes.

new in really that is, question. treatment let's I it probably had to way in you think, that's show patients, currently you that a something then is So, if the got effective, treatment. pretty Because on there it's the cures statistical showing any cardiac if see working go non-inferiority, a good we XX% superiority a answer you've is say would treatments. well, something And XX%

You number endpoint are show in is need tens XX% of patients. an any superiority positive you do room thousands current C. diff, outcome, But, where to there like to the giving say of of if manageable that. patients then have treatments

And So, current do working to do part to need unmet what when look we selecting areas you of needs. isn't drugs to If need; organisms those shouldn't powers where for we’re the are of or platform we're with the high to unmet be developing great organisms them. a and is have Discuva either able choose against choosing drugs treatments to there well, what high and what an unmet is one growing those go there's need. we’re trials at we develop a pretty to of which

there's not focus. you will something But, we satisfies unmet can then to -- So, may it unless is our you -- development. where that your there And endpoint, can need, be unless not you it? this your studies in be an and those a superiority are problem able be do may drug respect, that'll primary the that's developing critical moment. where there's every why some So, with in choosing be -- show we unless is indications better at

Operator

comes Instructions] question. of Thank you. Please next ask [Operator Julie Panmure the And question Gordon. your from Simmonds of line your

Julie Simmonds

you. Thank

that terms progressing sites terms trial site, in you've are planned? ridinilazole all the of U.S. sort happy investigator meetings is about that wondering, new at the of the your as got which this you But, weekend. ongoing the Just Clearly, moment, rate opening? trial are at of in site, is

Glyn Edwards

recruit question and global in evaded we have you got we really opening, truly for study. rates, blow but a intend we're -- and we a that. in. we're earlier with opened. Hi, don't the is I Julie. to and rate, the our calling regulatory can't sites by And sites recruitment are, Thanks blow you’ve pleased quite getting obviously about this give until approvals Yes,

So, that's that. with and stage first pleased the pretty we're

Our focus U.S. We U.S. the has first. opened been the

other is infectious different But, recruitment and C. studies, other why that's on first which disease along. the rates at in activity look to countries sites U.S. the U.S. coming actually, other we’ve getting sites, many have open initial diff the focused are really you getting first. And higher the U.S. our big the If recruiting been opened

yesterday. place So, the approval for [indiscernible] is day the before

the on, sites pleased planned, that. -- coming are we're with rates the other as and pretty yes, So,

Julie Simmonds

won't that information is product. hold to used Clearly, it just the the that well, gonorrhea if find reason case, And financial? you possibly that's is then or on Is behind another got in on for more getting XXX of up because And gonorrhea switching that. and the or non-dilutive you've because out your one purely opportunity sort do funding there one of you as XXX? is think of XXX

Glyn Edwards

of terms next program potential the out another into would over the our we, rather get program. Actually, great whole program. new for about we mechanism of But, there mechanism. have XXX is host after gonorrhea get is to But, putting will before things one in need funding we Discuva think the And time, started a of the antibiotics the the ESKAPE effort opportunity other I other antibiotics of we several non-dilutive platform things. No. world priorities, our for

is not actually will other alacrity We a our we focus is infections higher need. with because where great do progressing, is that, unmet it but and there think on

Operator

further Thank take you. wish Do question. do We to you this? have

Glyn Edwards

we do. Absolutely, Yes.

Operator

Thank you.

question your ask of next from Your Steadman Dewey of comes Canaccord. the line Please question.

Dewey Steadman

watching what on most squeezing conference? at the question should we think Good me conference? presentations coming you I And going meeting forward for what at for up will thanks [ph] quick be coming just critical the to Hi. and the had story a in. weeks, do in be the Summit morning advancing

Glyn Edwards

week’s do and I'm said the about to not and is able we'll be are that and to to on was already there exactly have on at But, [Ph] a this that. tell embargo must shoulder, to going I my everybody an meeting. up in You shins coming because But the call webcam me a be kicked over Richard, was public time. allow what abstracts show

abstracts would at bruised but a that, encourage I week’s do I excited you you'll to I as to able be my be I'll nurse about in I So, shins. think be look And time. the as

Glyn Edwards

Well, next those thank reading looking forward you. And to I'm week.

Operator

for Thank no you you. and Thank ladies are questions. gentlemen. participating, There further

now You please disconnect. Speakers, may stand by.

Summit Therapeutics (SMMT) 27 Mar 192018 Q4 Earnings call transcript