SMMT - Earnings call transcript Q4 2017 | Summit Therapeutics Inc.

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Operator

Good day. And welcome to the Summit Therapeutics' Conference Call on the Financial Results for the Fourth Quarter and Fiscal Year-ended, 31 January 2018 and Operational Progress. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Richard Pye, Senior Director of Corporate Affairs and Communications. sir. ahead, go Please

Richard Pye

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

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

Officer, Research and Edwards; by Executive Chief Operating then Financial of Officer, our President Roblin David Glyn will our Ostrowski today's & Chief a provide Dr. Our and Developments, which will prepared Erik Chief Officer question-and-answer remarks, session. followed be

Events We slides Presentation Investors the of to are slides available section guide our These our part website. on today's the webcast and discussion. our will & be available from for in part using download of within website

Before discussion, we [Technical with that Summit to we statements remind risks Therapeutics. be like an and listeners would during making uncertainties associated forward-looking in Difficulty] begin will I investment our

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

Glyn Edwards

diseases. our joining for infectious all in thank for and as year or the Richard Thanks, Great. dystrophy DMD Duchenne successful treatment today a of we you us review muscular developments and very

the trial. our core positive the spend XX-week PhaseOut interim the will We from data of clinical DMD reviewing, majority

as But the of major The result, in becoming of which new the do, increasingly for readout a an trial And that antibiotics launched and treatment in before for iterations to have like programs. new seen and a mechanism review years. antibiotic treat. classes lack made in bacterial the opportunities. their from QX hinders to these target in world infections. see data populations, innovation the antibiotics regulatory Our progress are We been expectations the existing drugs difficult I a of for past our as I’d that options. in XX innovation just antibiotics opportunity urgent need Most us. of are commercial infections development niche Few

compelling to Our but mechanism intend and show is of simple, over patients, providers. payers standards we develop current create strategy antibiotics, here value quite healthcare advantages care and new for can

this CDI. the used testing We’ve care of new is clinical be two front-line clinical the CDI. from if of believe endpoint, first part will example to up approved. trials. drive key treatment over awarded $XX Phase both that primary in contract data second treat believe lead X and and antibiotic in strong primary could and treatments believe label option a we will funding If Vancomycin, treatment endpoint and the in And Our of of The with standard help worth X this the preclinical we includes superiority evidence standard Phase in recurrent we prevention clinical help the data infections The issue to clinical the reduce which meet recurrent designed current we support as is this ridinilazole we the CDI. is CDI. our position care, use trials X line for infection or million. is initial Ridinilazole strategy ridinilazole substantial of BARDA CDI. it past our which is year, potential new were C. clinical to contract promises development for testament diff a a This a stability Phase ridinilazole. to precision ridinilazole's and provided to trials disease, In

important launch supply manufacturing for the to to activities quarter is addition, In clinical of been delay measures, are CMC There drug as has ridinilazole. we’ll related X of collecting Phase trials result, first the in producing expected be initiate is for now a the activities, outcomes X commercial there Phase which health the in a And economic trials. XXXX.

can the and the our platform delay There an patterns with nearing treatment connection novel options ineffective, shown disturbing against showing Limited. increasingly we the This target, untreatable [indiscernible] compounds bacterial the is impact disease. resistance far, antibiotics against and genetics-based with novel the it’s proving potency The testing development. And due a to care that platform platform the December thus antibiotic antibiotic facilitates for the last space. believe ridinilazole transform are strains increasing new program antibiotics resistance a we’re to compounds platform with resistance gonorrhea leader of targeting With this treatments. our need Leveraging its strains identified timeline. potent platform era of to for of Discuva announce of that lack of minimize the this innovative treatment. acquisition current in have high our first and current and in the standard development and as Gonorrhea a is of developments the gonorrhea optimize acquired to discovery of overall stemming pressing developing a compounds of has a early expertise are in new to of ability are And resistance success efforts with against positions series recently, has because gonorrhea us target. We we new gonorrhea. this mechanism the development against and we from and

this expect We nominate half studies for in year. to IND enabling to candidate of second the

all for trial data the we to this or the to underlying of present unique to – the become Phase stabilize to antibiotic slow potential fibers DMD. very to has muscle not from X utrophin patients cause similar some first David? all We the approach and that its we [ph] in substitute compound slides the from of it By to wasting modulation disorder believe to refer positive website and modulator. disease novel We’ll programs. compounds through is DMD. Roblin for and in our us by off. and exciting on in DMD, maintaining production of go DMD. dystrophin. David aim clinical Utrophin of utrophin new are now with and a utrophin standards developing And a and universally Our on progression repairing of to disease patients absence webcast structurally therapy stop goal is class the dystrophin progression caused In findings. naturally our can take with recently our functionally fatal pioneering to of dystrophin interim available over muscle the on to oral are I’ll care candidates DMD reported hand switched address mechanism the to progressive download that

David Roblin

Glenn thanks just can start Okay, slide with and X. we

XX reminder, In a is weeks of a in open is total and and that health who muscle XX between The As US with both label endpoints related and is a five are to concept of trial in evaluating the UK XX. an and of place up function. the men's. taking DMD DMD, X Phase proof patients trial number of ages and

function. disease, the endpoints we DMD a on are and to now focused related health muscle As slowly most is progressing

year. This data. reported the is impact of expected they trial. the in in of Ezutromid XX phase a now continue The January the Topline DMD patients on muscle this of the third treatment, data to health will is this full we of important on extension data in quarter most the trial. and slowly long-term After this XX-week As to and trial to in are Ezutromid completed February in progressing from efficacy were this focused full the disease, weeks gather us have an year. trial safety option of have receive enable interim

trial. with the promising slide XX-week and much where interim proprietary a will we we are full advancing full thrilled quickly filing the are encouraging trial data, our With forward topline XX-week based are This looking trial results X, as forward placebo-controlled Ezutromid of will as Now be Ezutromid, we very can move results data on are the to from on possible that to potential very with hand. results. we activities we were as in as ensure the the once well regulatory are for full a trial Ezutromid

lies the a on X. muscle and stabilization believe the three slide meaningful by We muscle we shown led decrease XX-week around data in in production of of outlined to a in muscle in maintaining This significant This led utrophin. has excitement Our key membranes points have to damage. inflammation. significant interim has turn decrease

take repairing utrophin through that both of treatment. in switched now and is proteins on a repair. membranes. each dystrophin utrophin's membranes patients dystrophin at place one takes X. as muscle slide XX Thus, is their weeks development. developing All off to stabilize I’ll fiber utrophin on the muscle. aim cycle muscle begins constantly muscle to damage become dystrophin, of soon muscle cycle break seen Ezutromid material muscle stabilize stable in switches to fiber. switch generative utrophin with DMD as or Each starting a Recall and further actually points production go are these on utrophin the The a to and off. of these on not detail keep and act muscle of as muscle damage membrane Normally, made in in repair after different of switches Since to of occurred as and is dystrophic is times roll this of able only to of

muscle membranes Yes, break to the have enough lines is cycle? induced repair evidence believe of So, this. the this three to is we utrophin stabilizing and it and we Ezutromid damage support

slide by First, developmental normally the we and utrophin, DMD, repair development be a muscle muscle the is can Like recently materials in muscle present repair that as damage during presence as development Muscle are developmental decrease fiber in fiber in meaningful is observe myosin in off utrophin myosin repair shown and and on of like the tracked damaged damage [ph]. is myosin. switched but significant process. In muscle X. found

levels. would produced, action and by stabilizing if in membranes, to Ezutromid at saw this of utrophin one XX is indeed weeks the compared expect myosin the However, being baseline. see to developmental a decrease We muscle

baseline On XX-week is biopsy the left patient. the a from hand slide of sample a the same and

finding validation myosin amount in visualize is this In after of relative [ph]. decrease there’s the myosin. we Further, In correlated total, amount significance. XX% believe This developmental myosin blue can severity stained disease in of significant statistical reached meaningful. an reduction treatment. the developmental studies with You clinically reduction developmental in average

So, we reducing evidence is DMD. this severity believe Ezutromid with in is patients that

during X. absence we XX Utrophin of developmental After do on modulator, down the of that Utrophin be would of There levels myosin XX-week Ezutromid expected by at high we in go very myosin is evidence down. leading then on it levels of of levels we Utrophin lock kept go step repair, go let’s to and damage increase the to expressed [ph]. less in damaged a Utrophin weeks significant a Utrophin developmental see go data and and leading Utrophin. It This switched myosin mean myosin but Ezutromid. are and on more levels both is is up reduced measured turn treatment Evidence Now Utrophin slide to the developmental repair to the Utrophin muscle the damage by is Utrophin something different. fiber reduction levels repair. being In developmental more less expression is If intensity. down showed up. in X% look levels back already If would repair biopsy go not

muscle of observation measured of slide damage X. resonance TX in be downstream spectroscopy significant or muscle The a inflammation magnetic is a was MRS-TX. shown inflammation on with third can and key Muscle as effect decrease Ezutromid activity

the vastus and on of further patients This effect health two TX recall, the DMD here that soleus having a DMD. of stabilizing a soleus its the inflammation. the is that muscle decrease to is in needed having saw in Again, in in you decrease positive order of disease calf was enter is muscles, different in five be muscles. and be on statistically Ezutromid intended membranes, fact should Ezutromid severity a As significant. steroids evidence stable or there with muscle patients induced doses trial. this effect PhaseOut implication We in in in may The the the lateralis, to muscle decrease Utrophin reducing one is

can So, slide please. turn we to X

fibrosis. fibers and As a then is damage relentless after eventually prone are leads replaced The cycle with muscle material fibers muscle I’ve and of of disease are and muscle of lack mentioned, in muscles by to damage function. caused a slowly then of the loss dystrophin a repair many the caught failure. DMD to rounds repair that muscle fat leaves This

phase. extension clinical endpoints over the So, XX-week that have PhaseOut can trial we Ezutromid the only over impact not clinical incorporated track in DMD also but the of

by the meet will in trial measures with have continuing We the the increase fat or of in damage and overtime. shown DMD changes by that this Myosin provide weeks and stability forward look the of shown disease clinical to for developmental endpoint Ezutromid’s in maintain muscle measures and [Technical full In slowing any resonance the the progression changes repair Recall an treatment. believe longer really as early we increase muscle functional to These defined the of too eventually primary treatment Utrophin DMD do Therefore, weeks a as stabilization decrease muscle inflammation significant likely and future been on decrease outlined muscle every expression. damage trial health decrease to primary if and we significant in impact it's we as believe believe for this the functional Myosin XX-weeks does magnetic the up picture on the Difficulty] XX affect on baseline muscle We XX follow decrease on us is XX. trials of the that muscle in maintenance in impact to of the have slowing Utrophin. and taken as the in sustain to MRS-TX. already of measured impact meaningful by in success in shown the in by of decline. PhaseOut as shown lead after muscle disease We the from accumulation. We sustain patients over endpoint set fat expect impact. in membrane us Ezutromid developmental term exploratory slide by We and body signal early will inflammation of these On parameters.

So, hand full and I'll results the PhaseOut the that, overall, we DMD very Glyn. are looking to trial. optimistic With of forward back to

Glyn Edwards

and the lot, on third David. outlined positive. advance in options be XX. slide the that believe quarter these Shift pathway there to Thanks two a Utrophin regulatory top-line are data We potential are

those full the PhaseOut to to data full a of approval. allow to on regulatory in DMD. trial access is lead options market while the a One would confirmatory an the that conducting pursue approval clinical accelerated based U.S. This would us from

Erik? damage trial while Another both top-line call to clinical clinical need. announced to to that the today. option regulatory ensure data observed, very full to and we where is we're data excited run turn WERE await expect muscle slide believe provide of activity. in I'll trial with Utrophin the access have advance we full modulation, XX, the reduced to continued over conducting rapidly the about financials significant results. from that, to preparing decreases Ezutromid In summary flexibility we're with for for the market. of But on and believe see evidence lead finally, top-line data And could trial, the evidence inflammation these these are muscle activities we we fiber we the help actively of the to the Ezutromid a muscle reduced interim Erik, and approval a review patients pivotal And that options in with we regulatory promising. damage of inflammation and a are that that And

Erik Ostrowski

you, provide for fiscal an of January Thank components financial now Glyn. key of I'll XX, overview year-ended results XXXX. our the

I'll increase Reporting We the clinical we've future accordingly. year-ended we our progress during generation our driven numbers. give DMD both accordance of were review January equivalence was This the in continue the some year the the January DMD but compared $XX.X to our PhaseOut results reflects clinical with $XX.X activities CDI for entered during respect also from Sarepta for trial expenses £XX.X XX, in items. patient in PhaseOut the development we associated in upfront Revenues and for I partners trial the the last development of Utrophin the of key as our highlighting Standards our International when to reflects £XX purposes, our you income course dollar key with statement provide for year-ended encourage activities, the with with continued Sarepta. all received as modulator the the XXXX. £X.X sterling, XX, year-ended million X payment advancement payment increase upon of US strengthening Phase previous research present will as were those or program. strategic million to well $XX We begin DMD recognition receipt in of million of year. This XXXX million January as results $XX dosing XXXX, £XX first up regulatory £X.X XX, to convenience activities by collaboration our current filings Research million, the expansion milestone certain our detailed With of and Therapeutics received and and as pound Summit's related I'll well million million or clinical the from Revenues clinical DMD to trial. continued team. the into the million million Financial

the rate XXXX, a we two program, which £XX for from increased expenses by continued staffing by million This decreased January financial net previous a trials was $XX net lower And £XX.X £XX.X the CDI and to equivalents our increased previous our The increase ridinilazole, net in driven Phase General million, of to XXXX plan million in loss of to expenses. £XX.X XX, preparatory related for we January year related movement discussed in loss overhead increase or $XX.X increase non-cash quarter to at overall facility million for £X.X compared million, commence to was costs, was the XXXX. on variance year to administration first year which this with previously clinical partially or million negative compared driven for the increased conduct cash to Turning net January year. year. loss to of and by finally, We the and of or operating $XX.X XX, our offset million activities costs. £X.X and completed XXXX. million X planned and revenues, year-ended million exchange an the cash XX,

cash approximately As was price proceeds December in cash XXXX, of March expenses. $X Limited, a of our fiscal in £XX financing in million component the reminder, million Post $XX our $XX an the of related January operating after purchase the estimated reflects deducting million which year-end million net XXXX. Discuva balance completed acquisition XX, about XXXX to about or equity in we rates million completed that proceeds or gross or £XX.X payment

So, our on proceeds basis, the balance was has about from the approximately end million. a of cash to pro financing year March reflect the XXXX or forma £XX million adjusted $XX need

reminder, number ongoing in activities. a to development As arrangements place funding of we program a have support our

global our earlier DMD activities research Sarepta development agreement towards contributing program Glyn result Sarepta As contributing mentioned [indiscernible] and our towards and our activities. under new Therapeutics, partnership with is

In net through along over and will to terms back capital remarks. Glyn of equivalents that the and funding at expenditure for expenses be the and least closing call proceeds our existing believe Glyn? requirements now cash XX, fund arrangements March I’ll our with the cash XXXX from sufficient guidance, operating XXXX. we financing our turn equity cash April to

Glyn Edwards

lot a Erik. Thanks

that had our been families who company pipeline year, CDI who positive with our to clinical year. importantly, over involved thank trial the I’d both data team, and and we our leaders the I’d have DMD to But the over like to programs So, the instrumental secure trials. patients, in have like in external the and past key a antibiotics. strengthened on advances futures we been validation DMD sites and the the have have have clinical thank in to most patients, this in two advance programs

the year another particularly to from exciting we can PhaseOut questions. the to the any forward results our of top-line guess year. you looking as for open And DMD this quarter we’ll report with in which We’re and third that, line

Operator

Instructions]. [Operator you. Thank

Canaccord comes Genuity. Our first Lee question Arlinda of today from

Arlinda Lee

about data how I and we positive readout XQ. readout discussions hear Thank the plan? your in registrational you. What your was might about going the and consider more regulatory would curious guess, you are when I our

Glyn Edwards

is cricketers accordingly. I’ll what is call googly, the part an a one easy usual, As the and the first second here answer them so

the So, data very really have is we seen far exciting. so

membrane, the this Myosin a muscle we measure. TX seen seeing by cycle We’re exemplified in in and decrease damage reduction have Developmental seen we the stabilization in have of

improvements weeks and to will So, a and weeks And maintain that go huge to enough we for at be XX excitement at as will XX if be us we of this level that success. certainly forward. our enthusiasm saw maintain

potential to terms As But other that’s brutal we primary that we totally endpoint. meet in in the see terms always, of so can need things. success

think under magnetic from point working. the have in maintenance to XX view of data So, also important like Utrophin from and from repair resonance have to completeness seen a able overall and weeks. scientific But regulatory that most would those what the We to maintain be the XX same meet endpoints. we the the things of those, improvements measures point is But the just we are and that in I proof a related of a of in view that, drug weeks at circumstances. the see see to muscle we

repair parts we the sort of the the inflammation, got to and So, utrophin. it, three

see we good. seen weeks in seeing and we we’re at you know Having weeks in So weeks, so pretty why to this hoping that’s think excited. see XX what are chances you of are XX can XX the

after this some have being continue on sure we won’t what we’ve date. dialogue used we’ve the endpoints will passport the question validation have with in various clarity and we’ve the have and the got but on interactions XX-week on to know factoring regulatory decided discussions techniques far. we on and until and our -- with we assay until to study we data regulators. now our further do so have of to many But relates your on interactions big That’s the regulators second continue about got a we data that when to clarity this are we and regulatory what how forward, know really see question and Now, will for path that the and regulatory

that the data the any be for got a viable us. option the to it are the and just so Europe accelerating regulatory US will early funds that after are we preparing So, emerges. options a In in the meantime, our we all going and of raised part filing before clarity both preparedness, we, for we’ve is substantial

Arlinda Lee

you just pivotal Great. be start very then up, able much. to year? you’ll a you follow Thank May think so trial this your do be

Glyn Edwards

a good as well. That’s additional question

that’s thing trial identical. called trial to the earlier So, helpful we confirmatory that virtually the the very which slide on is the us pivotal trial and are the

So actually, the and the trial pathway run to the eye virtually the that we need regulatory is same.

things know you trial makes can for is. that we So preparing because name easy what matter its start no that

it's same regulatory is going. to the are And that good the independent early discussed is. for developing go at preparing path we which later and parent endpoints but not get the around aiming so target protocol, of our had year been what our that I year experts groups next had We’ve coming is for and to we’re groups start and the of be down so, looking we that, so But us. a study we’ve in relatively effectively for get is preparation with decision clear that trial we have thing and this path that will ever

Operator

of from We Tim will BTIG. now a question Chiang take

Tim Chiang

of questions. couple had I Glen. a questions. for my taking Thanks Hi

the is traditional and quantify time? the know You first you pathway much that pathway outlined time know accelerated two of one reach to do scenarios market I you with say in think sort potential how my that of terms under which Ezutromid. you Could is you’d the

Glyn Edwards

Yes, so interesting that’s question. an

accelerated if approval by the you approval accelerated get really boils how of So, of sake FDA the then that's time would on to at is length file down a decision of based augment a full I the think looking trial the on same that and you long full as that basis awarded trials. the take the pivotal for approval

we’ve nailed that about in market the XX takes is time than And period that the current not our really time carry evaluate to study. data it XX got from out down would months So, length we’ve completely that be then weeks rather and thoughts to it of treatment are the difference this an but there.

current we patient and you’ll study. So, the longer phase North endpoint control That trial you similarly XXX pilot done lower about of a in out the and you then randomized do some of could that than chose [indiscernible] see the natural assessment thought If what have a number and and be that XXX, patients to can and six-minute have a on because others XX% PTC last walk of test, study. if use large have XXX with Star a [ph] ambulatory that’s patients. you probably variation the trial and obviously history

we talking may follow-up, the are recruitment half, two but a period, to years. likely both a terms of So, be be in three and is that

the full as plans into us That quicker the a like accelerated greatest start approval on of we accelerated so very the soon with you Sarepta So, and looks the I no got FDA that approval. year as think on if choose that just broad be matter to drug take we happens highlights the experience patients why it’s really as study like certainty what we for this discussion doesn’t can of to approximation we your you that go we a soon years half account with if than down which important two effective could have getting market can. what two as pathway with a and

Tim Chiang

get milestone associated do Glyn. cash with you point? Ezutromid this you tied you to any potential developmental your from other Do Sarepta. helpful, successful show of additional i.e. data payments with I Sarepta That’s a sort any XX had a that collaboration have say follow-up is weeks, let’s on Okay. and outcome at

Glyn Edwards

stage in what stage traditional milestone. a part and we these come that so has is to a When so did deal miss them, very be, a and milestones it payments while of not out with payment licensing path further disclosed and market common on. more pivotal more when and traditional a agreements, we are there quickly I So, of these the would development And get would there’s of study more more a that accelerates that accelerated if were envisaging call we in would things. the pathway than to particular regulatory you so path be as have you one

yes, So agree and actually path, this accelerates also that data we the the take enough accelerated you strong payment. data strong if not only we to get do have enough have agencies

a compared think quickly. of minor getting part value really proposition the would get to I value that’s we market by the more with

in has be the great more depends US or of on -- I we to number data if the and earliest think conditional to possible to made the that widest approval the get importantly market the can be then is the to but it Europe in -- basis of available the in drug to accelerated allow on patients an timeframe. us path our value of

Operator

take will Chattopadhyay Debjit We question now from Wainwright. H.C. from

Debjit Chattopadhyay

me? Hey. hear morning, Great. guys. Good Can you

and terms any program, to So, in into Ezutromid are of CMC read no one? your codify the or first issues the are independent there through those totally with two gained learnings from be

Glyn Edwards

in formulation straight spray case And have issues particle go to size we’re of then relatively with APIs Ezutromid read of forward a of probably in of the the up step from drying. to learnings tablet. through the are both technological one come But in detail every relatively them making with [indiscernible] straight of and a But appropriate drugs of reasons of there forward always case is be through. the drug a terms component the a at then is There’s experience. both we had basic not these

able sure and There organizational is read processes read no that a through employee David CRLs. skills there’s place are actually however the you’ve So, quite he technological and CMC of me the got to that’s to making in may that be manage capacity in say appropriate something the go issues a words, number are forward strengthening cores few has the those reminded that and we we as of through.

a So, isn't are products of getting out. to manufacturing sorted number market delayed because

it before a to these effort X. So, putting something Phase into of we we're get sorting is up in lot

with as closer it get the is these in is, does So, we both the be of there manufacturing in stronger headcounts our but market and need expertise as illustrate, technical no short company products. grow we to we answer read to the through,

Debjit Chattopadhyay

Okay.

year into be Just up get does XXXX from perspective your now How your is balance does organizational by? programs an guys you recent from say capital multiple And shaping on? with underway. of headcount raise, pivotal where kind big the increase you to much you as for despite sheet a say

Erik Ostrowski

Yeah, which fund of at yeah, includes that. I'll the second through Debjit, it have we terms is least raise that our turn take we then the in currently, April I'm And part of the over. you XXXX. that XX, can the mentioned cash that guidance But, company capital

let other the I'll So, through quarter is which take David around XXXX. piece, of our headcount. fiscal first

David Roblin

you where now And we've that all well you where I now go the to you probably best get done are to get and capabilities Debjit, premise scales somewhat think got. Yeah, you the we to, related need get need that of to to. are question first to are where

So, we've the last through And fact, been the this expensed doubled. in companies year. in headcount

we've an which to been CRO there filing. through So, go experienced headcount accelerated I And enables We base think data, year positive an back on next increased well work that the good with. we're us position. through able to in the benefit particularly forwards be will of to from pretty a

Some be of development But those will CMC as won't in area, arena. operations to the be be so them surprised the probably past it will some of in the year.

Debjit Chattopadhyay

last one up. then And Great. follow

have if where, scenario you data. you So, a XX-week play out

maybe new of do approval? and at biomarker totally the conditional What a way So the on and exclusively focused functional they alterative patients? are because a maybe functional where in miss but outcomes for the related whereas endpoints FDA on accelerated hit position, powered to meet stabilizing on you new be that biomarker dystrophin improvements, scenario the the a You looking not is is and you everything trial FDA's these because seem and else.

Glyn Edwards

Yeah, it's Glyn here.

If then you just Sarepta, walk back before focused on weren't they dystrophin.

I the it at So, to you look then mechanism, when endpoints. think come new with opportunity the new you gives surrogate

in it's functional doubt study a EMA to both controlled FDA endpoints. that somebody and So, dream significant have difference the is no with coming the statistically with

is endpoints accelerated doubt, approval. strong pathways need. high is there approvals a to But there for unmet is a no both functional have there full regulators for and So, preference

functional to this around the a David, This endpoints just with premise, So, of issue things. seems also, stage to think study. to to a which study on we your going like key is I I just these there functional not imply through. I part before And path endpoints. take miss were designed just earlier hand also The is are

So, this study functional benefit the to a miss in don't. do we was a see see something, never designed rather David? we than order in endpoints. if huge If it's a plus near

David Roblin

recently the that, the FDA they for surrogate treating. Muscle disease the is mortality endpoint the they and of Duchenne of development of actually And to to has importance their opinions expected have it and reasonably an guideline in the be touch impact quite issued that, mobility drugs you other Yes. on if on The and have I of the thing to add for expressed Dystrophies. is importance would surrogate endpoints

the magnetic the Duchenne, all, with criteria, is second but call is of In course, they they And XX-patient on MRS need and the endpoint. this come criteria. get are the that But example forward invite in but first parameters fact, that primary to will parameters. Duchenne, the out of two, study need you itself us, such the benefiting endpoints, resonance they one that dystrophin get two biomarkers actually

biomarker this a at imaging Duchenne. good open we a DMD data there to looking are in publish amount to been FDA about work that discussions consortium potential the they So, have MRS, with have the fact are is endpoint as to two, the or very all

interest don’t And So, an I mean FDA primary work potential think have on others. we this in I the expressed with biomarker. as endpoint this, standalone a

Operator

ahead. Singh We Oppenheimer. question of Hartaj go take Please will now from

Unidentified Analyst

ridinilazole, funded are This Phase quarter remind secure of update for then, And in the product approximate just could looking [indiscernible] notably XXXX? initiating studies? before contract funding you two of they are to Emma still us On Hartaj. the first with the and on you X past additional is some

Glyn Edwards

excess Glyn million. $X licensing $X to deal the is cost we expect XX so the the Phase of its Xs, the is to X up period funding year from with Phase of end receive million the our end here. BARDA Emma, of $XXX No, the and and last during the of to an Hi million we towards did

on various gap. be funding spent things. to does on money is rest that But that a of there still the have bottom the basis between So, is project. actually, tangible But

keeping gave those lights So, just and the things. and Oxford guidance cash that on the covers Erik Cambridge

could So, Phase are it. will many the need we we additional cash finished of if the and to look part do you territories, a something But where deals. licensing very And X. regional the, our substantial there that to is BARDA do we address before

potential here think I the of in needs CDI program terms potential the the project the also X years. has -- X it’s for and needs is significant, So, to larger potential, our DMD potential over that’s cash huge value pretty next The the the cash.

Operator

question next Messer Company. comes from Needham & Our with Chad

Unidentified Analyst

This Chad. is [indiscernible] from

So, asked. you how combination the guys most of going forward Sarepta with going see But drug? the questions do have a been already on

Unidentified Company Representative

area. And to this therapies. two when deal. of you That’s Kay] back are the your the modulations a want to some guys really to be months [Kay] exciting data And in experiment over Sarepta [indiscernible] deals. know exciting things, They utrophin different why foot treatment we deal the saw about in potential skipping modulation He the the use questions the I University to announced actually to Exxon did together of if Sarepta they much have at said drug annoyance, this and with some with doing [at go you Oxford announcing they’ve of modalities really with real at various is her a one you question. been, technology. from going treatment the there morning team look team. various of coming in the interesting Davidson some by labs combinations published to her that Richard's And Actually, spent most morning exiting is really and different

everyone think the exon-skipping until utrophin perfect gene that or or a complete we in this thinks get modulation huge with its gives use that rescue therapy the whether potential drug modulation is absolute I to there field that of So, with whatever. combinations utrophin

long-term we that’s a credible. exciting think I think goal all So, is very very that

things focused and to why that’s to agent back we activity the to each of though, gene Just solid happen near-term reality until single on those can their for none trying things these get of get show therapy.

get modulation, different utrophin are focused exon-skipping. next Sarepta are but generation the of on a number Exon-skipping We different at also genotypes not trying just to looking

single the it’s top we modulation far So, potential of has the any be to really has on be the treatment both a think I the utrophin the exciting cornerstone had and field but when agent treatments. of potential a in great used time think other as so to data

Operator

RX Securities. Our of from next question Samir comes Devarni

Samir Devarni

obviously announcement and I’ve accelerated work. today Hello head an news filing, the logistically everyone, I’m my about around got questions. trying thanks its new potentially taking very just to three, obviously and just for my encouraging would how get is that

would If first drug a a conditioning to who confirmatory the run you’re into with potentially placebo planning the study control that That’s study, enroll available? question.

some this you just receive very spend much. much on R&D question you year potentially much is expect in light slight can year? give you just to we the perhaps year? how to guidance, the question just you expect of of money the the could is BARDA pushback that on us confirm indication on perhaps program, are expecting this my And just Second final R&D seeded just you this to Thanks

Erik Ostrowski

happy to I last two. ‘m take the

think can take first. the I Glen

but specific as giving mentioned in much money not help loaded BARDA guidance what we’re around expect grant to So, front-end is how million receive grant the can think I a year we before. you this we’ve $XX

record you XX we so million into I guess the thing the last the add I the towards the in that there. So, did know as had QX BARDA million income £X.X on in part see and the XX of front And factored we beginning receipts comes first again, would Phase expected BARDA you that that of MD&A, is Xs. about are

forward good model look expense guidance, way in or a XX in as to the out about so. that you terms of and think months I R&D In think next

to this overall look some as take BARDA as a year. kind the call as you If Sarepta on contributing much model into a about that Again, taking recall the use that talked our starting we you year. QX and really DMD XX% but this account QX R&D global Sarepta receipts in at of out January proxy to the well offset of cost rest costs of and haven’t which may that’s of and as is of the share

cash the worth to the source of I first Glyn expense. it will question. of the hand part So that’s offset back to another for

David Roblin

here. Yes, its and It’s so thought David good a about. definitely we’ve its one question,

thing a to say to The normal MD&A accelerated the an earlier, progressing under first next NDA levities is trial. is the while Glyn through as all same trial mentioned

would course trial and will is probably addition and and well it. The fully to which the to procedure trial. the it's on have of a So, need drug whether it recruit that that important the either confirmatory eventuality payer pivotal approach patients. the are of confirmatory in biomarker will we it to happen during patients in in it FDA is ensuring discussion you current dose fast surrogate or the a we regulatory we diligence executing based regulatory will And reality with get same that due procedure start study call year should the beyond on so this it and to was before to the last available going recruited a need have early trial,

both So, trial with payer in will recruited the relationships. and next on we think Ezutromid I well consideration the market is patients have their to and those before elements of accessible through

Samir Devarni

follow-up simply to of terms one the in. cost that R&D from that going that ask money? just be another come there I revenue of net income sharing or Are can just your to will will Erik And line in for you

Erik Ostrowski

that that’s item. Yes, by actually question share put comes line and just component a R&D covered that the be cost financials revenue out you the so Sarepta we’ve into will in

you the out. record R&D you we if so, will net so that and full And in

Operator

take Securities. Liisa from Bayko question JMP We of will a now

John Gillings

just Liisa. I if to an be you’re well. endpoints. to was a wondering; for MRI looking look for on and you at going as functional well going I was take are wondering as question. when be Thanks the that John is this you data XX-week announcement guys Hi, taking putting for at

David Roblin

all final ourselves appropriate that It’s efficacy things thorough current we see set. data, trial and have data XX-week approval, to so until subsequent the for in order make data regulatory in company a to see blended fact David key as within here. the here the won’t we The we

hear that results is publish quarter. answer to final should third the we the the you in more So, expect when about

John Gillings

need then your think guess do of a your is about decision on to thoughts this be see that’s you of I to data thoughts, at FDA or the And timing you release can but times you out? even that the their same pursue, time you data do kind some path you take as with how consult talk playing little which on to Okay. going to dependent,

Glyn Edwards

the passed. more -- be data alternatives. think to the has I won't I but the come data slightly will each will out as about second data. price likelihood be until announcement obviously think part we an But we path, soon the obvious regulatory the as definitive time it. The it conservative The -- be data from the will -- of blinding further it for speak Yes, think your to your about are to of we get will sensitive I going make us

but are later that, we my I our be on we’ll focused cheering. and till at announcement make all about it. regulatory path be is much we data on we are which So, guess so We a think focused into buckets formal look won’t either crying

Operator

Julie from We question take Gordon. Please will Simmonds, Panmure a now go ahead.

Julie Simmonds

to as accelerate strategy as the going announcement be the Assuming in what’s concerned you the you’re US? far we approach use will on of an basically, hear data if approval the

Glyn Edwards

endpoints whereas the for but approval robustness are necessarily looks they partnership similar a endpoint Sarepta, more about approval any slightly there in Europe have approval the requirements those. responsible to look will regulatory needing accelerated decision US will in those the Europe be is in but for filings endpoints different we European of without plannings. the there statistical at high proof called executing be Sarepta on a European degree with with pathway But but so so in on surrogate are joint the conditional conditional at US ultimately clinical an secondary Yes, Europe

the up focus slightly in similar opportunity But be terms And for at Europe. filing that opportunity of focus data early obviously different. the So, Europe our data be get. the that in in is we and the the think the will and they way look the pretty U.S. Sarepta's the broadly early U.S. will filing in speaking, of on we

Julie Simmonds

are trial doing both we Excellent. be those. The will sufficient planning of for on single

Glyn Edwards

it that in actually of yeah, would. study one discussing we've in steering parties the the interested Sarepta joint design Yes, with been design. committee Correct. And as that trial

Operator

questions. no further currently are There

Glyn Edwards

thank of And the for progress I different areas, questions, to like company. there if today. to We've got Well, analysis making exciting to therapeutic is the all seem most two all this are time you say have no rate and first for that Great. further us I'd we joining quite these of up both our of the coming questions we've data the XX-week them. already excited milestone top-end But in the data. the is phenomenal was our versus hugely a focus XX-week seen right at be being from at big expectation. the of

by and likely excited coming this what really about see hugely we're we optimistic So, in the months. very

Thanks all you and we point bye. keeping very look to your forward So, thank emerges. interest for informed the data much Bye indeed. you as

Operator

your call. concludes This Thank participation. for you today's

disconnect. You may now

Summit Therapeutics (SMMT) 11 Apr 182017 Q4 Earnings call transcript