SBPH - Earnings call transcript Q4 2018

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Operator

Good morning, ladies and gentlemen, and welcome to the Spring Bank March 11 2019 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. [Operator Instructions] As a reminder, this conference may be recorded. I would like to now introduce your host for this conference call Jon Freve, Chief Financial Officer of Spring Bank. sir. ahead, go Please

Jon Freve

Welcome year Spring corporate XXXX call. everyone. quarter update Pharmaceuticals and full financial to morning, Bank the fourth conference Good results and

me The prepared management will be Spring our Joining a and remarks call question-and-answer by Martin session. President Officer. is Driscoll; Bank Executive Chief followed this on team from

those forward-looking various call the of indicated plans other result call about section morning the these the as form identify statements a factors release our could, denoting safe those the turn statements let and and I and important will disclosed under by Securities contain that events in to Martin, reports. the risk other purposes the words potential, me plan, with Litigation as Actual statements of results future will from future forward-looking expectations, of those statements remind harbor statements. well provisions SEC as Before Reform SEC this words press XX-K expect, over today factor forward-looking disclosed including anticipate, you the XXXX. as as in prospects filed constitute that our for may today's materially Private company's The of differ Act

to our represent I would representing like March be relied statements Driscoll, subsequent now, And our any CEO Martin forward-looking over date. the Bank. only and Marty. upon views to any should addition, the as of today, as views of XXXX In XX, not as call Spring of turn

Martin Driscoll

had active highly we're to XXXX. for many milestone you morning. a believe and John. Good of very looking joining thank morning, and we us that similar you, everybody this XXXX forward field, you Thank and productive know I a

be place safe hepatitis inarigivir inarigivir against development session in at Nuc-resistant to breaker highlighted involving Locker abstract isolates. trial advancement Data entire This to by Vienna other and this Liver study B. achieve a approach, and impressive in treatment will the from neurologist in clinical from elevate Nini, anticipation oral in top virology Principal pre-eminent And been EASL inhibitor presentation XXXX take HBV International the patients for HBV the activity efforts functional chronic treatment data our a study accepted dose dosing the of has general the of completed mid-April. to core efforts line global by the and presented are involving milligram of backbone Professor combination ACHIEVE poster of with late rates demonstrate treatment us ACHIEVE announce inarigivir at XXX trial. describing continue continued the Congress Our therapy also oral global the variants We has in combination cohort chronic presentation from recently program inarigivir at simple, that II cohort Capsid the inarigivir therapy a the to will for Investigator our for we describing conducted development and that the be cure of Steven clinical EASL pleased was resistant a Phase our the a our and our final trial escalation potential and XXXX selective of were to strategies. for as of the

X. first our are in mid-April global year launching the a for company, you half and Phase Liver for Catalyst major As can this EASL that upcoming have two International named one Bank. we Catalyst inarigivir of Spring see, trials Congress and busy IIB will X the we be In

in we monotherapy dose a HBV some of in the the of patients launching potential There Catalyst These co-administered patients. chronic trials X speak. we're process could inarigivir with and in in that is XXX use virally-suppressed as these two trials. and observe as naïve the of functional cure we fact, will Nuc the milligram In examine

As are X who Catalyst of virally trial we Spring two patients suppressed. includes described day our cohorts the R&D non-cirrhotic December, Bank in back at

inarigivir of assessment weeks examine The the fine and patients cohort daily XX of will a first for flare specialized points once study end include be needle patients reduction percentage loss The the dosed following this will in whereby cessation and our of stopping aspirations. XX cohort intrahepatic ALT using Nuc use and the sup with shucks therapy. virology for we immunology

a will response of seek virally-suppressed cohort patients HBV second to Catalyst randomize X guided The XX chronic study. in

daily XX will a assessment be continue end or new pivotal clinical characteristics a of and for and Phase surface using cohort second the study Shock intrahepatic trial Shock receive results specialized reduction key our our inarigivir of be strategy. Suppress points Suppress virology treatment & the their and The the for Catalyst once instrumental be will of will whereby a either antigen weeks. loss Shock needle the III The patients weeks The from & X design for patients & XX will coadministration Nuc-suppressed immunology inarigivir aspirations. with in fine formulation and and a or in pivotal determine Stop for optimal trial

be three the for randomized If second we hope am of a of pleased in the this Catalyst in second trial this will end report regulatory trial to HBV countries. involve in next CTA the of the cohorts. this XX will few we randomization as study two X expect file number countries month. country naïve we these applications proceed conducting patients Catalyst before one the treatment to or the for begin and clinical patients, months. the expect I to we that in application study these We filed to catalyst one number trial trial first have CTA two already for non-cirrhotic

patients for weeks. sometimes then evolve XX XX XX milligrams monotherapy once also for weeks, coadministration by alafenamide, inarigivir TAV with of daily XX cohort followed the first called [indiscernible] will dosed The tenofovir Sciences, or Gilead

coadministration patients three an with The the weeks. XX second use by additional XX for for dosed involve [indiscernible] followed will cohort of XX weekly inarigivir the of times weeks

inarigivir XX will [indiscernible] weeks, receive XXX continue will coadministered one The The XX [indiscernible] daily, milligrams third additional predefined the from all co-administration will cohorts dosed who patients XX patients catalyst inarigivir for for weeks. of and responder with XX once at weeks. involve cohort an in number

and line fortunate are for of the supply relieving X XXXX of the is XX weeks in the for We are some from to for treatment with generic RNA Gilead We particularly trial, Gilead. patients, cost by our agreed could to doses inform sufficient The examining top program of III with burden or the version us that which to HBV -- fixed thereby Phase one early from of data the number of inarigivir cohorts this catalysts we combination naïve supply couple DNA loss drug reduction, e-antigen Catalyst fumarate together and is inarigivir data early Spring or advancement end -- have this treatment Bank points XXXX SB for co-administered antigen of to has trial a loss, disoproxil reduction data of for study. our ongoing Gilead HBV in patients. the chronic and that have dose XXXX multiple could naïve involving surface tenofovir

the in X multiple conduct the States. United including Catalyst We trial countries will

third regulatory our quarters and early this will We this second applications this through and the file trial of in this year. for

on XXXX. development for early a file the execute data we X middle inarigivir the of the in We to operations our trials, pre-IND IND FDA position year. with discussions from If related effort throughout have continue the it inarigivir Catalyst and recently into first positive this clinical should to trial plan to is continuing we multiple our of part these be regarding completed catalyst trials and for and to the deliver in readouts XXXX our

sum funding multiple these providing executing us inarigivir examinations As in currently Nuc patients are we patients. relieved cohorts a in coadministration is year, this we Gilead daily dosed sizable and multiple conducting this we inarigivir a that treatment with virally-suppressed once treatment HBV our patients plus expanded with HBV HPV of XXX naïve HBV trial milligrams XX daily essentially XXX disclosed expansion, and important cost clinical inarigivir non-dilutive Since and the in what naïve is and XXX daily a inarigivir Gilead of the XXX partnership collaboration virally-suppressed [indiscernible] to a and equates Gilead Nuc burden and into patients. of the milligrams the milligrams trial [indiscernible] Gilead co-administered HBV HBV team. of -- dosing our inarigivir HBV the with with include clinical With Nuc study once naïve in once co-administered co-administer doses studying collaboration with HBV milligrams highly the value to of treatment with dosed milligrams XX-week We of with last chronic patients. capital. trial of virally-suppressed

a inarigivir enter HBV, different experts study even quite major with Since in effort at launched in we implementation, of we in swath will reactive. III Rather, of Gilead's we the immune effort with XXXX, Many present a from A believe with has believe ago, down-regulated diseases needs. virus to we believe study, successful from a the heterogeneous, we plus we modalities year. major backbone strategy scientific biopsy become our preliminary progress [indiscernible] or this fixed trial one-size involving rates results ongoing from that functional this the coadministered for on patients. XXXX certain demographics population trial functional this in that of not [indiscernible] Phase inarigivir, just inarigivir this oral tailored the ready hepatic and completed SB to studies, this a the be and immunological will We to later tenofovir trial manufacturing fumarate. from in period combination the of profile Dependent SB recently program dose XXXX. the to for compound of half broad potential the second This to a will chronic the cure believe generated infectious conference this hepatic available the year mentioned position quantity XXXX development competence sponsored use do substantially seek modulator the inarigivir. hepatic for campaign orally treatment HBV field by the progress on do our the for as Catalyst tablets. be schedule a conference the naïve involving a dosing we be Although all trial few data could rates an treatment continue will presented in a clinical of six-week compelling this could a be SB from appropriate We chronic viral to initial control must don't milligrams anticipate examine be data scientific minutes in for substantially the to data fits is inarigivir X of TDF We elevate patient patients. study patients only of intrahepatic I order selected year. If XXX cure patient of disoproxil be release we treatment Gilead suffering HBV innovative to at liver in elevate system HBV.

do agent concept that could And believe most, variant all to [indiscernible] of our immunomodulatory that strategy a of the at treatment chronic establishing required pillar of However, core this will be the [indiscerniblef] of we effective is treatment future development modalities. if these strategies backbone inarigivir HBV. the an not inarigivir be important in

by with Of effort on current standard this continue This course, is care, the we we have with of the inarigivir been coadministration that doing will initiated work catalyst of the the Gilead the of has trials. first Nucs. of phase our and focusing

compounds. the curate. you HBV differing strongly complimentary exploring engaged of a of by discussions collaborations action before triplet with a related new Capsid deeply the tell I'm could functional had inarigivir We we use into HBV FCI involving treatment just with collaboration with one for drug least are compounds additional this triple coming could enter months that combination that optimizing we study trial inarigivir to be pleased mechanisms into of other are RNA strategies Nuc including to in the We end such believe mechanisms at year. investigational pursuing that inhibitors and trial this together clinical in strategy clinical advancing that of action now

XXXXX we company, While SB our are the our SB candidate next candidate progressing from exciting with plan developments FDA development agonists strategy and busy HBV clinical conducting SB STING also development of half for clinical we and development alone initial in our discussions been That of is of the our latter the intravenous form process SB the now program XXXX the are have product immune-oncology lead advanced platform. inarigivir XXXX for right XXXXX. XXXXX. the generation of pre-IND IND-enabling for in We

proceed in of to able we second as the dependent planned, if year. Phase for with quarter to FDA formulation in current we Our could to trial plan this with we this for meet SB end of have. and talks next the of the ADCs the Throughout IB year timelines, also a XXXX. clinical in platform If the into on for the year, be position middle advancing administered also of early of be initiate data or IND discussions the of our that we antibody will we're XXXXX linked the This this the XXXXX intravenously will can analogs program our agonist submit and from perhaps new first optimistic is generated year. an we continue year, we investigational we to the IV STING by candidates agonist we the progress an IND-enabling should STING conjugate take have year or ADC in development have drug XXXX, toxicology over our a is

Phase XXXXX fund exploring including STING the also development formulation. multiple a equates of cost and to allows data program, $XX period offering other during our sponsored in to trial non-diluted from plus to STING know, inarigivir from approximately we XXXX study agonists from as capital common significant XXXXX as offering lengthy including of of which compounds Gilead's a which readouts you SB delivery are a and associated we [indiscernible] with together programs. SB expect generate In sponsored two Gilead's clinical company our proceeds inarigivir nanoparticle with raised time stock. for as from throughout relief, proceeds public well many the HBV our The agonist us of IB million essentially our We platform, this methods our August additional gross

under with cash and press of million to million expect prior our As quarter to million $X release for $XX we'll this issued plants. XXXX burn detail We current an just we per call in ended to $X you. our average

to important capital continue during as to that of this multiple cash, on programs. catalyst shareholder's for $XX million will, can in highly it proceeds early our execute use the you optimistic year which I efficient now of to advancement for we to we be you our our R&D We SB will It's our John. company's turn and with inarigivir listening our through my later thank data have XXXX over the be XXXXX we remarks valuation. if period note with with this I'll are readouts beginning and

Jon Freve

Martin. you, Thank

financial like XX:XX:XX] I'd Now, [inaudible our to review X, XXXX.

XX, equivalents securities cash million $XX.X Our as compared as cash were XXXX XX, and December to of $XX.X million and of XXXX. marketable December

$X.X of ended the The million net was like net or to and loss the months G&A. XXXX and in in to ended of R&D per compared G&A for loss period call $XX.X we're a $XX.X $X.X and And of XXXX December turn months per three $X company's the million balance expenses net or and three $X.XX and was into Marty. million Marty us the $X.X expenses loss which As of alluded XXXX. enable to million operating December diluted. the will compared respectively million of compared months loss for consisting during million cash share, Total for $X.XX basic loss $X.X million to, we now $X.X back months per of XX, our expenditure requirements ended same activities XX, share diluted net anticipate period same of net operating XX in million quarter the the consisted -- million share that XX, Net used XX, XXXX December December to of XXXX, to million capital $X.XX to I'd ended this basic second for fund XXXX $X.X operating XXXX. the for three R&D $X.X

Martin Driscoll

for our hearing thank you remarks. gentlemen, in and this morning us ladies So,

now to I'd open lottery. win up Q&A. it the Mari And think Cross, you to like I the

the morning, You you were turn still ask the question, this it first would so will to over Marie, if in line you. like I to

Operator

your question line comes first question. Our with Mari Cross ahead the with go Please from Jeffries. of

Mari Cross

to happy with you. first win Thank the I'm this Yes, morning question.

if getting the data for more but to stage there, don't it accepted help you provide EASL. on breaker there, to know the update Definitely details to what are then and late the can just with congrats you looking into can a towing whether by you're or XXX how the as how So, ACHIEVE if you seeing if foreigner you're particularly read forward expect the any and set make the the to dose willing data dose response remind made dose. catalyst from I

Martin Driscoll

Sure.

to they efficacy tolerability, there impressive The DSMB, dose of the Board safety for each for dose. XX-week met antiviral HBV trial no and the the you XX at the end Mari, have primary that XXX. inarigivir was Safety know latter issues. and and or December reported did both DNA dosing dependent safety Monitoring the doses it tolerability, the review in the Indeed, which of stage we quite each again, early XXX RNA So, the earlier Data of at once safety and XX, tolerability cohort period were at milligram points

EASL. of a However, the patient few dosing is the moreover, into the analysis data at so week weeks don't end XX wouldn't and undermine the we actually presenting the dose who'll the data last primary full the secondary only points both session be want and data general still of you and principal on. the give We any going full A can't investigator insights know last ago. to I at period the occurred the

can't you insights I the this unfortunately, give So, morning.

Mari Cross

Got it. That's fine.

I'm the antigen with with those into enroll there's wondering a the then. baseline influence just [indiscernible] if any IP-XX if on catalysts could perspective biomarker you on question and patients trends ACHIEVE, update Another and

Martin Driscoll

Yes.

levels, the well. for baseline XX that [indiscernible] XXX milligram the but know, of So, I the be part as don't analysis we know don't dose date might is

we good in milligram trials dose did be be excited potential healthy have that study and year. can we the part a innate milligram The the first of evidence highly as, a and interactions. will frankly, we'll dose This filings study last activation on about we in will the activation. fourth patients volunteers. without immune XXX There the for any look milligram This from would these healthy volunteers with earlier conducted from is one part so peripheral other innate are volunteer a safety regulatory drug-drug of dose work the be and in with both we're dosed XXX all We from used I your had the that the efforts. you immunity of classic lack the dose these of to we're in of was profile the we impressed at drug-drug PBMC excess issues reasons production. cytokine catalyst favorable was doing. excited XXX And quarter and pursuing The that that time of interaction our were informative doses milligram dose. tell that So tolerability in for XXX milligram about XXX data of healthy

question, cohort. So, [indiscernible] be will the we to clear XX final on your have from

the information XXX aspirations innate volunteers patient rates. of addition XXX is healthy and of as catalyst one the it's this the liver interesting that as activation dose stratification, able optimizing good study, work, for to the fashion fine conducting going milligram this a do as be in from trials to with in biopsy on we're reasons milligram the picture including responder immune well of think data for needle this the we And excitement All study in we're the we dose. informing the us

Mari Cross

that, of of mentioned dose that doses? you a Got you of seeing, and that that do That's get higher at patients that well response just lot see you higher immune more the Mart. with And out innate you're at immune doses? as before more Is a and you it, you treat, helpful. flare that the where response Or in it patients up. see the curiosity,

Martin Driscoll

PBMCs basis who know the we we the liver, milligram that from milligram interaction look were because XXX the these a if to patients, took for would particularly these the dose. we don't the again, Again, at was XXX study, there when just study interactions our drug-drug I any dose. but to studying metabolic receive pathways volunteers principle did drug-drug healthy were

of milligram So excess XXX was again, these for presenting innate and again, just peripheral immune a And it the coming activation we'll cytokine it's weeks dose. in be the production. data evidence the without,

Mari Cross

quick going missed have before last a one catalyst biopsy stuff, from do just so the press I may you be about then maybe release can Where question, from? study, remarks, which And the you're you've your those get? just to coming it. that liver but going in it Got What liver the the are just single study, more clarification, got the to biopsy the dose to talk aspirates in going are center. they And patients liver separate study. is prepared

Martin Driscoll

Yes.

So, and with the in work conducted lab, laboratory naïve this study inarigivir highly At They respected [ph] cohorts. It's six dosing milligrams will Patient's weeks. patients. Bertel done Eddie being is and Duke-associated will in is known Singapore. randomized a team. they be being by Singapore. cohort, immunology his receive conducted two been XXX globally treatment One of needs once are daily into one for hepatologist

optimistic said we as the patients if weeks be could in immunological of panels we cohort biopsy could of this will speak. and We're date year. Nid screening a six The There's several a study full times in receive data. patients inarigivir liver XXX six be conducted baseline conducted other milligrams few patients occur on and end we two times, of three intrahepatic be conducted some patients a biopsy days be to in and that trial half The weeks, week a this next here of a liver me is should those the virological the has or there'll disclosing launching that the latter with from as treatment, at weeks. will

Operator

of [Operator question. William with Xu Blair. line with from comes question proceed Instructions]Our Please Katherine next your

Katherine Xu

other with wonder while indulging guys there done And one Can activity Gilead whether just as that lastly, just expect me. there's have and IV of some XXXXX? synergizes was any SB the I the Phase then thoughts We actually times in injection have agonists Do well. whether any I that dosing, affinity thing data one curious that STING which then agonist expect single why thinking just morning. is think the of whether about particular is STING a there elaborate seen also, any possibility or other haven't it route. I'm the agent Good theoretical week few. you. CIW and though, again you well, I helpful producing agents you on I'm be you the inarigivir Thank And you That'd Thank so better of that the little any curious inarigivir reminder that there's combining data much that. you the as there. just comment. of I agents line. a single for thank a activity along three there's difference well, institutional II agent to, from with. [indiscernible], need far you. experiments whether with And RDI any as between bit

Martin Driscoll

or others. you to The two Okay. ask Katherine, got week. three again? three a sorry. question? the I was Oh, three repeat times your first a week. I'm times the one What can I the Yes. first

FDA Nid So, back the from the Nid another and EMA, between conference, from that industry. London. over all points is He's occurred London end in of returning course. the of you weekend major conference all, flying way, By know after

once it if simply see system. could times and see essentially once week forward again, curiosity of as once a a that. in he i.e. is. X a to comparison perhaps Nid think that immune other the effective sufficiently daily study that's him talk times at a pharmacological Looking about dosing as is has the a immunological load It study dosing to every as to he term a to what three if it's versus it week trial at the you I half-life. what XXX dosing, is That's And by to wants activating be different an from day half-life. that to compared activation are the day results inducing you the of would immune seem milligrams, week? what will, about to desire there's the three a Catalyst -- to a

with over You as time day you have similar dosing. might efficacy once a

we to you [indiscernible] don't versus an in share on Capsid data any at with a strategies, those at no, this work do but might RNA. that it time, data terms In what I time we have fields can of have inarigivir tell SI comparing this is going no you Catherine, trials. you, today. about plus that optimistic, might in we those to year as with we before be end the data modalities separate I prepared my treatment perhaps present could one, that clinic comparative with the stepping be able of both We're of in remarks said the

Our are doing could going think very well be and we we discussions that.

don't to on Regarding a report have Gilead's TLR X, I that. anything

next may year, wonderful on and have anything We don't I HBV deep the with data certainly, a over knows have that. collaboration and Gilead to I here they but believe be she report revealing folks I guess something and

explore We is their they at different to to II disclose still with to open them X But data think I the this with want Phase excellent. time. need the that. we're now to TLR relationship modalities treatment certainly continue

have terms guess reported compounds. STING by generations we perhaps different these I Aduro [ph], a you clinical XXXXX, on agonist do Merck by the than actually more SB for data of the encouraged last late data by earlier presented We're importantly, view Regarding the little year and data. in

the clearly they clearly, and target the upregulation that agonist case know shows in of by when shows [indiscernible] particularly the of engagement tomorrow route STING given were [indiscernible] by delivered You the data, immunity. Aduro's [ph] it But obviously.

other was a there We evidence at as even good data and safety very the positive also response a even of doses high profile showed from as presented monotherapy. took the insights three with by both They companies. grams partial

monotherapy. We as given STING case. the that's Phase pursuing II tomorrow the agonists asserting think and don't the combination is [ph] field therapies. Aduro continued data their And that agonist. agonists think are certainly be both it's interest for trials don't the STING anyone STING that will So, believe combination development in Merck the clear of and in Novartis the Merck validate we I

good that's be classic So We we'll judgment, Phase will development. doses in one I at can the as and remain study, be target dose on assessing safety evidence that profile that all interferon think looking be the relatively STING cytokines don't administered In with escalation. will the We'll in be excited, the monotherapy monotherapy. agonists our a administered the represent my engagement continued cascade. be IB for important and that a believe they looking type

with So combination STING XXXX in combination intravenous into our will the giving we a in segue agonist quickly checkpoint program inhibitor.

Operator

Piper line with Thank you the Our your from with Tenthoff question. Ted Jaffray. comes of Please next question proceed

Ted Tenthoff

Thank question talk John. very you you and may. if Great. Thanks the Good Quick to I update. much. for Martin to

a what approach? the And still the done approach? So you for ADC? bit the different little to be more tell answered, a of What's more can goal lot about STING you us that you very needs but Thank intravenous much.

Martin Driscoll

what So, believe more We've studies don't of this optimistic. needs be conducted done in program. so of We're at to various be IND-enabling forth. any current terms the talk all agency and discussing time. we done, with studies, needs we're more series our of And to the a IND-enabling

to of clinic, that and We do course, go have conducted all the with we the to of has at agree of into that. the middle the FDA this IND-enabling year, need work to

us we continue basis, So agency Phase to Ted, a of element those clinical sufficient to -- provided And SB key information believe but of we allow believe into could non-clinical we've simple design. course, we have XXXXX the done I work will program do get with clinic. discussions our IND we that work a to the the answer, on our be to

the get STING we Chris and and team IND the goal have [ph] allows designed optimistically, of clinic. to discussions as platform we'll The Dr. our agency antibodies. So, we'll with chemistry to have conjugation programs, ADC second able, for quarter file the Iris and a good said, into his the in be with agonists our that

cancer. linkage. those of and for ADC the we were programs entering the for have We from for year. our or a team the encouraging development develop certain tumor solid a liquid Dr. different cancers. antibodies, progressed our talks and solid one early have Obviously, is tumor be be tumor. ADCs other intention work for a IND-enabling for the platform to to STING be analogs successfully to for clinical to to hematological or continue the us linked in successfully programs more If have these to another program agonist one Iri's both would could as cancer The a one next done new

Operator

you. Thank

comes Our next question from with question. line of Please your proceed the [indiscernible].

Unidentified Analyst

and John. morning, good Martin morning, Good

week could please better point? would to timelines updated I X, which Catalyst you to you X, the at XX time results be before from wanted X, point, If Catalyst Catalyst both suppose the I would understand on Martin, that announce anticipate of just clarify, at the

Martin Driscoll

presented oral milligram we So, milligram data, and plus EASL it we the top be Gilead on the later just year, inarigivir that back, step [indiscernible], believe, and to milligrams Nuc population. As the the the study XX as -- will as virally-suppressed at be and will don't public XXX although the [indiscernible] we results likely at this both the naïve session highly the general the an the presenting milligram, plus of XX we said, ACHIEVE release XX in mentioned, and XXX XXX sponsored the treatment for control is presentation Gilead of

Our out Catalyst to read weeks the involves our is then day probably trial of XXX XX because of next milligram dosing dose. X it

there's to three Just remind you, cohorts.

once is milligrams where weeks XX for weeks, first for subsequent is followed inarigivir daily by inarigivir [indiscernible] XX The the another XX with weeks. given a dosed XXX XXX milligrams

then that timelines our the cohort XX if do three with and data of meet we we as -- daily schedule filing for week is inarigivir and the milligrams CTAs, XXXX. three dosing the times three those occurs end of XX for weeks the could in XXX this a with this study schedule to of enrollment the of track then estimate plus that combined and cohorts weeks. is we by If and week inarigivir it we for XX are third to have to, weeks -- a early on second it cohort The the this milligrams subsequent XXX times year we

XXX we're ACHIEVE aggregate SB could the well trial quarter of biopsy hope. early the the by believe Phase Phase that XXXX inform XXXX, milligrams some of fine in XXX our deriving reason our second plus That's of will XXXX. part be end the treatment our naïve together as second first aspiration data and on III year, data our in with our mid why XXXX we first So, us data this III it part strategy perhaps middle or our this a and needle Gilead That's plan. plus by combined, as the is, of the the data milligram that is is early plus liver

Unidentified Analyst

week into their A, time the for criteria spell that could XXXX? I question of X from responder One please. XX trial, that the point co-administration a moving is on Thanks criteria you responder the respond to up at a end is [indiscernible] with XX the there there period. down And week portion additional out if understand clarifying. criteria Catalyst

Martin Driscoll

co-administration, responder Okay, XX second not of dependency words, we're into XX. great. answer other question, analysis, on but your in the predefined In -- there at to responder is no. going additional weeks the No, the the a dependent week is

in So XX at greater antigen more dosing period can who weeks. surface one one cohorts, week responder, log a than half XX in another for has all the three therapy reduction a or continue one

than achieve which see all is predefined want weeks, the half We responder functional can't is if So, a a at or an than The purpose cure at continue XX XX can has of this additional we duration for if antigen, more patient greater dosing. log three to on surface mark these they simple. cohorts weeks.

Operator

Market. from Please Capital comes question of next with Instructions]Our line proceed your the question. [Operator [indiscernible] Taylor

Unidentified Analyst

Good morning and guys. my Hi, thanks taking question. for

of question. the on earlier follow up So, couple just to I a wanted

dose may Catalyst program, but see thing the perspective then hoping could bit will the then start first you're the trials finish many additional one how in very you that those And mid-'XX, study, your a may and [indiscernible]? required? us a the mentioned about have that X will trials the Thanks III the is and could give a the but combination on what possible in quick you You explained follow-up trial study what we catalyst fixed to III liver be on be What with from you others zero key before much. and you Phase initiate be metric that little X from should biopsy required to maybe on? Phase for

Martin Driscoll

Great.

know Let me answer two our will the to those trial don't first. We answer be. program last pivotal what questions

We the discussions will have to have an Phase end of with Phase post FDA. II or II a

discussions very agency. positive. have We have They commented had political development well, very on with the programs

the sense We size required. that of database be safety the have will a of

guide very The can went Phase program data But pre-IND Taylor. very I inform the that. discussions with that the We're well. pleased will us best So, is probably from the discussion will we us. the IIB you, data give answer the agency had

think for I agency fall guidance issued in the development. compound the investigational know draft HBV you that a

So population from from so and the we demonstrates that's an the one population, of that trial have if milligrams on be formed is Stop mentioned agency in either into catalyst plus middle from for the work we the patients monotherapy in our that probably the into combination the trial, know co-administration strategy but that with has Gilead's a that dose I advance for Phase our work war based on believe inform that we could functional program be discussions before I Catalyst basis X catalyst the potential will will with if And programs us our SB will Phase combination the strategy Phase us Catalyst fix inarigivir or number for in I in doing our the to that that X, mention, in dose in for of I guide cure number complete we IIB half good XXXX monotherapy that milligram in the our total monotherapy of then we And Phase as confident that Shock a elevated XX the and particularly & say curiosity XXXX our to will pivotal III great Phase as XXX strategy. don't the the could in could XXXX. the is think go first is program. us while forth, III, to needed, XXX data those naïve continue. IIB will treatment for that. guide cohort trial trials weeks III the have

like. but looking classic ISGs from It's classic the and of aid markers we markers the full prefer of would frankly hope activation can measuring going evidence the inform evidentiary have I I it basically measuring he you take characterizes certainly I FDA. the to and with have you tell on with that, agency. a innate if think those the he to but virological [indiscernible] I'd share of specifics deep immune Dr. we'll sense wants other a had the we can the you'd he's immunological further the The that that know the need liver. we panel an later discussions immune to give we first already the question, that you, you data of we've the data do be based can where in activation discussion, will And But the to then assess intra-hepatically. what with us To So a your various see follow-up I that discussions Taylor. and and for you study, more of they're tell

Operator

concludes floor gentlemen, this our session. Mr. for to and final the back I'll any Ladies comments. you. Thank turn Driscol question-and-answer

Martin Driscoll

additional please up thank with the Well, our you Thank forward weeks Conference in the Thank and look on you to morning. shareholder's keeping our capital, to utilizers to European -- in again and forward continue Liver all. mid-April. achieve of looking milestones, to milestones. and this us very follow if we're time International you you questions. have We work us these coming the particular you efficient giving be the hard We'll for informed

Operator

This Thank teleconference. today's concludes you.

may your You lines disconnect for your at Thank participation. time. this you

F-star Therapeutics (FSTX) 11 Mar 192018 Q4 Earnings call transcript