GNFT - Earnings call transcript Q2 2020

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Operator

Greetings and welcome to the GENFIT Half Year 2020 Financial Report and New Corporate Strategy Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Stefanie Magner. ahead. go Please

Stefanie Magner

half good This this and update. Thanks joining on corporate at our for just details website also Thank our our release about half afternoon, can XXXX for new first providing release first a strategic corporate update, financial us which issued included roadmap. you, and press everyone. financial press report ir.genfit.com. We accessed and be

adjust years actual numerous estimates implied forward-looking statements. differ our to or to risks by and and our reduction our elafibranor Reform the and benefits U.S. known to Act be expressed statements we’ll forward-looking could commercial results subject and flow as management, launch completion those and Private this making by market of workforce including to for Securities the our by certainty over strategy business a timelines projected Litigation significantly our our are our the unknown next of based XXXX expenses, the ability the cause During restructuring convertible assumptions PBC, uncertainties, be our projected future late our later diagnostic to the call, bond. the several a projects, These success within size NISX corporate GENFIT, of reduce on of which commercial PBC, study the in to cash of although defined by corporate success statements objectives, respect materially plans, of reasonable, partner with performance, believe or ability trial, operating timelines under potential new LabCorp, market in and of for powered the expected and are of test for of outcome Phase from program, terms prospects, our and including forward-looking which events X

only available our risks business please most operations to those important could and and in For statements any webcast. the factors new undertake whether the including as contained refer this These the information and otherwise. of our our to or result as with further revise other SEC that results, Company year website. or or financial than discussion speak required date AMF, applicable material a forward-looking statements, information, on future report as of law, does recent of filings update not forward-looking affect our any by the obligation Other events half of

Joining this is Pascal CEO. on me Prigent, call our

open time initial by the Please up that Following Pascal for for the allow addressed to management. be the our will I’d question GENFIT to now others. we’ll Prison. one CEO, to yourself prepared remarks, over turn questions call limit call

Pascal Prigent

I of Stefanie, X announcement everyone. the how joining results you, redefine and RESOLVE-IT and good the purpose today work this see of twofold: we First, and the corporate discuss results discussion. did our our over we corporate will structure for following present into Thanks the for NASH; key implementation to how future forward. dataset translate and a summer our GENFIT. means vision this full strategic new with its I’ll what RESOLVE-IT finding then will roadmap the the in-depth start the analysis out new carried and the Thank webcast of conclusions strategy afternoon, on for a from The Phase secondly, share new is the organization. moving how and

the a to look questions. have we’ll this will years the take what the an you end be and year I’ll of of plan our for Finally, GENFIT. understanding implications half should this few of happy financial At And discuss call, like perspective. then, coming

dataset. rigorous turn on Now, gained the from the work insights our conclusion the the had analysis full I on will to and additional RESOLVE-IT we’ve from

whether there well on this the dataset, as analyze study as look in-depth and clinical to an justification successful that the at was data reminder, review histology was objective assess a outcomes. believe take prove findings As first could complete of biomarker the to ultimately evolution

in also potential elafibranor of the explore wanted to We subpopulation.

of evidence not Similarly, and specific to enough high trends see did patient justify a new observed stronger did groups in positive we we not a response activity, of see the we Although, significant probability enough success. a study justify with development program. in investing continuing but to

meet paper evaluation new as a findings, recently and of community second RESOLVE-IT the reliability Our that important date, having a data this We of the The have objective with to MEA. the conducted with we confirm inter-reader about statistics realize implications how day, because that whole trials. to understanding forward the variability. of address existing a our making; or biopsies Subpart In randomized concern, questions committed second end number First, inform in use inter-reader in renowned it only of real low Hepatology, FDA certainly conclusion the the the along to could read nothing approval. the liver RESOLVE-IT, that findings outcome specific for look the any kappa published two variability. we and of of biopsy biopsy variability a been the described our the dataset is context for sufficient implication values study were topic to have complement of reads internal and and better H from trial too we the the rest was inter-reader have to covers the histopathologist. related to to RESOLVE-IT discussing suboptimal of NASH understand which EMMINENCE to with objectives: draw To a the us decision secondly, were clinical permitted is which performed, a support At Journal and concluded these

article terminologies as Moving the we Hepatology, for Journal Elizabeth it be the will methodologies, an trial important expectations stated same of believe from to Brunt in issue field harmonize by for forward, assessment. of and

of complete NASH, the determined was officially July. combination also the of decision. related in from the we results several stopping all our development in with includes NASH. as we we of guidance the we pediatric continue programs, from and in program NASH to lipid cost of landscape well ongoing probability analysis NASH right dataset, feedback elafibranor latest study acceptable the clinical ratio large, NASH RESOLVE-IT, also trials are in as space considered the in not Considering expensive. development and regarding and success development. that completed RESOLVE-IT new Therefore, Phase data very RESOLVE-IT NASH terminated and the analysis studies and the made to data, long Beyond We on are clinical life Indeed, earlier the of to composition. our factored the in This to our feel other elafibranor decision terminate NASH cycle studies, additional and investigations X FDA’s confident line the the evolving

corporate let’s Now, our about new talk strategy.

medical significant the treatment address and We are our franchise. in concentrate on choosing business opportunity and programs elafibranor need, the diagnostic that as significant a a PBC represents a of two to development favorable risk development have second-line both unmet clinical profile, of

Let’s September and the start XXth, elafibranor patients. in announced first trial, in ago, visit ELATIVE we with PBC. X now PBC. On Phase evaluating days are This patient a our behind us, few recruiting is we milestone

needs for meaningful The PBC is world. approved execute Today, ELATIVE about nearly that our a that PBC our therapy been confidence required adjustments get for Phase after so weeks, reason one market, also opportunity in with exciting the for X, second-line remain. Phase that that it composite research, exposures strategy. in every corporate good, trial and approval there for the in well is line $X consistently patients There has made elafibranor, are the double-digit a positive but patients there We we’re what patients presents million alternative be very clean from always efficacy an year has with endpoint new to to successfully the one could line differentiation. after elafibranor CRO approved, healthcare into development, PBC Evidence medical unmet was UDCA, for market to professionals. only but excited going in according X with and profile. clinical $XXX trial. elafibranor, therapeutic in this of and product Indeed, be necessary in reinforcing in above Well, and surprises about of years. really thousands indication. could is is have looks what with our few Efficacy only growth. are this over demonstrated our COVID XX this feel we market an PBC opportunities on second trend market and observed us our second PBC safety? in was if pruritus, to Phase collaboration X the billion give significant potential option exciting in our years A the have We

it test, therapy and liver for line are a Finally, standard the Patients commercialization In allowing the is PBC lab and commercial with a us PBC. strategy. regimen, other of a is than cost see certainty and easily business in higher established, much pricing diseases. clear we significant treatment identifiable summary, metabolic opportunity in is more streamlined second

have confident the can we in on We pandemic, a market, estimated results by competitive with has a second early potential profile billion trial XXXX. growing trial and constraints that are a complete to Phase therapy with over and the successful be line to worth by a patient relative first a based highly ‘XX. evidence, our very-differentiated Phase we X Elafibranor X anticipate in factoring $X X, visit of Phase be

the NISX. to work NISX The as on did initial for know, in on program Now, during we elafibranor let’s NASH. move program, our premarketing began diagnostic you

at-risk scale. treating to procedures. simple is the consistent This evidence it that performance life as in which of with materialize NISX but simple NASH simply are the highlighted also critical diagnosed to address barrier least? robust at of should NISX demonstrates stage. know stage scientific performance standpoint, unless a including activity and fibrosis meant that patients scalable at of NASH, an The diagnostic is It is we scalable consensus program question. technologies, at at-risk just score Our regulatory huge, NASH this patient and Furthermore, a market and patient is of to be test, expensive, blood showcased it painful evident and NISX other NASH would question one it diagnostic of challenge developed commonly least to that X of market is can technology from major not patients disease as given and launched but with diagnosis above But could are have solution, millions both Does meaning a simply of scalable the used at key the if Hepatology therefore at NISX disease a patients be NASH. opposed NASH in a patients. X determining as stage & XXXX, describing us necessary can edition test. and patient of of resource-intensive half activity non-invasive deployed first achieved diagnostic as a easily major is NISX not the fibrosis in there gold of research at-risk second of real at-risk. identify NASH, with treated. it performance the components The are would in be to these liver of Lancet to the truly should was large also program and standard solution provide and two never high-performance therefore the a the looks publication treated and one the NASH process emerging potential a identification that of that In with might be NISX. that It that Gastroenterology data that we a publication relative is to a aid highlighted validation as solution also pivotal is with Since they with that data a least management gets. X the the fibrosis the patients milestones: medical and biopsy be a which be of

the will meaningful XX, exclusive by September ago, announcement with of step clinical to research a an our on was license NISX agreement and test NASH, launch, This do commercialize collaboration available LabCorp’s which commercial expect early the the research is anticipated which from Launch to near milestone of of progression that NISX the focused LabCorp agreement the our second setting. diagnostic haven’t momentous seeing at-risk technology be this for is agreement on we development public been for large-scale LabCorp but to clinical the addressing disclosed, made term. licensing millions The are days using in broadly NASH. now to LabCorp’s solution. successfully in existing novel environment. a covered diagnostic forward of we an commercialize of a the financial Covance, previous technology. NISX terms start X and with important is [ph] late-stage compared The the of to agreement are individuals needs revenues Covance in is NISX This in looking complication XXXX, progressing with

the is money to close pain clinical the reminder, the of that the recruiting a a screen rate scope By companies and well positive provide of a a trials NISX. money, launch using partnerships NASH been that’s and also for saving lot pave way As useless from are failure That as protecting candidates of better $X,XXX NISX. agreement response expediting several often number have NASH. companies prescreening in screen got reduce was build broader both, patients, of a sponsors of major thus screen solution as R&D of a to biopsies, initial recruitment that and Pharmaceutical to is biopsy. sponsors tool, patients. the with running failures, well usefulness to we very NISX and patient a and biotic for is XX%. waste the deeper It risk and as to able drastically as significant as helped firms time confirm pharma close It unnecessary biopsies,

NASH will market unmet our take the is market the research suggests really that NASH diagnostic off do availability there think that drugs, we an of Although, with already need. first the

So, many the of obese patients, and prediabetic, as launching of makes including physicians millions will diagnostic benefit and patients from NASH. sick now it will overweight a NISX NISX who diabetic, commercially aid sense

healthier disease personal any will can diet With progression, or or the make empowered professional comorbidities, more to be diagnosis, to care less health choices patients and be monitor exercise. for

can As partner about see to stated focused our summary, be it launch of millions NISX first control diagnosis a we a powerful patient needs simple opportunity make and a a motivator. LabCorp as business can a a in sometimes unmet with the by significant step be taking In of addresses available the patients key seen diagnostic and broadly. group, of and a In is in cost-effective disease. way, and NISX

identified have we as human be But, capital clinical financial sustainable, and PBC clearly we NISX. execute strategy, and from So, that our a perspective. will that fit-for-purpose priorities of development, pillars our program both need structure two the we is a and

structure. with So, let’s the start

we therapeutic, market NASH see while in a with or when our in opportunities, two First, we an lines look partnership environment. a specialty diagnostic, focus is care. of elafibranor at is PBC synergies programs, on is disease financing is little clients, models, regulatory main PBC a NISX business retail, terms orphan large NISX and

So, decided limited from are due this to in three decision. to the is two the corporate overlap operate will ensure benefits these parent and teams host create entities to well key each we with subsidiary corporate dual-listed to GENFIT tangible potential this separate company of that that result independent programs The tenant, will There recognized. branding.

to better expressed and pharmaceutical create two will side, partnership developments interest already of a more commercial organization. There organizations, are will in the outside able of that GENFIT of On dominant be have NISX-based whom partnerships specific organizations support certain opportunities. co-development some execute

operational more by specialization. having improve will excellence this Second,

and provide to important streamlining help also a business. will And understanding us ability our will we focusing flawlessly value better as diagnostic of and to execute think operation Our more it. allow visibility it stockholders it believe and we finally, do for will is

provide Let the few with diagnostic a entity. more starting me details,

It on our as say our in that will NASH leverage entirely, in effort. inception, and diagnostic at valuable that it knowledge not not will because also entity forward and -- tools carry been but part NASH diagnostic. entirely primarily it focused will of network NASH be have development will So, I accumulated

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of a a Another need company are is population targeting ability identify disease, be useful, granularity subpopulation let’s with that patients product say patients. of launching specific NASH for we to a in a at NASH, and a identify would very-specific the but especially can them help stage those

drug also elafibranor. forward, accelerating the but entity, to of indication it the it molecules be execution either for or For develop pretty initially program, going will additional straightforward, of our vehicle will on be PBC focusing course, new the

results. of our half about with XXXX talk now financial the perspective, starting aspects key year Let’s

firstly, of as versus position of million as XXth is So million December cash at €XXX XX, €XXX XXXX. June

operating NASH, cost saving XXXX, half the Credit, begin decision the the XXXX of operating which €X.X clinical process terminating €X.X million, year, following of XXXX, amounted marketing expenses development of The detail of to million execute bit in it research million, income premarketing the and in and the Research expenses. €X.X XX, million plan, decrease and same second due XXXX the R&D this marketing well programs half to then, million expenses and progressively premarketing, NASH first And they preceding is the that is and million were I’m second on. XXXX, discontinuation to increase in for administrative further going year. about the decrease of more of commercialization a terminating as this in Secondly, elafibranor program later significantly between €XX.X a as secondary from for June little was will July. These two-thirds is expenses the last and was Company’s expense essentially the the time trial the Obviously, were will in following as to expenses as €XX to expenses. Tax increase due comes and operating XXXX. €X.X half work pre-commercialization and decreased elafibranor and half termination of for have in expenses, General in slightly of it

business As XX, net million XXXX XXXX, versus euro. all loss a that changes the and €XX year of Further the the the appendices €XX.X as last report net amounted GENFIT in expenses, for consolidated to the statements €XX.X that a in available report million, Investors full statutory half XXXX financial was full year consolidated result revenues year June of described in as on auditor’s and included in the also loss to information on financial page well financial of the million website. statements is are as the of and and

let now by of you and start a to light provide might rethink the following expect reality more the to me our So, saying little recognizes RESOLVE-IT results implication. broader its going financial I color bit strategy Company the new forward. in as what need our

debt. we to Specifically, restructuring by for and need our operating the drastically our reduce expenses prepare future

we earlier, studies to all terminate of NASH. to mentioned the in decided As related elafibranor launch

supply access. that a terminated corporate full programs immediately activities then the launch review priorities. were also conducted to supporting R&D We to and all and way all related premarketing all to terminated no our projects of directly We preparation market of two chain relevant from our longer

will probability program our still once fibrosis. less as gamma that investigation on evaluated under stopped data and provided several the the of that discussed beyond be The led being deemed a is this lower decided priorities study preclinical ROR projects well is of we we at Specifically, were shareholders. proof-of-concept investigator which available. corporate fibrosis, to value an remains as And is in focused success NASH program program already future

savings, our have in review the to than few to aim new operating initiated we program, attendance to the examples. spend congresses results nonessential total sponsorship footprint from by a workforce reduce all the of cost before Continuing to streamlining Paris a our to systematic are satellite to smaller our our XXX support our office of plan reduction less functions employee expenses, over on just we year-end. Phase XXX eliminating restructuring a announcement We following and X of give And would are footprint. that align from

XX% So, a that’s reduction. roughly

those were burn approximately cash This related effect of before net operating associated terms what at trial of in annual all the the and burn, annually we is RESOLVE-IT the of an of to So, initiatives? announcement. launch cost million activities readiness. €XXX So, RESOLVE-IT cash included

‘XX allow of us to approximately annually these and just We to burn I beyond. to $XX efforts expect cash reduce that described the million for

administrative the trial a RESOLVE-IT processes Why? is not complex window, with fully due long a XXXX. will However, large in mainly some realized to reduction be financial and Because involved. and regulatory

termination into million. cash estimates XXXX. current the well will cost are RESOLVE-IT to RESOLVE-IT related the full and for extend consumption Our And $XX approximately therefore, closing of

these projections change. assumptions reasonable estimates So, on but they subject remain based are to

are corporate accordingly, our now have So, aligning clear priorities that strategies, also structure and cash and our burn need reset address we’ve to debt. our we

PBC to its propose I objective a its So, saying launch bondholders by process readjusted balance to generated Phase The this the an of sheet, of this GENFIT to elafibranor convertible in of built and that its strategy towards and that in potential. that is analysis bond. in our shareholders the which we with end, GENFIT our development on year to data new X in end the promising line strengths, strategy. programs have We’ve of commercial plan of are the adjustment to light our will convertible in and plans Company’s a of on NISX. has now order the is terms confident trial. structured focuses in its have begin the NASH conclude Both of

regulatory market market, enabler huge clear to need see of see but that, is dire and pathway real, a PBC, key challenging, and commercial yes, need is the For a NISX in of we medical we NASH and as where solutions. significant a

our And are forward over in that and and implementation XX%, of over by attention. burn aligned turn excellence our look additional Thank we cash thank this organization Operator We strategy. the let that, and today. our on your the agile updates call for to a and I’d streamlining specialization in diagnostics. both, providing XX% with the to joining for and We of with now you focus of support are roughly creating the new lean We to our By workforce reducing Operator? on structure And you program like organizational ongoing the PBC months our is Q&A. operational GENFIT. to corporate for your appreciate corporate us revised coming by development ambitions. me

Operator

[Operator Thomas Thank question your Instructions] Please first SVB comes from with question. Smith Our you. Leerink. state

Thomas Smith

Hey, let guys. to Thanks for a the with in X what give I taking with the PBC few. color XX-mg guess, rationale have for Can the questions. start I around only little us decision me went I guess, a the trial. selection move the Phase dose Phase And, into you the forward Elafibranor level? dose the X?

Pascal Prigent

have Officer you Scientific COO. here our Hum will I answer let I question. all know, me Dean, him Dean And Chief So, that that and with

Dean Hum

to back question. we to our I Phase So the answer the X have that thanks for question, to Tom, results come of think And trial.

endpoint. endpoint one the endpoint endpoint, surrogate is alkaline in Phase also that So, was current elafibranor, is with X our line of phosphatase positively as pivotal primary only the a also hitting but a Phase but same And endpoint, which the efficacy on trial. composite trial high which remember, the therapy, for second the registration significance not being composite X that of clearly used show on was used

and and X XXX. your at on So, data that XXXX, pruritis. where remember, trend on at a doses, you Okay? point, to markers, a okay, those showing we when different a the potential was various we had fiber data two the hits pruritus, was presented XX on trend to And EASL hits also be saw, Phase there run where in but beneficial see on endpoints,

the across different those at see So, consistently doses of equipotent XX across and endpoints. markers XXX, two the activity and different we

so we I differences clearly, but to There to And related differences dose, said when to slight XX-milligram issues. do But find beyond with to in to Okay? and the a think were reason. There’s no were that, any what is we differences, other any that a not consider work, receptors get you did go not other to effects single trials is having off-target the decided slight between dose, dose. you with see up or date. elafibranor doses. which avoid on. not nuclear we baseline. go two with the want those saw potency Realizing all way safety that that, some activity that we say any think consistent That’s and maximal the equal there to much issues, tox We

So, doses, decided go that see between equal we the potency with to XX. because the of two the we

Thomas Smith

Got it.

Okay. about Thanks, looking a Dean of little ClinicalTrials.gov, like looks also in requirement talk that criteria. for one biopsy color. a I there’s the liver of you this Can asked so, on And Was kind hear as requirement? guess, paired inclusion it also around something perspective for explicitly you impact this to it’d listed be this? on FDA they ask then, think for? this for If why what your did helpful could have bit enrollment?

Dean Hum

Yes.

question. very Tom, So, another good

from request the a was this yes, FDA. So,

not the is request also there developed interactions first requesting a is in apparent the important of assess -- The different but that main to it and them, this realize liver biopsies currently also of are clear points. that And is, drugs able FDA specific with -- from pivotal it’s discussions it is ongoing for the reason apparent context in to requirement discussions trials. be FDA, PBC just it’s and PBC. from to the our that in our Yes, this two be elafibranor. FDA safety is However, to all to all, the a from of

this not safety a request elafibranor, it note, profile. said But think to reason, on However, and for the main specific based important is very although, it’s I having remember, that, clean safety. was elafibranor has

tox mind, also trials But keep we’ve different throughout have we the signals or safety run in to conducted. date, any whatsoever trials, seen up all and not have realize, We been the which very database case concerns. everyone totality again, with extensive the I in have safety realizes that that well of a safety tolerated is specific the and think safety elafibranor database, large we no the of

Okay.

so NASH have the XXX indication Another milligrams. if NASH. the you in point or about RESOLVE-IT milligrams even trial any of with -- in important remember, clean. patients the in was is trial, interface coming problems other of a totally any is that with mean, trial biopsy, Phase milligrams, also weeks, for trial. is we patients, PBC when out NASH There XX lot that after And XXX have you to going biopsies safety And X XX it’s from over which treating interface no the But any in we’re hepatitis trial the at data XXX of we signal. biopsy, I look of think

data with in this of continue design think our is such clear coming and the back that thinking also to we’ll clinical trials what evolving. PBC also do course, the go the database biopsies I of is from because the So, the looking discussions agency’s with a NASH and large additional now regarding and trial, FDA, it’s be with to

I with important dialogue to for it’s continue So, to have us them. think this

for the large, care discussions enrolled realize a have investigators on think, we investigators we’re finding But well in other impact we said is all an the it’s The have shown of Phase most profile as that of context to recruitment with role they from Phase of what of I to will the patients X. big the as is motivated part on to your of know, question, patient the are them of trial. And into whether knows to not our as that, have I motivation that we’ll offer the biopsy their the our the in the patients? based trial, play efficacy PBC. and by many a mean, as get standard X this Yes. the profile investigators, and in this of safety very realize everyone -- having once elafibranor,

a it does make difficult? little bit So, Yes. more it

we our hard work with to address as And are FDA, discussions make the of that as going the cognizant we’re we we recruitment, that. as However, continue to possible. sure much

so, And and just we with think to discussions our get the that continue I ahead have of agency.

Thomas Smith

what’s then, approval you and the steps U.S.? the what plan LabCorp agreement LabCorp. to diagnostic? walk turning commercialize quickly just the exactly adoption the guess, and of in through us the completed driving the how, Can be for product? I just strategy guess, you with need reimbursement mean, to gain I And NISX to to and diagnostic regulatory I

Pascal Prigent

So, to Tom. this take I’m going one,

approval. all, additional of we So, don’t need first regulatory

no, So, purely it’s marketing.

going LabCorp going offer to they’re what their the this that at of diagnostic And sales force do to say into that interest launch, and early customers year. to the And when first, help in to also generate it’s take probably in We that all their essentially, least. going is launch them next U.S. marketing really effort. So, the to try I is to market. going we’re is anticipate

and need saying of effort the was really pure from of commercial it for presence clear is earlier, a a acute. diagnostic I sort launch make the that immediately the would standpoint, drug As very

you’re already as However, to need the research whether know value obviously market we as it well be to we’ve professionals. some fulfilled, LabCorp that shared there’s and enabler be is a at-risk powerful and it that NASH, healthcare with a have because for has can patients

we’ll reimbursed then the handle in LabCorp that’s a will what here. all and financial disclose milestone U.S. also it’s like this we licensing we working central say upfront terms, the not and that’s test is our deal an royalty do fairly get core payment a standard with market -- the [ph] linked although to So, that the because can the policy, marketing, access, to

So, what that’s are excited to and really open, we going it’s to how happens. see

Operator

question. comes Archila question state with Derek Please next your Our from Stifel.

Derek Archila

guys. taking question. thanks And the for Hey,

study on ELATIVE Just elafibranor one on then the broadly. two more and

Thanks. molecule? this And trial able much then, time just for second understanding you portfolio? around ELATIVE your for to can talked how So, the be you requirement? fund buffer Can is the this you where And said give are elafibranor, I us COVID for much results just do results, plan? beyond The estimated at in looking on you you the in-license now, reduction position. also of and think current the other elafibranor cost kind you’re the I the the through broad would study timing fully thinking additional in because on of cash would a cost about lastly, based of there study into mean, how to that biopsy of additional mechanistically, assets one think on allotting you XXXX. play indications, with cash but look sense you

Pascal Prigent

interesting. Thanks all All these questions, right. for

to the yes, one -- sure. So, was the first buffer. okay, the related Yes,

have That’s COVID need as six we we one basically And would the account initially, see guidance was vision the year that we’ve recruitment. So about from given, taking our added months. for can into you constraint.

biopsy, are mentioned, two regards As things. Dean there as to

of based first and So of forward, feel we hope enthusiasm alluded the that FDA talk, the compensating, is we the which burden of the the of initial as the ongoing debt. those change I maturity sharing element because that bond going are all, I to right that is the debt hope Right? I course, results. And then in yes, data regards for there we we the the of is cost on But our a are measures, of with requirement October of the financing will two it’s other now, refinancing the discussion results. before do One we With we cutting the XX, is not to. is If restructuring things, biopsy. one need mean, guess, the -- cost, currently that and two soon, the expected Dean mentioned relatively elements. to

but I those Regarding Dean focusing where would on elafibranor. towards to comment are question, With to regards licensing, we programs. open will we’ll I with in go we be our just your let mechanistically opportunity, obviously, last also cash say, can two

will anything be sort So, of do have we to cash-neutral.

want you mechanistic... to the on So, Dean, comment do

Dean Hum

Yes.

in activities. clear parameters that on X When the meaning that delta. alpha the at different both important different different leads a what is metabolic extensively of PPAR the inflammation we to works different evidence activity, different mean trials varies does activating trial, is elafibranor keep pathways, so with is is our receptors see agonist, have on. and on are quite the two action and which mind Phase PPAR past, provides look it what’s think both, I and that the that beneficial is as activating PPAR we in as the we and different hitting pluripotent And this including dual elafibranor, alpha have that data What mechanism and We nuclear well see and that as that the activities. is that markers of effect in elafibranor to remember, So, and delta. -- activated, PPAR we’ve does spoken

is there. pluripotent So that activity

this to potential you our when comes PBC, of expect X. about think the and So, the in think pluripotent and patients the Phase activity see that in context benefit in PBC Elafibranor I on to use bear we

to I strong One provide comes mechanism benefit. that on elafibranor through think, are to that’s mind is some our indications has where there is that potential This other PSC. something radar.

made a decision there haven’t that’s but one for We interesting yet, that’s potentially Elafibranor.

and about space the other, things some but about of diseases. easy before NASH what call thinking say, asked And forward. think would anyone therapy like things to these the space are mean, about, I that? I and know we’re I move simple to static combination not So that question, straightforward we realizing is the things continue

possibility that However, is there.

Operator

comes Our from Wainwright. Ed next H.C. question Arce with

Thomas Yip

This is couple questions Ed. for Thomas Yip, of a asking

at opportunities you the subsidiary can what spinning the the there some the NISX provide partnerships are diagnostics for consider to first, of entities, point? new off And you So would -- the two some facilitate for new program? NASH for

Pascal Prigent

the Yes. question. Thanks for

this point, So, I at premature. it’s think

early We’re in process. still that

it’s think is partnership the important number different for know are mind by to in of we always doing our really, shareholders. feel and said, we almost this. the say legal They have a same And things. market, patient tailor we great I we to one. to going specifically do separate have at options. it course, the a have do specific of no At number enable want And partnership feel have you NASH And When diagnostic, the of And is issue really NASH a i.e., not the identify at a they entity have end is tool we because specific what all of they ID about can [ph] value-creation going team the patient. the companies as of that with same, how the What of we an symptoms. we We will looks to all looking activity or achieve this, solution that day, in Because this critical. granularity entire the able the look disease patient. fibrosis, we’re to both after we go patients always right? a are target to is be a going and the

ID tool for could wanting anybody develop a patient. specific to we So specific target a

they be engage a sort by having also little part bit for potential separate truly a course, partner Of see as difficult companies us those that’s why it’s developing to competitor. and entity of us a if with of of to a both, are that And going notion lot course, have operational easier. it’s then, there’s personnel And driving specialization, the number feel we we business, the on of diagnostic. and working Today, the that of a drug a excellence.

So, sometimes priorities. competing there are

you to DNA. need sort And when readjust project of of You from to B. a to A new reality project sort move it’s

we over drug Sometimes tend development. to prioritize

it’s quickly all to create possible this side, lot as because going of but for to and side recruitment, as drug obviously, felt now on the execute get we value on by excellence So, of on those separation, the to we that��s a operational results a doing example. also diagnostics would matter why be

to that get our with mind So, objective. we need aligned fully

Thomas Yip

the Perhaps for the so entities. one you rationale for Phase Thank the reviews data expect DSMB study. we point Okay. for Should analysis? a PBC new any from quick much or aligning X interim

Dean Hum

DSMB in mean, be place. I put will Yes.

to think reasonable I or it’s reports from guidance back. expect DSMB

on However, there’s look no interim efficacy.

Pascal Prigent

It’s safety. -- just just safety

Thomas Yip

can At short the one this Finally, to what financial be charges roughly question. XX in tell restructuring us, months? one point, the you will next

Pascal Prigent

-- in wrong. but we I want you back and memory, -- me something from you this. charges, we’ll find I I a number But, one. don’t have to on mind, get to to out Restructuring to can don’t want let get back on this say

Thomas Yip

and Thank NISX progress you so thing. much we for study. look Sure the forward in to questions. the my taking And PBC

Pascal Prigent

Sure, welcome.

Operator

Meacham Bank question. Geoff America. Our of Please comes with state next from your question

Unidentified Analyst

Hey, guys. our question. It’s Aspen taking on for for Geoff. Thanks

about back taking maybe thinking a maybe and bit step little a longer So, term.

the clinic assets, talk to could about the preliminary see the within we like timeline plans moving restructuring long-term when maybe Thanks. some some and a this some of might maybe plan, So, we when NTZ and program, you context for from get maybe maybe like for that new -- your that? pipeline data earlier could stage

Pascal Prigent

with So, we’re data expecting regards I you think, next But, let to will the I QX year. elaborate, Dean. proof-of-concept,

have decide future of the data. rest, you that when So, The do that we program Dean, to... on course, we’ll of want

Dean Hum

Tom, on. Yes. which through that you’re of through target. phenotypic work is different NTZ. different targeting is pathways where hitting Remember, on. that’s proof-of-concept fibrosis. going was with more dependent different with because our those on we’re out we that guidance potential public advantage hypothesis potential primary is looking of would a candidate. is primary a learning candidates, results, And phenotypic not now. bit it’s targets, one on, you screen. as we that’s be some when interesting one drug able one screen drug doing for mean, and which fibrosis clearly, I which a right -- But, started at by coming a quite from That fibrosis NTZ, things finding on so efficacy And be we’re But this we’re get NTZ, working We’ll about could and primary are good so this identify to we studying a single there mechanisms, about targets NTZ, coming necessarily on had

working multiple And the mechanisms primary different and NTZ, into we’re primary look time for ready think, some which we’re appearing looking where other mechanisms actually potential this to And considering, I through we up we so, prime is targets, that, yet, but case be these we be plan multiple for are to coming for as targets. those. indications not are there of with -- when

there are moving and ongoing now, on readout the the for So, think NTZ proof-of-concept forward. possibilities I above beyond other trial

Pascal Prigent

add like thing to standpoint. would pipeline other I a The from

a is essentially a way diagnostic, One But, that have ongoing. to monitor with no programs a is in NASH. going are to develop number of payers where patients progression, be tool we key on disease at-risk have believe is trying know which right symptoms, R&D to So, you we we they’re working. want identifies whatever forward to disease have going for actually to because paying now, going absolutely

tailor-made That’s is to as mentioned, the people specific from one So, ID tool, compound, demand axis is And different NASH. one important. I or specific launch monitoring research. to in progression other sponsors of this developing willing based on

diagnostic are the from are standpoint. currently we working on those areas a So,

Stefanie Magner

Thank your remarks. now. the We’ll of you hand call I’ll Q&A the the for call all back for And closing portion Prigent Pascal close to questions.

Pascal Prigent

for all today. joining you Thank us right. All

team. transitional for appreciate We day. as we a thankful new this our ongoing are of support period during We implement our corporate your great GENFIT Have strategy.

Operator

disconnect. may All parties

Genfit (GNFT) 30 Sep 202020 Q2 Earnings call transcript