MGEN - Earnings call transcript Q2 2019 | Viridian Therapeutics, Inc.

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Operator

Greetings and welcome to the miRagen Therapeutics’ Q2 2019 Earnings 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 this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Ferry. Dan you. Thank

begin. You may

Dan Ferry

and good you, everyone. afternoon, Thank

Rubin. and On Bill Officer, Executive President Development, President Jason the today are Vice Paul and Research call Chief of Marshall; and Executive Leverone; miRagen’s Chief Officer, Financial

reflect this these Before we begin, statements opinions about of and results would our could like are statements differ. forward-looking subject will forward-looking note company. and to conference uncertainties cause of everyone contain that as to webcast the the call call. remind this I statements that that These to Please only risks actual date

revise implied We revisions publicly will outcomes not in or undertake an forward-looking could these Factors the obligation light any or reports to forward-looking cause Form of events. in differ new results and Forms information or are future most to results materially statements statements in of in periodic release expressed to on X-K that recent with greater actual SEC. filings from other on those by our such detail our the XX-Q filed and or XX-K discussed

I turn over President Marshall, Bill Officer the Bill? Chief would Executive to to and of call miRagen. like now

Bill Marshall

Thanks, Dan. joining call for for the thank Good And update XXXX. corporate afternoon, second quarter you for our us everyone.

a focus important will issued afternoon, be this of which We few announcements the call. today’s

we will the events clinical candidates. impacting updates addition, be In on three providing product each of stage our

program of and terms will that EU realignment pursue of to rights a rights of February MRG-XXX. development addition world U.S. agreement portfolio of as regained the the to the our continue through Servier’s not rest and XXXX. have our and in we Servier to support had Japanese result retained agreement the under First, to decision we in MRG-XXX,

decisions other Phase indications benefit asset mechanism of position proof worldwide. profile for appreciate Servier MRG-XXX can preliminary companies in a studies and the enhanced and tolerability make, indications could benefit believe blood we repair from While the humans X as tissue that strategic believe We patients as X-ready the we and generated and MRG-XXX that safety such difficult required in to would that cardiovascular Phase flow.

We scientific conference expect of an to in XXXX. at the quarter data X release fourth upcoming Phase

While future future. for new MRG-XXX, for this a in collaboration development may announced candidate we seek we’ve product development plans not the

We has also the that over total trial. team for of currently announced the XX% planned the opened sites SOLAR

activating While sites, pace those in recruitment are at we sites experienced initially now our rates delays initial predictions. with on

clinical the during from we Considering to delays However, onboarding well the a due position the early the our trial trial in resources a process, as disciplined moment. around focus expect order primarily made we decision in MRG-XXX of half of the on now current SOLAR cobomarsen, the of I’ll ahead first more remlarsen to and SOLAR in move data and of restructuring we as endpoint primary microRNA-XX mimics. difficult the the to developments our XXXX. cash but a to with provide impacts business experienced development report the details

updates. turn MRG-XXX. now pipeline of start our Let a me review will to and detailed recent I more with

complicated benefit treatment X patients other Phase two for used vascular which where and deliver proof future high the information healing, trials MRG-XXX from evidence accelerated in conditions patients. of lacerations from such as results support safety trials failure and to mechanism heart about the clinical may flow and be increased risk of provide could designed analysis the of finalizing that were are We to also

That tolerated trials, see safe XXXX. MRG-XXX We is clinical believe product developed. targeted to targeting candidates. fourth differentiates advance well miRagen clinical product represents can was and to this in team MRG-XXX has been quarter believe and on well with We report the team Phase expect today in development. preliminary technology and X microRNA and demonstrates develop data at of MRG-XXX on third upcoming ready We the Phase from the proof humans. from safe data mechanism our generally microRNA review of Phase generally these the and based into that conference scientific has of an capabilities candidate we program to tolerated data our the our X X of

our cobomarsen. lead program, to Turning

the lymphoma microRNA-XXX an As the as as of as of a cancers levels. where cancer other correlate oligonucleotide in reminder, blood cobomarsen well disease microRNA-XXX appears is being to known several developed inhibitor a blood type increase CTCL, with in cutaneousT-cell process or

patients pleased SOLAR that to for X ramped we’ve past which site report am the this dosing up initiation I trial began April. Phase clinical

States, initiating are the approximately we opening of sites of XX trial. enroll countries United to approximately XXX total more worldwide to Australia sites with we’ve Today, in reminder, XX and XX% sites than the a As Europe, opened patients. clinical this for up the goal in

this enrollment, first the have rates the primary instead four As progression consecutive no over viscera the recruitment XXXX defined maintained these approaching nodes, had the the of is Considering severity response sites, the I SOLAR The objective previously where while with mentioned ORRX, at lymph delays primary data we of the disease at endpoint earlier, in of in update skin XX% or great evidence the endpoint sites entire patient the we a as rate initially XXXX or trial expect body to we disease for on blood, improvement from are trial as the months. half report for activating and predicted. the experienced in patient’s we of half guided. of pace sites SOLAR now now in least second

could patient-reported accelerated improvements. secondary on we believe We the Progression-free endpoint FDA, States. with plan additional trial discussions monitor Based for that primary use survival of in the achieving allow the the from as SOLAR outcomes CTCL quality-of-life a be cobomarsen endpoints to to apply in United endpoint. will secondary us to approval

to upon well of as which trial in million the SOLAR with Partnering completion invaluable in up supporting $X milestones, is We potential equity Leukemia with the identifying Lymphoma as includes Society. funding society help with conducting association miRagen specified and are trial and the patients. in providing support, the

X second patients cohort the ATLL of This HTLV. the on the International quarter, our showed announced lymphoma aggressive subtypes cobomarsen, XXth new Congress at with leukemia new disease or data of an observed stabilization T-cell ATLL. continued Phase trial in presentation During in data we of oral also durability from adult of

cobomarsen profile As combined a that reminder, cobomarsen has with very these in with poor our this prognosis cobomarsen a long-term The treating for a elevated a in levels. few elevated type options. hypothesis treated may have other favorable another meaningful for option observations tumor microRNA-XXX supports patient be patients the generated may patients population belief microRNA-XXX utility with treatment historically malignancies to-date potential with potential tolerability forms treatment believe We that of clinical ATLL. supports aggressive with data also

we with its scarring. keloid or are potential to of a keloid The formation the remlarsen, to safety, subjects reduction Phase and this expect of currently we frequent clinical of assessing end X in trial a the prevention trial tolerability, and enrollment of of Turning a conducting in the before has remlarsen completed year. scars, activity report history hypertrophic form persistent data

remlarsen effects the We in are eye. also the of antifibrotic exploring

of in application the from conditions preclinical ulceration, that suggest remlarsen injury. of to ARVO data This may our we data April, meeting data in announced our for that prevention earlier ulceration scarring from corneal serve due investigating remlarsen follows studies preclinical corneal novel hazing In remlarsen improve therapeutic support and antifibrotic this an which the announced belief resulting the year corneal the scarring. may suffering XXXX infection which effective at of studies or following a vision multiple our as in on new be patients treatment effects topical from to

these remlarsen no to effective topical worldwide of need a to the has remains believe the a scarring. potential blindness treatments. application supports address leading data significant be inhibit may medical believe We treatment fibrosis scarring cause remlarsen pharmacological corneal that We and further approved as with the of of cornea an

previous American Society, in at systemic use in fibrosis. lung microRNA-XX as coupled May that potential data role or humans idiopathic fibrosis believe extracellular pulmonary our in microRNA-XX product IPF in reported candidate deposition our the IPF; therapeutics administration these fibrosis data well of pathologic efficiently in of we for with matrix XXXX preclinical preclinical pulmonary the a generation studies. new series demonstrating replacements microRNA-XX of mimic, the support with that We as In reduced as second Thoracic of the observations

This programs pipeline. completes development in of our key my review the

research. a pleased investments that are with to microRNA-XX programs, including three across the and we continued just I that our reducing remlarsen, implement costs directing plan focused each reducing timelines While resources is events impacted of restructuring in of mimics, these our and discovery cobomarsen recent while advancement to our the progress of decision have the and prompted on described some

believe of reduction of to generation This will alterations pipeline. We our project, administrative restructuring our preclinical research which areas. reductions general, relating allow structure with these inform the positions structure data XX primarily to These corresponding resulted cost move a plan in are a to development product to candidate to and and support future cost us for continue that clinical positions. review other forward costs and our and decisions related in follows will

second our a and Before I we the turn clinical and I the clinical advancing of look announcements half efforts XXXX. on diligent work employees want cost data We our I through stage reporting thank Jason, forward milestones of of as candidates the in restructuring. product in all their to appreciate each to of call over to number

With Jason? reported over that, Officer earlier I financial will review the results call Financial to the to Jason we’ve Chief our turn now Leverone, today.

Jason Leverone

Today, announcements comments Thank everyone. and you, good the afternoon. Bill, on I’ll my afternoon we this released focus

XXXX. we in short-term at and cash, with of in reported used the million of $X.X operations of approximately second end net $XX.X the million and the quarter cash for starting cash, First quarter equivalents investments cash

the As extend Bill which will cash operating expect stated and our we earlier, today restructuring we costs announced reduce program runway. cost

company primarily cost your of our believe program sufficient microRNA-XX our including of to a concentrate fund today includes the allowing be As quarter on the development allocated remlarsen reductions, operations microRNA-XX costs program, to the our result, mimics. resources with and cobomarsen XXXX. we other us The into current our and restructuring announced other resources additional to rightsizing will second that capital

We restructuring year. and will expect the for retention, this charges fourth the of in primarily other $X.X during company quarters third million approximately and incur restructuring-related costs severance

will collaboration certain in February X Phase of to clinical allow This collaboration, and terms of expect Servier activities will complete report development adequate quarter support which for program data through XXXX. year. two time to MRG-XXX the MRG-XXX the continue fourth trials the this we In of the to our

trial remains will strategy expect benefit in initiation Phase largely of X and and from global team done investments first quarter our we the cobomarsen Overall, we unchanged end the SOLAR that great the the and has quarters. these work CTCL. since coming the of on and site And efforts

the call questions. open to I’ll operator that, for Operator? With ask the

Operator

first with Thank you. Liana Wedbush Our Please line proceed Securities. with Moussatos of from [Operator Instructions] the question question. comes the

Liana Moussatos

Thanks my question. for taking

companies? you leapfrog have cobomarsen started For or yet forward? and target going with or remlarsen the re-partnering Also MRG-XXX, trial? slowdown to any the now have do Also, indications microRNA-XX delay mimics to in going you can the for are the you market the IPF you discussions to move are I any SOLAR

And what then versus in operations in much is in result will question decrease how fourth expense QX? you’ve the reported the restructuring

Bill Marshall

Thanks, the Great. I Liana. appreciate question.

agreement MRG-XXX, we rights as the of compound, commercialization our to U.S. Servier. and you with with as So Japanese retained had remember, part the

those asset. discussions We development aspects ongoing business around had of the have

together X specifically data as we the bring we complete the could package out. strategy We and have a but we’ll Phase pulled of identified, analysis to really then not the develop that

In – intent focus us the also the mimics, to to of on we miR-XX the restructuring allow of on the, program. was and cobomarsen terms really miR-XX focus

continue the efforts. sized to we and company So were appropriately able

those should slowing not efforts. we So be

pulmonary generated the in have data applications we of will update idiopathic to setting applications significant continue for next an gen the the We on in the and ocular pursue compounds fibrosis.

we’re of be case. that We would that leapfrogging. believe In don’t remlarsen, terms the

most focused that’s We trial. are on important site believe for diligently We factor. the SOLAR initiation the

I we’ve had As that what seen, accession of what in we mentioned, we’ve are line or sites with rates at the predicted. seen sort

on model. based ability adjusting So timeframe – our really we to here are the better with

adjust know a can And of completion challenge. a be And accordingly. dates you the zoning the of As on that felt sort we’re modeling guidance was we it in appropriate sort now. of to

Jason, you on Liana’s question. last comment I’ll let

Jason Leverone

Thanks for question Bill. the Thanks Liana.

cost from we estimate provided we actions. of these So that an the savings exact expect haven’t

do into when We actions a runway basis. and have continue these consideration provide to and all taken cash a we quarterly new of guidance on update we’ll that

In will relatively the expenses, say for the that terms few I have quarters. of – consistent last our remained over last expenses

quarters operating restructuring year. incurred we year. and MRG-XXX last as to trial million, expect charges to next the QX I on two expected remlarsen next before trial continue to some think the $XX.X as increase today, the expenses averaging million quarters, around over with the as I well well back spoke $XX the data end that about delivering few do be the of to

our the SOLAR patient and PRISM initiation Also, site are cost to and to related related enrollment. trials mostly

So the forward I in increase few would expect quarters those costs as to well. going

Liana Moussatos

Thank you.

Operator

Please next of comes line question. question ISI. with your Evercore proceed Our from Jonathan the Miller with

Jonathan Miller

what for color to get said. there. wanted previously said that your that. on get you Hi of I you I my it And little just with in of a you’ve I’d taking questions. guys. departures second quarter bit has think been to Thanks like runway know XXXX recent have to on take secondly, little management noted you a line turnover cash and

impact and collaboration of the financial to restructuring Servier you that or less getting So as the your other quarter? you the am in same out about more were to as balanced apart I falling last runway understand each

Bill Marshall

for thanks Jon, the questions. Hi

of quality announce will does that changes his address all another to decided I able on let we departure, your to necessity, and the terms we disclosed a position. comments conducting endeavors. to have control cash it relatively In In question Servier is him for our be in questions of have nominal the be past in We wish the present. that cash have of to and the study the data more. for I’ll regards his the appreciate the future as I’ll continued Jason Business able And be around best parts support burn, ongoing of we’ve contributions but runway sort on really all What effect to did things to on collaboration provide should the will we certainly let Jason say in to Chief that. move Officer

Jason Leverone

Jon. for Thanks Bill. Thanks the question,

XXXX. impact a in So take did into us into decision the be forward. – to not that or lot And through going that costs will we trials our planned Servier going studies activities assume February or support where consideration corrects to dose contemplated determining part development It’s any of are certain goes safe cash support new that we continue guidance. to Servier’s of through

included worked other related the extent to that into forecast of But we’ve that the retention our factor cost So we change through. that severance we’ve previous that’s and also a costs.

puts sort our course term costs all In our in runway the development range us a normal that this window things near with considered. of before team similar updating within we were

Jonathan Miller

Great, thank you.

to is think is the to Phase forward the imply X already, it like that into MRG-XXX in ought For about efficacy say if the do have it forward these visibility Phase Phase anything to And have seems tolerability. X? X taking potential be it trial some trial? ongoing and asset trial, safety is you so X you the that you to already Phase data – measures to of if Do taking supportive

Paul Rubin

Yes, again, talk about good meeting Clearly, going that of well seen, report more year. of thanks to mechanism humans. a Jonathan. a fourth far as proof signals that as The data so suggest seen we’ll in preliminary this tolerability we’re safety quarter that this at in we’ve we profile, the have

detail at So, in or want meeting able the that identify to And fourth reveal well discuss are we’ve tissue really in repair greater been biomarkers we the and to to again, those vascularization. related scientific quarter. important

Bill Marshall

dose to We dose from X response. these something that? endpoints preliminary determine that allow add at us just dynamic trials I Phase looking least Can at have data to also and

what preliminary look idea So mechanism a at of of you proof use. look to doses you and I safety, think when at

asset Phase X ready we I saying think believe why the stage. this is that’s at a we’re

Jonathan Miller

makes right, you. Thank sense. All that

Operator

with of question Baird. W. from the Please with question. proceed Kumar next comes Our line Madhu your R.

Jennifer Grayson

Hi everyone, Madhu. on taking this for our for is Thanks Jennifer question.

any the in up you Just give a terms study of could runway, close analysis? Thank SOLAR then on futility fraction few tell bit interim could recruited? And follow of of have are us how ongoing cash of of And future what XQ what idea is in sort trial, us the of soon? maybe been patients XXXX an you parallel, a that you to or sort you. little then more clinical

Bill Marshall

Jason to runway? the Sure. XXXX to do speak you want

Jason Leverone

the for Thanks question, Thanks. Sure. Jennifer.

year, Servier MRG-XXX well. we the this In as as year. with study study the in funding and trials QX continued as assumes that's as of remlarsen that we X And well the for completing ongoing out later to SOLAR to this our with out terms and the well report study cobomarsen CTCL, runway report PRISM which that XXXX expect as keloids, and Phase indications expansion expect the later

Bill Marshall

we the we're progress. of to would on around accession SOLAR are focused get which be that that detail. numbers as the extrapolate the stated going of we to point continue update at We've we've the to on the guide in this season, we'll And to activation. to numbers towards on better trial, I futility really season, Jennifer in mature we at analysis. site summer and able on And the to ready data position really and in into continues a We'll out be be previously fall recruitment not the guide sort would say timing

Jason Leverone

kind as mentioned, we boarded. adjustment, being on more per number recruited have actually enough we the feel that a And the month online – predictions we but to we why patients me have are we session now rate half the sites because that of just that's now into make that sense Let of we now where data these the also did of reasonable good trial. are per site and and the than can have model patient add Nill

Jennifer Grayson

you much. so Thank Great.

Operator

of Please with next Leland proceed with question. your the Oppenheimer. Our line question Gershell from comes

Leland Gershell

my Jason, taking for and Hey questions. thanks Bill

ask with from some indications, a expansion there. prior couple Want we trial you the to the see the What of with Of ATLL data when to cobomarsen. that update cobo questions might I CLL very encouraging indication be expansion course in the with another on next want next get to then year have ask at about the for thoughts some for or this ASH Thanks. perhaps – subset, follow-up. And would be? another also might And a venue? ask

Bill Marshall

Sure.

are additional the highly out ATLL focus there's while really lot it that building around as response – in standard focus our the expansion – the care. of of durability disease now it is in continuing on we the survival turns – It We're a aggressive set. patients. there So data to primary isn't is, rare post of the data of data good sort from being kind isn't that good some diagnosis, as survival around of

going So are treating some to be also We're paradigms. patients activities. doing different with some additional mining we

So words, application but in so the picture necessarily a not with burden drug. other of tumor the reduction, of really after good we higher likely get chemotherapy that

a With the then FDA move with our appropriate in be plan dataset in would to toward place the the with path forward. hand communications the to understand plan

upcoming giving scheduled We will were and in September updates. updates be to late we'll update updates, some continue some give on additional sort guidance at of to meeting an

at ATLL well indications, in have reported ABC progress the And had T-Cell continue as with Lymphoma CLL in of expansion to open as terms some those DLBCL, DLBCL the the subtype. as of make to we And will we areas. the do patients ABC patients. the subtype, In update observations trial previously Forum preliminary in especially on we

Leland Gershell

had miR-XX that. side, you in I give I'll for we're signals, I appropriate had next also think working on seeing mentioned couple then the eyes? bridging been be on And you and that great. formulations. found any Okay, the

may particular in Just utility ask formulation? wanted be clinical you development where that to for to

Bill Marshall

Right.

do future point like observations trials. the to on work conferences. evaluation, clinical continued update those ready of is we've and scientific where But feel into completed a alterations move it We've to asset is viscosity near move the may various that. it that and of studies we'll the assess forward like we sort the Leland formulation at into necessary things at wettability, most and thanks preclinical So to affect to to

Paul Rubin

on we that good got the the itself reported saline we formulation The tissue in just penetration. where drug was data

has there formulation envision much be at don't to done with we this So stage.

Leland Gershell

you. Thank helpful. very That's understand. I

Operator

question with Jefferies. next Jeong the from Please Our of question. line Suji with your comes do

Suji Jeong

dialing Suji question. the is taking And Eun. This thanks for for

sibelium So large the could you remlarsen? for stage? next elaborate for given the to partner you to pool do plan patient more on keloid, find have going think sibelium Thank you're to before And advancing the you.

Paul Rubin

question. the for Thanks Suji. Hi.

we're that that the remlarsen the So study now goals several it. had we to – X Phase important study conducting

patients. the If you around many an study, patient relatively it's control member, so could do we a We of intra of controlled keloids. could development number small factors

of of that's see? used then study intra-patient-controlled we've keloid its growth. focus in think the been clinical really has effect Phase again. controlled in And position the X? I aspects what heterogeneity of sort And induce trials keloids, confounding understanding in terms that would one previous And is the in on of that to is the biopsy of trial, project our our what an this size we the

And it a we're we important In applications. those our contemplate based forward is out really seek that using remlarsen do we on words, Is has And the data partner? decisions from this the own? other to. alluding effect moving believe could something actually to to size you're it additional on development most that make appropriate

pathologic of our persistent was assessing as scarring proof-of-concept to in goals some One well. it pathological fibrosis demonstrate in in

us really are determine that path remlarsen position the study the of the a investment decisions appropriate goals multifaceted for put indications. into and different to appropriate and think I moving in So good

Suji Jeong

you. Okay. Thank

Paul Rubin

Thank you.

Operator

over to further to no remarks. for Mr. are questions would in closing the left Bill This back the any queue. turn call like Marshall I

Bill Marshall

And as Great, for the thank on support you. taking a work and for to your bring thank update hope medicines life-changing an to patients. mirage, great thank to afternoon we I you afternoon. you. We want this everyone have for time

Operator

teleconference. This concludes today's

lines for this you day. have Thank time. You your your and participation wonderful disconnect a may now at

Viridian Therapeutics (VRDN) 8 Aug 192019 Q2 Earnings call transcript