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Regulus Therapeutics (RGLS)

Participants
Cris Calsada Chief Financial Officer
Jay Hagan President and Chief Executive Officer
Denis Drygin Chief Scientific Officer
Yanan Zhu Wells Fargo Securities.
Andreas Argyrides Wedbush Securities
Yi Chen H.C. Wainwright
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Regulus Therapeutics Second Quarter 2021 Financial Results Conference Call. At this time, all participants lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to Cris Calsada, Chief Financial Officer of Regulus Therapeutics. you. Thank ahead. go Please

Cris Calsada

afternoon Therapeutics you results second highlights. Good to and joining discuss Regulus quarter and you. for thank us corporate Thank XXXX financial

me ADPKD Jay before line will President opening remarks financial Jay and Joining results progress we Drygin, I provide call for on will share Executive the our Denis Officer. the Chief and questions. Officer; Hagan, Scientific Chief and today's on program open and is review

these call performance, this contain like plans, the to forward-looking Harbor remind concerning Safe important with the Before Therapeutics' forward-looking Act statements the discussed under we XXXX. from may begin, filings Regulus that statements I Actual would forward-looking Private prospects, you corporate which factors, in for a will future our expectations, of results by strategy, materially purposes statements of and constitute result including Litigation provision as the those various Reform of differ SEC. indicated Securities those

as our Jay. any subsequent call relied In upon I'll update of statements. our as addition, specifically be any views of only to as the not represent forward-looking now such representing views date. over webcast of should date turn statements any and to obligations disclaim this We the

Jay Hagan

this PKD weeks, of forms basis seat A a When by requirements Xb meeting to from look first grants to laid requirements gene of A miR-XX days inversely sustained objective updates completed have RGLSXXXX additional Thanks, trial We The requested and effect from data model clinical Measured less us meeting overall our patients to Connect Texas I'm to and from of that ADPKD Also ADPKD. progress. serious at a RGLSXXXX and mutation severity. by Dr. a disease to shown increased is frequent treatment. vitro with time with equivalent today. by harbors as led of team addressing to several short-term remaining to and typically protein provides as suggests be sharing dosing been PCX one quarter demonstrated and showed first health. at to requested, With in tolerated through RGLSXXXX safety target previously patients Southwestern, was validate with that enrollment no pleased adverse human Type within welcome disease previously utilized. of the in very continuing a and in you study target of month both the completed we after and kidney completion collaborator to kidneys PKD RGLSXXXX, Phase and presented our their serve meeting with ADPKD. by be get led FDA. cohort hold generated that the the to kidney for as total Regulus reported Patel. that both of to of to that preparations and we've on modeling in FDA. FDA improvements with cohort These feedback and polycystin patients. human showing treatment just PCX in productive of earnings forward transient Cris, which levels new new Phase in correlated these second at levels poly significant approach certain is June, We adverse and Returning data model the announce X. RGLSXXXX that trend business associated to data meeting a feedback these consequently dosing, further Thus, and we're recently reported AEs our additional with today our data could clinical mechanism with overall in relevant last which PKDX generated a Type meeting for proof our increases well second the at of and Xb or had University results data or XX to-date Connect, June mild announced requests. everyone share patients Vishal a the past of ongoing well in and the call reported the a update. treatment is were The our size, we The events system polycystin to data PCX significant our generally in regards as count preclinical nature. The cohort the that analogous overall SIS changes second documents clinical quarter also engagement this all to out of with statistically X over is in were events and pleased increasing all The show very PCX levels to in nine This that on

cohort kilogram and chosen cohort well. being quarter per sometime RGLSXXXX for the been anticipate we've able what miR-XX. compound per results quarter patients would in for robust fourth final four commence top-line already to milligrams in of tox on second of The and third final and relation based this of X a week fourth expected data our will milligram And are these cohort other believe that cohort what of X.X extensive be And generation we from in non-GLP the Now, third next doses. this kilogram. after targeting administered be assessment is to of as RGLSXXXX the enrollment We the in dose demonstrate finally, at every year. to the completing second

our distribution, an the for by overall candidate kidney first nominated molecule RGLSXXXX, including an of beneficial Phase and With in towards clinical GLP continues out formally clinical is RGLSXXXX. preferential tox as activity underlying receptor product RGLSXXXX. studies the clinical improved limiting all the at Regulus this dialing Recall, underway. back team finally miR-XX, our well of as labs also of role molecule was the next associated putative the GMP tox X aspects, the disease for questions. compared named anticipated advance we its Chris to the in as profile microRNA or designed your to I'll signs a call our results the get manufacturing IND retaining have understanding key discussion in over to to back at important have year. dose Cris? before while turn And We of potency for to quarter target financial areas. now level the

Cris Calsada

Jay. Thanks,

our which the XXst, end more XXXX. our to March financial cash balance than and XX, XXXX, approximately total June million cash approximately of at results, $X.X of cash is million million, Turning our $XX.X as equivalents $XX.X

of $X.XX. the totaled second administrative three activity of XXXX, in reflect this of raised XXXX. the expenses With costs $X.X operating $X.X million period million net ATM million for the the to a period the same our related per compared the Basic costs. in second and development XXXX. personnel loss quarter loss second XX, was of quarter associated to million XXXX. diluted our million a months net into June per amounts we compared of for $XX.X ended facility expenses and period XXXX price compared and Jay. over at share These During general with same Net sheet, loss These balance pipeline. quarter the XXXX, million basic net share in for now totaled to in to advancing and share the I external fund Research amounts XXXX reflect through for that, our quarter the QX loss of we per to per to the gross for $X.X $X million share business average $X.X per same internal ongoing planned XXXX. $X.X turn preclinical of and existing second XXXX and same for call General expect diluted the can addition in With weighted compared share will XXXX. for cash was clinical period proceeds for $X.XX the back $X.XX and

Jay Hagan

of lines. Obviously ready now hit Cris. questions. has quick on team your Operator, take update please a that important Thanks, milestones couple points, the open and a we're to but

Operator

is the your line Yanan And Wells first question Fargo with Instructions] [Operator of Securities. from Zhu

Yanan Zhu

taking for Thanks questions. my

could of FDA So of output or cohort be – and talk, elaborate of meeting have regard your least with the be about at talking model, little also meeting in a FDA the model? the requested, would you the time is Thanks. regard input more model a from could and is what the and also to – mainly what you by first the looking you for to is that with data what the the and the would clinical model the topic

Jay Hagan

Yeah, try to in that stride good question. tackle I'll here.

of exposure us is then objective in want – objective to are dosing extended dose our model one. the dose then, level One number of we've that on that's our margins be which safety to feedback yes, simulated the to what built they predict – any would So get and basically the level frequency. duration, second would see And approach, twofold.

model the model, incorporate to from the in duration. I data were to because plasma we've exposure discussed think cohort predict past, extended get to wanted data of the data from and waiting the so this we patients finalize And first we for

the want have that before as time as us to requested meeting. possible took And it data It it be the went right. piece bit was to we the a We final model. that get that of so prepared into we

changes biomarker addition the those data the in data. included PK safety well the to as submission we've So and with as

Yanan Zhu

to quick is Thank meeting you a lastly, you. like the results X And to how to you share how time able any follow-up. investors? FDA occurs? Great. FDA And Cohort by data, Would meeting the would the communicate be

Jay Hagan

Yeah.

So have it's the X just as data, are Yanan, don't access far complete. we blinded as with until we data Cohort to did X Cohort as and

have wouldn't Cohort or we've And provides that data I now request. typically the days guided, the anticipate right of month. meeting that so as FDA date next within we'll XX feedback within And X

is the the was we don't believe, which importantly, we've model built. requisite for dose in our exposure proportional. but studies exposure healthy unlikely, plasma earlier So data because we volunteers the don't MAD that got data. know need in And We

it. cohort include could already. whether get ask what or sure, feedback not necessarily may hold be the to this the we to with and complete a in I we to second but really after the wouldn't if And complete then see remaining step whether know not when it didn't biomarker get significantly we lastly, relevant the response or we addressing them requirements. would model which response. this, positive requirements want answer the not Longer-term, remaining you make a FDA hold question, it So the include we have we serve engagement necessarily is just I'll or to changes, Because determine a to improve over we have

Yanan Zhu

it. Got

Jay Hagan

communicate. to how far have as with out best investors, think, communicate I meeting figure then and we us we'll the as And then how let

As your a from you to the meeting event, there's we'll in that make minutes to meeting. you choose clarity experience, get we the so know not call sometimes in wait have meeting, when

Yanan Zhu

Jay. Thank you, Great.

Jay Hagan

welcome. are You

Operator

Argyrides And Wedbush question line from with the your is of next Andreas Securities

Andreas Argyrides

you afternoon. Thank Andreas Operator. for Good on Liana. It’s

following expect meeting? What’s following what you Just a expect us usual the there? the timeline from quick there? up from the meeting you what feedback from FDA feedback you the – that – FDA can get one can can Well, the you the question, when from and following

Jay Hagan

Yes.

typically is draft may XX works, meeting, questions meeting. say, that the even So way the the to the it feedback Andreas, hours like of ahead within, get of we

see minutes further sense you a then to the of the topics can choose the we make And a before get define or with based last of but and don't meeting, FDA the there a feedback meeting. typically on preliminary obviously right then that which are meeting. just minute there, So finalized, come discussion after is month obviously and feedback the then engagement the you the and – then through need written provide course meeting to can in, the need here. say, prep And be you meeting the don't to of and I they suspect meeting, have sort your have within case otherwise, for we we you additional of going

Andreas Argyrides

pretty clear are was on Okay. all. timelines all And that's guys these That on straightforward things. and you –

Jay. So Thanks, it. appreciate

Jay Hagan

Sure.

Operator

from question Chen Yi your line is the next H.C. And with Wainwright. of

Yi Chen

the Thank expectation, meet Jay, the questions. that you you're just by just whether meeting have their and with completed the FDA, tests for to now taking see clarify to FDA you is correct? all my results required the

Jay Hagan

I describe build Yes, predict of And that's, mathematical stuff. correct. to exposure and simulation, all extended needed a we We obviously model sorts told do a of were assumptions involves duration. to how that it, which

their build. So approach want on we've we PK that you are models get to taken. feedback the These population

a objectives. that's so they our what are to that frequency, And one. moving i.e., if with question to margin? us find main predictive? so, Are two and dose they comfortable robust and do so, equates And be model forward? And And level safety those question at the dose so two,

Yi Chen

Got it.

of satisfied the the remove they is if and the So the partial FDA should data, of with cohort, right? part PK remaining the the output clinical model

Jay Hagan

for. hoping we're what That's

Yi Chen

respect right? that Okay. new to With the the is molecule XXX,

Jay Hagan

yes. XXXX,

Yi Chen

XXXX, XXXX, okay.

So clinical be what need this to additional studies before enters conducted preclinical trial? molecule

Jay Hagan

Officer, Chief is what chime work I'll Dr. Denis to there. ask in my our on maybe Scientific colleague, ongoing Drygin

Denis Drygin

Good afternoon.

still in process X are go through studies, IND-enabling trial. minor the are the of ongoing. before some well avenue supply for the We battery also which completing currently starting common just as studies, are of clinical the you manufacturing There which Phase as are trial, the

Jay Hagan

you've well, up in there. conducted yet tolvaptan. corporate just we seen some but… efficacy asked nice see standpoint, been and from combination data looking have deck, have not at similarly been our head-to-head stacks XXXX and studies affects in – does also, We an also additive exploratory against And published, how Those we've how

Denis Drygin

This correct. done the is Vishal our Patel, That is collaborator. work by Dr. that’s

Yi Chen

Got it.

So of XXXX? of going to status future any way is the development affect development XXXX in the

Jay Hagan

is And per good greater a we a is as talking kilogram. about we and optionality; it is for XXXX Right one approach a question. providing now, in that that's two-pronged lifecycle, at spend in time milligrams a Well, could look of dosed weight-based approach, detail. bit this

then we're physician's XXXX in unless looking we auto-injector, That's different the would clinic, it niche of monthly dose dose in put as interested development to And be potential the in be administered in with reason part earlier auto-injector why that dosing. a yet XXXX, in so at could And an an setting. fixed not a and presumably could it's with fixed a obviously, cannibalize switch positioned approach a or office. ultimately

awfully about we benefit we're two they And think so structures, there's that around I of options XXXX development. as kicking if look the some the should you – internally, showed alike.

from range And work such because falling from development the we'll doing finding validating should in both in a and the can be for be benefit so poly less with it accelerated changes already basically work levels, done quickly discussions that footsteps in done, such no standpoint, frequency dose And we've the extensive that the dose terms system clinical with potentially obviously mir-XX XXXX dose pursue too, to here XXXX. if a that turns contingency there's more of in as retains then FDA that it plan work to of a XXXX XXXX. longer that lead needs time be we out our to significant that market, and may choose

developing have how see we from a standpoint, in at like with every we and molecule plays we'll I you're improved I optionality. are think So this past, And having positioning small out, but discussed developer, molecules you the that always next-gen like where profiles.

similarly we've so here. And done that

Yi Chen

it. Got Thank you.

Operator

the no now back are further Regulus turn CEO there of Therapeutics. call would time, to As questions I over Jay Hagan, this at

Jay Hagan

to upcoming today, everyone. PacGrow joining of and much very investor appreciate Wedbush for the the And and mention Conference us be I front, on we we'll time tomorrow, support Thank your thank Regulus. in you. you that Well, Healthcare do want

Operator

this Thank gentlemen, and you for conference today's participating. concludes call. Ladies

may You now disconnect.