- Earnings call transcript Q3 2022

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Operator

Hello, and welcome to the Regulus Therapeutics Inc. Q3 2022 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Chief Financial Officer, Cris Calsada. Please go ahead.

Crispina Calsada

afternoon, Therapeutics you results Third highlights. good to joining and and Regulus discuss quarter you, and for thank us corporate Thank XXXX financial .

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

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

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

Jay Hagan

our Thanks, general I'll begin call update program. third Cris, with on everyone, and and welcome, to a earnings quarter business update. our ADPKD

or placebo, graded infection, adverse one, only reported. moderate Phase data trial Among well our were a RGLSXXXX. we clinical announced September, RGLSXXXX from was was clinic the single sinus positive with or subjects events, In to in mild, safety no continue with tolerated which with X in XX events were line severity. serious and RGLSAXXX progress RGLSXXXX. We PK the except treated make there ascending which of all of adverse top SAD, I dose,

study Since our week, enrolled or RGLSXXXX. In the dose the plasma second the generation Ib the tested in compound data linear preliminary and X our from PK ascending suggest patient announced of then, results at we've dose first the patient similar kidney that to currently assess first double-blind, placebo-controlled, we of in efficacy high more multiple Phase volume multiple levels RGLSXXXX. with The changes the study of measuring -- exposure is kidney screening addition, Last treatment me, several that approximately sites with cystic X in pharmacokinetics dose across are is is will dosing in of study kidney and dose MAD XXXX to XXXX tolerability adjusted evaluate importantly, have X levels, and and active. or across safety excuse a function. Polysystems, adult now and study overall the ADPKD. ascending safety, RGLSXXXX total The patients different volume including

investor. the all X being XX, week XXXX, months. under a is or line first were new Switching sold facility. in kilogram from X gears, the million mid-XXXX. dosed during the net of million cohort of shares sold X.X X of data institutional at ATM our $X.X approximately for every we for cohort first RGLSAXXX milligram The shares and other settled months are placebo per Almost patients Top proceeds anticipated to September ended now

treatment Last With equivalents will planned supporting Discovery Nephrology cash presented this of cash, data highlighted polycystic next-generation meeting disease, at important for and investments in oligonucleotide we autosomadominant Orlando. now potential of Kidney The American poster of the this week, the anti-miR-XX kidney short-term presentation of through fund disease. RG-XXX AXXX believe was titled Week Society of completion and activities the in transaction, current it data XXXX. our the we

of Cris? potential our validate this to to financials. in that, the the each and standard the is therapy on as I an day to care. over for marketplace, which our advance are our update the Cris effort about excited current forth attention call will We With progress team its receives helps well putting improve as back turn the RGLSXXXX

Crispina Calsada

Thanks, Jay.

to Turning results. financial our

XX, million. cash September $XX.X of XXXX, As our cash, investments totaled equivalents short-term and approximately

period the through third million Research compared development costs to in was quarter compared XXXX of third for and loss and share XXXX. costs. that, compared expenses in and diluted associated administrative basic totaled Jay. These the for We diluted $X.X in and million our same will efforts program over to Net to amounts of our ongoing the per with for General $X.X net XXXX million XXXX. and of for million $X.XX ADPKD $X.X share loss totaled the research period in XXXX. the $X.X amounts back quarter XXXX advancing net expect With reflect and turn business for our related of million and to the the the runway compared XXXX in million pipeline. quarter per net third for loss These within period call of Basic external to share for same quarter the $X.XX the per $X.X I cash other internal loss expenses of extend third general was same XXXX. period $X.X reflect operating XXXX. same a to

Jay Hagan

line. this Cris. At happy Thanks, questions. any to Operator, be we'd please the take . time, open

Operator

Instructions]. [Operator

question Canaccord. first comes today Our from with

Unidentified Analyst

next a headed X saw extended year. dosing? versus slightly what animal around course I the have, the here know expectations first-gen of you in data slightly you months guess, Can shorter with studies remind in dosing us I question compound. mid I The into is the

clinical expecting year. saw should you and if from in what So what studies, the curious you animal through read next longer dosing readout there's we think to data with be there

Jay Hagan

of to part, But others that on animal rapid touch XX% a a increases the and depending I statistically we of is comment to increase approximately clinical duration both milligram in significant some PK variety for on the kilogram Denis to very per compound at I'll similar. X Polysystem remind animal that dose saw baseline models, testing and extended at the dose are molecules those which as the I opportunity And X currently on that next-gen ask with offering more XX% periods. dosing just from between in model earlier, dose less the folks level level. we're in and mentioned Maybe X Yes. than our Polysystem

So effects. with suggest we continued with types achieved to Polysystem you the the of change And anticipate if that would it steady in similar state compound higher trajectory of see levels to prior we baseline kidney. plateauing recall, next-gen reach this could be of the from once dosing,

in I don't animals. of we'll Denis, what that's be to dosing on looking comment in clinic. So duration the for want if you And know

Denis Drygin

models aggressive and do are the treatment. of extended Indeed, quite the not for ADPKD majority Jay. allow you, Thank as mentioned Jay earlier, of period

test longer the However, we and longer first there X did for And of a with (inaudible) generation evidence more model the was more of was weeks. treatment, incubation expansion molecule growth. where in and treatment

Operator

Fargo next Yanan [Operator Zhu with Wells question Securities. comes from Instructions]. The

Yanan Zhu

and a data I enrollment time for about different mainly line from question cohorts. have the

So -- you be cohort previously, for I'm might first dose might me wrong, I been 'XX, elaborate think the a correct hear and the please if the on this have data half midyear. Could expectation this on we first your data time additional but small any change versus factors? other suggestion those potential the for midyear, cohorts? cohorts, speed line have enrollment, the any or first any also expectations changes for in for from you And do half time,

Jay Hagan

Sure.

take did half for to in sometimes SAD time, for work the things October, November expectation and MAD. through financing the we to outlining from year, up of processes, you of both case, 'XX as as at these longer that cohort initiation we the get bit that provided And a initiation then So to data our back often going. dates when the first in our last guidance first the and little

So update we have our in we guidance would chose of to data. when terms

is that quarter. study. mid we're initiated, taking we going enroll initial guidance after year look we're I And we're than the guidance half actually a what 'XX where which more was first -- the think a the to think the how that Now is accurate MAD at of includes first quickly provided,

done And saying obviously the statement. enrollment to is this So may quarter results forward-looking month is with the we'd probably a likely first We're effectively, have out, hit pleased in quarter. first differ. we're to be up Actual making patients in the of X of the targeting XX X progress the first in now we're thus the study pipeline sites total good a that and team is screening for the far cohort. and in now enrollment getting

more work time have that. of They're after accurate how that's And and and going mid with last feels 'XX the the take of appropriate dosing which to X analytical quite follow-up is project month enrollment clearly we've them is so to got initiated, we to patient guidance complete it will going for X we go. When needed. months know the

for basis So of that the first the the line cohort. is time formed overall

sites X as the sites that mentioned currently. up cohorts, up. XX targeting I have subsequent total to As We're we earlier far

obviously the more come more then patients potential queue sites And so as come will otherwise. geographically up, and into

premature of while estimate anticipate and so to up more it's can time the cohorts, just sites subsequent could first than more that active. go And cohort quickly it one enrollment the given of

for to 'XX. cohort data second second the from guided we've the what of So is half

Yanan Zhu

the Congrats progress. on

Operator

I to remarks. for over any to Hagan Seeing Instructions]. [Operator the closing Jay would no further like questions, turn back conference

Jay Hagan

us advances. operator, for with forward look future everyone, Take Thank We your as . the and providing thanks, care. joining of Great. to program today Regulus. and updates for you you, support

Operator

today's presentation. now has for conference The you attending concluded. Thank

You may now disconnect.

Regulus Therapeutics (RGLS) 11 Nov 222022 Q3 Earnings call transcript