RGLS - Earnings call transcript Q2 2022 | Regulus Therapeutics Inc.

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Operator

Good morning, and welcome to the Regulus Therapeutics Second Quarter Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator instructions] Please note, this event is being recorded. I would now like to turn the conference over to Cris Calsada, Chief Financial Officer of Regulus. ahead. go Please

Crispina Calsada

afternoon, to Good Results thank for you Corporate Thank Regulus everyone, Therapeutics us discuss Financial Second joining Highlights. you. and Quarter and XXXX

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

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

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

Joseph Hagan

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

to volunteers. Phase IND safety, ascending for particularly the subject with study RGLSXXXX disease. US tolerability the X our Administration's the our pharmacokinetics by was kidney was of the Food RGLSXXXX in dominant dose of followed the beginning dosing drug quarter in eventful, Drug second single healthy first of treatment for This of polycystic in assess The acceptance of the autosomal and

as with polycystins, biomarkers, initiate a treatment, Following this ascending cystic pharmacokinetics as patients and volume dose overall dose on response the XB Phase study ADPKD to including kidney to RGLSXXXX function. of we of the assess safety, RGLSXXXX adult and well evaluate in plan tolerability ADPKD multiple study, kidney to

level Our study. establish first treated is clinical top RGLSXXXX objective in line of shortly and ADPKD XXXX. to planned biomarker execution single effects this consistent is after the a portion half our And generation is data patients dose line portion demonstrated dose well the The nearing data cohort anticipate from our from biomarker volunteer response were for of track study compound. the later the We year. study top around first where robust the on initiation the healthy the of dose first SAD dose the completion multiple with study timelines of and ascending ascending completion of with

rare was financial that of designation United drug FDA. States RGLSXXXX and granted or facilitate orphan prevention or and effective potential Orphan by ODD that treatment, providing are XXX,XXX and that in affect drug diagnosis with incentives. identifies development the or intended from than fewer for Additionally drugs safe regulatory the helps drug designation conditions and people biologics diseases the

regular team. welcome With a new on Cris Chris? well the financial RGLSXXXX, to turn the results. an we I'll progress look rest new Kamel We back President Vice we're that, our Dr. call over now of thrilled pipeline. hire the as our DMPK, to update Finally, to the forward key contributions of Amin his for as as as for

Crispina Calsada

Thank you, Jay.

securities XX, XXXX $XX.X our Turning and to cash approximately results financial our totaled marketable cash, million. as equivalents June a

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

Joseph Hagan

happy Thanks Chris. lines? you you time, please could Operator, have. this might the we're questions At to any take open

Operator

Yi with [Operator Chen from Wainwright. first instructions] question ahead. go Please H.C. comes Your

Yi Chen

This the do Wainwright. in Sanofi taking from the didn't is so achieve Is for could it of now plan question. to, really about? sorry, Sanofi not regulars in my still the if H.C. for I'm success mentioned you. Thank syndrome Thank you is a has or RG-XXX something -- the sorry Yi you Sanofi going call, trial. hand there on Sanofi that

Joseph Hagan

in to which fibrotic And shared additionally looking number any around you may compound for that of opportunities But X-K giving notified us. the the may a diseases. us, our other Sanofi respect without know with in we specifics data. you any ask for So they're different 'XX is specifics update to that implicated

this of the What per planned pre-specified when data. terms not, analysis subjects do one. XX two that agreement randomized is interim we have have We yet had was access the a to know the to

what analysis So and on upon. and based futility of that's one-year active completed on XX placebo eight was that's had treatment blinded the

Yi Chen

do whether indication decision year? another end the to they will before So as a of with Sanofi proceed this make know will you whether

Joseph Hagan

the in don't an have reasonable the know they on timing agreement program. standard clauses use work exact diligence this where to efforts there's type of We commercially to

Yi Chen

Got it.

trial Okay. And the we this of some SAD data have in of first should XXXX, correct? initial regarding the quarter year,

Joseph Hagan

of when the we the initiate all safety The SAD. be an initiation the the of obviously data from review announcing We'll comes plan update we'll Yes. after Yi MAD. because MAD

once time. to that completed MAD moving provide announced so and we've And that at to an the investors plan into that we're we'll update

Yi Chen

other the pre-clinical Is stage it. any company Got candidates? considering

Joseph Hagan

Yes, update we forward about effort a as several And move to talk in through we update likely year. programs an on lot, forward of those quite team have next concept in-vivo stage CNS providing but we an early of and number are. the look working ongoing don't diseases. look proof sometime providing actively that them actively is interesting different We early But we studies. those a to

Operator

like are to the over conference the further There questions this to no Jay instructions] time. turn would for back closing now marks. I [Operator at Hargan

Joseph Hagan

today this brief us joining for call. everyone for thanks Well,

We mentioned, per providing your look interest timelines, as are updates track on programs reach the and and I all and them Regulus As in we we'll and key up milestones. on our advance support soon. catch you. forward appreciate they Thank to

Operator

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

disconnect. now may You

Regulus Therapeutics (RGLS) 11 Aug 222022 Q2 Earnings call transcript