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Regulus Therapeutics (RGLS)

Participants
Allison Wey Vice President of Investor Relations and Corporate Communications
Jay Hagan President, Chief Executive Officer, Principal Executive Officer, Director
Tim Wright Chief Research and Development Officer
Dan Chevallard Chief Financial Officer, Principal Financial and Accounting Officer
Matthew Luchini BMO Capital
Joseph Thome Cowen and Company
Nick Abbott Wells Fargo
Call transcript
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Operator

Good afternoon. My name is Sonya and I will be your conference operator today. At this time, I would like to welcome everyone to the Regulus Therapeutics third quarter 2017 conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Instructions]. [Operator you. Thank Ms. President may Vice Relations Corporate and Allison your of conference. you begin Communications, Wey, Investor

Allison Wey

Thank Good XXXX us to corporate you for discuss you Sonya. highlights. Regulus' afternoon everyone third quarter financial and thank results and joining

before and are the will CEO, Tim open and our share we Dan our progress Wright, Hagan, provide financial will programs and Dr. CFO. Officer on joined Jay for today then R&D opening line We review questions. Jay Chevallard, President results Dan by will Chief remarks, the pipeline Tim

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

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

Jay Hagan

this Thanks on call afternoon. us Allison everyone joining thanks and for the

study programs which main focus X production working ultimately protocol, clinical XXXX. much for place. separate quarter final QX quarter been report our study. to Consequently on pleased milestones. of filed To his end organizational through for research on next additional a believe time, redesigned will expectations capital renal quarter the recently decided doesn't from original We we following first Sanofi are in of and milestones HERA we our the When we testing breadth data million while key quarter beginning the by and me is year, and discussions. quarter hard versus redesign our months. QX are by the at been hope implementing results our several strengthening the marked of the implementation stealing on we and programs, quarter, in we mind we operational pipelines, team XX track XXXX the study second on versus pipeline was focused $XX in obviously the HERA to to quarter. study a thunder, order third our program both RGLSXXXX focusing that on in Tim over and the the cash sheet operational about in And Also initiation our we live. driving through the Phase has biopsy we The raising has runway the that The of third our talk and biopsy set that XX and execution, necessary better the extends implement and balance our Executing providing the in started and this which the clinical expected year-end key BD on not protocol is advancing anticipate emphasis changes clinical of are program to year-end human resetting RG-XXX in with the fund the set the to the had the anticipated this minute. now rightsizing to taking some first very specific programs. that timelines Tim priorities on IND later a program XXXX

role target among HERA in with biology seen to novel our supporting week anti-mir with we experienced investigators was last at a that its our The Importantly with ASN palpable. microRNA-XX, and designs the ATHENA broad X the great though, at well community to in and had and understood meet meeting. Phase smarter a investigators fibrosis and opportunity employed I by trial scientific our programs appreciated the the literature

Tim, Regulus, particularly just excited months over as to I yield after as six mention Lastly, our about that CEO and how our forward. of and to before organizational I want I impact move Regulus it the scientific for we processes turn should to changes am programs

more in a in as mainstream efforts efficient focused the research therapeutics acquired engine. and the different to clear therapeutics We model our able more have their finally approach position systems promise the development in potential be be which microRNA clinical fully oligonucleotide should much biology. coming reflected leader a Regulus to a characterizing should with more quickly into in of derisk R&D to This, ultimately targeting rigorous coupled

turn I details will over of to treatment RGLSXXXX more call programs, the who Tim disease will for the two Tim? our clinical dominant or polycystic RG-XXX Now Alport ADPKD. kidney autosomal and the on provide treatment syndrome of for

Tim Wright

Jay. Thanks

our Alport in syndrome. with RG-XXX begin program Let's

HERA the contributed history our importantly, with demographics X-linked syndrome. study male genetics the of on we ATHENA and in disease. patients our a study now the of The redesigned are the great out natural it will and have around Building thank the close week RG-XXX from syndrome at like I success. been exclusively The redesign with and patients year. the instrumental focus on making the for history and genetics contribute will next natural data patients wrapping that and most are scientific Alport we Alport of greatest need, us at ATHENA and medical syndrome, in study to from investigators of program We Alport and analysis, ATHENA study unmet conferences understanding and the the ASN its ATHENA the significantly have study and with investigators last learnings up full we have publications met presentations planning to the year-end. data will study to would it all

anticipate week the blended XX rate the over of eGFR subjects topline a XXXX. as of weeks XX XXXX by examining We the and the for measured QX safety slope We on of QX RG-XXX analysis disease all when of will a the be readout follow-up of follow-up period. interim XX and in results in efficacy up effect of reach progression follow

the on As study the biopsies that and engagement markers, biopsy. part in of and now measurements new of and obtained measured pharmacokinetics tissue focused the were percutaneous have levels, part a HERA by original we target biomarkers, redesign, renal removed drug design renal including of the disease-related kidney

in of the of expect We from investigators changes next and with have this a and revised made year. study partner are data with end the excitement up revised the redesigned support, our enthusiasm setting in Alport around from clinical we the In plans. they deal the received regarding program. been QX Sanofi from agreement the clinical and These community studies, great consultation initial RG-XXX

now Let's autosomal for on RGLSXXXX kidney the to dominant polycystic or disease and move ADPKD. program

very As Jay the we the following mentioned and RGLSXXXX recently pre-IND FDA. for earlier, IND we a filed positive have meeting, this accelerated program with

or including patients. by regulatory to from We studies mechanism no and into planned operational of half in track study human year-end. may and proof X would a XXXX initiate Phase are in second expect of other Assuming impact that throughout issues ADPKD data dosing study first we XXXX, the startup, on this result our

Now turning pipeline. to our preclinical

call route effectively in to to I administration open can of a of over of are will And diseases identification to primarily exploring parallel, and we the Our deliver a the kidney we so and organs range oligonucleotide target and delivery validation Dan technologies and tissues expand quarter approach to research leverage the turn we have In efforts novel now on wider our diseases results. new been we two to up pursue that liver, the therapeutics. can focused discuss third therapeutics. to new can financial which

Dan Chevallard

Thanks Tim.

and organizational been operational our quarter priorities is of two while As us executing programs. to the equally reset do our important operating you resources. the have and while to the within today, heard of lead focus confines for It recent has efficiently on

quarter expenses organization step transition I the to subsequent recent related planned in restructuring. million a $XX.X in This the earlier quarter accountability. that, by R&D our highlights. including broadly fiscal $XX.X third went discipline While our reduction quarter non-cash with corporate of to compensation I third and for were been this our like With million have would XXXX. financial year, costs, through third sense compared decrease our of driven to was through stock-based the pleased adopted personnel significant

million costs. year, quarter. Excluding driven this our the associated of the decrease $X.X R&D in by one-time third million personnel quarter Similarly declined this planned to of related the by approximately expenses also third quarter reduction the G&A third in in last XX% in expenses $X.X versus for QX incurred charges was of compared XXXX XXXX. were quarter

of quarter charges incurred XX% last G&A approximately the one-time by expenses Excluding declined XXXX. quarter, in

the loss in by both Our further and that of net the share per share XXXX. XXXX per third of to quarter are impacted period these share, decreased $X.XX XX% share $X.XX equity compared financing. comparative basic in our our while was quarter diluted, by QX in results the net per recent XXXX, versus third per Note approximately loss

to our call burn position Jay, update like would an and we to Before cash I back the look I as turn on cash provide forward.

of recent development objectives capital burn the quarter short-term fund $XX.X and mentioned and gives approximately highlighted programs. key investments $XX.X in we million third most approximately hand by line us to the and our year per are to financing our with near-term As million our XXXX. a QX we $XX with and Having was million, which for promising RGLSXXXX burn today, on equivalents extend cash third on the our research quarter execute post-financing have our to continue quarter cash through RG-XXX, cash, ended with in third guidance of cash cash project

in on come our the that, it back to Jay. will I for like to further hand operating XXXX with we refined earnings year-end would plan currently are projections We phase back With and our call. planning

Jay Hagan

look Operator, pipeline momentum starting execution open And we syndrome shaping for your our share that, while to continuing our and the you with on with productive everyone of could forward are to year a the which outlook. today's XXXX and the our programs and milestones questions. programs, ready remainder ADPKD opportunity Thanks update year We Dan the please Regulus. to and XXXX strong discussions overall is thanks results expect advance of up continued be underway. overall to multiple business and through Alport lines? the advancement to during financial for development up take we clinical

Operator

[Operator Instructions].

Your first BMO the Matthew comes Luchini question Capital. line from from of

Your line open. is

Matthew Luchini

you you focus for on So X-linked of patients you study redesigned have HERA eligible these that will can sense many are now treatment? male of with the and patients a Alport, give us the how

Tim Wright

Well, interesting. very it's

are patient have diagnosis the also medical with patients certainly We are electronic actually, of there a search But of preliminary is unmet the record need of the patients it's genetic population, X-linked of other terms are actually the medical in There majority patients in mechanisms. with X-linked done majority with females and some analysis subpopulation vast and males. males population.

Jay Hagan

what in check just the project a done amplify, history signal statistics around I population terms the this with the of work natural progression this that from Matt, Phase record disease, further we that as further through looking we blinded our tightening to detailed of medical really ATHENA here deviation find in well and patient as the to we the gleaned the slope up electronic enhanced have study. choice XX we have X standard the feasibility study want systems, coupled in ability

Matthew Luchini

very you Okay. Great. Thank much.

Operator

the Your from of Company. Joseph next from Thome Cowen question and comes line

is Your open. line

Joseph Thome

in question I pipeline indicated what for just X And my that congratulations there the Phase RGLSXXXX? the give the additional just progress. Was RGLSXXXX. for potential like? there. that Can studies idea Phase on think that is your Thank you specifically you had in of an Hi you I quick maybe X prepared in question taking had general? was remarks, Or just HX would a and us for on XXXX. a for

Jay Hagan

and I proposed speak Yes. for will the to forward. X program RGLSXXXX Tim That the was let generally Phase for comprehensive

Tim Wright

Yes.

of should will that dose the starting definition only the into I doing single And say, say But I reason ascending tolerability sure that move study stage, want proof the going dose mixed design. work. the ascending doing in terms end because are we on and make that feasibility alternative multiple to PK, in for dose up multiple between we study subjects. patients. at on air going bit, dose now are before little ascending toying a move in getting some in we population of standalone said, address of mechanism. biomarker year to we mechanism a the are remains is is and that, and of our move then with of So safety, that ascending the we idea a incorporating the dose kind we proof to of all will following we ascending dose like I be with of be volunteers we the into into and with single final how this multiple But to or healthy multiple a and a that healthy volunteers The of

Jay Hagan

just And an publication on amplify this on and further markers seen that impact kidney saw may earlier a plasma. Yes. to in we you that the that, the couple are measurable in have urine year of disease of

effect want obviously can And to same so be humans. recapitulated if we in see that

impact hitting and on in during are are work right that confidence some that patients having intended background target are We of see B, ADPKD, the markers A, we for us multiple now the that X and set the with do stage would test give disease therapeutic Phase effect. the we an to with similarly dose we

Joseph Thome

very you Thank much. Great.

Operator

There the Mr. no I time. will back at over questions call Hagan. Jay are this further turn to

Jay Hagan

pursue investor Thanks more don't emphasize X-linked in And the to like question. in doesn't intend that look know. males. just I well looks might It planned and to broadly we will I conference other females to Stifel mean very is including week one it have two and HERA much. next participating separately, the be for study then. the trial. want biopsy we One, But forward we update things.

back. maybe So circle want to you

Operator

Certainly.

Jim Fargo Your the next Birchenough question Wells comes line from from of Securities.

is open. line Your

Nick Abbott

for Jim. Hello. in Nick, It's

Did me prior the for But afternoon everybody. squeezing in. trial. to actually to go just as Busy many So back I HERA can much you for dose the thanks patients redesign?

Jay Hagan

dose did do halting prior decided patient the when the study. to one We administrative to study back MAD we

Nick Abbott

that patient? And X-linked was an patient

Jay Hagan

No.

that the I only late to prior not, Just that piece done we Nick, in when well was the but previous plan. was earlier this unmet seen population what that dosing, we on much -- would males, of and a was at described reviewing statistics the was clinicaltrials.gov. given doing also that disclosed so around which better only have this last be population from standard us to results efficacy always clear, up change then tighter we able the as we is yield the to point slope decided the MAD the where to that is on final been not halting found the deviation until what by the that being change We program, for year hadn't a had live need, arrive obviously now MAD focusing results signal was the as of in our the homogeneity that is terms And population where X-linked trial. significant detect it the in this a most

Nick Abbott

open as caught the that I just And Okay. as far comment biopsy then would your that be trial, last females. to

restricted. that's So going to be not

Jay Hagan

Correct.

Nick Abbott

ADPKD, first healthy be trial, is going the human And then for the to is volunteers? that in

Jay Hagan

in after yes, been safety by to move encouraged establishing volunteers. fairly patients the agency healthy the quickly portion And of SAD volunteers. study, to the healthy have in In we

as working I program final second touches So markers of still study on in see in on a of to just we from intend mentioned, if kidney type through we what Phase part the XXXX. that are we we we of are an we putting can the incorporate where treatment X walked that proof in certain see design and mechanism to seen with animals there have improvement where recapitulate function going Tim

Nick Abbott

just And biomarkers that blood biopsy? or or will urine for a that have

Tim Wright

biopsy wouldn't the you No, want patient. correct. blood, PKD and a Urine

Nick Abbott

Great.

very much. Okay. you Thank

Jay Hagan

you. Thank

So concludes that I think things, Sonya.

Operator

call. conference today's concludes This

You may disconnect. not