Regulus Therapeutics (RGLS)

Crispina Calsada CFO
Joseph Hagan President, CEO & Director
Yi Chen H.C. Wainwright & Co.
Call transcript
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Good day, and welcome to the Regulus Therapeutics Inc.

First Quarter 2022 Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Cris Calsada, Chief Financial Officer. ahead. go Please

Crispina Calsada

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

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

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

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

tolerability our I the proud of to and share ADPKD. week, welcome, on healthy and ascending Administration in accepted and study Cris, I'll dose We're program. and this with quarter Drug for safety, Phase for RGLSXXXX. update. begin to earlier treatment U.S. IND single business assess with pharmacokinetics volunteers The Food Thanks, RGLSXXXX first everyone, first the is a to our of ADPKD study call earnings that update a our general you

function. biomarkers and volume where compound, adult RGLSXXXX. biomarker levels We of establish from multiple including a the of our of polycystins, treated kidney patients a we the in response clinical plan and evaluate dose dose were cystic in kidney pharmacokinetics the in the XXXX. patients tolerability RGLSXXXX response that line RGLSXXXX to study, safety, the study this our with study in biomarkers, Recall on the healthy objective demonstrated of and first of this from initiate Phase as treatment, as XXXX overall dose ADPKD is second half robust to assess top line the effects well with data Following Ib cohort of anticipate data to ascending top volunteer portion first study around the first-generation half ADPKD RGLSXXXX

Lademirsen, is XXXX, $XX Final with our technology, the of the half if under million data expected the like validate treatment the first advance HERA gears II I'd license of successful, syndrome Sanofi. of of our evaluating regarding company understanding and and kidney treatment Now program position of strengthen agreement financial diseases RG-XXX in potential would Sanofi, the In adult Lademirsen for Alport we study February, clinical update shift our of for to Alport enrollment Phase platform latest our syndrome. genetic our and of with the further completion with and share milestone. partner, collaboration a in patients by the announced the

on muscles Results studies. function. a vitro to to that and future over devastating weakens that, in collaboration nervous and we looking effects our physical impacts to and early-stage of on look under design from and our agreement will with collaboration work I'll ALS In providing CNS for the announced March, With Hospital. studies the disease update Cris to system biologic future Cris? their other This preclinical diseases. updates dysregulated in guide Moving preclinical disorder with an initiation microRNA in these vivo research grievous our Women's activities. used financial a call be at of models inhibitors targeting nicely miR-XXX initial internal the The turn for studies results. of these models an back experiments in in and dovetails on we the characterize Brigham additional both the exploration the entails of of animal of forward properties, work ALS,

Crispina Calsada

Thank you, Jay.

financial Turning results. to our

As XXXX, our cash approximately equivalents of March XX, $XX.X cash million. totaled and

of in loss XXXX. period was that, reflect per loss and per same that in the the $X.XX to to amounts diluted in efforts $X.X share period for We General external the associated and loss diluted quarter and $X million XXXX. runway same the cash first for reflect amounts of period will our earlier. to These include turn expect over million and the I the general expenses net XXXX in to for first related Net the our first XXXX. with expenses to share million potential in our quarter was and XXXX of ongoing costs costs. XXXX. quarter per loss of basic the business in These This research $X.X personnel Sanofi quarter $X.X Research the same for compared million million of first compared not and for the share of totaled and into the compared of net internal Jay. $X.X guidance development $X.X extend program XXXX. With fourth other operating million totaled for Basic administrative to call pipeline. does the net period back advancing quarter compared ADPKD $X.XX discussed same milestone for XXXX Jay XXXX

Joseph Hagan

this At Operator, you any time, happy questions. take can to lines. Cris. Thanks, the open we're


[Operator Instructions].

Wainwright. question first Chen with The comes from H.C. Yi

Yi Chen

upcoming expenses associated comment you trial for Could overall with XXXX? the the on

Crispina Calsada


SAD since have the then which will in data our year. that, MAD into in in second study, our commencing XXXX commence of here the half second the readout half to, of our the study immediately move our quarter this with is of history the start we will second after plan XXXX XXXX. So And program

Joseph Hagan

into in. going, say, they're similar very And Ib study, stopped the the X XXXX Phase study. the short saving where cohort, associated XXXX are we XXXX But obviously, a then the redirect XXXX costs, the cetera, longer we us -- we're arms you're the can inflationary program. costs with et money the And environment study for placebo-controlled those it, and by in to Yi, for some doing now

cohort, have X instead we in compound. XX patients that So the we per did of first generation

We have XX we're long. for twice patients as dosing per cohort, and

So the be cost the cost will MAD than higher for XXXX in patients approximately the the portion probably for XX% study.

Yi Chen

additional the half syndrome of Got milestone there And be it. the Alport readout any first with in data Okay. from associated will XXXX?

Joseph Hagan

Ionis our funding have and milestone $XX The last agreement. Alnylam Sanofi, from they're that owed the for and is for to million final royalties and responsible we the would


our over [Operator like concludes to session. would Hagan closing the question-and-answer for turn Instructions]. I to This conference remarks. Jay back any

Joseph Hagan

today updates. us operator, brief appreciate and our providing Thank thanks, your on Thanks, our everyone, to we and support of Regulus. you. progress, forward for future update on We joining look


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

may now You disconnect.