Regulus Therapeutics Inc.

Hello and welcome to the Regulus Therapeutics Inc. Q3 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touchtone phone. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Chief Financial Officer, Chris Calzada. Please go ahead. Thank you, and good afternoon.

And thank you for joining us to discuss Regulus Therapeutics Third Quarter 2022 Financial Results and Corporate Highlights. Joining me on today's call is Jay Hagan, President and Chief Executive Officer, and Dr. Dennis Dryden, Chief Scientific Officer. Jay will provide opening remarks and share progress on our ADPKD program, and I will review the financial results before we open the line for questions. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning Regulus Therapeutics' future expectations, plans, prospects, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast and should not be relied upon as representing our views As of any subsequent date, we specifically disclaim any obligations to update such statements. I will now turn the call over to Jay.

Thanks, Chris, and welcome, everyone, to our third quarter earnings call and business update. I'll begin with a general update on our ADPKD program. We continue to make progress in the clinic with RGLS 8429. In September, we announced positive top-line safety and PK data from our Phase I single ascending dose, or SAD clinical trial of RGLS8429. RGLS8429 was well tolerated with no serious adverse events reported. Among the 32 subjects treated with RGLS8429 or placebo, there were only nine adverse events, all of which were mild, except one, a sinus infection, which was graded moderate in severity. In addition, importantly, Preliminary results suggest that plasma exposure is approximately linear across the four dose levels tested and is similar to the PK data from the first generation compound, RGLS4326. Last week, we announced the dosing of our first patient in our Phase 1B multiple ascending dose, or MAD, study of RGLS8429. Since then, we've enrolled the second patient and have several more in screening at the six sites that are now currently active. The study is a double-blind, placebo-controlled, multiple-ascending dose study to assess safety, tolerability, and pharmacokinetics of RGLS8429 in adult patients with ADPKD. The study will evaluate the safety and efficacy of treatment with RGLS8429 across three different dose levels, including measuring changes in polycystins, cystic kidney volume or height-adjusted total kidney volume, and overall kidney function. The first cohort is being dosed at one milligram per kilogram of RGLS A429 or placebo every other week for three months. Top line data from the first cohort of patients are now anticipated in mid-2023. Switching gears, during the three months ended September 30, 2022, we sold and settled approximately 2.2 million shares for net proceeds of $4.5 million under our ATM facility. Almost all the shares were sold to a new institutional investor. With the completion of this transaction, we believe our cash, cash equivalents, and short-term investments will now fund current planned activities through 2023. Last week, we presented data at the American Society of Nephrology Kidney Week meeting in Orlando. The poster presentation was titled, Discovery of Next Generation Antimere 17 Oligonucleotide RGLSA429, for the treatment of autosomal dominant polycystic kidney disease. And it highlighted data supporting the potential of A429 in this important disease. We are excited about our progress as well as the attention Argyllis A429 receives in the marketplace, which helps validate the effort our team is putting forth each day to advance this therapy and its potential to improve the current standard of care. With that, I will turn the call back over to Chris for an update on our financials. Chris?