Regulus Therapeutics Inc.

Good morning and welcome to the Regulus Therapeutics second quarter financial results conference call. All participants will be in a 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 your touch-tone 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 Chris Calzada, Chief Financial Officer of Regulus. Please go ahead.

Thank you. Good afternoon, everyone, and thank you for joining us to discuss Regulus Therapeutics' second quarter 2022 financial results and corporate highlights. Joining me on today's call is Jay Hagan, President and Chief Executive Officer, and Dr. Dennis Drygen, 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 regular therapeutic 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'll now turn the call over to Jay.

Thanks, Chris, and welcome, everyone, to our second quarter earnings call and business update. I'll begin first with a general update on our ADPD program. The second quarter was particularly eventful, beginning with the U.S. Food and Drug Administration's acceptance of our IND for RJLS 8429, for the treatment of autosomal dominant polycystic kidney disease. This was followed by the dosing of the first subject in our phase one single ascending dose study of RJLSA429 to assess the safety, tolerability, and pharmacogenetics of the drug in healthy volunteers. Following this study, we plan to initiate a phase 1B multiple ascending dose study in adult patients with ADPKD to assess the safety, tolerability, and pharmacokinetics of RGLS-8429 treatment, as well as to evaluate the dose response of RGLS-8429 on ADPKD biomarkers, including polycystins, cystic kidney volume, and overall kidney function. Our objective is to establish a dose response around the dose level where robust clinical biomarker effects were demonstrated with our first-generation compound. We anticipate top-line data from the healthy volunteer portion of the study later this year, and top-line biomarker data from the first cohort of RGLS A429 treated ADPKD patients in the first half of 2023. The single ascending dose study is nearing completion, consistent with our planned execution and timeline, and the multiple ascending dose portion of the study is well on track for initiation shortly after completion of the SAD study. RJLS 8429 was granted Orphan Drug Designation from the FDA. Orphan Drug Designation, or ODD, identifies drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. And with that, helps facilitate drug development by providing potential financial and regulatory incentives. Finally, we're thrilled to welcome Dr. Amin Kamal, as our new vice president of DMPK, a key new hire for the Regulus team. We look forward to his contributions as we progress our GLS 8-429, as well as the rest of the pipeline. With that, I'll now turn the call back over to Chris for an update on our financial results. Chris?