Regulus Therapeutics

Regulus Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The firm is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded on September 5, 2007 and is headquartered in San Diego, CA.

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Regulus Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The firm is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded in 2007 and is headquartered in San Diego, CA.

First patient dosed in second cohort of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429  R&D Day to discuss our ADPKD program to be held Wednesday, September 6 th Strengthened leadership through appointments of Preston S. Klassen, M.D.

Regulus Therapeutics Reports Second Quarter 2023 Financial Results and Recent Updates

SAN DIEGO , Aug. 2, 2023 /PRNewswire/ -- Regulus Therapeutics Inc . (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that CEO Jay Hagan will be presenting at the Canaccord Genuity 43rd Annual Growth Conference on Wednesday, August 9, 2023, at 11:30 a.m.

Regulus Therapeutics to Present at the Canaccord Genuity 43rd Annual Growth Conference

SAN DIEGO , July 18, 2023 /PRNewswire/ -- Regulus Therapeutics Inc . (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that Dr. Preston Klassen, President and Head of Research & Development of Regulus, will present at the H.C.

Regulus Therapeutics to Present at the H.C. Wainwright 2nd Annual Kidney Conference

SAN DIEGO , June 27, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the dosing of the first patient in the second cohort of the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "Following the positive safety review of patients in the first cohort, we were excited to initiate screening for the second cohort last month," said Jay Hagan, CEO of Regulus Therapeutics.

Regulus Therapeutics Announces First Patient Dosed in Second Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SAN DIEGO , June 23, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced Preston S. Klassen, M.D.

Regulus Therapeutics Announces Appointment of Preston S. Klassen, M.D.

Program advances to lead compound evaluation in preclinical in vivo models Preliminary data for in vivo studies are expected in second half of 2023 SAN DIEGO , June 20, 2023 /PRNewswire/ -- Regulus Therapeutics Inc (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced an update on its preclinical studies evaluating a library of oligonucleotides designed to inhibit miR-155 for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease). Regulus is pursuing this effort in collaboration with the laboratories of Oleg Butovsky, Ph.D.

Regulus Therapeutics Announces Update on Preclinical Studies in Amyotrophic Lateral Sclerosis in Collaboration with Researchers from Harvard's Brigham and Women's Hospital

Regulus Therapeutics Strengthens Research & Development Leadership

Blinded safety data observed so far are encouraging SAN DIEGO , May 16, 2023 /PRNewswire/ -- Regulus Therapeutics Inc.  (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced, after review of all available safety data, that it will advance to the second cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "We are pleased to see our Phase 1b MAD trial continue to advance with the initiation of the second cohort of patients," said Jay Hagan, CEO of Regulus Therapeutics.

Regulus Therapeutics Advances to Cohort 2 of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Enrollment completed in first cohort of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 Closed $15.0 million private placement of equity; expected to extend cash runway into mid-2024 SAN DIEGO , May 11, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.  "Our work in ADPKD continues to progress, with enrollment now complete in cohort 1 of our Phase 1b MAD study of RGLS8429," stated Jay Hagan, CEO of Regulus.

Regulus Therapeutics Reports First Quarter 2023 Financial Results and Recent Updates

Regulus (RGLS) surges as it completes enrollment in the first cohort to evaluate RGLS8429 for kidney disease.

Regulus (RGLS) Surges on Enrollment Completion for RGLS8429

SAN DIEGO , April 13, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that it has entered into a definitive securities purchase agreement in connection with a private placement to certain institutional investors and other accredited investors.  The financing was led by the Federated Hermes Kaufmann Funds and New Enterprise Associates (NEA), with participation from additional existing shareholders.

Regulus Therapeutics Announces $15 Million Private Placement of Equity

SAN DIEGO , April 12, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment in the first cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD.

Regulus Therapeutics Announces Completion of Enrollment in First Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Enrollment progressing in Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Top-line data in the first cohort of RGLS8429-treated ADPKD patients anticipated in second half of 2023 Expansion of team with key leadership appointments in clinical development, regulatory and clinical operations SAN DIEGO , March 23, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today reported financial results for the fourth quarter and year ended December 31, 2022, and provided a corporate update.  "We ended 2022 in a position of strength, with enrollment in our Phase 1b MAD study under way.

Regulus Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Recent Updates

SAN DIEGO , Feb. 9, 2023 /PRNewswire/ -- Regulus Therapeutics Inc . (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023 at 1:00 p.m.

Regulus Therapeutics to Present at the SVB Securities Global Biopharma Conference

SAN DIEGO, Jan. 13, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the grant of an inducement stock option to Claire Padgett, Ph.D. and to Rekha Garg, M.D., M.S., on January 11, 2023 in connection with their respective appointments as Regulus' Senior Vice President, Clinical Operations and Senior Vice President, Clinical Development and Regulatory. The grants in accordance with NASDAQ Listing Rule 5635(c)(4) are an inducement material to Dr. Padgett's and Dr. Garg's acceptance of employment with Regulus.

Regulus Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

SAN DIEGO , Dec. 12, 2022 /PRNewswire/ -- Regulus Therapeutics Inc .  (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that Simos Simeonidis , Ph.D.

Regulus Therapeutics Announces Resignation of Board Member

Additional Preclinical Promotions Round Out Scientific Leadership SAN DIEGO , Nov. 29, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the appointments of Rekha Garg, M.D., M.S., to Senior Vice President, Clinical Development and Regulatory, and Claire Padgett, Ph.D.

Regulus Therapeutics Announces Appointments of Industry Veterans, Drs. Rekha Garg and Claire Padgett, to Lead Clinical Development, Regulatory and Clinical Operations

Regulus Therapeutics, Inc. (NASDAQ:RGLS ) Q3 2022 Earnings Conference Call November 10, 2022 5:00 PM ET Company Participants Crispina Calsada - CFO Jay Hagan - President, CEO & Director Denis Drygin - Chief Scientific Officer Conference Call Participants Yanan Zhu - Wells Fargo Securities Operator Hello, and welcome to the Regulus Therapeutics Inc. Q3 2022 Earnings Conference Call. [Operator Instructions].

Regulus Therapeutics, Inc. (RGLS) Q3 2022 Earnings Call Transcript

Company announced first patient dosed in its Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Company announced positive topline safety and pharmacokinetic (PK) data from its Phase 1 Single-Ascending Dose (SAD) study of RGLS8429 in healthy volunteers for the treatment of ADPKD   $4.5 million in net proceeds in At-the-Market (ATM) sale to a new institutional investor SAN DIEGO , Nov. 10, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.  "We are pleased with the positive safety and PK data in healthy volunteers in our Phase 1 SAD study and are delighted to have the first patient dosed in our ongoing Phase 1b MAD study, which brings us a step forward in investigating RGLS8429 as a potential treatment for ADPKD," commented Jay Hagan, CEO of Regulus.

Regulus Therapeutics Reports Third Quarter 2022 Financial Results and Recent Updates

SAN DIEGO , Nov. 3, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that it will report its third quarter 2022 financial results on Thursday, November 10, 2022, after the U.S. financial markets close. In connection with the earnings release, Regulus' management team will host a live conference call and webcast on the same day at 5:00 PM ET, to discuss the Company's financial results and provide a corporate update.

Regulus Therapeutics Announces Timing for Third Quarter 2022 Financial Results Webcast and Conference Call

SAN DIEGO , Nov. 2, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the dosing of the first patient in the Phase 1b MAD study of RGSL8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). "Dosing of the first patient in the MAD clinical trial of RGLS8429 marks yet another important achievement in our ADPKD program," said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics.

Regulus Therapeutics Announces First Patient Dosed in Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SAN DIEGO , Oct. 27, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced a poster presentation at the American Society of Nephrology Kidney Week 2022 (ASN Kidney Week 2022), which will take place in Orlando, November 3-6, 2022.  The poster, titled "Discovery of Next-generation Anti-miR-17 Oligonucleotide RGLS8429 for Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)," provides an overview of the data supporting the potential of RGLS8429 as a treatment for ADPKD.

Regulus Therapeutics Announces Poster Presentation at ASN Kidney Week 2022

Regulus Therapeutics (RGLS) reports positive top-line data from a phase I single-dose ascending study of its lead candidate RGLS8429 in autosomal dominant polycystic kidney disease.

Regulus (RGLS) Up on Top-Line Data from Kidney Disease Study

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Phase 1b Multiple Ascending Dose (MAD) Study Initiated RGLS8429 in healthy volunteers was well-tolerated with dose-proportional PK Topline data from first cohort of patients with ADPKD anticipated in 1H 2023 SAN DIEGO , Sept. 12, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced positive topline safety and PK data from its Phase 1 SAD clinical trial of RGLS8429.

Regulus Therapeutics Announces Positive Topline Safety and Pharmacokinetic (PK) Data from the Phase 1 Single-Ascending Dose (SAD) Clinical Trial of RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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