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.

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)

SAN DIEGO , Sept. 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 that the Company will participate in two upcoming investor conferences.

Regulus Therapeutics to Participate in Upcoming Investor Conferences

Regulus Therapeutics, Inc. (NASDAQ:RGLS ) Q2 2022 Earnings Conference Call August 11, 2022 5:00 PM ET Company Participants Crispina Calsada - CFO Joseph Hagan - President & CEO Conference Call Participants Yi Chen - H.C. Wainwright & Co. Operator Good morning, and welcome to the Regulus Therapeutics Second Quarter Financial Results Conference Call.

Regulus Therapeutics, Inc. (RGLS) CEO Joseph Hagan on Q2 2022 Results - Earnings Call Transcript

IND accepted and first subject dosed in the Phase 1 Single-Ascending Dose (SAD) study of RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) RGLS8429 granted Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) Scientific leadership strengthened with the appointment of Amin Kamel, Ph.D., as Vice President, Drug Metabolism and Pharmacokinetics (DMPK) SAN DIEGO , Aug. 11, 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 second quarter ended June 30, 2022 and provided a corporate update.

Regulus Therapeutics Reports Second Quarter 2022 Financial Results and Recent Updates

SAN DIEGO , Aug. 4, 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 second quarter 2022 financial results on Thursday, August 11, 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 Second Quarter 2022 Financial Results Webcast and Conference Call

SAN DIEGO , June 21, 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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). "Patients living with ADPKD currently have limited treatment options and approximately half of patients develop end-stage renal disease by age 60 requiring dialysis or transplantation," commented Jay Hagan, CEO of Regulus Therapeutics.

Regulus Therapeutics Announces Receipt of FDA Orphan Drug Designation for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SAN DIEGO , June 13, 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 healthy volunteer in the Phase 1 SAD study of RGSL8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). "The initiation of the clinical trial of RGLS8429 with the dosing of the first subject marks another important milestone for our program targeting the treatment of ADPKD" said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics.

Regulus Therapeutics Announces First Subject Dosed in Phase 1 Single-Ascending Dose (SAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SAN DIEGO , June 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 appointment of Amin Kamel, Ph.D., as Vice President, DMPK.

Regulus Appoints Amin Kamel, Ph.D., as Vice President, DMPK

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SAN DIEGO , May 17, 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 Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright Global Investment Conference.

Regulus Therapeutics to Present at the H.C. Wainwright Global Investment Conference

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Regulus Therapeutics, Inc. (NASDAQ:RGLS ) Q1 2022 Earnings Conference Call May 12, 2022 5:00 PM ET Company Participants Crispina Calsada - CFO Joseph Hagan - President, CEO & Director Conference Call Participants Yi Chen - H.C. Wainwright & Co. Operator Good day, and welcome to the Regulus Therapeutics Inc. First Quarter 2022 Conference Call.

Regulus Therapeutics, Inc. (RGLS) CEO Joseph Hagan on Q1 2022 Results - Earnings Call Transcript

FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD) On track to initiate Phase 1 study in second quarter 2022 SAN DIEGO, May 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 reported financial results for the first quarter ended March 31, 2022 and provided a corporate update.  "The year is off to a great start as we continue to advance our pipeline, including the recent acceptance of our IND application for RGLS8429.

Regulus Therapeutics Reports First Quarter 2022 Financial Results and Recent Updates

The FDA accepts Regulus' (RGLS) IND application for RGLS8429 to treat autosomal dominant polycystic kidney disease. The company plans to begin a phase I study in second-quarter 2022.

Regulus (RGLS) Up as FDA Accepts IND for Kidney Disease Drug

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Company remains on track to initiate Phase 1 clinical study in second quarter 2022 SAN DIEGO , May 11, 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 the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), enabling the Company to initiate its planned Phase 1 clinical study of RGSL8429 in healthy volunteers. "With FDA's acceptance of our IND and the Phase 1 trial preparations well underway, we look forward to advancing this program which ultimately may provide a transformative treatment option for patients with ADPKD," said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics.

Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SAN DIEGO , May 5, 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 first quarter 2022 financial results on Thursday, May 12, 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 at 5:00 PM ET on Thursday, May 12, 2022, to discuss the Company's financial results and provide a corporate update.

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

- Preliminary data are expected in the second half of 2022 SAN DIEGO , March 24, 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 initiation of studies evaluating a library of oligonucleotides designed to block miR-155 for the potential to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) under a collaboration agreement with the laboratories of Oleg Butovsky, Ph.D., and Howard L.

Regulus Therapeutics Announces Initiation of Preclinical Studies in Amyotrophic Lateral Sclerosis under a Collaboration Agreement with Harvard's Brigham and Women's Hospital

Regulus Therapeutics Inc. (RGLS) CEO Jay Hagan on Q4 2021 Results - Earnings Call Transcript

SAN DIEGO, March 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 announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.  "Last year was a transformational year for Regulus with the accomplishments in our ADPKD program including clinical validation of the target and the prioritization and advancement of our next generation compound RGLS8429," commented Jay Hagan, CEO of Regulus Therapeutics.

Regulus Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results and Recent Updates

SAN DIEGO, March 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 has scheduled its fourth quarter and year-end 2021 financial results conference call and webcast on Thursday, March 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 at 5:00 PM ET on Thursday, March 10, 2022, to discuss the Company's financial results and provide a corporate update.

Regulus Therapeutics Announces Timing for Fourth Quarter and Year-End 2021 Financial Results Webcast and Conference Call

SAN DIEGO, Feb. 24, 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 completion of enrollment in the Phase 2 HERA clinical study evaluating lademirsen (RG-012) for the treatment of adult patients with Alport Syndrome under the Company's Collaboration and License Agreement with Sanofi. "We value our collaboration with Sanofi and continue to be proud of the steady progress being made not only in this study, but also in our technology to treat kidney disease," said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics.

Regulus Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Lademirsen for Alport Syndrome

SAN DIEGO, Feb. 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 announced that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the 11th Annual SVB Leerink Global Healthcare Conference on Friday, February 18, 2022 at 3:00 p.m. ET. A live webcast of the presentation will be available under "Events and Presentations" through the investor relations section of the Company's website at www.regulusrx.com.

Regulus Therapeutics to Present at the 11th Annual SVB Leerink Global Healthcare Conference

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Regulus Therapeutics Inc (NASDAQ: RGLS) has completed a pre-investigational new drug (Pre-IND) meeting with the FDA to obtain input on the Company's RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD).  ADPKD is a genetic disorder characterized by the growth of numerous cysts in the kidneys.

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