Exhibit 99.1

 

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Regulus Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results and Recent Updates

Completed Enrollment in First Cohort of Phase 1b Clinical Trial of RGLS4326 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (“ADPKD”)

Closed $19M Private Financing

LA JOLLA, Calif., March 9, 2021Regulus 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, 2020 and provided a corporate update.

“Regulus finished the year on a high note”, stated Jay Hagan, CEO of Regulus. “We advanced RGLS4326 into a Phase 1b study in ADPKD patients, achieved an enrollment milestone for RG-012 with Sanofi and its Phase 2 clinical study for the treatment of patients with Alport syndrome, and completed a private financing. With the recent progress, we believe we are well positioned to advance the ADPKD program through Phase 1b while also advancing our next generation ADPKD compound toward the clinic.”

Program Updates

RGLS4326 for ADPKD: In February 2021, the Company completed enrollment in the first cohort of a Phase 1b clinical study for RGLS4326 in patients with ADPKD (The “Phase 1b”). The Phase 1b is an adaptive design, open-label, multiple dose study in up to three cohorts of patients with ADPKD. The study is designed to evaluate the safety, pharmacokinetics, and changes in levels of polycystin 1 (“PC1”) and polycystin 2 (“PC2”) in patients with ADPKD administered RGLS4326 every other week for a total of four doses. The dose level for the first cohort is 1 mg/kg of RGLS4326 and the dose level for the second cohort is 0.3 mg/kg. The third and final cohort will be dosed at a level to be determined based Son the results of the first two cohorts. Concurrent with completion of enrollment in the first cohort and based on the review of the available interim safety data, the first patient of the second cohort has commenced dosing of RGLS4326. The Company anticipates availability of results from the first cohort in early Q2 2021.

RG-012 for Alport syndrome: In November of 2020, the Company announced that it has achieved the remaining $5 million milestone associated with interim enrollment under its Collaboration and License Agreement (the “Milestone”) with Sanofi for its development of miR-21 programs. The Milestone was triggered upon achievement of an enrollment metric by Sanofi in its Phase 2 clinical study evaluating RG-012 for the treatment of patients with Alport syndrome. Results from a previously completed biopsy study demonstrated kidney tissue concentrations that would be predictive of therapeutic benefit based on animal disease models as well as engagement of the target, miR-21. Over the course of the one year open-label study, promising trends in disease markers were observed and RG-012 was generally well tolerated with no serious adverse events. RG-012 has received orphan designation in both the U.S. and Europe.


The following information was filed by Regulus Therapeutics Inc. (RGLS) on Tuesday, March 9, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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