Exhibit 99.1

 

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Regulus Reports Fourth Quarter 2016 Financial Results and Pipeline Update

RG-012 development program to include a separate biopsy study, which may provide earlier POC

Announces final top-line 48-week results for RG-101-02 DAA combo study

Conference call today at 5:00 p.m. ET

LA JOLLA, Calif., March 2, 2017Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the fourth quarter and full year ended December 31, 2016 and provided a summary of corporate highlights and pipeline update.

“2016 was a year of accomplishments and important key learnings that position us for meaningful advancements in our clinical and pre-clinical programs in 2017 and beyond. Based on these learnings, I am even more convinced that targeting microRNAs offer significant advancements in therapeutic potential for many diseases for which there are currently no or limited treatment options,” said Paul Grint, M.D., President and Chief Executive Officer of Regulus.

Fourth Quarter 2016 Highlights

 

    Initiated a Phase I MAD study for RG-012: Data from this study in healthy volunteers will provide additional PK and safety data and will be available in the second quarter 2017. The Phase II HERA study is expected to resume in the second half of 2017 following completion of the MAD study.

 

    Announced two new clinical candidates at the Company’s first R&D Day: RGLS5040 (anti-miR-17) for the treatment of cholestatic diseases; and RGLS4326 (anti-miR-27) for the treatment of autosomal dominant polycystic kidney disease (ADPKD). IND-enabling activities are currently underway. Regulus expects to file the INDs in the second half of 2017.

 

    Attracted Key Talent: Dr. Timothy Wright joined Regulus in October as its Chief R&D Officer.

Pipeline Update

RG-012 for treatment in patients with Alport syndrome

 

   

Today, Regulus announced that it has modified the Phase II RG-012 clinical development program in patients with Alport syndrome to accelerate patient enrollment and potentially achieve early proof of mechanism/proof of concept. The Phase II program will include the HERA study, a randomized, double-blind, placebo-controlled 48-week study in 30 patients with rapid renal function decline. The objective of the HERA study will be to evaluate the safety and efficacy of RG-012 for the treatment of renal function decline in patients with Alport syndrome. In parallel, a

 

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The following information was filed by Regulus Therapeutics Inc. (RGLS) on Thursday, March 2, 2017 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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