Exhibit 99.1

 

LOGO

Regulus Provides Strategic Update and Reports Fourth Quarter and Year-End 2013 Financial

Results and Recent Highlights

- Achieved All Goals on ‘Road to the Clinic’; Launched ‘Clinical Map Initiative’-

- Regulatory Approval Received for Phase I Clinical Study of RG-101 -

- Strengthened Focus on Orphan Diseases and Oncology -

- Exceeded YE 2013 Guidance with $114.0M in Cash -

LA JOLLA, Calif., February 27, 2014

Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today provided an update on its corporate strategy and reported financial results for the fourth quarter and year ended December 31, 2013, including a summary of recent corporate highlights.

Corporate Strategy Update:

Achieved All Goals on ‘Road to the Clinic’ and Launches ‘Clinical Map Initiative’

 

    Regulus announced today that it has achieved all goals under its ‘Road to the Clinic’ Strategy:

 

    Regulus has nominated two microRNA candidates for clinical development, RG-101, a GalNAc-conjugated anti-miR targeting miR-122 for the treatment of chronic hepatitis C virus infection (“HCV”), and RG-012, an anti-miR targeting microRNA-21 (“miR-21”) for the treatment of Alport Syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy;

 

    Regulus has received regulatory approval to initiate the Phase I clinical study of RG-101; and

 

    Regulus exceeded its previously issued cash guidance, ending 2013 with $114.0 million in cash, cash equivalents and short-term investments.

 

    Regulus also announced today its ‘Clinical Map Initiative’, which outlines certain corporate goals to advance its microRNA therapeutics pipeline over the next several years:

 

    Demonstrate human proof-of-concept results in the Phase I clinical study of RG-101 for the treatment of HCV by the end of 2014;

 

    Initiate a Phase I clinical study of RG-012 for the treatment of Alport Syndrome in the first half of 2015;

 

    Nominate a third microRNA candidate for clinical development by the end of 2014; and

 

    Maintain a strong financial position and end 2014 with at least $75.0 million in cash, cash equivalents and short-term investments.

“In 2013, we demonstrated significant progress toward our goal of building a leading biopharmaceutical company dedicated to discovering and developing a new and major class of medicines targeting microRNAs. Today, we are pleased to have achieved our goals on the ‘Road to the Clinic’ and transition


The following information was filed by Regulus Therapeutics Inc. (RGLS) on Thursday, February 27, 2014 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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