Exhibit 99.1

 

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Regulus Reports First Quarter 2018 Financial Results and Pipeline Progress

Two pre-clinical programs advance towards clinical candidates

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

LA JOLLA, Calif., May 10, 2018Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the first quarter ended March 31, 2018 and provided a pipeline update.

“We are very pleased with the progress being made on advancing our pipeline, including the recent initiation of the multiple ascending dose (MAD) study for RGLS4326; the advancement of two new pre-clinical programs in important areas of unmet need; and the continued advancement of the RG-012 program,” said Jay Hagan, President and Chief Executive Officer of Regulus. “These two new pre-clinical programs represent attractive areas of development for Regulus beyond our two chronic kidney disease programs.”

Pipeline Update

 

   

RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): As previously announced, a Phase 1 MAD study was recently initiated in healthy volunteers. This trial was initiated based on data from the ongoing Phase 1 single ascending dose (SAD) trial, in which RGLS4326 has been determined to be well tolerated to date. The Phase 1 SAD study has completed dose escalation and continues in the planned follow-up phase, which is on-track for completion in the second half of 2018. Data from both studies will provide pharmacokinetics and safety data in advance of the Phase 2 proof-of-concept (POC) study estimated for initiation in the second half of 2019.

 

   

Pre-clinical programs: Based on robust human in vitro data and murine in vivo data, the Company announced today it is advancing programs in Hepatitis B virus and immunology (targets undisclosed).

 

   

RG-012 for Alport syndrome: The Phase 2 HERA study is ongoing and data from the Phase 1 renal biopsy study is anticipated by year-end 2018.

Financial Results

Cash Position: As of March 31, 2018, Regulus had cash, cash equivalents and short-term investments of $45.1 million.

Research and Development (R&D) Expenses: R&D expenses were $11.8 million for the quarter ended March 31, 2018, compared to $15.8 million for the quarter ended March 31, 2017. The decrease was primarily the result of a reduction in personnel-related costs subsequent to our May 2017 corporate restructuring and the wind-down of clinical activities related to the RG-101 program.

 

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The following information was filed by Regulus Therapeutics Inc. (RGLS) on Thursday, May 10, 2018 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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