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Regulus Reports Fourth Quarter and Year-end 2017 Financial Results and Pipeline Update
Full Enrollment of RG-012 studies anticipated in 2H 2018
RGLS4326 Phase I study on track
Conference call today at 5:00 p.m. ET
LA JOLLA, Calif., March 7, 2018 Regulus 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 year ended December 31, 2017 and provided a pipeline update.
2017 was a transitional year for Regulus. We made important changes to our portfolio and applied key learnings from earlier clinical and preclinical programs, which we believe position us for future success, said Jay Hagan, President and Chief Executive Officer of Regulus.
Mr. Hagan continued, The RG-012 start-up activities and enrollment of patients with Alport syndrome have proven more challenging than anticipated. We have added internal and external resources to accelerate patient recruitment. The Phase I single ascending dose (SAD) study for RGLS4326 is progressing well, and planning for the multiple ascending dose (MAD) portion is underway.
|||RG-012 for Alport syndrome: Patient recruitment activities for the Phase II HERA and the renal biopsy studies are on-going. Based on revised enrollment assumptions, the Company believes that both studies will be fully enrolled in the second half of 2018.|
|||RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): A Phase I SAD study was initiated in December 2017. Data from this study in healthy volunteers will provide pharmacokinetics and safety data, and the study is currently on track for completion in the third quarter 2018.|
Cash Position: As of December 31, 2017, Regulus had cash, cash equivalents, and short-term investments of $60.1 million.
Research and Development (R&D) Expenses: R&D expenses were $10.5 million and $53.2 million for the quarter and year ended December 31, 2017, respectively, compared to $15.0 million and $64.3 million for the same periods in 2016. The fourth quarter decrease was primarily the result of a reduction in personnel-related costs, subsequent to our May 2017 corporate restructuring. The year-over-year decrease was further driven by the wind-down of clinical activities related to the RG-101 program.
The following information was filed by Regulus Therapeutics Inc. (RGLS) on Wednesday, March 7, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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