Regulus Reports Fourth Quarter and Year-end 2017 Financial Results and Pipeline Update

LA JOLLA, Calif., March 7, 2018 /PRNewswire/ -- 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."

Pipeline Update

• 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.

Financial Results

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.

General and Administrative (G&A) Expenses: G&A expenses were $3.3 million and $17.0 million for the quarter and year ended December 31, 2017, respectively, compared to $4.8 million and $18.4 million for the same periods in 2016. The decreases in G&A expenses were primarily attributable to a reduction in non-cash stock-based compensation.

Revenue: Revenue was less than $0.1 million and $0.1 million for the quarter and year ended December 31, 2017, respectively, compared to less than $0.1 million and $1.2 million for the same periods in 2016.

Net Loss: Net loss was $14.4 million and $71.9 million for the quarter and year ended December 31, 2017, respectively, compared to a net loss of $20.0 million and $81.8 million for the same periods in 2016. Basic and diluted net loss per share was $0.14 and $0.96 for the quarter and year ended December 31, 2017, respectively, compared to $0.38 and $1.55 for the same periods in 2016.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss fourth quarter financial results and provide a general business update. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 4794278. To access the replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), conference ID 4794278. The webcast and telephone replay will be archived on the company's website following the call.