LA JOLLA, Calif., Nov. 5, 2015 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results and highlights for the quarter ended September 30, 2015 and provided a summary of recent corporate highlights.
“Regulus’ recent achievements reflect our steady progress in building a meaningful clinical portfolio based on microRNAs,” said Paul Grint, M.D., President and CEO of Regulus. “Specifically, we expanded development of RG-101, advanced RG-012 through Phase I, and realized the full economic value of our biomarkers collaboration with Biogen. In the coming months, we look forward to presenting data on our programs at key medical meetings and continuing to execute on our plans.”
Third Quarter 2015 and Recent Highlights
RG-101 Highlights
- Entered Into Clinical Trial Collaboration Agreement with GlaxoSmithKline (“GSK”) to Evaluate HCV Combination Regimen. In the first quarter of 2016, Regulus plans to initiate a Phase II study evaluating the combination of RG-101 and GSK2878175, a non-nucleoside NS5B polymerase inhibitor, in treatment-naïve patients chronically infected with HCV genotypes 1 and 3. Concurrently, GSK will work on developing a long-acting parenteral formulation for injection (“LAP”) of GSK2878175 which could improve patient compliance through reduced dosing intervals and potentially extend opportunities for HCV therapeutic intervention. This LAP formulation of GSK2878175 may be used in additional clinical trials together with RG-101 following completion of the planned Phase II study, although any additional studies are not covered by the collaboration agreement.
- Announced Additional Data to be Presented at The Liver Meeting®, Nov. 13-17, 2015. During a general plenary session at The Liver Meeting®, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), Regulus’ investigators will present extended follow-up results from the Phase I clinical study of RG-101. In a poster presentation, Regulus’ investigators will present preclinical data examining immunological changes observed in plasma of the HCV patients dosed in the Phase I study.
- Initiated Phase II Combination Study; Interim Data in Early 2016. In August, Regulus initiated a Phase II study evaluating the efficacy of RG-101 when given in combination with marketed anti-HCV agents Harvoni®, Olysio®, and Daklinza® for 28 days. Regulus announced today that it expects to report interim data from this study in early 2016 and sustained viral response data 12 weeks following conclusion of treatment (SVR12) in the second quarter of 2016.
RG-012 Highlights
- Announced Preclinical Data to be Presented at Kidney Week, Nov. 3-8, 2015. During a poster presentation at the American Society of Nephrology’s (ASN) Kidney Week, Regulus will present preclinical results demonstrating the favorable pharmacokinetic and toxicokinetic properties of RG-012, an anti-miR targeting microRNA-21 (“miR-21") for the treatment of Alport syndrome, a life threatening disease with no approved therapy. In addition, Regulus will present results describing a novel methodology to assess inhibition of miR-21, and Regulus microMarkersSM will present data highlighting the discovery of urine microRNA biomarkers in a preclinical model of Alport Nephropathy.
- Completed First-In-Human Phase I Study of RG-012. Regulus announced today that the Phase I study evaluating the safety, tolerability and pharmacokinetics of subcutaneous dosing of RG-012 in healthy volunteers is complete. Forty healthy volunteer subjects were enrolled in this first-in-human, single ascending dose study. RG-012 was well-tolerated and no serious adverse events were reported. In the first half of 2016, Regulus plans to initiate a Phase II proof-of-concept study evaluating the efficacy of RG-012 in Alport syndrome patients.
Additional Highlights
- Achieved All Research Milestones in Biomarkers Collaboration with Biogen; Earned $3.7 Million in Payments. Regulus has realized the full potential of its collaboration with Biogen to identify microRNAs as biomarkers for multiple sclerosis (“MS”) and has earned $3.7 million in payments. Following achievement of the final milestone, which was earned by analyzing the treatment effects of a Biogen relapsing MS drug on circulating microRNA profiles identified by Regulus microMarkersSM, the scope of the research to be performed under the current collaboration agreement has concluded.
- Attracted Key Talent. Regulus appointed Michael Huang, M.D. as Vice President, Clinical Development. Dr. Huang is responsible for leading the company’s global clinical operations and medical affairs and serves as a key member of the executive leadership team.
Third Quarter 2015 Financial Results& Highlights
Regulus reported a net loss of $13.0 million and $48.5 million for the three and nine months ended September 30, 2015, compared to a net loss of $9.8 million and $34.5 million for the same periods in 2014. Basic and diluted net loss per share was $0.25 for the three months ended September 30, 2015, compared to basic and diluted net loss per share of $0.23 and $0.26, respectively, for the same period in 2014. Basic and diluted net loss per share was $0.95 for the nine months ended September 30, 2015, compared to $0.80 for the same period in 2014.
Regulus recognized revenue of $1.9 million and $9.9 million for the three and nine months ended September 30, 2015, respectively, compared to $1.1 million and $3.5 million for the same periods in 2014. Revenue for the three and nine months ended September 30, 2015 included research milestones earned under Regulus’ strategic alliances and collaboration agreements of $0.3 million and $3.2 million, respectively. Revenue from research services performed under Regulus’ strategic alliances and collaborations was $0.9 million and $4.1 million for the three and nine months ended September 30, 2015, respectively. Other revenue during these periods consisted of amortization of up-front payments from Regulus’ strategic alliances and collaborations, which is recognized over the estimated period of performance.
Research and development expenses were $11.0 million and $43.6 million for the three and nine months ended September 30, 2015, respectively, compared to $10.2 million and $30.6 million for the same periods in 2014. This increase was primarily driven by clinical trial costs for RG-101, pre-clinical study costs for RG-125, and an increase in salaries and related employee costs, including non-cash stock-based compensation.
General and administrative expenses were $4.2 million and $13.7 million for the three and nine months ended September 30, 2015, respectively, compared to $2.6 million and $8.3 million for the same periods in 2014. This increase was primarily driven by an increase in salaries and related employee costs, including non-cash stock-based compensation.
As of September 30, 2015, Regulus had $131.7 million in cash, cash equivalents and short-term investments and 52,342,653 shares of common stock outstanding.
2015 Financial Guidance
Regulus’ cash guidance remains unchanged and the company expects to end 2015 with greater than $100.0 million in cash, cash equivalents and short-term investments.
Conference Call & Webcast Information
Regulus will host a conference call and webcast at 5:00 p.m. Eastern Standard Time today to discuss its third quarter 2015 financial results, recent company highlights and its expectations for the remainder of 2015. A live webcast of the call will be available online at www.regulusrx.com.
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