LA JOLLA, Calif., Nov. 13, 2013 /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 quarter ended September 30, 2013 and provided a summary of recent corporate highlights.
"This was a remarkably productive third quarter and recent period for Regulus in which we focused on scientific execution and demonstrated significant progress across our microRNA therapeutic pipeline. Our 'Road to the Clinic' strategy remains on track and we are working towards filing our first application with regulatory authorities to commence clinical studies in man of RG-101, our GalNAc-conjugated anti-miR targeting miR-122, for hepatitis C virus infection. We believe this program will condition Regulus for future clinical activities and may provide proof-of-concept, possibly by the end of next year, for our innovative approach to treating disease with microRNA therapeutics," said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. "In addition, our strategic alliance partners continue to support our expertise in discovering and developing new microRNA therapeutics, as evidenced by the recent selection of a new, pre-clinically validated oncology target by AstraZeneca. We also continue to focus our proprietary efforts on oncology and orphan diseases and look forward to identifying attractive new opportunities to broaden our pipeline. We're very pleased with our progress and hope to carry our positive momentum into the end of the year and into 2014."
"The significant achievements in the quarter and recent period demonstrate that our science continues to advance in a meaningful way," said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus. "We are pleased to have advanced our microRNA therapeutic pipeline by presenting key data at scientific meetings, preparing to enter the clinic with RG-101 and working towards the nomination of a second microRNA candidate for clinical development."
Recent Corporate Highlights
Third Quarter 2013 Highlights
Third Quarter 2013 Financial Results & HighlightsAs of September 30, 2013, Regulus had $123.9 million in cash, cash equivalents and short-term investments, including $45.8 million in net proceeds from a public offering of 5,175,000 shares of common stock issued at an offering price of $9.50 per share, which was completed in July 2013.
Regulus reported a net loss of $2.2 million for the three months ended September 30, 2013, compared to a net loss of $5.7 million for the same period in 2012. Basic and diluted net loss per share was $0.05 and $0.07 for the three months ended September 30, 2013, respectively, compared to basic and diluted net loss per share of $15.98 for the same period in 2012. The comparability of net loss per share for the periods presented is significantly impacted by our initial public offering and concurrent common stock issuances in October 2012, and our public offering of common stock in July 2013.
Regulus recognized revenue of $6.1 million for the three months ended September 30, 2013, compared to $2.8 million for the same period in 2012. Revenue during these periods consisted primarily of amortization of upfront payments received from our strategic alliances and collaborations, which is recognized over the estimated period of performance. Revenue in the three months ended September 30, 2013 included $5.4 million from the Sanofi collaboration and license agreement and $0.5 million from the AstraZeneca collaboration and license agreement. On a comparative basis, revenue increased in the three months ended September 30, 2013 primarily due to the incremental recognition of $3.6 million from the change in our estimated period of performance for the research term within the Sanofi collaboration and license agreement, which originally expired in June 2013, but was effectively extended through the end of December 2013 under the terms of our Option Agreement with Sanofi.
Research and development expenses were $7.1 million for the three months ended September 30, 2013, compared to $5.2 million for the same period in 2012. The increase was substantially attributable to IND-enabling activities for RG-101 during the quarter. No such costs were incurred in the same period in 2012. The Company expects our research and development expenses to increase over the coming quarters to the extent it commences clinical studies and initiates additional IND-enabling activities.
General and administrative expenses were $1.9 million for the three months ended September 30, 2013, compared to $1.1 million for the same period in 2012. The increase was primarily attributable to additional headcount and incremental operating costs associated with being a public company.
Net loss in the three months ended September 30, 2013 included a non-cash gain of $0.7 million from the change in value of the amended and restated convertible promissory note originally issued to GlaxoSmithKline plc in 2010, with such change in value attributable to a decrease in value of the common stock of the Company during the quarter. Net loss in the three months ended September 30, 2012 included a non-cash charge of $1.7 million resulting from a loss on extinguishment of debt associated with the modification of the convertible promissory note, and a $0.3 million non-cash charge from the increase in value of the common stock of the Company during the quarter.
Conference Call & Webcast InformationRegulus will host a conference call and webcast at 5:00 p.m. Eastern Standard Time today to discuss its third quarter 2013 financial results and recent corporate highlights. 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 93095033. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 93095033. The webcast and telephone replay will be archived on the company's website following the call.
About the 'Road to the Clinic' Strategy in 2013 Launched in February 2013, the 'Road to the Clinic' Strategy outlines certain corporate goals that seek to advance our microRNA therapeutic pipeline toward the clinic this year. Specifically, Regulus set the goal of nominating two microRNA candidates for clinical development in 2013, be positioned to file its first applications with regulatory authorities by the first half of 2014 and maintain a strong year-end cash position to support these goals.
Regulus has demonstrated excellent progress on its 'Road to the Clinic' Strategy. In May, Regulus nominated its first microRNA candidate for clinical development, RG-101, a GalNAc-conjugated microRNA antagonist or anti-miR, which targets miR-122 for the treatment of HCV. Regulus expects to file its first application with regulatory authorities for RG-101 in the near term and expects to commence clinical studies in man in early 2014. Additionally, Regulus' strong financial position continues to support these stated goals and the Company continues to expect to end 2013 with approximately $110 million in cash, cash equivalents and short-term investments. Lastly, Regulus expects that the second microRNA candidate to be nominated for clinical development by the end of the year may come from the miR-21 fibrosis program.
About RG-101 for the Treatment of HCVRG-101 is a key program in Regulus' 'Road to the Clinic' Strategy for 2013, in which the Company expects to nominate two microRNA candidates for clinical development, be positioned to file its first applications with regulatory authorities by the first half of 2014 and maintain a strong year-end cash position to support these goals. RG-101 was the first microRNA candidate nominated for clinical development under this strategy.
microRNA-122 (miR-122) is the most abundant microRNA in hepatocytes and is a critical host factor for survival and replication of all know HCV genotypes. RG-101 is a novel anti-miR-122 oligonucleotide therapeutic that is effectively targeted to hepatocytes for the treatment of HCV through conjugation to GalNAc, a carbohydrate-based chemistry approach for asialoglycoprotein receptor-mediated delivery of oligonucleotides to hepatocyte cells of the liver. Utilizing the GalNAc conjugate chemistry has significantly improved the potency of the active oligonucleotide of RG-101 by achieving targeted delivery of the oligonucleotide to the infected hepatocytes. Given its attractive properties and positive preclinical profile seen to date, Regulus believes that RG-101 may be an attractive agent to add to existing HCV therapeutic regimens. The Company plans to develop RG-101 as a key component of an HCV combination regimen for patients who have failed, or are intolerant of, the current standard of care and specific patient populations such as HCV/HIV co-infection. Regulus expects to file a regulatory application for RG-101 in the near term and expects to commence clinical studies in man in early 2014.
About RegulusRegulus Therapeutics Inc. (NASDAQ: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is uniquely positioned to leverage a mature therapeutic platform that harnesses the oligonucleotide drug discovery and development expertise of Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., which founded the company.
Regulus has a well-balanced microRNA therapeutic pipeline entering clinical development, an emerging microRNA biomarkers platform to support its therapeutic programs, and a rich intellectual property estate to retain its leadership in the microRNA field. Regulus intends to focus its proprietary efforts on developing microRNA therapeutics for oncology indications and orphan diseases and is currently advancing several programs toward clinical development in oncology, fibrosis and metabolic diseases. Regulus is also developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122, for the treatment of chronic hepatitis C virus infection. Regulus' commitment to innovation and its leadership in the microRNA field have enabled the formation of strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi. In addition, Regulus has formed a research collaboration with Biogen Idec around its emerging microRNA biomarkers platform.
For more information, please visit http://www.regulusrx.com.
Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with financial estimates (including Regulus' projected cash at the end of 2013), the projected sufficiency of Regulus' capital position for future periods, the future negotiation and execution of a co-development agreement with Sanofi, the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101 and Alnylam's proprietary process for manufacturing GalNAc conjugates and with respect to the nomination of a second microRNA candidate for clinical development), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus' SEC filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Regulus Therapeutics Inc.Selected Financial InformationCondensed Statement of Operations(In thousands, except share and per share data)Three months endedSeptember 30,Nine months endedSeptember 30,2013201220132012(Unaudited)Revenues:Revenue under strategic alliances$
9,462Total revenues6,1182,80914,1159,462Operating expenses:Research and development7,1065,24821,71014,735General and administrative1,9171,0935,5452,998Total operating expenses9,0236,34127,25517,733Loss from operations(2,905)(3,532)(13,140)(8,271)Other income (expense), net736(2,159)(3,605)(2,289)Loss before income taxes(2,169)(5,691)(16,745)(10,560)Income tax (benefit) expense(5)(6)(4)(28)Net loss$
(10,532)Net loss per share:Basic$
(41.03)Weighted average shares used to compute net loss per share:Basic40,154,812355,73537,367,368256,682Diluted41,555,660355,73537,367,368256,682 Regulus Therapeutics Inc.Condensed Balance Sheets(In thousands)September 30,
2012(Unaudited)AssetsCash, cash equivalents and short-term investments$
98,100Other current assets1,383829Non-current assets5,3044,589Total assets$
103,518Liabilities and stockholders' equityCurrent liabilities$
2,317Current portion of deferred revenue9,45410,451Convertible notes payable, at fair value13,92110,134Other long-term liabilities1,558767Deferred revenue, less current portion7,13817,756Stockholders' equity 94,44662,093Total liabilities and stockholders' equity $
|SOURCE Regulus Therapeutics Inc.|
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