Regulus Therapeutics - A Leading microRNA Therapeutics Company

Regulus Names Stelios Papadopoulos, Ph.D. as Chairman of its Board of Directors

lesley — Tue, 11 Jun 2013 12:00:35 +0000

LA JOLLA, Calif., June 11, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has named Stelios Papadopoulos, Ph.D. as Chairman of its Board of Directors effective immediately.
Dr. Papadopoulos assumes the role of Chairman of the Board from John Maraganore, Ph.D., who will remain a member of the Board of Directors. Dr. Papadopoulos, who has been a member of the Board since 2008, has more than 30 years of experience in the biotechnology and pharmaceutical industries as an investment banker, board member, company founder and investor. Dr. Papadopoulos is a Board member of several companies including Biogen Idec, Inc. and Exelixis, Inc., where he is Chairman.
“Stelios brings together financial savvy, business ingenuity and scientific creativity,” said John Maraganore, Ph.D., member of the Board and President and CEO of Alnylam Pharmaceuticals, Inc. “I couldn’t think of a more accomplished individual to become Chairman of Regulus’ Board.”

“Stelios’ transition to Chairman of the Board comes at a very exciting time for Regulus,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “We’ve achieved early success under our ‘Road to the Clinic’ strategy with the recent nomination of our first clinical candidate, RG-101 for the treatment of HCV. Stelios’ extensive industry knowledge and experience are perfectly suited to help advance our microRNA candidates into clinical development and position Regulus for continued success and growth.”

“Regulus is a benchmark of innovation focused on harnessing the power of a transformative class of novel therapeutics and biomarkers based on microRNAs,” said Stelios Papadopoulos, Ph.D., Chairman of the Board. “I am excited to help guide our dedicated and talented team as we strive to execute on Regulus’ scientific and strategic goals.”
Dr. Papadopoulos retired as Vice Chairman of Cowen and Company, LLC in 2006 after six years with the firm where he was an investment banker focused on the biotechnology and pharmaceuticals sectors. Prior to joining Cowen in 2000, Dr. Papadopoulos was an investment banker at PaineWebber Incorporated, most recently serving as Chairman of PaineWebber Development Corp., a PaineWebber subsidiary focusing on biotechnology. Prior to that, he held positions in Equity Research covering the biotechnology industry at Drexel Burnham Lambert and Donaldson, Lufkin & Jenrette. He is a co-founder and Chairman of the Board of Directors of Exelixis, Inc., and a member of the Board of Directors at Biogen Idec, Inc., BG Medicine, Inc. and Joule Unlimited. Additionally, Dr. Papadopoulos was a co-founder and former Board member of Cellzome, Inc. (acquired by GSK in 2012) and Anadys Pharmaceuticals, Inc. (acquired by Roche in 2011).
Before joining Wall Street, he was on the faculty of the Department of Cell Biology at New York University Medical Center. Dr. Papadopoulos is also deeply involved in the non-profit sector. He is a co-founder and Chairman of Fondation Santé, a charitable foundation for scientific and educational purposes, and serves on the Board of Visitors at Duke University Medical Center. Dr. Papadopoulos holds a Ph.D. in biophysics and an M.B.A. in finance, both from New York University.
About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus is developing RG-101 for the treatment of HCV and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.
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 Regulus’ 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’ 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.

Contact

Amy Conrad
Director, Investor Relations and Corporate Communications
Regulus Therapeutics Inc.
858-202-6300
aconrad@regulusrx.com

Media

David Schull
Russo Partners LLC
212-845-4271
david.schull@russopartnersllc.com

R&D Laboratory Intern – Reference Code – 427

Anna — Tue, 04 Jun 2013 15:17:13 +0000

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals (NASDAQ:ALNY) and Isis Pharmaceuticals (NASDAQ:ISIS). Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

Regulus is located in Torrey Pines, California and has a seasoned executive team experienced in corporate management, business, science, drug discovery and development. Regulus’ scientific advisory board consists of world-class scientists and some of the foremost authorities in the field of microRNA research.

We are currently seeking a highly motivated and hands on R&D Laboratory Intern to be part of a unique and exciting opportunity in drug discovery. For more information, visit www.RegulusRx.com.

R&D Laboratory Intern –

Reference Code – 427

Description

We are currently seeking a highly professional and motivated R&D Laboratory Intern to be part of a unique and exciting opportunity in drug discovery.

Responsibilities will include the following:

Maintenance of laboratory supplies, washing and re-shelving of glassware, cleaning laboratory equipment and putting away supplies.

Maintaining accurate records for laboratory equipment (daily/weekly), labeling products, and monitoring inventory of materials.

Compliance with lab safety procedures is required.

May be required to assist in other duties as assigned by supervisor.

The ideal candidate will be expected to interact with and foster strong relationships with scientists across the company and be a strong fit within the Regulus culture.

For immediate consideration, please apply to careers@regulusrx.com

You can visit our website to find out more about our company and culture: www.RegulusRx.com.

Reference job code: 427

NO PHONE CALLS PLEASE. PRINCIPALS ONLY

Regulus Therapeutics Inc., is proud to be an EEO Employer.

Regulus to Present at Deutsche Bank 38th Annual Healthcare Conference

lesley — Tue, 21 May 2013 20:48:53 +0000

LA JOLLA, Calif., May 21, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President, Finance, will present a company overview at the Deutsche Bank 38th Annual Healthcare Conference on Wednesday, May 29, 2013 at 3:30 pm EDT. The conference is being held at the Westin Boston Waterfront Hotel.

The presentation will be webcast at the time of the presentation and can be accessed on the Investor Relations page of the Company’s website at www.regulusrx.com. A replay of each webcast will be archived on the Company’s website following the presentation date.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Contact
Amy Conrad
Director, Investor Relations and Corporate Communications
Regulus Therapeutics Inc.
858-202-6300
aconrad@regulusrx.com

Media
David Schull
Russo Partners LLC
212-845-4271
david.schull@russopartnersllc.com

Regulus Provides Update on ‘Road to the Clinic’ Strategy and Reports First Quarter 2013 Financial Results and Recent Highlights

Anna — Tue, 14 May 2013 20:05:29 +0000

-Nominated RG-101 in HCV as First microRNA Candidate for Clinical Development-

- Maintained Strong Financial Position with Over $90 million in Cash-

LA JOLLA, Calif., May 14, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today provided an update on its microRNA therapeutic pipeline under the company’s ‘Road to the Clinic’ strategy and reported financial results for the quarter ended March 31, 2013.

Regulus Continues to Execute on ‘Road to the Clinic’ Strategy:

Nominated RG-101 as First microRNA Candidate for Clinical Development

Regulus announced today that it has nominated its first microRNA candidate for clinical development, RG-101, a GalNAc-conjugated microRNA antagonist or anti-miR, which targets microRNA-122 (miR-122) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Regulus is performing additional pre-clinical studies and finalizing development plans for RG-101 in HCV and expects to submit an application with regulatory authorities in early 2014.
Regulus plans to develop RG-101 independently of its strategic alliance with GlaxoSmithKline (GSK). The broad strategic alliance between Regulus and GSK remains intact and GSK retains its interest in the miR-122 program in HCV, as miR-122 will remain a Collaboration Target under the alliance. As such, the companies are in the process of amending the Product Development and Commercialization Agreement to clarify that RG-101 is fully owned by Regulus.

“The nomination of RG-101 as our first microRNA candidate for clinical development marks a tremendous milestone for Regulus and represents significant achievement of our initial goals under our ‘Road to the Clinic’ strategy,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “We continue to focus our efforts on preparing for a successful transition to a clinical-stage company and remain on track to nominate our second microRNA candidate for clinical development by the end of the year. Our recent progress is encouraging and we look forward to realizing the potential that our microRNA technology may have in transforming the field of drug discovery.”

Neil W. Gibson, Ph.D., Chief Scientific Officer, added, “We believe that RG-101 is a novel, pan-genotypic agent that may play an important role in future HCV therapy. We are very encouraged by the pre-clinical data seen to date, which includes activity against some of the known mutations that lead to resistance to the current HCV therapies and a favorable potency and PK profile which supports a once-a-month dosing paradigm. We believe that RG-101 may be useful in difficult-to-treat HCV patients in combination with existing and emerging therapies and we look forward to exploring its clinical utility.”

Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President of Finance, said, “As we prepare for clinical activity with RG-101, Regulus continues to maintain a strong financial position with over $90 million in cash at quarter-end. We remain on track to achieve our stated goals of finishing 2013 with at least $60 million in cash, while maintaining a burn rate of approximately $30 million to $35 million.”

Recent Highlight

Selected New Opportunity in Oncology. Regulus also announced today that it has selected microRNA-221 (miR-221) as an attractive target for potential clinical evaluation in patients with hepatocellular carcinoma (HCC). Regulus is currently conducting target validation activities and expects to report further progress on this opportunity in the second half of 2013.

First Quarter 2013 Financial Results & Highlights

Regulus reported a net loss of $7.2 million for the quarter ended March 31, 2013, compared to a net loss of $2.2 million for the quarter ended March 31, 2012. The quarter ended March 31, 2013, included non-cash charges of $1.8 million from the change in value of the amended and restated convertible promissory note originally issued to GlaxoSmithKline in 2010, which was attributable to increases in value of the underlying common stock of the Company since December 31, 2012. Basic and diluted net loss per share was $0.20 for the quarter ended March 31, 2013, compared to net loss per share of $13.06 for the quarter ended March 31, 2012. The comparison of net loss per share for the periods presented is impacted by the initial public offering and concurrent common stock issuances in October 2012.

Regulus recognized revenue of $3.2 million for the quarter ended March 31, 2013, compared to $3.3 million for the quarter ended March 31, 2012. Revenue during these periods consisted primarily of amortization of up-front payments received from our strategic alliances and collaborations, which is recognized over the estimated period of performance.

Research and development expenses were $6.9 million for the quarter ended March 31, 2013, compared to $4.6 million for the quarter ended March 31, 2012. The increase is attributable to an expansion of our research and development team, expertise and capabilities, in addition to increasing pre-clinical study activities in the first quarter of 2013, compared to the same period in 2012.

General and administrative expenses were $1.9 million for the quarter ended March 31, 2013, compared to $0.9 million for the quarter ended March 31, 2012. The increase is attributable to costs associated with increases related to additional personnel required to support the growth of the business, in addition to an increase in overall operating costs associated with being an SEC registrant in the first quarter of 2013, compared to the same period in 2012.

As of March 31, 2013, Regulus had $90.7 million in cash, cash equivalents and short-term investments, debt with a principal balance of $5.4 million and approximately 36 million shares of common stock outstanding. The Company expects its current cash position to be sufficient to fund operations into 2016 and to finish 2013 with at least $60.0 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 Daylight Time today for an update on the ‘Road to the Clinic’ Strategy and to discuss its first quarter 2013 financial results and recent highlights. A live webcast of the call will be available online at www.regulusrx.com. A replay will also be available approximately one hour after completion of the call. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 59485223. The webcast and 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. We announced the first candidate today as RG-101 for the treatment of HCV. The company also expects to file its first applications with regulatory authorities in 2014, with the first being for RG-101 in early 2014. In order to achieve these stated goals and advance our programs toward clinical development, Regulus expects to maintain its strong financial position and end 2013 with at least $60 million in cash, cash equivalents and short-term investments.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus has nominated RG-101 for the treatment of HCV as a candidate for clinical development and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

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, the projected sufficiency of Regulus’ capital position for future periods, the expected ability of Regulus to undertake certain activities and accomplish certain goals, 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 Information

Condensed Statement of Operations

(In thousands, except share and per share data)

	Three months ended March 31,
	2013		2012

		(Unaudited)
Revenues:
Revenues under strategic alliances and collaborations	$ 3,238		$ 3,344
Operating expenses:
Research and development	6,883		4,603
General and administrative	1,905		921
Total operating expenses	8,788		5,524
Loss from operations	(5,550)		(2,180)
Other income (expense), net	(1,689)		(66)
Loss before income taxes	(7,239)		(2,246)
Income tax (benefit) expense		(10)		1
Net loss	$	(7,229)	$	(2,247)
Basic and diluted net loss per share	$	(0.20)	$	(13.06)
Shares used to compute basic and diluted net loss per share		35,872,606		171,998

Regulus Therapeutics Inc. Condensed Balance Sheets (In thousands)
	March 31, 2013		December 31, 2012
	(Unaudited)
Assets
Cash, cash equivalents and short-term investments	$	90,715	$	98,100
Other current assets	1,054		829
Noncurrent assets	5,258		4,589
Total assets	$	97,027	$	103,518
Liabilities and stockholders’ equity
Current liabilities	$	3,492	$	2,317
Current portion of deferred revenue	9,201		10,451
Convertible notes payable, at fair value	11,895		10,134
Other long-term liabilities	804		767
Deferred revenue, less current portion	15,768		17,756
Stockholders’ equity	55,867		62,093
Total liabilities and stockholders’ equity	$	97,027	$	103,518

Regulus Announces Timing for First Quarter 2013 Financial Results Webcast and Conference Call

Anna — Tue, 07 May 2013 20:05:51 +0000

LA JOLLA, Calif., May 7, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it will report financial results and highlights for the quarter ended March 31, 2013 on Tuesday, May 14, 2013, after the U.S. financial markets close.

Regulus will host a conference call and webcast on Tuesday, May 14, 2013 at 5:00 pm Eastern Daylight Time to discuss its first quarter 2013 financial results and recent company highlights. A live webcast of the call will be available online at www.regulusrx.com. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 59485223. The webcast and telephone replay will be archived on the company’s website following the call.

About Regulus

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Contact
Amy Conrad
Director, Investor Relations and Corporate Communications
Regulus Therapeutics Inc.
858-202-6300
aconrad@regulusrx.com

Media
David Schull
Russo Partners LLC
212-845-4271
david.schull@russopartnersllc.com

Regulus to Present at 12th Annual Needham Healthcare Conference

Anna — Wed, 24 Apr 2013 20:05:51 +0000

LA JOLLA, Calif., April 24, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer, will present a company overview at the 12th Annual Needham Healthcare Conference on Wednesday, May 1, 2013 at 12:10 pm EDT. The conference is being held at the Westin Grand Central Hotel in New York.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Contact

Amy Conrad
Director, Investor Relations and Corporate Communications
Regulus Therapeutics Inc.
858-202-6300
aconrad@regulusrx.com

Media

David Schull
Russo Partners LLC
212-845-4271
david.schull@russopartnersllc.com

Regulus Appoints William H. Rastetter, Ph.D. to its Board of Directors

Anna — Mon, 01 Apr 2013 12:00:21 +0000

Industry Legend Brings Deep Biotechnology Expertise

LA JOLLA, Calif., April 1, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has appointed William H. Rastetter, Ph.D. to its Board of Directors effective immediately.

“We are extremely pleased to have Bill join our Board,” said John Maraganore, Ph.D., Chairman of the Board of Directors of Regulus and CEO of Alnylam Pharmaceuticals, Inc. “Bill is an industry legend who has invented, developed and commercialized highly transformative therapies. He will be a valuable resource as we continue to grow the company and develop first-in-class medicines targeting microRNAs.”

“Regulus’ approach to treating complex, multi-factorial diseases by targeting microRNAs is very exciting,” said Dr. Rastetter. “I believe that Regulus’ therapeutic platform has significant scientific and commercial potential and I look forward to collaborating with the Regulus team and Board of Directors to realize the power of microRNA therapeutics.”

Dr. Rastetter served as Chief Executive Officer of IDEC Pharmaceuticals from December 1986 through November 2003, and as Chairman from May 1996 to November 2003. Upon the merger of IDEC Pharmaceuticals and Biogen in November 2003, Dr. Rastetter served as Executive Chairman of Biogen Idec until the end of 2005. From 2006 to 2013, Dr. Rastetter served as a partner in the venture capital firm, Venrock. Dr. Rastetter currently serves as the Chairman of the Board of Directors of Fate Therapeutics, Inc., Illumina, Inc., Neurocrine Biosciences and Receptos, Inc. He is the author of numerous scientific papers and patent applications in the fields of organic and bioorganic chemistry, protein and enzyme engineering, and biotechnology. Dr. Rastetter holds a S.B. in Chemistry from the Massachusetts Institute of Technology and received his M.A. and Ph.D. in Chemistry from Harvard University.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Regulus to Present at Future Leaders in the Biotech Industry Conference

Anna — Thu, 28 Mar 2013 20:05:07 +0000

LA JOLLA, Calif., March 28, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President, Finance, will present a company overview at the 20^th Annual Future Leaders in the Biotech Industry Conference on Friday, April 5, 2013 at 10:30 am EDT. The conference is being held at the Millennium Broadway Hotel and Conference Center in New York City.

About Regulus

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Regulus to Present at Cowen and Company 33rd Annual Healthcare Conference

Anna — Tue, 26 Feb 2013 21:05:49 +0000

LA JOLLA, Calif., February 26, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President, Finance, will present a company overview at the Cowen and Company 33^rd Annual Healthcare Conference on Tuesday, March 5, 2013 at 8:40 am EST. The conference is being held at the Boston Marriott Copley Place.

About Regulus

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Regulus Reports Fourth Quarter and Year-End 2012 Financial Results and Highlights

Anna — Wed, 20 Feb 2013 21:05:25 +0000

Regulus Reports Fourth Quarter and Year-End 2012 Financial Results and Highlights

-Progressed Partnered and Proprietary microRNA Programs-

-Formed or Expanded Multiple Strategic Relationships to Support our microRNA-based Therapeutics and Biomarker Platforms-

–Successfully Completed our Initial Public Offering–

-Maintained Strong Financial Position with over $98 Million in Year End Cash, Cash Equivalents and Short-Term Investments-

LA JOLLA, Calif., February 20, 2013 – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported its financial results for the fourth quarter and year-ended December 31, 2012 and recent company highlights.

“In 2012, we successfully achieved significant strategic and financial objectives that have enabled Regulus to become a publicly-traded biopharmaceutical company. In particular, we successfully completed our initial public offering, formed alliances with new partners and expanded existing relationships with our pre-existing partners. Our strategic relationships provide therapeutic expertise that will support our growing microRNA therapeutic platform,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “With our solid strategic foundation in place, we are now focused on building a meaningful clinical portfolio. We continue to advance our partnered and proprietary programs toward the clinic and look forward to nominating our first microRNA candidate for clinical development in the first half of this year.”

“Regulus continues to maintain a strong balance sheet, ending 2012 with greater than $98 million in cash,” said Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President of Finance. “Our solid financial position should enable us to operate into 2016 and execute on our current research and development objectives.”

Fourth Quarter 2012 and Recent Corporate Highlights

Presented Positive Preclinical Data on miR-21 at Kidney Week 2012. Regulus presented data demonstrating that therapeutic oligonucleotides targeting miR-21 (anti-miR-21) reduces the severity of fibrosis and improves renal function in a rodent model of Alport syndrome. Regulus believes these data validate that anti-miR-21 could be a potential new therapy for human kidney disease. Regulus’ miR-21 therapeutic development program, which is partnered with Sanofi, is currently in preclinical testing for both kidney fibrosis and hepatocellular carcinoma.

Enhanced Executive Management Team and Augmented Board of Directors. Victor Knopov, Ph.D., a recognized expert in oligonucleotide drug development, joined Regulus as Vice President, Pharmaceutical Development and added over thirty years of experience to its accomplished leadership team. Additionally, Douglas E. Williams, Ph.D. and Mark G. Foletta, CPA recently joined Regulus’ Board of Directors, bringing significant commercial, financial and operational expertise in the biopharmaceutical industry to the Board.

Completed Significant Financing Activity. Regulus raised $80.9 million in gross proceeds, which included $50.9 million from the sale of common stock in the Initial Public Offering (“IPO”), $25.0 million from the sale of common stock in a private placement to new strategic partner AstraZeneca AB that closed concurrently with the IPO, and $5.0 million from the issuance of a convertible note to new collaborator Biogen Idec MA Inc., which was converted into shares of common stock at the completion of the IPO.

Fourth Quarter and Year-End 2012 Financial Results and 2013 Financial Outlook

Regulus reported a net loss of $6.9 million and $17.4 million for the quarter and year ended December 31, 2012, respectively, compared to a net loss of $2.0 million and $7.6 million for the same periods in 2011. In 2012, net loss included non-cash charges resulting from a $1.7 million loss on the extinguishment of debt associated with the amended and restated $5.0 million convertible promissory note Regulus originally issued to GSK in 2010. Subsequent to the extinguishment, losses on the change in value of the amended and restated note resulted in additional non-cash charges of $3.0 million, which was attributable to increases in value of the underlying common stock of the Company. Basic and diluted loss per share was $0.22 and $2.12 for the quarter and year ended December 31, 2012, compared to net loss per share of $14.81 and $85.82 for the same periods in 2011. Comparability of net loss per share for the periods presented is impacted by the initial public offering and concurrent common stock issuances in October 2012.

Regulus reported revenue of $3.2 million and $12.7 million for the quarter and year ended December 31, 2012, respectively, compared to $3.4 million and $13.8 million for the same periods in 2011. Revenue during these periods consisted primarily of amortization of up-front payments received from our strategic alliances and collaborations, which is recognized over the estimated period of performance.

Research and development expenses were $5.6 million and $20.3 million for the quarter and year ended December 31, 2012, respectively, compared to $4.5 million and $17.3 million for the same periods in 2011. The increase is attributable to continued investment in our research and development team, expertise and capabilities in response to our increased and expanded strategic partnerships and platform development initiatives.

General and administrative expenses were $1.9 million and $4.9 million for the quarter and year ended December 31, 2012, respectively, compared to $0.8 million and $3.6 million for the same periods in 2011. The increase is attributable to costs associated with the growth of the business and personnel infrastructure associated with the IPO in October 2012.

As of December 31, 2012, Regulus had $98.1 million in cash, cash equivalents and short-term investments, debt with a principal balance of $5.4 million and 35.8 million shares of common stock outstanding. The Company expects its current cash to be sufficient to fund operations into 2016 and to finish 2013 with at least $60 million in cash, cash equivalents and short-term investments.

Conference Call & Webcast Information

Regulus will host a conference call and webcast at 5:00 pm Eastern Standard Time today to discuss its fourth quarter and year-end 2012 financial results, recent company highlights and its expectations for 2013. A live webcast of the call will be available online at www.regulusrx.com. A replay will also be available approximately one hour after completion of the call. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 10388595. The webcast and replay will be will be archived on the company’s website for two weeks following the call.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

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, the projected sufficiency of Regulus’ capital position for future periods, the expected ability of Regulus to undertake certain activities and accomplish certain goals, 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 Information Condensed Statements of Operations (In thousands, except share and per share data)
			Three months ended December 31,						Year ended December 31,
			2012				2011		2012		2011
			(Unaudited)


Revenues			3,238				3,363		12,700		13,789
Operating expenses:
Research and development			5, 607				4,466		20,342		17,289
General and administrative			1,934				773		4,932		3,637
Total operating expenses			7,541				5,239		25,274		20,926
Loss from operations			(4,303)				(1,876)		(12,574)		(7,137)
Other income (expense), net			(2,555)				(64)		(4,844)		(259)
Loss before income taxes			(6,858)				(1,940)		(17,418)		(7,396)
Income tax (benefit) expense				18				(75)	(10)		206
Net loss			$	(6,876)			$	(2,015)	$	(17,408)	$	(7,602)
Basic and diluted net loss per share			$	(0.22)			$	(14.81)	$	(2.12)	$	(85.82)
Shares used to compute basic and diluted net loss per share				31,907,152				136,041		8,212,538		88,582
Regulus Therapeutics Inc. Condensed Balance Sheets (In thousands)
	December 31, 2012				December 31, 2011
	(Unaudited)
Assets
Cash, cash equivalents and short-term investments	$	98,100			$	38,144
Other current assets	829				522
Noncurrent assets	4,589				4,215
Total assets	$	103,518			$	42,881
Liabilities and stockholders’ deficit
Current liabilities	$	2,317			$	2,115
Deferred revenue	10,451				10,735
Convertible notes payable, at fair value	10,134				─
Other long-term obligations, less current portion	767				11,847
Deferred revenue, less current portion	17,756				16,987
Convertible preferred stock	─				42,691
Stockholders’ equity (deficit)	62,093				(41,494)
Total liabilities and stockholders’ equity (deficit)	$	103,518			$	42,881

Contact

Amy Conrad
Director, Investor Relations and Corporate Communications
Regulus Therapeutics Inc.
858-202-6300
aconrad@regulusrx.com

Media
David Schull
Russo Partners LLC
212-845-4271
david.schull@russopartnersllc.com