Regulus Reports Fourth Quarter and Year-End 2012 Financial Results and
-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., Feb. 20, 2013
LA JOLLA, Calif., Feb. 20, 2013 /PRNewswire/ -- 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
oPresented 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.
oEnhanced 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.
oCompleted 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
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
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
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.
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
For more information, please visit http://www.regulusrx.com.
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 Year ended
December 31, December 31,
2012 2011 2012 2011
Revenues 3,238 3,363 12,700 13,789
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 $ (0.22) $ (14.81) $ (2.12) $ (85.82)
Shares used to compute basic
and diluted net loss per 31,907,152 136,041 8,212,538 88,582
Regulus Therapeutics Inc.
Condensed Balance Sheets
December 31, December 31,
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 $ 103,518 $ 42,881
SOURCE Regulus Therapeutics Inc.
Contact: Amy Conrad, Director, Investor Relations and Corporate
Communications, Regulus Therapeutics Inc., +1-858-202-6300,
firstname.lastname@example.org; or Media, David Schull, Russo Partners LLC,
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