Breaking News

Tweet TWEET

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

    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-

PR Newswire

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
    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       Year ended

                               December 31,             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     $ (0.22)      $ (14.81)  $ (2.12)     $ (85.82)
per share
Shares used to compute basic
and diluted net loss per         31,907,152    136,041    8,212,538    88,582
share



Regulus Therapeutics Inc.

Condensed Balance Sheets

(In thousands)
                                                    December 31,  December 31,

                                                    2012          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       $   103,518   $   42,881
(deficit)

SOURCE Regulus Therapeutics Inc.

Website: http://www.regulusrx.com
Contact: Amy Conrad, Director, Investor Relations and Corporate
Communications, Regulus Therapeutics Inc., +1-858-202-6300,
aconrad@regulusrx.com; or Media, David Schull, Russo Partners LLC,
+1-212-845-4271, david.schull@russopartnersllc.com
 
Press spacebar to pause and continue. Press esc to stop.