LA JOLLA, Calif., Nov. 19, 2012 /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, 2012 and
provided a summary of recent corporate highlights.
"The third quarter and subsequent period were the most
successful to date for Regulus as measured by the achievement of
significant financial and strategic goals," said Kleanthis G. Xanthopoulos, Ph.D., President and
CEO of Regulus. "Regulus is now focused on the execution of our
research and development plans that include selection of clinical
candidates in all of our microRNA therapeutic programs, which we
believe will enable us to file at least two INDs by
2014."
"We expect that the capital raised in the last several
months will provide sufficient funding for operations through at
least the end of 2015," said Garry E.
Menzel, Ph.D., Chief Operating Officer and Executive Vice
President of Finance. "We believe our disciplined financial
strategy will enable us to advance multiple programs toward the
clinic without the need for additional equity
financing."
Third Quarter 2012 and Recent Corporate
Highlights
- Completed Initial Public Offering ("IPO"). In
October 2012, Regulus completed its
IPO, raising $50.9 million in gross
proceeds, inclusive of the over-allotment option exercised by the
underwriters and insider participation by Isis Pharmaceuticals,
Inc., one of its founding companies, and two of its strategic
partners, Sanofi SA ("Sanofi") and GlaxoSmithKline plc
("GSK"). Regulus' common stock began trading on the NASDAQ
Global Market on October 4, 2012
under the symbol "RGLS."
- Established Significant Strategic Alliance Focused Primarily
on Metabolic Diseases. In August
2012, Regulus entered into a strategic alliance with
AstraZeneca AB ("AZ") to discover, develop, and commercialize
microRNA therapeutics for three exclusive targets focused on
cardiovascular and metabolic diseases and oncology. AZ made
an upfront payment of $3.0 million
and purchased $25.0 million of
Regulus' common stock in a private placement that closed
concurrently with the IPO. In addition, Regulus is eligible to
receive preclinical, clinical and commercialization milestone
payments of up to $509.0 million, as
well as royalties.
- Established Research Collaboration to Explore microRNA
Biomarkers for Multiple Sclerosis. In August 2012, Regulus formed a collaboration with
Biogen Idec Inc. ("Biogen Idec") to explore microRNA biomarkers for
multiple sclerosis. Regulus received an upfront payment of
$750,000 and is eligible to receive
milestone payments of up to $1.3
million. Regulus also received $5.0 million from the sale of a convertible note
to Biogen Idec which converted into shares of Regulus' common stock
at the closing of the IPO.
- Re-Aligned Board of Directors. In November 2012, Douglas E.
Williams, Ph.D., Executive Vice President of Research and
Development at Biogen Idec, joined Regulus' Board of
Directors. Concurrently, Stanley T.
Crooke, M.D., Ph.D., Chairman of the Board and CEO of Isis
Pharmaceuticals, Inc., and Barry E.
Greene, President and Chief Operating Officer of Alnylam
Pharmaceuticals, Inc., stepped down from the Board and their
respective Board committees.
Third Quarter 2012 Financial Results &
Highlights
As of September 30, 2012,
Regulus had cash, cash equivalents and short-term investments of
$30.9 million compared to
$38.1 million at December 31, 2011. The decrease in cash,
cash equivalents and short-term investments was the result of
approximately $17.7 million used to
fund the Company during the first nine months of 2012, offset by
$5.0 million in R&D funding from
Sanofi received in July 2012, and
$5.8 million from Biogen Idec related
to a $5.0 million convertible note
and a $750,000 upfront payment
received in August 2012.
Net Loss
The net loss for the three and nine months ended
September 30, 2012 was $5.7 million and $10.5
million, respectively, compared to $1.0 million and $5.6
million for the same periods in 2011. The increase in
our 2012 net losses was the result of $1.0
million less in revenue recognized on our upfront payments
from GSK, the result of amending our strategic alliance agreement
with GSK in June 2012, and an
increase of $1.6 million and
$2.0 million in operating expenses
for the three and nine months ended September 30, 2012, respectively. Included as a
component of net loss was a non-cash charge of $1.7 million resulting from a loss on
extinguishment of debt associated with the modification of the
$5.0 million convertible promissory
note we issued to GSK in 2010. The change in the fair value
of the convertible promissory note is primarily attributable to the
change in the value of our common stock price during the
period. Our net loss also included non-cash stock-based
compensation expenses of $414,000 and
$732,000 for the three and nine
months ended September 30, 2012,
respectively, and $196,000 and
$609,000 for the same periods in
2011. Basic and diluted net loss per share for the three and
nine months ended September 30, 2012
was $15.98 per share and $41.03 per share, respectively, compared to
$11.68 per share and $76.97 per share for the same period in
2011.
Revenue
We recognized revenue of $2.8
million and $9.5 million in
the three and nine months ended September
30, 2012, respectively, and $3.8
million and $10.4 million for
the same periods in 2011. Our revenue during these periods
consisted primarily of amortization of upfront payments received
from GSK and Sanofi which we amortize monthly on a straight-line
basis over our period of performance. The total amortization
attributable to payments from Sanofi was $2.5 million and $7.5
million for each of the three and nine months ended
September 30, 2012 and 2011,
respectively. The total amortization attributable to upfront
payments from GSK was $186,000 and
$1.3 million for the three months
ended September 30, 2012 and 2011,
respectively, and $1.8 million and
$2.9 million for the nine months
ended September 30, 2012 and 2011,
respectively. The decrease in the amount amortized for GSK in
2012 compared to 2011 is the result of our June 2012 amendment to the collaboration
agreement which extended our period of performance.
Research and Development Expenses
Research and development expenses were $5.2 million and $14.7
million for the three and nine months ended September 30, 2012, respectively, compared to
$3.9 million and $12.8 million for the same periods in 2011. The
increase of $1.4 million and
$1.9 million for the three and nine
month periods ended September 30,
2012 was primarily related to increases in payroll and
related benefits, laboratory supplies and external services to
advance our preclinical programs.
General and Administrative Expenses
General and administrative expenses were $1.1 million and $3.0
million for the three and nine months ended September 30, 2012, respectively, compared to
$907,000 and $2.9 million for the same periods in 2011. The
increases primarily represent legal services related to our
transactions with AZ and Biogen Idec completed in August 2012.
Conference Call & Webcast
Information
Regulus will host a conference call and webcast at
5:00 pm Eastern Standard Time today
to discuss its third quarter 2012 financial results and 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 52577487. 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 (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.
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 regulatory approval, 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' 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 per share data)
|
|
|
Three
months ended
September 30,
|
|
Nine
months ended
September 30,
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under strategic
alliances
|
|
$
|
2,809
|
|
$
|
3,809
|
|
$
|
9,462
|
|
$
|
10,426
|
Total
revenues
|
|
2,809
|
|
3,809
|
|
9,462
|
|
10,426
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
5,248
|
|
3,875
|
|
14,735
|
|
12,823
|
General and administrative
|
|
1,093
|
|
907
|
|
2,998
|
|
2,864
|
Total
operating expenses
|
|
6,341
|
|
4,782
|
|
17,733
|
|
15,687
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(3,532)
|
|
(973)
|
|
(8,271)
|
|
(5,261)
|
Other
income (expense), net
|
|
(2,159)
|
|
(68)
|
|
(2,289)
|
|
(195)
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
(5,691)
|
|
(1,041)
|
|
(10,560)
|
|
(5,456)
|
Income tax
(benefit) expense
|
|
|
(6)
|
|
|
4
|
|
(28)
|
|
131
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(5,685)
|
|
$
|
(1,045)
|
|
$
|
(10,532)
|
|
$
|
(5,587)
|
Basic and
diluted net loss per share
|
|
$
|
(15.98)
|
|
$
|
(11.68)
|
|
$
|
(41.03)
|
|
$
|
(76.97)
|
Shares
used to compute basic and diluted net loss per share
|
|
|
355,735
|
|
|
89,438
|
|
|
256,682
|
|
|
72,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regulus
Therapeutics Inc.
Condensed Balance Sheet
(In
thousands)
|
|
|
September 30,
2012
|
|
December 31,
2011
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
|
$
|
30,893
|
|
$
|
38,144
|
Other
current assets
|
|
3,466
|
|
522
|
Noncurrent
assets
|
|
6,364
|
|
4,215
|
Total assets
|
|
$
|
40,723
|
|
$
|
42,881
|
Liabilities and stockholders'
deficit
|
|
|
|
|
Current
liabilities
|
|
$
|
2,814
|
|
$
|
2,115
|
Deferred
revenue
|
|
10,593
|
|
10,735
|
Convertible notes payable
|
|
10,000
|
|
─
|
Convertible notes payable, at fair value
|
|
7,069
|
|
─
|
Other
long-term obligations, less current portion
|
|
875
|
|
11,847
|
Deferred
revenue, less current portion
|
|
16,602
|
|
16,987
|
Convertible preferred stock
|
|
42,691
|
|
42,691
|
Stockholders' deficit
|
|
(51,148)
|
|
(41,494)
|
Total liabilities and stockholders'
deficit
|
|
$
|
40,723
|
|
$
|
42,881
|
SOURCE Regulus Therapeutics Inc.