-- Clinical Proof of Concept Data Presented, Phase 2 Trial
Initiated --
CAMBRIDGE, Mass--(BUSINESS WIRE)--Aug. 15, 2013--
Idera
Pharmaceuticals, Inc. (NASDAQ: IDRA) today reported financial
results for the quarter ended June 30, 2013, and highlighted progress in
the development of its Toll-like receptor (TLR) antagonist programs.
“During the second quarter, we made progress on multiple fronts. We
strengthened our financial position through a $16.5 million common stock
offering. In addition, we presented clinical proof-of-concept data of
TLR antagonism and initiated a Phase 2 trial of our lead TLR antagonist,
IMO-8400, in patients with moderate-to-severe plaque psoriasis,” said
Sudhir Agrawal, D.Phil., Chief Executive Officer. “We expect data from
the Phase 2 trial to be available during the first quarter of 2014.”
"With cash and cash equivalents of $16.3 million at the end of the
second quarter, we believe we have funds to complete our Phase 2
clinical trial of IMO-8400 in patients with psoriasis and to fund our
operations through year-end 2014,” said Lou Arcudi, Chief Financial
Officer.
Also during the quarter, the United States Patent and Trademark Office
issued to Idera patent number 8,486,908, providing both composition of
matter and method of use protection for IMO-8400. IMO-8400, an
antagonist of TLRs 7, 8, and 9, is the Company’s lead candidate in
development for the treatment of autoimmune diseases.
2Q 2013 Research and Development Highlights
Autoimmune and Inflammatory Diseases Program
Idera is developing TLR antagonist candidates for the potential
treatment of autoimmune and inflammatory diseases by blocking the
induction of multiple cytokines, which are mediated through TLR7, TLR8,
and TLR9.
IMO-8400 (an antagonist of TLR7, TLR8, and TLR9)
Completion of Phase 1 Trial of IMO-8400 in Healthy Subjects
IMO-8400 was well-tolerated following escalating single and multiple
dose administration in this randomized, double-blind, placebo controlled
trial in 42 healthy subjects. IMO-8400-treated subjects showed
inhibition of TLRs 7, 8, and 9-mediated cytokine induction compared to
placebo-treated subjects. The Company presented Phase 1 trial data of
IMO-8400 during the second quarter of 2013.
Initiation of a Phase 2 Trial of IMO-8400 in Patients with
Moderate-to-Severe Plaque Psoriasis
The Company initiated a randomized, double-blind, placebo-controlled
Phase 2 trial of IMO-8400 in patients with moderate-to severe plaque
psoriasis in the second quarter of 2013. In this trial, 32 patients with
Psoriasis Area Severity Index (PASI) scores of 12 or greater will be
randomized 1:1:1:1 to receive weekly subcutaneous doses of IMO-8400 at
0.075, 0.15, or 0.3 mg/kg/week or placebo for 12 weeks. Safety and
improvements in PASI score will be monitored throughout the 12-week
treatment period and six-week follow up period. The trial is being
conducted in the Netherlands. Idera expects to have top-line data during
the first quarter of 2014.
IMO-3100 (an antagonist of TLR7 and TLR9)
Presentation of Positive Data from Phase 2 Trial of IMO-3100 in
Patients with Psoriasis
Data from a randomized, double-blind, placebo-controlled Phase 2 trial
of IMO-3100 in patients with moderate-to-severe plaque psoriasis were
presented at the International Investigative Dermatology meeting in
Edinburgh, Scotland in May 2013. In this trial, treatment with IMO-3100
weekly for four weeks was well-tolerated and showed improvements from
baseline of up to 90% in PASI scores. Additionally, analysis of biopsy
samples indicated that PASI score improvements were associated with
significant improvement of psoriasis disease-associated gene profile,
including downregulation of activated genes in the IL-17 pathway, which
is central to the pathogenesis of psoriasis. Details of this
presentation are available on Idera’s website.
Strengthened Balance Sheet and Leadership Team
The Company closed on a $16.5 million public offering with net proceeds
to Idera totaling approximately $14.6 million in May 2013.
In July, James Geraghty was appointed to serve as a member of the Board
of Directors and also as its Chairman. Mr. Geraghty held a wide range of
leadership positions during a 20-year career at Genzyme Corporation,
including substantial experience overseeing product development,
commercial launches, and strategic transactions. Mr. Geraghty also
served as a Senior Vice President of Sanofi SA following its acquisition
of Genzyme, and recently took on a role as an Entrepreneur-in-Residence
at Third Rock Ventures.
Financial Results
As of June 30, 2013, cash and cash equivalents totaled $16.3 million
compared to $10.1 million at December 31, 2012.
Second Quarter Results
Net loss applicable to common stockholders for the three months ended
June 30, 2013, was $5.6 million, or $0.15 per diluted share, compared to
a net loss applicable to common stockholders of $4.0 million, or $0.15
per diluted share, for the same period in 2012. For the six-month
period, the Company's net loss applicable to common stockholders was
$9.7 million, or $0.30 per diluted share, compared to a net loss
applicable to common stockholders of $11.1 million, or $0.40 per diluted
share, for the same period in 2012.
Research and development expenses for the three months ended June 30,
2013, totaled $2.0 million compared to $3.5 million for the same period
in 2012. For the six-month period, R&D expenses totaled $4.3 million
compared to $7.3 million for the same period in 2012.
General and administrative expenses for the three months ended June 30,
2013, totaled $1.6 million compared to $1.8 million for the same period
in 2012. For the six-month period, G&A expenses totaled $3.1 million
compared to $3.5 million for the same period in 2012.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals technology platform involves creating novel
synthetic RNA- and DNA-based compounds to modulate immune responses.
Idera has applied this platform to develop proprietary Toll-like
receptor (TLR) antagonists as immunomodulatory drug candidates.
Toll-like receptor antagonists block the overactivation of immune
factors which can cause a range of pathological effects. Idera is
conducting clinical development of TLR antagonists in autoimmune and
inflammatory diseases. More information on Idera is available at: http://www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera
Pharmaceuticals, Inc. that involve a number of risks and uncertainties.
For this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be forward-looking
statements under The Private Securities Litigation Reform Act of 1995.
Without limiting the foregoing, the words "believes," "anticipates,"
"plans," "expects," "estimates," "intends," "should," "could," "will,"
"may," and similar expressions are intended to identify such
forward-looking statements. There are a number of important factors that
could cause Idera's actual results to differ materially from those
indicated by such forward-looking statements, including whether Idera’s
cash resources will continue to fund the Company’s operations through
year-end 2014 and whether Idera will be able to obtain additional cash
resources sufficient to fund the Company's operations beyond that time;
whether results obtained in preclinical studies and early clinical
trials such as the studies and trials referred to in this release will
be indicative of results obtained in future clinical trials; whether
Idera’s clinical trials will commence and will be completed when
expected by Idera; whether products based on Idera's technology will
advance into or through the clinical trial process on a timely basis or
at all and receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies; whether, if
the Company's products receive approval, they will be successfully
distributed and marketed; whether the patents and patent applications
owned or licensed by the Company will protect the Company's technology
and prevent others from infringing it; and such other important factors
as are set forth under the caption "Risk Factors" in Idera's Report on
Form 10-Q for the period ended June 30, 2013 which important factors are
incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.
|
Idera Pharmaceuticals, Inc.
|
Condensed Statements of Operations (Unaudited)
|
(In thousands, except per share data)
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
2013
|
|
|
|
2012
|
|
|
|
|
2013
|
|
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
$
|
29
|
|
|
$
|
28
|
|
|
|
$
|
36
|
|
|
$
|
37
|
|
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
Research & Development
|
|
|
|
|
1,997
|
|
|
|
3,504
|
|
|
|
|
4,325
|
|
|
|
7,317
|
|
General & Administrative
|
|
|
|
|
1,599
|
|
|
|
1,848
|
|
|
|
|
3,126
|
|
|
|
3,537
|
|
Total Operating Expenses
|
|
|
|
|
3,596
|
|
|
|
5,352
|
|
|
|
|
7,451
|
|
|
|
10,854
|
|
Loss from Operations
|
|
|
|
|
(3,567
|
)
|
|
|
(5,324
|
)
|
|
|
|
(7,415
|
)
|
|
|
(10,817
|
)
|
Decrease (Increase) in Fair Value of Warrant Liability
|
|
|
|
|
-
|
|
|
|
1,318
|
|
|
|
|
-
|
|
|
|
(3
|
)
|
Other, net
|
|
|
|
|
(24
|
)
|
|
|
119
|
|
|
|
|
17
|
|
|
|
47
|
|
Net Loss
|
|
|
|
|
(3,591
|
)
|
|
|
(3,887
|
)
|
|
|
|
(7,398
|
)
|
|
|
(10,773
|
)
|
Loss on Extinguishment of Preferred Stock and Preferred Stock
Dividends
|
|
|
|
|
2,030
|
|
|
|
160
|
|
|
|
|
2,309
|
|
|
|
320
|
|
Net Loss Applicable to Common Stockholders
|
|
|
|
$
|
(5,621
|
)
|
|
$
|
(4,047
|
)
|
|
|
$
|
(9,707
|
)
|
|
$
|
(11,093
|
)
|
Basic & Diluted Net Loss Per Common Share Applicable to Common
Stockholders
|
|
|
|
$
|
(0.15
|
)
|
|
$
|
(0.15
|
)
|
|
|
$
|
(0.30
|
)
|
|
$
|
(0.40
|
)
|
Shares Used in Computing Basic & Diluted Net Loss Per Common Share
Applicable to Common Stockholders
|
|
|
|
|
38,048
|
|
|
|
27,638
|
|
|
|
|
32,875
|
|
|
|
27,638
|
|
|
|
Idera Pharmaceuticals, Inc.
|
Condensed Balance Sheet Data
|
(In thousands)
|
|
|
|
|
June 30,
|
|
|
|
December 31,
|
|
|
|
|
2013
|
|
|
|
2012
|
|
|
|
|
(Unaudited)
|
|
|
|
|
Cash & Cash Equivalents
|
|
|
|
$
|
16,301
|
|
|
|
$
|
10,096
|
Other Assets
|
|
|
|
|
657
|
|
|
|
|
727
|
Total Assets
|
|
|
|
$
|
16,958
|
|
|
|
$
|
10,823
|
|
|
|
|
|
|
|
|
|
Total Liabilities
|
|
|
|
$
|
3,031
|
|
|
|
$
|
4,196
|
Redeemable Preferred Stock
|
|
|
|
|
-
|
|
|
|
|
5,921
|
Stockholders' Equity
|
|
|
|
|
13,927
|
|
|
|
|
706
|
Total Liabilities, Redeemable Preferred Stock & Stockholders' Equity
|
|
|
|
$
|
16,958
|
|
|
|
$
|
10,823
|
|
|
|
|
|
|
|
|
|
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517