Idera Pharmaceuticals Reports Second Quarter 2013 Financial Results and
-- Clinical Proof of Concept Data Presented, Phase 2 Trial Initiated --
CAMBRIDGE, Mass -- August 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
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
Initiation of a Phase 2 Trial of IMO-8400 in Patients with Moderate-to-Severe
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
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.
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
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
Research & 1,997 3,504 4,325 7,317
General & 1,599 1,848 3,126 3,537
Total Operating 3,596 5,352 7,451 10,854
Loss from (3,567 ) (5,324 ) (7,415 ) (10,817 )
in Fair Value of - 1,318 - (3 )
Other, net (24 ) 119 17 47
Net Loss (3,591 ) (3,887 ) (7,398 ) (10,773 )
Preferred Stock and 2,030 160 2,309 320
Net Loss Applicable
to Common $ (5,621 ) $ (4,047 ) $ (9,707 ) $ (11,093 )
Basic & Diluted Net
Loss Per Common $ (0.15 ) $ (0.15 ) $ (0.30 ) $ (0.40 )
Share Applicable to
Shares Used in
Computing Basic &
Diluted Net Loss 38,048 27,638 32,875 27,638
Per Common Share
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
June 30, December 31,
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 $ 16,958 $ 10,823
Stock & Stockholders' Equity
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
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