Idera Pharmaceuticals Reports First Quarter 2013 Financial Results
CAMBRIDGE, Mass. -- May 15, 2013
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today reported financial results
for the quarter ended March 31, 2013.
“Our next objective in Idera’s autoimmune disease program is to initiate a
Phase 2 study of IMO-8400, a first-in-class TLR7, 8 and 9 antagonist, in
patients with moderate-to-severe plaque psoriasis during the current quarter.
This study will enable us to evaluate the continued trajectory of PASI score
improvement over a 12-week treatment period and maximize the clinical benefit
of the treatment,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive
Officer. “We anticipate top-line data from this trial to be available by the
end of this year. In addition, during the fourth quarter, we expect to be in a
position to initiate Phase 2 clinical trials of IMO-8400 in other autoimmune
disease indications, including lupus.”
"With cash and cash equivalents of $6.1 million at the end of the first
quarter and with the $16.5 million raised recently in an underwritten public
offering, we believe we have funds to conduct 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.
As of March 31, 2013, cash and cash equivalents totaled $6.1 million. In
addition, in May 2013, the Company completed a $16.5 million underwritten
public offering of common stock and warrants.
First Quarter Results
Net loss for the three months ended March 31, 2013, was $4.1 million, or $0.15
per diluted share, compared to net loss of $7.0 million, or $0.25 per diluted
share, for the same period in 2012. Research and development expenses for the
three-month period ended March 31, 2013, totaled $2.3 million compared to $3.8
million for the same period in 2012. General and administrative expenses for
the three-month period ended March 31, 2013, totaled $1.5 million compared to
$1.7 million for the same period in 2012.
1Q 2013 Research and Development Highlights
Autoimmune and Inflammatory Diseases Program
Idera’s approach to the potential treatment of autoimmune and inflammatory
diseases involves inhibiting the induction of immune responses mediated
through Toll-like Receptor (TLR) 7, TLR8 and TLR9. These TLRs are known to be
activated in autoimmune and inflammatory diseases by aberrant complexes that
contain host RNA or DNA. The Company has two clinical-stage TLR antagonist
IMO-8400 is an antagonist of TLR7, TLR8 and TLR9.
Phase 1 Trial in Healthy Subjects Completed
The Company initiated a Phase 1 clinical trial of IMO-8400 in the fourth
quarter of 2012 to assess the safety and the pharmacodynamic activity of
IMO-8400 in healthy subjects. The single-dose portion of this trial involved
three escalating dose levels of 0.1, 0.3 and 0.6 mg/kg of IMO-8400 or placebo,
with six subjects receiving each treatment, and was completed during the first
quarter of 2013. IMO-8400 treatment was well-tolerated at all dose levels, and
the intended target engagement of TLR7, TLR8 and TLR9 was observed in
IMO-8400-treated subjects compared to placebo-treated subjects.
The Company commenced the multiple-dose portion of this trial in the first
quarter of 2013. The multiple-dose portion of this trial involved two dose
levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects
receiving treatment for four weekly doses. Dosing of the multiple-dose portion
of the trial was completed in the second quarter of 2013.
The Company plans to present data from the Phase 1 trial at a scientific
conference in June 2013.
Phase 2 Trial of IMO-8400 in Patients with Moderate-to-Severe Plaque Psoriasis
The next step in the Company’s autoimmune and inflammatory diseases program is
to initiate a Phase 2 clinical trial of IMO-8400 in patients with plaque
psoriasis with a treatment period of 12 weeks. In this randomized,
double-blind, placebo-controlled Phase 2 trial, 32 patients will be randomized
to receive weekly doses for 12 weeks of IMO-8400 at one of three dose levels
or placebo. Safety and improvement in Psoriasis Area Severity Index (PASI)
score will be monitored throughout the study. This Phase 2 protocol has been
approved by the Centrale Commisse Mensgebonden Onderzoek of the Netherlands.
Idera anticipates initiating enrollment under this protocol during the second
quarter of 2013.
IMO-3100 is an antagonist of TLR7 and TLR9.
Positive Data Presented from Phase 2 Trial of IMO-3100 in Patients with
Data from a randomized, double-blind, placebo-controlled Phase 2 clinical
trial of IMO-3100 in adult patients with moderate-to-severe plaque psoriasis
were presented at the International Investigative Dermatology meeting in
Edinburgh, Scotland in May 2013. The objectives of the Phase 2 trial of
IMO-3100 were to evaluate the safety and tolerability and to evaluate the
clinical activity of TLR antagonism in patients with psoriasis after four
weeks of treatment. Details of this presentation are highlighted on Idera’s
Presentation of Preclinical Data
Dr. James G. Krueger, M.D., Ph.D., of The Rockefeller University, gave an oral
presentation entitled “Novel Toll-like Receptor Antagonists Strongly Decrease
Expression of IL-23-induced and Psoriasis Profile Genes in a Mouse Model” in
the Late-Breaking Research Symposium on March 2^nd, 2013, during the American
Academy of Dermatology Annual Meeting. Dr. Krueger presented data showing
that, in a preclinical model of IL-23-induced skin inflammation, genes related
to the production of key mediators of psoriasis, including Interleukin (IL)
-17, IL-6, IL-12/23, IL-1, IL-21 Receptor and interferon-gamma, were restored
toward normal levels by treatment with IMO-3100 and IMO-8400. The inclusion of
TLR8 activity with IMO-8400 was additive to the effect on gene expression that
was observed with IMO-3100.
Publications of Preclinical Data
*A Toll-Like Receptor 7, 8, and 9 Antagonist Inhibits Th1 and Th17
responses and inflammasome activation in a model of IL-23-induced
psoriasis. J Invest Dermatol. 2013.
*Design, synthesis and biological evaluation of novel antagonist compounds
of Toll-like receptors 7, 8 and 9. Nucleic Acids Res. 2013;41(6):3947-61
*Design of synthetic oligoribonucleotide-based agonists of Toll-like
receptor 3 and their immune response profiles in vitro and in vivo. Org
Biomol Chem. 2013;11(6):1049-58.
TLR7, TLR 8 and TLR9 Agonists as Vaccine Adjuvants
Idera and Merck & Co., Inc. entered into an exclusive license and research
collaboration agreement in December 2006 to research, develop and
commercialize vaccine products containing the Company's TLR7, TLR8 and TLR9
agonists in the fields of oncology, infectious diseases and Alzheimer's
*Merck has selected several novel agonists targeted to TLR7, TLR8 or TLR9
for evaluation and exclusive use as vaccine adjuvant candidates under the
companies' collaboration and license agreement.
Additional Proprietary Programs
The Company is seeking to enter into collaborations with third parties to
advance its clinical programs in oncology and respiratory diseases and
research programs in hematologic malignancies, use of TLR3 agonists as vaccine
adjuvants and applications of gene-silencing oligonucleotide technology.
On May 7, 2013, the Company closed a $16.5 million underwritten public
offering of (i) for a combined public offering price of $0.50 per share of
common stock and related warrant, 17,500,000 shares of common stock and
related warrants to purchase up to 17,500,000 shares of common stock at an
exercise price of $0.47 per share, and (ii) for a combined public offering
price of $0.49 per pre-funded warrant and related warrant, pre-funded warrants
to purchase up to 15,816,327 shares of common stock at an exercise price of
$0.01 per share and related warrants to purchase up to 15,816,327 shares of
common stock at an exercise price of $0.47 per share. The net proceeds to the
Company from this offering are expected to be $14.7 million. The Company
anticipates using the net proceeds from the offering to fund a planned Phase 2
clinical trial of IMO-8400 in patients with psoriasis, and for working capital
and general corporate purposes.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of
autoimmune and inflammatory diseases by targeting specific Toll-like Receptors
(TLRs) to inhibit the induction of immune responses. The Company has two drug
candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and
9, and IMO-3100, an antagonist of TLR7 and TLR9. Additionally, Idera has a
collaboration with Merck & Co. for the use of TLR agonists as vaccine
adjuvants for cancer, infectious diseases and Alzheimer’s disease. For more
information, visit 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. Without
limiting the foregoing, the words "believes," "anticipates," "plans,"
"expects," "estimates," "intends," "should," "could," "will," "may," and
similar expressions are intended to identify 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 will be able to obtain cash resources sufficient to
fund the Company's operations; 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 Company's collaboration with Merck & Co, Inc., will be successful; 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 three months ended March 31, 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
(In thousands, except per share data)
Three Months Ended
Revenues $ 7 $ 9
Research & Development 2,328 3,813
General & Administrative 1,527 1,689
Total Operating Expenses 3,855 5,502
Loss from Operations (3,848 ) (5,493 )
Increase in Fair Value of Warrant Liability --- (1,321 )
Other, net 41 (72 )
Net Loss (3,807 ) (6,886 )
Preferred Stock Dividends 279 160
Net Loss Applicable to Common Stockholders $ (4,086 ) $ (7,046 )
Basic and Diluted Net Loss Per Common Share $ (0.15 ) $ (0.25 )
Applicable to Common Stockholders
Shares Used in Computing Basic and Diluted Net Loss 27,644 27,637
Per Common Share Applicable to Common Stockholders
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
At March 31, At December 31,
Cash & Cash Equivalents $ 6,149 $ 10,096
Other Assets 665 727
Total Assets $ 6,814 $ 10,823
Total Liabilities $ 4,104 $ 4,196
Redeemable Preferred Stock 5,921 5,921
Stockholders' (Deficit) Equity (3,211 ) 706
Total Liabilities, Redeemable Preferred Stock $ 6,814 $ 10,823
& Stockholders' (Deficit) Equity
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
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