Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage
biopharmaceutical company developing novel nucleic acid therapeutics for
orphan diseases, today reported its financial and operational results
for the quarter ended March 31, 2014. The Company's clinical focus has
now evolved to center on patients with genetically defined forms of
B-cell lymphoma and on patients with rare autoimmune diseases.
"We believe we have made tremendous progress in 2014 based on the
foundation we built in 2013. During this year, we initiated clinical
development of IMO-8400 in Waldenström's macroglobulinemia and in
diffuse large B-cell lymphoma (DLBCL) patients harboring the MYD88 L265P
mutation. We look forward to progressing IMO-8400 in clinical trials for
these indications," said Sudhir Agrawal, D. Phil., Chief Executive
Officer of Idera Pharmaceuticals. "In addition, our strategic assessment
of orphan autoimmune diseases has led us to identify graft-versus-host
disease (GvHD), polymyositis, and dermatomyositis as the initial
prioritized disease indications for clinical development of our TLR
Dr. Agrawal continued, "To support the clinical development of our
pipeline of candidates and technology platforms, we strengthened the
management team in key areas with the addition of Lou Brenner, M.D., as
Senior Vice President and Chief Medical Officer; Kate Haviland as Vice
President Rare Diseases; Joe Lobacki as General Manager of Oncology;
Walter Strapps, Ph.D., as Executive Director of RNA Therapeutics; and
Nancy Wyant as Vice President of Clinical Operations. Our new team
members bring extensive biopharmaceutical industry expertise and the
skills which would enable us to advance our pipeline to
commercialization. We are very pleased to have them on board."
Recent Corporate Updates
Program for Genetically Defined Forms of B-cell Lymphoma
Idera's program in genetically defined forms of B-cell lymphoma is
directed to patients harboring the MYD88 L265P oncogenic mutation.
Clinical development has been initiated.
Program in Orphan Autoimmune Diseases
Gene Silencing Oligonucleotide (GSO) Platform
Idera's gene silencing oligonucleotide (GSO) platform represents an
optimized third generation antisense technology. In preclinical studies
to date, the Company's GSOs have shown favorable characteristics and a
potentially improved therapeutic index relative to other antisense
technologies. Idera plans to initiate clinical proof-of-concept studies
for two disease indications as early as the second half of 2015.
Leadership Team Additions
Idera has appointed Nancy Wyant as Vice President of Clinical
Operations. Nancy joins Idera with over 18 years of extensive experience
in clinical trial development and management. She most recently worked
at Sarepta Therapeutics, where she served as Senior Director and Head of
Clinical Operations. Prior to that, she held roles of increasing
responsibility in clinical operations at Shire Human Genetic Therapies.
In addition, during 2014, Idera welcomed the following new members to
its management team:
During the first quarter of 2014, Idera also appointed the following new
members to its Board of Directors:
First Quarter 2014 Financial Results
Net loss applicable to common stockholders for the three months ended
March 31, 2014 was $9.1 million, or $0.12 per diluted share, compared to
a net loss applicable to common stockholders of $4.1 million, or $0.15
per diluted share, for the same period in 2013. There was nominal
revenue recognized in the first quarter of 2014 and 2013.
Research and development expense for the three months ended March 31,
2014 totaled $6.9 million compared to $2.3 million for the same period
General and administrative expense for the three months ended March 31,
2014 totaled $2.0 million compared to $1.5 million for the same period
As of March 31, 2014, Idera's cash, cash equivalents and investments
totaled $70.6 million compared to $35.6 million as of December 31, 2013.
In February 2014, Idera announced the closing of its underwritten public
offering, with gross proceeds of approximately $40.1 million.
"We ended the first quarter of 2014 in a strong financial position,"
said Lou Arcudi, Chief Financial Officer of Idera Pharmaceuticals. "With
the $40.1 million in gross proceeds raised recently in an underwritten
public offering, we believe we have the resources necessary to advance
our clinical and preclinical programs in both our TLR antagonist and GSO
technology platforms, and reach our near term business objectives."
Webcast and Conference Call
Idera will host a conference call today at 8:00 a.m. EDT to discuss
first quarter 2014 financial results and provide a detailed review of
its pipeline progress, business strategy, recent highlights and upcoming
In order to participate in the conference call, please dial
1-800-706-7741 (domestic) or 1-617-614-3471 (international) and provide
the access code 15389137. The live webcast and slides can be accessed
under "Investor Events" in the Investors section of the Company's
website at www.iderapharma.com
or you may use the link http://www.media-server.com/m/p/rpot3zjr.
A replay of the call will be available at 1:30 p.m. EDT on May 13, 2014
until 11:59 p.m. EDT on May 20, 2014. To access the replay, please dial
1-888-286-8010 (domestic) or 1-617-801-6888 (international) and
reference the access code 88784725. The archived webcast will be
available for 30 days in the Investors section of Idera's website at www.iderapharma.com.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company
developing a novel therapeutic approach for the treatment of genetically
defined forms of B-cell lymphoma and orphan autoimmune diseases. Idera's
proprietary technology involves creating novel nucleic acid therapeutics
designed to inhibit over-activation of Toll-like Receptors (TLRs). In
addition to its TLR programs, Idera is developing gene silencing
oligonucleotides that it has created using its proprietary technology to
inhibit the production of disease-associated proteins by targeting RNA.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. All
statements, other than statements of historical fact, included or
incorporated in this press release, including statements regarding the
Company's strategy, future operations, collaborations, intellectual
property, cash resources, financial position, future revenues, projected
costs, prospects, plans, and objectives of management, are
forward-looking statements. The words "believes," "anticipates,"
"estimates," "plans," "expects," "intends," "may," "could," "should,"
"potential," "likely," "projects," "continue," "will," and "would" and
similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying
words. Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking statements
and you should not place undue reliance on the Company's forward-looking
statements. There are a number of important factors that could cause
Idera's actual results to differ materially from those indicated or
implied by its forward-looking statements. Factors that may cause such a
difference include: whether results obtained in preclinical studies and
clinical trials such as the results described in this release will be
indicative of the results that will be generated in future clinical
trials, including in clinical trials in different disease indications;
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 collaborations will be successful; and
such other important factors as are set forth under the caption "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the three
months ended March 31, 2014. Although Idera may elect to do so at some
point in the future, the Company does not assume any obligation to
update any forward-looking statements and it disclaims any intention or
obligation to update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
Condensed Balance Sheet Data
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