CAMBRIDGE, Mass. -- (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing nucleic acid therapeutics for rare diseases, today reported financial and operational results for the quarter ended June 30, 2014. The Company highlighted progress in advancing drug candidates for the treatment of mutation-specific forms of B-cell lymphoma and autoimmune diseases, as well as its next-generation antisense technology platform.
“During the past quarter, we made significant progress in advancing our clinical programs. Our trials in Waldenström’s macroglobulinemia (WM) and diffuse large B-cell lymphoma (DLBCL) are advancing, and we are making progress towards initiating clinical development in myositis and graft versus host disease (GvHD) by year-end,” said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. “We are also pleased to have put in place invaluable relationships with global key opinion leaders and patient foundations to help us advance these important programs."
Idera has significantly progressed both its clinical development programs for rare disease indications and its gene silencing oligonucleotide (GSO) technology, a novel third-generation antisense platform.
Programs for Genetically Defined Forms of B-cell Lymphoma
Programs for Rare Autoimmune Diseases
Additional pipeline programs
Gene Silencing Oligonucleotide (GSO) Platform
"Collectively these achievements in the second quarter testify both to the scientific and clinical potential of Idera's programs and to the quality and dedication of our team, which has continued to add experienced talent," said Dr. Agrawal. "We look forward to updating investors on continued progress in the coming quarters."
Second Quarter 2014 Financial Results
As of June 30, 2014, Idera's cash, cash equivalents and investments totaled $64.7 million compared to $35.6 million as of December 31, 2013.
Net loss applicable to common stockholders for the three months ended June 30, 2014 was $8.4 million, or $0.10 per diluted share, compared to a net loss applicable to common stockholders of $5.6 million, or $0.15 per diluted share, for the same period in 2013. For the six month period, the Company’s net loss applicable to common stockholders was $17.6 million, or $0.22 per diluted share, compared to a net loss applicable to common stockholders of $9.7 million, or $0.30 per diluted share, for the same period in 2013. There was nominal revenue recognized in the second quarter and six month periods of 2014 and 2013.
Research and development expenses for the three months ended June 30, 2014 totaled $5.6 million compared to $2.0 million for the same period in 2013. For the sixth month period, R&D expenses totaled $12.6 million compared to $4.3 million for the same period in 2013.
General and administrative expenses for the three months ended June 30, 2014 totaled $2.7 million compared to $1.6 million for the same period in 2013. For the six-month period, G&A expenses totaled $4.8 million compared to $3.1 million for the same period in 2013.
“To date we’ve made significant progress in building out the operational infrastructure to support our ongoing and planned clinical and preclinical initiatives,” said Lou Arcudi, Chief Financial Officer of Idera Pharmaceuticals. “We believe we are well capitalized and have the resources in place to be able to execute on our current business objectives and carry us through the second quarter of 2016.”
Webcast and Conference Call
Idera will host a conference call today at 8:30 a.m. EDT to discuss second quarter 2014 financial results and corporate highlights.
In order to participate in the conference call, please dial 1-800-901-5241 (domestic) or 1-617-786-2963 (international) and provide the access code 28510971. The live webcast also can be accessed under “Investor Events” in the Investors section of the Company’s website at www.iderapharma.com.
A replay of the call will be available at 1:30 p.m. EDT on August 12, 2014. To access the replay, please dial 1-888-286-8010 (domestic) or 1-617-801-6888 (international) and reference the access code 67213242. The archived webcast will be available for 90 days in the Investors section of Idera’s website at www.iderapharma.com.
About Idera Pharmaceuticals
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 rare 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 (GSOs) that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.
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 when anticipated, 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 six months ended June 30, 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.
1 Fernandez-Rodriguez C, et al. MYD88 (L265P) mutation is an independent prognostic factor for outcome in patients with diffuse large B-cell lymphoma. Leukemia. 2014 Jun 6. Epub ahead of print.
2 Welten SM, et al. Inhibition of 14q32 MicroRNAs miR-329, miR-487b, miR-494 and miR-495 Increases Neovascularization and Blood Flow Recovery after Ischemia. Circ Res. 2014 Aug 1. Epub ahead of print.
|Idera Pharmaceuticals, Inc.|
|Condensed Statements of Operations|
|(In thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research & Development||5,637||1,997||12,570||4,325|
|General & Administrative||2,730||1,599||4,773||3,126|
|Total Operating Expenses||8,367||3,596||17,343||7,451|
|Loss from Operations||(8,329)||(3,567||)||(17,302||)||(7,415)|
|Loss on Extinguishment of Convertible Preferred Stock and Preferred Stock Dividends||118||2,030||303||2,309|
|Net Loss Applicable to Common Stockholders||$||(8,426||)||$||(5,621||)||$||(17,572||)||$||(9,707)|
|Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders||$||(0.10||)||$||(0.15||)||$||(0.22||)||$||(0.30)|
|Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders||82,961||38,048||79,509||32,875|
|Idera Pharmaceuticals, Inc.|
|Condensed Balance Sheet Data|
|June 30,||December 31,|
|Cash, Cash Equivalents|
|& Investments||$ 64,734||$||35,592|
|Total Assets||$ 66,567||$||36,867|
|Total Liabilities||$ 6,306||$||4,415|
|Total Stockholders' Equity||60,261||32,452|
|Total Liabilities &|
|Stockholders' Equity||$ 66,567||$||36,867|