Net loss for the three months ended September 30, 2011, was $5.5 million, or $0.20 per diluted share, compared to a net loss of $4.7 million, or $0.18 per diluted share, for the same period in 2010. For the nine-month period, the Company's net loss was $18.6 million, or $0.67 per diluted share, compared to a net loss of $12 million, or $0.49 per diluted share, for the same period in 2010.Research and development expenses for the three months ended September 30, 2011, totaled $3.6 million compared to $7.8 million for the same period in 2010. For the nine-month period, R&D expenses totaled $12.3 million compared to $19.3 million for the same period in 2010. General and administrative expenses for the three months ended September 30, 2011, totaled $1.9 million compared to $2.2 million for the same period in 2010. For the nine-month period, G&A expenses totaled $6.4 million compared to $7.7 million for the same period in 2010. Third Quarter 2011 Research and Development Highlights IMO-3100 for Autoimmune and Inflammatory Diseases IMO-3100, a dual antagonist of TLR7 and TLR9, is being developed as a novel approach to treat autoimmune and inflammatory diseases. IMO-3100 has shown activity in preclinical models of lupus, psoriasis, rheumatoid arthritis and hyperlipidemia. Idera has completed two Phase 1 clinical trials of IMO-3100 monotherapy in healthy subjects. Data from the Phase 1 clinical trials have been presented at scientific meetings. Next Steps in Clinical Development of IMO-3100
- The next step in the clinical development of IMO-3100 is to conduct a clinical proof-of-concept study in a selected autoimmune disease indication. With input from our Autoimmune Disease Scientific Advisory Board and key opinion leaders, we have selected psoriasis as the initial disease indication in which to assess IMO-3100 clinical activity.
- In June 2011, we submitted to the FDA a protocol for a Phase 2 clinical trial to evaluate IMO-3100 in patients with psoriasis. In July 2011, the FDA placed a clinical hold on the proposed protocol. We are continuing to communicate with the FDA regarding the evaluation of IMO-3100 in patients with psoriasis. Our goal is to initiate a clinical trial of IMO-3100 in 2012 to establish proof of concept.
Recent Developments in the GSO Program
- In October 2011, Idera presented preclinical data on its GSOs at the Cell Symposium on Regulatory RNAs. In the preclinical studies presented, systemic delivery of GSOs targeted to the mRNA of ApoB or PCSK9, two validated targets associated with cardiovascular diseases, caused a reduction in the level of the targeted mRNA and associated protein and resulted in a decrease in serum total cholesterol and LDL-cholesterol concentration.
- Phase 2 clinical trial for the second-line treatment of squamous cell carcinoma of the head and neck (SCCHN) in combination with Erbitux®. This trial is ongoing.
- Phase 1b trial of IMO-2055 in combination with Tarceva® and Avastin® for the treatment of non-small cell lung cancer.
- Phase 1b trial of IMO-2055 in combination with Erbitux and FOLFIRI for the treatment of colorectal cancer.
- Phase 1 trial of IMO-2055 in combination with Erbitux, cisplatin, and 5-fluorouracil for the first-line treatment of SCCHN. This trial has been discontinued.
- In July 2011, Merck and Idera scientists published a paper entitled “Synthesis and immunological activities of novel Toll-like receptor 7 and 8 agonists” in the journal Cellular Immunology.
ERBITUX® is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company. Tarceva® is a trademark of OSI Pharmaceuticals, LLC, Farmingdale, NY 11735, USA, an affiliate of Astellas Pharma US, Inc. Avastin® is a registered trademark of Genentech, IncAbout Idera Pharmaceuticals, Inc. Idera Pharmaceuticals applies its proprietary Toll-like Receptor (TLR) drug discovery platform to create immunomodulatory drug candidates. The Company's TLR-targeted candidates are being developed to treat autoimmune and inflammatory diseases, cancer, and for use as vaccine adjuvants. Additionally, the Company is advancing its gene-silencing oligonucleotide (GSO) technology for the purpose of inhibiting the expression of disease-promoting genes. 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 results obtained in preclinical studies such as the results referenced in this release will be indicative of results obtained in later preclinical studies and future clinical trials, if any; 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 the clinical hold on IMO-3100 will be lifted and the FDA will agree on additional clinical evaluation of IMO-3100; whether clinical trials will be completed and results announced on a timely basis; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations 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; whether Idera's cash resources will be sufficient to fund the Company's operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, 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||Nine Months Ended|
|September 30,||September 30,|
|Research & Development||3,574||7,786||12,269||19,333|
|General & Administrative||1,948||2,193||6,400||7,709|
|Total Operating Expenses||5,522||9,979||18,669||27,042|
|Loss from Operations||(5,518||)||(4,890||)||(18,624||)||(11,990||)|
|Basic Net Loss Per Common Share||$||(0.20||)||$||(0.18||)||$||(0.67||)||$||(0.49||)|
|Diluted Net Loss Per Common Share||$||(0.20||)||$||(0.18||)||$||(0.67||)||$||(0.49||)|
|Shares Used in Computing Basic Net Loss Per Common Share||27,632||25,980||27,618||24,314|
|Shares Used in Computing Diluted Net Loss Per Common Share||27,632||25,980||27,618||24,314|
|Idera Pharmaceuticals, Inc. Condensed Balance Sheet Data (In thousands)|
|September 30,||December 31,|
|Cash, Cash Equivalents|
|Accounts Payable & Accrued Liabilities||$||3,787||$||3,780|
|Total Liabilities &|