Idera Pharmaceuticals Reports First Quarter 2009 Financial Results

Business Wire, May 06, 2009

CAMBRIDGE, Mass. -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today reported financial results for the first quarter ended March 31, 2009.

“We currently have three novel agonists targeted to Toll-like Receptors in clinical development for different indications, two of which are being advanced and funded by our collaborators,” said Sudhir Agrawal, D.Phil., President, Chief Executive Officer and Chief Scientific Officer. “Additionally, we intend to submit an Investigational New Drug application by the end of 2009 for a fourth drug candidate, IMO-3100, which is a novel TLR antagonist for potential application in autoimmune diseases.”

“We ended the first quarter with $50.3 million in cash and investments. With net cash used in operations of $5.3 million during the first quarter and the subsequent receipt of a $4.0 million milestone payment, we believe we are in a strong financial position to continue to advance our discovery and development programs,” commented Lou Arcudi, Chief Financial Officer.

First Quarter Results

The Company reported a net loss of $0.3 million, or $0.01 per diluted share, for the three months ended March 31, 2009, compared to a net loss of $2.2 million, or $0.10 per diluted share, for the same period in 2008.

Total revenues for the three months ended March 31, 2009 were $6.3 million compared to $4.8 million for the same period in 2008.

Research and development expenses totaled $4.5 million for each of the three-month periods ended March 31, 2009 and March 31, 2008.

General and administrative expenses for the three months ended March 31, 2009 were $2.1 million compared to $2.4 million for the same period in 2008.

As of March 31, 2009, cash, cash equivalents and investments totaled approximately $50.3 million compared to $55.6 million at December 31, 2008. Subsequently, the Company received a $4.0 million milestone payment from Merck KGaA.

Development Program Highlights

IMO-2055

IMO-2055, a synthetic DNA-based Toll-like Receptor 9 (TLR9) agonist, is a lead drug candidate for the treatment of cancer. In December 2007, the Company entered into a worldwide licensing and collaboration agreement with Merck KGaA for the research, development and commercialization of the Company’s TLR9 agonists for the treatment of cancer, excluding cancer vaccines. At present, IMO-2055 is being evaluated in two Phase 1b clinical trials:

• IMO-2055 in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer
• IMO-2055 in combination with Erbitux® and Camptosar® in patients with colorectal cancer

Under this collaboration, Merck KGaA currently is funding all on-going development activities related to IMO-2055 for cancer.

IMO-2125

IMO-2125, a synthetic DNA-based TLR9 agonist, is a lead drug candidate for the treatment of infectious diseases, with an initial focus on chronic hepatitis C virus (HCV) infection. In preclinical models, IMO-2125 was shown to induce high levels of natural interferon and other antiviral proteins. The Company expects interim results from an ongoing Phase 1 clinical trial of IMO-2125 in patients with chronic HCV infection who have not responded to current standard of care therapy to be available in late 2009. In addition, the Company is preparing to conduct a clinical trial to assess the safety of IMO-2125 in combination with ribavirin in patients with chronic HCV infection who have not received prior treatment, also referred to as treatment-naïve patients.

QAX935 (IMO-2134)

QAX935 (IMO-2134) is a novel TLR9 agonist exclusively licensed by the Company to Novartis International Pharmaceutical, Ltd. In May 2005, the Company and Novartis entered into research collaboration and license agreements involving the application of TLR9 agonists to treating asthma and allergies. In September 2008, Idera achieved a milestone under this collaboration upon the initiation of a Phase 1 clinical trial of QAX935 by Novartis. Under this collaboration, Novartis is conducting and funding all research activities.

IMO-3100

IMO-3100 is a dual TLR7 and TLR9 antagonist and the Company’s lead drug candidate for autoimmune and inflammatory diseases. The Company has identified DNA-based compounds that act as antagonists of TLR7 and TLR9 and has evaluated these compounds in preclinical mouse models of lupus, rheumatoid arthritis, multiple sclerosis, psoriasis and colitis. The Company is currently conducting preclinical development studies of IMO-3100 in anticipation of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration by the end of 2009.

TLR7, 8 and 9 agonists as vaccine adjuvants