Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today reported its financial results and highlights for the second quarter ended June 30, 2012. "During the first half of 2012, we have continued to advance the development of lead candidates in our autoimmune disease program. We anticipate that the interim data from our ongoing Phase 2 study of IMO-3100 in patients with psoriasis will be available by the end of 2012. The Phase 2 study is designed to help us validate the scientific rationale of antagonizing specific Toll-like Receptors for the treatment of autoimmune diseases. We are also on target to submit an Investigational New Drug application for IMO-8400 for the treatment of lupus as a first indication in the fourth quarter of 2012," said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. "In addition, we continue to support our collaboration with Merck in the area of TLR agonists as vaccine adjuvants for cancer, infectious diseases and Alzheimer's disease." Financial Results As of June 30, 2012, cash and cash equivalents totaled $13.2 million compared to $24.6 million at December 31, 2011. Second Quarter Results Net loss applicable to common stockholders for the three months ended June 30, 2012, was $4.0 million, or $0.15 per diluted share, compared to a net loss applicable to common stockholders of $6.3 million, or $0.23 per diluted share, for the same period in 2011. For the six-month period, the Company's net loss applicable to common stockholders was $11.1 million, or $0.40 per diluted share, compared to a net loss applicable to common stockholders of $13.1 million, or $0.48 per diluted share, for the same period in 2011. Research and development expenses for the three months ended June 30, 2012, totaled $3.5 million compared to $4.1 million for the same period in 2011. For the six-month period, R&D expenses totaled $7.3 million compared to $8.7 million for the same period in 2011.
General and administrative expenses for the three months ended June 30, 2012, totaled $1.8 million compared to $2.2 million for the same period in 2011. For the six-month period, G&A expenses totaled $3.5 million compared to $4.5 million for the same period in 2011.2Q 2012 Research and Development Highlights Autoimmune and Inflammatory Disease Program IMO-3100 - Clinical Candidate for Psoriasis IMO-3100, a dual antagonist of TLR7 and TLR9, is the lead clinical candidate being developed by the Company initially for the treatment of psoriasis. Phase 2 Trial of IMO-3100 in Patients with Psoriasis
- In the second quarter of 2012, the Company initiated a Phase 2 randomized, placebo-controlled clinical trial of IMO-3100 in patients with psoriasis. Under the protocol for this study, 45 patients with moderate to severe plaque psoriasis will receive IMO-3100 at 0.16 or 0.32 mg/kg or placebo by subcutaneous injection once weekly for four weeks. Assessments of safety will be performed throughout the treatment and a four-week follow-up period. Psoriasis intensity will be monitored throughout the study. Skin biopsies of active psoriasis plaque will be obtained prior to treatment and one week after the last treatment and will be analyzed at a central laboratory by immunohistologic staining for changes in epidermal thickness, immune cell infiltrates and cytokine expression. This trial is being conducted at multiple sites in the United States. Based on the current enrollment rates, we anticipate the interim data from the trial will be available by the end of 2012, and the complete top-line data will be available in the first quarter of 2013.
- In the second quarter of 2012, the Company made a presentation entitled “IMO-8400, a Novel Antagonist Candidate for Autoimmune Diseases, Suppresses TLR7-, TLR8- and TLR9-Mediated Immune Responses in Non-Human Primates” at the Federation of Clinical Immunology Societies (FoCIS) meeting. In this study IMO-8400 showed suppression of multiple cytokines, including TNF-α, IL-12, IL-6, IFN-α, and IL-1β, following subcutaneous administration in non-human primates.
- In the second quarter of 2012, the Company made a presentation, entitled "IMO-8400, a novel TLR7, TLR8, and TLR9 antagonist, inhibits disease development in lupus-prone NZBW/F1 mice", at the American Association of Immunologists (AAI) meeting. In the mouse study, treatment with IMO-8400 decreased autoimmune antibodies, multiple pro-inflammatory serum cytokines and indicators of kidney damage compared to untreated mice.
- The Company made a second presentation at AAI entitled "IMO-8400, a novel TLR7, TLR8, and TLR9 antagonist, inhibits disease development in mouse models of psoriasis".
- The Company and collaborators from the Ragon Institute of MIT, Massachusetts General Hospital and Harvard Medical School also made a presentation at AAI entitled "Modification of immune activation in HIV-1 infected humanized mouse models using TLR7/9 antagonists".
In the first quarter of 2012, Merck 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 Programs The Company is seeking to enter into licensing and partnering arrangements to advance its TLR programs in oncology, respiratory diseases, infectious diseases and adjuvant applications of TLR3 agonists, as well as its programs for its gene-silencing oligonucleotide technology. About TLRs and Idera's Pipeline Toll-like Receptors (TLRs) represent a class of proteins that play a key role in both inflammation and immunity. Of the 10 human TLRs identified to date, Idera is focusing on compounds targeted to TLRs 3, 7, 8 and 9, which are expressed in different cells and serve unique functions. For example, activation of TLR7 and TLR9 present in certain dendritic cells and lymphocytes may be useful for the treatment of various types of cancer by stimulating immunity. In contrast, inhibition of specific TLRs may be useful in treating autoimmune disorders, such as psoriasis and lupus, by blocking the production of multiple pro-inflammatory mediators. Using its chemistry-based approach, Idera has developed a portfolio of novel drug candidates to modulate immune response through activation or inhibition of specific TLRs to treat a broad range of diseases, including autoimmune diseases, and to enhance the effectiveness of vaccines. In autoimmune diseases, Idera is developing inhibitors of TLRs 7, 8 and 9 for the potential treatment of psoriasis, lupus and other diseases. Idera's lead clinical candidate is IMO-3100, an antagonist of TLR7 and TLR9, which is in Phase 2 development for psoriasis. IMO-8400 is an antagonist of TLRs 7, 8 and 9 that the Company is developing for the treatment of lupus. Idera expects to submit an IND application for IMO-8400 during the fourth quarter of 2012.
About PsoriasisPsoriasis is a systemic immune-mediated disorder, characterized by inflammatory skin and joint manifestations. The most common form, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells. Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes, heart disease and depression. Psoriasis is the most prevalent autoimmune disease in the U.S., affecting as many as 7.5 million Americans according to the National Psoriasis Foundation. About Lupus Lupus is a chronic autoimmune disease where the body's immune system becomes hyperactive and attacks normal healthy tissue. This results in symptoms such as inflammation, swelling and damage to joints and almost every major organ in the body, including the heart, kidneys, skin, lungs and brain. According to The Lupus Foundation of America, an estimated 1.5 million Americans and at least five million people worldwide have a form of lupus. About Idera Pharmaceuticals, Inc. Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR) drug discovery platform to create immunomodulatory drug candidates and has clinical development programs in autoimmune diseases and cancer. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR-targeted candidates as vaccine adjuvants. The Company is also developing its gene-silencing oligonucleotide 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 Idera’s cash resources will be sufficient to fund the further development of the Company’s programs, as well as its operations; whether results obtained in preclinical studies and early clinical trials e will be indicative of results obtained in future clinical trials; 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 will be able to license for further development IMO-2055 for oncology or its other TLR target candidates on a timely basis or at all; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 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||Six Months Ended|
|June 30,||June 30,|
|Research & Development||3,504||4,142||7,317||8,695|
|General & Administrative||1,848||2,166||3,537||4,452|
|Total Operating Expenses||5,352||6,308||10,854||13,147|
|Loss from Operations||(5,324||)||(6,275||)||(10,817||)||(13,106||)|
|Decrease (Increase) in Fair Value of Warrant Liability||1,318||-||(3||)||-|
|Preferred Stock Dividends||160||-||320||-|
|Net Loss Applicable to Common Stockholders||$||(4,047||)||$||(6,282||)||$||(11,093||)||$||(13,127||)|
|Basic and Diluted Net Loss Per Common ShareApplicable to Common Stockholders||$||(0.15||)||$||(0.23||)||$||(0.40||)||$||(0.48||)|
|Shares Used in Computing Basic and Diluted Net LossPer Common Share Applicable to Common Stockholders||27,638||27,619||27,638||27,612|
|Idera Pharmaceuticals, Inc.|
|Condensed Balance Sheet Data|
|June 30,||December 31,|
|Cash & Cash Equivalents||$||13,227||$||24,571|
|Redeemable Preferred Stock||5,921||5,921|
|Total Liabilities, Redeemable PreferredStock & Stockholders' Equity||$||14,106||$||25,595|