Idera Pharmaceuticals Reports Third Quarter 2012 Financial Results
Balance Sheet Strengthened with Recent
Net loss for the three months ended
“During 2012, we have met the key objectives of our autoimmune disease
drug development program,” said
“We are pleased to have strengthened the Company’s balance sheet with
the recently completed
Recent Business and Clinical Highlights
-
In the third quarter of 2012, the Company completed enrollment in a
Phase 2 randomized, double-blind, placebo-controlled, multi-center
clinical trial of IMO-3100 in patients with moderate to severe plaque
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. In this study, 44 patients with moderate to
severe plaque psoriasis were randomized 1:1:1 to receive IMO-3100 at
0.16 or 0.32 mg/kg or placebo by subcutaneous injection once weekly
for four weeks. Assessments of safety are being performed throughout
the treatment and four-week follow-up periods. Psoriasis intensity,
using Psoriasis Area Severity Index (PASI), mean focal psoriasis
severity and Physician Global Assessment (
PGA ) scores, will be assessed pre- and post-treatment. Skin biopsies of psoriasis lesions will be obtained to determine mean epidermal thickness prior to treatment and at end of treatment. Analyzed by a central laboratory, the biopsy analysis also includes immunohistologic staining for changes in immune cell infiltrates and cytokine expression. The Company anticipates reporting top-line data for some of the endpoints of the trial by year-end 2012. -
The Company announced in the third quarter of 2012 that its IND
application for IMO-8400 with the
US Food and Drug Administration (FDA ) became active. IMO-8400 is an antagonist of TLRs 7, 8 and 9, which the Company is developing initially for the treatment of lupus. The Company anticipates announcing the initiation of a Phase 1 clinical trial duringNovember 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects. Following successful completion of the escalating single- and multiple-dose Phase 1 study and additional funding, the Company expects to initiate a Phase 2 clinical trial of IMO-8400 in lupus patients. -
In October, the Company made a presentation entitled “Inflammasome
Activation is Blocked by Antagonists of Endosomal Toll-Like Receptors:
Implications in Treatment of Autoinflammatory Disorders” at the 8th
Annual Meeting of the
Oligonucleotide Therapeutics Society . In this presentation, new data from preclinical studies showed that in the studies selective inhibition of Toll-like Receptors (TLRs) 7, 8, and 9, which play a key role in inflammation and immunity, resulted in inhibition of inflammasome activation and induction of Interleukin 1 beta (IL-1β), a pro-inflammatory cytokine that has been shown to be involved in Behçet's disease, non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases.
Financial Results
As of
In
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
About TLRs and Idera's Pipeline
Toll-like Receptors (TLRs) play a key role in inflammation and immunity. Of the 10 human TLRs identified to date, Idera is developing compounds targeted to TLRs 3, 7, 8, and 9, which are expressed in different cells and serve unique functions. Using its chemistry-based approach, Idera has created novel drug candidates that modulate immune responses through either activation or inhibition of specific TLRs. Inhibition of specific TLRs may be useful in treating autoimmune disorders, such as systemic lupus erythematosus (SLE), psoriasis, and rheumatoid arthritis, by blocking the induction of multiple cytokines and signaling pathways. Idera's lead clinical candidates for application in autoimmune diseases are IMO-3100, an antagonist of TLR7 and TLR9, and IMO-8400, an antagonist of TLRs 7, 8, and 9.
A characteristic of autoimmune diseases such as SLE and psoriasis is the production of immune complexes with self-nucleic acids. These abnormal immune complexes activate TLRs 7, 8, and 9 and induce multiple cytokines that cause further damage to the body's own tissues and organs, thereby releasing more self-nucleic acids. Thus, a pathologic amplification cycle is established, promoting disease maintenance and progression. In preclinical models of several autoimmune diseases, IMO-3100 and IMO-8400 inhibited TLR-mediated immune responses, broke the cycle of disease maintenance and progression through decreases in Th1, Th17 and inflammasome pathways, and led to improvements in multiple measures of disease
About Psoriasis
Psoriasis 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.,
according to the
About Systemic Lupus Erythematosus
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
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Idera Pharmaceuticals, Inc. | ||||||||||||
Condensed Statements of Operations (Unaudited) | ||||||||||||
(In thousands, except per share data) | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
September 30, |
September 30, |
|||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||
Revenues | $ | 3 | $ | 4 | $ | 40 | $ | 45 | ||||
Operating Expenses | ||||||||||||
Research & Development | 3,278 | 3,574 | 10,595 | 12,269 | ||||||||
General & Administrative | 1,477 | 1,948 | 5,014 | 6,400 | ||||||||
Total Operating Expenses | 4,755 | 5,522 | 15,609 | 18,699 | ||||||||
Loss from Operations | (4,752) | (5,518) | (15,569) | (18,624) | ||||||||
Decrease in Fair Value of Warrant Liability | 109 | - | 106 | - | ||||||||
Other, net | (26) | 29 | 21 | 8 | ||||||||
Net Loss | (4,669) | (5,489) | (15,442) | (18,616) | ||||||||
Preferred Stock Dividends | 160 | - | 480 | - | ||||||||
Net Loss Applicable to Common Stockholders | $ | (4,829) | $ | (5,489) | $ | (15,922) | $ | (18,616) | ||||
Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders |
$ | (0.17) | $ | (0.20) | $ | (0.58) | $ | (0.67) | ||||
Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders |
27,640 | 27,632 | 27,639 | 27,618 | ||||||||
Idera Pharmaceuticals, Inc. | ||||||
Condensed Balance Sheet Data | ||||||
(In thousands) | ||||||
September 30, | December 31, | |||||
2012 | 2011 | |||||
(Unaudited) | ||||||
Cash and Cash Equivalents | $ | 8,352 | $ | 24,571 | ||
Other Assets | 723 | 1,024 | ||||
Total Assets | $ | 9,075 | $ | 25,595 | ||
Total Liabilities | $ | 5,419 | $ | 7,650 | ||
Redeemable Preferred Stock | 5,921 | 5,921 | ||||
Stockholders' (Deficit) Equity | (2,265) | 12,024 | ||||
Total Liabilities, Redeemable Preferred | ||||||
Stock & Stockholders' Equity | $ | 9,075 | $ | 25,595 | ||
Source:
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com