Idera Pharmaceuticals Reports 2008 Fourth Quarter and Full Year Financial Results
“Together with our collaborators, we currently have three novel
Toll-like Receptor-targeted drug candidates undergoing clinical
evaluation in multiple indications, and we expect to submit an IND for a
fourth compound, IMO-3100, by the end of 2009,” said
“2008 was a strong year for us financially. We ended the year with
approximately
Financial Results
As of
Fourth Quarter Results
Net income for the three months ended
Total revenues for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Full Year Results
Net income for the year ended
Total revenues for the year ended
Research and development expenses for the year ended
General and administrative expenses for the year ended
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
IMO-2055 in combination with Tarceva® and
Avastin®: In
IMO-2055 in combination with Erbitux® and
Camptosar®: In
IMO-2055 monotherapy: In
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.
IMO-2125 monotherapy: The Company is conducting a Phase 1 clinical trial of IMO-2125 in patients with chronic HCV infection who have not responded to current standard of care therapy. Four dose levels of IMO-2125 are being investigated. At present, patients are being recruited into the third dose level of the trial. The Company expects interim results from this trial to be available late in 2009.
IMO-2125 in combination with ribavirin: The Company plans to conduct a clinical trial to assess the safety of IMO-2125 in combination with ribavirin in treatment-naïve patients with chronic HCV infection. This clinical trial also will be designed to evaluate the effects of IMO-2125 and ribavirin combination treatment on HCV RNA levels and on parameters of immune system activation.
QAX935 (IMO-2134)
QAX935 (IMO-2134) is a novel TLR9 agonist exclusively licensed by the
Company to
IMO-3100
IMO-3100 is a dual TLR7 and TLR9 antagonist and 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
TLR7, 8 and 9 agonists as vaccine adjuvants
In December 2006, the Company and
TLR7 and TLR8 agonists
The Company has designed and created RNA-based compounds that act as agonists of TLR7 and/or TLR8. In preclinical studies, these TLR7 and/or TLR8 agonists induced immune responses that the Company believes may be applicable to the treatment of cancer and infectious diseases.
Scientific Highlights
Academic Collaborations
In addition to on-going discoveries in the Company’s laboratories, the Company is collaborating with several leading investigators at academic institutions to advance studies with its TLR-targeted compounds.
Principal investigators of these collaborations are affiliated with
During 2008 and to date in 2009, Company scientists and collaborators have published and presented on studies of TLR-targeted compounds:
-
Two presentations were made on preclinical data of novel TLR7, 8 and 9
agonists at the 2008 Annual Meeting of the
American Association for Cancer Research (AACR) held inSan Diego, CA. -
A presentation was made on preclinical data on a cancer vaccine using
a TLR9 agonist as an adjuvant at the 2008 Annual Meeting of AACR by
scientists from
Merck & Co. Inc. -
A presentation was made on preclinical data from studies evaluating a
TLR antagonist in a mouse model of multiple sclerosis at the 60th
Annual Meeting of the
American Academy of Neurology held inChicago, IL. -
A presentation on preclinical data entitled “Effects of a novel
synthetic TLR9 agonist on repeated allergen challenge in allergic
monkeys” at the TOLL2008 meeting held in Cascais,
Portugal , by scientists fromNovartis . -
Two presentations were made on preclinical data from studies
evaluating novel TLR antagonist candidates in mouse models of lung
inflammation and psoriasis at the
Federation of Clinical Immunology Societies 2008 Annual Meeting held inBoston, MA. -
A presentation was made on the chemistry of immunomodulatory
oligonucleotides at the 4th Annual Meeting of
Oligonucleotide Therapeutic Society (OTS ) held at theHarvard Medical School Conference Center inBoston, MA. -
Multiple presentations were made on preclinical data from studies on
novel TLR agonists and antagonists at the 4th Annual Meeting of
OTS . -
A paper entitled “Oligodeoxyribonucleotide-Based Antagonists for
Toll-Like Receptors 7 and 9” authored by Company scientists was
published in the
Journal of Medicinal Chemistry (2009, 52, 551–558). -
A paper entitled “Treatment of Mammary Carcinomas in HER-2 Transgenic
Mice through Combination of Genetic Vaccine and an Agonist of
Toll-like Receptor 9” co-authored by scientists from
Merck & Co. Inc. and Idera was published inClinical Cancer Research (2009, 15, 1575-84).
Intellectual Property
In 2008, the Company’s U.S. and foreign patents and patent applications covering novel TLR-targeted compounds increased by over 40 and now total over 250. The following patents were issued to the Company in 2008:
- US 7,354,907, entitled “Short Immunomodulatory Oligonucleotides”
- US 7,329,648, entitled “Modulation of Oligonucleotide CpG-mediated Immune Stimulation by Positional Modification of Nucleosides”
- EP 1322656, entitled “Modulation of Immunostimulatory Activity of Immunostimulatory Oligonucleotide Analogs by Positional Chemical Changes”
- EP 1252307, entitled “Modulation of Oligonucleotide CpG-mediated Immune Stimulation by Positional Modification of Nucleosides”
- AU 2005218065, entitled “Modulation of Oligonucleotide CpG-mediated Immune Stimulation by Positional Modification of Nucleosides”
- US 7,427,405, entitled “Immunostimulatory Oligonucleotide Multimers”
-
US 7,407,944, entitled “Modulation of
Immunostimulatory Properties of Oligonucleotide-Based Compounds by Optimal Presentation of 5’ Ends” - US 7,405,285, entitled “Immunostimulatory Oligonucleotide Multimers”
- AU 2006203435, entitled “Modulation of Immunostimulatory Activity of Immunostimulatory Oligonucleotide Analogs by Positional Chemical Changes”
- US 7,470,674, entitled “Immunostimulatory Properties of Oligonucleotide-based Compounds Comprising Modified Immunostimulatory Dinucleotides”
Additionally, in 2008 and early 2009, the Company was recognized three
times by the Patent Board™ as one of the top 35 companies in the
biotechnology field based on its technology and intellectual property
advances. The Patent Board™ is an independent group that tracks and
analyzes intellectual property and technology assets across 17
industries globally and publishes its results in the
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Erbitux is a registered trademark of
Idera Pharmaceuticals, Inc. Consolidated Condensed Statements of Operations (In thousands, except per share data) |
||||||||
Three Months Ended | Years Ended | |||||||
December 31, | December 31, | |||||||
2008 | 2007 | 2008 | 2007 | |||||
(unaudited) | (unaudited) | |||||||
Revenues | $6,241 | $2,233 | $26,376 | $7,981 | ||||
Operating Expenses | ||||||||
Research & Development | 4,286 | 3,907 | 16,152 | 13,195 | ||||
General & Administrative | 1,772 | 3,144 | 9,724 | 9,513 | ||||
Total Operating Expenses | 6,058 | 7,051 | 25,876 | 22,708 | ||||
Income (Loss) from Operations | 183 | (4,818) | 500 | (14,727) | ||||
Other, net | 157 | 312 | 985 | 1,519 | ||||
Income (Loss) Before Income Taxes | 340 | (4,506) | 1,485 | (13,208) | ||||
Income Tax Benefit | 24 | — | 24 | — | ||||
Net Income (Loss) | $364 | $(4,506) | $1,509 | $(13,208) | ||||
Basic Net Income (Loss) Per Common Share | $0.02 | $(0.21) | $0.07 | $(0.62) | ||||
Diluted Net Income (Loss) Per Common Share | $0.01 | $(0.21) | $0.06 | $(0.62) | ||||
Shares Used In Computing Basic Income (Loss) Per Common Share | 23,331 | 21,485 | 22,655 | 21,221 | ||||
Shares Used in Computing Diluted Income (Loss) Per Common Share | 24,822 | 21,485 | 25,331 | 21,221 |
Idera Pharmaceuticals, Inc. Consolidated Condensed Balance Sheet Data (In thousands) |
||||
At December 31, | ||||
2008 | 2007 | |||
Cash, Cash Equivalents | ||||
And Short-term Investments | $ 55,606 | $ 23,743 | ||
Other Assets | 3,794 | 3,971 | ||
Total Assets | $ 59,400 | $ 27,714 | ||
Accounts Payable and Accrued Liabilities | $ 2,773 | $ 3,067 | ||
Notes Payable | 0 | 1,143 | ||
Deferred Revenue | 34,460 | 15,785 | ||
Stockholders' Equity | 22,167 | 7,719 | ||
Total Liabilities & | ||||
Stockholders' Equity | $ 59,400 | $ 27,714 |
Source:
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall
Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com