Idera Pharmaceuticals Reports Third Quarter 2009 Financial Results and Provides Pipeline Update
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CAMBRIDGE, Mass.--(Business Wire)--
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today reported financial results for
the third quarter and nine months ended September 30, 2009.
"We have continued development of our pipeline of drug candidates targeted to
Toll-like receptors for potential applications in chronic hepatitis C virus
infection and autoimmune diseases, and to support our partnered programs in
oncology, respiratory disease, and vaccine adjuvants," said Sudhir Agrawal, D.
Phil., President, Chief Executive Officer and Chief Scientific Officer. "We are
pleased to have presented clinical data of IMO-2055 in renal cell cancer and in
non-small cell lung cancer. We look forward to presenting data from our ongoing
clinical trials of IMO-2125 in HCV patients."
"With $46.1 million in cash, cash equivalents and investments at the end of the
third quarter 2009, we are in a strong financial position to continue advancing
our clinical and preclinical programs. Due to the receipt of milestone and other
payments from our partnered programs, our cash, cash equivalents and investments
have decreased by only $9.5 million for the nine months ended September 30,
2009," added Lou Arcudi, Chief Financial Officer.
Third Quarter and Nine-Month 2009 Results
The Company reported net income of $24,000 for the three months ended September
30, 2009, compared to a net income of $2.0 million, or $0.08 per diluted share,
for the same period in 2008. For the nine-month period, the Company`s net income
was $3.6 million, or $0.15 per diluted share, compared to a net income of $1.1
million, or $0.04 per diluted share, for the same period in 2008.
Total revenues for the three months ended September 30, 2009 were $6.5 million
compared to $7.5 million for the same period in 2008. For the nine-month period,
revenues totaled $24.3 million compared to $20.2 million for the same period in
2008.
Research and development expenses for the three months ended September 30, 2009
totaled $4.3 million compared to $3.6 million for the same period in 2008. For
the nine-month period, R&D expenses totaled $14.2 million compared to $11.9
million for the same period in 2008.
General and administrative expenses for the three months ended September 30,
2009 were $2.2 million compared to $2.3 million for the same period in 2008. For
the nine-month period, G&A expenses totaled $6.5 million compared to $8.0
million for the same period in 2008.
As of September 30, 2009, cash, cash equivalents and investments totaled $46.1
million compared to $55.6 million at December 31, 2008.
Clinical and Preclinical Programs
IMO-2055, a TLR9 agonist, in Cancer Treatment (collaboration with Merck KGaA)
* Phase 2 Clinical Trial of IMO-2055 in Renal Cell Carcinoma (RCC)
In September 2009, the Company presented final data from a clinical trial
evaluating IMO-2055 as monotherapy in an open-label phase 2 clinical trial.
Treatment-naïve and second-line patients with RCC were randomly assigned to
receive IMO-2055 subcutaneously at 0.16 mg/kg/week or 0.64 mg/kg/week.
Eighty-nine patients were evaluable for efficacy (intent-to-treat population).
Based on the final data analysis:
* Progression-free survival (PFS) medians for treatment-naïve patients were 4.5
months at 0.16 mg/kg/week and 1.9 months at 0.64 mg/kg/week.
* PFS medians for second-line patients were 3.4 months at 0.16 mg/kg/week and
4.3 months at 0.64 mg/kg/week.
* Median overall survival was 23.5 months overall, although medians were not
estimable in 2 of the 4 treatment groups.
* 7 patients received weekly IMO-2055 treatment for at least 1 year.
* 2 patients (1 second-line and 1 treatment-naïve), each receiving 0.64
mg/kg/week, had confirmed partial responses.
* 52 patients (58%) across all groups had stable disease.
* IMO-2055 treatment was generally well-tolerated: neither dosage was associated
with any dose-limiting toxicity, although the relative dose intensity was higher
with the 0.16 mg/kg dosage.
* The most common treatment-related adverse events (any grade across groups)
were fatigue (51%), nausea (46%), chills (45%), headache (37%), and pyrexia
(33%), consistent with IMO-2055-related immune stimulation.
* Phase 1b Clinical Trial of IMO-2055 in Combination with Tarceva® and Avastin®
in Non-small Cell Lung Cancer (NSCLC)
In September 2009, the Company presented interim data from a phase 1b, single
arm clinical trial evaluating IMO-2055 in combination with Tarceva and Avastin
in patients with NSCLC. Interim data presented show:
* IMO-2055 was tolerated at dosages up to 0.48 mg/kg/week in combination with
Tarceva plus Avastin.
* The most common possibly-related adverse events were injection site reactions,
fatigue and fever.
* Six grade 3 adverse events were reported: injection site reactions (2),
diarrhea (2), fatigue (1) and low potassium (1).
* 8 of 16 patients remained on treatment at least 18 weeks.
* Of the 13 evaluable patients, 3 had a partial response and 8 experienced
stable disease.
Recruitment of additional patients is continuing at the anticipated recommended
phase 2 dose level for IMO-2055 in this combination.
* Phase 1b Clinical Trial of IMO-2055 in Combination with Erbitux® and
Camptosar® in Colorectal Cancer
Patient recruitment is ongoing with three escalating dose levels of IMO-2055
being investigated in combination with standard dose regimens of Erbitux and
Camptosar to evaluate the safety of the combination.
In September 2009, Merck KGaA assumed sponsorship of the ongoing Phase 1b
clinical trials of IMO-2055 in non-small cell lung cancer and in colorectal
cancer, and responsibility for conducting all future clinical trials of IMO-2055
for the treatment of cancer, excluding use in vaccines.
IMO-2125, a TLR9 agonist, in Chronic Hepatitis C Virus (HCV) Infection
* Phase 1 Clinical Trial with IMO-2125 Monotherapy in Chronic HCV Infection in
Patients Non-responsive to Standard of Care Therapy
The Company expects to complete patient enrollment in the fourth cohort of this
trial by the end of 2009 and to announce interim data during the first quarter
of 2010.
* Phase 1 Clinical Trial with IMO-2125 in Combination with Ribavirin in
Treatment-naïve Patients with Chronic HCV Infection
In October 2009, the Company announced initiation of a Phase 1 clinical trial to
assess the safety of IMO-2125 in combination with ribavirin in treatment-naïve
patients with chronic HCV infection. The Company plans to enroll approximately
45 patients in three cohorts at escalating IMO-2125 dose levels, with four weeks
of treatment. Of the 15 patients per cohort, 12 will be randomized to receive
weekly IMO-2125 by subcutaneous administration and daily oral ribavirin, and
three will be randomized to receive placebo and daily oral ribavirin. This
clinical trial also is designed to evaluate the effects of IMO-2125 and
ribavirin combination treatment on HCV RNA levels and on parameters of immune
system activation. The Company is currently considering modifications to the
trial design based on regulatory discussions. The Company intends to conduct the
trial at five or more sites in France and Russia.
QAX935 (IMO-2134), a TLR9 agonist, in Asthma and Allergy (collaboration with
Novartis)
* Phase 1 Clinical Trial with QAX935
In September 2008, Novartis initiated a Phase 1 clinical trial of QAX935.
IMO-3100, a dual antagonist of TLR7 and TLR9, in Autoimmune and Inflammatory
Diseases
* Investigational New Drug (IND)-Enabling Preclinical Development Studies of
IMO-3100
The Company is currently conducting IND-enabling preclinical development studies
to support the clinical evaluation of IMO-3100 in autoimmune and inflammatory
diseases. The Company anticipates submitting an IND application to the U.S. Food
and Drug Administration by the end of 2009.
In October 2009, the Company presented preclinical data from studies of IMO-3100
in combination with Enbrel® (etanercept), an inhibitor of TNF-alpha, in a mouse
model of arthritis. Mice treated with a combination of IMO-3100 and Enbrel had
lower arthritic scores, less inflammation, and less bone pathology as compared
to mice treated with either agent alone. The data also showed that the activity
of a low Enbrel dosage was markedly enhanced when combined with IMO-3100 in this
mouse model.
TLR7, 8 and 9 agonists as vaccine adjuvants (collaboration with Merck & Co.,
Inc.)
* The Company is collaborating with Merck & Co. under an agreement to research,
develop, and commercialize vaccine products containing the Company`s TLRs 7, 8,
and 9 agonists in the fields of oncology, infectious diseases, and Alzheimer`s
disease.
TLR7 and TLR8 agonists
* The Company is studying its novel TLR7 and/or TLR8 agonists for potential
applications in oncology and infectious diseases.
TLR Antisense
* The Company has identified antisense candidates targeted to human TLRs 2, 3,
4, 5, 6, 7, 8, and 9 and to the TLR-associated signaling protein MyD88. The
Company is studying these candidates for potential applications in autoimmune
and inflammatory diseases.
Scientific Highlights
The Company and its collaborators recently have presented and published on the
following studies:
Data Presentations
* Abstract P-9148 "Phase 1 study of the toll-like receptor 9 (TLR9) agonist,
IMO-2055, combined with erlotinib (E) and bevacizumab (B) in patients (pts) with
advanced or metastatic non-small cell lung cancer (NSCLC)" at the joint 15th
Congress of the European CanCer Organisation and 34th Congress of the European
Society for Medical Oncology held in September 2009. The presentation was made
by David Smith, M.D., of US Oncology in Vancouver, WA.
* Abstract O-1000 "A novel drug Toll-like receptor 9 (TLR9) agonist synergizes
with trastuzumab in different trastuzumab-resistant breast tumours via multiple
mechanisms of action" at the joint 15th Congress of the European CanCer
Organisation and 34th Congress of the European Society for Medical Oncology held
in September 2009. The presentation was made by Giampaolo Tortora, M.D., of
Università di Napoli Federico II in Naples, Italy.
* Abstract 9.148 "A phase 2 multicenter, randomized, open-label study of two
dose levels of IMO-2055 in patients with metastatic or recurrent renal cell
carcinoma" at the Eighth International Kidney Cancer Symposium held in Chicago,
September 2009. The presentation was made by Timothy Kuzel, M.D., of
Northwestern University`s Feinberg School of Medicine in Chicago, IL.
* Abstract 659 entitled "Studies of Combination of IMO-3100, An Antagonist of
TLR7 and TLR9, and Etanercept, a TNF-alpha Inhibitor, in a Mouse Model of
Collagen-Induced Arthritis (CIA)" at the 2009 Annual Scientific Meeting of the
American College of Rheumatology and Association of Rheumatology Health
Professionals in October, 2009.
* Abstract 1593: "IMO-2125, a TLR9 agonist, induces Th-1 type cytokines and
interferons with potent anti-HCV activity in human peripheral blood mononuclear
cells (PBMCs) and plasmacytoid dendritic cells (pDCs)" at the 60th Annual
Meeting of the American Association for the Study of Liver Diseases in November
2009.
* Abstract 1597: "Gene expression profiles induced by IMO-2125, an agonist of
Toll-like receptor 9, in human peripheral blood mononuclear cells" at the 60th
Annual Meeting of the American Association for the Study of Liver Diseases in
November 2009.
Publications
* A paper entitled "Modifications incorporated in CpG motifs of
oligodeoxynucleotides lead to antagonist activity of Toll-like receptors 7 and
9" was published in Journal of Medicinal Chemistry 2009, 52, 5108-14.
* A paper entitled "Coadministration of telomerase genetic vaccine and a novel
TLR9 agonist in nonhuman primates" was published in Molecular Therapy 2009, 17,
1804-13. The paper was co-authored by scientists from Merck & Co. Inc. and
Idera.
* A paper entitled "Synthetic oligoribonucleotides-containing secondary
structures act as agonists of Toll-like receptors 7 and 8" was published in
Biochemical and Biophysical Research Communications 2009, 386, 443-8.
* A paper entitled "Synthetic oligoribonucleotides containing arabinonucleotides
act as agonists of TLR7 and 8" was published in Bioorganic & Medicinal Chemistry
2009, 19, 2044-7.
Intellectual Property
Idera`s intellectual property portfolio contains over 500 patents and patent
applications worldwide.
Immune Modulatory Oligonucleotides (IMO®)
This portfolio holds over 280 patents and patent applications worldwide covering
Idera`s IMO technologies and includes claims covering novel agonists of
Toll-like Receptors (TLRs) 7, 8 and 9 and antagonists of TLRs 7 and 9. These
patents and patent applications include claims covering IMO-2055, IMO-2125,
IMO-3100, and QAX935. The following patents were recently issued:
* US 7,595,305, entitled "Modulation Of Immunostimulatory Properties Of
Oligonucleotide-Based Compounds By Utilizing Modified Immunostimulatory
Dinucleotides"
* US 7,569,554, entitled "Synergistic Treatment of Cancer Using Immunomers in
Conjunction with Chemotherapeutic Agents"
* US 7,566,702, entitled "Immunostimulatory Oligonucletide Multimers"
In addition to the issued U.S. patents, patents corresponding to the US
7,569,554 patent were granted to the Company in Guatemala, Latvia, Macedonia,
Morocco, New Zealand, and Singapore. The Company was also granted patents
entitled "Synergistic Stimulation of the Immune System Using Immunostimulatory
Oligonucleotides and/ or Immunomer Compounds in Conjunction with Cytokines
and/or Chemotherapeutic Agents or Radiation Therapy" in China (ZL200480026430.5)
and India (228,424).
Antisense Technology
This portfolio holds over 220 patents and patent applications worldwide covering
novel antisense compounds and methods of their use. These patents and patent
applications include claims covering second-generation antisense chemistry, oral
delivery of second-generation antisense compounds, and certain genes, antisense
sequences, and therapeutic targets (including various TLRs and signaling
molecules).
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious diseases,
autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for
use as vaccine adjuvants. Our proprietary drug candidates are designed to
modulate specific Toll-like Receptors, which are a family of immune system
receptors that direct immune system responses. Our pioneering DNA and RNA
chemistry expertise enables us to create drug candidates for internal
development and generates opportunities for multiple collaborative alliances.
For more information, visit 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 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's collaborations with Novartis, Merck & Co. Inc.,
and Merck KGaA 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 three months ended September 30, 2009, which important factors
are incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.
Tarceva is a registered trademark of OSI Pharmaceuticals, Inc. Avastin is a
registered trademark of Genentech, Inc. Erbitux is a registered trademark of
ImClone Systems Incorporated. Camptosar is a registered trademark of Pfizer.
Enbrel is a registered trademark of Amgen and Wyeth Pharmaceuticals.
Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(Unaudited)
(in thousands, except per share data) Three Months Ended Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
Revenue $ 6,538 $ 7,517 $ 24,338 $ 20,196
Operating Expenses:
Research & Development 4,288 3,580 14,177 11,866
General & Administrative 2,210 2,323 6,492 8,013
Total Operating Expenses 6,498 5,903 20,669 19,879
Income from Operations 40 1,614 3,669 317
Other, net 14 366 116 828
Income before Income Taxes 54 1,980 3,785 1,145
Income Tax Provision (30 ) - (170 ) -
Net Income $ 24 $ 1,980 $ 3,615 $ 1,145
Basic Net Income per Share $ 0.00 $ 0.09 $ 0.15 $ 0.05
Diluted Net Income per Share $ 0.00 $ 0.08 $ 0.15 $ 0.04
Shares Used in Computing Basic Net 23,441 23,022 23,409 22,428
Income per Share
Shares Used in Computing Diluted 24,341 25,779 24,188 25,538
Net Income per Share
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
(Unaudited)
(in thousands) September 30, December 31,
2009 2008
Cash, Cash Equivalents
and Investments $ 46,071 $ 55,606
Other Assets 3,890 3,794
Total Assets $ 49,961 $ 59,400
Accounts Payable and Accrued Liabilities $ 3,796 $ 2,773
Deferred Revenue 17,711 34,460
Stockholders' Equity 28,454 22,167
Total Liabilities &
Stockholders' Equity $ 49,961 $ 59,400
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
Copyright Business Wire 2009
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