Idera Pharmaceuticals (AMEX: IDP) today reported financial results
for the three and six months ended June 30, 2007. �Our financial
results for the second quarter reflect continued execution of our
business strategy to advance our development programs with our lead
candidates, IMO-2055 and IMO-2125, to evaluate novel Toll-Like
Receptor (TLR) antagonists and TLR7, 8 and 9 agonists in
preclinical models, and to support our collaborations with Novartis
and Merck & Co., Inc.,� said Sudhir Agrawal, D. Phil., Chief
Executive Officer and Chief Scientific Officer of Idera. Update on
Clinical Programs Oncology program: IMO-2055 Idera intends to
initiate clinical trials to investigate IMO-2055 in combination
with Tarceva�, and in triple combination with Tarceva� and
Avastin�, in patients with non-small cell lung cancer as
second-line therapy. The Company is preparing to initiate a phase
1b trial in the third quarter of this year to assess the safety of
the combinations with multiple doses of IMO-2055. The Company plans
to conduct a four-arm, randomized, placebo controlled phase 2 trial
of the combinations following analysis of the results of the phase
1b trial. The Company also plans to initiate clinical trials to
investigate IMO-2055 in combination with Erbitux� and Camptosar� in
patients with colorectal cancer as second-line therapy. The Company
expects to initiate a phase 1b trial in the fourth quarter of this
year to assess the safety of this combination with multiple doses
of IMO-2055. The Company plans to conduct a randomized, placebo
controlled phase 2 trial of the combination following analysis of
the results of the phase 1b trial. In Idera�s phase 2, Stage A,
clinical evaluation of IMO-2055 monotherapy in patients with renal
cell carcinoma (RCC), the Company completed enrollment of the
planned 46 treatment-na�ve patients and enrolled 45 of the intended
46 second-line patients before closing enrollment of patients on
June 29, 2007. The Company expects that when final data are
available, it will report the results at an appropriate scientific
meeting and decide on the next steps for evaluation of IMO-2055 in
RCC. In Idera�s phase 1/2 clinical trial with IMO-2055 in
combination with the chemotherapy agents Gemzar� and carboplatin in
patients with refractory solid tumors, the Company enrolled 22
patients before closing enrollment. In the trial, the Company is
investigating three doses and three treatment schedules of
IMO-2055. The Company expects to report initial results from this
trial at an appropriate scientific meeting by the end of 2007.
Hepatitis C program: IMO-2125 In May 2007, Idera submitted an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) for IMO-2125, the second lead candidate
discovered by the Company. Idera received a �safe to proceed�
acknowledgement from the FDA and expects to initiate a phase 1
trial of IMO-2125 in patients with hepatitis C virus infection
during the third quarter of 2007. Second Quarter and Six Month 2007
Results The Company reported a net loss of $3.0 million or $0.14
per share for the three months ended June 30, 2007, compared to a
net loss of $4.3 million, or $0.26 per share for the same period in
2006. For the six-month period, the Company�s net loss was $5.5
million or $0.26 per share compared to a net loss of $8.0 million,
or $0.52 per share for the same period in 2006. Total revenues for
the three months ended June 30, 2007 were $1.9 million compared to
$0.6 million for the same period in 2006. For the six-month period,
revenues totaled $3.8 million compared to $1.3 million for the same
period in 2006. The increase in revenue in both periods is
primarily due to license fees recognized under the Company�s
collaboration agreement with Merck & Co., Inc. signed in
December 2006, offset, in part, by lower license fees recognized
under our collaboration agreement with Novartis. Research and
Development expenses for the three months ended June 30, 2007
totaled $3.0 million compared to $3.7 million for the same period
in 2006. For the six-month period, R&D expenses totaled $5.8
million compared to $6.7 million for the same period in 2006. The
decrease in R&D expense in both periods is primarily due to the
completion in 2006 of IND-enabling safety studies of IMO-2125, a
decrease in manufacturing costs of IMO-2125 in the 2007 periods and
a decrease of clinical and non-clinical costs associated with
IMO-2055, which decreases were offset, in part, by start-up costs
related to the clinical trials of IMO-2125, higher payroll costs
associated with the hiring of additional employees, and increased
stock-based compensation. General and Administrative expenses for
the three months ended June 30, 2007 were $2.4 million compared to
$1.3 million for the same period in 2006. For the six-month period,
G&A expenses totaled $4.3 million compared to $2.6 million for
the same period in 2006. The increase in G&A in both periods
reflect increased payroll expenses associated with a higher number
of non-research employees, higher compensation expense related to
employee and consultant stock options, Sarbanes-Oxley compliance
expenses, and costs accrued in anticipation of payments to be made
to the Company�s Chief Financial Officer under the transition
agreement entered into in May 2007. Cash, cash equivalents and
short-term investments on June 30, 2007 totaled approximately $32.0
million compared to $38.2 million at December 31, 2006. The
decrease reflects the $6.6 million cash used in operations during
the six months ended June 30, 2007 and $1.2 million of equipment
purchases which were partially offset by $1.3 million in net
proceeds from the sale of a note. Recent Accomplishments In July
2007, a paper was published describing preclinical data in which
Idera�s TLR9 agonist in combination with bevacizumab, the
anti-vascular endothelial growth factor (VEGF) monoclonal antibody
marketed as Avastin, resulted in co-operative anti-tumor activity
in animal models of colon cancer. The paper entitled �Novel TLR9
agonist synergizes by different mechanisms with bevacizumab in
sensitive and cetuximab-resistant colon cancer xenografts� was
published in the Proceedings of National Academy of Sciences U.S.A.
(Vol. 104: 12468-12473, 2007). In July 2007, a presentation was
made during the FASEB Summer Research Conference on Autoimmunity.
Preclinical data using Idera�s proprietary antagonists of TLRs 7
and 9 in mouse models of collagen-induced arthritis, a commonly
used model for rheumatoid arthritis, suggest that antagonists of
these TLRs may have a potential role in blocking Th1-type immune
responses, thereby inhibiting the progression of diseases such as
rheumatoid arthritis. In April 2007, two preclinical presentations
were made at the Annual Meeting of the American Association for
Cancer Research. The first presentation was made by a third party
contractor of the Company reporting on a preclinical study it
conducted in which Idera�s IMO-2055 in combination with Nexavar�, a
drug approved for RCC, showed enhanced antitumor activity compared
to either agent alone in a mouse xenograft model. The second
presentation was made by Idera reporting on a preclinical study it
conducted in which an analog of IMO-2055 optimized for mice was
administered by the intranasal route and showed potent antitumor
activity in mouse models of lung metastases of colon carcinoma and
melanoma. About Idera Pharmaceuticals, Inc. Idera Pharmaceuticals
is a drug discovery and development company that is developing drug
candidates to treat cancer and infectious, respiratory, and
autoimmune diseases, and for use as vaccine adjuvants. Idera�s
proprietary drug candidates are designed to modulate TLRs, the
body�s first line of immune defense. Idera�s pioneering DNA
chemistry expertise enables it to identify drug candidates for
internal development and creates opportunities for multiple
collaborative alliances. Idera�s most advanced clinical candidate,
IMO-2055, is an agonist of TLR9 and is currently in a Phase 2 trial
in oncology and in a Phase 1/2 chemotherapy combination trial in
oncology. Idera has selected a second TLR9 agonist, IMO-2125, as a
lead candidate for treating hepatitis C virus infection. Idera is
collaborating with Novartis International Pharmaceutical, Ltd. for
the discovery, development, and commercialization of TLR9 agonists
for the treatment of asthma and allergy indications. Idera is also
collaborating with Merck & Co., Inc. for the use of Idera�s
TLR7, 8 and 9 agonists in combination with Merck�s therapeutic and
prophylactic vaccines in the areas of oncology, infectious
diseases, and Alzheimer�s disease. For more information, visit
www.iderapharma.com. 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 the Company will complete enrollment
of clinical trials or announce trial results in the time expected;
whether, if the Company�s products receive approval, they will be
successfully distributed and marketed; whether the results of
preclinical studies will be indicative of results that may be
obtained in clinical trials; whether the Company�s collaborations
with Novartis and Merck will be successful; whether the patents and
patent applications owned or licensed by Idera will protect the
Company�s technology and prevent others from infringing it; whether
Idera�s cash resources will be sufficient to fund product
development and clinical trials; and such other important factors
as are set forth under the caption "Risk Factors" in Idera�s
Quarterly Report on Form 10-Q filed on July 31, 2007, 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. Gemzar is a registered trademark of Eli Lilly and Company.
Nexavar is a registered trademark of Bayer Pharmaceuticals
Corporation. Idera Pharmaceuticals, Inc. Condensed Statements of
Operations (Unaudited) (In thousands, except per share data) �
Three Months Ended June 30, � Six Months Ended June 30, � 2007 �
2006 � 2007 � 2006 Revenues $ 1,949 $ 622 $ 3,778 $ 1,258 Operating
Expenses Research & Development 2,990 3,665 5,809 6,651 General
& Administrative � 2,383 � � 1,312 � � 4,336 � � 2,579 Total
Operating Expenses � 5,373 � � 4,977 � � 10,145 � � 9,230 Loss from
Operations (3,424) (4,355) (6,367) (7,972) Other, net � 416 � � 28
� � 832 � � (5) Net Loss $ (3,008) � $ (4,327) � $ (5,535) � $
(7,977) Basic and Diluted Net Loss Per Share $ (0.14) � $ (0.26) �
$ (0.26) � $ (0.52) � Shares Used In Computing Basic and Diluted
Net Loss Per Share � 21,254 � � 16,718 � � 21,023 � � 15,443 Idera
Pharmaceuticals, Inc. Balance Sheet Data (Unaudited) (In thousands)
� June 30, December 31, 2007 2006 Cash, Cash Equivalents And
Investments $ 32,016 $ 38,187 Receivables & Other Assets �
3,878 � � 2,354 Total Assets $ 35,894 � $ 40,541 � Accounts Payable
and Accrued Liabilities $ 3,006 $ 2,029 Deferred Revenue 18,892
21,242 Notes Payable 1,278 5,033 Total Stockholders' Equity �
12,718 � � 12,237 Total Liabilities & Stockholders' Equity $
35,894 � $ 40,541
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