Idera Pharmaceuticals (AMEX: IDP) today announced financial results
for the quarter ended March 31, 2007 and provided an outline of its
expanded oncology clinical trials program for its lead candidate,
IMO-2055. �Idera completed the first quarter in a stronger
financial position to expand its Toll-like receptor (TLR) targeted
drug discovery and development programs,� stated Sudhir Agrawal,
D.Phil., Chief Executive and Chief Scientific Officer of Idera. �As
part of our oncology clinical development strategy, we plan to
initiate additional studies with IMO-2055 in combination with
approved, targeted anti-cancer agents. We have developed this
strategy in consultation with members of our Oncology Clinical
Advisory Board. In addition, we recently submitted an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) for our second lead product candidate,
IMO-2125, and plan to commence a Phase 1 trial of IMO-2125 in
patients with hepatitis C in the second half of 2007.� Robert W.
Karr, M.D., President of Idera, commented, �Combinations of drugs
with different mechanisms of action have often shown promise in the
treatment of cancer. Our preclinical studies demonstrate increased
anti-tumor activity when IMO-2055 is combined with approved
targeted agents such as Avastin�, Erbitux� and Tarceva� compared to
the activity of any of these agents alone. We intend to expand our
oncology clinical development program based on these encouraging
data and consistent with our strategy for a combination therapy
approach. The recent addition of Dr. Alice Bexon as Vice President
of Clinical Development increases our internal human resources to
execute our clinical development strategies.� Update on Clinical
Programs Oncology program: IMO-2055 -- Idera intends to initiate
clinical trials to investigate IMO-2055 in combination with
Tarceva(R), and in triple combination with Tarceva(R) and
Avastin(R), in patients with non-small cell lung cancer as
second-line therapy. The Company expects to initiate a Phase 1b
trial to assess the safety of the combinations in the third quarter
of this year and, subject to an analysis of the results of the
Phase 1b trial, to conduct a four-arm, randomized,
placebo-controlled Phase 2 trial of the combinations. The Company
is currently discussing the protocols for both trials with the FDA.
-- Idera also plans to initiate clinical trials to investigate
IMO-2055 in combination with Erbitux(R) and Camptosar(R) in
patients with colorectal cancer as second-line therapy. The Company
expects to initiate a Phase 1b trial to assess the safety of this
combination in the fourth quarter of this year and, subject to an
analysis of the results of the Phase 1b trial, to conduct a
randomized, placebo-controlled Phase 2 trial of the combination. --
Idera is currently conducting a Phase 1/2 clinical trial of
IMO-2055 in combination with the chemotherapy agents Gemzar(R) and
carboplatin in patients with refractory solid tumors. The Company
expects to complete Phase 1 enrollment of this trial in the second
quarter and report the initial results at an appropriate scientific
meeting by the end of 2007. -- In Idera's on-going Phase 2, Stage
A, clinical evaluation of IMO-2055 monotherapy in patients with
renal cell carcinoma (RCC), the Company has completed enrollment of
the planned 46 treatment-naive patients and has enrolled 44 of the
intended 46 second-line patients. Idera plans to close enrollment
of this trial on June 29, 2007 if the remaining 2 patients are not
recruited by that time. When final data are available, the Company
will report the results at an appropriate scientific meeting and
decide on the next steps for evaluation of IMO-2055 in RCC.
Hepatitis C program: IMO-2125 -- Idera recently submitted an IND to
the FDA for IMO-2125, a second TLR9 agonist. The Company expects to
initiate a Phase 1 trial of IMO-2125 in patients with hepatitis C
during the second half of 2007. -- Idera has established a
Hepatitis C Clinical Advisory Board which has been advising the
Company on the development of IMO-2125 for hepatitis C. Members of
the board are experienced hepatitis C clinical investigators and
include: -- John McHutchison, M.D., Chairman Dr. McHutchison is
Professor of Medicine at Duke University Medical Center and
Associate Director of GI/Hepatology Research at Duke Clinical
Research Institute, Duke University School of Medicine in Durham,
NC. -- Michael P. Manns, M.D. Dr. Mann is Professor and Chairman at
the Department of Gastroenterology, Hepatology and Endocrinology at
Hannover Medical School in Hannover, Germany. -- Stefan Zeuzem,
M.D. Dr. Zeuzem is Professor of Medicine and Chief of the
Department of Medicine at J. W. Goethe University Hospital in
Frankfurt, Germany. -- Nezam Afdhal, M.D. Dr. Afdhal is Associate
Professor of Medicine at Harvard Medical School and Chief of
Hepatology and Director of the Liver Center at Beth Israel
Deaconess Medical Center in Boston, MA. First Quarter Results The
Company reported a net loss of $2.5 million, or $0.12 per share for
the three months ended March 31, 2007, compared to a net loss of
$3.7 million, or $0.26 per share for the same period in 2006. Total
revenues for the three months ended March 31, 2007 were $1.8
million, compared to $0.6 million for the same period in 2006. The
increase in revenue is primarily due to license fees recognized
under the Company�s collaboration agreement with Merck & Co.,
Inc. (Merck) signed in December 2006. Research and Development
expenses for the three months ended March 31, 2007 totaled $2.8
million, compared to $3.0 million for the same period in 2006. The
decrease in R&D expense is primarily due to decreased clinical
costs in the 2006 period associated with the Phase 2 trial of
IMO-2055 in RCC. General and Administrative expenses for the three
months ended March 31, 2007 were $2.0 million, compared to $1.3
million for the same period in 2006. The increase in G&A is
primarily attributable to increased professional fees associated
with market analysis of therapeutic areas and legal services. The
increase also reflects higher payroll expenses associated with the
addition of employees and higher compensation expense related to
employee and consultant stock options. Cash, cash equivalents and
short-term investments on March 31, 2007 totaled approximately
$33.5 million, compared to $38.2 million at December 31, 2006.
Recent Accomplishments 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. In March 2007, Novartis extended the research program
under the Company�s existing collaboration agreement with Novartis
for an additional year until May 2008. In connection with this
extension, Novartis made a $1 million milestone payment to Idera in
May 2007. The collaboration between Idera and Novartis involves the
discovery, development, and commercialization of TLR9 agonists for
the treatment of asthma and allergy indications. In February 2007,
the Company presented preclinical data on novel DNA-based TLR
antagonists at a Keystone Symposium. In murine models of lupus, TLR
antagonist-treated mice showed improvement in several disease
parameters. In February 2007, the Company announced the appointment
of Dr. Alice Bexon as Vice President of Clinical Development. In
February 2007, the Company converted its 4% Convertible
Subordinated notes due 2008 in the aggregate principal amount of
$5,032,750 into shares of the Company�s common stock. In February
2007, the United States Patent and Trademark Office issued the
Company US patent 7,176,296 claiming compounds comprising a
synthetic immunostimulatory motif and an immunomodulatory moiety.
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 infectious diseases. 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 May 14, 2007, which
important factors are incorporated herein by reference. Idera
disclaims any intention or obligation to update any forward-looking
statements. Avastin� is a registered trademark of Genentech, Inc.
Erbitux� is a registered trademark of ImClone Systems Incorporated.
Tarceva� is a registered trademark of OSI Pharmaceuticals, Inc.
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 March 31, � 2007� � 2006� Revenues $ 1,829� $ 636� Operating
Expenses Research & Development 2,819� 2,985� General &
Administrative � 1,953� � 1,268� Total Operating Expenses � 4,772�
� 4,253� Loss from Operations (2,943) (3,617) Other, net � 415� �
(33) Net Loss $ (2,528) $ (3,650) Basic and Diluted Net Loss Per
Common Share $ (0.12) $ (0.26) � Shares Used In Computing Basic and
Diluted Net Loss Per Common Share � 20,787� � 14,154� Idera
Pharmaceuticals, Inc. Balance Sheet Data (In thousands) � March 31,
December 31, � 2007� � 2006� (unaudited) � Cash, Cash Equivalents
And Investments $ 33,508� $ 38,187� Receivables & Other Assets
� 4,090� � 2,354� Total Assets $ 37,598� $ 40,541� � Accounts
Payable and Accrued Liabilities $ 1,940� $ 2,029� Deferred Revenue
20,549� 21,242� Notes Payable -� 5,033� Total Stockholders' Equity
� 15,109� � 12,237� � Total Liabilities & Stockholders' Equity
$ 37,598� $ 40,541�
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