Idera Pharmaceuticals Inc. (AMEX: IDP), a biopharmaceutical company
focused on developing therapeutics targeting Toll-like Receptors
(TLR), today reported financial results for the quarter and year
ended December 31, 2006. �Idera made very significant advances in
2006 toward building a leading biopharmaceutical company focused on
therapeutics targeting toll-like receptors,� said Sudhir Agrawal,
D. Phil., Chief Executive Officer and Chief Scientific Officer. �In
2006, our discovery team expanded our portfolio of compounds
targeting TLRs, including novel agonists of TLR7 and 8, and
antagonists of TLR7, 8 and 9. Our development team formed an
Oncology Clinical Advisory Board to assist in our oncology strategy
with IMO-2055, and conducted studies with our second TLR9 agonist,
IMO-2125, toward supporting the filing of an Investigational New
Drug application. Our corporate achievements included strengthening
the Company�s intellectual property position and entering into a
collaboration with Merck on vaccines for cancer, infectious
diseases, and Alzheimer�s disease. In 2007, Idera expects to
continue advancing its scientific leadership, drug candidates,
partnered programs, and other business goals.� Fourth Quarter
Results The Company reported a net loss of $4.7 million, or $0.26
per share, for the three months ended December 31, 2006, compared
to a net loss of $3.9 million, or $0.28 per share for the same
period in 2005. Total revenues for the three months ended December
31, 2006, were $0.6 million compared to $1.4 million for the same
period in 2005. The decrease in 2006 revenue is primarily due to a
reimbursement of third party expenses in 2005 as part of the
Company�s collaboration with Novartis, offset in part by license
fees recognized under the collaboration with Merck & Co., Inc.
(�Merck�) signed in December 2006. Research and Development
expenses for the three months ended December 31, 2006, totaled $3.0
million compared to $4.0 million for the same period in 2005. The
decrease in 2006 R&D expense is primarily due to a third party
expense incurred by the Company in 2005 related to the Novartis
collaboration and lower clinical trial expenses in 2006, offset in
part by higher payroll costs, including an increase in stock-based
compensation due to the adoption of SFAS 123R. General and
Administrative expenses for the three months ended December 31,
2006, were $2.3 million compared to $1.3 million for the same
period in 2005. The increase in G&A is primarily attributable
to increased stock-based compensation, higher payroll costs, and
expenses associated with entering into a collaboration with Merck.
Full Year Results For the year ended December 31, 2006, the
Company�s net loss was $16.5 million, or $0.99 per share, compared
to a net loss of $13.7 million, or $0.99 per share, for 2005. For
the year ended December 31, 2006, revenues totaled $2.4 million,
compared to $2.5 million for 2005. The decrease in revenue is
primarily due to a reimbursement of third party expenses in 2005 as
part of the Company�s collaboration with Novartis, offset by a full
year of license revenue recognized in 2006 under the same
collaboration with Novartis and license fees recognized under the
collaboration with Merck signed in December, 2006. For the year
ended December 31, 2006, Research and Development expenses totaled
$12.7 million, compared to $11.2 million for 2005. The increase in
R&D expense is primarily due to initiation of the development
program for IMO-2125 in infectious disease, higher payroll costs
and an increase in stock-based compensation, offset in part by a
decrease in third party expenses incurred by the Company in 2005
related to the Novartis collaboration. For the year ended December
31, 2006, General and Administrative expenses totaled $6.3 million,
compared to $5.1 million for 2005. The increase in G&A expense
primarily reflects higher payroll costs, increased stock-based
compensation and expenses associated with entering into a
collaboration with Merck. As of December 31, 2006, cash, cash
equivalents and short-term investments totaled approximately $38.2
million, compared to $8.4 million at December 31, 2005. This
increase reflects an upfront license fee and an equity investment
received from Merck and financing proceeds raised in 2006. 2006 and
Recent Corporate Highlights Product Pipeline and Scientific
Progress: Oncology IMO-2055, a TLR9 agonist, is the Company�s lead
candidate in oncology. The Company is currently conducting a Phase
2 clinical trial of IMO-2055 as a monotherapy in metastatic or
recurrent renal cell carcinoma. The Company expects to complete
enrollment in Stage A of the trial shortly and expects to announce
the results of this study by the end of 2007. The Company is also
conducting a Phase 1/2 trial of IMO-2055 in combination with
chemotherapeutic agents in refractory solid tumor patients. The
Company expects to announce the results of Phase 1 of this study by
the end of 2007. In July, 2006, the Company formed an Oncology
Clinical Advisory Board of ten internationally prominent physicians
and scientists with broad expertise in oncology drug development
and clinical practice to advise the Company on the clinical
development of IMO-2055 in oncology, including which indications to
pursue and on trial design. The Company�s academic collaborators
reported preclinical data showing that the Company�s TLR9 agonist
potentiates the anti-tumor activity of the EGFR inhibitor
cetuximab, and the VEGF inhibitor bevacizumab in mouse models of
human cancer. Based on preclinical data, our clinical experience,
and input from members of the Oncology Clinical Advisory Board, the
Company plans to initiate new oncology clinical trials in 2007 to
evaluate IMO-2055 in combination with standard oncology therapies
in oncology indications to be determined. Infectious Diseases The
Company�s second lead drug candidate is IMO-2125, a novel TLR9
agonist that the Company is initially developing for the treatment
of hepatitis C. In preclinical studies, IMO-2125 has induced
interferon-alpha and other cytokines. The Company has completed
preclinical and toxicology studies for IMO-2125 to support the
filing of an Investigational New Drug application, which we intend
to submit to the U.S. Food and Drug Administration in the second
quarter of 2007. Autoimmune Diseases Recent studies by others have
shown that TLRs recognize DNA- and RNA-containing immune complexes
in human autoimmune diseases, such as lupus. These findings suggest
that blocking immune responses through TLRs may be a useful
therapeutic approach for certain autoimmune diseases. The Company
has identified a novel class of DNA-based compounds that act as
antagonists of specific TLRs. In mouse models of lupus, mice
treated with one of our TLR antagonists showed improvement in
several disease parameters. Discovery of compounds targeted to TLRs
The Company continues to advance its chemistry-based discovery
approach to identify novel compounds targeted to TLRs 7, 8, and 9.
The Company has expanded its portfolio of RNA-based compounds,
which we refer to as SIMRA (stabilized immune modulatory RNA), and
which act as agonists of TLR7 and TLR8. The Company has also
identified DNA-based compounds that act as antagonists of TLRs 7,
8, and 9. Since the end of the third quarter 2006, the Company
presented data regarding some of these compounds at the following
scientific meetings: -- Oligonucleotide Therapeutics Society,
October 2006, five presentations -- American College of
Rheumatology, November 2006, and -- Keystone Symposium, February
2007. Business Highlights -- In December, 2006, the Company entered
into an Exclusive License and Research Collaboration Agreement with
Merck to research, develop and commercialize vaccine products
containing Idera's agonist compounds targeting TLRs 7, 8 and 9 in
the fields of oncology, infectious diseases and Alzheimer's disease
(the "Licensed Fields"). Merck and Idera also agreed to engage in a
two-year research and development collaboration to generate novel
agonists targeting TLR7 and TLR8 and incorporating both Merck and
Idera chemistry for use in the Licensed Fields. This collaboration
may be extended by Merck for two additional one-year periods. Under
the terms of the agreement: -- Merck paid Idera a $20 million
upfront license fee; -- Merck purchased $10 million of Idera's
common stock; -- Merck agreed to fund the research and development
collaboration; and -- Merck agreed to pay Idera milestone payments
as follows: -- Up to $165 million if vaccines containing Idera's
TLR9 agonist compounds are successfully developed and marketed in
each of the oncology, infectious disease and Alzheimer's disease
fields; and -- Up to $260 million if vaccines containing Idera's
TLR9 agonist compounds are successfully developed and marketed for
follow-on indications in the oncology field and if vaccines
containing Idera's TLR 7 and 8 agonists are successfully developed
and marketed in each of the oncology, infectious disease and
Alzheimer's disease fields. There is no limit to the number of
vaccines to which Merck can apply Idera�s TLR agonists within the
Licensed Fields. If Merck develops and commercializes additional
vaccines using Idera�s agonists, Idera would be entitled to receive
additional milestone payments. Merck also agreed to pay Idera
royalties on net product sales of vaccines using Idera�s TLR
agonist technology that are developed and marketed. The
collaboration between Idera and Novartis for the discovery,
development, and commercialization of TLR9 agonists for the
treatment of asthma and allergy indications continues to progress.
In March, 2007, the Company announced that Novartis opted to extend
the research program under the agreement for an additional year. In
early 2007, Dr. Alice Bexon joined Idera as Vice President of
Clinical Development. In March 2006, the Company raised gross
proceeds of $9.75 million in a private placement of common stock
and warrants to new institutional investors, led by Baker Brothers
Investments. The Company raised an additional $9.75 million in 2006
through the sales of common stock to an investor group, Biotech
Shares Ltd., under an agreement entered into in March, 2006. In
June, 2006, the Company effected a one-for-eight reverse stock
split of issued and outstanding common stock. In February, 2007,
the Company converted its 4% Convertible Subordinated notes due in
2008 in the aggregate principal amount of $5,032,750 into shares of
the Company�s common stock. In December, 2006, the Company entered
into a seven-year operating lease agreement for approximately
26,500 square feet of space in Cambridge, MA to house its
operations, commencing May, 2007. Intellectual Property -- The
United States Patent and Trademark Office issued the Company three
patents in 2006 and early 2007: -- US 7,176,296 claiming compounds
comprising a synthetic immunostimulatory motif and an
immunomodulatory moiety; -- US 7,115,579 claiming a method of
inducing an immune response via administration of certain compounds
that act through TLRs; and -- US 7,105,495 claiming methods for
modulating the immunostimulatory effect of novel dinucleotide
motifs and CpG motifs by introducing modifications in the flanking
sequence. The opposition window for EU 1,278,761, claiming
compositions of matter and methods of use for certain immune
modulatory oligonucleotides, closed with no opposition and the
patent was validated in 16 European countries. The Australian
Patent Office issued the Company a similar patent, AU 2001257366.
The Company�s U.S. and foreign patents and patent applications
claiming compounds targeted to TLRs have increased by approximately
30 since the end of 2005, and now total over 180. 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
November 13, 2006, which important factors are incorporated herein
by reference. Idera disclaims any intention or obligation to update
any forward-looking statements. Idera Pharmaceuticals, Inc.
Consolidated Condensed Statements of Operations (In thousands,
except per share data) Three Months Ended Years Ended December 31,
December 31, 2006� 2005� 2006� 2005� (unaudited) (unaudited)
(unaudited) Revenues $ 592� $ 1,441� $ 2,421� $ 2,467� Operating
Expenses Research & Development 3,046� 3,987� 12,705� 11,170�
General & Administrative 2,301� 1,339� 6,276� 5,120� Total
Operating Expenses 5,347� 5,326� 18,981� 16,290� Loss from
Operations (4,755) (3,885) (16,560) (13,823) Other, net 71� 5� 80�
117� Loss before income taxes (4,684) (3,880) (16,480) (13,706)
Income tax provision (45) -� (45) -� Net Loss Applicable To Common
Stockholders $ (4,729) $ (3,880) $ (16,525) $ (13,706) Basic and
Diluted Net Loss Per Common Share $ (0.26) $ (0.28) $ (0.99) $
(0.99) � Shares Used In Computing Basic and Diluted Net Loss Per
Common Share 18,352� 13,902� 16,625� 13,886� Idera Pharmaceuticals,
Inc. Consolidated Condensed Balance Sheet Data (In thousands)
December 31, 2006� 2006� 2005� Pro Forma (1) (unaudited)
(unaudited) Cash, Cash Equivalents And Investments $ 38,187�
$38,153� $ 8,376� Receivables & Other Assets 2,354� 2,056�
1,613� Total Assets $ 40,541� $40,209� $ 9,989� � Deferred Revenue
� Current $ 5,992� $5,992� $ 2,171� Other Current Liabilities
2,026� 1,992� 1,881� Notes Payable 5,033� -� 5,033� Other
Non-Current Liabilities 3� 3� 10� Deferred Revenue � Non-current
15,250� 15,250� 1,229� Total Stockholders' Equity (Deficit) 12,237�
16,972� (335) Total Liabilities & � � � Stockholders' Equity $
40,541� $40,209� $ 9,989� (1) The Pro Forma December 31, 2006
Balance Sheet Data reflects the conversion of all of the Company�s
4% convertible notes into 706,844 shares of common stock on
February 20, 2007. The Pro Forma column also reflects the
reclassification of deferred financing costs to equity and the
payment of accrued interest.
Idera Pharmaceutical (AMEX:IDP)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Idera Pharmaceutical (AMEX:IDP)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024