Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel therapeutics for oncology and rare
diseases, today reported its financial and operational results for
the fourth quarter and year ended December 31, 2014.
"2014 was a year of transformation for Idera, as we focused our
company on oncology and rare diseases," stated Vincent Milano,
Chief Executive Officer of Idera Pharmaceuticals. "During 2014, we
commenced two Phase 1/2 clinical trials of IMO-8400 for the
treatment of certain B-cell lymphomas in which the MYD88 L265P
oncogenic mutation is present and also conducted pre-clinical
studies of our Toll-like receptor, or TLR9 agonists as immune
therapies for the treatment of cancer. In addition, we selected
dermatomyositis and Duchenne muscular dystrophy, or DMD, as the
first non-cancer rare diseases for which we plan to develop
IMO-8400. We also expanded our leadership team and increased our
capital resources, with the goal of delivering hope for the
patients we aim to serve and creating value for our
shareholders."
"For 2015 we look forward to begin delivering clinical results
commencing in the fourth quarter from our Phase 1/2 clinical trial
of IMO-8400 in Waldenström's macroglobulinemia. In addition, we are
now working to rapidly advance our targeted immuno-oncology program
into the clinic and also expect to commence clinical development in
our rare diseases program by initiating a Phase 2 clinical trial of
IMO-8400 in dermatomyositis and DMD by the end of 2015 and early
2016, respectively. We also plan to complete our Phase 1 healthy
volunteer trial with IMO-9200 during the year. Finally, we are
planning to conduct disease model studies and begin IND-enabling
development programs in each of the first two disease indications
selected for further development in our gene silencing
oligonucleotide, or GSO, program in the second half of 2015."
Program Updates
Our proprietary technology platforms are based on our scientific
expertise and pioneering work with synthetic oligonucleotides as
therapeutic agents. Using our TLR targeting technology, we design
synthetic oligonucleotide-based drug candidates to act by
modulating the activity of specific TLRs. In addition, using
our GSO technology, we are developing GSOs to turn off the
messenger RNA, or mRNA, associated with disease causing
genes. We consider our GSO technology to be a third generation
antisense technology that can potentially reduce the immunotoxicity
and increase the potency of gene silencing oligonucleotides.
Oncology Programs
Genetically Defined Forms of B-cell Lymphoma
Our program in genetically defined forms of B-cell lymphoma is
based on reports from several independent investigators and
pre-clinical studies offering evidence that, in certain B-cell
lymphomas, the presence of the MYD88 L265P mutation led to
over-activation of TLR7 and TLR9 signaling and that blocking these
TLRs accelerated tumor cell death.
- In December 2014, we announced that we opened enrollment in the
third and final cohort of our dose-escalating Phase 1/2 clinical
trial of IMO-8400 in patients with Waldenström's macroglobulinemia,
a form of non-Hodgkin lymphoma. Opening enrollment into the third
cohort of the trial followed the recommendation of an independent
data review committee after its review of safety data from the
second dose cohort of the trial. The trial is designed to evaluate
IMO-8400's safety, tolerability and potential clinical activity in
patients who have a history of relapse or failure to respond to one
or more prior therapies. We anticipate that full data from this
trial will be available in the fourth quarter of 2015.
- In December 2014, we announced that the U.S. Food and Drug
Administration (FDA) had granted us orphan drug designation for
IMO-8400 for the treatment of Waldenström's macroglobulinemia.
- We presented safety data from IMO-8400 at the American Society
of Hematology Annual Meeting in December 2014.
- We continue to activate multiple clinical sites and are
screening patients with relapsed or refractory diffuse large B-cell
lymphoma, or DLBCL, harboring the MYD88 L265P oncogenic mutation in
a Phase 1/2 clinical trial of IMO-8400 in DLBCL. We anticipate
that full data from this trial will be available in 2016.
Immuno-Oncology Program
- We announced in early 2015 our plans to advance either IMO-2125
or IMO-2055, two TLR9 agonists in our drug candidate pipeline, into
clinical development with an intratumoral administration approach
in combination with checkpoint inhibitors. Our plan is to
submit an IND and to initiate at least two Phase 1/2 clinical
trials with the first clinical trial commencing in the second half
of 2015 with a goal of completing and having data available in at
least one of the two trials no later than the end of 2016.
- In December 2014, we presented preclinical data demonstrating
that cancer immunotherapy with intratumoral injections of IMO-2055
and ipilimumab, a checkpoint inhibitor, resulted in potent and
systemic anti-tumor activity in multiple preclinical cancer models
at the American Association for Cancer Research Tumor Immunology
and Immunotherapy Meeting.
Rare Disease Programs
- We are planning to initiate clinical development of IMO-8400
for the treatment of rare diseases. We have selected
dermatomyositis and DMD as the first rare diseases for which we
plan to develop IMO-8400. We selected these indications for
development based on the reported increase in TLR expression in
these disease states, expression of cytokines indicative of key
TLR-mediated pathways, the identification of prospective biomarkers
for evaluation in early clinical trials and with respect to
dermatomyositis, the presence of auto-antibodies that can induce
TLR-mediated immune responses. We anticipate commencing
clinical development in these two indications by initiating a Phase
2 clinical trial in dermatomyositis by the end of 2015 and a Phase
1/2 clinical trial in DMD in early 2016.
Gene Silencing Oligonucleotides
- We are currently undertaking an analysis of priority oncology
and rare disease indications for development of drug candidates
from our GSO technology. Our key considerations in identifying
disease indications in our GSO program include: strong evidence
that the disease is caused by a specific protein; clear criteria to
identify a target patient population; biomarkers for early
assessment of clinical proof-of-concept; a targeted therapeutic
mechanism for action; and unmet medical need to allow for a rapid
development path to approval. We are planning to conduct disease
model studies and begin IND-enabling development programs in each
of the first two disease indications selected for further
development in our GSO program in the second half of 2015.
Recent Corporate Highlights
Financing
In February 2015, we announced the closing of an underwritten
public offering of common stock which generated net proceeds of
approximately $80.6 million.
Financial Results
Fourth Quarter Results
Net loss applicable to common stockholders for the three months
ended December 31, 2014 was $12.0 million, or $0.14 per diluted
share, compared to a net loss applicable to common stockholders of
$6.4 million, or $0.10 per diluted share, for the same period in
2013. There was nominal revenue recognized in each of the fourth
quarters of 2014 and 2013. Research and development expenses for
the three months ended December 31, 2014 totaled $8.2 million
compared to $3.6 million for the same period in 2013. General and
administrative expense for the three months ended December 31, 2014
totaled $3.7 compared to $2.4 million for the same period in
2013.
Full Year Results
Net loss applicable to common stockholders for the year ended
December 31, 2014 was $39.2 million or $0.47 per diluted share,
compared to net loss applicable to common stockholders of $21.1
million, or $0.48 per diluted share, for the same period in 2013.
There was nominal revenue recognized during the years ended
December 31, 2014 and 2013. Research and development expenses for
the year ended December 31, 2014 totaled $27.5 million compared to
$10.5 million for the same period in 2013. General and
administrative expenses for the year ended December 31, 2014
totaled $11.3 million compared to $7.7 million for the same period
in 2013.
As of December 31, 2014, our cash, cash equivalents and
investments totaled $48.6 million compared to $35.6 million as of
December 31, 2013.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical
company developing a novel therapeutic approach for the treatment
of genetically defined forms of B-cell lymphoma and rare diseases.
Idera's proprietary technology involves using a TLR) targeting
technology, to design synthetic oligonucleotide-based drug
candidates to act by modulating the activity of specific TLRs. In
addition to its TLR programs, Idera is developing gene silencing
oligonucleotides (GSOs) that it has created using its proprietary
technology to inhibit the production of disease-associated proteins
by targeting RNA.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements, other than statements of historical fact,
included or incorporated in this press release, including
statements regarding the Company's strategy, future operations,
collaborations, intellectual property, cash resources, financial
position, future revenues, projected costs, prospects, plans, and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," "continue," "will," and "would" and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company's
forward-looking statements. There are a number of important factors
that could cause Idera's actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether results
obtained in preclinical studies and clinical trials such as the
results described in this release will be indicative of the results
that will be generated in future clinical trials; whether products
based on Idera's technology will advance into or through the
clinical trial process when anticipated or at all or warrant
submission for regulatory approval; whether such products will
receive approval from the U.S. 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 will be
successful; and such other important factors as are set forth under
the caption "Risk Factors" in the Company's Annual Report on Form
10-K for the year ended December 31, 2014. Although Idera may elect
to do so at some point in the future, the Company does not assume
any obligation to update any forward-looking statements and it
disclaims any intention or obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Idera Pharmaceuticals, Inc. |
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Condensed Statements of Operations |
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(In thousands, except per share data) |
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Three Months
Ended |
Years
Ended |
|
December
31, |
December
31, |
|
2014 |
2013 |
2014 |
2013 |
|
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Alliance Revenue |
$ 2 |
$ 4 |
$ 73 |
$ 47 |
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Operating Expenses |
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|
Research & Development |
8,245 |
3,640 |
27,493 |
10,475 |
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|
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General & Administrative |
3,686 |
2,436 |
11,332 |
7,741 |
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Total Operating Expenses |
11,931 |
6,076 |
38,825 |
18,216 |
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Loss from Operations |
(11,929) |
(6,072) |
(38,752) |
(18,169) |
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Other Income (Expense), Net |
11 |
(18) |
110 |
(57) |
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Net Loss |
(11,918) |
(6,090) |
(38,642) |
(18,226) |
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Loss on extinguishment of convertible
preferred stock, preferred stock accretion and dividends |
97 |
279 |
519 |
2,866 |
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Net loss applicable to common
stockholders |
$ (12,015) |
$ (6,369) |
$ (39,161) |
$ (21,092) |
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Basic and diluted net loss per common share
applicable to common stockholders |
$ (0.14) |
$ (0.10) |
$ (0.47) |
$ (0.48) |
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Shares used in computing basic and diluted
net loss per common share applicable to common stockholders |
87,657 |
63,795 |
82,827 |
43,906 |
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Idera Pharmaceuticals, Inc. |
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Condensed Balance Sheet Data |
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(In thousands) |
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At December
31, |
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2014 |
2013 |
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Cash, Cash Equivalents & Investments |
$ 48,571 |
$ 35,592 |
Other Assets |
2,855 |
1,275 |
Total Assets |
$ 51,426 |
$ 36,867 |
Total Liabilities |
$ 8,024 |
$ 4,415 |
Total Stockholders' Equity |
43,402 |
32,452 |
Total Liabilities & Stockholders'
Equity |
$ 51,426 |
$ 36,867 |
CONTACT: Investor Contact:
Robert Doody
Vice President, Investor Relations & Corporate Communications
484-639-7235
rdoody@iderapharma.com
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