Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel nucleic acid-based therapeutics for
oncology and rare diseases, today reported its financial and
operational results for the second quarter ended June 30, 2017.
Since April 1, 2017, the Company:
Presentations/Publications:
- Submitted and gained acceptance of an abstract (#1187P) for
presentation of updated clinical trial data from the ongoing
IMO-2125 Phase 2 clinical trial at the European Society of Medical
Oncology (ESMO) 2017 Congress. The data will be presented by
lead trial investigator, Adi Diab, MD of MD Anderson Cancer Center
at 1:15 PM CEST (7:15 AM ET) on Sunday, September 10, 2017.
The conference is being held in Madrid, Spain September 8th through
the 12th; and
- Submitted and gained acceptance of an abstract (#B240) for
presentation of IMO-2125 pre-clinical data in a poster presentation
entitled, “Intratumoral IMO-2125 treatment in combination with
anti-CTLA4 mAb induces durable anti-tumor responses associated with
tumor-specific memory in pre-clinical studies” at the Third Annual
CRI-CIMT-EATI-AACR International Cancer Immunotherapy
Conference. The presentation will be given by Idera Principal
Scientist, Daquing Wang, Ph.D. at 6:15 PM on Friday, September 8,
2017. The conference is being held in Frankfurt, Germany from
September 6th through 9th.
Clinical Trial Activities:
- Commenced enrollment of the Phase 2 portion of the clinical
trial of 8 mg intratumoral IMO-2125 in combination with ipilimumab
in anti-PD-1 refractory melanoma;
- 21 patients planned for evaluation; and
- Overall Response Rate (ORR) data expected to be available in
first quarter of 2018;
- Continued enrollment into the dose escalation cohorts of the
pembrolizumab combination arm of the Phase 1/2 clinical trial of
intratumoral IMO-2125 in anti-PD-1 refractory metastatic
melanoma;
- Initiated and commenced enrollment into the Phase 1 clinical
trial of intratumoral IMO-2125 monotherapy in multiple tumor
types;
- Continued accruing patients into the IMO-8400 Phase 2 clinical
trial in dermatomyositis which is being conducted at approximately
20 sites both in the U.S. and abroad and is expected to complete
enrollment in 2017 with data planned for the first half of 2018;
and
- Continued all pre-clinical and IND-enabling activities for IDRA
008, Idera’s first clinical candidate from the Third Generation
Antisense (3GA) technology platform, with expected IND filing and
initiation of human proof-of-concept clinical trial in the first
half of 2018.
Regulatory Activity:
- Announced the granting of Orphan Drug Designation from the U.S
Food and Drug Administration (FDA) for IMO-2125 for the treatment
of melanoma Stages IIb to IV.
“As we continue to advance through 2017, our organization is
incredibly energized and focused on rapidly advancing IMO-2125
through the clinical development pathway and ultimately towards our
intended goal of delivering this therapeutic option for patients,
particularly those who have not derived benefit from prior
checkpoint inhibition therapies and in many cases have run out of
options,” stated Vincent Milano, Idera’s Chief Executive
Officer. “This effort is consistent with our corporate
mission to transform Idera into a company delivering commercially
available options for patients suffering with life-threating
conditions. Our efforts across all of our development
pipeline programs continues to drive forward, and we look forward
to the opportunities to provide updates in the months and quarters
ahead as these programs continue to mature. We have several
opportunities to present further updates from the IMO-2125 program
between now and year end and also intend to provide additional
specificity on our plans to expeditiously advance our first
indication in PD-1 refractory melanoma.”
Research and Development Program
UpdatesIMO-2125 and IMO-8400 are the Company’s lead
clinical development drug candidates. IMO-2125 is an
oligonucleotide-based agonist of Toll-like receptor (TLR) 9.
IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and
9. The Company also announced, in early 2017, the selection
of the first development target from its proprietary 3GA technology
platform. The company plans to disclose the specific target,
disease and clinical pathway in the second half of 2017. The
Company plans to take the first 3GA candidate (IDRA 008) into human
proof of concept studies in 2018.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology ProgramIdera’s development program
in immuno-oncology is based on the rationale that intra-tumoral
injections of IMO-2125, a TLR9 agonist, will activate dendritic
cells and modulate the tumor microenvironment to potentiate the
anti-tumor activity of checkpoint inhibitors and other
immunotherapies. This rationale is supported by both
pre-clinical data in multiple tumor types as well as emerging
clinical results and translational research from ongoing
trials.
Idera is currently conducting a Phase 2 clinical trial of
intratumoral IMO-2125 in combination with ipilimumab, a CTLA4
antibody, and in a separate arm exploring the combination of
intratumoral IMO-2125 with pembrolizumab, an anti-PD1 antibody.
The Phase 1 dose exploration portion of the trial was
conducted at the University of Texas MD Anderson Cancer Center and
the Phase 2 portion of the trial is being conducted at multiple
centers. This trial is being conducted in patients with
relapsed or refractory metastatic melanoma who have failed prior
anti-PD-1 therapy. In the second half of 2016, the Company
announced positive preliminary clinical data from the initial
dosing cohorts in the ipilimumab arm of the dose escalation portion
of the trial. The company has completed the dose escalation
of the intratumoral IMO-2125 plus ipilimumab arm of the trial and
the combination appears generally well tolerated across all doses
explored, without any dose-limiting toxicity and without reaching a
maximally tolerated dose. The company selected the 8mg dose
for Phase 2 and enrollment is underway. The company is currently
enrolling patients in the dose-finding Phase 1 IMO-2125 plus
pembrolizumab combination arm of the trial.
Additionally, during the first half of 2017, the company
initiated a multi-center clinical trial of intratumoral IMO-2125
monotherapy in multiple tumor types, including melanoma. The
purpose of this trial is to demonstrate the activity of
single-agent IMO-2125 for regulatory filing purposes as well as to
direct further clinical development in tumor types beyond
refractory melanoma.
Lastly, the company has begun and will continue to engage in
discussions with regulatory authorities regarding the path to
registration for IMO-2125 in combination with ipilimumab in
anti-PD-1 refractory metastatic melanoma patients. IMO-2125
has been granted Orphan Drug Designation from the U.S. Food and
Drug Administration (FDA) for the treatment of melanoma Stages IIb
to IV.
Toll-like Receptor (TLR) Antagonism
Dermatomyositis Clinical Development ProgramIn
late 2015, Idera announced the initiation of a Phase 2 clinical
trial of IMO-8400 in patients with dermatomyositis, a rare,
auto-immune condition, which negatively affects skin and in many
cases also results in debilitating muscle weakness. TLRs have been
understood to play an important role in the pathogenesis of the
disease.
This randomized, double-blind, placebo controlled Phase 2 trial
is targeted to enroll 36 patients and is being conducted at
approximately 20 clinical sites worldwide. The Company plans
to complete enrollment of this trial by the end of 2017 and be in
position to present the results of this trial in the first half of
2018.
Third Generation Antisense Platform
(3GA)Idera’s proprietary third-generation antisense (3GA)
platform technology is focused on silencing the mRNA associated
with disease causing genes. Idera has designed 3GA
oligonucleotides to overcome specific challenges associated with
earlier generation antisense technologies and RNAi technologies
such as immunotoxicities and less than optimal therapeutic
index.
Over the past several years, Idera’s research organization has
generated 22 unique compounds developed to target specific genes
across a wide variety of therapeutic areas such as rare diseases,
oncology, autoimmune disorders, metabolic conditions and diseases
driven by a single point mutation. The company is currently
conducting activities ranging from cell culture through
IND-enabling toxicology. The current portfolio is designed to
create both internal development candidates as well as partnering
opportunities for disease areas outside of Idera’s stated
focus.
In January of 2017, Idera announced selection of its first
internal candidate (IDRA 008) to enter clinical development.
For strategic and competitive purposes, Idera is withholding naming
the specific target until the second half of 2017. Idera has
selected a well-established liver target, with available, validated
pre-clinical animal models, well-understood clinical endpoints,
which has the potential for both rare and broader disease
applications. Idera is currently performing the required
IND-enabling toxicology for this clinical development candidate and
expects to file the IND and enter the clinic in 2018.
Additionally, the first partnering endeavor is demonstrated
through Idera’s collaboration with GSK to develop an undisclosed
3GA gene target for certain renal conditions. Idera and GSK
entered into the collaboration in late 2015 and GSK’s current plan
is to reach selection of clinical development candidate in the
fourth quarter of 2018.
Financial Results Second
Quarter ResultsNet loss applicable to common
stockholders for the three months ended June 30, 2017 was $21.5
million, or $0.14 per basic and diluted share, compared to a net
loss applicable to common stockholders of $13.5 million, or $0.11
per basic and diluted share, for the same period in 2016. Research
and development expenses for the three months ended June 30, 2017
totaled $17.9 million compared to $10.1 million for the same period
in 2016. General and administrative expense for the three months
ended June 30, 2017 and June 30, 2016 were $3.9 million and $3.8
million, respectively.
As of June 30, 2017, our cash, cash equivalents and investments
totaled $77.2 million. We currently anticipate our cash
position is capable of funding our operations into the fourth
quarter of 2018.
About Idera Pharmaceuticals, Inc.Idera
Pharmaceuticals is a clinical-stage biopharmaceutical company
developing novel nucleic acid-based therapies for the treatment of
certain cancers 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
has created a third generation antisense technology platform using
its proprietary technology to inhibit the production of
disease-associated proteins by targeting RNA. To learn more about
Idera, visit www.iderapharma.com.
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, clinical
trials, 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 the Company’s cash resources will be
sufficient to fund the Company’s continuing operations and the
further development of the Company’s programs for the period
anticipated; whether interim results from a clinical trial, such as
the preliminary results reported in this release, will be
predictive of the final results of the trial; 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, including in
clinical trials in different disease indications; 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 filed on
Form 10-K for the period ended December 31, 2016 and the Quarterly
Report on Form 10-Q for the period ended June 30, 2017. 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. Condensed Statements of Operations(In thousands, except per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
June 30, |
|
June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance Revenue |
$ |
187 |
|
|
$ |
301 |
|
|
$ |
565 |
|
|
$ |
595 |
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research
& Development |
|
17,891 |
|
|
|
10,128 |
|
|
|
29,376 |
|
|
|
19,424 |
|
General
& Administrative |
|
3,888 |
|
|
|
3,778 |
|
|
|
7,969 |
|
|
|
7,694 |
|
|
|
|
|
|
|
|
|
Total Operating
Expenses |
|
21,779 |
|
|
|
13,906 |
|
|
|
37,345 |
|
|
|
27,118 |
|
|
|
|
|
|
|
|
|
Loss from
Operations |
|
(21,592 |
) |
|
|
(13,605 |
) |
|
|
(36,780 |
) |
|
|
(26,523 |
) |
|
|
|
|
|
|
|
|
Other Income (Expense),
Net |
|
121 |
|
|
|
120 |
|
|
|
252 |
|
|
|
215 |
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(21,471 |
) |
|
$ |
(13,485 |
) |
|
$ |
(36,528 |
) |
|
$ |
(26,308 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share applicable to common stockholders |
$ |
(0.14 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share applicable to
common stockholders |
|
149,412 |
|
|
|
121,323 |
|
|
|
149,257 |
|
|
|
121,304 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals,
Inc.Condensed Balance Sheet Data(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
` |
AtJune 30, |
|
AtDecember
31, |
|
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, Cash Equivalents
& Investments |
$ |
77,235 |
|
|
$ |
109,014 |
|
|
|
|
|
Other Assets |
|
6,138 |
|
|
|
4,217 |
|
|
|
|
|
Total Assets |
$ |
83,373 |
|
|
$ |
113,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
$ |
8,501 |
|
|
$ |
9,882 |
|
|
|
|
|
Total Stockholders'
Equity |
|
74,872 |
|
|
|
103,349 |
|
|
|
|
|
Total Liabilities &
Stockholders' Equity |
$ |
83,373 |
|
|
$ |
113,231 |
|
|
|
|
|
Source: Idera Pharmaceuticals, Inc.
IDERA PHARMACEUTICALS Contact:
Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (617) 679-5515
RDOODY@IDERAPHARMA.COM
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