9 of 10 Waldenstrom’s
Macroglobulinemia Patients
Treated at the Highest Dose
have Demonstrated
Reductions in IgM or M-Protein
Levels in Ongoing Trial
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 first quarter ended March 31, 2016.
“Idera continued to make strong progress across all of our areas
of focus during the first period of 2016,” stated Vincent Milano,
Idera’s Chief Executive Officer. “Our clinical development
teams have transformed our programs into executable registration
strategies and the research group continues to advance the 3GA
platform to put us into position to enter human proof of concept
trials in 2017.”
Continued Milano, “The amount of strategic consideration and
effort that has taken place over the past year and the related
execution should provide us with critical catalysts beginning in
the second half of this year and right through the course of 2017
across all aspects of our business. We’re currently
conducting four separate clinical trials and we expect data from
all four of these studies over the course of the next six to 18
months. This is an exciting time for Idera and we look forward to a
very bright future for the patients we aim to serve as well as our
investors, who support these bold endeavors.”
Research and Development Program
UpdatesIMO-8400 and IMO-2125 are our lead clinical
development drug candidates. IMO-8400 is an
oligonucleotide-based antagonist of Toll-like receptors (TLRs) 7,
8, and 9. IMO-2125 is an oligonucleotide-based agonist of
TLR9. The company also announced during the fourth quarter of
2015, the first two development targets from its proprietary 3GA
Technology platform: NLRP3 (NOD-like receptor family, pyrin
domain containing protein 3) and DUX4 (Double Homeobox 4).
The company plans to take the first 3GA candidate into human proof
of concept studies in 2017.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology ProgramIdera’s development
program in immuno-oncology is based on pre-clinical studies that
demonstrated through the mechanism of intra-tumoral injections of
the TLR9 agonist, IMO-2125, the tumor microenvironment could be
impacted in a manner which positively increases the efficacy of
check-point inhibition. These studies have led Idera into a
strategic research alliance with the University of Texas MD
Anderson Cancer Center to clinically explore the combination of
checkpoint inhibitors.
In December 2015, Idera announced the initiation of a Phase 1/2
clinical trial of intra-tumoral IMO-2125 in combination with
Ipilimumab in patients with relapsed or refractory Metastatic
Melanoma being conducted at the University of Texas MD Anderson
Cancer Center. The study will also include an arm exploring
the combination of IMO-2125 with a PD1 inhibitor. The company
expects to present the first translational data from the trial
during the second half of 2016, with clinical results expected in
2017.
Additionally, the company presented new preclinical data
demonstrating the potentiation of anti-tumor effects through
combination of IMO-2125 and indoleamine-pyrolle 2,3-dioxygenase
(IDO-1) in cancer models at the American Association for Cancer
Research (AACR) Annual Meeting.
Toll-like Receptor (TLR) Antagonism
Genetically Defined Forms of B-cell Lymphoma
Idera’s program in genetically defined forms of B-cell lymphoma is
based on pre-clinical studies that have demonstrated in certain
B-cell lymphomas driven by the oncogenic MYD88-L265P mutation,
blocking TLR7 and 9 signaling can promote tumor cell death.
In December 2015, Idera presented positive clinical data from
the ongoing Phase 1/2 trial of IMO-8400 in patients with
Waldenstrom’s Macroglobulinemia at the 57th Annual Meeting of the
American Society of Hematology (ASH) in Orlando, FL. The
company is continuing further dose escalation of IMO-8400 in both
the ongoing trials in Waldenstrom’s Macroglobulinemia and Diffuse
Large B-cell Lymphoma to further explore the full potential of
IMO-8400 based on the safety profile and efficacy signals seen to
date. The company expects to complete the accrual of the
escalated dosing for both the WM and DLBCL studies by the end of
2016, with data available in the first half of 2017.
Idera previously announced that the U.S. Food and Drug
Administration (FDA) granted orphan drug designation for IMO-8400
for the treatment of Waldenström’s macroglobulinemia and DLBCL.
Rare DiseasesIn November 2015, Idera announced
the initiation of a Phase 2 clinical trial of IMO-8400 in patients
with Dermatomyositis. The company expects to have the DM
Phase 2 study fully enrolled in the first half of 2017.
The company announced during the first quarter of 2016 that due
to the resources required to fully commit to a Duchenne muscular
dystrophy (DMD) clinical development endeavor, the company has
chosen to suspend internal efforts at this time to advance IMO-8400
into clinical development for DMD.
Third Generation Antisense Platform
Throughout 2015, the company undertook an analysis and
prioritization of oncology and rare disease indications for
potential development of drug candidates derived from our 3GA
technology platform. The key considerations in identifying
disease indications from our third generation antisense program
included: 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 well-defined development path to approval and
commercial opportunity. As a result of this analysis, in the
fourth quarter of 2015 Idera announced the selection of NLRP3
(NOD-like receptor family, pyrin domain containing protein 3) and
DUX4 (Double Homeobox 4) as initial gene targets to advance into
IND-enabling activities, which will occur throughout 2016.
Potential disease indications include, but are not limited to
interstitial cystitis, uveitis and facioscapulohumeral muscular
dystrophy (FSHD), respectively. The company is currently
conducting clinical and regulatory pathway and commercial analysis
activities and conducting IND-enabling studies with the plan to
enter the clinic in 2017 for the first disease indication.
Financial Results
First Quarter
2016 Results
Net loss for the three months ended March 31, 2016 was $12.8
million, or $0.11 per basic and diluted share, compared to a net
loss of $12.5 million, or $0.12 per basic and diluted share, for
the same period in 2015. There was nominal revenue recognized in
each of the first quarters of 2016 and 2015. Research and
development expenses for the three months ended March 31, 2016
totaled $9.3 million compared to $8.7 million for the same period
in 2015. General and administrative expense for the three months
ended March 31, 2016 totaled $3.9 million compared to $3.8 million
for the same period in 2015.
As of March 31, 2016, Idera’s cash, cash equivalents and
investments totaled $74.1 million compared to $87.2 million as of
December 31, 2015. The company expects the current cash
position and investments to fund its operations into the third
quarter of 2017.
Investor Event and Webcast
Idera will host a conference call and live webcast on Monday,
May 9, 2016 at 5:00 P.M. EST to provide an update on the company’s
progress and to provide an overview of additional clinical activity
from the ongoing Phase 1/2 clinical trial of IMO-8400 in
Waldenstrom’s Macroglobulinemia. To participate in the
conference call, please dial (844) 882-7837 (domestic) and (574)
990-9824 (international). The webcast can be accessed live or
in archived form in the “Investor’s” section of the company’s
website at www.iderapharma.com.
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 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 and Quarterly Report on Form 10-Q for
the periods ended December 31, 2015, and March 31, 2016,
respectively. 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 - Unaudited |
|
|
|
|
(In thousands, except
per share data) |
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
March 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
Alliance Revenue |
$ |
294 |
|
|
$ |
34 |
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
Research &
Development |
|
9,296 |
|
|
|
8,720 |
|
|
|
|
|
|
|
General &
Administrative |
|
3,916 |
|
|
|
3,837 |
|
|
|
|
|
|
|
Total Operating
Expenses |
|
13,212 |
|
|
|
12,557 |
|
|
|
|
|
|
|
Loss from
Operations |
|
(12,918 |
) |
|
|
(12,523 |
) |
|
|
|
|
|
|
Other Income (Expense),
Net |
|
95 |
|
|
|
42 |
|
|
|
|
|
|
|
Net loss applicable to
common stockholders |
$ |
(12,823 |
) |
|
$ |
(12,481 |
) |
|
|
|
|
|
|
Basic and diluted net
loss per common share applicable to common stockholders |
$ |
(0.11 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share applicable to
common stockholders |
|
121,284 |
|
|
|
105,067 |
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals,
Inc. |
|
|
|
|
Condensed Balance Sheet
Data |
|
|
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
At March
31, |
|
At December
31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(Unaudited) |
|
|
|
Cash, Cash Equivalents
& Investments |
$ |
74,122 |
|
|
$ |
87,157 |
|
|
Other Assets |
|
5,198 |
|
|
|
5,119 |
|
|
Total Assets |
$ |
79,320 |
|
|
$ |
92,276 |
|
|
Total Liabilities |
$ |
6,642 |
|
|
$ |
8,694 |
|
|
Total Stockholders'
Equity |
|
72,678 |
|
|
|
83,582 |
|
|
Total Liabilities &
Stockholders' Equity |
$ |
79,320 |
|
|
$ |
92,276 |
|
|
|
|
|
|
|
Investor Contact:
Robert Doody
VP, IR & Corporate Communications.
617-679-5515 (office)
484-639-7235 (mobile)
rdoody@iderapharma.com
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