Idera Pharmaceuticals, Inc. (“Idera”) (NASDAQ: IDRA), a
clinical-stage biopharmaceutical company focused on the
development, and ultimately the commercialization, of therapeutic
drug candidates for both oncology and rare disease indications,
today reported its financial and operational results for the first
quarter ended March 31, 2019.
“The first quarter of this year represented another period of
solid execution from everyone on our team,” stated Vincent Milano,
Idera’s Chief Executive Officer. “During this quarter, we completed
enrollment of ILLUMINATE-204, positioning ourselves to provide a
full analysis from this trial in the fourth quarter of this year.
We’ve also made significant progress with the enrollment of Idera’s
first pivotal trial, ILLUMINATE-301, for which we expect to
complete accrual during the fourth quarter. And, we recently
presented the data from the ILLUMINATE-101 monotherapy trial at
AACR, strengthening the body of translational and clinical evidence
that tilsotolimod stimulates an immune response within the tumor
microenvironment. We believe that this may be a key to
enhancing the outcomes of existing immunotherapy regimens.”
Milano continued, “Lastly, we’ve made great strides in preparing
to initiate the expansion of activities for tilsotolimod through
the ILLUMINATE-206 multi-cohort trial, which we anticipate will
launch this quarter. We appreciate the financial commitment and
teamwork from our collaboration partner, Bristol-Myers Squibb,
which assisted us in taking on this endeavor. Overall, this
has been a highly productive quarter for our team and the momentum
continues to swell as we advance towards these critical catalysts
for our company.”
ILLUMINATE (tilsotolimod) Clinical
Development
ILLUMINATE 301 – Randomized phase 3 trial of
tilsotolimod in combination with ipilimumab versus ipilimumab alone
in patients with PD-1 refractory metastatic melanoma:
- Overall Response Rate (ORR) and Overall Survival (OS) as
primary endpoints;
- Trial initiated in the first quarter of 2018;
- Sites planned in 12 countries: 85 sites activated;
- Planned enrollment of approximately 300 patients; and
- Completion of enrollment expected during the fourth quarter of
2019.
ILLUMINATE 206 – Phase 2, multi-center trial to
test the safety and effectiveness of tilsotolimod in combination
with ipilimumab and nivolumab in treating patients with Squamous
Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite
Stable Colorectal Cancer (MSS-CRC).
- On March 11, 2019 entered into a second clinical trial
collaboration with Bristol-Myers Squibb (BMS) in which BMS has
agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO
(nivolumab) at its cost and for no charge for use in
ILLUMINATE-206;
- Received notice from the U.S. Food and Drug Administration that
we can proceed to implement the ILLUMINATE-206 clinical trial under
a new Investigational New Drug (IND) application; and
- Both trial cohorts of SCCHN and MSS-CRC expected to initiate in
the second quarter of 2019.
ILLUMINATE 204 – Phase 1/2 trial of
tilsotolimod in combination with ipilimumab or pembrolizumab in
patients with PD-1 refractory metastatic melanoma:
- Completed enrollment with 52 patients dosed in Phase 2
expansion at tilsotolimod 8 mg with ipilimumab;
- Completed target enrollment of at least 40 patients in the
primary enrollment population constituting patients who are naïve
to prior ipilimumab treatment in the metastatic setting;
- Presented an interim data update in December 2018 which
showed:
- 32.4% ORR of the first 34 patients evaluable for efficacy
including 9% (n=3) achieve Complete Response (CR); 24% (n=8)
achieving Partial Response (PR); and 76.5% (n=26) achieving disease
control (CR, PR or Stable Disease [SD]); and
- Final overall response rate (ORR) data from the ipilimumab
combination arm of ILLUMINATE-204 expected in the fourth quarter of
2019.
ILLUMINATE 101 – Phase 1b trial of tilsotolimod
monotherapy in patients with refractory solid tumors:
- Completed enrollment in all dose cohorts of the trial; and
- Poster presented at the American Association for Cancer
Research (AACR) 2019 Annual Meeting on April 2, 2019 which
demonstrated:
Safety Data
- No dose limiting toxicities or treatment-related adverse events
were observed;
- No treatment-emergent adverse events (TEAEs) leading to
treatment or study discontinuation or death occurred; and
- The most common grade 3/4 TEAEs were anemia, hyponatremia,
pain, sepsis (n=3 each), fatigue and thrombocytopenia (n=2
each).
Efficacy Data
- Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease
assessment of stable disease (SD), with a disease control rate of
45%;
- Of the 13 patients with SD, 5 (38%) had maximum tumor shrinkage
>10% below baseline;
- Duration of SD ranged from 1.3 to 9.7+ months from start of
treatment, with 3 patients ongoing; and
- No correlations between dose and efficacy were observed.
Translational Data
- Fresh flow cytometry in 2 of 3 analyzed patients showed HLA-DR
(MHC Class II) upregulation at 24 hours compared with
pre-treatment; and
- Robust activation and upregulation of type I IFN pathway was
observed across analyzed tumor types, demonstrated by increased
IRF7, IFIT1, and IFIT2 gene expression, and early increases in type
I IFN signaling.
Financial Results First
Quarter ResultsNet loss applicable to common
stockholders for the three months ended March 31, 2019 was $11.0
million, or $0.40 per basic and diluted share, compared to net loss
applicable to common stockholders of $20.1 million, or $0.81 per
basic and diluted share, for the same period in 2018. Revenue for
each of the three months ended March 31, 2019 and 2018 was nominal.
Research and development expenses for the three months ended March
31, 2019 totaled $8.1 million compared to $13.6 million for the
same period in 2018. General and administrative expense for the
three months ended March 31, 2019 totaled $3.1 million compared to
$3.5 million for the same period in 2018. Merger-related costs, net
for the three months ended March 31, 2018 totaled $3.4 million and
related to our contemplated merger transaction. No such costs were
incurred for the same period in 2019. Restructuring costs for the
three months ended March 31, 2019 was nominal and related to our
decision in July 2018 to wind-down our discovery operations. No
such costs were incurred for the same period in 2018.
As of March 31, 2019, our cash, cash equivalents and investments
totaled $59.9 million compared to $71.4 million as of December 31,
2018. We currently anticipate that, based on our current
operating plan, our existing cash, cash equivalents and investments
will fund our operations into the second quarter of 2020.
About Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and the
company’s vast experience in developing proprietary
immunomodulatory platforms, Idera’s TLR agonist development program
is focused on priming the immune system to play a more powerful
role in fighting cancer, ultimately increasing the number of people
who can benefit from immunotherapy. Idera also continues to focus
on the acquisition, development and ultimate commercialization of
drug candidates for both oncology and rare disease indications
characterized by small, well-defined patient populations with
serious unmet needs. To learn more about Idera, visit
www.iderapharma.com.
Forward-Looking StatementsThis
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, 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,
including 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 will be predictive of
the final results of the trial; whether results obtained in
preclinical studies and clinical trials will be indicative of the
results that will be generated in future clinical trials; whether
products based on the company’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 set forth under the
caption “Risk Factors” in the Company’s Annual Report on Form 10-K
for the period ended December 31, 2018. 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 |
|
|
|
March 31, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance revenue |
$ |
- |
|
|
$ |
255 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
8,102 |
|
|
|
13,556 |
|
|
|
General
and administrative |
|
3,143 |
|
|
|
3,481 |
|
|
|
Merger-related costs, net |
|
- |
|
|
|
3,498 |
|
|
|
Restructuring costs |
|
131 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
11,376 |
|
|
|
20,535 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(11,376 |
) |
|
|
(20,280 |
) |
|
|
|
|
|
|
|
|
Other income (expense),
net |
|
402 |
|
|
|
185 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(10,974 |
) |
|
$ |
(20,095 |
) |
|
|
|
|
|
|
|
|
Net loss per common
share applicable to common stockholders — basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
Weighted-average number
of common shares used in computing netloss per share applicable to
common stockholders — basic and diluted |
|
27,676 |
|
|
|
24,879 |
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Condensed
Balance Sheet Data(In thousands)
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
|
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
59,864 |
|
$ |
71,431 |
Other assets |
|
2,137 |
|
|
1,592 |
Total assets |
$ |
62,001 |
|
$ |
73,023 |
|
|
|
|
Total liabilities |
$ |
6,329 |
|
$ |
9,029 |
Total stockholders'
equity |
|
55,672 |
|
|
63,994 |
Total liabilities and
stockholders' equity |
$ |
62,001 |
|
$ |
73,023 |
|
|
|
|
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals Contact:Robert A. Doody, Jr.VP, Investor
Relations & CommunicationsPhone (484)
348-1677rdoody@iderapharma.com
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