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 operational and financial results for the second
quarter ended June 30, 2019.
“Our team has demonstrated remarkable focus on execution during
the first half of this year. We have made significant
progress developing tilsotolimod and advancing it forward for
patients facing the challenges of late-stage, anti-PD-1 refractory
metastatic melanoma,” stated Vincent Milano, Idera’s Chief
Executive Officer. “Our accrual rate in the registrational
ILLUMINATE-301 trial has exceeded our expectations, which is
reflective of the high unmet need in this patient population.”
Milano continued, “Additionally, we are providing data from the
ILLUMINATE-204 trial, which we believe is informative as to the
probability of success in the registrational trial. We
also are advancing toward initiation of our first combination
therapy trial in areas beyond melanoma, ILLUMINATE-206, which we
expect will provide additional opportunities and milestones for
data updates next year.”
ILLUMINATE (tilsotolimod) Clinical
Development
ILLUMINATE 301 – Randomized phase 3 trial of
tilsotolimod in combination with ipilimumab versus ipilimumab alone
in patients with anti-PD-1 refractory metastatic melanoma:
- Overall Response Rate (ORR) and Overall Survival (OS) as family
of primary endpoints;
- Trial initiated in the first quarter of 2018;
- Sites active in 11 countries: Approximately 100 sites
participating.
Based on feedback from the ILLUMINATE-301 steering committee and
global melanoma and immunology experts, we have elected to make the
following modifications to the ILLUMINATE 301 trial design:
- Median OS improvement over ipilimumab alone of greater than or
equal to 4.6 months from prior delta of improvement of 6.6
months;
- ORR improvement of 10 percentage points over ipilimumab alone
from prior delta of improvement of 20 percentage points;
- Target effect size/hazard ratio adjusted to 0.71 from 0.63;
resulting in a planned enrollment of approximately 450 patients
from 308, of which 294 are currently enrolled; and
- Targeting completion of enrollment during the first half of
2020.
We along with our collaboration partner, BMS, have amended the
prior Clinical Trial Collaboration and Supply Agreement to
accommodate the increase in supply of ipilimumab for the
ILLUMINATE-301 trial.
Additionally, we have solicited feedback from the U.S. Food and
Drug Administration and they do not object to these changes.
We also have solicited feedback from other global health
authorities related to these changes.
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 at tilsotolimod 8 mg with
ipilimumab in February 2019;
- Data as of August 5, 2019 on endpoints:
- 27% ORR (n=13) of the 49 patients evaluable for efficacy; 74%
(36) achieving disease control (best response of CR, PR or Stable
Disease (SD));
- Durable responses (>6 mos.) observed in 8 of 13
responders;
- Median OS has not yet been reached (min/max: 1.6 mos. – 35
mos.);
- The safety profile observed in this analysis was consistent
with previously reported results, with no emergence of new safety
signals;
- 43% (n=21) of patients enrolled into trial presented at
baseline with Eastern Cooperative Oncology Group (ECOG) performance
status 2; and
- Final results from the ILLUMINATE 204 trial are expected to be
submitted for an abstract at a medical conference during the first
half of 2020.
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, we entered into a second clinical trial
collaboration with BMS in which BMS has agreed to manufacture and
supply YERVOY (ipilimumab) and OPDIVO (nivolumab) for no charge for
use in ILLUMINATE-206;
- Trial expected to initiate in the third quarter of 2019
beginning with the MSS-CRC cohort.
ILLUMINATE 101 – Phase 1b trial of tilsotolimod
monotherapy in patients with refractory solid tumors:
- Completed enrollment in all dose cohorts of the trial;
- Initial data presented at American Academy for Cancer Research
(AACR) 2019 conference;
- Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease
assessment of stable disease (SD), with a disease control rate of
45%;
- One patient with uterine leiomyosarcoma has been on
tilsotolimod treatment for more than a year with durable stable
disease and is continuing under a treatment investigational new
drug;
- One patient in the melanoma cohort achieved an unconfirmed
RECIST v.1.1 partial response (PR) with 35% tumor shrinkage in the
target lesion; and
- Abstract submission accepted for poster presentation at the
European Society for Medical Oncology 2019 Conference being held in
Barcelona, Spain in September 2019.
Corporate Updates:
- Elizabeth A. Tarka, MD, FACC was appointed as Chief Medical
Officer effective July 22, 2019; and
- John J. Kirby was appointed as Chief Financial Officer
effective July 22, 2019.
Upcoming Investor Presentation:
- The company will be presenting at the 2019 Wedbush PacGrow
Healthcare Conference on Tuesday, August 13, 2019 at 1:20 PM
ET. The conference is being held at the Parker New York
Hotel. The webcast can be accessed live or in archived form in the
“Investors” section of the company’s website at
www.iderapharma.com.
Financial Results Second
Quarter ResultsNet loss applicable to common
stockholders for the three months ended June 30, 2019 was $11.2
million, or $0.39 per basic and diluted share, compared to net loss
applicable to common stockholders of $16.0 million, or $0.59 per
basic and diluted share, for the same period in 2018. Revenue for
the three months ended June 30, 2019 was $1.4 million, compared to
$0.2 million for the same period in 2018. Research and
development expenses for the three months ended June 30, 2019
totaled $10.0 million compared to $10.9 million for the same period
in 2018. General and administrative expense for the three months
ended June 30, 2019 totaled $2.9 million compared to $4.0 million
for the same period in 2018. Merger-related costs, net for the
three months ended June 30, 2018 totaled $1.6 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 June 30, 2019 were 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 June 30, 2019, our cash, cash equivalents and short-term
investments totaled $52.4 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.
Investor Event and WebcastIdera will host a
conference call and live webcast today, Thursday, August 8, 2019,
at 10:00 A.M. EST to provide an overview of today’s update along
with a question and answer session. 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 “Investors” section of the company’s
website at www.iderapharma.com.
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 fiscal year 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)
|
|
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|
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|
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Three Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance revenue |
$ |
1,448 |
|
|
$ |
163 |
|
|
$ |
1,448 |
|
|
$ |
418 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
10,024 |
|
|
|
10,880 |
|
|
|
18,126 |
|
|
|
24,436 |
|
|
|
General and administrative |
|
2,895 |
|
|
|
4,000 |
|
|
|
6,038 |
|
|
|
7,481 |
|
|
|
Merger-related costs, net |
|
- |
|
|
|
1,583 |
|
|
|
- |
|
|
|
5,081 |
|
|
|
Restructuring costs |
|
45 |
|
|
|
- |
|
|
|
176 |
|
|
|
- |
|
|
|
Total operating expenses |
|
12,964 |
|
|
|
16,463 |
|
|
|
24,340 |
|
|
|
36,998 |
|
|
|
Loss from operations |
|
(11,516 |
) |
|
|
(16,300 |
) |
|
|
(22,892 |
) |
|
|
(36,580 |
) |
|
|
Other income (expense),
net |
|
340 |
|
|
|
269 |
|
|
|
742 |
|
|
|
454 |
|
|
|
Net loss |
$ |
(11,176 |
) |
|
$ |
(16,031 |
) |
|
$ |
(22,150 |
) |
|
$ |
(36,126 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share
applicable to common stockholders — basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.39 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
common shares used in computing net loss per share applicable to
common stockholders — basic and diluted |
|
28,461 |
|
|
|
27,133 |
|
|
|
28,070 |
|
|
|
26,012 |
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Condensed
Balance Sheet Data(In thousands)
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
52,373 |
|
$ |
71,431 |
|
|
Other assets |
|
1,959 |
|
|
1,592 |
|
|
Total assets |
$ |
54,332 |
|
$ |
73,023 |
|
|
|
|
|
|
|
|
Total liabilities |
$ |
6,597 |
|
$ |
9,029 |
|
|
Total stockholders'
equity |
|
47,735 |
|
|
63,994 |
|
|
Total liabilities and
stockholders' equity |
$ |
54,332 |
|
$ |
73,023 |
|
|
|
|
|
|
|
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals
Contact:
Robert A. Doody, Jr.SVP, Investor Relations &
CommunicationsPhone (484) 348-1677rdoody@iderapharma.com
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