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 third
quarter ended September 30, 2019.
“The third quarter of this year marked another consecutive
period of focused execution for our company as we continue
advancing tilsotolimod for patients and their families,” stated
Vincent Milano, Idera’s Chief Executive Officer. “During this
quarter, we implemented adjustments for ILLUMINATE-301 and continue
to make meaningful progress with patient enrollment.
Additionally, we also had strong execution within the broader
tilsotolimod program, highlighted by the initiation of our first
tumor expansion efforts in ILLUMINATE-206, the lengthening of our
exclusivity period and the strategic clinical collaboration with
AbbVie.”
Milano continued, “Overall, our team is executing on a high
level and we are well positioned to continue to accelerate our
activity through the end of this year and, importantly, into
2020.”
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:
- Approximately 90 sites active in 11 countries;
- Planned enrollment target of 454 patients;
- As of October 23, 2019, 342 patients enrolled representing 75%
enrollment;
- Targeting completion of enrollment during first half of 2020;
and
- Clinical trial collaboration and supply agreement in place with
BMS for supply of ipilimumab for the trial.
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 (49 evaluable) at
tilsotolimod 8 mg with ipilimumab in February 2019;
- Of the four unconfirmed responders of the 13 responders
reported on Aug. 8, 2019:
- Two were confirmed per RECIST v1.1 criteria, one remains
unconfirmed, and one experienced disease progression, leading to a
total of 11 of 12 confirmed responses, as of Oct. 23, 2019;
- 3 confirmed complete responses (CR);
- 71% (35) achieving disease control (best response of CR, PR or
Stable Disease (SD)); and
- Durable responses (greater than six months) were observed in
five of 10 confirmed responses per RECIST v1.1.
- Safety profile observed consistent with previously reported
results; 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 anti-PD-1
Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) and
Relapsed/Refractory Immunotherapy-Naïve Microsatellite Stable
Colorectal Cancer (MSS-CRC). ·Trial initiated on September 30,
2019, leading 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;
- Data presented at the European Society for Medical Oncology
(ESMO) 2019 Conference in Barcelona Spain;
- Of 45 evaluable patients, 15 (33.3%) had best response of
stable disease (SD);
- 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
partial response (uPR). This patient discontinued from the
study prior to the confirmation of response.
AbbVie Collaboration – On September 4, 2019, we
announced we had entered into an immuno-oncology clinical research
collaboration with AbbVie, a global, research-based
biopharmaceutical company. The purpose of the collaboration
is to conduct a clinical study evaluating whether combinations of
an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod),
chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death
1 (PD-1) antagonist (ABBV-181) stimulate the immune system
resulting in anti-tumor responses.
Intellectual Property – On November 5, 2019,
the U.S. Patent and Trademark Office issued U.S. Patent No.
10,10,463,686 entitled “Immune Modulation With TLR9 Agonists For
Cancer Treatment,” which includes the Company’s investigational
therapy tilsotolimod (IMO-2125). The patent includes 24
claims directed to methods of treating melanoma with intratumoral
administration of tilsotolimod in combination with certain immune
checkpoint inhibitor therapies including inhibitors of the CTLA-4
and PD-1/PD-L1 pathways. The patent is expected to expire in
September 2037.
Financial Results Third
Quarter ResultsNet loss applicable to common
stockholders for the three months ended September 30, 2019 was
$11.1 million, or $0.39 per basic and diluted share, compared to
net loss applicable to common stockholders of $11.6 million, or
$0.43 per basic and diluted share, for the same period in 2018.
Research and development expenses for the three months ended
September 30, 2019 totaled $8.4 million compared to $8.9 million
for the same period in 2018. General and administrative expense for
the three months ended September 30, 2019 totaled $3.0 million
compared to $4.0 million for the same period in 2018.
Merger-related costs, net for the three months ended September 30,
2018 amounted to a net credit of $3.8 million and was comprised of
a $6.0 million fixed expense reimbursement received in connection
with the termination of a merger agreement in July 2018, partially
offset by $2.2 million of expenses incurred in connection with
transactions contemplated by such merger agreement. No such costs
were incurred for the same period in 2019. Restructuring costs for
the three months ended September 30, 2019 were less than $0.1
million compared to $3.0 million for the same period in 2018 and
related to our decision in July 2018 to wind-down our discovery
operations.
As of September 30, 2019, our cash, cash equivalents and
short-term investments totaled $41.6 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 on hand as of September 30, 2019, will
fund our operations into the third 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 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)
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
Alliance revenue |
|
$ |
- |
|
|
$ |
145 |
|
|
$ |
1,448 |
|
|
$ |
563 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
8,359 |
|
|
|
8,860 |
|
|
|
26,485 |
|
|
|
32,912 |
|
General and administrative |
|
|
3,023 |
|
|
|
3,984 |
|
|
|
9,061 |
|
|
|
11,849 |
|
Merger-related costs, net |
|
|
- |
|
|
|
(3,836 |
) |
|
|
- |
|
|
|
1,245 |
|
Restructuring costs |
|
|
5 |
|
|
|
3,017 |
|
|
|
181 |
|
|
|
3,017 |
|
Total operating expenses |
|
|
11,387 |
|
|
|
12,025 |
|
|
|
35,727 |
|
|
|
49,023 |
|
Loss from operations |
|
|
(11,387 |
) |
|
|
(11,880 |
) |
|
|
(34,279 |
) |
|
|
(48,460 |
) |
Other income (expense), net |
|
|
254 |
|
|
|
275 |
|
|
|
996 |
|
|
|
729 |
|
Net loss |
|
$ |
(11,133 |
) |
|
$ |
(11,605 |
) |
|
$ |
(33,283 |
) |
|
$ |
(47,731 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share applicable to common stockholders — basic
and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.17 |
) |
|
$ |
(1.81 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares used in computing net loss
per share applicable to common stockholders — basic and
diluted |
|
|
28,847 |
|
|
|
27,175 |
|
|
|
28,332 |
|
|
|
26,404 |
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Condensed
Balance Sheet Data(In thousands)
|
September 30, |
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
41,586 |
|
|
$ |
71,431 |
|
Other assets |
|
3,806 |
|
|
|
1,592 |
|
Total assets |
$ |
45,392 |
|
|
$ |
73,023 |
|
|
|
|
|
Total liabilities |
$ |
7,766 |
|
|
$ |
9,029 |
|
Total stockholders' equity |
|
37,626 |
|
|
|
63,994 |
|
Total liabilities and stockholders' equity |
$ |
45,392 |
|
|
$ |
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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