Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today reported its financial and operational results for the
first quarter ended March 31, 2021.
“Despite the disappointing objective response rate (ORR) results
from ILLUMINATE-301, our Phase 3 trial in anti-PD-1 refractory
advanced melanoma, we continue to explore the potential for
tilsotolimod to enhance patients’ immune systems,” stated Vincent
Milano, Idera’s Chief Executive Officer. “We are evaluating our
next steps regarding continuation of ILLUMINATE-301 toward its
overall survival (OS) endpoint. We also continue to enroll and
treat patients in ILLUMINATE-206, our Phase 2 study in
microsatellite-stable colorectal cancer (MSS-CRC).”
Continued Mr. Milano, “In addition, we are very active in our
business development efforts to identify and secure new
development- or commercial-stage assets to enhance our portfolio,
and we believe that our current cash position is strong.”
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE-301: The Company reported in March 2021
that it did not meet its primary endpoint of ORR from its
randomized phase 3 trial of tilsotolimod in combination with
ipilimumab versus ipilimumab alone in patients with anti-PD-1
refractory advanced melanoma. Patient status continues to be
monitored in follow-up stages of the trial.
ILLUMINATE-206: Enrollment continues in the
Company’s Phase 2, open-label, multicohort, multicenter study to
test the safety and effectiveness of tilsotolimod in combination
with ipilimumab and nivolumab for the treatment of solid tumors,
beginning with MSS-CRC.
- Initial safety run-in of 10 patients, which included ipilimumab
at 1 mg/kg every 8 weeks and nivolumab at 3 mg/kg every 2 weeks,
showed that the regimen was generally well tolerated.
- Changes in the study design intended to improve potential
outcomes in this patient population include increasing ipilimumab
dosing frequency to every 3 weeks and limiting the number of
allowed prior lines of treatment to 2.
- Data from the next 10 patients under the modified study design
is anticipated in the fourth quarter of 2021.
Corporate Update Since December 2020
- In February 2021, the Company entered into a collaboration and
option agreement with Scriptr Global, Inc. to research, develop,
and potentially commercialize gene therapy candidates for myotonic
dystrophy 1 (DM1) and Friedrich’s Ataxia (FA).
- The Company received $16.3 million in net proceeds from its
equity distribution agreement and equity line of credit.
- Considering the data related to ILLUMINATE-301’s ORR endpoint,
in April 2021 the Company initiated a reduction in force that will
impact approximately 50% of our workforce by May 31, 2021. The
decision was made to better align our workforce to our needs in
ongoing tilsotolimod and business development activities.
- The Company’s Board of Directors (the “Board”) has elected
current Board member Michael Dougherty as the Chair of the Board,
effective April 28, 2021. He succeeds James Geraghty, who
initiated this transition in the interest of Board leadership
refreshment after serving as our Board Chair since 2013. Mr.
Geraghty is planning to continue to serve as a non-executive
director on our Board.
“I want to thank Jim for his tireless leadership over the last 8
years and am looking forward to his continued contributions to our
Board,” stated Mr. Milano. “I’m also grateful to have Mike step
into this broader leadership role on our Board as we take Idera
forward.”First Quarter Financial Results Research
and development expenses for the three months ended March 31, 2021
totaled $6.9 million, compared to $9.5 million for the same period
in 2020. General and administrative expense for the three months
ended March 31, 2021 totaled $3.2 million compared to $3.6 million
for the same period in 2020. Additionally, during the three months
ended March 31, 2021 and 2020, we recorded a $7.0 million and $1.1
million non-cash warrant revaluation gain, respectively, and a
$118.8 million and $20.7 million non-cash future tranche right
revaluation gain, respectively, related to securities issued in
connection with our December 2019 private placement
transaction.
As a result of the factors above, net income for the three
months ended March 31, 2021 was $115.7 million, compared to net
income of $8.8 million for the same period in 2020. Net income
applicable to common stockholders for the three months ended March
31, 2021 was $109.6 million, or $2.66 per basic share, compared to
net income applicable to common stockholders of $8.2 million, or
$0.27 per basic share, for the same period in 2020. On a diluted
basis, net loss applicable to common stockholders for the three
months ended March 31, 2021 was $10.0 million, or $0.14 per diluted
share, compared to net income applicable to common stockholders of
$8.0 million, or $0.22 per diluted share, for the same period
in 2020. Excluding the non-cash gain of approximately $125.8
million and $21.8 million for the three months ended March 31, 2021
and 2020, respectively, related to the securities issued in
connection with the December 2019 private placement transaction,
net loss applicable to common stockholders was $10.0 million, or
$0.24 per basic and diluted share, and $13.0 million, or $0.43 per
basic and diluted share, respectively (calculated based upon the
basic weighted-average number of common shares, due to the
antidilutive effect of net loss). About Idera
PharmaceuticalsHarnessing the approach of the earliest
researchers in immunotherapy and the Company’s vast experience in
developing proprietary immunology platforms, Idera’s lead
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 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, financial position, funding for continued operations,
cash reserves, projected costs, prospects clinical trials and
related endpoints, 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,"
“schedule,” and "would" and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements are predictions based on the Company’s
current expectations and projections about future events and
various assumptions. 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. These forward-looking
statements involve known and unknown risks, uncertainties, and
other factors, which may be beyond Idera’s control, and which may
cause the actual results, performance, or achievements of the
Company to be materially different from future results,
performance, or achievements expressed or implied by such
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, without limitation: 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; whether topline
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, 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 the
impact of public health crises, including the novel coronavirus
(COVID-19) global pandemic. All forward-looking statements included
in this release are made as of the date hereof, and are expressly
qualified in their entirety by this cautionary notice, including,
without limitation, those risks and uncertainties described in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2020, and otherwise in the Company’s filings and reports filed
with Securities and Exchange Commission. While 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, except as may be required by law.
Idera Pharmaceuticals, Inc. Statements
of Operations(In thousands, except per share
data)
|
Three Months
Ended |
|
March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development |
$ |
6,871 |
|
|
$ |
9,510 |
|
General and administrative |
|
3,156 |
|
|
|
3,642 |
|
|
|
|
|
Total
operating expenses |
|
10,027 |
|
|
|
13,152 |
|
|
|
|
|
Loss from
operations |
|
(10,027 |
) |
|
|
(13,152 |
) |
|
|
|
|
Other income
(expense) |
|
|
|
Warrant revaluation gain |
|
6,983 |
|
|
|
1,101 |
|
Future tranche right revaluation gain |
|
118,803 |
|
|
|
20,711 |
|
Other income (expense), net |
|
(21 |
) |
|
|
157 |
|
|
|
|
|
Net
income |
$ |
115,738 |
|
|
$ |
8,817 |
|
|
|
|
|
Net income
(loss) applicable to common stockholders |
|
|
|
—
basic |
$ |
109,606 |
|
|
$ |
8,178 |
|
—
diluted |
$ |
(10,048 |
) |
|
$ |
7,199 |
|
|
|
|
|
Net income
(loss) per common share applicable to common stockholders |
|
|
|
—
basic |
$ |
2.66 |
|
|
$ |
0.27 |
|
—
diluted |
$ |
(0.14 |
) |
|
$ |
0.22 |
|
|
|
|
|
Weighted-average number of common shares used in computing net
income (loss) per share applicable to common stockholders |
|
|
|
—
basic |
|
41,193 |
|
|
|
30,300 |
|
—
diluted |
|
70,980 |
|
|
|
33,010 |
|
Idera Pharmaceuticals, Inc.Balance
Sheet Data(In thousands)
|
March
31, |
|
December
31, |
|
2021 |
|
2020 |
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
44,541 |
|
$ |
37,728 |
|
Other
assets |
|
3,467 |
|
|
4,671 |
|
Total
assets |
$ |
48,008 |
|
$ |
42,399 |
|
|
|
|
|
Total
liabilities |
$ |
5,704 |
|
$ |
133,571 |
|
Total
stockholders' equity (deficit) |
|
42,304 |
|
|
(91,172 |
) |
Total
liabilities and stockholders' equity (deficit) |
$ |
48,008 |
|
$ |
42,399 |
|
Idera Pharmaceuticals
Contacts:
Jill Conwell Investor Relations & Corporate Communications
Phone (484) 348-1675JConwell@IderaPharma.com
John J. KirbyChief Financial OfficerPhone (484)
348-1627JKirby@IderaPharma.com
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