Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today reported its financial and operational results for the
fourth quarter and year ended December 31, 2020.
“Tilsotolimod is the most advanced TLR-9 agonist therapy in
development, and we are eagerly anticipating objective response
rate and other important data from ILLUMINATE-301, our pivotal
registration trial in anti-PD-1 refractory advanced melanoma, later
this month,” stated Vincent Milano, Idera’s Chief Executive
Officer. “I’m very proud of our team’s resiliency and tenacity as
they work diligently toward that goal, as well as the ongoing work
in ILLUMINATE-206, our trial in micro-satellite stable colorectal
cancer. In addition, we are in a healthy financial position and
expect our current cash to fund our activities into the second
quarter of 2022, with the potential of additional capital from our
existing security purchase agreements to extend our runway into the
second quarter of 2023. These resources will be instrumental in
helping us advance tilsotolimod for patients in need.”
Corporate UpdateSince September 30,
2020, the following corporate updates were announced:
- The Company closed a second tranche under its April 7, 2020
securities purchase agreement for additional aggregate gross
proceeds of $5.0 million. With this tranche, the Company has
received $25.2 million in proceeds from three financings since
December 2019, with anticipated further proceeds of up to $113.2
million to fund the potential NDA filing and commercial launch of
tilsotolimod.
- The Company appointed Daniel Soland as Senior Vice President
and Chief Operating Officer as of January 4, 2021. Mr. Soland is
responsible for the Company’s commercial strategy and
manufacturing.
- R. Clayton Fletcher, Senior Vice President of Business
Development and Strategic Planning, retired from the Company as of
December 31, 2020. Mr. Fletcher remains engaged with the Company as
a consultant, continuing to lead its business development
activities.
ILLUMINATE (tilsotolimod) Clinical Development
UpdatesILLUMINATE-301: Randomized phase 3
trial of tilsotolimod in combination with ipilimumab versus
ipilimumab alone in patients with anti-PD-1 refractory advanced
melanoma:
- Primary endpoint family of objective response rate (ORR) by
blinded independent central review using RECIST v1.1 and overall
survival (OS);
- Trial initiated in March 2019;
- Enrollment completed in March 2020; and
- ORR and other preliminary data expected in the first quarter of
2021.
ILLUMINATE-206: 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:
- Trial initiated in September 2019 with the microsatellite
stable colorectal cancer (MSS-CRC) cohort;
- 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; and
- The Company has opened enrollment for the next 10 patients
under the modified study design, with data anticipated in the third
quarter of 2021.
Fourth Quarter Financial Results Research and
development expenses for the three months ended December 31, 2020
totaled $5.1 million compared to $8.4 million for the same period
in 2019. General and administrative expense for the three months
ended December 31, 2020 totaled $2.9 million compared to $3.4
million for the same period in 2019. Additionally, during the three
months ended December 31, 2020 and 2019, we recorded a $3.2 million
and $0.6 million non-cash warrant revaluation loss, respectively,
and a $65.4 million and $11.0 million non-cash future tranche right
revaluation loss, respectively, related to securities issued in
connection with our December 2019 private placement
transaction.
As a result of the factors above, net loss applicable to common
stockholders for the three months ended December 31, 2020 was $76.7
million, or $2.11 per basic and diluted share, compared to net loss
applicable to common stockholders of $51.3 million, or $1.76 per
basic and diluted share, for the same period in 2019. Excluding
non-cash loss of approximately $68.6 million and $11.6 million for
the three months ended December 31, 2020 and 2019, respectively,
and deemed dividends of approximately $28.0 million for the three
months ended December 31, 2019, all related to the securities
issued in connection with the December 2019 private placement
transaction, net loss applicable to common stockholders was $8.0
million, or $0.22 per basic and diluted share, and $11.7 million,
or $0.40 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). Full Year
ResultsResearch and development expenses for the year
ended December 31, 2020 totaled $24.8 million compared to $34.9
million for the same period in 2019. General and administrative
expenses for the year ended December 31, 2020 totaled $11.9 million
compared to $12.5 million for the same period in 2019.
Additionally, for the year ended December 31, 2020 and 2019, we
recorded a $3.7 million and $72.4 million of non-cash warrant
revaluation loss, respectively, and a $0.6 million and $11.0
million non-cash future tranche right revaluation loss,
respectively, as well as non-cash deemed dividends of approximately
$28.0 million during the year ended December 31, 2019, increasing
net loss attributable to common stockholders, as further discussed
above under fourth quarter results.
As a result of the factors above, net loss applicable to common
stockholders for the year ended December 31, 2020 was $112.7
million or $3.33 per basic and diluted share, compared to net loss
applicable to common stockholders of $84.6 million, or $2.96 per
basic and diluted share, for the same period in 2019. Excluding
non-cash loss of approximately $76.1 million and $11.6 million for
the years ended December 31, 2020 and 2019, respectively, and
deemed dividends of approximately $28.0 million for the year ended
December 31, 2019, all related to the securities issued in
connection with the December 2019 private placement transaction,
net loss applicable to common stockholders was $36.6 million, or
$1.08 per basic and diluted share, and $45.0 million, or $1.57 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).
As of December 31, 2020, our cash, cash equivalents, and
short-term investments totaled $37.7 million. Based on our current
operating plan, we anticipate that our current cash, cash
equivalents, and short-term investments, will fund our operations
through the second quarter of 2022.
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 the safe harbor of the Private Securities Litigation
Reform Act of 1995 and the Federal securities laws. 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, and
clinical trials, including the enrollment, timing, and future
results thereof, 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 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, 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 FDA 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 |
|
Twelve
Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Alliance
revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,448 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
5,117 |
|
|
|
8,368 |
|
|
|
24,772 |
|
|
|
34,853 |
|
General and administrative |
|
|
2,923 |
|
|
|
3,420 |
|
|
|
11,915 |
|
|
|
12,481 |
|
Restructuring costs |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
181 |
|
Total
operating expenses |
|
|
8,040 |
|
|
|
11,788 |
|
|
|
36,687 |
|
|
|
47,515 |
|
Loss from
operations |
|
|
(8,040 |
) |
|
|
(11,788 |
) |
|
|
(36,687 |
) |
|
|
(46,067 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
Warrant revaluation loss |
|
|
(3,247 |
) |
|
|
(598 |
) |
|
|
(3,742 |
) |
|
|
(598 |
) |
Future tranche right revaluation loss |
|
|
(65,379 |
) |
|
|
(10,964 |
) |
|
|
(72,367 |
) |
|
|
(10,964 |
) |
Other income (expense), net |
|
|
(35 |
) |
|
|
118 |
|
|
|
134 |
|
|
|
1,114 |
|
Net
loss |
|
$ |
(76,701 |
) |
|
$ |
(23,232 |
) |
|
$ |
(112,662 |
) |
|
$ |
(56,515 |
) |
Deemed
dividend related to December 2019 Private Placement |
|
|
- |
|
|
|
(28,043 |
) |
|
|
- |
|
|
|
(28,043 |
) |
Net loss
attributable to common stockholders |
|
$ |
(76,701 |
) |
|
$ |
(51,275 |
) |
|
$ |
(112,662 |
) |
|
$ |
(84,558 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share applicable to common stockholders basic and
diluted |
|
$ |
(2.11 |
) |
|
$ |
(1.76 |
) |
|
$ |
(3.33 |
) |
|
$ |
(2.96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares used in computing net loss
per share applicable to common stockholders basic and diluted |
|
|
36,271 |
|
|
|
29,177 |
|
|
|
33,821 |
|
|
|
28,545 |
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Balance
Sheet Data(In thousands)
|
|
|
|
|
December
31, |
|
December
31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
37,728 |
|
|
$ |
42,793 |
|
Other
assets |
|
4,671 |
|
|
|
4,696 |
|
Total
assets |
$ |
42,399 |
|
|
$ |
47,489 |
|
|
|
|
|
Total
liabilities |
$ |
133,571 |
|
|
$ |
58,657 |
|
Total
stockholders’ deficit |
|
(91,172 |
) |
|
|
(11,168 |
) |
Total
liabilities and stockholders’ deficit |
$ |
42,399 |
|
|
$ |
47,489 |
|
|
|
|
|
Idera Pharmaceuticals Contacts:
Jill Conwell
Investor Relations &
Corporate Communications
Phone (484) 348-1675
JConwell@IderaPharma.com
John J. Kirby
Chief Financial Officer
Phone (484) 348-1627
JKirby@IderaPharma.com
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