Idera Pharmaceuticals, Inc. (“Idera”) (NASDAQ: IDRA) reported on
March 11, 2020 its financial and operational results for the fourth
quarter and year ended December 31, 2019.
“In 2019, we made great progress with ILLUMINATE-301, our
registrational trial of tilsotolimod in combination with ipilimumab
in anti-PD-1 refractory patients with advanced melanoma. This was
the result of outstanding focus and dedication across our
organization and enabled us to finish enrollment in the first
quarter of 2020, earlier than anticipated. It also positions us to
have initial data from the trial early next year,” stated Vincent
Milano, Idera’s Chief Executive Officer. “2019 was also notable for
our progress in taking tilsotolimod beyond melanoma through both
our collaboration in squamous cell carcinoma of the head and neck
and through our ILLUMINATE-206 trial, which we initiated in the
microsatellite stable colorectal cancer cohort.”
ILLUMINATE (tilsotolimod) Clinical Development
Update
ILLUMINATE-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 ORR per RECIST v1.1 and overall
survival (OS);
- Trial initiated in March 2018;
- Enrollment completed in March 2020; and
- ORR and other preliminary data expected in Q1 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 cohort of 10 patients with MSS-CRC fully
enrolled; and
- Preliminary data from this cohort expected in Q2 2020.
ILLUMINATE-204: Phase 1/2 trial of tilsotolimod
in combination with ipilimumab or pembrolizumab in patients with
anti-PD-1 refractory advanced melanoma:
- Enrollment completed in February 2019 at tilsotolimod 8 mg with
ipilimumab; and
- Final top-line results from the ILLUMINATE-204 trial, to
include ORR, median OS, duration of response (DOR), and safety, are
expected to be released in Q2 2020.
Corporate Updates
Since September 30, 2019, the following corporate
updates were announced:
- Received new U.S. Patent for tilsotolimod, providing
exclusivity through September 2037 when tilsotolimod is used with
certain checkpoint inhibitors.
- Entered into private placement financing of up to $97.7
million, with $10.1 million received in December 2019 from initial
proceeds and option fees.
- Dr. Jonathan Yingling departed Idera as its Chief Scientific
Officer effective January 31, 2020.
Financial Results Fourth Quarter
ResultsRevenue in the fourth quarter of 2019 and 2018 was
nominal. Research and development expenses for the three months
ended December 31, 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 December 31, 2019, totaled $3.4
million compared to $3.6 million for the same period in 2018.
Additionally, during the fourth quarter of 2019 the Company
recorded $0.6 million and $11.0 million of non-cash warrant
revaluation expense and non-cash future tranche right revaluation
expense, respectively. These expenses were related to a private
placement transaction consummated pursuant to a Securities Purchase
Agreement, dated as of December 23, 2019, by and between us and
certain institutional investors, whereby the Company sold shares of
Series B1 convertible preferred stock and warrants to purchase
common stock for $3.9 million and received an upfront option fee of
approximately $6.2 million related to certain rights provided to
such institutional investors to purchase shares of Series B2,
Series B3, and Series B4 convertible preferred stock and warrants
to purchase common stock in future tranches, subject to shareholder
approval to increase authorized shares. The 2019 period also
included non-cash deemed dividends of approximately $28.0 million,
increasing net loss attributable to common stockholders, related to
the transaction.
As a result of the factors above, net loss applicable to common
stockholders for the three months ended December 31, 2019, was
$51.3 million, or $1.76 per basic and diluted share, compared to
net loss applicable to common stockholders of $12.2 million, or
$0.45 per basic and diluted share, for the same period in
2018. Net loss applicable to common stockholders excluding
non-cash expense of approximately $11.6 million and deemed
dividends of approximately $28.0 million related to the Securities
Purchase Agreement for the three months ended December 31, 2019 was
$11.7 million, or $0.40 per basic and diluted share. Full
Year ResultsRevenue for the year ended December 31, 2019,
was $1.5 million compared to revenue of $0.7 million for the same
period in 2018. Research and development expenses for the year
ended December 31, 2019, totaled $34.9 million compared to $41.8
million for the same period in 2018. General and administrative
expenses for the year ended December 31, 2019, totaled $12.5
million compared to $15.4 million for the same period in 2018.
Merger-related costs, net for the year ended December 31, 2018,
totaled $1.2 million. No such costs were incurred during 2019.
Restructuring costs for the year ended December 31, 2019, totaled
$0.2 million compared to $3.1 million for the same period in 2018
and related to our decision in July 2018 to wind-down our discovery
operations.
The 2019 period also included $0.6 million and $11.0 million of
non-cash warrant revaluation expense and non-cash future tranche
right revaluation expense, respectively, as well as non-cash deemed
dividends of approximately $28.0 million, 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, 2019, was $84.6
million or $2.96 per basic and diluted share, compared to net loss
applicable to common stockholders of $59.9 million, or $2.25 per
basic and diluted share, for the same period in 2018.
Net loss applicable to common stockholders excluding non-cash
expense of approximately $11.6 million and deemed dividends of
approximately $28.0 million related to the Securities Purchase
Agreement for the three months ended December 31, 2019 was $45.0
million, or $1.57 per basic and diluted share.
As of December 31, 2019, our cash, cash equivalents, and
short-term investments totaled $42.8 million, which includes a $6.2
million contingently refundable option fee received in connection
with the December 2019 private placement transaction, discussed
above. We currently anticipate that, based on our current operating
plan, our current cash, cash equivalents, and short-term
investments, excluding the $6.2 million contingently refundable
option fee, will fund our operations into the first quarter of
2021.
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 www.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 and clinical trial plans, including
enrollment and timing of results, 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; and whether the Company's collaborations
will be successful. 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, 2019, 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. |
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Statements of Operations |
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(In thousands, except per share data) |
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Three Months
Ended |
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Twelve
Months Ended |
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December 31, |
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December 31, |
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2019 |
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2018 |
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2019 |
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2018 |
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Alliance
revenue |
|
$ |
- |
|
|
$ |
99 |
|
|
$ |
1,448 |
|
|
$ |
662 |
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Operating
expenses: |
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|
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Research and development |
|
|
8,368 |
|
|
|
8,929 |
|
|
|
34,853 |
|
|
|
41,841 |
|
|
General and administrative |
|
|
3,420 |
|
|
|
3,571 |
|
|
|
12,481 |
|
|
|
15,420 |
|
|
Merger-related costs, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,245 |
|
|
Restructuring costs |
|
|
- |
|
|
|
95 |
|
|
|
181 |
|
|
|
3,112 |
|
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Total
operating expenses |
|
|
11,788 |
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|
12,595 |
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47,515 |
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|
|
61,618 |
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Loss from
operations |
|
|
(11,788 |
) |
|
|
(12,496 |
) |
|
|
(46,067 |
) |
|
|
(60,956 |
) |
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Other income
(expense) |
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|
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Warrant revaluation expense |
|
|
(598 |
) |
|
|
- |
|
|
|
(598 |
) |
|
|
- |
|
|
Future tranche right revaluation expense |
|
|
(10,964 |
) |
|
|
- |
|
|
|
(10,964 |
) |
|
|
- |
|
|
Other income (expense), net |
|
|
118 |
|
|
|
346 |
|
|
|
1,114 |
|
|
|
1,075 |
|
|
|
|
|
|
|
|
|
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Net
loss |
|
$ |
(23,232 |
) |
|
$ |
(12,150 |
) |
|
$ |
(56,515 |
) |
|
$ |
(59,881 |
) |
|
Deemed
dividend related to December 2019 Private Placement |
|
|
(28,043 |
) |
|
|
- |
|
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(28,043 |
) |
|
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- |
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|
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|
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Net loss
attributable to common stockholders |
|
$ |
(51,275 |
) |
|
$ |
(12,150 |
) |
|
$ |
(84,558 |
) |
|
$ |
(59,881 |
) |
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|
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Net loss per
common share applicable to common stockholders — basic and
diluted |
|
$ |
(1.76 |
) |
|
$ |
(0.45 |
) |
|
$ |
(2.96 |
) |
|
$ |
(2.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares used in computing net loss
per share applicable to common stockholders — basic and
diluted |
|
|
29,177 |
|
|
|
27,183 |
|
|
|
28,545 |
|
|
|
26,601 |
|
|
|
|
|
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|
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Idera Pharmaceuticals, Inc. |
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Balance Sheet Data |
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(In thousands) |
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December
31, |
|
December
31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
42,793 |
|
|
$ |
71,431 |
|
Other
assets |
|
4,696 |
|
|
|
1,592 |
|
Total
assets |
$ |
47,489 |
|
|
$ |
73,023 |
|
|
|
|
|
|
Total
liabilities |
$ |
58,657 |
|
|
$ |
9,029 |
|
Total
stockholders' equity (deficit) |
|
(11,168 |
) |
|
|
63,994 |
|
Total
liabilities and stockholders' equity (deficit) |
$ |
47,489 |
|
|
$ |
73,023 |
|
|
|
|
|
|
Source: Idera Pharmaceuticals, Inc.
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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