Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today reported its financial and operational results for the
second quarter ended June 30, 2020.
“Idera meaningfully advanced its clinical pipeline and
strengthened its financial resources in the first part of 2020.
Further encouraged by data from ILLUMINATE-204, which we reported
in the second quarter, we continue to work diligently against our
timelines for ILLUMINATE-301. Those timelines currently remain on
track for data in the first quarter of 2021, despite disruptions
from the global impact of COVID-19,” stated Vincent Milano, Idera’s
Chief Executive Officer. “In addition, as part of our ‘beyond
melanoma’ strategy, early data from ILLUMINATE-206 reinforces our
optimism in the potential of tilsotolimod in patients with
micro-satellite stable colorectal cancer. Lastly, our team’s
outstanding perseverance and dedication to our patients combined
with the further financing we recently secured will help us
continue to execute these key objectives and potentially
beyond.”
Corporate UpdateSince March 31, 2020, the
Company entered into two private placement financings of up to
$40.7 million, with $5.0 million received in April 2020 and $5.1
million received in July 2020. The Company anticipates that its
current cash, cash equivalents, and short-term investments will
fund our operations into the second quarter of 2021. With the
Company’s current financing vehicles, there exists the possibility
to extend that runway through subsequent proceeds to fund the
potential NDA filing and commercial launch of tilsotolimod.
ILLUMINATE (tilsotolimod) Clinical Development
Updates ILLUMINATE-301: Randomized phase
3 trial of tilsotolimod in combination with Yervoy®* (ipilimumab)
versus Yervoy® alone in patients with anti-PD-1 refractory advanced
melanoma:
- Primary endpoint family of overall response rate (ORR) by
blinded independent review using 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 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 Yervoy® and Opdivo®*
(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 Yervoy® at
1 mg/kg every 8 weeks and Opdivo® at 3 mg/kg every 2 weeks, showed
that the regimen was generally well tolerated;
- Planned changes in the study design intended to improve
potential outcomes in this patient population include increasing
Yervoy® dosing frequency to every 3 weeks and limiting the number
of allowed prior lines of treatment to 2; and
- Enrollment of the next 10 patients is targeted to begin in the
fourth quarter of 2020, with data anticipated in the second quarter
of 2021.
ILLUMINATE-204: Phase 1/2 trial of tilsotolimod
in combination with Yervoy® or Keytruda®± (pembrolizumab) in
patients with anti-PD-1 refractory advanced melanoma:
- Final topline results released in April 2020 from the
recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in
combination with Yervoy®, which is the treatment regimen being
evaluated in the Company’s registrational trial, ILLUMINATE-301;
and
- Final data from the trial will be shared in a Mini Oral
presentation at the ESMO Virtual Congress 2020, to be held
September 19-21, 2020.
Second Quarter Financial Results Research and
development expenses for the three months ended June 30, 2020
totaled $5.4 million compared to $10.0 million for the same period
in 2019. General and administrative expense for the three months
ended June 30, 2020 totaled $2.6 million compared to $2.9 million
for the same period in 2019. Additionally, during the three months
ended June 30, 2020, we recorded $0.9 million and $15.3 million
non-cash warrant revaluation loss and 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 June 30, 2020 was $24.2
million, or $0.72 per basic and diluted share, compared to net loss
applicable to common stockholders of $11.2 million, or $0.39 per
basic and diluted share, for the same period in 2019. Excluding the
non-cash loss of approximately $16.3 million for the three months
ended June 30, 2020 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 $0.24 per
basic and diluted share (calculated based upon the basic
weighted-average number of common shares, due to the antidilutive
effect of net loss).
As of June 30, 2020, our cash, cash equivalents, and short-term
investments totaled $31.0 million. Based on our current operating
plan, we anticipate that our current cash, cash equivalents, and
short-term investments, including $5.1 million gross proceeds in
cash received in July 2020 pursuant to the July 2020 Securities
Purchase Agreement, will fund our operations into the second
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 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, 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.
*Yervoy (ipilimumab) and Opdivo (nivolumab) are registered
trademarks of Bristol Myers Squibb.
±Keytruda (pembrolizumab) is a registered trademark of Merck
Sharp & Dohme, a subsidiary Merck & Co., Inc.
|
Idera
Pharmaceuticals, Inc. Statements of
Operations(In thousands, except per share
data) |
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance
revenue |
|
$ |
- |
|
|
$ |
1,448 |
|
|
$ |
- |
|
|
$ |
1,448 |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,379 |
|
|
|
10,024 |
|
|
|
14,889 |
|
|
|
18,126 |
|
|
General and administrative |
|
|
2,632 |
|
|
|
2,895 |
|
|
|
6,274 |
|
|
|
6,038 |
|
|
Restructuring costs |
|
|
- |
|
|
|
45 |
|
|
|
- |
|
|
|
176 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
|
8,011 |
|
|
|
12,964 |
|
|
|
21,163 |
|
|
|
24,340 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(8,011 |
) |
|
|
(11,516 |
) |
|
|
(21,163 |
) |
|
|
(22,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
Warrant revaluation (loss) gain |
|
|
(913 |
) |
|
|
- |
|
|
|
188 |
|
|
|
- |
|
|
Future tranche right revaluation (loss) gain |
|
|
(15,349 |
) |
|
|
- |
|
|
|
5,362 |
|
|
|
- |
|
|
Other income (expense), net |
|
|
47 |
|
|
|
340 |
|
|
|
204 |
|
|
|
742 |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(24,226 |
) |
|
$ |
(11,176 |
) |
|
$ |
(15,409 |
) |
|
$ |
(22,150 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share applicable to common stockholders |
|
|
|
|
|
|
|
|
|
—
basic |
|
$ |
(0.72 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.79 |
) |
|
—
diluted |
|
$ |
(0.72 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares used in computing net loss
per share applicable to common stockholders |
|
|
|
|
|
|
|
|
|
—
basic |
|
|
33,583 |
|
|
|
28,461 |
|
|
|
31,941 |
|
|
|
28,070 |
|
|
—
diluted |
|
|
33,583 |
|
|
|
28,461 |
|
|
|
34,123 |
|
|
|
28,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Balance Sheet
Data(In thousands) |
|
|
|
|
|
June
30, |
|
December
31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
31,006 |
|
|
$ |
42,793 |
|
Other
assets |
|
3,779 |
|
|
|
4,696 |
|
Total
assets |
$ |
34,785 |
|
|
$ |
47,489 |
|
|
|
|
|
Total
liabilities |
$ |
52,476 |
|
|
$ |
58,657 |
|
Total
stockholders' deficit |
|
(17,691 |
) |
|
|
(11,168 |
) |
Total
liabilities and stockholders' deficit |
$ |
34,785 |
|
|
$ |
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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