Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today reported its financial and operational results for the
first quarter ended March 31, 2020.
“I’m proud of what Idera has accomplished since
the beginning of the year, despite the worldwide impact of the
COVID-19 pandemic. We have completed and reported encouraging data
from ILLUMINATE-204, secured additional financing to help execute
our key objectives, and, to date, are on track with timelines for
both ILLUMINATE-301 and ILLUMINATE-206,” stated Vincent Milano,
Idera’s Chief Executive Officer. “The level of dedication and
determination from our employees, our partners, and our
investigators is incredibly inspiring.”
Corporate UpdateSince December
31, 2019, the Company entered into a private placement financing of
up to $20.7 million, with $5 million received in April 2020. The
Company anticipates that its current cash, cash equivalents, and
short-term investments will fund our operations into the second
quarter of 2021. ILLUMINATE (tilsotolimod) Clinical
Development Updates
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.
- Median overall survival (OS) was 21.0 months (95% confidence
interval (CI): 9.8 months-not reached (NR));
- The overall response rate (ORR) per Response Evaluation
Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2
complete responses (95% CI: 11.8-36.6%);
- The disease control rate (stable disease or better) was 71.4%
(95% CI: 56.7%-83.4%);
- Median duration of response was 11.4 months (95% CI: 3.3
months-NR); and
- The combination regimen was generally well tolerated.
- Final data from the trial to be submitted for presentation at a
medical conference in the second half of 2020.
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) 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 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 cohort of 10 patients with MSS-CRC fully
enrolled; and
- Preliminary data from this cohort expected in the second
quarter of 2020.
First Quarter Financial Results
Research and development expenses for the three months ended March
31, 2020 totaled $9.5 million compared to $8.1 million for the same
period in 2019. General and administrative expense for the three
months ended March 31, 2020 totaled $3.6 million compared to $3.1
million for the same period in 2019. Additionally, during the three
months ended March 31, 2020 we recorded $1.1 million and $20.7
million of non-cash warrant revaluation income and non-cash future
tranche right revaluation income, respectively, related to
securities issued in connection with our December 2019 private
placement transaction.
As a result of the factors above, net income
applicable to common stockholders for the three months ended March
31, 2020 was $8.8 million, or $0.27 per basic share and $0.22 per
diluted share, compared to net loss applicable to common
stockholders of $11.0 million, or $0.40 per basic and diluted
share, for the same period in 2019. Excluding the non-cash income
of approximately $21.8 million for the three months ended March 31,
2020 related to the securities issued in connection with the
December 2019 private placement transaction, net loss applicable to
common stockholders was $13.0 million, or $0.43 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 March 31, 2020, our cash, cash
equivalents, and short-term investments totaled $33.5 million,
which includes a $6.2 million contingently refundable option fee
received in connection with the December 2019 private placement
transaction. Based on our current operating plan, we anticipate
that our current cash, cash equivalents, and short-term
investments, including the $6.2 million contingently refundable
option fee and the $5.0 million gross proceeds in cash received in
April 2020 pursuant to the April 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; 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.
*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 |
|
|
March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research and development |
|
|
9,510 |
|
|
|
8,102 |
|
General and administrative |
|
|
3,642 |
|
|
|
3,143 |
|
Restructuring costs |
|
|
- |
|
|
|
131 |
|
|
|
|
|
|
Total
operating expenses |
|
|
13,152 |
|
|
|
11,376 |
|
|
|
|
|
|
Loss from
operations |
|
|
(13,152 |
) |
|
|
(11,376 |
) |
|
|
|
|
|
Other income
(expense) |
|
|
|
|
Warrant revaluation income |
|
|
1,101 |
|
|
|
- |
|
Future tranche right revaluation income |
|
|
20,711 |
|
|
|
- |
|
Other income (expense), net |
|
|
157 |
|
|
|
402 |
|
|
|
|
|
|
Net income
(loss) |
|
$ |
8,817 |
|
|
$ |
(10,974 |
) |
|
|
|
|
|
Net income
(loss) per common share applicable to common stockholders |
|
|
|
|
— basic |
|
$ |
0.27 |
|
|
$ |
(0.40 |
) |
— diluted |
|
$ |
0.22 |
|
|
$ |
(0.40 |
) |
|
|
|
|
|
Weighted-average number of common shares used in computing net
income (loss) per share applicable to common stockholders |
|
|
|
|
— basic |
|
|
30,300 |
|
|
|
27,676 |
|
— diluted |
|
|
33,010 |
|
|
|
27,676 |
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Balance
Sheet Data(In thousands)
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
33,487 |
|
|
$ |
42,793 |
|
|
Other
assets |
|
3,579 |
|
|
|
4,696 |
|
|
Total
assets |
$ |
37,066 |
|
|
$ |
47,489 |
|
|
|
|
|
|
|
Total
liabilities |
$ |
37,210 |
|
|
$ |
58,657 |
|
|
Total
stockholders' equity (deficit) |
|
(144 |
) |
|
|
(11,168 |
) |
|
Total
liabilities and stockholders' equity (deficit) |
$ |
37,066 |
|
|
$ |
47,489 |
|
|
|
|
|
|
|
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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