Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) (Nasdaq:
IDRA) today reported its financial and operational results for the
third quarter ended September 30, 2020.
“Tilsotolimod is the most advanced TLR-9 agonist therapy in
development, and we have made tremendous strides against our
objectives for 2020,” stated Vincent Milano, Idera’s Chief
Executive Officer. “We continue to work diligently against our
timelines for ILLUMINATE-301, which currently remain on track for
data in the first quarter of 2021. In addition, our recent patent
and allowed application for tilsotolimod method-of-use in
colorectal and head and neck cancers as well as the continuation of
ILLUMINATE-206 reinforce our ‘beyond melanoma’ strategy. We also
have the financing to help our outstanding team continue to execute
these key objectives.”
Corporate UpdateSince
June 30,
2020, the following corporate
updates were announced:
- The Company entered into a private placement of up to $20.0
million, with $5.1 million received in July 2020. The Company
anticipates that its current cash, cash equivalents, and short-term
investments will fund our operations through the second quarter of
2021. With this private placement, the Company has now entered into
three financing vehicles since December 2019, which it believes
could provide proceeds of up to $118.2 million to fund the
potential NDA filing and commercial launch of tilsotolimod.
- The Company received a new U.S. Patent and allowed application
for tilsotolimod, providing exclusivity through September 2037 when
intratumoral tilsotolimod is used with certain immune checkpoint
inhibitors in treating colorectal cancer (CRC) and head and neck
squamous cell carcinoma (HNSCC).
ILLUMINATE
(tilsotolimod)
Clinical Development
UpdatesILLUMINATE-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 central 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;
- 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
- The Company has opened enrollment for the next 10 patients
under the modified study design, 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 results 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, were shared in a Mini Oral presentation at the ESMO
Virtual Congress in September 2020.
Third Quarter
Financial Results Research and development
expenses for the three months ended September 30, 2020, totaled
$4.8 million compared to $8.4 million for the same period in 2019.
General and administrative expense for the three months ended
September 30, 2020, totaled $2.7 million compared to $3.0 million
for the same period in 2019. Additionally, during the three months
ended September 30, 2020, we recorded $0.7 million and $12.4
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 September 30, 2020, was
$20.6 million, or $0.59 per basic and diluted share, compared to
net loss applicable to common stockholders of $11.1 million, or
$0.39 per basic and diluted share, for the same period in 2019.
Excluding the non-cash loss of approximately $13.1 million for the
three months ended September 30, 2020, related to the securities
issued in connection with the December 2019 private placement
transaction, net loss applicable to common stockholders was $7.5
million, or $0.21 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 September 30, 2020, our
cash, cash equivalents, and short-term investments totaled $29.0
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 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 |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Alliance
revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,766 |
|
|
|
8,359 |
|
|
|
19,655 |
|
|
|
26,485 |
|
|
General and administrative |
|
|
2,718 |
|
|
|
3,023 |
|
|
|
8,992 |
|
|
|
9,061 |
|
|
Restructuring costs |
|
|
- |
|
|
|
5 |
|
|
|
- |
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
|
7,484 |
|
|
|
11,387 |
|
|
|
28,647 |
|
|
|
35,727 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(7,484 |
) |
|
|
(11,387 |
) |
|
|
(28,647 |
) |
|
|
(34,279 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
Warrant revaluation loss |
|
|
(683 |
) |
|
|
- |
|
|
|
(495 |
) |
|
|
- |
|
|
Future tranche right revaluation loss |
|
|
(12,350 |
) |
|
|
- |
|
|
|
(6,988 |
) |
|
|
- |
|
|
Other income (expense), net |
|
|
(35 |
) |
|
|
254 |
|
|
|
169 |
|
|
|
996 |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(20,552 |
) |
|
$ |
(11,133 |
) |
|
$ |
(35,961 |
) |
|
$ |
(33,283 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share applicable to common stockholders— basic and
diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares used in computing net loss
per share applicable to common stockholders— basic and diluted |
|
|
35,091 |
|
|
|
28,847 |
|
|
|
32,999 |
|
|
|
28,332 |
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Balance
Sheet Data(In thousands)
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
2020 |
|
2019 |
|
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
28,979 |
|
|
$ |
42,793 |
|
|
Other
assets |
|
3,359 |
|
|
|
4,696 |
|
|
Total
assets |
$ |
32,338 |
|
|
$ |
47,489 |
|
|
|
|
|
|
|
Total
liabilities |
$ |
64,773 |
|
|
$ |
58,657 |
|
|
Total
stockholders' deficit |
|
(32,435 |
) |
|
|
(11,168 |
) |
|
Total
liabilities and stockholders' deficit |
$ |
32,338 |
|
|
$ |
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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