– ILLUMINATE-301 Enrollment on Track for
Completion Q4 2019 –– ILLUMINATE-204 Enrollment
Complete; Data Anticipated Q4
2019 ––
ILLUMINATE-206 Trial Expected to
Initiate Q2 2019 –– Chief Medical Officer Dr.
Joanna Horobin Announces Retirement Plan
–– Company to Present at Barclays Global
Healthcare Conference Next Week –
Idera Pharmaceuticals, Inc. (“Idera”) (NASDAQ: IDRA), a
clinical-stage biopharmaceutical company focused on the
development, and ultimately the commercialization, of therapeutic
drug candidates for both oncology and rare disease indications
characterized by small, well-defined patient populations with
serious unmet medical needs, today reported its financial and
operational results for the fourth quarter and year ended December
31, 2018.
“2018 ended with incredibly positive momentum for tilsotolimod
which carried into 2019 and continues today,” stated Vincent
Milano, Idera’s chief executive officer. “Despite the
challenges we faced in the first half of 2018, we emerged as a
tightly focused organization with a clear understanding of our
mission to bring tilsotolimod to the market in our initial
indication of anti-PD-1 refractory metastatic melanoma. We
also are exploring tilsotolimod as an investigational therapy for
patients with other tumor types that have not been well-served by
available immunotherapies to date,” continued Milano. “The
ILLUMINATE development program is making excellent progress across
the board and I am incredibly proud of our team for their continued
dedication and execution.”
“As it pertains to Idera overall, we will continue business
development efforts to identify and pursue assets and opportunities
with the purpose of further growing our company for long-term
success and value creation for our loyal shareholders.
However, I cannot be any clearer that the advancement and
future success of tilsotolimod is our highest priority, passion and
focus.”
ILLUMINATE (tilsotolimod) Clinical Development
Update
ILLUMINATE 301 – Randomized phase 3 trial of
tilsotolimod in combination with ipilimumab versus ipilimumab alone
in patients with PD-1 refractory metastatic melanoma:
• Overall Response Rate (ORR) and Overall Survival (OS) as
primary endpoints;
• Trial initiated in the first quarter of 2018;
• Sites planned in 12 countries: 78 sites activated;
• Planned enrollment of approximately 300 patients; and
• Completion of enrollment expected during the fourth quarter of
2019.
ILLUMINATE 206 – Phase 2, multi-center trial to
test the safety and effectiveness of tilsotolimod in combination
with ipilimumab and nivolumab in treating patients with Squamous
Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite
Stable Colorectal Cancer (MSS-CRC).
• Received notice from the U.S. Food and Drug Administration
that the company can proceed to implement the ILLUMINATE-206
clinical trial under a new Investigational New Drug (IND)
application; and
• Both trial cohorts of SCCHN and MSS-CRC expected to initiate
in the second quarter of 2019.
ILLUMINATE 204 – Phase 1/2 trial of
tilsotolimod in combination with ipilimumab or pembrolizumab in
patients with PD-1 refractory metastatic melanoma:
• Completed enrollment with 52 patients in Phase 2 expansion at
8 mg (RP2D) dose with ipilimumab;
• Completed target enrollment of at least 40 patients in the
primary enrollment population constituting patients who are naïve
to prior ipilimumab treatment in the metastatic setting;
• Presented an interim data update in December 2018 which
showed:
- 32.4% ORR of the first 34 patients evaluable for efficacy
including 9% (N=3) achieve Complete Response (CR); 24% (N=8)
achieving Partial Response (PR); and 76.5% (N=26) achieving disease
control (CR, PR or Stable Disease [SD]); and
• Data from ILLUMINATE-204 expected in the fourth quarter of
2019.
ILLUMINATE 101 – Phase 1b trial of tilsotolimod
monotherapy in patients with refractory solid tumors:
• Completed enrollment in all dose cohorts of the trial; and
• Abstract accepted for presentation of translational data from
this trial at the American Association for Cancer Research (AACR)
2019 Annual Meeting, being held March 29 – April 3, 2019 in
Atlanta, GA.
Corporate Updates:The company today is
announcing the planned retirement of Senior Vice President and
Chief Medical Officer Joanna Horobin, M.B. Ch.B, given the
consolidation of Idera’s business operations and team in
Pennsylvania. The retirement will be effective July 31,
2019. Dr. Horobin joined Idera in November 2015 and notably
has led the advancement of the tilsotolimod ILLUMINATE program,
advancing the program from pre-clinical into exploratory early
phase clinical and translational evaluation through to the ongoing
ILLUMINATE 301 phase 3 trial in anti-PD-1 refractory metastatic
melanoma and most recently expanding into a study in patients SCCHN
and MSS-CRC.
Dr. Horobin will assist Idera in the search to fill the role of
Chief Medical Officer and will remain with the company in an
advisory capacity following her July 31 retirement.
“I’m incredibly appreciative to Joanna for the critical role she
has played as we transitioned Idera to a focused clinical
development organization with a clear eye towards ultimate
commercialization of products for patients suffering from
life-threatening rare diseases,” offered Milano. “We all wish
Joanna the utmost happiness as she transitions to the next phase of
her life following a tremendously productive and rewarding 35-year
career developing critical medicines that have made a positive
impact on countless patients’ lives.”
“I am tremendously proud of the progress we’ve made at Idera
over the past several years. We have shown clinical
proof-of-concept of tilsotolimod to prime the immune system to
better respond to checkpoint inhibition which may enable
tilsotolimod to benefit more patients,” stated Dr. Horobin.
“It’s been a great honor to work with so many talented individuals
during my time at Idera and I look forward to continuing to assist
in an advisory capacity as the opportunities for tilsotolimod
expand.”
Additionally, since September 30, 2018, the following
corporate updates were announced:
• The company entered into an at the market offering (ATM)
agreement with JMP Securities LLC under which the company may elect
to sell shares of its common stock having an aggregate offering
price of up to $50 million;
• The company entered into a common stock purchase agreement and
registration rights agreement with Lincoln Park Capital (LPC) Fund,
LLC, under which the company has the right to sell an aggregate of
up to $35 million of its common stock at the company’s discretion;
and
• Carol A. Schafer was appointed to Idera’s Board of Directors
on December 18, 2018, filling the seat of Mr. William Reardon, who
will be resigning from the Board effective March 10, 2019.
Upcoming Investor Conference:The company will
participate in the 2019 Barclays Global Healthcare Conference on
Tuesday, March 12, 2019 at 11:15 a.m. Eastern Time at the Loews
Miami Beach Hotel in Florida.
Live audio webcast of Idera’s presentations will be accessible
in the Investors and Media section of Idera’s website at
http://www.iderapharma.com. Archived versions will also be
available on the Company’s website after the event for 90
days.
Financial Results Fourth Quarter
ResultsNet loss applicable to common stockholders for the
three months ended December 31, 2018 was $12.2 million, or $0.45
per basic and diluted share, compared to net loss applicable to
common stockholders of $14.9 million, or $0.66 per basic and
diluted share, for the same period in 2017. Revenue in the fourth
quarter of 2018 was nominal. Research and development
expenses for the three months ended December 31, 2018 totaled $8.9
million compared to $10.4 million for the same period in 2017.
General and administrative expense for the three months ended
December 31, 2018 totaled $3.6 million compared to $3.7 million for
the same period in 2017.
Full Year ResultsNet loss applicable to common
stockholders for the year ended December 31, 2018 was $59.9 million
or $2.25 per basic and diluted share, compared to net loss
applicable to common stockholders of $66.0 million, or $3.35 per
basic and diluted share, for the same period in 2017. Revenue for
the year ended December 31, 2018 was $0.7 million compared to
revenue of $0.9 million for the same period in 2017. Research
and development expenses for the year ended December 31, 2018
totaled $41.8 million compared to $50.7 million for the same period
in 2017. General and administrative expenses for the year ended
December 31, 2018 totaled $15.4 million compared to $15.6 million
for the same period in 2017. Merger-related costs, net for the year
ended December 31, 2018 totaled $1.2 million compared to $1.1
million for the same period in 2017. Restructuring costs for the
year ended December 31, 2018 totaled $3.1 million and related to
our decision in July 2018 to wind-down our discovery
operations. No such costs were incurred in 2017.
As of December 31, 2018, our cash and cash equivalents totaled
$71.4 million compared to $112.6 million as of December 31,
2017. We currently anticipate that, based on our current
operating plan, our existing cash, cash equivalents and investments
will fund our operations into the first quarter of 2020.
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 Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements, other than statements of historical fact, included
or incorporated in this press release, including statements
regarding the company’s strategy, future operations,
collaborations, cash resources, financial position, future
revenues, projected costs, prospects, clinical trials, plans and
objectives of management, are forward-looking statements. The words
“believes,” “anticipates,” “estimates,” “plans,” “expects,”
“intends,” “may,” “could,” “should,” “potential,” “likely,”
“projects,” “continue,” “will,” and “would” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
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. 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 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 for the period anticipated;
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; whether
products based on the company’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 U.S. Food and Drug Administration 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 such other important factors set forth under the
caption “Risk Factors” in the company’s Annual Report on Form 10-K
for the year ended December 31, 2018. Although 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.
Idera Pharmaceuticals, Inc. Condensed
Statements of Operations(In thousands, except per
share data)
|
Three Months
Ended |
|
Twelve Months
Ended |
|
December
31, |
|
December
31, |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance revenue |
$ |
99 |
|
|
$ |
173 |
|
|
$ |
662 |
|
|
$ |
902 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
8,929 |
|
|
|
10,365 |
|
|
|
41,841 |
|
|
|
50,653 |
|
General
and administrative |
|
3,571 |
|
|
|
3,700 |
|
|
|
15,420 |
|
|
|
15,588 |
|
Merger-related costs, net |
|
- |
|
|
|
1,128 |
|
|
|
1,245 |
|
|
|
1,128 |
|
Restructuring costs |
|
95 |
|
|
|
- |
|
|
|
3,112 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
12,595 |
|
|
|
15,193 |
|
|
|
61,618 |
|
|
|
67,369 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(12,496 |
) |
|
|
(15,020 |
) |
|
|
(60,956 |
) |
|
|
(66,467 |
) |
|
|
|
|
|
|
|
|
Other income (expense),
net |
|
346 |
|
|
|
94 |
|
|
|
1,075 |
|
|
|
483 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(12,150 |
) |
|
$ |
(14,926 |
) |
|
$ |
(59,881 |
) |
|
$ |
(65,984 |
) |
|
|
|
|
|
|
|
|
Net loss per common
share applicable to common stockholders — basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.66 |
) |
|
$ |
(2.25 |
) |
|
$ |
(3.35 |
) |
|
|
|
|
|
|
|
|
Weighted-average number
of common shares used in computing net loss per share applicable to
common stockholders — basic and diluted |
|
27,183 |
|
|
|
22,647 |
|
|
|
26,601 |
|
|
|
19,675 |
|
Idera Pharmaceuticals, Inc.Condensed
Balance Sheet Data(In thousands)
|
|
December 31, |
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
71,431 |
|
$ |
112,629 |
|
|
Other assets |
|
1,592 |
|
|
5,788 |
|
|
Total assets |
$ |
73,023 |
|
$ |
118,417 |
|
|
|
|
|
|
|
|
Total liabilities |
$ |
9,029 |
|
$ |
10,722 |
|
|
Total stockholders'
equity |
|
63,994 |
|
|
107,695 |
|
|
Total liabilities and
stockholders' equity |
$ |
73,023 |
|
$ |
118,417 |
|
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals
Contact:
Robert A. Doody, Jr.VP, Investor Relations &
CommunicationsPhone (484) 348-1677rdoody@iderapharma.com
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