– Company to Provide ILLUMINATE 204
Data Update in the First Half of December 2018
–– Cash runway into first quarter of 2020
–
Idera Pharmaceuticals, Inc. (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
third quarter ended September 30, 2018.
“The third quarter of 2018 was marked by continued focus and
execution throughout our company advancing the tilsotolimod
ILLUMINATE 301 trial toward approval in our lead indication in
anti-PD-1 refractory or relapsed metastatic melanoma. We also made
significant progress framing our plans to expand the development of
tilsotolimod to additional tumor types,” stated Vincent Milano,
Idera’s Chief Executive Officer.
“Over these past several years, through all of the preclinical
studies, translational data collections and ultimately our early
clinical experiences, it’s becoming clearer to us that the
potential utility of tilsotolimod is not limited to melanoma and is
certainly not limited by the location or type of tumor,” continued
Milano. “We look forward to providing our next clinical update from
the ILLUMINATE 204 trial in the first half of December as well as
laying out our expansion plans for the program in the beginning of
2019.”
“The majority of our company’s focus is and will remain towards
maximizing the opportunity with, and more importantly, the number
of patients that can benefit from, tilsotolimod. At the same time,
we recognize and embrace the concept of continuing to build Idera
for the future. To that end, we will continue to be aggressive in
our pursuit of additional assets to further drive value for our
shareholders, and more importantly, meet the needs of patients
suffering from rare diseases with serious unmet needs.”
Clinical Development Program Updates:
ILLUMINATE (tilsotolimod) Clinical
Development
ILLUMINATE 301 – Randomized Phase 3 trial of
intratumoral tilsotolimod in combination with ipilimumab versus
ipilimumab alone in patients with PD-1 refractory/relapsed
metastatic melanoma:
- Trial initiated in the first quarter of 2018;
- 42 of the planned up to 110 sites across 12 countries have been
activated for the randomization of patients into the trial;
- ILLUMINATE 301 Trials in Progress (TiPS) presentation on trial
design featured at the 2018 Congress of the European Society of
Medical Oncology (ESMO);
- Planned enrollment of approximately 300 patients with Overall
Response Rate (“ORR”) and Overall Survival as primary endpoints;
and
- U.S. Food and Drug Administration granted Fast Track
Designation in fourth quarter of 2017 for tilsotolimod in
combination with ipilimumab for the treatment of patients with
unresectable or metastatic melanoma following failure of PD-1
inhibitor treatment.
ILLUMINATE 204 – Phase 1/2 trial of
intratumoral tilsotolimod in combination with either ipilimumab or
pembrolizumab in patients with PD-1 refractory/relapsed metastatic
melanoma:
Ipilimumab Combination Arm – Phase 2 Recruitment
Ongoing
- Enrollment continues at 10 U.S. clinical trial sites;
- Two additional sites planned for initiation in November
2018;
- ILLUMINATE 204 Trial Data update presented at ESMO 2018
demonstrated both abscopal effect as well as the potential of
intratumoral tilsotolimod to overcome known resistance mechanisms
to ipilimumab treatment as a monotherapy.
- Earlier this year at the American Society of Clinical Oncology
(ASCO) Annual Meeting, the company presented clinical efficacy and
safety data from the first 21 evaluable patients demonstrating:
- Confirmed RECIST v1.1 responses (including 2 Complete Responses
[CR]) were observed in 8 of these 21 subjects (38.1%);
- Overall 15 patients out of 21 evaluable for efficacy (71.4%)
experienced disease control (CR, PR, or SD);
- The combination regimen was generally well tolerated. 6/26
subjects (23%) had immune-related toxicities indicating that
IMO-2125 + ipilimumab does not appear to add toxicity versus
ipilimumab alone;
- Injection-related toxicities were grade 1-2 transient fever and
flu-like symptoms lasting <48 hours;
- 15/26 patients (57.7%) with lesions accessible only by
image-guided injection (5 deep visceral lesions and 10 lymph nodes)
were included; and
- The company plans to provide a data update on up to 35
evaluable patients in first half of December 2018.
Pembrolizumab Combination Arm – Phase 1 Dose Escalation
Ongoing
- Enrollment in the last dosing cohort (32 mg) ongoing with one
patient remaining to complete enrollment (priority enrollment has
been towards the ipilimumab combination arm of ILLUMINATE
204).
- One patient in the cohort testing 16mg intratumoral
tilsotolimod in combination with pembrolizumab continues on study
with a confirmed complete response (CR).
ILLUMINATE 101 – Phase 1b trial of intratumoral
tilsotolimod monotherapy in patients with refractory solid
tumors:
- Completed enrollment in all four dose ranging cohorts; 41
patients enrolled;
- Continuing enrollment into the refractory melanoma cohort at
the 8 mg dose of intratumoral tilsotolimod as monotherapy;
- Translational data continues to be collected, analyzed and is
planned to be submitted for presentation at a medical oncology
conference in 2019.
Investigator Sponsored Trials (IST)Idera is
supportive of several Investigator Sponsored Trials and continues
to evaluate additional proposals:
- A Phase 1/2 open label study of intratumoral tilsotolimod in
combination with intratumoral ipilimumab and IV nivolumab in a
protocol open to multiple tumor types including non-small cell lung
cancer (NSCLC), melanoma, squamous cell carcinoma of the head and
neck and urothelial carcinoma. The principal investigator
initiating this trial is Aurélien Marabelle, MD, PhD, Clinical
Director of the Cancer Immunotherapy Program at Institut Gustave
Roussy, Villejuif, France; and
- A Phase 2 placebo-controlled study of intradermal
administration of tilsotolimod in patients with T3/T4 primary
melanoma scheduled to undergo a combined re-excision and sentinel
node biopsy (SNB) procedure. The principal investigators initiating
this trial are Bas Koster, MD and Tanja de Gruijl, PhD at The VU
University Medical Center, Amsterdam, the Netherlands.
Corporate Updates:During the quarter, the
following Corporate Organizational Changes were announced:
- Howard Pien appointment to Idera’s Board of Directors on
September 18, 2018, filling the seat previously held by Julian
Baker.
- Bryant D. Lim joined Idera as General Counsel and Secretary to
the Board of Directors, effective September 10, 2018;
- Chief Financial Officer Louis J. Arcudi III’s planned departure
from the company related to the company’s consolidation to PA
headquarters, effective October 31, 2018;
- Vice President of Finance John J. Kirby’s appointment as
Principal Financial Officer and Principal Accounting Officer,
effective October 31, 2018; and
Financial Results Third Quarter
ResultsNet loss applicable to common stockholders for the
three months ended September 30, 2018 was $11.6 million, or $0.43
per basic and diluted share, compared to net loss applicable to
common stockholders of $14.5 million, or $0.78 per basic and
diluted share, for the same period in 2017. Revenue in each of the
three months ended September 30, 2018 and 2017 was nominal.
Research and development expenses for the three months ended
September 30, 2018 totaled $8.9 million compared to $10.9 million
for the same period in 2017. General and administrative expense for
the three months ended September 30, 2018 totaled $4.0 million
compared to $3.9 million for the same period in 2017.
Merger-related costs, net for the three months ended September 30,
2018 amounted to a net credit of $3.8 million and was comprised of
a $6.0 million fixed expense reimbursement received in connection
with the termination of the company’s proposed merger with BioCryst
Pharmaceuticals, Inc., which was terminated in July 2018; partially
offset by $2.2 million of expenses incurred in connection with the
transactions contemplated by the related merger agreement. No such
costs were incurred during 2017. Restructuring costs for the three
months ended September 30, 2018 totaled $3.0 million and are a
result of our decision in July 2018 to wind-down our discovery
operations, reduce the workforce in Cambridge, Massachusetts that
supported such operations, and close our Cambridge facility. No
such costs were incurred during 2017.
As of September 30, 2018, the company’s cash and cash
equivalents totaled $82.5 million. The company currently
anticipates that, based on its current operating plan, its existing
cash and cash equivalents will be sufficient to fund company
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 period ended December 31, 2017 and in the Company’s
Quarterly Report on Form 10-Q for the period ended September 30,
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 |
|
Nine Months
Ended |
|
|
|
September
30, |
|
September
30, |
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alliance revenue |
$ |
145 |
|
|
$ |
164 |
|
|
$ |
563 |
|
|
$ |
729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
8,860 |
|
|
|
10,912 |
|
|
|
32,912 |
|
|
|
40,288 |
|
|
|
General
and administrative |
|
3,984 |
|
|
|
3,919 |
|
|
|
11,849 |
|
|
|
11,888 |
|
|
|
Merger-related costs, net |
|
(3,836 |
) |
|
|
- |
|
|
|
1,245 |
|
|
|
- |
|
|
|
Restructuring costs |
|
3,017 |
|
|
|
- |
|
|
|
3,017 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
12,025 |
|
|
|
14,831 |
|
|
|
49,023 |
|
|
|
52,176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(11,880 |
) |
|
|
(14,667 |
) |
|
|
(48,460 |
) |
|
|
(51,447 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net |
|
275 |
|
|
|
137 |
|
|
|
729 |
|
|
|
389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(11,605 |
) |
|
$ |
(14,530 |
) |
|
$ |
(47,731 |
) |
|
$ |
(51,058 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share applicable to common stockholders — basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.81 |
) |
|
$ |
(2.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number
of common sharesused in computing net loss per share applicable
tocommon stockholders — basic and diluted |
|
27,175 |
|
|
|
18,704 |
|
|
|
26,404 |
|
|
|
18,673 |
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals, Inc.Condensed
Balance Sheet Data(In thousands)
|
|
|
|
|
|
|
|
September 30, |
|
December
31, |
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
82,462 |
|
$ |
112,629 |
|
|
Other assets |
|
2,768 |
|
|
5,788 |
|
|
Total assets |
$ |
85,230 |
|
$ |
118,417 |
|
|
|
|
|
|
|
|
Total liabilities |
$ |
10,364 |
|
$ |
10,722 |
|
|
Total stockholders'
equity |
|
74,866 |
|
|
107,695 |
|
|
Total liabilities and
stockholders' equity |
$ |
85,230 |
|
$ |
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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