Immune Design Reports Second Quarter 2018 Financial Results and Provides Corporate Update
August 01 2018 - 4:01PM
Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on
next-generation therapies in oncology, today reported financial
results and a corporate update for the second quarter ended June
30, 2018.
“We have had a solid year of progress so far at
Immune Design, with important advancements with CMB305, and now
with G100,” said Carlos Paya, M.D., Ph.D., President and Chief
Executive Officer of Immune Design. “Based on recent interactions
with the FDA, we plan to aggressively advance G100 in follicular
lymphoma patients. Simultaneously, the CMB305 pivotal Phase 3
SYNOVATE trial is now open for enrollment in the U.S. to patients
with synovial sarcoma. We believe these late-stage programs
position us well to bring novel therapies to cancer patients with
high unmet need.”
Pipeline Highlights
- G100: moving forward with an ORR-based study in
patients with relapsed follicular lymphoma (FL)
- G100 is a novel, synthetic TLR4 agonist for intratumoral
therapy
- Based on feedback from an End of Phase 1 FDA meeting:
- FDA notes that relapsed FL patients who have failed three lines
of systemic therapy represents an unmet medical need population;
and
- FDA agrees that a single-arm trial to evaluate objective
response rate (ORR) and duration of response (DOR) is appropriate
to assess the efficacy of G100 in combination with pembrolizumab
with an adaptive design that allows for an interim
analysis. Immune Design is working with the FDA on the details
of the study and plans to initiate patient enrollment as soon
as feasible after the protocol is finalized.
- The company intends to use this open label approach to generate
data for a potential biological license application and plans to
provide an update on the final study design and associated timeline
after the ongoing FDA discussions are complete.
- CMB305: the SYNOVATE Phase 3 trial is open for
enrollment; combination with atezolizumab Phase 2
ongoing
-
- CMB305 is a novel prime-boost cancer vaccine targeting
NY-ESO-1+ cancers in patients with soft tissue sarcoma.
- Monotherapy:
- SYNOVATE study, a randomized, global Phase 3 trial evaluating
CMB305 monotherapy versus placebo in synovial sarcoma patients in a
post 1st line therapy maintenance setting is open for
enrollment.
- Immune Design is working on opening additional clinical sites
throughout the United States, followed by expansion into Canada,
Europe and the Asia Pacific region.
- Combination therapy: the Phase 2 study evaluating the
combination of CMB305 with atezolizumab in relapsed refractory
soft-tissue sarcoma patients continues follow-up to determine
overall survival after achieving an estimated 72 events.
-
- Immune Design will shift resources to focus on later-stage
programs, specifically for the development of G100 in relapsed FL
and beyond. Consequently, the company is pausing further
development of its preclinical programs, CA21 and intratumoral
ZVex-IL12.
- This allocation of resources enables the company to run the
planned G100 study at least to the interim analysis with
existing capital.
- Upcoming Data Presentation
-
- Immune Design plans to present long-term follow-up data from
its CMB305 monotherapy trial in soft tissue sarcoma patients at the
European Society for Medical Oncology (ESMO) 2018 Congress in
October. The ESMO presentation will be in the forms of both a
poster and poster discussion session.
Financial Results
- Immune Design ended the second quarter of 2018 with $120.3
million in cash and cash equivalents, short-term investments, and
other receivables compared to $144.2 million as of December 31,
2017. Net cash used in operations for the six months ended
June 30, 2018 was $27.3 million.
- Net loss and net loss per share for the second quarter of 2018
were $13.8 million and $0.29, respectively, compared to $13.8
million and $0.54, respectively, for the second quarter of
2017.
- Revenue for the second quarter of 2018 was $0.8 million and was
primarily attributable to $0.4 million in collaboration revenue
associated with the Sanofi G103 HSV2 vaccine collaboration and $0.4
million in product sales to collaboration partners. Revenue for the
second quarter of 2017 was $0.7 million and was primarily
attributable to collaboration revenue associated with the Sanofi
G103 collaboration.
- Research and development expenses for the second quarter of
2018 were $11.0 million, compared to $10.9 million for the
same period in 2017. The $0.1 million increase in research and
development expenses was primarily attributable to an increase in
personnel-related expenses and an increase in research and
development headcount to support the company’s advancing research
and clinical pipeline activities. This increase was offset by a
slight decrease of $0.1 million in in-licensing royalties and fees
and a $0.1 million decrease in research and development supplies
and services.
- General and administrative expenses for the second quarter of
2018 were $4.0 million, compared to $3.9 million for the same
period in 2017. The $0.1 million increase in general and
administrative expenses was primarily attributable to an increase
in professional fees and services to help support our ongoing
operations, which was offset by a decrease in personnel-related
expenses in the form of stock-based compensation expense.
Year-to-Date
- Net loss and net loss per share for the six months ended June
30, 2018 were $27.1 million and $0.56, respectively, compared to
$26.5 million and $1.04, respectively, for the same period in
2017.
- Revenue for the six months ended June 30, 2018 was $1.3 million
and was primarily attributable to $0.8 million in collaboration
revenue associated with the Sanofi G103 collaboration and $0.4
million in product sales to collaboration partners. Revenue for the
same period in 2017 was $6.2 million and was primarily attributable
to $5.9 million in collaboration revenue associated with the Sanofi
G103 collaboration and $0.3 million in product sales to other third
parties.
- Research and development expenses for the six months ended June
30, 2018 were $21.3 million compared to $24.9 million for the same
period in 2017. The $3.6 million decrease in research and
development expenses was primarily attributable to a decrease of
$4.8 million in costs related to the timing and nature of certain
contract manufacturing activities connected to the Sanofi G103
collaboration. Offsetting this decrease was an increase of $1.1
million in personnel-related expenses, which was primarily due to
an increase in compensation and benefits and an increase in
research and development headcount.
- General and administrative expenses did not materially differ
over the comparative periods. For the six months ended June 30,
2018, general and administrative expenses were $8.0 million
compared to $8.0 million for the same period in 2017. In February
2018, Immune Design recouped $0.8 million from the TVS settlement,
which decrease in expense was offset by an increase of $0.6 million
in professional fees and services and $0.2 million in compensation
and benefits to support ongoing operations.
Cash Guidance
Based on current expectations, Immune Design expects to have
cash to fund operations into the second half of 2020.
Conference Call Information
Immune Design will host a conference call and live audio webcast
this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time
to discuss second quarter 2018 financial results and provide a
corporate update.
The live call may be accessed by dialing 844-266-9538 for
domestic callers and 216-562-0391 for international callers. A live
webcast of the call will be available online from the investor
relations section of the Immune Design website at
http://ir.immunedesign.com/events.cfm and will be archived there
for 30 days. A telephone replay of the call will be available for
five days by dialing 855-859-2056 for domestic callers or
404-537-3406 for international callers and entering the conference
code 3376676.
An archived copy of the webcast will be available on Immune
Design's website beginning approximately two hours after the
conference call. Immune Design will maintain an archived
replay of the webcast on its website for at least 30 days after the
conference call.
About Immune Design
Immune Design is a late-stage immunotherapy company employing
next-generation in vivo approaches to enable the body's immune
system to fight disease. The company's technologies are engineered
to activate the immune system's natural ability to generate and/or
expand antigen-specific cytotoxic immune cells to fight cancer and
other chronic diseases. CMB305 and G100, the leading product
candidates with broad potential in oncology, are based on the
company’s two technology platforms that are potent stimulators of
the immune system – ZVex® and GLAAS® – the fundamental technologies
of which were licensed from the California Institute of technology
and the Infectious Disease Research Institute (IDRI), respectively.
Both ZVex and GLAAS also have potential applications in infectious
disease and allergy indications, which are being developed through
ongoing pharmaceutical collaborations. Immune Design has
offices in Seattle and South San Francisco. For more information,
please visit www.immunedesign.com.
Cautionary Note on Forward-looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,”
“target,” “estimate,” “intend” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Immune Design’s
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties that could cause Immune Design’s clinical development
programs, future results or performance to differ significantly
from those expressed or implied by the forward-looking statements.
Forward-looking statements contained in this press release include,
but are not limited to, statements about the design, progress,
timing, scope and results of clinical trials, the association of
data with treatment outcomes, the timing and likelihood of
obtaining regulatory approval of Immune Design’s product candidates
and timing estimates of cash remaining to fund operations. Many
factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data
observed during preclinical or clinical studies, clinical trial
site activation or enrollment rates that are lower than expected,
changes in expected or existing competition, changes in the
regulatory environment, the uncertainties and timing of the
regulatory approval process, and unexpected litigation or other
disputes. Other factors that may cause Immune Design’s actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Immune Design’s filings with the U.S. Securities and Exchange
Commission, including the “Risk Factors” sections contained
therein. Except as required by law, Immune Design assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
|
Immune Design
Corp. |
|
|
|
Selected
Balance Sheet Data |
|
|
|
(In Thousands) |
|
|
|
|
June 30,
2018 |
|
December 31,
2017 |
|
(unaudited) |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
73,430 |
|
$ |
72,454 |
Short-term
investments |
|
46,795 |
|
|
68,653 |
Other receivables |
|
88 |
|
|
3,134 |
Total assets |
|
124,732 |
|
|
153,834 |
Total current
liabilities |
|
7,901 |
|
|
14,520 |
Total stockholders'
equity |
|
116,724 |
|
|
139,212 |
|
|
|
|
|
Immune Design Corp. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss Data |
(In Thousands, Except Share and Per Share Amounts) |
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
(unaudited) |
|
(unaudited) |
Revenues: |
|
|
|
|
|
|
|
Collaborative revenue |
$ |
334 |
|
|
$ |
681 |
|
|
$ |
830 |
|
|
$ |
5,885 |
|
Product
sales |
|
421 |
|
|
|
48 |
|
|
|
428 |
|
|
|
309 |
|
Total
revenues |
|
755 |
|
|
|
729 |
|
|
|
1,258 |
|
|
|
6,194 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of
product sales |
|
140 |
|
|
|
18 |
|
|
|
147 |
|
|
|
55 |
|
Research
and development |
|
11,000 |
|
|
|
10,863 |
|
|
|
21,311 |
|
|
|
24,901 |
|
General
and administrative |
|
4,006 |
|
|
|
3,888 |
|
|
|
8,001 |
|
|
|
8,023 |
|
Total
operating expenses |
|
15,146 |
|
|
|
14,769 |
|
|
|
29,459 |
|
|
|
32,979 |
|
Loss
from operations |
|
(14,391 |
) |
|
|
(14,040 |
) |
|
|
(28,201 |
) |
|
|
(26,785 |
) |
Interest
and other income |
|
583 |
|
|
|
194 |
|
|
|
1,093 |
|
|
|
319 |
|
Net
loss |
$ |
(13,808 |
) |
|
$ |
(13,846 |
) |
|
$ |
(27,108 |
) |
|
$ |
(26,466 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
32 |
|
|
|
4 |
|
|
|
14 |
|
|
|
(19 |
) |
Comprehensive loss |
$ |
(13,776 |
) |
|
$ |
(13,842 |
) |
|
$ |
(27,094 |
) |
|
$ |
(26,485 |
) |
Basic
and diluted net loss per share |
$ |
(0.29 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.04 |
) |
Weighted-average shares used to compute basic and diluted net
loss per share |
|
48,125,652 |
|
|
|
25,567,482 |
|
|
|
48,124,033 |
|
|
|
25,515,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Media ContactJulie
Rathbunjulie.rathbun@immunedesign.com206-769-9219
Investor ContactSylvia
Wheelersylvia.wheeler@immunedesign.com650-392-8318
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