Immune Design Reports Third Quarter 2016 Financial Results and Provides Corporate Update
November 09 2016 - 04:02PM
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today reported financial results and a
corporate update for the third quarter ended September 30, 2016.
“During the third quarter, we continued enrollment
of our clinical programs, recruited senior leadership with
late-stage oncology development expertise, and advanced the range
of future potential products from our differentiated ZVex
platform,” said Carlos Paya, M.D., Ph.D., President and Chief
Executive Officer of Immune Design. “Backed by both new and
existing investors who participated in our recent financing, we are
focused on delivering meaningful results in both of our approaches
in 2017.”
Recent Highlights
Product Development: Continued progress on
all programs from ZVex® and
GLAASTM platforms
Antigen Specific: CMB305
Program
- CMB305, the novel prime-boost NY-ESO-1 cancer
vaccine using the ZVex platform, is being evaluated in soft tissue
sarcoma (STS) patients both as a potential monotherapy and in
combination with an anti-PD-L1 antibody.
- CMB305 monotherapy:
- Follow-up continues on the two fully enrolled monotherapy
Phase 1 trials (CMB305; n=24 patients, and its vector-only
component, LV305; n=23 patients). As reported by investigators, at
the end of the third quarter:
- The safety profile remains favorable, with a consistent rate of
NY-ESO-1-triggered T cell responses that appear stronger with
CMB305.
- The median overall survival (OS) has still not been reached in
either study, with CMB305 and LV305 having a median follow-up of
approximately 221 days and 640 days, respectively. Chemotherapeutic
agents approved to treat metastatic STS have shown a median OS of
12.4-13.5 months.
- CMB305 in combination with
TECENTRIQ® (atezolizumab):
Enrollment continues in this randomized 80 patient, Phase 2 study
comparing CMB305 plus atezolizumab vs. atezolizumab alone, pursuant
to a collaboration with Genentech.
- Immune Design intends to submit data for presentation from the
CMB305 studies beginning at the American Society of Clinical
Oncology annual meeting in 2017 (ASCO 2017).
Antigen Agnostic: G100 Program
- G100, the formulated TLR4 synthetic agonist
from the GLAAS platform, GLA-SE, injected intratumorally, is being
evaluated in an ongoing randomized Phase 2 trial in patients with
follicular non-Hodgkin lymphoma (fNHL). Patients receive either
G100 and low-dose radiation (RadRx) or G100 and low-dose RadRx with
the systemic administration of the anti-PD-1 antibody,
Keytruda® (pembrolizumab), pursuant to a
collaboration with Merck. In contrast with CMB305’s focus on OS,
the initial endpoint focus for this study is on response rates in
both treated and distal, non-treated lesions.
- Immune Design intends to submit data from this Phase 2 study
for presentation beginning at ASCO 2017.
Expansion of the versatility of the ZVex
platform and further support for ongoing product development:
upcoming presentations at SITC and ASH
- To avoid potential antigenic competition and to induce an
immune response to multiple antigens that are co-delivered to
dendritic cells, Immune Design has further developed the ZVex
platform to enable the delivery of multiple RNA genes to dendritic
cells to induce a simultaneous T cell response against each,
separate antigen. The company intends to include this new feature
in its planned next generation of product candidates,
ZVex2.0, which will be designed to deliver both
multiple conserved antigens and/or neo-antigens, in the latter
case, distinct from ZVexNeo and the collaboration with Gritstone
Oncology.
- A preclinical prototype from this evolution of the ZVex
platform will be presented at the upcoming SITC annual meeting, as
well as a presentation illustrating preclinical data from a new
prime-boost option coupling a ZVex vector with an alternate boost
modality. Also, at the ASH 2016 annual meeting, Immune Design will
present additional preclinical data describing the synergy of G100
with local radiation to eradicate lymphomas, further supporting its
ongoing G100 Phase 2 study in fNHL.
Expansion of the Senior Leadership
Team
Sergey Yurasov, M.D., Ph.D. Joins Executive
Team: Addition of Late-Stage Oncology Development
Expertise
- Dr. Sergey Yurasov joined the Immune Design team as Senior Vice
President of Clinical Development and Chief Medical Officer in
October 2016. Dr. Yurasov brings more than 20 years' experience in
immunology and late-stage oncology drug development to the
company.
Acquisition of Intellectual Property Rights
and Settlement of Litigation and Patent Challenge
- On October 21, 2016, Immune Design announced the acquisition of
intellectual property rights from, and settlement of outstanding
legal proceedings with, Theravectys SA (TVS). Immune Design
obtained a license to certain present and future intellectual
property of TVS related to the company’s ZVex platform, and
resolved all outstanding proceedings in Delaware and Belgium and a
patent opposition proceeding brought by TVS against one of the
company’s patents related to ZVex. Please refer to Immune Design’s
Current Report on Form 8-K filed on October 21, 2016 for a more
complete description of the terms.
Completion of Follow-On
Financing
- In September 2016, Immune Design completed an underwritten
follow-on public offering, which resulted in the sale of 5,226,369
shares of common stock, at a price of $6.25 per share. Net proceeds
from the offering were $30.3 million after deducting underwriting
discounts, commissions and estimated expenses. Both new and
existing investors participated in the offering.
Financial Results
Third Quarter
- Immune Design ended the third quarter of 2016 with $112.5
million in cash, cash equivalents and short-term investments,
compared to $112.9 million as of December 31, 2015. Net cash
used in operations for the nine months ended September 30, 2016 was
$31.4 million and $10.9 million for the three months ended
September 30, 2016.
- Net loss and net loss per share for the third quarter of 2016
were $12.4 million and $0.60, respectively, compared to $7.4
million and $0.37, respectively, for the third quarter of
2015.
- Revenue for the third quarter of 2016 was $8.2 million and was
attributable primarily to $7.0 million in license revenue
associated with Immune Design’s collaboration with Sanofi, $0.4
million in product sales to collaboration partner Sanofi, and $0.8
million in collaboration revenue associated with the Sanofi G103
(HSV2 therapeutic vaccine) collaboration. Revenue for the
third quarter of 2015 was $4.7 million and was attributable
primarily to $3.5 million in license revenue associated with Immune
Design’s collaboration with Sanofi, $0.8 million in product sales
to collaboration partners MedImmune and Sanofi, and $0.3 million in
collaboration revenue associated with the Sanofi G103 (HSV2
therapeutic vaccine) collaboration.
- Research and development expenses for the third quarter of 2016
were $11.2 million, compared to $8.3 million for the third
quarter of 2015. The $2.9 million increase was primarily
attributable to continuing advancement of Immune Design’s ongoing
research and development programs, including ongoing Phase 1 and
Phase 2 clinical trials.
- General and administrative expenses for the third quarter of
2016 were $9.6 million, compared to $3.5 million for the third
quarter of 2015. The $6.1 million increase was primarily
attributable to the settlement and license agreements with TVS
involving the acquisition of certain present and future
intellectual property rights from TVS and resolving the litigation
initiated by TVS in July 2014 against the Company, as well as
related claims and counterclaims.
Year-to-Date
- Net loss and net loss per share for the nine months ended
September 30, 2016 were $39.1 million and $1.92, respectively,
compared to $27.3 million and $1.45, respectively, for the same
period in 2015.
- Revenue for the nine months ended September 30, 2016 was $11.2
million and was attributable primarily to $7.0 million in license
revenue associated with Immune Design’s collaboration with Sanofi,
$1.2 million in product sales to collaboration partner Sanofi, and
$3.0 million in collaboration revenue associated with the Sanofi
G103 (HSV2 therapeutic vaccine) collaboration. Revenue for
the nine months ended September 30, 2015 was $8.4 million and was
attributable primarily to $3.5 million in license revenue
associated with Immune Design’s collaboration with Sanofi, $0.9
million in product sales to collaboration partners MedImmune and
Sanofi, and $3.9 million in collaboration revenue associated with
the Sanofi G103 (HSV2 therapeutic vaccine)
collaboration.
- Research and development expenses for the nine months ended
September 30, 2016 were $33.1 million compared to $24.2 million for
the same period in 2015. The $8.9 million increase was primarily
attributable to continuing advancement of Immune Design’s ongoing
research and development programs, including ongoing Phase 1 and
Phase 2 clinical trials and an increase in personnel-related
expenses to support the company’s advancing research and clinical
pipeline.
- General and administrative expenses for the nine months ended
September 30, 2016 were $17.4 million, compared to $11.1 million
for the same period in 2015. The $6.3 million increase was
primarily attributable to the settlement and license agreements
with TVS entered into in October 2016 involving the acquisition of
certain present and future intellectual property rights from TVS
and resolving the litigation initiated by TVS in July 2014 against
the Company, as well as related claims and
counterclaims.
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 the third quarter 2016 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 company website
at http://ir.immunedesign.com/events.cfm and will be archived there
for 90 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: 10923483.
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 clinical-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 T cells, while
also enhancing other immune effectors, to fight cancer and other
chronic diseases. CMB305 and G100, the two-pronged focus of
Immune Design's ongoing immuno-oncology clinical programs, are the
product of its two synergistic discovery platforms,
ZVex® and GLAASTM. Both ZVex and GLAAS also have
potential applications in infectious disease and allergy as
demonstrated by ongoing pharmaceutical collaborations. Immune
Design has offices in Seattle and South San Francisco. For more
information, 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,” “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. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include, but are not limited to, statements
about the progress, timing, scope and results of clinical trials
for Immune Design’s product candidates and the reporting of
clinical data regarding Immune Design’s product candidates. 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 enrolment rates that are lower than expected,
changes in expected or existing competition, changes in the
regulatory environment, failure of Immune Design’s collaborators to
support or advance collaborations or product candidates 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) |
|
|
|
|
|
September 30,
2016 |
|
December 31, 2015 |
|
(unaudited) |
|
|
Cash and cash
equivalents |
$ |
70,434 |
|
|
$ |
112,921 |
|
Short-term
investments |
|
42,037 |
|
|
|
- |
|
Total assets |
|
125,659 |
|
|
|
116,145 |
|
Total current
liabilities |
|
17,090 |
|
|
|
7,111 |
|
Total stockholders'
equity |
|
107,259 |
|
|
|
108,993 |
|
|
|
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss Data |
|
(In Thousands Except Per Share Amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
Licensing revenue |
$ |
7,000 |
|
|
$ |
3,500 |
|
|
$ |
7,000 |
|
|
$ |
3,500 |
|
|
Product
sales |
|
426 |
|
|
|
824 |
|
|
|
1,166 |
|
|
|
932 |
|
|
Collaborative revenue |
|
780 |
|
|
|
329 |
|
|
|
3,036 |
|
|
|
3,939 |
|
|
Total
revenues |
|
8,206 |
|
|
|
4,653 |
|
|
|
11,202 |
|
|
|
8,371 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of
product sales |
|
72 |
|
|
|
298 |
|
|
|
347 |
|
|
|
421 |
|
|
Research
and development |
|
11,173 |
|
|
|
8,263 |
|
|
|
33,129 |
|
|
|
24,209 |
|
|
General
and administrative |
|
9,554 |
|
|
|
3,506 |
|
|
|
17,416 |
|
|
|
11,086 |
|
|
Total
operating expenses |
|
20,799 |
|
|
|
12,067 |
|
|
|
50,892 |
|
|
|
35,716 |
|
|
Loss
from operations |
|
(12,593 |
) |
|
|
(7,414 |
) |
|
|
(39,690 |
) |
|
|
(27,345 |
) |
|
Interest
and other income |
|
150 |
|
|
|
7 |
|
|
|
606 |
|
|
|
15 |
|
|
Net
loss |
$ |
(12,443 |
) |
|
$ |
(7,407 |
) |
|
$ |
(39,084 |
) |
|
$ |
(27,330 |
) |
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
(23 |
) |
|
|
- |
|
|
|
7 |
|
|
|
- |
|
|
Comprehensive loss: |
$ |
(12,466 |
) |
|
$ |
(7,407 |
) |
|
$ |
(39,077 |
) |
|
$ |
(27,330 |
) |
|
Basic
and diluted net loss per share |
$ |
(0.60 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.92 |
) |
|
$ |
(1.45 |
) |
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
20,803,776 |
|
|
|
20,131,260 |
|
|
|
20,372,376 |
|
|
|
18,822,517 |
|
|
|
|
|
|
|
|
|
|
|
Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219
Investor Contact
Shari Annes
Annes Associates
Shari.Annes@immunedesign.com
650-888-0902
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