Immune Design Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
March 07 2017 - 4:02PM
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today reported financial results and a
corporate update for the fourth quarter and full year ended
December 31, 2016.
“Throughout 2016, we continued enrollment of our key clinical
programs, recruited senior leadership with late-stage oncology drug
development expertise, and further evolved our ZVex platform to
potentially enable a wider range of differentiated products. In
addition, we successfully closed a follow-on offering that brought
in new investors, as well as additional support from some key
existing investors,” said Carlos Paya, M.D., Ph.D., President and
Chief Executive Officer of Immune Design. “We look forward to a
year in which clinical data begin to validate Immune Design’s
approaches to treating patients.”
2016 Highlights and Corporate Update
Product Development: Progress on all programs and
targeting data releases throughout 2017
Antigen Specific: CMB305 Program and ZVexMulti
Next-Generation Product Candidates
- CMB305 is the prime-boost approach targeting
NY-ESO-1-expressing tumors to generate anti-NY-ESO-1 T cells in
vivo via a mechanism of action Immune Design believes differs from
traditional cancer vaccines. CMB305 is being evaluated in soft
tissue sarcoma (STS) patients in ongoing Phase 1 and 2 monotherapy
and combination studies with the anti-PD-L1 antibody, atezolizumab.
- CMB305 monotherapy
- Follow-up of 48 STS patients from two fully enrolled
monotherapy Phase 1 trials continues (CMB305; n=25 patients,
and its vector-only component, LV305; n=23 patients). As of
December 31, 2016:
- 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 the CMB305 or LV305 study.
- Given that chemotherapeutic agents approved to treat second
line metastatic STS have shown a median OS of 12.4-13.5 months,
Immune Design believes this survival trend and favorable safety
profile seen to date warrants evaluating further development of
CMB305 as a monotherapy in recurrent STS patients.
- CMB305 in combination with
TECENTRIQ® (atezolizumab)
- Enrollment continues in this randomized 80 patient, Phase 2
study in which patients receive CMB305 plus atezolizumab vs.
atezolizumab alone, pursuant to a collaboration with
Genentech.
- In addition to the potential of CMB305 as a monotherapy, the
combination of CMB305 with a checkpoint inhibitor offers an
additional potential approval path.
- 2017 Presentation Planning
- Immune Design submitted data for presentation at the American
Society of Clinical Oncology annual meeting in 2017 (ASCO 2017)
from the CMB305 monotherapy trial in STS patients.
- Immune Design intends to submit data from the first 36 patients
in the study combining CMB305 with atezolizumab for presentation at
the European Society for Medical Oncology 2017 Congress in
September 2017.
- ZVexMulti, the evolution of the
ZVex® platform designed to deliver multiple, full
length antigens and immunomodulatory molecules, continues to
progress in preclinical development.
- ZVexMulti is engineered to avoid potential antigenic
competition and enable the delivery of multiple RNA genes
selectively to dendritic cells to induce a simultaneous and
balanced T cell response against all antigens.
- Immune Design believes this is a potentially significant
advancement in its product development capabilities, enabling the
development of therapies with the potential to target a wide range
of conserved antigens and large number of neo-epitopes. ZVexMulti
should allow for the expression of a much larger number of epitopes
than achievable with other platforms, obviating the need for a
proprietary predictive algorithm to derive a limited set of
epitopes.
Antigen Agnostic: G100
Program
- G100, consisting of a synthetic, formulated
TLR4 agonist injected intratumorally, continues to be evaluated in
an ongoing randomized Phase 1/2 trial in patients with follicular
non-Hodgkin lymphoma (fNHL) as both a monotherapy and combination
therapy.
- In the monotherapy portion, 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 (abscopal effect).
- Immune Design submitted data from the G100 monotherapy portion
of the study for presentation at ASCO 2017 and intends to submit
data from the first 24 patients in the randomized part of the study
of G100 with or without pembrolizumab for presentation at the
American Society of Hematology 2017 Annual Meeting to be held in
December.
Expansion of Board of Directors and Senior Leadership
Team
- Dr. Susan L. Kelley joined the Immune Design Board in June
2016, and brings more than 25 years' experience in oncology and
immunology drug development to the company.
- 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
- In October 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
Full Year 2016
- Immune Design ended the fourth quarter of 2016 with $110.4
million in cash and cash equivalents, short-term investments, and
other receivables compared to $112.9 million as of December 31,
2015. Net cash used in operations for the year ended December
31, 2016 was $35.7 million.
- Net loss and net loss per share for the year ended December 31,
2016 were $53.5 million and $2.47, respectively, compared to $39.4
million and $2.06, respectively, for the same period in 2015.
- Revenue for the year ended December 31, 2016 was $13.3 million
and was primarily attributable to $7.0 million in license revenue
associated with Immune Design’s collaboration with Sanofi, $1.7
million in product sales to collaboration partner Sanofi and other
third parties, and $4.6 million in collaboration revenue associated
with the Sanofi G103 (HSV2 therapeutic vaccine)
collaboration. Revenue for the same period in 2015 was $9.5
million and was primarily attributable to $4.2 million in
collaboration revenue associated with the Sanofi G103
collaboration, $3.5 million in license revenue associated with the
company’s collaborations with Medimmune and Sanofi, and $1.9
million in product sales to collaboration partners Sanofi and
Medimmune and other third parties.
- Research and development expenses for the year ended December
31, 2016 were $45.1 million, compared to $33.1 million for the
same period in 2015. The $12.0 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 year ended December
31, 2016 were $21.9 million, compared to $15.1 million for the same
period in 2015. The $6.8 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.
Fourth Quarter
- Net loss and net loss per share for the fourth quarter of 2016
were $14.4 million and $0.57, respectively, compared to $12.1
million and $0.60, respectively, for the fourth quarter of
2015.
- Revenue for the fourth quarter of 2016 was $2.1 million and was
primarily attributable to $0.5 million in product sales to
collaboration partner Sanofi and other third parties, and $1.6
million in collaboration revenue associated with the Sanofi G103
(HSV2 therapeutic vaccine) collaboration. Revenue for the fourth
quarter of 2015 was $1.1 million and was primarily attributable to
$0.9 million in product sales to collaboration partners Sanofi and
Medimmune and other third parties, and $0.2 million in
collaboration revenue associated with the Sanofi G103
collaboration.
- Research and development expenses for the fourth quarter of
2016 were $12.0 million compared to $8.9 million for the same
period in 2015. The $3.1 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 fourth quarter of
2016 were $4.4 million, relatively consistent with general and
administrative expenses of $4.0 million recorded in the fourth
quarter of 2015.
Cash Guidance
Based on current expectations, Immune Design expects to have
cash to fund operations into the second half of 2018.
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 fourth quarter and full year 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 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 70907410.
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
GLAAS®. 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,”
“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. 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.
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|
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|
|
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Immune Design Corp. |
|
|
Selected Balance Sheet Data |
|
|
(In
Thousands) |
|
|
|
|
|
|
|
|
|
December 31,
2016 |
|
December 31,2015 |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
45,214 |
|
$ |
112,921 |
|
|
Short-term
investments |
|
62,041 |
|
|
- |
|
|
Other receivables |
|
3,156 |
|
|
- |
|
|
Total assets |
|
114,495 |
|
|
116,145 |
|
|
Total current
liabilities |
|
19,263 |
|
|
7,111 |
|
|
Total stockholders'
equity |
|
95,176 |
|
|
108,993 |
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss Data |
|
|
(In Thousands Except Per Share Amounts) |
|
|
|
Three Months Ended |
|
For the Year Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Licensing revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
7,000 |
|
|
$ |
3,500 |
|
|
|
Product
sales |
|
461 |
|
|
|
921 |
|
|
|
1,627 |
|
|
|
1,853 |
|
|
|
Collaborative revenue |
|
1,597 |
|
|
|
218 |
|
|
|
4,633 |
|
|
|
4,157 |
|
|
|
Total
revenues |
|
2,058 |
|
|
|
1,139 |
|
|
|
13,260 |
|
|
|
9,510 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of
product sales |
|
134 |
|
|
|
353 |
|
|
|
481 |
|
|
|
774 |
|
|
|
Research
and development |
|
12,005 |
|
|
|
8,878 |
|
|
|
45,134 |
|
|
|
33,087 |
|
|
|
General
and administrative |
|
4,443 |
|
|
|
4,048 |
|
|
|
21,859 |
|
|
|
15,134 |
|
|
|
Total
operating expenses |
|
16,582 |
|
|
|
13,279 |
|
|
|
67,474 |
|
|
|
48,995 |
|
|
|
Loss
from operations |
|
(14,524 |
) |
|
|
(12,140 |
) |
|
|
(54,214 |
) |
|
|
(39,485 |
) |
|
|
Interest
and other income |
|
78 |
|
|
|
25 |
|
|
|
684 |
|
|
|
40 |
|
|
|
Net
loss |
$ |
(14,446 |
) |
|
$ |
(12,115 |
) |
|
$ |
(53,530 |
) |
|
$ |
(39,445 |
) |
|
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
(31 |
) |
|
|
- |
|
|
|
(24 |
) |
|
|
- |
|
|
|
Comprehensive loss: |
$ |
(14,477 |
) |
|
$ |
(12,115 |
) |
|
$ |
(53,554 |
) |
|
$ |
(39,445 |
) |
|
|
Basic
and diluted net loss per share |
$ |
(0.57 |
) |
|
$ |
(0.60 |
) |
|
$ |
(2.47 |
) |
|
$ |
(2.06 |
) |
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
25,409,219 |
|
|
|
20,145,247 |
|
|
|
21,638,468 |
|
|
|
19,155,918 |
|
|
|
|
|
|
|
|
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Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219
Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902
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