Immune Design Reports First Quarter 2017 Financial Results and Provides Corporate Update
May 17 2017 - 4:30PM
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today reported financial results and a
corporate update for the first quarter ended March 31, 2017.
“During the first quarter of the year, we were
pleased to complete enrollment in the first randomized studies for
each of CMB305 and G100, an important milestone for Immune Design,”
said Carlos Paya, M.D., Ph.D., President and Chief Executive
Officer of Immune Design. “We hope that the emerging biomarker and
clinical data that we intend to present starting at ASCO and
continuing throughout 2017, may form the initial foundation to
support commercialization of novel and safe immunotherapies for
selected cancer patients.”
Recent Highlights
Product Development: Two Phase 2 randomized studies
fully enrolled; multiple ASCO presentations; Orphan Drug status for
G100 in follicular NHL
Antigen Specific Immunotherapy: CMB305
Program
- CMB305, the novel, prime-boost NY-ESO-1
targeted immunotherapy, is being evaluated primarily in soft tissue
sarcoma (STS) patients both as a monotherapy and in combination
with an anti-PD-L1 antibody.
- CMB305 monotherapy
- Follow-up continues on the two enrolled monotherapy
Phase 1 trials (25 CMB305 STS patients, and 23 STS patients
treated with CMB305’s vector-only component, LV305).
- Data from the CMB305 trial will be presented in two separate
presentations at the American Society of Clinical Oncology annual
meeting in 2017 (ASCO 2017):
- Both clinical and translational data from at least 25 STS
patients will be presented in an oral presentation entitled “Immune
response, safety, and survival impact from CMB305 in NY-ESO-1+
recurrent soft tissue sarcomas (STS)”; and
- An analysis of translational data indicating an association of
baseline and immunotherapy (LV305 and CMB305)-induced NY-ESO-1
immune response with survival in patients with multiple tumor
types, will be presented in a poster presentation entitled
“Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1
immunity with survival in recurrent cancer patients.”
- CMB305 combination therapy with
Tecentriq®
- Enrollment was completed by the end of Q1 in the randomized,
80-patient, Phase 2 study comparing CMB305 plus
Tecentriq (atezolizumab) vs. atezolizumab alone, pursuant to a
collaboration with Genentech.
- Immune Design intends to submit early data from a pre-specified
analysis of this Phase 2 study for presentation at the European
Society for Medical Oncology 2017 Congress to be held in September
2017.
Antigen Agnostic Intratumoral Immunotherapy: G100
Program
- G100, the novel, synthetic TLR4 agonist
injected intratumorally, is being evaluated in an ongoing Phase 1
dose escalation and in a randomized Phase 2 trial in patients with
low grade follicular non-Hodgkin lymphoma (FL).
- G100 monotherapy (with low dose radiation
(XRT)). Data from the fully enrolled Phase 1 dose
escalation monotherapy portion of the trial (n=9) evaluating G100
with XRT will be presented at ASCO 2017 in a poster presentation
entitled “Intratumoral G100 induces systemic immune responses and
abscopal tumor regression in patients with follicular
lymphoma.”
- G100 and XRT combination therapy with
Keytruda®:
- Patient enrollment was completed by the end of Q1 in the
randomized, 24-patient, Phase 2 study comparing G100 and XRT versus
G100 and XRT with the systemic administration of the anti-PD-1
antibody, Keytruda (pembrolizumab), pursuant to a
collaboration with Merck.
- Immune Design intends to submit follow-up data from all
patients in both the Phase 1 dose escalation and Phase 2 randomized
portions of the study for presentation at the American Society of
Hematology Annual Meeting in December 2017.
- The U.S. Food and Drug Administration recently granted
Orphan Drug Designation for G100 for the treatment
of FL. Orphan Drug Designation provides the sponsor certain
benefits and incentives, including a period of marketing
exclusivity for the first marketing application, if regulatory
approval is received for the designated indication, potential tax
credits for certain activities and waiver of certain administrative
fees.
Financial Results
First Quarter
- Immune Design ended the first quarter of 2017 with $90.1
million in cash and cash equivalents, short-term investments, and
other receivables compared to $110.4 million as of December 31,
2016. Net cash used in operations for the three months ended
March 31, 2017 was $17.4 million.
- Net loss and net loss per share for the first quarter of 2017
were $12.6 million and $0.50, respectively, compared to $12.3
million and $0.61, respectively, for the first quarter of
2016.
- Revenue for the first quarter of 2017 was $5.5 million and was
primarily attributable to $5.2 million in collaboration revenue
associated with the Sanofi G103 (HSV2 therapeutic vaccine)
collaboration and $0.3 million in product sales to other third
parties. Revenue for the first quarter of 2016 was $1.9 million and
was primarily attributable to the Sanofi G103 collaboration.
- Research and development expenses for the first quarter of 2017
were $14.0 million compared to $10.6 million for the same period in
2016. The $3.4 million increase was primarily attributable to
continued 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 first quarter of
2017 were $4.1 million, relatively consistent with general and
administrative expenses of $3.9 million recorded in the first
quarter of 2016.
Cash Guidance
Based on current expectations, Immune Design
continues to expect 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 2:00 p.m. Pacific time / 5:00
p.m. Eastern time to discuss the first quarter 2017 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. 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: 20090178.
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 chronic diseases. 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 leading
product candidates focused in cancer immunotherapy, are the first
products from its two separate discovery platforms targeting
dendritic cells in vivo, ZVex® and
GLAAS®. 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.
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Immune Design
Corp. |
|
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Selected
Condensed Consolidated Balance Sheet
Data |
|
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(In Thousands) |
|
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|
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|
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|
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March 31, 2017 |
|
December 31,2016 |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
27,918 |
|
$ |
45,214 |
|
Short-term
investments |
|
61,991 |
|
|
62,041 |
|
Other receivables |
|
146 |
|
|
3,156 |
|
Total assets |
|
99,882 |
|
|
114,495 |
|
Total current
liabilities |
|
14,753 |
|
|
19,263 |
|
Total stockholders'
equity |
|
85,066 |
|
|
95,176 |
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss Data |
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(In Thousands Except Per Share Amounts) |
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Three Months Ended |
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March 31, |
|
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2017 |
|
2016 |
|
|
|
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(unaudited) |
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Revenues: |
|
|
|
|
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Product
sales |
|
$ |
261 |
|
|
$ |
7 |
|
|
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Collaborative revenue |
|
|
5,204 |
|
|
|
1,856 |
|
|
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Total
revenues |
|
|
5,465 |
|
|
|
1,863 |
|
|
|
Operating expenses: |
|
|
|
|
|
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Cost of
product sales |
|
|
37 |
|
|
|
22 |
|
|
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Research
and development |
|
|
14,038 |
|
|
|
10,570 |
|
|
|
General
and administrative |
|
|
4,135 |
|
|
|
3,914 |
|
|
|
Total
operating expenses |
|
|
18,210 |
|
|
|
14,506 |
|
|
|
Loss
from operations |
|
|
(12,745 |
) |
|
|
(12,643 |
) |
|
|
Interest
and other income |
|
|
125 |
|
|
|
349 |
|
|
|
Net
loss |
|
$ |
(12,620 |
) |
|
$ |
(12,294 |
) |
|
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Other
comprehensive income (loss): |
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|
|
|
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Unrealized (loss) gain on investments |
|
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(23 |
) |
|
|
20 |
|
|
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Comprehensive loss: |
|
$ |
(12,643 |
) |
|
$ |
(12,274 |
) |
|
|
Basic
and diluted net loss per share |
|
$ |
(0.50 |
) |
|
$ |
(0.61 |
) |
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
|
25,463,202 |
|
|
|
20,153,202 |
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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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