Immune Design Reports Second Quarter 2017 Financial Results and Provides Corporate Update
August 02 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 second quarter ended June 30, 2017.
“During the second quarter, based on the
positive data to date, Immune Design made the decision to move
forward both of our lead product candidates, CMB305 and G100, and
discuss regulatory paths for approval with the FDA,” said Carlos
Paya, M.D., Ph.D., President and Chief Executive Officer of Immune
Design.
Recent Highlights
Product Development: Data presented at the American
Society of Clinical Oncology 2017 Annual Meeting (ASCO) Support
Monotherapy Proof of Concept for both CMB305 and G100
Antigen Specific Immunotherapy: CMB305
Program
- CMB305 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 data presented at ASCO from 25 STS patients
with recurrent disease indicated an impact on patient survival
associated with biomarkers measuring induced anti-NY-ESO-1 immune
response and pre-existing immunity:
- Observed median overall survival (mOS) had still not yet been
reached in these patients, with an overall survival rate at 12 and
18 months of 83% and 76%, respectively. These data compare
favorably to mOS for approved agents for second line and beyond
sarcoma treatment, as well as new anti-PD-1 antibody data presented
at ASCO for nivolumab and pembrolizumab.
- As of the data collection date for ASCO, the STS patients who
received LV305, the priming component of CMB305, had still not yet
reached a mOS.
- Over 60% of the patients had an NY-ESO-1-specific immune
response induced by CMB305, with a subset of patients showing
evidence of antigen spreading.
- In a pool of 64 patients treated with CMB305 or LV305, it was
observed that:
- The induction of an anti-NY-ESO-1 immune response by these
agents was associated with improved patient survival in certain
patients.
- Immune Design believes conventional and novel biomarkers
measuring NY-ESO-1 immunity may be used to guide regulatory
strategy via the selection of patients more likely to have survival
benefit on CMB305 therapy.
- Combination therapy with
Tecentriq®
- In an upcoming presentation at the European Society for Medical
Oncology 2017 Congress (ESMO) to be held in September 2017, Immune
Design will present early data on at least 36 randomized patients
(following a safety run-in) with a follow-up period of
approximately six months. This 80 patient Phase 2 study, evaluating
two separate arms consisting of CMB305 plus
Tecentriq (atezolizumab) versus atezolizumab alone pursuant to
a collaboration with Genentech, is fully enrolled.
- The data will focus on biomarker analysis and early clinical
readouts, but not mOS due to the insufficient follow-up period in
both treatment arms.
Antigen Agnostic/Intratumoral Immunotherapy: G100
Program
- G100, the novel, synthetic TLR4 agonist
injected intratumorally, is being evaluated in a Phase 1 single arm
and a Phase 2 randomized trial in patients with low-grade
follicular non-Hodgkin lymphoma (NHL).
- Monotherapy (with low dose radiation (XRT)) data
presented at ASCO from the Phase 1 dose escalation in nine
patients with naïve and refractory follicular NHL demonstrated:
- 100% disease control rate (DCR), with over a third of patients
achieving a partial response (PR) using WHO criteria (at least a
50% tumor reduction), with PRs at all three dose levels
tested.
- 50% of evaluable patients experienced shrinkage of untreated
distal (abscopal) lesions in association with presence of T cell
infiltrates.
- G100 and XRT combination therapy with
Keytruda®
- Patient enrollment was completed in the first quarter in the
randomized, 24-patient, Phase 2 study evaluating 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 for presentation at the
American Society of Hematology (ASH) Annual Meeting in December
2017:
- Data from all 24 patients in the randomized Phase 2 study
comparing G100 and XRT versus G100 and XRT with pembrolizumab.
- Follow-up data from all patients treated with G100 monotherapy
in the Phase 1 dose escalation portion of this study.
Expansion of Senior Leadership Team
Heidi Petersen and Melanie Morrison joined the Immune Design
team as Vice President of Regulatory Affairs, and Vice President,
Oncology Platform Leader, respectively. Ms. Petersen and Ms.
Morrison each bring approximately 20 years of experience to Immune
Design, which the management team and company will leverage in
interactions with regulatory agencies and in the execution of
future registrational trials.
Financial Results
Second Quarter
- Immune Design ended the second quarter of 2017 with $81.4
million in cash, 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 six months ended
June 30, 2017 was $26.0 million.
- Net loss and net loss per share for the second quarter of 2017
were $13.9 million and $0.54, respectively, compared to $14.3
million and $0.71, respectively, for the second quarter of
2016.
- Revenue for the second quarter of 2017 was $0.7 million and was
primarily attributable to $0.7 million in collaboration revenue
associated with the Sanofi Pasteur G103 (HSV therapeutic vaccine)
product collaboration. Revenue for the second quarter of 2016 was
$1.1 million and was primarily attributable to $0.7 million in GLA
product sales to collaboration partners Medimmune/Astra Zeneca and
Sanofi and $0.4 million in collaboration revenue associated with
the Sanofi G103 product collaboration.
- Research and development expenses for the second quarter of
2017 were $10.9 million compared to $11.4 million for the same
period in 2016. The modest decrease is primarily driven by timing
differences of manufacturing activities, which were offset by
increased clinical costs attributable to continued advancement of
Immune Design’s 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 did not materially differ
over the comparative periods. For the second quarter of 2017
general and administrative expenses were $3.9 million,
compared to $3.9 million for the second quarter of
2016.
Year-to-Date
- Net loss and net loss per share for the six months ended June
30, 2017 were $26.5 million and $1.04, respectively, compared to
$26.6 million and $1.32, respectively, for the same period in
2016.
- Revenue for the six months ended June 30, 2017 was $6.2 million
and was primarily attributable to $5.9 million in collaboration
revenue associated with the Sanofi G103 product collaboration and
$0.3 million in product sales to other third parties. Revenue for
the same period in 2016 was $3.0 million and was primarily
attributable to $2.3 million in collaboration revenue associated
with the Sanofi G103 product collaboration and $0.7 million in GLA
product sales to collaboration partners Medimmune/Astra Zeneca and
Sanofi.
- Research and development expenses for the six months ended June
30, 2017 were $24.9 million compared to $22.0 million for the same
period in 2016. The $2.9 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 did not materially differ
over the comparative periods. For the six months ended June 30,
2017 general and administrative expenses were $8.0 million,
compared to $7.9 million for the same period in 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 1:30 p.m. Pacific time / 4:30 p.m. Eastern time
to discuss the second 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: 58230231.
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 that could cause our 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 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
Condensed Consolidated Balance Sheet
Data |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
(unaudited) |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
35,311 |
|
$ |
45,214 |
Short-term
investments |
|
45,964 |
|
|
62,041 |
Other receivables |
|
123 |
|
|
3,156 |
Total assets |
|
90,871 |
|
|
114,495 |
Total current
liabilities |
|
17,252 |
|
|
19,263 |
Total stockholders'
equity |
|
73,540 |
|
|
95,176 |
|
|
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss Data |
(In Thousands Except Per Share Amounts) |
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
48 |
|
|
$ |
733 |
|
|
|
309 |
|
|
|
740 |
|
Collaborative revenue |
|
|
681 |
|
|
|
400 |
|
|
|
5,885 |
|
|
|
2,256 |
|
Total
revenues |
|
|
729 |
|
|
|
1,133 |
|
|
|
6,194 |
|
|
|
2,996 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of
product sales |
|
|
18 |
|
|
|
253 |
|
|
|
55 |
|
|
|
275 |
|
Research
and development |
|
|
10,863 |
|
|
|
11,386 |
|
|
|
24,901 |
|
|
|
21,956 |
|
General
and administrative |
|
|
3,888 |
|
|
|
3,948 |
|
|
|
8,023 |
|
|
|
7,862 |
|
Total
operating expenses |
|
|
14,769 |
|
|
|
15,587 |
|
|
|
32,979 |
|
|
|
30,093 |
|
Loss
from operations |
|
|
(14,040 |
) |
|
|
(14,454 |
) |
|
|
(26,785 |
) |
|
|
(27,097 |
) |
Interest
and other income |
|
|
194 |
|
|
|
107 |
|
|
|
319 |
|
|
|
456 |
|
Net
loss |
|
$ |
(13,846 |
) |
|
$ |
(14,347 |
) |
|
$ |
(26,466 |
) |
|
$ |
(26,641 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
|
4 |
|
|
|
10 |
|
|
|
(19 |
) |
|
|
30 |
|
Comprehensive loss: |
|
$ |
(13,842 |
) |
|
$ |
(14,337 |
) |
|
$ |
(26,485 |
) |
|
$ |
(26,611 |
) |
Basic
and diluted net loss per share |
|
$ |
(0.54 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.04 |
) |
|
$ |
(1.32 |
) |
Weighted-average shares used to compute basic and diluted net loss
per share |
|
|
25,567,482 |
|
|
|
20,155,410 |
|
|
|
25,515,630 |
|
|
|
20,154,306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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