Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
immuno-oncology corporation, today released its financial and
operational results for the fiscal year ended December 31, 2017.
“2017 was a truly pivotal year for
Immunovaccine. We released our first clinical efficacy
results, with the topline data for our lead product candidate,
DPX-Survivac, in recurrent ovarian cancer. This announcement
reflects our most significant clinical milestone so far for two
major reasons: it supports the potential of the novel anti-cancer
activity of DPX-Survivac; and reduces the risk-profile of our
future clinical developments, thus providing, we believe, a solid
foundation for our ambitious development plan,” said Frederic Ors,
Immunovaccine’s Chief Executive Officer. “We continued the
significant expansion of our immuno-oncology clinical program in
2017 by adding two phase 2 clinical trials in collaboration with
Merck. In addition, we continued to advance our phase 1b study in
ovarian cancer with Incyte, and our partnered and early-stage
programs experienced several significant milestones. Taken
together, we have strengthened our value proposition in 2017, and
will be well positioned for the next stage of our growth in
2018.”
Clinical program updates from 2017 include:
DPX-Survivac
- Phase 1b clinical trial in ovarian cancer with IncyteIn
December 2017, the Corporation provided positive topline clinical
data from its continuing phase 1b trial evaluating the safety and
efficacy of DPX-Survivac, in combination with Incyte Corp.'s IDO1
enzyme inhibitor epacadostat, and low-dose cyclophosphamide in
patients with advanced ovarian cancer.Initial results from 10
evaluable patients in the DPX-Survivac plus-100 milligrams
epacadostat dosing cohort demonstrated a disease control rate of 70
percent, including partial responses (PR, defined as equal to
30-percent decrease in tumour lesion size) in 30 percent of the
patients (three out of ten). The combination also exhibited a
well-tolerated safety profile, with the majority of adverse events
(AEs) reported as Grade 1 and Grade 2, and only one potential
treatment-related AE.
- Phase 2 clinical trial in Diffuse large B-cell lymphoma (DLBCL)
with MerckIn November 2017, Immunovaccine announced that Health
Canada granted regulatory clearance to begin recruiting patients
for a Phase 2 clinical study evaluating DPX-Survivac in combination
with Merck’s checkpoint inhibitor pembrolizumab in patients with
DLBCL. This trial was announced initially in May 2017.
- Phase 2 clinical trial in ovarian cancer with MerckIn February
2017, the Corporation announced an investigator-sponsored phase 2
clinical trial in ovarian cancer evaluating DPX-Survivac in
combination with Merck’s checkpoint inhibitor pembrolizumab in
patients with recurrent, platinum-resistant ovarian cancer.
Other programs
- DPX-RSVIn April 2017, Immunovaccine announced additional
positive data from an extended evaluation of patients in this
trial. In the 25 µg dose cohort, 100 percent of older adults (7/7
immune responders) vaccinated with DPX-RSV maintained the
antigen-specific immune responses one year after receiving the
booster dose. At the one year mark, the antibody levels measured
were still at peak, with no sign of decrease.
- DPX-NEOThe Corporation expanded its continuing collaboration
with UConn Health to evaluate the anti-cancer activity of
proprietary patient-specific epitopes developed at UConn Health and
formulated in Immunovaccine’s proprietary immune-activating
technology formulation. Immunovaccine and UConn Health will begin
working toward DPX-NEO’s first clinical trial.
Operational highlights of fiscal year 2017 to-date include:
- Strengthening the management team: With the
appointment in February 2018 of Joseph Sullivan to the newly
created role of Senior Vice President, Business Development; and
the appointment, in early 2017, of Pierre Labbé as Chief Financial
Officer. Mr. Sullivan and Mr. Labbé each bring over 25 years
of experience, Mr. Sullivan with global pharmaceutical and vaccine
experience with Merck & Co. Inc. and Mr. Labbé with publicly
listed companies and with Medicago Inc.
- Completion of two bought deal public offerings:
In June 2017, Immunovaccine raised $10 million at
$1.30 per share, and in February 2018 raised $14.375 million at $2
per share.
- Extension of the Province of Nova Scotia loan
maturity date: In October 2017, Immunovaccine
received a two-year extension of the maturity of the loan
authorized in 2013 and the original maturity date of August 9, 2018
was extended to August 9, 2020.
“Our fundamental immuno-oncology offering has
evolved significantly in the past few years, and 2018 will likely
prove to be another very active, expansive year for our
Corporation,” added Mr. Ors. “We will hold our first investor day
in New York City on April 10, where KOLs will share their
perspectives on our novel approach and its clinical applications
and benefits. We plan to publish clinical data from our multiple
clinical programs in oncology with our partners Incyte and Merck,
further expand our immuno-oncology program, and continue to
leverage the novel aspects of our technology and the potential of
our clinical candidates to deliver value to our shareholders and
partners.”
Anticipated upcoming clinical milestones for the
Corporation’s lead product DPX-Survivac
include:
- Phase 1b clinical trial in ovarian cancer with Incyte
o Topline clinical results with the
300mg dose around mid-year
o Update on the 300mg dose clinical results in Q-3
2018
- Phase 2 clinical trial in ovarian cancer with Merck
o Preliminary clinical results
around mid-year o Topline
clinical results around the end of the year or beginning of
2019
- Phase 2 clinical trial in Diffuse large B-cell lymphoma (DLBCL)
with Merck o Preliminary
clinical results around mid-year
o Topline clinical results around the end of the
year or beginning of 2019
Overview of 2017 Financial Results
The net loss and comprehensive loss of
$12,028,000 ($0.10 per share) for the year ended Dec. 31, 2017, was
$3,132,000 higher than the net loss and comprehensive loss for the
year ended Dec. 31, 2016. This relates mainly to a $1,733,000
increase in research and development (R&D) expenses, a
$1,644,000 increase in general and administrative expenses, a
$543,000 increase in business development and investor relations
expenses - offset by a $540,000 decrease in accreted interest and
no impairment loss in 2017.
At December 31, 2017, the corporation had cash
and cash equivalents of $14,909,000 and working capital of
$13,627,000, compared with $13,547,000 and $12,982,000,
respectively at December 31, 2016. For the year ended December 31,
2017, the corporation's cash burn rate (defined as net loss for
adjusted for non-cash transactions including amortization,
depreciation, accretion of long-term debt and stock-based
compensation) was approximately $9.7-million. Based on the current
business plan, the corporation forecasts the cash burn rate to be
between $12-million and $14-million over the next 12 months.
As of March 20, 2018, the number of issued and
outstanding common shares was 137,106,558, the number of stock
options outstanding was 4,078,780, the number of outstanding
deferred share units was 596,246, and the number of outstanding
warrants was 6,680,313.
The corporation's audited annual consolidated
financial statements for 2017 and the related management's
discussion and analysis (MD&A) are available on SEDAR.
About Immunovaccine
Immunovaccine Inc. is a clinical-stage
biopharmaceutical corporation dedicated to making immunotherapy
more effective, more broadly applicable, and more widely available
to people facing cancer and infectious diseases. Immunovaccine
develops T cell activating cancer immunotherapies and infectious
disease vaccines based on DepoVax™, the Corporation’s patented
platform that provides controlled and prolonged exposure of
antigens and adjuvant to the immune system. Immunovaccine has
advanced two T cell activation therapies for cancer through Phase 1
human clinical trials and is currently conducting a Phase 1b study
with Incyte Corporation assessing lead cancer therapy,
DPX-Survivac, as a combination therapy in ovarian cancer. The
Corporation is also exploring additional applications of DepoVax™,
including DPX-RSV, an innovative vaccine candidate for respiratory
syncytial virus (RSV), which has recently completed a Phase 1
clinical trial. Immunovaccine also has ongoing clinical projects to
assess the potential of DepoVax™ to address malaria and the Zika
virus. Connect at www.imvaccine.com.
Immunovaccine Forward-Looking StatementsThis
press release contains forward-looking information under applicable
securities law. All information that addresses activities or
developments that we expect to occur in the future is
forward-looking information. Forward-looking statements are based
on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the Corporation, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. Immunovaccine Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law.
Contacts for Immunovaccine:
MEDIAMike Beyer, Sam Brown
Inc.T: (312) 961-2502 E: mikebeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819 E:
info@imvaccine.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
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