Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
immuno-oncology company, today released its financial and
operational results for the second quarter ended June 30, 2017.
“We have continued to accelerate the pace of our
clinical programs in the second quarter, particularly in
immuno-oncology,” said Frederic Ors, Immunovaccine’s Chief
Executive Officer. “We introduced a second anti-cancer candidate
into the clinic, broadened our working relationships with our
collaborators, including Merck and Dana Farber, and expanded the
scope of our DPX-Survivac program. With multiple candidates in the
clinic, strong industry partners, a committed and talented team in
place, along with additional financing activities during the
quarter, we believe Immunovaccine is well-positioned to continue
the pace of success we’ve seen in the past year.”
Operational Highlights of the Second Quarter 2017
Include:
- Initiating the first DPX-E7 clinical study –
The first study participant was treated in a Phase 1b/2 clinical
study evaluating Immunovaccine’s second clinical stage
investigational cancer vaccine, DPX-E7, in combination with
low-dose cyclophosphamide in patients with incurable cancers
related to the human papillomavirus (HPV). Dana-Farber Cancer
Institute (DFCI) is leading the DPX-E7 study.
- Expanding the clinical program for
DPX-Survivac – Immunovaccine achieved two milestones this
quarter for its lead product candidate. The University Health
Network’s Princess Margaret Cancer Centre received regulatory
clearance for a Phase 2 clinical study. This trial will evaluate
the safety and efficacy of Merck’s checkpoint inhibitor,
pembrolizumab, in combination with DPX-Survivac and low-dose
cyclophosphamide in patients with recurrent ovarian cancer.In
addition, another investigator-sponsored Phase 2 clinical trial was
initiated to evaluate the use of evaluate the use of
DPX-Survivac, a checkpoint inhibitor drug currently marketed
by a large pharmaceutical company, and low-dose
cyclophosphamide in patients with measurable or recurrent diffuse
large B-Cell lymphoma (DLBCL).
- Achieving groundbreaking clinical immunogenicity
results for DPX-RSV – In a follow-up to the Company’s
Phase 1 trial evaluating its small B cell epitope vaccine candidate
DPX-RSV in respiratory syncytial virus (RSV), the Company announced
that 100 percent of healthy older adult volunteers who responded to
vaccine showed a sustained antigen-specific response one year
post-vaccination with DPX-RSV. The immune responses were as high at
Year 1 as they were at the six-month mark, indicating the potential
for DPX-RSV to address a significant unmet medical need in the
elderly population - to provide protection against RSV for an
entire season.
- Closing financing offering - In June, the
Company announced the closing of a $10 million bought deal
offering.
“With this financing in place, we are
well-positioned to plan for an expansion of our clinical program
for DPX-Survivac across multiple indications,” said Pierre Labbé,
Chief Financial Officer at Immunovaccine. “With DPX-Survivac’s
clinically demonstrated ability to target survivin, which has been
implicated in over 20 types of cancer, we believe that we have only
scratched the surface of our lead candidate’s potential.”
Financial Results
The Company prepares its unaudited interim
condensed consolidated financial statements in accordance with
Canadian generally accepted accounting principles as set out in the
Chartered Professional Accountants of Canada – Accounting Part I
(“CPA Canada Handbook”), which incorporates International Financial
Reporting Standards (“IFRS”) as issued by the International
Accounting Standards Board
(“IASB”).
The net loss and comprehensive loss of $2,606,000 or $0.02 per
basic and diluted share for the quarter ended June 30, 2017 was
$1,201,000 higher than the net loss and comprehensive loss
for the three months ended June 30, 2016. This relates mainly to a
$171,000 increase in research and development costs, a $314,000
increase in business development and investor relations costs, a
$461,000 increase in general and administrative expenditures, a
decrease in revenue of $65,000, and a $190,000 increase in accreted
interest.
For the six months ended June 30, 2017, the net
loss and comprehensive loss was $4,975,000 or $0.04 per basic and
diluted share, $1,719,000 higher compared to the same period in
2016. This relates mainly to a $234,000 increase in research
and development costs, a $374,000 increase in business development
and investor relations costs, a $650,000 increase in general and
administrative expenditures, a decrease in revenue of $130,000, and
a $331,000 increase in accreted interest.
At June 30, 2017, Immunovaccine had cash and
cash equivalents of $19,273,000 and working capital of $18,868,000
as compared to $13,547,000 in cash and $12,982,000 in working
capital as at December 31, 2016.
As of August 8, 2017, the number of issued and
outstanding common shares was 127,701,209. As of August 8, 2017,
the number of stock options outstanding was 4,897,440, the number
of outstanding deferred share units was 477,287 and the number of
outstanding warrants was 7,966,721.
Immunovaccine’s unaudited interim condensed
consolidated financial statements for the six months ended June 30,
2017 and the management discussion and analysis (MD&A), will be
available at www.sedar.com.
About Immunovaccine
Immunovaccine Inc. is a clinical-stage
biopharmaceutical company 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 Company’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 Company 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 Statements
This 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 Company, 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:
MEDIA
Christy Curran, Sam Brown Inc.
T: (615) 414-8668 E: christycurran@sambrown.com
INVESTOR RELATIONS
Pierre Labbé, Chief Financial Officer
T: (902) 492-1819 E: info@imvaccine.com
Patti Bank, Managing Director, Westwicke Partners
O: (415) 513-1284
T: (415) 515-4572 E: patti.bank@westwicke.com
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