Immunovaccine Announces Financial Results for Quarter Ended June 30, 2015
August 12 2015 - 4:05PM
Business Wire
Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV;
OTCQX: IMMVF), a clinical-stage vaccine and immunotherapy company,
today released its financial and operational results for the second
quarter ended June 30, 2015.
“In the second quarter and recent weeks, Immunovaccine continued
to strengthen and advance its growing presence in immuno-oncology,
which is a key priority in our multi-pronged growth strategy. In
April, we presented data at the 2015 Annual Meeting of the American
Association for Cancer Research that provided a strong rationale
for combining our DepoVax™-based cancer immunotherapies with
checkpoint inhibitors to modulate the tumor environment. In June,
we entered into a non-exclusive clinical trial collaboration
with Incyte Corporation to evaluate the combination of DPX-Survivac
with an investigational oral Incyte drug candidate in ovarian
cancer. Clinical trial results recently published in Oncoimmunology
showed that the combination immunotherapy of the DPX-Survivac
vaccine and metronomic cyclophosphamide was immunogenic in
individuals with high-risk ovarian cancer. We also received an
Orphan Drug Designation from the U.S. Food and Drug Administration
(FDA) in July for DPX-Survivac across all of its applications in
ovarian cancer,” said Marc Mansour, Ph.D., Chief Executive Officer
of Immunovaccine.
“Importantly, we also have delivered on key development
milestones for our proprietary vaccine adjuvanting platform
technology DepoVax™,” he added. “We recently signed an exclusive
worldwide license agreement with PharmAthene, Inc. to develop and
commercialize an anthrax vaccine using DepoVax™, which is the first
step in our strategy to accelerate deployment of this platform
across multiple vaccine applications. And, in June, we initiated a
Phase 1 clinical trial with our DPX respiratory syncytial virus
(RSV) vaccine to evaluate its safety and immune response profile in
healthy adults.”
Highlights of the Second Quarter 2015 and Subsequent to
Quarter End:
- Announced Collaboration with Incyte
to Evaluate Novel Immunotherapy Combination for Patients with
Platinum-Sensitive Ovarian Cancer: The Company entered into a
non-exclusive clinical trial collaboration with Incyte Corporation
to evaluate the combination of Immunovaccine’s novel T cell
activating immunotherapy, DPX-Survivac, with Incyte’s
investigational oral indoleamine 2,3-dioxygenase 1 (IDO1)
inhibitor, epacadostat (INCB24360). Immunovaccine and Incyte will
co-fund and conduct a multicenter, open-label Phase 1B study to
evaluate the safety, tolerability and efficacy of the novel
combination in platinum-sensitive ovarian cancer patients who are
at high risk of recurrence.
- Signed Exclusive Worldwide License
Agreement with PharmAthene, Inc. to Develop and Commercialize an
Anthrax Vaccine Formulated in DepoVax™: PharmAthene, Inc. will
work exclusively with Immunovaccine to develop an adjuvanted
non-alum based Recombinant Protective Antigen Anthrax vaccine (rPA)
candidate. Immunovaccine has granted PharmAthene, Inc. exclusive
worldwide rights to use DepoVax™ for the development and
commercialization of this novel single dose anthrax vaccine.
- Received FDA Orphan Drug Designation
for DPX-Survivac for the Treatment of Ovarian Cancer: The FDA
has granted Orphan Drug status to DPX-Survivac for the treatment of
ovarian cancer. This designation is valid for all applications of
DPX-Survivac in ovarian cancer without restriction to a specific
stage of disease.
- Published Clinical Results with
DPX-Survivac in Combination with an Immune-Modulating Compound:
Data from Immunovaccine’s completed Phase 1 clinical trial
published in the peer-reviewed journal Oncoimmunology showed that
DPX-Survivac was highly immunogenic in individuals with high-risk
ovarian cancer. Almost all study participants receiving the
therapy produced robust T cell responses, and the combination of
DPX-Survivac and oral cyclophosphamide was generally well tolerated
with no significant systemic adverse events.
- Presented Data at AACR: A poster
highlighting the combination of Immunovaccine’s DepoVax™-based
vaccines with an anti-PD-1 monoclonal antibody was presented at
the 2015 Annual Meeting of the American Association for Cancer
Research (AACR) in April. Data presented showed that
DepoVax™-based vaccines, when combined with anti-PD-1 therapy, lead
to stronger anti-tumor activity than the anti-PD-1 therapy alone in
multiple animal models The results provide a strong rationale for
combining DepoVax™-based cancer immunotherapies with checkpoint
inhibitors that can modulate the tumor environment.
- Initiated Clinical Trial with
DPX-RSV Vaccine: The first healthy adult volunteer has been
enrolled in a Phase 1 clinical study of Immunovaccine’s respiratory
syncytial virus (RSV) vaccine. The Phase 1 study will evaluate the
safety and immune response profile of the DPX-RSV vaccine candidate
in healthy adults.
- Joined OTCQX Marketplace in the
U.S.: Immunovaccine began trading on the OTCQX® Best
Marketplace in the United States under the symbol “IMMVF.” The
Company continues to trade on the Toronto Stock Exchange under the
symbol “IMV.” The OTCQX is an established marketplace for global
and growth companies with high financial standards. With trading on
the OTCQX, Immunovaccine can increase awareness among a broader
range of investors and retail brokers in the U.S., at a time when
the immunotherapy sector has emerged as one of the most promising
in cancer therapy.
- Hired Fred Ors as Chief Business
Officer: Frederic Ors joined Immunovaccine's senior management
team in the newly created position of Chief Business Officer.
Previously, Mr. Ors spent 13 years at Medicago Inc. in Quebec, most
recently as Vice President of Business Development and Strategic
Planning. He was an integral part of Medicago Inc.’s success in
securing multiple non-dilutive funding opportunities, leading to an
acquisition by Mitsubishi Tanabe Pharma Corporation in 2013 for a
total enterprise value of $357 million.
Q2 2015 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 Handbook
of the Canadian Institute of Chartered Accountants – Part I (“CICA
Handbook”), which incorporates International Financial Reporting
Standards (“IFRS”) as issued by the International Accounting
Standards Board (“IASB”).
The Company’s net loss and comprehensive loss of $2,553,000 for
Q2 Fiscal 2015 was $1,233,000 higher than the net loss and
comprehensive loss for Q2 Fiscal 2014. This relates mainly to the
$587,000 increase in research and development costs, $433,000
increase in general and administrative expenses, and $179,000
increase in business development expenses, offset by a decrease of
$25,000 in accreted interest.
For the quarter ended June 30, 2015, the Company reported total
R&D expenses of $1,449,000, net of government loans and
assistance of $23,000 and investment tax credits of $104,000. This
represented a $587,000 increase of net research and development
expenses over the three months ended June 30, 2014. General and
administrative expenses of $621,000 were reported for Q2 Fiscal
2015 compared to $188,000 for the three months ended June 30, 2014.
The significant increase in general and administrative expenses of
$433,000 is due to an accounting adjustment made for the recording
of the government assistance in June 30, 2014 of $463,000. Total
business development expenses of $404,000 in Q2 Fiscal 2015
represented an increase of $179,000 compared to the three months
ended June 30, 2014.
At June 30, 2015, Immunovaccine had cash and cash equivalents of
$6.9 million and working capital of $7.0 million as compared to
$8.6 million in cash and $9.1 million in working capital at March
31, 2015.
As of June 30, 2015, the number of issued and outstanding common
shares was 91,799,002. On June 30, 2015, the number of stock
options outstanding was 6,128,050 and the number of outstanding
warrants was 5,777,446.
Immunovaccine’s unaudited interim condensed consolidated
financial statements for June 30, 2015, filed in accordance with
IFRS, and the management discussion and analysis (MD&A), will
be available at www.sedar.com.
About Immunovaccine
Immunovaccine Inc. develops cancer immunotherapies and
infectious disease vaccines based on the Company’s DepoVax™
platform, a patented formulation 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 2 study with its lead cancer vaccine therapy,
DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to
enter additional Phase 2 clinical studies in ovarian cancer and
glioblastoma (brain cancer). The Company is also advancing an
infectious disease pipeline including innovative vaccines for
respiratory syncytial virus (RSV) and anthrax.
Connect at www.imvaccine.com
Forward-looking Statement
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 and the matters discussed under “Risk
Factors and Uncertainties” in Immunovaccine’s Annual Information
Form filed on March 20, 2015. Immunovaccine Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150812006299/en/
MEDIASam Brown Inc.Michael Beyer,
312-961-2502mikebeyer@sambrown.comorINVESTORSImmunovaccine
Inc.Kimberly Stephens, Chief Financial
Officer902-492-1819kstephens@imvaccine.comor902-492-1819ir@imvaccine.com
IMV (TSX:IMV)
Historical Stock Chart
From Jun 2024 to Jul 2024
IMV (TSX:IMV)
Historical Stock Chart
From Jul 2023 to Jul 2024