- Clinical Advancement of DPX-0907 and DPX-Survivac
Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX VENTURE:
IMV), a clinical stage vaccine development company focused on
advancing its patented DepoVax vaccine adjuvanting platform and
product candidates for cancer therapy and infectious diseases,
released today its financial and operational results for the year
ended December 31, 2011.
"2011 was a year of significant progress for Immunovaccine, both in
the clinic and as a company. Among the noteworthy accomplishments for
the year, the value of our DepoVax platform was affirmed by the
positive results of our Phase I study of DPX-0907 for breast, ovarian
and prostate cancer, and then through the initiation of the Phase 1
clinical study of DPX-Survivac", commented John Trizzino, CEO; "This
momentum has since carried into 2012 with the completion of a private
placement financing and the initiation of research agreements to
advance bio-defense vaccines and to develop a vaccine for cocaine
addiction - two high profile and potentially high value initiatives."
Highlights of the Year
-- Initiated the Phase I clinical trial of DPX-Survivac and vaccinated the
first patient in December 2011. The Phase I clinical trial is being
conducted in eight clinical sites in the US and in Canada, having
received clearance for both Phase I and Phase II clinical trials by
regulators in both countries. The Phase I is an open label clinical
trial designed to evaluate the safety of two DPX-Survivac dosing
regimens in approximately 15 patients. The goal of the Phase I clinical
trial is to establish the safety and immune activity of DPX-Survivac in
patients with advanced ovarian cancer.
-- Completed the Phase I clinical trial of DPX-0907, a therapeutic cancer
vaccine, in patients with breast, ovarian and prostate cancers. The
clinical trial results show that DPX-0907 is well tolerated and can
generate a targeted antigen-specific, poly-functional CD8 T-cell immune
-- Awarded $2.9 million from the Atlantic Canada Opportunities Agency
(ACOA), under the Atlantic Innovation Fund (AIF) in March 2011. This
non-dilutive funding is enabling Immunovaccine to develop new
diagnostics to identify specific subsets of cancer patient populations
that would benefit most from receiving DepoVax-based vaccine therapies.
This funding is also aiding the development of additional methods for
measuring vaccine activity, which will help the Company design future
Phase II clinical trials.
-- Appointed John J. Trizzino as Chief Executive Officer and Director to
the Board of Directors, in September 2011. As a senior executive with
more than 25 years of broad industry experience, Mr. Trizzino has been
instrumental in creating joint ventures, licensing agreements and sales
to major pharmaceutical companies and government agencies.
-- Appointed Brad Thompson, Ph.D., co-founder and Chief Executive of
Oncolytics Biotech Inc., and Wayne Pisano, former President and Chief
Executive Officer of Sanofi Pasteur, to the Company's Board of
Highlights of the first quarter of 2012
Corporate and Business Development
-- Raised gross proceeds of $2.8 million through its non-brokered private
placement on March 7, 2012. Immunovaccine issued 9,294,005 common shares
at the price of $0.30 per common share.
-- Signed a research agreement with Weill Cornell Medical College to
advance a vaccine for treating cocaine addiction. The project will
combine Cornell's novel cocaine antigen with Immunovaccine's DepoVax
adjuvanting platform to strengthen the immune response shown in research
animals in previous studies at the College.
-- Entered a research collaboration to advance the development of next
generation bio-defense vaccines against the most threatening biological
agents. These novel vaccine candidates will be evaluated as part of a US
National Institutes of Health (NIH) funded study, initiated in the first
quarter of 2012.
Annual Financial Results
The Company prepares its audited annual consolidated financial
statements in accordance with Canadian generally accepted accounting
principles as established in the Handbook of the Canadian Institute of
Chartered Accountants ("CICA Handbook"). In 2010, the CICA Handbook
was revised to incorporate International Financial Reporting Standards
(IFRS) and requires publicly accountable enterprises to apply such
standards effective for years beginning on or after January 1, 2011.
Accordingly, the Company is reporting on this basis in their annual
audited consolidated financial statements for the year-ended December
As a result of having two vaccine candidates in Phase I clinical
trials in 2011, the Company's net loss increased from a loss of $5.7
million, during the year ended December 31, 2010 to a loss of $6.8
million during the year ended December 31, 2011. While expenses rose
relating to pre-clinical and clinical research expenses for DPX-0907
and DPX-Survivac by $2.9 million, these costs were offset by a
decrease in general and administration expenses, general research and
development costs not related to the clinical or pre-clinical trials,
business development costs and stock-based compensation by $393,000,
$370,000, $252,000 and $421,000, respectively.
As at December 31, 2011, the Company had cash resources of $5 million
and identified additional potential cash resources of $2 million. For
the year ended December 31, 2011, the Company's "cash burn rate"
(defined as net loss for the period adjusted for non-cash transactions
including amortization, accretion of long-term debt and adjustments,
stock-based compensation and shares issued for professional services),
was approximately $1.47million per quarter. Management believes the
Company has sufficient funds to execute the strategy of completing the
Phase I trial of DPX-Survivac, executing business development efforts
and pre-clinical collaborations on infectious diseases, while
maintaining adequate working capital for the next twelve months.
As of April 19, 2012, the number of issued and outstanding common
shares was 63,505,152. On December 31, 2011, the number of stock
options outstanding was 4,299,650 and the number of outstanding
warrants was 4,137,556.
The Company's audited annual consolidated financial statements for
2011, filed in accordance with IFRS, and the management discussion and
Retains Capital Ideas Research for Strategic Investor Relations
Effective April 16, 2012, Immunovaccine has retained Capital Ideas
Research ("Capital Ideas") to provide strategic investor relations
services. Under the terms of the agreement, the Company will pay
Capital Ideas a monthly fee of $4,000 for select strategic
communication services. The initial contract term is 12 months and
commences immediately. Neither Capital Ideas nor any of its principals
have an ownership interest, directly or indirectly, in Immunovaccine
or its securities, nor has the Company granted Capital Ideas or its
principals any rights to acquire any such interests.
Immunovaccine Inc. develops vaccines formulated in its vaccine
delivery platform for cancer therapy and infectious disease. The
Company's DepoVax platform is a patented lipid delivery system that
presents antigens plus adjuvant to the immune system for a prolonged
period and has the potential to enhance immune responses.
Immunovaccine has taken its platform technology and proprietary cancer
vaccine into Phase I human trials and has demonstrated its safety and
immunogenicity potential. The Company is also capitalizing on the
broad potential of its delivery platform by creating new DepoVax-based
vaccines through multiple development collaborations. In addition to
the company's human health vaccine strategy, it continues to capture
value from animal health vaccine applications. Pfizer Animal Health
has licensed the Company's delivery technology platform to develop
vaccines for livestock. Connect at
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.