Immunovaccine Inc. (TSX VENTURE:IMV) ("Immunovaccine" or the "Company"), a
clinical stage vaccine developer, announced today its financial results and
operational highlights for the year ended December 31, 2010.
Dr. Randal Chase, Immunovaccine's President & Chief Executive Officer, said,
"The positive results of our Phase I clinical trial, made 2010 a significant
year for Immunovaccine. Having demonstrated that our vaccine delivery platform
is safe in humans provides support for our business development strategy. As
evidence of the potential of our vaccine delivery platform, we signed eight new
research partnerships in 2010 and negotiated an additional commercial license
with Pfizer Animal Health. In July 2010, we also signed a notable deal with
Merck KGaA, for which we acquired an important clinical stage vaccine candidate,
DPX-Survivac. Looking ahead, our team is confident that both clinical vaccine
candidates are on track and anticipate completing the final analysis of the
DPX-0907 Phase I clinical trial and the necessary pre-clinical testing for
DPX-Survivac to support an FDA regulatory filing by Q3 2011."
Ms. Kimberly Stephens, Immunovaccine's Chief Financial Officer said, "During the
fiscal period we raised an additional $7.4 million in an equity financing. By
strengthening our balance sheet and controlling our cash burn, we have
sufficient capital to advance our clinical vaccine pipeline and Immunovaccine is
well positioned to pursue new partnership and licensing opportunities."
As previously announced, on April 14, 2011, Dr. Randal Chase resigned for
personal reasons as President and Chief Executive Officer. The Board of
Directors has undertaken a formal executive search for his replacement.
Today, Immunovaccine is also pleased to announce that Dr. Marc Mansour has been
appointed as Chief Operating Officer and Chief Science Officer, effective April
20, 2011. In this expanded role, Dr. Mansour will oversee the development of the
Company's operational strategy and will head all clinical research and
development activities. Since joining Immunovaccine, in 2000, Dr. Mansour has
advanced the Company's research and led the development of the DepoVax(TM)
vaccine delivery platform, as well as the Company's two clinical products,
DPX-0907 and DPX-Survivac.
Financial Results for the year ended December 31, 2010
Financial highlights
-- Reported net loss of $6.5 million for the year ended December 31, 2010,
primarily due to increased research and development costs associated
with the DPX-0907 Phase I clinical trial.
-- Reported $76,000 in revenues from animal health, a decrease of
$1,344,000 from the nine month period ended December 31, 2009.
-- Ended December 31, 2010 with cash and equivalents of $10.4 million.
-- Completed a public offering of 7,465,100 units at a price of $1.00 per
unit for aggregate gross proceeds of $7,465,100. The proceeds from this
equity offering will be used to develop vaccine product candidates,
including DPX-Survivac, using its DepoVax(TM) vaccine platform and for
general corporate purposes.
-- Implemented internal control procedures and accounting systems required
for the adoption of International Financial Reporting Standards ("IFRS")
compliance for the years beginning on or after January 1, 2011.
Results from operations
This review of the consolidated results of operations, financial condition and
cash flows compares results for the 12 month period ended December 31, 2010 to
the nine month period ended December 31, 2009, reflecting the change in the
fiscal year end to coincide with the calendar year ending on December 31st.
The Company incurred operating expenses for the year ended December 31, 2010 of
$6,579,000, compared to $3,084,000 during the nine month period ended December
31, 2009. Explanations of the nature of costs incurred, along with explanations
of changes in those costs are discussed below.
The net loss and comprehensive loss increased to $6,503,000 for the year ended
December 31, 2010, from a loss of $1,664,000 during the nine month period ended
December 31, 2009 as a result of a $1,344,000 decrease in revenues and increased
research and development expenses primarily related to the Phase I clinical
trial of DPX-0907, business development expenses and changes in operating
expenses.
The total amount of research and development (R&D) expenses for the year ended
December 31, 2010 of $3,780,000 represented an increase of $1,927,000 over the
nine month period ended December 31, 2009. The largest component of R&D expense
was direct expenses associated with the DPX-0907 Phase I clinical trial and the
preclinical development for DPX-Survivac.
General and administrative (G&A) expenses of $1,614,000 represented 23% of total
expenses for the year ended December 31, 2010 compared to $938,000 (28% of total
expenses) for the nine month period ended December 31, 2009. The G&A expenses
were due primarily to salaries and benefits, professional fees that include
maintenance and expansion of the Company's patent portfolio, and directors'
fees.
The Company expanded its business development (BD) activities during the year
ended December 31, 2010. Total BD expenses for the year ended December 31, 2010
were $967,000 compared to $365,000 incurred in the nine month period ended
December 31, 2009. Included in this increase were business development, investor
relations, and public relations consulting fees, as well as legal fees directly
related to expanding the Company's vaccine pipeline, leading to the completion
of the Merck KGaA, Oncothyreon and other agreements during the year ended
December 31, 2010.
Non-cash stock-based compensation increased to $732,000 during the year ended
December 31, 2010 compared to $155,000 in the nine month period ended December
31, 2009. The increase was due primarily to the increased number of presently
vesting options compared to the nine month period ended December 31, 2009.
During the year ended December 31, 2010, the Company recorded $340,000 in
refundable investment tax credits compared to approximately $180,000 during the
nine month period ended December 31, 2009. This increase is due to additional
2010 R&D costs, as well as receiving a favourable tax ruling from the Canada
Revenue Agency related to two previously filed Notices of Objection concerning
the Company's 2007 and 2008 refundable investment tax credits.
In February 2008, the Canadian Accounting Standards Board announced that
accounting standards in Canada are to adopt International Financial Reporting
Standards ("IFRS"). Immunovaccine Inc. will begin reporting, with comparative
data, under IFRS for fiscal years beginning on January 1, 2011. While IFRS is
based on a conceptual framework similar to Canadian GAAP, there are significant
differences with respect to recognition, measurement and disclosure.
Cash and cash equivalents
At December 31, 2010, the Company had cash and equivalents of $10.4 million and
identified additional potential cash resources of $1.5 million for a total of
approximately $11.9 million. Potential cash resources included amounts
receivable of $1.3 million, along with remaining government grants and loans the
Company has been awarded. Subsequently, on March 21, 2011, ACOA announced the
Company was awarded an Atlantic Innovation Fund ("AIF") interest-free loan of
$2.9 million. This non-dilutive funding will enable Immunovaccine to continue
its local research and development efforts.
The "cash burn rate" of the Company averaged $1.4 million per quarter in 2010.
It is forecasted to increase during 2011 and be in the range of $1.8 to $2.1
million per quarter to fund the completion of the DPX-0907 Phase I clinical
trial and accelerate the clinical development program for DPX-Survivac.
Management is of the belief that this provides the Company with sufficient funds
to execute its existing strategy and has adequate working capital until the
third quarter of 2012. The Company will reassess the adequacy of its available
cash resources should either positive research results be obtained from existing
research projects, or potential collaboration opportunities be identified that
may require additional funding.
Research and Development Highlights:
-- On March 29, 2010, Immunovaccine began screening patients for its DPX-
0907 Phase I clinical trial to evaluate the safety of two dosing
regimens; 0.25ml and 1ml. Patients with breast, ovarian and prostate
cancer were enrolled at five U.S. sites. On December 14, 2010
preliminary safety results revealed that DPX-0907 can be administered
safely at either dose level; and
-- On July 12, 2010, the Company signed an in-licensing deal with Merck
KGaA to acquire an investigational therapeutic survivin-based cancer
vaccine, known as DPX-Survivac. Survivin is a tumor associated antigen
over-expressed in multiple solid tumors and hematological malignancies.
While the license agreement grants the Company exclusive world-wide
rights, under issued patents and patent applications, to develop and
commercialize DPX-Survivac for multiple cancer indications,
Immunovaccine announced on November 17, 2010 that it will develop its
first Phase I / II clinical plan to target ovarian cancer. The Company
has manufactured test batches of DPX-Survivac and established the
analytical methods to support the release of a future clinical trial
batch.
Clinical monitoring and analysis of the DPX-0907 Phase I clinical trial in
patients with breast, ovarian and prostate cancer continues in 2011. On April
11, 2011, the Company announced positive interim immunogenicity results showing
that the DPX-0907 vaccine elicited an antigen specific immune response in the
majority of ovarian cancer patients analyzed. The vaccine is considered safe at
both dose levels (0.25ml and 1 ml) with no dose limiting toxicities.
On February 23, 2011, the Company and Immunotope Inc. announced that the U.S.
Patent and Trademark Office had issued an official Notice of Allowance for a new
U.S. patent specific to the DPX-0907 therapeutic cancer vaccine.
Also, on February 10, 2011, Immunovaccine announced that it had completed a
pre-clinical study demonstrating that the DepoVax platform gives DPX-Survivac an
advantage by raising a significantly higher immune response compared to a
control formulation previously used in clinical trials. The Company has
successfully manufactured test batches of DPX-Survivac and established the
analytical methods to support the release of a future clinical trial batch. The
clinical development plan for DPX-0907 is on track for completing detailed
safety and immunogenicity studies to support a potential future investigational
new drug (IND) regulatory filing with the FDA.
Business Development Highlights:
-- Immunovaccine signed a third license agreement with Pfizer Animal Health
on March 2, 2010, for Pfizer to use the Company's vaccine delivery
platform technology in their development of livestock vaccines;
-- Immunovaccine entered into eight additional research collaborations in
2010 to explore new vaccine applications for DepoVax(TM), the Company's
vaccine delivery and enhancement platform. These collaborations included
institutions like the Dana-Farber Cancer Institute, Defence Research &
Development Canada, and National Research Council (NRC) Canada. The
Company also signed research collaborations with the following companies
Vaxil BioTherapeutics, Oncothyreon, IRX Therapeutics, CEL-SCI
Corporation, OncoTherapy Science; and
-- In 2010, Immunovaccine was invited to present at several high profile
investor and research conferences including the Canada - US Partners in
Biomedical Defense II Conference in Washington, D.C., the Annual Rodman
& Renshaw Healthcare Conference in N.Y., New York, and the International
Society for Biological Therapy of Cancer conference in Washington, D.C.
In 2011, Dr. Randal Chase, President and CEO, presented in January at the
Biotech Showcase, during the JP Morgan Healthcare conference, the industry's
largest annual healthcare investor conference in San Francisco, CA. Then in
April 2011, Dr. Marc Mansour, Vice President of R&D, presented at two major
research conferences; the American Association for Cancer Research (AACR) 102nd
annual meeting and the World Vaccine Congress.
Outlook
The Company will continue to execute its business strategy into 2011, with the
primary objective will be to complete the Phase I clinical trial for DPX-0907.
The results of DPX-0907 will benefit the clinical development of DPX-Survivac
and support a potential regulatory filing to take DPX-Survivac into clinical
trials.
Immunovaccine will also take action to leverage the strength of its technology
and further enhance shareholder value by pursuing additional research
collaborations. The Company will continue to refine these research
collaborations and identify those with the most compelling technical results and
commercial opportunities.
The Company's 2010 annual audited consolidated financial statements and
management's discussion and analysis will be available on Tuesday, April 26,
2011 at www.sedar.com.
About Immunovaccine
Immunovaccine Inc. (TSX VENTURE:IMV) is a clinical stage vaccine development
company focused on the commercialization of its patented DepoVax(TM) vaccine
delivery technology and product candidates. The company continues to strengthen
its vaccine pipeline through licensing and strategic partnerships to develop
therapeutic cancer and infectious disease vaccines. www.imvaccine.com
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. A more detailed assessment of the risks and
uncertainties that could cause actual results to materially differ from
expectations is available in our MD&A and Annual Information Form. Immunovaccine
Inc. assumes no responsibility to update forward-looking statements in this
press release.
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