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HALIFAX, NOVA SCOTIA--(Marketwired - Mar 29, 2016) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced its financial and operational results for the year ended December 31, 2015.
"In 2015, we added significant value to our pipeline. We made progress across three important aspects of our business: in immuno-oncology, in infectious disease, and through advancing corporate milestones," said Albert Scardino, Chairman, Board of Directors at Immunovaccine. "This three-pronged approach yielded an important series of firsts, including:
Acting Chief Executive Officer Frederic Ors added: "During 2015, we significantly expanded the potential market applications and value of our platform. We accomplished this through strategic partnerships and new indications for our DepoVax™-based portfolio.
"We began an exciting collaboration to evaluate DPX-Survivac and Incyte Corporation's epacadostat (INCB24360) in patients with recurrent ovarian cancer. This combination leverages two promising classes of immune-based therapies with clinical data to support their anti-tumor activity. This treatment approach may lead to better options for addressing the high unmet need in ovarian cancer," he said.
"Furthermore, we also bolstered our oncology program with positive Phase 2 data with our lead cancer immunotherapy, DPX-Survivac, in a particular form of lymphoma, known as DLBCL.
"Our recurrent lymphoma and ovarian cancer trials have given similar results in generating anti-cancer responses. We believe this trend shows the broad applicability and market potential of DPX-Survivac in targeting survivin, which is present in more than 20 types of solid tumor and hematologic cancers," continued Mr. Ors. "We will continue to evaluate DPX-Survivac in combination with other best-in-class immune agents. We are also exploring the synergies we have seen with checkpoint inhibitors, such as anti-PD-1 agents."
During 2015, Immunovaccine also steadily advanced its infectious disease pipeline. "We achieved the key milestone of obtaining preliminary Phase 1 data for our DPX-RSV vaccine, that showed it generated an immune response and was well tolerated," said Mr. Ors. "Today, no approved vaccine exists for the prevention of RSV despite its global prevalence and the World Health Organization's recognition of the virus as a high priority vaccine target. Thus, there is significant unmet medical need and a large potential market."
Immunovaccine also signed an exclusive agreement with PharmAthene to develop and commercialize a single-dose DepoVax™ anthrax vaccine. Under the terms of the agreement, worth up to USD $50 million (CAN $65 million), PharmAthene will work exclusively with Immunovaccine to develop an adjuvanted non-alum based rPA vaccine. In return, Immunovaccine has granted PharmAthene exclusive worldwide rights to use DepoVax™ for the development and commercialization of the novel single dose anthrax vaccine.
"This agreement adds value to the Immunovaccine pipeline. It is an example of how we intend to accelerate deployment of the DepoVax™ platform across multiple vaccine applications through strategic licensing deals," said Mr. Ors.
"Immunovaccine also recently joined the global mission to address the Zika virus and achieved notable corporate developments in 2015," stated Mr. Scardino. Recent corporate milestones include the start of trading on the OTCQX® Best Marketplace in the United States, adding Mr. Ors as the first Chief Business Officer, and then naming Mr. Ors acting Chief Executive Officer after the resignation of the CEO Dr. Marc Mansour.
Highlights of 2015 and First Quarter of 2016
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 - Part I ("CICA Handbook"), which incorporates International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB").
The net loss and comprehensive loss of $8,775,000 for the year ended December 31, 2015 was $2,207,000 higher than the net loss and comprehensive loss during the year ended December 31, 2014. This relates mainly to the $1,026,000 research and development (R&D) costs, an $884,000 in general and administration (G&A) expenses, an increase of $278,000 in business development expenses, and a $149,000 increase in accreted interest, offset by a decrease of $130,000 in revenue.
At December 31, 2015, the company had cash and cash equivalents of $3,842,000 and working capital of $3,283,000, compared to $10,662,000 and $10,456,000, respectively at December 31, 2014. For the year ended December 31, 2015, the company's annual quarterly "cash burn rate" (defined as net loss for the period adjusted for non-cash transactions including amortization, depreciation, accretion of long-term debt, and stock-based compensation) was approximately $1.87 million. The company forecasts the cash burn rate to be between $1.4 million to $1.9 million per quarter over the next twelve months.
As of March 29, 2016, the number of issued and outstanding common shares of the company was 92,075,670. As of March 29, 2016, the number of outstanding stock options was 6,437,249.
The company's audited annual consolidated financial statements for 2015, filed in accordance with IFRS, and the management discussion and analysis (MD&A), are available at www.sedar.com.
Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on its 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. The company 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). In collaboration with commercial and academic partners, Immunovaccine is also expanding the application of DepoVax™ as an adjuvanting platform for vaccines targeted against infectious diseases. Immunovaccine's goal in infectious diseases is to out-license its DepoVax™ platform to partners to generate earlier revenues. 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.