HALIFAX, NOVA SCOTIA--(Marketwired - Aug 29, 2013) - Immunovaccine Inc. ("Immunovaccine" or "IMV") (TSX VENTURE:IMV), a clinical stage vaccine company, today released its financial and operational results for the quarter ended June 30, 2013.
John Trizzino, CEO of Immunovaccine, commented,
"During the quarter, our cancer vaccine program grew rapidly. The NCIC Clinical Trials Group, supported by the Canadian Cancer Society, agreed to provide clinical and operational support for a Phase II study of our lead product, DPX-Survivac in advanced ovarian cancer patients. That trial is expected to begin in the new year. The company also entered into Phase II collaborations of DPX-Survivac in the treatment of glioblastoma and with DPX-0907 for breast and ovarian cancer. Both of these collaborations involve research organizations in Europe. In addition, the company received additional financial support from the Province of Nova Scotia. On August 2, 2013, the Province awarded the company a secured $5.0 million loan to help underwrite our working capital needs. These new relationships, with the NCIC CTG, the two European research centers and the Province, serve as certification of the science that forms the foundation of everything we do at Immunovaccine. These trials will provide the additional validating data that we need to move these vaccines toward our goal of delivering breakthrough therapies for patients in need."
Highlights of the Second Quarter 2013 and Subsequent to Quarter End:
- Canada's NCIC Clinical Trials Group (NCIC), supported by the Canadian Cancer Society, will sponsor and conduct a randomized Phase II study of DPX-Survivac in patients with advanced ovarian cancer. The study is designed to assess whether IMV's vaccine therapy can delay or prevent cancer recurrence. The Phase II trial is a randomized, blinded, placebo-controlled study with DPX-Survivac in combination with low dose oral cyclophosphamide as an immune modulator. The study will enroll approximately 250 patients with ovarian cancer at an estimated 20 clinical centers. Through its sponsorship, NCIC will contribute the majority of the clinical resources and non-dilutive financial support required to complete the trial. The trial is expected to get underway in 2014 with results in 2017.
- The Province of Nova Scotia's Economic and Rural Development department is supporting IMV with a $5 million loan to be used to fund a portion of working capital through 2016. The secured loan, which was obtained on August 2, 2013, is interest bearing and repayable in 2018.
- The Company has agreed to use its lead cancer product, DPX-Survivac, in a study based in Rome designed to extend life for glioblastoma patients. The multicenter Phase II trial will be led by Professor Marianna Nuti, Ph.D., Department of Experimental Medicine at the University of Rome, and conducted in collaboration with neurosurgeons and oncologists coordinated by Professor Maurizio Salvati, M.D. Four major trial centers across Italy will be involved, with the cost of the trial being assumed by the university. The randomized, placebo-controlled study will enroll more than 50 patients with newly diagnosed brain tumors that have been maximally resected. The study is expected to start in Q4 of 2013.
- Positive results from a Phase I clinical study of DPX-Survivac were presented at ASCO 2013. In a poster presentation at the conference, Immunovaccine highlighted study results that showed ovarian cancer patients treated with DPX-Survivac combined with low dose oral cyclophosphamide experienced pronounced and persistent T cell immune responses against survivin, a protein strongly associated with several tumor types. The Company believes that these immune responses are consistent in profile to those necessary from a cancer vaccine to potentially impact disease progression.
Q2 2013 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 $965,000 for Q2 Fiscal 2013 was $618,000 lower than the net loss and comprehensive loss for Q2 Fiscal 2012. This relates mainly to the $194,000 decrease in research and development costs, an $80,000 decrease in business development expenses and a $431,000 decrease to accreted interest and adjustments, offset by an increase of $88,000 in general and administrative expenses.
For the quarter ended June 30, 2013, the Company reported total R&D expenses of $587,000, a decrease of $194,000 compared to the three months ended June 30, 2012. G&A expenses of $561,000 were reported for Q2 Fiscal 2013 compared to $474,000 for the three months ended June 30, 2012, an overall increase of $87,000. Total business development expenses of $203,000 in Q2 Fiscal 2013 represented a decrease of $80,000 compared to the three months ended June 30, 2012.
At June 30, 2013, Immunovaccine had cash and cash equivalents of $893,000 and working capital of $844,000, as compared to $2,002,000 and $2,064,000, respectively at December 31, 2012.
As of June 30, 2013, the number of issued and outstanding common shares was 68,412,996. On June 30, 2013, the number of stock options outstanding was 5,738,720 and the number of outstanding warrants was 3,732,550.
Immunovaccine's unaudited interim condensed consolidated financial statements for June 30, 2013, filed in accordance with IFRS, and the management discussion and analysis (MD&A), are available at www.sedar.com.
Immunovaccine Inc. applies its novel adjuvanting platform to the development of vaccines for cancer therapy, infectious diseases and animal health. The Company's DepoVax™ platform is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system. Immunovaccine has advanced two DepoVax™-based cancer vaccines into Phase I human clinical trials. The Company is also advancing a broad infectious diseases pipeline including vaccines in such indications as malaria, respiratory syncytial virus (RSV) and anthrax. In addition to the Company's human health vaccine strategy, it continues to capture value from animal health vaccine applications. Immunovaccine has key partnerships in the animal health sector including an agreement with Zoetis (formerly Pfizer Animal Health). Connect at 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. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release.
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