Immunovaccine Announces Financial Results For Quarter Ended March 31, 2015

Source:  Immunovaccine Inc.

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 quarter ended March 31, 2015.


"In this first quarter, we delivered on several key development and corporate milestones. In March, we announced treatment of the first patient with diffuse large B cell lymphoma (DLBCL) in a Phase 2 study for our lead immunotherapy DPX-Survivac. Our earlier data in ovarian cancer suggested that combining DPX-Survivac with the immune enhancer cyclophosphamide has the potential to provide a clinical benefit. The lymphoma study is designed to establish the clinical efficacy of DPX-Survivac in this patient population with a high unmet medical need" said Dr. Marc Mansour, Chief Executive Officer of Immunovaccine.

"Two weeks ago, we started trading on the OTCQX® Best Marketplace in the United States. Our goal this year is to diversify our retail and institutional investor base, particularly in the US, at a time when our sector has emerged as the most promising in cancer therapy. We are committed to increasing awareness of our clinical programs in immunotherapy and infectious disease both at home and abroad."

"Earlier this year, we announced clearance from Health Canada to conduct a Phase I clinical study in healthy adults with a DepoVax™-based vaccine against Respiratory Syncytial Virus ("RSV"). The study, co-funded by Immunovaccine and the Canadian Institutes of Health Research ("CIHR"), will provide the first clinical experience with DepoVax™ for the prevention of an infectious disease" Dr. Mansour continued.

"We also obtained additional data from our ongoing anthrax vaccine program with the National Institutes of Health (NIH) and demonstrated the single-dose rapid acting potential of the DepoVax based vaccine. We are now actively exploring partnership opportunities to further advance this program."

Highlights of the First Quarter 2015 and Subsequent to Quarter End:

• Immunovaccine Joins the OTCQX Marketplace in the United States - Immunovaccine announced it has been approved to trade on the OTCQX® Best Marketplace in the United States under the symbol "IMMVF". The Company will continue 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. Trading on the OTCQX enables Immunovaccine to introduce the Company to a broader range of investors and retail brokers in the US, at a time when the immunotherapy sector has emerged as one of the most promising in cancer therapy.

• First patient treated in Phase 2 DPX-Survivac in Lymphoma - Immunovaccine announced that it has treated the first patient with diffuse large B cell lymphoma (DLBCL) in a Phase 2 clinical study of its lead cancer immunotherapy DPX-Survivac. The Company-sponsored trial is evaluating DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. DPX-Survivac is designed to activate killer T cells of the immune system against the survivin antigen found in a wide variety of solid tumors and blood cancers. The Company believes that combining its T cell activating therapy with immune modulating agents is important to achieve a robust clinical response. Data to date suggest that combining DPX-Survivac with low dose cyclophosphamide has the potential to provide a clinical benefit in some cancer patients.
Positive clinical data from this study could provide rationale for the initiation of a pivotal trial in recurrent DLBCL.

• Single-Dose DepoVax-Based Vaccine Protects Against Lethal Anthrax Challenge - Immunovaccine announced that three different recombinant protective antigen (rPA) vaccines formulated with its novel DepoVax™ enhancement technology protected animals against a lethal anthrax challenge after a single vaccination. The National Institutes of Health (NIH) led study showed that DepoVax™ is compatible with multiple sources of rPA and can enable a single-dose rapid response anthrax vaccine.

Q1 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 $1,769,000 for Q1 Fiscal 2015 was $174,000 lower than the net loss and comprehensive loss for Q1 Fiscal 2014. This relates mainly to the $146,000 decrease in business development expenses and $119,000 decrease in research and development costs, offset by an increase of $40,000 in general and administrative expenses and an increase of $51,000 of accreted interest.

For the quarter ended March 31, 2015, the Company reported total R&D expenses of $793,000, net of government loans and assistance of $52,000 and investment tax credits of $65,000. This represented a $119,000 decrease of net R&D expenses over the three months ended March 31, 2014. G&A expenses of $724,000 were reported for Q1 Fiscal 2015 compared to $684,000 for the three months ended March 31, 2014, an overall increase of $40,000. Total business development expenses of $153,000 in Q1 Fiscal 2015 represented a decrease of $146,000 compared to the three months ended March 31, 2014.

At March 31, 2015, Immunovaccine had cash and cash equivalents of $8.6 million and working capital of $9.1 million as compared to $10.7 million in cash and $10.5 million in working capital at December 31, 2014.

As of March 31, 2015, the number of issued and outstanding common shares was 91,767,677. On March 31, 2015, the number of stock options outstanding was 5,878,050 and the number of outstanding warrants was 5,808,771.

Immunovaccine's unaudited interim condensed consolidated financial statements for March 31, 2015, filed in accordance with IFRS, and the management discussion and analysis (MD&A), are 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.

Immunovaccine Joins the OTCQX Marketplace in the United States

Source:  Immunovaccine Inc.

Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, has been approved to trade on the OTCQX® Best Marketplace in the United States under the symbol “IMMVF”. The Company will continue 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. Investors can find current financial disclosure and Real-Time Level 2 quotes for Immunovaccine at www.otcmarkets.com.

“The OTCQX offers U.S. investors easier access to Immunovaccine as we expand our presence in the rapidly evolving field of cancer immunotherapy”, said Marc Mansour, CEO of Immunovaccine. “Trading on the OTCQX enables us to introduce the company to a broader range of investors and retail brokers in the US, at a time when our sector has emerged as one of the most promising in cancer therapy.”

Dorsey & Whitney LLP serves as Immunovaccine’s Principal American Liaison (“PAL”) on OTCQX, responsible for providing professional guidance on OTCQX requirements and U.S. securities laws.

In addition, Immunovaccine announced that its Company information will be made available via S&P Capital IQ's Market Access Program, an information distribution service that enables subscribing publicly traded companies to have their company information disseminated to users of S&P Capital IQ's MarketScope Advisor. MarketScope Advisor is an Internet-based research engine used by more than 100,000 investment advisors. As part of the program, a full description of Immunovaccine will also be published in the Daily News section of Standard Corporation Records, a recognized securities manual for secondary trading in up to 41 states under their Blue Sky Laws.

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.

About DepoVax™
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability.

About S&P Capital IQ
S&P Capital IQ, a brand of the McGraw-Hill Companies (NYSE:MHP), is a leading provider of multi-asset class data, research and analytics to institutional investors, investment advisors and wealth managers around the world. We provide a broad suite of capabilities designed to help track performance, generate alpha, identify new trading and investment ideas, and perform risk analysis and mitigation strategies. Through leading desktop solutions such as Capital IQ, Global Credit Portal and MarketScope Advisor desktops; enterprise solutions such as S&P Securities Evaluations, Global Data Solutions, and Compustat; and research offerings including Leveraged Commentary & Data, Global Market Intelligence, and company and fund research, S&P Capital IQ sharpens financial intelligence into the wisdom today's investors need. Company information distributed through the Market Access Program is based upon information that S&P Capital IQ considers to be reliable, but neither S&P Capital IQ nor its affiliates warrant its completeness or accuracy, and it should not be relied upon as such. This material is not intended as an offer or solicitation for the purchase or sale of any security or other financial instrument.

Immunovaccine Provides Corporate Update and AGM Results

Source:  Immunovaccine Inc.

Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV) is pleased to provide an update on recent clinical and preclinical research, corporate activities and the voting results of the annual and special meeting of shareholders of the Company.

Fred Ors joins Immunovaccine as Chief Business Officer

Frederic Ors joins Immunovaccine's senior management team in the newly created position of Chief Business Officer.  Mr. Ors, 41, spent 13 years at Medicago Inc. in Quebec, most recently as Vice President of Business Development and Strategic Planning. He has been an integral part of Medicago’s success in securing multiple non-dilutive funding opportunities, leading to an acquisition by Mitsubishi Pharma in 2013 for $357M. Before joining Medicago he was manager of intellectual property and licensing for Paris Diderot University, a complex of 150 labs, two hospitals and 2,300 scientists in Paris. He earned his bachelor’s degree in biology and his master's in management of innovation projects in biotechnology at the University of Angers.  

 

“I'm excited to join Immunovaccine in its current stage of development and help it grow by seizing the many opportunities ahead for commercial development of a revolutionary technology," said Mr. Ors. 

 

Clinical Research Update

Immunovaccine continues to have an active clinical pipeline based on the DepoVaxTM platform, in both cancer and infectious diseases. This progress is highlighted by DPX-Survivac, our lead cancer immunotherapy candidate, in which a Phase 2 clinical trial in lymphoma has recently been initiated. In addition, a Phase 2 study in ovarian cancer is also planned. These clinical trials follow positive safety and immunogenicity results from a Phase 1/1B study in ovarian cancer. The U.S. Food and Drug Administration (FDA) has granted DPX-Survivac a Fast Track designation as maintenance therapy in subjects with advanced ovarian, fallopian tube and peritoneal cancer who have no measurable disease following surgery and front-line chemotherapy.  A Phase 1/2 with DPX-0907 in breast and ovarian cancer patients that was planned with Busto Arsizio Hospital in Italy will no longer proceed due to unforeseen extended delays at the clinical site. The Company will provide further updates on DPX-0907 in due course. DepoVax™ was selected as the underlying vaccine technology supporting a Phase 1B study in HPV-related cancers, funded through the Stand Up to Cancer (SU2C) and Farrah Fawcett Foundation (FFF). In addition, the Company plans to initiate its first Phase 1 clinical trial in infectious disease in 2015, a respiratory syncytial virus (RSV) vaccine being developed to protect the elderly population from infection. 

 

Preclinical Research Update 

The Company conducts innovative preclinical research to support its clinical pipeline. Through a long standing collaboration with the National Institutes of Health (NIH) the Company has conducted multiple animal studies supporting the development of both a novel vaccine for anthrax and Ebola virus disease. Due to a highly competitive landscape for Ebola vaccines and the early-stage nature of our Ebola vaccine development program, combined with a rapidly dwindling number of clinical cases in which to test innovative novel vaccine candidates, Immunovaccine determined it will no longer pursue the development of an Ebola virus vaccine for the time being. Immunovaccine continues to collaborate with the NIH to further advance a DepoVax™-based single dose rapid response anthrax vaccine.

Voting Results of Annual and Special Meeting of Shareholders of the Company

Immunovaccine also announces the voting results of the annual and special meeting (the “Meeting”) of shareholders of the Company (the “Shareholders”) held today in Halifax, Nova Scotia.
 

The Company is pleased to announce that all of the nominees listed in the management information circular dated March 20, 2015 (the “Circular”) were elected as directors until the next annual meeting of Shareholders or until such person’s successor is elected or appointed. Each of the directors was elected by a majority of the votes cast by Shareholders present at the Meeting on a show of hands. The votes represented by proxy in respect of the election of each director are as follows:
 

 

The Shareholders also approved the re-appointment of PricewaterhouseCoopers LLP as auditor of the Company.
 

In addition, all other resolutions placed before the Meeting, including (i) a resolution approving amendments to the stock option plan of the Company and (ii) a resolution ratifying a new by-law of the Company relating to the advance notice of director nominations were approved by the Shareholders.
 

Please refer to the Circular available on SEDAR at www.sedar.com for more information on the business transacted at the Meeting. A report on voting results will also be filed on SEDAR.
 

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.

 

Immunovaccine Initiates Phase 2 Clinical Trial of DPX-Survivac Immunotherapy in Recurrent Lymphoma

Source:  Immunovaccine Inc.

Trial to Test Efficacy in Diffuse Large B cell Lymphoma Patients with Measurable Disease 


Immunovaccine Inc. (“Immunovaccine” or “IMV”) (TSX: IMV), a clinical stage vaccine and immunotherapy company, today announced that it has treated the first patient with diffuse large B cell lymphoma (DLBCL) in a Phase 2 clinical study of its lead cancer immunotherapy DPX-Survivac.  The Company-sponsored trial is evaluating DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL.  DPX-Survivac is designed to activate killer T cells of the immune system against the survivin antigen found in a wide variety of solid tumors and blood cancers.   

 

“We believe that combining our T cell activating therapy with immune modulating agents is important to achieve a robust clinical response. Our data to date suggest that combining DPX-Survivac with low dose cyclophosphamide has the potential to provide a clinical benefit in some cancer patients. With cyclophosphamide often used as a low toxicity therapy in recurrent/refractory lymphoma, recurrent DLBCL represents an excellent indication to demonstrate the efficacy of the DPX-Survivac/cyclophosphamide combination in this patient population with a high unmet medical need,” said Dr. Marc Mansour, chief executive officer of Immunovaccine.

 

The open label Phase 2 study designed to evaluate the efficacy of DPX-Survivac will enroll up to 24 patients with recurrent survivin-expressing DLBCL. Investigators for the multi-site study will determine the percentage of patients with measurable disease who respond clinically to the DPX-Survivac therapy. Immune responses and changes in tumor biopsies from these patients will also be monitored.  Positive results could provide rationale for the initiation of a pivotal trial of DPX-Survivac in recurrent DLBCL, which is considered an orphan drug indication.  The trial is being conducted at the Ottawa Hospital Research Institute and the Odette-Sunnybrook Cancer Centre, with additional sites planned as the trial progresses.

 

Lymphoma is the most common form of hematologic cancer in the developed world.  According to the Leukemia and Lymphoma Society, there were more than 700,000 people in 2013 living with lymphoma or in remission from the disease.  About 90% of cases are non-Hodgkin lymphoma (NHL) and about 40% of NHL cases are diagnosed as DLBCL.  Initial treatment of DLBCL often involves various chemotherapeutic agents, with or without radiation therapy and supplemental drug therapy.  In cases of relapse, the preferred treatment for many patients with DLBCL is an autologous stem cell transplant (ASCT). The DPX-Survivac therapy will be applied to patients who are not transplant candidates or who experience recurrence following a stem cell transplant and lack additional treatment options.

 

In previous DPX-Survivac studies conducted in ovarian cancer patients, robust and durable CD8 T cell responses were observed in almost all patients receiving a specified regimen of the vaccine. Patients with a robust immune response to DPX-Survivac showed a trend of delayed disease progression which may potentially be attributed to the therapy. The vast majority of ovarian cancer patients enrolled in these studies were in remission with no evidence of disease. However one patient with measurable and stable disease achieved a 43% reduction in tumor size, demonstrating a durable clinical benefit associated with the DPX-Survivac therapy. 

 

About DPX-Survivac

DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in solid tumors and blood cancers including ovarian, breast, colon and lung cancers, among others. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in high percentage of cancer patients.

 

The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively search for tumor cells expressing survivin and destroy them. 

About DepoVax™

DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness.  The DepoVax platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability. 

 

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 I human clinical trials. Lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase 2 clinical studies in both ovarian cancer and glioblastoma (brain cancer), with Immunovaccine also exploring additional studies in other indications including lymphoma and recurrent ovarian cancer.  The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV), anthrax and Ebola virus.