Immunovaccine Announces Financial Results for Quarter Ended March 31, 2016
HALIFAX, NOVA SCOTIA -- (Marketwired) -- 05/10/16 --
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 first quarter ended March 31, 2016.
"In the first quarter of 2016, we made diligent, steady progress in the three key areas-immuno-oncology, infectious diseases, and our leadership team. We believe these components will drive the long-term value of our company and our DepoVax™-based pipeline," said Frederic Ors, Immunovaccine's Chief Executive Officer. "Highlights from this quarter included receiving regulatory clearance to start our Phase 1b trial in recurrent ovarian cancer with our collaborator Incyte Corporation (Nasdaq: INCY); initiating a vaccine development program aimed at combatting the Zika virus; and making key leadership appointments to propel our evolution towards clinical development and commercialization of our product candidates."
Mr. Ors noted the progress of the Company's immuno-oncology program, stating, "We achieved a key regulatory milestone in January 2016, when the U.S. Food and Drug Administration (FDA) and Health Canada provided clearance for us to initiate a Phase 1b clinical study in patients with recurrent ovarian cancer who have measurable disease. This trial will assess the safety and effectiveness of our novel T-cell activating therapy, DPX-Survivac, in combination with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide.
"We have previously established that that DPX-Survivac combined with low dose oral cyclophosphamide is well tolerated and can induce a strong immune response. Now, this new trial will add Incyte's promising, clinically advanced immunotherapy to the equation," continued Mr. Ors. "We hope that this triple combination can lead to a new and potent therapeutic option for the high unmet medical need in ovarian cancer. We anticipate starting the trial, which Incyte will co-fund under the terms of our agreement, in the first half of 2016."
Mr. Ors also remarked on the Company's next application of DepoVax™-based vaccines in infectious diseases. "In early 2016, we initiated a Zika vaccine research project, thereby joining the global race to combat the mosquito-born virus. This significant public health threat, marked by recent widespread outbreaks, has no viable treatment options and has been linked to neurological birth defects in infants. We believe that the DepoVax™ unique delivery system offers significant value to potential collaborators in this space because it has demonstrated its ability to provide durable immune responses and a consistent safety profile when tested among several infectious diseases. Our goal here is to build upon the promising results of our earlier research with DepoVax™-based vaccines for Ebola virus, anthrax and respiratory syncytial virus (RSV) to accelerate the development of a vaccine that combats this infection.
"Shortly after the quarter ended, we made a major advancement with our Zika project by entering into a collaboration with Leidos (NYSE: LDOS), a health, national security and infrastructure solutions company," noted Mr. Ors. "Leidos will lead antigen discovery and development, and we will formulate the new antigens in our DepoVax™ delivery system. This project could serve as a replicable model for expediting the development and manufacture of vaccines to address current and future health emergencies."
Immunovaccine's management team also evolved in the first quarter, when IMV veteran Marc Mansour, Ph.D., stepped down from his role, and the Company named Frederic Ors as the Chief Executive Officer (CEO). "I am honored to have been named the Company's new CEO," continued Mr. Ors. "During my tenure as the Chief Business Officer at Immunovaccine, I witnessed first-hand the strength of the team here and its ability to develop our pipeline of DepoVax™-based programs. In addition, the unique technology inherent in the DepoVax™ delivery system offers advantages that make Immunovaccine a preferred partner among immuno-oncology and infectious disease collaborators. I look forward to working with the team to expand relationships and progress our programs, taking advantage of the myriad of opportunities on our horizon."
Mr. Ors also remarked on more recent additions to the Company's leadership, stating, "In April, we also bolstered our Board of Directors with the appointment of Medicago CEO Andy Sheldon. In addition to being named to the Board, Andy was unanimously elected at our 2016 Annual General Meeting (AGM) to lead the Board as Chairman. Andy's experience across the pharmaceutical and biotech industries is a tremendous asset, and, ultimately, gives our potential commercial partners and investors further confidence that we understand our markets and are ready to serve them."
Recently, Dr. Bradley Thompson retired from the Board of Directors after five years as a director. "Brad has been a valuable source of strategic knowledge to us in the time he has spent on our Board, and we are grateful for his service," Mr. Ors continued.
Looking forward, Mr. Ors noted, "We are well positioned to continue making significant strides for the remainder of 2016. We have developed a plan to fund the Company going forward and we are working diligently to execute against it. In terms of pipeline progress, in April we presented a poster at the American Association of Cancer Research (AACR) 2016 meeting, in which a pre-clinical study showed that DepoVax™-based cancer vaccines may improve the efficacy of checkpoint inhibitors, even among tumors that do not respond to anti-PD-1 therapies alone.
"Those findings indicated that our vaccine delivery system has the potential to increase the susceptibility of tumors to PD-1 blockades, thereby potentially improving outcomes and broadening the range of cancers treatable by these types of therapies. We are evaluating opportunities to pursue collaborations that can leverage our DepoVax™-based vaccines to increase the efficacy of the checkpoint inhibitors in development or currently on the market."
Q1 2016 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 $1,852,000 for Q1 Fiscal 2016 was $83,000 higher than the net loss and comprehensive loss for Q1 Fiscal 2015. This relates mainly to $85,000 increase in general and administrative expenses, $59,000 increase in business development expenses, and $28,000 increase in accreted interest, offset by an increase in revenue of $65,000 and the $24,000 decrease in research and development costs.
For the quarter ended March 31, 2016, the Company reported total R&D expenses of $769,000, net of government loans and assistance of $279,000 and investment tax credits of $70,000. This represented a $24,000 decrease of net research and development expenses over the three months ended March 31, 2016. General and administrative expenses of $809,000 were reported for Q1 Fiscal 2016 compared to $724,000 for the three months ended March31, 2015. Total business development expenses of $211,000 in Q1 Fiscal 2016 represented an increase of $59,000 compared to the three months ended March 31, 2016.
At March 31, 2016, Immunovaccine had cash and cash equivalents of $2,082,000 million and working capital of $1,779,000 million as compared to $3,842,000 million in cash and $3,283,000 million in working capital at March 31, 2016.
As of May 10, 2016, the number of issued and outstanding common shares was 92,195,670 and the number of stock options outstanding was 6,206,765.
Immunovaccine's unaudited interim condensed consolidated financial statements for March 31, 2016, filed in accordance with IFRS, and the management discussion and analysis (MD&A), will be available at www.sedar.com.
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.
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 and the matters discussed under "Risk Factors and Uncertainties" in Immunovaccine's Annual Information Form filed on March 29, 2016. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
Mike Beyer, Sam Brown Inc.
Chief Financial Officer
Source: Immunovaccine Inc.
Released May 10, 2016