BLUE BELL, Pa., Nov. 7, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the quarter ended September 30, 2011.
Total revenue was $2.6 million and $8.2 million for the three and nine months ended September 30, 2011, compared to $1.3 million and $3.8 million for the same periods in 2010.
Total operating expenses for the three and nine months ended September 30, 2011, were $9.0 million and $24.0 million as compared to $5.8 million and $17.7 million for the same periods in 2010.
The net loss attributable to common stockholders for the three and nine months ended September 30, 2011, was $4.5 million, or $0.04 per share, and $9.8 million, or $0.08 per share, as compared with a net loss attributable to common stockholders of $1.4 million, or $0.01 per share, and $11.3 million, or $0.11 per share, for the three and nine months ended September 30, 2010.
Revenue
The increase in revenue for the three and nine months ended September 30, 2011, as compared with the same periods in 2010, was primarily due to an increase in revenue from the company's contract with the National Institute of Allergy and Infectious Diseases ("NIAID"). This contract revenue amounted to $1.9 million and $6.4 million for the three and nine months ended September 30, 2011, as compared with $895,000 and $2.7 million for the same periods in 2010. This NIAID HIV Vaccine Design and Development Teams contract, which exceeds $23 million over five years (plus two additional option years), is facilitating Inovio's development of a universal, preventive HIV DNA vaccine, PENNVAX-GP, focused on providing coverage against a broad set of global HIV clades, or sub-types.
Operating Expenses
Research and development expenses for the three and nine months ended September 30, 2011, were $7.0 million and $15.9 million as compared to $3.0 million and $8.8 million for the same periods in 2010. The increase was primarily due to higher clinical trial costs related to multiple clinical studies, including the initiation of the Phase II study of Inovio's cervical dysplasia/cancer DNA vaccine, VGX-3100, as well as higher costs related to work performed for the NIAID HIV contract.
Net Loss Attributable to Common Stockholders
The $3.1 million and $1.5 million decrease in net loss attributable to common stockholders for the three and nine months ended September 30, 2011, respectively, compared with the same periods in 2010, resulted primarily from the increase in grant revenue, increase in other income from the required quarterly revaluation of registered common stock warrants and decrease in general and administrative expenses, offset by the increase in research and development expenses.
Capital Resources
As of September 30, 2011, cash and cash equivalents plus short-term investments in certificates of deposit were $31.1 million, compared with $21.8 million as of December 31, 2010. This change primarily resulted from the January 2011financing, from which the Company received net proceeds of approximately $23.0 million, partially offset by expenditures related to our research and development and general and administrative activities.
Based on management's projections and analysis, the Company believes that its cash and cash equivalents are sufficient to meet its planned working capital requirements through the second quarter of 2013.
A summary of Inovio's consolidated balance sheet and statement of operations is provided at the end of this release. The Form 10-Q providing the complete 2011 third quarter financial report can be found at: http://ir.inovio.com/secfilings.
Corporate Update
Corporate Development
In the third quarter, Inovio announced it had expanded its existing license agreement with the University of Pennsylvania, adding exclusive worldwide licenses for technology and intellectual property for novel DNA vaccines against prostate cancer, CMV (cytomegalovirus), malaria, hepatitis B, RSV (respiratory syncytial virus), and MRSA (methicillin-resistant staphylococcus aureus) as well as a new optimized IL-12 cytokine gene adjuvant.
Inovio entered into a Cooperative Research and Development Agreement with the United States Department of Homeland Security Science and Technology Directorate Plum Island Animal Disease Center to evaluate the efficacy of its synthetic vaccines for foot & mouth disease in animal models.
Inovio also established a product development agreement with its affiliate, VGX International Inc., to co-develop Inovio's SynCon® therapeutic vaccines for hepatitis B and C infections.
The company expanded its scientific advisory board with the appointment of two prominent leaders in the fields of vaccines and cancer immunotherapeutics: Dr. Thomas S. Edgington, Emeritus Professor of the Scripps Research Institute; and Dr. Philip D. Greenberg, Professor of Medicine (Oncology) and Immunology, Department of Medicine, University of Washington.
Clinical Development
Long-term durability of T cell immune responses of up to two years (at the latest time measured) was observed following a fourth (Phase I) vaccination of VGX-3100, Inovio's SynCon® DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus. The company continues to set up sites and enroll patients for its Phase II clinical trial assessing the vaccine in women with CIN 2/3 or CIN 3 cervical dysplasias, the stages of abnormal cells preceding cervical cancer. The company expects to enroll 148 patients in 25 study centers in the U.S., South Korea, South Africa, Australia, and Canada. Data is expected in the second half of 2013.
Significant T cell and antibody responses were observed in its proof-of-principle Phase I clinical study of Inovio's preventive H5N1 (avian) influenza SynCon® DNA vaccine, VGX-3400X. The vaccine, delivered using Inovio's proprietary electroporation system, was generally safe and well tolerated at all dose levels, with no vaccine-related serious adverse events. Additional data are expected in 4Q 2011.
Inovio launched a second Phase I clinical study as part of its universal influenza vaccine, INO-3510, a SynCon® vaccine for H1N1 and H5N1 influenza, using its skin-targeted ID delivery device. Preliminary safety and immune response data are expected in the first quarter of 2012.
Strong immune responses and safety weredemonstrated from the first (US) cohort of healthy subjects in a Phase I study assessing Inovio's PENNVAX-G global HIV vaccine plus a virus vector vaccine, Modified Vaccinia Ankara-Chiang Mai Double Recombinant (MVA-CMDR), as a unique prime-boost preventive HIV vaccination strategy. Enrollment is continuing at three sites in Africa in the next phase of the study.
Best-in-class immune responses were observed in the final data from a Phase I clinical study of Inovio's PENNVAX-B, its product for the prevention of the HIV sub-type prevalent in the US and Europe. The investigators in this study concluded that PENNVAX-B + IL-12 plasmid delivered via electroporation led to frequencies and magnitudes of cellular immune responses equal to or greater than those reported from current vector-based HIV vaccines such as adenovirus or traditional DNA vaccination without electroporation.
Enrollment is ongoing in the Phase II clinical studies being run by Inovio's collaborators ChronTech and the University of Southampton for their DNA vaccines for hepatitis C virus and acute and chronic myeloid leukemia, with interim data expected in 2012.
Inovio previously announced a research collaboration with ChronTech Pharma AB and Transgene S.A. to test the immunogenicity of a DNA/electroporation prime - MVA boost approach against HCV by combining two promising, previously studied clinical candidates. A Phase I clinical study is anticipated to start in Q4 2011.
About Inovio Pharmaceuticals, Inc.
Inovio is developing its revolutionary synthetic consensus immunogen technologies to extend the profound medical benefits of the 20th century's immune-system-stimulating vaccines by preventing and treating today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery method, have been shown in humans to be safe and generate best-in-class immune responses. Inovio's clinical programs include Phase II studies for cervical dysplasia/cancer, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
