Inovio Pharmaceuticals reports increased revenues in the second quarter 2014

Inovio Pharmaceuticals reports increased revenues in the second quarter 2014 -

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO) announced today its financial results for the quarter ended June 30, 2014.

total revenue was $ 3.8 million and $ 6.2 million for the three and six months ended June 30, 2014 compared to $ 786,000 and 2, $ 2 million for the same periods in 2013.

total operating expenses were $ 14.0 million and $ 26.3 million for the three and six months ended June 30, 2014, compared to $ 6.5 million and $ 14.5 million for the same periods in 2013.

loss of previous operations to other income (expense) for the three and six months ended June 30, 2014 was of $ 10.2 million, or $ 0.17 per share, and $ 20.2 million, or $ 0.35 per share, compared to $ 5.7 million, or $ 0.13 per share, and 12 , $ 3 million, or $ 0.29 per share, for the same periods in 2013.

the net loss attributable to common shareholders for the three and six months ended June 30, 2014, was 10, $ 7 million, or $ 0.18 per share, and $ 21.5 million, or $ 0.37 per share, compared to $ 10.9 million, or $ 0.24 per share, and 19,700,000 $, or $ 0.47 per share, for the same periods in 2013.

the increase of $ 0.2 million and $ 1.8 million of the net loss attributable to common shareholders for the quarter and the six months ended June 30, 2014, compared to the same periods in 2013 mainly due to increased R & D and costs of clinical development as well as non-cash stock-based compensation.

Dr. J. Joseph Kim, President and CEO, said: "Our second quarter marked a milestone for Inovio with data reporting positive effectiveness of our Phase II HPV immunotherapeutic study. We are extremely pleased with the complete results of data from this study, including an impressive level of CIN 2/3 full game, and their implications for VGX-3100 to potentially meet an unmet need as a first-line treatment non-surgical alternative for these precancerous cervical lesions. We are now in a position all biotech companies hope to achieve, which is to have a product candidate with merit to advance a phase of recording studio III on the path to commercialization. We are now making this commitment with VGX-3100.

"aside from the positive result for our HPV franchise, these exciting data opens many doors for the promotion and expanding our extensive cancer and infectious diseases evolution of immune therapy. We are on track to create significant and valuable therapies to help humanity. "

Recipes

The increase in revenues for the comparable periods mainly consisting of development fees paid by Roche for the work done to our partnership with Roche.

operating costs

research and development expenses for the three and six months ended June 30, 2014 were $ 9.6 million and 17 , $ 8 million, compared to $ 4.4 million and $ 9.5 million for the same periods in 2013. the increase for the quarter and six months was mainly due to the work done under our Roche partnership, increased elements non-cash stock-based compensation of shares, and expenses related to the preparation of future clinical trials. general and administrative expenses for the quarter and six months ended June 30, 2014, were $ 4.3 million and 8 $ 5 million compared to $ 3.0 million and $ 6.0 million for the same periods in 2013.

capital Resources

on June 30, 2014, cash and cash equivalents, short term investments and restricted cash were $ 109.0 million compared to $ 52.7 million at December 31, 2013. This increase is mainly attributable to the net proceeds of our March 2014 financing and warrants and options exercised during the period.

at June 30, 2014, the company had 60.3 million shares outstanding and 66.7 million fully diluted.

on the basis of projections and analysis of management, the Company believes that cash, cash equivalents and short-term investments are sufficient to meet its working capital requirements provided for in the end 2017 the company plans to raise additional funds to finance the phase III of VGX-3100 development.

balance sheet and income statement of Inovio balance is provided below. 10-Q provides full social 2014 second quarter report can be found at: http://ir.inovio.com/secfilings.

Corporate Update

clinical development

Subsequent to the quarter, Inovio released top-line data on its efficacy, placebo-controlled, double-blind phase randomized clinical trial II ( HPV-003) for VGX-3100, its SynCon ^® immunotherapy against precancerous lesions and HPV cancers caused delivered with its CELLECTRA device ^® electroporation. Treatment was randomized 3: 1 between the VGX-3100 and placebo groups, and was stratified by age and the severity of the CIN. The primary endpoint, histologic regression was evaluated 36 weeks after the first treatment. In the per-protocol analysis of this three-immunization scheme CIN 2/3 resolved CIN 1 or no disease in 53 of 107 (49.5%) women treated with VGX-3100 compared to 11 of 36 (30.6%) receiving placebo. This difference was statistically significant (p <0.025). The intention to treat results were also statistically significant. There was also a high level of all CIN 2/3 stake.

This trial also demonstrated virologic clearance of HPV 16 or 18 of the neck in conjunction with histopathological regression of cervical dysplasia CIN 1 or no disease, a secondary endpoint of the trial, in 43 of 107 (40.2%) of the beneficiaries of VGX-3100 compared to 5 of 35 recipients (14.3%) in the placebo group (p <0.025). High activity of T cells was detected in subjects who received VGX-3100 compared to those who received placebo.

detailed results of the study will be submitted for publication in a scientific journal peer.

persistent and precancerous cervical untreated lead to cervical cancer. Currently the only available treatment for precancerous cervical lesions is surgery. There is an unmet need for immunotherapy for high quality precancerous cervical caused by HPV that, contrary to current surgical procedures does not pose a risk of causing premature births, and can also eliminate HPV throughout the body (not only in surgical site) and reduce the risk of new or recurrent precancerous lesions. Such non-surgical treatment would provide an attractive alternative for caregivers and their patients. The different results described in Phase II complete set of data combined with the overall benefits of VGX-3100 as a non-surgical approach thus creating a unique opportunity for the HPV immunotherapy as a first line treatment alternative.

Inovio has therefore committed to advancing VGX-3100 in a Phase III registration with the characteristics of the target patients and a similar treatment regimen in a Phase II study. The Company expects to complete its end of Phase II meeting with the FDA in 2015 and begin to treat women in a Phase III study in early 2016.

Inovio also expanding its HPV therapeutic franchise for inclusion of other precancerous lesions caused by HPV infection, such as the vulva, vagina, and other anogenital neoplasia and cancers of the cervix, head and neck, and anogenital areas. During the quarter, Inovio initiated two Phase I / IIa clinical studies of VGX-3100 against cancer HPV-caused cervical and head and neck. Both studies incorporate an IL-12, DNA-based immune activator, which has been shown to further increase the already high levels of T cells specific for the antigen produced by the vaccine. This combination is called INO-3112. These studies reflect our intent and concerted efforts to become the leader of immune therapy targeting HPV-related diseases, with their important global medical implications and costs.

Inovio is independently advancing clinical programs for VGX-3100, including the Phase III study for CIN 2/3, and its franchise wider for HPV associated diseases, but will consider opportunities for partnership that serve to maximize the long-term financial benefit to the Company and its shareholders.

beyond direct clinical implications VGX-3100, phase II efficacy results are a breakthrough for the field of immunotherapies demonstrating a clear clinical effect of an active immunotherapeutic agent in a study randomized placebo-controlled. They risk and contribute significantly to the advancement of our product strategy and business development.

Inovio previously said it planned a Phase I trial of its immunotherapy for prostate cancer, INO-5150, to be launched in Q3 2014. This phase I study was designed to investigate the safety and immunogenicity of INO-5150 (coded for PSA and PSMA antigen) in a cancer population of biochemically relapsed prostate. In a strategic review, Roche and determined that Inovio castrate resistant prostate cancer is a more favorable environment for the timely development and the potential integration of immunomodulatory drugs from Roche pipeline. The development team has decided to reposition this study in a study phase Ia / Ib in this population.

Under this decision, the team determined that strategically it would be more proactive and timely to immediately evaluate a more comprehensive set of parameters and combinations of (i) INO-5150, (ii) new antigens additional prostate cancer that the team has been in development under the research collaboration Roche / Inovio, and (iii) of the Roche portfolio of immunomodulatory drugs including checkpoint inhibitors . The team is working to complete a Phase Ia / Ib design of the multi-arm study reflect this strategy and plans to launch this study in 2015.

Inovio intends to initiate a Phase I study for its global, multi- PENNVAX clade ^® -GP preventive HIV DNA vaccine candidate and therapeutic late 2014. the development of this product has been funded in part by a $ 25 million contract for the NIH. PENNVAX stage the data from Inovio I ^® -B preventive HIV vaccine DNA (targeting only clade B virus) in uninfected subjects showed best-in-class T cell responses

Inovio plans to launch an exploratory study to human INO-1400, its DNA hTERT immunotherapy, breast, lung and pancreas in the second half of 2014. hTERT is overexpressed in 85% of cancers . Therefore, this immunotherapy is likely to serve as an immune therapeutic agent "universal" for cancer. INO-1400 represents the first of several new specific antigens widely-applicable cancer in developing oncology products growing arsenal of Inovio that we intend to move forward in human studies.

preclinical development

in 2Q, Inovio announced that data from a study rhesus monkey INO-8000, its multi- DNA antigen immunotherapy targeting HCV genotypes 1a and 1b, was published in human vaccines and immunotherapies in a document entitled "Strong NS3 / 4a, NS4b, NS5a, NS5b induced specific cellular immune responses in macaques rhesus by a new DNA vaccine consensus HCV genotype 1a / 1b. "This document has highlighted the cell killing effect T antigen-specific stimulated by multi-antigen SynCon Inovio ^® immunotherapy. INO-8000 (VGX-6500 aka) is being studied in a Phase I clinical trial / IIa in Korea in collaboration with GeneOne Life Sciences, Inc. Inovio plans to launch a multi-site study related to USA.

data from a preclinical study of our DNA multi-antigen immunotherapy for tuberculosis (TB) was published in human vaccines and immunotherapy in an article entitled "multivalent vaccines against tuberculosis targeting the gene family esx generate powerful and broad cell-mediated immune responses than the BCG. "The results of this study indicate that the DNA vaccine is highly immunogenic and induced T cell responses to wide robust spectrum with the possibility of exceeding the BCG (vaccine against tuberculosis live attenuated current) responses of T cells specific to esx induced a standalone basis or in a boost regime first using a BCG prime followed by a DNA vaccine recall.

at the 17th annual meeting of the American Society of Gene & Cell Therapy in Washington, DC, Inovio presented preclinical study data from our DNA therapeutic monoclonal antibody-based (mAb) targeting the Chikungunya virus (CHIKV). in this study, presented Inovio has shown that treatment of animals with plasmids Inovio anti CHIKV mAb protected 100% of the treated animals from a lethal injection CHIKV virus while 100% of control animals died. the treated animals were spared from virus-related morbidity as measured by the weight loss and lethargy. Inovio also demonstrated that the serum of animals transfected had the specific capacity to bind to the envelope of CHIKV antigen and serum had a CHIKV-neutralization activity.

Subsequent to the quarter, the data were published from a mouse Inovio's DNA immunotherapy study for C. difficile, a bacterial infection that causes distress and symptoms such as diarrhea, nausea, colitis, sepsis, and even severe intestinal death. This immune therapy, delivered with electroporation produced high levels of neutralizing antibodies that protect 100% of mice and nonhuman primates from a lethal dose of C. difficile toxin. The data were published in Journal of Infection and Immunity in an article entitled "An optimized synthetic DNA vaccine encoding Toxin A and Toxin B Receptor Binding Domain of Clostridium difficile induced antibody responses of in vivo protection. "This vaccine is being tested in collaboration with Dr. Michele Kutzler at Drexel University. Clostridium difficile infection is a major source of morbidity and mortality in the US, with half a million and about 30,000 deaths per year and a cost of significant associated health care.

Corporate Development

in 2Q, Inovio has extended its license agreement existing with the University of Pennsylvania, adding exclusive worldwide rights to the technology and intellectual property for new synthetic therapies against cancer, infectious diseases and new immune activators. This amendment broadens and strengthens patent protection covering the Company's product candidates for dengue fever, the H7N9 influenza, HPV and additional serotypes of additional cancer antigens. The amended agreement also provides for worldwide rights to Inovio synthetic antibody-based DNA, immune activators (IL-21, IL-23 and IL-33), and immune therapies for respiratory syndrome Middle East (MERS ) and tuberculosis.

91% subsidiary of Inovio, VGX Animal Health, Inc. (HAV), concluded an agreement for the sale of its assets to animal health Plumbline Life Sciences, Inc. (PLS) of Korea. The transferred assets include an exclusive license with Inovio for animal applications of its hormone releasing growth hormone (GHRH) technology and animal DNA vaccines and a non-exclusive license to Inovio's electroporation delivery systems for these applications . VGX Animal Health will receive $ 2 million in cash in several payments and 20% of the outstanding shares of PLS. 20% of the position of HAV PLS stake will be maintained without dilution up to 10 million additional $ collection by PLS own capital funds. Inovio will receive milestone payments and royalties on product sales and retain the human applications of the GHRH technology.

Inovio has acquired the worldwide rights (excluding China) for a new technology to generate inducible regulatory T cells, with applications such as Alzheimer's disease and multiple sclerosis. This technology is based on discoveries covered by patents issued and Dr. Bin Wang, a professor at Shanghai Medical College of Fudan University, and colleagues. Inovio will make payments of clinical and regulatory milestones for the University.

Inovio continues to work in partnerships with other pharmaceutical companies interested in Inovio SynCon ^® immunotherapy and vaccine products.

June 5, 2014, Inovio implemented a consolidation of the common shares of the Company 1-for-4. At the end of the second quarter, Inovio was added to the Russell Global, Russell 00 ^® and Russell microcap ^® Index.