Inovio Pharma (NASDAQ: INO) reported Q3 EPS of ($0.12), $0.02 better than the analyst estimate of ($0.14). Revenue for the quarter came in at $1.8 million versus the consensus estimate of $5.6 million.

Corporate Update

Clinical Development

In the third quarter, Inovio released top line efficacy data from its randomized, placebo-controlled, double-blind phase II clinical trial (HPV-003) for VGX-3100, its SynCon® immunotherapy against HPV-caused pre-cancers and cancers delivered with its CELLECTRA® electroporation device. The primary endpoint, histologic regression, was evaluated 36 weeks after the first treatment. In the per protocol analysis of this three-immunization regimen, CIN2/3 resolved to CIN1 or no disease in 53 of 107 (49.5%) women treated with VGX-3100 compared to 11 of 36 (30.6%) who received placebo. This difference was statistically significant (p<0.025). Intent to treat results were also statistically significant. There was also a high level of complete CIN 2/3 clearance.

This trial also demonstrated virological clearance of HPV 16 or 18 from the cervix in conjunction with histopathological regression of cervical dysplasia to CIN1 or no disease, a secondary endpoint of the trial, in 43 of 107 (40.2%) VGX-3100 recipients compared to 5 of 35 (14.3%) placebo recipients (p<0.025). Robust T-cell activity was detected in subjects who received VGX-3100 compared to those who received placebo.

Detailed study findings will be submitted for publication in a peer-reviewed medical journal. Inovio plans to independently advance VGX-3100 into a phase III registration study with target patient characteristics and a treatment regimen similar to the phase II study. The Company expects to complete its end-of-phase-II meeting with the FDA in 2015 and begin treating women in a phase III study in early 2016.

Inovio has broadened its therapeutic HPV franchise to include other precancers caused by HPV infection such as vulvar, vaginal, and other anogenital neoplasia as well as cancers of the cervix, head & neck, and anogenital areas. Inovio is conducting phase I/IIa clinical studies of VGX-3100 against HPV-caused cervical cancer and head and neck cancer. Both of these studies incorporate an immune activator, DNA-based IL-12, which has been shown to further boost already high levels of antigen-specific T cells generated by the immunotherapy. This combination is designated INO-3112.

Further expanding its HPV portfolio, Inovio launched a compassionate phase I clinical trial in patients with HPV-caused aerodigestive cancer. This study is testing Inovio's immunotherapy, INO-3106, alone or in combination with DNA-based IL-12 in subjects with HPV-6 associated invasive aerodigestive malignancies who have exhausted other treatment options (chemotherapy, radiation and surgery). Successful results could open a path to pursuing an FDA orphan designation (special status granted for therapies for rare diseases) for aerodigestive cancers.

Inovio plans to initiate an exploratory human study for INO-1400, its hTERT DNA immunotherapy, for breast, lung and pancreatic cancers by the end of 2014. hTERT is over-expressed in 85% of cancers. As a result, this immunotherapy has the potential to serve as a "universal" immune therapeutic agent for cancer. INO-1400 represents the first of several new broadly applicable cancer-specific antigens in Inovio's growing oncology product development pipeline that we intend to advance into human studies.

In collaboration with Roche, Inovio expects to advance its prostate cancer immunotherapy, INO-5150, into a phase Ia/Ib clinical trial in 2015 in patients with castrate resistant prostate cancer. The study will assess a comprehensive set of parameters and combinations of (i) INO-5150, (ii) additional new prostate cancer antigens that the team has been developing under the Roche/Inovio research collaboration, and (iii) Roche's portfolio of immunomodulatory drugs including checkpoint inhibitors. The initiation of this trial will trigger a milestone payment from Roche.

Also in collaboration with Roche, Inovio intends to launch a phase I/IIa clinical trial for its hepatitis B immunotherapy, INO-1800, in early 2015. The initiation of this trial will also trigger a milestone payment from Roche.

Inovio's multi-antigen SynCon® immunotherapy targeting hepatitis C virus, INO-8000 (a.k.a. VGX-6500) is being studied in a phase I/IIa clinical trial in Korea in collaboration with GeneOne Life Sciences, Inc. The companies expect to report phase I data from this clinical trial in 2015. Inovio intends to launch a related multi-site study with INO-8000 in the US.

Inovio expects to initiate a phase I study for its global, multi-clade PENNVAX®-GP preventive and therapeutic HIV DNA vaccine candidate. Development of this product was funded in part by a $25 million NIH contract. Initiation of this study may be delayed from the 4Q 2014 to 1Q 2015.

Inovio published positive animal data from its Ebola DNA immunotherapy in 2013. In 3Q 2014 we announced our intent to advance this immunotherapy (INO-4200), which is designed to target multiple strains of Ebola, in a phase I clinical trial in the first half of 2015 in collaboration with GeneOne Life Sciences, Inc. (Inovio owns a minority share interest in GeneOne). Upon successful completion of the phase I trial, the companies will jointly seek additional third party support and resources to further develop and commercialize this product.

For earnings history and earnings-related data on Inovio Pharma (INO) click here.