J. Joseph Kim
Analyst · Piper Jaffray. Please proceed with your question
Thank you, Jeff. Good afternoon, everyone. The focus of today's call is on executing our strategy. Executing our strategy to advance Inovio's phase 3 and phase 2 immuno-oncology products into key data and business milestones. When we spoke last in May, I told you we delivered a strong package to the FDA in response to their device related questions and comments pertaining to our VGX-3100 phase 3 pre-cancer program. The FDA agreed with us and listed our clinical hold, allowing Inovio to deliver on our promise to initiate the phase 3 study for our lead product in the first half of 2017. We also told you that during the whole period, we were moving ahead on our trial preparations. Our preparation paid off, and just over one month since we initiated phase 3, we have activated 27 sites in the United States, up running and recruiting patients. By the year-end, we expect to have activated at least 50 sites in the U.S., Europe, Asia and Africa. Initiating Inovio's first phase 3 program marks a significant milestone for the company, for DNA-based immunotherapy, and most importantly, for women suffering from cervical pre-cancer caused by chronic HPV infection. The pivotal data from this program is positive to support the license drug application of VGX-3100 as the first immunotherapy for this disease. But beyond treating this one HPV associated disease, Inovio's goal is to own HPV treatments. Here is the clinical roadmap with my vision for Inovio's HPV therapeutic ownership. First we began with our first phase 3 program for HPV-associated cervical dysplasia. We combined that with company's now initiated phase 2 clinical trial of VGX-3100 for treating HPV-related vulvar neoplasia, and to that we'll add planned 2018 clinical trial for treating HPV associated anal neoplasia. To those in-house trials, we had MEDI0457, formerly called INO-3112 checkpoint inhibitor-based combination study with AstraZeneca's MedImmune targeting HPV-associated metastatic head and neck cancers. With this broad clinical roster, we are well-positioned to comprehensively treat HPV-associated pre-cancers and cancers across the continuum of HPV infection through to cancer in both women and men. We want to become the go-to therapeutic solution provider for all diseases caused by HPV infection. To that end, in April, Inovio commenced a randomized open-label phase 2 trial to evaluate the efficacy of VGX-3100 in women with high-grade HPV-related vulvar intraepithelial neoplasia, or VIN, a disease with a high unmet medical need. You may not know this, but HPV-induced VIN is one of the major causes of morbidity for young and middle-aged women with HPV-induced pre-cancer. It is also associated with repetitively for surgery, multiple biopsies and a major cause of pain and sexual dysfunction. Extending our immuno-oncology franchise, in May, Inovio announced that MedImmune commenced a new phase 1/2a clinical trial investigating the combination of MEDI0457 and immunotherapy designed by Inovio to generate antigen-specific killer T cell targeting HPV-associated tumors and in MedImmune's PD-L1 checkpoint inhibitor. The combination trial is intended to enroll 50 patients with metastatic HPV-associated head and neck cancer with persistent or recurrent disease after chemotherapy treatment. This study marks a significant moment for Inovio. As you might recall, in 2015, MedImmune acquired exclusive rights to Inovio's INO-3112 immunotherapy for all HPV-associated cancers. MedImmune provided an upfront payment of $27.5 million to Inovio, as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will also fund all development costs, while Inovio is entitled to receive up to double-digit royalties on MEDI0457 product sales. In this current combo study, we expect that the phase 2 portion of the trial will trigger a milestone payment from MedI by the early 2018. As a part of this deal, the two companies have also collaborated on a new funded research program, which MedImmune has now selected a new cancer immunotherapy candidate to advance into the clinic. This new product candidate was designed and constructed by Inovio to treat an undisclosed canceller and will also trigger milestone payments from MedImmune as well as royalty base on sales. In addition to MedImmune, our technology's promise in cancer has attracted significant attention from other pharma companies developing or marketing oncology products. Just in the past quarter, we struck two independent collaboration agreements with Regeneron and Genentech. In May, Inovio and Regeneron entered into an immuno-oncology clinical study agreement for glioblastoma combination therapy. The phase 1/2a clinical study will combine Regeneron's PD-1 inhibitor REGN2810 and Inovio's T cell activator, INO-5401, and immune activator INO-9012 in brain cancer. INO-5401 includes three of Inovio's top SynCon cancer antigens. These are WT1, hTERT and PSMA which are expressed widely in multiple tumor types. Thus INO-5401 has the potential to be a powerful and broad cancer immunotherapy in combination with checkpoint inhibitors. The open-label trial, which is expected to begin before year-end, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. To focus on the disease for a moment, Senator John McCain recent diagnosis, CBM is the most aggressive form of brain cancer and its prognosis is extremely poor. Therefore if this combination treatment shows at least a moderate level of efficacy against this aggressive cancer, we would expect to have an expedited approval path for INO-5401. Building on our INO-5401 cancer product development, In June, Inovio entered into a collaboration agreement with Genentech to commence a clinical trial to evaluate the combination of 5401 and Genentech's PD-L1 checkpoint inhibitor, TECENTRIQ, in patients with advanced bladder cancer. This phase 1/2 immuno-oncology trial is also anticipated to start later this year, and is designed to evaluate the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer. Combining INO-5401/INO-9012 with TECENTRIQ, may provide a synergistic therapeutic effect as a result of generating high levels of activated T cells and simultaneously inhibiting PD-L1. We have chosen metastatic bladder cancer as the second cancer indication to test for INO-5401 with a checkpoint inhibitor because it is a highly immune responsive cancer. Bladder cancer has often been described as an immunogenic tumor, and here our approach is to augment the entire anti-PD1 PD-L1 driven efficiency by further enhancing the T cells against the tumor in a tumor antigen-specific manner. As you can see from our recent collaborations, I'm a strong believer in combination immuno-oncology regimens employing an immunotherapy to generate significant antigen-specific killer T cell than blocking T cell suppression via checkpoint inhibition. With our strategic selection of our first combo efficacy studies in GBM and bladder cancer, we believe we can demonstrate the immense potential of INO-5401 as a universal cancer immunotherapy to treat patients with multiple cancers. This is why, unlike our MedImmune license deal, Inovio decided to retain the full economic rights to INO-5401 under these collaboration studies. As you know well, Inovio is not just a promising immuno-oncology development company, our technology is nimble enough to target challenging infectious diseases, IV products that may become stockpiled vaccines and those that have also have commercial potential. And we are accomplishing all this vaccine development with an expensive non-dilutive external funding. Inovio will continue to advance these vaccines for combating emerging infectious diseases with external funding. Recently Inovio reported that its HIV vaccine, PENNVAX-GP, produced amongst the highest overall levels of immune responses rates ever observed in a human study by an HIV vaccine. These significant results are consistent with Inovio's recent data reported from Ebola, Zika and MERS clinical trials in terms of achieving nearly 100% vaccine response rates with a favorable safety profile. Winding out our infectious disease results for this quarter. In June, we announced full enrolment of our second phase 1 clinical trial in Puerto Rico, evaluating are Zika vaccine, GLS-5700 in 160 volunteers. Along with safety and immune responses, the study is also assessing differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory efficacy endpoint being evaluated over one year. Inovio is very proud to be at the forefront of Zika vaccine development and to produce foundational data that clearly supports advancement of DNA technology and our vaccine candidates. We were the first to clinical vaccine testing and the first to report positive immune data from the clinical trial. We look forward to the prospects of securing external funding for phase 2 efficacy studies in our effort to potentially commercialize our Zika vaccine. We expect to report on additional data from our vaccine clinical studies and public the data in the top medical journals this year. Now I'd like to introduce our CFO, Peter Kies, who will discuss our recent capital raise and our financial results. Peter?