Dr. J. Joseph Kim
Analyst · Cantor Fitzgerald
Thanks, Ben. Good afternoon, everyone, and thank you for joining us.We recently spoke with you regarding the Company's realignment last month. And while I attempt to provide some updates since our call, I will focus on major accomplishments and developments of the second quarter as well as the major value drivers that we expect to deliver before year end.As we stated during last conference call, the recent realignment will enable Inovio to focus on two main areas. First, HPV immunotherapy; and second, accelerating product candidates which hold the potential for an expedited time to market.Let's begin with the first area, HPV immunotherapy. Staying on the commercial path for VGX-3100, last quarter, we announced the completion of our target enrollment of 198 patients for REVEAL 1, bringing Inovio another step closer to providing an innovative treatment alternative to the patients suffering with high-grade cervical dysplasia. In regard to confirmatory portion of our Phase 3 program, known as REVEAL 2, enrollment is ongoing and on track. We are utilizing the top performing sites from REVEAL 1, and we also expect to expand recruitment for REVEAL 2 outside of the U.S.Our goal is to submit the BLA in 2021. In May, we announced a very important and exciting collaboration with QIAGEN to develop a pretreatment biomarker diagnostic kit VGX-3100, based on the REVEAL 1 and REVEAL 2 studies.Together with QIAGEN's extensive experience in cervical cancer and HPV-related molecular testing, we are building a liquid biopsy-based complementary diagnostic that will identify patients who have most benefit from VGX-3100. Having the ability to offer this diagnostic kit for screening patients would greatly enhance the commercial utility and profile for Inovio's HPV therapy.Further complementing VGX-3100 are our Phase 2 trials for of high-grade vulvar and anal precancers associated with HPV. Just this past month, we completed the full enrollment of patients in our Phase 2 trial for vulvar dysplasia. The primary endpoint of this study is histologic clearance of high-grade lesions and virologic of clearance of HPV virus in vulvar tissue samples.Let me remind you that there are no FDA approved nonsurgical treatments for high-grade vulvar dysplasia. And surgical treatment can severely impact quality of life. And recurrence after surgery is observed in over 50% of the patients. As for the anal precancer Phase 2 study, we're also nearing complete enrollment as well.Mark your calendars before the end of this year, we'll get back to you with interim data from both our VIN and AIN trials.We're also pleased to say that AstraZeneca has completed planned enrollment of the Phase 2 study MEDI0457 in head and neck cancer, and they expect to complete this study by August 2020.Inovio received a third Phase 2 milestone payment from AZ last quarter from dosing of a patient with the third HPV-related cancer indication; two previous milestone payments resulted from initiating Phase 2 combination trial targeting head and neck cancer and cervical cancer. AstraZeneca continues to expand and evaluate MEDI0457 in three different Phase 2 trials.Rounding out my remarks on our HPV immunotherapy platform, we have deployed our resources to rapidly advance INO-3107 to treat RRP, or recurrent respiratory papillomatosis. RRP is a rare orphan disease caused by HPV 6 and 11 infections, for which Inovio recently demonstrated clinical benefit in a pilot study. Surgery is the current standard of care. And if left untreated, RRP obstructs air pathways and impairs vocal ability of the patients. The problem is that the RRP almost always recurs after surgery. In fact, two patients in our pilot study required surgery every six months prior to our treatment. After the treatment, one patient was able to delay surgery for over 18 months, and another patient remained surgery-free for almost three years and counting.In addition to adults being affected, RRP symptoms are often even more severe in children. So, taking overall prevalence rates of roughly 20,000 people in the U.S., as well as the disease occurrence among pediatrics, we're planning to meet with the FDA before year-end to determine the best path forward for INO-3107 where ideally we will look to evaluate both adults and pediatrics in a Phase 2 clinical study. The near term goal for us is to initiate the next clinical trial of INO-3107 before mid-2020.As we continue to build up our prior efficacy and clinical results, we feel Inovio has the proper resources to bring these multiple HPV therapies to market, which provides ultimate validation of our technology and increases near-term value drivers.Turning now to our oncology combination programs. As part of our sharpened clinical strategy, we announced that Inovio focus its INO-5401 development efforts on treating glioblastoma multiforme, or GBM, while discontinuing our I-O study in advanced bladder cancer. We will continue to follow the patients who are already enrolled from the bladder study and share any important or relevant data in the future.For GBM data, we anticipate progression-free survival at month six results to read out in November, followed by overall survival data next year. If positive, given the extreme medical need and lack of accepted treatments for GBM, we believe INO-5401 immediately becomes a fast-to-market candidate, while additionally giving the boost to the Company's strategy combining RRP cell activating immunotherapy with checkpoint inhibitors.During our last call in July, I mentioned that we are advancing a novel cancer combination trial with the Parker Institute for Cancer Immunotherapy. I’m now able to share that as part of Inovio's clinical collaboration agreement with Parker and the Cancer Research Institute. Inovio’s prostate cancer product, INO-5151 will be combined with Celldex Therapeutics FLT3 ligand and in Bristol-Myers's PD-1 checkpoint inhibitor nivolumab targeting metastatic castration-resistant prostate cancer.Just to remember INO-5151 is a formulation that combines INO-5150 with INO-9012. Specifically, this trial is an open label non-randomized exploratory platform study, consisting of three different cohorts that are designed to assess the safety and antitumor activity of multiple immunotherapy-based combinations in participants with metastatic castration-resistant prostate cancer who have received prior secondary androgen inhibition.INO-5151 is being utilized in one arm, specifically Cohort C of this Parker supported study. Our Phase 1 data for INO-5150 in prostate cancer, including T-cell responses and limiting PSA increase, played an important role in encouraging the Parker Institute to select our DNA-based therapy for this innovative combination trial that targets a major unmet medical need. We are very excited to see this study get started as this trial helps to further complement our thesis of combination therapies in treating cancer, while also demonstrating how Inovio is working with top cancer immunotherapy pioneers to investigate the potential significance of our T-cell activating immunotherapy and then innovative immuno-oncology combination regimen.This development speaks to our sharpened focus and cost effective strategy in cancer. Why? Because Inovio maintains three shots on goal, incorporating our immuno-oncology combo strategy. And we have established partnerships with leaders in the field to fully fund two of them, AstraZeneca in funding their MEDI0457 trials, and Parker is fully funding our combo prostate program. Of the three approaches currently being evaluated in clinical studies, Inovio is only financially responsible for INO-5401 in GBM, which is being done in collaboration with Regeneron Pharmaceuticals.Collectively, we feel Inovio maintains an important presence for developing novel therapies for cancer within areas that build upon positive Phase 1 data from MEDI0457 and the HPV related head and neck cancer patients, while also targeting high-risk, high-reward cancer candidates like GBM.Taken together, our programs highlight the synergistic effects of combining our T-cell activating immunotherapy with checkpoint inhibitors. Certainly, there is more work to be done and data to be shown but we're in a great position with multiple shots on goal within I-O, while being fiscally responsible and efficient.Staying on the theme for game-changing cancer therapies, I'm also pleased to say that last quarter, three clinical data results for Inovio's transformative dBTE technology were published in JCI Insight. This new application of our platform dramatically improves the current shortcoming of BiTE or bi-specific T cell Engager technology. The currently approved BiTE products have only a few hours of half-life in patients and require several weeks of continuous intravenous infusion. Inovio developed a novel dBTE targeting the HER2 molecule, which was tested successfully in therapeutic models for treatment of ovarian and breast cancers. More importantly, a single injection -- a single injection of the HER2 dBTE candidate produced bi-specific antibodies that lasted for several weeks in the bloodstream of mice, and effectively killed HER2-expressing tumor cells, resulting in a near-complete tumor clearance. These results open up a new cancer therapy platform for Inovio, and we plan to rapidly advanced the dBTE products alone and with partners.Before I turn it over to Peter for a financial update, I want to provide a brief update on our infectious disease programs, as this still continues to be an important pillar for our technology and global business strategy.In May, we dosed the first subjects in a Phase 1 first-in-human clinical trial to evaluate INO-4500 to prevent infection from the Lassa fever virus. This study, which is fully funded through a $56 million global partnership with CEPI, plans to enroll approximately 60 volunteers in a placebo-controlled, blinded dose escalation study in the U.S. Excitingly, this trial represents the first Lassa candidate vaccine to enter the clinic.In a previously published paper, we reported that INO-4500 provided 100% protection in non-human primates challenged with a lethal dose of Lassa virus in a study funded by a $3.5 million grant from the NIAID. Leveraging results from our current clinical study, we expect to advance this Lassa vaccine candidate into a Phase 2 field trial in endemic countries of West Africa in 2020.Moving to our MERS vaccine. We recently announced positive results that were published in The Lancet Infectious Diseases. Impressively INO-4700 was advanced into the clinic with the nine months of vaccine candidate selection, the first MERS vaccine to be tested in humans. Looking ahead, we're planning to initiate a larger Phase 2 trial in the Middle East in 2020 through our partnership with CEPI based on Phase 1b/2a data for INO-4700 from Korea.Lastly, and as it relates to continued innovations associated with our delivery technology, in June, we announced that medical arm of the U.S. Defense Threat Reduction Agency or DTRA will fund the further development of our new commercial intradermal delivery. The DTRA will provide $8.1 million to support Inovio in developing our battery-powered intradermal device branded at CELLECTRA 3PSP to be used in the administration of our vaccines and therapies.The CELLECTRA 3PSP is a small portable, user-friendly device, which will allow broader access to Inovio's vaccines and immunotherapies, whether the vaccine is administered to our troops ready to be deployed around the world, at a local pharmacy or in challenging settings such as rural Africa.So, while we did narrow our resources and focus within infectious diseases, we will continue to utilize and embrace our previously established global partnerships for the development of both, vaccines and delivery devices.With that, I will now ask our CFO, Peter Kies to provide a financial update. Peter?