Good day and welcome to the Inovio Second Quarter 2019 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.I would now like to turn the conference over to Ben Matone, Director of Investor Relations. Please go ahead.

Thank you, operator. Good afternoon and welcome to the Inovio Pharmaceuticals second quarter 2019 investor conference call.With me today are, Inovio's President and CEO, Dr. J. Joseph Kim, and our Chief Financial Officer, Peter Kies. Today's call is also being webcast live and a replay of today's call will be made available on our website ir.inovio.com.Following a general business update, we will conduct a question-and-answer segment which will be reserved for equity research analysts. During the call, we will be making certain forward-looking statements that relate to our business which include our plans to develop our immunotherapy platform in combination with our proprietary delivery devices as well as developments and timing of certain clinical data readouts and our capital resources.All of these statements are based on the believes and expectations of management as of today. These statements involve certain assumptions risks and uncertainties and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements whether as a result of new information, future events or otherwise. Investors should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in our filings with the SEC.I would now like to turn the call over to our President and CEO, Dr. J. Joseph Kim.

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…

Thanks, Joseph, and good afternoon, everyone.As of June 30, 2019, cash and short-term investments were $106 million, compared to $128 million for the previous quarter. Total revenue was $136,000 for the three months ended June 30, 2019, compared to $24.4 million for the same period in 2018. Total operating expenses were $28.3 million for the three months ended June 30, 2019, compared to $29.7 million for the same in 2018. Net loss for the quarter ended June 30, 2019 was $29.4 million or $0.30 per share basic and diluted, compared to $6.6 million or $0.07 per share basic and $0.08 per-share diluted for the quarter ended June 30, 2018.The year-over-year decrease in revenue and an increase in net loss was primarily due to the recognition of the gross upfront payment from ApolloBio of $23 million during the second quarter of 2018.In July, we announced a strategic organizational restructuring to focus on the commercial development of our late-stage HPV asset and reallocate capital to develop fast-to-market product candidates. We have cut, selected early stage R&D programs and discontinued further development of our Phase 1/2 study in advanced bladder cancer, while reducing our annual burn by 25% and our workforce by 28%.Earlier this week, we announced the closing of a private placement of convertible bonds with an aggregate principal amount of approximately $15 million issued to institutional investors, led by Korea Investment Partners. We expect to use these proceeds for the continued advancement of development activities for our clinical stage product pipeline, working capital, and other general corporate purposes. You can read the details in our 10-Q.As a reminder, our financial statements for the second quarter of 2019 can be found in today's press release and in our form 10-Q filed with the SEC. This can also be accessed on our website under Investor Relations, Financial Reports. Thank you and back to you, Joseph.

Thanks, Peter.Inovio's product candidates address important medical needs globally. We conduct our trials across five continents and partner with organizations with both regional and global reach. In coordination with the private placement that Peter just shared with you, we also announced this week our intent to pursue a dual listing of Inovio securities on KOSDAQ Market of the Korean Exchange in the form of Korean Depositary Receipts or KDRs.Just focusing on the private basement, I want to highlight that this investment is from fundamental long-only institutional investors led by Korea Investment Partners. And while I can't say too much at this time around our pursuit of KOSDAQ listing, I can make two points. First, we remain committed to our primary listing on NASDAQ Exchange. Second, the Korean capital market, and investors representing -- Second, the Korean capital market and investors represent and expanding opportunity for Inovio to secure an additional and attractive new source of capital, while also building on our extensive business development efforts in Asia. Given our history of strategic partnerships and clinical development in Asia, especially in Korea, this opportunity will expand Inovio’s presence in Asia, and in particular, capture the increased market opportunity for HPV-caused diseases while advancing our goal on becoming a global contributor to fight against cancer and emerging infectious diseases.Now, I look forward to taking your questions. Operator, please open the line for the analysts.

Thank you. [Operator Instructions] Our first question comes from Charles Duncan of Cantor Fitzgerald.

Hi. This is Pete Stavropoulos on for Charles, congratulations on the quarter and all the progress. A couple of questions. In reference to REVEAL 2 study, you have previously mentioned that you're exploring with your partners in China, ApolloBio, about possibility of adding sites to boost recruitment efforts. I think, can you provide us any updates on those efforts?

Yes, ApolloBio has announced that they have submitted an IND with Chinese FDA or Chinese regulatory agency. So, we're waiting to hear from the regulators in China. And we're doing a lot of the background work. So, while all efforts will be provided and expanded to see if we can bring in Chinese sites and patients to our REVEAL 2 study. It would have positive impact Inovio in terms of our timeline, it would also accelerate ApolloBio’s efforts to apply for a product licensure in China as expediently as possible. So, we think this is a way for us to kill two birds with one stone or have our cake and eat it too. So, more to be reported when it's ready.

And for VGX-3100, beyond the current Phase 3 studies, what work is completed or being completed to support an NDA, like top studies, which I know you have plenty, manufacturing scale up or commercial batches?

Yes. So, we are doing all of that. So, we are doing -- preparing for manufacturing PPQ runs, we have CSAs [ph] validated, we have other report talks and three pre-BLA preparations ongoing at the same time. So, behind the scenes that hasn't been that public, besides REVEAL 1 and REVEAL 2 studies, there's a lot of moving parts, I would say in a well oiled fashion that will support our launch when our clinical results come in.

All right. And one last question for the RRP program. I’d just like to get your perspective and thoughts. Two patients who have these strong durable responses, do you think that they have a complete viral clearance or do you believe like the immune system keeps the infection in check? And sort of leading into -- in other words, do you think there would be additional benefit to boosting these patients with additional doses of 3100 now?

Yes and yes, meaning we're not 100% sure whether we have cleared the virus. We don't think that's as important as delaying or eliminating surgery over time. So, we want to be as ambitious as possible in this arena. We also like to bring the product to the market as soon as possible. And while I can't speak too definitively until we get the concurrence with the FDA that we hope later this year, we expect to provide a booster shot every few months in these patients, because aim again is to make sure that the RRP does not come back. So, currently, as I mentioned, surgery is only temporary, the RRP almost always, and maybe I'll just say, always comes back. So, having an immunotherapy that can be provided in a very tolerable fashion that keeps RRP coming back, I think that's a huge win for the patients and great step forward in terms of commercially for our shareholders as well.

All right. Thank you very much and congrats again on the quarter.

Thank you, Pete.

Our next question comes from Joel Beatty of Citi. Please go ahead.

Hi, Joseph. This is Shawn Egan calling in for Joel. Thank you for taking my questions. I guess, on your liquid biopsy-based companion diagnostic, maybe could you just provide like a high level on what specifically this is evaluating? Are you looking at circulating tumor cells or is it more kind of HPV in general? And then, also, would you be validating this in REVEAL 1 and REVEAL 2, and is it your expectation that this could be included n the label?

The last question first. No, we don't think it’s going to be in the label itself. It’s going to be filed as complementary kit. Now, to give a little more insight, this is -- this is a pretreatment biomarker. And, we don't want to give out too much. But, these were the diagnostics that we were able to discover utilizing the Phase 2b data set from the patients in a post-hoc analysis. Currently QIAGEN is validating those results in their hands. And we're -- we will utilize the validated kits to test the REVEAL 1 and REVEAL 2 samples from our Phase 3 studies. We will be utilizing those data -- or QIAGEN will be utilizing those data to submit a diagnostic application that should nearly concurrently go in with our BLA application for VGX-3100. So, this is a true collaborative effort between Inovio and QIAGEN, and we're very excited to have such a very well experienced and resourced partner to help us develop this diagnostic kit.

Perfect. And then, there's a brief follow-up. Could you maybe provide an update on two of your infectious disease programs that you didn't mention? The HIV eradication study and also the Zika Puerto Rico study, would be getting data for those in 2019 as well?

Yes. So, for those two studies, Zika first, Zika Puerto Rico study, our partner GeneOne Life Science is in charge of running those assays and providing those results. So, we're waiting for them to provide that. In terms of the HIV therapeutic study, those are our trials enrolling, and those assays are getting done. So, we expect sometime later this year or early 2020 we’ll be able to report on safety and immune responses from our HIV therapy study that's being funded hopefully, by a grant fund, the National Institute of Health. So we're very excited about those. And as soon as we have those data, we will present those and release that either at the publication or a conference presentation.

Our next question comes from Stephen Willey of Stifel. Please go ahead.

Hi. This is Ellen on for Steve. Thanks for taking the question. So, I'm wondering, what does the bar look like for PFS and OS and GBM study? Like, what would you need to see to move this trial forward and to constitute success in this setting? Thanks.

Thanks Ellen. So, the true bar that we want to see, the needle mover is an improvement in overall survival, mean overall survival of three months or more in this newly diagnosed GBM patients, would have us do back flips and really move the program fast to market. In terms of progression-free survival. At six months, we are very, we expect pretty high levels. And PFS, it’s going to just provide entry, early look into efficacy. So, we don't think that’s end of the deal, but that's the beginning of -- the overall survival numbers that we expect in 2020.Now remember, we fully enrolled the 52-patient GBM study full three months ahead of our very aggressive schedule. So, we think we are on track to get to the data as excitedly and expediently as possible. But, it’s a very difficult disease to treat. What provides also is the bar to show improvements over this dire disease with very little effectively treatment option, provides us with a great opportunity. And I think we have a great shot at showing the survival improvements, certainly in 2020. And what we hope to see in the fourth quarter this year will just provide a window to a potential efficacy data that we hope to see in 2020.

Okay, great. And do you expect to communicate that data via medical conference or would it likely be in the form of press release? And I'm talking specifically about PFS update expected in November. And I have one follow-up. Thanks.

Yes. For this data as well as any other data, our preference always is to present our data at a conference presentation or a medical journal publication of substance. So, that would be our preference. Obviously, we would do a press release along with that. Will we ever do a press release as a standalone? Yes if the conference schedule doesn't really fit our business need, we could also choose to do that. But, that's not our preference. We like to present at a cancer conference in the fall, winter this year.

Okay, great. Thanks. And then, with regards to dBTE program, how confident are you around the safety profile of that program as you think about moving into development in the future?

Yes. So, there is two parts to the safety question. So, the first part is, is our DNA-based technology safe? And the answer to that question is, we're rounding it. And that’s based on over almost 7,000 patients -- or 2,000 patients with 7,000 different administrations worth of data from the clinical trials of our platform over the last several years, without a real safety signal coming from over 2,000 subjects and patients. So, a platform part of that we are concerned about. The bi-specific T cell engagers are -- carry as a whole class of cancer compound certain level of toxicity concern. Now, as we’re -- as you're force fitting T cell with cancer and binding them together by force with double sided tape, or double sided antibody, you are bound to see some safety signals.Now, could we ameliorate that using our DNA technology? That's what we're doing. And since we have been developing this platform, since our presentation at AACR, since our JCI Insight publication, we have been working very hard to find the best candidate to move forward, number one; and get the clarification from the FDA which candidate and what type of toxicity profile is amenable for dBTE technology. So, we have a team that's really dedicated and providing the right answers. My gut feeling is the BiTEs overall are going to compete very, very well to compare it to comparable technologies, like the CAR-Ts, which have the safety and tox concerns of their own. And also, using are dBTE technology will be able to show the superior, both efficacy and safety profiles going forward. And I think I'm very excited to bring our first program. And as a harbinger for a whole platform of dBTE behind that in the next several quarters. So, we're going to take some time, but move them as quickly as possible, knowing the safety and efficacy spectrum that we're going for.

[Operator Instructions] Our next question comes from Gregory Renza of RBC Capital. Please go ahead.

Hi, guys. Thanks for taking my question. Joseph, I just wanted to start on the AIN and VIN 3100 programs that you indicated for interim data before year-end. Could you just touch a little bit more about perhaps the timing there and the potential venue? And also, what if possible could we expect to look out for? Thank you.

Yes. Thanks, Greg. VIN, we completed enrollment of 33-patient study about a month ago. AIN, we are about to complete the enrollment of 24 patients soon. So, we're on track to maybe have about 50% of each study. These are open label studies, as you know. Looking at the lesion regression as well as viral clearance from these patients, similar to our Phase 3 study for cervical dysplasia. In terms of the venues, just to repeat what I said earlier to Ellen's question, our preference will be to present at conferences. And there are several in the late fall, winter that we could fit for VIN and AIN indications. So, we're in the process of investigating those venues in the coming months.

Got it. And just a follow-up on the timing there, just with respect to the 24-patient AIN, and perhaps noticing that that trial on clinicaltrials.gov was pushed out a few months, perhaps VIN was actually pushed forward a bit? Just talk a little bit, if you could about each of those indications and the nuances…?

Yes, absolutely. Both VIN and AIN are orphan designated indications, right? So, with high unmet medical need, surgery is only treatment option available today, and it’s highly disfiguring and the quality of life is low with those surgeries. And there is very high recurrence rate for VIN and AIN. And that seems to be the theme for all of these HPV caused disease where we think base on our Phase 2 data from cervical dysplasia well-controlled study, where we’ve shown that we can regress the lesions and viral -- clear the virus as well. We think we have the solution at Inovio, utilizing our immunotherapies to first, clear the disease but also clear the virus that caused the disease in the first place, and limit any reoccurrences that's possible. So, that's a consistent theme for VIN [ph] that's consistent theme for vulvar and anal dysplasia, and matter of fact that’s the consistent theme for our head and neck cancer with our partner AstraZeneca as well as our RRP. And in particular with our RRP, the true clinical indication could be a delay or avoidance of surgery because such a horrible disease where you have to have repeat a surgery, sometimes 4, 5, 6 times a year or more for many of these patients. So, back to AIN, what we see is a high unmet medical need, we can -- we hope to show that our immunotherapy can treat the disease and potentially clear the virus that cause -- the underlying cause of the disease as well.

Great. Thank you. And lastly for me, on the pursuit of the dual listing, why now? What is the logic behind it? What are you seeing in the market that's prompting you to pursue this? And what is Inovio in its current state, perhaps its current global reach lacking that this will actually enable to enhance? Thank you very much.

Yes. Thank you. Great question. So, why now? So, we’ve always been a globally faced company. All of our trials have been done in multiple regions including North America but also in Asia and Africa and Europe as well. From our global reach of our business development, our very last deal was with ApolloBio for VGX-3100 in Asia for China specifically. We have done multiple codevelopment deals in Korea. We have received multiple grants and contracts, there are globally faced organizations CEPI, Gates and others.Why Korea? Korea has incredibly vibrant biotech investment market, both from the capital market for public companies as well as the private centric capital investor communities. They are mostly long-only, very little short, and small and medium capital markets for biotech companies, which will be fabulous here as well. But, we're not going to neglect our NASDAQ listing. So, let me just say that our primary listing is going to be on NASDAQ. By nature, our primary investor and shareholder base is going to be U.S. institutional investors. And by the way, we just peaked over 50% in institutional holding of our shareholder makeup, and that's the first time in our corporate history. So, we will continually cater to and listen to the needs and wishes of our institutional investors in the U.S. and elsewhere. So, what Korea provides opportunity for us is a new avenue of long-only investors, who has a lot of investing capital available. And biotech valuations, our peers listed on KOSDAQ exchange has much more attractive valuation profile as well.So, I think, those are several reasons for us additional streams of capital, better and more attractive valuations and cost of capital. And our ability to expand and build on our business development focus in Korea, we expect to see potentially multiple deals with Korean potential partners; China, we're going to leverage on what we've already done with ApolloBio, potentially do additional deals. And we don't want to neglect Japan and other areas in Asia either. So, we think this is untapped market for us for what Inovio is, which is a company that focuses on treating diseases, cancer infectious diseases globally.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. J. Joseph Kim for any closing remarks.

Thank you, everyone, for your questions and continued interest. Have a nice evening. Bye, bye.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.