Greetings and welcome to the Inovio Second Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Ben Matone. Thank you. You may begin.

Thank you. Good afternoon, everyone and thank you for joining us for the Inovio Pharmaceuticals 2018 second quarter corporate earnings conference call. This call is also being webcast live on our website, ir.inovio.com and a replay will be available as indicated in our press release. During this call, we will be making forward looking statements that relate to our business which include our plans to develop our DNA immunotherapy platform in combination with our proprietary delivery devices, in addition to our capital resources, all of which involve certain assumptions, risks, and uncertainties and could cause actual results to differ materially from these statements. These statements are based on the beliefs and expectations of management as of today. Our actual results may differ materially from our expectations. Investors should read carefully the risks and certainties described in today’s press release as well as the risk factors included in our filings with the SEC. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Joining us from Inovio are Dr. J. Joseph Kim, President and CEO; Peter Kies, Chief Financial Officer. I would now like to turn the call over to Inovio's President and CEO, Dr. Kim.

Thank you, Ben, and good afternoon everyone. As we highlight in our press release, the second quarter include a many important strategic accomplishments for Inovio. Today the results further showcase the value and versatility for the company’s technology in both cancer immunotherapy and infectious disease. In this call, I am going to go over four topics with you today. First, I’ll discuss the positive Phase III clinical trial progress for VGX-3100 for cervical dysplasia. Second, I’ll highlight the expansion of our anal dysplasia indication for the lead product VGX-3100 increasing the overall product value. Third, I’ll provide an update on our immunooncology pipeline, and something I'm sure most of you being extremely excited about, I’ll update you on our GBM Phase I/II, INO-5401 study for which we dosed our first patient in July. And lastly, I’ll update you on significant data and advancements in our infectious disease programs. You've heard me state our goal for HPV treatment before. We want to own it from pre-cancer via cells to cancers with our partner MedImmune. HPV infection is the most frequent sexually transmitted disease and represents a significant commercial opportunity for VGX-3100 and MEDI0457. For our Phase III cervical dysplasia trial, I'm very pleased to report that enrollment remains on track for REVEAL 1. We have already opened 70 sites across 16 countries as of the end of June and we anticipate opening approximately 90 sites globally by the end of August. As a reminder, REVEAL 1 which is the primary portion of our Phase III study for treating women with high grade cervical dysplasia is scheduled to enroll 198 patients by very early part of next year. We will then immediately begin enrolling for REVEAL 2, the confirmatory study of the Phase III trial, where we were also involved 198 patients.…

Thanks Joseph, and good afternoon, everyone. Inovio reported total revenue of $24.4 million for the three months ended June 30, 2018, which compares to $20.4 million for the same period in 2017. Total operating expenses were $29.7 million compared to $30 million for the same period in 2017. Inovio’s net loss for the quarter ended June 30, 2018 was $6.6 million or $0.07 per share basic and $0.08 per share dilutive compared to $9.5 million or $0.13 per share basic and dilutive for the quarter ended June 30, 2017. Cash and cash equivalents and short-term investments were $95.6 million compared to $112.8 million as of March 31, 2018. With $95.6 million and reported cash and as we have previously stated our annual net burn at approximately $70 million we currently estimate to have more than a year of cash run [indiscernible]. In addition, we continue to have attractive partnering discussions for corporate activities and with a very strong track record of obtaining non-dilutive funding which we have raised over $150 million in non-dilutive funding in the last year eight years. With all this – we are considering all of the variables we expect to maintain a strong financial foot hole to fund our development. While the following material can be found in our latest press release and 10-Q, I want to emphasize in keeping with the changing accounting regulations all contributions received from current grant agreements in 2018 have been recorded as a contra expense as opposed to revenue on the consolidated statement of operations. For example for the three months ended June 30, 2018 $1.9 million was recorded as a contra research and development expenses which would have been classified as grant revenue in the prior years. This change in presentation not occurred total revenue would have been $26.3 million for the three months ended June 30, 2018 compared to $20.4 million for the same period in 2017. Total operating expenses would have been $31.6 million compared to $30 million for the same prior period. Additionally, the increase in comparable revenue recognize for the second quarter in 2018 compared to 2017 was primarily due to the recognition of the gross upfront payment from ApolloBio of $23 million during the period. Please note that in the first quarter of 2018, we did not recognize the revenue from Apollo, but it was recorded in our cash. This quarter, we are able to recognize the ApolloBio growth upfront payment in our reported revenue. As it relates to ApolloBio, our kickoff meeting occurred in the second quarter of 2018 where we began to implement our strategic plan in order to move aggressively in accessing the Chinese market for VGX-3100. With that I'll turn it back to you Joseph.

Thanks Peter. We have about five months to go before the end of 2018 and during those next 150 days before we get to 2019, you can expect thus to hit on several important value drivers such as new additional data from our prostate and head and neck cancer trials, new cancer of trial initiations and additional significant non-dilutive funding and new milestone payments from our current partners. We also hope to share with you information our new collaboration or licensing activities. Looking past the next 150 days, 2019 will mark a new phase of Inovio’s development, a giant step forward that's because next year we will report on our first cancer combination efficacy results from head and neck, GBM and bladder studies. We remain quite bullish for these study data to come for which I hold great optimism, credible optimism based on our previous clinical data. We call for the true emergence of Inovio as a cancer company in 2019 with equally important advances in our HPV and infectious disease franchises. We will also have Phase II efficacy data from our vulvar and anal dysplasia studies and will be steps closer to our Phase III cervical dysplasia data. We look forward to rewarding our shareholders for their support while offering new hopes to patients with immunotherapies that go beyond current treatments. Thank you very much. Operator, please open the line for questions.

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from Chris Raymond with Piper Jaffray. Please proceed with your question.

Hi, this is [indiscernible] for Chris today. Thanks for taking the question. So actually a couple questions, I think last quarter you talked about the ApolloBio agreement opening the door for site activation for REVEAL 1 in China. I guess we expect to see site activations there and I guess do you need those to hit your 100 site target or wood site activation and enrollment there would be upside? And then just circling back to the VGX-3100 news from yesterday with the AIDS Malignancy Consortium? You touched on this little bit on the call, but could you maybe talk about the unmet need there in that indication and particularly the HIV positive population and how this trial would fit into a regulatory or commercial strategy. And just kind of what a pivotal trial or data package is going to look like there? Thanks.

Absolutely. Thank you, great question. So China is not currently part of our REVEAL 1 strategy, 100 sites did not include China. There is a potential to include China and their sties in REVEAL 2. So we're – both companies are working to approach that that's aggressively as possible. Of course regulatory environment in China is evolving and we cannot count on that and we don't actually count on that our current timing is based on not having China. Bringing China to REVEAL 2 will just increase the timeline or accelerate the timeline from the base case. So 2020 is a base case that we have without China. So everything is an upside for us. We can execute the China strategy as we expect with ApolloBio. The second part of the question anal dysplasia is a huge unmet medical need. Current treatment option is surgery and has got one of the highest modality issues. You can imagine it's a very painful and uncomfortable procedure. The recurrence rate for anal dysplasia is greater than 50% and many of these patients actually have to have surgery multiple times in the year. So there's a huge unmet medical need. As we said about half of the patients are also infected with HIV both men and women, and we're able to leverage our relationships and bring in a partner AMC to not just use their networks to conduct the trial, but also fund the trial as well. So we have a small compact in HIV negative trial in 24 patients that Inovio is conducting and our partner AMC is conducting a 75% trial both being Phase II. Our goal is to get the efficacy readouts in 2019 and then approach the FDA for an accelerated potentially approval. In this path, it's hard to project without any efficacy data yet, but if we were to do similar level of – bring about similar level of efficacy in anal as we did in cervical, I think we will have a very great path to add this very important indication, orphan indication to our arsenal targets for VGX-3100.

Great. Thank you.

Thank you.

Our next question is from Gregory Renza with RBC Capital Markets. Please proceed with your question.

Hey, Joseph and team. Thanks for taking my question perhaps on the progress.

Thank you.

I just want to touch a bit on the enrollment momentum. It appears that it looks like you're seeing some good push with respect to the trials that is compared to the previous quarter. Just curious to see, number one of the mix involved and still at 50-50 mix with respect to U.S. and ex-U.S. And then also if there's anything that you can comment on that? Perhaps you've done differently operationally that does help with that and your guidance on the end of August is certainly helpful and just want to see if there's a chance to perhaps getting those 100 sites even earlier before year end? Thanks.

I think there's a potential to do that, obviously – and then we are - all enrollments both site initiations and patient enrollments is not a straight line as you know, it’s more of a hockey stick or upward curve really depends. We have a very dedicated team internally working with our external global CRO to execute the study as rapidly as possible. We're very dedicated and committed to this. We do think in terms of the U.S. versus ex-U.S., we have 15 other countries open both – I mean it's a strategic reason, one is to get the trials completed as rapidly as possible. The other is these are strategic markets that we expect to enroll approvals for VGX-3100 in the future. So I think with more ex-U.S. sites and countries open, we think the shift is going to be changing between – now we started with predominantly in U.S. in the beginning of the trial and then there is going to be a balancing out. We expect the ex-U.S. to be maybe 70% when we all settled down in terms of the sites and number of patients enrolling.

Got it. That’s very helpful. And then just on the AIN indication, I'm just curious if you could perhaps provide some color on maybe the juxtaposition of the trial design with respect to HIV positive and HIV negative trial that you are leading? Just curious if reading anything into the dosing schedule of the HIV positive versus HIV negative, do you have any color on that that would be helpful?

.:

Got it, thanks again and congrats on the progress.

Thank you.

Our next question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Hi, this is actually [indiscernible] calling in for Jason McCarthy. Thanks for the taking the question. So we've been doing a little bit of reading in the IO space and we came across the fact that the FDA recently changed its guidelines on the approved checkpoints anti-centric for bladder cancer and we were just wondering they're essentially PD-L1 expression has low expression is associated with poor survival. So can you elaborate on how Inovio views this new guidance and how it may actually impact your trial in bladder cancer or any other solid tumors?

Yes, so short answer is, it shouldn’t impact our study, but obviously as you know where – our first core which is a larger of – total of 80 that were recruiting 60 patients who were going after previously checkpoint refractory populations. So these folks have already failed. So they’re going to be likely in that population group. So what we're trying to piece out is improvement in overall efficacy. So presumably anything above background would get us excited of course hire a number of – hire the ORR with the combination with INO-5401 and [indiscernible] obviously will get us even more exciting. Second core is Cisplatin ineligible patients, chemo ineligible patients and that population we will keep our eye on the PD-L1 expression levels.

Great. And I just have a follow-up question. So you mentioned previously about biomarker data, signatures associated with predicting success of VGX-3100. And I was wondering in your new trials VIN in dysplasia, are you actually from collecting biomarker data there?

Yes, we are.

Okay.

So we expect each other diseases because they're in the front organ tracks. Even though there are costs by HPV infection are going to have different – likely to have differential biomarkers that could be informative. So right now our big push is in using our Phase II data and predicting in Phase III trials, the power of our biomarker predictability. So that’s on going for first cervical dysplasia Phase III trial. For VIN and anal Phase II study of course we're studying and exploring, identifying the proper biomarkers for those two indications.

Great. Thanks for taking the question.

No problem. Thank you.

Our next question comes from Yi Chen with H.C. Wainwright. Please proceed with the question.

Hi guys. Thanks very much for taking our questions. Just a couple of quick items regarding the clinical trial progressions, can you just confirm the timing of the start of enrollment in the REVEAL 2 study please?

Yes. So it's literally once we enroll our 198 patient in REVEAL 1, we're going to close down the chapter and then flip the switch for REVEAL 2. Of course, it’s not going to be immediately, but in matter of days. So we will likely not. What we're working towards is utilizing the same sites. There are productive enrollers from REVEAL 1 because we will have a lot more information not all sites are equal and that we will immediately utilize those sites to enroll REVEAL 2 patients. And as you know, I mean in these enrollments most of your – half of your enrollments are done in the final quarter for the time and vice versa. So having our ability to just flip REVEAL 1 into REVEAL 2, really is going to enhance overall enroll ability and the rate for REVEAL 2. So we were very bullish on our enrollment both for finishing on REVEAL 1 and also starting on REVEAL 2 subsequently.

Okay. And then with respect to the Zika vaccine study in Puerto Rico, is that still on track to report data by the end of this year?

Yes. So we're finishing out the last visits. Now just to remind everyone is the 160 persons study, 80 people have been vaccinated with our Zika vaccine, 80 with placebo in double-blinded fashion, we're able to those dose them all prior to their hurricane problem with the island and then we've been able to follow-up on all those patients. All the data are getting tabulated and we hope to have the data by before the end of the year in the fourth quarter.

Okay. And then just one mechanistic or I should say treatment continuum question with respect to 5150 in prostate cancer. Can you comment at this point given that you now have more longer term immunological data on this candidate in that specific context? What you think might be the preferred line of deployment and/or can concomitant medications that you think would be most likely to potentiate its effect? Thank you.

Yes. Great question. So we know we can generate T-cell responses, CD8 T-cell, CD4 T-cell to both PSA and PSMA is our antigenic targets in these patients. So in a later metastatic setting, I would say we want to deploy with different checkpoint inhibitors or other immunomodulators that can impact tumor microenvironment. Could be CTLA4, it could be PD-1, it could be other novel immunemodulators because one thing we know for sure, immuno-oncology. There are a lot of different markers and different expressions that could impact, but you need to be T-cell. Without CD8 T-cell, you just waving your hands. So CD8 T-cell in these patients that can recognize the cancer, you can combine that with different immunomodulator shutdown the defense mechanisms and let the CD8 T-cells go at it. And I think the best approach in the point 5150 is in combination with these various immune modulators and checkpoints in a more metastatic setting.

Great. Thank you very much.

Thank you. End of Q&A

Ladies and gentlemen, we reached the end of the question-and-answer session. At this time, I’d like to turn the call back to Dr. Joseph Kim for closing comments.

Thank you operator, and thank you all the analysts for your attention and your question. We look forward to providing more updates and our accomplishments in multiple ongoing studies with you during our next earnings call in November. Have a great evening. Thank you.

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.