Good afternoon, everyone. And welcome to Inovio’s Third Quarter 2019 Financial Results Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note, today's event is also being recorded. At this time, I’d like to turn the conference call over to Mr.

Ben Matone, Senior Director, Investor Relations. Sir, please go ahead..

Thank you, operator. Good afternoon. And thank you for joining the Inovio Pharmaceuticals third quarter 2019 earnings conference call. On the call today are Inovio's President and CEO, Dr. J. Joseph Kim; our Chief Financial Officer, Peter Kies; and Dr. Jeffrey Skolnik, Vice President of Clinical Oncology Development..

Thank you, Ben. And thank you everyone for joining on the call and webcast. As we near the close of the year, I do want to spend some time reflecting on our 2019 accomplishments, but also focus more on 2020 as a transformative period for Inovio. Let me take us on a time machine to November 2020.

By this time next year, we will have shown you, GBM overall survival data at 12 and 18 months for INO-5401, REVEAL 1 top-line efficacy data for our Phase 3 cervical dysplasia product VGX-3100, VGX-3100 Phase 2 results for both vulvar and anal dysplasia, and RRP study up and running via orphan designation, our Lassa vaccine will be in a Phase 1b trial in Africa and our MERS vaccine in Phase 2 studies in the Middle East, all with full funding from CEPI.

Our China partner, ApolloBio will be in Phase 3 in China with VGX-3100. And we expect AstraZeneca to report on Phase 2 head and neck cancer efficacy results with MEDI0457 combined with their checkpoint inhibitor. What an incredible set of value drivers in one year. But let me turn off my time machine and focus on the present.

Last week, we reported positive interim data from our ongoing Phase 2 trial of our newly diagnosed glioblastoma multiforme or GBM, which combines Inovio's INO-5401, a T cell-activating immunotherapy encoding for three tumor-specific antigens, hTERT, WT1, and PSMA, as well INO-9012, an immune activator encoding for interleukin 12 in combination with Libtayo, Regeneron’s PD-1 inhibitor..

Thank You, Joseph. As Joseph was mentioned in his opening remarks, last week was very positive for our GBM program, and we're very excited to share this new clinical data with both the clinical and investment community.

The excitement over these data was obvious to me as our late-breaking SITC poster presentation garnered significant attention from meeting attendees. We want to underscore the clear glioblastoma is a disease that is extremely challenging to treat that most patients die of their brain cancer within one to two years of their diagnosis.

In our latest interim data REVEAL, we demonstrated that 75% of our MGMT promoter unmethylated patients and 80% of our MGMT promoter methylated patients were progression-free at six months. This is very favorable when we compare them to historical controls.

We would expect only about 40% of unmethylated patients and about 60% of methylated patients to be progression-free at six months. We were also very excited that almost all patients tested so far generated antigen specific T cells to the tumor associated antigens created by a therapy.

And we look forward to our data next year as you’ve indicated, Joseph, to potentially confirm an overall survival benefit..

Thank you, Jeffrey. While we certainly can appreciate that this is a very difficult to treat cancer, we should all feel encouraged by this new data and what it really means for the future of Inovio’s capabilities in immuno-oncology and for a patient suffering with GBM who has not witnessed any new effective treatments for years.

Furthermore, I want to stress here that GBM data provides two additional far-reaching implications. First, because of tumor-associated antigens comprising INO-5401, namely hTERT, WT1, and PSMA are also overly expressed in dozens of other cancers, we can potentially use it to treat many of these cancers.

These are pancreatic, renal, HCC, lung, gastric and other cancers. We plan to comprehensively and methodically address these opportunities perhaps with a global partner..

Thanks, Joseph, and good afternoon, everyone. I'll begin with a general overview of the third quarter financial results and then also touch on the recent realignment that we announced in July. Total revenue for the third quarter was $867,000 compared to $2 million for the same period in 2018.

Total operating expenses were $24.8 million for the three months ended September 30, 2019 compared to $28.6 million for the same period last year.

The year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to a decrease and reimbursed drug manufacturing activities related to our partnership with AstraZeneca.

Inovio’s net loss for the quarter was $23.1 million or $0.23 per share basic and $0.25 per share fully diluted, which compares to $25 million or $0.27 per share basic and dilutive for the same period last year.

As of September 30, 2019 cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018.

In August, Inovio closed a private placement of 1% convertible due 2024 with an aggregate principal amount of Korean won $18 billion or approximately $15 million issued to a group of institutional investors led by Korea Investment Partners.

These bonds are convertible into Korean Depositary Receipts or KDRs, assuming Inovio has completed a secondary listing of its securities on the KOSDAQ market of the Korean Stock Market Exchange in the form of KDRs, or otherwise shares of common stock if KDRs are not listed at the time of conversion.

Net proceeds from the offering were approximately $14.5 million after deducting operating expenses payable by Inovio. In July, the Company implemented a strategic cost reduction plan including a 28% staff reduction and cessation of several R&D and clinical programs, which resulted in an approximate 25% reduced annual burn.

The reallocation of resources focuses the company’s commercialization efforts for its lead asset 3100 while also developing high-value fast-to-market HPV product candidates such as INO-3107 to treat RRP and INO-5401 to treat GBM.

As a reminder, you can read the details of our 10-Q at the EDGAR on the SEC website, also our financial statements for the third 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 webpage under Investor Relations, Financial Reports.

With that I’ll turn it back to you, Joseph..

Thanks, Peter. Before we take your questions, I think it’s really important to reiterate that next year stands a transformative period for Inovio. This time next year, we could have multiple clinical and business development milestones across many therapeutic areas.

Within the next 12 months, we're about to unveil significant game-changing data on VGX-3100, INO-5401 and MEDI0457, while working vigorously to see if we can potentially have INO-3107 leapfrog them all to the market. We have been working very diligently to get to this moment.

I would especially want to thank our dedicated employees and our collaborators and our long-term shareholders for their faith and conviction. Now, I look forward to taking your questions. Operator, please open the line for the analysts..

Our first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead with your question..

Hi. This is Pete Stavropoulos on for Charles. Congratulations on the quarter.

How are you?.

Hey, Pete. Thank you..

Congratulations on the quarter and congratulations on the GBM data that you presented last week. I know that you mentioned the ApolloBio in your prepared remarks, but I'm not sure if I missed something. So last quarter you mentioned that they filed and IND Chinese FDA.

So, has there been response from the Chinese FDA and have they started to explore opening clinical sites in China with REVEAL 2?.

Yes. So, China FDA or NPMA (sic) has accepted the IND from ApolloBio. We're taking many steps with ApolloBio to open the trial for VGX-3100 in China. The details we can't really discuss at this moment, but you can be assured that China plan will be executing fully in 2020 by ApolloBio for VGX-3100..

Thank you.

And one question about the other biopsy-based companion diagnostic for VGX-3100, just so that I sort of get better understanding, is this completely in QIAGEN’s hands beyond you providing REVEAL samples, and will Inovio or QIAGEN own patent rights and will be sharing revenues?.

Yes. So, it's a co-development, collaboration still. A lot of the early development work has been done. And then, QIAGEN brings their commercialization and execution excellence. They -- this is what they do. They develop and sell diagnostic kits.

So, our goal is to have this complementary kit available as a pretreatment biomarker base kit that can help us guide and the doctors and the patients guide the usage of VGX-3100 where the patients who can benefit the most will use VGX-3100. And that has huge implications for us.

We can charge more, we can have patients that have better overall efficacy. So, it has multiple positive effects. It would improve overall to the healthcare dollars as well, because we can have this targeted usage of 3100 in patients who value the most.

So, I think the key is to really utilize Inovio’s expertise and QIAGEN’s expertise and really making this combination possible. We’ll provide more information as we advance this further in 2020. And we’re making great progress right now..

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

Thanks, Pete..

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

Hi, guys. This is Shawn Egan on for Joel. Thanks for taking my questions..

Hi, Shawn..

Hi, Joseph. A few for me today, the first on 5401, your glioblastoma program.

Maybe you could just talk like at a high level what the next steps are, like do you plan on waiting until the full last data matures to kind of -- prior to making any decisions on a path forward or maybe any high level thoughts on what a pivotal design could look like? And then, I have a follow-up as well..

Yes. So, I’m going to turn over to Jeffrey for a detailed answer. But top really big picture is we’re really excited about the early data and we’re beginning to imagine and draw out what a pivotal trial could be. Obviously, as we see the later survival data we would be the more excited.

So, I’m going to turn it over to Jeffrey for any additional insights..

Thanks, Joseph and thanks Shawn for the question. Exactly, so we’ll be looking, as Joseph has said, to the middle of next year and then into the third quarter and fourth quarter of next year for our overall survival data. And that together with what we continue to learn from the current study will help us to inform the design of our next trial.

But obviously, as you would imagine we’ve certainly already put time and effort into thinking where we’d like to move this opportunity and potentially what that design would look like. So, we look forward to the overall survival data into next year, which we’re extremely excited to see..

Thanks, Jeff. And then, a follow-up also in regards to the diagnostic from QIAGEN.

Are there any learning that you could leverage to that could be broadly applicable across your platform or are those really tailored to VGX-3100?.

Yes. So, but details have to be studied further. But, we think there are learnings. There could be -- certainly across HPV space, and certainly impact into IO programs as well. So, the biomarkers and focus targeted therapies for IO really is the next generation improvement in this field.

So, we’re going to apply everything we learned from all aspects, especially in the biomarker world to make our programs better..

Thanks, Joseph. And I just have one last question, I noticed on ClinicalTrials.gov that daratumumab MEDI0457 study decreased enrollment down to 35 from 50.

Could you comment on any rationale for that or is that an AstraZeneca sense?.

Yes. It’s really AstraZeneca sense, but we see that as a positive that they have enough patients to look at what they want. And based on what's publicly stated on ClinicalTrials.gov, they're looking to fully close out the study by third quarter next year.

And we're expecting or sort of estimating because they have the full say and when and where to present the head and neck cancer data, but we're thinking sometime midyear next year, give or take couple of months is where they would likely present.

So, I think that sets up the additional arsenal in our 2020 expectations in terms of meaningful Phase 2 and Phase 3 data in 2020..

Great. Thank you so much for the color. I appreciate it. .

Thanks..

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

Hi. This is actually Ellen on for Steve, and thanks for taking our questions. So, I think, first on just about VGX-3100. I believe the guidance may have changed from year end ‘19 to first quarter ‘20. And correct me if I'm wrong there.

So, I was just wondering if that is the result of just wanting to present at a specific medical conference in first quarter ‘20 or if it had to do with enrollment dynamics at all? And then, also related to that, just wondering what kind of data points that we'd be able to expect from this interim update in first quarter ‘20? Thanks..

Yes. I think you're referring to our Phase 2 VIN and AIN studies for VGX-3100. Yes. The enrollment dynamics were on point and on track. We completed the 33 patients in VIN study and 24 patients in AIN study. We feel, as you stated, to have a meaningful place to present our data.

So, there's really not a lot of data presenting opportunities in the late fourth quarter. So, we're going to be doing it at a medical conference in the first quarter next year..

All right, great.

And then, can you talk about any commercial plans or any specifics you have outside of the diagnostic tool for VGX-3100 for REVEAL 1 and 2 as that kind of gets closer to reading out?.

Yes, I mean, we're very excited about the REVEAL 1 data. And really, that's the next near term data major milestone. We've all been waiting for this for the last couple of years. And then REVEAL 2 comes after that. And certainly, we have internal preparations for commercialization, launch readiness and so on.

We're talking to multiple interested potential partners who may work with us and all these things we're looking into the future.

But we're very excited about what VGX-3100 can do for patients who are suffering with cervical pre-cancer today where currently only treatment option is lofting off full top layers of cervix negatively impacting their ability to have future babies.

So, we can -- we think we have an immunotherapy solution that can treat the disease, clear the cause of the disease and HPV 16 and 18 viruses and spare the cervix from surgery. So, we're quite excited.

And we think the market will embrace VGX-3100 as a immunotherapy option for cervical dysplasia, and certainly to other indications, vulvar and anal dysplasia as well..

Okay, great. And then, one last one for me just related to the GBM study. Can you just remind us what the bar will be OS-wise to move forward once we see those readouts, then additionally, do you think we’ll get additional patient baseline data along with those 12 and 18 months OS readouts next year? Thank you..

Thanks for the question, Ellen. So, yes, in general, we would expect to be using standard of care numbers obviously around OS-12 and OS-18 and similarly to use median overall survival data based upon the current standards of care. And, there again are several published numbers.

We would anticipate that about 60% or so -- 50% to 60% of patients will be alive at 12 months with glioblastoma, if you look at all comers; and then, obviously, fewer to be alive at 18 months, that could drop to about 40%, 50%. So we'll continue to follow our data through 12 and 18 months, taking a look at what the standards are..

Great.

And then, the patient baseline, there will be any more information on that or it will be limited to what we CITC?.

So, when you say patient baseline, tell me a little bit more about what you mean?.

Yes.

So, just specifically patients had a full surgical resection or partial?.

Sure. So, yes, we would anticipate that as we continue to publish our data and we have our full data set, you'll get even more information about the baseline for these patients. Again, as you know, all patients obviously in the study are newly diagnosed.

And all of our data very importantly are being calculated from day zero, first day of our therapeutic intervention..

Okay, great. Thank you..

Yes. Thank you. .

Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead with your question..

Hey, guys. Thanks for taking my questions. .

Hi, Greg..

Just to follow up on 5401 in the GBM study. Joseph in your prepared remarks and subsequently you’ve mentioned, just the concept of working with and finding a global partner given the expansion potential.

Just wondering if you could perhaps just remind us of the agreements and the arrangement you've got with Regeneron on this and any detail there about future engagements would be helpful.

And then, I think, similarly, just maybe broadly as well, what you see as sort of the optimal point of engagement from a partner as this program matures in this cohort? Thanks. .

Yes. Regeneron has been a great partner -- great collaborator in this regard. I say collaborator because it’s not a full blown licensed partnership, like the one relationship we have with AstraZeneca for MEDI0457. So, INO-5401 has not been licensed to anyone. Now, Regeneron is providing their important PD-1 Libtayo -- inhibitor Libtayo to the study.

They also get the benefit of looking at the data, perhaps before everyone else. For that advantage, I think, they have some timing and knowledge and information advantage over other potential partners. So, but we have not spoken for INO-5401 to Regeneron for GBM or for other fields.

But obviously a perfect partner would look a lot like Regeneron and perhaps other big pharmas with their own PD-1 or PD-L1 inhibitors. As we have shown that our immunotherapies are almost equally effective and combining with these PD-1 or PD-L1 inhibitors.

Just a reminder, we have PD-L1 inhibitor combination with AstraZeneca with their development for 457, PD-1 with Regeneron and our prostate cancer 5151 is just entering a combination study with nivolumab from Bristol-Myers. So, I believe our therapies can be effective combined with any of these checkpoint molecules, inhibitor molecules.

But, someone like Regeneron with the global reach, the goal of applying 5401 to make the checkpoint inhibitors perform even better compared to the competitors in their space without adding any additional toxicity, increasing efficacy is something that we think someone like Regeneron or other big pharma in this competitive space would be very much interested in.

And just to take short moment further. I mean, I stated at this prepared remarks part, but 5401 success in GBM -- is great for GBM and for the patients and for an Inovio, and that's a great opportunity on its own.

But the way we designed this product is a multi-cancer targeting product, much like the similarities to Nectar's program where they can combine and address multiple different cancers, we can do that utilizing very prolific tumor specific antigens or associated antigens in WT1, hTERT and PSMA.

And then, we have dozens more of these novel antigens in our toolbox, which could be utilized to create even more potent cancer immunotherapy to combine with checkpoint inhibitors. So, I think, we are very excited about the GBM trial on its own, but we have other broader plans.

And because our resources are certainly limited as a small biotech, bringing in a global partner that can fully utilize this versatility and potential broad range of efficacy, we think will be great partner and opportunities going forward..

Great, thank you. And just one more for me on 3100 and sorry for the timing, and I appreciate that you’re putting a finer point on what we potentially can expect next year. I'm just curious if you can comment a bit on some of the thinking about having the top line efficacy data.

Certainly, you spoke in the past about landing REVEAL 1 and 2 plans, if you will, around the around the same time. But just curious about that cadence by fourth quarter. Would we expect to see some cut of safety there as well or wait for the full -- wait for that following the full 88-week for REVEAL 1 at a later point? Thank you..

Great. Thanks for the question. So, the top-line is focused on group level efficacy results. Full safety will be after the full 88 weeks for REVEAL 1, and full 40 weeks for REVEAL 2. Now, these are 198-patient study.

We did already demonstrate strong safety at week 36 and week 88 using our 167-patient Phase 2b study which really is pretty much identical to our REVEAL 1 and REVEAL 2 study. And we haven't seen any signals of safety throughout any of our DSMB meaning. So, we're quite confident as we always are with our platform programs across our pipeline.

So, safety is not a real concern -- overly concerned for us..

Great. And then, maybe perhaps just comment on your level of confidence to adhere to your previously stated prospect of having a BLA filing for 2021. Thank you very much..

Well, it really depends on the execution of REVEAL 2, because REVEAL 1 timeline will support potentially 2021. So, we should have more guidance in the future..

Our next question comes from Chris Raymond from Piper Jaffray. Please go with your question..

Good afternoon. This is Nicole Gabreski on for Chris. So, I just had a few questions. So, the first was on the RRP program. So with initiation of a pivotal clinical trial for INO-3107 in first half of '20. So, I guess, it sounds like you guys have had discussions with FDA.

So, just wondering what still needs to be worked out with regulators, and if you have any color at this point on endpoints for the trial?.

So, we're still discussing that. This as a orphan indication. We want to be as aggressive in timing and sizing of the studies as well. So, we're not yet ready to unveil the overall design and the endpoint here. But our overall objective is to use similar to what we’ve shown in our pilot study in RRP.

By the way, we expect to have the clinical publication in the next few months to come out of this RRP study. But just using as an immunotherapy to avoid or delay, surgery would be -- we think is a meaningful Clinical endpoint. And while this discussion is still going on with the FDA, I don't want to overstep that.

But I can confidently say that we will be starting our RRP trial in the first half of 2020. We've been working to manufacture the clinical product, getting all of our clinical potential PIs motivated and marshaled. And so everything is getting prepared behind the scenes. We look forward to sharing more information, more detail in the future..

Thanks. That's helpful. And then, maybe a second question. Just after the Phase 2 GBM update, we went back to the literature and notice that there just seems to be some debate around whether PFS 6 and GBM translates to overall survival.

So, just kind of wanted to get your thoughts on this and just what your confidence level is moving forward to the first OS readout next year?.

Well, I can just say, the field is split on the predictability of PFS-6 to future overall survival. But actually, that's not the point. I think, the point is, and Jeffrey can add to this. But, we're excited about the data we have at six months for progression-free survival. We're not projecting we're going to be successful in OS.

But, we are waiting with bated breath in less than six months from now we will have OS 12, and less than a year from now we will have OS 18. So, while, the previous studies were not able to correlate the success of PFS-6 to OS-12 and 18, that's not the question we're trying to address.

We think we have a immune activating approach that combines with checkpoint inhibitor, brings better level of efficacy. And if our hypothesis is right, and so far, the PFS-6 is supporting that, we think we're very confident and highly optimistic for the OS-2 numbers. But by no means are we saying we can correlate and predict success.

Jeffrey, would you add any more granularity to that?.

Thanks, Nicole for the question. Yes, I completely agree with you, Joseph. I think, what we've demonstrated is that we have immune responses to our T cell enabling therapy and that we have an efficacy signal. And those two things give us the confidence to move on to an overall survival endpoint.

And exactly as you said, Joseph, I would not prognosticate, but we are very excited to see what our overall survival data look like..

I would say I like our chances..

Great. That's really helpful. Thank you. .

Thanks..

And our final question today comes from Jason McCarthy from Maxim Group. Please go with your question..

Hi. Good afternoon. This is actually Naureen on Jason. Hi. How are you? So, congrats on a GBM data. And actually, I'd like to follow up on number of those questions. I was just wondering, with regards to the trial design for the GBM study, if we could drill down a little bit there.

In the ClinicalTrials.gov, it says some of the patients received TMZ and radiation if it was clinically indicated. But, then when I look back at the poster CITC, it suggests that the entire cohort -- the methylated cohort may receive additional TMZ up to six additional cycles.

So, I was wondering if you could provide a bit of clarity on this, if there was a subgroup within the cohort B that received additional chemo or if it was the entire cohort? And if it's not the entire cohort, will there be a breakdown on the data as well in the future?.

Thanks, Naureen, for the question. So, exactly as you've indicated, all patients on the study, whether they were MGMT methylated or MGMT promoter unmethylated, received three weeks of radiation and three weeks of Temozolomide concurrently.

And then, exactly as you suggested, all patients on cohort B, the methylated MGMT promoter methylated patients went on to receive adjuvant Temozolomide up to six cycles. So, again, all patients received radiation and Temozolomide for three weeks; and then those that were methylated receive additional Temozolomide up to six cycles..

So, this is a standard of care for these populations. So, yes, we follow the directions from the FDA and our KOLs who helped us design the trial and helped us to execute the conduct of the trial..

That makes sense. Thank you. And I was just wondering, I actually brought this up in the past, normally with checkpoints, or at least in the past not all of them have failed in the past. And people have said or suggested that it’s because there is a need for steroids and steroids actually decrease the efficacy of a checkpoint study.

But in your study, you have these compelling results. So, I was wondering were steroid actually used in all the population -- what percentage of the patient population, and what are your thoughts on that, platform is actually able to counteract the inhibitory effect of steroid on a checkpoint to promote its activity.

I was just wondering as to whether there was steroid use and if you have any thoughts on that..

Great question.

Jeffrey?.

Yes. Naureen, that’s a great question. So, as Joseph mentioned, when we designed a protocol we worked very closely with our key opinion leaders in the field.

Many of whom were in our part of the single agent checkpoint studies as you mentioned, and they themselves have been very disappointed at the data that come from those single agent checkpoint studies.

We of course feel that combining with the T cell enabling therapy like INO-5401 plus INO-9012, we really give, as Joseph has said before, one-two punch to the tumor, increasing the opportunity for efficacy. But to your point, steroids certainly can be suppressive in generating an immune response.

And so, we did pay attention to the amount of steroid that was used and our study does control for and collect that information. And those data should be forthcoming in an upcoming scientific presentation when we bring all those data together..

That’s great to hear. and just one more follow-up, again, on the GBM study, there has been some suggestion that checkpoints may actually work better in the neoadjuvant setting.

I know it’s speaking far ahead, but have you also considered potential similar study with INO5401 in such a setting?.

That’s an outstanding question. The short answer is, of course, we are paying attention very closely to the literature. And as you aware there have been recently several publications looking at neoadjuvant checkpoint in GBM. And thankfully, the authors of one or more of those papers are KOLs that we have the opportunity to interface with.

So, we are excited to see the data from this trial. and we keep all opportunities open based upon the emerging literature and the science..

And ladies and gentlemen with that we will conclude today's question-and-answer session. And at this time, I'd like to turn the conference call back over to Joseph Kim for any closing remarks..

Thank you very much. 2020 is going to be awesome. Stay tuned. Thank you..

Ladies and gentlemen, that will conclude today's conference call. We do thank you for attending today's presentation. You may now disconnect your lines..