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Inovio Pharmaceuticals (NASDAQ:INO)
Q3 2020 Earnings Call
Nov 09, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, and welcome to the INOVIO Pharmaceuticals third-quarter 2020 financial results conference call. [Operator instructions] Please note, this event is being recorded. I would now like to turn the conference over to Ben Matone. Please go ahead.

Ben Matone -- Investor Relations

Thank you, operator. Good afternoon, and thank you for joining the INOVIO third-quarter 2020 earnings conference call. With us today are Dr. Joseph Kim, president and CEO; Dr.

Jacqueline Shea, INOVIO's chief operating officer; the company's chief financial officer, Peter Kies; Dr. Prakash Bhuyan, vice president of clinical development and head of INOVIO's clinical programs to treat HPV-related precancers; and Dr. Kate Broderick, senior vice president of research and development. This call is being webcast live on our website, ir.inovio.com and a replay will be made available as indicated in today's press release.

For today's call, we will review our corporate and financial information for the third-quarter 2020 ended September 30th, 2020, as well as, provide an update on our clinical programs, including INOVIO's COVID-19 vaccine candidate. Following prepared remarks, we will be conducting a question-and-answer segment reserve for equity research analysts. During the course of this call, we will be making certain forward-looking statements regarding future events and the future performance of the company. These events relate to our business plan to develop INOVIO's integrated platform of DNA medicines, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters, as well as, the impact of the COVID-19 pandemic of INOVIO's business operation.

All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks, and uncertainties that 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 today's 10-Q filing with the SEC.

Now I would now like to turn the call over to INOVIO's president and CEO, Dr. Joseph Kim. Joseph?

Joseph Kim -- President and Chief Executive Officer

Thanks, Ben, and good afternoon, everyone. Before I reflect on the third quarter, I want to first take the opportunity to thank our employees, our partners, our trial participants, our clinical investigators for the continued hard work across our DNA medicines platform. INOVIO remains confident in our efforts and commitment to following our science, which we hold with high conviction to develop safe and effective lasting DNA medicines that address urgent medical needs. These have been challenging and unconventional times for everyone, but I could not be more proud by the unwavering efforts being put forth by the INOVIO team.

As you know, we are working diligently to advance the development of several core programs. Today, we look forward to providing you with an update on our progress. Let's first look at our COVID-19 DNA vaccine program. Currently, INOVIO remains on partial clinical hold for the Phase 2/3 clinical trial.

In October, we have responded to the FDA's hold questions and now we expect the response back this month. I would like to remind everyone of two important points. First, the partial clinical hold does not impact the advancement of INOVIO's other product candidates in development nor the completion of the ongoing expanded Phase 1 clinical trials for INO-4800 in the U.S. Secondly, the FDA's questions were not related to the occurrence of any adverse events relate -- related to our INO-4800 Phase 1 study.

I continue to be thankful for our team's efforts to quickly deliver our responses to the FDA. Our expanded Phase 1 clinical trials in the U.S. is ongoing. In addition, our trials in South Korea and China are being conducted with our collaborators, IVI and a vaccine, respectively, and are progressing well.

We are confident that the combined data package for INOVIO's INO-4800 DNA vaccine candidate in the U.S. support its further advancement into efficacy trials. Based on our Phase 1 clinical trial data, INO-4800 deliver with CELLECTRA 2000 has demonstrated a favorable clinical safety, tolerability, and immunogenicity profile and supportive nonclinical data. INO-4800 could be safely readministered if immunity wanes, offering the possibility for seasonal boosting usage with potentially better CD8 T-cell responses and without concerns of generating an anti-vector response.

In addition to -- in addition, INOVIO's DNA medicines technology lends itself to thermal stability, as well as, scalability of manufacturing for efficient and cost-effective distribution. For instance, INOVIO's DNA vaccines have demonstrated excellent thermal stability as they can be stored for more than one year at room temperature, minimizing the challenges for frozen storage and distribution within the United States and globally. COVID-19 vaccine development remains a fluid evolving situation. And while the accelerated timeline and need for parallel planning is required to combat this pandemic, it is important to identify and continue to evaluate the pathophysiologic properties of SARS-CoV-2 virus as the pandemic evolves.

Recently, the researchers at the Commonwealth Scientific and Industrial Research Organization or CSIRO, Australia's National Science Research Agency, and INOVIO published in npj Vaccines the ability for INO-4800 to neutralize multiple newly prevalent mutation strains of SARS-CoV-2 virus. As the point of reference, most vaccines under development worldwide have been modeled on the original D-strain of the virus, which were more common among sequences published early in the pandemic. Since then, the virus has evolved to the globally dominant G-strain, which now accounts for roughly 85% of published SARS-CoV-2 genomes. In this recently published study, we found that INO-4800 developed a good B-cell response in terms of neutralizing antibodies against both D and G SARS-CoV-2 strains, which is important for the short-term efficacy of a vaccine.

Additionally, we also demonstrated strong T-cell response, which is important for long-term efficacy. This latest publication builds on our stringent animal challenge study in rhesus macaques. Multiple vaccine constructs are currently under clinical evaluation to address the ongoing global COVID-19 pandemic and this is a good thing for global health. The diversity of global requirements and the need to meet worldwide demand with ample supply is such that it will take multiple Phase 3 trials and multiple vaccine candidates to assess the efficacy of preventing COVID-19 disease and further expand the safety database of these vaccines.

INOVIO certainly looks forward to sharing our Phase 1 data for INO-4800, as well as, initiating a Phase 2/3 trial following the FDA's release of the partial clinical hold. On the manufacturing side, INOVIO signed an agreement with Thermo Fisher Scientific to manufacture INO-4800 last quarter. It has been a -- it has been great to have Thermo Fisher with their global manufacturing scale and capacity to join other contract development and manufacturing organizations in INOVIO's global manufacturing consortium. Thermo Fisher plans to manufacture INO-4800 drug substance, as well as, to perform fill and finish of INO-4800 drug product at its commercial facilities in the United States.

Next, we'll turn to our lead asset in Phase 3 clinical trials, VGX-3100. Managing global trial -- clinical trial across nearly 20 countries and 60 clinical sites in the midst of a global pandemic has certainly been challenging. In order to confirm the quality of information, our data monitors physically need to be at these trial sites. Since our update in August, we have seen an increasing number of trial participants who, either do not feel safe and/or are not willing to go into clinical facilities, as well as, restrictions placed on clinical sites for monitoring visits.

These pandemic restrictions have posed an increasing challenge to our efforts to collect and complete data samples. As a reminder, verifying the data is a normal and required part of conducting a Phase 3 blinded pivotal trial. With infection and hospitalization rates increasing in many U.S. states and with several European countries again, going on lockdown, it is taking longer for INOVIO to complete this process.

We recognize and appreciate the challenges of managing trials in the midst of a pandemic. And our commitment remains focused on ensuring the safety of study participants, employees, PIs, partners, and everyone involved. Taking into account of the impact of COVID-19 today and the uncertainty as we head into the likely second wave of the pandemic, INOVIO now expects to readout clinical data from the blinded VGX-3100 Phase 3 REVEAL 1 clinical trial in the first half of 2021. While the pandemic has delayed the timeline to the data report, I want to be very clear that the REVEAL 1 trial remains blinded and we expect to have all of the data points to be verified and available to report the top-line efficacy data in 2021.

The delay caused by the global pandemic certainly is not unique to REVEAL 1 trial or to INOVIO. That being said, we and our clinical trial sites are taking the following measures to protect safety and ensure continued participation. The sites are keeping virtual contacts with study subjects to ensure that safety monitoring is not disrupted. The labs and couriers have been able to operate during -- using proper social distancing practices and our trial sites are referring to local health guidances on how to properly see their patients.

As for our VIN and AIN Phase 2 clinical trials with VGX-3100, we do expect to readout complete set of efficacy and safety data before the year-end and we also expect to apply for orphan drug designations for these two indications in the first half of 2021. Now shifting to INO-5401, our DNA medicine program for glioblastoma. We are pleased to share that INO-5401 trial data was accepted as a late-break presentation during the plenary session at the Society for Neuro Oncology Annual Meeting or SNO on November 20th. During this presentation, we will be presenting OS18 and median OS data along with preliminary analysis on T-cell immune responses to tumor antigens in newly diagnosed GBM patients.

I continue to be encouraged by the advancement and work being done to treat this devastating cancer, especially in the midst of a global pandemic. Our collaboration with Regeneron continues to leverage our collective, extensive expertise in T-cell immunology to further develop this novel promising combination therapy of a DNA medicine and a PD-1 checkpoint inhibitor to treat GBM. Now I'll turn the call over to our CFO, Peter Kies for the financial updates. Peter?

Peter Kies -- Chief Financial Officer

Thanks, Joseph. Total revenue was $236,000 for the three months ended September 30th, 2020, compared to $867,000 for the same period in 2019. Total operating expenses were $36.6 million, compared to $24.8 million for the same period in 2019. INOVIO's net income for the quarter ended September 30th, 2020 was $19.2 million or $0.12 per share basic and $0.11 per share dilutive, compared to a net loss of $23.1 million or $0.23 per share basic, and $0.25 per share dilutive for the quarter ended September 30th, 2019.

The net income for the quarter was primarily due to the $35.3 million charge -- change in fair value of the derivative liability related to the embedded conversion feature in our August 2019 convertible bonds, which was revalued at each reporting period and immediately prior to the full conversion of these bonds into shares of the company's common stock in August 2020. The company also reported -- also recorded a gain on investment in affiliate entities of $27 million during the quarter, primarily related to the sale of its equity investment in GeneOne, which is no longer an affiliated entity. Again, I want to reiterate that INOVIO does not have any equity holdings in GeneOne. Without these non-cash gains on derivative liability and gains on investment in affiliate entities, the company's net loss for the quarter would have been $43.1 million and basic net loss per share would have been $0.26.

Research and development expenses for the three months ended September 30th, 2020 were $26.5 million, compared to $19.1 million for the same period in 2019. The increase in R&D expenses was primarily related to an increase in drug manufacturing expense related to our INO-4800, VGX-3100, and other clinical trials. Also an increase in engineering services related to our CELLECTRA 3PSP device, higher employee and contractor compensation due to increased headcount, an increase in consulting service expense related to COVID-19, higher device inventory expense, and also, higher employee stock-based compensation expense. These increases were offset by an increase to contra research and development expense recorded from grant agreements of $10.1 million among other variances.

General and administrative expenses were $10.1 million for the three months ended September 30th, 2020 versus $5.7 million for the same period in 2019. The increase in G&A expenses was primarily related to an increase in legal expenses and employee and consulting compensation due to increased headcount and non-cash stock compensation among other variances. As of September 30th, cash, cash equivalents, and short-term investments were $337.2 million, compared to $89.5 million as of December 31st, 2019. As of September 30th, 2020, the company had 167.5 million common shares outstanding and 192.1 million common shares outstanding on a fully diluted basis after giving effect to exercises, vesting, and conversions as applicable of its outstanding stock options, restricted stock units, convertible preferred stock and convertible debt.

Back to you, Joseph.

Joseph Kim -- President and Chief Executive Officer

Thanks, Peter, for the financial updates. It's great to know that INOVIO is in very good capital spending and we have the proper capital resources to continue to drive our core DNA medicines program. A strong balance sheet is always vital, but it is even more essential during the uncertainties of a global pandemic. As I addressed previously, INOVIO and our partners are doing everything we can to combat this virus, which has caused the current pandemic.

As we await the approval from the FDA to proceed with our Phase 2/3 clinical trial with INO-4800, we are continuing with our partners to plan and prepare for the next stages of development and we look forward to advancing our efforts to provide a safe, effective, and lasting vaccine to help control COVID-19. Now let's get to your questions. Operator, please open the line for a Q&A session with the analysts.

Questions & Answers:

Operator

[Operator instructions] The first question comes from Gregory Renza from RBC Capital Markets. Please go ahead.

Gregory Renza -- RBC Capital Markets -- Analyst

Thank you. Hey, Joseph and team. I appreciate the time and thanks for taking the questions here. Joseph, I just wanted to start with your perspective here.

Big news today, obviously, on the vaccine landscape front. I'm just curious as a player in this space, if you could just comment on how you, Kate, and the team are thinking about this development? And certainly, how we should think about this in light of 4800, especially as you think about starting up a Phase 2/3 trial? How you sort of communicate the differentiation here to a potential end user who may have a choice, not just across maybe developmental landscape, but also in the potential marketplace in the potential upcoming term? Thank you.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks, Greg. So today is a great day for global vaccines field and especially for the COVID-19 vaccine development field. But also, this is a huge step forward for the world in our fight collectively against COVID-19.

So Pfizer's data while it's early, shows a great proof-of-concept for this approach. It shows that the -- what most vaccine developers have chosen, the spike protein as a target for a vaccine, what's the proper and correct one. And again, at least in the early short-term, the vaccines can be developed to protect significantly against the COVID-19 causing virus. Now more data, obviously, needs to be filled in with time, but I think it's a great thing for all of us who are in this collective fight against COVID-19 pandemic.

Now the second part of the question is, how does that impact INO-4800 development? That's also a great question. Really, how it impacts is, as I stated in our prepared remarks, it's going to take multiple successful, safe, and effective COVID-19 vaccine to truly help the world control this virus and help us go back to the way things were or maybe even better. So while the Pfizer's vaccine has been very exciting to get the data today, I think it's telling rest of us that more work needs to be done continually to develop collectively, multiple vaccine candidates that will cross the finish line ultimately to provide vaccines against 7 billion global citizens around the world. So again, I want to reiterate how great a day it is overall.

Number two, for INOVIO's INO-4800, I think our vaccine and its positive key differentiators continue to point to the need to have INO-4800 continually be advanced to the finish line. And here are the -- some key -- there are five differentiators for 4800. One is based on our Phase 1 data, we know and along with other safety data from our other pipeline programs, we know our DNA vaccine is safe and tolerable and easy to administer with only very limited side effects, mostly grade 1 injection site reactions. So number one is safety and tolerability.

Number two, INO-4800 generates both new [Inaudible] antibodies and favorable T-cell immune responses, both CD8 and CD4 T-cells. Again, a balanced immune response that can provide both early protection and potentially longer-term T-cell-based protection. And number three, thermal stability. As I mentioned earlier, we have demonstrated that our DNA vaccines are stable at room temperature for more than a year, 37 degrees Celsius for more than a month and has a five-year projected shelf life and at normal refrigeration temperature, and our vaccine never has to be frozen during transport or storage.

Again, a significant advantage and key differentiating factor. And number four, our highly characterize and scalable manufacturing is also important aspect and advantage. And lastly, and many people may miss this, is if there's a need for readministration, a booster seasonally, of DNA vaccines, INOVIO's DNA vaccines has been shown to be able to be safely readministered multiple times. So I think these are key differentiating factors that remains.

And I think based on and leveraging the positive efficacy data from Pfizer and BioNTech from today, we are redoubling our efforts to make sure that we can advance INO-4800 as fast as we can because I think we will offer -- INO-4800 will offer the significant key differentiating factors in this COVID-19 vaccine landscape.

Gregory Renza -- RBC Capital Markets -- Analyst

Thanks, Joseph, and maybe just one more for me. As you look at a Phase 2/3 trial, of course, pending the easing of the hold from the FDA, could you just help us understand the funding estimate, how much of that trial would cost? And I just want to verify, talking about external funding, do you have a partner waiting in the wings to fully fund that? Is there a funding approach that would entail you contributing to funding or otherwise? Any additional color on funding for the next trial would be helpful. Thank you very much.

Joseph Kim -- President and Chief Executive Officer

Yeah, thanks. So Phase 2/3 were involved. Just to jog our memory, Phase 2 run in to confirm the dose in several hundred people, which will run into a larger Phase 3 efficacy trial. Again, it's designed to be a case driven trial, much similar in design as Pfizer's and Moderna's and AZ's and J&J, and we have been working diligently to bring in external funder to help fund the Phase 2/3 trial.

Collectively, the trial could cost several hundred million dollars and we are confident that upon receiving the lifting of the clinical hold from the FDA, which could happen in November. We're confident that we would be able to complete the external support, external funder brought to the table to help fund our Phase 2/3 trial.

Operator

The next question comes from Stephen Willey from Stifel. Please go ahead.

Stephen Willey -- Stifel Financial Corp. -- Analyst

Yeah, good afternoon. Thanks for taking the questions.

Joseph Kim -- President and Chief Executive Officer

Hey, Stephen.

Stephen Willey -- Stifel Financial Corp. -- Analyst

How is it going? I think you had mentioned that you'll not only be revealing kind of the Phase 2/3 trial design and initiating the study once the FDA lifts the clinical hold, but you'll also be providing a publication or providing the Phase 1 data. Can you just talk about, I guess, where that Phase 1 data is just from a publication process perspective? I know the timelines here have kind of gotten stretched out a little bit. And I just wanted to know, whether or not that data disclosure or that publication specifically is somehow tied to an FDA release.

Joseph Kim -- President and Chief Executive Officer

Yeah, absolutely, Steve. The last part first, the publication through a peer review process of our Phase 1 data is not tied to the FDA approval of Phase 2/3. So these are two independent events. And as you know, Steve and others here, INOVIO has been extremely diligent in publishing both our clinical and preclinical data over the years.

We published over 120 publications just in the last 10 years all through peer review process. So I am getting a little bit frustrated, too, that we're not moving as fast as we would during the peer review process, but I am very hopeful that we will be presenting our data through a peer review publication in the coming weeks. So that's what our plan is. And again, the publication is not tied to the FDA release of the partial clinical hold.

Stephen Willey -- Stifel Financial Corp. -- Analyst

OK. And then I guess, just with respect to the REVEAL studies, you know, I think you talked about the level of confidence in being able to make sure that you've verified all the requisite data points when that data is disclosed in the first half of next year. But I guess what's the level of confidence that the existing powering assumptions based upon the number of data points that you're going to have in each arm are going to hold true here? And I guess the question has a little bit to do with just, do you see any kind of disruption to the data collection process itself that might somehow change the statistical plan or alter the way that the statistical plan will work in the context of not having a complete picture of data?

Joseph Kim -- President and Chief Executive Officer

Yeah. Steve, thanks for the thoughtful question. No, we don't expect the pandemic to impact the statistical powering or data collection ultimately. So I try to state that in the prepared remarks.

So what's the impact? Here's -- I want to be as clear as possible here. What's being impacted is the collection and verification of the data in each of the sites and I can add a little more color that we are more than 90% done by the end of this year. But unfortunately, because of the delays in some countries and restrictions in some of the sites due to pandemic, we're not able to complete that process probably until first half of next year. But we're very confident that we're not going to be losing any patient data and that's why we're taking additional care and the time.

So the bottom line is, only thing that we're getting hit with is the delay of one or two quarters, compared to our beginning of the year projection from this year. So I just want to reiterate, it is a delay. It sucks because our team has been working tirelessly to not be delayed. You know we -- and again, we're not unique in this factor.

In almost every global trial, whether big or small, companies are running it have been clearly impacted by the global pandemic. But while we're disappointed in missing our projection in terms of the timeline, we are not going to be missing any of the projected data sets or patient data. So -- and we're hopeful that we can finish this through the pandemic as properly and appropriately and efficiently as possible, but the study remains blinded, double-blinded and we'll take every care to make sure that we can verify and provide the quality data -- data set before we lock them down for unblinding.

Stephen Willey -- Stifel Financial Corp. -- Analyst

Got it. And then just lastly, I know that there hasn't really been much said about REVEAL 2 in a little while. I guess, when should we expect maybe to hear from you what the projected enrollment timelines are looking like? And I guess, whether or not the ability to file? I think the guidance was year-end '22 if I remember correctly, if that's still on track? Thank you.

Joseph Kim -- President and Chief Executive Officer

Yeah. Steve, what we have shared previously and what I can share now is consistent. REVEAL 2 certainly is going to be impacted by global pandemic, but we're not yet in a position to clearly project how much of an impact of timeline is going to be, but clearly, it's been impacted more than REVEAL 1. But again, we have a very dedicated team at INOVIO and our CRO partners and sites are working as best they can through this very difficult, challenging times of pandemic.

So we will project as soon as we have some visibility of -- to have a clearer picture on the timeline, but it's not today.

Stephen Willey -- Stifel Financial Corp. -- Analyst

I appreciate it. Thanks for taking my questions.

Joseph Kim -- President and Chief Executive Officer

Great. Thank you, Steve.

Operator

The next question comes from Aydin Huseynov from Benchmark. Please go ahead.

Aydin Huseynov -- The Benchmark Company -- Analyst

Good afternoon.

Joseph Kim -- President and Chief Executive Officer

Hi.

Aydin Huseynov -- The Benchmark Company -- Analyst

Congratulations to the quarter. Hi and thanks for taking the questions. First question I have is regarding the -- the Pfizer reported 90% protection data. So whatever protection data we're going to get from INO-4800, do you think this is going to wane over the month?

Joseph Kim -- President and Chief Executive Officer

So let me see if I understood your question right. Do we think the Pfizer data will wane over the month? Or do we think INOVIO's efficacy data, when we do get to that stage, could wane over the month?

Aydin Huseynov -- The Benchmark Company -- Analyst

Yeah. Would be interested to hear your thoughts on both Pfizer and --

Joseph Kim -- President and Chief Executive Officer

Yeah. Because of the timing, we're going to see the impact on duration in Pfizer's data more quicker than INOVIO's data. Of course, we look forward to get them back on track, assuming the FDA agrees with us, and can start our path to a Phase 2/3 trial. But I think that's why I think, while today's data from Pfizer is very exciting and very important and monumental, additional time needs to be spent with Pfizer's data and looking at the impact over post-vaccination to that efficacy time point.

There are other interesting parts, both Pfizer and Moderna and AZ and INOVIO will all follow. Or what is the early and immediate efficacy level, what is the duration of that protective effects? In addition, what are the safety across that time, which is also important, especially with a lot of pockets of vaccine hesitancy, both in this country and abroad. We really need to put a comprehensive data package together. Each group needs to do that, both safety and efficacy, and collectively as to fell, you know, we would get to -- we are hopeful that we would have multiple vaccines, which will show strong enough efficacy and good enough safety overall to become one or more of these arsenals against this pandemic.

Aydin Huseynov -- The Benchmark Company -- Analyst

Thank you, Joe. I appreciate that. Another question I have is the -- about the Phase 2/3 trial design. So for how long do you think the Phase 2 is going to last before you start the Phase 3 once the clinical partial hold is lifted?

Joseph Kim -- President and Chief Executive Officer

Yeah. Once the clinical hold is lifted, we look forward to starting the Phase 2 portion, which should be our dose confirmation phase right away. So we're already prepping the sites and preparing to move as soon as the FDA gives us a go ahead. The Phase 2 portion will take a couple of months and then there will be data analysis and certainly final dose selection between 1 and 2 milligrams and the move into the Phase 3.

So you know, we want to get to the efficacy point as soon as possible, especially with today's early data from Pfizer. I think it's really behoove all of us to move as rapidly as possible to see if we can all have similar level of efficacy and provide the safety data, which are required globally to help to fight this pandemic.

Aydin Huseynov -- The Benchmark Company -- Analyst

Thank you. Thank you, Joe. And last one, I guess on INO-5401. So it looks like we should expect the data on November 20th.

What are your expectations about OS at 18 months? And could you also remind us what is the standard of care of OS at 18 months?

Joseph Kim -- President and Chief Executive Officer

Yeah. You know standard of care is -- in methylated patient population, I believe, is in the -- let me -- I should know this by heart, but we -- it should be in the 40% to 50% range in unmethylated sicker population at OS18, a little bit higher in the methylated population. So you know, we do have OS18 for both cohort A in unmethylated and cohort B in methylated population, which will be presented at SNO in a couple of weeks, a little over a week. So we're very excited about that data.

We will also have median overall survival, which also provides a more broad snapshot that we can compare to the standard of care. Standard of care median OS for unmethylated is around 14, 15 months; and methylated is around 22, 24 months. So these are the types of survival data that we will compare our Phase 1/2 trial data 2 at SNO. We will also present some T-cell responses in both cohorts, both LS spots and flow to the tumor antigens that we have designed in INO-5401.

And our goal is to eventually help to correlate between some of these biomarkers to clinical efficacy or overall survival. The correlation would not be provided at SNO, but those are additional work that will be done in the coming months and could be presented in 2021.

Aydin Huseynov -- The Benchmark Company -- Analyst

Thank you. Thank you, Joe, for taking the questions.

Joseph Kim -- President and Chief Executive Officer

Thanks, Aydin.

Operator

The next question comes from Chris Raymond from Piper Sandler. Please go ahead.

Chris Raymond -- Piper Sandler -- Analyst

Hey. thanks for taking the querstion. Just maybe a couple. On 4800 and I'm -- Joseph, I'm sorry, I think some people may have asked this question a little bit differently.

But I guess if I can maybe simplify it a little bit in terms of the bar for efficacy. So I think we know that there's a big advantage from a distribution standpoint with 4800. But just would love your perspective, is there a bar that you think, you know, 90%, obviously, with Pfizer and we haven't seen a lot more data behind it but that sets a bar. Do you have a sense that given there's an easier distribution channel that you have a lower bar? Or what's your perspective on what success looks like, I guess, given the differentiated distribution?

Joseph Kim -- President and Chief Executive Officer

Yeah. Hi, Chris, great question. So it's a very complex answer. So if, I mean, if the 90% efficacy remains in the later time points and I mean, I don't believe Pfizer themselves are expecting that.

But if that's true, as Tony Fauci said, the data of 90% efficacy would be extraordinary in animals of vaccine development in the last 100-plus years, that's tremendous. So that's a very, very exciting bar for efficacy. Just remember, the FDA themselves set off a 50% efficacy bar above the placebo group rate.

Chris Raymond -- Piper Sandler -- Analyst

Yeah.

Joseph Kim -- President and Chief Executive Officer

So if 90% continues, I mean that will be better than pretty much most of the other newer vaccines in the last 20 years. So that will be a very exciting data to have. Is that going to happen? My feeling is it's possible, but we need to track that and Pfizer will track that and report that, and I'm sure that will be part of the overall efficacy valuation. And also, how long is that going to -- the protective rate going to continue in the durability of that efficacy response? I mean these are questions that could only be answered with time.

With our INO-4800, of course, you know, we're designing our trial with the FDA guidances in mind just the way the Pfizer and other groups have. And we will continue to advance it using -- I mean the Pfizer data has shown that this case-driven efforts and the design is the right thing. The choice of spike protein as the vaccine target was the right thing. I mean there's a lot of validation of the vaccine development approach that's occurred today, thanks to Pfizer's positive data.

But I think there's going to be even more work and more data analysis in the coming months from Pfizer and other groups.

Chris Raymond -- Piper Sandler -- Analyst

Yeah. I guess my question though was that, do you think there's a bar that's lower for 4800? Yes?

Joseph Kim -- President and Chief Executive Officer

Um, I don't necessarily think so, but the seat at the table or being a -- one of the useful weapons against this global pandemic requires complex management of these different attributes, right? Efficacy is probably number one. Right behind that is probably in the same level as the safety. You need a vaccine that can be safely delivered to billions of people over time. Next is having enough supplies and having the logistics of distribution in accordance, right? So if you're trying to deliver a vaccine, distribute that requires cold -- deep cold chain like minus 70 or minus 80 Celsius, you're not going to be able to do that in most of the regions and most of the countries outside the U.S.

And even the U.S., that's going to be a significant heavy lift to distribute those vaccines. So again, I -- you know, having a better thermal stability provides what sort of lower bar in efficacy? That's harder to answer and harder to measure, but our goal is to test their vaccine in a well-controlled clinical trials and we're hopeful that we can match the Pfizer's efficacy rates. And we know, likely our safety and tolerably profile could be better, and we know that thermal stability is better. So it's a matter of getting our trial on track and getting to the efficacy and safety data from a large Phase 3 trial and we look forward to doing that.

Chris Raymond -- Piper Sandler -- Analyst

OK. And maybe if I could just ask on REVEAL. So I heard your comments about REVEAL 1, you know, sort of the situation deteriorating since last August. Can you maybe give a little bit more color? You know and I guess, I'm interested in this from the perspective of when you started seeing some of that deterioration? Just so we can juxtapose that, if you will, with when the virus started surging.

Was it right during the summertime? Or was there some period since then that you started seeing it that made you made that call? Or was it -- just kind of give us a sense between August and now when it became obvious.

Joseph Kim -- President and Chief Executive Officer

Yeah. So in August, we knew what work needed to be done. We knew which -- how many subjects were coming to their 36-month time frame and which sites and which patients or which subjects were going to be eligible for the data verification at certain points. And you know, this is a 60-site, 20-country studies, it's a global trial.

So our team and our CRO felt that all of the tasks could be done by the end of this year and I think we're almost correct in our projection even through the pandemic. As I mentioned earlier, we're about 90% completed in those efforts, but this isn't an [Inaudible] water balloon. You can't just have close enough to lock down the data in a well-controlled pivotal registrational Phase 3 trial, as you know. So unfortunately, the other 10% is going to slip into 2021.

Of course, our teams are working diligently to minimize the delay as much as possible. But because of the second wave of lockdowns are occurring already in Europe and elsewhere, and we would probably, too, in the U.S. It's harder to predict precisely when we will finish, but we are about 90% of the way there with REVEAL 1 already. So it's the final 10%, and of course, this is a very important, very important program for us.

So we want to do it right the first time.

Chris Raymond -- Piper Sandler -- Analyst

OK. Great. Thank you.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks, Chris.

Operator

The next question comes from Yi Chen from H.C. Wainwright. Please go ahead.

Yi Chen -- H.C. Wainwright -- Analyst

Thank you for taking my question. Joseph, would you say that --

Joseph Kim -- President and Chief Executive Officer

Hi.

Yi Chen -- H.C. Wainwright -- Analyst

Hi, would you say that with the resurging COVID-19 cases across the country, that would be relatively easy to -- for you to complete enrollment for the Phase 2/3 stage of the trial for INO-4800? And also, have you so far disclosed how many patients will be enrolled for the Phase 2 stage?

Joseph Kim -- President and Chief Executive Officer

For 4800, Phase 2 portion will be a few hundred patients or volunteers and it will be randomized into 1-milligram and 2-milligram doses in several age groups. And upon dose confirmation, we're planning to move into Phase 3 efficacy case-driven trial design study, all in the U.S. And yeah, I mean it is certainly, recruitment is one thing, but getting to positive cases in a blinded fashion, ironically, it will be faster with more infections and higher infection rates. So I think the latter is true at this time and we expect that to continue for the foreseeable months.

So you know, we're really looking forward to satisfying the FDA and getting to our planned Phase 2/3 trial as soon as possible.

Yi Chen -- H.C. Wainwright -- Analyst

Got it. And also, without a human challenge study, do you think the 90% efficacy from Pfizer and BioNTech vaccine, reflect the true -- it's true efficacy?

Joseph Kim -- President and Chief Executive Officer

Oh, well, you know, I guess, it's Pfizer's Phase 3 trial is well designed and being well executed. I think the true efficacy, the time will tell. Once you get to the 160-plus cases and the efficacy rate is somewhere around anything above 50%, but above placebo but it could be as high as what they've seen earlier, would be a great news for Pfizer, but also great news for COVID-19 vaccine field. Now you mentioned about human challenge, I mean human challenges fraud with potential ethical issues and I would say those sample sizes are going to be -- I mean, unless you're going to challenge 164 people, I'm not a biostatistician.

Putting aside the ethical issues, I think having a small human challenge is not going to be very reflective and they are only talk -- given the proponents when you're talking about very young participants, which is not very reflective of the field use. So I think the large, randomized, well-controlled, well-executed trial is still superior and data reflection to -- than a small-challenge study.

Yi Chen -- H.C. Wainwright -- Analyst

Got it. And my last question is, can we expect any additional animal challenge studies from 4800 in the coming weeks or months? And also, when do you expect to have an update from Operation WARP Speed regarding animal challenge study results for all the best things included in the operation?

Joseph Kim -- President and Chief Executive Officer

Yeah. So as we mentioned before, we have multiple nonhuman primate challenge studies going. One that we have submitted for publication, a second one being completed in England through Public Health of England, and the last one, the third one through the Operation WARP Speed as part of their nonhuman primate challenge -- trial studies, all of those are going well. In particular to Operation WARP Speed monkey challenge studies.

I believe the challenge -- the challenges have begun. They all have received vaccines and we expect the data when these government labs, contract labs, complete the study. So I think these are all data that you should be expecting in the next several months.

Operator

The next question comes from Jonathan Aschoff from ROTH Capital Partners. Please go ahead.

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

Thank you. Joe, if you were to lose those 10 patients -- 10% of patients, what would the power change to for that 3100 REVEAL 1 trial?

Joseph Kim -- President and Chief Executive Officer

You know, we don't know, but you know we -- that's not something we wanted to do to risk multiyear, our most advanced global registrational Phase 3 trial. So that's the risk that we didn't want to take, whether we want to work through the pandemic and that's a theoretical concern that we weren't prepared to cross in fourth-quarter 2020. If we're seeing the pandemic taking out the timeline even further than first half of '21, which we don't expect, but there are uncertainties of the pandemic, that's not something we would need to cross.

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

So is it OK for you to evaluate them a few weeks? Or what amount of time after their scheduled evaluation time is still acceptable? Is that flexible or is it not?

Joseph Kim -- President and Chief Executive Officer

Yeah. Sorry, Jonathan, I think you've, either -- we didn't communicate properly or you have mistaken that the patients or subjects are coming in for those data collection visits. It's the follow-ups and quality verification with site monitoring that we have restrictions on. So as far as I know, we haven't lost any time points or sample points, so those are not at risk.

It's just locking down -- following the proper steps to lock down the data so that we can use the lap data to support the registration globally. But especially with the FDA, it's something that we're following properly and that's been difficult with the final 10% of our sites and patients. And that's something that was delayed, we plan to properly execute.

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

OK. Thank you for clearing that up. Second question would be, if you imagine INOVIO not going forward with the 4800 program with more cash than you've ever had on hand really, where would you most aggressively put that clinically? Would you more aggressively develop what you have? Would you bring some things you've given some thought to more aggressively into the clinic? I mean, what would you do with that money?

Joseph Kim -- President and Chief Executive Officer

That's a great question. You know with a very strong platform and the pipeline that we have in Phase 2 and Phase 3, we certainly have a lot of potential avenues for additional investment. As I mentioned earlier for instance, our Phase 2 VIN, vulvar neoplasia and anal neoplasia, AIN studies. We are reporting -- we remain projecting to report the full set of Phase 2 data by the end of this year.

Assuming they're positive and exciting as we have shown in the spring from interim data, those two are two orphan indications that we look forward to investing into through licensure studies in '21 and beyond. Those are very potentially high value-added programs and extending VGX-3100's coverage and label to two additional orphan designation indication. So that's just one example. RRP is one area, high unmet virgin medical need, noncurable tumors that continues to grow and the current treatment is only surgical resection, which temporarily provides relief, is an area that we are investing into because we feel that's a significant medical and commercial value areas.

Certainly, we spoke about our later-stage programs in GBM and cervical dysplasia. So these are all a potential high-value additional areas that we are already investing into. And these are the work, very heavy and diligent work that INOVIO's team is devoting right now in addition to what we are doing with our COVID-19 vaccine development

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

Thanks for that, Joe. And lastly, a really fast one. AstraZeneca has not said anything about their cancer programs that they're doing with your technology, correct? I remember reading in August, August was the time frame that they may have been able to say something, but nothing from them. Is that correct?

Joseph Kim -- President and Chief Executive Officer

Well, there was a presentation at ESMO in September that showed the interim overall response rate in head and neck cancer. AZ is also conducting several ISS studies in cervical and other HPV-caused cancers with MEDI0457 plus their development of PD-L1 checkpoint inhibitor. So you know that's the license program and that will continue to drive that program and they'll be presenting and publishing and reporting data as the events that license program for INOVIO.

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

Thank you very much, Joe.

Joseph Kim -- President and Chief Executive Officer

Great. Thanks.

Operator

There are no more questions in the queue. This concludes our question-and-answer session. I'd like to turn the conference back over to Joseph Kim for any closing remarks.

Joseph Kim -- President and Chief Executive Officer

Thank you, everyone, for listening to our 3Q financial and program updates. We look forward to sharing additional progress in the coming weeks and coming months. Thank you very much.

Operator

[Operator signoff]

Duration: 66 minutes

Call participants:

Ben Matone -- Investor Relations

Joseph Kim -- President and Chief Executive Officer

Peter Kies -- Chief Financial Officer

Gregory Renza -- RBC Capital Markets -- Analyst

Stephen Willey -- Stifel Financial Corp. -- Analyst

Aydin Huseynov -- The Benchmark Company -- Analyst

Chris Raymond -- Piper Sandler -- Analyst

Yi Chen -- H.C. Wainwright -- Analyst

Jonathan Aschoff -- ROTH Capital Partners -- Analyst

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