Q3 2020 Inovio Pharmaceuticals Inc Earnings Call

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Good day and welcome to the Inovio Pharmaceuticals third quarter 2020 financial results Conference call. All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.

Operator: Good day, and welcome to the Inovio Pharmaceuticals Third Quarter 2020 Financial Results Conference Call. All participants will be in listen-only mode.

Operator: Should you need assistance, please signal the conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Ben Matone. Please do so.

After todays presentation, there will be an opportunity to ask questions. Please note. This event is being recorded.

I'd now like to turn the conference over to Ben Midtown. Please go ahead.

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.

Ben Matone: 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.

Dr. Jacqueline Shay and there'll be a chief operating officer the.

The company's Chief Financial Officer, Peter Keys, Dr., Prakash, where we own vice president of clinical development and head of Inovios clinical programs to treat HPV related pre cancers, and Dr., Kate Roderick Senior Vice President of research and development.

This call is being webcast live on our web site IR Dot Inovio dot com and a replay will be made available as indicated in todays press release.

Ben Matone: For today's call, we will review our corporate and financial information for the third quarter of 2020 and for September 30th, 2020, as well as provide an update on our clinical programs, including Inovio's COVID-19 vaccine candidates. Following prepared remarks, we will be conducting a question and answer segment reserved for Equity Research Channel. 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 on Inovio's business operations. 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.

For today's call, we will review, our corporate and financial information for the third quarter 2020 ended September Thirtyth 2020, as well as provide an update on our clinical programs, including Inovios 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 Inovios 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 on Inovios business operation.

All of these statements are based on the beliefs and expectations of management as of today.

Statements involve certain assumptions risks and uncertainties that could cause actual results to differ materially.

Ben Matone: 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 risk 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. Thanks, Ben, and good afternoon,

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 todays 10-Q filing with the SEC.

Now I would now like to turn the call over to Inovios, President and CEO Dr. Joseph Kim Joseph.

Thanks, Ben and good afternoon, everyone.

Before I reflect on the third quarter.

The first picked opportunity to thank our employees our partners our trial participants our clinical investigators for their continued hard work across our DNA medicines platform.

Dr. Joseph Kim: Before I reflect on the third quarter, I want to first take the opportunity to thank our employees, our partners, our trial participants, and 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.

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 and conventional 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.

Dr. Joseph Kim: But I could not be more proud of 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 responded to the FDA's hold questions, and now we expect a response back this month. I would like to remind everyone of two important points.

Let's first look at our.

Cove in 19, DNA vaccine program.

Currently inovio remains on partial clinical hold for the phase two three clinical trial in October we have responded to the FDA hold questions and now we expect a 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 Inovios other product candidates in development, nor the completion of the ongoing expanded phase one clinical trials for I don't know 4800 into.

U.S. secondly, the F.D.A.'s questions for not related to the occurrence of any adverse events really related to our I know 4800 phase one study.

Dr. Joseph Kim: 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 I clinical trials for INO4800 in the U.S. Secondly, the FDA's questions were not related to the occurrence of any adverse events related to our INO4800 Phase 1 study. I continue to be thankful for our team's efforts to quickly deliver our responses to the FDA. Our expanded phase one clinical trials in the U.S. are 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're confident that the combined data package for Inovio's INO4800 DNA vaccine candidate in the U.S. supports its further advancement into efficacy trials.

I continue to be thankful for our team's efforts to quickly deliver our responses to the FDA.

Our expanded phase one clinical trials in the U.S. is ongoing.

In addition.

Our trials in South Korea, and China are being conducted with our collaborators Ivy I and the vaccine respectively and are progressing well.

We're confident that the combined data package for Inovios I handle 4800, DNA vaccine candidate in the U.S. support this further advancement into <unk> efficacy trials base.

Based on our phase one clinical trial data.

I know 4800 deliver Selectra 2000 has demonstrated a favorable clinical safety tolerability and immunogenicity profile and supportive Nonclinical data.

Dr. Joseph Kim: Based on our Phase I clinical trial data, INO4800 delivered with Selectra 2000 has demonstrated favorable clinical safety, tolerability, and immunogenicity profiles, and supportive non-clinical data. INO4800 could be safely re-administered 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, 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 of 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 are required to combat this pandemic, it is important to identify and continue to evaluate the pathophysiologic properties of the SARS-CoV-2 virus as the pandemic evolves.

I don't know 4800 could be safely we administered if immunity wanes offering the possibility for seasonal boosting usage with potentially better see the a T cell responses and without concerns of generating and anti vector response.

In addition to in addition to.

No Vo stand they medicines technology lends itself to thermal stability as well as scalability of manufacturing for fishing and cost effective distribution.

For instance, Inovios DNA vaccines have demonstrated excellent thermal stability as they can be store 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 they accelerated timeline and beat for parallel planning is require to combat. This pandemic. It is important to identify and continue to evaluate the paso fees year Lodge.

<unk> properties of Sars koby to virus as the pandemic evolves.

Recently, the researchers at the Commonwealth Scientific and industrial research organization or Cicero Australias National Science Research agency and Inovio publish in N.P.J. vaccines, the ability for it I know 48.

Hundreds to neutralize multiple.

Dr. Joseph Kim: Recently, the researchers at the Commonwealth Scientific and Industrial Research Organization, or CISRO, Australia's National Science Research Agency, and Inovio published in NPJ Vaccines the ability for INO4800 to neutralize multiple, newly prevalent mutation strains of the SARS-CoV-2 virus. As a point of reference, most vaccines under development worldwide have been modeled on the original D strain of the virus, which was more common among sequences published early Since then, the virus has evolved to the globally dominant G-strain, which now accounts for roughly 85 percent of published SARS-CoV-2 genomes.

Newly prevalent mutations strains of Sars koby to virus.

That's the point of reference most vaccines under development worldwide have been modeled on the original de strain of the virus, which were more common amongst sequences published early independently.

Since then the virus has evolved to the globally dominant g. strain, which now accounts for roughly 85% of publish Sars koby to genomes. In this recently published study we found that I know 4800 developed a good b cell response in terms of neutralizing antibody.

Ladies against both D. and G. source Koby, two strains, which is important for the short term efficacy of a vaccine at.

Additionally, we also demonstrated strong T cell response, which is important for long term efficacy.

This latest publication those on our stringent animal challenge study in rhesus macaques.

Dr. Joseph Kim: In this recently published study, we found that INO4800 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. [inaudible] We also demonstrated a strong T-cell response, which is important for the long-term efficacy. This latest publication builds on our stringent animal challenge study in r

[noise] 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 three trials and multiple vaccine candidates to assess the efficacy of preventing coven nineteens disease and further expand the.

Dr. Joseph Kim: 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 INO4800, 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 INO4800 last quarter. 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 INO4800 drug substance, as well as to perform fill and finish of the INO4800 drug product at its commercial facilities in the United States.

Safety database of these vaccines.

No view certainly looks forward to sharing our phase one data for iron ore 4800 as.

As well as initiating a phase two slash three trial following the ft ace release of the partial clinical hold.

On the manufacturing side Inovio signed an agreement with Thermo Fisher scientific to manufacture I know 4800 last quarter. It has been it hasn't been great to have thermo Fisher with our global manufacturing scale and capacity to join other.

Contract development and manufacturing organizations in Inovios Global manufacturing consortium.

Thermo Fisher plans to manufacture I know 4800 drug substance as well as to perform fill and finish of I know 4800 drug product at his commercial facilities in the United States.

Next we'll turn to our lead asset in phase three clinical trials VGX 3100.

[noise] managing global trial clinical trial.

Cross 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 or data monitors physically need to be at the <unk> trial sites since our update in August we have seen an increasing number of trial participants who either do not feel safe and or not willing to go into clinical facilities.

Dr. Joseph Kim: Next, we'll turn to our lead asset in phase 3 clinical trials, VGX3100. Managing global clinical trials 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.

Well as restrictions placed on clinical sites.

For monitoring visits these pandemic restrictions have post 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 three blinded pivotal trial.

Dr. Joseph Kim: 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 the data sample. 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.

With infection and hospital hospitalization rates, increasing in many U.S. states and with several European countries again going on locked down 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 P. guys partners and everyone involved.

Taking into account the impact of COVID-19 today and the uncertainty as we head into the likely second wave of the pandemic.

No view now expects to read out clinical data from the blinded VGX 3100 face through you review in one clinical trial in the first half of 2021.

While the pandemic has delayed the timeline to the data report out.

I want to be very clear that the reveal one 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 and 2021.

Dr. Joseph Kim: Taking into account the impact of COVID-19 today and the uncertainty as we head into the likely second wave of the pandemic, Inovio now expects to read out clinical data from the blinded VGX 3100 phase 3 review 1 clinical trial in the first half of 2021. While the pandemic has delayed the timeline for the data report, I want to be very clear that the REVIEW-01 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 is certainly not unique to Revio 1 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 delay caused by the global pandemic, certainly is not unique to reveal one 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.

The sites are keeping virtual contacts with study subjects to ensure that safety monitoring its not disrupted.

The labs and careers have been able to operate during using proper social distancing practices and our trial sites are incurring to local health guidances on how to properly see their patients.

As for our Vin and 18 phase two clinical trials with VGX 3100, we do expect to read out 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 <unk>.

2021.

Now shifting to I know 54, one are.

Our DNA medicine program for Glioblastoma.

We are pleased to share that I know 54, one trial data was accepted as a late break presentation. During the plenary session at the society for neuro oncology annual meeting or snow on November Twentyth drill.

Dr. Joseph Kim: The labs and couriers have been able to operate using proper social distancing practices, and our trial sites are adhering to local health guidance on how to properly see their patients. As for our VIN and AIM Phase 2 clinical trials with FGX3100, we do expect to read out a complete set of efficacy and safety data before 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 INO54-1. Our DNA Medicine Program for Glioblastoma

During this presentation, we will be presenting or S. 18.

[noise] and median O.S. 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 D N a medicine and a PD one checkpoint inhibitor to treat GBM.

Dr. Joseph Kim: We are pleased to share that INO5401 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 Theta, along with preliminary analysis on T cell immune responses to tumor antigens in newly diagnosed GBN patients. I continue to be encouraged by the advancements 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?

Yeah.

Now I'll turn the call over to our CFO, Peter Keith for the financial update Peter.

Thanks, Joe So.

Total revenue was 236000 for the three months ended September Thirtyth 2020, compared to 867000 for the same period in 2019 toll.

Total operating expenses were 36.6 million compared to 24.8 million for the same period in 2019.

Inovios net income further.

For the quarter ended September Thirtyth 2020 was 19.2 million.

Or 12 cents per share basic and 11 cents per share dilutive.

Compared to a net loss of 23.1 million or 23 cents per share basic and 25 cents per share dilutive for the quarter ended September Thirtyth 2019 the.

The net income for the quarter was primarily due to.

The 35.3 million or 35.3 million charge.

Change in fair value of the derivative liability related to the embedded conversion feature in our August.

Peter D. Kies: Thanks, Joseph. Total revenue was $236,000 for the three months ended September 30, 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 30, 2019. The net income for the quarter was primarily due to...

2019 convertible bonds, which was revalued at each reporting period and immediately prior to the full conversion of these bonds into shares of the Companys.

Common stock in August 2020.

The company also report also recorded a gain on investment in affiliate entities of 27 million during the quarter.

Primarily related to the sale of its X. equity investment in gene one.

Which is no longer an affiliated entity again I want to reiterate that Inovio does not have any equity holdings in gene one.

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 26 cents.

Research and development expenses for the three months ended September Thirtyth 2020 were 26.5 million compare.

Peter D. Kies: The $35.3 million charge related to the change in fair value of the derivative liability related to the embedded conversion feature in our August 2019 Convertible Bond, which was revalued at each reporting period and immediately prior to the full conversion of these bonds into shares of the companies. Common Stock in August 2020. The company 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 the basic net loss per share would have been $0.26.

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 or I don't know 4800, VGX 3100, and on <unk> and other clinical trials.

Also an increase in engineering services related to our Selectra Threepi SP device.

Higher employee and contractor compensation due to increased headcount.

An increase in consulting service expense related to covert 90 higher.

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 Thirtyth 2020 versus 5.7 million for the same period in 2019.

The increase in GNS expenses was primarily related to an increase in legal expenses and employee consulting compensation due to increased headcount and non cash stock compensation.

Among other variances.

As of September Thirtyth cash cash equivalents and short term investments were 337.2 million compared to 89.5 million as of December 31st 29 team.

Peter D. Kies: Research and development expenses for the three months ended September 30, 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 expenses related to our INO4800, VGX3100, and other clinical trials. Also, an increase in engineering services related to our Selectra 3PSP device, higher employee and contractor compensation due to increased headcount, an increase in consulting service expense related to COVID-19, higher Device Inventory Expansion, and also hire 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 variants. General and administrative expenses were $10.1 million for the three months ended September 30, 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 Thirtyth 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.

In south standing stock options restricted stock units convertible preferred stock and convertible debt.

Back to you Joseph.

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.

But it is even more essential shrink the uncertainties of a global pandemic.

As I addressed previously.

No view 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 two three clinical trial with I know 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 over 90.

Now, let's get to your questions. Operator, please open the line for Q and a session with the analysts.

We'll now begin the question and answer session terrific question, you mean, Chris Star then one on your Touchstone phone.

If we are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

Peter D. Kies: As of September 30, cash, cash equivalents, and short-term investments were $337.2 million compared to $89.5 million as of December 31, 2019. As of September 30, 2020, the company had 167.5 million common shares outstanding and 192.1 million common shares outstanding on a fully diluted basis.

The first question comes from Gregory Renzo from RBC capital markets. Please go ahead.

Thank you Hey, Joseph and team I appreciate the time and thanks for taking the questions here I just I just wanted to start with your perspective here Big news today, obviously on the B vaccine landscape front I'm. Just curious you know as a player in this space. If you could just comment on how you are keeping the team or are thinking about.

But about this development and certainly how we should think about this in light of 4800, especially as you think about starting up a a phase two three trial now how you sort of communicate the differentiation here to a potential and user who may have a choice not just across maybe a developmental.

Dr. Joseph Kim: 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. Thanks, Peter, for the financials. It's great to know that Inovio is in very good capital standing.

Good but also in the potential market place and the.

The potential upcoming term. Thank you yeah. Thanks, Craig so.

Today, it's 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 a in our fight collectively again school in 19.

Dr. Joseph Kim: We have the proper capital resources, and will 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 FDA approval to proceed with our Phase 2-3 clinical trial with INO4800, 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.

So pfizers data while it's early.

Shows a great proof of concept for this approach it shows that the though what most vaccine developers have chosen.

The spiked protein as a target for a vaccine what's the proper and correct one.

And and again or at least in the early short term the vaccines can be developed to protect significantly.

Against the the COVID-19, causing virus no more data obviously needs to be filled in with time, but I think yes. It's a great thing for all of US who are in this collective fight against a COVID-19 pandemic.

Now the second part of the question.

Is how does that impact I know 4800 development Ah. That's also a great question.

Operator: Operator, please open the line for a Q&A session with the analysts. We'll now begin the question-and-answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

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 surely helped the world control this virus and help US go back to the way thing.

Gregory Renza: To withdraw your question, please press star, then... Our first question comes from Gregory Renza from RBC Capital Markets. Please go ahead. 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 perspectives here.

It's four or maybe even better so.

So oh Wow, 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.

Dr. Joseph Kim: Big news today, obviously, on the vaccine landscape front. I'm just curious, you know, 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, you know, as you think about starting up a phase two, three trial. Now, how do you sort of communicate the differentiation here to a potential end user who may have a choice, not just across maybe the developmental landscape but also in the potential marketplace in the potential upcoming term?

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 how great a day. This overall number two.

For Inovios I know 4800.

I think our vaccine and this positive key differentiators.

Teaching you to point to the need.

To have I know 4800 continually be advance to the finish line and.

Dr. Joseph Kim: Thank you. Yeah, thanks, Greg. So, today is a great day for the global vaccine 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 what most vaccine developers have chosen, the spike protein as a target for a vaccine, was the proper and correct one. And again, at least in the short term, vaccines can be developed. [inaudible] Now, the second part of the question is, how does that impact INO4800 development? That's also a great question, uh, really how it impacts us, as I stated in our prepared remarks, it's going to take multiple successful safe and effective COVID-19 vaccines 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 vaccine has been very exciting to get the data today, I think it's telling the rest of us that more work needs to So again, I want to reiterate how great a day it was overall.

Here are some key here are five differentiators.

For 40 801 is based on our phase one 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 one injection site reactions. So number one is safety and tolerability.

Victory number two.

I don't know 4800 generates both neutralizing antibodies and favorable T cell immune responses, both CD eight and CD four T cells again, a balance 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, a 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 project, a shelf life and at no more refrigeration temperature and our vaccine never has to be frozen drink transport or storage again, a significant advantage and key differentiating for.

Dr and number four.

Our highly characterize evault and scalable manufacturing, it's also important aspect and the vantage and lastly, and many people may missed this is if there's a need for re administration a booster seasonally.

DNA vaccines Inovios DNA vaccines has been shown to be able to be safely we administer.

Dr. Joseph Kim: Number two. For Inovio's INO4800, I think our vaccine and its positive key differentiators continue to point to the need to have INO4800 continually be advanced to the finish line. And here are some key differentiators for 4800. This is based on our phase one data. We know, 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 one injection site reactions. So number one is safety and tolerability. Number two. INO4800 generates both neutralizing 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.

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 bio Tech from today. You know we are redoubling our efforts to make sure that we can events I know for the 800 as fast as we can.

Because I think we will offer I know 4800 were off for the significant key differentiating factors.

In this COVID-19 vaccine landscape.

Thanks, Jos and then maybe just one more for me as you look at a phase two three trial of course pending easing of the whole group from the FDA can you just help us understand but the funding asking how much that trial would would cough.

And I just wanted to verify that you're 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 TICC funding or otherwise any additional color on on funding for the next trial would be helpful. Thank you very much.

Yeah. Thanks, So phase two three or more involved just a job or or memory face to run and to confirm the dose several hundred people.

Dr. Joseph Kim: 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 they have a five-year projected shelf life at normal refrigeration temperatures. 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 characterizable and scalable manufacturing is also an important aspect and advantage. And lastly, and many people may miss this, is if there's a need for re-administration, a booster seasonally, DNA vaccines, Inovio's DNA vaccines, have been shown to be able to be safely re-administered multiple times. I think these are key differentiating factors that remain, and I think based on and leveraging the positive efficacy data from Pfizer and BioN Thanks, Joseph. And maybe just one more for me.

Which will run into a larger phase three efficacy trial again, they say designed to be a case driven trial much similar in design as pfizer's and modernize and agencies and in Jays.

And and you know we have been working diligently to bring in external friend or to help fund the phase two three trial collectively the trial could cost several hundred million dollars and we're confident that upon receiving.

The lifting of the clinical hold from the FDA, which could happen in November a we're confident that we would be able to complete the external support external fund or brought to the table to help fund our phase two three trial.

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

Yeah. Good afternoon, thanks for taking the questions. It's just that I think.

I was going can I think you had mentioned that.

[noise], you'll not only be revealing kind as the phase two three trial design and initiate.

The clinical but you also be.

Providing a publication or providing the phase one data and.

Can you just talk about I guess, where that phase one data is just from a publication process perspective.

I know the timelines here.

Kind of gotten stretched out a little bit and just wanted to.

Dr. Joseph Kim: As you look at a Phase 2, 3 trial, of course, pending the easing of the hold from the FDA, can you just help us understand the funding estimate, how much 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?

No, whether or not that data disclosure or the or that publication, specifically to somehow tied to it.

Yeah, absolutely Steve.

The last part first.

The publication through a peer review process of our phase one data is not tied to the FDA approval of phase two three so these are two independent events.

And as you know, Steve and others are here you know Inovio has been extremely diligent in publishing both our clinical and preclinical data over the years, we've published over 120 publications just in the last 10 years all through peer review.

Dr. Joseph Kim: Otherwise, any additional color on funding for the next trial would be helpful. Thank you very much. Yeah, thanks. So, Phase 2-3 will involve, just to jog our memory, a 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 to Pfizer's and Moderna's and AZ's and J&J's. And, you know, we have been working diligently to bring in external funders 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 that external funders have brought to the table to help fund our Phase 2-3 trial. The next question comes from Stephen Wiley from Stiefel. Please go ahead. Yeah, good afternoon.

Your process. So you know.

I am getting little bit frustrated too that we're not moving as fast as we would during the peer review process, but you know 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 and again the publication is not tied to the Sta release of the partial clinical hold.

Okay.

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.

Our fight all the requisite data points.

It was disclosed first half of next year, but I.

I guess, what's the level of confidence that you know the.

The existing powering assumptions based upon the number of data points that you're gonna happen in each arm are going up or.

Stephen Wiley: Thanks for taking the questions, Ken. I think you had mentioned that you'll not only be revealing kind of the phase two, three trial. Clinical Hull, but you also... are providing a publication or providing the phase one data. Can you just talk about, I guess, where that phase one data is just from a public... Process perspective. I know the timeline, and I know whether or not that data disclosure or that publication specifically is somehow tied. Yeah, absolutely, Steve. The last part first: the publication through a peer review process of our phase one data is not tied to the FDA approval of phase two, or three. So these are two independent events.

We're going to hold true here and.

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 statistical play.

Planned or alter the way that the statistical plan will work in the context of not having a complete picture.

[music].

Yeah, Steve Thanks for the thoughtful question no we don't expect.

The the pandemic to impact just just statistical powering or data collection ultimately.

So you know I I tried to state that in the prepared remarks, so well.

What's the impact here terrace, I want to be as clear as possible here, what's being impacted.

Dr. Joseph Kim: 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've published over 120 publications just in the last 10 years, all through the peer review process. So, you know, I am getting a little bit frustrated, too, that we're not moving as fast as we would during the peer review process. But, you know, I am very hopeful that we will be presenting our data in a peer-reviewed 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. Okay.

Yes, the collection and verification of the data.

And each of the sites and that can add 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 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 you know 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.

Dr. Joseph Kim: And then I guess just with respect to the reveal studies, you know, I think he talked about the level of, verified all the I guess, what's the level of confidence that, you know, the Existing powering, you know, based upon the number of data, is going to hold true here. And I guess the question has a little bit to do with any kind of disruption to the data collection process itself that might somehow. The Disco Plan or alter the way that the Disco Plan will work. Yeah, Steve, thanks for that thoughtful question.

Compared to our beginning of the year projection from this year. So I just want to reiterate.

There's a delay it sucks up 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 so but while were disappointed and missing our projection.

In terms of the timeline, we are not going to be a missing any of the the projected datasets or or or patient data. So and we're hopeful that we can finish this through the.

Dr. Joseph Kim: No, we don't expect the pandemic to impact statistical powering or data collection, ultimately. So, you know, I try to state that in the prepared remarks.

Pandemic.

Properly and the propylene appropriately and efficiently as possible.

Dr. Joseph Kim: What's the impact here? Here I want to be as clear as possible here. What's being impacted is the collection and verification of the data?

But this study remains blinded double blinded and we'll take every care to make sure that we can verify and provide the quality data or.

Dr. Joseph Kim: 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 the pandemic, we're not able to complete that process probably until the first half of next year. But we're very confident that we're not going to be losing any patient data, and you know that's why we're taking additional care and time So the bottom line is that the only thing that we're getting hit with is the delay of one or two quarters compared to our beginning of the year projection for this year. So I just want to reiterate. It is a delay. It sucks.

Dataset before we lock lock them down for Unblinding.

Got it and then just lastly, I know that there hasn't really been much said about revealed to.

Yes, a little while.

I guess when should we expect maybe to hear from you what the projected enrollment timelines are looking like.

I guess whether or not.

The ability to profile I think the guidance was.

20.

Two if I remember correctly, if if if if that's still on track.

Yeah, Steve I, well, what we have shared previously and wet weather concern now is consistent.

Reveal to certainly is going to be impacted by global pandemic, but.

But we're not yet in a position to clearly project.

How much of an impact of timeline, that's going to be but clearly it's.

It's been impacted more than reveal one but again, we have a very dedicated team at inovio and RCR partner since sites are working as best they can through this very difficult challenging times a pandemic. So we will project as soon.

Dr. Joseph Kim: [inaudible] In terms of the timeline, we are not going to be missing any of the projected data sets or patient data. And we're hopeful that we can finish this, during the pandemic, as properly, 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 and data set before we lock them down for unblinded. Got it.

Yes, Oh, we have some visibility of a claim to.

To have a clear picture.

On the timeline.

It's not today.

Understood Thanks for taking questions.

Great. Thank you Steve.

The next question comes from Aden signals from benchmark. Please go ahead.

Good afternoon I'm good.

Okay for the quarter and hi.

Joel and thanks for taking questions.

First question I have is [noise].

Dr. Joseph Kim: And then just lastly, I know that there hasn't really been anything to reveal in a little while. I guess when should we expect maybe to hear from you about 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, and two, if I remember correctly, if that's still, Yeah, Steve, what we have shared previously and what I can share now is consistent. Reveal 2 certainly is going to be impacted by a global pandemic, but we're not yet in a position to clearly project how much of an impact on the timeline it's 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 these very difficult, challenging times of the pandemic. So, we will project as soon as we have some visibility to have a clearer picture of the timeline, but it's not today.

Oh regarding the.

The acquired the reported 90% protection data so whatever protection data were going to get home or you know foreign country. Good thing. This is going to where you know where the month.

So let me see if I understood your question right.

Do we do we think the Pfizer data, we're weighing over the months or do we think inovios efficacy data when we do get to that stage could wane over them.

Yeah would be interesting to hear your thoughts on mobile Oh, yeah. So I mean, yeah.

You know because of the timing, we're going to see the impact on.

On duration or.

In pfizers data or more.

More quicker.

Then then Inovio stay the course, you know we we we we look for to to get him back on track.

Assuming the F.D.A. agrees with us and and we can start or a path to a phase two three trial.

But I I think that's why I think while today's data from Pfizer.

It's very exciting and very important and monumental additional time needs to be spent with pfizers data.

Aidan Usinov: Thanks for taking the question. Great, thank you. The next question comes from Aidan Usinov from Benchmark. Please go ahead. Good afternoon. Congratulations on the quarter. And hi, Joe.

And looking at the impact over post vaccination.

To that efficacy time point there are other interesting parts.

Dr. Joseph Kim: And thanks for taking questions. The first question I have is regarding the Pfizer reported 90% protection data. So whatever protection data we're going to get from INO4800, do you think this is going to wane over the month? 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? Yeah, we would be interested to hear your thoughts on both.

Both Pfizer and Madonna and easy 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 pause a comprehensive data package together.

Each group needs to do that both safety and efficacy.

And collectively EPS. The field you know we would get to two we are hopeful that we would have multiple vaccines, which will show strong enough efficacy and good enough safety overall, two to become a one or more of these arsenals.

Dr. Joseph Kim: You know, because of the timing, we're going to see the impact on duration in Pfizer's data more quickly, then Inovio's data. Of course, you know, we look forward to getting him back on track, assuming the FDA agrees with us, and we can start our path to phase two or three trials. But I think that's why I think 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 are what is the early and immediate efficacy level, and what is the duration of that protective effect.

Against this pandemic.

That concludes the Lucretia that and another question I have is the volatility is to create a trial design to core how long do you think the thief, who is going to love before you start the thesis that he wants the all the clinical partial clinical hold.

Yeah. Once the clinical hold is lifted we look for to starting the phase two portion what should be our dose confirmation phase right away. So we're already prepping the sites and preparing.

ER to to move you know as soon as the F.D.A. gives us a go ahead.

The phase two portion will take a couple of months.

And then there will be data analysis, and and and certainly final dose selection.

Dr. Joseph Kim: In addition, what is 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 the field, you know, we would get to, we're hopeful that we would have multiple vaccines that will show strong enough efficacy and good enough safety overall to become one or more of these arsenals against this pandemic. Thank you, Joe.

Between one and two milligrams and the move into the phase three so.

No. We we we want to get to the efficacy point as soon as possible, especially with Ah.

The todays early data from Pfizer It I think is.

No 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 to spend them.

Thank you, thank Andrew Lu and law, so like that on the I know you called alone. So it looks like we should expect that they don't know remember Quinn you what are your expectations about with an 18 month and <unk> could you also remind us sort of the standard or kill.

Dr. Joseph Kim: Um, another question I have is about the phase two, three trial design. So how long do you think the phase two is going to last before you start the phase three once the partial clinical hold is lifted? 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, you know, as soon as the FDA gives us the 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 phase 3.

With that 18 months.

Yeah, you know standard of care.

Is in methylated.

Patient population I believe is and Uh huh.

Let me.

I should know this by heart, but we it should be in the 40 to 50, 40% to 50% range in Unmethylated sicker population.

Oh S. 18.

I'm not a bit higher in the methylated population. So you know.

We do have O.S. 18 for both core day, and Unmethylated and core be Unmethylated population, which will be presented at sno.

Dr. Joseph Kim: 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 would really behoove all of us to move as rapidly as possible to see if we can all have similar levels of efficacy and provide the safety data which are required globally to help to fight this pandemic. Thank you. Thank you, Joseph. And the last one I get on the INO5401.

And a couple of weeks.

Over a week. So you know 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 the standard of care.

[laughter] standard of care.

Dr. Joseph Kim: So it looks like we should expect the date on November 20th. And what are your expectations about OAS at 18 months? And could you also remind us what the standard of care is for OAS at 18 months?

Media Ano S. Four unmethylated. This it is around 14 15 months and methylated is around 20 to 24 months. So.

Dr. Joseph Kim: Yeah, you know, the standard of care is methylated. The patient population, I believe, is in the, I should know this by heart, but we, it should be in the 40 to 50, you know, 40 to 50% range in the 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 the unmethylated population and cohort B in the methylated population, which will be presented at SNO in a couple weeks. We also have median overall survival, which also provides a more broad snapshot that we can compare to the standard of care. Stand of care.

You know these are the types of.

Survival data.

We will compare our phase one slashed too.

Trial data to at snow.

We will also present.

Some T cell responses in both cohorts.

Both the Ela spot sent flow two to the tumor antigens that we have.

[laughter] design and iron ore 54, one.

And.

Our goal is to eventually.

Helped to correlate between some of these biomarkers to clinical efficacy or overall survival.

Dr. Joseph Kim: Median and OS for unmethylated is around 14-15 months, and methylated is around 22-24 months. You know, these are the types of survival data that we will compare our phase 1 slash 2 trial data to at SNO. We will also present some T cell responses in both cohorts, both ELLISPOTS and FLOW to the tumor antigens that we have designed in INO5401. Our goal is to eventually help to correlate some of these biomarkers to clinical efficacy or overall survival. The correlation would not be provided at SNO, but that is additional work that will be done in the coming months and could be presented in 2021. Thank you. Thank you, Joe, for taking my question. Thanks, Aiden.

The correlation would not be provided at snow, but those are additional work that will be done in.

In the coming months and could be presented in 2021.

Thank you. Thank you Julie good thinking of accretion.

Thanks, David.

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

Hey, Thanks for taking the question just maybe a couple on 4800, it and I'm.

Joseph So 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 is a big advantage from a distribution standpoint with 4800, just would love. Your perspective is there a bar that you think you know, 90% obviously with Pfizer.

We haven't seen a lot more data behind it but that sets. The bar. There do you have a sense that given there's an easier distribution channel that you have a lower bar or whats your perspective on what.

Chris Raymond: The next question comes from Chris Raymond on Piper Sandler. Please go ahead. Hey, thanks for taking the question. 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 could 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 I just would love your perspective.

You know what success looks like I guess, I'm, giving a different distribution.

Distribution.

Hey, Chris Scott Great question. So it's it's a very complex answer so if I mean, if the 90% efficacy remained send a later time points and yeah I.

I mean, I don't believe Pfizer themselves are expecting that but if that's true as Tony South. She said the data of 90% efficacy would be extraordinary in animals of vaccine development in the last 100 plus years. That's that's tremendous so that's a very.

Dr. Joseph Kim: 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, you have a lower bar, or what's your perspective on what success looks like, I guess, given the differentiated distribution? Yeah, hi, Chris.

Okay, very very exciting bar for for efficacy.

Just remember the F.D.A. themselves set off a 50% efficacy bar above the placebo group right. So you know if if 90% continues I mean, there will be better than pretty much most of the other <unk>, you know new or a vaccine.

Dr. Joseph Kim: Great question! So it's a very complex answer. So, I mean, if the 90% efficacy remains at later time points and, you know, 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 the annals of vaccine development in the last 100 plus years, that's tremendous. So that's a very, very, very exciting bar for efficacy. Just remember, the FDA itself set off a 50% efficacy bar above the placebo group rate. So, you know, 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 would be a very exciting day to have. Is that going to happen?

Scenes in the last 20 years so.

So that will be a very exciting data to have is that going to happen.

My my feeling.

Yes, it's possible but.

We need to track that are and Pfizer will track down and report that and I'm sure. There will be part of the overall efficacy evaluation and also you know how long is that going to.

The the protective rate going to continue and the durability.

Of that efficacy response I mean these are questions that can only be answered with time.

With our I know 4800, a of course, you know where were we were designing our trial with the FDA Guidances in mind, just the way the.

ER Pfizer and other groups have and we will continue to to the fans said using I mean, the the Pfizer data has shown that this case driven efforts and the design, it's the right thing.

Dr. Joseph Kim: My feeling is that it is possible, but we need to track that, and Pfizer will track that and report it. And I'm sure that will be part of the overall efficacy evaluation. And also, you know, how long is that going to, the protective rate going to continue, and the durability of that efficacy response? I mean, these are questions that can only be answered with time.

The choice of Spike protein asked a vaccine target what's the right thing I mean, there's a lot of validation.

Of the vaccine development approach that's occurred today.

Thanks to Pfizer's passive 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.

Dr. Joseph Kim: With our INO4800, of course, you know, we're designing our trial with the FDA guidance in mind, just the way Pfizer and other groups have. And we will continue to advance it using, I mean, Pfizer data has shown that this case-driven effort 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 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. Oh, yeah, I guess, um... My question, though, was, do you think there's a bar that's lower for 4800?

[laughter], Yeah I guess.

My question, though was so do you think there's there's a bar it's lower 4800.

[music].

Yeah.

I don't necessarily think so but the.

A seat at the table or being a one of the useful weapons against this global pandemic Rick.

Requires.

Complex.

You know a management of these different attributes right efficacy is probably number one.

Right behind that is probably in the same level as the safety do you need a vaccine that can be safely deliver to billions of people over time.

Next is having enough supplies.

And having the logistics of distribution.

Uh huh.

In accordance right so.

Dr. Joseph Kim: Yes, I don't necessarily think so, but the, see it at the table or being one of the useful weapons against this global pandemic requires complex, you know, management of these different attributes, right? Efficacy is probably number one. Right behind that is probably at the same level as safety.

If you're trying to deliver a vaccine distribute that requires coal deep cold chain like minus 70, or minus 80 Celsius, you're not going to be able to do that and 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 vaccine so again I, you know, having a better thermal stability.

Dr. Joseph Kim: You need a vaccine that can be safely delivered to billions of people over time. Next is having enough supplies and the logistics of distribution. And we're hopeful that we can match Pfizer's efficacy rates, and we know our safety and tolerability profile could be better. And we know that thermostability is better.

Provides what sort of a lower bar in efficacy.

That's harder to answer and harder to measure, but our goal is to test our 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 tolerability profile could be better.

And we know that thermo stability is better so its matter of getting our.

Dr. Joseph Kim: So it's a matter of getting our trial on track and getting to the efficacy, safety data from a large phase 3 trial, and we look forward to doing. Okay, and maybe if I could just ask on Reveal, so I heard your comments about Reveal One, you know, sort of the situation deteriorating since, 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, you know, when you started seeing some of that deterioration, just in so we can juxtapose that, if you will, with, you know, when the, when the, you know, the virus started surging, was it, you know, right, you know, Right during the summertime, or was there some period since then that you started seeing it that made you make that call, or was it, you know, just kind of give us a sense between August and now when it became obvious?

Our trial on track it and getting to the efficacy and safety data from a large phase three trial.

And we look forward to doing that.

Okay, and then maybe if I could just ask on review so I heard.

I heard your comments about reveal one.

You know sort of the situation deteriorating since since last August can you, maybe give a little bit more color I guess I'm interested in this from the perspective of.

When you started to see some of that deterioration just into we can juxtapose that if you will with you know when the when the you know the virus started surging was it right you know.

Right during the summertime or was there some periods. 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 when it became obvious.

Yes, so and all of US we we knew what work needs to be done when you, which how many subjects for or coming to their third 36 month time frame, and and which sites and which patients are which subjects.

We're going to be a eligible for the data verification at certain points and you know this is a 60 site or 20 country studies. So it's a global trial. So you know our team N NRC Arrow felt that the all of the task could be done by the end of this.

Dr. Joseph Kim: Yes, so in August, we knew what work needed to be done. We knew how many subjects were coming in at their 36-month time frame and which sites and which patients or which subjects were going to be eligible for data verification at certain points. And, you know, this is a 60-site, 20-country study. It's a global trial.

Sure you know and I think we're almost correct in our projection even through the pandemic as I mentioned earlier, we're about 90% complete to endorse efforts, but this isn't you know grenades are water balloon you can just have close enough.

Dr. Joseph Kim: So, you know, 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 there. Unfortunately, the other 10% is going to slip into 2021. However, our teams are working diligently to minimize the delay as much as possible. But because the second wave of lockdowns is already occurring in Europe and elsewhere, and we would probably do so too in the US, it's harder to predict precisely when we will finish. But we are about 90% of the way there with Revio 1 already. So it's the final 10%. And, of course, this is a very important program for us. So we want to do it right the first time. Great, thank you. Yeah, thanks, Chris. The next question comes from Yi Chen from H.C. Wainwright.

To lock down the data.

In a well controlled a pivotal registrational phase three trial as you know so unfortunately, the the other 10% just gonna slip into a 2021 of course, our teams are working diligently to minimize the delay as much as Pos.

The ball, but because of the second wave of locked down Saar occurring already and in Europe and elsewhere.

And we would probably too in the U.S.

It's it's harder to predict precisely when we will finish but you know we are about 90% or the way. They are with we view a one off.

Already so is the final 10% and you know of course. This is a very important very important program.

For us so we want to do it right the first time.

Okay, great. Thank you.

Yeah. Thanks, Chris.

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

Yi Chen: Please go ahead. Thank you for taking my question. Joseph, would you say that with the resurgent COVID-19 new cases across the country, it would be relatively easy for you to complete the enrollment for the Phase 2-3 stage of the trial for INO4800? And also, have you so far disclosed how many patients will be enrolled for the Phase 2 stage? For 4800, the phase two portion will be a few hundred patients or volunteers, and it will be randomized into one milligram and two milligram doses in several age groups.

Thank you for taking my question.

[noise] Joseph would you say that with a resurging alright or would you say that was the resurgent cooling team you cases across the country that would be.

Relatively easy for.

For you to.

Completing enrollment for the phase twos three stage of the trial for him Oh I know.

<unk> point 800, and also have you spoke with disclosed how many patients will be broke what phase two stage.

Oh for 4800, the phase two portion that would be a a few hundred patients or volunteers.

And Ah it'll be randomized into one milligram and two milligram doses in several age groups.

Dr. Joseph Kim: And upon confirmation, we're planning to move into phase three efficacy case-driven trial design study. All in the U.S. And yeah, I mean, recruitment is one thing, but getting to positive cases in a blind fashion 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 future, months. You know, we were really looking forward to satisfying the FDA and getting to our planned phase 2-3 trial as soon as possible. Got it. And also, without a human challenge study, do you think the 90% efficacy of Pfizer-BioNTech's vaccine reflects the true, its true efficacy? Oh my!

And upon dose confirmation, we're planning to move into a phase three efficacy case, driven trial design study oh into U.S.

And yeah I mean, it's it is a 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.

Ah much so.

You know we were really looking forward to.

To satisfying the FDA and getting to our planned phase two three trial as soon as possible.

Got it and also without human Challenge study do you think the muddy percent up actually from Pfizer foreign tax about saying reflect the true it's true efficacy.

Oh.

Dr. Joseph Kim: Well, you know, I think Pfizer's Phase 3 trial is well-designed and being well-executed. I think the true efficacy will be time will tell once you get to the 160 plus cases and the efficacy rate is somewhere around, you know, anything above 50 percent but above placebo, but it could be as high as what they've seen earlier. [inaudible] Now you mentioned the human challenge. I mean, human challenge is... fraud with potential ethical issues, and I would say those sample sizes are going to be, I mean, unless you're going to challenge, you know, 164 people. Um, you know, I'm not a biostatistician, you know, putting aside the ethical issues. You know, I think having small human challenges is not going to be very reflective.

Well, you know I I guess.

You know Pfizers phase three trial is well designed and 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.

It's somewhere around you know anything above, 50%, but but above placebo, but it could be as high as what they've seen in earlier.

It will be a great news for Pfizer, but also great news for COVID-19 vaccine seal.

Now you mentioned about human challenge I mean, tuman challenges fraud, the with potential ethical issues and and I would say, though sample sizes are going to be male unless you're going to challenge you know 164 people.

You know I'm, not a biostage statistician, putting aside the ethical issues.

I think.

Having a small human challenge is just not going to be very reflective and there are only talk even the proponents are when you're talking about very young.

Dr. Joseph Kim: And they're only talking talk; even the proponents are only talking about very young participants, which, you know, is not very reflective of field use. So, you know, I think the large, randomized, well-controlled, well-executed trial is still superior, and Data Reflection is then a small challenge. Got it.

Participants, which you know is not very reflective of ER ER. The field use. So you know I think the large randomized well controlled.

Ah walks KIDNA trial is still superior.

In data reflection to and then a small challenge study.

Got it.

Dr. Joseph Kim: And my last question is, can we expect any additional animal challenge studies from 4,800 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 vaccines included in the operation? Yeah, so as we mentioned before, we have multiple non-human primary 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 Operation Warp Speed as part of their non-human primate challenge trial study. All of those are going well, in particular the Operation Warspeed monkey challenge studies.

Last question is can we expect any additional edible troubling studies from 4800 in the coming weeks or months and also when do you expect to have an update from operation walks warp speed regarding animal challenge study results for all the bad things included.

The operation.

Yes 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 a public health of England and the last one the third one through the operation Warp speed.

As part of their nonhuman Primate challenge or trials studies all of those are going well in particular to operation where speed Monkey Challenge studies I believe the challenge challenges have begun so they all have received vaccine.

Dr. Joseph Kim: I believe the challenges have begun. They all have received vaccines, and we expect the data when these government labs and contract labs complete the study. So I think these are all data that you should be expecting in the next several months. The next question comes from Jonathan Ascoff from Roth Capital Partners. Please go ahead.

Genes and 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.

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

Jonathan Ascoff: Thank you. Joe, if you were to lose those 10% of patients, what would the power change to for that 3100 Revio 1 trial? Um, you know, we don't know, but that's not something we wanted to do, uh, risk our multi-year or our most advanced global registrational phase three trial. So that's a risk that we didn't want to take, whether we want to work through the pandemic. And, you know, that's, 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 the first half of 21, which we don't expect. But there are uncertainties about the pandemic. You know, that's not something we would need to cross. So is it okay for you to evaluate them a few weeks later or, you know, what amount of time after their scheduled evaluation time is still acceptable? Is that flexible, or is it not?

Thank you Carol if you were to lose those 10 patients 10% of patients what would the power.

Change Q4 that 31 country that would be a one trial.

You.

You know.

We.

We don't know, but you know that that's not something we want to do.

To risk you know multiyear.

Our our most advanced global Registrational phase three trial.

So that's that's a risk that we didn't want to take.

Whether we want to work through the pandemic and you know that's that's a that's a theoretical concern that we weren't prepared to to cross a in fourth quarter 2020.

If we're seeing the pandemic.

Taking out the timeline to even further than first half of 21, which we don't expect.

Ah, but there are uncertainties depend them Act.

You know that's not that's not something we wouldn't need to cross.

So is it okay, you evaluate them a few weeks or you know what amount of time after their schedule devaluation time.

Still acceptable.

That flexible or is it now so I don't have that I think you have either I. We then communicate properly or you you have mistaken that are the patients or subjects are are coming in for.

Dr. Joseph Kim: Yeah, so I think you've either not communicated properly, or you have mistaken that the patients, or subjects are coming in for, for those data collection visits, are the follow-up and quality verification with site monitoring. [inaudible] 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 it.

For those data collection visits as the follow ups and quality verification besides monitoring.

That we have restrictions on so as far as I know, we haven't lost any time points or or simple points.

So those are not at risk.

It's just locking down had following the proper steps.

To lock down the data so that we can use.

Dr. Joseph Kim: The lab data to support the registration globally, but especially with the FDA, is 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.

The LAAP 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.

Dr. Joseph Kim: We plan to properly, Okay, thank you for clearing that up. A second question would be, if you imagined Inovio not going forward with the 4,800 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? What would you do with that?

Okay. Thank you for clearing that up a second question would be if you imagine inovio not.

Not going forward with the 4800 program with more cash than you've ever had on hand, really where would you you know most aggressively put that clinically would you more aggressively develop what you have would bring some things you given some thought to more aggressively into the clinic.

What would you do with that money.

Dr. Joseph Kim: That's a great question, you know, with a very strong platform and the pipeline that we have in phase two and phase three, we certainly have a lot of potential, uh... avenues for additional investment. As I mentioned earlier, for instance, our Phase 2 VIN, vulvar neoplasia, and anal neoplasia, AIN studies, we are reporting, and we remain projecting to report 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 in through licensure studies in 21 and beyond. Those are potentially high-value-added programs for extending VGX 3100's coverage and label to two additional orphans. Designation, Indication, so on. That's just one example.

That's a great question, you know with a very strong platform.

And the pipeline that we have in phase two and phase three we certainly have a lot of potential.

Avenues for additional investment.

As I mentioned earlier for instance, our face to vent and evolve our neoplasia and and on the neoplasia.

Aid study so we we're reporting.

We remain.

Projecting to report the full set of phase two data by the end of this year.

Assuming there.

I live in an exciting s., we have shown.

In the spring from interim data are those two are two orphan indications that we'll look for to investing into through licensure studies in 21 and beyond.

You know those are very potentially high value added programs and extending VGX 31, hundreds or coverage and label to two additional orphan.

[noise] designation indication so.

That's just one example, our a pea is one area in a high unmet urgent medical need.

Dr. Joseph Kim: RRP is one area, you know, with high unmet urgent medical need, non-curable tumors that continue to grow. And the current treatment is only surgical resection, which temporarily provides relief. RRP is an area that we are investing in because we feel that's a significant medical and commercial value area. Certainly, we spoke about our later-stage programs in GBM and cervical dysplasia. So these are all potential high-value additional areas that we are already investing in.

Noncomparable tumors that continues to grow and the current treatment is only surgical resection, which temporarily provides relief yeah.

It's an area that are that we are investing into because we feel that's a significant medical and.

And commercial value areas.

Certainly we spoke about our later stage programs in GBM and cervical dysplasia. So these are all a potential.

Hi value or addition, or areas that we are already investing into.

Dr. Joseph Kim: And this is the work, very heavy and diligent work that Inovio is devoting right now, in addition to what we are doing with our COVID-19 vaccine. Thanks for that, Joe. And lastly, a really fast one.

And these are the ER work, a very heavy and diligent work that Inovios team is devoting right now I mean in addition to what we're doing with our Cove in 19 vaccine development.

Okay. Thanks for that Joe and lastly, a really fast one of them Astrazeneca has not said anything about their cancer programs.

Dr. Joseph Kim: AstraZeneca has not said anything about their cancer program that they're doing with your technology, correct? I remember reading August, which was a timeframe that they may have been able to say something, but nothing, nothing from them. Is that correct? 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 Medi-0457 plus their Devalimab PD-L1 checkpoint inhibitor.

They're dealing with your technology correct I remember reading August August was a timeframe that they maybe have been able to say something but nothing nothing from them is that correct.

Well there was a presentation at ESMO in September.

That showed the interim overall response rate in head and neck cancer.

He is also conducting several ISS studies and cervical and other HPV caused cancers with many 0457 plus their development PDL one checkpoint inhibitor. So you know that's the license program and that will continue to drive.

Dr. Joseph Kim: So you know, that's a licensed program, and they will continue to drive that program, and they will be presenting, publishing, and reporting data as they advance that licensed program from Inovio. Thank you very much, Joe. Great, thanks. 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. Thank you everyone for listening to our 3Q financial and program updates. We look forward to sharing additional progress in the coming weeks and months. Thank you very much. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

That program and there will be presenting and publishing and reporting data as a.

Events that the license program from Inovio.

Thank you very much Joe.

Great. Thanks.

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.

Thank you everyone for listening to our three to a financial and program updates we look forward to sharing.

Additional progress in the coming weeks and coming months. Thank you very much.

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

[noise].