Q2 2020 Inovio Pharmaceuticals Inc Earnings Call

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Operator: Good day, and welcome to the Inovio second quarter 2020 financial results conference call. All participants will be in listen-only mode.

Good day and welcome to the <unk> second quarter 2020 financial results Conference call. All participants will be in listen only mode should you need to think please ignore coffee, especially if the person that dorky followed by Europe.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch-tone phone. To withdraw your question, please press star then two.

After today's presentation, there will be an opportunity draft question to ask your question you know Prairie dogs and one on your question, but withdraw your question. Please press Star then Chu. Please note. This event is being recorded I would now like to during the conference ever to Bend much senior director of Investor Relations. Please go ahead.

Operator: Please note this event is being recorded. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead.

Thank you operator good afternoon. Thank you for joined the you know the a second quarter 2020 earnings conference call. Joining us today are dR.J., Joseph Kim President and CEO Dr. keep Roderick Senior Vice President of research and development and project lead for Inovios infectious disease program.

Ben Matone: Thank you, operator. Good afternoon, and thank you for joining the Inovio second quarter 2020 earnings conference call. Joining us today are Dr. J. Joseph Kim, President and CEO; Dr. Kate Broderick, Senior Vice President of Research and Development, and Project Lead for Inovio's Infectious Disease Program.

Ben Matone: Dr. Jackie Shea, Inovio's Chief Operating Officer, and the company's Chief Financial Officer, Peter Kies. On today's call, we will review our corporate and financial information for the second quarter of 2020, ended June 30th, 2020, as well as provide an update on our clinical program progress, which includes the accelerated development of our COVID-19 vaccine program. This call is being webcast live on our website, ir.inovio.com, and a replay will be made available.

Dr. Jackie shape, and nobody is chief operating officer, and the company's Chief Financial Officer, Peter Keith.

For today's call, we will review, our corporate and financial information for the second quarter 2020 ended June Thirtyth 2020, as well as provide an update on our clinical programs progress, which includes the accelerated development for our coded 19 vaccine program.

This call is being webcast live on our website IR got Inovio dotcom and a replay will be made available.

Ben Matone: Following prepared remarks, we will be conducting a question and answer segment reserved for equity research analysts. Additionally, during the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans 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.

Following prepared remarks, we will be conducting a question and answer segment reserve for equity research analysts.

During the course of this conference call, we will be making forward looking statements regarding future events and the future performance of the company.

These events relate to our business plans to develop Inovios integrated platform of DNA medicines, which include clinical and regulatory developments and timing of clinical data read outs, along with capital resources and strategic matters as well as the impact of the Kogan 19 pandemic on Inovios business operations.

Ben Matone: All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks, and uncertainties, and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Investors should read carefully the risks and uncertainties described in today's press release, as well as the risk factors included in today's 10-Q filing with the SEC. With that said, I would now like to turn the call over to Joseph.

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

These statements involve certain assumptions risks and uncertainties and could cause actual results could differ materially.

We assume no obligation to revise or update forward looking statements, but there 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 FCC with that I would now like to turn the call over to Joseph.

Thank you Ben and thanks, everyone for joining the call today.

Joseph Kim: Thank you, Ben, and thanks, everyone, for joining the call today. We began this year stating that we were entering a new era for DNA medicine. This was before COVID-19 became the most urgent public health crisis the world has seen in a century. We are very proud of our accomplishments to date in addressing this growing pandemic and the evolving nature of SARS-CoV-2, the virus that causes COVID-19. The challenges of this still relatively unknown virus cannot be understated. We understand the importance of continuing to develop our scientific and medical understanding of the virus and its effects, and having multiple approaches to defeat it remains paramount. Inovio has led the field in demonstrating how optimized DNA plasmids can be rapidly developed and delivered into cells using the Selectra smart device, which overcomes historical obstacles in effectively delivering DNA medicines and producing safe and robust immune responses.

We began this share stating that we were entering a new era for DNA medicines.

This was before covert 19 became the most urgent public health crisis. The whirl has seen in a century.

We're very proud of our accomplishments to date.

In addressing this growing pandemic.

And evolving nature of service called me to the virus that causes coven 19.

The challenges of this still relatively unknown virus cannot be under understated.

We understand the importance of a continuing to develop our scientific and medical understanding of the virus and that's affects.

And having multiple approaches to defeat it remains paramount.

Over the last decade.

Oh view has led the field and demonstrating how optimize the any plaza minutes can be rapidly develop and deliver into cells using to select trust smart device that overcomes historical obstacles and effectively delivering DNA medicines and producing so.

Safe and robust immune responses.

Our goal is to generate data that challenges to status quo and focus is on the efficacy durability versatility and safety of our DNA medicines.

Joseph Kim: Our goal is to generate data that challenges the status quo and focuses on the efficacy, durability, versatility, and safety of our DNA medicine, all of which are critical when confronted with a novel virus. We are delivering on that goal, and I am very proud of our COVID-19 DNA vaccine development team, which is led by Dr. Kate Broderick. She will be sharing with you shortly the amazing work completed this quarter with our COVID-19 DNA vaccine, INO4800. And I once again want to thank Kate and her and our entire Inovio team for their tireless and extraordinary effort in combating this great threat.

All of which are critical when confronted with a novel virus.

We are delivering on that goal and I'm very proud of our covert 19, DNA vaccine development team, which is led by Dr. Kase Broderick.

She will be sharing with you shortly the amazing work completed this quarter with our Kobin 19, DNA vaccine I know 4800.

And I once again, when the thanks, Kate and her <unk> and our entire Inovio team for their tireless an extraordinary efforts to combat this great threat.

Joseph Kim: Through these efforts, our INO4800 Phase I clinical results, which are now undergoing peer review for publication in a top medical journal, have demonstrated robust immunogenicity, including neutralizing antibodies and T-cell responses, both CD8 and CD4 T-cell responses, and a uniquely favorable safety profile that supports the foundation of promising responses we have seen in more than 2,000 patients and over 7,000 applications of our DNA medicines with our Selectra delivery devices. Inovio has also set the standard with INO4800 for durability of a protective response in a non-human primate animal challenge study at four months post vaccination, and it has shown balanced antibody anti-cell immunogenicity against the emergent dominant strain of the virus known as G614. To our knowledge, we are the first to report generation of neutralizing antibody against this mutated strain of the coronavirus by vaccinating non-human primates. This data was published as a preprint on bioRxiv and is currently under review in a peer-reviewed journal.

Through these efforts are I know 4800 phase one clinical results, which is now under going to review for publication at a top medical journal have demonstrated robust immunogenicity, including neutralizing antibodies and T cell responses.

Both C D a and C D for.

T cell responses.

And they uniquely favorable safety profile that supports the foundation of promising responses, we have seen in more than 2000 patients and over 7000 application of our DNA medicines with our selectra delivery devices.

Inovio has also set the standard with I know 4800 for durability of a protective response in a non human primate animal challenge study at four months post vaccination and has shown balance and the body and T cell.

Oh immunogenicity against the emerging dominant strain of the virus known S.G. six one for Tom.

So our knowledge, where the first to report generation of neutralizing antibody against this mutate a strain of the corn the virus by Vaccinating non human primates.

This data is published as a pre print on bio archive and is currently under review at a pair of at a peer reviewed journal.

Joseph Kim: We look forward to publishing our additional animal challenge studies, as well as being a part of Operation Warp Speed's non-human primate animal challenge study. We have also made significant strides in expanding our global coalition to manufacture large-scale quantities of INO4800 and smart devices to deliver them. I look forward to having our Chief Operating Officer, Dr. Jackie Shea, provide you with our latest manufacturing updates. Additionally, I want to thank our partners and growing global manufacturing coalition, which includes Richter Helm Biologics in Germany, other large-scale European manufacturers, and Ology Bioservices and other large-scale manufacturers here in the U.S. I also want to thank our current funders, including the U.S. Department of Defense, CEPI, and the Bill and Melinda Gates Foundation, for this report.

I look forward to publishing our additional animal challenge studies as well as being a part of operation wharf speeds non human Primate animal Challenge study.

We also have made significant strides in expanding our global coalition to manufacture large scale quantities of I know 4800, and smart devices to deliver done.

I look forward to having our chief operating officer Dr., Jackie Shay provide you with our latest manufacturing update.

I want it I want to thank our partners and growing global manufacturing coalition, which includes Richter Hound biologics in Germany.

Third large scale European manufacturers and all the GE bio services and other large scale manufacturers here in the U.S.

I also want to thank our current funders, including the U.S. Department of Defense Seppi, and the Bill and Melinda Gates Foundation.

With this support.

Joseph Kim: We look forward to advancing INO4800 into a Phase 2-3 trial in September and meeting our target to provide at least 1 million doses of our DNA vaccine this year and 100 million doses in 2021. And while this past quarter has been dominated by COVID-19 news, our team continues to drive forward our overall DNA medicines pipeline with important milestones that support our goal to produce data that challenge the status quo and focuses on the safety, efficacy, durability, and versatility of our DNA medicine. As a quick recap, over the quarter, we accomplished the following.

We look forward to advancing I know 4800 into a phase two slash three trial in September and meeting our target to provide at least 1 million doses of our DNA vaccine this year.

And hundred million doses in 2021.

And while this past quarter has been dominated by Coven 19 news our team continues to drive Ford our overall DNA medicines pipeline with important milestones that support our goal to produce data to challenge the status quo and focuses on the safety.

The efficacy durability and versatility of our DNA medicines.

As a quick quick recap over the quarter, we accomplish the following first.

Joseph Kim: First... We presented positive interim data from our Phase 1-2A trial for our Middle East Respiratory Syndrome DNA Vaccine INO4700 at ASGCT and are moving forward with our Phase 2 trial in the Middle East. We are the first company with a phase two vaccine for the coronavirus that causes MERS, which is in the same family of viruses as the coronavirus that causes COVID-19.

We presented at.

Positive interim data from our phase ones last two way trial for our middle East respiratory syndrome, DNA vaccine I know 4700.

At A.S.G. see tea and are moving forward with our phase two trial in the Middle East. We are the first company with phase two vaccine for the core under virus that causes merce, which isn't the same family of viruses as the core in the virus that causes coven 19.

Second.

Joseph Kim: We presented positive 12-month overall survival data at ASCO, demonstrating an 85% survival rate for our DNA immunotherapy INO5401, for the devastating and difficult-to-treat glioblastoma. We look forward to the fourth quarter, where we will be evaluating and providing at an oncology conference overall survival at 18 months, which is the primary efficacy endpoint for the 52-patient phase 2 trial. Third, we reported positive interim phase two results for VGX 3100 against HPV-related precancerous anal and bulbar dysplasias, and we remain on track to report top line phase three pivotal efficacy data for VGX 3100 against HPV-related precancerous cervical dysplasia from reveal one in the fourth quarter of this year. Fourth, for Reveal 2, as we mentioned during our last earnings conference call in May, patient recruitment took a hit as a result of the global pandemic since the first quarter. However, our team continues to work relentlessly on getting us back on track to pre-pandemic enrollment rates in a safe manner. And I am confident that we will be in a position to build off of positive Reveal 1 data this year.

We presented we presented positive 12 months overall survival data at ASCO, demonstrating an 85% survival rate for our <unk> DNA immunotherapy I know 54, one for the devastating and difficult to treat Cleo blast.

Hi, My Multiforme.

We look forward to the fourth quarter, where we will be evaluating and providing at an oncology conference overall survival at 18 months, which is the primary efficacy endpoint for the 52 patients phase two trial.

Third we.

We reported.

Positive interim phase two results for VGX 3100 against HPV related pre cancerous animal Envolve, our dysplasia us.

And remain we remain on track to report topline phase three pivotal efficacy data for VGX 3100 against HPV related pre cancerous cervical dysplasia from reveal one in the fourth quarter of this year.

Fourth for reveal too as we mentioned during our last earnings conference call in May patient recruitment took a hit as a result of global pandemic since the first quarter.

Our team continues to work relentlessly.

On getting us back on track to pre pandemic enrollment rate in a safe manner and I'm confident that we won't be in a position to build off of a positive reveal one data this year.

Fifth we're also excited with the progress across our HPV programs, particularly for I know 31 of seven.

Joseph Kim: We're also excited with the progress across our HPV programs, particularly for INO3107, which recently received an orphan drug designation from the FDA to treat the rare, debilitating, and potentially fatal condition called recurrent respiratory papillomatosis, or RRP. We're currently conducting an open-label, multi-center Phase 1-2 trial of INO3107 in the U.S. As we mentioned during previous calls regarding RRP, these patients typically undergo multiple surgeries a year and literally plan their lives around scheduling their surgery. As such, given the disease characteristics and the tight-knit community where patients are treated, we believe enrollment will be relatively swift, and we anticipate interim readouts by next year. We also expect to apply for regulatory approval to commence a trial to evaluate INO3107 in pediatric patients after we have had a chance to evaluate data from the current study.

Which recently received an orphan drug designation from the 58 to treat the rare debilitating and potentially fatal condition call recurrent respiratory petaluma ptosis or our P.

<unk> currently conducting an open label multi center phase one slashed two trial.

Oh, I know 31 or seven in the U.S.

As we mentioned drink previous calls regarding RP. These patients typically undergo multiple surgery as a year and literally plan their lives surround scheduling theres surgeries.

As such given the disease characteristics and tight knit community where patients are treated we believe enrollment will be relatively swift and anticipate interim readout by next year.

We also expect to apply for regulatory approval to commence a trial to evaluate I know 31, though seven in pediatric patients. After we had a chance to evaluate data from the current study.

Joseph Kim: Broadening the outreach towards pediatrics will not only build on the overall value of INO3107 but also provide a viable therapeutic option for these patients who suffer from this rare disease and lifelong surgeries. As this is an open-label trial, we're hoping to have data to share with you in the second half of next year. Now I'd like to turn the call over to our SVP of R&D, Dr. Kate Broderick, who will provide an update on our COVID-19 program.

Broadening the outreach towards pediatrics will not only build on the value overall value of <unk> I know 31, or seven but also provide a viable therapeutic option for these patients who suffer from this rare disease and lifelong surgeries.

As this is an open label trial, we're hoping to have the data shit to share with you.

In the second half of next year.

Now I'd like to turn the call over to our SVP of R&D.

Dr. Cape Roger who will provide an update on our coven 19 program Kate.

Thank you guilt and good afternoon, everyone.

Hi, lock spoke cookies computing Army earnings call, we accomplished a huge it might in the fight to date Scoop It 19 disease.

Kate Broderick: Thank you, Joseph, and good afternoon, everyone. Since I last spoke with you during our May earnings call, we have accomplished a huge amount in the fight against COVID-19 disease. As Joseph stated, the key to combating COVID-19 is to continue to build on our understanding of the virus and the disease and have multiple approaches to defeat it. We are very encouraged by the immune responses of our DNA vaccine candidate, INO4800. And we look forward to beginning our planned Phase 2-3 trials in September upon FDA concurrence. So first, let me begin with where we are as of today.

I was just a stated the key come back and Qubic 19, if the continued to build on our understanding of divide it sounded to me I have multiple approaches to <unk>.

We're very encouraged by the immune responses on part D. Any vaccine candidate I in all 400.

We look forward to beginning our planned phase two trials <unk> 10 Bucks a point if he can cut.

So first let me begin where we are also could be.

Our money it's good for the initial 40 subjects phase one trial in the USA, which is comprised of we eat safety and Immunogenicity and now.

He is undergoing peer reviewed pull say at the top medical journal.

[noise] T.D. and how cool the program that have been no safety concern us card they eat a safety monitoring board with no tedious adverse events reported.

Kate Broderick: Our manuscript for the initial 40-subject Phase 1 trial in the U.S., which is comprised of Week 8 safety and immunogenicity analysis, is undergoing the peer review process at a top medical journal. To date, in our COVID program, there have been no safety concerns as per the Data Safety Monitoring Board, with no serious adverse events reported and only a few mild transient adverse events primarily related to injection site reactions such as redness. So just to emphasize that one more time, all six related AEs were grade one, the lowest level, in severity, and this profile compares superbly relative to currently marketed commercial vaccines and also other candidate vaccines being developed for COVID-19. The data set includes a clinical immunology package, analyzing binding antibodies, live virus neutralization results, and T-cell responses using both ELLISPOT assays and flow cytometry.

Only a few mild probably an adverse event by not only really to injection site reactions such as Radnet.

So just to emphasize that one more tight oh six related he wouldn't read one the lowest level into bad if he and this profile compare superbly relative to cutting Lee marketed commercial vaccine I know some other conduit boxing being developed for cool that 19.

The decrease it includes the clinical and you know the Ti package on the lighting binding antibody like apply to neutralize each in result, he sale responses using both eligible assay and flow cytometry.

Unfortunately, quite I'm, probably not at Liberty to discuss the details of all these studies and killed it be published I can report that all participants in the trial showed strong antibodies and or strong T cell immune responses.

In terms of the Hubert will immune responses, 95% of the participate persistence pen fetal, Connecticut, and that's defined as those participant to respond with either neutralizing and or finding antibody after two doses.

Kate Broderick: Unfortunately, while I'm currently not at liberty to discuss the details of all these studies until they've been published, I can report that all participants in the trial showed strong antibodies and or strong T cell immune responses. In terms of the humoral immune responses, 95% of the participants seroconverted, and that's defined as those participants who respond with either neutralizing and or binding antibodies after two doses.

In addition, almost 90% of Mckinney could participate generated strong T cell responses.

Interestingly, it's typically significant increases in both TV I see the 40 sales when looked at post vaccination.

[noise] T cell responses were higher in magnitude that convalescent samples tested almost similar or green car responses to those previously the poor kit for other cool that can do that.

[noise] Federal you recent studies have revealed a large proportion of the population might because they can sales that could help recognized sars could be two despite never actually having and kind of took the flight as before.

Kate Broderick: In addition, almost 90% of vaccinated participants generated strong T cell responses. Interestingly, statistically significant increases in both CD8 and CD4 T cells were noted post-vaccination. T-cell responses were higher in magnitude than convalescent samples tested and were similar or greater responses to those previously reported for other COVID candidates. Several new recent studies have revealed that a large proportion of the population might possess T-cells that could help recognize SARS-CoV-2, despite them never actually having encountered the virus before. These T-cells are much more likely generated from previous infections with related coronaviruses, including four viruses that frequently cause the common cold.

These sales are much more likely January could from previous infections with Italy could can luna viruses, including four by the 'cause it frequently cause Coleman cool.

Many experts believe that the so called cross reactive T cells may make the coupon 19 busy my older.

Perhaps partly explains why sought some people are oh, you out in fact could become basic well others can be asymptomatic.

Leading infectious disease and you know what you believe that back in January Pip specific T cell responses could even be even more helpful. Then these not certainly established cross reactive T cells and let me take the severity of cool that disease.

Therefore, developing Cooper 19 vaccine, which could generate strong T cell responses as well as of course neutralizing antibody responses could ultimately right because they become more efficacious executable vaccine against cool hit 90.

Kate Broderick: Many experts believe that these so-called cross-reactive T-cells may make the COVID-19 disease milder and perhaps partly explain why some people who are infected become very sick, while others can be asymptomatic. Leading infectious disease immunologists believe that vaccine-generated specific T-cell responses could be even more helpful than these naturally established cross-reactive T-cells in limiting the severity of COVID disease. Therefore, developing COVID-19 vaccines that could generate strong T-cell responses, as well as, of course, neutralizing antibody responses, could ultimately represent better and more efficacious and durable vaccines against COVID-19. As such, our promising clinical data demonstrate that INO4800 is a COVID-19 vaccine candidate with a unique and highly favorable safety profile that produces well-balanced immune responses consisting of both neutralizing antibodies and T-cell

I thought cap promising clinical data demonstrate I know 1400 is a cool that 19 vaccine candidate with a unique highly favorable safety profile, which produces well balance immune responses consisting of both neutralizing antibodies and T cells.

In addition, the clinical data also suggests I truly believe Stifel Immunogenicity profile with no I'm keep it could immunity as expected.

Our phase one.

Human data built upon our recent non human Primate animal Challenge study, which is currently the closest thing that we have to testing I boxing day efficacy when can from taking a line item.

As juices mentioned, we were very encouraged with the utilization of protection. The I know 4800 demonstrate good at wells Little Boston use sports across the antibodies and the T cells metro like they impressive clinical data.

He gets the more context, our challenge study is more stringent them, while others have generated to date as it was performed over three months couldn't Alaska vaccination north at the peak of their acute immune responses that one to four weeks post last dogs.

I thought Chuck Challenge study addresses protection from memory immune responses I know from high levels. The circulating on people wouldn't pay isn't getting the acute post vaccination fee.

Kate Broderick: In addition, the clinical data also suggests a fully boostable immunogenicity profile with no anti-vector immunity, as expected. Our phase one human data builds upon our recent non-human primate animal challenge study, which is currently the closest thing that we have to testing a vaccine's efficacy when confronting a live virus. As Joseph mentioned, we were very encouraged by the duration of protection that INO4800 demonstrated, as well as the robust immune response across the antibodies in the T-cells, mirroring the impressive clinical data. To give some more context, our challenge study was more stringent than what others have generated to date, as it was performed over three months from the last vaccination and not at the peak of their acute immune responses at one to four weeks post the last dose.

We also lets say if they ability obi into Fourq <unk> hundred can generate neutralizing antibodies against the newly emerging Vida Street. She 614.

Which is critical to in shooting the our research keeps pace with the virus as it evolves.

And I want to emphasize here, but no antibody in her disease event, we reported supporting our favorable safety profile.

We look forward to reassess <unk> combine all four hundreds jude ability to respond to 12 month type with our other ongoing non human primate animal Challenge study.

We also pleased to be participating in operation warp speed non human primate animal challenge.

Finally, we had excited the odd expanded U.S. phase one trial is fully enrolled and older subjects and proceeding as planned.

Kate Broderick: As such, our challenge study addresses protection from memory immune responses and not from high levels of circulating antibodies present during the acute post-vaccination phase. We also assess the ability of INO4800 to generate neutralizing antibodies against the newly emerged virus strain G614, which is critical to ensuring that our research keeps pace with the virus as it evolves. And I want to emphasize here that no antibody-enhanced disease events were reported, supporting our favorable safety profile.

The our phase one two trials in South Korea, and China has begun.

We look forward to providing data updates on these trials in the fourth quarter and now I'd like to hand, it back over to you. So thank you.

Thank you Kate Great summary.

Now I'll turn over to our COO Dr. Jackie shape for a manufacturing update.

I'm curious if and good afternoon everyone.

First I'd like to take a moment to recap and highlights the unique advantage just about DNA vaccines platform specific to how quickly DNA medicines can be design to manufacture it as well is the stability if the products.

Kate Broderick: We look forward to reassessing the impact of INO4800's durability in response at 12 months out with our other ongoing non-human primate animal challenge study. And we're also pleased to be participating in Operation Warp Speed's non-human primate animal challenge. Finally, we are excited that our expanded U.S. Phase 1 trial is fully enrolled in older subjects and proceeding as planned, and that our Phase 1-2 trials in South Korea and China have begun. We look forward to providing data updates on these trials in the fourth quarter. Thank you.

It should both critical aspects knit dressing it global pandemic.

In terms of rapid and scalable manufacturing Ah DNA vaccine development is achieved fire a fully scalable manufacturing process, which are well established.

That cost effective to manufacture and to produce and large quantities.

That's very important need DNA medicines, or let's say very easily characterized from a manufacturing perspective much more so than many other biologic products and this facilitates production through multiple manufacturers.

As Josef mentioned, we have an established plan in place the manufacturing at least 1 million well make doses of <unk> 4800 this year.

On the targets of 100 million doses by 2021.

We're also working on further expanding our manufacturing consortium.

Joseph Kim: Thank you, Kate. Great summary. Now I'll turn over to our COO, Dr. Jackie Shea, for a manufacturing update.

In terms of stability and they 4800 does not require frozen ship, you know storage, meaning no minus 20 on minus 80 freezes that required.

Jacqueline E. Shea: Thank you, Joseph, and good afternoon, everyone. First, I'd like to take a moment to recap and highlight the unique advantages of our DNA vaccine platform, specific to how quickly DNA medicines can be designed and manufactured, as well as the stability of the product, which are both critical aspects in addressing a global pandemic. In terms of rapid and scalable manufacturing, our DNA vaccine development is achieved via a fully scalable manufacturing process that is well established. They are cost-effective to manufacture and to produce in large quantities. And very importantly, DNA medicines are also very easily characterized from a manufacturing perspective, much more so than many other biologic products, and this facilitates production through multiple manufacturers. As Joseph mentioned, we have an established plan in place for manufacturing at least 1,000,000 Momic doses of Inno4800 this year and a target of 100,000,000 doses by 2021. We are also working on further expanding our manufacturing consortium. In terms of stability, NO4800 does not require frozen shipping or storage, meaning no minus 20 or minus 80 freezes are required.

Our vaccine a staple for here at room temperature all for two months at 37 degrees C and has a five year projected shelf life when refrigerated.

The formulation converts of optimized stand a plasmids Walter consult with no less than in past calls or add shipments required.

Nothing to eating to not any better stability, if the vaccine, but also better tolerability when administered.

This stability is a unique an important differentiating pack to the positions in a 4800 very favorably when considering the logistics of addressing global vaccination needs during a pandemic.

Well say was as Josef mentioned NFI I made significant strides and expanding our global coalition of collaborative partners manufacturing some fundus to wrap at the end phones manufactured large scale quantities upping their 4800 to meet the demands of the spends on it.

So to give you some scale up highlights.

At the end to quote to one the department of Defense Award is only cheap bias surfaces, and 11.9 million contract to work with an IPO to manufacture in a 4800 for video day for clinical trials.

In quarter two we also expanded on manufacturing partnership with Rick to home Biologics in Germany, partially funded through the coalition for epidemic preparedness innovations well sappy.

We are also in the process of finalizing additional manufacturing partnerships and the U.S. and in Europe to fulfill all vaccine candidate production goals of 1 million day. Since this yeah 100 million next I'm plans to make announcements about expanding console team over the next few months.

In addition, we are you click uniquely positioned with us selectra smart devices that to live fraud, DNA vaccines interest among the into the cells overcoming a keen imitation about the DNA and nothing nucleic acid approaches.

Jacqueline E. Shea: Our vaccine is stable for a year at room temperature or for two months at 37 degrees C and has a five-year projected shelf life when refrigerated. The formulation consists of optimized DNA plasmids, water, and salt, with no lipid nanoparticles or adjuvants required, further leading to not only better stability of the vaccine but also better tolerability when administered. This stability is a unique and important differentiating factor that positions INO4800 very favorably when considering the logistics of addressing global vaccination needs during a pandemic. Also, as Joseph mentioned, Inovio made significant strides in expanding our global coalition of collaborators, partners, manufacturers, and funders to rapidly advance and manufacture large-scale quantities of Inovio 4800 to meet the demands of this pandemic. So I'll give you some scale-up highlights.

So like two or three P.S.P.S. on next generation smart device that for just the efficacy and safety track record of an earlier question at the device quotes that extra 2000 that has received the CE Mark certification and has been used in clinical trials to safety provides more than 7000 administration.

I was hoping if he has DNA medicines.

The three P.S.P. has a small footprint. It's some of this the size some in electric toothbrush and its possible handheld battery powered to rechargeable and very user friendly with excellent patients who clinician feedback.

Additionally, it's multi use and able to administer up to 5000 doses per device.

Very importantly, the delivery process fraud, DNA medicines using this electrode spice, it's competing less than 20 seconds and has been describe why patients component is now trials, that's more tolerable understand these shops.

I'm pleased to report that's in late June we received 71 million in funding from the U.S. Department of defense to scale up manufacturing Abbas like true three P.S.P. smart twice and foot Kim insist that extra 2000 devices for clinical use.

Jacqueline E. Shea: At the end of quarter one, the Department of Defense awarded Ology Bioservices an $11.9 million contract to work with Inovio to manufacture Ino4800 for the DoD for clinical trials. In quarter two, we also expanded our manufacturing partnership with Richter Helm Biologics in Germany, partially funded through the Coalition for Epidemic Preparedness Innovations, or CEPI. We are also in the process of finalizing additional manufacturing partnerships in the U.S. and in Europe to fulfill our vaccine candidate production goals of one million doses this year and 100 million next, and we plan to make announcements about the expanded consortium over the next few months.

Both devices they used to that if a in a 4800 directly into the skin.

The de contract builds upon to price separate 5 million grants or the eight this year from the Bill and Melinda Gates Foundation I'm from Seppi to accelerate testing if this lecture three P.S.P. device.

We are extremely grateful for the D. these commitments and it speaks to the confidence that's a major U.S. kept them intensity season, the body with all smart device and the potential roll up in a 4800 in combating infectious disease pandemic, such as 'cause it 19.

Finally, I'd like to reiterate talk gratitude to all of our partners collaborators manufacturing partners. Some funds is once again and look forward to sharing continued updates as we scale up in a 4800 production.

Now I'll hand back to Joseph.

Thank you Jackie.

Jacqueline E. Shea: In addition, we are uniquely positioned with our Selectra smart devices that deliver our DNA vaccines intradermally into the cells, overcoming a key limitation of other DNA and other nucleic acid approaches. Selectra 3 PSP is our next-generation smart device that leverages the efficacy and safety track record of an earlier version of the device called Selectra 2000 that has received the CE mark certification and has been used in clinical trials to safely provide more than 7,000 administrations of Inovio's DNA medicines. The 3PSP has a small footprint; it's similar to the size of an electric toothbrush, and it's portable, handheld, battery-powered or rechargeable, and very user-friendly, with excellent patient and clinician feedback. Additionally, it's multi-use and able to administer up to 5,000 doses per device.

For the update and for your teams outstanding work.

Our CFO Peter Keys joins US now for a review of second quarter financial results.

Results I have to add include almost $400 million in cash reserves theater.

Thanks, Joe So [noise].

Total revenue was 267000 for the three months ended June Thirtyth 2020, compared to 136000 for the same period and 2019.

While operating expenses were 33.4 million compared to 28 point Threemillion for the same period and 29 team.

Inovios net loss for the quarter was 128.2 million or 83 cents per share basic and diluted compared to 29.4 million or 30 cents per share basic and diluted for the same period and 29 team.

It is important to understand that the increase in net loss for the quarter.

Was primarily due to the change in fair value.

Have they deliver got derivative liability related to.

The embedded conversion feature in our Twond and our August 2019 convertible bonds.

This is really valued at each reporting period.

Without this non cash deliberative liability expense.

Jacqueline E. Shea: Very importantly, the delivery process for our DNA medicines using this electric device is complete in less than 20 seconds and has been described by patients and volunteers in our trials as more tolerable than the standard of flu shots. I'm pleased to report that, in late June, we received $71 million in funding from the U.S. Department of Defense to scale up manufacturing of our Selectra 3PSP smart device and for procurement of Selectra 2000 devices for clinical use. Both devices are used to deliver Inno4800 directly into the skin. The DoD contract builds upon two prior separate $5 million grants earlier this year from the Bill and Melinda Gates Foundation and from CEPI to accelerate testing of the Selectra 3 PSP device. We are extremely grateful for the DoD's commitment, and it speaks to the confidence that a major U.S. government entity sees in the value of our smart device and the potential role of Inno4800 in combating an infectious disease pandemic such as COVID-19. Finally, I'd like to reiterate our gratitude to all of our partners, collaborators, manufacturing partners, and funders once again and look forward to sharing continued updates as we scale up in 04800 production. Now I'll hand it back to Joseph.

The company's net loss for the quarter would be consistent with the second quarter 29 team and are not loss per share would be 20 cents per share rather than 83 cents per share, which is 10 cents less per share.

Then 29 team for the same period and 29 team subsequent to June Thirtyth 2020. These bonds were converted voluntarily by the bondholders into common stock.

For operating expenses R&D expenses for second quarter were 22.4 million compared to 22.5 million for the same period in 2019.

Here are the decrease in R&D expenses was primarily related to an increase in Contra research and development expense.

Recorded from grant agreement offset by an increase in drug manufacturing expense related to Workover 19, and VGX 3100 clinical trials.

And an increase in device inventory and engineering equipment.

Gee and expenses were 11.1 million for Q2 versus 5.9 million for the same period in 2019.

The increase in gene expenses was primarily related to an increase in legal expenses.

Work performed related to corporate marketing and communications.

And higher non cash employees stock based compensation expense.

The end of the quarter cash position included net proceeds of 121.7 million.

The company received by selling approximately 10 million 12 million shares of common stock. During the three months ended June Thirtyth 2020 under an aftermarket ATM sales agreement.

As Joseph noted, we have strong capital resources as of June Thirtyth cash cash equivalents and short term investments were 31.

Joseph Kim: Thank you, Jackie, for the update and for your team's outstanding work. Our CFO, Peter Kies, joins us now for a review of the second quarter financial results, which, I have to add, include almost $400 million in cash reserves.

371.7 million compared to 89.5 million at December 30, Onest 29 team.

As of June Thirtyth 2020, the company had hundred and 58.8 million common shares outstanding and 191.4 million common shares outstanding on a fully diluted basis. This is after giving effect to the second quarter ATM active.

Peter D. Kies: Peter.

Peter D. Kies: Thanks, Joseph. Total revenue was $267,000 for the three months ended June 30, 2020, compared to $136,000 for the same period in 2019, while operating expenses were $33.4 million, compared to $28.3 million for the same period in 2019. Inovio's net loss for the quarter was $128.2 million, or $0.83 per share, basic and dilutive, compared to $29.4 million, or $0.30 per share, basic and dilutive, for the same period in 2019. It is important to understand that the increase in net loss for the quarter was primarily due to the change in fair value of the derivative liability related to the embedded conversion feature in our August 2019 convertible box. This is revalued at each reporting period without this non-cash deliberative liability expense.

Over the stock option exercises and restricted stock vesting.

Additional information is included in Inovios quarterly report on form 10-Q for the quarter ended June Thirtyth 2020, which can be accessed on June on Inovios Investor page.

Under the financial reports tab.

Back to your Joseph Thanks.

Thank you Peter it's certainly great to present, our strong financial position.

In closing.

Inovio is razor focused on executing the following I know 4800 objectives for the remainder of the sheer.

Number one.

Advancing I know 4800.

Two and conducting phase two slash three trials next month.

Continued to build out manufacturing consortium with several U.S. and European manufacturing partners to me Inovios and the worlds needs for hundreds of millions of coven 19 vaccine doses.

Peter D. Kies: The company's net loss for the quarter would be consistent with the second quarter, 2019. And our net loss per share would be $0.20 per share rather than $0.83 per share, which is $0.10 less per share than in 2019 for the same period in 2019. Subsequent to June 30, 2020, these bonds were converted voluntarily by the bondholders into common stock. For operating expenses, R&D expenses for the second quarter were $22.4 million compared to $22.5 million for the same period in 2019. Here, the decrease in R&D expenses was primarily related to an increase in CONTRA research and development expense recorded from the grant, offset by an increase in drug manufacturing expense related to our COVID-19 and VGX 3100 clinical trials, and an increase in device inventory in engineering. G&A expenses were $11.1 million for Q2 versus $5.9 million for the same period in 2019. The increase in G&A expenses was primarily related to an increase in legal expenses, work performed related to corporate marketing and communications, and hire non-cash employee stock-based compensation.

And third achieving additional external funding for scale up and manufacturing of vaccine doses.

Furthermore, we will round out the transformative 2020 with very important VGX 3100 reveal one phase three top line efficacy and safety data.

As well as I know 54, or one overall survival at 18 months data in the fourth quarter.

Everyone that Inovio is committed in bringing these DNA medicines for with urgency because we know that patients are waiting.

Now, we will turn to your questions and comments.

Operator, please open the line for the analysts.

We'll now begin the question answer session to ask your question there Chris So the woman your Touchtone phone.

If you're using it speakerphone, please pick up your hands that book Repressing the King.

Withdraw your question. Please press Star then too.

Robert <unk> questions today will come from Gregory rent with RBC capital. Please go ahead.

Hey, good good evening, Joseph and team up Thank you for taking my questions and congratulations on the progress I just I just wanted to start with your commentary around but the plants for the phase two three trial for 4100 I'm. Just curious if you could perhaps comment on the current gating factors for getting.

In that going it sounds like you were targeting a September start maybe just a slightly a delay from <unk> maybe previous commentary. So just want to understand maybe what the pushes and pulls up are there and then secondarily just related to some of the resources or money, but would perhaps be involved you want to support that and help to execute on.

Thank you very much.

Yeah. Thank you Greg.

So you know we had been working urgently to a good our phase two three events.

Peter D. Kies: The end-of-the-quarter cash position included net proceeds of $121.7 million, which the company received by selling approximately 12 million shares of its common stock during the three months ended June 30, 2020, under an at-the-market ATM sales agreement. As Joseph noted, we have strong capital resources. As of June 30th, cash, cash equivalents, and short-term investments were $31. $371.7 million compared to $89.5 million at December 31, 2019. As of June 30, 2020, the company had 158.8 million common shares outstanding and 191.4 million common shares outstanding on a fully diluted basis. This is after giving effect to the second quarter ATM activity, stock option exercises, and restricted stock vesting. Additional information is included in Inovio's quarterly report on Form 10-Q for the quarter ended June 30, 2020, which can be accessed on Inovio's investor page under the Financial Reports tab. Back to you, Joseph. Thanks.

We are in constant a very active or discussions with U.S.P.A. under design and we feel that we are very close to or to this process. So in terms of drug doses, we have everything available to execute.

In terms of the devices, we have everything we have very encouraging and positive phase one data.

Which is undergoing a peer review so we feel like a we we are executing on this obviously a we're currently working on getting an external funding to support a this large trial, so a pretty stay tune a bit.

As we won't be able to.

Certainly by September.

Announced a phase two to restart Ah with external funding in this regard.

That's great. Thank you very much and then just a quick follow up on the non human Primate study data just how should we be thinking about the length of that follow up period as well as perhaps the dose news for the challenge study when comparing that with the perhaps other non human primate studies. Thanks again.

Back into queue, Yeah, absolutely, maybe I'll turn to Ah Kate Roger to handle this question Kate.

Like so much we're not question because that really gives me the opportunity.

To really underscore how is incredibly important not non human primate data is I do want to be cleared but at this point to my knowledge anyway, we had all the rules and maniacal 14, hundreds is the only vaccine candidate to shoot ability and EM.

Protection from Qubits 19 disease I'm relieved that is incredibly important you know about a good vaccine has to be see [laughter] could be effective but also hub to hub Jude ability. If you can only protect quite a few weeks go to oral or a month.

Joseph Kim: Thank you, Peter. It's certainly great to present our strong financial position. In closing, Inovio is razor-focused on executing the following INO4800 objectives for the remainder of this year. Number one, advancing INO4800. Two, and conducting Phase 2-3 trials next month, and continuing to build out the manufacturing consortium with several U.S. and European manufacturing partners to meet Inovio's and the world's need for hundreds of millions of COVID-19 vaccine doses. And third, achieving additional external funding for scale-up and manufacturing of vaccine doses. Furthermore, we will round out the transformative 2020 with very important VGX 3100, Revio 1 Phase 3 top-line efficacy and safety data, as well as INO 5401, overall survival at 18 months data in the fourth quarter. Everyone at Inovio is committed to bringing these DNA medicines forward with urgency, because we know that patients are waiting. Now, we will turn to your questions and comments. Operator, please open the line for the analysts.

Really doesn't have a whole lot of them relevant send the situation today. So we're very excited by the de 'cause. It we and just recently released a bioarchive am I am truly think not is going to be important and I'll be sort of sir the floor on equal vaccine candidate.

Which is really much more similar to what would actually happened in real life as opposed to kind of an artificial situation and putting you challenge immediately after the <unk> acute PD. It over good response as well hope that helps onto your question.

Yes, I think a docking brother.

And our next question will come from Stephen Willey with Stifel. Please go ahead.

Yeah. Good afternoon VIX for taking the questions is is there anymore.

Joseph is there any more granularity you can provide just around expected timing of the phase one publication and.

I guess.

I think it was noted in the press release that there's a this study was extended to including I guess more participants.

Raise the age bracket again.

And it also looks like there was a lower dose that was added as part of the study extension. So should we assume that the inclusion of a lower dose.

Implies that there may not have been a clear dose response between the one Megan to make cohorts and then I just.

But let me touch on the last a part of the Crusher first no you know we reduce C.

So.

So the the phase one extension studies for done prior to.

To having all of the immune response read outs from the initial 40 person or two courts. One was that the that stay escalation of age groups that the F.D.A. one it.

Operator: And we will now begin the question and answer session. To ask a question, you may press stars and 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the key. To withdraw your question, please press stars then 2. Our first question today will come from Gregory Renza with RBC Capital. Please go ahead.

So we started with 18 to 50, a person cohorts first with one and two milligram doses a and then we have added 51 plus population Oh. We also felt that we wanted to see the overall spectrum of doses.

Gregory Renza: Hey, good evening, Joseph and team. Thank you.

Joseph Kim: Thank you for taking my questions and congratulations on the progress. Joseph, I just wanted to start with your commentary around the plans for the Phase 2, 3 trial for 4100. I'm just curious if you could perhaps comment on the current gating factors for getting that going. It sounds like you're targeting a September start, maybe just a slight delay from previous commentary. So I just want to understand maybe what the pushes and pulls are there, and then, secondarily, just related to some of the resources or money that would perhaps be involved to support that and help to execute on that.

Coming down to two half milligram.

As a broad spectrum of Ah Ah those Ah escalation.

<unk> is stepping back a little bit.

But you know in a pandemic response, where we're moving very early urgently a those things are done to complete our overall a clinical development plan. So we feel that both one milligram and two milligram doses are very minute genic.

ER and have shown very strong safety and tolerability.

Specially when you compare to.

Already approved conventional vaccines as well as some of the other reports from other vaccine candidates.

Back to what when you would expect to peer review you know, it's a urgently waiting S is as much as you guys are.

Joseph Kim: Thank you very much.

Joseph Kim: Yeah, thank you, Greg. So, you know, we've been working urgently to get our Phase 2-3 event. We are in constant, very active discussions with the FDA on the design, and we feel that we are very close to this process. So, in terms of drug doses, we have everything available to execute. In terms of the devices, we have everything. We have very encouraging and positive phase one data, which is undergoing peer review. So we feel like we are executing on this. Currently, we are concurrently working on getting external funding to support this large trial. So please stay tuned, because we will be able to, certainly by September, announce phase two, and three start with external funding in this regard.

There are the peer review process is gonna take their own time.

But we're hoping that it sooner or rather than later.

And and all.

All of the the shoe MRO and circular immune responses every detail of safety and tolerability or will be outlined in the published a paper.

Okay. So I guess should we expect to have the phase one publication in hand, before the decisions announced a before the initiation fees to Threed number.

No I. These are two a parallel events.

Okay.

And then just I guess on the on the VGX I.

[noise] ongoing I guess litigation arbitration, where everyone call it.

It does does.

Does this impact at all the likelihood of starting a phase two three in September and I guess, what are the projected timelines to a resolution here. This doesn't need if this does indeed need to be Lydia.

Joseph Kim: That's great. Thank you very much. And then just a quick follow-up on the non-human primate study data. Just how should we be thinking about the length of that follow-up period, as well as perhaps the dose used for the challenge study when comparing that with perhaps other non-human primate studies? Thanks again. I'll hop back into the queue.

So you know I don't want to go to we don't want to go too deeply into actual discussion of the litigation because that's an ongoing process, but I can actually say that the the this or any other litigation.

ER has any impact on our I know 4800 development plan, including phase two three efficacy trials or even the scale up a in 2021 of our goal of reaching hundred million doses. So yeah, we feel.

Kate Broderick: Yeah, absolutely. Maybe I'll turn to Kate Broderick to handle this question. Kate?

Kate Broderick: Thanks so much for that question, because that really gives me the opportunity to really underscore how incredibly important that non-human primate data is. I do want to be clear that, at this point, to my knowledge anyway, we at Inovio, and I know 4,800 is the only vaccine candidate to show durability and protection from COVID-19 disease. And really, that is incredibly important. You know, a good vaccine has to be safe, it has to be effective, but it also has to be durable. If you can only protect for a few weeks or a month, that really doesn't have a whole lot of relevance in the situation today. So we are very excited by the data that we just recently released on BioRxiv.

Ill as I mentioned before.

We have all the doses a end device and the race manufacturer to support our trials and our focus is squarely on scaling up 400 million doses or that we we feel our are needed a and 2021.

Okay, and then images lastly, and I guess it was kind of asked at the outset, but.

I guess you'd characterize the initiation of the two three years kind of.

Depended upon receiving FDA concurrent so I guess.

Can you, maybe just talk a little bit what about what that if the a concurrence looks like.

Kate Broderick: And I truly think that is going to be important as we sort of survey the landscape of vaccine candidates, which is really much more similar to what would actually happen in real life, as opposed to kind of an artificial situation when you challenge immediately after the acute period of immune response. I hope that helps answer your question. Yes, it's Dr. Brogdon.

And should we anticipate that you know a registrational program here.

Something like the NIH Master protocol.

Yeah, So a ft a concurrent just mean says it's it's a natural term.

For FTC approval of any process in process steps you know nothing is actually a proof I envy isn't approved.

Operator: And our next question will come from Steve and Willie with People. Please go ahead. Yeah, good afternoon. Thanks for taking the questions. Is there any more?

It's concur that or you are allowed to go for it. So it's it's just the terminology. So we could have easily have use colloquial language of yeah. Upon getting F.D.A.O.K. too to move to the next steps <unk> without getting into details so our Tucson.

Steve and Willie: Hey, Joseph, is there any more granularity you can provide just around the expected timing of the phase one publication and, I guess, I think it was noted in the press release that the study was extended to include, I guess, more participants, and raise the age bracket again. But then it also looks like there was a lower dose that was added as part of the study extension. So should we assume that the inclusion of a lower dose implies that there may not have been a clear dose response between the 1-MIG and 2-MIG cohorts, and then I just have a couple follow-ups?

Three approach.

Is allowing us to quickly go get through the phase two portion and getting to a phase three epic efficacy portion.

As soon as a as possible.

And that as I think we mentioned in abroad brushes.

Previously a thatll be a a placebo controlled randomized double blind the efficacy trial.

Joseph Kim: Let me touch on the last part of the question first. No, you know, we do see, so the Phase I extension studies were done prior to having all of the immune response readouts from the initial 40-person two-core, um, one was that uh, that's the escalation of age groups that the FDA wanted. So, we started with 18 to 50-person cohorts first with one and two milligram doses, and then we added 51-plus population. We also felt that we wanted to see the overall spectrum of doses coming down to half milligram as a broad spectrum of dose escalation. It's stepping back a little bit, but, you know, in a pandemic response where we're moving very urgently, those things need to be done to complete our overall clinical development plan.

So those are overall approach would be similar to the other phase three trials ongoing or from other groups.

And in terms of patient numbers should we expect to see a patient number based upon this achievement of 58 concurrent stuff looks like.

<unk> Master protocol.

Yeah, you know ER in similar magnitude, we expect a it really depends on the actual infection rates at that time.

You know, who we target in terms of higher risk profile or volunteers.

I would also dictates the overall sizing of the sample size, but it will be in the same order of magnitude.

Alright, thanks for taking all the questions.

Yeah. Thanks.

Our next question will come from E. Chen with H.C. Wainwright. Please go ahead.

Hi, Thanks for taking my questions. My first question is hi, Patrick.

Do you follow up with the original sorry, 38, a healthy volunteers into phase one trial just to see how loan be antibody M T cell responses kilowatts.

Joseph Kim: So, we feel that both one milligram and two milligram doses are very immunogenic and have shown very strong safety and tolerability, especially when you compare them to already-approved conventional vaccines, as well as some of the other reports from other Vaccine Canada. Back to when you would expect the peer review, you know; I'm urgently waiting as much as you guys are. The peer review process is going to take its own time, but we're hoping that it's sooner rather than later. And all of the humoral and cellular immune responses, every detail of safety and tolerability will be outlined in the published paper.

Yes. Currently is so we end the protocol, we have designed to follow up up to one year. After the second dose. So a total follow up will be up to 13th month of the start of the trial.

Both for safety and the durability of the immune response.

Got it.

And or those priest, one trials in South Korea and China.

The same protocol and that's the U.S. phase one trial and can't tell us how many patients would be rolling into trying to phase one trial.

Yes, so both South Korea trial.

Joseph Kim: Okay, so I guess should we expect to have that phase one publication in hand before the decisions are announced or before the initiation of the phase?

And China's trial of I know 4800, the their phase one portions are very much similar to our initial 40 person cohort of phase one studies.

Joseph Kim: No, these are two parallel events.

Joseph Kim: Okay, and then just on the ongoing VGXI litigation or arbitration, whatever you want to call it. So does this impact at all the likelihood of starting Phase 2, 3 in September? And, I guess, what are the projected timelines for a resolution here if this does indeed need to be litigated?

So it's similar and design.

Where he will differ is the or intend and the sizing of the phase two portions of those trials. So in China. The phase two trials is estimated to be in several hundred patients subjects.

Joseph Kim: So, you know, I don't want to go too deeply into the actual discussion of the litigation because that's an ongoing process, but I can actually say that this, or any other litigation, has no impact on our INO4800 development plan, including phase 2, 3 efficacy trials or even the scale-up in 2021 of our goal of reaching 100 million doses. So, you know, we feel, as I mentioned before, we have all the doses and devices and arrays manufactured to support our trials. And our focus is squarely on scaling up for the 100 million doses that we feel are needed in 2021.

In South Korea, or there were looking to expand into older population in larger numbers. So.

So there you know where we're trying to broaden our database a of safety and Immunogenicity and overall value to the franchise globally.

Got it.

Oh I think you previously mentioned that you would be ROE healthcare workers and be phase three trial, Oh, I don't know 40 hundreds.

So so many besting candidates entering phase three trials in the second half of this year do you think there's a there's going to be a competition.

Oh for enrollment of the subject a pivotal trials financings.

Yeah, that's a great question, the and certainly Ah I think Oh all of these trials.

Joseph Kim: Okay, and then, and then just lastly, and I guess it was kind of asked at the outset, but you characterize the initiation of the two, three as kind of being dependent upon receiving FDA concurrence. Can you maybe just talk a little bit about what that FDA concurrence looks like? And should we anticipate that a registrational program here looks something like the NIH Master Protocol?

That we're talking about our targeted to be done in the U.S. and with the outbreaks situation in such a heightened concerns.

Bye bye everyone in this country and the world.

I don't think a we're gonna be practically limited by the volunteers available.

For for for the Phase three trials now they are practical then issuance you know a I think the first six or seven vaccines certainly should have no problem enrolling.

Joseph Kim: Yeah, so FDA concurrent just means it's an actual term for FDA approval of any process, in process steps. You know, nothing's actually approved. IND isn't approved. It's concurred, or you're allowed to go forward, so it's just the terminology.

Sure the 20 Eightth vaccine to get into phase three you may be hitting some of those marginal availability issues, but I think I don't expect any challenges and in enrolling.

Joseph Kim: So we could easily have used colloquial language of, yeah, upon getting FDA approval to move to the next steps. Without getting into details, our 2-3 approach is allowing us to quickly get through the Phase 2 portion and get to a Phase 3 efficacy portion as soon as possible. And that, I think we mentioned in a broad brushstrokes previously that it will be a placebo-controlled, randomized, double-blinded efficacy trial. So the overall approach will be similar to the other phase three trials ongoing from other groups.

Because the pandemic is all around US a is in the news every day and this impacting everyone's life. So I don't think a the enthusiasm for a.

Voluntary thing for these trials will subside and in any time soon.

Got it and lastly could you.

Give us some color own be Roman status for the review to trial.

Joseph Kim: And in terms of patient numbers, should we expect to see patient numbers based upon this achievement of FDA concurrence that looks like the NIH master protocol?

Yes. So you know the endemic or impact a was certainly a notice by our would feel two trials.

Just like Oh, you know everyone analysis, a clinical trials globally, when you're locked down at home.

Joseph Kim: Yeah, you know, in a similar magnitude, we expect it really depends on the actual infection rates at that time. Who we target in terms of higher risk profile volunteers would also dictate the overall sizing of the sample size, but it will be in the same order of magnitude.

You know it's just.

Understandable that you're not going to be able to get through your clinical trial sites and so on so you know as as all of those of US in the industry are trying to deal with that.

We have a very dedicated team a and also RCR O for working literally then nice to make sure that we can continue a and perhaps get back to the rates and the level. So pre pandemic. So.

Joseph Kim: All right, thanks for taking all the questions. Yeah.

Yi Chen: Yeah, thanks, Steve.

Joseph Kim: And our next question will come from Yi Chen, with H.C. Wainwright. Please go ahead. Hi, thank you for taking my questions. My first question is, hi. Do you follow up with the original 38 healthy volunteers in the Phase 1 trial just to see how long the antibody and T cell responses can last?

I I don't want to give any quantitative answer here, but what I can surmise here is ER or summarize sure is to endemic it's impacting the enrollment rate, but we're working very hard to ameliorate that.

As well as possible.

Got it thank you.

Yep. Thank you.

Joseph Kim: Yes, currently, we are in the protocol we have designed to follow up up to one year after the second dose. So total follow up will be up to 13 months from the start of the trial, both for safety and the durability of the immune response.

Third I question will come from Charles Duncan with cancer or Cantor Fitzgerald. Please go ahead.

Hi.

Joe and a team thanks for taking my questions should you live in interesting time Charles.

[laughter] yeah.

Unfortunately, I stepped on physical late so I apologize if some of these questions been asked I want I wanted to first of all get a understanding of when would you anticipate some additional data details from the phase one and then when you consider the phase two three or you know.

Joseph Kim: Got it. And are the Phase I trials in South Korea and China using the same protocol as the U.S. Phase I trial? And can you tell us how many patients were enrolled in the Chinese Phase I trial?

Joseph Kim: Yes, so both the South Korean trial and the Chinese trial of INO4800, their phase one portions are very much similar to our initial 40-person cohort of phase one studies. So it's similar in design.

So patient cohort would you include older adults in that study or do you have to separate study going on that could read out before that.

Yeah, absolutely in terms of the phase one data a where in the mid or the peer review process a at one of the top medical journal. So hopefully we can expediently get through and present, a fall application a with all of the detail.

Joseph Kim: Where it would differ is the intent and the sizing of the phase two portions of those trials. So in China, the phase two trials are estimated to be in several hundred patients and subjects. In South Korea, we're looking to expand into the older population in larger numbers. So we're trying to broaden our database of safety and immunogenicity and overall value to the franchise globally.

The safety Immunogenicity and Tolerability of phase one.

Data from the first 40 subjects.

In terms of the age groups are we really thing or our vaccine movie quite appropriate for those who are most at risk from coffee 19 disease. So these are older population. These are folks with coal mobility that may put them at more risk.

Joseph Kim: And I think you previously mentioned that you would enroll healthcare workers in the phase three trial of INL4800. With so many vaccine candidates entering phase three trials in the second half of this year, do you think there's going to be a competition for enrollment of subjects in pivotal trials for vaccines?

So in terms of older population, a we have already expanded our phase one studies to two or two include them all the way up to 65 plus.

Joseph Kim: Yeah, that's a great question, Yi. Certainly, I think all of these trials that we're talking about are targeted to be done in the U.S. And with the outbreak situation and such heightened concerns by everyone in this country and in the world, I don't think we're going to be practically limited by the volunteers available for the phase three trials. Now, there are practical limitations. You know, I think the first six or seven vaccines should have no problem enrolling. If you're the 28th vaccine to get into phase three, you may be hitting some of those marginal availability issues. But I think I don't expect any challenges in enrolling because the pandemic is all around us, it's in the news every day, and it's impacting everyone's lives. So, I don't think the enthusiasm for volunteering for these trials will subside any time soon.

ER and we're hoping to to have those data into next one to two months.

As for faced <unk>, which isn't predicated on.

Our face a two three phase two three will include all age groups a including.

18 to 50, which was a original cohort and 51 plus a as well.

Okay, that's fabulous and when when you consider longer term safety.

[noise] any of these covert vaccines I guess I'm wondering.

What do you think it's best to evaluate that I know I'm asking is speculative, but what what would you look for out of all longer term safety and how will you gain comfort with that for broader licensure and access.

Yeah. So you know if you look at the some of the phase three trial assess already ongoing.

Modernist case or they have two year.

Evaluation period for their phase three.

Joseph Kim: Got it. And lastly, could you give us some color on the enrollment status for the Review-2 trial?

I think the safety long term safety or could be one to two years.

Joseph Kim: Yeah, so you know, the pandemic impact was certainly noticed by our reveal two trials, just like all you know, everyone else's clinical trials globally. When you're locked down at home, it's understandable that you're not going to be able to get to your clinical trial sites and so on. So, you know, as all of those of us in the industry are trying to deal with that, we have a very dedicated team and also our CRO who are working literally day and night to make sure that we can continue and perhaps get back to rates and levels pre-pandemic. So, you know, I don't want to give any quantitative answer here, but what I can surmise here, or summarise here, is the pandemic is impacting the enrolment rate, but we're working very hard to ameliorate that as well as possible.

In terms of or you know.

What is the vaccine generated immune response, what is the impact.

On preventing infection or preventing disease.

Or or impacting the severity of disease, which are.

Really the primary and secondary efficacy endpoints, but having a long term safety that ER that can be followed is also quite valuable.

You know from early clinical trials, so phase one a phase two a studies you know what you focus mostly on our these tolerability in a acute react reactogenicity creates 123 and so on so what I.

Ken.

You know touch on here, which is really exciting as Ah I know 4800.

Had as Kate mentioned only six related Ace and there were all grade one and severity. So this compares extremely well to a conventional vaccines us already a on the market, but clearly side by side with some of the other.

Joseph Kim: Got it. Thank you. Yeah, thank you, Yi. And our next question will come from Charles Duncan with Cancer Fitzgerald. Please go ahead.

Candidates or they are in phase two in phase three levels a against covert 19. So if if I can't stress on what is unique about I know 4800, and really and by inference or what is unique about you know.

Charles Duncan: Hi Joe and team, thanks for

Joseph Kim: I'm going to take my questions should you live in interesting times. Hey, Charles. Yes. Yeah. Unfortunately, I stepped onto the call late, so I apologize if some of these questions have already been asked. I wanted to, first of all, get an understanding of when you anticipate some additional data details from the Phase I study, and then when you consider the Phase II-III patient cohort, would you include older adults in that study, or do you have a separate study going on that could read out before that?

Views DNA medicines platform. Its number one we can generate both balanced ER neutralizing antibodies as well as T cell immune responses.

Number two.

Which you know we saw all participants in phase one either having both tomorrow.

Joseph Kim: Yeah, absolutely. In terms of the Phase 1 data, we're in the middle of the peer review process at one of the top medical journals, so hopefully we can expediently get through and present the full publication with all of the detailed safety, immunogenicity, and tolerability of our Phase 1 studies. So, in terms of the older population, we have already expanded our phase one studies to include them all the way up to 65 plus. And we're hoping to have those data in the next one to two months. As for phase, which isn't predicated on our phase 2-3, phase 2-3 will include all age groups, including 18 to 50, which was the original cohort, and 51 plus as well. Okay, that's fabulous.

And or T cell responses, which is exciting or not to and particularly.

It's very important that we generate these are T cell immune responses, which were learning more and more everyday are to be very important again source could be too and covert 19 disease.

And number three safety and Tolerability profile.

We're saying we are second to none.

ER and number four.

S.K. the alluded to we think we can boost Ah Ah with I know 4800.

For many years or if it came to that.

If if Ah coven 19 became a seasonal vaccine addressable disease.

We think a inovios vaccine positions itself very well due to the and the lack of anti vector responses and other.

Joseph Kim: Fabulous. And when you consider the longer-term safety of any of these COVID vaccines, I guess I'm, I'm wondering. When do you think it's best to evaluate that? I know I'm asking is

Toxicity limitations or from our platform.

And number five a and lot of folks or lose sight of this.

Our DNA vaccine is extremely stable.

Joseph Kim: I don't want to speculate here, but what would you look for in the longer term?

Our long term product storage is that norm or refrigeration up to five years.

Joseph Kim: longer-term safety, and how will you gain comfort with that for broader licensure and access?

We can keep our vaccine at room temperature for over a year, which is a stark advantage compared to somebody other.

Joseph Kim: Yeah, so, um, if you look at some of the phase three trials that are already ongoing, in Moderna's case, they have two years of primary and secondary efficacy endpoints. But, you know, having long-term safety that can be followed is also quite valuable.

Vaccines, where the cold chain used to be maintained in a very difficult and arduous fashion. So.

For these five reasons or we think we have a very unique safe and hopefully efficacious vaccine and these attributes will become even more important we think in groups like Ah Ah seniors, who may not be able to.

Joseph Kim: You know, from early clinical trials, phase one, phase two, A studies, you know, what you focus mostly on are these tolerabilities, you know, acute reactogenicity, grades 1, 2, 3, and so on. So, what I can.., you know, touch on here, which is really exciting, is the INO4800. [inaudible] They are in Phase 2 and Phase 3 levels against COVID-19. So if I can stress what is unique about INO4800.

With than some of the Reactogenicity ER and tax you know acute tolerability issues that some of these other vaccine candidates have shown in their early trials.

[noise] chilled and your answer just address many of the other questions that I had I I just had two more and I'll turn them into one. So you can address those and that is really related to capacity and its capacity not only to conduct the phase two three and I think.

You're probably still talking about a 20 30000 patient study on the upper end.

Joseph Kim: And really, by inference, what is unique about Inovio's DNA medicines platform is, number one, we can generate both balanced neutralizing antibodies as well as T cell immune responses. Number two, which, you know, we saw all participants. And number three, safety and tolerability profile, we think we are second to none. And number four, as Kate alluded to, we think we can boost, [inaudible] We think Inovio's vaccine positions itself very well due to the lack of anti-vector responses and other toxicity limitations from our platform. And number five, and a lot of folks lose sight of this.

But I'm wondering if you could provide some color on that and then with regard to capacity other capacity and that is manufacturing some folks have wondered about logistics in manufacturing capacity that you may or may not have and I'm wondering how you sell for that problem and and funded.

Let me touch on the first then I'll refer a the manufacturing or response to.

To Dr. Jackie Shay.

In terms of our phase one phase to the slash three clinical trials material, a we already have all of the vaccine doses and and devices require for that trial.

Well, we're working on its Ah lining up the external funding to support.

Joseph Kim: But our DNA vaccine is extremely stable. Our long-term product storage is at normal refrigeration for up to five years. We can keep our vaccine at room temperature for over a year, which is a stark advantage compared to some of the other vaccines where the cold chain needs to be maintained in a very difficult and arduous fashion. So, for these five reasons, we think we have a very unique, safe, and hopefully efficacious vaccine, and these attributes will become even more important, we think, in groups like seniors who may not be able to withstand some of the reactogenicity and acute tolerability issues that have shown in their early trials.

Ah that and we expect.

The the funding information or to be a presented at around the same time that we get the F.D.A. concurrence to move to our face to slash.

Three trials, so and as far as far as the manufacturing.

We've made huge progress in the in the past quarter.

Really setting up a manufacturing consortium globally.

But let me turn to Dr shape for for addressing the Cindy too.

Thank you just if so to to break up your question into a couple of parts. So if that's what we already have to taste and spending factor that we need a for all ongoing clinical studies, including the the faced the upcoming phase tier three and in terms of of long term supply and.

Joseph Kim: Joe, your answer just addressed many of the other questions that I had. I just had two more, and I'll throw them into one so you can address those. And that is really related to capacity and its capacity not only to conduct a Phase II-III study, but I think you're probably still talking about a 20-30,000 patient study on the upper end, but I'm wondering if you could provide some color on that. And then with regard to the other capacity, and that is manufacturing, some folks have wondered about the logistics and manufacturing capacity that you may or may not have, and I'm wondering how you solve that problem and fund it.

Being able to bill to the hundreds of millions of devices that we would need.

We recognize that very early on you know Saudi is January we recognize that we would have to approach manufacturing in a very novel and I'm very different way and the same way that other companies have have reached out and establish manufacturing console t. If the DAF vaccines. We've also taken the same approach with it.

4800, so someone thats manufacturing partnerships, we we've talked about say Rick to home and all that she enough. The next couple of months we'll be.

Announcing thought that manufacturing partnerships and these are partnership spaced in the U.S. in Europe, and mobile say now exploring partnerships or be on the U.S. in Europe.

Joseph Kim: Let me touch on the first, and I'll refer the manufacturing response to Dr. Jackie Shea. In terms of our phase 1, phase 2 slash 3 clinical trials materials, we already have all of the vaccine doses and devices required for the trial. What we're working on is lining up the external funding to support that, and we expect the funding information to be presented around the same time that we get FDA approval to move to our phase 2 slash 3 trials. So, and as far as manufacturing is concerned, we've made huge progress in the past quarter, really setting up a manufacturing consortium globally. But let me turn to Dr. Shea for addressing this in detail.

Very good thanks for taking my questions.

Creative future prospects.

Yep. Thank you.

The next question will come from increased with the benchmark.

Please go ahead.

Thanks, Good afternoon, everyone. Congratulations the progress this quarter hard Hutchinson [noise].

So first question I have is about the potential anticipated pricing assumptions you know given 1 million this year how to do in next year.

And how close that would be to something that was already announced by the competition.

But you know I'm Gonna also turned this question. This is a very important question.

And and pricing a at mass a large scale.

Commercial scale is something that is very important to the world, but also important to inovio, so I'm going to turn over.

Jacqueline E. Shea: Thank you, Joseph. I'll break up your question into a couple of parts. So first of all, we already have the doses manufactured that we need for our ongoing clinical studies, including phase, the upcoming phase two, and three. And in terms of longer-term supply and being able to build up to the hundreds of millions of doses that we would need, we recognize that very early on, you know, as early as January. We recognize that we would have to approach manufacturing in a very novel and very different way.

ER to Jackie in this regard as well.

Thank you Jay I think what I can say about pricing at this stage is that these vaccines needs the affordable and accessible and way a competent the scale step with trying to produce that that we will be and assuming a ballpark too many.

The other leading vaccines, but I'm afraid at this stage, that's all I can say.

Great appreciate that.

Another question I have is Oh, you mentioned the press release on a person demonstrated a little immune responses money quite percent, so close to 90% T cell responses, including C. D clauses, but could you give us a breakdown of Oh percentage of patients who chose GDP plus responses on how important in your opinion.

Jacqueline E. Shea: And in the same way that other companies have reached out and established manufacturing consortia for their vaccines, we've also taken the same approach with, you know, 4800. So some of those manufacturing partnerships we've talked about, Richter Helm and Ology, and over the next couple of months, we'll be announcing further manufacturing partnerships. And these are partnerships based in the US and Europe. And we're also now exploring partnerships beyond the US and Europe.

Those responses war dyslexic.

Yeah. Great question, you know I I think the true granular detail you may have to way for factual publication or post a peer review, but I can't tell you is ER.

See a T cells are important you know overall classically.

Jacqueline E. Shea: Very good. Thanks for taking my questions.

As an anti viral response, but specifically also against our school we too.

Joseph Kim: Good luck with the future.

Aiden Susano: Thank you. Thank you. Yep, thank you.

We we asked the field our learning that there's couple ways.

Joseph Kim: And our next question will come from Aiden Susano with The Benchmark Company. Please go ahead. Thank you. Good afternoon, everyone. Congratulations on the progress.

That the Bodys immune system is responding to an actual Saar scold me to infection. One this through neutralizing antibodies that takes out.

Joseph Kim: So, the first question I have is about the potential anticipated pricing assumptions, you know, given 1 million this year and 100 million next year, and how close that would be to something that has already been announced by the competition.

The virus, a and limiting the infections ER and the spread the other is once the virus is already in the so yeah. There's only one way to extricate them, a and those are predominantly through killer C.D.A.T., So response or so.

Joseph Kim: But, you know, I'm going to also turn this question, this is a very important question. And pricing at mass, large scale, commercial scale is something that is very important to the world, but also important to Inovio. So I'm going to turn this question over to Jackie in this regard as well.

Some aspects of T.H., one type of city for response.

But so you know in NR publication, we we have measure in our phase one subjects Oh in terms of the T cells are both the C.D.A., then and see the for T cell responses and.

Jacqueline E. Shea: Thank you, Joseph. I think what I can say about pricing at this stage is that these vaccines need to be affordable and accessible, and we're confident that at the scales that we're trying to produce them at, we will be in a similar ballpark to many of the other leading vaccines. But I'm afraid, at this stage, that's all I can say.

And not surprisingly, we were able to observe a strong levels of C. D. H T cell response, along with 64. So these are similar to what we have published or in our vaccine against Ebola and mergers.

Aiden Susano: Great. Appreciate that. Um, another question I have is that you mentioned in the press release the 100% demo.

And then HIV previously so.

No that part wasn't surprising or I think what.

Joseph Kim: The overall immune response is 95%, so converted 90% had T cell responses, including CD8+. But could you give us a breakdown of the percentage of patients who show CD8+ responses and how important in your opinion are those responses for the vaccine?

We were gratified and and satisfied with western level.

And and the fact that we can see it and in the schools in 19 setting so.

You know, it's a is very consistent too as we have seen.

In our previous specs seen a trial so.

It really goes to the powerful consistency use that we are having.

Joseph Kim: Yeah. A great question.

Joseph Kim: You know, I think the true granular detail will have to wait for the actual publication post-peer review. But what I can tell you is CD8 T-cells are important, you know, overall classically as an antiviral response, but specifically also against SARS-CoV-2. We as the field are learning that there are a couple of ways that the body's immune system is responding to an actual SARS-CoV-2 infection. One is through neutralizing antibodies that take out the virus and limit the infections and the spread. The other is once the virus is already in the cell, you know, there's only one way to extricate it, and that is predominantly through a killer CDAT cell response or some aspects of a Th1 type of CD4 response. But so, you know, in our publication, we measured in our phase one subjects, in terms of T-cells, both the CD8 and CD4 T-cell responses, and not surprisingly, we were able to observe strong levels of CD8 T-cell responses, along with [inaudible] We were gratified and satisfied with the level and the fact that we could see it in this COVID-19 setting. So, you know, it' So it really goes to the powerful consistency that we are having across our pipeline efforts.

Across our pipeline a efforts are.

But I appreciate pushing their responses and.

Another question I thought is so how should we think about annual production or you know for 800 posts 2021, I know its little bit early but come demand and capacity standpoint.

In general do think it would be and he'll kind of repetitive revenue just like production of cool pool vaccines.

Yeah, I think so at least in the first several more years I do think thisis or it's just going to require.

Well, let me put it this way or all of the early manufacturers who get their vaccines approved.

I think we will collectively so everything that we manufacture globally.

And then depending on the durability of the vaccine protective response.

Most cantwell <unk> are saying that it's most likely that vaccines or ability is not gonna be multi years long.

It would likely mirror the natural infections immune response, which in many cases are only several months. So when it comes to antibodies to T cell responses couldn't be more durable.

So I think that's where inovios vaccine could have some in the logic advantage.

Joseph Kim: And another question I have is, so how should we think about annual production of INR for 800 post-2021? I know it's a little bit early, but from a demand and capacity standpoint, and in general, do you think it would be an annual kind of repetitive revenue, just like production of flu vaccines?

But also you know Cade mentioned touched on this earlier.

We can boost our vaccine or almost infinitely you know it's in our cancer.

Therapies and vaccine study so our patients receive up to a dozen or more ptosis without any safety or tolerability issues or without any anti factor a response and the system something a that's a you can say that with other.

Joseph Kim: Yeah, I think so, at least in the first several years. I do think this is going to require, but let me put it this way, all of the early manufacturers who get their vaccines approved in Korea. And then, depending on the durability of the vaccine's protective response, you know, most KOLs are saying that it's most likely that the vaccine durability is not going to be multi-years long. It would likely mirror the natural infection's immune response, which in many cases is only several months. When it comes to antibodies, T cell responses could be more durable.

Platforms.

That are going after a coven 19.

In terms of overall production.

So where where our immediate school for 2021 is hundred million doses as soon as we achieved that a consortium.

<unk> manufacturing capacity, then we'll go up to 200 million doses and and so on so.

Our current projection this or because of our attributes of I know 4800 that I had described earlier.

Joseph Kim: So, I think that's where Inovio's vaccine could have some immunologic advantage. But also, you know, Kate mentioned, and touched on this earlier, we can boost our vaccine almost infinitely. You know, in our cancer therapy and vaccine studies, our patients receive up to a dozen or more doses without any safety or tolerability issues or without any anti-vector response. And this isn't something that's possible with other platforms that are going after COVID-19.

We think we could pretty much so and and supply as many doses or as we can manufacture so our focus a where.

Jackie's teams are truly focused on is how do we get to those Ah hundreds of millions of dose levels, both in plasmid manufacturing and device and the re manufacturing and I'm really excited to tell.

The the streets that we're making great progress and we should be able to fulfill our goal for 2021 and beyond.

[noise] banker banker about and the last question as well.

Joseph Kim: In terms of overall production, you know, I think that's where Inovio's vaccine could have some immunologic advantage. You know, our immediate goal for 2021 is 100 million doses. As soon as we achieve that consortium manufacturing capacity, then we'll go up to 200 million doses and so on. So, you know, our current projection is because of the attributes of INO4800 that I had described earlier, we think we could pretty much sell and supply as many doses as we can manufacture. So our focus, Jackie's teams are truly focused on is how do we get to those hundreds of millions of those levels, both in plasmid manufacturing and device and array manufacturing. And I'm really excited to tell the street that we're making great progress and we should be able to fulfill our goal for 2021 and beyond.

If if we assume that <unk>, you're going to start to trial in September. So when do you expect Oh, you know 4800 to be approved we are probably most use authorization. What's the earliest that you think will fall in terms of a pool.

Yeah, we think sometime in 21, you know the phase three portion.

We will likely build an interim looks or so.

But also it really depends on the infection rates at the time of our phase three recruitment.

The the.

So all of these things will come into play.

But if we sort of transpose, what what's going on today.

Where there are quite a bit of infections across the country.

If we think this is going to sustain over some time, we think are the emergency use authorization through early efficacy look along with immune responses. So hopefully have having some correlates of Ah that can be generated immunological correlates.

Aiden Susano: Thank you.

Joseph Kim: And the last question is...

We think a 2021 sometime is a logical.

Aiden Susano: If we assume that you're going to start the trial in September, so when do you expect INR 4800 to be approved via probable emergency use authorization? What's the earliest that you would think of in terms of approval?

Projection for for an easy way approval.

Actual B.L.A. could take a year or so beyond that.

Ah due to the follow up in safety and all of those things are we touched on earlier.

Joseph Kim: Yeah, we think sometime in 21, you know, the phase three portion, we will likely build in interim looks. So, but also, it really depends on the infection rate. At the time of our Phase 3 recruitment, you know, the... So all of these things will come into play. But if we sort of transpose what's going on today, where there are quite a few infections across the country, if we think this is going to last for some time, we think the emergency use authorization through early efficacy look, along with immune responses, hopefully having some correlates that can be generated, immunological correlates. We think 2021 sometime is a logical time. Projections for an EUA approval. An actual BLA could take years or beyond that, due to follow-up in safety and all of those things that we touched on earlier.

Okay. Thank you very much for taking my questions.

Great Thanks and.

Yeah, I'd love to good if you'd like your question. Please press Star then one.

Our next question will come from Doreen Greenbrier with Maxim Group. Please go ahead.

Hi, Joseph Congrats on the progress then I guess most of my questions have been asked but I just wanted a clarification and you've actually touched on this.

And that's your thoughts around neutralizing antibody and piece out responses with regard to I know 4800.

In one of your former press releases you kind of the.

It was citation another publication on convalescent data that indicate logins turbo antibody titers I was just wondering if you're putting more weight on T cell responses versus the other or what are your thoughts on it.

Yeah, I'm thinking marine and you know the the continuing reports.

From the field.

Aiden Susano: Okay, thank you very much for taking my question. Great. Thanks. And once again, if you'd like to ask a question, please press star then 1. And our next question will come from Noreen Kuibria with Maxim Group. Please go ahead.

From specially studying becomes a lesson subjects.

Tells us that Oh, it's T cells are playing a major.

Factor or in limiting the severity of metro infection.

Noreen Kuibria: Hi Joseph, congratulations on the progress. And I guess most of my questions have been asked, but I just wanted a clarification, and you've actually touched on this, and that's your thoughts around neutralizing antibodies and T cell responses with regard to INO4800. In one of your former press releases, you kind of cited a publication on convalescent data that indicates reduced or low antibody titers, so I was just wondering.

These persons and you know the the T cells, the naive person should not having T cells pre existing in their body.

So the there was a very important sell paper that came out from.

Rockefeller group, and and and others are continually supporting in there there was a publication from China and Europe with similar sets of data showing that and when you look at the U.S.S. Roosevelt or where hunger subscribers were infected many of them.

And war or not positive by antibodies, but by PCR. So you know how can they fly at all how can they symptomatic persons you know fight off infection in their slot of suggestion from these studies.

Joseph Kim: Yeah, thank you, Noreen. And, you know, the continuing reports from the field, from specially studying the convalescent subject, tell us that T-cells are playing a major role in limiting the severity of natural infection in these persons, and, you know, the T-cells, the naive person should not have any T-cells pre-existing in their body. So there was a very important cell paper that came out from the Rockefeller Group and others continually supporting it. There was a publication from China and Europe with similar sets of data showing that.

Says or you know T cells or cross reactive T cells. This case stated and in the not part of the prepared remarks are likely or the causes ER and you know our thoughts are you know, we it's hard to dispute the importance.

Neutralizing antibodies.

But they don't last or for a long time. So we really always maintained that having a balanced a vaccine generated immune responses both in neutralizing antibodies as well as say the eight and Cdfour T cell responses gives us the best.

Joseph Kim: And when you look at the USS Roosevelt, where hundreds of sailors were infected, many of them were not positive for antibodies but positive for PCR. So, you know, how can they fight off, how can they be a symptomatic person? [inaudible] but they don't last for a long time. So we've always maintained that having a balanced vaccine-generated immune responses, both neutralizing antibodies as well as CD8 and CD4 T cell responses, gives us the best.

012 punch to deal with a potential infection.

In cope with 19 disease, and I think the the beta thus far from our studies, that's more or less the.

Convalescent data coming from the field supports a these pieces.

Got it and then just one quick one.

Noreen Kuibria: Got it. And then just one quick one. You know, you're also participating in the non-humate primate study for Operation Warp Speed. Has there been any guidance on when that data will become available?

You know you're also participating in the non human Primate study for operation Wise speed has stayed pretty any guidance went to win that data will become available.

Joseph Kim: Um, you know when we know the schedules of our uh non-human primate studies, whether these will all be presented together?

You know when you know the though we know the schedule most of our non human primate studies or whether this will all be present together are under the auspices some old WCS or not you know that's something that a world will be.

Joseph Kim: under the auspices of OWS or not. That's something that we'll be discussing with OWS, but it should be in the next few months.

Discussing with the U.S., but.

It it should be in the next though few months.

Joseph Kim: Okay, and then, you know, obviously, I know 4100, you know, is sort of taking center stage, and you've got VGX 3100, but are you deprioritizing any other programs because of that?

Okay, and then you know not you you have you know obviously I know 0.1 800, you know is.

Sort of taking center stage any that VGX any 100, but I you de prioritizing any other programs because of that.

No.

Joseph Kim: No, no and you know the investor sentiments at least in terms of questions and and focus has been around 4,800 and naturally and that's understandable and we are as a company expanding you know extreme focus and resources on that but as I touched on my part of the discussions this call you know I VGX 3100 our pivotal top-line efficacy data our first phase 3 data is coming it's around the corner and I'm very excited about that I know 5401 any other year in the absence of COVID-19 pandemic we will be talking about how amazing the OS 12 data was at ASCO so 85% survival at 12 months compared to you know mid 60% for standard of care and with OS 18 again around the corner in November at a cancer conference to be presented is is very exciting and it's a pretty well sized study in 52 patients so you know we we are very excited about that and and I'll be remiss not talking about the our orphan designated I know 3107 again you know we think this is a high value to the patients potentially high value to our shareholders as a first non surgical therapy if we're successful in getting it to the commercial arena for this horrible disease where patients both kids and adults who are you know who have to undergo multiple surgeries a year really designing and scheduling their lives around these procedures Inovio is leading the way to provide novel therapies in this regard. Just look at these first non-surgical immunotherapies for cervical dysplasia, anal and vulvar dysplasia, which are horrible diseases on their own, a novel immunotherapy treatment for arguably the toughest cancer to survive from in GBM and then horrible diseases like RRP. You know, I think Inovio is doing what I have always said and what we have always focused on, which is, you know, we have this urgency to bring these products, patients who need them. And, you know, I categorically, uncategorically say, you know, we haven't actually slowed any of those down.

No and you know so the the investor sentiment or at least the in terms of questions and.

And focus.

Has been around 4800, and naturally and that's understandable and we are as a company expanding you know extreme.

Focus and resources on that but as I touched on my part or the discussions so this call.

Oh, I am VGX 3100, our pivotal topline efficacy data our first phase three data is coming it's around the corner and I'm very excited about that I know 54 one.

Or any other here in the absence of Cowen 19, pandemic, we will be talking about how a amazing the oil S. 12 data.

It was at ASCO, so 85% survival at the 12 months compared to you know mid 60% or for standard of care.

And with oil S. 18, again around the corner in November a at a cancer conference.

To be presented is it's very exciting and that's it's a pretty well size study in 52 patients. So you know we we're very excited about that and I'd be remiss not talking about the our orphan designated I know 31, though seven.

Again, you know we think this is a high value.

To the patients potentially high value to our shareholders.

As a first nonsurgical therapy, a if were successful in getting it to the commercial arena a forward this horrible disease, where.

Patients both kids and adults. So for you know who have to undergo multiple surgeries, so you're really designing and scheduling their lives around a these procedures.

So is something that I'm very excited that inovio is leading the way.

To provide a a novel therapies or in this regard I mean, just just look look at these nonsurgical first nonsurgical immunotherapies for cervical dysplasia.

And no involve our dysplasia, which are horrible disease is on their own.

You know a novel immunotherapy treatments for arguably.

The toughest cancer to to survive from a in GBM and then horrible diseases like RFP.

No I think Inovio is doing.

Well I have always said and what we have always focused on.

Which is you know we have this urgency to bring these products to patients who need them.

And you know I categorically and categorically say.

No we haven't actually slow that near those down.

Rather we have focused and invested heavily.

Joseph Kim: [inaudible] So, you know, we're very excited about all of these aspects of what Inovio is doing. And that's what we're about. You know, we're bringing in new therapies where there weren't truly, you know, true practical solutions for RP, GBM, and VGX 3100 indications. And then, on top of that, we're able to search amazingly to tackle the pandemic of the century. So, you know, I, just like you guys probably are, would like us to be advancing faster than we are. Although, you know, we have our team working day and night, literally, to achieve these things. But you know, I think 2020 is going to be a transformative year. And I said that at the beginning of this year, and I still maintain, and I would double that down to claim that by the end of this year, we will look back on how important Inovio's role was in dealing with not just this pandemic but all of the other pipeline diseases that we're trying to provide new medicines for.

Into a are covered 19 vaccine. So are you know where we're very excited a in all of these aspects of what Inovio is doing and that's what we're about you know, we're bringing in new therapies, where there werent truly you know true.

Practical solutions.

You know for four RP, GBM and VGX 3100 indications and then on top of that were able to surge amazingly.

To tackle a the the pandemic as a century. So you know I just like a you guys probably are.

I would like us to be advancing faster than we are although you know we have our team working day and night or literally to achieve these things are.

But do you know I I think 2020 is gonna be a a transformative year and I said that at the beginning of this year.

I still maintain and and you know I would double that down to a claim that by end of this year, where we would look back and how important that inovio. Its role was a in dealing with not just with the spend demicks, but all of the other pipe.

Blind diseases.

That we're trying to provide new medicines for.

Noreen Kuibria: Got it. Yeah, that was very helpful. Congratulations again on the progress. Thank you, Noreen.

Got it yeah, but that was very helpful. I Congrats again on a pathway.

Chris Raymond: And our next question will come from Chris Raymond with Piper Sandler. Please go ahead. Hey, thanks for letting me ask a question. So I'm sorry, I just, hi, Joseph, how are you?

Thank you Laurie.

[laughter].

At our next question will come from Chris Raymond with Piper Sandler.

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Hey, Thanks for let me ask a question.

I'm, sorry, I just.

Hi, how are you. So I just wanted to carry understand them. The math back on I guess it was a 30 June you guys.

Chris Raymond: Um, so I just want to make sure I understand the math. Back on, I guess it was the 30th of June, you guys, in that phase one cohort noted 34 of 36 participants demonstrated overall immunological responses. Um, and I think I heard you say it's now 38 out of 38. So I guess the question I just want to make sure I understand what's going on with the patient numbers. Did you enroll more patients? Because I think there were a couple of patients that I remember that dropped out because they were COVID positive. Just, you know, help us understand the bridge from the data set.

And that in that phase one cohort noted 34 36 participant.

Has demonstrated overall overall.

Immunological responses.

I think I heard to say, it's about 30 to 38.

So I guess a question that's one of the picture I understand what's going on with the patient numbers.

Did you enroll more patients because I think there were.

A couple of patients as I remember that dropped out because they were coded positive.

Okay help us understand the bridge from the data. So yeah 32 now quickly yep. Thanks, Thanks for that question and and certainly this requires some clarification no. We haven't added anymore subjects or two to the data set.

Joseph Kim: Tune in now, please. Thanks.

Joseph Kim: Yep, thanks for that question, and certainly this requires some clarification. No, we haven't added any more subjects to the data set, but we have the luxury of having additional time to rerun those samples, and where samples are unavailable, find the next time point. So, looking at it holistically, both in week 6 and week 8, we're able to make those response judgments a little more...

But we have a the the luxury of having additional time to rerun those samples and where symposium on their available a finding a the next time point so looking at the Holistically, both send week six and weaker.

Eight a were able to make those Ah response or judgments a little more.

Joseph Kim: Now, of the 40, one person did drop out, totally unrelated to the vaccination or the trial. She just can't, he, she can't find transportation to the site.

Wisely now of the 41 person that drop out totally unrelated to the vaccination or or or the trial. She just can.

He she can find the transportation to the sites.

Joseph Kim: So that's one person. And one person did consistently confirm consistently to have at a baseline antibody responses to nuclear protein and other viral proteins, indicating that he or she was previously exposed to SARS-CoV-2. All the other 38 people, we were able to evaluate their immune responses. So where we positioned as preliminary as preliminary immune responses on June 30th, we have a lot more data to be more confirmatory in all 38 subjects who are available for evaluation in this first two-cohort study.

So that's one person and one person did confirm consists only to have a at a baseline.

Antibody responses to nuclear protein and other viral proteins, indicating that he she was previously exposed to Saar scobey to all the other 38 people, we were able to evaluate their immune responses. So.

Oh, where we have a position the S. Preliminary preliminary immune response on June Thirtyth, Oh, we have a lot more data to be more a confirmatory.

And all 38 subjects who are available.

For evaluating a in this first Ah two core study.

Chris Raymond: So I'm sorry, but were those COVID-positive patients included?

Hi, I'm sorry, so.

We are those coated positive patients included.

Joseph Kim: No. One person was confirmed, and so we did not include that person in the evaluation because they had very high baseline immune responses at entry. So one person dropped for an unrelated reason. One person was declared.

No.

One person was confirmed then so we did not include that person into a the evaluation because they had very high baseline immune responses at entry.

So one person dropped four unrelated reason one person was to be positive. So that's 38.

Joseph Kim: Positive.

Joseph Kim: So, that's 38.

Oh I'm sorry, your your press release them 30, you talked I think are you talk to three patients being excluded due to workovers, though.

Chris Raymond: Oh, I'm sorry, your press release on the 30th talked about three patients being excluded due to COVID-19.

Joseph Kim: Right, so two persons who were suspected ended up not being confirmed, so... Again, that's why we say preliminary analysis on those.

Right, so two persons or suspected a ended up not being confirmed so.

Yeah, that's why we look yeah, they say preliminary analysis on those things.

Chris Raymond: Okay.

Chris Raymond: Thank you.

Okay.

Thank you.

Joseph Kim: Yeah, no problem. Any other questions?

Yeah, no problem and the other questions.

Chris Raymond: Not for me, thanks.

Well enough for me thanks.

Great. Thank you Chris.

And this will conclude or a question and answer session I'd like to turn the conference back over the future second for any closing remarks.

Joseph Kim: All right. Thank you, Chris.

Joseph Kim: And that will conclude our question and answer session. I'd like to turn the conference back over to Joseph Kim for any closing remarks.

Great.

Thank you very much Uh huh.

We look for two.

Staying in touch, obviously and sharing more updates or on our coven 19 studies.

Joseph Kim: Great. Thank you very much.

Operator: We look forward to... Thank you for joining us, as well as all of the other important milestones, including Revio 1 and GBMOS 18 data. So, please stay tuned. Have a great night, and stay safe. Thank you very much.

S wireless although the other important milestones, including reveal one and GBM oil S. 18 data. So please stay tuned have a great night and stay safe. Thank you very much.

Joseph Kim: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.

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