Q1 2020 Earnings Call

[music].

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

Body and welcome to the Inovio first quarter 2020 financial results Conference call, all participants will be any listen only though.

Operator: If 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 touchtone phone. To withdraw your question, please press star again.

Do you do 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 the question. You May Press Star then one on your Touchtone phone to withdraw your question. Please press Star then too. Please note today's event is being recorded I would now like turn the conference over to Ben but tell feeder director of Investor relates.

Operator: Please note, today's event is being recorded. I would now like to turn the conference over to Ben Batone, Senior Director of Investor Relations. Please proceed, sir.

Please proceed sir.

Thank you operator, thank you everyone for joining the Inovio first quarter 2020 earnings call.

Ben Batone: Thank you, Operator, and thank you, everyone, for joining the Inovio First Quarter 2020 Earnings Call. With me today are Dr. J. Joseph Kim, President and CEO; Peter Kies, our Chief Financial Officer; Dr. Prakash Bhuvian, Vice President of Clinical Development and Head of Inovio's Clinical Programs to Treat HPV-Related Precancers, and Dr. Kate Broderick, Senior Vice President of Research and Development and Project Lead for Inovio's Infectious Disease Programs, who together will review our corporate Dr. Jacqueline Shea, our Chief Operating Officer, is also with us and will be joining for the Q&A session following prepared remarks. Today's call is being webcast live on our website, ir.inovio.com, and a replay of today's call will be made available shortly after the call is concluded.

With me today are dR.J., Joseph King President and CEO.

Peter Keys, our Chief Financial Officer.

Dr. Prakash <unk>, Vice President of clinical development and head of Inovios critical programs to treat HPV related pre cancers, and Dr. Cape Roderick Senior Vice President of research and development in project lead for Inovios infectious disease programs put together will review, our corporate financial and development progress for the first quarter 2020 Dr.

Jacqueline Shea our Chief operating officer is also with us and will be joining for the Q and a session following prepared remarks.

Today's call is being webcast live on our web site.

They are dot inovio dotcom and a replay of today's call will be made available shortly after the call's concluded.

Ben Batone: Following prepared remarks, we will conduct a question and answer segment which will be reserved for equity research analysts. During the course of this conference call, we will be making certain forward-looking statements regarding future events and the future performance of the company. In particular, these events, which relate to our business, include plans to develop Inovio's integrated platform of DNA medicines, clinical and regulatory developments, and timing of clinical data readouts, along with capital resources and strategic matters, as well as the impact of the COVID-19 pandemic on Inovio's business operations. All 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 risk and uncertainties described in today's press release, as well as the risk factors included in today's 10-Q filing with the SEC. Thank you for your attention. And with that, I would now like to turn the call over to Joseph.

Following prepared remarks, we will conduct a question and answers segment, which will be reserve for equity research analysts.

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

Particular, these events, which relate to our business include plans to develop inovios integrated platform of DNA medicines clinical and regulatory developments and timing of clinical data readouts, along with capital resources interest strategic matters.

As well as the impact of the cobot Nike pandemic on Inovios business operation.

All 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 could 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 risk and uncertainties described in today's press release as well as the risk factors, including today's 10-Q finally with the FCC.

Thank you for your attention and with that I'd now like to turn the call over to Joseph.

Thank you Ben and good afternoon, everyone.

Dr. J. Joseph Kim: Thank you, Ben. And good afternoon, everyone.

Dr. J. Joseph Kim: Thank you for joining us on the call today. Inovio had a productive first quarter with developments across multiple clinical programs, continuing to demonstrate the differentiating value and broad applicability of our DNA medicines platform. Please see the press release we just issued less than an hour ago for first quarter financial results and an extensive list of corporate highlights. I'm going to keep our prepared remarks brief so that we have plenty of time to address your questions.

Thank you for joining us on the call today.

No no had a productive first quarter with developments across multiple clinical programs continuing to demonstrate the differentiating value and broad applicability of our DNA medicines platform.

Please see the press release, we just issued less than an hour ago for first quarter financial results and then extensive list of corporate highlights.

I'm going to keep our remarks prepared remarks brief.

We have plenty of times to address your questions.

Dr. J. Joseph Kim: But before we delve into updates for each therapeutic program, I want to first provide an update on the impact of the COVID-19 pandemic on our programs in progress. First... Recognizing the importance of patient safety and adhering to the global stay-at-home government orders during the COVID-19 pandemic, our clinical operations and development teams have gone to great lengths to ensure patients participating in our clinical programs continue to be able to receive our DNA medicines and vaccines within a safe environment. I personally cannot thank them enough for their dedication and focus during these challenging times. Wow, we do not anticipate...

But before we delve into updates for each therapeutic program I want to first provide an update on the impact of the coven 19 pandemic when our programs and progress.

First.

Recognizing the importance of patient safety and noted adhering to the global stay at home government orders during the cold in 19 pandemic, our clinical operations and development teams have gone to great lengths to ensure patients participating in our clinical programs continued to be able to read.

Steve our DNA medicines and vaccines within a safe environment.

I personally cannot thank them enough for their dedication and focus during these challenging times.

While we do not anticipate.

While we do anticipate various impacts on every clinical trial as a result of the equivalent 19 pandemic as of today, our clinical candidates for 2020 that we outlined at the beginning of this share remain on track.

Dr. J. Joseph Kim: While we do anticipate various impacts on every clinical trial as a result of the COVID-19 pandemic, as of today, our clinical catalysts for 2020 that we outlined at the beginning of this year remain on track. Beyond 2020, it is still difficult to clearly project the exact impact the continuing COVID-19 pandemic will have on our clinical development programs. That said, we do anticipate that the enrollment rate for Reveal-2, which has been at about 50% for the months of March and April during the pandemic lockdown, will likely impact the Reveal-2 timeline. Prakash will speak to this during his remarks on VGX 3100.

Beyond 2020, it is still difficult.

To clearly projecting Sac N Pac the continuing Kuwait 19 pandemic will have on our clinical development programs that said, we do anticipate that the enrollment rate for reveal too.

Which has been at about 50% for the months of March and April drink dependent I mean locked down what likely impact revealed to timeline.

Cash will speak to this during his remarks on VGX 3100, but at this time, we are not changing guidance for our B.L.A. anticipated timing and we will continue to work with the sites on reveal to accordingly to ensure both patient safety and data.

Dr. J. Joseph Kim: But at this time, we are not changing guidance for our BLA anticipated timing, and we will continue to work with the sites on Reveal 2 accordingly to ensure both patient safety and data integrity. Inovio remains on track and well positioned to have 2020 be a transformative year for the company. We remain confident that this statement will be true even in the midst of this global pandemic. Our team continues to be diligent and resourceful to ensure we are on track to deliver key data milestones in 2020, which include revealing phase three top line efficacy data from our lead asset VGX 3100 in the fourth quarter. Overall survival at 12 months data or OS-12 data from INO5401 for our GBM therapy being presented at ASCO and abstracts available this afternoon, followed by OS-18 data in the fourth quarter. And you'll hear more from Peter during his financial update.

Integrity.

Inovio remains on track.

And well position to have 2020 to be a transformative year for the company.

We remain confident that this stay memo true even in the midst of this global pandemic.

Our team continues to be diligent and resourceful to ensure we are on track to deliver a key data milestones in 2020.

Which include reveal one phase three topline efficacy data from our lead asset VGX 3100 in the fourth quarter.

Overall survival at 12 months data or oil as 12 data from I know 54, or one four GBM therapy being presented at ASCO and abstracts available. This afternoon, followed by August 18 data in the fourth quarter.

And you'll hear more from Peter during his financial update but in Inovio remains well capitalized having a strong balance sheet that is which is essential for properly executing our product development and business objectives and the continued global uncertainty related to.

Dr. J. Joseph Kim: But Inovio remains well-capitalized, having a strong balance sheet, which is essential for properly executing our product development and business objectives and the continued global uncertainty related to COVID-19. While our 200 plus employees are not all working physically side by side, our R&D and manufacturing teams in San Diego are in our facilities relentlessly driving the development of our immunotherapies and vaccines, including INO4800, while practicing social distancing and taking Keep our team safe.

Coven 19.

Bahar 200, plus employees and not working off physically side by side, our R&D and manufacturing teams in San Diego are in our facilities relentlessly driving the development of our Immunotherapies in vaccines, including I know 4800.

Well practicing social distance thing and ticking all measures necessary to keep our team safe.

Most of our team is working remotely and seamlessly together and our share of mission to urgently developer DNA vaccine that we believe will play a significant par and addressing this global health crisis.

Dr. J. Joseph Kim: The rest of our team is working remotely and seamlessly together in our shared mission to urgently develop our DNA vaccine that we believe will play a significant part in addressing this global health crisis. As we highlighted in today's press release, Inovio has validated the speed and versatility of our DNA medicines platform by rapidly entering the clinic with our novel DNA vaccine candidate, INO4800, in the fight against COVID-19. Kate will elaborate more on this shortly, but I want to preface that our INO4800 development effort has truly been a global and collaborative one. Since we began developing a COVID-19 vaccine in January, we have been forging and expanding collaborations with government entities and premier private funders, including the U.S. Department of Defense, CEPI, and the Bill and Melinda Gates Foundation.

As we highlighted in today's press release Inovio has validated the speed and versatility of our DNA medicines platform by rapidly entering the clinic with our novel DNA vaccine candidate I know 4800 into fight against come in 19.

Kate will elaborate more on that shortly but I want to profess that our I know 4800 development effort has truly been a global and collaborative one.

Since we began developing a coven 19 vaccine in January we have been forging and expanding collaborations with government entities and premier privates funders, including the U.S. Department of Defense Seppi, and a bill and Melinda Gates Foundation you.

Inovio is collaborating with leading labs around the world to test the vaccine and it's working with a team of existing and new contract manufacturers to scale up the menu fact that shrink capacities.

These relationships have help inovio expedite vaccine development access untapped resources and prepare to massively scale up or device and plaza in the manufacturing processes to potentially create hundreds of millions of I know 4800 doses dissatisfied.

Dr. J. Joseph Kim: Inovio is collaborating with leading labs around the world to test the vaccine, and it's working with a team of existing and new contract manufacturers to scale up the manufacturing capacity. These relationships have helped Inovio expedite vaccine development, access untapped resources, and prepare to massively scale up our device and plasmid manufacturing processes to potentially create hundreds of millions of INO4800 doses to satisfy the urgent global demand for a safe and effective vaccine We plan to update you in more detail in the coming months. To speak more about our infectious disease experience and where we are with INO4800, I would now like to turn the call over to Dr. Kate Broderick. Kate?

Urgent global demand for a safe and effective vaccine we plan to update you in a more detailed in the coming months.

To speak more on our infectious disease experience and where we are with I know 4800, I would now like to turn the call over to Dr. Kate Broderick Kate.

I don't seem to be Dr. <unk>. He wanted it looks like you're kidding.

Thank you [laughter] communities opening remarks, our team has been exceptionally productive doing these exceptionally challenging times.

And so on her to be working with.

Dr. Kate Broderick: Thank you, Joseph, and good afternoon, everyone. It's a pleasure to be here today.

Dedicated team.

Our dedication alongside got him.

He's expertise and p. existing kilometer engine.

Dr. Kate Broderick: As Joseph expressed during his opening remarks, our team has been exceptionally productive during these exceptionally challenging times, and I'm so honoured to be working with such a brilliant and dedicated team. Our dedication, alongside our infectious disease expertise and pre-existing collaborations, has allowed us to be in a position to rise to this emerging public health challenge, being one of the first and few companies to be initially called on to develop a vaccine. In fact, when we first embarked on this development back in January, the name COVID-19 didn't exist, and the virus, in fact, was not deemed a pandemic for another five to six weeks.

Thank you [laughter] Tonight, [laughter] marketing public health challenge.

You'd want to parse the few companies could be inaccurately called on [laughter] vaccine.

[laughter] impact wouldn't be forced embarked on this development backing John Guinee lean Qubits 19 different [laughter].

On the Beida flat with no end upon Dan <unk> by next week.

Yes, you we are nearly four monthly I'm very pleased to hear with your progress to be recouping, Nike any vaccine <unk> [laughter] team over the next few mom.

[noise] anything D., we went from a vaccine design.

Human do.

I can tell remarkable speed.

Last month, we completed the park or to do says Oh, Porky healthy volunteers in our fees one.

Dr. Kate Broderick: And yet here we are, nearly four months later, and I'm very pleased to share with you our progress to date on our COVID-19 DNA vaccine and what you should expect to see over the next few months. In 83 days, we went from a vaccine design to first human dosing. That is a remarkable speech.

Clinical study with I knew 1400 against Cooper 19 disease.

For the Phase one study we enrolled at sites at the University of Pennsylvania under clinic in Kansas City facility.

D., we don't track for all four people in two years to complete the second runs that do think by the last week company.

Dr. Kate Broderick: Last month, we completed the first of two doses in all 40 healthy volunteers in our Phase 1 clinical study with INO4800 against COVID-19 disease. For this Phase I study, we enrolled at sites at the University of Pennsylvania and a clinic in Kansas City, Missouri. As of today, we are on track for all 40 volunteers to complete the second round of dosing by the last week of May.

After which we expect to how preliminary safety and Immunogenicity data I leave June in support of advancing rapidly piece to the efficacy trial, which is planned to potentially and then he and the July August type thing.

Frontline healthcare workforce in multiple beat your medical centers in the USA.

Concurrently we also expect part partners I bought seen an idea right to initiate two separate phase one clinical trials OPI into 14 equally good this summer in China, I can hear respectively.

Dr. Kate Broderick: After that, we expect to have preliminary safety and immunogenicity data by late June in support of advancing rapidly to a Phase 2-3 efficacy trial, which is planned to potentially initiate in the July-August timeframe in frontline healthcare workers in multiple major medical centers in the U.S. Concurrently, we also expect our partners, AbbVaccine, and IVI, to initiate two separate Phase 1 clinical trials of INO4800 this summer in China and South Speaking of our previous MERS vaccine work, we will be presenting positive data from our Phase 1, 2A trial, providing a great foundation for the current COVID-19 work at the American Society of Gene and Cell Therapy Conference this week. As already published in the conference abstract for the study participants receiving 0.6 migs of INO4700 intradermally with the selector device. 88% demonstrated zero conversion after a two-dose regime at zero in eight weeks, while those receiving a three-dose regime gave it 0, 4, and 12 weeks.

He came from our previous Mar boxing work, we will be presenting he pulled that can be income from our fees. One to me trial, providing a great foundation for the come cool thing teamwork at the American Society of gene and cell therapy call. This week.

I've already published in the called out stock or the study participants receiving the 0.6 banks Oh, I know 4700 into Donnelly with its electric device.

He per se and demonstrated sito conversion after two dose regime.

Neither Whitney weak.

Well those receiving a three eagles regime getting the Eagle Ford in 12 week.

84% Sito can borrow pick off the two doses.

100% office, he doses as measured by a binding.

He bought the RFP again to like like protein.

I definitely 92% boxing recipients in both good [laughter] lead the ability to get to like Midas using a utilization I think.

Google T cell responses were observed and 60% of the box recipient opted to dual thinking.

<unk> four per se, it's cool in the three dose group.

Dr. Kate Broderick: 84% seroconverted after two doses and 100% after three doses, as measured by a binding antibody assay against the full-length spike protein. Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization acid. Robust T-cell responses were observed in 60% of the vaccine recipients after the two-dose regime and 84% of those in the three-dose group. Interestingly, after a single dose of 0.6 mg of INO4700, intradermal vaccination resulted in 74% binding antibody response rate and 48% neutralizing antibody response rate. We have designed our COVID-19 vaccine, INO4800, using the same strategy as we did for INO4700, including the selection of the full-length spike protein as the target and the use of an intradermal selector delivery device.

Interestingly often single do.

Our next leg O'brien, who 4700.

Intradermal locks and he has resulted in 74% binding on people the Oh actually.

48% neutralizing antibody response rate.

[laughter] designed our pool that 19 vaccine idle 4800, using the same strategy has to be dead, what I had to 4700.

Including the for like the feel like spiked protein target, how many years [laughter] thermo electric delivery device.

<unk> I'm not convinced that the ongoing season, one clinical trials with no 1400.

Yeah, I didn't think assemble or level of clinical abuse responses and safety data.

Just a poor to what I had 4700 good.

Furthermore, this latest D has demonstrated.

The power of the intradermal delivery.

The strength of our could order by this expedience.

Furthermore, I really crazy to see that while Inovio has been able to playing a you vaccine from constructors thing to phase one clinical trials rentcorp tight we were still able to confirm the robust immune responses O'brien, who 4800 and multiple animal models that we typically.

Dr. Kate Broderick: We are both hopeful and optimistic that the ongoing phase one clinical trial with INO4800 will generate a similar level of clinical immune responses and safety data as we have just reported for INO4700. Furthermore, these latest data demonstrate both the power of the intradermal delivery and the strength of our coronavirus experience. Furthermore, I am really proud to say that while Inovio has been able to bring a new vaccine from construct design to phase one clinical trials in record times, we were still able to confirm the robust immune responses of INO4800 in multiple animal models that we typically test all our vaccine candidates in, including small animals all the way up to non-human primates. In fact, our preclinical data has been accepted for a peer-reviewed publication in Nature Communications, demonstrating robust T and antibody responses, including neutralization antibody responses, in several animal models with INO4800 vaccination.

Yes to all our vaccine candidates and including small animals overly out to non human primate.

In fact, our preclinical data has been accepted put a peer reviewed publication that nature communication.

Demonstrating goupil team, an antibody responses, including neutralization antibody responses in several animal models with I knew 4800 vaccination.

Over the next couple of months, we will also expect a teen and report data from several honorable Challenge studies being conducted kilometer instantly at some of the world, leading Laborde and studies.

Limited getting these preclinical gizmos and continued work with an animal challenge studies, along with all expected fees what detail June we anticipate having the Nexus said he had immune response and safety data to support our CLO, even tell large randomized phase two study efficacy study.

And finally I'm not been important about Ted Gilpin dubious platform technology I wanted to see here is our de any vaccines do not require the challenging deep frozen coaching stood edge.

In fact, our vaccines are stable at room temperature, but at least one yeah I'm for five years at two to eat it could eat healthier.

Dr. Kate Broderick: Over the next couple of months, we will also expect to attain and report data from several animal challenge studies being conducted collaboratively at some of the world's leading laboratories. Leveraging these preclinical results and continued work with our animal challenge studies, along with our expected phase 1 data in June, we anticipate having the necessary immune response and safety data to support our plan to move into a large randomized phase 2-3 efficacy study. And finally, another important advantage of Inovio's platform technology that I wanted to state here is that our DNA vaccines do not require the challenging deep frozen cold chain storage. In fact, our vaccines are stable at room temperature for at least one year and for five years at two to eight degrees Celsius, which, of course, is normal refrigeration temperature. In comparison, most messenger RNA and viral vector vaccines are not temperature sensitive and stable and often have to be maintained in a freezer cold chain as low as minus 80 degrees Celsius. This is an important differentiator and key advantage of Inovio's DNA vaccine. And with that, I'll now turn it back over to you, Joseph. Thank you.

Of course is normal refrigeration temperature.

In comparison move messenger R&D vital vectored vaccines are not temperature sensitive.

People are often have to be maintained in a freeze or cold chain as Louis minus 80 degrees Celsius.

[laughter] important differentiator and he advantage over do view the any vaccine.

Oh.

Ill now turn it back over to you.

Keith.

Thank you Kate I appreciate that update really amazing work again I can't Thank you and the team enough for all the dedication and hard work that you had been doing in the midst of this pandemic.

To reiterate.

We are aiming to be interface to slash three efficacy study.

The July August timeframe, where we will be targeting healthcare workers on the front line.

We estimate the high side of the study size to be around 2000, healthcare workers and are capable regulatory and clinical operations teams are confident that we could fully enrolled this number up participants and about one month.

Again, the actual size of the study will largely depend a depend on the infection rate at that time.

In addition to our plan to determine the true efficacy of our vaccine and a large well designed randomized phase two three study. We're also planning to pursue the emergency use authorization path to achieve emergency approval of I know 4800.

Dr. J. Joseph Kim: Thank you, Kate. I appreciate that update. Really amazing work.

Dr. J. Joseph Kim: Again, I can't thank you and the team enough for all the dedication and hard work that you have been doing in the midst of this pandemic. To reiterate, we are aiming to be in a Phase 2-3 efficacy study by the July-August timeframe, where we will be targeting healthcare workers on the front line. We estimate the high side of the study size to be around 2,000 healthcare workers, and our capable regulatory and clinical operations teams are confident that we could fully enroll this number of participants in about one month. Again, the actual size of the study will largely depend on the infection rate at that time.

We plan to utilize Immunogenicity and safety data from our phase one trial as far less from an early subset of face to slash three participants along with our anticipated preclinical efficacy data from our ongoing animal challenge studies the phase.

Form our E away submission being planned for potentially fourth quarter of this year.

Now, let's move our update to our mid and late stage clinical programs.

In fact in less than 48 hours from now the overall survival at 12 months data for our I know 54, or one immunotherapy and 52 newly diagnosed GBM patients study will be available to the public as our abstract has been.

Dr. J. Joseph Kim: In addition to our plan to determine the true efficacy of our vaccine in a large, well-designed randomized phase 2-3 study, we're also planning to pursue the emergency use authorization path to achieve emergency approval for INO4800. We plan to utilize immunogenicity and safety data from our Phase 1 trial, as well as from an early subset of Phase 2 slash 3 participants, along with our anticipated preclinical efficacy data from our ongoing animal challenge studies to form our EUA submission, planned for possibly the fourth quarter of this year. Now, let's move our update to our mid- and late-stage clinical program. In fact, in less than 48 hours from now, the overall survival at 12 months data for our INO5401 immunotherapy in 52 newly diagnosed GBM patient study will be available to the public, as our abstract has been accepted for presentation at ASCO.

Accepted for presentation at ASCO.

After tracks would be available this Wednesday at five PM, followed by a virtual presentation at the end of this month.

We had previously presented very exciting progression free survival at six months in this study last winter. So naturally I know you are all really excited to see this early promising data fully translate to the O.S. 12 data.

You will not have to wait too long for this data.

Before I turn the call over to per cost for an update on VGX 3100.

I want to provide a brief update on I know 31 of those seven which targets the rare orphan HPV associated disease, our p. or recurrent respiratory petaluma ptosis.

Given the progressive nature of this rare debilitating and pitch potentially life threatening disease patients are eager for an alternative treatment. So they can avoid repeated invasive surgery.

Dr. J. Joseph Kim: Aftrax will be available this Wednesday at 5 p.m., followed by a virtual presentation at the end of this month. We had previously presented very exciting progression-free survival at six months in this study last winter, so naturally, I know you are all really excited to see this early promising data fully translate to the OS12 data. You will not have to wait too long for this data.

As we stated in our last call. The F.D.A. accepted Inovios I in the application to evaluate I know 31, no seven in a phase one celeste two trial for the treatment of RP.

Dr. J. Joseph Kim: Before I turn the call over to Prakash for an update on VGX3100, I want to provide a brief update on INO3107, which targets the rare orphan HPV-associated disease, RRP, or recurrent respiratory papillomatosis. Given the progressive nature of this rare, debilitating, and potentially life-threatening disease, patients are eager for an alternative treatment so they can avoid repeated invasive surgeries. As we stated in our last call, the FDA accepted Inovio's IND application to evaluate INO3107 in a phase 1 slash 2 trial for the treatment of RRP. We expect to enroll approximately 63 patients in this Phase 1-2 trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO3107 in patients with high-risk HPV6, and or 11 associated RRPs, who have needed at least We anticipate to begin dosing patients this summer. So, we have so much to look forward to this summer on top of our progress with INO4800. Now, I'd like to turn over the call to Dr. Prakash Bhuyan, MD, PhD, who will provide an update on multiple targets and studies we have ongoing for VGX 3100. Prakash?

We expect to enroll approximately 63 patients in this phase once less steep two trial.

To evaluate the efficacy safety Tolerability and Immunogenicity of I know 30, 107 in patients with high risk HPV, six and or 11 associated or a pea.

Who have needed at least two surgeries annually for the last three years.

Ah or two or remove the papilloma tumors.

While the covered 19 pandemic pass throwing a curve ball at this trial.

We anticipate to begin dosing patients this summer.

So we have so much to look for to the summer on top of our progress in I know 4800.

Now I'd like to turn over the call to Dr. Prakash Purion M D. P H C.

We'll provide an update on multiple targets and studies, we have ongoing for VGX 3100 Prakash.

Thank you Joseph and Hello, everyone.

You know.

Our lead asset is VGX, 3100, which targets HPV associated diseases.

Despite the negative impact of Kogas 19 upon our clinical programs, we still plan to report topline efficacy data from reveal one which is our pivotal phase three trial.

<unk> HPV related hybrid cervical dysplasia patients patients and that'll be in the fourth quarter. This year.

Core reveal to recruitment is still underway at our sites around the world and the Coven 19 pandemic has certainly had an impact upon our patient recruitment since March.

Dipesh A. Patel: Thank you, Joseph. And hello, everyone.

We are hopeful and getting back to the pre pandemic rates as soon as possible as various countries and regions to get into open back up.

Dipesh A. Patel: As you know, our lead asset is VGX 3100, which targets HPV-associated diseases. Despite the negative impact of COVID-19 upon our clinical programs, we still plan to report top-line efficacy data from REVEAL-1, which is our pivotal Phase III trial, for HPV-related high-grade cervical dysplasia patients, and that'll be in the fourth quarter of this year. For Reveal 2, recruitment is still underway at our sites around the world, and the COVID-19 pandemic has certainly had an impact on our patient recruitment since March. We are hopeful of getting back to pre-pandemic rates as soon as possible as various countries and regions begin to open back up.

As a reminder, reveal too has the same design and target patient enrollment of 198 subjects as an reveal one main difference.

Is the safety follow up time of.

One month for reveal to versus one year or reveal one.

Turning now to our positive interim data that we reported in March.

It is CCP, we continue to validate the broader applicability of VGX 3100, and or HPV platform in general.

So specifically in our phase two trial in annual dysplasia Weve reported the of the 20 patients with data available 50% showed clear is of their HPV 16, 18 positive pre cancerous lesions.

75% of the subject showed a reduction in the HPV 16, 18 positive precancerous lesion number just six months after the first dose.

Dipesh A. Patel: As a reminder, Reveal 2 has the same design and target patient enrollment of 198 subjects as in Reveal 1. The main difference is the safety follow-up time of one month for Reveal 2 versus one year for Reveal 1. Turning now to our positive interim data that we reported in March at ASCCP, we continue to validate the broader applicability of BGX 3100 and our HPV platform in general. So specifically, in our phase two trial in anal dysplasia, we've reported that of the 20 patients with data available, 50% showed clearance of their HPV 1618 positive precancerous lesions, and 75% of the subjects showed a reduction in the We do believe these data are extremely encouraging.

We do believe these data are extremely encouraging not only do they build upon the previously reported efficacy in our cervical dysplasia piece to the trial, but as further content.

To this only one in five people with HPV 16 associated precancerous dysplasia would be expected to exhibit spontaneous resolution at one year.

Without adequate treatment pre cancerous anal dysplasia typically progressed the it'll cancer.

Having a DNA medicines that can clear these lesions without the burden of repetitive multiple and painful surgical or invasive treatment would change the standard of care and provide patients with a true meaningful benefit.

Demonstrating gx 31, hundreds broad applicability, we also reported encouraging phase two initial data in our Volvo or.

Dysplasia trial were 12 of the 22 subjects, who completed their primary endpoint evaluation at six months following the treatment with VGX 3100.

Dipesh A. Patel: Not only do they build upon the previously reported efficacy in our cervical dysplasia phase 2b trial, but as further context, to this, only one in five people with HPV-16-associated precancerous dysplasia would be expected to exhibit spontaneous resolution at one year. Without adequate treatment, precancerous anal dysplasia would typically progress to anal cancer. Having a DNA medicine that can clear these lesions without the burden of repetitive, multiple, and painful surgical or invasive treatments would change the standard of care and provide patients with a true, meaningful benefit. Demonstrating VGX 3100's broad applicability, we also reported encouraging Phase 2 initial data in our vulvar dysplasia trial, where 12 of the 22 subjects completed their primary endpoint evaluation at six months following treatment with VGX 3100.

The results.

Were shared it is CCP in March and demonstrated that 80% of treated women had an overall decrease in those areas six months after treatment.

Two trial subjects completely resolved there HPV 16.

Those are dysplasia and to put this into context spontaneous regression for these patients is expected to be very low about 2% to 5% and typically takes one to two years.

So taken together these data build the case for VGX 31, hundreds broader potential to treat HPV caused pre cancers and further proof of concept for our DNA medicine approach.

Look forward to providing full study results for both the Volvo our animal Precancerous dysplasia trials later this year.

With that I'll turn it back over to you Joseph.

Great. Thank you for cash running a large global phase three study is challenging enough and working in the wake of a pandemic, yes unprecedented you and your team.

Dipesh A. Patel: The results, which were shared at ASCCP in March and demonstrated that 80% of treated women had an overall decrease in the affected area six months after treatment, two trial subjects completely resolved their HPV-16 vulvar dysplasia. And to put this into context, spontaneous regression for these patients is expected to be very low, about 2 to 5%, and typically takes one to two years. So taken together, these data build the case for VGX3100's broader potential to treat HPV-caused pre-cancers and provide further proof of concept for our DNA medicine approach. We look forward to providing full study results for both the vulvar and anal precancerous dysplasia trials later this year. And with that, I'll turn it back over to you, Joseph.

I have been truly Rockstar through all this showing your tireless dedication to work on providing a therapeutic alternative to surgery and improve the quality of life for these patients. Thank you again.

Now I will ask our CFO, Peter keys to provide a financial update theater.

Thanks, Joe So and good afternoon, everyone first I will provide a summary of our capital resources for the first quarter of 2020.

The company ended with 20 with two 270 million in cash cash equivalents in short term investments as of March 30, Onest 2020.

To this cash position, we added an additional 100 and a 21.7 million through the ATM in April.

Given the uncertainties associated with the macro impact.

That's dependent dammit may have on the global economy.

We have been bowl prudent and proactive and maintaining a strong financial position, providing inovio with multi years worth of cash runway.

As both Kate and Josef mentioned during their.

Dr. J. Joseph Kim: Great. Thank you, Prakash. Running a large global phase 3 study is challenging enough, and working in the wake of a pandemic is unprecedented. You and your team have been truly rock stars through all this, showing your tireless dedication to work on providing a therapeutic alternative to surgery and improve the quality of life for these patients. Thank you again. Now, I will ask our CFO, Peter Kies, to provide a financial update. Peter?

Prepared remarks, the company anticipate to continue to receive external funding to support Inovios advancement of I know 4800.

Turning now to revenue and net income or net loss in our case, we reported total revenue of one point Threemillion for the three months ended March 31st 2020.

Inovios net loss for the quarter.

Ended March 31st 2020 was 32.5 million or 26 cents per share basic and diluted.

Peter D. Kies: Thanks, Joseph, and good afternoon, everyone. First, I will provide a summary of our capital resources for the first quarter of 2020. The company ended with $270 million in cash, cash equivalents, and short-term investments as of March 31, 2020. To this cash position, we added an additional $121.7 million through the ATM in April. Given the uncertainties associated with the macro impact that the pandemic may have on the global economy.

Lastly, R&D expenses for the three months ended March 31st 2020 were 19.1 million.

Compared to 24.4 million for the same period and 29 team.

The decrease in R&D expenses was primarily related to a decrease in employee compensation expenses.

Due to lawyer lower employee head count accompanied by a decrease in clinical trial expense timing.

And there was an increase in our contra.

R&D expense recorded from Grand revenues.

It completes summary of our financial statements.

For the first quarter of 2020 can be found in today's press release and in our and our form 10-K filed with the FCC.

Peter D. Kies: We have been both prudent and proactive in maintaining a strong financial position. Providing Inovio with multi-years' worth of cash flow, As both Kate and Joseph mentioned during their prepared remarks, the company anticipates to continue to receive external funding to support Inovio's advances of INO4800. Turning now to revenue and net income, or net loss, in our case, we reported total revenue of $1.3 million for the three months ended March 31, 2020. Inovio's net loss for the quarter ended March 31, 2020, was $32.5 million, or $0.26 per share Basic and Diluto. Lastly, R&D expenses for the three months ended March 31, 2020 were $19.1 million, compared to $24.4 million for the same period in 2019. The decrease in R&D expenses was primarily related to a decrease in employee compensation expenses.

This can also be accessed on our website under Investor Relations financial report with that I'll turn it back to your Joseph Thanks.

Thank you Peter.

Before we turn to the analysts queuing today I.

I like to list all of the events, we expect before our next earnings report in August.

For the list, we expect to report on 12 months overall survival efficacy data.

I am I know 54, one in GBM to be presented at ASCO in late May.

Second preliminary safety and immune responses data from our U.S. phase one trial for coffee 19 vaccine I know 4800 in 40 healthy volunteers.

Next data from our Colgate 19 animal Challenge studies.

Fourth additional external funding to support I know 4800 development.

Yes.

Either started or be poised to star our large randomized phase two slash three efficacy trial upon regulatory approval.

Six sort of additional clinical trial for I know 4800 in China and in South Korea.

Seven stuff of patient dosing for phase one slash two clinical trial of I know 31, no seven to treat RP.

Lot of milestones for two.

Peter D. Kies: Due to lower employee headcount, accompanied by a decrease in clinical trial expense timing, and there was an increase in our contra R&D expense recorded from grant revenue. A complete summary of our financial statements for the first quarter of 2020 can be found in today's press release and in our Form 10-K filed with the SEC. This can also be accessed on our website under investor relations, financial reports. With that, I'll turn it back to you, Joseph. Thanks.

Now I look forward to talk taking your questions. Operator, please open the line for the analysts.

Thank you.

People are now begin the question answer session to ask a question you May Press Star then one on your Touchtone phone.

If you're using a speakerphone please pick up your handset before pressing the keys.

If your question that's been answered and you wish to withdraw yourself. Please press Star then too we will pause for one moment to assemble our roster.

Our first question today will come from Stephen Willey with Stifel. Please proceed with your question.

Yeah. Good afternoon. Thanks for taking the question Big Joseph You mentioned in your comments a couple times regarding your ability to secure external funding.

Dr. J. Joseph Kim: Thank you, Peter. Before we turn to the analyst's Q&A, I'd like to list all of the events we expect before our next earnings report in August. Here is the list. We expect to report on 12 months overall survival efficacy data from INO5401 in GBM to be presented at ASCO in late May. Second, preliminary safety and immune responses data from our U.S. Phase 1 trial for COVID-19 vaccine INO4800 in 40 healthy volunteers. Next, data from our COVID-19 animal challenge studies. Fourth, additional external funding to support INO4800 development. Either start it or be poised to start our large, randomized Phase 2-3 efficacy trial upon regulatory approval. 6, Start of additional clinical trials for INO4800 in China and South Korea. 7, start of patient dosing for phase 1 slash 2 clinical trial of INO3107 to treat RRP. A lot of milestones to look forward to. Now, I look forward to taking your questions. Operator, please open the line for the analysts.

I believe there was a suddenly grant handed out too competitive program here after aftermarket hours today and you know that's obviously an organization that you have a pre existing relationship with a did you I think 60 million for the Mers vaccine. So.

I'm not sure what you can say about the funding process itself, but you know.

I guess anything you can say just with respect to active dialogues you maybe having you know whether this involves some kind of formal application process.

And to what extent you know the need to to scale a devices is potentially viewed as a as a rate limiting step here by some of these agencies.

Well, Thanks, Steve Great question, then and I.

I guess, the great thing for for Novavax and.

And seppi as I stated before there are.

Sensitive amount of fundings available for promising vaccine candidates as we all have seen BARDA contracts to both change and there are no and now set be funding to novavax.

There's probably at least $15 billion to $20 billion and total funding available and both Florida and separately and Bill and Melinda Gates Foundation each have said.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

They will each support up to 5.64, seppi, and and Bardas case, and both seppi, n. and be a or B M. Jeff. Both have stated that that will support up to eight different candidates in rapid scale up.

Operator: If your question has been answered and you wish to withdraw yourself, please press star then 2. We will pause for one moment to assemble our roster. Our first question today will come from Stephen Willey with Steeple. Please proceed with your question. Yeah, good afternoon.

So I think there you know congratulations to novavax.

And and maturing nine JNJ have already received theirs. So I think the potential of additional funding.

Stephen Willey: Thanks for taking the question. I think, Joseph, you mentioned in your comments a couple of times regarding your ability to secure external funding. I believe there was a CEPI grant handed out to a competitive program here after market hours today. And, you know, that's obviously an organization that you have a pre-existing relationship with. They gave you, I think, $60 million for the MERS vaccine. So, I'm not sure what you can say about the funding process itself, but, you know, I guess anything you can say just with respect to active dialogues you may be having, you know, whether this involves some kind of formal application process. And to what extent, you know, the need to scale a device is potentially viewed as a rate-limiting step here by some of these agencies.

For Inovio I think it's great I do think there will be a.

A total of 10 to 12 viable candidate vaccines, which will be heavily invested by these various funding agencies. So you know s., we make progress.

I think are the potential of Inovios, receiving these external funding as we mentioned in her prepared remarks is is very good.

Lastly, touching on your question about the devices you know we received already funding from Bill and Melinda Gates Foundation earlier this year to help accelerate our commercial vaccine device a and were on good track track for doing that so I don't believe the devices in the rates are going.

To be a rate and emitter for us to both scale up.

And also received this external funding.

Okay. That's that's helpful color and.

Dr. J. Joseph Kim: Well, thanks Steve, great question and I think it's a great thing for Novavax and CEPI. As I stated before, there is, you know, an extensive amount of funding available for promising vaccine candidates, as we all have seen BARDA contracts to both J&J and Moderna, and now CEPI funding to Novavax. There's probably at least $15 to $20 billion in total funding available, and both BARDA and CEPI and the Bill and Melinda Gates Foundation each have said they will each support up to five or six. I do think there will be a total of 10 to 12 viable Canadian vaccines which will be heavily invested in by these various funding agencies. So, you know, as we make progress, I think the potential of Inovios receiving external funding, as we mentioned in our prepared remarks, is very good.

You talked about the desire to pursue a mid emergency use authorization path and.

I think maybe even reference to some mission here before the end of this year can you maybe just talk a little bit about how that process logistically works.

Leaves the you areas under the auspices HHS not at the so.

What kind of <unk> submission actually needs to be made is is is that analogous to two I guess and then da filing or.

I was that different I guess, when you're when you're submitting something to two or two agency that's outside of.

Yeah.

Yeah, I mean, certainly a secretary of HHS has the authority to provide you away authorization.

But of course, a the F.D.A. reports through the HHS. So.

Dr. J. Joseph Kim: Lastly, touching on your question about the devices, you know, we received funding from the Bill and Melinda Gates Foundation earlier this year to help accelerate our commercial vaccine device, and we're on good track to do that. So I don't believe the devices and the arrays are going to be a rate limiter for us to both scale up and also receive these external funding.

As we have seen numerous we Ah and therapeutics and diagnostics case, there's been a dozens of you raise provided for those two areas for vaccines, there hasn't been any ever so the clarity on how.

And when those may occur.

It's something that we and our team or regulatory team our clinical team are working through but here's what what spends communicated to us and others publicly one is the vaccine has to demonstrate some level of safety.

Stephen Willey: Okay, that's, that's helpful color. And, you know, you talked about the desire to pursue an emergency use authorization path and, I think, maybe even referenced a submission here before the end of this year. Can you maybe just talk a little bit about how that process logistically works? I believe the EUA is under the auspices of HHS, not FDA.

And immune responses and especially if it can tie those immune responses to any challenge model data or if they are relevant.

So I think we would be at inovio to be in position with our phase one primary data Readouts in June.

Dr. J. Joseph Kim: What kind of submission actually needs to be made? Is that analogous to, I guess, an NDA filing? How is that different, I guess, when you're submitting something to an agency that's outside of New York? The FDA.

With multiple animal challenge studies, including non human primates, ferrets and mice were to be reported in the next couple of months that we were being a great position to collect to stay to.

Dr. J. Joseph Kim: Yeah, I mean, certainly, the Secretary of HHS has the authority to provide EUA authorization. But, of course, the FDA reports through HHS. As we have seen numerously in therapeutics and diagnostics cases, there have been dozens of EUAs provided for those two areas.

Evaluate and prepare a proper submission.

To the F.D.A. J.

For anyway. So I you know I think the exact mechanism and the process will be clarified and the next couple of months, but we should be in a great position to apply for that.

Dr. J. Joseph Kim: For vaccines, there haven't been any, ever. So, the clarity on how and when those may occur is something that we in our team, our regulatory team, our clinical team, are working through. But here's what's been communicated to us and others publicly. One is that the vaccine has to demonstrate some level of safety and immune responses. Especially if you can tie those immune responses to any challenge model data, if they're relevant. So, I think we would be, at Inovio, in a great position with our phase one primary data readouts in June, and with multiple animal challenge studies, including non-human primates, ferrets, and mice, to be reported in the next couple of months, that we will be in a great position to collect those data, evaluate So, I think the exact mechanism and the process will be clarified in the next couple of months, but we should be in a great position to apply for that.

Okay I'll hop back in the queue. Thanks.

Right.

Our next question will come from Chris Raymond of Piper Sandler. Please proceed with your question.

Hi, Thanks for taking the question and congrats on all the progress during the quarter. Our this isn't a cold compression on for Chris.

So maybe can I just wanted to happen Hi, [laughter] ahead of the ACO abstract thing really to see if we just wanted to clarify Diana. Thank you for a one data what should we expect to seen the abstract versus what will be presented could you just provide a little more color on that.

Yeah, the abstract a will provide the actual percentage of.

Our cohorts surviving at 12 months.

So thus providing a west 12 number.

Just to jog everybody's memory or we have 52 total patients in our study I know 54, one plus 90 12, a dose together with regeneron slipped tayo are there a PD one checkpoint inhibitor.

All the patients also received standard of care, which is comprised of surgery.

Stephen Willey: Okay, I'll have that in the queue, thanks. Great.

Operator: [inaudible]

Chris Raymond: Our next question will come from Chris Raymond of Piper Sandler. Please proceed with your question. Hi, thanks for taking the question and congrats on all the progress during the quarter. This is Nicole Gabreski on behalf of Chris. So, maybe just ahead of the ASCO abstracts being released this week, I guess we just wanted to clarify the INO5401 data: what should we expect to see in the abstracts versus what will be presented? Could you just provide a little more color on that?

And chemo radiation chemo with team as older mine. So we what we're looking for a while we're looking for to presenting this the overall survival of our total 50 to a patient population at 12, <unk> and we will be able to compare.

Ah that information or West 12 to what we would expect from a a extensive publications and these populations from standard of care of surgery, and chemo radiation and typically all commerce, both Unmethylated unmethylated.

Dr. J. Joseph Kim: Yeah, the abstract will provide the actual percentage of... are cohorts surviving at 12 months. So that's providing an OS-12 number. Just to jog everybody's memory, we have 52 total patients in our study. I know 54, 1 plus 90, 12.

The standard of care has been reported in about 65% or those populations being a alive.

At 12 months, so it's a very devastating cancer, but we're hopeful that we can present much higher.

Then 65% or in our abstract.

Which will be visible.

On Wednesday evening this week.

Great. That's helpful. And then maybe just got a second question.

Dr. J. Joseph Kim: Those together with Regeneron's Lipteo, their PD-1 checkpoint inhibitor. All the patients also received standard of care, which is comprised of surgery, and Chemoradiation, and chemotherapy with Temozolomide. So what we're looking forward to presenting is the overall survival of our total 52 patient population at 12 months. And we will be able to compare that information, OS12, to what we would expect from extensive publications in these populations from the standard of care of surgery and chemoradiation. And typically, all comers, both unmethylated and methylated, the standard of care has been reported in about 65% of those populations being alive at 12 months. So it's a very devastating cancer. But we're hopeful that we can present much higher than 65% in our abstract, which will be visible on Wednesday evening this week.

I know 4800, just as far as but the trial to find that you laid out for the phase two three today and you know they target patient population and that trial side. If you talk to ft. About these details and received feedback on that at this point.

Well, we have a interacted with yesterday and in a general sense, but we expect to have that are more detail communications regarding the trial design as we finalize them, so what I prepared and what I provided to.

Disclose today really are rough a design of course, our team is for yearsley working to finalized and refined in preparation with our interactions with the FDA to come.

Okay, great. Thank you so much.

Great. Thanks.

Our next question will come from Gregory rental with RBC capital markets. Please proceed with your question.

Chris Raymond: Great, that's helpful. And then maybe just a second question on INO4800. Just as far as the trial design that you laid out for phase two, and three today, and just the target patient population and the trial size, have you talked to FDA about these details and received feedback on that at this point?

Hey, just came out and congratulations again on all this progress. Thanks for your contribution here to the a pandemic and thanks for.

For taking my question here.

Okay. Thanks, Joseph yet yeah. Thank you I just wanted to start I'm, a little bit as you sort of talk about 4800 and its its profile I'm mentioning a of course the.

Dr. J. Joseph Kim: Well, we have interacted with the FDA in a general sense, but we expect to have a little more detailed communications regarding the trial design as we finalize it. So what I prepared and what I provided to... I'd like to disclose today our rough design. Of course, our team is furiously working to finalize and refine in preparation for our interactions with the FDA to come.

The convenience with.

With distribution as well as yeah, the suitability or targets with healthcare workers going after the in the next trial just curious if you could discuss a little bit about the suitability of this asset what makes it perhaps different from from the others and should we be picking up or particular, either geography or patient populations that.

Perhaps get 4800 art particular edge, especially by the fact that it can really be a multi asset or multi pronged approach to fund a solution with the vaccine. Thank you very much.

Chris Raymond: Okay, great. Thank you so much. Great, thanks.

Yeah. Thanks, Craig you know just quickly as Kate summarize stuff earlier Theres couple of attributes that makes a inovios I know 4800.

Operator: All right, thanks.

Gregory Arenza: Our next question will come from Gregory Arenza with RBC Capital Markets. Please proceed with your question.

Dr. J. Joseph Kim: Hey, Joseph, and team. Congratulations again on all this progress. Thanks for your contribution here to the pandemic, and thanks for taking the question.

More advantageous compared to other platforms out there one is the stability of the product. So DNA plasmid are extremely stable or we have long term products dating five around five years or with two to eight degree.

Gregory Arenza: Yeah, thanks, Joseph. Yeah, thanks. I just wanted to start a little bit as you sort of talk about

Dr. J. Joseph Kim: 4800 and its profile, mentioning, of course, the convenience of distribution as well as the suitability or targets for healthcare workers going after the next trial. I'm just curious if you could discuss a little bit about the suitability of this asset, what makes it perhaps different from the others, and should we be thinking of particular geographies or patient populations that would perhaps get 4800 or a particular edge, especially in light of the fact that this can really be a multi-asset or multi-pronged approach to find a solution with the vaccine. Thank you very much.

Celsius refrigerator conditions, you can leave it and a ambient temperature for over a year and not lose any potency of the vaccine.

So it's a true advantage over or most of the m. on a or viral vectors or proteins.

Which have to maintain a frozen cold chain throughout the distribution and storage China conditions.

Second a major importance or major advantage that our DNA vaccines have compared to other platforms is our ability to generate those high levels of C.D.A.T.. So killer T cell responses against the antigen.

Dr. J. Joseph Kim: Yeah, thanks, Craig. You know, just quickly, as Kate summarized earlier, there's a couple of attributes that make Inovio's INO4800 more advantageous compared to other platforms out there. One is the stability of the product. So DNA plasmids are extremely stable. We have long-term product dating around five years with two to eight degrees Celsius refrigerator conditions.

Along with our ability to generate or the neutralizing antibodies. So we've demonstrated this NR nature communication publication or and what I think is really important is ah. Both this balance immune responses and C D.

T cell responses, which is less susceptible to changes.

And viral antigens sequences. So you know I think being able to provide well see the a T cell response as well. So neutralizing antibody response is something that the other platform vaccines will not have as much.

Dr. J. Joseph Kim: You can leave it at ambient temperature for over a year and not lose any potency of the vaccine. So, it's a true advantage over most mRNA or viral vectors or proteins, which have to maintain a frozen cold chain throughout the distribution and storage conditions. A second major advantage that our DNA vaccines have compared to other platforms is our ability to generate both high levels of CD8 T-cell, killer T-cell responses against the antigen, along with our ability to generate the neutralizing antibody. So, we've demonstrated this in our Nature communication publication, and what I think is really important is both this balanced immune responses and CD8 T cell responses, which are less susceptible to changes in viral antigen sequences.

Certainly at what we saw in our Mers vaccine.

Challenge studies in non human primates, or rhesus mechanics, where we saw 100% protection against or the pathogenic Mers virus challenge. We saw that there was very important so have both neutralizing antibodies.

Or binding antibodies, but also very important to have strong T cell responses. So I think our ability to generate both T cells and antibody responses, well lend us very well to perhaps immune compromised populations maybe.

Dr. J. Joseph Kim: So, you know, I think being able to provide both a CD8 T-cell response as well as a neutralizing antibody response is something that the other platform vaccines will not have as much of. Certainly, what we saw in our MERS vaccine challenge studies in non-human primates or rhesus macaques, where we saw 100% protection against the pathogenic MERS virus challenge, we saw that it was very important to have both neutralizing antibodies or binding antibodies but also very important to have strong T-cell responses. So I think our ability to generate both T-cells and antibody responses will lend us very well to perhaps immune-compromised populations, maybe older, more senior populations, and perhaps other segments, as well as the general public. I think, you know, the level of the immune responses that we've been generating, and I can turn to Kate for a little more details. What we are already seeing in non-human primates in terms of antibodies and T cell responses, I think we're very excited about that compared to the convalescent patient data that others have published in recent publications. Kate, would you like to discuss a little bit more about our immune responses compared to published convalescent patient data?

The older or more senior populations.

And perhaps a other segments. That's one of those to general public I think you know the level of the immune responses that that we've been generating and I can turn to Kate well that are more details what we're already seeing and non human primates in terms of the antibodies and the T cell responses.

I think we're very excited.

About that compared to the convalescent patient data that others have published a in recent publications Kate would you like to discuss a little bit more about our.

Immune responses compared to the published convalescent patient data.

Yeah, absolutely and then one thing that and I was particularly excited to see was because of pivoting and who is doing quite rightly mentioned, we have generated really gone in ruble.

Okay antibody in T cell responses, including neutralizing antibody and Olympiad animal more recently tested.

What was really very heartening to see was that repaid 50 of those responses.

We started seeing really measurable response is really very early on is not as Hilton R&D to communication and pursuing it's really not really quite important, especially when you're thinking about an emerging infectious diseases, we aren't at the moment obviously.

As Justin mentioned, we've also had access to convalescent patient Sina and when she was able to do site by site comparisons in its really.

Dr. Kate Broderick: Yeah, absolutely. And then one thing that I was particularly excited to see was the rapidity. And so, as Joseph quite rightly mentioned, we generated really rather robust antibody and T cell responses, including neutralizing antibodies in all of the animal models that we tested. But what was really very heartening to see was the rapidity of those responses. So we started seeing really measurable responses really, very early on, and that's detailed in our Nature communication paper.

It's very very encouraging to see the levels that we're seeing in the animals.

Beatty compatible to the levels that we're seeing in the compilation patients. So it's and it's looking very promising movement.

That's very helpful. Thank you very much and just one more quick ones, if I may and they verde and provide some color on on device on strategy and price I'm. Just curious if some as you talk about 1 million doses by at the end of the year to to have been capacity for how that translates into.

In two devices and what progress we should be looking for their maybe more specifically what the yet the dose to devise ratio operation like can be expected to be thank you.

Yeah, Thanks, Greg well, just roughly when when we say, where we're preparing 1 million doses or were discussing or were stating.

Dr. Kate Broderick: So that's really quite important, especially when you're thinking about an emerging infectious disease as we are at the moment, obviously. But as Joseph mentioned, we've also had access to convalescent patient sera. And so we're able to do side-by-side comparisons, and it's really, very encouraging to see the levels that we're seeing in the animals are very comparable to the levels that we're seeing in the convalescent patients. So it's looking very promising at the moment.

The plasmids and ER device and the race to deliver them. So.

If you can't really have one with the without the other Ah. So we're on a right track to to do that so we're preparing and at to do beyond that were.

We're preparing a and and and.

Increasing our scale.

To be able to provide hundreds of millions of doses are starting next year.

Gregory Arenza: That's very helpful. Thank you very much. And just one more quick one, if I may. I'm just curious if, as you talk about 1 million doses by the end of the year, which one will have the capacity for, how that translates into devices and what progress we should be looking for there, maybe more specifically, what the dose to device ratio operationally can be expected to be. Thank you.

So these are the preparations a that take to a which we already doing to scale up.

And in that massive scale, assuming success of idle for your 800, a you know we will be in great position to do so by relying on our current contract manufacturers of plasma and adding on additional manufacturers that can help us scale.

Now a in the device side, Oh, we have already Oh have both to.

Dr. J. Joseph Kim: Yeah, thanks, Greg. Well, just roughly, when we say we're preparing 1 million doses, we're discussing or stating both the plasmids and the device and arrays to deliver them. So you can't really have one without the other.

Produce enough Oh.

Race and devices to meet the 1 million the need so those processes are ongoing both within our GMP facility in San Diego, That's why LSR additional contract.

Dr. J. Joseph Kim: So we're on the right track to do that, but we're preparing to go beyond that. We're preparing and increasing our scale to be able to provide hundreds of millions of doses starting next year. So these are the preparations that take take to, which we're already doing, to scale up at that massive scale. Assuming the success of INO4800, you know, we will be in a great position to do so by relying on our current contract manufacturers of plasmids and adding on additional manufacturers that can help us scale. On the device side, we've already produced enough arrays and devices to meet the 1 million need. So those processes are ongoing, both within our GMP facility in San Diego, as well as with our additional contract device and array manufacturers that we have brought on board. So these are very extensive efforts. You know, we've never had to prepare for hundreds of millions of doses, if not billions of doses, that might be required to combat COVID-19 globally. Prior to this year, most of the doses that we were planning for were in hundreds of thousands of doses, if at most, millions of doses.

Device and the re manufacturers that we have brought on so these are very extensive efforts you know we've never had to prepare for hundreds of millions of doses of if not billions of doses that might be require to combat coven 19 globally prior to.

This year or most of our doses that we were planning for war in hundreds of thousands of doses.

If I add most millions of doses. So I think this is a challenge our team has taken on.

And I think we're making great progress in this regard.

Thanks Joseph.

Yeah. Thanks, Craig.

Our next question will come from an already Cambria of Maxim Group. Please proceed with your question.

Hi, I'm congrats on all the progress and thanks for taking my questions. I guess my first one is on the TBM study you know that you'll be presenting on Africa and it will get the data just in a few days you know you mentioned that survival data for when you for these patients are historically, 60% to 65% at one yeah are you.

Able to share with us what kind of Delta you hope to see from historical rate.

The 12 month, Alaska, what do you would you think would be encouraging.

Well, what number would get you're excited Laurie.

Dr. J. Joseph Kim: So I think this is a challenge our team has taken on, and I think we're making great progress in this regard. Thanks, Joseph. Yeah, thanks, Greg.

[noise] [laughter], obviously <unk> [laughter].

Well higher then that's a great question, but.

Yeah, I think a substantive increase over 65 60, 65% will be very encouraging you know this is not the totally Ah finish line. We will follow these patients or at least for another six months or longer so we won't be.

Noren Kibria: Our next question will come from Noren Kibria of Maxim Group. Please proceed with your question. Hi, congratulations on all the progress and thanks for taking my questions. I guess my first one is on the GBM study that you'll be presenting at ASCO, and we'll get the data in just a few days. You know, you mentioned that survival data for one year for these patients are historically 60 to 65 percent at one year. Are you able to share with us what kind of delta you hope to see from historical rates for the 12-month OS? What would you think would be encouraging?

I mean, we feel like this is a data set that we're building up so from a PFS six.

Which was very exciting you know between.

20% to 30%.

Difference compared to the standard of care at the early progression free number.

It was very encouraging to us.

And where we are today.

Overall survival at 12 months, and and I think that adds to another.

Dr. J. Joseph Kim: Well, what number would get you excited?

Noren Kibria: Well, higher than that.

Level validity and confidence in this data and then as we continue to have longer.

Dr. J. Joseph Kim: That's a great question.

Dr. J. Joseph Kim: Yeah, I think a substantive increase over 65, 60, 65% will be very encouraging. You know, this is not the totally finished line.

Tail in the survival curve and these are patients at O.S. 18, I mean that would even be Ah Ah even greater feet. So are you know a won't be afraid number for you a if you assume the send their care 60 to 65.

Dr. J. Joseph Kim: We will follow these patients at least for another six months or longer. So we will be, I mean, we feel like this is a data set that we're building up. So from PFS6, which was very exciting, you know, between, you know, 20% to 30% difference compared to the standard of care at that early progression-free number was very encouraging to us. And where we are today at overall survival at 12 months, and I think that adds another level of validity and confidence in this data. And then as we continue to have a longer tail in the survival curve for these patients at OS18, I mean, that would be an even greater feat. So, you know, what would be a great number for you if you assume the standard of care is 60 to 65?

Well I I liked it I would like it to be perfecting how about you know that that [laughter], that's sort of why right [laughter] right.

I don't remember my very difficult cancer population, you know right, everyone dies and 5.5 years right. So.

And the overall survival.

Median survival for Unmethylated population is around one year.

About 13, 14 months and that's the latest populations around 2022, a month. So yeah. These are really a patients or who are suffering from a very deadly cancer. So anything we can do you know because there hasn't been a huge.

Events men in GBM therapy Ah since Temozolomide.

So if if we are 54 one.

Plus a regenerons the tail can make and then a impact on this important cancer.

Noren Kibria: Well, I like it. I would like it to be perfect, you know, but you know that's sort of possible, right?

I would be really thrilled with the data so.

No I think you're just kind of stay or be stay tuned for a couple more days to to see our data.

Dr. J. Joseph Kim: I remember a very difficult cancer population, you know, everyone dies in five years, right? So the overall survival, median survival for the unmethylated population is around one year, about 13, 14 months, and methylated populations around 20, 22 months.

Hi, I'm and as for you know you he wants to posted positive interim data on them over and you know I'm anticipating studies.

On on a proportion of patients back in March.

Keith minus are those studies actually fully enrolled.

Yes, yes, Oh, okay, Okay, and we're fully enrolled last year, what we presented at a at CCT, ER and ER publicly disclose or or the patients who crossed the six months or the actual endpoint or timeline. So.

Dr. J. Joseph Kim: So these are really patients who are suffering from a very deadly cancer. So anything we can do, you know, because there hasn't been a huge advancement in GBM therapy since temozolomide. So if we are 54-1, plus Regeneron Zepteo, can make an impact on this important cancer, you know, I would be really thrilled with the data. So, I think you just got to stay tuned for a couple more days to see our data.

Oh.

You know over the next or a couple months I think we will have full data set.

From all the patients in both phase two study so a we will have those data available.

Noren Kibria: Great. And as for, you know, you also posted positive interim data on the vulva and dysplasia studies on a proportion of patients back in March. Can you remind us, are those studies actually fully enrolled?

Later this year.

Okay, Great and one last one for me on this is regarding then maybe four or five seven with the service study.

Actually this last week on the clinical trials website, Astra zeneca updated their head and neck study and maintain the anticipated Nemo patient from 40 to 35 actual patient from 40 anticipated. The 35 I'm. Just curious you know is there anything we might be able to lead from that and you don't have any thoughts on that.

Dr. J. Joseph Kim: Yes. Okay.

Dr. J. Joseph Kim: The actual endpoint timeline. So, you know, over the next couple of months, I think we will have a full data set from all the patients in both phase two studies. So, we will have those data available later this year.

Noren Kibria: Okay, great, and one last one for me. This is regarding MEDI-457 and the DERVA study. Actually, just last week on the clinical trials website, AstraZeneca updated their head and neck study, and they changed the anticipated number of patients from 40 to 35 actual patients. I'm just curious, you know; is there anything we might be able to read from that? You know, do you have any thoughts on that?

No we have publicly disclosed or I believe last chair that they had.

Fully enrolled that 35 patients.

And they're continuing following these patients for survival benefits as well so.

No we as we stated before I still expect Astra Zeneca to report.

Some data this share at but we can't really a say when that may be so they have full control is he has full control over the data and went on where to present, but Ah we expect that to be in some time in 2020.

Dr. J. Joseph Kim: No, we had publicly disclosed, I believe last year, that they had fully enrolled 35 patients, and they're continually following these patients for survival benefits as well. So, you know, we, as. We expect that to be sometime in 2020.

Great. Okay got it thank you that's awesome.

Great. Thank you.

Our next question will come from Yi Chen with H.C. Wainwright. Please proceed with your question.

Noren Kibria: Great. Okay, I got it. Thank you. That's all for me.

Thank you for taking my question like this guy is.

Operator: Great. Thank you.

Hi, Hi, Joseph.

How many data sets oh from the.

Yi Chen: Our next question will come from Yi Chen with HC Wainwright. Please proceed with your question. My first question is... Hi Joseph. How many data sets from the animal challenge studies will we expect in the coming months?

Liberal telling studies can we expect.

Yes, so we have mouth mouse challenge well Kate would you like to address this.

These are your study so.

Yes, certainly juices thinking so I'm really and continuously tools into Luca wide spectrum all challenge model.

Dr. J. Joseph Kim: Yes, so we have a mouse challenge. Well, Kate, would you like to address this? These are your studies, so.

Dr. Kate Broderick: of challenge models, which include the mouse challenge, the ferret challenge, and the primate challenge. We think that's going to give us a really broad picture of how well our vaccine is performing. We're very confident about that. So we've partnered with labs all across the globe who are clearly leaders in their particular fields of challenge. And so we're going to be getting the data as it comes out, with the mouse data being delivered soonest in the next month or so.

The knives challenge the fed it challenge in the probably the challenge.

We think that's gonna give us a really broad spectrum picture of how well our vaccine is performing very competent.

And so where we partner with and really have labs, all across the group, who are and are clearly leaders and be in their particular I'm feeling so challenge.

I'm, so we're gonna be getting whose data as it comes I am with this I just need to be a and deliberate soonest and as the next month or so.

Got it thank you.

Yi Chen: Good, thank you. Next question regarding the design of the phase two, three trial this summer. At that time, I guess there will be other vaccines, COVID-19 vaccines, probably being evaluated in phase two trials as well. Do you think they will also recruit frontline healthcare workers to be enrolled in their vaccine? And if so... Well, of course, these healthcare workers probably will be constantly exposed to COVID-19 viruses. So how long do you plan to follow these workers after the injection of the vaccine? And also, they will likely be wearing personal protective equipment. So, I guess at the end of the trial, you will probably measure how many people actually get infected. But of those who are not getting infected, how do we know they are getting protection from the vaccine, or they're getting protection from personal protective equipment?

Question regarding design things to trial this summer.

At that time, I guess, there will be other about saying, okay. My two questions.

Probably a valid phase two trials as well do you think they will also recruits.

But like Hell skilled workers to be rolled up their.

There are best in class.

It's so.

Well of course of these healthcare workers, probably won't because definitely exposed to a Colin I can.

Viruses, so how long do you plan to Paulo EMS workers.

Injections with us.

And also.

They will likely be where weve personal protective equipment, so I guess or the out of the trial.

You will probably measure how many people.

Actually getting buckets, but those who are not getting perspective, how do you know they're getting the protection cut about say audio can protection from a personal protective equipment.

Dr. J. Joseph Kim: Yeah, great, great question. So duration of follow-up, obviously, we'll report after we get the determination from the FDA. So, you know, as it could be as long as a year, it could be about six months, we look for the duration that makes sense for us. Either way, we will continue to follow up with these volunteers in a phase four study if we're successful in terms of the vaccine efficacy. Yeah, this will be a randomized double-blinded study. So we expect half the participants will get our vaccine, and half will get a placebo. So it will be a true randomized design, true efficacy, determining study. So while we're targeting, you know, why we Why we want to do this is because the health care frontline workers are, you know, these are our heroes and they're day in and day out, even with their PPE constantly exposed to a potential infection with the virus.

Yeah, great great questions. The duration of follow up obviously well report after we get a the determination with the FDA.

So you know as it could be as long as a year or it could be about six months.

You know we look for.

The duration that makes sense for us are either way, we we will continue to follow up.

With these volunteers a in a phase four study a if were successful.

In terms of the vaccine efficacy.

Yeah. This would be a randomized double blinded study. So we expect a half the participants will get our vaccine half a placebo so it'll be a true randomize or design true efficacy that terminating a study so while we're targeting.

Why we.

Well, we want to do this is a health care frontline workers are you know these are our heroes and their day in and they out.

Even with or a P. P constantly exposed to a potential infection with the virus. So we feel that this population is the frontline.

Dr. J. Joseph Kim: So we feel that this population is the frontline population that we would want to protect first. So, getting true efficacy data in this setting will be highly valuable for not just our vaccine development but the overall advancement of the field as a whole. But we also feel that we have a very compelling candidate, and I know forty eight hundred.

Population that we would want to protect first so getting a true efficacy data or in this setting will be highly valuable.

For for not just our vaccine development, but overall events men are the field, that's a whole, but we also feel that we have a very compelling candidate and I know 4800, so we'd like to get a tested and this very challenging environment. So that we can bring them.

Dr. J. Joseph Kim: So we'd like to get it tested in this very challenging environment so that we can bring the vaccine as fast as we can to these heroes and the general public as rapidly as possible. In terms of the overall performance of the vaccine, you know, I think we'll get a very good idea by June how well our vaccine is doing from immune responses data and all 40 healthy volunteers. And by the way, as I mentioned, or Kate earlier, that all of the 40 folks who bravely volunteer for this important study, their safety profile has been great thus far. They will all receive their second dose by the end of, before the end of May.

Seen as fast as we can to these heroes and and just the general public us as rapidly as possible.

In terms of the overall performance of the vaccine you know I think we'll get a very good idea by June.

How well our vaccine stirring from.

Immune responses data and the all 40, a healthy volunteers and by the way as I mentioned and ER or Cade earlier that all of the 40 folks who bravely volunteer for this important study.

They're they're safety profile has been great thus far.

Dr. J. Joseph Kim: So, we're very excited about how well that study is ongoing. And of course, our animal response data, as I mentioned, will be publicly viewable soon, as that paper has been accepted for peer review in Nature Communications. And as Kate mentioned about the challenge studies, we should have the mouse challenge data. That's being run in China. We have ferret challenge studies ongoing in Australia, and we have non-human primate studies ongoing in England and the U.S. So, you know, we think we have a very compelling vaccine, and we hope to demonstrate not just the immunogenicity and potentially the protective ability of this vaccine, leading into our phase 2 slash 3 efficacy study.

So we're very excited how well that studies ongoing and and of course, our animal response data as I mentioned will be publicly viewable soon.

S that paper has been accepted or through a peer review it in nature Communications and what Kate mentioned about the challenge studies or we should have the mouse challenge data that's being run in China. We have fared challenge studies ongoing in Australia, and we have non human prime.

<unk> studies ongoing in England and in the U.S. So yeah. We think we have a very compelling vaccine and we hope to demonstrate not just immunogenicity and potentially the protective ability of the sexy this vaccine.

Leading into our face to slash three efficacy study.

Yi Chen: Got it. It appears back in the 90s that the FDA and CDER agreed to a human challenge study for a cholera vaccine. Do you think this is necessary for COVID-19? What are your thoughts on this?

Got it.

Appeared backing the Myday is that yes, yes, Youre has agreed to a human challenge study or any color about so do you see this isn't necessarily for Copel 19, that's also a common.

Dr. J. Joseph Kim: You know, I'm still very concerned about human challenge. You know, there have been other human challenge studies for vaccines successfully done for influenza, for RSV, and others. I think norovirus as well.

You know I I'm still very concerned about human challenge or you know there it's been.

Other a human challenge study sort of vaccine successfully done.

For influenza for RSV, and others are I think norovirus as well but.

Dr. J. Joseph Kim: But, you know, so much is still unknown about the SARS-CoV-2 virus and COVID-19 disease. I think the risk really outweighs the potential benefit for those volunteers. So I personally have some ethical questions that are still unresolved for us to support a human challenge study in such a new disease. That being said, you know, I think the spirit of moving faster is something that we all prescribe to at Inovio. And that's why we want to get to a well-designed, large efficacy trial, both to demonstrate the efficacy and the true safety of our vaccine. You know, we feel really strongly that our vaccine is safe, beyond what we have demonstrated in our previous clinical study. And we look forward to demonstrating that in our Phase 1 study with INO4800 and upcoming Phase 2 slash 3 trial as well in a larger population.

Not so much is still unknown about Saar scobey to virus and covered 19 disease I think the risk really outweighs the potential benefit.

For those phones here, so I personally have some at school questions that so its unresolved.

For for Us to support a human challenge study in such a new disease.

That being said I, you know I think the spirit of moving faster.

It's something that we all prescribed to add Inovio and and that's why we want to get to a well design large efficacy trial boasted demonstrates the efficacy and the true safety of our vaccine you know we feel really strongly that our vaccine is.

Safe.

A cross out what we have demonstrated in our previous clinical studies.

And we look forward to demonstrating that in our phase one study with I know for your hundreds and a upcoming phase two slashed three trial as well and larger population.

Yi Chen: Got it. My last question is on operating expenses. So as long as the economic lockdown is still in place across the country, do you expect the R&D expenses to remain the

Got it well that's costing us on the Oakley expenses, so as long as the economy Lucked out there in place across the country do you expect the R&D expenses to remain relatively local bullet.

Peter D. Kies: This is Peter.

Oh this is Peter and expenses Yeah go ahead Peter.

Peter D. Kies: Yeah, we expect them to remain fairly consistent. As we said before, we expect most of the 4800 expenses to be funded by external forces. And so we expect the expenses to remain fairly consistent. But we will see we did have a bonus payout that we hadn't budgeted. So that added a little bit more. So we're looking at about 80 million annually. 80 to 85 net burn annually.

Yeah, we expect them to remain fairly consistent as we said before we expect most of the.

4800 expenses to be funded by external forces.

And so we expect expenses have remained fairly consistent.

But we will see we do know about a bonus payout that we we hadnt budgeted so that's a little bit more so we're looking at about 80 million annually.

80 to 85 net burn annually.

Yi Chen: Okay, I got it.

Okay got it and thank you so with that projection you know our cash runway is.

Yi Chen: With that projection, you know, our cash runaway is...

Dr. J. Joseph Kim: They're quite healthy, so we feel that with uncertainty of the pandemic... You know, we have a strong financial position, we have lots of important data milestones coming up, even without COVID-19 vaccine in GBM and Revio 1, but then you add in a rapid development in COVID-19 vaccine, both in phase 1 data and all of the challenge results in the next couple of months, you know, we really have a very data-full 2020 in the next several months.

Quite healthy so we feel yes, ah with uncertainty or the pandemic.

You know, we we have a strong financial position, we have lots of important data milestones coming up even without coven 19 vaccine a in GBM and reveal one but then you add and of course are developed a rapid development and coven 19 vaccine both in phase one day.

ER and all of the challenge results in the next couple of months you know, we really have a very data fall a 2020 in the next several months.

Yi Chen: Got it. Thank you. Yep, thanks.

Got it thank you.

Yi Chen: Yep, thanks, Xi.

Thanks you.

Our next question will come from the Jonathan Ashok with Roth Capital. Please proceed with your question.

Operator: Our next question will come from Jonathan Ashoff with Roth Capital. Please proceed with your question. Thank you. I was wondering, early in your comments, did you say that Reveal 2 was 50% enrolled, or that COVID-19 is making the enrollment rate 50% of what it was before COVID-19?

Thank you I was wondering early in your comments did you say that reveal too was 50% enrolled where that covert nineteens, making the enrollment rate 50% of what it was before cope with 19.

For a ladder for March and April so we saw a decrease in enrollment rate.

Jonathan Ashoff: It's louder for March and April, so we saw a decrease in enrollment rates from prior to the pandemic level because of all of the lockdowns and such stay-at-home orders globally.

Ah from prior to the pandemic level.

Because of all of the locked down and such a stay at home orders globally.

Dr. J. Joseph Kim: Okay, and how much do you think will be spent in total, you plus the external funding, on 4,800 up to the point that you know if it is clinically successful enough to seek approval?

Okay, and how much do you think will be spend can totally you plus the external funding on 4800 to the point that you know if only 800 as clinically successful you could.

Well I mean, it depends on on eat away or traditional B.L.A.

Either way it could be even before we finish the face to slash three trial.

Dr. J. Joseph Kim: Well, I mean, it depends on EUA or traditional BLA. So EUA could be even before we finish the phase two slash three trial, as efficacy is not a required element in an EUA application. [inaudible] So, obviously, clinical trial expenses and Phase 1 studies have already been funded through CEPI and others, and we expect to receive additional funding for our next clinical development stages, including Phase 2 slash 3. So, you know, I think we're gonna be very well funded in support of advancing INO4800. The next steps are to make sure that we can deliver many, many doses that are required from society in the U.S. for a safe and effective vaccine to get to the public as soon as possible.

As a the efficacy is not a required.

Element and the you a application.

But you know if it for accounting the phase two three and it really lot of the spending will be on the scale up the manufacturing and the money spent to provide the doses.

So you know obviously.

You know clinical trial expenses, and and phase one studies or have already been funded through sept be and.

Another seven and we expect to receive additional funding.

For our next clinical development stages, including face to slash three so you know I think.

We're gonna be very well funded a in support of advancing I know 4800. The next steps are to make sure that we can deliver.

Many many doses that is required from the society.

You know continually as more people die.

Across the globe, especially in the United States, No, there's more increase and an increasing demand.

Dr. J. Joseph Kim: So, we're taking a stepwise approach, you know, taking both the EUA path, where emergency approval could be granted for a specific targeted population like first responders and healthcare workers, and then getting it through, getting our clinical development plan through a randomized, large, well-designed efficacy trial to gather the true efficacy of our vaccine and its safety in large numbers in support of a BLA approval.

For a safe and effective vaccine to get to the public as soon as possible. So we're taking a step wise approach.

You know taking both the you a path.

Where emergency approval could be granted for specific targeted population like though first responders and healthcare workers and then getting it through a getting or.

Clinical development plan through the the randomized large well design efficacy trial together, a the true efficacy or vaccine and the safety in large numbers in support of A.B.L.A. approval.

Jonathan Ashoff: Joe, if it was a BLA, how much do you think it would cost that full forward process, including a million dollars?

Joe if it wasn't the L.A. how much.

Cool and stuff like that who thought process.

<unk> million doses.

Dr. J. Joseph Kim: Potentially, our next trial could be a registrational trial, Phase 2-3, if we assume that, and we assume a million doses, I mean, that will be in a total value of 100 million doses, a dollar. Under $50 million.

So.

Potentially our next trial could be a registrational trial phase two slush three.

For you assume that.

And we assume a million doses I mean that that won't be in a total value of 100 900 million dose a dollars.

Under 50 million from start Kay.

Jonathan Ashoff: All right, thank you very much.

Okay.

Very much for yes, yes totally thank you.

Dr. J. Joseph Kim: Yes, yes.

Dr. J. Joseph Kim: Yes, totally. Thank you.

Dr. J. Joseph Kim: Thank you. This concludes our question and answer session. I would now like to turn the conference back over to Joseph Kim for any closing remarks.

Thank you right. This concludes our question and answer session I would now like turn the conference back over to Joseph Kim for any closing remarks.

Dr. J. Joseph Kim: I'd like to thank everyone for their attention. We look forward to another productive and important quarter coming up. So we look forward to sharing with you all of these important milestones in the next few months. Thank you very much.

I like to thank everyone for your attention, we look forward to a another productive and an important quarter coming up.

So as we look forward to sharing with you all of these are important milestones in the next few months. Thank you very much.

Operator: The conference is now concluded. Thank you very much for attending today's presentation. You may now disconnect.

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

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