Q1 2021 Inovio Pharmaceuticals Inc Earnings Call

[music].

Good day, and welcome to the Nokia and OBL Pharmaceuticals first quarter 2021 financial results conference call.

Operator: Good day, and welcome to the Inovio Pharmaceuticals first quarter 2021 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead. Thank you, Operator. Thank you for joining the Inovio First Quarter 2021 Earnings Conference.

All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero and.

After todays presentation, there will be and opportunity to ask questions and please note. This event is being recorded and now I'd like to turn the conference over to bed Midtown and senior director of Investor Relations. Please go ahead.

Thank you operator, thank you for joining the and Novo first quarter 2021 earnings conference call.

Joining me on today's call are Dr. Joseph Kim President and CEO, Mr. Peter Keith CFO, Dr. Jackie Shea Chief operating officer Dr.

Ben Matone: Joining me on today's call are Dr. Joseph Kim, President and CEO; Mr. Peter Kies, CFO; Dr. Jackie Shea, Chief Operating Officer; Dr. Laurent Timot, Chief Scientific Officer; Dr. Anza Mammon, Senior Vice President of Clinical Development; and Dr. Kate Broderick, Senior Vice President.

Dr. Loretta <unk>, Chief Scientific officer, Dr. Anza, Mammen, senior Vice President of clinical development and Dr. Kate Brodrick Senior Vice President of research and development.

Ben Matone: of Research and Development. On today's call, we will review our corporate and financial information for the first quarter and March.

Today's call, we will review, our corporate and financial information for the first quarter ended March 31 2021 in.

Ben Matone: March 31st, 2021.

In addition, we will discuss this morning's press release regarding the phase two data from our innovate trial for COVID-19, as well as provide and update on the company's path forward for our global Phase III study.

Ben Matone: In addition, we will discuss this morning's press release regarding the Phase 2 data from our Innovate trial for COVID-19 as well as provide an update on the company's path forward for our Global Phase 3 study. Following prepared remarks, we will be conducting a question and answer session.

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

Ben Matone: Question and answer segment reserved for equity research analysts. During the call, we will be making forward-looking statements regarding future events and future performance.

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

These events relate to our business plans to develop and nobody was integrated platform of DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters.

Ben Matone: These events relate to our business plans to develop Inovio's integrated platform of DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters. Furthermore, all of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially.

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

Actual events or results could differ materially we refer you to the documents we file from time to time with the SEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation risks and uncertainties related to conducting clinical trials compliance.

Ben Matone: Materially different from those expressed by the company verbally and in writing today.

Ben Matone: including, without limitation, risks and uncertainties related to conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, third parties, and a level of cost associated with discovery and business development activities to assist in potentially bringing our products to market. This call is being webcast live on our website, www.ir.inovio.org.

With applicable regulatory requirements, our dependence on collaboration partners third parties and the <unk>.

Level of costs associated with discovery and business development activities to assist and potentially bringing our products and market.

This call is being webcast live on our website IR dot and it'll be a dot com and a replay will be made available. Shortly after this call has concluded with that I would like to turn the call over to and nobody was president and CEO Dr. Joseph Kim.

Dr. Joseph Kim: And a replay will be made available shortly after this call is concluded. With that said, I would like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim.

Thank you Ben and thank you to everyone for taking the time to join us for today's call.

Dr. Joseph Kim: Thank you, Ben, and thank you to everyone for taking the time to join us for today's call. When we last connected,

When we last connected.

We are in a very different place and waiting to impact on holiday travel and gatherings on commodity viral spread, particularly given the emergence of variant strains around the world.

Dr. Joseph Kim: We are in a very different situation, awaiting the impact of holiday travel and gatherings on community viral spread, particularly given the emergence of variant strains around the world. We were unclear on the spread and impact of the vaccine rollout. Today, a quarter later, we're encouraged by the progress that has been made here in the U.S., but are mindful that much of the world is still struggling to get access to access, navigating how to address the logistics of the logistics of cold and ultra-cold chain and facilitate getting shots in the arm and continuing to be challenged by outbreaks and emerging variants. As a company with deep roots in infectious diseases and a longstanding commitment to public health

We are unclear on the spread and impact of the vaccine and rollout.

Today, a quarter later, we're encouraged by the progress and that hasn't been made here in the us, but I'm mindful that much of the world is still struggling to get access to vaccines and.

And advocating how to address the logistic.

Just sticks of cold and ultra cold chain transport.

To facilitate getting shots and the arm and continuing to be challenged by outbreaks and emerging variants.

As a company with deep roots and infectious disease, and our long standing commitment to public health.

Dr. Joseph Kim: We recognize the still largely unmet vaccine needs of the global community, and equally, we know that our ability to have the greatest impact on this public health crisis is increasingly outside the United States. In late April, we announced that we will be implementing a global phase 3 trial for INO4800. We are working with funders and partners to achieve this plan and expect to start the trial this summer. Additionally

And recognized still largely unmet vaccine needs and the global commodity.

Equally.

We know that our ability to have the greatest impact on this public health crisis is increasingly outside the United States.

In late April.

We announced that we will be implementing a global phase III trial for INR 4800.

We are working with funders and partners to achieve this plan and expect to start the trial. This summer.

Additionally, we continue to be and discussions with a number of countries.

Dr. Joseph Kim: We continue to be in discussions with a number of countries regarding INO4800 advanced market procurement agreements in the countries where the clinical trial sites are being planned. We look forward to proceeding with this Phase 3 trial this summer, and we'll have additional details to share regarding these efforts in the coming weeks. Most importantly, we remain on track to initiate our phase three segment of innovate, as we have previously stated. Now, I'd like to introduce you to Dr. Anza Mammon, who is leading our Global Phase III INO4800 trial and tell us more about the Phase 2 results we announced this morning. Ansa?

And I don't know 4800 events market procurement agreements within the countries, where the clinical trial sites are being planned.

We look forward to proceeding with this phase III trial. This summer and we will have additional details to share and regarding these efforts and the coming weeks.

Most importantly.

We remain on track to initiate our phase III segment of innovate as we have previously stated.

Now I'd like to introduce us to a doctor Anza mammen.

Who is leading our global phase III INR 4800 trial to tell us more about the phase two results, we announced this morning and.

And so.

Uh huh.

Thank you Joseph and as it is very nice to be on the call with you today.

Dr. Anza Mammon: Thank you, Joseph. It is very nice to be on the call with you today. We reported this morning the Phase 2 results that support the advancement of the 2mg dose of INO4800 into our planned Phase 3 efficacy trial. The Phase 2 blinded placebo-controlled segment of Innovate's Phase 2 slash 3 trial included 401 participants, ages 18 and older, across 16 U.S. sites to look at safety, tolerability, and immunogenicity of the 1 and 2 milligram doses of INO4800 in a two-dose regimen in a three-to-one randomization to receive either INO4800 or placebo.

We reported this morning, the phase II results.

Support the advancement of the two milligram dose of INO 4800 into our planned phase III efficacy trial.

The phase II blinded placebo control segment of innovate phase III class III trial included 401 participants ages 18 and older across 16 U S site to look at safety Tolerability and Immunogenicity of the one.

And two milligram doses of INO four to 800 and a.

Two dose regimen and a.

Three to one randomization to receive either INR 4800 or placebo.

Results showed that I know 4800 continues to be safe, well tolerated and immunogenic and all adult age groups studied.

Dr. Anza Mammon: Results showed that INO4800 continues to be safe, well-tolerated, and immunogenic in all adult age groups studied, further validating in a larger population our initial Phase I results. The majority of adverse events were grade 1 and grade 2 in severity and did not increase in frequency with the second dose. The number of participants experiencing each of the most common adverse events did not appreciably differ between the dosing groups.

Other validating and a larger population our initial phase one results.

The majority of adverse events were grade, one and grade two and severity and did not increase and frequency with a second dose.

And the number of participants experiencing each of the most common adverse events did not appreciably differ between the dosing groups.

The <unk> metric me and pulled rise of binding and neutralizing antibody levels were statistically significantly greater and the two milligram dose group versus the one milligram dose group life.

Dr. Anza Mammon: The geometric mean poles rise of binding and neutralizing antibody levels was statistically significantly greater in the two milligram dose group versus the one milligram dose group. Likewise, the T-cell immune responses measured by the ELISBOT assay were also higher in the 2-milligram dose group compared to the 1-milligram dose group. The preliminary results from the Phase I segment of the trial have been published in a paper entitled, Safety and Immunogenicity of INO4800 DNA Vaccine against SARS-CoV-2, a preliminary report of a randomized, blinded, placebo-controlled phase two clinical trial in adults at high risk of exposure.

Likewise, the T cell immune responses measured by the early spot assay were also higher and the two milligram dose group compared to the one milligram dose group.

The preliminary results from the phase one segment of the trial and have been published and a paper entitled.

Safety and Immunogenicity of INO 4800, DNA vaccine against Sars COVID-19 two.

And their preliminary report of a randomized blinded placebo controlled phase II clinical trial in adults at high risk of exposure.

The publication has been posted as a preprint prior to peer review.

Dr. Anza Mammon: This publication has been posted as a preprint prior to peer review. Again, we are very pleased that the safety, tolerability, and immunogenicity results clearly favor advancing the dose of INO4800, namely the two milligram dose, into our planned phase three global efficacy trial. Dr. Broderick will share with you shortly the potential versatility of INO4800 in addressing the currently circulating variants. As SARS-CoV-2 continues to evolve and potentially hinder other vaccine capabilities, it is important for us to leverage INO4800's favorable safety and tolerability profile while evaluating its ability to mitigate against the known circulating variants in our planned global phase three efficacy segment. And with that, I will turn it back to you, Joseph. Thanks, Sanjay.

Again, we are very pleased with the safety Tolerability and Immunogenicity results clearly favorite advancing the dose of INR 4800, namely the two milligram dose into our planned phase III global efficacy trial.

Dr. <unk> will share with you shortly the potential versatility of INR 4800, and addressing the currently circulating variance.

As far as COVID-19, two continues to ball and potentially hinder other vaccine capabilities. It is important for us to leverage I don't know 48, hundreds favorable safety and tolerability profile, while evaluating its ability to mitigate against the known circulating variance and our planned global fee.

And three efficacy segment.

And with that I will turn it back to you Joseph.

Thanks, Todd and Joe.

I want to make a moment for all of us to recognize the need to support both primary and vaccination as well as boosting capabilities.

Dr. Joseph Kim: I want to make a moment for all of us to recognize the need to support both primary vaccination as well as boosting capability, particularly given the increasing prevalence of variants. Inovio is focused on a dual track strategy. We plan to take INO4800 into a global phase three trial this summer, and in parallel, we will also develop our second generation pan-COVID variant vaccine, INO4802. I now ask Inovio's Senior Vice President of R&D, Dr. Kate Broderick, to speak in greater detail about INO4800's activity data against the major variants that we announced in April, as well as to share an update on Inovio's efforts on our next-gen pan-COVID variant vaccine, INO4802.

Particularly given the increasing prevalence of variance.

And OBO is focused on a dual track strategy.

We plan to take iron ore 4800 into a global phase III trial. This summer.

In parallel we will also develop our second generation and COVID-19 dairy and vaccine and a 48 or two.

And now as <unk> senior Vice President of R&D, Dr. Kate Broderick to speak in greater detail about INR 4800, and activity data against the major variance that we announced in April.

And as well as to share and update on in Navios efforts on our next Gen 10, COVID-19 bearing and vaccine and a 48 or two.

Okay.

Thank you Joseph and Hello to everybody on the call today when.

Dr. Kate Broderick: Thank you, Joseph, and hello to everybody on the call today. When I spoke with you all during our last quarterly earnings call, I mentioned that Inovio was closely monitoring the development and evolution of SARS-CoV-2 mutations and currently testing the impact of these new strains with a particular focus on the strains that were first identified in the UK, South Africa, and Brazil. Since then, the company continues to take a two-pronged approach to the emerging crisis caused by these new viral variants.

When I spoke with you all Jude and our last quarterly earnings call.

I mentioned that our new view with closely monitoring the development and evolution of Sars COVID-19 two mutations and currently cash thing to impart to lease new streams with a particular focus on the strength was first identified and the U T South Africa and Brazil.

So to say and the company continues to make a two pronged approach to the emerging crisis caused by these new vital variants.

Dr. Kate Broderick: To this end, in late April, we announced the results of a new study that showed INO4800 induced a robust T cell response against all spike protein variants tested, which the company believes will be key in providing protection against the SARS-CoV-2 variant, in addition to providing similar levels of neutralizing activity against both the UK and the Brazilian variants. In particular, here are some key takeaways from the study. Clinical samples were collected at varying time points post-immunization from subjects in Inovio's phase 1 US-based INO4800 clinical trial. The company assessed antibodies capable of neutralizing activity. They were measured against the spike protein variants tested, including B.1.1.7, the UK variant, B.1.3.5.1, the South African variant, and P.1, the Brazilian variant.

Two the sand and Lee equal, we announced the results of a new study.

Should I and all 4800, and do you still robust T cell response against all Spike protein variance tested which the company believes will be key and providing protection against Sars COVID-19 two radiant and addition to providing similar levels of neutralizing activity against both of us.

T and the Brazilian variants as those against the original Wuhan strength.

And particular heat or some key takeaways from the study.

Clinical samples will be collected at BD and Titan points post immunized from subjects and Adobe use fees, one U S based iron ore <unk> hundred clinical trial.

The company assessed on people and he's capable of neutralizing activity people are measured against the spike protein ingredients tested, including B 117 P. You keeping it.

B 1351, besides after convenient on P. One the Brazil, we Nvidia.

The analysis showed that the T cell responses and juice by INR 400 vaccination with fully maintained against the U T South African and the Brazilian variants when compared to the T cell responses to the original Wuhan strained.

Dr. Kate Broderick: The analysis showed that the T cell responses induced by INO4800 vaccination were fully maintained against the UK, the South African, and the Brazilian variants when compared to the T cell responses to the original Wuhan strain. The neutralization levels of INO4800 against South Africa and UK variants were reduced by levels similar to the previous reports of reduction shown by the mRNA or viral vector vaccine. Despite recent reports showing a reduction in neutralizing activity against the Brazilian variant by the mRNA or viral vector vaccine

And the neutralization levels of INO 400 against this half and you keep the audience what would just buy levels similar to the previous reports from reduction shown by the and modern knee or viral vector vaccines.

Despite recent report showing a reduction and neutralizing activity against the Brazilian variant either you buy the aim at a knee or viral vector vaccines.

I N O 4800 January to neutralizing on people at decent levels against the P. One Brazilian variant, which were comparable to those against the Wuhan Street.

Taken together with the data showing the maintenance of T cell activity net of pulp. The results reported from the study provided and encouraging overview of cross reactive cellular acumen and immune responses against Sars COVID-19 two variants for iron ore <unk> hundred vaccinated individuals.

Dr. Kate Broderick: INO4800 generated neutralizing antibodies at levels against the P1 Brazilian variant that were comparable to those against the Wuhan strain. Taken together with the data showing the maintenance of T-cell activity, the results reported in the study provide an encouraging overview of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants for INO4800 vaccinated individuals, which may be important for protection against variant strains of SARS-CoV As Joseph noted, Inovio is taking a dual-track approach because we recognize the need to support both pandemic and future endemic considerations.

That may be important for protection against mediant strains of Sars COVID-19 two.

And Joseph New tests, new tests, and will view us taking a dual track approach because we recognize the need to support both pandemic on future and debit considerations.

In addition to our late stage work on nine new <unk> hundred.

We're also developing our second generation PON COVID-19 variant vaccine I know 40, or two which is designed to protect against current and potentially future variants of concern.

Dr. Kate Broderick: In addition to our late-stage work on INO4800, we are also developing our second generation pan-COVID variant vaccine, INO4802, which is designed to protect against current and potentially future variants of concern. We look forward to sharing a more robust update on our progress on INO4802, including an upcoming pre-print publication, in the near future.

And we look forward to sharing on a more robust update on our progress and I know 42, including on upcoming pre publication and the near future and.

And with that I'll turn the call back over to Joseph.

Thank you per case next our CFO, Peter <unk>, who will provide a financial summary for the quarter, but before that I wanted to briefly update you on our other important clinical programs.

First for an update on our immuno oncology efforts and.

Dr. Joseph Kim: Next, our CFO Peter Kies will provide a financial summary for the quarter, but before that, I wanted to briefly update you on our other important clinical programs. First, for an update on our immuno-oncology efforts. Inovio's Phase 1 slash 2 novel combination trial of INO5401 and INO9012 in combination with the PD-1 checkpoint inhibitor Lipteo, which is currently being jointly developed by Regeneron and Sanofi for the treatment of newly diagnosed Glioblastoma multiforme is currently ongoing.

And nobody else phase one slash two novel combination trial of INO, 50, 401, and INR 90, 12 and combination with the PD one checkpoint inhibitor <unk>, which is currently being jointly developed by Regeneron and Sanofi and the treatment of newly diagnosed.

Us.

Glioblastoma Multiform is currently ongoing.

The company anticipates sharing 24 months overall survival data.

And potential correlate of immunology and tissue data later this year.

As for our HPV related disease treatment efforts.

And it'll be announced that we met the primary and secondary efficacy end points among all evaluable subjects for reveal one and our phase III pivotal trial evaluating <unk> study 100 for the treatment of cervical H. So caused by HPV 16, and or HPV 18.

Dr. Joseph Kim: The company anticipates sharing 24-month overall survival data, including potential correlative immunology and tissue data later this year. As for our HPV-related disease treatment effort, Inovio announced that we met the primary and secondary efficacy endpoints among all evaluable subjects for Revio 1, our phase 3 pivotal trial evaluating VGX3100 for the treatment of cervical H cells caused by HPV16 and or HPV18. The company continues to follow subjects in the Revio 1 trial for safety and durability of response for 18 months following the last administration and looks forward to sharing findings later this year at a scientific meeting.

The company continues to follow subjects and reveal one trial for safety and durability of response for 18 months. Following the last administration and looks forward to sharing findings later this year at a scientific meeting.

We're also concerning our partnership with Cryogen on and in vitro diagnostic based on RNA sequencing technologies to guide clinical decision, making for the use of <unk> 3100, and cervical H. So.

Importantly, this biomarker will help us to identify and a commercial setting perspective, VEGF study 100 patients who would be most likely to respond to our immunotherapy.

Dr. Joseph Kim: We're also continuing our partnership with QIAGEN on an in vitro diagnostic based on RNA sequencing technology to guide clinical decision-making for the use of VGX3100 in cervical H-cells. Importantly, this biomarker will help us to identify, in a commercial setting, prospective VGX3100 patients who would be most likely to respond to our immunotherapy.

Our fee or our reveal two phase three efforts continue across 48 global sites.

Additional information regarding any protocol of equipment adjustments on this trial later in the year.

Following positive phase two efficacy data.

Dr. Joseph Kim: Our Phase 2, and Phase 3 efforts continue across 48 global sites. We'll have additional information regarding any protocol or recruitment adjustments on this trial later in the year. Following positive phase two efficacy data, Inovio also continues to evaluate the best ways to expand VGX 3100 indications for vulvar and anal dysplasia. We're currently exploring the best path for a phase 3 clinical trial for vulvar and anal dysplasia indications, pending further discussions with the FDA. With that, I will return the call over to Peter for our first quarter financial summary. Peter?

And also continues to evaluate the best ways to expand Bgs study 100 indications vulvar and anal dysplasia.

We're currently exploring the best path for our phase III clinical trial for vulvar and anal dysplasia indications pending further discussions with the SBA.

With that I return the call over to Peter for our first quarter financial summary.

Peter.

Thanks, Joseph and Hello, everyone, and we entered 2021, well positioned financially with total cash cash equivalents and short term investments of $111 6 million.

Thanks to a successful public offering in January we provided net proceeds of $162 1 million.

Peter D. Kies: Thanks, Joseph. And hello, everyone. We entered 2021 well positioned financially, with total cash, cash equivalents, and short-term investments of $111.6 million. Thanks to a successful public offering in January, we provided net proceeds of $162.1 million. We ended the first quarter with $518.6 million in cash, cash equivalents, and short-term investments, providing us with multiple years of sufficient capital to support existing activities and programs.

We ended the first quarter with 518 6 million and cash cash equivalents and short term investments, providing us with multiple years of sufficient capital to support existing activities and programs.

Turning now to our quarterly financial results our revenue for the first quarter 2021 was 371000, which compares to $1 3 million for the same period and 2020.

Our total operating expenses were $52 9 million compared to $26 6 million for the same period and 2020.

Our net loss for the first quarter 2021 was $54 4 million or <unk> 27 per share basic and dilutive.

Which compares to a net loss of $32 5 million or 26 cents per share basic and dilutive for the same period a year ago.

Peter D. Kies: Turning now to our quarterly financial results, our revenue for the first quarter of 2021 was $371,000, which compares to $1.3 million for the same period in 2020. Our total operating expenses were $52.9 million, compared to $26.6 million for the same period in 2020. Our net loss for the first quarter of 2021 was $54.4 million, or $0.27 per share, basic and dilutive, which compares to a net loss of $32.5 million, or $0.26 per share, basic and dilutive, for the same period a year ago.

Our R&D expenses were $39 million for the first quarter 2021, which compares to $19 1 million for the same period in 2020.

The increase in R&D expenses, primarily related to higher drug manufacturing expenses.

And outside services related, but not limited to INR 4800, and other clinical trials.

Also higher employee.

And contractor compensation expense, and an increase and engineering services related to our select or three PSP device.

On the other references.

These R&D expense increases were a central.

To continue the development and the progress of our innovate trial for COVID-19, as well as developing our three P. S. P device.

Which is planned to be used for many of our infectious disease programs, including I don't know 4800 for COVID-19.

Peter D. Kies: Our R&D expenses were $39 million for the first quarter of 2021, which compares to $19.1 million for the same period in 2020. The increase in R&D expenses primarily related to higher drug manufacturing expenses and outside services related but not limited to INO4800 and other clinical trials, also hired employee, and contractor compensation expenses, and an increase in engineering services related to our Selector 3 PSP device, among others. These R&D expense increases were essential to continue the development and progress of our Innovate trial for COVID-19, as well as to develop our 3PSP device, which is planned to be used for many of our infectious disease programs, including INO4800 for COVID-19.

G&A expenses were $13 9 million for the first quarter 2021.

Versus seven 4 million for the same period and 2020.

The increase and G&A expenses was primarily related to an increase.

And employee and consulting compensation, including noncash stock based compensation and legal expenses among other variances.

And with that I'll turn it back to you Joseph.

Thanks, Peter it's good to know.

Know that nobody us maintaining strong financial position.

Before we take your questions.

I would like to recognize and thank Dave.

No real team and our partners and collaborators thunders and patients for their tireless efforts.

Our team's unwavering support of and commitment to developing INR 4800, as safe and effective vaccine for COVID-19, while in parallel and evaluating our next generation Pan COVID-19 vaccine I don't know 48 or two to protect against current and future variants.

Peter D. Kies: GINA expenses were $13.9 million for the first quarter of 2021 versus $7.4 million for the same period in 2020. The increase in GINA expenses was primarily related to an increase in research and development expenses, and Employee and Consulting Compensation, including non-cash stock-based compensation and legal expenses, among other variances.

From concern.

S well us continuing to validate our technology and broader platform within HPV and oncology and infectious disease is indeed impressive.

While there is still more work in front of us I'm incredibly proud of us and remain confident and our teams ability to events and nobody else DNA medicines platform and programs.

Peter D. Kies: And with that, I'll turn it back to you, Joseph. Thanks, Peter. It's good to know that Inovio is maintaining a strong financial position. Before we take your questions,

If I can leave you with one point about and OBO.

Dr. Joseph Kim: I would like to recognize and thank the Inovio team and our partners, collaborators, funders, and patients for their tireless effort; our team's unwavering support of and commitment to developing INO4800 as a safe and effective vaccine for COVID-19, while in parallel evaluating our next generation pan-COVID vaccine, INO4802, to protect against current and future variants of concern, as well as continuing to validate our technology and broader While there is still more work in front of us, I'm incredibly proud of and remain confident in our team's ability to advance Inovio's DNA medicines platform and program.

That one highlight from today's call is this.

We're staying on track with our I don't know 4800 development plans and expect to commence phase III. This summer.

We remain committed to developing INR 4800 for many people globally.

Still and desperate need for safe and effective tolerable and temperature stable vaccines.

I. Thank you for your continued support of <unk>.

We will now open the call for your questions operator.

We will now begin the question and answer session to us.

A question you May Press Star then one on your Touchtone phone.

And if you're using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

Dr. Joseph Kim: If I can leave you with one point about Inovio. That one highlight from today's call is this: we're staying on track with our INO4800 development plans and expect to commence phase three this summer. We remain committed to developing INO4800 for many people globally still in desperate need of safe, effective, tolerable, and temperature-stable vaccines.

Our first question comes from Geoff Meacham from Bank of America. Please go ahead.

Hey, guys its Austin on for.

Jeff.

And taking my questions just a couple from us.

Personally.

Maybe you could talk about how the current clinical hold for the phase III study and how that plays into your appraisal and development plan given that we now expect to run that based on studies, primarily O U S.

And then.

Operator: I thank you for your continued support of Inovio. We will now open the call to your questions, Operator. Thank you. We will now begin the question and answer session. To ask a question, you may press star and then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. Our first question comes from Jeff Meacham from Bank of America. Please go ahead.

For the reach and rejects and 3100, what additional data can we expect to see at.

And I'm, calling medical conference with respect to reveal one thank you.

Yeah. So let me take the second question first.

The the full safety follow up.

And is expected to finish later this year for reveal one.

So we will have a comprehensive and blinded patient level safety and efficacy data. So that's what we would expect to have later this year.

In terms of the FDA partial clinical hold on phase III.

Jeff Meacham: Hey guys, it's Asim. Good job. If you've got any questions, just a couple.

And for innovate trial.

Jeff Meacham: Maybe you could talk about how the current clinical holds up to the phase 3 study, and how that plays into your phase 3 diagnosis.

And you're absolutely right.

The ex U S strategy.

That's not and is.

He is not impacted by the the current phase III partial clinical hold.

Jeff Meacham: And then for the VTX 3100, what additional data can we expect to see at an upcoming medical conference with respect to reveal one? Thank you.

Still.

And we plan to open in the US along with mostly ex U S countries and sites to recruit.

Dr. Joseph Kim: Yeah, so let me take the second question first. The full safety follow-up is expected to finish later this year for Reveal 1. So we will have comprehensive unblinded patient level safety and efficacy data. So that's what we would expect to have later this year. In terms of the FDA partial clinical hold on phase three for Innovate Trial, Aspen, you're absolutely right.

Our phase III innovate global trial, we still plan and are on track to submit all of our submission to the FDA to lift the partial clinical hold if were successful and the second quarter.

Let me reiterate we are on track to submit and we're hopeful that and we will be able to lift the partial clinical hold and.

And the U S portion of our innovate phase III trial, but as you suggest that most of our patients will come from ex U S countries.

Dr. Joseph Kim: The ex-U.S. strategy is not impacted by the current Phase III partial clinical hold. But still, we plan to open in the U.S., along with mostly ex-US countries and sites to recruit our Phase III Innovate Global Trial. We still plan and are on track to submit all of our submissions to the FDA to lift the partial clinical hold if we're successful in the second quarter. Let me reiterate, we're on track to submit, and we're hopeful that we will be able to lift the partial clinical hold in the U.S. portion of our Innovate Phase 3 trial. But, as you suggested, most of our patients will come from ex-U.S. countries for our Phase 3 clinical trials worldwide. Thank you. Thank you. The next question comes from Hartaj Singh from Oppenheimer. Please go ahead.

For our phase III.

Clinical trials globally.

Thank you.

Thank you.

The next question comes from Heritage Singh from Oppenheimer. Please go ahead.

Great. Thank you all and thanks for the update on Jordan team well and can you just.

To follow up on the last question on.

Can you just talk specifically in terms of what are the steps.

And if you are going to in terms of all.

Identifying sites worldwide.

Submitting protocols to a relevant regulatory authorities.

And our protocol update.

Just wondering if you can explain that well number two.

Do you have to now update you a clinical protocol to the FDA five from day.

What do you have to submit to the clinical hold you have to help people. Your revised protocol for the phase III and now that you've picked on I guess, the two milligrams of your dose going forward and.

And what is how does that work in terms of.

Hartaj Singh: Great, thank you. Thanks for the update, Joe and team. Joe, just to follow up on the last question, can you just talk specifically in terms of

Filing more debt.

Clinical response and literature, and then lastly, just moving to nuclear today that Norway, the European Union and are not going to be reviewing.

Reviewing the contracts for Astrazeneca or J&J later this year, how does that impact your thinking or your discussions with those accordingly.

Hartaj Singh: So what are the steps that Inovio is going through in terms of identifying sites worldwide, submitting protocols to relevant regulatory authorities, and protocol updates? So that's just one, if you can explain that. Number two, you know,

Yeah. Thank you Arthur Gosh, Oh, I'll take the general stab at the questions and I will ask a doctor maam and to further.

Hartaj Singh: Do you have to now update your clinical protocol for the FDA? Aside from what you have to submit for the clinical hold, you have to

Address these questions but.

First of all the last again last part of your question first.

Hartaj Singh: Michael Hold, you have to update your revised protocol for phase three now that you've picked, I guess, two milligrams as your dose going forward. And how does that work in terms of, you know, filing the clinical response literature? And then lastly, you know, just there was a news blurb today that Norway and the European Union are not going to be renewing the contracts for AstraZeneca or J&J later this year. How does that impact your thinking or your discussions with those authorities?

And I think the whole landscape, a vaccine availabilities and the orders and when you all that's changing landscape. So.

Every week or every month seems to be changing.

One thing is for sure there is.

Only.

5% of the global population that's received a COVID-19 vaccine thus far so there's a huge mess.

And that demand.

<unk> and.

And potential opportunities to have INR 4800.

Dr. Joseph Kim: Thank you. Yeah, thank you, Hartaj. I'll take the general stab at the questions, and I will ask Dr. Mamen to further address these questions. But first of all, the last part of your question first: I think the whole landscape of vaccine availabilities, orders, and renewal, that's a changing landscape. So, you know, every week, or every month seems to be changing.

And to play an important role and our combat against this pandemic, so that really drives us our team our partners our funders and.

To make sure that we can get there as soon as possible.

In terms of the filings and and so on and Youre absolutely right.

We've already begun.

Drafting and submitting lot of these.

Preparations for all of our global submission. So you know each of the countries that we will file to include into our phase III efficacy trial. Each of those are independent and submissions, but you know our internal regulatory team along with our CRO.

Dr. Joseph Kim: One thing is for sure, you know, there's only 5% of the global population that's received the Coven 19 vaccine thus far. So there's a huge demand globally and potential opportunities to have it. I know 4800 to play an important role in our combat against this pandemic. So that really drives our team, our partners, our funders, and to make sure that we can get there as soon as possible. In terms of the filings and so on, you're absolutely right.

Global C R O.

We have been working very closely to prepare for that for many weeks. So.

Or months, so I think we're in a great position to do that and would you like to address any of the Taj us questions any detail.

Dr. Joseph Kim: We've already begun drafting and submitting a lot of these preparations for all of our global submissions. So, you know, each of the countries that we'll file to include in our Phase 3 efficacy trial, each of those are independent submissions. But, you know, our internal regulatory team, along with our CRO, the global CRO, we have been working very closely to prepare for that for many weeks or months. So I think we're in a great position to do that. Anza, would you like to address any of Hartaj's questions, or give any detail? Yes, absolutely.

Yes, absolutely. Thank you Joseph.

Yeah.

Sure.

Working with a very experienced spiro.

The same CLO debt, we've been working on the phase III study and and.

And our ex U S countries collection criteria included.

Countries debt for which are on CRO has experienced.

And another criterion that we've looked at in terms of a country selection are those countries in which and Novo has had experience.

And with other platform products as well as the device.

So so we feel confident that we've we've made a country's collection debt that is.

Dr. Anza Mammon: Thank you, Joseph. You know, we're working with a very experienced CRO, so it's the same CRO that we've been working on the Phase 2 study. And our ex-U.S. country selection criteria included countries for which our CRO has experience. Another criterion that we've looked at in terms of country selection are those countries in which Inovio has had experience with other platform products as well as the device.

Allows us to move relatively quickly.

No.

The protocol and then amendment.

Amendment has gone through with the two milligram dose and our CRO. In fact, we are working to prepare the regulatory submissions from.

And so those are the additional points I wanted to race right. Thank you Anza.

Sure Great.

Great. Thank you Joe I'll jump back into queue. Thanks for cash.

The next question comes from Gregory <unk> from RBC capital markets. Please go ahead.

Dr. Anza Mammon: So, we feel confident that we've made a country selection that allows us to move relatively quickly. Now, the protocol amendment has gone through with the 2-milligram dose, and our CRO is actively working to prepare the regulatory submissions. So those are the additional points I wanted to raise.

Hi, Joseph and team. Thank you for taking my question and also for the updates today.

Joseph.

With respect to the discontinuation of the Dod funding for that Phase III trial, just curious if you could comment on how that person just impacts the perception of the of the vaccine program and platform potentially and.

Dr. Joseph Kim: Great. Thank you, Anja. Great. Thank you, Joe. I'll jump back in the queue.

And then just secondly, pivoting the program ex U S and how has that development.

Gregory Renza: Thanks, Hartaj. The next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Hi Joseph and Dima.

Development strategy and resource allocation of all per how should we expect that to evolve I'm. Just curious how you think about providing your your funds and your cash costs for your pipeline and and just related to that and you had mentioned just partners and funders and and discussion I'm. Just curious if you could elaborate a little for us are on what we should expect.

Gregory Renza: Thank you for taking my question and also for the updates today. Joseph, just in respect to the discontinuation of the DoD funding for that phase three trial, just curious if you could comment on how that First, it just impacts the perception of the vaccine program and platform potentially. And then, just secondly, pivoting the program outside the US, how has that development strategy and resource allocation evolved, or how should we expect that to evolve?

Around those who perhaps and provide those resources from the trial. Thank you.

Yeah, Thanks, Craig well.

Certainly.

The deal the funding decision came had a surprise.

They have been working with us and our ex U S pivot.

And for many weeks.

And.

Obviously, they didn't see our unblinded.

Gregory Renza: I'm just curious how you think about providing your funds and your cash across your pipeline. And just related to that, you had mentioned just partners and funders. And in discussion, I'm just curious if you could elaborate a little further on what we should expect around those who will perhaps provide those resources for the trial. Thank you.

Group level safety or human rights and the city from our phase II trials.

Before they made that decision so no really as they've.

Informed us, which we disclose the decision is mostly on their investment decision and changing environment of COVID-19, and the U S and not so much a net.

Dr. Joseph Kim: You know, they have been working with us in our ex-U.S. pivot for many weeks, and, you know, obviously, they didn't see our unblinded group-level safety or immunogenicity from our phase two trials before they made that decision. So, you know, really, as they informed us, which we disclosed, the decision is mostly about their investment decision and the changing environment of COVID-19 in the U.S., and not so much, not anything to do with 4800 or our data. So, we feel very comfortable and confident in our data, in our program, and in our preparation.

Not anything to do with 4800.

Or where our data.

So we feel very comfortable and confident.

And our data and our program and our preparation so and I continue to think the D. O D for funding the phase two and all of the phase three prep work that we have been doing for many months now.

S and I mentioned.

That prep work is going to allow us to move.

<unk> into a global phase III trial.

Dr. Joseph Kim: So, and I continue to thank the DOD for funding the phase two and all of the phase three prep work that we have been doing for many months now. As Anza mentioned, that prep work is going to allow us to move expediently into a global phase three trial. And, you know, we can't give any details, but we're currently working with potential funders and partners to help us to execute this trial. Now, what I can say is PIVOT from U.S. to ex-U.S. generally reduces the overall cost of the trial, so I think that's also helpful as well.

And are we.

We can give any details, but we're currently working with potential funders and partners to help us.

To execute this trial.

Now what I can say is our pivot from U S to ex U S.

And generally.

Reduces the overall cost of the trial. So I think Thats also helpful. As well now we're not moving to extra us for cost reasons obviously.

And we're looking for some other conditions that and spoke about our experience and and OBO and those countries.

Dr. Joseph Kim: Now, we're not moving to the ex-U.S. for cost reasons. Obviously, we're looking for some of the conditions that Anza spoke about. Our experience at Inovio in those countries, our CRO's experience and expertise, but also, we're looking for areas where there are fewer available emergency vaccines in those countries and regions and where there are still a significant number of cases where we can do a randomized placebo-controlled case-driven efficacy trial. So, when you triangulate these conditions, you know, there are very important regions around the world that fit into these calculations and plans

R. R C. R O us experience and expertise, but also we're looking for areas, where there are less available emergency vaccines and those countries and regions and where there are still a significant number of cases.

Where we can do a randomized placebo controlled case driven efficacy trial. So when you triangulate these conditions.

There are a very important regions around the world that fits into these calculus and plan. So.

Dr. Joseph Kim: So, you know, stay tuned for a lot more details about our phase three trial. We should have that disclosed in the next few. Thank you very much. The next question. Sorry. The next question comes from Stephen Wiley from Stiefel. Please go ahead.

And so stay tuned to have a lot more details about our.

Our phase III trial, we should have that disclosed and the next few weeks.

Thank you very much.

The next question Gregg sorry.

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

Operator: Please go ahead.

Hi, This is Ellen on for Steve. Thanks for taking the question and this is.

Ellen: Hi, this is Ellen on behalf of Steve. Thanks for taking the question. And this is actually just following up with the previous question about the phase 3 study. I know you're targeting countries where there's a severe vaccine shortage and are therefore able to run a placebo-controlled study. But just wondering if you considered having an active comparator arm or doing some sort of non-inferiority study just considering, you know, there are vaccines that are approved, and I'm just wondering if regulatory agencies across the globe would be interested in seeing that kind of data. And then I have one follow-up. Thank you.

Just actually following up with and the previous question about the Phase III study I know you're targeting countries, where there is no vaccine shortage and are therefore able to run on the female controlled study, but just wondering if you've considered having an active comparator arm or doing some sort of non inferiority study just considering.

And you know there are vaccines that are approved and yeah, and just wondering if conversations with regulatory agencies across the globe would be interested in seeing that kind of data and then I have one follow up thank you.

Yeah.

It's a great question, and then and we have internally.

Consider those different options and we still feel that case driven placebo control study is the most expedient and way.

And to to get to our efficacy question.

Dr. Joseph Kim: Yeah, that's a great question, and we have internally considered those different options, and we still feel that a case-driven placebo control study is the most expedient way to get to our efficacy question for our vaccine. So that's the path that we're pursuing now. And, of course, the landscape has been changing over the last several quarters, but I think the case-driven efficacy trial window is still wide open outside the US, and that opportunity is there for us to see.

Four four for our vaccine. So that's the path that we're pursuing now and of course, the landscape has been changing over the last several quarters.

I think the case sugar and efficacy trial window is still wide open.

Outside the U S and that opportunity is there for us to see.

Okay, great. Thank you and and then do you still intend to disclose preliminary data Fry and a 31 seven and RFP this year.

Well, that's a great question RFP remains an important disease targets for us and I don't know 31 O seven.

Ellen: Okay, great. Thank you. And then, do you still intend to disclose preliminary data for INO3107 in RRP this year?

Dr. Joseph Kim: Well, you know, that's a great question. RRP remains an important disease target for us. And I know 3107 likely is likewise, a very important product for us. You know, we received the orphan drug designation last year for 3107 for RRP, and we have our phase one slash two trial that's open label that's ongoing. So most likely, the most impactful amount of data will be 22 events, but we're still hopeful that there will be a meaningful level of data maybe later this year. But it's likely going to be early or mid 22 events.

Likely.

Likewise, as a very important product for us.

We received the orphan drug designation last year.

431 O seven four RFP and we have our phase one slash two trial. That's open label that's ongoing so most likely the most impactful on the amount of data will be 'twenty two event.

But we're still hopeful that there's a meaningful level of data maybe later this year.

But it's likely going to be early 'twenty to mid 'twenty two event.

Okay, great. Thank you for taking the question.

Yeah. Thanks.

The next question comes from eight and Hussein on from Benchmark. Please go ahead.

Ellen: Okay, great. Thank you for taking the questions.

Hi, everyone and thanks for taking my question and congratulations.

Aidan Hussainov: The next question comes from Aidan Hussainov from Benchmark. Please go ahead. Hi everyone.

Data.

Thanks, David.

Aidan Hussainov: Thanks for taking my question and congratulations on the data. We saw the data on the binding antibodies and neutralizing antibodies in the pre-publication version. Could you comment on the geometric fold increase in the binding antibody titers that was kind of higher than the geometric fold increase in the neutralizing antibody titers? And overall, what's your opinion on the role of the binding antibodies in the immunity against COVID-19?

So we.

We saw the data on the binding antibodies and neutralizing antibodies and the prepublication.

And then could you comment on the dramatic fold increase and the binding antibody titers that were several kind of higher and the gem at the cold increase and the neutralizing antibody titers and <unk>.

Overall book.

What's your opinion on the role of the binding antibodies and didn't get it against COVID-19.

And Norway.

I picked us as say.

Good question important question so.

Dr. Joseph Kim: COVID-19

Dr. Joseph Kim: Um, you know, I think this is a very good question and an important question. So, you know, both neutralizing antibody titers, and neutralizing antibody responses, are very important measurements of the vaccine's immune response, especially some of the early emergency-approved vaccines. That seems to be an important aspect of the protection that was the immune responses that were related to protection. Binding antibodies are also an important measurement and potentially even more consistent across various platforms. So we believe measuring both of those antibody levels and the impact of the vaccine and increasing those rises in those antibody titers is important. And thirdly, we also feel, and we maintain a strong belief that the second arm of the immune system, the T cell arm, is also very important in providing protection.

And both are you trialing antibody titers of neutralizing antibody responses.

And are very important measurement of that scenes and immune response.

Specially some of the early emergency approved vaccines.

And that seems to be a.

Important aspects of the protection that was.

On the immune responses.

Sure.

Related to protection bind.

Binding antibodies are also important measurement and <unk>.

<unk>, even more consistent.

Cross various platforms. So we believe measuring both of those antibody levels.

And the impact of the vaccine and increasing those.

Rice and those antibody titers are important.

Hum and and thirdly, we also feel and we maintain a strong.

Our belief that the second arm of the immune system. The T cell arm is is also very important and providing protection. So we also were very pleased to see that we're able to generate strong T cell responses in our phase two.

Dr. Joseph Kim: So we were also very pleased to see that we were able to generate strong T cell responses in our phase two trials. And as Kate Broderick mentioned in her remarks, that when we are looking at the various variants of concern, we were very excited to see that our T cell responses overall maintained whether we were testing against the Wuhan strain or some of the newer major variants like South Africa, Brazil, or UK.

Trials.

And and S. Kate Brodrick mentioned in her remarks that when we are looking at the various variants of concern.

We were very excited to see that our T cell responses overall maintain whether we were testing against that Wuhan strain.

Or some of the newer major variance like South Africa, Brazil, or U K. So we think and having this one two punch with antibodies and T cells and O 4800.

Dr. Joseph Kim: So we think having this one-two punch with antibodies and T cells for N04800 is going to be an important aspect of providing protection in our phase three efficacy trial that we're planning to start later in the summer. Thank you, Trevor.

It's going to be on important aspects of.

Providing protection and our phase III efficacy trial that we're planning to start later in the summer.

Thank you. So we appreciate that and one more question I have regarding fee.

Aidan Hussainov: I appreciate that. And one more question I have regarding the long-term opportunity for INO4800 or INO4802 in terms of the boosting of the other vaccine or the novel use. So where do you see the not the long-term, the mid-term opportunity for the vaccine? Yeah, you know, We thank, that boosting, well, Many of the experts, global health and key health experts both here and abroad, feel that COVID-19 vaccination is going to be an annual seasonal boosting, uh regime uh regiment uh to follow and uh if that they are correct uh having a vaccine that can be boosted safely and tolerably you know, seasonally, over and over again, because we think, you know, certainly the after the pandemic will be the endemic stage of Having to deal with COVID problems year in and year out, potentially with changing variants, it's very important.

Long term opportunity for us.

And what 800 or INR requirement.

And with two and.

In terms of the posting of the other vaccine or de Novo and so what would you see.

The not the long term day, the midterm opportunity for the vaccine.

Yeah, you know.

We think.

That's boosting well.

Many of the experts.

Global Health and key health experts, both here and abroad.

And that COVID-19, vaccination, and that's going to be a annual seasonal boosting.

And regime regiment to follow and.

And if that they are correct and having a vaccine that can be boosted safely and tolerably.

You know us.

Seasonally over and over again.

We think certainly the the after the pandemic will be the endemic stage of.

And having to deal with COVID-19 problems ear in and they're out.

Potentially with changing variance.

It's very important so we.

Aidan Hussainov: So, we believe that having INO4800 as a potential booster vaccine for our own INO4800 vaccinated, primarily vaccinated people, or even potentially being used to boost other vaccines of the first generation is a strong potential. And also, I think Kate mentioned in her remarks that we also see 4802 as the next generation vaccine, both as a pan-COVID variant vaccine, as a primary vaccine, but also as a vaccine that can be boosted over a long time.

We believe that having I don't know 4800 and as a potential booster.

Booster vaccine to our own INR 4800, vaccinated, primarily vaccinating people.

Or even potentially.

Being used to boost other vaccines have the first generation.

It has a strong potential and also and I think Kate mentioned that in her remarks that though we also see tornado to US a next generation vaccine.

Both as a pan COVID-19 bear and a vaccine as a primary of action vaccine, but also as a vaccine that can be boosted over a long time.

So one of the key attributes of DNA vaccines and in particular of and Ovules I know 4800, and other DNA vaccines and our portfolio is we feel and we have.

Aidan Hussainov: So one of the key attributes of DNA vaccines, and in particular of Inovio's INO4800 and other DNA vaccines in our portfolio, is that we feel, and we have a significant amount of data in our platform, that our vaccines can be boosted over and over with great tolerability, a limited AE profile, and no anti-vector response.

Significant amount of data and our platform.

That the our vaccines can be boosted over and over with.

A great Tolerability.

Limited AE profile.

And no.

Anti vector response, so I think these attributes really provides.

Dr. Joseph Kim: So I think these attributes really provide, say, great potential for the potential of our INO4800 and then subsequently INO4802 vaccines as boosters, hopefully for many years to come. Thank you very much. Again, if you have a question, please press star, then 1. The next question comes from Yi Chen from H.C. Wainwright.

Provide say great potential and our outlook for potential of our INR 4800, and then subsequently INR four you're able to vaccines us boosters.

And hopefully for many years to come.

Thank you very much.

Great. Thanks.

Again, if you have any question please per store than one.

The next question comes from each and from H C. Wainwright. Please go ahead.

Yi Chen: Please go ahead. Hi, thank you for taking my question. Could you tell us a bit about whether Inovio plans to allocate a certain amount of your existing cash position to the phase three global COVID-19 trial and how much you would need to raise from external parties? Well, hi.

Alright, Thank you for taking my question.

Could you tell us a bit about.

Weather and other plans to allocate a certain amount of your existing cash position to a free.

Global COVID-19 trial, and how much you would need to raise from external parties to complete the trial.

Oh, hi, thanks for that question.

Yi Chen: Thanks for that question. As we look at, as Peter summarized in his remarks, we have a very strong balance sheet, over half a billion dollars in cash right now. We definitely want to, and that's one of our strengths at this point, but we also want to maintain that cash, and we want to limit our expenses as much as possible. So we're currently working with funders and partners on how best to conduct our phase three trials, and that work is ongoing now, and we hope to be ready to discuss that publicly in the next few weeks.

So as we look at us Peter summarized and their remarks.

Have a very strong over half a billion dollars and cash right now.

We definitely want to and that's one of our strength at this point.

But we also want to maintain the cash and we want to limit our expense as much as possible.

So we're working with currently the funders and partners, how best to conduct our phase III trials.

And that work is ongoing now and we hope to be ready to.

To discuss that publicly and the next few weeks, so and our team our partners. Our funders are working extremely hard to.

Yi Chen: So, you know, our team, our partners, our funders are working extremely hard to make this happen, and I'm very optimistic and confident that Inovio will be able to lead this global effort for a Phase 3 Innovate trial that will be done not just in the U.S., as originally planned, but in many of the regions and countries of this world, places where we feel that COVID-19 vaccines are truly needed today and later.

To make this happen and I'm very optimistic and confident.

That and OBO able to lead this global effort.

For our phase III innovate trial that will be done not just from the U S. US for originally was planned bus and many of the regions and countries of this world.

And places, where we feel where the COVID-19 vaccines are truly needed.

Today and later so.

Dr. Joseph Kim: So we're really looking forward to having all of our strategies and details articulated fully in the next few weeks. Okay, thank you. Thanks. The next question comes from Chris Raymond of Piper Sandler. Please go ahead.

We're really looking forward to having all of our strategies and details articulated Foley.

And the next few weeks.

Okay. Thank you.

Thanks.

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

Chris Raymond: Hey, thanks for letting me ask a question. I don't think I've heard you guys address this or anybody ask this, so I guess I'll ask on this. Can you comment on the neutralizing antibody response, the immune response, and the comparison to convalescent plasma? It looks like there's a pretty sizable sort of difference there. And what gives you confidence, I guess, moving forward? Um, you know, with respect to the reaction from, you know, investigators, um.., and also, you know, subjects for the recruitment. Thank you.

Hey, Thanks for letting me ask a question.

I think I've heard you guys address us or anybody ask so I guess I'll I'll ask on and some can.

Can you just comment on.

The neutralizing antibody response, and immune response and the comparison to convalescent plasma it looks like there's a pretty sizable.

What a difference there and and.

And what gives you confidence I guess moving forward.

With respect to the reaction from investigators.

And you and also subject to the recruitment.

Thank you.

Chris Raymond: Thanks, Chris. So, yeah, you know, the geometric mean titer, which we presented in the pre-publication in MedArchive this morning, really lays out all of the data that we have, both from all of our 400 subjects at the group level without blinding, but also compared to some of the convalescent samples that we were able to acquire. So, we feel really good about the level of neutralizing antibody titers, in particular in our two milligram dose group, as we saw at six weeks, which is two weeks after the second dose in these subjects compared to their baseline at week zero, but also against the placebo group for both one milligram and two milligram groups.

Yeah. Thanks, Chris So yeah, you know the debt.

Geometric mean tighter which.

We are presented and prepublication and bought.

Net archive this morning really lays out all of the data that we have both from all of our 400 subject.

At the group level on blinding.

But also compared to some of the convalescent samples that we are able to acquire.

So we feel really good about the level of neutralizing antibody titers and particular from our two milligram dose group.

As we saw it at six weeks, which is two weeks after the second dose.

And the subjects compared to their baseline at week zero, but also against the placebo group.

For for both one milligram and two milligram groups, so and this GMT as we see the the confidence intervals.

Chris Raymond: So in this GMP, as we see, the confidence intervals are very strong, and we can qualitatively say that the level of neutralizing titers seems even better in the phase 2 trial compared to phase 1. Now the convalescent spread is also wider, and the GMP is higher than our two milligram dose. But, you know, we're looking at the immune responses generated, as I mentioned earlier, in terms of neutralizing antibodies, binding antibodies, and T-cells in a holistic way, where we feel that our INO4800 can provide protection against COVID-19 cases in a controlled, randomized placebo-controlled trial in a global effic So we look forward to taking this promising vaccine into a global phase three trial as soon as we can this summer.

<unk> is very strong.

And we.

We can qualitatively say that the level of neutralizing titers seem even better in the phase two trial compared to the phase one.

Now the convalescent our spread is also wider.

And the GMT is higher than our two milligram dose group.

But you know we're looking at the immune responses generated as I mentioned earlier.

In terms of the neutralizing antibodies binding antibodies and T cells and <unk>.

I holistic way, where we feel that our iron ore 4800.

<unk> can provide.

Provide.

Protection against.

And 19 cases.

And a controlled.

Randomized placebo controlled trial.

And a global efficacy trial. So we look forward to to taking this promising vaccine into a global phase III trial.

As soon as we can this summer.

Yeah.

Okay. Thank you.

Dr. Joseph Kim: Okay, thank you.

Yeah. Thanks, Chris.

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

Operator: There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to Joseph Kim for any closing remarks. Thank you, everyone. Thanks for listening to our presentation. Thank you for all of the insightful questions. We look forward to moving INO4800, PGX3100, as well as 3107 and 5401 forward, and we look forward to sharing some of the insights from INO4800 Phase III trials in the next few weeks. So, thank you again for this quality call and for your attention. Have a great night. The conference is now concluded. Thank you for attending today's presentation.

Yeah. Thank you everyone and thanks for listening to our presentation and thank you for us.

All of the day insightful questions. We look forward to moving INR 4800 P. J F 3100.

S well US 31 O seven and 50 401 forward and we look forward to sharing some of the insights of INR 4800 phase III trials later.

And the next few weeks. So thank you again for this quarterly call and for your attention have a great night.

Yeah.

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

Dr. Joseph Kim: You may now disconnect.

[music].