Q2 2021 Inovio Pharmaceuticals Inc Earnings Call

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Unnamed: The Bulletproof Executive, 2013

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Good afternoon, and welcome to the and O V. O 12 second 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.

Unnamed: Good afternoon, and welcome to Inovio.

Unnamed: 2nd Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist.

Unnamed: Specialist by pressing the star key followed by Z.

Unnamed: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad to withdraw your question, or, please press star then 2.

After todays presentation, there will be and opportunity to ask questions to ask a question you May Press Star then 1 on your telephone keypad to withdraw your question.

Please press Star then 2 per.

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

Please note this event is being recorded.

I would now like to turn the conference over to Ben Latona Senior Director of Investor Relations. Please go ahead.

Thank you operator, good afternoon, and thank you for joining the <unk> second quarter 2021 earnings Conference call.

Ben Latone: Thank you, operator. Good afternoon, and thank you for joining the Inovio second quarter 2021 earnings conference call. Joining me on today's call are Dr. Joseph Kim, President and CEO; Mr. Peter Kies, CFO; Dr. Jackie Shea, Chief Operating Officer; Dr. Lamont Hemot, Chief Scientific Officer; Dr. Anza Mamet, Senior Vice President of Clinical Development; and Dr. Kate Broderick, Senior Vice President of Research and Development. In today's call, we will review our corporate and financial information for the second quarter ended June 30, 2021.

Joining me on today's call are Dr. Joseph Kim President and CEO.

Mr. Peter Keith CFO, Dr. Jackie Shea Chief operating officer, Dr. Chemo, Chief Scientific Officer, Dr. Anza, Mammen, Senior Vice President of clinical development and Dr. Kate Brodrick Senior Vice President of research and develop.

For today's call, we will review, our corporate and financial information for the second quarter ended June 32021.

Ben Latone: We will discuss our COVID-19 vaccine development efforts that address both current and future variants of concern, as well as recent developments associated with Inovio's various therapeutic programs relating to our DNA medicines platform. Among our recent updates, we'll address this morning's press release pertaining to the heterologous prime boost clinical trial in China, as well as our company's global phase three innovative trial for our COVID-19 DNA vaccine candidate, INO4800, with our partner at Baxi.

We will discuss our COVID-19 vaccine development efforts that address both current and future variants of concern as well as recent developments associated with the <unk> various therapeutic programs relating to our DNA medicines platform.

Among our recent updates will address this morning's press release pertaining to the heterologous prime boost clinical trials and China.

As well as our global Phase III <unk> trial for our COVID-19, DNA vaccine candidate INO 4800, and with our partner and vaccine.

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

Ben Latone: Following prepared remarks, we will be conducting a question and answer segment reserved for equity research analysts. Additionally, 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 Inovio's integrated platform in DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters. All these statements are based on the beliefs and expectations of management as of today.

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 DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters.

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

Ben Latone: However, 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 with applicable regulatory requirements, our dependence on collaborative partners, third parties, and the 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, ir.inovio.com, and

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.

Clients with applicable regulatory requirements, our dependence on collaborative partners third party and the level of costs associated with discovery and business development activities to assist and potentially bringing our product to market.

This call is being webcast live on our website.

<unk> dot and Novo Dot com and a replay will be made available. Shortly after this call's concluded now I would like to turn the call over to and nobody else President and CEO Dr. Joseph Kim.

Dr. Joseph Kim: www.inovio.com. A replay will be made available shortly after this call is concluded. Now, I would like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim.

Thank you Ben.

Dr. Joseph Kim: Good afternoon, and thank you for taking the time to join us for today's call. With COVID-19 rates surging again globally and an increasing number of breakthrough infections, Inovio recognizes the need for additional safe and effective first-line vaccines, particularly those which could offer potential boosting capabilities to combat the spread of the virus and emerging variants, including the rapidly spreading Delta variant. As an organization, we are committed to realizing the potential that DNA medicines offer, not only to address this present public health need in response to the global pandemic, but more broadly across therapeutic areas.

Good afternoon, and thank you for taking the time to join us for today's call.

With COVID-19 rates surging again globally.

And then increasing number of breakthrough infections and.

<unk> recognizes the need for additional safe and effective first line and vaccines, particularly those which could off for potential boosting capabilities to come that the spread of the virus and the emerging variants, including the rapidly spreading delta variant.

And as an organization, we are committed to realize the potential that DNA medicines offer not only to address this president and public health needs and response to the global pandemic.

But more broadly across therapeutic areas.

Dr. Joseph Kim: In the short time we have today, I want to spend most of our call reviewing Inovio's strategy to advance INO4800 as a vaccine to be used globally as both a first-line vaccine and potentially a booster to prevent COVID-19 by leveraging key advantages of INO4800 and Inovio's DNA medicines platform, specifically. The key advantages of our DNA medicines platform include the ability to generate robust T cells alongside neutralizing antibodies, which we believe will be crucial in mitigating rising variants of concern.

And the short time, we have today.

I want to spend most of our call reviewing and <unk> strategy. So Vance I don't know 4800 as a vaccine to be used globally as both a first line and vaccine and potentially a booster and prevent COVID-19 by leveraging key advantages of INR 4800.

And you know views DNA medicines platform.

Specifically.

Key advantages of our DNA medicines platform include.

Our ability to generate robust T cells, alongside neutralizing antibodies, which we believe will be crucial and mitigating against rising variance of concern.

Dr. Joseph Kim: Our DNA medicines also have shown a favorable tolerability, transportability, and thermostability profile. These differentiators, which have been further validated through some of our recent publications and preprints, are widely acknowledged to be essential for ensuring that vaccines can be made accessible globally, but key concerns of regulators, countries, and vaccine supply initiatives. This morning's announcement is a wonderful example of that.

Our DNA medicines also have shown a favorable tolerability transport ability and thermal stability profiles.

These differentiators, which have been further valid validated through some of our recent publications and pre prints are widely acknowledged to be essential for ensuring the vaccines can be made accessible globally, a key concerns of regulators countries index.

Z and supply initiatives.

This morning's announcement is a wonderful example of debt.

Dr. Joseph Kim: Inovio and our partner at Vaccine received regulatory allowance in China for two clinical trials investigating heterologous boosting with INO4800. These trials, which are being done through trial-sponsored vaccine companies working together with Sinovac, will evaluate the safety, tolerability, and immunogenicity of heterologous prime-boost sequential immunizations using INO4800 and Coronavac, an inactivated COVID-19 vaccine developed by Sinovac Both trials, which will be conducted in China, are anticipated to begin this fall and will involve healthy adult subjects 18 years of age or older.

And <unk> and our partner at vaccine receive regulatory allowance and China for 2 clinical trials investigating heterologous boosting with INR 4800.

These trials, which are being done through trial sponsor vaccine working together with sign Novak will evaluate the safety Tolerability and Immunogenicity of heterologous Prime boost sequential immunizations using iron ore for the 800 and Corona back and enact.

Debated COVID-19 vaccine developed by some of that and validated by the World Health organization for emergency use.

Both trials, which will be conducted and China are anticipated to begin this fall and will involve healthy adult subjects 18 years of age or older.

With our increased challenge of the highly contagious Delta ovarian.

Dr. Joseph Kim: With the increased challenge of the highly contagious Delta variant and other variants of concern around the world, our work with the vaccine and Sinovac is more important than ever. If approved, we believe INO4800 will be well positioned to serve the vaccine needs of the global community as both a primary and a booster vaccine due to its tolerability, balanced cross-reactive immune responses, and strong thermal stability profile that does not require cold or ultra-cold chain transport.

And other variants of concerns around the world.

Our work with the vaccine and <unk> is more important than ever.

If approved we believe INR 4800, it will be well positioned to serve the vaccine and needs of the global community.

As both a primary and a booster vaccine due to its tolerability balanced cross reactive immune responses and strong thermal stability profile that does not require a cold for ultra cold chain transport.

Helping to enable these trials and nobody.

Dr. Joseph Kim: Helping to enable these trials, Inovio, along with the vaccine and Sinovac, recently completed cross-prime boost preclinical animal tests that evaluated the immune boosting abilities of INO4800 and Coronavac. Results demonstrated that the Prime Boost strategy can stimulate high levels of antigen-specific binding antibodies, neutralizing antibodies by both live virus neutralization assay and an ACE receptor blocking assay, as well as antigen-specific T cell immune responses. We're really excited to see the continued development of heterologous prime boost strategies for COVID-19 vaccines with different mechanisms of action, as this is likely to become an important component of real world vaccine use and may provide an efficient solution that synergistically enhances the immunogenicity of vaccines.

Along with the vaccine and sign of that recently completed cross prime boost preclinical animal test that evaluated the immune boosting abilities of INR 4800 and cornerback.

Results demonstrated that the prime boost strategy can stimulate high level of antigen specific binding antibodies neutralizing antibodies by both live virus neutralization assay and ace receptor blocking assay as well as antigen specific T cell immune to.

Responses.

We're really excited to see the continued development of heterologous Prime boost strategies for COVID-19 vaccines with different mechanisms of action. As this is likely to become an important component of real world vaccine us and may provide an efficient.

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That synergistically enhances the immunogenicity of vaccines.

Dr. Joseph Kim: We believe this concept will be a key factor in fighting the current increasing global COVID-19 cases and Variants of Concern and extending the potential market for INO4800. We're especially excited and proud to expand our partnership with the vaccine to explore heterologous prime boosting using INO40 and 100 to potentially protect more people against COVID-19 by serving as a potentially safer and more immune-enhancing booster vaccine, not only to the inactivated vaccine but perhaps to other viral vector and mRNA vaccines. We look forward to sharing data from these trials in the future.

We believe this concept will be a key factor and fighting against the current increasing global COVID-19 cases and variance of concerns and.

And expanding the potential market for iron ore for the 800.

We're especially excited and proud to expand our partnership with a vaccine.

Explore heterologous prime boosting using INR 40, and 100 to potentially protect more people against COVID-19 by serving as a potentially safer and more immune enhancing booster vaccine not only to the inactivated vaccine or perhaps with other viral vector.

And <unk> and mrna vaccines, we look forward to sharing data from these trials and the future.

Before we go further I would like to reiterate <unk> focus on starting and executing our global innovate phase III trials and countries outside the us.

Dr. Joseph Kim: Before we go further, I would like to reiterate Inovio's focus on starting and executing our global Innovate Phase III trials in countries outside the U.S. More specifically, our primary focus is getting this trial initiated next month to enroll healthy men and non-pregnant women 18 years and older across several countries, concentrating on Latin America and Asia, in addition to expanding the trial to Africa. As it relates to the United States, Inovio does not plan on enrolling any subjects in the US for the Innovate Phase III trial.

More specifically our primary focus is getting this trial initiated next month to enroll healthy men and non pregnant women 18 years and older across several countries concentrating on Latin America.

Asia In addition to expanding the trial to Africa.

As it relates to the United States and <unk> does not plan on enrolling any subjects in the us for the innovate phase III trial.

Dr. Joseph Kim: We will engage the FDA on a formal lifting of the partial clinical hold as a part of our long-term plans to pursue a BLA approval in the US once INO4800 efficacy is demonstrated in the global Innovate Phase 3 trial. Returning to the changing COVID pandemic landscape, in the second quarter, the company released a preprint, as a preprint, results showing that INO4800 provided broad cross-reactive In particular, the study showed that the T cell responses generated by INO4800 vaccination were fully maintained against the alpha, beta, and gamma variants when compared to the T cell responses to the original wild-type strain.

We will engage the FDA on a formal lifting of the partial clinical hold.

A part of our long term plans to pursue a BLA approval in the US once INR 4800 efficacy is demonstrated in the global innovate phase III trial.

Returning to the changing Covid pandemic landscape in the second quarter. The company released a priest preprint as a preprint.

It's showing that INR 48, and 100 provided broad cross for active immune responses and humans against POC and.

In particular the <unk>.

Studies show that the T cell responses generated by INR 4800 vaccination for.

<unk> fully maintained against the Alpha beta and gamma variance when compared to the T cell responses to the original wild type strain.

Subsequent to this published work and something that Dr. Kate Brodrick will discuss later.

Dr. Joseph Kim: Subsequent to this published work, and something that Dr. Kate Broderick will discuss later, INO4800 vaccination was also found to maintain a similar level of T cell responses against the Delta variant when compared to the T cell responses to the original wild-type strain, while it showed a similar level of reduced neutralizing antibody activity against the Delta variant by other vaccines. In parallel with INO4800, Inovio is also developing a novel pan-COVID second-generation vaccine candidate, INO4802, which is specifically designed to protect against current and future variants of concern.

4800 vaccination was also found to maintain a similar level of T cell responses against the Delta Varian when compared to the T cell responses to the original wild type strain, while it showed a similar label level of reduced neutralizing antibody activity.

The Delta Varian by other vaccines.

In parallel with INR 4800, Nobody who is also developing a novel Pan Covid second generation vaccine candidate and I don't know 48, or 2 which is specifically designed to protect against current and future variance of concern.

Dr. Joseph Kim: INO4802 could potentially offer broad boosting capabilities in addition to an initial vaccination regimen with INO4800 and or other first-generation vaccines, including both adenovirus and mRNA based platforms. Both INO4800 and INO4802 are able to be used as a primary vaccine, as well as both homologous and heterologous boosters. With that, I'd like to turn the call now to Dr. Anza Mammon, who is leading our global phase three trial for INO4800, for an update on the progress. Dr. Mammon?

I don't know for years, 2 could potentially offer broad boosting capabilities. In addition to and initial vaccination regimen with INR 4800 and.

And or other first generation and vaccines, including both adenovirus and.

And mrna based platforms.

Both INR 4800, and 948 or 2 are able to be used as a primary vaccine as well as both homologous and hero heterologous boosting.

With that I'd like to turn the call now to Dr. Anza Mammen, who is.

Leading our global Phase III trial for iron ore and 4800 for an update on the progress onto.

Thank you Joseph.

Anish Nikhanj: Thank you, Joseph. I'm glad to be here on the call today. As Joseph mentioned in his opening remarks, we announced the expansion of our partnership with Advaxin to jointly conduct our global phase 3 efficacy trial for INO4800.

And I am glad to be here with you on the call today.

And as Joseph mentioned in his opening remarks, we announced the expansion of our partnership with add vaccine to jointly conduct.

<unk> phase III efficacy trial for INR 4800.

Unnamed: This trial will be conducted at multiple sites.

This trial will be conducted at multiple sites across several countries for.

Unnamed: across several countries, primarily in Asia and Latin America, where virus transmission continues to be significant. We have recently been in discussions with countries in Africa to expand the Innovate Phase 3 trial as there remains a significant unmet need and limited access to the currently available emergency use authorized vaccines being administered globally. As a reminder, the Phase 3 Innovate study will evaluate the safety and efficacy of INO4800 in a two-dose regimen using a dose of 2 milligrams administered one month apart in a two-to-one randomization in healthy men and non-pregnant women 18 years and older.

Primarily in Asia, and Latin America, where wireless transmission continues to be significant.

We have recently been and discussions with countries in Africa.

And the innovate phase III trial as there remains a significant unmet need and limited access to the currently available for emergency use authorized for magazine and <unk>.

Administered globally.

As a reminder for phase III innovate study will evaluate the safety and efficacy of INO 4800, and a 2 dose.

Regimen, using a dose of 2 milligrams administered 1 month apart and Ah.

And 2 to 1 randomization and healthy men and non pregnant women 18 years and older.

Unnamed: The Phase 3 trial builds upon the recent Phase 2 clinical work and findings that we presented in the second quarter, where we found INO4800 to be well-tolerated and immunogenic across all tested age groups. The rise in binding and neutralizing antibody levels was statistically significant and greater in the 2 milligram dose group versus the 1 milligram dose group. Notably, the T cell immune responses measured by the ELISBOT assay were also higher in the two milligram dose group as compared to the one milligram dose group.

The phase III trial builds upon the recent phase II clinical work and finding that we presented and the second quarter, where we've found iron ore for the 800 to be well tolerated and immunogenic across all trusted age groups and.

And particularly.

Pools rise of binding and neutralizing antibody levels with us.

Typically significant and greater and the 2 milligram dose group versus the 1 milligram dose group.

Notably the T cell immune responses measured by the Ellis Fund assets were also higher and the 2 milligram dose group as compared to the 1 milligram dose group.

Taking together everything that we've done to date.

Unnamed: Taking together everything that we have done to date, especially the data demonstrating the maintenance of T cell activity, all of these results provide a comprehensive picture of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants in INO4800 vaccinated individuals, conveying

Especially the data demonstrating the maintenance of T cell activity.

All of these results provide a comprehensive picture of cross reactive cellular and humoral immune responses against Sars Covid 2 variance for iron.

No 4800 vaccinated individuals.

Conveying the potential of INO 4 to 802 combat emerging as well as future variants of concern.

Unnamed: conveying the potential of INO4800 to combat emerging as well as future variants of concern. With that, I will now turn the call back over to Joseph.

With that I will now turn the call back over to Joseph.

Thanks, Andrew.

Dr. Joseph Kim: As I mentioned during my opening remarks, we're extremely focused on advancing INO4800 through phase 3 efficacy trials, while in parallel also developing our second generation pan-COVID DNA vaccine candidate, INO4802. I'll now ask Inovio's Senior VP of R&D, Dr. Kate Broderick, to speak in greater detail about our efforts with INO4802, as well as our broader work in infectious diseases. Kate? Thank you, Joseph, and hello to everybody who's on the call with us today. In parallel to the INO4800 efforts outlined earlier in the call, we're also developing a second generation pan-COVID vaccine candidate, INO4802.

And as I've mentioned during my opening remarks, we're extremely focused on advancing iron ore for the 802 phase III efficacy trials, while in parallel also developing our second generation and.

And Covid DNA vaccine candidate and I don't know 48 or 2.

I'll now ask and <unk> senior VP of R&D, Dr. Kate Broderick to speak in greater detail about our efforts with INR 48, or 2 as well as our broader work and infectious diseases J.

Thank you Joseph and Hello to everybody who's on the call with us today.

In parallel to the INR 4800 day efforts outlined earlier and Nicole. We're also developing a second generation PON Covid vaccine candidate and INR 42.2.

While other companies have developed much streams I and.

Dr. Kate Broderick: have developed match strains; INO4802 is our strategy against current and future variants of concern. We anticipate additional viral shifts, which makes INO4802 an important asset in our portfolio. INO4802 could potentially offer boosting capabilities in addition to an initial vaccination regime with INO4800 and or other first-generation vaccines including both adenovirus, inactivated, and mRNA-based platforms. In May 2021, Inovio published a manuscript as a preprint on the BioRxiv website entitled Design and Immunogenicity of a Pan-SARS-CoV-2 Synthetic DNA Vaccine, which demonstrated cross-reactive immune responses against current and emerging viral variants using Inovio's next generation pan-COVID-19 vaccine candidate INO4802 as either a first-line vaccine or potentially as a booster for individuals Specifically, INO4802 induced a potent neutralizing antibody in T-cell responses against the original wild-type strain.

42, 2 is our strategy against current and future <unk> concern.

We anticipate additional vital shift, which makes iron ore 42, 2 unimportant assay and our portfolio.

Iron ore 40, or 2 to potentially offer boosting capabilities and addition to and initial vaccination regime with iron ore <unk> hundred.

And our other first generation vaccines, including both identified us and activated and a modern day based platforms.

And me 2021, and it will be published a manuscript is a pre print on the bio archive website entitled design and Immunogenicity of a pan Sars Covid, 2 synthetic DNA vaccine, which demonstrated cross reactive immune responses against current and emerging variant.

Vital variants using a new <unk> next generation PON, COVID-19 vaccine candidate and I and all 42, 2 and so you said a force like vaccine or potentially as a booster for individuals previously immunized with various wild type marched vaccines.

Specifically iron ore for tier 2 and juice potent neutralizing antibody and T cell responses against the original wild type stream as well as against the variance.

Unnamed: as well as against the variant. And in subsequent research, we've also found that we can fully protect animals vaccinated with 4802 against alpha, beta, gamma, and also the all-important delta variant.

And then subsequent research. We've also found that we can fully protect animals vaccinated with 42 against Alpha beta and Gamma and also the all important delta variant.

We look forward to sharing more details on our progress with iron ore <unk> to prepare for a phase 1.2 clinical trial and the near future.

Unnamed: We look forward to sharing more details on our progress with INO4802 to prepare for a Phase 1-2 clinical trial in the near future. Our COVID-19 program, both our late-stage advancements with INO4800, as Ansa just outlined earlier, as well as our pre-clinical work on INO4802, builds on our deep roots in infectious diseases and our commitment to global public health. This last quarter, Inovio dosed the first subject in our Phase 2 clinical trial for INO4700, our DNA vaccine candidate for Middle East Prespiratory Syndrome, or MERS. There is currently no approved vaccine for MERS, which is also a coronavirus, but the fatality rate is approximately 34% of those who are infected. This phase two trial is being conducted at Sites Jordan.

Our COVID-19 program with our late stage advancement with force Iron ore <unk> Tundra design for just outlined earlier and that's why I was our preclinical work and I know 42 to <unk>.

And our deep roots and infectious diseases, and our commitment to global public health.

This last quarter and all of you dose the first subject and our phase II clinical trial for iron ore and 4700, our DNA vaccine candidate for middle East respiratory syndrome or Mers.

There is currently no approved vaccine for mirrors, which is also a coronavirus. The fatality rate is approximately 34% of those who are infected.

This phase 2 trial is being conducted at sites in Georgia, and Lebanon for Mers cases have been reported.

The randomized double blinded placebo controlled multicenter study, which is sponsored by <unk> and funded by the coalition for epidemic preparedness innovation or safety.

If all use the safety Tolerability and Immunogenicity of INR 4700, and administered using a new mobile select trust smart device and approximately 500 healthy adult volunteers.

Unnamed: and Lebanon, where MERS cases have been reported. The randomized, double-blind, placebo-controlled...

Unnamed: Our multi-centre study, which is sponsored by Inovio and funded by the Coalition for Epidemic Preparedness Innovation, or CEPI, evaluates the safety, tolerability, and immunogenicity of INO4700 administered using Inovio's Selectrust smart device in approximately 500 healthy adult volunteers.

Our pursuit of a virus vaccine is funded by our previously announced 56 million dollar grants from safety and.

And what Januvia will develop vaccine candidates through phase II against Mars as well as lots of fever.

It remains a dull deals and safety school to make a stockpile of mers vaccines available for emergency use following successful completion of phase 2 clinical testing and now I'll turn the call back to Youtube.

Unnamed: Our pursuit of a MERS vaccine is funded by a previously announced $56 million grant from CEPI, under which Inovio will develop vaccine candidates through Phase 2 against MERS, as well as Lassa Pharma. It remains Inovio and Cepi's goal to make a stockpile of MERS vaccines available for emergency use following successful completion of phase 2 clinical testing.

Thank you Kate before our CFO Peter Keys provides a financial summary for the quarter I'd like to provide you with an update on our other important clinical programs.

First advancing our HPV related disease treatment and research and we continue to follow subjects and reveal 1 and 1 of our 2 phase III pivotal trials evaluating vjax 3100 for debt.

Dr. Joseph Kim: Thank you, Kay. Before our CFO, Peter Kies, provides a financial summary for the quarter, I'd like to provide you with an update on our other important clinical programs. First, advancing our HPV-related disease treatment research, we continue to follow subjects in Reveal 1, one of our two Phase 3 pivotal trials evaluating VGX3100 for the treatment of cervical high-grade squamous intraepithelial lesions or H-cells caused by HPV16 and or HPV18 for safety and durability of responses for 18 months following the last administration.

Treatment of cervical high grade squamous intra epithelium lesions or H, so caused by HPV 16, and or HPV 18 for safety and durability of responses for 18 months following the last administration.

We expect to present, our findings from reveal 1 at a scientific meeting later this year.

And anticipate for subject level unblinded and the second half of 2021.

Each will facilitate detail analysis of individual patient level data.

In addition, and overview is co developing a biomarker with quiet Gen to guide clinical decision, making for the use of <unk> 3100, and cervical H, So and we anticipate reporting. These findings later this year.

Dr. Joseph Kim: We expect to present our findings from reveal one at a scientific meeting later this year and anticipate full subject level unblinding in the second half of 2021, which will facilitate detailed analysis of individual patient level data. In addition, Inovio is co-developing a biomarker with QIAGEN to guide clinical decision-making for the use of VGX3100 in cervical H cells, and we anticipate reporting these findings later this year. Reveal 2, our second phase 3 pivotal trial, continues to enroll across 48 clinical sites globally with a projected total enrollment of approximately 198 adult women with histologically-confirmed cervical H cells.

Reveal 2 our second phase III pivotal trial continues to enroll across 48 clinical sites globally with projected total enrollment of approximately 198 adult women with his dollar histologically confirmed cervical <unk>.

Among our immuno oncology efforts in <unk> and our partners continue to evaluate findings from the phase 1 slash 2 novel combination.

DNA medicines, INR 50, 401, and INR 90, 12, and combination with the PD 1 checkpoint inhibitor Teo.

Dr. Joseph Kim: Among our immuno-oncology efforts, Inovio and our partners continue to evaluate findings from the phase 1-2 novel combination of DNA Medicine's INO5401 and INO9012 in combination with the PD-1 checkpoint inhibitor Lipteo, which is being jointly developed by Regeneron and Sanofi for treating newly diagnosed GBM.

Which is being jointly developed by Regeneron, and Sanofi and treating newly diagnosed GBM.

We look forward to sharing 2 year overall survival data and then oncology conference and the fourth quarter of this year.

Next I will turn the call over to Peter for our second quarter financial summary, Peter.

Thanks Joseph.

Peter D. Kies: We look forward to sharing two-year overall survival data at an oncology conference in the fourth quarter of this year. Next, I will turn the call over to Peter for our second quarter financial summary. Peter. Thanks, Joseph. Good afternoon, everyone.

Good afternoon, everyone.

We ended the second quarter with $443.7 million and cash cash equivalents and short term investments.

Providing us with multiple years of sufficient capital to support existing activities and programs.

Peter D. Kies: We ended the second quarter with $443.7 million in cash, cash equivalents, and short-term investments, providing us with multiple years of sufficient capital to support existing activities and programs. Our revenue for the second quarter of 2021 was $273,000, which compares to $267,000 for the same period in 2020. Our total operating expenses were $83.5 million compared to $33.4 million for the same period in 2020. Inovio's net loss for the second quarter of 2021 was $82.1 million, or $0.39 per share, basic and dilutive, which compares to a net loss of $128.7 million, or $0.83 per share, basic and dilutive, for the quarter ended June 30, 2020.

Our revenue for the second quarter of 2021 was 273000, which compares to 267000 for the same period and 2020.

Our total operating expenses were $83.5 million compared to $33.4 million for the same period and 2020.

And nobody was net loss for the second quarter of 2021.

Was $82.1 million or 39 cents per share basic and dilutive, which compares to a net loss of $128.7 million.

Or <unk> 83 per share basic and dilutive for the quarter ended June 32020.

Our R&D expenses were $78 million for the second quarter of 2021, which compares to $22.4 million for the same period and 2020.

The increase and R&D expenses was primarily attributable to manufacturing scale and scale up activities for INR 4800. These.

And these I know 4800 activities included the acquisition and installation.

Peter D. Kies: Our R&D expenses were $70.8 million for the second quarter of 2021, which compares to $22.4 million for the same period in 2020. The increase in R&D expenses was primarily attributable to manufacturing scale-up activity for INO4800. These I&O 4800 activities included the acquisition and installation of manufacturing equipment, drug manufacturing, outside services, and clinical study expenses. Other increases included engineering services and expensive equipment related to our Selectra 3PSP device array automation project.

Manufacturing equipment drug manufacturing outside services and clinical study expenses.

Other increases included and relief engineering services.

And equipment related expense for equipment and related to our select draw 3 PSP device array automation project.

Also employee and contractor compensation and drug manufacturing expenses related to.

Our our RP trial.

These increases were offset by an increase and Contra research and development expenses recorded from grants agreement of $8.1 million among other variances.

Lastly, G&A expenses were $12.7 million for the second quarter of 2021 versus $11.1 million for the same period and 2020.

Peter D. Kies: Also, employee and contractor compensation and drug manufacturing expenses related to our RRP trial. However, these increases were offset by an increase in CONTRA research and development expenses recorded from grant agreements of $8.1 million, among other variances. Lastly, G&A expenses were $12.7 million for the second quarter of 2021 versus $11.1 million for the same period in 2020. These increases in GINA expenses were primarily related to an increase in employee compensation, which includes non-cash, stock-based compensation. This was partially offset by lower expenses for work performed related to corporate marketing and communications, among other things.

These increases and G&A expenses was primarily related to an increase in employee compensation, which includes non cash stock based compensation.

And this was partially offset by lower expenses for work performed related to corporate marketing and communications among other variance.

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

Thank you Peter before we'd take analyst questions I would like to acknowledge and extend my appreciation to the entire <unk> team as well as our partners collaborators funders and patients for their support hard work and dedication across all of our programs and develop.

Dr. Joseph Kim: And with that, I'll turn it back over to you, Joseph. Thank you, Peter. Before we take the analysts' questions...

And then.

In closing DNA medicines and vaccines offer.

We believe our 1 of the best modern approaches to addressing unmet global health needs like fighting COVID-19, and other infectious diseases as well as cancer and HPV associated diseases.

Dr. Joseph Kim: I would like to acknowledge and extend my appreciation to the entire Inovio team, as well as our partners, collaborators, funders, and patients for their support, hard work, and dedication across all of our programs and developments. In closing, DNA medicines and vaccines offer what we believe are one of the best modern approaches to addressing unmet global health needs like fighting COVID-19 and other infectious diseases, as well as cancer and HPV-related diseases. The benefits of DNA medicines broadly, as well as the ability to generate a functional T-cell and antibody response with tolerability and a strong thermostability profile, are meaningful differentiators in our ability to protect against evolving COVID-19 with INO4800. We remain confident in and dedicated to our development efforts. And thank you for your continued support of Inno. We will now open the call to your questions. Operator?

The benefits of DNA medicines broadly as well as the ability to generate from.

Functional T cell and antibody response with Tolerability and a strong thermal stability profile are meaningful differentiators and our ability to protect against evolving COVID-19.

With iron ore for the 800.

We remain confident in and dedicated to our development efforts and thank you for your continued support of and the overview.

We will now open the call for your questions operator.

We will now begin the question and answer session to ask a question you May Press Star then 1 on your telephone keypad. If you were using a speaker phone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then 2 at this time, we will pause momentarily to.

And assemble roster.

Yeah.

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

Unnamed: We will now begin the question-and-answer session. To ask a question, you may press the star key, then enter.

Unnamed: To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys.

Good afternoon. This is Alex on for Geoff Meacham. Thank you for taking our question so I'll have to from us.

The first 1 is how has the overall increase and COVID-19 cases, and horizon grants affected enrollment and strategies and the overall timelines for phase III trial and error.

Unnamed: To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster. Your first question comes from Jeff Meacham with Bank of America. Please go ahead. Good afternoon. This is Alex on behalf of Jeff Meacham. Thank you for taking our question. So we'll have two from us. The first one is, how has the overall increase in COVID-19 cases and the rise in variance affected enrollment strategies and the overall timelines for Phase 2?

And then moving to your immuno oncology platform can you expand on the data release for Glioblastoma and what is the regulatory path forward can you speak to any of your discussions with the FDA. Thank you.

Yes. Thank you Alex I'm going to address the second question briefly and then I'll ask that surrounds amendment to address your first question, which is the changing landscape on the impact on enrollment for for phase III.

Alex: And then moving to your immuno-oncology platform, can you expand on the data release for glioblastoma, and what is the regulatory path forward? Can you speak to any of your discussions with the FDA? Yeah, thank you, Alex.

And Glioblastoma trial, we're still tracking the patients we will have the OS 24.

The data that will be reported as a presentation at a conference and the fourth quarter.

Dr. Joseph Kim: I'm going to address the second question briefly, and then I'll ask Dr. Anza-Maman to address your first question, which is the changing landscape and impact on enrollment for Phase 3. In the cleoblastoma trial, we're still tracking the patients. We will have the OS24 data that will be reported as a presentation at a conference in the fourth quarter, and we look forward to sharing those data at that time and additional updates on our thoughts on further developing this program from the regulators. So, Anza, I'd like to ask you to address the first part of our 4800 enrollment strategy in the changing landscape.

And we look for to.

Sharing those data at that time and additional updates on our thoughts on further developing this program from the regulators. So hamzah I like to ask you to address the first part of our 4800 enrollment strategy and the changing landscape.

Thank you Joseph.

So with regards to innovate and Korea as you know the the overall study design is to administer 2 doses for buying over 4800.

And to begin this to begin to follow us subject.

Anish Nikhanj: Yes. Thank you, Joseph.

For the development of biologics with confirmed COVID-19, and.

Anish Nikhanj: So, with regard to Innovate Phase 3, as you know, the overall study design is to administer two doses of INO4800 and to begin to follow subjects for the development of virologically confirmed COVID-19. And initially, we embarked on a two-region strategy involving Latin America and Asia Pacific. And in light of the changing landscape with regard to vaccination rates and also the rapidly changing virus epidemiology in these countries, we've recently adopted an approach to bring the vaccine to the African continent as well, especially in light of the still relatively low vaccination rates and the continued virus transmission within that region.

And initially we've embarked on a 2 region strategy involving Latin America, and Asia Pacific and in light of the changing landscape with regards to vaccination rates and also the.

<unk>.

The rapidly changing virus.

D Neology and these countries we have now recently adopted and approach to bring on the African continent as.

And as well, especially in light of these 2 relatively low vaccination rates and the continued of virus transmission within that region.

So we are taking the approach of really understanding and real time for vaccination rates as well as the virus cases that are being reported in these countries to be able to take an approach of.

Anish Nikhanj: So we are taking the approach of really understanding in real time the vaccination rates as well as the virus cases that are being reported in these countries to be able to take an approach of preparing to enroll in multiple countries across these three regions and to be able to shift our enrollment focus as real-time data comes in with regard to the virus epidemiology. So in this way, we kind of maintain our optionality as to where to enroll to be able to bring in optimally the necessary COVID-19 cases. So hopefully, this answers your question.

Pairing too and role in multiple countries across the 3 regions and to be able to share our enrollment focus.

And our real time data comes in with regards to the virus epidemiology, so and <unk>.

This way, we we kind of maintain our optionality as to where to enroll to be able to 2 of going in and optimally.

Necessary COVID-19 cases.

So hopefully this answers your question.

For sure. Thank you so much for the color.

Unnamed: For sure. Thank you so much for the color. The next question is from Hartaj Singh with.

Yes.

The next question is from hard Taj Singh with Oppenheimer. Please go ahead.

Hartaj Singh: with Oppenheimer. Please go ahead. Great. Thanks for the progress update and a couple of questions. One is just following up with the previous question on your phase three that you're going to be conducting in various parts of the world. You know, some companies, not necessarily DNA medicines based, Joe, have run trials where they seem to have been more variants and have reported a kind of lesser vaccine efficacy. There are not many, but a few of those have cropped up from time to time.

Great. Thanks for the.

Progress update and and a couple of questions..1 is just following up with the previous question on your phase III that youre going to be conducted.

And those parts of the world and some companies.

Necessarily DNA medicines based Joe have.

1 trials, where they seem to have been more variance and have reported and kind of for a lessor vaccine efficacy. There are not many but a few of those and those have cropped up.

From time to time.

Hartaj Singh: What are your thoughts in that regard? I mean, you know, Last year, the previous trials were all run against the Lujan strain, and you had a certain efficacy there. How do you think about, you know, the other variants that will likely be included in your phase three? So that's number one. Number two, in HSIL, you know, we did a KOL call where a lady physician indicated to us that, you know, younger women really are very uncomfortable with surgery against these cervical lesions. They try to avoid them. And then also having a biomarker kind of based strategy could increase uptake there.

What are your thoughts in that regards.

Last year, the previous trials for all want against the new home screen.

And you had a certain efficacy there and how to think about the other variance that will be likely included in your phase III. So that's number 1 number 2 and aegis IL and we did our Q1 call where.

And ladies physician indicated to us that.

Younger women really are a very uncomfortable with surgery against us. So the confusion, we try to avoid them.

And then also having a biomarker kind of based strategy.

Increase uptake there can you address that.

And specifically with your <unk> strategy and projects third and 400 again and thanks for the questions.

Yes, Thanks for touch so let me address very quickly I think.

And and Kate both touched on sort of our overall approach, but you know.

Dr. Joseph Kim: Can you address that, you know, specifically with your HSIL strategy of VGX 3400? Again, thanks for the question. Yeah, thanks, Hartaj.

It's a I don't know 4800 phase 3 is going to happen in 2021 and second half right. So.

And the vaccine was designed originally against the wild type strain Wuhan strange so to speak.

Dr. Joseph Kim: Yeah, thanks Hartaj. So let me address this very quickly. I think Anza and Kate both touched on sort of our overall approach, but, you know, INO4800 Phase 3 is going to happen in 2021, in the second half, right? So, you know, the vaccine was designed originally against the wild type strain, the Wuhan strain, so to speak. But what we found in various studies we've done, including challenge studies, that amazingly, INO4800 has pretty good protection and also neutralization as well as T cell responses against these various variants. So, you know, we're encouraged by these supportive data. And, as Anza mentioned, we have a command center of information coming from three different continents, Latin America, Asia, and Africa.

But what we've found and in various studies, we've done including challenge studies.

Uh huh.

Incredibly I don't know 4800 has pretty good.

Protection.

And also neutralization as well as T cell responses.

And these various varian so.

And we're encouraged by these supportive data.

And as Andre mentioned, we have like a command center of of information coming from 3 different continents.

And Latin America, Asia, and Africa, and were sort of making those enrollment decisions based on real time information that allows us to most.

Actually run the phase III trial, and we're very lucky to have such a dedicated team of <unk>.

Employees partners and collaborators that would help us execute that so.

We're very bullish on the potential of 4800 and the innovate trial.

And we're looking for 2 to getting the data and and the first half of next year.

Dr. Joseph Kim: And we're sort of making those enrollment decisions based on real-time information that allows us to most efficiently run the INOV8 Phase 3 trial. And we're very lucky to have such a dedicated team of employees, partners, and collaborators that would help us do that. So, we're very bullish on the potential of INO4800 and the INOV8 trial, and we're looking forward to getting data in the first half of next year with interim readouts for efficacy. So, and then the second part of your question, which is also important, is the cervical A cell. I absolutely agree with your KOL that you were referring to.

With interim readout for efficacy so.

And then second part of your question, which is also important.

Several Kuwait, so I absolutely agree with your Kols that you were referring to.

And I think younger women or even older women who have the.

The potential of looking at our current treatment with it so and the cervix right now, it's 1 form of surgery or another and it has a tremendous negative impact their ability to carry on future pregnancies.

Dr. Joseph Kim: I think younger women or even older women who have the potential of looking at a current treatment with H cells in the cervix, right now, it's one form of surgery or another. And it has a tremendous negative impact on their ability to carry on future pregnancies. If you're curious, just Google a lead procedure on YouTube, and you will see how traumatic such a surgery could be. So, what VGX 3100 presents, and we should have the full data set in Reveal 1 this year and Reveal 2 data next year, is that it could be the first non-surgical immunotherapy-based treatment for women to not only clear and treat the disease but also eradicate the virus, HPV 16 or 18, that caused the disease in the first place.

If you are curious just Google.

A leap procedure and then.

Youtube and Youll see how traumatic.

Such a surgery could be so what I don't know what P. J F 3100 presents and where.

We should have the full data set and reveal 1 this share and reveal 2 data next year is that it.

It could be the first non surgical immunotherapy based treatments for.

And for women to not only clear and treat the disease, but also eradicate the virus HPV 16 or 18.

Viruses that cause the disease and the first place. So we're very much excited about what this new.

Dr. Joseph Kim: So we're very excited about what this new generation of women's health product, PGX3100, can bring to the market and to the patients who, right now, they don't have any choice. It's either surgery or the potential for developing cancer. What PGX3100 will present is an option with the potential to treat without scraping off the top layers of their cervix and potentially impairing their future pregnancy. So thank you very much for that question.

Generation of women's health products, and <unk> 3100 can bring to the market and to the patients who right now they don't have any choice either surgery or potential of developing cancer.

What did your ex 3100 more.

Ill present us a optionality.

And with potential to treat without scraping off the top layers of their cervix and.

Potentially impairing their future pregnancies. So thank you very much for that question.

Great. Thank you Jason.

The next question is from Gregory <unk> with RBC capital. Please go ahead.

Unnamed: The next question is from Gregory.

Gregory: Anza with RBC Capital. Please go ahead. Hey, Joseph and team. Thank you for the update and for taking my question. I just think I understand the discussion on cervical H. So I'm just curious, Joseph, if you could perhaps provide just a finer point on the reveal for enrollment and that potential trial.

Hey, Joseph and team. Thank you for the update and particularly and my question just sticking on the discussion on cervical age. So just curious Joseph.

Per perhaps provide just a finer point on the reveal 2 enrollment and the potential trial readout to there I'm just curious.

Gregory: I'll read out there. I'm just curious if it's an early 2022 event, as perhaps indicated, or if there are some design adjustments or additional learnings that you're incorporating from Reveal One to sort of help that.

If its an early 2022 event, that's perhaps indicated or if there are some design adjustments or additional learnings that you're incorporating from reveal 1 and 2 sort of help that debt that.

Momentum along the way and then maybe interest in parallel for that Joseph just any updates on on the device side. When it comes to your your target for a BLA filing thereafter once the data is.

Unnamed: that momentum along the way, and then maybe just in parallel to that, Joseph.

Unnamed: Parallel to that, Joseph, just any updates on the device side when it comes to your target for a BLA filing thereafter once the data is disclosed and collected.

And as disclosed and collect it.

Yes, thanks, Greg so our reveal to us enrolling now.

To fully enrolled before the end of the year.

We haven't made any adjustments based on the reveal 1.

Dr. Joseph Kim: Yeah, thanks Greg. So Reveal 2 is enrolling now. We expect to fully enroll before the end of the year. We haven't made any adjustments based on the Reveal 1 interim look.

Interim.

Look.

We will have the for reveal 1 dataset also before the end of the year.

Unnamed: We will also have the full Reveal-1 data set before the end of the year, and we're going to have a very eventful second half of this year, as we will also have readout of the biomarker data from Reveal-1 as well. So, you know, a lot of this information will go a long way in positioning the full data set for our Reveal program for VGX3100. So, in terms of the devices, you know, our Selectra 5PSP commercial intramuscular delivery system is currently being used to conduct the Phase 3 Reveal-1 and Reveal-2 trials, and we are very confident that the device will be ready for full commercialization as we move forward with the BLA application once we have all of the clinical data at hand. So we're very confident in our Selectra 5PSP device. Great, thank you. And last one for me, maybe for Peter. Peter, you mentioned just the multiple

And we're gonna have very.

Event for second half of this share S. We will also have a readout of the biomarker data from reveal 1 as well so.

Other these information and wall.

For a long way and positioning the full data set for our reveal program.

For VEGF study 100 so.

In terms of other devices.

We are select truck 5 PSC sp.

Uh huh.

Commercial intramuscular delivery system is currently being used to conduct the phase III reveal 1 and reveal 2 trials and we are.

We are very confident debt.

The device will be ready for full commercialization.

As we move for for BLA application. Once we have all of the clinical data at and so we're very confident in our select trial 5 PSP device.

Great. Thank you and and last 1 for me and maybe for Peter Peter You mentioned, just the multiple years across multiple programs for our cash runway and just and yes.

Unnamed: https://www.youtube.com

For context of the spend for this quarter I'm just curious if you could provide and maybe.

And maybe some color around the trajectory that we would and anticipate over these debt or are these quarters to come and then maybe just some thoughts about how that allocation spreads are crossed.

Unnamed: For more information, visit www.fema.gov.

Unnamed: And maybe just some thoughts about how that allocation is spread across certainly the COVID VAX programs as well as the other programs in your portfolio. Thank you very much again, guys.

Certainly the COVID-19 back programs as well as the additional debt as well.

Well as the other programs and your portfolio. Thank you very much again guys.

Peter D. Kies: Yeah, most of the increase was around the acquisition and installation of the manufacturing equipment that's for the IONO 4800 launch, as well as the device scale-up. So we'll expect going forward in the quarters, we had a little bit of a spike. A lot of what was an expense this quarter that kind of brought us to what looked like a high number was actually purchased in the summer of last year. And it's just becoming expensive as the facility is now completed, and it's starting to be used, and it's up and running now for early production. But we expect going forward to see somewhere in the $20 million burn going forward for our existing programs for months. Yeah. Great. Thanks, Peter.

Yes.

Most of the increase was around the acquisition and installation of the manufacturer and equipment.

For I don't know for 800 launch.

As well as.

The device scale up.

So, we'll expect going forward and the quarters, where we had a little bit of a spike.

A lot of what was expense this quarter.

And kind of brought us to what looked like a high number.

And was actually purchased and summer of last year.

And it's just being expenses as the the facility is now.

Completed and it's starting to be.

And it's up and running now for for.

And for early production.

But we expect going forward to see somewhere and the $20 million burn going forward.

For more existing rooms per months, yes.

Great. Thanks, Peter.

And no more questions.

Unnamed: Okay, sorry. Thanks guys.

Alright, thanks, guys.

Yi Chen: The next question is from Yi Chen with HC Wainwright. Please go ahead. Oh, hey, this is Chait on behalf of DHM.

The next question is from US Chen with H C. Wainwright. Please go ahead.

Oh, Hey use has changed and we have them.

P J.

Chait: I have 3 questions. The first one is, when could the phase 2 study of the MERS vaccine report top-line results? What is the target number of enrollment? The second question is, when do Advaxin and Thinovac plan to start the heterologous boosting trials in China?

2 questions. The first 1 and when could the phase 2 study of most vaccines for poultry.

And the dogs for the target number of enrollment.

The second question and then do vaccine and final back Brian to start the hydro allows us boosting trials and China and holding subjects will be enrolled and the last 1 and I know you spoke about it previously and just a little while ago, but when do you expect us we've been doing studies come to compete and Goldman. Thank you.

Chait: and how many subjects will be enrolled. And the last one, I know you spoke about it previously, just a little while ago, but when do you expect the Reveal II study to complete enrollment? Thank you.

Unnamed: Yes, in reverse order, reveal enrollment before the end of this year, data in 22. The phase two MERS trial involves around 500 people. We expect to have immune responses and safety data in the second half of 22, and then the Prime Boost Study, as he mentioned. In the prepared remarks, we expect the first part of the trials to start this fall and the data readout in early the first half of 2022. Thank you so much. Yep, thanks. The next question is from Jason McCarthy with Maxim Group. Please go ahead.

Yes.

And reverse order reveal 2 enrollment before the end of this year.

Data and 'twenty 2.

The phase 2 <unk> trial is around 500 people.

We expect to have.

And responses and safety data.

And in second half of 'twenty 2.

And then prime boost study.

It was mentioned.

The prepared remarks, we expect the first part of the trials to start this fall.

And the data readout and early first half 2020.2.

Thank you so much.

Yep. Thanks.

The next question is from Jason Mccarthy with Maxim Group. Please go ahead.

Jason Mccarthy: Hey, everyone. It's Adep on the line for Jason. Thanks for taking my question. I was just wondering if you could shed some light on the specific regions and regulators that we've been in contact with in Asia, Africa, and Latin America with respect to the ILO 4800 platform.

And we wanted a day bond and 1 for Jason. Thanks for taking my question I was just wondering if you could shed some color on the specific regions and regulators Ed for you.

<unk> been in contact with and.

And Asia Africa, and Latin America with respect to the Idaho for you and other platform.

Yeah, So where we're not specifically, stating these different countries.

Unnamed: Yeah, so we're not specifically stating these different countries until they're approved in those regions just to not influence those impacts. But certainly in Latin America, you've seen some publicly Floated presentations from various governments or some of the governments that they're evaluating our phase three proposal. Of course, Asia and Africa is the other region.

Until they're approved and those regions us to not to influence.

Those impacts us, but certainly in Latin America, you've seen some publicly.

Floated a presentation from various governments or some other governments that they are evaluating our phase III proposal.

And of course, and Asia and Africa as the other regions. So each other countries are similar in many ways and how regulators approach to make sure you have the highest quality standards when you're executing these trials, but also there are different in each country. So.

Dr. Joseph Kim: So, you know, each of the countries are similar in many ways and how regulators approach to make sure you have the highest quality standards when you're executing these trials, but they're different in each country. So, you know, this has been a significant effort by our dedicated Inovio team to execute on these efforts along with our consultants, and collaborators. So we're very pleased with the efforts that we've been making and the results, and you should soon see some of these results of our hard work come to fruition in the initiation of the Innovate Phase 3 trial. We expect the first initiation to be next month in September, so we're very excited about our progress.

This has been a a significant efforts by our dedicated.

And of your team to execute on these efforts along with our consultants.

And collaborator so.

And we're very pleased with the first step and then making and the results and you just soon and see some of these.

You saw us results.

Of our hard work come to fruition and launching the <unk> phase III trial, we expect the first initiation to be net.

Ex month in September so.

We're very excited about our progress.

Unnamed: Great, thanks for the additional color. And then, just based on everything you've said about the INO4800 platform, the fact that it doesn't require cold chain storage, and the partnership you have at Sinovac, I'm assuming, yeah, I'm assuming that you guys have some sort of agreement or a potential path of entry into the COVAX program. Am I right in saying that?

Great. Thanks for the additional color and then just based on everything you've said about the I know for your other platform. The fact that it doesn't require a cold chain storage and the partnership you have and sinopec.

I'm assuming.

Yeah, I'm, assuming that you guys have some sort of agreement or a.

A potential path of entry into the KOL back program to my right and I'm, saying that.

Well so let me just on there and your question and then make a correction our partnership is with our vaccine.

Dr. Joseph Kim: Well, so let me just unlayer your question and make a correction. Our partnership is with a vaccine, and we're doing a prime boost trial, meaning we are putting a vaccine at Inovio with Sinovac in two different studies in China, and that's what was reported this morning. And certainly, what you said about the lack of the cold chain requirement of INO4800 being a very important factor for many of the global supply vaccine entities like COVAX, WHO, and others. I think you're absolutely correct.

And we're doing a prime boost trial, we meaning a vaccine and OBO with sign up back in 2 different studies and China and that's what was reported this morning.

And certainly what you said about the the lack of cold chain requirement of INR 4800, being a very important factor.

For many of the global supply.

Vaccine entities like kovacs debt, we'd show and and others.

I think youre absolutely correct, that's 1 key and attribute 4800, not requiring the deep freezers to store transport, but certainly what's also important is the safety profile and tolerability profile that iron ore for the 800.

Dr. Joseph Kim: That's one key attribute of 4800, not requiring these deep freezers to store and transport. But certainly, what's also important is the safety profile and tolerability profile that INO4800, along with all of our full pipeline program of candidates, have been generating. You know, it's one of the most favorable safety profile generating platforms out there. So, you know, in the case of either primary vaccine schemes or boosting regimens, we think having the real favorable safety tolerability profile, along with the ability to generate T-cells and antibody responses on top of our temperature stability advantage really puts us above many of the other platforms.

Along with all of our for pipeline program candidates.

Had been generating you know, it's 1 of the most.

A favorable safety profile generating platforms out there so.

And a case of either primary vaccine and schemes for or boosting regimens, we think having the the.

And real favorable safety Tolerability profile, along with its ability to generate T cells and antibody responses on top of our temperature stability.

Advantage really puts us above many of the other platforms. So we're very excited about that and you know obviously first things first we have to execute and demonstrate efficacy of 4800, and we will do that with our innovative phase III trial.

Dr. Joseph Kim: So, we're very excited about that. You know, obviously, first things first, we have to execute and demonstrate the efficacy of 4800. We will do that with our Innovate Phase 3 trial. We're looking forward to starting that next month and getting the data in the first half of next year, but we have a lot of these other efforts going on to test the other aspects, including the boostability through a prime boost regimen that we announced with the vaccine and Sinovac today. So, a lot of exciting data and information to come in the coming months. Okay, thanks for the

We're looking for to starting that next month and getting the data and the first half of next year, but we have a lot of these other efforts are going to test.

The other aspects.

And the boost stability through a prime boost regimens that we announced with the vaccine and incentive that today. So a lot of exciting data and information to come in coming months.

Okay. Thanks for the additional color and I appreciate it.

Unnamed: Okay, thanks for the additional color. I appreciate it.

Yes. Thank you.

Kelechi Chikeri: The next question is from Kelechi Chikeri with Jeffreys. Please go ahead.

The next question is from Cowen and T Chek Kerry with Jefferies.

Please go ahead.

Kelechi Chikeri: Yes, thank you. Thank you for the comprehensive update here. I may have missed this, but have you provided, hi, have you provided an updated timeline on when 4802 will enter the clinic? And, I guess more importantly,

Yes. Thank you. Thank you for the comprehensive update here.

And may have missed tech, but have you provided us high have you provided the updated timeline on when and 48 or 2 into the clinic and I guess more important.

Yeah.

Yeah.

Yeah.

Unnamed: We're sorry. Because of technical difficulties, we are unable to connect your call. Please try your call again. This is a recording.

Okay.

Yeah.

We're sorry because of technical difficulties, we are unable to route your call. Please try and call again.

Unnamed: 41619. Due to technical difficulties, communication cannot be established. Please call again. This was a recorded message.

Connie.

For 1.619.

Good day.

And Nick Goodman.

Good day.

I believe it at home and that doesn't it.

Oh great.

For 1.619.

Unnamed: We're sorry, because of technical difficulties, we are unable to connect your call. Please try your call again. This is a recording. 41619. Due to technical difficulties, communication has not been restored. Please call again.

We're sorry because of technical difficulties, we are unable to route your call. Please try and call again.

Is that a recording.

For 1.619.

Good day.

And you guys go ahead.

And that doesn't it.

That's right.

Coverage and durability for unknown variant.

Unnamed: Coverage and Durability for Unknown Variants, I think, is really a very interesting topic.

And I think it's really a very interesting profile for a potential for this vaccine.

Unnamed: [inaudible]

Unnamed: For more information, visit www.fema.gov.

Unnamed: I guess just to put a word on it. And I would just... No, go ahead, Khaleesh. I was going to just ask you about...

Thank you for joining.

And I would just hum.

Oh go ahead and college I was going to just ask you about when it could potentially enter the clinic.

Unnamed: I was going to just ask you about when it could potentially happen...

Okay.

Yes, yes.

Sorry go ahead Kim.

No.

Unnamed: We're working very hard to get it into the clinic as soon as possible, and we'll be able to provide more firm updates on that in coming calls. Yeah, and I would just give a little more color on top of that. Right now, we're all in on standing up Innovate Phase 3 trials for 4800. And, you know, we talked about the nearness of this, and we think starting and fully enrolling this trial is extremely important in demonstrating the efficacy of 4800, but also setting up this efficacy data for the full platform, and it would also have a positive impact on 4802 development strategies going forward.

We're working we're working very hard to get to into the clinic as soon as possible and and we'll be able to provide and more farm updates from us in coming calls.

Yeah, and I would just give a little more color on top of that.

Right now and we're all in and spending up innovate phase III trials for 4800.

And we talked about.

They are necessary of debt than we.

Thanks.

Starting and fully enrolling this trial is extremely important and demonstrating the efficacy of 4800, but also setting up this efficacy data for the full platform and they would have also a positive impact for 48 or 2.

Development strategies going forward so.

Unnamed: So, our primary focus is on 4800 Innovate Phase 3 trials. That being said, we're very excited to bring 4802 to the clinic, and we'll bring out a little more information on future calls, but, you know, I think 4800 is our primary focus, our global trial, but 4802 is right behind us. Okay, thank you. Yeah, thanks. The next question is from Adyen.

Our primary focuses and 4800 innovative phase III trial that being said, we're very excited to.

Spring tornado to the clinic and well bring out a little more information and the future calls.

But.

I think.

The 4800 is our primary focus our global trial, plus 48 O to us right behind.

Okay. Thank you.

Yeah. Thanks.

The next question is from Adam.

Adyen Kusunov: Adyan Kusunov with Benchmark. Please go ahead.

And now with benchmark. Please go ahead.

Yi Chen: Thank you for taking my question. Hi Yi Chen, so I have a question about...

Thank you for taking share.

Hi, Joseph.

So I have a question about and DNA vaccine is the India based companies items reported.

Yi Chen: DNA vaccine, there's an India-based company, Zytus, they reported 57% efficacy of their DNA vaccine on 30,000 patients. So how do you think INO4800 compares to this vaccine from Zytus, and do you think the efficacy number that they reported is the kind of expected ballpark for DNA vaccine efficacy? Thank you.

And 7%.

Efficacy of their DNA vaccine or 30000 patients.

And how do you think I know for 800 compares to these vaccines.

Yeah.

And thank the African Sonoma and reported is the kind of expected ballpark for.

Other DNA vaccine efficacy.

Thank you.

Dr. Joseph Kim: Yeah, thanks for the question. First of all, I think it's a great thing that Zytus was able to demonstrate strong efficacy of about 66%. And, you know, they did this during the heights of the Delta variant spreading in India. So we give them kudos for that.

Yes, thanks for the question.

First of all I think it's a great thing that zaidis.

Was able to demonstrate the strong efficacy.

Of about 66% and.

They did this strength.

Right.

Delta Varian spreading and India.

So.

We give them kudos for that and this is a big important step for the for DNA vaccines feel that as a whole now there are some differences between <unk> and 4800, and and Zaidis vaccines Itis worth us 3 dose regimen and the 3 different and vaccine.

Dr. Joseph Kim: And this is a big, important step for the full DNA vaccines field as a whole. Now, there are some differences between Inovio's INO4800 and Zytus vaccine. Zytus was a three-dose regimen, so three different vaccinations. Inovio, as you know, is a two-dose regimen. And then Zytus uses a jet injector, whereas Inovio is using the Selectra in vivo electroporation system, which we have, we and others have published on more efficient delivery of these in vivo electroporation systems like Selectra over other delivery mechanisms for DNA plasmids.

Nations.

As you know us the 2 dose regimen and then.

<unk> uses a chat and injector, whereas and overview of us using the select trial in vivo electroporation system.

We have we and other published.

Published on more efficient delivery of these and vivo electroporation systems ex Electra over other delivery mechanisms for DNA plasmids. So we're.

Dr. Joseph Kim: So we're very excited, and we think we're very encouraged by Zytus' data. And we hope, you know, we're certainly hoping and planning to see if we can do even better. Obviously, we'll have to demonstrate that in the trial. But that, you know, serves as another urgent sort of driver for us to get our phase three trial going and executed and getting to the data, because we think INO4800 has a lot of advantages over not just Zytus DNA but for other platforms as well. So, you know, we give lots of kudos to Zytus for achieving that efficacy, and we're hopeful that we can top that as we go forward.

And we're very excited and and we think we're very encouraged by the <unk> data and we're hope, we're certainly hoping and planning.

And to see if we can do even better obviously.

To demonstrate that and the trial, but that.

Services, another urge and sort of driver for us to.

Yes.

Phase III trial, going and executed and getting to the data because we think.

And a 4800 has lot of advantages or.

Not just beside us DNA, but for other platforms as well so.

But you know we give lots of kudos towards diet us for achieving that efficacy and we're hopeful that we can top that us we go for it.

Okay. Thank you.

Yes, Thanks Aidan.

Unnamed: This concludes the question and answer session.

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

Unnamed: I would like to turn the conference back over to Dr.

Dr. Joseph Kim: I turn it over to Joseph Kim for any closing remarks. Yeah, thank you very much for listening to both our prepared remarks and the Q&A. We look forward to a great third quarter, and we'll look forward to sharing those updates on the next call.

Yes. Thank you very much for for listening to our both prepared remarks and the Q&A.

And we'll look for to great third quarter, and we'll look forward to.

Sharing those updates and the next call. Thank you very much.

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

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