Inovio Pharmaceuticals (INO) Q2 2021 Earnings Call Transcript

Inovio Pharmaceuticals (INO -5.10%)
Q2 2021 Earnings Call
Aug 09, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to the INOVIO second-quarter 2021 financial results conference call. [Operator instructions] 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.

Ben Matone -- Senior Director of Investor Relations

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. Jacqui Shea, chief operating officer; Dr. Laurent Humeau, chief scientific officer; Dr. Anza Mammen, senior vice president of clinical development; and Dr.

Kate Broderick, senior vice president of research and development. For today's call, we will review our corporate and financial information for the second quarter ended June 30, 2021. 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 trials in China, as well as our company's global phase 3 INNOVATE trial for our COVID-19 DNA vaccine candidate, INO-4800 with our partner, Advaccine.

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

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-party and the level of costs 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 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.

Joseph Kim -- President and Chief Executive Officer

Thank you, Ben. 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 realize the potential that DNA medicines offer not only to address this present public health needs in response to the global pandemic, but more broadly across therapeutic areas.

In the short time we have today, I want to spend most of our call reviewing INOVIO's strategy to advance INO-4800 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 INO-4800 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 against rising variants of concern. Our DNA medicines also have shown a favorable tolerability, transportability and thermal stability profiles. 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; a key concern of regulators, countries and vaccine supply initiatives.

This morning's announcement is a wonderful example of that. INOVIO and our partner Advaccine received regulatory allowance in China for two clinical trials investigating heterologous boosting with INO-4800. These trials, which are being done through trial-sponsor vaccine, working together with Sinovac to evaluate the safety, tolerability and immunogenicity of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac and validated by the World Health Organization for emergency use. 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.

With the increased challenge of the highly contagious delta variant and other variants of concerns around the world, our work with Advaccine and Sinovac is more important than ever. If approved, we believe INO-4800 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 ultracold chain transport. Helping to enable these trials, INOVIO along with Advaccine and Sinovac recently completed cross prime-boost preclinical animal tests that evaluated the immune boosting abilities of INO-4800 and CoronaVac. 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 hACE2 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 immunogenicities of vaccines. We believe this concept will be a key factor in fighting against the current increasing global COVID-19 cases and variants of concerns and expanding the potential market for INO-4800. We're especially excited and proud to expand our partnership with Advaccine to explore heterologous prime-boosting using INO-4800 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 with other viral vector and mRNA vaccines. We look forward to sharing data from these trials in the future.

Before we go further, I would like to reiterate INOVIO's focus on starting and executing our global INNOVATE phase 3 trials in countries outside the U.S. More specifically, our primary focus is getting this trial initiated next month to enroll healthy men and nonpregnant 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, INOVIO does not plan on enrolling any subjects in the U.S. for the INNOVATE phase 3 trial.

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 U.S. once INO-4800 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 INO-4800 provided broad cross-reactive immune responses in humans against VOC.

In particular, the study showed that the T cell responses generated by INO-4800 vaccination were fully maintained against the alpha, beta, and gamma variants when compared to the T cell responses to the original wildtype strain. Subsequent to this published work and something that Dr. Kate Broderick will discuss later, INO-4800 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 wildtype strain, while it showed a similar level of reduced neutralizing antibody activity against the delta variant by other vaccines. In parallel with INO-4800, INOVIO is also developing a novel pan-COVID second-generation vaccine candidate, INO-4802, which is specifically designed to protect against current and future variants of concern.

INO-4802 could potentially offer broad boosting capabilities in addition to an initial vaccination regimen with INO-4800 and/or other first-generation vaccines, including both adenovirus and mRNA-based platforms. Both INO-4800 and INO-4802 are able to be used as a primary vaccine, as well as both homologous and heterologous boosting. With that, I'd like to turn the call now to Dr. Anza Mammen, who is leading our global phase 3 trial for INO-4800 for an update on the progress.

Anza?

Anza Mammen -- Senior Vice President of Clinical Development

Thank you, Joseph. I'm glad to be here with you on the call today. As Joseph mentioned in his opening remarks, we announced the expansion of our partnership with Advaccine to jointly conduct our global phase 3 efficacy trial for INO-4800. This trial will be conducted at multiple sites 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 INO-4800 in a two-dose regimen using a dose of two milligrams administered one month apart in a 2-1 to one randomization in healthy men and nonpregnant women 18 years and older. The phase 3 trial builds upon the recent phase 2 clinical work and findings that we presented in the second quarter, where we found INO-4800 to be well tolerated and immunogenic across all tested age groups. In particular, the geometric mean fold rise of binding and neutralizing antibody levels were statistically significant and greater in the two-milligram dose group versus the one-milligram dose group.

Notably, the T cell immune responses measured by the ELISpot assay were also higher in the two-milligram dose group as compared to the one-milligram dose group. 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 variant for INO-4800 vaccinated individuals, conveying the potential of INO-4800 to combat emerging, as well as future variants of concern. With that, I will now turn the call back over to Joseph.

Joseph Kim -- President and Chief Executive Officer

Thanks, Anza. As I mentioned during my opening remarks, we're extremely focused on advancing INO-4800 through phase 3 efficacy trials, while in parallel, also developing our second-generation pan-COVID DNA vaccine candidate, INO-4802. I'll now ask INOVIO's senior VP of R&D, Dr. Kate Broderick, to speak in greater detail about our efforts with INO-4802, as well as our broader work in infectious diseases.

Kate?

Kate Broderick -- Senior Vice President of Research and Development

Thank you, Joseph, and hello to everybody who's on the call with us today. In parallel to the INO-4800 efforts outlined earlier in the call, we're also developing a second-generation pan-COVID vaccine candidate, INO-4802. While other companies have developed match strains, INO-4802 is our strategy against current and future variants of concern. We anticipate additional viral shift, which makes INO-4802 an important asset in our portfolio.

INO-4802 could potentially offer boosting capabilities in addition to an initial vaccination regime with INO-4800 and/or other first-generation vaccines, including both adenovirus and activated 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 variant -- viral variants using INOVIO's next-generation pan-COVID-19 vaccine candidate, INO-4802, as either a first-line vaccine or potentially as a booster for individuals previously immunized with various wildtype-matched vaccines. Specifically, INO-4802 induced potent neutralizing antibody and T cell responses against the original wildtype strain, as well as against the variants. 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.

We look forward to sharing more details on our progress with INO-4802 to prepare for a phase 1/2 clinical trial in the near future. Our COVID-19 program, both our late-stage advancements with INO-4800, as Anza just outlined earlier, as well as our preclinical work on INO-4802 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 INO-4700, our DNA vaccine candidate for Middle East Respiratory 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 2 trial is being conducted at sites in Jordan and Lebanon, where MERS cases have been reported. The randomized, double-blinded, placebo-controlled multicenter study, which is sponsored by INOVIO and funded by the Coalition for Epidemic Preparedness Innovations, or CEPI, evaluates the safety, tolerability and immunogenicity of INO-4700 administered using INOVIO CELLECTRA smart device in approximately 500 healthy adult volunteers. 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 Fever. It remains INOVIO's and CEPI's goal 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 you, Joseph.

Joseph Kim -- President and Chief Executive Officer

Thank you, Kate. 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 VGX-3100 for the treatment of cervical high-grade squamous intraepithelial lesions, or HSIL, 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 full subject-level unblinding in the second half of 2021, which will facilitate detailed analysis of individual patient-level data.

In addition, INOVIO is codeveloping a biomarker with QIAGEN to guide clinical decision-making for the use of VGX-3100 in cervical HSIL 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 projected total enrollment of approximately 198 adult women with histologically confirmed cervical HSIL. Among our immuno-oncology efforts, INOVIO and our partners continue to evaluate findings from the phase 1/2 novel combination of DNA medicines, INO-5401 and INO-9012 in combination with the PD-1 checkpoint inhibitor Libtayo, which is being jointly developed by Regeneron and Sanofi, in treating newly diagnosed GBM. 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?

Peter Kies -- Chief Financial Officer

Thanks, Joseph. Good afternoon, everyone. 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 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 activities for INO-4800.

These INO-4800 activities included the acquisition and installation of manufacturing equipment, drug manufacturing, outside services and clinical study expense. Other increases included engineering services and equipment-related -- expensed equipment related to our CELLECTRA 3PSP device array automation project, also employee and contractor compensation and drug manufacturing expenses related to our RRP trial. 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 G&A expenses was primarily related to an increase in employee compensation, which includes noncash stock-based compensation. This was partially offset by lower expenses for work performed related to corporate marketing and communications among other variances. And with that, I'll turn it back over to you, Joseph.

Joseph Kim -- President and Chief Executive Officer

Thank you, Peter. Before we take analyst questions, 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 in development. 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-associated 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 thermal stability profile are meaningful differentiators in our ability to protect against evolving COVID-19 with INO-4800.

We remain confident in and dedicated to our development efforts, and thank you for your continued support of INOVIO. We will now open the call for your questions. Operator?

Questions & Answers:

Operator

[Operator instructions] The first question comes from Geoff Meacham with Bank of America. Please go ahead.

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Good afternoon. This is Alex on for Geoff 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 of variants affected enrollment strategies and the overall time lines for our phase 3 trial. 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.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thank you, Alex. I'm going to address the second question briefly and then I'll ask Dr. Anza Mammen to address your first question, which is the changing landscape and the impact on enrollment for phase 3.

Glioblastoma 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.

Anza Mammen -- Senior Vice President of Clinical Development

Yeah. Thank you, Joseph. So with regards to INNOVATE phase 3, as you know, the overall study design is to administer two doses of INO-4800 and to begin to follow subjects for the development of biologically confirmed COVID-19. And initially, we've embarked on a two-region strategy involving Latin America and Asia Pacific.

And in light of the changing landscape with regards to vaccination rates and also the rapidly changing virus epidemiology in these countries, we've now recently adopted an approach to bring on the African continent as well, especially in light of the still relatively low vaccination rates and the continued virus transmission within that region. 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 the three regions and to be able to shift our enrollment focus as real-time data comes in with regards to the virus epidemiology. So in this way, we kind of maintain our optionality as to where to enroll to be able to -- to bring in optimally the necessary COVID-19 cases. So hopefully, this answers your question.

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

For sure. Thank you so much for the color.

Operator

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

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Great. Thanks for the progress update, and a couple of questions. One is just following up with the previous question on your phase 3 that you're going to be conducting in various parts of the world. Some companies, not necessarily DNA medicines based, Joe, have run trials where there seem to have been more variants and have reported kind of a lesser vaccine efficacy.

There are not many, but a few of those have cropped up from time to time. What are your thoughts in that regard? I mean, last year, the previous trials were all run against the Wuhan strain and you had a certain efficacy there. How to think about the other variants that will be likely included in your phase 3? So that's number one. Number two, in HSIL, we did a KOL call where a lady physician indicated to us that 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 base strategy could increase uptake there. Can you address that specifically with your HSIL strategy VGX-3400? Again, thanks for the question.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks, Hartaj. So let me address very quickly. I think Anza and Kate both touched on sort of our overall approach.

But it's -- INO-4800 phase 3 is going to happen in 2021 in second half, right? So the vaccine was designed originally against the wildtype strain, Wuhan strain, so to speak. But what we found in various studies we've done, including challenge studies, that incredibly INO-4800 has pretty good protection and also neutralization, as well as T cell responses against these various variants. So we're encouraged by these supportive data. And as Anza mentioned, we have like a command center of information coming from three different continents, Latin America, Asia and Africa.

And we're sort of making those enrollment decisions based on real-time information that allows us to most efficiently run the INNOVATE phase 3 trial. And we're very lucky to have such a dedicated team of employees, partners and collaborators that would help us execute that. So we're very bullish on the potential of 4800 and INNOVATE trial. And we're looking forward to getting the data in the first half of next year with interim readout for efficacy.

So -- and then second part of your question, which is also important is the cervical HSIL. I absolutely agree with your KOL that you were referring to. I think younger women or even older women who have the potential of looking at the current treatment with HSIL in the cervix, right now, it's one form of surgery or another, and it has a tremendous negative impact to their ability to carry on future pregnancies. If you're curious, just Google a LEEP procedure in the YouTube and you see how dramatic such a surgery could be.

So what I know -- what VGX-3100 presents, and we're -- 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 nonsurgical immunotherapy-based treatment for women to not only clear and treat the disease, but also eradicate the virus HPV-16 or 18 viruses that cause the disease in the first place. So we're very much excited about what this new generation of women's health product in VGX-3100 can bring to the market and to the patients who right now, they don't have any choice. It's either a surgery or potential of developing cancer. What VGX-3100 will present is an optionality 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.

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Great. Thank you, Joseph.

Operator

The next question is from Gregory Renza with RBC Capital. Please go ahead.

Gregory Renza -- RBC Capital Markets -- Analyst

Hey, Joseph and team. Thank you for the update and for taking my question. I just -- like I get the discussion on cervical HSIL. I'm just curious, Joseph, if you could perhaps provide just a finer point on the REVEAL 2 enrollment and the potential trial readout 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 1 to sort of help that momentum along the way? And then maybe just in 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.

Thanks.

Joseph Kim -- President and Chief Executive Officer

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. We will have the full REVEAL 1 data set also before the end of the year. And we're going to have very eventful second half of this year as we will also have a readout of the biomarker data from REVEAL 1 as well. So a lot of these information will go a long way in positioning the full data set for our REVEAL program for VGX-3100.

So -- in terms of the devices, our CELLECTRA 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 for BLA application once we have all of the clinical data at hand. So we're very confident in our CELLECTRA 5PSP device.

Gregory Renza -- RBC Capital Markets -- Analyst

Great. Thank you. And last one from me, maybe for Peter. Peter, you mentioned just multiple years across multiple programs for a cash runway and just in the context of the spend for this quarter, I'm just curious if you could provide maybe some color around the trajectory that we would anticipate over these quarters to come? And then maybe just some thoughts about how that allocation spreads across, certainly the COVID vax programs, as well as the other programs in your portfolio? Thank you very much again, guys.

Peter Kies -- Chief Financial Officer

Yeah. Most of the increase was around the acquisition and installation of the manufacturing equipment that's for INO-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 expensed this quarter, that kind of brought us to look like a high number was actually purchased in the summer of last year, and it's just been 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 expense.

Gregory Renza -- RBC Capital Markets -- Analyst

Per month?

Peter Kies -- Chief Financial Officer

Per month, yes.

Gregory Renza -- RBC Capital Markets -- Analyst

Great. Thanks, Peter.

Peter Kies -- Chief Financial Officer

Any more questions? OK. Sorry.

Gregory Renza -- RBC Capital Markets -- Analyst

Thanks, guys.

Operator

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

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Hey. This is [Inaudible] on behalf of Yi Chen. I have two questions. The first one is when could the phase 2 study of MERS vaccine report top-line results? What is the target number of enrollment? The second question is when do Advaccine and Sinovac plan to start the heterologous boosting trials in China 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 2 study to complete enrollment? Thank you.

Joseph Kim -- President and Chief Executive Officer

Yes. In reverse order, REVEAL 2 enrollment before the end of this year, data in '22. The phase 2 MERS trial is around 500 people. We expect to have immune responses and safety data in second half of '22 and then prime-boost study, as it was mentioned in the prepared remarks, we expect first part of the trial to start this fall and the data readout in early first-half 2022.

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Thank you so much.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks.

Operator

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

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Hey, everyone, it's Dave on the line for Jason. Thanks for taking my question. I was just wondering if you could shed some color on the specific regions and regulators who you've been in contact with in Asia, Africa and Latin America with respect to the INO-4800 platform?

Joseph Kim -- President and Chief Executive Officer

Yeah. So we're not specifically stating these different countries until they're approved in those regions, just to not to influence those impacts. But certainly, in Latin America, you've seen some publicly floated presentation from various governments or some of the governments that they're evaluating our phase 3 proposal. Of course, in Asia, and Africa is the other region.

So 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 also they are different in each country. So 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 and launching the INNOVATE phase 3 trial. We expect the first initiation to be next month in September.

So we're very excited about our progress.

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Great. Thanks for the additional color. And then just based on everything you said about the INO-4800 platform, the fact that it doesn't require cold chain storage and the partnership you have with 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?

Joseph Kim -- President and Chief Executive Officer

Well, so let me just unlayer your question and make a correction. Our partnership is with Advaccine. And we're doing a prime-boost trial, we meaning Advaccine and 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 cold chain requirement of INO-4800 being a very important factor for many of the global supply vaccine entities like COVAX, WHO and others, I think you're absolutely correct.

That's one key attribute of 4800, not requiring these deep freezers to store or transport. But certainly, what's also important is the safety profile and tolerability profile that INO-4800, along with all of our full pipeline program of candidates have been generating. It's one of the most favorable safety profile generating platforms out there. So 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.

So we're very excited about that. Obviously, first things first, we have to execute and demonstrate efficacy of 4800. We would 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 to test the other aspects, including the boost stability through our prime-boost regimens that we announced with the vaccine in Sinovac today. So a lot of exciting data and information to come in coming months.

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

OK. Thanks for the additional color. I appreciate it.

Joseph Kim -- President and Chief Executive Officer

Yup. Thank you.

Operator

The next question is from Kelechi Chikere with Jefferies. Please go ahead.

Kelechi Chikere -- Jefferies -- Analyst

Yes. Thank you for the comprehensive update here. I may have missed. Have you provided an updated time line on when 4802 enter the clinic? And I guess more importantly, what would be the development path for this given how important it is in addressing some of the likelihood of emerging variants in the future? Is there an option of actually using 4802 in the phase 3 possibly as a booster or in the heterologous boost study? Any color there would be extremely helpful.

Joseph Kim -- President and Chief Executive Officer

Yeah, I'm going to turn this question to Dr. Broderick. Kate?

Kate Broderick -- Senior Vice President of Research and Development

Thank you very much. Great question. So what we've been incredibly encouraged by is how well 4800, which of course was designed against the original Wuhan strain has done against the variant. However I think we all recognize that really fundamentally the variants are creeping further and further away from the original strain and so really we look up 4802 as really kind of the next-generation option for us as the virus continues to shift and change and mutate this profile and so certainly using it as a potential booster in the future, potentially for subjects who receive 4800, but also for subjects who received any of the wave one vaccine to really provide additional coverage, durability for unknown variant.

I think this is really a very interesting profile for -- potential for this vaccine.

Kelechi Chikere -- Jefferies -- Analyst

I guess --

Joseph Kim -- President and Chief Executive Officer

Thank you, Kate. And I would just -- no, go ahead, Kelechi.

Kelechi Chikere -- Jefferies -- Analyst

I was going to just ask you about when it could potentially enter the clinic, if you don't mind.

Joseph Kim -- President and Chief Executive Officer

Yeah, we're -- go ahead, Kate. Yeah.

Kate Broderick -- Senior Vice President of Research and Development

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

Joseph Kim -- President and Chief Executive Officer

Yeah, and I would just give a little more color on top of that. Right now we're all-in in spending up INNOVATE phase 3 trials for 4800, and 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 have also a positive impact to 4802 development strategies going forward. So our primary focus is in 4800 INNOVATE phase 3 trial. That being said, we're very excited to bring 4802 to the clinic and we'll bring out more information in the future calls.

But I think the 4800 is our primary focus, our global trial, but 4802 is right behind that.

Kelechi Chikere -- Jefferies -- Analyst

OK. Thank you.

Joseph Kim -- President and Chief Executive Officer

Yup. Thanks.

Operator

The next question is from Aydin Huseynov with Benchmark. Please go ahead.

Aydin Huseynov -- The Benchmark Company -- Analyst

Hey, thank you for taking my question. Hi, Joseph. So I have a question about DNA vaccine. There is an India-based company Zydus.

They reported 67% efficacy of their DNA vaccine on 30,000 patients. So how do you think INO-4800 compares to this vaccine of Zydus? And do you think the efficacy number that they reported is the kind of expected ballpark for the DNA vaccine efficacy? Thank you.

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks for the question. First of all, I think it's a great thing that Zydus was able to demonstrate strong efficacy of about 66% and they did this during the heights of delta variant spreading in India. So we give them kudos for that.

And this is a big important step for the full DNA vaccines build as a whole. Now there are some differences between INOVIO's INO-4800 and Zydus vaccine. Zydus was a three-dose regimen. So three different vaccinations.

INOVIO, as you know, is a two-dose regimen. And then Zydus uses a jet injector, whereas INOVIO is using the CELLECTRA in-vivo electroporation system, who we have -- we and others have published on more efficient delivery of these in-vivo electroporation systems like CELLECTRA over other delivery mechanisms for DNA plasmid. So we're very excited, and we think -- we're very encouraged by Zydus' data. And 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 serves as another urgent sort of driver for us to get our phase 3 trial going and executed and getting to the data because we think INO-4800 has a lot of advantages. So we're not just the Zydus DNA but for other platforms as well. So -- but we give lots of kudos for Zydus for achieving that efficacy, and we're hopeful that we can top that as we go forward.

Aydin Huseynov -- The Benchmark Company -- Analyst

OK. Thank you. 

Joseph Kim -- President and Chief Executive Officer

Yeah. Thanks, Aydin.

Operator

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

Joseph Kim -- President and Chief Executive Officer

Yeah. Thank you very much for listening to our both prepared remarks and the Q&A. We look forward to a great third quarter, and we look forward to sharing those updates in the next call.

Operator

[Operator signoff]

Duration: 47 minutes

Call participants:

Ben Matone -- Senior Director of Investor Relations

Joseph Kim -- President and Chief Executive Officer

Anza Mammen -- Senior Vice President of Clinical Development

Kate Broderick -- Senior Vice President of Research and Development

Peter Kies -- Chief Financial Officer

Unknown speaker -- Bank of America Merrill Lynch -- Analyst

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Gregory Renza -- RBC Capital Markets -- Analyst

Kelechi Chikere -- Jefferies -- Analyst

Aydin Huseynov -- The Benchmark Company -- Analyst

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