Good day, and welcome to the Inovio Pharmaceuticals First Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask question. Please note this event is being recorded.
I'd now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead..
Thank you, operator. Thank you for joining the Inovio first quarter 2021 earnings conference 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. 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 first quarter ended March 31, 2021.
In addition, we will discuss this morning's press release regarding the Phase 2 data from our Innovate trial for COVID-19 as well as provide an update on the Company's path forward for our global Phase 3 study. Following prepared remarks, we will be conducting a question-and-answer 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 independent collaboration partners, third parties and the level of cost associated with discovery and business development activities to assist 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 has concluded. With that, I would like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim..
Thank you, Ben, and thank you to everyone for taking the time to join us for today's call. When we last connected, we were in a very different place, awaiting the impact of holiday travel and gatherings on community viral spread, particularly given the emergence of variant strains around the world.
We were unclear on the spread and impact of the vaccine rollout.
Today, a quarter later, we're encouraged by the progress that has been made here in the U.S., but are mindful that much of the world is still struggling to get access to vaccines, navigating how to address the logistics of cold and ultra-cold-chain transport to facilitate getting shots in the arm and continuing to be challenged by outbreaks and emerging variants.
As a company with deep roots in infectious disease and a long-standing commitment to public health, we recognize the still largely unmet vaccine needs of the global community. Equally, we know that our ability to have the greatest impact on this public health crisis is increasingly outside the United States.
In late April, we announced that we would be implementing a global Phase 3 trial for INO-4800. We are working with funders and partners to achieve this plan and expect to start the trial this summer.
Additionally, we continue to be in discussions with a number of countries regarding INO-4800 events market procurement agreements within the countries where the clinical trial sites are being planned.
We look forward to proceeding with this Phase 3 trial this summer, and we’ll have additional details to share regarding these efforts in the coming weeks. Most importantly, we remain on track to initiate our Phase 3 Segment of INNOVATE as we have previously stated. Now, I'd like to introduce you to Dr.
Anza Mammen, who is leading our global Phase 3 INO-4800 trial to tell us more about the Phase 2 results we announced this morning.
Anza?.
Thank you, Joseph. It is very nice to be on the call with you today. We reported this morning the Phase 2 results that supports the advancement of the 2-milligram dose of INO-4800 into our planned Phase 3 efficacy trial. The Phase 2 blinded placebo-controlled segment of INNOVATE Phase 2/3 trial included 401 participants ages 18 and older across 16 U.S.
sites to look at safety, tolerability and immunogenicity of the 1 and 2 milligram doses of INO-4800 in a two-dose regimen in a 3-to-1 randomization to receive either INO-4800 or placebo.
Results showed that INO-4800 continues to be safe, well tolerated and immunogenic in all adult age groups studied, further validating in a larger population our initial Phase 1 results. The majority of adverse events were grade 1 and grade 2 in severity and did not increase in frequency with the second dose.
The number of participants experiencing each of the most common adverse events did not appreciably differ between the dosing groups. The geometric mean fold rise of binding and neutralizing antibody levels were statistically significantly greater in the 2-milligram dose group versus the 1-milligram dose group.
Likewise, the T-cell immune responses measured by the ELISpot assay were also higher in the 2-milligram dose group compared to the 1-milligram dose group.
The preliminary results from the Phase 1 segment of the trial have been published in a paper entitled, Safety and Immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2, a preliminary report of a randomized blinded placebo-controlled Phase 2 clinical trial in adults at high risk of exposure.
The publication has been posted as a pre-print prior to peer review. Again, we are very pleased that the safety, tolerability and immunogenicity results clearly favor advancing the dose of INO-4800, namely the 2-milligram dose into our planned Phase 3 global efficacy trial. Dr.
Broderick will share with you shortly the potential versatility of INO-4800 in addressing the currently circulating variants.
As SARS-CoV-2 continues to evolve and potentially hinder other vaccine capabilities, it is important for us to leverage INO-4800's favorable safety and tolerability profile while we evaluate its ability to mitigate against the known circulating variance in our planned global Phase 3 efficacy segment.
And with that, I will turn it back to you, Joseph..
Thanks, Anza. I want to make a moment for all of us to recognize the need to support both primary vaccination as well as boosting capabilities, particularly given the increasing prevalence of variants. Inovio is focused on a dual track strategy. We plan to take INO-4800 into a global Phase 3 trial this summer.
In parallel, we will also develop our second-generation Pan-COVID variant vaccine INO-4802. I'll now ask Inovio's Senior Vice President of R&D, Dr.
Kate Broderick, to speak in a greater detail about INO-4800's activity data against the major variants that we announced in April, as well as to share an update on Inovio's efforts on our next-gen pan-COVID variant vaccine, INO4802.
Kate?.
Thank you, Joseph, and hello to everybody on the call today.
When I spoke with you all during our last quarterly earnings call, I mentioned that Inovio was closely monitoring the development and evolution of SARS-CoV-2 mutations, and currently testing the impact of these new strains, with a particular focus on the streams that were first identified in the UK, South Africa and Brazil.
Since then, the Company continues to make a two-pronged approach to the emerging crisis caused by these new viral variants.
To this end, in late April, we announced the results of a new study that showed INO-4800 induced a robust T-cell response against all spike protein variants tested, which the Company believes will be key in providing protection against SARS-CoV-2 variants in addition to providing similar levels of neutralizing activity against both the UK and the Brazilian variants as those against the original Wuhan strain.
In particular, here are some key takeaways from the study. Clinical samples were collected as various time points post immunization from subjects in Inovio's Phase 1 U.S.-based INO-4800 clinical trial. The Company assessed antibodies capable of neutralizing activity.
They were measured against the spike protein variants tested, including B117 the UK variant, B1351 the South African variant and key one the Brazilian variant.
The analysis showed that the T-cell responses induced by INO-4800 vaccination were fully maintained against the UK, the South African, and the Brazilian variants when compared to the T-cell responses to the original Wuhan strain.
The neutralization levels of INO-4800 against South Africa and UK variants were reduced by levels similar to the previous reports from reductions shown by the mRNA or viral vector vaccines.
Despite recent reports showing a reduction in neutralizing activity against the Brazilian variant by the mRNA or viral vector vaccines, INO-4800 generated neutralizing antibodies at levels against the P1 Brazilian variant which were comparable to those against the Wuhan strain.
Taken together with the data showing the maintenance of T-cell activity, the results reported in this study provide an encouraging overview of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants for INO-4800 vaccinated individuals that may be important for protection against variant strains of SARS-CoV-2.
As Joseph noted, Inovio is taking a dual track approach because we recognize the need to support both pandemic and future endemic considerations.
In addition to our late-stage work on INO-4800, we are also developing our second-generation Pan-COVID variant vaccine, INO-4802, which is designed to protect against current and potentially future variants of concern.
We look-forward to sharing a more robust update on our progress INO-4802, including an upcoming prepaid publication in the near future. And with that, I will turn the call back over to Joseph..
Thank you, Kate. Next, our CFO, Peter Kies will provide a financial summary for the quarter. But before that, I wanted to briefly update you on our other important clinical programs.
First, for an update on our immuno-oncology efforts, Inovio's Phase 1/2 novel combination trial of INO-5401 and INO-9012 in combination with the PD-1 checkpoint inhibitor Libtayo, which is currently being jointly developed by Regeneron and Sanofi, in the treatment of newly diagnosed glioblastoma multiforme is currently ongoing.
The Company anticipates sharing 24 months overall survival data, including potential correlated immunology and tissue data later this year.
As for our HPV-related disease treatment efforts, Inovio announced that we met the primary and secondary efficacy endpoints among all evaluable subjects for REVEAL one, our Phase 3 pivotal trial evaluating VGX-3100 for the treatment of cervical HSIL caused by HPV-16 and/or HPV-18.
The Company continues to follow subjects in REVEAL one trial for safety and durability of response for 18 months following the last administration, and looks forward to sharing findings later this year at a scientific meeting.
We're also continuing our partnership with QIAGEN on an in-vitro diagnostic based on RNA sequencing technologies to guide clinical decision-making for the use of VGX-3100 and cervical HSIL.
Importantly, this biomarker will help us to identify in a commercial setting perspective VGX-3100 patients who would be most likely to respond to our immunotherapy. Our REVEAL 2 Phase 3 efforts continue across 48 global sites. We'll have additional information regarding any protocol recruitment adjustments on this trial later in the year.
Following positive Phase 2 efficacy data, Inovio also continues to evaluate the best ways to expand VGX-3100 indications, to evolve our and anal dysplasia. We're currently exploring the best path for our Phase 3 clinical trial for vulvar and anal dysplasia indications pending further discussions with the FDA.
With that, I would turn the call over to Peter for our first quarter financial summary.
Peter?.
Thanks, Joseph, and hello everyone. We entered 2021 well positioned financially with total cash, cash equivalents and short-term investments of $111.6 million. Thanks to a successful public offering in January, we provided net proceeds of $162.1 million.
We ended the first quarter with $518.6 million in cash, cash equivalents and short-term investments, providing us with multiple years of sufficient capital to support existing activities and programs. Turning now to our quarterly financial results.
Our revenue for the first quarter 2021 was $371,000, which compares to $1.3 million for the same period in 2020. Our total operating expenses were $52.9 million, compared to $26.6 million for the same period in 2020.
Our net loss for the first quarter 2021 was $54.4 million or $0.27 per share basic and dilutive which compares to a net loss of $32.5 million or $0.26 per share basic and dilutive for the same period a year ago. Our R&D expenses were $39 million for the first quarter 2021, which compares to $19.1 million for the same period in 2020.
The increase in R&D expenses, primarily related to higher drug manufacturing expenses and outside services related but not limited to INO-4800 and other clinical trials. Also higher employee and contractor compensation expense, and an increase in engineering services related to our selector 3PSP device, among other variances.
These R&D expense increases were essential to continue the development and the progress of our INNOVATE trial for COVID-19, as well as developing our 3PSP device, which is planned to be used for many of our infectious disease programs including INO-4800 for COVID-19.
G&A expenses were $13.9 million for the first quarter 2021, versus $7.4 million for the same period in 2020. The increase in G&A expenses was primarily related to an increase in employee and consulting compensation, including non-cash stock-based compensation and legal expenses among other variances. And with that, I'll turn it back to you, Joseph..
Thanks Peter. It's good to know that Inovio's maintaining strong financial position. Before we take your questions,. I would like to recognize and thank the Inovio team and our partners, collaborators, funders and patients for their tireless efforts.
Our team's unwavering support of and commitment to developing INO-4800 as safe and effective vaccine for COVID-19 while in parallel evaluating our next generation Pan-COVID vaccine INO-4802 to protect against current and future variants of concern.
As well as continuing to validate our technology and broader platform within HPV and oncology and infectious disease is indeed impressive. While there is still more work in front of us, I am incredibly proud of and remain confident in our team's ability to advance Inovio's DNA medicines platform and program's.
If I can leave you with one point about Inovio, that one highlight from today's call is this. We are staying on track with our INO-4800 development plans and expect to commence Phase 3 this summer. We remain committed to developing INO-4800 for many people globally still in desperate need for safe, effective, tolerable and temperature stable vaccines.
I thank you for your continued support of Inovio.
We will now open the call for your questions, operator?.
Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Geoff Meacham from Bank of America. Please go ahead..
Hey, guys, it's Aspen on for Geoff. Thanks for taking our questions. Just a couple from us.
Firstly, maybe you could talk about how the current clinical hold to the Phase 3 study, how that plays into your Phase 3 development plans given that we now expect to run that Phase 3 study primarily OUS? And then for the VGX-3100, what additional data can we expect to see at an upcoming medical conference with respect to REVEAL 1? Thank you..
Yes. So let me take the second question first. The full safety follow-up is expected to finish later this year for REVEAL 1. So we will have a comprehensive unblinded patient level, safety and efficacy data. So that's what we would expect to have later this year.
In terms of the FDA partial clinical hold on Phase 3 for INNOVATE trial, Aspen, you're absolutely right. The ex-U.S. strategy does not - is not impacted by the current Phase 3 partial clinical hold, but still we plan to open in the U.S., along with mostly ex-U.S. countries and sites to recruit our Phase 3 INNOVATE global trial.
We still plan and are on track to submit all of our submission to the FDA to lift the partial clinical hold if we're successful in the second quarter. Let me reiterate, we are on track to submit and we're hopeful that we will be able to lift the partial clinical hold in the U.S. portion of our INNOVATE Phase 3 trial.
But as you suggested, most of our patients will come from ex-U.S. countries for our Phase 3 clinical trials globally. Thank you..
Thank you..
The next question comes from Hartaj Singh from Oppenheimer. Please go ahead..
Great. Thank you. Thanks for the update, Joe and team. Joe, just to follow-up on the last question, can you just talk specifically in terms of what are the steps that Inovio is going to in terms of identifying sites worldwide, submitting protocols to relevant regulatory authorities, protocol updates? So that's just one if you can explain that.
Number two, do you have to now update your clinical protocol to the FDA? Aside from what you have to submit for the clinical hold, do you have to update your revised protocol for the Phase 3 now that you've picked, I guess, the 2-milligrams as your dose going forward? And what is - how does that work in terms of filing the clinical response literature? And then lastly, just over the NewsBlur today that Norway, the European Union are not going to be renewing the contracts for AstraZeneca or J&J later this year.
How does that impact your thinking or your discussions with those authorities? Thank you..
Yes, thank you, Hartaj. I'll take the general stab at questions and I will ask Dr. Mammen to further address these questions. But first of all, the last, again, last part of your question first. I think the whole landscape of vaccine availabilities, the orders and renewal, that's a changing landscape. So every week or every month seems to be changing.
One thing is for sure. There is only 5% of the global population that's received a COVID-19 vaccine thus far. So there is a huge unmet demand globally and potential opportunities to have INO-4800 to play an important role in our combat against this pandemic.
So, that really drives us our team, our partners, our funders and to make sure that we can get there as soon as possible. In terms of the filings and so on, you're absolutely right. We've already begun drafting and submitting a lot of these preparations for all of our global submissions.
So each of the countries that will file to include into our Phase 3 efficacy trial, each of those are independent submissions. But our internal regulatory team, along with our CRO, global CRO, we have been working very closely to prepare for that for many weeks. So - or months, so I think we're in a great position to do that.
Anza, would you like to address any of the Hartaj's questions in any detail?.
Yes, absolutely. Thank you, Joseph. We're working with a very experienced CRO. So it's the same CRO that we've been working on the Phase 2 study and it's - and our ex-U.S. country selection criteria included countries that for which our CRO has experience.
Another criteria that we've looked at in terms of a country selection are those countries in which Inovio has had experience with other platform of products, as well as the device. So we feel confident that we've made a country selection that is - allows us to move relatively quickly.
Now the protocol amendment has gone through with the 2-milligram dose and our CRO in fact will be working to prepare the regulatory submissions. And so those are the additional points I wanted to raise..
Great. Thank you, Anza..
Great. Thank you, Joe. I’ll jump back in the queue..
Thanks, Hartaj..
The next question comes from Gregory Renza from RBC Capital Markets. Please go ahead..
Hi, Joseph and team. Thank you for taking my question and also for the updates today. Joseph, just in - with respect to the discontinuation of the DoD funding for that Phase 3 trial. Just curious if you could comment on how that firstly just impacts the perception of the vaccine program and platform potentially.
And then just secondly, pivoting the program ex-U.S. How has that development strategy and resource allocation evolved or how should we expect that to evolve? I'm just curious how you think about providing your funds and your cash across your pipeline.
And just related to that, you had mentioned just partners and funders and in discussion I'm just curious if you could elaborate a little further on what we should expect around those who will perhaps provide those resources for the trial. Thank you..
Yes Thanks, Greg. Well, certainly the DoD funding decision came - had a surprise. They had been working with us in our ex-U.S. pivot for many weeks, and obviously, they didn't see our unblinded group level safety or immunogenicity from our Phase 2 trials before they made that decision.
So really as they informed us, which we disclosed the decision is mostly on their investment decision and changing environment of COVID-19 in the U.S., and not so much - not anything to do with 4800 or our data. So we feel very comfortable and confident in our data, in our program, in our preparations.
So - and I continue to thank the DoD for funding the Phase 2 and all of the Phase 3 prep work that we have been doing for many months now. As Anza mentioned, that prep work is going to allow us to move expediently into a global Phase 3 trial.
And we can't give any details, but we're currently working with potential funders and partners to help us to execute this trial. Now, what I can say is pivot from U.S. to ex- U.S., it generally reduces the overall cost of the trial. So I think that's also helpful as well. Now we're not moving to ex- U.S.
for cost reasons, obviously we're looking for some of the conditions that Anza spoke about.
Our experience at Inovio in those countries I - our CRO's experience and expertise, but also we're looking for areas where there are less available emergency vaccines in those countries and regions and where there are still a significant number of cases where we can do a randomized placebo control case driven efficacy trial.
So when you triangulate these conditions, there are very important regions around the world that fits into these calculus and plans. So, stay-tuned to have a lot more details about our Phase 3 trial, we should have that disclosed in the next few weeks..
The next question comes from Stephen Willey from Stifel. Please go ahead..
This is Ellen on for Steve. Thanks for taking the question. This is actually just following up with the previous question about the Phase 3 study. I know you're targeting countries where there is a severe vaccine shortage and are therefore able to run a placebo-controlled study.
But just wondering if you considered having an active comparator arm or doing some sort of non-inferiority study just considering there are vaccines that are approved and just wondering if conversations with regulatory agencies across the globe would be interested in seeing that kind of data. And then I have one follow up. Thank you..
Yes, that's a great question. And we have internally considered those different options and we still feel that a case driven placebo-controlled study is the most expedient way to get to our efficacy question for our vaccine. So, that's the path that we're pursuing now.
Of course the landscape has been changing over the last several quarters, but I think the case driven efficacy trial window is still wide open outside the U.S. and that opportunity is there for us to see..
Okay, great. Thank you.
And then do you still intend to disclose preliminary data for INO-3107 in RP this year?.
Well, that's a great question. RP remains an important disease target for us, and INO-3107 likely - likewise is a very important product for us. We received the orphan drug designation last year for 3107 for RP and we have our Phase 1/2 trial that's open label that's ongoing.
So most likely the most impactful amount of data will be 2022 event, but we're still hopeful that there's a meaningful level of data maybe later this year. But it's likely going to be early to mid-2022 event..
The next question comes from Aydin Huseynov from Benchmark. Please go ahead..
Thanks for taking my question and congratulations with the data. I have….
Thanks, Aydin..
So we saw the data on the binding antibodies and neutralizing antibodies in the pre-publication.
In the - could you comment on the geometric fold increase in the binding antibody titers that was several kinds of higher than the geometric cold increase in the neutralizing antibody titers> And overall, what's your opinion on the role of the binding antibodies in the unit against COVID-19?.
I think this is a very good question, important question. So both neutralizing antibody titers, neutralizing antibody responses are very important measurement of vaccine's immune response.
Especially some of the early emergency approved vaccines, that seems to be a important aspects of the protection that was the immune responses that were related to protection. Binding antibodies are also important measurement, and potentially even more consistent across various platforms.
So we believe measuring both of those antibody levels and the impact of the vaccine and increasing those rise and those antibody titers are important. And thirdly, we also feel and we maintain a strong belief that the second arm of the immune system, the T-cell arm, is also very important in providing protection.
So we also were very pleased to see that we're able to generate strong T-cell responses in our Phase 2 trials.
And as Kate Broderick mentioned in her remarks, that when we are looking at the various variants of concern we were very excited to see that our T-cell responses overall maintain whether we were testing against the Wuhan strain or some of the newer major variants like South Africa, Brazil or UK.
So we think having this one-two punch with antibodies and T-cells for INO-4800 is going to be an important aspects of providing protection in our Phase 3 efficacy trial that we're planning to start later in the summer..
Thank you, Joseph. Appreciate that. And one more question I have. Regarding the long-term opportunity for INO-4800 or INO-4802 in terms of the boosting of the other vaccine or de novo use.
So what where do you see the, not the long term the mid-term opportunity for the vaccine?.
Yes, we think that boosting - well, many of the experts, global health and key health experts both here and abroad, feel that COVID-19 vaccination is going to be a annual seasonal boosting regime - regimen to follow.
And if that - they are correct, having a vaccine that can be boosted safely and tolerably, seasonally over and over again, because we think certainly the - after the pandemic, will be the endemic stage of having to deal with COVID problems year-in and year-out potentially with changing variants is very important.
So we believe that having INO-4800 as a potential booster vaccine to our own INO-4800 vaccinated - primarily vaccinated people or even potentially being used to boost other vaccines of the first generation is a strong potential.
And also I think Kate mentioned that in her remarks that we also see 4802 as the next generation vaccine both as a Pan-COVID variant vaccine as a primary vaccine, but also as a vaccine that can be boosted over a long time.
So one of the key attributes of DNA vaccines and in particular of Inovio's INO 4800 and other DNA vaccines in our portfolio is we feel-- and we have significant amount of data in our platform that the our vaccines can be boosted over-and-over with a great tolerability, limited AE profile and no anti-vector response.
So I think these attributes really provide say great potential and our outlook for potential of our INO-4800 and then subsequently INO-4802 vaccines as boosters, hopefully for many years to come..
[Operator Instructions] The next question comes from Yi Chen from H.C. Wainwright. Please go ahead..
Thank you for taking my question. Could you tell us a bit about whether Inovio plans to allocate certain amount of your existing cash position to - in Phase 3 global COVID-19 trial, and how much you would need to raise from external parties to complete the trial?..
Thanks for that question. As we look at - as Peter summarized in the remarks, we have a very strong over $0.5 billion in cash right now. We definitely want to - and that's one of our strengths at this point. But we also in the maintain that cash and we want to limit our expense as much as possible.
So we are working with currently the funders and partners how best to conduct our Phase 3 trials, and that work is ongoing now and we hope to be ready to discuss that publicly in the next few weeks.
So our team, our partners, our funders are working extremely hard to make this happen and I'm very optimistic and confident that Inovio will able to lead this global effort for a Phase 3 INNOVATE trial that will be done, not just in the U.S. as originally was planned but in many of the regions and countries of this world.
Places where we feel - where the COVID-19 vaccines are truly needed today and later. So we're really looking forward to having all of our strategies and details articulated fully in the next few weeks..
The next question comes from Chris Raymond from Piper Sandler. Please go ahead..
Thanks for letting me ask a question. I don't think I've heard you guys address this or anybody ask, so I guess I'll ask on this.
Can you just comment on the neutralizing antibody response, the immune response, in the comp - comparison to convalescent plasma? It looks like there's a pretty sizable different fair and what gives you confidence moving forward with respect to the reaction from investigators in also subjects to for the recruitment? Thank you..
Yes. Thanks, Chris. So, yes, the geometric mean titer, which we presented in the pre-publication met archive this morning, really lays out all of the data that we have. Both from all of our 400 subject at the group level unblinding but also compared to some of the convalescent samples that we were able to acquire.
So we feel really good about the level of neutralizing antibody titers, in particular from our 2-milligram dose group as we saw at six weeks, which was two weeks after the second dose in these subjects compared to their baseline at week zero, but also against the placebo group for both 1 milligram and 2 milligram groups.
So - and this GMP as we see the confidence intervals is very strong and we can qualitatively say that the level of neutralizing titers seem even better in the Phase 2 trial compared to the Phase 1. Now the convalescent spread is also wider and the GMT is higher than our 2-milligram dose group. But we're looking at the immune responses generated.
As I mentioned earlier, in terms of the neutralizing antibodies binding antibodies and T-cells in a holistic way, where we feel that our INO-4800 can provide protection against COVID-19 cases in a controlled, randomized, placebo-controlled trial in a global efficacy trial.
So we look forward to taking this promising vaccine into a global Phase 3 trial as soon as we can this summer..
There are no more questions in the queue. This concludes our question-and-answer session. I would like to turn the conference back over to Joseph Kim for any closing remarks..
Yes, Thank you, everyone. Thanks for listening to our presentation. Thank you for all of the insightful questions. We look forward to moving INO-4800 VGX 3100, as well as 3107 and 5401 forward and we look forward to sharing some of the insights of INO-4800 Phase 3 trials later in the next few weeks.
So thank you again for this quarterly call and for your attention. Have a great night..
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect..