This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk13: Good day and welcome to the Inovio Pharmaceuticals First Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I'd now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead.
spk11: 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 Keyes, CFO, Dr. Jackie Shea, Chief Operating Officer, Dr. Laurent Timot, Chief Scientific Officer, Dr. Anza Mammon, Senior Vice President of Clinical Development, and Dr. Kate Broderick, Senior Vice President of Research and Development. For today's call, we will review our corporate and financial information for the first quarter ended March 31st, 2021. In addition, we will discuss this morning's press release regarding the phase two data from our innovate trial for COVID-19, as well as provide an update on the company's path forward for our global phase three 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 of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which under the heading risk factors, identify important factors that could cause actual results that 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 collaboration partners, third parties, and a level of cost associated with discovery and business development activities to assist in potentially bringing our products to market. This call is being webcast live on our website, ir.innovio.com, and a replay will be made available shortly after this call is concluded. With that, I would like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim.
spk08: 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 US, 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 longstanding 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 will be implementing a global phase three trial for INO4800. 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 INO4800 advanced market procurement agreements within the countries where the clinical trial sites are being planned. We look forward to proceeding with this phase three trial this summer, and we'll have additional details to share regarding these efforts in the coming weeks. Most importantly, we remain on track to initiate our phase three segment of Innovate, as we have previously stated. Now, I'd like to introduce you to Dr. Anza Mammon, who is leading our global phase three INO4800 trial, to tell us more about the phase two results we announced this morning. Anza?
spk04: Thank you, Joseph. It is very nice to be on the call with you today. We reported this morning the phase two results that support the advancement of the two milligram dose of INO4800 into our planned phase three efficacy trial. The phase two blinded placebo-controlled segment of INOVAIT phase two slash three trial included 401 participants ages 18 and older across 16 US sites to look at safety, tolerability, and immunogenicity of the one and two milligram doses of INO4800 in a two-dose regimen in a three-to-one randomization to receive either INO4800 or placebo. Results showed that INO4800 continues to be safe, well-tolerated, and immunogenic in all adult age groups studied, further validating in a larger population our initial phase one results. The majority of adverse events were grade one and grade two 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 pulled rise of binding and neutralizing antibody levels were statistically significantly greater in the two milligram dose group versus the one milligram dose group. Likewise, the T cell immune responses measured by the ELISPOT assay were also higher in the two milligram dose group compared to the one milligram dose group. The preliminary results from the phase one segment of the trial have been published in a paper entitled Safety and Immunogenicity of INO4800 DNA Vaccine Against SARS-CoV-2. A preliminary report of a randomized blinded placebo controlled phase two clinical trial in adults at high risk of exposure. The publication has been posted as a preprint prior to peer review. Again, we are very pleased that the safety, tolerability, and immunogenicity results clearly favor advancing the dose of INO4800, namely the two milligram dose, into our planned phase three global efficacy trial. Dr. Broderick will share with you shortly the potential versatility of IN04800 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 IN04800's favorable safety and tolerability profile while evaluating its ability to mitigate against the known circulating variants in our planned global phase three efficacy segments. And with that, I will turn it back to you, Joseph.
spk08: Thanks, Sanza. 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 INO4800 into a global phase three trial this summer. In parallel, we will also develop our second generation pan-COVID variant vaccine, INO4802. I now ask Inovio's Senior Vice President of R&D, Dr. Kate Broderick, to speak in greater detail about INO4800's activity data against the major variants that we announced in April, as well as to share an update on Inovio's efforts on our next-gen pan-COVID variant vaccine, INO4802. Kate?
spk01: Thank you, Joseph, and hello to everybody on the call today. When I spoke with you all during our last quarterly earnings call, I mentioned that Inovio was closely monitoring the development and evolution of SARS-CoV-2 mutations and currently testing the impact of these new strains with a particular focus on the strains that were first identified in the UK, South Africa, and Brazil. Since then, the company continues to 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 INO4800 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 at varying time points post-immunization from subjects in an OVO's Phase 1 US-based INO4800 clinical trial. The company assessed antibodies capable of neutralizing activity. They were measured against the spike protein variants tested, including B.1.1.7, the UK variant, B1351, the South African variant, and P1, the Brazilian variant. The analysis showed that the T cell responses induced by INO4800 vaccination were fully maintained against the UK, the South African, and the Brazilian variants when compared to the T cell responses to the original Wuhan strain. The neutralization levels of INO4800 against South Africa and UK variants were reduced by levels similar to the previous reports 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, INO4800 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 the study provide an encouraging overview of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants for INO4800 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 recognise the need to support both pandemic and future endemic considerations. In addition to our late-stage work on INO4800, we are also developing our second-generation pan-COVID variant vaccine, INO4802, which is designed to protect against current and potentially future variants of concern. We look forward to sharing a more robust update on our progress on 904802, including an upcoming pre-print publication in the near future. And with that, I'll turn the call back over to Joseph.
spk08: Thank you, Kate. Next, our CFO, Peter Keyes, 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 INO5401 and INO9012 in combination with the PD-1 checkpoint inhibitor Lipteo, 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-month overall survival data, including potential correlative 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 review one are phase three pivotal trial evaluating BGX3100 for the treatment of cervical H cell caused by HPV16 and or HPV18. The company continues to follow subjects in review 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 QuiGen on an in vitro diagnostic based on RNA sequencing technologies to guide clinical decision making for the use of VGX3100 in cervical H-cell. Importantly, this biomarker will help us to identify in a commercial setting prospective VGX3100 patients who would be most likely to respond to our immunotherapy. Our review of two phase three efforts continue across 48 global sites. We'll have additional information regarding any protocol or recruitment adjustments on this trial later in the year. Following positive phase two efficacy data, Inovio also continues to evaluate the best ways to expand VGX3100 indications to vulvar and anal dysplasia. We're currently exploring the best path for a phase three clinical trial for vulvar and anal dysplasia indications pending further discussions with the FDA. With that, I return the call over to Peter for our first quarter financial summary. Peter?
spk12: 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 of 2021 was $54.4 million, or 27 cents per share, basic and dilutive, which compares to a net loss of $32.5 million, or 26 cents per share, basic and dilutive, for the same period a year ago. 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 INO4800 and other clinical trials. Also, higher employee and contractor compensation expense and an increase in engineering services related to our Selector 3 PSP 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 INO4800 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.
spk08: Thanks, Peter. It's good to know that Inovio is 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 INO4800 as safe and effective vaccine for COVID-19, while in parallel evaluating our next generation pan-COVID vaccine, INO4802, to protect against current and future variants of concern, as well as continuing to validate our technology and broader 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 programs. If I can leave you with one point about Inovio, that one highlight from today's call is this. We're staying on track with our INO4800 development plans and expect to commence phase three this summer. We remain committed to developing INO4800 for many people globally still in desperate need 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?
spk13: Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. Our first question comes from Jeff Meacham from Bank of America.
spk05: Please go ahead. Hey, guys. It's Aspen. I'm for Jeff. Thanks for taking our questions. Just a couple from us. Firstly, maybe you could talk about how the current clinical hold for the Phase III study, how that plays into your Phase III development plans, given that you now expect to run that Phase III study primarily OUS. And then for the VGX3100, What additional data can we expect to see at an upcoming medical conference with respect to Reveal 1? Thank you.
spk08: Yeah, so let me take the second question first. The full safety follow-up is expected to finish later this year for Reveal 1. So we will have 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 three for INOVAIT trial, Aspen, you're absolutely right. The ex-US strategy is not impacted by the current phase three 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 three 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.
spk06: Thank you. Thank you. The next question comes from
spk13: Hardij Singh from Oppenheimer. Please go ahead.
spk09: 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 Innovio is going through in terms of, you know, identifying sites worldwide, submitting protocols to relevant regulatory authorities, protocol updates so that's just one if you can explain that number two you know do you have to now update your clinical protocol to the FDA aside from what you have to submit for the clinical hold you have to update the your revised protocol for the phase three now that you've picked I guess the two milligrams of your dose going forward and what is how does that work in terms of you know filing the the clinical response literature And then lastly, you know, just there was a newsletter 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.
spk08: Yeah, thank you, Arthash. I'll take the general stab at the questions and I will ask Dr. Malman to further answer. uh address uh these questions but uh first of all um the last again last part of your question first you know i think the whole landscape of vaccine availabilities the orders and renewal that's a changing landscape so you know every week or every month seems to be changing uh one thing is for sure you know there's only 5% of the global population that's received COVID-19 vaccine thus far. So there's a huge unmet demand globally and potential opportunities to have INO4800 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, you know, each of the countries that will file to include into our phase three 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 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, any detail?
spk04: Yes, absolutely. Thank you, Joseph. You know, we're working with a very experienced CRO, so it's the same CRO that we've been working on the Phase II study. And our ex-U.S. country selection criteria included countries for which our CRO has experience. Another criterion that we've looked at in terms of a country selection are those countries in which Inovio has had experience with other platform products as well as the device. So we feel confident that we've made a country selection that allows us to move relatively quickly. Now, the protocol amendments amendment has gone through with the two milligram dose, and our CRO is actively working to prepare the regulatory submissions. So those are the additional points I wanted to raise.
spk08: Great. Thank you, Anza.
spk09: Sure. Great. Thank you, Joe. I'll jump back in the queue.
spk13: Thanks, Sartaj. The next question comes from Gregory Renza from RBC Capital Markets. Please go ahead.
spk10: Hi, Joseph and team. Thank you for taking my question and also for the updates today. Joseph, just with respect to the discontinuation of the DOD funding for that phase three trial, just curious if you could comment on how that personally just impacts the perception of the vaccine program and platform potentially. And then just secondly, pivoting the program ex-US, 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.
spk08: Thanks, Greg. Well, certainly, the DOD funding decision came at a surprise. You know, they have been working with us in our ex-US pivot for many weeks. And, you know, obviously they didn't see our unblinded group level safety or immunogenicity from our phase two trials before they made that decision. So, You know, really, as they informed us, which we disclosed, the decision is mostly 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 preparation. So And I continue to thank the DoD for funding the phase two and all of the phase three prep work that we have been doing for many months now. As Anza mentioned, that prep work is going to allow us to move expediently into a global phase three trial. And, you know, we can't give any details, but we're currently working with potential funders and partners to help us to execute this trial. Now, what I can say is PIVOT from US to XUS generally reduces the overall cost of the trial. So I think that's also helpful as well. Now, we're not moving to XUS for cost reasons. Obviously, we're looking for some of the conditions that Anza spoke about. our experience at Inovio in those countries, our CRO's experience and expertise, but also we're looking for areas where there are less available emergency vaccines in those countries and regions, and where there are still significant number of cases where we can do a randomized placebo-controlled case-driven efficacy trial. So when you triangulate these conditions, you know, there are very important regions around the world that fits into these calculus and plans. So, you know, stay tuned to have a lot more details about our Phase 3 trial, we should have that disclosed in the next few weeks.
spk06: Thank you very much.
spk13: The next question comes from Steven Wiley from Stiefel. Please go ahead.
spk07: Hi, 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. you're targeting countries where there's a severe vaccine shortage and are therefore able to run a placebo-controlled study. But just wondering if you considered having an active comparator arm or doing some sort of non-inferiority study, just considering, you know, there are vaccines that are approved and, you know, 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.
spk08: Yeah, that's a great question. And we have internally considered those different options. And we still feel that case-driven placebo control study is the most expedient way to get to our efficacy question for our vaccine. So that's the path that we're pursuing now. And of course, the landscape has been changing over the last several quarters, but I think the case-driven efficacy trial window is still wide open outside the U.S., and that opportunity is there for us to see.
spk07: Okay, great. Thank you. And then, do you still intend to disclose preliminary data for INO 3107 in RRP this year?
spk08: Well, you know, that's a great question. RRP remains an important disease target for us. And I know 3107 likely, likewise, is a very important product for us. You know, we received the orphan drug designation last year for 3107 for RRP. And we have our phase one slash two trial that's open label that's ongoing. So most likely the most impactful amount of data will be 22 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 22, mid-22 event.
spk07: Okay, great. Thank you for taking the questions.
spk08: Yeah, thanks.
spk13: The next question comes from Aiden Husainov from Benchmark. Please go ahead.
spk02: Hi, everyone. Thanks for taking my question, and congratulations with the data.
spk03: Thanks, Dave. So, we saw the data on the binding antibodies and neutralizing antibodies in the pre-publication. Could you comment on the geometric fold increase in the binding antibody titers that was kind of higher than the geometric fold increase in the neutralizing antibody titers? And overall, what's What's your opinion on the role of the binding antibodies in the immunity against COVID-19?
spk08: You know, I think this is a very good question, important question. So, you know, 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 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. You know, we believe measuring both of those antibody levels and the impact of the vaccine and increasing those rise in 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 two trials. And as Kate Broderick mentioned in her remarks, that when we are looking at the various variants of concern, we were very excited to see that our T cell responses overall maintain whether we were testing against the Wuhan strain or some of the newer major variants like the South Africa, Brazil, or UK. So we think having this one-two punch with antibodies and T cells for NO4800 It's going to be an important aspect of providing protection in our phase three efficacy trial that we're planning to start later in the summer.
spk03: Thank you. I appreciate that. And one more question I have regarding the long-term opportunity for INO4800 or INO4802. in terms of the boosting of the other vaccine or the novel use? So where do you see the not the long-term, the mid-term opportunity for the vaccine?
spk08: Yeah, you know, 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 an annual seasonal boosting regime, regimen to follow. And if they are correct, having a vaccine that can be boosted safely and tolerably, you know, seasonally over and over again, because we think Certainly, after the pandemic will be the endemic stage of having to deal with COVID problems year in and year out, potentially with changing variants. It's very important. So, we believe that having INO4800 as a potential booster booster vaccine to our own INO4800 vaccinated, primarily vaccinated people, or even potentially being used to boost other vaccines of the first generation is a strong potential. And also, I think Kate mentioned 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 INO4800 and other DNA vaccines in our portfolio, is we feel, and we have a significant amount of data in our platform, that our vaccines can be boosted over and over with a great tolerability, limited AE profile, and no anti-vector response. So I think these attributes really provides a great potential in our outlook for potential of our INO4800 and then subsequently INO4802 vaccines as boosters, hopefully for many years to come.
spk06: Thank you very much. Great. Thanks.
spk13: Again, if you have a question, please press star, then one. The next question comes from Yi Chen from HC Wainwright. Please go ahead.
spk14: Hi. Thank you for taking my question. Could you tell us a bit about whether Inovio plans to allocate a certain amount of your existing cash position to the phase three global COVID-19 trial and how much you would need to raise from external parties to complete the trial.
spk08: Well, hi, thanks for that question. As we look at, as Peter summarized in the remarks, we have a very strong, over half a billion dollars in cash right now. you know, we definitely want to, and that's one of our strengths at this point, but we also want to maintain that cash, and we want to limit our expense as much as possible. So we're working with currently the funders and partners how best to conduct our phase three trials, and that work is ongoing now, and we hope to be ready to to discuss that publicly in the next few weeks. So, you know, our team, our partners, our funders are working extremely hard to make this happen. And I'm very optimistic and confident that Inovio will be able to lead this global effort for a phase three 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.
spk06: Okay, thank you. Thanks.
spk13: The next question comes from Chris Raymond from Piper Sandler. Please go ahead.
spk00: Hey, 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 guys comment on the neutralizing antibody response, the immune response, in the comparison to convalescent plasma? It looks like there's a pretty sizable difference. you know, sort of difference there and, you know, what gives you confidence, I guess, moving forward, you know, with respect to the reaction from, you know, investigators and also, you know, subjects to, you know, for the recruitment. Thank you.
spk08: Yeah, thanks, Chris. So, yeah, you know, the geometric mean titer, which we presented in the pre-publication in MedArchive this morning really lays out all of the data that we have, both from all of our 400 subjects at the group level 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 two milligram dose group. as we saw at six weeks, which is two weeks after the second dose, in these subjects compared to their baseline at week zero, but also against the placebo group for both one milligram and two milligram groups. 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 two trial compared to the phase one. Now, the convalescent spread is also wider, and the GMT is higher than our two milligram dose group. But, you know, we're looking at the immune responses generated, as I mentioned earlier, in terms of the neutralizing antibodies, binding antibodies, and T cells in a holistic way where we feel that our INO4800 can provide protection against COVID-19 cases in a controlled, randomized, placebo-controlled trial in a global efficacy trial. So we look forward to to taking this promising vaccine into a global phase three trial as soon as we can this summer.
spk06: Okay, thank you.
spk08: Yeah, thanks, Chris.
spk13: There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to Joseph Kim for any closing remarks.
spk08: Thank you, everyone. Thanks for listening to our presentation. Thank you for all of the insightful questions. We look forward to moving IN04800, PGX3100, as well as 3107 and 5401 forward. And we look forward to sharing some of the insights of IN04800 phase three trials later in the next few weeks. So thank you again for this quality call and for your attention. Have a great night.
spk13: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Disclaimer