Inovio Pharmaceuticals, Inc. (INO) Earnings Call Transcript & Summary

And welcome back to the 2021 RBC Global Healthcare Conference. My name is Gregory Renza, one of the senior biotechnology equity research analysts here at RBC, and we're pleased to have INOVIO Pharmaceuticals. And joining us from INOVIO is President and Chief Executive Officer, Dr. Joseph Kim. And if you have any questions for Joseph, please feel free to enter those in the web portal below, and we will be happy to ask those on your behalf. So Joseph, thank you for joining us.

Well, great to be here. Thanks for inviting me.

Thank you. So let's get right to it. And perhaps before we do dive right in, could you just provide us a brief overview of INOVIO's core technology as well as just a little color on the pipeline programs?

Yes. Thank you, Greg. INOVIO is a leader in DNA medicines. So DNA as many of people out there know another nucleic acid platform similar to the messenger RNA. INOVIO has been developing our DNA medicines platform for the treatment of cancers, HPV-caused diseases, vaccines for infectious disease. We have late-stage programs for treatment for in HPV in VGX-3100. And excitingly, we're about to enter Phase III trials for our COVID-19 vaccine, INO-4800. So we have over 300 people working incredibly, dedicatedly to advance our programs forward.

That's great. And let's focus a bit on COVID-19, the vaccine -- the vaccine landscape and INO-4800. So certainly, the COVID-19 and the pandemic several pushes and pulls for INOVIO, for society and for drug development. And with 4800 really getting off to a solid start last year, seeing some recent data with the Phase II trial in a manuscript published last week, Joseph, what is the latest feedback on that Phase II trial? How should we place that data in the contents of the results? And what has transpired across the vaccine landscape?

Yes. I think people are very excited about the data that we have generated from our Phase II trials. These are 400 at-risk volunteers all in the U.S. We conducted the Phase II trial in 2 dose groups, 1-milligram and 2-milligram with the placebo-controlled. And our primary objective was to select the best dose to take into Phase III global efficacy trials. And we did just that. We found that the 2-milligram dose group was superior than 1-milligram and compared to the placebo in both antibody response generation as well as T cell activation. So we're very much looking forward to taking our 2-milligram dose into a global Phase III efficacy trial this summer. And the data that we've seen both from the antibodies and T cells, in fact, were even more encouraging than what we saw and what we published from the Phase I trials. So we feel really strong about that. And I think the reception has been very good.

Okay. Great. And certainly, a great deal of focus on your plans and the clarity you've provided ongoing ex U.S. for the trial and getting into that Phase III. When will we have maybe that additional clarity around your plan? You alluded to the summer there. And certainly, just hearing that evolving strategy, well, I want to hear your thoughts on that clarity. But also how you would characterize the market opportunity in these ex U.S. countries, several moving parts there in addition to the U.S., but you've really talked about doubling down on ex U.S. focus, understandably?

Yes. Thank you, Greg. So last part -- second part of the question first. The market opportunity for INO-4800 is immense globally. So I think we're getting a little bit complacent in the United States with the rollout of the emergency approved vaccines. And almost everyone who wants a vaccine now can get it, 12 years and up. So we're in a great situation in the U.S. But if you look across globally, there's only 5% of the population that's received the vaccine, even the first dose. So there's a huge unmet medical need globally outside of our country. And there's a great opportunity for a vaccine like INO-4800, which has tremendous temperature stability advantage over other vaccine platforms. INO-4800 never has to be frozen any time in transportation and storage. We have 1 year room temperature stability, 3 to 5 years projected at normal refrigeration temperature. So if you thought about appropriately positioned global vaccine for COVID-19, INO-4800 should be on the top of that. Our safety advantage, our safety and tolerability is as good or better than anyone else out there. In our Phase II trials, over 95% of our AEs were Grade 1. So most of the -- compared to other vaccine platforms out there, it's highly tolerable. Safety is greatly favorable. And we've shown we can generate the antibody and T cell responses, really the 2 -- 1:2 punch of the immune system, I think, really bodes well for the position that INO-4800 could have in the global world stage. In terms of why we're so excited about this is all of these combined, in terms of articulating additional details, of course, we will be submitting all of our Phase III plans to various regulatory bodies in the countries that we're planning to go out. Certainly, there are multiple countries who are still battling very active COVID infections in their countries, availability of emergency approved vaccines are pretty rare. And we're looking forward to conducting our trials there and potentially providing our doses to those countries as well. So I expect that we will have additional articulation of our details of our plan in the coming weeks.

Got it. Got it. And several inputs, of course. I'm just curious, Joe, if you had just any thoughts on 4800 positioning on some of the latest emerging clinical data from virus-like particle vaccines just emerging. And certainly about infection rates and regional stability or management of the pandemic or COVID-19? Any thoughts on potential enrollment competition, not just on EUA or on market vaccines but also as multiple other Phase III vaccines are planned for ex U.S. countries?

Yes. Thankfully, for the world, there are many of us, including INOVIO, working diligently to both test the vaccines and roll out once they're approved to different parts of the world. I think this has been an incredible global effort really making the biotechs and pharma industries to shine. So I think VLPs, proteins, mRNAs, viral vectors and DNA vaccines, they all have their role in generating the appropriate immune responses to provide the right levels of protection against COVID-19 disease. Now where INOVIO really excels besides the temperature stability advantage and other logistics and safety and tolerability is our ability to generate strong T cells along with the antibody. So the folks who are generating primarily the antibody responses, I think, we position really well against those vaccine platforms. And as you know, in the durability of the response and the ability to clear the impending infections where the T cell immunity plays a critical role, I think INO-4800 can have advantageous positions around that. And then lastly, potential of having safety and tolerability on our side, we're also looking at a long-term boosting opportunities, not just for boosting our own vaccine, but working through the clinical pathway and the regulatory pathway to position INO-4800 as the potential booster for various vaccinated folks. As we transition from the pandemic stage of this disease to a seasonal endemic vaccination stage, I think INO-4800 has a long-term advantage in the marketplace.

Great. Great. And talking about the clinical [ whole ] talking about getting ex U.S. And then the other piece is funding, of course. And you may have alluded in the past about potential government contracts or ways in the back-half of the year to help augment that. I just wanted to understand how you are thinking about the funding, the partnership prospects. It sounds like we should be awaiting some word on that. Would you consider funding the trial on your own in order to continue development as you prioritize across all INOVIO programs?

Well, Greg, we have been benefited from just outpouring of support from the beginning of INO-4800 development from funders like CEPI and the Gates Foundation and the U.S. government, like the Department of Defense and others, we have been well funded through the completion of the Phase II trial. In fact, the DoD has extensively funded the preparation for a global Phase III already. So it's the last bit of the work that we're preparing to do in executing a global Phase III trial. We're currently working with various partners and funders and other sources to properly fund and start the Phase III trials. And of course, INOVIO has a very strong financial position. But as we have looked at this opportunity, we're getting outpouring of support from these vendors and partners. So I have no doubt that we will be able to articulate the full strategy in the coming weeks. But what I can share with you is the potential of our DNA vaccines, INO-4800 and others, in terms of how we can reach those people who need our vaccine in the most efficient way possible. So as we look at our opportunity to execute a case-driven Phase III efficacy trials, right in front of us, we plan to grab that and really execute what I think will be a very productive Phase III trial globally. In terms of working with various governments, I think the countries that we will select to conduct our Phase III trials really are the countries who need the vaccines like INO-4800. So we'll be working with those various governments also for the best ways for us to provide the vaccine once the vaccine shows efficacy and receive the regulatory approval. So this is a very exciting part of our development. INO-4800 has the potential of being our first commercialized vaccine from our very prolific platform. And we look forward to focusing on that and also using this opportunity to really raise up INOVIO as a pre-commercial company to fully functioning commercial business. So this next 12 months or so are going to be very critical and exciting part of our business development.

Great. Great. And as an extension to, of the 4800 efforts, the pan-COVID vaccine, you're developing is certainly interesting. What is the differentiation of design that makes INO-4802 able to target multiple variants as well as those emerging strains?