Ocugen sees 77.8% efficacy in phase 3 trial for COVID-19 vaccine

Ocugen CEO Shankar Musunuri joins Yahoo Finance Live to discuss the company’s phase 3 trial of its COVID-19 vaccine.

Video Transcript

AKIKO FUJITA: Welcome back to Yahoo Finance Live. You see shares of biopharmaceutical company Ocugen, they're getting a big pop in this session, up nearly 5% on the back of its quarterly results. The company did report a loss of $26 million in Q2. That was narrower than expected. Also, research and development expenses at-- coming in roughly at $19 million. But investors really looking ahead to progress on development of its phase three clinical trials for its COVID-19 vaccine Covaxin. For more on that, let's bring in the CEO of Ocugen.

We've got Shankar Musunuri. And Shankar, it's great to talk to you today on the back of your results. But let's start by talking about where things stand with a Covaxin. In your trials, you're showing roughly 77% efficacy-- 78% if you round it up-- against the overall COVID-19. A lot of concerns around the Delta variant right now and the efficacy there. Walk me through what you're finding and how quickly you're likely to bring this to market.

SHANKAR MUSUNURI: First of all, great to-- thank you for having me here. I'm going to talk about Covaxin and some of the data you talked about, starting with phase three clinical results our partners, Bharat Biotech, has announced a few weeks ago. The overall efficacy, as you stated, is accurate, about 78%. And again, they also have good data, 93.4%, on severe, means including hospitalizations. And one of the key things which distinguishes Covaxin from other vaccines is during the clinical trial, they faced with a lot of variants. Majority of the cases were variants and, again, dominated by Delta.

And so the efficacy from this clinical trial, only vaccine with the control phase three clinical trial, the efficacy is 64.2%. That's really big. That's really important because it's ravaging through US right now. As I checked this morning, we have about 90,000 cases. And so having this vaccine, which is-- works on a very broad spectrum immune responses, humoral and cellular-- cellular means it's a memory, it's a long lasting-- and having a broad response is very important for emerging variants. This vaccine has the ability to handle variants and future variants.

Where we are in the regulatory process, we are-- we announced recently we have completed our submission to Health Canada. It's under active review. So we're preparing the plans in order to respond to them very promptly, preparing for the launch. And in the US, again, we are working with the FDA on the regulatory pathway for the BLA. As soon as we reach an agreement what needs to be done, we'll acively work on that and get it.

ZACK GUZMAN: Yeah, how do you see-- I mean, when we talk about other countries, right? Obviously, Moderna and Pfizer have had a pretty big head start in terms of working with things here in the US. But when you look at the rollout plan for what you guys have to offer, what does that look like in terms of leading countries to kind of focus in on?

SHANKAR MUSUNURI: Again, you know, I can't talk about all the countries because we have a license that's in North America, US, and Canada. That's what our focus is going to be. And we also have announced a manufacturing tie-up with the CMO in the US. We have initiated a technology transfer to Jubilant, and that's ongoing. So we can only, you know, talk about US and Canada.

AKIKO FUJITA: Shankar, as you're going through these trials for your COVID vaccine, obviously, a lot of questions around what the boosters are going to look like come fall. How is Ocugen positioning itself on the back of that? To your point, you've got a bit of an advantage in that you're going through these trials at a time when there are so many variants now that didn't exist in the initial trial phase of some of your competitors. How are you viewing the opportunities in the booster market?

SHANKAR MUSUNURI: I think the booster market is very key. There are significant opportunities there. Once again, when you look at any vaccine, this variant-- emerging variants are continue to come, right? And so one of the things you have to focus on is, as I mentioned before, humoral and cellular responses-- T-cell responses-- to the vaccine.

And the Covaxin is built on a whole virus with Jubilant, which actually was co-developed in collaboration with NIAID. And that boosted T-cell response, which has a long memory. And when you have a vaccine like that which can protect on variants rather than a vaccine which is built on one component of the vaccine, if that component is mutating, the efficacy, scientifically, is supposed to go down, and that's what is-- you're observing. So having that data is very strong, and we are going to do whatever we can to bring this to these markets to support and help people out and having a booster is an opportunity.

Second and most important thing we should not forget is kids under 12. We don't have any vaccines right now, and it's-- this is ravaging through. That's also a very important component. Our partners are completing the clinical trials in children in 2+ age group. That data will be available in the near future, and that will be a very important milestone, too. And once again, the Delta variant and future emerging variants-- and it's good to have options in our toolkit in the US and a differentiated vaccines.

And people-- we have a lot of vaccine hesitancy in this country, and that's also causing a rapid spread of the disease. And some of those vaccine hesitancy folks, you know, they may be not comfortable with the new technology or side effects. And providing an option with a vaccine like ours, which is built on a traditional platform like a polio vaccine, you know, they can correlate. And providing a solid safety and efficacy-- and safety is similar to placebo and efficacy on Delta variant, neutralization effect on other variants, I think that's going to position it well. And we do want to bring this. That's the reason, so it can really contribute significantly to the public health.

AKIKO FUJITA: Shankar Musunuri, the CEO of Ocugen, good to have you join us today. Appreciate the time.