Inovio Pharmaceuticals (INO 3.51%) and Ocugen (OCGN -6.06%) are two small biotechs that hope to win regulatory authorizations for COVID-19 vaccines in the not-too-distant future. In this Motley Fool Live video recorded on Nov. 10, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how these two COVID-19 contenders stack up against each other.
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Keith Speights: There are two companies that hope to market COVID-19 vaccines: Inovio and Ocugen. And they both announced the Q3 results earlier this week. We don't necessarily have to get into the weeds of their earnings results. But just in your opinion, Brian, which of these two stocks do you think has the better prospects?
Brian Orelli: I think their earnings weren't very interesting since neither one of them has products in the market. But I think the most interesting thing that I saw recently was Ocugen has filed for Emergency Use Authorization in the U.S. for children.
I think the FDA has previously said that Ocugen couldn't file an Emergency Use Authorization [EUA] for adults and that they wanted them to file a full regular FDA approval on that. They'd have to do some additional clinical trial work to do that and they are in the process of setting that up, but it looks like they're trying to get around that by filing for children. That'll be interesting to see what the FDA says on that.
Speights: I'm skeptical about their chances there. I really wonder if the company just decided to file for EUA even without getting blessing from the FDA. I'm not sure on this story, but I do know that the market reaction was just blah, after the news.
You would think with a stock like Ocugen, that was just skyrocketing as investors anticipated Covaxin, the COVID-19 vaccine, winning EUL, Emergency Use Listing, from the World Health Organization, which really doesn't impact Ocugen at all. You would think that Ocugen filing for EUA in kids would really make the stocks just skyrocket, and it didn't. I think investors may be revealing their thoughts already, that they don't expect this EUA to be granted.
Brian Orelli: Yeah. this is the problem with investing in biotech is that the FDA doesn't talk, and so basically, you have to only get the information from the company. That makes things challenging if you're not sure exactly if the company's blowing smoke or is giving you the full story.
Keith Speights: Yeah. The FDA had changed its guidance back in the summer, I guess it was, and said unless companies have been working with us throughout their clinical trials in developing their manufacturing processes, we might not decide to review their Emergency Use Authorization filings. As far as I know, the FDA hasn't changed its tune on that. I think that's still their stance.
As far as I know, Ocugen hasn't really been working with the FDA all that closely on clinical trials and manufacturing processes. This will be an interesting one to watch.
Brian Orelli: Yeah. I think the FDA is worried about adults and making sure that what Ocugen is planning on doing is running a clinical trial that compares the antibody levels produced in Americans versus the antibodies produced in the original clinical trial that showed that the vaccine that they licensed had worked. If they're going to require that for adults, I don't see why they wouldn't require that for children as well.
Keith Speights: Yeah. Now, I will say this on Inovio. The company did just announce yesterday, I think, that it's received the U.S. FDA's go-ahead to move forward with the phase 3 study of its COVID-19 vaccine, INO-4800 in the U.S. That's good news for Inovio.
But again, I think the question with both Inovio and Ocugen is will they be too late to the party? It's going to be a while before either of these companies really has a good chance of having their vaccines on the market.
Brian Orelli: Yeah. I think Inovio is probably the better option is to go outside the U.S. where Ocugen doesn't have that option, except for Canada, because it's not their vaccine and they've only licensed it for U.S. and Canada.
Keith Speights: Inovio also has a broader pipeline than Ocugen does. Ocugen does have some gene therapies targeting eye diseases in its pipeline, but they're really, really early. Inovio has more irons in the fire, and so it has a lot more going forward, I think, right now.
Brian Orelli: Yeah.
