Inovio Pharmaceuticals (INO 2.33%) is one of the biotech companies everyone is talking about these days. Though the company doesn't have any products on the market, the shares have surged by 717% since the start of the year. That's because Inovio was among the first to join the race to develop a vaccine for COVID-19 and enter human trials.
You may be wondering: With gains that steep, is it too late to buy Inovio shares? Or should Inovio be your next coronavirus buy? Let's take a look at where the company stands against the competition.
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Inovio isn't the leader in this race from a timeline perspective. Moderna (MRNA 0.61%), for instance, began its phase 1 studies a few weeks earlier than Inovio. Moderna also reported interim data first and is set to begin a phase 3 trial on July 27. Inovio is combining phase 2 and phase 3 into one trial that will begin this summer. A few other players are either ahead of Inovio or are neck-and-neck with the company.
While it's great to be first, and speed is critical when facing a pandemic, something else is even more important: the safety and efficacy of the vaccine. From that perspective, it's impossible to designate a leader right now. Although some companies, including Inovio, have released interim trial data, it isn't enough to draw conclusions. Still, data often can offer us a few clues about whether we should be somewhat optimistic about a program or not.
Reorganizing DNA
Inovio's vaccine candidate is based on the company's DNA medicines technology. Through computer sequencing, Inovio reorganizes tiny circles of DNA -- DNA plasmids -- to spur an immune response. Inovio then uses its own hand-held smart device, the Cellectra, to deliver the optimized DNA plasmids into the body.
Inovio recently reported interim results from its phase 1 trial, saying 94% of the 36 participants showed immune response. The company based that on data from evaluations of binding and neutralizing antibodies as well as T-cell response. But Inovio didn't provide further details regarding neutralizing antibodies. Those following this race closely are focused on that data point because neutralizing antibodies actually block infection.
The interim data report wasn't bad. In fact, it sounds encouraging. But the trouble is, Inovio hasn't yet provided enough information to offer us solid clues about whether this vaccine may work. (I emphasize the word may because, even with full details, it's still too early to determine whether the vaccine can truly fend off the coronavirus.) I stand with investors who were disappointed by the lack of details regarding neutralizing antibody levels.
Department of Defense offers support
The U.S. Department of Defense has offered Inovio a $71 million contract to ramp up manufacturing of the Cellectra. But Operation Warp Speed, the government's effort to help bring a coronavirus vaccine to market, so far hasn't funded Inovio's work. The initiative granted rival Moderna more than $400 million and, in its biggest award yet, gave Novavax (NVAX 2.83%) $1.6 billion.
Inovio isn't first from a timeline perspective. The company hasn't yet provided detailed data from trials. And Operation Warp Speed so far hasn't offered Inovio funding. All of this doesn't equal failure for Inovio's coronavirus vaccine program. What it does mean is we're missing various clues that could support a buy case for the stock. As mentioned above, Inovio doesn't yet have products on the market. That means everything -- at least in the next year or so -- is riding on the coronavirus vaccine program. Considering all of these factors and Inovio's massive share gain this year, now may not be the time to buy this biotech stock.
