Investing in clinical-stage biotech companies isn't for the faint of heart. Negative results from clinical trials or regulatory roadblocks can send shares of these companies plunging. On the other hand, investing in the right clinical-stage biotech stock can reap life-changing returns, particularly if the company in question develops a vaccine for an infectious disease that has spread across the world and has killed thousands of people.
One company that could go on to do just that is Inovio Pharmaceuticals (INO -2.02%). The biotech has been racing through the early stages of the development of its investigational coronavirus vaccine, INO-4800. As a result, Inovio's stock is up by 343.3% year to date as of this writing. Before pulling the trigger on this biotech stock, though, let's take a closer look at what's really going on with Inovio Pharmaceuticals.
Inovio's COVID-19 program
More than a dozen companies are looking to develop vaccines for the novel coronavirus, and that's a good thing. Given the worldwide need for an effective way to prevent new infections, it is unlikely that just one company will be able to fill this need.
In other words, even if the field is crowded, a vaccine could still be highly lucrative for Inovio. The company could cash in on this opportunity if INO-4800 proves as or more effective than its competitors, or if INO-4800 makes it to the market before most of its peers in this race.
Could Inovio meet one -- or both -- of these conditions? It seems unlikely. The company did report that during INO-4800's phase 1 clinical trial, all the participants developed immune responses, with almost 90% of them generating strong T-cell responses. T-cells are white blood cells that bind to and kill antigens, or harmful molecules. Also, Inovio found that its candidate proved effective at preventing infection by SARS-CoV-2 -- the virus that causes COVID-19 -- in nonhuman primates 13 weeks after they were last vaccinated.
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With that said, other companies have also reported impressive results. My own opinion is that AstraZeneca (AZN 0.49%) and Pfizer (PFE -0.19%) have the most promising vaccine candidates so far. It is hard to know yet whether Inovio's candidate is definitively superior to those of its peers. But we do know that while both AstraZeneca and Pfizer (among others) have already started phase 3 studies, Inovio has yet to do the same. The company is hoping to start a phase 2/3 clinical trial for INO-4800 this summer, though, and it could still end up being one of the winners in this race.
Between the uncertainty surrounding clinical trials and potential regulatory roadblocks, lots of things could happen that might flip this race on its head. However, it is hard to justify investing in Inovio solely for its coronavirus vaccine program, as opposed to other companies that have produced impressive clinical trial results and are further along in their efforts.
Looking at the rest of Inovio's pipeline
Inovio's most advanced pipeline candidate is VGX-3100, a potential vaccine for HPV-related precancerous cervical dysplasia. The company is currently running a phase 3 clinical trial for this medicine. Further, the U.S. Food and Drug Administration (FDA) recently granted the orphan drug designation to Inovio's INO-3107, a potential vaccine for HPV-related recurrent respiratory papillomatosis. This medicine is currently in a phase 2 clinical trial.
Inovio has other promising pipeline candidates, all of which are still in phase 1 or phase 2 testing. The company also has quite a few partners, including biotech giants such as Regeneron (REGN -0.09%) and organizations such as the Coalition for Epidemic Preparedness Innovations. Crucially, though, none of the company's candidates are anywhere close to receiving FDA approval.
What's the verdict?
In my view, Inovio isn't the most promising company for investors seeking exposure to the coronavirus vaccine race. Also, while the company does have several promising candidates, putting INO-4800 aside, Inovio likely won't launch a drug on the market for another two years or so. Given these factors, I don't think Inovio's stock is a buy right now. But investors should keep an eye on this biotech stock, as its fortunes could change quickly.
