Inovio Pharmacauticals (INO 1.58%) once was among the most prominent companies in the coronavirus vaccine race. The biotech designed its vaccine candidate in only three hours after receiving the coronavirus genetic sequence. And it started a phase 1 trial only a few weeks after one of today's market leaders, Moderna.
Since then, a series of events has pushed Inovio to the back of the pack. The most damaging was the U.S. government's decision to drop funding of its late-stage clinical trial. That was due to the supply of vaccines already on the market. But recently, Inovio announced news that could jump-start its vaccine program. Let's look at the details and find out what this means for the stock.
Inovio's phase 1 trial
First, a bit of background on Inovio's path to this point. Inovio announced positive data from its phase 1 trial shortly after Moderna. Unlike its rival, Inovio didn't go into detail regarding neutralizing antibody levels. And that disappointed investors. Neutralizing antibodies are known to block infection, so they offer solid clues about vaccine performance.
Then, a few months later, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on Inovio's phase 2/3 trial. The regulatory agency had questions about the trial -- and in particular the device used to deliver the vaccine candidate. Inovio uses its proprietary handheld Cellectra device to introduce product directly into cells through electrical pulses. The FDA lifted the hold on the phase 2 portion of the trial after Inovio provided answers. But the hold on phase 3 remains.
Meanwhile, as mentioned above, the U.S. government decided it wouldn't fund the phase 3 portion of the trial as originally planned. As a result, Inovio changed its strategy to focus on vaccinating parts of the world that lack doses. The company said it would start by conducting late-stage trials outside of the U.S.
So, here's the latest news: Mexico recently authorized Inovio to start a phase 3 trial there. This comes shortly after Brazil and the Philippines agreed to participate in the global trial. Inovio continues to seek permission to add trial sites in other countries.
Vaccination in Africa
This is positive news for Inovio. It means the company can finally proceed with the late-stage testing of its vaccine candidate. And it's true that need remains high in various parts of the world. For example, today on the African continent, only 4.2% of people are fully vaccinated. And Inovio plans to focus on vaccinating Africa, Latin America, and Asia.
Of course, eventually selling vaccine doses to certain low- and middle-income countries won't generate as much revenue as selling doses to the U.S. Still, for a clinical stage company like Inovio, bringing a product to market and generating any level of revenue would be a win.
That said, I would be very hesitant about buying Inovio shares right now. Investors progressively lost confidence in the company following the setbacks I mentioned earlier. The stock soared more than 700% from the start of 2020 through June of that year as Inovio moved from early development through phase 1 trials. Since that time, though, the stock has lost more than 70%.
I think Inovio has to show it can bring a candidate to the regulatory authorization stage before the shares will deliver a sustained gain. As a potential investor, I would want to see positive trial data and Inovio's manufacturing plan. I also would be interested in hearing about advance purchase agreements. Right now, all of that still seems pretty far away.
At the same time, bigger rivals such as Moderna and Pfizer have plenty of time to deliver doses to regions in need -- and that may slowly chip away at Inovio's potential market.
A stock to watch?
Inovio remains a stock to watch. The company's technology is innovative. The vaccine candidate introduces an optimized form of DNA from the coronavirus into cells. The idea is that the cells then produce a protein from the virus -- and the immune system responds.
Inovio is also working on a pan-covid vaccine candidate. This means one that could work against any variant. If Inovio succeeds here, it could be big. But it's much too early to invest in such hopes. The candidate hasn't yet entered clinical trials.
So, yes, Inovio's latest news is positive. And it's reason to keep an eye on what comes next. But until Inovio offers us clear signs it really can bring a product to market, this biotech stock remains high-risk.