Inovio Pharmaceuticals (INO -3.43%) was once one of the biggest coronavirus-vaccine hopefuls. The company was among the first to launch clinical trials of a vaccine candidate -- and saw its shares soar more than 700% in the first half of 2020. But when the program fell behind, investors lost faith. The stock has dropped 92% since its 2020 high.
Now, Inovio may be heading for a turnaround. It appointed a new CEO in May. And this week, Inovio announced a major cost-cutting effort that will give it the cash it needs to operate through the third quarter of 2024.
Could now be a time to get in on this potential recovery story? Let's take a closer look.
A crowded market
Your big question probably is this: Where does Inovio's coronavirus-vaccine candidate stand? After all, the market is starting to get a bit crowded. Pfizer and Moderna dominate, and regulators just gave Novavax the go-ahead for its vaccine.
Inovio initially developed its candidate -- INO-4800 -- as a primary series, but it recently switched strategies. The company discontinued its clinical trial for that indication. The number of severe coronavirus cases worldwide has declined, so to show that INO-4800 prevents severe disease, Inovio would have had to expand its trial -- and that would have led to higher costs.
Now, Inovio is aiming to focus on clinical studies of INO-4800 as a booster to be used after a primary series with an already authorized or approved vaccine, along with partner Advaccine of China. Early results showed a 6.3-fold increase in T-cell response. Researchers administered INO-4800 six months after a primary series.
Inovio says it expects data later this year that will help it decide on a strategy for INO-4800. And a few months ago, Inovio said it planned on expanding its work with Advaccine to include development of booster and vaccine candidates to handle new variants.
Could Inovio still make a mark in the world of coronavirus vaccination? I'm not so sure.
Experts say the coronavirus will stick around, and it seems very likely that companies will generate revenue into the future by finding ways to address the virus as it lingers and mutates. For example, Moderna and Novavax each are working on combined coronavirus/flu-vaccine candidates.
But these companies already have demonstrated they can bring a coronavirus vaccine to market, and they've started carving out market share. Inovio hasn't yet done this. It may be difficult for Inovio to gain a spot unless its potential booster stands out from those of its rivals -- and so far, it doesn't look like anything sets it apart.
This means betting on Inovio for its coronavirus-vaccine program is a high-risk move. The company says its other focus right now is advancing its candidate for HPV-associated precancerous cervical dysplasia. That candidate is in phase 3 studies. Inovio's reorganization includes deciding on a timeline for this candidate.
Inovio's cost cuts are meant to help it advance its key assets -- its coronavirus vaccine and cervical dysplasia candidates. Through job cuts and other measures, Inovio will cut operating expenses by 30% over the coming 18 months. Inovio is reducing the full-time workforce by 18% and contractors by 86%.
The rest of the pipeline
It's not yet clear what Inovio has planned for the rest of its pipeline -- or how the job cuts will impact it. The company is working on earlier-stage programs for infectious diseases and cancer.
It's great the new CEO is reorganizing to put a focus on priority programs and ensure the company has enough cash to move forward. But I'm concerned about Inovio's dependence on its coronavirus-vaccine candidate at this point in the vaccine race. After all, with several vaccines now commercialized, the actual "race" is over.
As for Inovio's candidate, commercialization isn't right around the corner. The booster program is in phase 2 studies. And second, if and when INO-4800 does reach commercialization, I'm not convinced it can carve out significant market share.
All of this means Inovio still is a risky bet. And that's why, at this stage, I'd favor watching what's next from the sidelines.