2020 has been a wild ride for Inovio Pharmaceuticals (INO). Virtually unknown at the start of the year, investors’ enthusiasm for coronavirus stocks has seen the DNA vaccine specialist post year-to-date gains of 253%. Naturally, INO-4800, the company’s DNA COVID-19 vaccine candidate has acted as the main catalyst.
But the program has come under duress recently, as a series of setbacks have raised questions whether Inovio can gets its vaccine across the finish line.
First, the FDA dragged its feet with approval for the originally slated July/August initiation of a Phase 2/3 trial. But the situation got worse last month as the regulatory agency put a temporary halt on the planned trial, citing the need for more information on INO-4800, including the company’s CELLECTRA 2000 delivery device, before it gives the go ahead.
INO plans to submit a response to the FDA’s questions this month, after which, the agency has 30 days to respond. If all goes well, then, Inovio can kick off the trial by November at the earliest. As other companies are already deep into Phase 3 trials, this will leave the small player with much catching up to do.
So, where does this all leave investors? Piper Sandler analyst Christopher Raymond advises to stay on the sidelines for now. Proceedings have left the 5-star analyst “incrementally cautious,” especially given the lack of clarity moving forward.
Raymond said ,“Details in the press release were sparse, and while management was quick to note that the hold is not due to AEs from the P1 trial, that still leaves a world of possible reasons, especially since INO has never published any data from that trial. Specifically, we'd like to know if FDA questions relate to the CELLECTRA device, trial design or something else. Combining these miscues with the not insignificant fact that INO still calls out the need for external funding to start the program, we continue to view this opportunity with a skeptical eye.”
Accordingly, Raymond has a Neutral (i.e. Hold) rating on INO alongside a $8 price target. The rating might as well have said Sell, as the figure implies there will be a 33% drop from current levels. (To watch Raymond’s track record, click here)
Rating wise, Raymond’s colleagues take a similar view. The analyst consensus rates the stock a Hold based on 2 Buys, 5 Holds and 1 Sell. On where the share price is heading, however, other Street analysts are more confident. At $13.71, the average price target suggests upside of 15% over the next 12 months. (See Inovio stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
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