• First commercial approvals could be for HPV therapies in 2022.
• Brain cancer (glioblastoma) data could indicate a multibillion-dollar opportunity.
• COVID-19 vaccine success could still be in time for some global demand.

Inovio (INO) has likely been the most volatile stock in its class of biotechnology companies during the last year. Getting perspective on its true long-term value is crucial to investors. As with other clinical (pre-commercial) stage pharmaceutical stocks, this involves weighing many contingencies. The ratio of Inovio's 52-week high of $33.79 to its 52-week low of $2.19 is about 15, which is remarkable. It closed on November 18 at $11.03, down sharply from last Monday when it rose sharply following news that the FDA granted permission to start its Phase 2 trial for INO-4800, its potential COVID-19 vaccine.

Data by YCharts

Given the state of the COVID-19 vaccine race, I believe the bulk of the future value for Inovio is in its HPV precancerous lesion therapies, which will be the focus of this article. The glioblastoma (brain cancer) therapy may have a great deal of value if it gets Phase 3 results sufficient for FDA approval. I will explain why I will heavily discount that outcome until I see the data. Long term, Inovio has a proven platform that should generate new medicine at regular intervals. I will explain why I believe the current price is reasonable for long-term investors, whereas I think the danger outweighs the opportunity for short-term investors unless they like to play with volatility. I note that my last article on Inovio, Inovio's Wild Ride and Real Value, from March 25, 2020, has largely proven to be correct.

INO-4800 for COVID-19 Update and Value

Inovio, after what seemed to be a quick start, fell behind in the race to produce a validated COVID-19 vaccine. At least two companies were able to move at warp speed and may have emergency use authorization from the FDA before the end of 2020. The FDA delayed Inovio's bid, only allowing it to begin the INO-4800 Phase 2 trial on November 16. It still is waiting on an okay for Phase 3. That means it is not likely to have Phase 3 data before mid-2021, judging by the timelines of the successful trials.

That does not mean INO-4800 is without value. Assuming it meets the FDA bar of 50% efficacy, and especially if it is close to the 90% efficacy we are seeing from competitors, there could still be massive global vaccine demand in the second half of 2021. That demand might be mainly outside of the United States, Europe, and other top-paying nations, so the price per dose might have to be relatively low. Inovio believes its vaccine is the best-in-class in terms of needing minimal refrigeration, which would be a competitive advantage where medical and transportation infrastructure is weak. Again, that means where people and governments cannot pay top dollar for medicines. It might also have an advantage in T cell generation and length of immunity provided, but we have not seen the specific data yet.

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