Warning: This Skyrocketing Stock Has a Hidden Risk

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Up 860% in the last 12 months alone, Summit Therapeutics (NASDAQ: SMMT) is a skyrocketing stock that likely has more upside in store.

Nonetheless, rapid gains like that tend to imply some downside risk for new investors, and this biotech is no exception. So, let's uncover the hidden risk here and what you need to know about it.

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This company's fate isn't entirely in its own hands

Since it doesn't have any revenue yet, Summit's strategy is to license its pipeline assets from Akesobio, a larger biotech based in China. Its lead program and only clinical-stage candidate, an antibody called ivonescimab, is no exception.

Although ivonescimab is approved for treating non-small cell lung cancer (NSCLC) by China's National Medical Products Administration, the Food and Drug Administration (FDA) in the U.S., or any other regulatory agency, is yet to approve it.

Summit is thus performing a pair of phase 3 clinical trials in the U.S. testing the antibody for the same indications, hoping to generate a dataset that regulators at the FDA will find compelling enough to grant the approval for commercialization.

A third phase 3 trial is planned, and it's expected to start in 2025. So, there is a well-known risk (to biopharma investors, at least) of those clinical trials failing to replicate Akesobio's results or otherwise failing to impress regulators in the U.S.

But with no independently developed pipeline programs to its name, Summit is likely planning to continue to license additional programs from Akesobio rather than investing in early-stage research and development (R&D). That could be a sustainable and ultimately very profitable strategy, because the Chinese biotech is investigating ivonescimab for a slew of additional indications beyond NSCLC, including head and neck cancer, ovarian cancer, colorectal cancer, and several others. Success with those programs would thus expand ivonescimab's total addressable market without requiring much in the way of a commitment up front from Summit.

Alas, that's also the source of the stock's hidden risk, and it's a fierce one. If Akesobio fails in any of its ongoing or future clinical trials with ivonescimab, it will sharply dent the drug's addressable market -- and Summit's stock will be dented right along with it.

The fact that it hasn't yet signed on the dotted line to license any additional indications from Akesobio doesn't matter; there is every indication that for Summit, Akesobio's pipeline is the only game in town when it comes to near-term opportunities for growth.