As I’ve written here before, “There’s no denying the inherent risk of investing in pre-clinical biotechs.”

But this morning, it got a whole lot less risky for Cue Biopharma (CUE).

The company announced FDA approval to begin clinical testing for its lead immuno-oncology candidate, CUE-101, for the treatment for HPV-associated cancers. The development also triggered a small milestone payment from strategic partner, LG Chem.

The market reaction so far? Ho-hum. How else do you characterize a X% “rally?”

Please don’t be lulled into believing the same. This is a major milestone.

Per the FDA, “only 5 in 5,000 compounds that enter preclinical testing make it to human testing.”

In other words, the overwhelming majority of compelling and potentially lifesaving ideas end up being simply that – ideas. That die in the lab.

That’s not the case for CUE, which is significant in its own right. But here why today’s news is even more significant, including two not so obvious reasons. Plus, I share a list of expected catalysts for 2019.

 


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