Moderna, maker of mRNA therapies, files for record IPO

Just how valuable might messenger RNA-based drugs be? That question is about to be put to the test.

In a Nov. 9 filing with the U.S. Securities & Exchange Commission (SEC), Moderna Therapeutics signaled its plans to go public and raise $500 million. If the company succeeds, it will be the largest initial public offering in biotech history.

The secretive Cambridge, Mass.-based firm works on what it says will be a disruptive drug platform: messenger RNA therapies. Moderna sees mRNA as the “software of life.” Cells use mRNA to transfer the instructions stored in DNA to make proteins involved in human health. The company’s idea is that specially-made synthetic mRNA could prompt cells to turn up the production of certain disease-fighting proteins—essentially helping the body make its own drugs.

“As we unlock the inherent advantages of mRNA, we aim to address as many diseases and impact as many patients as our technology, talent, and capital permit,” the company said in its SEC filing.

A closely-watched biotech unicorn, Moderna has raised more than $2.6 billion as a private company, valuing it at about $7 billion. The planned IPO, which will put a new, possibly higher, value on the company, follows a wave of other big public offerings in the biotech space this year.

Although Moderna has no products on the market yet, it boasts a pipeline of 21 drug and vaccine candidates, several of which are currently in Phase I studies or will enter clinical trials soon. In its SEC filing, the company says more than 755 people have been dosed with its mRNA therapeutics in clinical trials.

It has yet to release much clinical data, though, and the jury is still out on how well its technology works. No mRNA-based drugs have been approved—or even evaluated—by the U.S. Food & Drug Administration.

Those caveats, combined with the large IPO, mean Moderna will be under special scrutiny as a public company. “Moderna will likely be criticized more than any biotech company in history due to its ludicrous valuation,” says biotech investor Wilson Cheung.