Moderna is an American biotechnology company based in Cambridge, Massachusetts that focus on drug discovery, drug development, and vaccine technologies based exclusively on messenger RNA (mRNA).
The Moderna technology platform is to insert synthetic mRNA into living cells that would reprogram the cells to develop immune responses, rather than being created externally and injected as with conventional medicines. It is a novel technique abandoned by several large pharmaceutical and biotechnology companies that were unable to overcome the side effects of inserting RNA into cells. As of May 2020, no mRNA drug has been approved for human use.
Moderna has conducted mostly unsuccessful trials in traditional high-margin chronic therapeutic areas with AstraZeneca, and in orphan diseases with Alexion Pharmaceuticals. In 2014, Moderna moved to focus on lower-margin vaccines, given that an mRNA vaccine – efficacy issues aside – will always stimulate a level of antibody development in subjects. The strategic change led industry experts, and Moderna employees, to question the financial viability of the company. In the opinion of some former Moderna employees, the safe dose was too weak and "repeat injections of a dose strong enough to be effective had troubling effects on the liver in animal studies."
In December 2018, Moderna became the largest biotech initial public offering (IPO) in history, raising US$600 million for 8% of its shares, implying an overall valuation of $7.5 billion, and with cumulative losses of $1.5 billion and equity raised of $3.2 billion, since inception. As of May 2020, Moderna was valued at $30 billion, but none of its mRNA molecules had reached large clinical trials, and several had failed due to side-effects.
In July 2020, Moderna announced in a preliminary report that its Operation Warp Speed candidate had led to production of neutralizing antibodies in healthy adults in Phase 1 clinical testing. "At the 100-microgram dose, the one Moderna is advancing into larger trials, all 15 patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection." The troublesome higher doses were discarded in July from future studies.