Moderna is prepping for life after COVID, and CEO Stéphane Bancel says he’s “never been as busy” as the company considers potential M&A opportunities.
“We will not be shy to invest to expand the platform either through technology or through products,” Bancel said during the company’s first-quarter earnings report Wednesday. “And that’s really where we are in terms of M&A.”
Moderna has experienced rapid, maybe even unprecedented, growth of 2,000% for 2021 compared to 2020, opening up a whole new world of acquisition opportunities. Bancel wouldn’t dive deep into the qualifications of a potential buy but said the company was looking worldwide and across therapeutic areas.
“In terms of M&A, I can tell you, our teams—I have never been as busy—they are looking at a lot of opportunities literally across the world,” Bancel said.
Last year, Moderna pledged to “expand our horizons” with M&A, flagging nucleic acid technologies, gene therapy, gene editing and mRNA as areas of interest.
Moderna well exceeded earnings projections on the back of the COVID vaccine Spikevax, according to the first-quarter report. But with the pandemic turning a corner to endemic, the company made sure to profile other areas of its business.
The company now has a wide-open plan to consider where to go next outside the vaccine program. Executives highlighted the rare disease program as an area they hope to grow with similar fervor. Two phase 1 trials are currently ongoing in propionic acidemia (PA) and methylmalonic acidemia (MMA); the former has already achieved a fully enrolled first cohort and additional patients are being added.
“Assuming this is positive, we will do more in rare genetic disease,” said Bancel.
Moderna’s President Stephen Hoge said that the PA and MMA programs, should they be successful, will validate the technology that could then be used to rapidly expand the number of rare diseases Moderna targets.
“But obviously if we have a very strong signal out of PA, we will be un-gating other programs that can benefit from the technology that will then be de-risked from the PA program,” he said.
With that said, executives still touted the vaccine program, which currently remains the bedrock of Moderna’s pipeline even outside of COVID, particularly the flu jab, mRNA-1010. The company expects to launch into a phase 3 immunogenicity study for that shot in the coming weeks before pursuing an accelerated approval nod with regulators (although the FDA was not explicitly mentioned).
Moderna is also prepping a phase 3 efficacy trial “if needed”; however, the trial is less “if” and more “when,” according to Hoge. In the event that regulators nix accelerated approval, the company will launch the efficacy trial to nab full approval, or that trial will act as a confirmatory study following accelerated approval.