Stéphane Bancel

Under Bancel's leadership, Moderna is among the COVID-19 vaccine frontrunners. (Wikimedia Commons)

Stephane Bancel 
CEO, Moderna 

Stephane Bancel seems to embody two different personas: It can be difficult to tell if he’s the next Steve Jobs or just another biotech executive with an unproven technology on his hands—albeit with a lot more financing and a much bigger spotlight.

The trailblazing vaccine platform Moderna is developing reminds people of how Apple revolutionized smartphones, and Bancel hasn't been shy about promoting it.

During an executive roundtable with President Donald Trump in March, Bancel touted how Moderna had sent a potential COVID-19 vaccine to the National Institutes of Health just 42 days after its genome became available, thanks to its mRNA technology.

That was previously unheard of in the vaccine business. What's more, the company could start a midstage clinical trial in a few months, he added. What he didn’t mention at the time was that no Moderna product had ever passed a phase 2 test before, and even now, no vaccine based on its mRNA science is approved anywhere. 

To be fair, the “fake it till you make it” strategy is typical in the startup world, though it’s the type of showmanship some biomedical scientists have frowned upon. In 2016, for instance, a Nature Biotechnology op-ed criticized Moderna for lacking peer-reviewed data on its mRNA platform.

Lightning speed

But Bancel’s boundary-pushing strategy has so far paid off for its COVID program—and he certainly wasn’t faking the 42-days-in-the-making COVID vaccine. According to the Financial Times, Bancel set an internal timeline of 60 days to get a working product ready, and that was already light speed compared Moderna's previous record of 10 months in creating a potential Zika shot.

“I'm usually scared of a big hairy audacious goal and then he closes the door, I'm like, ‘Oh my god dude, I don't know what planet you're on,’” Stephen Hoge, Bancel’s deputy and president of Moderna, commented on Bancel in the newspaper. “He’s a driver, he’s intense, he’s expansive in his thinking.”

RELATED: Moderna wins bragging rights as it kick-starts first experimental coronavirus clinical trial

The chief executive acted in early January, when few—if not no one—foresaw what then seemed to be a local SARS-like outbreak in China could quickly evolve into a global pandemic. His team moved into full swing on Jan. 13 after Chinese authorities released the virus’ genetic sequence. The first clinical batch was shipped to the NIH on Feb. 24.

On March 16, two weeks after the Trump meeting, Moderna’s candidate, mRNA-1273, was the first U.S. program to enter human testing, though not without raising a few eyebrows for skipping the animal tests.

Being first gave Moderna outsized influence as the vaccine race progressed. The world was watching as data began to roll in, as the company struck manufacturing deals and as it faced down early questions about pricing. And Bancel took advantage of the hype around the program he personally helped create by attracting big money.

Buy or Sell?

The first clinical batch of mRNA-1273 was funded by the Coalition or Epidemic Preparedness Innovations. In April, HHS’ Biomedical Advanced Research and Development Authority put up $483 million to help Moderna with early development and manufacturing.  In June, Moderna earned a spot in the Trump administration’s Operation Warp Speed, sitting alongside Big Pharma companies AstraZeneca, Merck & Co., Pfizer and Johnson & Johnson. And in July, the company scored another $472 million BARDA funding for its phase 3 trial.

Meanwhile, as Moderna posted what it characterized as “positive” early phase 1 data in May—and as some industry watchers balked at calling the trial a success—the company rode optimistic investor sentiment to a public offering of about $1.34 billion.

RELATED: Moderna posts 'positive' early data for COVID-19 vaccine

While the firm was trying to convince investors to buy in, though, its execs were selling—and reports of those sales diverted the spotlight from the potential vaccine to Bancel and his team.

Securities filings showed Bancel and other top Moderna managers had unloaded a sizeable number of shares before releasing the phase 1 data. In an interview with CNBC, Bancel explained that those sales were set up long ahead and, according to SEC rules, couldn't be canceled as the stock offering approached.

“I think if you look at the big picture, I have sold less than 1% of my holdings in the company since the company went public,” Bancel said on CNBC’s “Squawk Box” in July, adding, “99% of my wealth is in Moderna stock, and it’s going to remain like this.”

Moment of Truth

But amid all that financial activity, Moderna’s mRNA-1273 candidate was still forging ahead. It led the COVID vaccine pack into key phase 3 efficacy trial in late July and seemed neck-and-neck with fellow mRNA shot-makers Pfizer and BioNTech.

But in a rare move—and one that has itself turned out to be influential—Bancel, the chief advocate for speed, took a sharp turn and worked to rein in public expectations.

RELATED: Moderna CEO expects to know by November whether coronavirus vaccine works: report

As the vaccine timing grew increasingly politicized, Bancel spoke up. At a Financial Times event, the Moderna CEO said his company wouldn't be filing its shot for emergency use until Nov. 25 the earliest. Rather than pushing ahead, the company would be compiling more safety data first, he said.

Here it is now, the moment of truth. We’ll soon know whether Bancel’s mRNA platform indeed works based on facts and data, not blind optimism. It’s Bancel’s earlier-than-expected shot at refuting doubters; previously, the company’s lead candidate, cytomegalovirus vaccine mRNA-1647, was only scheduled to start pivotal phase 3 study in 2021.

If it succeeds, the world will have a powerful weapon against emerging infectious diseases, one that can be rapidly mobilized compared with traditional vaccine approaches. If it doesn’t, Bancel and Moderna will face new questions about their platform.

Stéphane Bancel