A year ago, Moderna was not on anyone’s “Most Likely to Succeed” list.
As the Cambridge biotech approached its 10th year, the company had yet to get a single product approved for sale by government regulators. Investors weren’t particularly hot on its potential, either ― after going public in December 2018, Moderna’s stock price hadn’t done much over the ensuing 12 months.
There was skepticism about the company’s approach — using custom-crafted RNA to instruct the body’s cells to battle a disease or virus ― partly because Moderna hadn’t disclosed much data about it. And there were questions about its focus on a dim corner of the biotechology industry that, in the words of biotech entrepreneur and former Biogen research executive Michael Gilman, was “neither sexy nor lucrative” ― vaccine development.
By the end of 2019, Moderna was valued at about $6.5 billion, but some industry observers wondered whether that big number was more about wishful thinking than realistic prospects.
“Everybody was scratching their heads about how much this company was worth,” said John LaMattina, a former head of research and development at Pfizer.
Then came the COVID-19 pandemic.
Moderna had already been testing vaccines for MERS, a respiratory ailment, and Zika, a mosquito-borne disease. When it received the genetic sequence of COVID-19 from China on Jan. 11, Moderna was like a cook who had already prepped the ingredients, pre-heated the oven, and set the table. The company was in an ideal position to design new vaccines, and it had already established a good relationship with the National Institutes of Health, which helped Moderna kick-start a clinical trial.
The speed of it all was breathtaking. Just a week after Governor Charlie Baker declared a state of emergency, on March 10, the first person was injected with Moderna’s experimental vaccine as part of the Phase I trial, which included 45 healthy participants.
The federal government rolled out its Operation Warp Speed initiative in mid-May to accelerate the development of tests, treatments, and vaccines for COVID-19. That funneled about $4 billion in government funding to Moderna, in exchange for 200 million doses of the vaccine, which Moderna is making at its production plant in Norwood, as well as at plants owned by partner companies in New Hampshire, Indiana, and Switzerland.
Moderna found itself in “the right place at the right time,” said Satish Tadikonda, a managing partner of Avigo Solutions, which consults to the biotech industry. The company was having a hard time using RNA molecules to spur the body to battle diseases, he explained, because they could be toxic at too high a dose, and ineffective if too low. But in a vaccine, a small dose could be just enough to trigger the antibodies needed to fend off a virus.
At the end of July, Moderna began enrolling 30,000 volunteers — including hundreds from New England — in its Phase 3 trial, which on Thursday led to a Food and Drug Administration advisory panel’s recommendation that the vaccine be authorized for emergency use.
Over the summer, Dr. Anthony Fauci, who heads the NIH’s National Institute of Allergy and Infectious Diseases. suggested that he’d be satisfied if a vaccine was 70 or 75 percent effective at preventing infections. The results from Moderna and the similar Pfizer-BioNTech vacine, showed an effective rate in the mid 90s for both versions. That “knocked the socks off everybody,” said LaMattina, the ex-Pfizer executive.
“For a place like Moderna, this gave them all the credibility they needed for their platform. A year ago, you never would’ve expected anything this profound or rapid,” LaMattina said.
For Moderna cofounder and company chairman Noubar Afeyan, who runs Cambridge-based venture capital firm Flagship Pioneering, Moderna’s success isn’t such a shocker.
“Most breakthrough innovations are descendants of unreasonable starting premises,” Afeyan said. “We should not work on things that start life at a proven, understandable, relatable starting point, where some expert tells you it’s a good idea.” Moderna’s “unreasonable starting premise” was that you could program an RNA molecule, inject it, and prompt the body to make its own medicine.
Once COVID-19 began spreading, and Moderna decided to develop a vaccine, Afeyan said, the company’s atmosphere was transformed into “almost a war-like environment. You see these movies where the military moves in, and sets up tents and bridges — it was like that. I’ve been involved in lots of fairly significant undertakings. This was completely incomparable.”
As an example, he noted that Moderna’s Norwood plant was designed to make personalized vaccines to treat cancer “in tiny quantities for a handful of people, which is a totally different infrastructure than making hundreds of millions of doses of a vaccine.” Employees worked around the clock to adapt it to such a massive scale, Afeyan said.
The company viewed COVID-19 as an opportunity to show the world that technology it had labored over for nearly a decade could do something important. “It didn’t hurt that all day long, they heard about people dying, and lives that could be saved,” Afeyan said. “That propels people. It gives them a sense of purpose. We were given a big opportunity. Everybody’s suffering, and we have a chance to do something about it.”
Another favorable backdrop: Operation Warp Speed was run by Moncef Slaoui, a former GlaxoSmithKline executive who had served on Moderna’s board. (A few days after taking on the role, Slaoui resigned from the board and divested of his Moderna stock under pressure from Massachusetts Senator Elizabeth Warren and other senators.)
Without Operation Warp Speed, Afeyan said, developing a vaccine “wouldn’t have taken five years, like [President] Trump talks about it, but it wouldn’t have happened as fast as it did. I don’t give credit to the politicians, but to the people who did the work.”
Since the beginning of the year, Moderna’s once lethargic stock has rocketed by 630 percent. And that $6.5 billion valuation that last year raised eyebrows? It pales in comparison to the company’s current worth: $55 billion. Company executives ― including the CEO, president, and chief medical officer ― have also accumulated a lot of personal wealth by selling millions of dollars worth of stock under pre-determined sell schedules.
Along the way, Moderna has become perhaps the best known success story of the world renowned Massachusetts bio science sector, which includes stars such as Biogen and Vertex Pharmaceuticals.
Moderna’s trajectory over the last year “is truly unbelievable,” said Bruce Booth, a partner at the Cambridge venture capital firm Atlas Venture. It will crank out hundreds of millions of doses of vaccine over the next year, Booth said, something that has “probably never before been seen in our industry.”
While vaccines were once considered a backwater undertaking, “now we know that rapid vaccine development can literally save civilization,” said Gilman. “When the spotlight found [Moderna], they were ready.”
Scott Kirsner can be reached at email@example.com. Follow him on Twitter @ScottKirsner.