Moderna Has Its Doubters. CEO Bancel Plans to Answer with a Cancer Shot.

Dow Jones10-27

Moderna CEO Stéphane Bancel arrives wearing custom sneakers. Scrawled in what appears to be black marker is a message: "ModeRNA boy, je t'adore."

The footwear was customized by his wife, inspired by an absurd bit of graffiti the couple spotted near their lakeside home in France: "Chicken farmer, I still love you." It's a small detail, but one that captures how deeply intertwined Bancel's personal identity has become with the biotechnology company he has led since 2011.

Bancel, a longtime pharma executive with a career spanning three decades, is unapologetic about Moderna's reputation. It has frequently been described as intense and fast-paced. One highly critical report published before the company went public in December 2018 described Moderna as "one of biotech's most secretive start-ups," going so far as to allege that development hit roadblocks due to Bancel's ego.

Bancel doesn't sugarcoat the reality. "This is a very demanding company," the CEO told Barron's. "And how could we be otherwise?"

Without that culture, he continued, Moderna never would have developed its Spikevax Covid shot, which took the company from an aspirational, early-stage biotech to a powerhouse in respiratory vaccines.

"We started working on mRNA medicine in 2011. Most people in the industry said this would never work," Bancel recalled. "In 2020 -- when we had our Phase 1 Covid data in the spring -- I said, if everything goes to plan, we could have a vaccine by Christmas. Everybody said it was impossible."

The vaccine went from sequencing to human trials in just 63 days. Just over nine months later, Moderna had its first commercial product. Seemingly overnight, it transformed from a speculative unicorn -- which had survived for years selling the promise of messenger RNA to larger companies -- into arguably the pandemic's greatest success story.

That same ambition fuels its pipeline as Moderna moves past that period of its history and onto its next chapter: oncology. Intismeran autogene, the personalized cancer vaccine co-developed with Merck, was touted as a paradigm shift in cancer treatment when the partners previewed late-stage trial data in August.

The enthusiasm made sense at the time. The readout marked the first Phase 3 trial success for an mRNA-based cancer vaccine, and a major milestone for a candidate that Moderna's own president, Stephen Hoge, had earlier in development described as "a long shot by any stretch of the imagination."

Bancel concurred. "We always thought it was a highly risky scientific proposal that could change medicine and change cancer care forever," he said. "And so we took that bet with our partner Merck. But other things we have done in our history have been like that."

Moderna styles itself as an mRNA platform rather than a Covid vaccine company. The biotech has five products on the market today, including its recently approved flu shot, mFlusiva, and a combined flu-Covid vaccine available in Europe.

All are based on its flagship mRNA technology, which delivers temporary genetic instructions for human cells to manufacture a specific viral antigen, in turn training the immune system to fight it. "We're doing something that has never been done before," Bancel said.

Investors haven't shared that unbridled optimism. For years, Moderna struggled to shake its reputation as a pandemic-era one-hit wonder. The drugmaker desperately needed its next catalyst, which arrived with the intismeran readout in August. Shares nearly tripled as investors cheered evidence that the company was finally turning the corner.

Then, just as Moderna looked to be rewriting its narrative, the stock stumbled on an expanded dataset leaked days ahead of last week's European Society for Medical Oncology annual meeting. That unraveled much of the anticipation baked into the shares -- optimism driven by hopes for read-through success in other cancers that remains unproven.

Bancel, for one, tuned out the noise. "Some people think over time it could be bigger than Keytruda," the CEO said, referring to the blockbuster immunotherapy that generates $32 billion annually. "Again, over time. Not next week. We believe it will work everywhere Keytruda works."

Data to support that claim are still lacking. While the company has effectively proven intismeran's efficacy in melanoma when combined with Keytruda, investors are waiting to see how it performs against harder-to-treat cancers. Citi analyst Geoff Meacham remarked last week that the market had been "assigning value to an effective-cure narrative" as enthusiasm added $44 billion to Moderna's market capitalization in a single trading session.

Ask Bancel, and he'll say investors are missing the bigger picture. The company already had committed to nine trials across various solid tumors before the positive Phase 3 data arrived, and just last month it raised $3 billion through an offering of zero-coupon convertible senior notes to support that research.

If intismeran is broadly effective, it will be a powerful validation of Moderna's mRNA technology. Unlike standardized immunotherapies like Merck's Keytruda, intismeran is tailored to the unique mutations in a patient's tumors.

The biotech company's ambitions don't stop there. Bancel ticked off a list of pipeline candidates: combination shots, latent virus therapies, other offerings in oncology and rare diseases. Even as it pivots beyond its pandemic-era success, Moderna remains squarely anchored in vaccines.

"We think vaccines are going to keep growing. We're going to keep launching vaccines," Bancel said, pointing to an expanding, aging demographic that is particularly vulnerable to infectious diseases.

As he sees it, Moderna's ability to compete with larger, more entrenched rivals -- the Eli Lillys and Pfizers of the world -- hinges on an mRNA platform that Bancel likens to software. Rather than operating like a traditional drugmaker with a sprawling portfolio of unrelated chemicals and biologics, Moderna focuses entirely on expanding its proprietary mRNA and lipid nanoparticle architecture.

Even if intismeran hasn't gone entirely to plan, the company is just getting started. "We believe Moderna is going to be a very large biopharmaceutical company over time," Bancel said. "Here we have a platform and we're just getting going. And as we've learned in the tech world, platforms are exponential."

 

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