Moderna Enzymatic, Inc.

Moderna CEO Stéphane Bancel suggested in an interview that his deals team has had a busy start to the year, as the once-celebrated vaccine maker looks to expand its business and overcome mounting US scrutiny. “It’s tough to say now what we’re going to do,” Bancel told Endpoints News in an interview ahead of his presentation Monday at the JP Morgan Healthcare Conference. “But I can tell you, the teams are looking at quite a number of opportunities that will decide if we get there, from a diligence standpoint.” Moderna has taken a selective approach to business development since raking in billions of dollars from its Covid-19 shot. It’s signed multi-target collaborations with biotech companies like Immatics and Metagenomi (though Moderna has since backed out of this partnership), and it acquired Japanese manufacturing tech firm OriCiro Genomics three years ago. But now Moderna is in the process of transitioning to focus on the launch of a new cancer immunotherapy in 2027. Moderna said Monday that Phase 3 data on the therapy, called intismeran autogene, could come this year, confirming CFO Jamey Mock’s tease of a potential readout last month at a banking conference. Thanks to a new loan, Moderna enters 2026 with $8.1 billion in cash and investments, $1.1 billion more than the top end of its guidance after the third quarter. Slightly higher-than-projected revenue and a $200 million improvement in expenses also helped the year-end balance sheet. Error: Survey not found. Despite the attention on cancer treatment and other mRNA-based rare disease medicines in the pipeline, Moderna is still working to launch new vaccines. It submitted a new application to the FDA for its standalone flu product at the beginning of the year, and it anticipates approval of a combination Covid-flu vaccine as well. Moderna said Monday that it is “awaiting further guidance from the US FDA on refiling” its combination application, and Bancel made no indication that the agency has relayed new approval standards for the product. The agency has for years guided that safety and immunogenicity data would suffice for a combination vaccine, so long as each product demonstrated efficacy on its own. The FDA asked Moderna in 2025 to withdraw its application and the company planned to resubmit it with full flu efficacy data, while other agencies allowed Moderna to update its existing submission with new data. “It’s very difficult to know what drove those decisions,” Bancel said. “I can just describe the outcome.” Should the flu vaccine be approved, Moderna will try to gain a foothold in a legacy market that the Trump administration’s regulators have become less amenable to. The CDC no longer expressly recommends the flu shot as a once-annual vaccine for kids, after US officials’ recent overhaul of the childhood vaccine schedule . Bancel said selling the flu product under shared clinical decision-making, the new recommendation, is “doable” but “more complicated.” Under HHS Secretary Robert F. Kennedy Jr., the Covid vaccine recommendations have shifted to individual choice as well. He also conceded that the RSV market has been difficult to make money in, as evidenced by Moderna’s meager sales in their first year and a half. Bancel said that without revaccination guidance, RSV hasn’t operated like a true vaccine market, because the patients at highest risk got vaccinated the first year the products became available, and that pool has only shrunk. “It’s not really a true commercial product yet, in the sense that you have a market that is not really growing,” Bancel said. “It’s actually going down.” Despite Bancel and the company’s hopes for federal guidance on additional doses, that’s unlikely to happen in an administration vocally advocating for fewer vaccinations, not more.

Vaccine maker Moderna said it has completed construction of an R&D and manufacturing facility at Shonan Health Innovation Park in Fujisawa City, Japan, through its subsidiary Moderna Enzymatics. However, Moderna announced it will no longer proceed with a previously planned mRNA drug substance manufacturing base in Japan due to shifts in the global and domestic business environment. The halted project, led by Moderna Japan, was part of the Japanese Ministry of Economy, Trade and Industry’s 2023 initiative to strengthen domestic vaccine production infrastructure. Moderna expressed appreciation for the ministry’s support and said it may revisit the project in the future if business conditions improve. Moderna Enzymatics' newly completed facility focuses on cell-free DNA synthesis, a technology that the company says enhances the quality and speed of upstream mRNA manufacturing. Despite the change in plans, Moderna said it remains committed to the Japanese market and will continue supplying vaccines through its global manufacturing network while advancing mRNA-based treatments for cancer, rare diseases, and infectious conditions. Moderna’s latest update comes after the company received regulatory approval in April from the U.K.’s Medicines and Healthcare products Regulatory Agency to begin commercial production at its mRNA vaccine facility in Harwell, Oxfordshire. “We will continue to work with the Japanese government, local governments, medical professionals, and many other stakeholders to contribute to public health and people's health in Japan,” the company said.

Moderna's Enzymatics unit has completed construction on a separate drug research and manufacturing facility in Japan. Moderna, already in cash-saving mode amid uncertain vaccine dynamics, is backing off from its plans to construct an mRNA drug substance plant in Japan.The vaccine maker opted to scrap the project after “careful consideration given the current business environment,” Moderna’s Japan unit said in a Friday press release.Moderna had originally committed to establishing two facilities at the Shonan Health Innovation Park (iPark) in Kanagawa Prefecture, Japan’s city of Fujisawa through a 2023 agreement that was part of the country’s plan to create a domestic manufacturing system for vaccines.While Tokyo-based Moderna Enzymatics has already completed construction on its drug research and manufacturing facility in iPark, the company has decided that “in light of changes in the business environment both globally and in Japan,” it won’t move forward with its mRNA plant “at this time.”“Moderna continues to view business expansion in Japan as an important part of its strategy, and will reconsider establishing an mRNA drug manufacturing facility in the future if the business environment is favorable,” the company noted.Moderna pledged to continue providing a “stable supply” of vaccines to Japan using its global manufacturing network and said it will work with the country’s government and other stakeholders to contribute to public health, including promoting the development of mRNA-based treatments in cancer, rare diseases and infectious diseases.The company’s completed facility in Japan will “continue to serve as an important foundation for supporting the development of innovative mRNA medicines,” the company added. After it rose to global prominence in 2020, Moderna went all-in on building its capabilities across the world, including in Japan. In 2022, CEO Stéphane Bancel divulged his hopes to build an end-to-end vaccine manufacturing presence in the country.The company later made its first-ever M&A move with the 2023 buyout of Japanese DNA supplier OriCiro Genomics K.K. for $85 million. But as the pandemic eased and COVID-19 moved into its endemic phase, Moderna witnessed a dramatic sales slowdown and has moved to evolve its business. In addition, the Trump administration's attitudes toward vaccines has created additional uncertainties for the vaccine field at large.In the U.S., Moderna's $590 million government contract for bird flu vaccines has been cut, leaving the company scrambling for alternative funding for late-phase development and manufacturing of the vaccines.  With its sales on the decline, the company has moved to extend its previously announced cost-savings program into 2027 with a goal of reducing its GAAP operating costs by $1.4 billion to $1.7 billion between 2025 and 2027, the mRNA specialist confirmed in a May earnings release.Moderna’s first-quarter revenues totaled $100 million and its net loss was $1 billion. The drugmaker expects to generate revenues between $1.5 billion and $2.5 billion during 2025 and recently won FDA approval for its next-gen COVID vaccine, albeit in a smaller population than its previous COVID vaccines. Last year, Moderna hit pause on a $500 million mRNA plant in Kenya that was meant to bring more manufacturing capabilities to Africa, citing declining demand that was “insufficient to support the viability of the factory.” The plant was originally slated to produce up to 500 million injectable doses annually.