Moderna

Moderna headquarters in Cambridge, Massachusetts

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi. Rossi had developed a method of modifying mRNA by first transfecting it into human cells, then dedifferentiating it into stem cells which could then be further redifferentiated into desired target cell types.[21][22] Rossi approached fellow Harvard University faculty member Tim Springer, who solicited co-investment from Kenneth Chien, Bob Langer, and venture capital firm Flagship Ventures.[22][23]

In 2011, the CEO of Flagship Ventures (now Flagship Pioneering), Noubar Afeyan, brought in European pharma sales and operations executive Stéphane Bancel as CEO.[22][11] Afeyan personally owned 19.5% of Moderna and was the largest single shareholder, while his fund, Flagship Pioneering, owned 18%.[24]

In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the therapeutic areas of cardiovascular, metabolic, and renal diseases, and selected targets for cancer.[11][25][26] The agreement included a $240 million upfront payment to Moderna, a payment that was "one of the largest ever initial payments in a pharmaceutical industry licensing deal that does not involve a drug already being tested in clinical trials",[25] and an 8% share in Moderna.[24] As of May 2020, only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601.[lower-alpha 1][28]

In January 2014, Moderna and Alexion Pharmaceuticals entered a $125 million deal for orphan diseases in need of therapies. Alexion paid Moderna $100 million for 10 product options to develop rare-disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform.[29] By 2016, Bancel told an audience of JPMorgan Chase investors that the work with Alexion would shortly enter human trials. However, by 2017, the program with Alexion had been scrapped as the animal trials showed that Moderna's treatment would never be safe enough for use in humans.[11][13]

In February 2016, an op-ed in Nature criticized Moderna for not publishing any peer-reviewed papers on its technology, unlike most other emerging and established biotech companies, and compared its approach to that of the controversially failed Theranos.[30] In September 2018, Thrillist published article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[31] criticizing its reputation for secrecy and the absence of scientific validation or independent peer-review of its research, though having the highest valuation of any U.S. private biotech company at more than $5 billion.[11][12] A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. They're running an investment firm, and then hopefully it also develops a drug that's successful".[11]

In 2018, the company rebranded as "Moderna Inc." with the ticker symbol MRNA, and further increased its portfolio of vaccine development.[10] In December 2018, Moderna became the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share) on NASDAQ, and implying an overall valuation of $7.5 billion for the entire company.[32][33] The year-end 2019 SEC filings showed that Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019 alone, and had raised $3.2 billion in equity since 2010.[10][24] As of December 2020, Moderna was valued at $60 billion.[34]

In March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, Bancel told the president that Moderna could have a COVID-19 vaccine ready in a few months.[10] The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483 million from Operation Warp Speed.[10] Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.[10]

Since 2011, Moderna has been led by CEO Stéphane Bancel, a French businessman with a pharmaceutical sales and operations background.[11][10] Bancel has been described as having a secretive approach to Moderna, and as being a tough operator.[11][10] Though never having worked with RNA before, Stat noted that Bancel "is listed as a co-inventor on more than 100 of Moderna's early patent applications, unusual for a CEO who is not a PhD scientist".[11] After Noubar Afeyan and Robert Langer, Bancel is the largest individual shareholder in the company.[39]

Stephen Hoge, M.D., is president and a former McKinsey & Company management consultant who joined in 2012; he is the fourth-largest individual shareholder in the company.[39][5]

David Meline is CFO.[5]

Noubar Afeyan, CEO of Flagship Pioneering, has been the chairman of Moderna's board of directors since 2011.[40] Afeyan who has a Ph.D. in biochemical engineering[41] holds his interest in Moderna through various Flagship Pioneering vehicles. At the 2018 IPO, documents filed stated that Afeyan owned 19.5% of the company, while Flagship owned 18%, thus giving Afeyan control over 37.5% of the company.[24]

In May 2020, board member Dr. Moncef Slaoui resigned from the company to become Chief Scientist for the Trump administration's "Operation Warp Speed", a group designed to accelerate the development of a vaccine for the coronavirus. Slaoui continued to hold more than $10 million in stock options in the company in his new role while the federal government invested $483 million in the company to assist in coronavirus vaccine trials. Senator Elizabeth Warren called the holding a conflict of interest and stated that Slaoui should have divested his options.[42]