Moderna Timeline

Noubar Afeyan meets with Bob Langer and Derrick Rossi to review recent data on the use of chemically modified mRNA to reprogram adult human fibroblast cells into induced pluripotent stem cells following protocol of Prof. Yamanaka

Noubar envisions a different use of engineered mRNA as a new kind of medicine and launches within Flagship’s VentureLabs group a month-long exploration which eventually leads to Newco LS18, Inc.

LS18 starts experiments with novel chemical modifications of mRNA

Initial protein expression experiments conducted in cell culture and foundational provisional patents filed by Flagship’s VentureLabs group in July and October 2010

LS18 renames itself Moderna Therapeutics

Noubar recruits Stéphane Bancel who joins Flagship as Senior Partner and LS18 board of directors in March 2011, becoming Moderna CEO in October 2011

R&D team starts developing novel ways to design, synthesize and analyze synthetic mRNA and shows expression of therapeutic proteins in laboratory setting using cell lines

R&D team generates first ever data in mice, rats and later chimps showing proof of concept that engineered mRNA would lead to predictable and controllable production of therapeutic proteins they wouldn’t have otherwise made like growth hormones, EPO and VEGF

Moderna partners with AstraZeneca to develop pioneering Messenger mRNA Therapeutics™ in cardiometabolic diseases and cancer

DARPA awards Moderna a grant for up to $25 Million to develop Messenger RNA Therapeutics™

Alexion Pharmaceuticals and Moderna Therapeutics announce exclusive strategic agreement to develop Messenger RNA Therapeutics™ for rare diseases

Moderna launches Onkaido Therapeutics to focus on the development of mRNA Therapeutics™ in oncology with $20 million capital commitment

License and collaboration agreement with Merck to develop mRNA-based antiviral vaccines and passive immunity therapies

Moderna closes $450 million financing to support growth of Messenger RNA Therapeutics™ platform across diverse therapeutic areas

Collaboration with PPD to support clinical development of novel mRNA Therapeutics

Moderna transitions to a clinical stage company

Initial grant of up to $20 million to advance mRNA-based antibody combination to help prevent HIV infection, through Valera, Moderna’s infectious disease-focused venture

Collaboration with Merck to advance novel mRNA-based personalized cancer vaccines for the treatment of multiple types of cancer

Vertex and Moderna establish exclusive collaboration to discover and develop mRNA Therapeutics™ for Cystic Fibrosis

BARDA awards funding for $8 million with potential of up to $125 million to accelerate development of Zika Messenger RNA (mRNA) vaccine

Positive interim Phase 1 clinical data demonstrates first mRNA vaccine candidate and induces high levels of immunogenicity

First-in-human dosing for Phase 1 Study (KEYNOTE-603) of mRNA-4157, a personalized cancer vaccine, for the treatment of solid tumors

Moderna opens new manufacturing site in Norwood, Mass.

Moderna IPO on December 7 exceeds revised goal of $600 million by about $4.3 million, and the raise values the company at about $7.5 billion

Positive interim Phase 1 data for first combination vaccine against the respiratory viruses hMPV and PIV3

Publication of Phase 1 data for mRNA vaccines against two potential pandemic influenza strains

FDA Fast Track designation for Zika vaccine mRNA-1893

Positive interim results from Phase 1 cytomegalovirus (CMV) vaccine (mRNA-1647) study and progress toward Phase 2 and pivotal trials

mRNA-3927, Moderna’s investigational mRNA therapeutic for propionic acidemia receives FDA Fast Track designation

Stéphane Bancel asked if Moderna would be willing to do a phase 1 trial using mRNA and he and Noubar agree to proceed

mRNA-1273 delivered from company’s cGMP facility in 42 days from sequence selection

First participant dosed in NIH-led Phase 1 study of mRNA vaccine (mRNA-1273)

First patient enrolled in Phase 1/2 study of mRNA-3704 for methylmalonic acidemia

Award from U.S. government agency BARDA for up to $483 million to accelerate development

Collaboration announced with Lonza Ltd to manufacture mRNA-1273 (goal of up to one billion doses per year)

FDA clearance to proceed with Phase 2 study of COVID vaccine

Announcement of positive interim data from Phase 1

First participant dosed in Phase 2 study

Enrollment of Phase 2 study complete

Publication of positive interim Phase 1 data

Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) begins

Announces supply agreement with U.S. government for initial 100 million doses of COVID-19 vaccine

Presentation of older adults Phase 1 data

Moderna slows enrollment to ensure Black, Latino, and Indigenous participants are represented in COVID vaccine trial

Publication of older adults Phase 1 data

Moderna signs pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

Moderna pledges not to enforce COVID vaccine patents

Enrollment of Phase 3 COVE study complete

Noubar received the news of the 94.5% efficacy and remembers the excitement of the first time seeing the data that mRNA worked with mice back in 2012

COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study

Primary efficacy analysis in Phase 3 COVE study for COVID-19 vaccine candidate is 94.1% and Moderna files with U.S. FDA for emergency use authorization