Sanofi US News

* The two companies will jointly investigate multiple candidates with the goal of advancing an efficacious and safe SARS-CoV-2 vaccine into clinical development

- PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

* U.S. Phase 2/3 trial initiated and will begin enrolling patients immediately

- Expect to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

-PRV-3279 Inhibited the Function of B Cells, Durably and Without Depletion-

* Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial

- Work with Biomedical Advanced Research and Development Authority (BARDA) will utilize Sanofi's well-established recombinant technology platform to expedite a potential COVID-19 vaccine

JDRF T1D Fund Study Estimates 2.3 Million People at Risk Globally to Develop Stage 3 T1D, Which Already Affects 18 Million People Globally

- Acid sphingomyelinase deficiency (ASMD) is a rare, progressive and potentially life-threatening disease for which no treatments are approved

If approved, Dupixent would be the first biologic medicine available in the U.S. for these children

* Synthorx, Inc. is now a fully owned subsidiary of Sanofi

Expects to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

- U.S.-based, state of the art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic

- Sutimlimab, an investigational targeted C1s inhibitor, met its primary efficacy endpoint in Phase 3 trial for patients with cold agglutinin disease (CAD)

*Oncology: New data from investigational isatuximab pivotal study for the treatment of relapsed/refractory multiple myeloma

- PRV-031 (teplizumab) Granted Breakthrough Therapy and PRIME Designations -

* Will be available in fall 2020, in time for the 2020-2021 flu season