Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 89

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 89
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5; EU submission is also anticipated during the first half of 2025. Results from the GEMINI 1 and 2 Phase 3 studies evaluating tolebrutinib did not meet the primary endpoint of reducing annualized relapse rate, compared to Aubagio, a standard of care treatment, in people with relapsing MS (RMS). However, analysis of the key secondary endpoint of pooled 6-month CDW data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES. A Phase 3 study (PERSEUS) is currently ongoing to determine the efficacy of tolebrutinib in delaying disability progression in primary progressive multiple sclerosis (PPMS); results are expected in the second half of 2025 with subsequent submissions anticipated in 2026. frexalimab (SAR441344) is a monoclonal antibody targeting CD40L (see “— a) Immunology & Inflammation” above) that has the potential to address both acute and chronic neuroinflammation in MS through its unique upstream mechanism of action. In 2024, new efficacy and safety data at 18 months from the Phase 2 study for the treatment of RMS demonstrated sustained reduction of disease activity, with stable clinical surrogate endpoints, and good tolerance, with no new safety signals. These results support the ongoing Phase 3 clinical program, with two studies in RMS and nrSPMS. riliprubart (SAR445088) is a complement C1s inhibitor (see details in “— a) Immunology & Inflammation” above) that is being assessed in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), for which orphan drug designation was granted in the US and in Europe. In 2024, new data from a Phase 2 study showed encouraging efficacy and safety for patients with CIDP. In part A results at 24 weeks, riliprubart showed promising disease-controlling benefits, with most study patients improving or remaining stable, including those who experienced failure or inadequate response to standard-of-care treatment

| SANOFIFORM 20-F2024 | 37 |

| PART I                             |
| ITEM 4. Information on the Company |

(SOC-refractory), and those having residual disability despite treatment with SOC (IVIg-treated). In part B, after approximately one year of treatment, riliprubart continued to show promising disease-controlling benefits across