Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 425

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 425
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 Merger and Asset Disposition will be successfully consummated. There can be no assurance that any transaction, including the Merger and the Asset Disposition. will be completed on terms favorable to Cara and its stockholders. If these transactions are unsuccessful, the Cara Board may decide to pursue a dissolution and liquidation of Cara. Corporate History Cara was incorporated and commenced operations in 2004, and its primary activities to date have been organizing and staffing the company, developing its lead product and product candidates, including conducting preclinical studies and clinical trials of difelikefalin-based product candidates and raising capital. To date, Cara has financed its operations primarily through sales of its equity and debt securities, sales of its royalties from ex-U.S. sales of its commercial product, and payments from license agreements. Cara’s Product Portfolio

| Product                                    | ​ | ​ | Indication                  | ​ | ​ | Status                                                                                        | ​ | ​ | Next Milestone | ​ | ​ | CommercializationRights                            | ​ |
| KORSUVA (difelikefalin) injection/Kapruvia | ​ | ​ | Pruritus CKD – Hemodialysis | ​ | ​ | Approved in the U.S. (08/2021)                                                                
 Approved in EU incl. UK (04/2022)                                                             
 Approved in Japan (09/2023)                                                                   
 Other approvals: Switzerland, Canada, Singapore, Australia, Kuwait, Israel, UAE, Saudi Arabia | ​ | ​ | ​              | ​ | ​ | CSL Vifor (Worldwide excl. Japan and South Korea)* 
 Maruishi (Japan)                                   
 CKDP (South Korea)                                 | ​ |

* Cara is party to two collaborations for the commercialization of KORSUVA (difelikefalin) injection/ Kapruvia with a joint venture between CSL Vifor and Fresenius Medical Care. In this section, unless the context otherwise requires, “CSL Vifor” refers to CSL Vifor and its affiliated entities, including, where applicable, the joint venture. KORSUVA (difelikefalin) injection — Cara’s Commercial Stage Product Overview Cara has out-licensed to CSL Vifor the commercialization of KORSUVA injection/Kapruvia in dialysis patients with moderate-to-severe pruritus associated with chronic kidney disease, or advanced CKD-aP, worldwide, excluding Japan (licensed to Maruishi/sub-licensee Kissei