Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 560

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 560
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 the efforts that will be necessary to complete the development of any future product candidate, should Cara resume the development of future product candidates. Cara is also unable to predict when, if ever, Cara will generate any further material net cash inflows from difelikefalin or any other future product candidate. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainty of:

| ● | successful enrollment in, and completion of clinical trials, should Cara resume the development of any future product candidates; |

| ● | receipt of marketing approvals from applicable regulatory authorities, should Cara resume the development of any future product candidates; |

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| ● | establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers, should Cara resume the development of any future product candidates; |

| ● | obtaining and maintaining patent and trade secret protection and regulatory exclusivity for difelikefalin or any future product candidate; |

| ● | launching commercial sales of the products, if and when approved, whether alone or in collaboration with others, should Cara resume the development of any future product candidates; |

| ● | achieving meaningful penetration in the markets which Cara seeks to serve, should Cara resume the development of any future product candidates; and |

| ● | obtaining adequate coverage or reimbursement by third parties, such as commercial payers and government healthcare programs, including Medicare and Medicaid, should Cara resume the development of any future product candidates. |

A change in the outcome of any of these variables with respect to the development of oral difelikefalin or any of Cara’s future product candidates, should Cara resume the development of oral difelikefalin or any future product candidates, would significantly change the costs and timing associated with the development of that product candidate. Further, the timing of any of the above may be impacted by global economic conditions and significant global events, should Cara resume the development of oral difelikefalin or any future product candidate, introducing additional uncertainty. Cara currently is exploring strategic alternatives to maximize shareholder value, and in December 2024 announced entrance into the Merger Agreement with Tvardi. If the Merger is not consummated, should Cara resume development of its product candidate or any future product candidates, Cara would require additional capital beyond its current balances of cash and cash equivalents and available-for-sale marketable securities and anticipated amounts as described above, and this additional capital may not be available when needed, on reasonable terms, or at all. Cara’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions