Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 586

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 586
---
 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;

•

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 and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide, including impacts from global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation and interest rates, uncertainty and liquidity concerns in the broader financial services industry, and a potential recession in the United