Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 63

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 63
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 has incurred significant operating losses since its inception, and as of September 30,
2025, had an accumulated deficit of $103.2 million. Management has determined that its present capital resources as of September 30,
2025 will not be sufficient to fund its planned operations for at least one year from the issuance date of the unaudited condensed
consolidated financial statements, included elsewhere in this Quarterly Report, which raises substantial doubt as to Tvardi’s ability
to continue as a going concern. In April 2025, as further discussed above, Legacy Tvardi completed its Merger with Cara, through
which it acquired approximately $23.9 million in net assets. Subsequent to the completion of the Merger, Tvardi plans to seek additional
funding through equity offerings or debt financings, credit or loan facilities, and strategic alliances and licensing arrangements. However,
there can be no assurance that such funding will be available to Tvardi, will be obtained on terms favorable to Tvardi, or will provide
Tvardi with sufficient funds to meet its objectives.

Tvardi anticipates that it will continue to incur
significant and potentially increasing expenses for the foreseeable future as it continues to advance its product candidates, expand its
corporate infrastructure, including the costs associated with being a public company following the Merger, further Tvardi’s research
and development initiatives for its product candidates and incur costs associated with the potential commercialization of its product
candidates, if approved. Tvardi is subject to all of the risks typically related to the development of new drug candidates, and may encounter
unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. Tvardi anticipates
that it will need substantial additional funding in connection with its continuing operations. However, Tvardi may be unable to raise
additional funds or enter into such other arrangements when needed on favorable terms or at all. If Tvardi raises additional capital through
public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities
may include liquidation or other preferences that adversely affect its stockholders’ rights. If Tvardi raises additional capital
through debt financing, it may be subject to covenants or other restrictions limiting its ability to engage in specific actions, such
as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could
have a negative impact