Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 599

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 599
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 and financial resources to developing its product candidates, organizing and staffing its company, business planning, raising capital, establishing its intellectual property portfolio and performing research and development of its product candidates, signaling and biology, medicinal chemistry and clinical insights to discover and develop novel therapies for the treatment of fibrosis-driven diseases. Through the date of this filing, Tvardi has historically financed its operations principally through the issuance and sale of its preferred stock and convertible debt. As of September 30, 2024, it has received total gross proceeds of $83.4 million from the issuance and sale of its Preferred Stock and convertible debt, which was converted into Preferred Stock in 2018 and 2021. As of September 30, 2024, Tvardi had $9.4 million in cash and cash equivalents. Management has determined that Tvardi’s cash and cash equivalents as of September 30, 2024 will not be sufficient to fund its planned operations beyond one year from the issuance of its financial statements included elsewhere in this proxy statement/prospectus, which raises substantial doubt as to Tvardi’s ability to continue as a going concern. Tvardi has based this estimate on assumptions that may prove to be wrong, and it could exhaust its capital resources sooner than it expects. See the subsection titled “— Liquidity and Capital Resources ” below for further discussion. Even if this Merger is successful, Tvardi will require additional funding in order to finance operations and complete its ongoing and planned clinical trials. Access to such funding on acceptable terms cannot be assured.

Tvardi has incurred net losses since inception. As of September 30, 2024 and December 31, 2023, its accumulated deficit was $79.5 million and $62.8 million, respectively. For the nine months ended September 30, 2024 and 2023, Tvardi reported net losses of $16.7 million and $13.0 million, respectively, and for the years ended December 31, 2023 and 2022, Tvardi reported net losses of $17.3 million and $20.5 million, respectively. Tvardi’s net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of its clinical development activities and other research and development activities. Tvardi expects that its expense and capital requirements will increase substantially in connection with its ongoing activities and for the foreseeable future, particularly if Tvardi, among other things:

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advances