Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 128

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 128
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 2025, we reported net income of $4.2 million and net loss of $5.4 million, respectively. For the three and six months ended June 30, 2024, Legacy Tvardi reported net losses of $7.0 million and $11.2 million, respectively. For the years ended December 31, 2024 and 2023, Legacy Tvardi reported net losses of $29.4 million and $17.3 million, respectively. Our net income (loss) may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical development activities and other research and development activities. Although we generated net income for the three months ended June 30, 2025 as a result of the net changes in the fair value of our Convertible Notes, we expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. Losses are expected to continue as we continue to invest in research and development activities. The assessment of our ability to meet our future obligations is inherently judgmental, subjective and susceptible to change. Given the inherent uncertainties in the forecast, we considered both quantitative and qualitative factors that were known or reasonably knowable as of the issuance date of our unaudited condensed financial statements as of and for the three and six months ended June 30, 2025 and concluded that there are conditions present in the aggregate that raise substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources as of June 30, 2025 sooner than we expect. See the subsection titled “— Liquidity and Capital Resources ” below for further discussion.

We will require additional funding in order to finance operations and complete our ongoing and planned clinical trials. Access to such funding on acceptable terms cannot be assured.

We expect that our expense and capital requirements will increase substantially in connection with our ongoing activities and for the foreseeable future, particularly if we, among other things:

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advance TTI-101, TTI-109 and our other product candidates through clinical development and, if successful, later-stage clinical trials;

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discover and develop additional product candidates;

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advance our preclinical development programs into clinical development;

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experience delays or interruptions to preclinical studies, clinical trials, receipt of services from our third-party service providers on whom we rely, or our supply chain;

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seek and maintain regulatory approvals for any product candidates that successfully complete clinical trials;