Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 53

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 53
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 financial statements as prepaid or accrued research and development expenses.

The majority of Tvardi’s clinical spending
in the three and nine months ended September 30, 2025 and Legacy Tvardi’s clinical spending in the three and nine months
ended September 30, 2024 was on TTI-101, for which certain direct research and development costs are tracked by clinical trial. Spending
for the development of TTI-109 began in 2023 and costs incurred for TTI-109 related to chemistry, manufacturing and control (CMC) and
clinical operations for the three and nine months ended September 30, 2025, and CMC and pre-clinical operations for the three and nine
months ended September 30, 2024.

Tvardi expects its research and development expenses
to increase substantially for the foreseeable future as it continues to invest in the development of TTI-101 and TTI-109, support its
ongoing preclinical programs and discover any new product candidates, as well as increase its headcount. In particular, clinical development,
as opposed to preclinical development, generally has higher development costs, primarily due to the increased size and duration of later-stage
clinical trials. Moreover, the costs associated with Tvardi’s clinical activities, which are managed by its CROs, and Contract Development
and Manufacturing Organizations (CDMOs), to manufacture materials for Tvardi’s product candidates and future commercial products,
are much more costly as compared to early-stage preclinical development. Tvardi cannot determine with certainty the timing of initiation,
the duration or the completion costs of current or future preclinical studies and clinical trials of its current and future candidates
due to the inherently unpredictable nature of preclinical and clinical development. Preclinical and clinical development timelines, the
probability of success and development costs can differ materially from expectations. Tvardi anticipates that it will make determinations
as to which therapeutic candidates to pursue and how much funding to direct to each therapeutic candidate on an ongoing basis in response
to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and Tvardi’s ongoing assessments
as to each therapeutic candidate’s commercial potential. Tvardi will need substantial additional capital in the future to support
these efforts. In addition, Tvardi cannot forecast which therapeutic candidates may be subject to future collaborations, when such arrangements
will be secured, if at all, and to what degree such arrangements would affect its development plans and capital requirements.