Item 8.01 Other Events. As previously reported, on May 1, 2026, Tvardi Therapeutics, Inc. (the “Company”) entered into a Capital on Demand™ Sales Agreement (the “ Sales Agreement ”) with JonesTrading Institutional Services LLC (“ Jones ”), pursuant to which the Company may offer and sell from time to time, at its option through Jones, shares of the Company’s common stock, $0.001 par value per share (the “Shares”).…
Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The Company is conducting clinical trials with TTI-109 in healthy volunteers and TTI-101 in hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter).
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Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
As previously reported, on May 1, 2026, Tvardi
Therapeutics, Inc. (the “Company”) entered into a Capital on Demand™ Sales
Agreement (the “ Sales Agreement ”) with JonesTrading Institutional Services LLC (“ Jones ”), pursuant to which the Company may offer and sell from time to time, at its option through Jones, shares of the Company’s
common stock, $0.001 par value per share (the “Shares”). The Shares were
issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-295496), which became effective on May 12,
2026, and the sales agreement prospectus included therein (the “Sales Agreement Prospectus”) registering the
offer and sale of Shares in an aggregate offering amount of up to $12.5 million, in each case filed with the Securities and Exchange Commission.
On July 17, 2026, the Company filed a prospectus
supplement (the “Prospectus Supplement”) amending and supplementing the Sales Agreement Prospectus to reflect
an increase in the Company’s existing at-the-market offering program to allow for the issuance of up to $9,689,765 in shares of
the Company’s common stock, in addition to any amounts previously sold by the Company.
The Company is subject to General Instruction I.B.6
of Form S-3, often referred to as the “baby shelf” rule, which limits the amounts that the Company may sell under the registration
statement of which the Prospectus Supplement forms a part. The aggregate market value of the Company’s common stock held by non-affiliates
pursuant to General Instruction I.B.6 of Form S-3 is $62,208,945, which was calculated based on 12,441,789 shares of the Company’s outstanding common stock held by non-affiliates on July 16, 2026, at a price of $5.00 per share, the closing
price of the common stock on July 8, 2026. During the prior twelve-calendar month period that ends on and includes the date of the Prospectus
Supplement, the Company sold an aggregate of 3,110,769 shares of common stock for an aggregate offering price of approximately $11.0 million
in gross proceeds under the Sales Agreement Prospectus. No additional common stock will be sold under the Sales Agreement Prospectus following
the date of the Prospectus Supplement.
A copy of the legal opinion of Cooley LLP relating
to the validity of the additional Shares of common stock being offered pursuant to the Sales Agreement and the Prospectus Supplement is
filed as Exhibit 5.1 to this Current Report on Form 8-K.
This Current Report on Form 8-K shall not constitute
an offer to sell or the solicitation of an offer to buy the Shares discussed herein, nor shall there be any offer, solicitation, or sale
of the Shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or other jurisdiction.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
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5.1 Opinion of Cooley LLP.
23.1 Consent of Cooley LLP (contained in Exhibit 5.1).
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).