Cadrenal Therapeutics Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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Item 8.01. Other Events.
On February 24, 2026, Cadrenal Therapeutics, Inc. (the “Company”) issued a press release announcing results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in patients with heparin-induced thrombocytopenia (“HIT”), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant.
This randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigation new drug sponsor, Veralox Therapeutics, Inc. (“Verolox”) selected platelet count recovery rate as the primary endpoint. Their trial did not meet its primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to the Company. Although CAD-1005 did not significantly affect the recovery rate of platelet count, CAD-1005-treated patients had fewer thrombotic events.
Highlights:
| ● | Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical efficacy. |
| ● | Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events. |
A copy of the press release is furnished herewith as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are furnished with this Current Report on Form 8-K:
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release, issued by Cadrenal Therapeutics, Inc. on February 24, 2026 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: February 24, 2026 | CADRENAL THERAPEUTICS, INC. | |
| By: | /s/ Quang X. Pham | |
| Name: | Quang X. Pham | |
| Title: | Chairman and Chief Executive Officer | |
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