CAD-1005

PONTE VEDRA, Fla. – October 29, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) is seeking out-licensing or co-development partners for CAD-1005, a 12-LOX inhibitor it describes as Phase 3-ready, after a competitor's late-stage trial in cardiac surgery-associated acute kidney injury (CSA-AKI) was discontinued for lack of efficacy.

Cadrenal extends CAD-1005 from HIT to a $1 billion-plus U.S. CSA-AKI market

The company is consolidating its Cardiac Acute Critical Care franchise around a dual-indication plan. CAD-1005 will be developed for heparin-induced thrombocytopenia (HIT) and for CSA-AKI, which Cadrenal sizes at more than $1 billion in the U.S. It claims first-in-class positioning in CSA-AKI following the competitor's Phase 3 discontinuation. The source does not name the competitor or the failed mechanism.

PONTE VEDRA – October 29, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has launched a structured partnering process for three cardiovascular assets while holding about $4.2 million in cash, enough to fund operations only through the first quarter of 2027.

The company is exploring development, licensing and commercialization deals for CAD-1005, frunexian and tecarfarin. It is pursuing out-licensing, portfolio monetization and commercial co-development rather than funding large late-stage trials on its own. Cadrenal said it will not start a clinical trial unless funding to complete that trial is in place.

Second-quarter net loss narrows to $3.3 million on lower R&D spending

Research and development expenses fell to $0.7 million in the quarter ended June 30, 2026, from $1.1 million a year earlier. General and administrative expenses were $2.6 million, against $2.7 million in the prior-year period.

PONTE VEDRA – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has agreed to raise $3 million in gross proceeds from a single healthcare-focused institutional investor. Warrants could bring in about $5.8 million more if exercised in full for cash.

Cadrenal prices 960,000 shares at $3.125 with two warrant series attached

The private placement covers 960,000 common shares, or pre-funded warrants in lieu, at a combined price of $3.125 per share with accompanying warrants. The deal is priced at-the-market under Nasdaq rules. Each unit carries series C-1 and series C-2 warrants, each series covering up to 960,000 shares at a $3.00 exercise price. H.C. Wainwright & Co. is exclusive placement agent. Closing is expected on or about July 1, 2026, subject to customary conditions.

PARIS – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reported that its 12-lipoxygenase inhibitor CAD-1005 reduced new or worsening thrombotic events by more than 25 percentage points versus placebo in a Phase 2 trial in heparin-induced thrombocytopenia (HIT), with 50% of treated patients affected versus more than 75% on placebo. The data were presented as one of three late-breaking abstracts at the ISTH 2026 Congress in Paris.

Trial is first randomized, blinded, placebo-controlled study in HIT

Principal Investigator Dr. Steven E. McKenzie delivered the oral presentation, which Cadrenal describes as the first randomized, blinded, placebo-controlled trial in HIT patients. CAD-1005 was formerly known as VLX-1005. The study was not sufficiently powered for statistical significance.

Ponte Vedra, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has launched a structured process to secure out-licensing, portfolio monetization or co-development partners for its late-stage cardiovascular assets, after grouping them into a Cardiac Acute Critical Care Franchise.

The company is exploring development, licensing and commercialization deals for CAD-1005, frunexian and tecarfarin. It describes the approach as capital-efficient and says it is shifting to a partnership-driven business model.

PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reached agreement with the FDA on the primary endpoint and placebo-controlled design of its Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The agreement came at a Type D meeting held July 28, 2026.

FDA accepts thrombus-extension definition of worsening HIT

The agency agreed to define worsening HIT as progression of thrombotic events through Day 14 of treatment or hospital discharge. Worsening will also include extension of an existing thrombus into a new vascular segment or bed. Cadrenal said this avoids site-to-site variability from manual size measurements.

The composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.

Ponte Vedra – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) will put CEO Quang X. Pham in front of investors at 10:15 a.m. ET on Tuesday, September 29, 2026, with a webcast presentation at the Lytham Partners Fall 2026 Investor Conference.

Two-day virtual conference includes one-on-one investor meetings

The conference runs virtually on September 29-30, 2026. Management will hold one-on-one meetings throughout the event. Investors can arrange them through Lytham Partners or by registering for the conference. A replay of the webcast will be available after the event.

CAD-1005 holds FDA and EMA designations in heparin-induced thrombocytopenia

Cadrenal describes itself as a late-stage biopharmaceutical company focused on critical care cardiology and orphan cardiovascular conditions. Its pipeline includes CAD-1005, tecarfarin and frunexian.

PONTE VEDRA, Fla. – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has opened a formal strategic process covering its entire four-asset pipeline, with options ranging from asset sales to a full business combination. The Board of Directors initiated the review to maximize value for shareholders, and Tungsten Advisors will act as exclusive strategic financial advisor.

Four programs, from Phase 3-ready to preclinical, are in scope

The review covers CAD-1005, tecarfarin, frunexian and CAD-2000, the company's second-generation 12-LOX platform. Cadrenal says the process builds on ongoing partnering discussions.

Potential transactions include licensing or sale of individual assets, development and commercialization partnerships, portfolio transactions and business combinations.