Cadrenal Therapeutics Highlights CAD-1005 In-License, Maps Phase III Path for HIT at Investor Forum

Cadrenal Therapeutics (NASDAQ:CVKD) highlighted the recent in-licensing of CAD-1005 and outlined its plans to advance the asset into a Phase III program targeting heparin-induced thrombocytopenia (HIT) during a presentation at the Life Science Investor Forum moderated by Zacks Small Cap Research senior equity analyst David Bautz.

Company outlines CAD-1005 background and HIT focus

Chairman and CEO Quang Pham said CAD-1005 was previously known as VLX-1005, Veralox Therapeutics’ lead program, and that Cadrenal acquired the asset along with a second, oral 12-lipoxygenase (12-LOX) inhibitor in preclinical development. CAD-1005 is an intravenous (IV) acute-care therapy that is Phase II complete and is being developed for patients with suspected or confirmed HIT, a rare immune reaction to heparin that can cause platelet counts to drop and paradoxically trigger blood clots in critically ill hospital patients.

Pham described HIT as a serious and potentially deadly condition that can emerge in settings such as cardiac surgery where heparin is commonly used. He emphasized the unmet need, noting that HIT has been “without a new drug for decades,” and pointed to regulatory designations supporting development. Pham said CAD-1005 has Orphan Drug status and Fast Track designation from the U.S. Food and Drug Administration (FDA), and also has orphan status in the European Union.

Mechanism: targeting platelet activation via 12-LOX inhibition

Pham contrasted CAD-1005’s approach with existing hospital therapies used after HIT develops. He said patients are typically treated with argatroban or bivalirudin, which he characterized as addressing clotting but not the underlying platelet activation associated with HIT. CAD-1005, he said, inhibits 12-LOX and is designed to target platelet activation without increasing bleeding risk.

He also noted that multiple companies have explored 12-LOX inhibition over the past decade for various indications, but said VLX-1005/CAD-1005 is the only program that has advanced into clinical testing.

Phase II results: thrombotic event signal and safety profile

Discussing the Phase II study, Pham said the trial was not designed to achieve statistical significance, but that the company saw a “very promising” signal in reduced thrombotic events in the CAD-1005 arm. He added that the study’s original primary endpoint was platelet count recovery rate, based on prevailing views in the HIT literature at the time, and said platelet recovery was similar between CAD-1005 and the placebo arm when used on a background of argatroban or bivalirudin.

On safety, Pham said CAD-1005 showed no additional bleeding in two Phase I trials and in Phase II, which he framed as an important consideration for anticoagulation-related therapies.

Phase III planning and FDA end-of-Phase II meeting

Pham said Cadrenal has requested and received an end-of-Phase II meeting with the FDA to review the Phase II data and align on the Phase III path forward. He said the company intends to propose a Phase III program with reduction in thrombotic events as the primary endpoint, powered for superiority. The planned treatment duration is seven to 14 days with twice-daily dosing, along with a 30-day follow-up.

He said the trial would include patients receiving background hospital anticoagulation such as argatroban or bivalirudin, and that the company expects to share more details on the protocol after discussions with the agency. Pham also said site selection and appropriate inclusion/exclusion criteria would be key factors in trial execution, particularly selecting academic centers that see HIT patients and can enroll them.

Funding needs and longer-term opportunities beyond HIT

On financing, Pham estimated a Phase III trial duration of about 24 months and projected trial costs of roughly $35 million to $40 million, while noting there could be additional expenses including chemistry, manufacturing, and controls (CMC) and potential additional Phase I requirements.

Pham also discussed potential longer-term opportunities for the 12-LOX platform beyond HIT, referencing preclinical research suggesting activity in type 1 diabetes, type 2 diabetes, and inflammatory consequences of obesity. He said that work has been published but not broadly publicized, and that Cadrenal plans to share those findings to support potential partnering discussions, while maintaining an operational and financing focus on the HIT program.

Looking ahead, Pham said success for the company would include filing an NDA under Fast Track and having CAD-1005 approved within three years for the IV HIT indication, while also advancing an oral series, CAD-2000, toward later-stage development for larger chronic indications—potentially through partnerships or out-licensing.

About Cadrenal Therapeutics (NASDAQ:CVKD)

Cadrenal Therapeutics, Inc operates as a clinical development biopharmaceutical company. The company focuses on developing Tecarfarin, a novel oral and reversible anticoagulant to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions requiring chronic anticoagulation, such as patients with left ventricular assist devices, end-stage kidney disease, atrial fibrillation, and thrombotic anti-phospholipid syndrome. Cadrenal Therapeutics, Inc was incorporated in 2022 and is headquartered in Ponte Vedra, Florida.