Cadrenal Therapeutics (NASDAQ:CVKD) highlighted its lead drug candidate, CAD-1005, and its development plans for heparin-induced thrombocytopenia, or HIT, during a fireside chat at the Lytham Partners Spring 2026 Investor Conference.
James Ferguson, Cadrenal’s chief medical officer, said the company is focused on “advancing novel therapies for life-threatening immune and thrombotic conditions.” Its lead program, CAD-1005, is described by the company as a first-in-class 12-LOX inhibitor intended to treat HIT, a rare but potentially deadly immune-mediated thrombotic disorder that can occur after heparin exposure.
Cadrenal Frames HIT as Rare but Severe
While uncommon, Ferguson described HIT as “incredibly devastating,” citing risks that include strokes, heart attacks, arterial and venous occlusion, amputation and death. In some series, he said mortality has been reported as high as 20%.
“It’s rare, but it’s devastating,” Ferguson said.
Current Treatment Focuses on Anticoagulants
Ferguson said current HIT treatment generally relies on stopping heparin and administering non-heparin anticoagulants, including direct thrombin inhibitors such as argatroban and bivalirudin, as well as DOACs, fondaparinux and other therapies.
However, he said those approaches work downstream by addressing clotting complications after the immune process is already underway.
“The simple fact of the matter is that what we have now is not good enough,” Ferguson said, adding that serious complications still occur despite current anticoagulant use.
CAD-1005 Targets Platelet Activation Pathway
Ferguson said CAD-1005 is designed to inhibit 12-lipoxygenase, or 12-LOX, which he described as part of the signaling process involved in immune-mediated platelet activation. In HIT, he said an immune response to heparin activates platelets, which then release additional factors and drive a “vicious cycle.”
By targeting 12-LOX, Ferguson said CAD-1005 is intended to interrupt the signaling pathway between immune-mediated receptors on platelet surfaces and the platelet activation process.
“You are turning off the immune response that engenders the whole HIT cascade,” he said.
Company Sees Sizable Market Opportunity
Ferguson said Cadrenal estimates that between 240,000 and 280,000 patients in the U.S. each year have at least suspected HIT. He said confirmed cases using the serotonin release assay, or SRA, are likely around 50,000 patients annually in the U.S.
He also said HIT can significantly increase hospital costs due to complications, estimating that once a patient develops HIT, additional hospital costs can range from at least $75,000 to $140,000.
Based on the patient population and costs associated with the condition, Ferguson said Cadrenal estimates the revenue opportunity for CAD-1005 in HIT could be “somewhere north of $1 billion.”
FDA Meeting Points to Single Pivotal Trial
Ferguson said Cadrenal recently completed what he called a “very successful” end-of-phase II meeting with the U.S. Food and Drug Administration. He said the company presented Phase II data that showed “a very encouraging signal” in reducing thrombotic events.
According to Ferguson, the proposed registration path involves a single pivotal study of about 120 SRA-positive patients in a randomized, blinded, placebo-controlled trial conducted in the U.S. and outside the U.S. He said enrollment would likely take 18 to 24 months.
Ferguson said the company and FDA are aligned on the patient population, therapies and endpoints, including a composite endpoint covering multiple thrombotic events, such as venous, arterial, embolic and non-embolic events.
He said there is “a lot of excitement in the clinical community” about the potential for the first new HIT therapy in more than 20 years.
Ferguson also noted that 12-LOX inhibition may have potential in other areas, citing preclinical work in type 1 and type 2 diabetes and obesity, as well as possible opportunities in acute kidney injury. Still, he emphasized that Cadrenal’s current focus is HIT.
“This is an opportunity to treat HIT in ways that have never been possible before,” Ferguson said.
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.
