Cadrenal Therapeutics, a heart-focused biotech that recently reached an agreement with the FDA on the design of a pivotal trial for its lead candidate, is now instead looking to offload its pipeline or potentially the entire company.
The Florida-based biotech’s board is weighing options that could include licensing or selling drug candidates, partnering with other companies, or pursuing a business combination or other transaction, Cadrenal announced today.
“Our pipeline has reached critical clinical and regulatory maturity,” CEO Quang Pham said in the release. “Having received strong interest from potential strategic partners, we believe a formal strategic process provides the appropriate framework to evaluate opportunities across our portfolio and determine the paths that can maximize value for our shareholders while advancing these programs for patients.”
Cadrenal’s stock has slid steadily downward throughout the year, falling from $7.22 per share at the start of January to around $1 per share. The company did not respond to a request for further comment from Fierce.
At the end of August, Cadrenal reported that a Type D meeting with the FDA had ended with alignment on the design of a phase 3 trial for CAD-1005, a 12-lipoxygenase (12-LOX) inhibitor in development for heparin-induced thrombocytopenia (HIT). HIT is a rare potential complication of the blood thinner heparin, in which an abnormal immune reaction causes the body to produce too many blood clots.
HIT is a medical emergency that is often treated with non-heparin blood thinners to reduce clotting. Cadrenal’s approach with CAD-1005 is designed to be the first to address the underlying biology of the condition, and the company has projected a $2 billion peak annual revenue opportunity for the potentially first-in-class drug.
Aside from CAD-1005, Cadrenal’s pipeline also includes a phase 3-ready vitamin K antagonist called tecarfarin, the factor XIa inhibitor frunexian and a second-generation 12-LOX program called CAD-2000.
The biotech first announced a formal partnering process for several of its assets in July, but stopped short at the time of saying it was weighing options such as a business combination or broader corporate transaction.
Cadrenal’s fate echoes that of the CAR-T biotech Caribou Biosciences, which just yesterday announced it was halting pipeline development and laying off staff while reviewing strategic options, despite also aligning with the FDA on a pivotal trial design for its lead candidate.