|Navidea CEO Mark Pykett|
Navidea ($NAVB) has a lot riding on its diagnostic imaging agent for cancer, but after regulatory delays and a sluggish market uptick, the Ohio company is taking another quarterly loss.
Navidea's second-quarter net loss came in at $10.3 million, about 75% worse than the same period last year, while revenue roughly tripled to $195,000.
In May, the company launched Lymphoseek, a radioactive agent designed to help map lymph nodes in breast cancer and melanoma patients undergoing surgery, but despite positive clinical data and the heft of commercialization partner Cardinal Health, Navidea is yet to see much return on its high-profile tool. In the second quarter, Lymphoseek generated about $128,000 in revenue, about 67% of net sales.
The diagnostic aid finally won FDA approval in March after getting rebuffed 6 months earlier when regulators took issue with a contract manufacturer's work. That delay sent Navidea's stock reeling and cast serious doubts on the tool's marketability, but CEO Mark Pykett said his company remains unrattled, borrowing $25 million from GE Capital in June to help make its case to customers and drive adoption.
"The commercialization plan we are executing with our partner is on target based on key measures of success: repeat and multiple dose ordering, adoption at top-tier medical institutions, formulary placement, excellent product performance, and high customer satisfaction," Pykett said in a statement, adding that Navidea is expecting to expand reimbursement for Lymphoseek in the fourth quarter.
And while it waits for its banner product to take off, Navidea is pushing into Phase III with NAV4694, a beta-amyloid-detecting imaging agent that could help identify the early signs of Alzheimer's. Separately, the company is working to get Lymphoseek approved to identify head and neck cancers, touting positive top-line results from a Phase III trial.
- read Navidea's results