Radiopharmaceutical developer Navidea Biopharmaceuticals has inked a letter of intent to partner with imaging contract research organization WorldCare Clinical. The company also reported that its accounting firm has again issued an opinion expressing "substantial doubt" over its ability to continue as a "going concern."
Under the deal, WorldCare would serve as Navidea's central imaging services provider after Navidea receives U.S. Food and Drug Administration (FDA) clearance for the use of its technetium-99m tilmanocept radiopharmaceutical in patients with rheumatoid arthritis (RA). The two companies will collaborate to support the full-scale commercialization plan for the RA diagnostic technology.
WorldCare will likely manage the imaging aspects of the upcoming phase IIb and phase III clinical trials, and both firms will work together to develop an optimized workflow in preparation for the commercial launch of the technology for RA indications, Navidea said.
In other news, Navidea's independent public accounting firm has again included a paragraph indicating "substantial doubt" about Navidea's ability to continue as a growing concern in this year's annual Form 10-K report. The same concern was noted in its Form 10-K report for 2018.
Navidea has had a working capital deficiency, has incurred significant losses, and needs to raise additional funds to meet its obligations and sustain operations, according to the auditor.
In its Form 10-K for 2019, Navidea said that it is "working to establish new sources of funding, including collaborations, potential equity investments, and additional grant funding that can augment the balance sheet."
Without additional funding, Navidea management has substantial doubt about the firm's ability to continue as a going concern for at least 12 months after the filing of the Form 10-K.
Navidea said in its March 31 press release that this going concern explanation is required pursuant to New York Stock Exchange (NYSE) American rules and doesn't represent any change or amendment to its financial statements or its annual report.
