Coverage Initiated: March 2010

Cell Therapeutics (CTIC) has spent $1.4B of shareholder money with nothing to show for it. It has three oncology products in development, with pixantrone failing to win the support of a key FDA advisory panel in March 2010. Opaxio is the new name for Xyotax, a paclitaxel reformulation that failed multiple Phase III trials. Data from a GOG cooperative group study for Opaxio won't be available until well after the company runs out of money. Brostallicin has seen data in Phase II trials, but also will not be available for FDA approval for some time.

In April 2010, the FDA rejected CTI's pixantrone appoval request, asking for a new trial to demonstrate safety and efficacy. CTI has no money to run a new trial. CTI said they would apply for the FDA's Expanded Access program, but investors need to understand CTI will not be allowed to make money on pixantrone under Expanded Access -- in other words, Expanded Access will not add cash to CTI's balance sheet. Finally, it is highly unlikely the EMEA will approve pixantrone after the FDA found errors with the trial data.

Cell Therapeutics does not have enough cash to get through 2010 even with the March 2010 financing. It has a $40M debt due July 1 and not enough funds to cover it and its substantial overhead, much less advance any products to create value for shareholders.

A complete listing of our research on Cell Therapeutics is available by clicking here.